Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on market surveillance of products and amending Council Directives 89/686/EEC and 93/15/EEC, and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 1999/5/EC, 2000/9/EC, 2000/14/EC, 2001/95/EC, 2004/108/EC, 2006/42/EC, 2006/95/EC, 2007/23/EC, 2008/57/EC, 2009/48/EC, 2009/105/EC, 2009/142/EC, 2011/65/EU, Regulation (EU) No 305/2011, Regulation (EC) No 764/2008 and Regulation (EC) No 765/2008 of the European Parliament and of the Council
Date: 2013-02-13
Institutions: European Commission
Subjects: customs inspection, economic growth, environmental protection, exchange of information, market supervision, marketing standard, product safety, single market

EUROPEAN 
COMMISSION 

Brussels, 13.2.2013  
COM(2013) 75 final 

2013/0048 (COD) 

PRODUCT SAFETY AND MARKET SURVEILLANCE PACKAGE 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on market surveillance of products and amending Council Directives 89/686/EEC and 
93/15/EEC, and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 1999/5/EC, 
2000/9/EC, 2000/14/EC, 2001/95/EC, 2004/108/EC, 2006/42/EC, 2006/95/EC, 
2007/23/EC, 2008/57/EC, 2009/48/EC, 2009/105/EC, 2009/142/EC, 2011/65/EU, 
Regulation (EU) No 305/2011, Regulation (EC) No 764/2008 and Regulation (EC) No 
765/2008 of the European Parliament and of the Council 

(Text with EEA relevance) 

{SWD(2013) 33 final} 
{SWD(2013) 34 final}

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

The European Union needs a Single Market that is operating at maximum efficiency 
to  help  get  its  economy  back  on  track.  The  free  movement  of  goods  is  the  most 
developed  and  best  established  of  the  four  fundamental  freedoms  laid  down  in  the 
Treaty on the Functioning of the European Union (TFEU) that make up the internal 
market.  But  it  would  be  complacent  to  believe  that  the  job  is  done.  True, 
harmonisation  rules1  have  now  been  put  in  place  for  most  products  and  the  free 
movement  provisions  of  the  TFEU,  supplemented  by  the  mutual  recognition 
principle, are sufficient for the rest. But even a good legislative framework is only as 
effective as those using it allow it to be. Alongside responsible economic operators, 
prepared to adapt their methods and incur the costs necessary to comply with the law, 
there will  always be those traders who  cut corners or deliberately flout the rules to 
‘make a fast buck’ or gain a competitive edge. 

These sharp practices not only skew the single market against the type of trader we 
wish  to  encourage,  damaging  its  effectiveness  and  causing  detriment  to  consumers 
and business, they also threaten the public interests that our legislation is designed to 
protect. In addition to financial burden, the European citizen is exposed to potentially 
dangerous  products.  The  environment  is  put  at  risk.  Public  security  may  even  be 
undermined. 

Market  surveillance  is  the  answer.  If  high  quality  legislation,  based  on  a  sound 
evaluation of market needs is one side of the coin, market surveillance is the other. It 
should enable unsafe or otherwise harmful products to be identified and kept or taken 
off the market and unscrupulous or even criminal operators punished. It should also 
act as a powerful deterrent. 

Market  surveillance  has  not  kept  pace  with  developments  in  the  Union  regulatory 
framework. In a single market in which products circulate freely throughout 27 (and 
in some sectors up to 32)2 national territories, market surveillance needs to be highly 
coordinated  and  capable  of  reacting  rapidly  over  a  huge  area.  Advances  have  been 
made  over  the  last  decade,  in  particular  with  the  implementation  of  Directive 
2001/95/EC  of  the  European  Parliament  and  of  the  Council  on  general  product 
safety3  (the  "General  Product  Safety  Directive"  or  simply  GPSD)  which  had  to  be 
transposed by 2004 and with the coming into application in 2010 of Regulation (EC) 
765/2008  setting  out  the  requirements  for  accreditation  and  market  surveillance4. 
However, overlap of market surveillance rules and obligations of economic operators 
laid  down  in  various  pieces  of  Union  legislation  (the  GPSD,  the  Regulation  (EC) 
765/2008  and  sector-specific  Union  harmonisation  legislation)  has  led  to  confusion 
on  the  part  of  both  economic  operators  and  national  authorities  and  has  seriously 
hampered the effectiveness of market surveillance activity in the Union. 

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3 
4 

Harmonisation rules seek to achieve free movement by protecting at a high level public interests that 
Member States might otherwise invoke to justify imposing restrictions on trade in products. 
In accordance with international agreements of the EU with the EFTA countries and Turkey. 
OJ L 11, 15.1.2002, p. 4. 
OJ L 218, 13.8.2008, p. 30. 

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This proposal aims at clarifying the regulatory framework for market surveillance in 
the  field  of  non-food  products.  It  merges  the  rules  on  market  surveillance  of  the 
GPSD,  Regulation  (EC)  765/2008  and  many  sector-specific  pieces  of  Union 
harmonisation  legislation  into  a  single  legal  instrument  that  applies  horizontally 
across all sectors. 

Market  surveillance  action  by  national  authorities  has  important  implications  for 
small  and  medium-sized  enterprises.  Consequently,  their  situation  should  be  taken 
into  account  particularly  in  relation  to  action  that  could  impose  additional 
administrative burdens. 

The proposal is part of the "Product Safety and Market Surveillance Package" which 
also includes a proposal for a regulation on consumer product safety (replacing the 
GPSD)  and  a  multi-annual  action  plan  for  market  surveillance  covering  the  period 
2013-2015.  After  the  Single  Market  Act  (2011)5  had  identified  the  revision  of  the 
GPSD  and  the  drawing  up  of  a  multi-annual action  plan  for  market  surveillance  as 
initiatives that will contribute to boosting growth and creating jobs, the Commission 
added  this  proposal  for  a  single  market  surveillance  regulation  to  the  other  two 
initiatives in response to calls from the European Parliament and from stakeholders 
in industry and public administrations. The Single Market Act II6, adopted in 2012, 
confirms the "Product Safety and Market Surveillance Package" as a key action "to 
improve  the  safety  of  products  circulating  in  the  EU  through  better  coherence  and 
enforcement of product safety and market surveillance rules". 

2. 

RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND 
IMPACT ASSESSMENTS 

From  2009  to  2011,  the  Commission  held  extensive  public  consultations  on  the 
revision  of  the  GPSD  (for  more  details  see  the  Proposal  for  a  Consumer  Product 
Safety Regulation). One of the main substantive areas related to the improvement of 
market  surveillance  cooperation  and  coordination,  including  the  functioning  of 
RAPEX.  

One  of  the  outcomes  of  the  public  consultation  process  and  the  dialogue  with 
interested  parties  was  to  transfer  the  market  surveillance  rules  from  the  current 
GPSD  into  a  new  standalone  Market  Surveillance  Regulation  to  be  developed  and 
adopted hand in hand with the proposal for the revision of the GPSD.  

The  impact  assessment  prepared  by  the  Commission  thus  covers  aspects  related  to 
both the GPSD revision and this proposal.  

The  Commission's  Impact  Assessment  Board  delivered  a  favourable  opinion  in 
September 2012. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

Main elements 

5 
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COM(2011)206 final. 
COM(2012)573 final. 

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The  overarching  objective  of  this  new  regulation  is  to  simplify  the  Union  market 
surveillance  framework  fundamentally  so  that  it  works  better  for  its  main  users: 
market surveillance authorities and economic operators. At present, different product 
evaluation requirements and procedures apply depending on the category of product 
involved. Market surveillance authorities should be able to do their job of evaluating 
the risk presented by  products  without being hindered by unnecessary complexities 
and to share the results of their work efficiently.  

The new Regulation will get rid of overlaps, close gaps, reduce the need to categorise 
products  to  a  minimum  and  assimilate  as  far  as  possible  the  rules  and  procedures 
applicable  to  all  products.  This  will  result  in  a  more  even  application  of  market 
surveillance  rules  across  the  Member  States,  providing  better  protection  for 
consumers and other users, more uniform trading conditions for economic operators, 
reduced  administrative  burdens  and  enhanced  information-  and  work-sharing 
between market surveillance authorities. This is particularly important in the context 
of the economic crisis and responds to the need to make the internal market for goods 
more efficient and competitive. 

• 

Reducing  the  number  of  pieces  of 
surveillance rules 

legislation  containing  market 

At first sight, this might seem to be a rather cosmetic objective but the current set of 
market  surveillance  rules  is  spread  across  the  GPSD,  Regulation  765/2008  and  a 
range  of  sector-specific  legislation  (which  is  increasingly  based  on  the  reference 
provisions  of  Decision  768/2008).  This  ‘3-tier’  system  causes  problems  for  market 
surveillance authorities and economic operators alike and was expressly targeted for 
criticism by the European Parliament. The new Regulation would produce a one tier 
system in which all of those rules are brought together in a single instrument. It may 
be  complemented  by  sector-specific  rules  laid  down  in  the  relevant  Union 
harmonisation legislation.  

• 

Eliminating overlaps in the current system 

Regulation 765/2008 and sector-specific legislation apply to all harmonised products 
regardless  whether  they  are  intended  (or  likely)  to  be  used  by  consumers  or 
professionals.  The  GPSD  applies  to  all  consumer  products  regardless  whether  they 
are  non-harmonised  or  harmonised.  This  obviously  creates  overlaps  in  relation  to 
harmonised products intended or likely to be used by consumers. The current system 
tries  to  deal  with  this  by  means  of  complicated  lex  specialis  provisions  but  this  is 
universally regarded as unsatisfactory.  

The new market surveillance Regulation would dispense with the distinction between 
consumer and professional products for market surveillance purposes. It would also 
avoid  making  a  distinction  between  harmonised  products  and  non-harmonised 
products except where this is unavoidable in applying certain specific provisions. To 
the greatest extent possible the applicable rules are the same for all products. 

• 

Dovetailing the RAPEX and Union evaluation procedures 

At present, two separate procedures operate, sometimes in parallel, which require the 
Member  States  to  notify  to  the  Commission  and  the  other  Member  States  certain 

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market surveillance action taken at national level. This is an especially problematic 
aspect  of  the  overlapping  categories  of  products  mentioned  above.  Under  the  new 
Regulation the two procedures become a single procedural flow with certain events 
triggering  a  single  notification  to  the  other  Member  States  and  the  Commission 
(made  using  either  the  proven  RAPEX  rapid  alert  system  or  the  Information  and 
Communication  System  for  Market  Surveillance  in  accordance  with  the  distinction 
made in this Regulation).  

In  the  case  of  products  which  are  subject  to  sector-specific  Union  harmonisation 
legislation, in the event of disagreement among Member States about action taken by 
one of their number, the proposal would empower the Commission to decide whether 
the measures taken by the original notifying Member State are reasonable, necessary 
and proportionate and should be followed by all Member States in the interests of the 
single  market.  In  this  way,  the  market  surveillance  process  may  be  brought  to  a 
definite close. This is not extended to products not subject to sector-specific Union 
harmonisation  legislation  as  such  a  decision  cannot  be  taken  in  the  absence  of  the 
essential requirements for products that are laid down in that legislation. 

In urgent situations the Commission is empowered to adopt temporary or permanent 
measures  requiring  consistent  action  across  the  EU  against  products  presenting  a 
serious  risk  where  the  risk  cannot  be  satisfactorily  addressed  by  one  or  several 
individual Member States.  

•  Making the legislation more accessible and user-friendly 

Apart  from  being  spread  across  three  tiers  of  EU  legislation  (and  in  the  case  of 
directives,  also  in  national  implementing  measures),  current  market  surveillance 
provisions  are  not  based  around  a  chronological  flow  of  events  -  from  the 
identification by market surveillance authorities of a product that may present a risk, 
through  risk  assessment,  involvement  of  the  economic  operators,  action  by  the 
national  authorities,  notification  to  the  other  Member  States,  up  to  possible  action 
across the Union by all Member States and, where necessary, evaluation and decision 
by  the  Commission  at  Union  level.  Instead,  market  surveillance  authorities  and 
economic operators must hunt around in the legislation for the provisions that affect 
them directly.  

The new Regulation sets out the whole process of a market surveillance exercise in a 
chronological,  sequential  manner.  It  presents  a  chain  of  events,  incorporating 
relevant provisions on natural justice aspects, publication of information, notification 
etc.  at  each  stage  of  the  procedure.  This  approach  substantially  improves  the 
accessibility and user-friendliness of the legislation, and hence its effectiveness. 

Legal basis 

The proposal is based on Articles 33, 114 and 207 of the Treaty on the Functioning 
of the European Union. 

Subsidiarity 

Market  surveillance  is  an  activity  which  is  carried  out  by  the  authorities  of  the 
Member States of the Union. This will not change. However, in order to be effective, 
the  market  surveillance  effort  must  be  uniform  across  the  Union.  If  market 

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surveillance is ‘softer’ in some parts of the Union than others, weak spots are created 
which threaten the public interest and create unfair trading conditions. Furthermore, 
much  of  the  risk  presented  by  products  to  the  various  public  interests  that  Union 
legislation  tries  to  protect  derives  from  products  entering  the  Union  from  third 
countries. There must be effective market surveillance along the entire length of the 
Union’s external borders. 

There is therefore a need for Union legislation which creates uniform obligations in 
relation  to  the  activities  to  be  carried  out,  the  resources  to  be  attributed  and  the 
powers  and  duties  of  market  surveillance  authorities.  Equally,  there  must  be  an 
obligation  to  cooperate  and  to  coordinate  market  surveillance  and  mechanisms  and 
tools must be established to make possible and facilitate these endeavours. Penalties, 
financing and reporting also all need to be addressed at Union level. 

Proportionality 

In  accordance  with  the  principle  of  proportionality,  the  proposed  modifications  do 
not  go  beyond  what  is  necessary  to  achieve  the  objectives  set.  The  modifications 
introduced  by  the  Regulation  do  not  impose  unnecessary  burdens  or  costs  on 
industry,  having  particular  regard  to  small  and  medium-sized  enterprises,  or 
administrations.  Many  modifications  to  the  existing  legislative  framework  relate  to 
improving 
introducing  significant  new 
requirements with cost implication. Where a modification has an impact on burdens 
or  costs,  the  impact  analysis  indicated  that  it  represents  the  most  proportionate 
response to the problem identified.  

its  clarity  and  workability  without 

4. 

BUDGETARY IMPLICATION  

The  budgetary  implications  are  already  envisaged  in  existing  or  proposed 
programmes and respect the Commission proposal for the new multiannual financial 
framework.  This  initiative  will  be  financed  through  redeployment  of  existing 
resources. The details are set out in the financial statement attached to this proposal. 

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2013/0048 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on market surveillance of products and amending Council Directives 89/686/EEC and 
93/15/EEC, and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 1999/5/EC, 
2000/9/EC, 2000/14/EC, 2001/95/EC, 2004/108/EC, 2006/42/EC, 2006/95/EC, 
2007/23/EC, 2008/57/EC, 2009/48/EC, 2009/105/EC, 2009/142/EC, 2011/65/EU, 
Regulation (EU) No 305/2011, Regulation (EC) No 764/2008 and Regulation (EC) No 
765/2008 of the European Parliament and of the Council 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Articles 33, 114 and 207 thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national Parliaments, 

Having regard to the opinion of the European Economic and Social Committee7, 

After consulting the European Data Protection Supervisor, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

In order to guarantee the free movement of products within the Union, it is necessary 
to  ensure  that  they  fulfil  requirements  providing  a  high  level  of  protection  of  public 
interests  such  as  health  and  safety  in  general,  health  and  safety  in  the  workplace, 
protection  of  consumers,  protection  of  the  environment  and  public  security.  Robust 
enforcement  of  these  requirements  is  essential  to  the  proper  protection  of  these 
interests  and  to  create  the  conditions  in  which  fair  competition  in  the  Union  goods 
market  can  thrive.  Rules  are  therefore  necessary  on  market  surveillance  and  on 
controls of products entering the Union from third countries. 

