COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE More Product Safety and better Market Surveillance in the Single Market for Products
Date: 2013-02-13
Institutions: European Commission
Subjects: administrative formalities, economic growth, market supervision, product safety, single market

EUROPEAN 
COMMISSION 

Brussels, 13.2.2013  
COM(2013) 74 final 

PRODUCT SAFETY AND MARKET SURVEILLANCE PACKAGE 

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

More Product Safety and better Market Surveillance in the Single Market for Products

(Text with EEA relevance) 

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

More Product Safety and better Market Surveillance in the Single Market for Products 

(Text with EEA relevance) 

1. 

PRODUCT  SAFETY AND  MARKET SURVEILLANCE ARE  AT  THE CORE OF THE SINGLE 
MARKET 

Europe  is  still  struggling  to  overcome  the  worst  of  the  economic  recession  and  to 
restore  growth  and  jobs.  The  EU  2020  Strategy  is  designed  to  haul  Europe  out  of 
recession through smart, sustainable and inclusive growth, leading to higher levels of 
employment. The single market must play a large part in achieving this objective. 

The free movement of goods is the most highly developed of the four ‘freedoms’ that 
make  up  the  single  market.  Around  75  %  of  intra-EU  trade  is  in  goods.  In  today’s 
single market for goods, it is easy to buy and sell products in 27 Member States with 
a total population of more than 503 million. Consumers have a wide choice and are 
able to shop around for the best offers. The free movement of goods is also vital to 
the success of thousands of EU businesses. 

We have free movement of goods in the Union because, for most products, we have 
managed  to  agree  on  the  extent  to  which  we  should  protect  at  Union  level  various 
public interests that could otherwise be invoked by Member States to justify barriers 
to goods entering (or leaving) their territories. So-called ‘harmonisation legislation’ 
specifies  essential  requirements  that  products  must  meet  to  benefit  from  free 
movement.  Legislation  on  general  product  safety  requires  consumer  products  to  be 
safe  when  made  available  on  the  Union  market.  In  the  absence  of  harmonisation 
legislation, the Treaty applies in accordance with the jurisprudence of the European 
Court of Justice, particularly that relating to the principle of mutual recognition.  

The most significant (but not the only) public interest invoked is the protection of the 
health  and  safety  of  persons,  which  in  the  context  of  free  movement  of  goods 
signifies the consumer. Safe products move freely. So, product safety rules and the 
market surveillance that underpins them are the basis of the single market for goods. 
If we want the full economic benefit of the single market for goods, we need a set of 
high  standards  and  rules  on  the  safety  of  products  sold  and  an  effective,  well-
coordinated, Union-wide market surveillance system to underpin it. Safer and more 
compliant  products  will  also  contribute  to  safer,  better  performing  services 
throughout  the  Union  and  will  foster  their  cross-border  provision,  thereby 
contributing to the achievement of a more integrated single market for services. 

In  the  context  of  the  economic  crises,  consumer  spending  has  fallen  due  in  a  large 
part to falling incomes and uncertainty about the future. This is why it is necessary to 
continue  to  ensure  that  consumers  can  be  confident  in  the  safety  and  fitness  for 

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purpose  of  products.  Fair  and  reliable  businesses  are  more  likely  to  start  up  and 
thrive if they know that they operate in a level playing field where competitors who 
cut corners and flout the rules are penalised.  

The single market for goods is an undoubted success. But, to continue to ensure its 
success in order to be the driver of lasting growth and the creation of new, long term 
employment, every single cog in the machinery of the single market for goods must 
work  properly.  There  is  still  untapped  potential  in  the  single  market  for  goods  and 
this  must  be  fully  realised.  There  is  scope  for  lowering  compliance  costs  for 
economic  operators,  reducing  the  administrative  burden  on  national  authorities  and 
eliminating  unfair  competition  from  unscrupulous  traders.  Products  on  the  market 
can be made even safer, boosting consumer confidence and stimulating sales. 

Although  new  rules  for  harmonised  products  came  into  force  on  1  January  2010, 
there  is  a  clear  need  to  streamline,  simplify  and  improve  market  surveillance  rules 
and procedures to make it easier for national authorities and economic operators to 
apply and follow them. In order to achieve this, the operation of the system on the 
ground must be improved in order to exploit synergies and ensure  cost efficiencies 
where  these  may  exist.  National  authorities  must  cooperate  better  within  their  own 
territories  and  with  their  counterparts  in  other  Member  States.  Market  surveillance 
action  must  be  more  focused  and  better  coordinated  across  the  Union.  This  means 
greater resource- sharing, better IT tools, tougher and more targeted external controls 
at the Union borders and harsher penalties for infringements. 

