COMMISSION STAFF WORKING DOCUMENT STAKEHOLDER CONSULTATION - SYNOPSIS REPORT Accompanying the document Proposal of the European Parliament and of the Council for a Regulation laying down rules and procedures for compliance with and enforcement of Union harmonisation legislation on products and amending Regulations (EU) No 305/2011, (EU) No 528/2012, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 and (EU) 2017/1369 of the European Parliament and of the Council, and Directives 2004/42/EC, 2009/48/EC, 2010/35/EU, 2013/29/EU, 2013/53/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU and 2014/90/EU of the European Parliament and of the Council
Date: 2017-12-19
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: approximation of laws, import (EU), market approval, market supervision, marketing standard, product quality, product safety, quality standard, single market, surveillance concerning imports

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 19.12.2017  SWD(2017) 468 final  COMMISSION STAFF WORKING DOCUMENT STAKEHOLDER CONSULTATION - SYNOPSIS REPORT Accompanying the document Proposal of the European Parliament and of the Council for a Regulation  laying down rules and procedures for compliance with and enforcement of Union harmonisation legislation on products and amending Regulations (EU) No 305/2011, (EU) No 528/2012, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 and (EU) 2017/1369 of the European Parliament and of the Council, and Directives 2004/42/EC, 2009/48/EC, 2010/35/EU, 2013/29/EU, 2013/53/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU and 2014/90/EU of the European Parliament and of the Council {COM(2017) 795 final} - {SWD(2017) 466 final} - {SWD(2017) 467 final} - {SWD(2017) 469 final} - {SWD(2017) 470 final}  
 
 
Contents 

1.  OBJECTIVES OF THE CONSULTATION............................................................... 2 

1.1.  Consultation methods and tools ........................................................................ 2 

2.  RESULTS OF THE CONSULTATION ACTIVITIES .............................................. 2 

2.1.  Meetings of the Expert Group on the Internal Market for Products – Market 

Surveillance Group ............................................................................................ 2 

2.2.  Meetings of the Customs Expert Group ............................................................ 2 

2.3.  Stakeholder conference ..................................................................................... 3 

2.4.  Public Consultation ........................................................................................... 3 

2.4.1.  Product  compliance  in  the  Single  Market  and  deterrence  of 

existing enforcement mechanisms ...................................................... 3 

2.4.2.  Compliance assistance in Member States and at EU level .................. 4 

2.4.3.  Business' demonstration of product compliance ................................. 4 

2.4.4.  Cross-border market surveillance within the EU ................................ 5 

2.4.5.  Market surveillance of products imported from non-EU countries .... 5 

2.5.  Targeted Consultation conducted by the Contractor ......................................... 6 

2.6. 

Informal  consultation  of  SMEs  at  the  Small  Business  Act  follow-up 
meeting with stakeholders in December 2016 .................................................. 6 

3.  FEEDBACK TO STAKEHOLDERS ......................................................................... 6 

1 

 
 
 
 
1.  OBJECTIVES OF THE CONSULTATION  

The  Commission  wanted  to  make  an  evidence-based  assessment  of  the  extent  to  which  the 
provisions  on  market  surveillance  of  Regulation  (EC)  No  765/2008  have  been  effective, 
efficient, relevant, coherent and achieved EU added-value. The results of the evaluation will 
support  taking  actions  to  enhance  efforts  to  fight  non-compliant  products  made  available  in 
the Single Market. 

1.1.  Consultation methods and tools 

The market surveillance authorities have been consulted during the meetings of the Expert 
Group on the Internal Market for Products in 2016. 

A  stakeholder  conference  -  open  to  all  interested  participants  -  was  organised  by  the 
Commission on 17 June 2016.  

A  public  consultation  in  all  EU  official  languages,  published  on  a  website  hosted  on 
Europa, run from 1 July to 31 October 2016. Participation of SMEs in the consultation was 
promoted and supported through the European Enterprise Network. 

2.  RESULTS OF THE CONSULTATION ACTIVITIES 

2.1.  Meetings  of  the  Expert  Group  on  the  Internal  Market  for  Products  –  Market 

Surveillance Group 

The Expert Group on the Internal Market for Products – Market Surveillance Group held its 
last meetings on 1st February 2016, 21st October 2016 and 31st March 2017.  