(2)  Market  surveillance  activities  covered  by  this  Regulation  should  not  be  directed 
exclusively towards the protection of health and safety but should also be applicable to 

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OJ C , , p. . 

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(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

the enforcement of Union legislation which seeks to safeguard other public interests, 
for  example,  by  means  of  regulating  the  accuracy  of  measurement,  electromagnetic 
compatibility and energy efficiency.  

It is necessary to establish an overall framework of rules and principles in relation to 
market  surveillance  which  should  not  affect  the  substantive  rules  of  existing  Union 
legislation  designed  to  protect  public  interests  such  as  health  and  safety,  consumer 
protection  and  the  protection  of  the  environment,  but  should  aim  at  enhancing  their 
operation. 

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 
2008 setting out the requirements for accreditation and market surveillance relating to 
the  marketing  of  products8  was  adopted  to  establish  a  framework  for  market 
surveillance to complement and strengthen existing provisions in Union harmonisation 
legislation relating to market surveillance and the enforcement of such provisions.  

For  the  purpose  of  ensuring  the  equivalent  and  consistent  enforcement  of  Union 
harmonisation  legislation,  Regulation  (EC)  No  765/2008  introduced  a  Union  market 
surveillance  framework,  defining  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. 

Directive 2001/95/EC of the European Parliament and of the Council of 3 December 
2001  on  general  product  safety9  established  rules  to  ensure  the  safety  of  products 
intended  for  or  likely  to  be  used  by  consumers.  Regulation  (EC)  No  765/2008 
maintained the possibility for market surveillance authorities to take the more specific 
measures available to them under that Directive. 

In  its  Resolution  of  8  March  2011  on  the  revision  of  the  General  Product  Safety 
Directive  and  market  surveillance10  the  European  Parliament  states  that  having  one 
single regulation is the only way to have one single market surveillance system for all 
products and therefore urges the Commission to establish a single market surveillance 
system  for  all  products,  based  on  one  act  covering  both  Directive  2001/95/EC  and 
Regulation (EC) No 765/2008. 

This  Regulation  should  therefore  integrate  the  provisions  of  Regulation  765/2008, 
Directive  2001/95/EC  and  several  sector-specific  acts  of  Union  harmonisation 
legislation  relating  to  market  surveillance  into  a  single  regulation  which  covers 
products  in  both  the  harmonised  and  non-harmonised  areas  of  the  Union  legislation, 
regardless whether they are intended for use, or are likely to be used, by consumers or 
professionals.  

Union  legislation  applicable  to  products  and  processes  of  the  food  chain,  and  in 
particular  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  rules11, 
establishes  a  comprehensive  framework  for  the  performance  of  official  controls  and 

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11 

OJ L 218, 13.8.2008, p.30. 
OJ L 11, 15.1.2002, p. 4. 
2010/2085(INI). 
OJ L 165, 30.4.2004, p. 1. 

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other official activities to verify compliance with feed and food law, rules on animal 
health  and  welfare,  genetically  modified  organisms,  plant  health  and  plant 
reproductive  material,  plant  protection  products,  and  pesticides.  These  areas  should 
therefore be excluded from the scope of this Regulation.  

(10)  Union legislation concerning medicinal products, medical devices, in vitro diagnostic 
medical devices and substances of human origin contain special provisions to ensure 
post-market  safety  based  in  particular  on  sector-specific  vigilance  and  market 
surveillance systems. Those products should therefore also be excluded from the scope 
of this Regulation, with the exception of its provisions on control of products entering 
the  Union  market  which  should  apply  insofar  as  the  relevant  Union  legislation  does 
not contain specific rules relating to the organisation of border controls.  

(11)  Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 
on transportable  pressure  equipment12 applies not only to  new transportable pressure 
equipment  for  the  purpose  of  making  it  available  on  the  market  but  also  to  certain 
other  transportable  pressure  equipment  for  the  purposes  of  its  periodic  inspections, 
intermediate  inspections,  exceptional  checks  and  use.  It  provides  for  the  specific  Pi-
marking  and  for  a  Union  safeguard  procedure  and  particular  procedures  for  dealing 
with  transportable  pressure  equipment  presenting  a  risk  at  national  level,  with 
compliant transportable pressure equipment which presents a risk to health and safety 
and  with  formal  non-compliance.  Therefore,  the  procedures  for  the  controls  of 
products  within  the  Union  laid  down  in  this  Regulation  should  not  apply  to 
transportable pressure equipment subject to Directive 2010/35/EU. 

(12)  This Regulation should establish a comprehensive framework for market surveillance 
in the Union. It should define the scope of the products covered and those excluded, 
impose an obligation on Member States to organise and carry out market surveillance, 
require Member States to appoint market surveillance authorities and to specify their 
powers  and  duties,  and  make  Member  States  responsible  for  setting  up  general  and 
sector-specific market surveillance programmes. 

(13)  Some Union harmonisation legislation contains provisions on market surveillance and 
safeguard  clauses.  These  may  be  based  on  the  reference  provisions  on  market 
surveillance  and  safeguard  clauses  contained  in  Decision  No  768/2008/EC  of  the 
European Parliament and of the Council of 9 July 2008 on a common framework for 
the  marketing  of  products13.  This  Regulation  should  contain  all  of  the  market 
surveillance  provisions  applicable  to  the  products  falling  within  its  scope.  This 
Regulation  should  therefore  include  the  reference  provisions  on  market  surveillance 
and safeguard clauses contained in Decision No 768/2008/EC. Provisions in existing 
Union  harmonisation  legislation  that  relate  to  market  surveillance  and  safeguard 
clauses, whether drafted before the adoption of Decision No 768/2008/EC or based on 
its reference provisions, should be removed from that harmonisation legislation unless 
there are specific sectoral reasons for retaining them. Exemptions from the safeguard 
provisions  should  be  made  in  relation  to  products  subject  to  Regulation  (EC)  No 
1907/2006  of  the  European  Parliament  and  of  the  Council  of  18  December  2006 
concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals 
(REACH),  certain  fittings  subject  to  Directive  2009/142/EC  of  the  European 

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13 

OJ L165, 30.6.2010, p.1. 
OJ L 218, 13.8.2008, p.82. 

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Parliament  and  of  the  Council  of  30  November  2009,  certain  pressure  equipment 
subject  to  Directive  97/23/EC  of  the  European  Parliament  and  of  the  Council  of  29 
May  1997  and  certain  pressure  vessels  subject  to  Directive  2009/105/EC  of  the 
European Parliament and of the Council of 16 September 2009. 

(14) 

In order to make the entire market surveillance process transparent and easy to follow 
for  both  market  surveillance  authorities  and  economic  operators,  the  Regulation 
should clearly set out the chronological steps of that process, from the moment when 
market  surveillance  authorities  identify  a  product  which  they  believe  may  present  a 
risk, to the assessment of the risk presented, the corrective action to be taken by the 
relevant economic operator within a specified period and the measures to be taken by 
market surveillance authorities themselves if economic operators do not comply or in 
cases of urgency.  

(15)  Market  surveillance  should  be  based  on  the  assessment  of  the  risk  presented  by  a 
product  taking  all  relevant  data  into  account.  A  product  that  is  subject  to  Union 
harmonisation  legislation  which  lays  down  essential  requirements  relating  to 
protection of certain public interests should be presumed not to present a risk to those 
public interests if it complies with those essential requirements.  

(16)  Products subject to Union harmonisation legislation that does  not lay down essential 
requirements but which is designed to ensure the protection of certain public interests 
should  be  presumed  not  to  present  a  risk  to  those  public  interests  provided  that  they 
comply with that legislation. 

(17)  Similarly, a product that is not subject to Union harmonisation legislation but which 
complies  with  national  rules  on  the  health  and  safety  of  persons  or  with  European 
standards  referenced  in  the  Official  Journal  of  the  European  Union  should  be 
presumed not to present a risk to health and safety. 

(18)  For the purposes of this Regulation risk assessment should be carried out to identify 
products which have the potential to affect adversely the public interests protected by 
[Regulation  (EU)  No  xxxx  (on  consumer  product  safety)],  sector-specific  Union 
harmonisation  legislation  and  other  Union  legislation  on  products  that  are  subject  to 
this Regulation. It should include, where available, data on risks that have materialised 
previously  with  respect  to  the  product  in  question.  Account  should  also  be  taken  of 
any  measures  that  may  have  been  taken  by  the  economic  operators  concerned  to 
alleviate the risks. The particular potential vulnerability of consumers, as opposed to 
professional users, should be taken into account as should the increased vulnerability 
of certain categories of consumer such as children, the elderly or the disabled. 

(19)  Both new and second hand products originating outside the Union may be placed on 
the  market  only  after  they  have  been  released  for  free  circulation.  Effective  controls 
are required at the external borders of the Union to suspend the release of products that 
may present a risk if placed on the market in the Union pending evaluation and a final 
decision by market surveillance authorities.  

(20)  Obliging  the  authorities  responsible  for  the  control  of  products  entering  the  Union 
market to carry out checks on an adequate scale therefore contributes to a safer Union 
market for products. In order to increase the effectiveness of such checks, cooperation 

EN 

8 

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and  exchange  of  information  between  those  authorities  and  market  surveillance 
authorities concerning products presenting a risk should be enhanced. 

(21)  Market surveillance authorities should be given the power to destroy products, render 
inoperable or order their destruction by the relevant economic operator, if they deem it 
necessary and proportionate to ensure that such goods cannot pose any further threats. 

(22)  The release for free circulation of products that are imported in the physical possession 
of  persons  entering  the  Union  for  their  personal,  non-commercial  use  should  not  be 
suspended  or  refused  under  this  Regulation  by  the  authorities  responsible  for  the 
control of products entering the Union market. 

(23)  There  should  be  effective,  speedy  and  accurate  exchange  of  information  among  the 
Member  States  and  between  the  Member  States  and  the  Commission.  It  is  therefore 
necessary  to  provide  for  effective  tools  for  such  exchange.  The  Union  rapid 
information  system  (RAPEX)  has  proved  its  effectiveness  and  efficiency.  RAPEX 
enables  measures  to  be  taken  across  the  Union  in  relation  to  products  that  present  a 
risk beyond the territory of a single Member State. To avoid unnecessary duplication, 
this  system  should  be  used  for  all  alert  notifications  required  by  this  Regulation 
relating to products presenting a risk.  

(24)  Coherent  and  cost-effective  market  surveillance  activity  throughout  the  Union  also 
requires well-structured, comprehensive archiving and sharing among Member States 
of all pertinent information on national activities in this context, including a reference 
to  notifications  required  by  this  Regulation,  to  form  a  complete  database  of  market 
surveillance  information.  The  Commission  has  established  a  database  called 
‘Information and Communication System for Market Surveillance’ which is suited for 
this purpose and should therefore be used.  

(25)  Given the size of the Union market for goods and as there are no internal borders, it is 
imperative  that  the  market  surveillance  authorities  of  the  Member  States  are  willing 
and able to cooperate with each other effectively and to coordinate joint support and 
action. Accordingly, mechanisms for mutual assistance should be established. 

(26) 

In order to facilitate market surveillance of products entering the Union market from 
third countries, this Regulation should provide a basis for cooperation between market 
surveillance authorities of Member States and the authorities of those countries. 

(27)  A  European  Market  Surveillance  Forum  composed  of  representatives  from  market 
surveillance authorities should be established. The Forum should provide a means of 
involving  all  stakeholders  concerned,  including  professional  organisations  and 
consumer  organisations,  in  order  to  take  advantage  of  available  information  relevant 
for  market  surveillance  when  establishing,  implementing  and  updating  market 
surveillance programmes. 

(28)  The Commission should provide support for cooperation between market surveillance 
authorities and participate in the Forum. The Regulation should set out a list of tasks to 
be  performed  by  the  Forum.  An  executive  secretariat  should  organise  the  Forum's 
meetings and provide other operational support for the accomplishment of its tasks.  

EN 

9 

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(29)  Where  appropriate,  reference  laboratories  should  be  established  with  a  view  to 
providing expert, impartial technical advice and conducting tests on products required 
in relation to market surveillance activities. 

(30)  This  Regulation  should  strike  a  balance  between  transparency  through  the  release  of 
the  maximum  possible  amount  of  information  to  the  public  and  maintaining 
confidentiality,  for  example  for  reasons  of  personal  data  protection,  commercial 
secrecy or the protection of investigations, in accordance with rules on confidentiality 
pursuant  to  applicable  national  law  or,  as  regards  the  Commission,  Regulation  (EC) 
No  1049/2001  of  the  European  Parliament  and  of  the  Council  of  30  May  2001 
regarding  public  access 
to  European  Parliament,  Council  and  Commission 
documents14. 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  data15  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 data16 apply in 
the context of this Regulation. 

(31) 

Information exchanged between competent authorities should be subject to the strictest 
guarantees  of  confidentiality  and  professional  secrecy  and  be  handled  in  a  way  that 
investigations are not compromised and that the reputations of economic operators are 
not prejudiced.  

(32)  Member States should provide means of redress in the competent courts and tribunals 

in respect of restrictive measures taken by their authorities. 

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

(34)  Market  surveillance  should  be  financed  at  least  in  part  by  fees  charged  to  economic 
operators where they are required by market surveillance authorities to take corrective 
action or where those authorities are obliged to take action themselves.  

(35) 

In  order  to  achieve  the  objectives  of  this  Regulation,  the  Union  should  contribute  to 
the  financing  of  activities  required  to  implement  policies  in  the  field  of  market 
surveillance  such  as  the  drawing-up  and  updating  of  guidelines,  preliminary  or 
ancillary  activities  in  connection  with  the  implementation  of  Union  legislation  and 
programmes of technical assistance and cooperation with third countries as well as the 
enhancement of policies at Union and international level.  

(36)  Union  financing  should  be  made  available  in  accordance  with  Regulation  (EU, 
Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 
2012 on the financial rules applicable to the general budget of the Union17, depending 
on the nature of the activity to be financed, in particular for support to the executive 
secretariat of the EMSF. 

14 
15 
16 
17 

OJ L 145, 31.5.2001, p. 43. 
OJ L 281, 23.11.1995, p. 31.  
OJ L 8, 12.1.2001, p. 1. 
OJ L 298, 26.10.2012, p. 1. 

EN 

10 

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(37) 

(38) 

In  order  to  ensure  uniform  conditions  for  the  implementation  of  this  Regulation, 
implementing  powers  should  be  conferred  on  the  Commission  as  regards  national 
measures  taken  and  notified  by  a  Member  State  in  relation  to  products  subject  to 
Union harmonisation legislation and the establishment of Union reference laboratories. 

In  order  to  ensure  uniform  conditions  for  the  implementation  of  this  Regulation, 
implementing  powers  should  be  conferred  on  the  Commission  as  regards  uniform 
conditions for the carrying out of checks by reference to particular product categories 
or sectors, including the scale of checks to be carried out and the adequacy of samples 
to  be  checked.  Implementing  powers  should  also  be  conferred  as  regards  the 
modalities  for  the  provision  of  information  to  market  surveillance  authorities  by 
economic operators, as regards establishing uniform conditions for determining cases 
in which such information need not be provided. Implementing powers should also be 
conferred  as  regards  the  modalities  and  procedures  for  the  exchange  of  information 
through  RAPEX  and  as  regards  the  adoption  of  temporary  or  permanent  marketing 
restrictions  on  products  presenting  a  serious  risk,  where  appropriate,  specifying  the 
necessary  control  measures  to  be  taken  by  the  Member  States  for  their  effective 
implementation where other Union legislation does not provide a specific procedure to 
address  the  risks  in  question.  Those  powers  should  be  exercised  in  accordance  with 
Regulation (EU) No 182/2011 of the European Parliament and of the Council laying 
down  the  rules  and  general  principles  concerning  mechanisms  for  control  by  the 
Member States of the Commission's exercise of its implementing powers18.  