The General Product Safety Directive 2001/95/EC (GPSD) contains the core safety 
provisions  that  must  be  respected  for  many  consumer  products:  it  requires  that 
consumer  products  be  safe,  provides  for  standard  setting,  imposes  obligations  on 
Member  States  and  national  market  surveillance  authorities  and  lays  down 
procedures for the exchange of information and for rapid intervention in relation to 
unsafe products. The Directive needs to be revised to update its product safety rules 
and  align  them,  as  far  as  possible,  with  those  in  place  for  harmonised  products.  In 
particular,  the  obligations  of  economic  operators  (especially  product  identification 
and  traceability  requirements)  must  be  strengthened  to  give  market  surveillance 
authorities the tools necessary to carry out their activities effectively.  

Today,  the  Commission  has  adopted  the  Product  Safety  and  Market  Surveillance 
Package  of  measures  which  will  simplify  and  make  more  uniform  the  safety  rules 
applying to non-food products, streamline market surveillance procedures and better 
coordinate and monitor the carrying out of market surveillance activities in the EU.  

The Package consists of – 

• 

• 

• 

• 

A proposal for a new Regulation on Consumer Products Safety 

A proposal for a single Regulation on Market Surveillance for Products 

A  Communication  on  Safer  and  compliant  products  for  Europe,  setting  out  a 
multi-annual plan for market surveillance 

A Report on the implementation of Regulation (EC) No 765/2008, including a 
financial evaluation. 

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2. 

THE CONSUMER PRODUCT SAFETY REGULATION 

Over  two  decades,  EU  legislation  on  general  product  safety  (Directive  92/59/EEC 
and  then  Directive  2001/95/EC)  has  established  a  product  safety  and  market 
surveillance  framework  that  has  contributed  enormously  to  the  safety  of  consumer 
products.  This  includes  a  rapid  alert  information  exchange  system  (RAPEX) 
concerning  dangerous  products  and  procedures  for  setting  European  standards  for 
products that are otherwise not covered by Union harmonisation legislation.  

In  response  to  calls  from  almost  all  groups  of  stakeholders  and  from  the  European 
Parliament  to  simplify  Union  rules  on  market  surveillance  and  make  them  more 
accessible,  the  provisions  of  the  GPSD  dealing  with  market  surveillance,  including 
RAPEX,  are  removed  and  integrated  into  the  new  market  surveillance  regulation 
which forms part of this package. 

As  for  the  remaining  provisions  of  the  GPSD,  recurrent  product  safety  alerts  have 
clearly  signalled  the  need  for  more  effective,  up  to  date  product  safety  rules.  The 
requirement  that  consumer  products  made  available  in  the  EU  must  be  safe  also 
remains  the  key  provision  of  the  new  Consumer  Product  Safety  Regulation.  Its 
interaction with sector-specific legislation applicable to consumer products, however, 
is  clarified  to  avoid  undue  overlaps  and  increase  legal  certainty  for  economic 
operators. 

To  reflect  the  challenges  of  a  globalised  market,  emphasis  is  put  on  enhanced 
product  identification  and  traceability.  The  obligations  for  economic  operators 
(manufacturers,  importers,  distributors)  are  aligned  to  the 
'New  Legislative 
Framework  for  the  Marketing  of  Products'  adopted  in  2008  to  ensure  consistency 
with  sector-specific  rules.  Last  but  not  least,  the  proposed  regulation  promotes 
enhanced  use  of  European  standards.  The  procedures  to  identify  or  update  existing 
standards  or  to  develop  new  ones  which  provide  the  presumption  that  a  product  is 
'safe',  is  significantly  simplified  and  aligned  with  the  recently  adopted  European 
Standardisation Regulation 1025/2012. 

The  new  Consumer  Product  Safety  Regulation  completes  the  EU  product  safety 
regulations of the 21st century. It will boost consumer confidence in the single market 
of products and ensure a level playing field for businesses.  

3. 