During  the  first  meeting,  the  Commission  recalled  the  challenges  reported  by  market 
surveillance  authorities  in  the  national  reviews  and  assessment  of  activities  carried  out 
between  2010  and  2013.  The  detailed  IMP  document  is  annexed  to  the  Impact  Assessment 
(Annex 2). 

During  the  meeting  held  on  21  October  2016,  the  Commission  informed  the  participants  of 
the state of play of the enforcement and compliance initiative and explained that the purpose 
was  to  receive  feedback  on  the  suitability  of  the  ideas  under  examination.  The  detailed 
minutes 
at:  http://ec.europa.eu/transparency/regexpert/index.cfm?do= 
groupDetail.groupDetailDoc&id=28611.    

can  be 

found 

The  meeting  held  on  31  March  2017  focused  on  the  legislative  proposal  and  especially  on 
how to enhance cooperation between the member states, create a uniform and sufficient level 
of  market  surveillance  and  have  stronger  border  controls  of  imported  products  to  the 
European market. 

2.2.  Meetings of the Customs Expert Group  

The  Customs  Expert  Group  that  met  on  22  April  was  informed  about  the  launch  of  the 
Enforcement and Compliance initiative. Customs authorities were invited to participate in the 
consultations and provide their views on possible challenges and actions needed.  

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The  Expert  Group  PARCS  met  to  discuss  product  safety  and  compliance  controls  on  1 
December 2016.  At the meeting the Commission presented the state of play on the revision 
of Regulation (EC) No 765/2008.  

2.3.  Stakeholder conference  

A stakeholders' event was organised on 17 June 2016, to identify the main issues related to 
the  compliance  and  better  enforcement  in  the  Single  Market  and  to  identify  possible  ways 
forward. 144 participants attended the event, representing businesses (62), national authorities 
(60)  and  others  (22).  The  detailed  minutes  of  this  conference  can  be  found  at: 
http://ec.europa.eu/DocsRoom/documents/17963. 

2.4.  Public Consultation 

239  replies  were  received  via  the  online  form  foreseen  during  the  public  consultation.  The 
numbers  and  percentages  used  to  describe  the  distribution  of  the  responses  to  the  public 
consultation  derive  from  the  answers  under  the  EU-Survey  tool.  Other  submissions  of 
stakeholders  to  the  public  consultation  have  been  taken  into  account,  but  without  being 
considered for the statistical representation. 

The  consultation  was  divided  into  five  parts.  Since  only  part  B1  was  obligatory,  the  other 
sections  were  partly  answered.  Therefore,  the  average  ratio  of  replies  was  80%  for  section 
B2, 66% for section B3, 80% for section B4  and 84% for section B5.  

All statistics included in this summary are based on the data gathered from the replies 
for  each  section.  Detailed  statistics  for  each  category  can  be  found  in  Annex  2  of  the 
Impact Assessment.  

Businesses were strongly represented (127), followed by public authorities (80), and citizens 
(32).  More  specifically  for  businesses,  49%  of  them  represent  product  manufacturers,  21% 
product  importer  /  distributors,  8%  product  users,  5%  conformity  assessment  bodies,  1% 
online intermediaries and 16% other.   

Concerning the geographical distribution of responses, all countries were represented except 
for  Latvia,  Luxembourg,  Malta,  and  Liechtenstein.  The  majority  of  respondents  (116)  exert 
their activities only in their country of establishment. 

2.4.1.  Product  compliance  in  the  Single  Market  and  deterrence  of  existing  enforcement 

mechanisms 

The  majority  of  respondents  (89%)  consider  that  their  products  are  affected  by  non-
compliance with product requirements laid down in EU harmonisation legislation.  

However, 45% of the respondents are unable to estimate the approximate proportion of non-
compliant  products  for  their  sector.  This  percentage  is  approximately  equal  for  all  type  of 
respondents.   

80% of  businesses  participating in  the consultation  confirm non-compliance has  a negative 
effect  on  sales  and/or  market  shares  of  businesses  complying  with  legal  obligations.  Many 
businesses (42%), however, are unable to estimate their approximate loss in sales due to non-
compliance.  

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As to the most important reason for product non-compliance in the Single Market, 33.47% of 
the respondents consider that it is about a deliberate choice to exploit market opportunities at 
the  lowest  cost,  followed  by  a  lack  of  knowledge  (26.78%),  a  technical  or  other  type  of 
inability to comply with the rules (10.88%), ambiguity in the rules (10.46%) and carelessness 
(9.62%).  