(39)  The  Commission  should  adopt  immediately  applicable  implementing  acts  where,  in 
duly justified cases relating to restrictive measures relating to products that present a 
serious risk, imperative grounds of urgency so require.  

(40)  The market surveillance provisions of Council Directive 89/686/EEC of 21 December 
1989  on  the  approximation  of  the  laws  of  the  Member  States  relating  to  personal 
protective equipment19, Directive 93/15/EEC of 5 April 1993 on the harmonization of 
the provisions relating to the placing on the market and supervision of explosives for 
civil  uses20,  Directive  94/9/EC  of  the  European  Parliament  and  the  Council  of  23 
March  1994  on  the  approximation  of  the  laws  of  the  Member  States  concerning 
equipment  and  protective  systems  intended  for  use  in  potentially  explosive 
atmospheres21, Directive 94/25/EC of the European Parliament and of the Council of 
16  June  1994  on  the  approximation  of  the  laws,  regulations  and  administrative 
provisions of the Member States relating to recreational craft22, European Parliament 
and Council Directive 95/16/EC of 29 June 1995 on the approximation of the laws of 
the Member States relating to lifts23, Directive 97/23/EC of the European Parliament 
and of the Council of 29 May 1997 on the approximation of the laws of the Member 
States  concerning  pressure  equipment24,  Directive  1999/5/EC  of  the  European 
Parliament  and  of  the  Council  of  9  March  1999  on  radio  equipment  and 
their 
telecommunications 

the  mutual  recognition  of 

terminal  equipment  and 

18 
19 
20 
21 
22 
23 
24 

OJ L 55, 28.2.2011, p. 11. 
OJ L 399, 30.12.1989, p. 18.  
OJ L 121, 15.5.1993, p. 20. 
OJ L 100, 19.4.1994, p. 1. 
OJ L 164, 30.6.1994, p. 15. 
OJ L 213, 7.9.1995, p. 1. 
OJ L 181, 9.7.1997, p. 1. 

EN 

11 

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conformity25, Directive 2000/9/EC of the European Parliament and of the Council of 
20  March  2000  relating  to  cableway  installations  designed  to  carry  persons26, 
Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 
on the approximation of the laws of the Member States relating to the noise emission 
in the environment by equipment for use outdoors27, Directive 2001/95/EC, Directive 
2004/108/EC of the European Parliament and of the Council of 15 December 2004 on 
the  approximation  of  the  laws  of  the  Member  States  relating  to  electromagnetic 
compatibility28, Directive 2006/42/EC of the European Parliament and of the Council 
of  17  May  2006  on  machinery29,  Directive  2006/95/EC  of  the  European  Parliament 
and of the Council of 12 December 2006 on the harmonisation of the laws of Member 
States relating to electrical equipment designed for use within certain voltage limits30, 
Directive 2007/23/EC of the European Parliament and of the Council of 23 May 2007 
on  the  placing  on  the  market  of  pyrotechnic  articles31,  Directive  2008/57/EC  of  the 
European Parliament and of the Council of 17 June 2008 on the interoperability of the 
rail  system  within  the  Community32,  Directive  2009/48/EC  of  the  European 
Parliament  and  of  the  Council  of  18  June  2009  on  the  safety  of  toys33,  Directive 
2009/105/EC  of  the  European  Parliament  and  of  the  Council  of  16  September  2009 
relating  to  simple  pressure  vessels34,  Directive  2009/142/EC  of  the  European 
Parliament  and  of  the  Council  of  30  November  2009  relating  to  appliances  burning 
gaseous fuels35, Directive 2011/65/EU of the European Parliament and of the Council 
of  8  June  2011  on  the  restriction  of  the  use  of  certain  hazardous  substances  in 
electrical and electronic equipment36, Regulation (EU) No 305/2011 of the European 
Parliament  and  of  the  Council  of  9  March  2011  laying  down  harmonised  conditions 
for  the  marketing  of  construction  products37,  and  Regulation  (EC)  No  765/2008 
overlap with the provisions of this Regulation. Therefore, these provisions should be 
deleted. Regulation (EC) No 764/2008 of the European Parliament and of the Council 
of 9 July 2008 laying down procedures relating to the application of certain national 
technical rules to products lawfully marketed in another Member State and repealing 
Decision No 3052/95/EC should be amended accordingly38.  

(41)  Since the  objective of this  Regulation, namely to ensure that products on the market 
covered  by  Union  legislation  fulfil  the  requirements  providing  a  high  level  of 
protection  of  health  and  safety  and  other  public  interests  while  guaranteeing  the 
functioning  of  the  internal  market  by  providing  a  framework  for  coherent  market 
surveillance in the Union, cannot be sufficiently achieved by the Member States as the 
attainment of this objective requires a very high degree of cooperation, interaction and 
uniformity of operation among all of the competent authorities of all Member States, 
and can therefore, by reason of its scale and effects, be better achieved at Union level, 

25 
26 
27 
28 
29 
30 
31 
32 
33 
34 
35 
36 
37 
38 

OJ L 91, 7.4.1999, p. 10. 
OJ L 106, 3.5.2000, p. 21. 
OJ L 162, 3.7.2000, p. 1. 
OJ L 390, 31.12.2004, p. 24. 
OJ L 157, 9.6.2006, p. 24. 
OJ L 374, 27.12.2006, p. 10. 
OJ L 154, 14.6.2007, p. 1. 
OJ L 191, 18.7.2008, p. 1. 
OJ L 170, 30.6.2009, p. 1. 
OJ L 264, 8.10.2009, p. 12. 
OJ L 330, 16.12.2009, p. 10. 
OJ L 174, 1.7.2011, p. 88. 
OJ L 88, 4.4.2011, p. 5. 
OJ L 218, 13.8.2008, p. 21. 

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12 

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the Union may adopt measures, in accordance with the principle of subsidiarity as set 
out in Article 5 of the Treaty on European Union. 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 that objective. 

(42)  This Regulation respects the fundamental rights and observes the principles recognised 
in  particular  by  the  Charter  of  Fundamental  Rights  of  the  European  Union.  in 
particular this  Regulation seeks  to ensure full respect for  obligation  to ensure a high 
level of human health protection and consumer protection as well as full respect of the 
freedom to conduct a business and the right to property,  

HAVE ADOPTED THIS REGULATION: 

CHAPTER I 

General provisions 

Article 1 

Subject matter 

This Regulation lays down a framework for verifying that products meet requirements which 
safeguard, at a high level, the health and safety of persons in general, health and safety in the 
workplace, consumer protection, the environment, public security and other public interests.  

Article 2 

Scope  

1. 

2. 

Chapters  I,  II,  III,  V  and  VI  of  this  Regulation  shall  apply  to  all  products  that  are 
subject  to  Regulation  (EU)  No  […  on  Consumer  Product  Safety]  or  Union 
harmonisation  legislation,  including  to  products  assembled  or  manufactured  for  the 
manufacturer's own use, and to the extent that Union harmonisation legislation does 
not contain a specific provision with the same objective. 

Chapters  I  and  IV  and  Article  23  shall  apply  to  all  products  covered  by  Union 
legislation  to  the  extent  that  other  Union  legislation  does  not  contain  specific 
provisions relating to  the organisation of external border controls or to cooperation 
between authorities in charge of external border controls.  

3. 

Chapters II, III, V and VI shall not apply to the following products:  

(a)  medicinal products for human or veterinary use;  

(b)  medical devices and in vitro diagnostic medical devices; 

(c)  blood, tissues, cells, organs and other substances of human origin. 

EN 

13 

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4. 

5. 

Chapter  III  of  this  Regulation  shall  not  apply  to  transportable  pressure  equipment 
subject to Directive 2010/35/EU. 

Articles 11 and 18 of this Regulation shall not apply to the following products: 

(a)  products subject to Regulation (EC) No 1907/2006; 

(b) 

fittings as defined in Article 1(2)(b) of Directive 2009/142/EC; 

(c)  pressure  equipment  subject  to  the  provisions  of  Article  3(3)  of  Directive 

97/23/EC;  

(d) 

simple  pressure  vessels  subject  to  the  provisions  of  Article  3(2)  of  Directive 
2009/105/EC.  

6. 

This Regulation shall not apply in the areas governed by Union legislation on official 
controls  and  other  official  activities  carried  out  for  the  verification  of  compliance 
with the following rules:  

(a) 

(b) 

(c) 

(d) 

rules  governing  food  and  food  safety,  at  any  stage  of  production,  processing 
and distribution of food, including rules aimed at guaranteeing fair practices in 
trade and protecting consumer interests and information;  

rules governing  the manufacture and use of  materials  and  articles  intended  to 
come into contact with food; 

rules  governing  the  deliberate  release  into  the  environment  of  genetically 
modified organisms; 

rules governing feed and feed safety, at all stages of production, processing and 
distribution of feed and the use of feed, including rules aimed at guaranteeing 
fair practices in trade and protecting consumer interests and information; 

(e) 

rules laying down animal health requirements; 

(f) 

rules  aiming  at  preventing  and  minimising  risks  to  human  and  animal  health 
arising from animal by-products and derived products; 

(g) 

rules laying down welfare requirements for animals; 

(h) 

rules on protective measures against pests of plants; 

(i) 

(j) 

rules on the production, with a view to placing on the market, and placing on 
the market of plant reproductive material; 

rules  laying  down  the  requirements  for  placing  on  the  market  and  the  use  of 
plant protection products and the sustainable use of pesticides; 

(k) 

rules governing organic production and labelling of organic products; 

(l) 

rules  on  the  use  and  labelling  of  protected  designations  of  origin,  protected 
geographical indications and traditional specialities guaranteed. 

EN 

14 

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Article 3 

Definitions 

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

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

(10) 

(11) 

(12) 

(13) 

‘product’ means a product obtained through a manufacturing process; 

‘making  available  on  the  market’  means  any  supply  of  a  product  for  distribution, 
consumption  or  use  on  the  Union  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 Union 
market; 

‘manufacturer’ means any natural or legal person who manufactures a product or has 
a  product  designed  or  manufactured  and  markets  that  product  under  his  name  or 
trademark; 

‘authorised representative’ means any natural or legal person established within the 
Union who has received a written mandate from a manufacturer to act on his behalf 
in relation to specified tasks; 

‘importer’  means  any  natural  or  legal  person  established  within  the  Union  who 
places a product from a third country on the Union market; 

‘distributor’  means  any  natural  or  legal  person  in  the  supply  chain,  other  than  a 
manufacturer or importer, who makes a product available on the market; 

‘economic  operators’  means  the  manufacturer,  the  authorised  representative,  the 
importer and the distributor;  

‘conformity assessment’ means conformity assessment as defined in Regulation (EC) 
No 765/2008; 

‘conformity  assessment  body’  means  conformity  assessment  body  as  defined  in 
Regulation (EC) No 765/2008; 

‘market surveillance’ means the activities carried out and measures taken by public 
authorities to ensure that products do not endanger health, safety or any other aspect 
of public interest protection and, in the case of products falling within the scope of 
Union  harmonisation  legislation,  that  they  comply  with  the  requirements  set  out  in 
that legislation; 

‘market surveillance authority’ means an authority of a Member State responsible for 
carrying out market surveillance on its territory; 

‘product presenting a risk’ means a product having the potential to affect adversely 
health and safety of persons in general, health and safety in the workplace, consumer 
protection, the environment and public security as well as other public interests to a 
degree  which  goes  beyond  that  considered  reasonable  and  acceptable  under  the 
normal  or  reasonably  foreseeable  conditions  of  use  of  the  product  concerned, 

EN 

15 

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(14) 

(15) 

(16) 

(17) 

(18) 

(19) 

(20) 

1. 

2. 

3. 

including  the  duration  of  use  and,  where  applicable,  its  putting  into  service, 
installation and maintenance requirements;  

‘product presenting a serious risk’ means a product presenting a risk requiring rapid 
intervention and follow-up, including cases where the effects may not be immediate; 

‘recall’  means  any  measure  aimed  at  achieving  the  return  of  a  product  that  has 
already been made available to the end user; 

‘withdrawal’ means any measure aimed at preventing a product in the supply chain 
from being made available on the market;  

‘release for free circulation’ means the procedure laid down in Article 79 of Council 
Regulation (EEC) No 2913/9239; 

‘Union  harmonisation 
conditions for the marketing of products;  

legislation’  means  Union 

legislation  harmonising 

the 

‘European  standard’  means  a  European  standard  as  defined  in  Article  2(1)(b)  of 
Regulation (EU) No 1025/2012 of the European Parliament and the Council40; 

‘harmonised standard’ means a harmonised standard as defined in Article 2(1)(c) of 
Regulation (EU) No 1025/2012.  

CHAPTER II 

Union market surveillance framework 

Article 4 

Market surveillance obligation 

Member States shall carry out market surveillance in respect of products covered by 
this Regulation. 

Market  surveillance  shall  be  organised  and  carried  out  in  accordance  with  this 
Regulation  with  a  view  to  ensuring  that  products  presenting  a  risk  are  not  made 
available on the Union market and, where such products have been made available, 
effective measures are taken to remove the risk presented by the product. 

The  implementation  of  market  surveillance  activities  and  external  border  controls 
shall be monitored by the Member States which shall report on these activities and 
controls  to  the  Commission  every  year.  The  information  reported  shall  include 
statistics regarding the number of controls carried out and shall be communicated to 
all Member States. Member States may make a summary of the results accessible to 
the public. 

39 
40 

OJ L 302, 19.10.1992, p. 1 
OJ L 316, 14.11.2012, p. 12. 

EN 

16 

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4. 

1. 

2. 

3. 

4. 

5. 

1. 

The results of the monitoring and assessment of market surveillance activities carried 
out pursuant to paragraph 3 shall be made available to the public, electronically and, 
where appropriate, by other means. 

Article 5 

Market surveillance authorities 

Each  Member  State  shall  establish  or  designate  market  surveillance  authorities  and 
define their duties, powers and organisation. 

Market  surveillance  authorities  shall  be  given  the  powers  and  entrusted  with  the 
resources and means necessary for the proper performance of their tasks. 

Each Member State shall establish appropriate mechanisms to ensure that the market 
surveillance  authorities  that  it  has  established  or  designated  exchange  information, 
cooperate  and  coordinate  their  activities  both  among  themselves  and  with  the 
authorities in charge of controls of products at the external borders of the Union. 

Each  Member  State  shall  inform  the  Commission  about  its  market  surveillance 
authorities  and  their  areas  of  competence,  providing  the  necessary  contact  details, 
and the Commission shall transmit this information to the other Member States and 
publish a list of market surveillance authorities. 

Member States shall inform the public of the existence, responsibilities and identity 
of  national  market  surveillance  authorities  and  how  those  authorities  may  be 
contacted. 

Article 6 

General obligations of market surveillance authorities 

Market  surveillance  authorities  shall  perform  appropriate  checks  on 
the 
characteristics  of  products  on  an  adequate  scale  and  with  adequate  frequency,  by 
means  of  a  documentary  check  and,  where  necessary,  a  physical  and  laboratory 
check  on  the  basis  of  an  adequate  sample.  They  shall  record  these  checks  in  the 
information and communication system for market surveillance referred to in Article 
21. 

In cases  of known or  emerging  risk related to the objectives set out in Article 1 of 
this  Regulation  and  concerning  a  particular  product  or  a  category  of  products,  the 
Commission  may  adopt  implementing  acts  to  establish  uniform  conditions  for  the 
carrying  out  of  the  checks  performed  by  one  or  several  market  surveillance 
authorities  in  relation  to  that  particular  product  or  category  of  products  and  the 
characteristics  of  that  known  or  emerging  risk.  These  conditions  may  include 
requirements  for  a  temporary  increase  of  the  scale  and  frequency  of  checks  to  be 
carried  out  and  the  adequacy  of  samples  to  be  checked.  These  implementing  acts 
shall be adopted in accordance with the examination procedure referred to in Article 
32(2). 

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17 

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2. 

3. 

4. 

Where appropriate, market surveillance authorities shall alert users in their territories 
within  an  adequate  timeframe  of  products  that  those  authorities  have  identified  as 
presenting a risk.  