THE MARKET SURVEILLANCE REGULATION 

Notwithstanding  legislation  in  place,  unsafe  and  non-compliant  products  still  find 
their way onto the market. People still suffer harm and harmful products still pollute 
the environment. Rogue traders persist - flouting the  rules  and  undermining  a clear 
level  playing  field  for  operators.  This  undermines  the  internal  market  and  is  a 
disincentive  to  businesses  that  invest  a  lot  of  resources  in  ensuring  that  the  design 
and manufacture of their products is safe. Often this is the result of the fact that the 
rules in place are not respected. Enforcement activity needs to be stepped up in order 
to avoid harm to consumers, to protect the environment and to give honest traders a 
chance to compete on equal terms. 

Market  surveillance  is  our  main  tool.  A  more  concerted  and  determined  market 
surveillance effort across the entire Union will help keep unsafe or otherwise harmful 

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products  off  the  market,  will  deter  rogue  traders  and  will  encourage  businesses  to 
respect the rules. 

3.1. 

Simpler, clearer and better 

Market  surveillance  is  carried  out  by  the  authorities  of  the  Member  States  by 
checking and testing products both on the market and arriving at the external border 
of the Union. Internal borders do not exist for products – it is vital that they do not 
exist  for  national  market  surveillance  authorities  either.  Improving  cross-border 
action and cooperation is the key to making market surveillance more effective. 

As a result of the various legislation adopted over the years, Union rules on market 
surveillance have become fragmented and confusing, creating gaps and overlaps and 
difficulties  for  operators.  In  particular,  consumer  goods  are  subject  to  different 
market  surveillance  rules  in  both  consumer  legislation  and  product  harmonising 
legislation. This is seriously hampering the efforts of market surveillance officers in 
the field. 

Specifically,  market  surveillance  rules  are  spread  across  three  separate  'tiers'  - 
Regulation  765/2008,  the  General  Product  Safety  Directive  and  various  pieces  of 
product  harmonisation  legislation  (which  is  gradually  being  aligned  with  reference 
provisions set out in Decision 768/2008). The relationship between the three tiers is 
often unclear, particularly as many consumer products are covered by all three. 

The Schaldemose Report of the European Parliament on the revision of the General 
Product  Safety  Directive  and  market  surveillance  was  highly  critical  of  this  ‘three 
tier’ approach, asserting that it led to uncertainties, incoherence and confusion in the 
internal  market.  The  Report  proposed  that  the  Commission  establish  a  common 
European framework for market surveillance concerning all products on the internal 
market or entering the EU market. It urged the Commission to set up a single market 
surveillance system for all products, based on one legislative act. 

This proposal for a new single regulation on market surveillance is a response to this 
call and addresses these failings paving the way for a more collaborative, joined-up 
system of market surveillance in the European Union. It proposes a number of very 
simple but very effective measures:  

• 

• 

It  collects  together  the  market  surveillance  rules  currently  spread  across  the 
three tiers of legislation. This not only simplifies the Union market surveillance 
framework  by  presenting  it  in  one  legislative  instrument  but  also  resolves 
incoherence and eliminates overlaps. 

As  far  as  possible,  the  proposed  regulation  does  not  distinguish  between 
consumer  and  non-consumer  products,  nor  between  harmonised  and  non-
harmonised products. All products are subject to the same rules except where 
the  specific  characteristics  of  a  category  of  products  dictates  otherwise.  On 
occasion,  distinctions  will  still  need  to  be  made  but  it  will  be  clear  to  both 
economic  operators  and  market  surveillance  authorities  how  they  must 
proceed.  

• 

Procedures  for  the  notification  by  Member  States  of  information  about 
products  presenting  a  risk  and  corrective  measures  taken  will  be  streamlined. 

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Hitherto, Member States often could not tell under which legislation to notify 
required  information.  To  a  great  extent,  the  same  system  of  notifications  will 
be  used  for  all  products.  Only  the  final  phase  of  the  market  surveillance 
procedure (in which, in the event of disagreement among the Member States, 
the Commission may decide whether measures taken by the original notifying 
State are legitimate) will be restricted to harmonised goods. 

3.2. 

Other, specific improvements 

The proposal would strengthen controls at external borders by making clear that the 
release  for  free  circulation  in  the  Union  of  any  product  within  the  scope  of  the 
regulation  should  be  suspended  if  the  authorities  responsible  for  external  border 
controls have cause to believe that it presented a risk. Market surveillance authorities 
would then check whether the product did in fact present a risk before instructing the 
border authorities to release or refuse release, as appropriate. Only products entering 
the  Union  in  the  physical  possession  of  natural  persons  and  destined  for  their 
personal  use  would  be  exempt.  Thus  internet  purchases  of  product  from  third 
countries may be controlled. 