All types of respondents have experience / knowledge of instances where market surveillance 
authorities lacked sufficient financial and human resources as well as the technical means to 
carry  out  specific  tasks.  Nevertheless,  67.36%  of  the  respondents  could  not  estimate  the 
approximate financial resource gap of the national authority.  

Regarding  the  increase  of  resources  for  market  surveillance  activities,  although  two  of  the 
three solutions receive a unanimous acceptance by the respondents, for the third one, namely 
that market surveillance authorities should levy administrative fees on operators in their sector 
to finance controls, the results are contradictory. 55.91% of the businesses and 40.63% of the 
consumers  and  others  strongly  disagree  with  this  option,  while  50.00%  of  the  public 
authorities agree with it (15% strongly agree and 35% agree).  

Stakeholders  have  similar  views  as  regards  the  effective  use  of  resources  for  market 
surveillance activities.  

Many  respondents  (46%)  agree  that  market  surveillance  does  not  provide  sufficient 
deterrence in their sector or that it provides deterrence to a moderate extent (34%) and that 
the options proposed by the Commission would improve the deterrence of market surveillance 
action.  

2.4.2.  Compliance assistance in Member States and at EU level 

This section of the questionnaire was optional, so the average ratio of replies came up to 80% 
(approximately 190 replies per question).  

There is a consensus on the fact that sometimes it is difficult to find but also understand the 
correct information on the technical rules that products need to meet before they can be placed 
on the domestic and on other EU markets.  

The approach taken by respondents to look for support and information on technical rules that 
products  need  to  meet  slightly  differs  according  to  the  type  of  respondent.  The  majority  of 
respondents prefer to refer to the information available on Commission websites. Regarding 
the  approaches  that  should  be  followed  by  national  authorities  to  reduce  the  level  of  non-
compliant  products  on  the  market,  the  respondents  consider  that  the  best  approach  is  the 
combination of information, support and enforcement by the public authorities.   

2.4.3.  Business' demonstration of product compliance 

This section of the questionnaire was optional, so the average ratio of replies came up to 66% 
(approximately 158 replies per question).  

Businesses  were  asked  to  provide  answers  on  how  they  supply  information  about  product 
compliance.  Approximately  30%  of  the  respondents  consider  that  the  proposed  options  are 
not applicable to them.  

4 

 
A  large  majority  of  respondents  strongly  agrees  or  agrees  that  a  broader  use  of  electronic 
means  to  demonstrate  compliance  would  help  to  reduce  the  administrative  burden  for 
businesses  (70.62%),  reduce  administrative  costs  of  enforcement  for  authorities  (65.14%), 
provide/allow information to  be  obtained  faster (82.29%),  and provide more and  up-to-date 
information to consumers/end users (68.00%).  

2.4.4.  Cross-border market surveillance within the EU 

This section of the questionnaire was optional, so the average ratio of replies came up to 80% 
(approximately 190 replies per question).  

Most of the respondents (91) were unable to estimate the approximate proportion of products 
placed on the market by manufacturers or EU importers located in another EU Member State.  

Public  authorities  believe  that  businesses  contacted  do  not  reply  to  requests  for 
information/documentation or for corrective actions, while for businesses the main difficulty 
is  that  authorities  find  it  more  costly  to  contact  businesses  located  in  another  EU  Member 
State.  

Concerning, the exchange of communication between national authorities in the EU Member 
States, the majority of respondents stated lack of opinion / experience (33%) while 25% of 
the  respondents  consider  that  national  authorities  rarely  restrict  the  marketing  of  a  product 
following  exchange  of  information  about  measures  adopted  by  another  authority  in  the  EU 
against the same product.  

Additionally,  as  to  the  adequate  mechanisms  to  increase  the  effectiveness  of  the  market 
surveillance  in  the  Single  Market,  the  results  showed  an  extremely  large  support  for  more 
exchange  of 
information  and  discussion  among  authorities,  but  also  for  close 
coordination between Member States and simultaneous applicability of decisions against  
non-compliant products. 

2.4.5.  Market surveillance of products imported from non-EU countries 

This section of the questionnaire was optional, so the average ratio of replies came up to 84% 
(approximately 201 replies per question).  