They shall cooperate with economic operators to prevent or reduce risks caused by 
products  made  available  by  those  operators.  For  this  purpose,  they  shall  encourage 
and  promote  voluntary  action  by  economic  operators  including,  where  applicable, 
through the development of and adherence to codes of good practice. 

Market surveillance authorities shall carry out their duties independently, impartially 
and  without  bias  and  shall  fulfil  their  obligations  under  this  Regulation;  they  shall 
exercise  their  powers  in  relation  to  economic  operators  in  accordance  with  the 
principle of proportionality. 

Where it is necessary and justified for carrying out their duties, market surveillance 
authorities  may  enter  the  premises  of  economic  operators  and  take  any  necessary 
samples of products.  

5. 

Market surveillance authorities shall:  

(a)  provide consumers and other interested parties with the opportunity to submit 
complaints  on  issues  relating  to  product  safety,  market  surveillance  activities 
and risks arising in connection with products and follow up those complaints as 
appropriate; 

(b)  verify that corrective action has been taken; 

(c) 

follow  and  keep  up  to  date  with  developments  in  scientific  and  technical 
knowledge concerning the safety of products. 

Adequate  procedures  shall  be  established  and  made  known  to  the  public  to  enable 
market surveillance authorities to fulfil these obligations. 

Without  prejudice  to  national  legislation  in  the  area  of  confidentiality,  the 
safeguarding  of  confidentiality  with  regard  to  information  received  and  collated  by 
market  surveillance  authorities  shall  be  ensured.  Information  exchanged  between 
national  market  surveillance  authorities  and  between  them  and  the  Commission  on 
condition of confidentiality shall remain confidential unless the originating authority 
has agreed to its disclosure.  

The  protection  of  confidentiality  shall  not  prevent  the  dissemination  to  market 
surveillance  authorities  of  information  necessary  to  ensure  effective  market 
surveillance. 

Article 7 

Market surveillance programmes 

Each Member State shall draw up a general market surveillance programme and shall 
review  that  programme,  and  update  it  if  necessary,  at  least  every  four  years.  The 
programme  shall  cover  market  surveillance  organisation  and  related  activities  and 

6. 

7. 

8. 

1. 

EN 

18 

   EN 

 
take  into  account  the  specific  needs  of  business  generally,  and  SMEs  in  particular, 
when  implementing  Union  harmonisation  legislation  and  Regulation  (EU)  No 
[…/…]  [on  consumer  product  safety],  and  provide  for  guidance  and  assistance.  It 
shall include the following: 

(a) 

(b) 

the  sectoral  and  geographical  competence  of  the  authorities  designated  under 
Article 5(1); 

the  financial  resources,  staff,  technical  and  other  means  attributed  to  the 
authorities; 

(c) 

an indication of the priority areas of work of the different authorities; 

(d) 

(e) 

(f) 

the  mechanisms  of  coordination  among  the  different  authorities  and  with 
customs authorities; 

the  participation  of  the  authorities  in  the  exchange  of  information  under 
Chapter V; 

the participation of the authorities in sectoral or project-oriented cooperation at 
Union level;  

(g) 

the means to fulfil the requirements of Article 6(5).  

Each Member State shall draw up sector-specific programmes and shall review these 
programmes,  and  update  them  if  necessary,  every  year.  These  programmes  shall 
cover all sectors in which authorities conduct market surveillance activities. 

their  updates  shall  be 
The  general  and  sector-specific  programmes  and 
communicated  to  the  other  Member  States  and  the  Commission  and,  subject  to 
Article  6(6),  shall  be  made  accessible  to  the  public  electronically  and,  where 
appropriate, by other means.  

Article 8 

General obligations of economic operators 

On  request,  economic  operators  and,  where  applicable,  conformity  assessment 
bodies,  shall  make  available  to  market  surveillance  authorities  any  documentation 
and  information  that  those  authorities  require  for  the  purpose  of  carrying  out  their 
activities, in a language which can be easily understood by them. 

Economic  operators  shall  provide  all  necessary  information  to  market  surveillance 
authorities including information that enables the precise identification of the product 
and facilitates the tracing of the product. 

CHAPTER III 

Control of products within the Union 

2. 

3. 

1. 

2. 

EN 

19 

   EN 

 
Article 9 

Products presenting a risk 

1. 

2. 

Where,  in  the  course  of  carrying  out  the  checks  referred  to  in  Article  6(1)  or  as  a 
result of information received, market surveillance authorities have sufficient reason 
to believe that a product that is placed or made available on the market or is used in 
the course of the provision of a service may present a risk, they shall carry out a risk 
assessment  in  relation  to  that  product  taking  account  of  the  considerations  and 
criteria set out in Article 13. 

Market surveillance authorities shall take due consideration of any readily available 
test result and risk assessment that has already been carried out or issued in relation 
to the product by an economic operator or any other person or authority including the 
authorities of other Member States. 

In  relation  to  a  product  that  is  subject  to  Union  harmonisation  legislation,  formal 
non-compliance  with  that  legislation  shall  give  market  surveillance  authorities 
sufficient  reason  to  believe  that  the  product  may  present  a  risk  in  any  of  the 
following cases: 

(a) 

(b) 

the CE marking or other markings required by Union harmonisation legislation 
have not been affixed or have been affixed incorrectly; 

the  EU  declaration  of  conformity,  where  required,  has  not  been  drawn  up  or 
has been drawn up incorrectly; 

(c) 

the technical documentation is incomplete or unavailable;  

(d) 

the required labelling or instructions for use are incomplete or missing.  

Regardless whether the risk assessment shows that the product in fact presents a risk, 
market  surveillance  authorities  shall  require  the  economic  operator  to  rectify  the 
formal non-compliance. If the economic operator fails to do so, market surveillance 
authorities shall ensure that the product is withdrawn or recalled. 

3. 

Without prejudice to Article 10(4), where market surveillance authorities find that a 
product does present a risk they shall without delay specify the necessary corrective 
action  to  be  taken  by  the  relevant  economic  operator  to  address  the  risk  within  a 
specified period. Market surveillance authorities may recommend or agree with the 
relevant economic operator the corrective action to be taken. 

The  economic  operator  shall  ensure  that  all  necessary  corrective  action  is  taken  in 
respect  of  all  the  products  concerned  that  it  has  made  available  on  the  market 
throughout the Union.  

The economic operator shall provide all necessary information to market surveillance 
authorities pursuant to Article 8, and in particular the following information: 

(a) 

a full description of the risk presented by the product; 

(b) 

a description of any corrective action undertaken to address the risk. 

EN 

20 

   EN 

 
Where  possible,  market  surveillance  authorities  shall  identify  the  manufacturer  or 
importer  of  the  product  and  take  action  in  relation  to  that  economic  operator  in 
addition to the distributor. 

4. 

Corrective  action  to  be  taken  by  economic  operators  in  relation  to  a  product 
presenting a risk may include: 

(a) 

(b) 

in the case of a product subject to the requirements laid down in or pursuant to 
Union  harmonisation  legislation,  taking  the  measures  necessary  to  bring  the 
product into compliance with those requirements;  

in the case of a product that is liable to present a risk only in certain conditions 
or only to certain persons and where such risk is not addressed by requirements 
of Union harmonisation legislation: 

(i) 

affixing  to  the  product  suitable,  clearly  worded,  easily  comprehensible 
warnings of the risks it may present, in the official language or languages 
of  the  Member  State  in  which  the  product  is  made  available  on  the 
market ; 

(ii)  making the marketing of the product subject to prior conditions; 

(iii)  alerting the persons at risk to the risk, in good time and in an appropriate 

form, including by publication of special warnings; 

(c) 

in the case of a product that may present a serious risk, temporarily preventing 
the product from being placed or made available on the market pending a risk 
assessment; 

(d) 

in the case of a product that presents a serious risk: 

(i) 

preventing  the  product  from  being  placed  or  made  available  on  the 
market; 

(ii)  withdrawing  or  recalling  the  product  and  alerting  the  public  to  the  risk 

presented; 

(iii)  destroying the product or otherwise rendering it inoperable. 

5. 

The  Commission  may  adopt  implementing  acts  establishing  the  modalities  for  the 
provision of information in accordance with the third subparagraph of paragraph 3, 
while  ensuring  the  effectiveness  and  proper  functioning  of  the  system.  These 
implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 32(2). 

Article 10 

Measures taken by market surveillance authorities 

1. 

Where  the  identity  of  the  relevant  economic  operator  cannot  be  ascertained  by  the 
market  surveillance  authorities  or  where  an  economic  operator  has  not  taken  the 
necessary  corrective  action  pursuant  to  Article  9(3)  within  the  period  specified, 

EN 

21 

   EN 

 
market surveillance authorities shall take all necessary measures to deal with the risk 
presented by the product. 

2. 

For  the  purpose  of  paragraph  1,  market  surveillance  authorities  may  oblige  the 
relevant economic operators to take, inter alia, any of the corrective action referred to 
in Article 9(4) or take such measures themselves, as appropriate.  

Market surveillance authorities may destroy or otherwise render inoperable a product 
presenting a risk where they deem it necessary and proportionate. They may require 
the relevant economic operator to bear the cost of such action. 

The  first  subparagraph  shall  not  prevent  Member  States  from  enabling  market 
surveillance authorities to take other, supplementary measures. 

3. 

4. 

Prior  to  taking  any  measure  under  paragraph  1  in  relation  to  an  economic  operator 
who has failed to take the necessary corrective action, market surveillance authorities 
shall allow him at least 10 days within which to be heard. 

Where market surveillance authorities consider that a product presents a serious risk, 
they  shall  take  all  necessary  measures  and  may  do  so  without  first  requiring  the 
economic  operator  to  take  corrective  action  pursuant  to  Article  9(3)  and  without 
giving  the  operator  the  opportunity  to  be  heard  beforehand.  In  such  cases  the 
economic operator shall be heard as soon as practicable.  

5. 

Any measure taken pursuant to paragraphs 1 or 4 shall: 

(a)  be  communicated  without  delay  to  the  economic  operator  together  with 
information  about  the  remedies  available  under  the  law  of  the  Member  State 
concerned; 

(b) 

state the exact grounds on which it is based; 

(c)  be lifted without delay where the economic operator has demonstrated that he 

has taken the required action. 

For the purposes of point (a) of the first subparagraph, where the economic operator 
to  whom  the  measure  has  been  communicated  is  not  the  economic  operator 
concerned,  the  manufacturer  located  within  the  Union  or  the  importer  shall  be 
informed of the measure, provided market surveillance authorities know his identity.  

6. 

shall  publish 

surveillance  authorities 

Market 
information  about  product 
identification,  the  nature  of  a  risk  and  the  measures  taken  to  prevent,  reduce  or 
eliminate that risk on a dedicated website to the fullest extent necessary to protect the 
interests of users of products in the Union. This information shall not be published 
where  it  is  imperative  to  observe  confidentiality  in  order  to  protect  commercial 
secrets,  preserve  personal  data  pursuant  to  national  and  Union  legislation  or  avoid 
undermining monitoring and investigation activities.  

7. 

Any  measure  taken  in  accordance  with  paragraphs  1  or  4  shall  be  subject  to  legal 
remedies, including recourse to the competent national courts. 

EN 

22 

   EN 

 
8. 

1. 

2. 

3. 

4. 

5. 

6. 

Market  surveillance  authorities  may  charge  fees  on  economic  operators  which 
wholly  or  partly  cover  the  costs  of  their  activities,  including  testing  carried  out  for 
the risk assessment, where they take measures in accordance with paragraphs 1 or 4. 

Article 11 

Union assessment for products controlled within the Union and subject to 
harmonisation legislation  

Within  60  days  of  communication  by  the  Commission  to  the  Member  States, 
pursuant to Article 20(4), of measures taken pursuant to paragraphs 1 or 4 of Article 
10  by  the  original  notifying  Member  State,  a  Member  State  may  object  to  those 
measures where they relate to a product subject to Union harmonisation legislation. 
The Member State shall state its reasons for objecting, indicate any difference in its 
assessment  of  the  risk  presented  by  the  product  and  mention  any  special 
circumstances and any additional information relating to the product in question.  

If  no  objection  is  raised  by  a  Member  State  pursuant  to  paragraph  1  and  the 
Commission  does  not  consider  that  the  national  measures  are  contrary  to  Union 
legislation,  the  measures  taken  by  the  original  notifying  Member  State  shall  be 
deemed  justified  and  each  Member  State  shall  ensure  that  restrictive  measures  are 
taken without delay in respect of the product concerned. 

Where  an  objection  is  raised  by  a  Member  State  pursuant  to  paragraph  1  or  the 
Commission  considers  that  the  national  measures  may  be  contrary  to  Union 
legislation,  the  Commission  shall  without  delay  enter  into  consultation  with  the 
relevant  economic  operator(s)  and  shall  evaluate  the  national  measures,  taking 
account of all available scientific or technical evidence.  

On the basis of the results of the evaluation conducted pursuant to paragraph 3, the 
Commission  may  decide  by  implementing  acts  whether  the  national  measures  are 
justified  and  similar  measures  should  be  taken  by  all  Member  States  that  have  not 
already  done  so.  In  this  case,  it  shall  address  the  decision  to  the  Member  States 
concerned  and  immediately  communicate  it  to  all  Member  States  and  the  relevant 
economic operator or operators.  

If  the  Commission  decides  that  the  national  measures  are  justified,  each  Member 
State shall take the necessary restrictive measures without delay. If it decides that the 
national measure is not justified, the original notifying Member State and any other 
Member State that has taken a similar measure shall withdraw the measure and the 
notification  made  under  the  rapid  information  exchange  system  pursuant  to  Article 
20. 

Where a national measure is considered justified and the product is found not to be in 
compliance  with  Union  harmonisation  legislation  because  of  shortcomings  in  the 
relevant  harmonised  standards,  the  Commission  shall  inform  the  relevant  European 
standardisation organisation and may make an appropriate request pursuant to Article 
11 of Regulation (EU) No 1025/2012.  

EN 

23 

   EN 

 
Article 12 

Union action against products presenting a serious risk 

Where it is evident that a product, or a specific category or group of products, when 
used  in  accordance  with  the  product's  intended  purpose  or  under  conditions  which 
can  be  reasonably  foreseeable,  presents  a  serious  risk  the  Commission  may,  by 
means of implementing acts, take any appropriate measures depending on the gravity 
of the situation, including measures prohibiting, suspending or restricting the placing 
or  making  available  on  the  market  of  such  products  or  laying  down  special 
conditions  for  their  marketing,  in  order  to  ensure  a  high  level  of  protection  of  the 
public interest, provided that the risk cannot be contained satisfactorily by means of 
measures taken by the Member State(s) concerned or by any other procedure under 
Union  legislation.  By  those  implementing  acts,  the  Commission  may  lay  down  the 
appropriate control measures to be taken by Member States to ensure their effective 
implementation. 

The  implementing  acts  referred  to  in  the  first  subparagraph  shall  be  adopted  in 
accordance with the examination procedure referred to in Article 32(2). 

On duly justified imperative grounds of urgency relating to the health and safety of 
persons  in  general,  health  and  safety  in  the  workplace,  consumer  protection,  the 
environment  and  public  security  and  other  public  interests,  the  Commission  shall 
adopt  immediately  applicable  implementing  acts  in  accordance  with  the  procedure 
referred to in Article 32(3).  

For products and risks subject to Regulation (EC) No 1907/2006, a decision taken by 
the Commission pursuant to paragraph 1 of this Article shall be valid for up to two 
years and may be extended for additional periods of up to two years. Such a decision 
shall be without prejudice to procedures provided in that Regulation. 

The exportation from the Union of a product that has been prohibited to be placed or 
made  available  on  the  Union  market  pursuant  to  a  measure  adopted  in  accordance 
with paragraph 1 shall be prohibited, unless the measure expressly so permits. 

Any  Member  State  may  submit  a  substantiated  request  to  the  Commission  to 
examine the need for the adoption of a measure referred to in paragraph 1. 