The regulation promotes the exchange and retention of information relating to market 
surveillance  activities  in  an  easily  accessible  database.  One  particular  intended 
consequence  is  that  the  market  surveillance  authorities  should  not  repeat  tests  and 
assessments already carried out in relation to a particular product by the authorities 
of another Member State. It should become standard practice to search the database 
for records of such tests and assessments. Given the high cost of product test this will 
lead to high savings for the Member State competent authorities and facilitate better 
surveillance in smaller markets within the Union.  

Market  surveillance  authorities  would  be  given  the  power  to  charge  economic 
operators  fees  where  they  require  corrective  action  to  be  taken  in  relation  to  a 
product or must monitor corrective action proposed by an operator.  

The  RAPEX  system,  used  to  process  notifications  by  Member  States  concerning 
products  presenting  a  risk,  is  being  improved.  Accordingly,  the  notification  criteria 
are being simplified, more detailed information must be notified for better relevance 
and  follow-up,  and  time-limits  for  sending  notifications  are  being  made  more 
realistic and workable.  

Experience  with  EU  product  safety  "emergency"  measures  has  also  shown  that  the 
validity  of  these  measures  (up  to  one  year)  is  not  enough  to  prepare  a  permanent 
solution  at  the  EU  level  and  they  usually  have  to  be  repeatedly  renewed,  creating 
legal uncertainty and confusion for economic operators who must decide whether to 
make  long-term  investment  to  adapt  their  products  to  the  new  product  safety 
requirements.  Under  the  new  Regulation,  the  Commission  should  be  given  more 
flexibility  as  regards  the  type  and  content  of  restricting  measures  in  respect  of 
dangerous  products.  To  this  end,  the  Commission  should  be  in  a  position  to  adopt 
measures  that  are  either  addressed  to  the  Member  States  or  that  are  directly 
applicable to economic operators. Those measures could either be limited in time or 
not. 

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The  Commission  is  committed  to  providing  guidance  and  useful  information  to 
companies  and  other  interested  parties  on  the  interpretation  and  application  of  the 
new  product  safety  and  market  surveillance  rules.  The  proposed  European  Market 
Surveillance  Forum  will  play  a  pivotal  role  to  develop  best  practices  for  a 
harmonised  implementation  across  the  Union.  Business  and  consumer  associations 
will  have  the  possibility  to  make  their  voice  heard  in  that  Forum.  The  European 
Enterprise Network (EEN) offices in each Member State should further disseminate 
the information, especially to SMEs and advise them, collectively and individually, 
on their rights and obligations under the new regulation. The Network, supported by 
SME  Envoys,  should  also  collect  feedback  from  SMEs  and  report  on  their  specific 
needs,  interests  or  concerns  to  be  taken  into  account  for  the  implementation  of  the 
new rules.  

4. 

THE MULTI-ANNUAL MARKET SURVEILLANCE PLAN 

Products (including products imported from outside the Union and released into free 
circulation)  move  easily  across  borders  within  the  Union.  Checks  on  their  safety 
must be done with sufficient frequency and consistency right across the Union. This 
means getting market surveillance authorities of the Member States to work together 
more closely and effectively. 

The  development  of  a  multi-annual  plan  for  market  surveillance  is  one  of  the  50 
action  points  in  the  Single  Market  Act.  Member  States  must  already  establish  and 
keep  up  to  date  national  market  surveillance  programmes.  The  multi-annual  plan 
must  not  duplicate  activities  already  planned  or  underway  at  national  level  but 
identify and pursue areas in which coordination by the Commission would add value 
and  bring  about  real  improvements.  It  sets  out  an  ambitious  list  of  20  individual 
actions to be undertaken over the next three years. 

(1)  Under  the  plan,  market  surveillance  authorities  in  the  Member  States  will  be 
encouraged  and  enabled  to  communicate  with  and  support  each  other  better. 
Information  about  national  rules  and  business  practices  will  be  gathered 
through  studies,  surveys  and  consultation.  Suitable  IT  will  be  put  in  place  to 
collect  and  store  information  in  an  easily  retrievable  manner.  Divergences, 
disparities  and  specific  needs  will  be  identified  and  appropriate  training, 
technical assistance and guidance offered.  