1. 

2. 

3. 

4. 

Article 13 

Risk assessment 

1. 

Risk assessment shall be based on available scientific or technical evidence. 

For  products  subject  to  Regulation  (EC)  No  1907/2006,  risk  assessment  shall  be 
carried  out  as  appropriate  in  accordance  with  the  relevant  parts  of  Annex  I  to  that 
Regulation. 

2. 

In the context of the risk assessment, market surveillance authorities shall take into 
account the extent to which the product complies with the following: 

EN 

24 

   EN 

 
(a) 

(b) 

any requirements laid down in or pursuant to Union harmonisation legislation 
that  apply  to  the  product  and  relate  to  the  potential  risk  under  consideration, 
taking full account of test reports or certificates attesting conformity and issued 
by a conformity assessment body; 

in  the  absence  of  requirements  laid  down  in  or  pursuant  to  Union 
harmonisation  legislation,  specific  rules  laying  down  health  and  safety 
requirements for such products in the national law of the Member State where 
it is made available on the market, provided that such rules are in accordance 
with Union law;  

(c) 

any  European  standards  the  references  of  which  have  been  published  in  the 
Official Journal of the European Union. 

Compliance with the criteria referred to in points (a), (b) and (c) of paragraph 2 shall 
raise  a  presumption  that  the  product  adequately  safeguards  the  public  interests  to 
which  those  criteria  relate.  However,  this  shall  not  prevent  market  surveillance 
authorities  from  taking  action  under  this  Regulation  where  there  is  new  evidence 
that, despite such conformity or compliance, the product presents a risk. 

The  feasibility  of  obtaining  higher  levels  of  protection  of  the  public  interest 
concerned and the availability of other products presenting a lesser risk shall not be a 
reason to consider that a product presents a risk. 

CHAPTER IV 

Control of products entering the Union 

Article 14 

Checks and suspension of release 

The  authorities  of  the  Member  States  in  charge  of  the  control  of  products  at  the 
external borders of the Union shall have the powers and resources necessary for the 
proper performance of their tasks. They shall carry out appropriate documentary and, 
where necessary, physical and laboratory checks on products before those products 
are released for free circulation. 

Where  more  than  one  authority  is  responsible  for  market  surveillance  or  external 
border controls in a Member State, those authorities shall cooperate with each other, 
by sharing information relevant to their functions. 

Subject  to  Article  17,  the  authorities  in  charge  of  external  border  controls  shall 
suspend  release  of  a  product  for  free  circulation  on  the  Union  market  when,  in  the 
course of the checks referred to in paragraph 1, they have reason to believe that the 
product may present a risk. 

In  relation  to  a  product  which  must  comply  with  Union  harmonisation  legislation 
when it is released for free circulation, formal non-compliance with that legislation 

3. 

4. 

1. 

2. 

3. 

EN 

25 

   EN 

 
shall  give  the  authorities  of  Member  States  sufficient  reason  to  believe  that  the 
product may present a risk in any of the following cases:  

(a) 

is not accompanied by the documentation required by the legislation; 

(b) 

is not marked or labelled in accordance with that legislation;  

(c)  bears  a  CE  marking  or  other  marking  required  by  Union  harmonisation 

legislation which has been affixed in a false or misleading manner.  

The  authorities  in  charge  of  external  border  controls  shall  immediately  notify  the 
market surveillance authorities of any suspension under paragraph 3. 

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

Where,  in  relation  to  products  that  are  not  declared  for  free  circulation,  the 
authorities  in  charge  of  external  border  controls  have  reason  to  believe  that  those 
products present a risk, they shall transmit all relevant information to the authorities 
in charge of external border controls in the Member State of final destination. 

Article 15 

Release 

A  product  the  release  of  which  has  been  suspended  by  the  authorities  in  charge  of 
external  border  controls  pursuant  to  Article  14  shall  be  released  if,  within  three 
working days of the suspension of release, those authorities have not been requested 
by the market surveillance authorities to continue the suspension or they have been 
informed  by  the  market  surveillance  authorities  that  the  product  does  not  present  a 
risk, and provided that all the other requirements and formalities pertaining to such 
release have been fulfilled. 

If  the  market  surveillance  authorities  conclude  that  a  product  the  release  of  which 
was  suspended  due  to  formal  non-compliance  in  accordance  with  the  second  sub-
paragraph of paragraph 3 of Article 14 does not in fact present a risk, the economic 
operator  shall  nevertheless  rectify  the  formal  non-compliance  before  the  product  is 
released. 

Compliance with the requirements of any Union harmonisation legislation that apply 
to the product upon its release which relate to the potential risk under consideration, 
taking full account of test reports or certificates attesting conformity and issued by a 
conformity  assessment  body,  shall  raise  a  presumption  on  the  part  of  market 
surveillance authorities that the product does not present a risk. However, this shall 
not  prevent  those  authorities  from  instructing  the  authorities  in  charge  of  external 
border controls not to release the product where there is evidence that, despite such 
compliance, the product does in fact present a risk. 

4. 

5. 

6. 

1. 

2. 

3. 

EN 

26 

   EN 

 
1. 

2. 

3. 

4. 

5. 

6. 

1. 

2. 

Article 16 

Refusal to release 

Where the market surveillance authorities conclude that a product does present a risk, 
they shall instruct the authorities in charge of external border controls not to release 
the  product  for  free  circulation  and  to  include  the  following  endorsement  on  the 
commercial 
the  product  and  on  any  other  relevant 
accompanying document: 

invoice  accompanying 

“Product presents a risk — release for free circulation not authorised — Regulation 
(EU) No XXX/XXXX”. 

Where  that  product  is  subsequently  declared  for  a  customs  procedure  other  than 
release  for  free  circulation  and  provided  that  the  market  surveillance  authorities  do 
not object, the endorsement set out in paragraph 1 shall also be included, under the 
conditions  set  out  in  paragraph  1,  on  the  documents  used  in  connection  with  that 
procedure. 

Market  surveillance  authorities  or  the  authorities  in  charge  of  external  border 
controls, as the case may be, may destroy or otherwise render inoperable a product 
presenting a risk where they deem it necessary and proportionate. The cost of such 
action shall be borne by the person declaring the product for free circulation. 

Market  surveillance  authorities  shall  provide  the  authorities  in  charge  of  external 
border  controls  with  information  on  product  categories  in  which  a  risk  has  been 
identified pursuant to paragraph 1.  

Any  measure  taken  in  accordance  with  paragraphs  1  or  3  shall  be  subject  to  legal 
remedies, including recourse to the competent national courts. 

Market  surveillance  authorities  may  charge  fees  which  wholly  or  partly  cover  the 
costs of their activities, including testing carried out for  the risk assessment, where 
they take measures in accordance with paragraph 1. 

Article 17 

Personal imports 

Where a product enters the Union accompanied by, and in the physical possession of, 
a  natural  person  and  reasonably  appears  to  be  destined  for  the  personal  use  of  that 
person, its release shall not be suspended pursuant to Article 14(3) except where the 
use of the product can endanger the health and life of persons, animals or plants. 

A  product  shall  be  deemed  to  be  destined  for  the  personal  use  of  a  natural  person 
bringing it into the Union if it is of an occasional nature and exclusively intended for 
use by that person or his family and does not by its nature or quantity indicate any 
commercial intent.  

EN 

27 

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Article 18 

Union assessment for products entering the Union and subject to harmonisation 
legislation 

1. 

2. 

3. 

4. 

5. 

6. 

Within  60  days  of  communication  by  the  Commission  to  the  Member  States, 
pursuant to Article 20(4), of any refusal to release a product for free circulation by 
the  original  notifying  Member  State,  a  Member  State  may  object  to  that  refusal 
where it relates to a product subject to Union harmonisation legislation. The Member 
State shall state its reasons for objecting, indicate any difference in its assessment of 
the  risk  presented  by  the  product  and  mention  any  special  circumstances  and  any 
additional information relating to the product in question.  

If no objection is raised by a Member State under paragraph 1 and the Commission 
does  not  consider  that  the  national  measures  are  contrary  to  Union  legislation,  the 
refusal  by  the  original  notifying  Member  State  shall  be  deemed  justified  and  each 
Member  State  shall  ensure  that  restrictive  measures  are  taken  without  delay  in 
respect of the product concerned. 

Where  an  objection  is  raised  by  a  Member  State  under  paragraph  1  or  the 
Commission  considers  that  the  refusal  may  be  contrary  to  Union  legislation,  the 
Commission  shall  without  delay  enter  into consultation  with  the  relevant  economic 
operator(s) and shall evaluate the refusal, taking account of all available scientific or 
technical evidence.  

On the basis of the results of the evaluation conducted pursuant to paragraph 3, the 
Commission  may  decide  by  implementing  acts  whether  the  refusal  is  justified  and 
similar action should be taken by all Member States that have not already done so. In 
this  case,  it  shall  address  the  decision  to  the  Member  States  concerned  and 
immediately  communicate  it  to  all  Member  States  and  the  relevant  economic 
operator or operators.  

If the Commission decides that the refusal is justified, each Member State shall take 
the necessary restrictive measures without delay. If it decides that the refusal is not 
justified, the original notifying Member State and any other Member State that has 
taken  a  similar  measure  shall  withdraw  it  and  the  notification  made  under  RAPEX 
pursuant to Article 20. 

Where  a  refusal  is  considered  justified  and  the  product  is  found  not  to  be  in 
compliance  with  Union  harmonisation  legislation  because  of  shortcomings  in  the 
relevant  harmonised  standards,  the  Commission  shall  inform  the  relevant  European 
standardisation organisation and may make an appropriate request pursuant to Article 
11 of Regulation (EU) No. 1025/2012. 

CHAPTER V 

Exchange of information 

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Article 19 

Union Rapid Information Exchange System - RAPEX 

1. 

2. 

3. 

4. 

The  Commission  shall  maintain  the  system  for  rapid  exchange  of  information 
(RAPEX).  Member  States  shall  use  RAPEX  for  exchanging  information  about 
products presenting a risk in accordance with this Regulation. 

Each Member State shall designate a single contact point for RAPEX.  

The Commission may, by means of implementing acts, prescribe the modalities and 
procedures  for  the  exchange  of  information  through  RAPEX.  Those  implementing 
acts  shall  be  adopted  in  accordance  with  the  examination  procedure  referred  to  in 
Article 32(2). 

Participation  in  RAPEX  shall  be  open  to  applicant  countries,  third  countries  or 
international  organisations  within  the  framework  of  and  in  accordance  with 
agreements  between  the  Union  and  those  countries  or  organisations.  Any  such 
agreements  shall  be  based  on  reciprocity  and  include  provisions  on  confidentiality 
corresponding to those applicable in the Union. 

Article 20 

Notification through RAPEX of products presenting a risk 

1. 

The RAPEX contact point shall immediately notify to the Commission information 
on any of the following: 

(a) 

any corrective action taken by economic operators pursuant to Article 9(3); 

(b) 

any measure taken by market surveillance authorities pursuant to Article 10(1) 
or  (4),  unless  it  concerns  a  product  subject  to  a  notification pursuant  to  point 
(a);  

(c) 

any refusal to release a product for free circulation pursuant to Article 16. 

The first subparagraph shall not apply where the RAPEX contact point has reason to 
believe  that  the  effects  of  the  risk  presented  by  a  product  do  not  go  beyond  the 
territory of its Member State.  

The  RAPEX  contact  point  shall  inform  the  Commission  without  delay  of  any 
relevant  update,  modification  or  withdrawal  of  the  corrective  action  or  measures 
referred to in the first subparagraph. 

2. 

The information provided in accordance with paragraph 1 shall include all available 
details relating to the risk and at least the following information: 

(a) 

the nature and level of the risk, including a summary of the results of the risk 
assessment; 

(b) 

the nature of any non-compliance with Union harmonisation legislation; 

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(c) 

the data necessary to identify the product; 

(d) 

the origin and the supply chain of the product;  

(e) 

the date on which the measure or corrective action was taken and its duration; 

(f) 

the  nature  of  the  measure  or  corrective  action  taken  and  whether  voluntary, 
approved, required;  

(g)  whether the economic operator has been given the opportunity to be heard. 

The  information  referred  to  in  the  first  subparagraph  shall  be  transmitted  using  the 
standard notification form made available by the Commission in the RAPEX system. 

3. 

Where  a  notification  relates  to  a  product  found  not  to  comply  with  Union 
harmonisation  legislation,  the  information  provided  shall  also  indicate  whether  the 
non-compliance is due to any of the following: 

(a) 

(b) 

the  failure  of  the  product  to  satisfy  the  requirements  of  the  applicable 
legislation; 

shortcomings in the harmonised standards referred to in that legislation which 
confer a presumption of conformity with those requirements. 

Where a measure or corrective action referred to in paragraph 1 relates to a product 
that  has  undergone  conformity  assessment  by  a  notified  body,  the  market 
surveillance authorities shall ensure that the relevant notified body is informed of the 
corrective action or measures taken. 

4. 

5. 

On  receiving  a  notification,  the  Commission  shall  communicate  it  to  the  other 
Member  States.  If  the  notification  does  not  satisfy  the  requirements  set  out  in 
paragraphs 1, 2 and 3, the Commission may suspend it. 

The  Member  States  shall  immediately  inform  the  Commission  of  the  action  or 
measures  taken  following  receipt  of  a  notification  and  shall  provide  any 
supplementary information, including the results of any tests or analyses carried out 
or  possible  differences  in  views.  The  Commission  shall  immediately  transmit  this 
information to other Member States. 

Article 21 

Information and communication system for market surveillance 

1. 

The  Commission  shall  maintain  an  information  and  communication  system  for 
market surveillance (ICSMS) for the collection and structured storage of information 
on issues relating to market surveillance, in particular the following information: 

(a)  market surveillance authorities and their areas of competence; 

(b)  market surveillance programmes; 

(c) 

the monitoring, review and assessment of market surveillance activities; 

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(d) 

complaints or reports about issues relating to risks arising from products;  

(e) 

(f) 

any non-compliance with Union harmonisation legislation other than measures 
or corrective action notified under RAPEX in accordance with Article 20; 

any  objection  raised  by  a  Member  State  in  accordance  with  Articles  11(1)  or 
18(1) and the follow-up. 

ICSMS  shall  contain  a  record  of  references  to  the  notifications  of  measures  or 
corrective action made under RAPEX in accordance with Article 20.  

ICSMS may also be made available, where necessary or appropriate, for use by the 
authorities in charge of controls at the external borders. 

2. 

3. 

For  the  purposes  of  paragraph  1,  Member  States  shall  enter  into  ICSMS  any 
information at their disposal and not already notified under Article 20 about products 
presenting a risk regarding, in particular, the identification of risks, results of testing 
carried  out,  restrictive  measures  taken,  contacts  with  the  economic  operators 
concerned and justification for action or inaction. 

Market  surveillance  authorities  shall  recognise  the  validity  and  make  use  of  test 
reports prepared by or for their counterparts in other Member States and entered into 
ICSMS. 

Article 22 

International exchange of confidential information 

The  Commission  and  Member  States  may  exchange  confidential  information,  including 
information  exchanged  through  RAPEX,  with  regulatory  authorities  of  third  countries  or 
international  organisations  with  which  the  Commission  and  the  Member  State  or  group  of 
Member States have concluded bilateral or multilateral confidentiality arrangements based on 
reciprocity. 

CHAPTER VI 

Cooperation  

Article 23 

Mutual assistance 

1. 

There shall be efficient cooperation and exchange of information among the market 
surveillance authorities of the Member States, among the different authorities within 
each Member State and between market surveillance authorities and the Commission 
and  the  relevant  Union  agencies  regarding  market  surveillance  programmes  and  all 
issues relating to products presenting a risk. 

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2. 

1. 

2. 

1. 

2. 

3. 

4. 

5. 

6. 

Market surveillance authorities shall, on receipt of a duly motivated request from a 
market  surveillance  authority  in  another  Member  State,  provide  any  relevant 
information or documentation and carry out checks, inspections or investigations and 
report on them and on any follow-up action taken to the requesting authority. 

The  information,  documentation  and  reporting  referred  to  in  the  first  subparagraph 
shall  be  used  only  in  respect  of  the  matter  for  which  it  was  requested  and  shall  be 
processed as quickly as possible, by electronic means.  

Article 24 

Cooperation with the competent authorities of third countries 

Market surveillance authorities may cooperate with the competent authorities of third 
countries  with  a  view  to  exchanging  information  and  technical  support,  promoting 
and facilitating access to Union information exchange systems including the RAPEX 
system  in  accordance  with  Article  19(4),  and  promoting  activities  relating  to 
conformity assessment and market surveillance. 

Cooperation with the competent authorities of third countries shall take the form of, 
inter alia, the types of activities referred to in Article 27. Member States shall ensure 
that their competent authorities participate in those activities. 

Article 25 

European Market Surveillance Forum 

A European Market Surveillance Forum (EMSF) is established.  

Each  Member  State  shall  be  represented  in  meetings  of  the  EMSF  by  a  person  or 
persons  selected  by  the  Member  State  having  the  particular  knowledge  and 
experience required in accordance with the subject matter of the meeting in question. 

The EMSF shall meet at regular intervals and, where necessary, at the request of the 
Commission or a Member State. 

The EMSF shall use its best endeavours to reach consensus. If consensus cannot be 
reached,  the  EMSF  shall  adopt  its  position  by  a  simple  majority  of  its  members. 
Members may request that their positions and the grounds on which they are based 
are officially recorded. 

The EMSF may invite experts and other third parties to attend meetings or provide 
written contributions. 

The EMSF may establish standing or temporary sub-groups which shall include the 
the 
administrative  cooperation  groups  for  market  surveillance  set  up  for 
implementation  of  Union  harmonisation  legislation.  Organisations  representing  the 
interests  of  industry,  small  and  medium-sized  enterprises,  consumers,  laboratories 
and  conformity  assessment  bodies  at  Union  level  may  be  invited  to  participate  in 
such sub-groups as observers.  

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7. 

8. 

1. 

2. 

The  EMSF  shall  establish  its  rules  of  procedure  which  shall  enter  into  force  after 
receiving a favourable opinion from the Commission. 

The  EMSF  shall  cooperate  with  the  Forum  for  Exchange  of  Information  on 
Enforcement established by Regulation (EC) No 1907/2006.  

Article 26 

Commission support and executive secretariat 

The Commission shall support cooperation between market surveillance authorities. 
It shall participate in the meetings of the EMSF and its sub-groups. 

To  perform  the  tasks  set  out  in  Article  27,  the  EMSF  shall  be  assisted  by  an 
executive secretariat that provides technical and logistic support to the EMSF and its 
sub-groups.  

Article 27 

Tasks of the EMSF 

The EMSF shall have the following tasks: 

(a) 

to  facilitate  the  exchange  of  information  on  products  presenting  a  risk,  risk 
assessment, test methods and results, recent scientific developments and other 
aspects relevant to control activities; 

(b) 

to  coordinate  the  preparation  and  implementation  of  the  general  and  sector-
specific market surveillance programmes referred to in Article 7; 

(c) 

to organise joint market surveillance and joint testing projects; 

(d) 

to exchange expertise and best practices; 

(e) 

to organise training programmes and exchanges of national officials; 

(f) 

to assist in monitoring activities as described in Article 4(3); 

(g) 

to organise information campaigns and joint visit programmes; 

(h) 

(i) 

(j) 

to  improve  cooperation  at  Union  level  with  regard  to  the  tracing,  withdrawal 
and recall of products presenting a risk;  

to  ensure  the  easy  access,  retrieval  and  sharing  of  product  safety  information 
collected  by  market  surveillance  authorities, 
information  on 
complaints, accidents, injury reports and investigation and test results; 

including 

to  contribute  to  the  development  of  guidance  to  ensure  the  effective  and 
uniform implementation of this Regulation, taking due account of the interests 
of  business,  in  particular  small  and  medium-sized  enterprises,  and  other 
stakeholders; 

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(k) 

(l) 

to provide advice and assist the Commission, at its request, in its assessment of 
any issue relating to the implementation of this Regulation; 

to  contribute  to  uniform  administrative  practices  with  regard  to  market 
surveillance in the Member States. 

Article 28 

European Union reference laboratories 

1. 

For specific products or a category or group of products or for specific risks related 
to a category or group of products, the Commission may by means of implementing 
acts  designate  Union  reference  laboratories  that  satisfy  the  criteria  set  out  in 
paragraph 2.  

2. 

Each Union reference laboratory shall satisfy the following criteria: 

(a)  have suitably qualified staff with adequate training in the analytical techniques 
used in their area of competence and an adequate knowledge of standards and 
practices; 

(b)  possess  the  equipment  and  reference  material  needed  to  carry  out  the  tasks 

assigned to them; 

(c) 

act in the public interest in an impartial and independent manner; 

(d) 

ensure that the staff respect the confidential nature of certain subjects, results 
or communications. 

3. 

Within  the  area  of  their  designation,  Union  reference  laboratories  shall  where 
appropriate have the following tasks: 

(a) 

(b) 

carrying  out  product  testing  in  relation  to  market  surveillance  activities  and 
investigations; 

contributing  to  the  resolution  of  disputes  between  the  authorities  of  Member 
States, economic operators and conformity assessment bodies; 

(c)  providing independent technical or scientific advice to the Commission and the 

Member States; 

(d)  developing new techniques and methods of analysis; 

(e)  disseminating information and providing training. 

CHAPTER VII 

Financing 

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Article 29 

Financing activities 

1. 

The Union may finance the following activities in relation to the application of this 
Regulation: 

(a) 

(b) 

(c) 

(d) 

(e) 

the  drawing  up  and  updating  of  contributions  to  guidelines  on  market 
surveillance; 

the making available to the Commission of technical or scientific expertise for 
the  purpose  of  assisting  the  Commission  in  its  implementation  of  market 
surveillance  administrative  cooperation  and  the  Union  assessment  procedures 
referred to in Articles 11 and 18; 

the  performance  of  preliminary  or  ancillary  work  in  connection  with  the 
implementation  of  market  surveillance  activities  linked  to  the  application  of 
Union  legislation  such  as  studies,  programmes,  evaluations,  guidelines, 
comparative analyses, mutual joint visits, research work, the development and 
maintenance  of  databases,  training  activities,  laboratory  work,  proficiency 
testing,  inter-laboratory  tests  and  conformity  assessment  work,  and  European 
market surveillance campaigns and similar activities; 

activities  carried  out  under  programmes  of  technical  assistance,  cooperation 
with  third  countries  and  the  promotion  and  enhancement  of  European  market 
surveillance  policies  and  systems  among  interested  parties  at  European  and 
international levels; 

the  functioning  of  cooperation  among  market  surveillance  authorities  and  the 
technical and logistic support by the Executive Secretariat to the EMSF and its 
sub-groups. 

The  Union's  financial  assistance  to  the  activities  under  this  Regulation  shall  be 
implemented  in  accordance  with  Regulation  (EU,  Euratom)  No  966/2012,  either 
directly, or indirectly by delegating budget implementation tasks to the entities listed 
in Article 58(1)(c) of Regulation (EU, Euratom) No 966/2012. 

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

The appropriations determined by the budgetary authority for the financing of market 
surveillance activities may also cover expenses pertaining to preparatory, monitoring, 
control, audit and evaluation activities which are required for the management of the 
activities  pursuant  to  this  Regulation  and  the  achievement  of  their  objectives;  in 
particular,  studies,  meetings  of  experts,  information  and  communication  actions, 
including corporate communication of the political priorities of the Union as far as 
they are related to the general objectives of market surveillance activities, expenses 
linked  to  information  technology  networks  focusing  on  information  processing  and 
exchange,  together  with  all  other  technical  and  administrative  assistance  expenses 
incurred  by  the  Commission  for  the  management  of  the  activities  pursuant  to  this 
Regulation. 

2. 

3. 

4. 

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5. 

1. 

2. 

3. 

4. 

The  Commission  shall  evaluate  the  relevance  of  the  market  surveillance  activities 
that  receive  Union  financing  in  the  light  of  the  requirements  of  Union  policies  and 
legislation  and  inform  the  European  Parliament  and  the  Council  of  the  outcome  of 
that evaluation by [five years following the date of application] and every five years 
thereafter. 

Article 30 

Protection of the Union's financial interests 

The  Commission  shall  take  appropriate  measures  ensuring  that,  when  actions 
financed under this Regulation are implemented, the financial interests of the Union 
are protected by the application of preventive measures against fraud, corruption and 
any other illegal activities, by effective checks and, if irregularities are detected, by 
the  recovery  of  amounts  wrongly  paid  and,  where  appropriate,  by  effective, 
proportionate and dissuasive penalties.  

The  Commission  or  its  representatives  and  the  Court  of  Auditors  shall  have  the 
power  of  audit,  on  the  basis  of  documents  and  on-the-spot  checks,  over  all  grant 
beneficiaries,  contractors  and  subcontractors  and  other  third  parties  who  have 
received Union funds under this Regulation. 

The  European  Anti-fraud  Office  (OLAF)  may  carry  out  on-the-spot  checks  and 
inspections on economic operators concerned directly or indirectly by such funding 
in  accordance  with  the  procedures  laid down  in  Council  Regulation  (Euratom,  EC) 
No 2185/9641 with a view to establishing whether there has been fraud, corruption or 
any other illegal activity affecting the financial interests of the Union in connection 
with a grant agreement or grant decision or a contract concerning Union funding. 

Without prejudice to paragraphs 1 and 2, cooperation agreements with third countries 
and  international  organisations  and  grant  agreements  and  grant  decisions  and 
contracts  resulting  from  the  implementation  of  this  Regulation  shall  expressly 
empower  the  Commission, the Court of Auditors and OLAF to conduct audits, on-
the-spot checks and inspections. 

CHAPTER VIII 

Final provisions 

Article 31 

Penalties 

The Member States shall lay down the rules on penalties applicable to infringements  of the 
provisions  of  this  Regulation  that  impose  obligations  on  economic  operators  and  to 
infringements  of  provisions  of  any  Union  harmonisation  legislation  on  products  covered  by 
this Regulation that impose obligations on economic operators where that legislation does not 

41 

OJ L292, 14.11.1996, p.2. 

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provide  for  penalties,  and  shall  take  all  measures  necessary  to  ensure  that  they  are 
implemented.  The  penalties  provided  for  must  be  effective,  proportionate  and  dissuasive. 
Member  States  shall  notify  those  provisions  to  the  Commission  by  [insert  date  -  3  months 
prior  to  the  date  of  application  of  this  Regulation]  and  shall  notify  it  without  delay  of  any 
subsequent amendment affecting them. 

The  penalties  referred  to  in  the  first  subparagraph  shall  have  regard  to  the  size  of  the 
undertakings  and  in  particular  to  the  situation  of  small  and  medium-sized  enterprises.  The 
penalties  may  be  increased  if  the  relevant  economic  operator  has  previously  committed  a 
similar infringement and may include criminal sanctions for serious infringements. 

Article 32 

Committee procedure 

1. 

2. 

3. 

The  Commission  shall  be  assisted  by  a  Committee.  That  Committee  shall  be  a 
committee within the meaning of Regulation (EU) No 182/2011. 

Where  reference  is  made  to  this  paragraph,  Article  5  of  Regulation  (EU)  No 
182/2011 shall apply. 

Where  reference  is  made  to  this  paragraph,  Article  8  of  Regulation  (EU)  No 
182/2011, in conjunction with Article 5 thereof, shall apply. 

Article 33 

Evaluation 

No  later  than  [five]  years  after  the  date  of  application,  the  Commission  shall  assess  the 
application  of  this  Regulation  and  transmit  an  evaluation  report  to  the  European  Parliament 
and  the  Council.  That  report  shall  assess  if  this  Regulation  achieved  its  objectives,  in 
particular with regard to ensuring more effective and efficient enforcement of product safety 
rules  and  Union  harmonisation 
improving  cooperation  between  market 
surveillance authorities, strengthening the controls of products entering the Union and better 
protecting  the  health  and  safety  of  persons  in  general,  health  and  safety  in  the  workplace, 
consumer protection, the environment, public security and other public interests, taking into 
account its impact on business and in particular on small and medium-sized enterprises. 

legislation, 

Article 34 

Amendments 

1. 

The following provisions are deleted: 

(a) 

 Article 18 of Directive 2011/65/EU;  

(b)  Article 7 of Council Directive 89/686/EEC;  

(c) 

 Paragraphs 2 and 3 of Article 7 and Article 8 of Directive 93/15/EEC;. 

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(d)  Article 7 of Directive 94/9/EC;  

(e)  Article 7, paragraph 4 of Article 10 and Article 11 of Directive 94/25/EC;  

(f)  Articles 7 and 11 of Directive 95/16/EC; 

(g) 

 Articles 8, 16 and 18 of Directive 97/23/EC;  

(h) 

 Article 9 of Directive 1999/5/EC;  

(i)  Articles 14, 15 and 19 of Directive 2000/9/EC;  

(j)  Article 5 of Directive 2000/14/EC; 

(k)  Paragraphs  2  and  3  of  Article  6  and  Articles  8,  9,  10,  11,  12  and  13  of,  and 

Annex II to, Directive 2001/95/EC; 

(l) 

 Articles 10 and 11 of Directive 2004/108/EC;  

(m)  Paragraphs  3  and  4  of  Article  4  and  Articles  11,  17  and  20  of  Directive 

2006/42/EC;  

(n) 

 Article 9 of Directive 2006/95/EC;  

(o) 

 Paragraphs  5  and  6  of  Article  14  and  Articles  15,  16  and  17  of  Directive 
2007/23/EC;  

(p)  Paragraph 5 of Article 13 and Article 14 of Directive 2008/57/EC;  

(q) 

 Articles 39, 40, 42 to 45 of Directive 2009/48/EC;  

(r)  Articles 7, 15 and 17 of Directive 2009/105/EC;  

(s)  Articles 7, 11 and 12 of Directive 2009/142/EC;  

(t)  Articles 56 to 59 of Regulation (EU) No 305/2011.  

2. 

Point  (a)  of  Article  3(2)  of  Regulation  (EC)  No  764/2008  is  replaced  by  the 
following:  

'(a) Article 10 of Regulation (EU) No […] [on market surveillance of products];' 

3. 

Regulation (EC) No 765/2008 is amended as follows: 

(a) 

 Paragraphs  2  and  3  of  Article  1,  points  14,  15,  17,  18  and  19  of  Article  2, 
Chapter III and Article 32(1)(e) of Regulation (EC) No 765/2008 are deleted; 

(b)  The title of Regulation (EC) No 765/2008 is replaced by the following: 

'Regulation (EC) No 765/2008 of the European Parliament and of the Council 
of  9  July  2008  laying  down  the  requirements  for  accreditation  of  conformity 
assessment  bodies  and  general  principles  of  CE  marking  and  repealing 
Regulation (EEC) No 339/93' 

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References  to  the  provisions  of  Articles  15  to  29  of  Regulation  (EC)  No  765/2008  shall  be 
construed as references to this Regulation and shall be read in accordance with the correlation 
table in the Annex. 

Article 35 

Transitional provisions 

Procedures initiated at national or Union level pursuant to any of the provisions referred to in 
Article 34 of this Regulation or to Articles 6 to 9 of Directive 2001/95/EC shall continue to be 
governed by those provisions. 

Article 36 

Entry into force 

This Regulation shall enter into force on [insert date - the same day as Regulation (EU) No 
[…/…] [on Consumer Product Safety] 

It shall apply from 1 January 2015. 