(2)  The nuts and bolts of market surveillance are the identification and assessment 
of  risk.  Common  practices  will  be  developed  and  followed  across  the  Union. 
The  Commission 
to  promoting  effective  methods  of 
communication, preparing guidance and drawing up a common approach to the 
conduct of physical documentary and laboratory checks of products. 

is  committed 

(3)  Greater centralised coordination of joint programmes and action will maximise 
their  useful  scope,  ensure  the  high  quality  of  their  content  and  thus  improve 
their effectiveness.  

(4)  The pooling of resources wherever possible helps eliminate the duplication of 
tasks and facilitates exchanges of experience and information. A large quantity 
of information on risk assessment, testing methods, corrective measures taken 
and so on, assembled from market surveillance authorities across the Union, is 

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being collated and stored in the ICSMS database, managed by the Commission. 
The  market  surveillance  authorities  of  one  Member  State  will  be  able  to  see 
quickly and clearly whether (and if so, how) a particular problem has already 
been  addressed  in  another.  The  results  of  laboratory  testing  will  be  available, 
obviating  the  need  for  repeat  testing  leading  to  savings  and  reduction  of 
administrative  burden.  The  usefulness  of  this  tool  depends  entirely  on  the 
speedy, accurate and diligent entering of information into the database and the 
authorities  of  all  Member  States  will  be  encouraged  to  play  their  part.  Any 
necessary training and guidance will be made available to ensure that the huge 
potential of this growing resource is fully realised. 

(5)  A  continuous  exchange  of  views  between  the  Commission,  consumers, 
business stakeholders and national authorities is essential to underpin this pan-
European  cooperation.  This  will  be  achieved  without  adding  to  the  over-
abundance of Union-citizen-business interfaces. 

(6) 

Improvement  of  the  efficiency  of  border  safety  controls  requires  enhanced 
cooperation between customs and market surveillance authorities as well as the 
use  of  modern  tools  to  better  target  the checks to be carried out in respect of 
products entering the Union market.  

The Union multi-annual market surveillance plan will bring real, tangible benefits to 
the  conduct  of  market  surveillance  activities  on  the  ground,  responding  to  the 
considerable demands of a modern, highly functional internal market for goods. 

5. 

THE REPORT ON THE IMPLEMENTATION OF REGULATION 765/2008 

The report, drawn up by the Commission in accordance with Articles 36(2) and 40 of 
Regulation  765/2008,  completes  the  Product  Safety  and  Market  Surveillance 
Package. With this report, the Commission informs the European Parliament and the 
Council about the outcome of its evaluation on the implementation of that Regulation 
and  on  the  relevance  of  the  conformity  assessment,  accreditation  and  market 
surveillance  activities 
the 
Commission's  evaluation  have  helped  to  identify  how  to  do  better  and  are  hence 
reflected in the proposed set of new rules. 

that  receive  Union  financing.  The  findings  of 

6. 

CONCLUSION 

The  aim  of  this  package  of  proposals  is  to  address  three  major  objectives:  more 
safety  for  consumers;  less  burden  for  businesses;  more  co-operation  among 
competent  authorities.  Ultimately  through  better  rules  that  are  fit  for  purpose  this 
package  seeks  to  build  more  confidence  in  the  single  market  and  thus  to  stimulate 
growth.  

Once these proposals are adopted and implemented, consumers will be able to rely 
on  a  safer  market  for  consumer  products  and  to  benefit  from  transparent  and 
comparable information, in line with the priorities set out in the European Consumer 
Agenda. The implementation of the package will also have significant advantages for 
economic operators, in particular SMEs, that will be able to rely on clear rules and to 
secure better competition in the Single Market. Ultimately public authorities across 

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Europe  will  benefit  from  the  rationalisation  of  the  market  surveillance  framework 
and  from  increased  synergies,  which  will  lead  to  a  more  efficient  use  of  public 
resources and expenditure and to a better enforcement. 

The co-legislators are invited to adopt the two legislative proposals in order to ensure 
that  this  key  action  of  the  Single  Market  Act  II,  like  all  other  key  actions,  will  be 
agreed at EU level as a priority by spring 2014. 

With  this  package  of  legislative  and  non-legislative  measures,  the  Commission 
strives to allow citizens and businesses to reap the full benefits of the Single Market 
for industrial and consumer products, thus contributing to more growth and jobs in 
Europe.  

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