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 

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ANNEX 

Correlation table 

Regulation EC No. 765/2008 

This Regulation 

Article 15(1), (2) and (5) 

Article 15(3) 

Article 15(4) 

Article 16(1) 

Article 16(2) 

Article 16(3) 

Article 16(4) 

Article 17(1) 

Article 17(2) 

Article 18(1) 

Article 18(2) 

Article 18(3) 

Article 18(4) 

Article 2 

- 

Article 3(1) 

Article 4(1) 

Article 4(2) read in conjunction with Article 
3(12); Article 17(1) and Article 26 (5) 

- 

-  

Article 5(4) 

Article 26(1) 

Article 5(3) 

Article 6(6) 

Article 5(2) 

Article 6(4) 

Article 18(5) and (6) 

Article 4(3), Article 6(7)(8) and (9) and 
Article 26(2) 

Article 19(1) first subparagraph 

Article 6(1) 

Article 19(1) second subparagraph 

Article 6(5) and Article 7 

Article 19(1) third subparagraph 

Article 8(1) second subparagraph 

Article 19(2) 

Article 19(3) 

Article 19(4) 

Article 19(5) 

Article 20(1) 

Article 6(2) 

Article 9(5)(a) 

Article 6(3) 

Article 26(5) and Article 27 

Articles 9(4) and 18(1)(b) 

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Article 20(2)  

Article 21 

Article 12 

Article 6(4) and Article 9 

Article 22(1), (2) and (3) 

Article 18(1) and (2) 

Article 22(4) 

Article 23(1) and (2) 

Article 23(3) 

Article 24(1) and (2) 

Article 24(3) 

Article 24(4) 

Article 25 

Article 26 

Article 27 

Article 28 

Article 29 

Article 17 

Article 19 

Article 27 

Article 20 

Article 19(1) 

Article 18(2) and Article 19(2) 

Articles 22 to 24 

Article 21 

Article 13 

Article 14 

Article 15 

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LEGISLATIVE FINANCIAL STATEMENT 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1. 

Title of the proposal/initiative  

1.2. 

Policy area(s) concerned in the ABM/ABB structure 

1.3. 

Nature of the proposal/initiative  

1.4. 

Objective(s)  

1.5. 

Grounds for the proposal/initiative  

1.6. 

Duration and financial impact  

1.7.  Management method(s) envisaged  

2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

2.2.  Management and control system  

2.3.  Measures to prevent fraud and irregularities  

3. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

3.1. 

Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget 
line(s) affected  

3.2. 

Estimated impact on expenditure  

3.2.1. 

Summary of estimated impact on expenditure  

3.2.2.  Estimated impact on operational appropriations  

3.2.3.  Estimated impact on appropriations of an administrative nature 

3.2.4.  Compatibility with the current multiannual financial framework 

3.2.5.  Third-party participation in financing  

3.3. 

Estimated impact on revenue 

EN 

42 

   EN 

 
LEGISLATIVE FINANCIAL STATEMENT 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1. 

Title of the proposal/initiative  

Proposal for a Regulation of the European Parliament and of the Council on market 
surveillance of products 

1.2. 

Policy area(s) concerned in the ABM/ABB structure42  

Title 2 – Enterprise - Chapter 02 03: Internal market for goods and sectoral policies 

Title 17 – Health and consumer protection – Chapter 17 02: Consumer policy 

1.3. 

Nature of the proposal/initiative  

The proposal/initiative relates to the extension of an existing action  

1.4. 

Objectives 

1.4.1.  The  Commission's  multiannual 

strategic  objective(s) 

targeted  by 

the 

proposal/initiative  

Internal  market  for  goods  and  sectoral  policies:  to  improve  the  functioning  of  the 
single market and to achieve a high level of protection of consumers, other users and 
other public interests; 

Security and citizenship – consumer policy.  

1.4.2. 

Specific objective(s) and ABM/ABB activity(ies) concerned  

ENTR specific objective: To continually review existing internal market acquis and 
propose new legislative or non-legislative action whenever appropriate. 

SANCO  specific  objective:  To  consolidate  and  enhance  product  safety  through 
effective market surveillance throughout the Union 

42 

ABM: Activity-Based Management – ABB: Activity-Based Budgeting. 

EN 

43 

   EN 

 
                                                 
1.4.3.  Expected result(s) and impact 

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 

The  expected  result  of  this  initiative  is  to  improve  the  framework  of  the  market 
surveillance  which is still  fragmented  in the Union. This proposal amalgamates the 
provisions  of  the  Regulation  765/2008/EC  and  of  the  General  Product  Safety 
Directive  regarding  the  market  surveillance  into  one  single  piece  of  legislation 
covering  products  in  both  the  harmonised  and  non-harmonised  acquis,  regardless 
whether  they  are  destined  for  use,  or  are  likely  to  be  used,  by  consumers  or 
professionals. 

This  proposal  will  have  an  impact  on  economic  operators  and  national  authorities 
who  will  be  better  informed  on  their  obligations  regarding  market  surveillance 
actions.  

The  proposal  will  also  enhance  the  protection  of  consumers  and  other  users  of 
products through more effective enforcement of product-related requirements. 

1.4.4. 

Indicators of results and impact  

Specify the indicators for monitoring implementation of the proposal/initiative. 

-  Number  of  notifications  regarding  unsafe  products  in  the  GRAS-RAPEX 
information system;  

- % of RAPEX notifications entailing at least one reaction (by other Member States 

- Ratio number of reactions / number of notifications (serious risks)-  

-  Volume  and  quality  of  data  exchanged  the  general  information  support  system 
ICSMS, 

- Number and results of joint market surveillance actions,  

- Work- and resource-sharing. 

-  Product  safety  enforcement  indicators  (budgets,  inspections,  laboratory  tests, 
measures taken etc.) 

1.5. 

Grounds for the proposal  

1.5.1.  Requirement(s) to be met in the short or long term  

The  general  objective  of  this  initiative  is  to  improve  the  functioning  of  the  single 
market and to achieve a high level of protection of consumers, other users and other 
public  interests  through  the  reduction  of  number  of  unsafe  or  non-compliant 
products. 

EN 

44 

   EN 

 
 
 
1.5.2.  Added value of EU involvement 

Despite  the  existence  of  the  single  European  market,  the  enforcement  of  product 
safety  requirements  is  the  Member  States'  competence.  Due  to  the  existing 
differences in the national organisation of market surveillance in the Member States 
and to the interdependence of the national market surveillance authorities, problems 
still appears. The EU has the right to act on the basis of Article 114 TFEU, in order 
to ensure the proper functioning of the single market for consumer products and to 
increase the efficiency of cross-border market surveillance. Article 169(1) of TFEU 
complements  this  right  to  act.  It  stipulates  that  in  order  to  promote  the  interests  of 
consumers  and  to  ensure  a  high  level  of  consumer  protection,  the  Union  shall, 
amongst others, contribute to protecting the health, safety and economic interests of 
consumers. However, in order to comply with the subsidiarity principle, this proposal 
does  not  affect  the  competence  of  the  Member  States  to  carry  out  procedures  and 
actions against concrete products posing risks.  

1.5.3.  Lessons learned from similar experiences in the past 

Although the EU has achieved the Single Market and the free movement of goods is 
the most developed and best established of the four freedoms making up the internal 
market, there are still  things to  be done. Public health and safety in the workplace, 
protection  of  consumers,  protection  of  the  environment  and  other  public  interests 
may be undermined due to some traders who do not comply with the law and place 
on the market dangerous products. Market surveillance is meant to be an answer to 
all  these  issues.  Nevertheless,  market  surveillance  has  not  kept  pace  with 
developments in the Union regulatory framework. It needs to be highly coordinated 
and capable of reacting rapidly throughout EU. It is true that progress has been made 
with  the  implementation  of  the  General  Product  Safety  Directive  and  with  the 
Regulation 765/2008/EC, but the fragmentation of market surveillance rules among 
different  pieces  of  EU  legislation  (the  General  Product  Safety  Directive,  the 
Regulation 765/2008/EC and many sectorial directives) has led to confusion of both 
economic operators and national authorities and to a reduced effectiveness of market 
surveillance activity in the Union. Therefore, this proposal for a single, self-standing 
market surveillance regulation would be essential to tackle these problems. 

1.5.4.  Coherence and possible synergy with other relevant instruments 

This initiative is entirely coherent with the acquis on the free movement of goods, in 
particular Directive 2009/48/EC of the European Parliament and of the Council of 18 
June  2009  on  the  safety  of  toys,  Directive  2011/65/EU  of  the  European  Parliament 
and of the Council of 8 June 2011 on the restriction of the use of certain hazardous 
substances  in  electrical  and  electronic  equipment,  Directive  2002/96/EC  of  the 
European Parliament and of the Council of 27 January 2003 on waste electrical and 
electronic  equipment  (WEEE),  Directive  2012/19/EU  of  the  European  Parliament 
and  of  the  Council  of  4  July  2012  on  waste  electrical  and  electronic  equipment 
(WEEE), Directive 2006/95/EC of the European Parliament and of the Council of 12 
December  2006  on  the  harmonisation  of  the  laws  of  Member  States  relating  to 
electrical  equipment  designed  for  use  within  certain  voltage  limits,  Directive 

EN 

45 

   EN 

 
2009/142/EC of the European Parliament and of the Council of 30 November 2009 
relating to appliances burning gaseous fuels.43 

This proposal is also coherent with the accompanying proposal for a Regulation on 
Consumer  Product  Safety  which  will  replace  Directive  2001/95/EC  on  General 
Product Safety. 

The proposal creates synergies with regard to the notification of unsafe products and 
of safeguard measures under sectoral legislation which in the future will need to be 
notified only once under the revised RAPEX system. 

43 

The whole list of the sectoral legislation can be found in the annex of this regulation. 

EN 

46 

   EN 

 
                                                 
1.6. 

Duration and financial impact  

Proposal/initiative of unlimited duration 

1.7.  Management mode(s) envisaged  

X Centralised direct management by the Commission  

X  Centralised  indirect  management  with  the  delegation  of  implementation  tasks 
to: 

• 

X 

executive agencies  

•  (cid:133) 

bodies set up by the Communities44  

•  (cid:133) 

national public-sector bodies/bodies with public-service mission  

(cid:133) 
persons entrusted with the implementation of specific actions pursuant to Title 
V of the Treaty on European Union and identified in the relevant basic act within the 
meaning of Article 49 of the Financial Regulation  

(cid:133) Shared management with the Member States  

(cid:133) Decentralised management with third countries  

(cid:133) Joint management with international organisations (to be specified) 

If more than one management mode is indicated, please provide details in the "Comments" section. 

Comment: 

This initiative does not require new budgetary resources but will be financed through 
redeployment of existing resources. Some actions will be managed by the Executive 
Agency for Health and Consumers (EAHC): In accordance with Council Regulation 
(EC)  No  58/2003  of  19  December  2002  laying  down  the  statute  for  Executive 
Agencies  to  be  entrusted  with  certain  tasks  in  the  management  of  Community 
programmes45, the Commission has entrusted46 the Executive Agency for Health and 
Consumers  with  implementation  tasks  for  the  management  of  the  Programme  of 
Community Action in the field of Consumer policy for 2007-2013. The Commission 
may therefore decide to entrust the Executive Agency for Health and Consumers also 
with implementation tasks for the management of the Consumers Programme 2014-
2020, which, once adopted, should be the legal basis for procurement and grants in 
the  field  of  product  safety.  The  envisaged  programme  delegation  will  be  the 
extension of tasks already externalised to the EAHC.  

Furthermore, this initiative does not require additional budget resources for the costs 
related  to  the  management,  maintenance  and  adaptations  for  both  IT  systems,  i.e. 

44 
45 
46 

As referred to in Article 185 of the Financial Regulation. 
OJ L 11, 16.1.2003, p. 1. 
Commission Decision C(2008)4943 of 9 September 2008. 

EN 

47 

   EN 

 
                                                 
GRAS-RAPEX  and  ICSMS,  compared  to  those  already  included  in  the  operational 
budgets of DG SANCO and DG ENTR proposed for the MFF 2014-2020.  

EN 

48 

   EN 

 
2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

Specify frequency and conditions. 

The future market Surveillance Forum (EMSF) will be the platform for discussions 
regarding the proper implementation of the future regulation. 

A final provision also proposes that the Commission makes an evaluation and drafts 
a report regarding the implementation five years after its entry into force. This should 
identify  possible  problems  and  shortcomings  of  the  Regulation  and  could  be  the 
starting point for further actions, including a possible proposal to amend it, in view 
of further improvement of market surveillance framework. 

2.2.  Management and control system  

2.2.1.  Risk(s) identified  

Risks  relating  to  the  proper  functioning  of  RAPEX  (e.g.  increase  of  number  of 
notifications  diverting  attention  from  really  dangerous  products  or  reducing  its 
credibility;  IT-related  probems  such  as  breakdown  of  the  system,  confidentiality 
issues). 

The  risks  related  to  the  functioning  of  ICSMS  relate  mainly  to  IT-related  probems 
such as a possible breakdown of the system and confidentiality issues. 

2.2.2.  Control method(s) envisaged  

The control methods envisaged are laid down in the Financial Regulation and Rules 
of Application. 

2.3.  Measures to prevent fraud and irregularities  

Specify existing or envisaged prevention and protection measures. 

The Commission must ensure that the financial interests of the Union 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 Regulations (EC, Euratom) No 2988/95, (Euratom, EC) No 2185/96 
and  (EC)  No  1073/1999.  In  addition  to  the  application  of  all  regulatory  control 
mechanisms,  the  competent  Commission  services  will  devise  an  anti-fraud  strategy 
in  line  with  the  Commission's  new  anti-fraud  strategy  (CAFS;  adopted  on  24  June 
2011) in order to ensure inter alia that its internal anti-fraud related controls are fully 
aligned  with  the  CASF  and  that  its  fraud  risk  management  approach  is  geared  to 
identify  fraud  risk  areas  and  adequate  responses.  Where  necessary,  networking 
groups  and  adequate  IT  tools  dedicated  to  analysing  fraud  cases  related  to  the 
Consumer Programme will be set up. In particular a series of measures will be put in 
place such as: 

EN 

49 

   EN 

 
• 

• 

• 

• 

decisions,  agreements  and  contracts  resulting  from  the  implementation  of  the 
Consumer Programme will expressly entitle the Commission, including OLAF, 
and  the  Court  of  Auditors  to  conduct  audits,  on-the-spot  checks  and 
inspections; 

during  the  evaluation  phase  of  a  call  for  proposals/tender,  the  proposers  and 
tenderers  are  checked  against  the  published  exclusion  criteria  based  on 
declarations and the Early Warning System (EWS); 

the rules governing the eligibility of costs will be simplified in accordance with 
the provisions of the Financial Regulation. 

regular training on issues related to fraud and irregularities is given to all staff 
involved  in  contract  management  as  well  as  to  auditors  and  controllers  who 
verify the beneficiaries' declarations on the spot. 

EN 

50 

   EN 

 
3. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

3.1. 

Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget 
line(s) affected  

Existing expenditure budget lines 

In order of multiannual financial framework headings and budget lines. 

Budget line 

Type of  
expenditure

Contribution  

Number  
[Description………………………...……….] 

Diff./non-
diff. 
(47) 

from 
48
EFTA
countries 

from 
candidate 
49
countries

from third 
countries 

within the 
meaning of Article 
18(1)(aa) of the 
Financial 
Regulation  

02.03.01. 

17.01.04.01 

Administrative  expenditure  in  support  of  the 
Consumer Programme 2014 - 2020 

New budget lines requested 

Diff 

YES 

NO 

NO 

NO 

Non-
diff. 

YES 

NO 

NO 

NO 

In order of multiannual financial framework headings and budget lines. 

Budget line 

Type of 
expenditure

Contribution  

Number  
[Heading……………………………………..] 

Diff./non-
diff. 

from 
EFTA 
countries 

from 
candidate 
countries 

from third 
countries 

within the 
meaning of Article 
18(1)(aa) of the 
Financial 
Regulation  

Heading of 
multiannual 
financial 
framework 

N° 1: 
Internal 
Market for 
goods and 
sectoral 
policies 

N° 3: 
Security and 
citizenship 

Heading of 
multiannual 
financial 
framework 

N° 3: 
Security and 
citizenship 

17 02 01 
Consumer Programme 2014 - 2020 

Diff. 

YES 

YES 

NO 

NO 

47 
48 
49 

Diff. = Differentiated appropriations / Non-diff. = Non-Differentiated Appropriations 
EFTA: European Free Trade Association.  
Candidate countries and, where applicable, potential candidate countries from the Western Balkans. 

EN 

51 

   EN 

 
 
 
 
                                                 
3.2. 

Estimated impact on expenditure  

3.2.1. 

Summary of estimated impact on expenditure50  

Heading of multiannual financial 
framework:  

1 

Internal market for goods and sectoral policies 

EUR million in current prices (to 3 decimal places) 

DG: ENTR 

2015 

2016 

2017 

2018 

2019 

2020 

TOTAL 

(cid:121) Operational appropriations  

Number of budget line 02.03.01 

Appropriations 
administrative 
 from the envelope for specific programmes51  

an 

of 

Number of budget line: 

Commitments 

Payments 

(1) 

(2) 

1,300 
1,300 

1,300 
1,300 

1,300 
1,300 

1,300 
1,300 

1,300 
1,300 

1,300 
1,300 

nature 

financed 

Commitments 

Payments 

(1a) 

(2a) 

0 

0 
0 

0 

0 
0 

0 

0 
0 

0 

0 
0 

0 

0 
0 

0 

0 
0 

TOTAL appropriations 
for DG ENTR 

Commitments 

=1+1a 

1,300 

1,300 

1,300 

1,300 

1,300 

1,300 

Payments 

=2+2a 

1,300 

1,300 

1,300 

1,300 

1,300 

1,300 

(cid:121) TOTAL operational appropriations  

Commitments 

Payments 

(3) 

(4) 

1,300 

1,300 

1,300 

1,300 

1,300 

1,300 

1,300 

1,300 

1,300 

1,300 

1,300 

1,300 

7,800 
7,800 

0 

0 
0 

7,800 

7,800 

7,800 

7,800 

50 
51 

EN 

Amounts subject to the outcome of the Commission proposal for the new Multi-annual Financial Framework 2014-2020. 
Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former "BA" lines), indirect research, 
direct research. 

52 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
(cid:121)  TOTAL  appropriations  of  an  administrative  nature 
financed from the envelope for specific programmes  

(5) 

0 

0 

0 

0 

0 

0 

0 

TOTAL appropriations  
under HEADING 02 
of the multiannual financial framework 

Commitments 

=3+ 5 

1,300 

1,300 

1,300 

1,300 

1,300 

1,300 

Payments 

=4+ 5 

1,300 

1,300 

1,300 

1,300 

1,300 

1,300 

7,800 

7,800 

Heading of multiannual financial 
framework:  

3 

Security and citizenship 

2015 

2016 

2017 

2018 

2019 

2020 

TOTAL 

DG: SANCO 

(cid:121) Operational appropriations  

Number of budget line 17.02.01 

Appropriations 
administrative 
 from the envelope for specific programmes52  

an 

of 

Number of budget line: 17.01.04.01 

Commitments 

Payments 

(1) 

(2) 

nature 

financed 

Commitments 

Payments 

(1a) 

(2a) 

3,000 

3,060 

3,121 

3,184 

3,247 

3,312 

1,500 

3,030 

3,091 

3,152 

3,215 

4,936 

0,100 

0,100 

0,100 

0,100 

0,100 

0,100 

0,100 

0,100 

0,100 

0,100 

0,100 

0,100 

TOTAL appropriations 
for DG SANCO 

Commitments 

=1+1a 

3,100 

3,160 

3,221 

3,284 

3,347 

3,412 

Payments 

=2+2a 

1,600 

3,130 

3,191 

3,252 

3,315 

5,036 

18,924 

18,924 

0,600 

0,600 

19,524 

19,524 

52 

EN 

Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former "BA" lines), indirect research, 
direct research. 

53 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
                                                 
(cid:121) TOTAL operational appropriations  

Commitments 

Payments 

(cid:121)TOTAL appropriations of an administrative nature financed 
from the envelope for specific programmes  

(3) 

(4) 

(5) 

3,000 

3,060 

3,121 

3,184 

3,247 

3,312 

1,500 

3,030 

3,091 

3,152 

3,215 

4,936 

0,100 

0,100 

0,100 

0,100 

0,100 

0,100 

TOTAL appropriations  
under HEADING 3 
of the multiannual financial framework 

Commitments 

=3+ 5 

3,100 

3,160 

3,221 

3,284 

3,347 

3,412 

Payments 

=4+ 5 

1,600 

3,130 

3,191 

3,252 

3,315 

5,036 

If more than one heading is affected by the proposal / initiative: 

(cid:121) TOTAL operational appropriations  

Commitments 

Payments 

(cid:121)  TOTAL  appropriations  of  an  administrative  nature 
financed from the envelope for specific programmes  

(6) 

(7) 

(8) 

4,300 

4,360 

4,421 

4,484 

4,547 

4,612 

2,800 

4,330 

4,391 

4,452 

4,515 

6,236 

0,100 

0,100 

0,100 

0,100 

0,100 

0,100 

Commitments 

=6+ 8 

4,400 

4,460 

4,521 

4,584 

4,647 

4,712 

TOTAL appropriations  
under HEADINGS 1 to 4 
of the multiannual financial framework 
(Reference amount) 

18,924 

18,924 

0,600 

19,524 

19,524 

26,724 

26,724 

0,600 

27,324 

Payments 

=7+ 8 

2,900 

4,430 

4,491 

4,552 

4,615 

6,336 

27,324 

EN 

54 

EN 

 
  
 
 
 
Heading of multiannual financial 
framework:  

5 

" Administrative expenditure " 

2015 

2016 

2017 

2018 

2019 

2020 

TOTAL 

EUR million in current prices (to 3 decimal places) 

DG: ENTR 

(cid:121) Human resources  

0,786 

0,786 

0,786 

0,786 

0,786 

0,786 

(cid:121) Other administrative expenditure  

0,079 

0,079 

0,079 

0,079 

0,079 

0,079 

DG SANCO 

(cid:121) Human resources  

1,048 

1,048 

1,048 

1,048 

1,048 

(cid:121) Other administrative expenditure (missions, meetings) 

0,079 

0,079 

0,079 

0,079 

0,079 

1,048 

0,079 

TOTAL 

Appropriations  

1,992 

1,992 

1,992 

1,992 

1,992 

1,992 

4,716 

0,474 

6,288 

0,474 

11,952 

TOTAL appropriations 
under HEADING 5 
of the multiannual financial framework  

(Total 
= Total payments) 

commitments 

1,992 

1,992 

1,992 

1,992 

1,992 

1,992 

11,952 

EUR million in current prices (to 3 decimal places) 

TOTAL appropriations  
under HEADINGS 1 to 5 

Commitments 

6,392 

6,452 

6,513 

6,576 

6,639 

6,704 

of the multiannual financial framework  Payments 

4,892 

6,422 

6,483 

6,544 

6,607 

8,328 

2015 

2016 

2017 

2018 

2019 

2020 

TOTAL 

39,276 

39,276 

EN 

55 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.2.  Estimated impact on operational appropriations  

The proposal/initiative requires the use of operational appropriations, as explained below: 

2015 

2016 

2017 

2018 

2019 

2020 

TOTAL 

Commitment appropriations in EUR million in current prices (to 3 decimal places) 

Indicate objectives 
and outputs  

(cid:216)  

Type 
of 
output
53

Avera
ge 
cost  
of the 
output 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

Total 
number 
of 
outputs 

Total  
cost 

54

OBJECTIVE

SPECIFIC 
To 
continually  review  existing  internal  market 
acquis  and  propose  new  legislative  or  non-
legislative action whenever appropriate 

: 

Guidelines and 
inter-comparison 
activities 

Technical expertise 
and assistance 

Promotion of 
European market 
surveillance 
policies 

0.050 

1 

0.050 

1 

0.050 

1 

0.050 

1 

0.050 

1 

0.050 

1 

0,050 

0.600 

1 

0.600 

1 

0.600 

1 

0.600 

1 

0.600 

1 

0.600 

1 

0,600 

6 

6 

0.300 

3.600 

0.050 

1 

0.050 

1 

0.050 

1 

0.050 

1 

0.050 

1 

0.050 

1 

0.050 

6 

0.300 

53 
54 

Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.). 
As described in Section 1.4.2. "Specific objective(s)…" 

EN 

56 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Cooperation with 
third countries 

Support to market 
surveillance 
authorities 
(including ICSMS) 

0.100 

1 

0.100 

1 

0.100 

1 

0.100 

1 

0.100 

1 

0.100 

1 

0.100 

6 

0.600 

0.500 

2 

0.500 

2 

0.500 

2 

0.500 

2 

0.500 

2 

0.500 

2 

0.500 

12 

3.000 

Sub-total for specific objective ENTR 

6 

1.300 

6 

1.300 

6 

1.300 

6 

1.300 

6 

1.300 

6 

1.300 

36 

7.800 

SPECIFIC OBJECTIVE: 

SANCO 

- Output 

Market surveillance 
and enforcement 
actions (joint 
actions, exchange 
of officials, funding 
of the Market 
Surveillance Forum 
Secretariat) 

Further 
development and 
management of 
RAPEX (especially 
IT applications) 

2,357 

3

2,242 

3

2,287

3

2,333

3 

2,380

3

2,427

3 

2,425 

18 

14,144 

0,797 

1

0,758 

1

0,773

1

0,788

1 

0,804

1

0,820

1 

0,837 

6 

4,780 

EN 

57 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sub-total for specific objective 
SANCO  

4

3,000 

4

3,060

4

3,121

4 

3,184

4

3,247

4 

3,312 

24 

18,924 

TOTAL COST 

4,300 

4,360 

4,421 

4,484 

4,547 

4,612 

26,724 

EN 

58 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.3.  Estimated impact on appropriations of an administrative nature 

3.2.3.1.  Summary  

The  proposal/initiative  requires  the  use  of  administrative  appropriations,  as 
explained below: 

EUR million in current prices (to 3 decimal places) 

2015 

2016 

2017 

2018 

2019 

2020 

TOTAL 

HEADING 5 
of the multiannual financial 
framework 

Human resources ENTR  

0,786 

0,786 

0,786 

0,786 

0,786 

0,786 

4.716 

1,048 

1,048 

1,048 

1,048 

1,048 

1,048 

6,288 

0,079 

0,079 

0,079 

0,079 

0,079 

0,079 

0,474 

0,079 

0,079 

0,079 

0,079 

0,079 

0,079 

0,474 

1,992 

1,992 

1,992 

1,992 

1,992 

1,992 

11,952 

Human resources SANCO 
(Average cost FTE: 131.000 €) 

Other administrative 
expenditure ENTR 

Other administrative 
expenditure SANCO 

Subtotal HEADING 5 
of the multiannual financial 
framework  

Outside HEADING 5

55

of the multiannual financial 
framework  

Human resources  

0 

0 

0 

0 

0 

0 

Other expenditure  
of an administrative nature 
SANCO 

Subtotal  
outside HEADING 5 
of the multiannual financial 
framework  

0,100 

0,100 

0,100 

0,100 

0,100 

0,100 

0,600 

0,100 

0,100 

0,100 

0,100 

0,100 

0,100 

0,600 

TOTAL 

2,092 

2,092 

2,092 

2,092 

2,092 

2,092 

12,552 

55 

Technical  and/or  administrative  assistance  and  expenditure  in  support  of  the  implementation  of  EU 
programmes and/or actions (former "BA" lines), indirect research, direct research. 

EN 

59 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.2.3.2.  Estimated requirements of human resources  

The proposal/initiative requires the use of human resources, as explained below: 

02 01 01 01 (Headquarters and Commission’s 
Representation Offices) – ENTR  

17 01 01 01 (Headquarters and Commission’s 
Representation Offices) – SANCO (Average 
cost FTE: 131.000 €)  

XX 01 01 02 (Delegations) 

XX 01 05 01 (Indirect research) 

10 01 05 01 (Direct research) 

XX 01 02 01 (CA, INT, SNE from the "global 
envelope") 

XX 01 02 02 (CA, INT, JED, LA and SNE in 
the delegations) 

XX 01 04 yy 56 

- at Headquarters57 

- in delegations  

XX 01 05 02 (CA, INT, SNE - Indirect 
research) 

10 01 05 02 (CA, INT, SNE - Direct research) 

Other budget lines (specify) 

TOTAL (ENTR, SANCO) 

EUR million in current prices (to 3 decimal places) 

2015 

2016 

2017 

2018 

2019 

2020 

0,786 

0,786 

0,786 

0,786 

0,786 

0,786 

1,048 

1,048 

1,048 

1,048 

1,048 

1,048 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

1,834 

1,834 

1,834 

1,834 

1,834 

1,834 

XX is the policy area or budget title concerned. 

The  human  resources  required  will  be  met  by  staff  from  the  DG  who  are  already 
assigned to management of the action and/or have been redeployed within the DG, 
together  if  necessary  with  any  additional  allocation  which  may  be  granted  to  the 
managing  DG  under  the  annual  allocation  procedure  and  in  the  light  of  budgetary 
constraints.  The  resources  required  are  indicated  without  taking  into  account  the 
tasks which will be implemented by an executive agency. The proposal does not lead 
to an increase of the resources already involved in the executive agency. 

Description of tasks to be carried out:  

Officials and temporary agents 

Administrators: 

•  Ensure, monitor and report on the proper implementation and 
application of EU policies in the area of market surveillance. 

•  Participate in developing tools and carrying out benchmarking of 

Member States' enforcement of the Market surveillance Regulation. 

•  Participate in the operation of the RAPEX system, including 

56 
57 

Under the ceiling for external personnel from operational appropriations (former "BA" lines). 
Essentially  for  Structural  Funds,  European  Agricultural  Fund  for  Rural  Development  (EAFRD)  and 
European Fisheries Fund (EFF). 

EN 

60 

   EN 

 
 
 
                                                 
assessment of notifications and reactions; 

•  Management and development of the ICSMS platform and the 

corresponding guidelines; 

•  Follow policy developments in the area of market surveillance and 

information exchange between Member States. 

•  Participate and represent the Commission in expert groups linked to 

market surveillance. 

•  Conceive new activities or extensions of existing activities and 

perform conceptual reflections.  

•  Develop and ensure Member States' market surveillance coordination 

and joint actions. 

•  Participate in the development, adoption and then implementation of 
revised RAPEX guidelines and revised risk-assessment guidelines. 

Assistants: 

•  Provide administrative assistance in relation to the operation of the 

RAPEX system as a member of the internal RAPEX team. 

•  Signal possible inconsistencies or overlaps in notifications and 
contribute to and provide assistance in RAPEX Contact Points 
meetings. 

•  Contribute to follow up of RAPEX notifications, under the supervision 
of the responsible Administrator, in case of a formal noncompliance of 
notification. 

•  Contribute towards the preparation of the weekly report regarding 

validated notifications. 

•  Co-ordinate and authorize translation requests through Poetry. 

•  Contribute to the implementation and the carrying out of the internal 
control standards in particular by ensuring business continuity in 
RAPEX alerting team coordinator and management in cases of issues 
arising requiring their attention 

•  Coordinate information and document management in relation to 

validation of notifications and reactions in RAPEX. 

•  Elaborate and manage statistics and reports related to RAPEX. 

•  Elaborate internal procedures relating to GRAS RAPEX management 

and contribute to corresponding manuals. 

External personnel 

EN 

61 

   EN 

 
 
 
3.2.4.  Compatibility with the current multiannual financial framework  

The  proposal  is  compatible  with  the  new  Multi-annual  Financial  Framework  2014-
2020 as proposed by the Commission. 

3.2.5.  Third-party contributions  

The proposal does not provide for co-financing by third parties  

3.3. 

Estimated impact on revenue  

The Proposal has no financial impact on revenue. 

EN 

62 

   EN