Many  respondents  (39%)  were  unable  to  estimate  the  approximate  proportion  of  products 
imported  from  non-EU  countries  in  their  sector.  However,  21%  of  them  indicated  that  the 
proportion of products imported from non-EU countries is more than 50%. At the same time, 
88%  of  the  respondents  believe  that  the  products  in  their  sector  imported  from  non-EU 
countries are affected by non-compliance.   

As  to  the  country  of  origin  of  often  non-compliant  imported  products,  China  lead  with  137 
replies, followed by India (30), Turkey and United States (18) and Hong Kong (17). Finally, 
the  most  preferred  options  in  taking  actions  against  non-compliant  products  traded  by 
businesses  located  in  a  non-EU  country  were  the  need  for  more  coordination  of  controls  of 
products entering the EU between customs and market  surveillance authorities (88.27%). 

5 

 
2.5.  Targeted Consultation conducted by the Contractor 

In general, all stakeholders consulted through the targeted surveys and interviews uniformly 
recognise  the  effectiveness  of  the  Regulation  needs  to  be  improved.1  Around  half 
respondents declare that the dimension of product non-compliance has not changed after the 
entry into force of the Regulation. While this is true for public authorities, respondents from 
the  private  sector  perceive  that  product  non-compliance  has  increased.  Most  economic 
operators,  industry  associations  and  civil  society  representatives  state  to  experience 
discrepancies across Member States in terms of market surveillance. Such discrepancies have 
more  negative  impacts  in  terms  of  hindering  the  free  circulation  of  goods,  influencing 
market behaviour, reducing the safety of products and raising costs for public authorities 
and economic operators to comply with the Regulation. Among all respondents, only customs 
have  a  positive  opinion on  the  adequacy  of  current  border  controls.  In  general,  industry 
representatives  want  to  be  more  involved  in  market  surveillance  activities.  According  to 
respondents,  the  efficiency  of  the  Regulation  could  be  improved  by  solving  the  existing 
discrepancies in its implementation.  

The majority of respondents confirm the Regulation’s relevance, this being confirmed by all 
economic  operators  and  a  large  part  of  customs  and  coordinating  authorities.  However,  the 
Regulation’s relevance can be challenged by its low capacity to address emerging issues. All 
stakeholders agree that the Regulation is not able to tackle issues deriving from online sales. 
No  stakeholder  category  reported  major  issues  in  term  of  coherence  of  the  Regulation, 
both within its provisions and with other legislations relevant for market surveillance.  

All stakeholders recognise the EU added value of the Regulation, which enhanced the free 
movement  of  goods  and  legislative  transparency.  The  harmonisation  of  rules  and 
cooperation  between  Member  States  are  also  reported  as  benefits  by  all.  Different 
categories  also  argued  that  the  Regulation  can  establish  a  level  playing  field  across 
businesses in the EU.  

2.6.  Informal  consultation of  SMEs at  the  Small Business Act  follow-up meeting  with 

stakeholders in December 2016 

The Commission presented the reflections on the possible options to address the problem of 
non-compliance and asked for feedback. Businesses representatives confirmed that SMEs are 
also hit by non-compliance like bigger companies.   

3.  FEEDBACK TO STAKEHOLDERS 

The  consultation  processes  provided  a  wide  range  of  views  regarding  the  functioning  of 
market surveillance in terms of what has worked well and what has not worked so well, seen 
through the eyes of these stakeholders. The meetings with the stakeholders provided an early 
opportunity to promote the engagement of the national authorities, thus enhancing the chances 
of a good response rate. 

The general objective of this initiative is to reduce the number of non-compliant products in 
the Single Market by improving at the same time incentives to comply and effectiveness of 
market surveillance.   

1   All questions of the Public Consultation were basically related to evaluating the effectiveness of the Regulation. 

6 

 
                                                 
The  considered  options  covered  in  order  of  increasing  ambition  and  EU  coordination  and 
action:  (1)  Baseline,  (2)  Improvement  of  existing  tools  and  cooperation  mechanisms;  (3)  in 
addition increased deterrence effect to enforcement tools and stepped up EU coordination and 
(4) further added-on centralised EU level enforcement in certain cases.   

The preferred option (3) includes: 

• 

• 

• 

• 

• 

the extension of Product Contact Points advice role to businesses and ad-hoc public-
private partnerships;  

digital  systems  through  which  manufacturers  or  importers  would  make  compliance 
information  available  to  both  consumers  and  market  surveillance  authorities  and 
common European portal for voluntary measures; 

regime  of  publicity  for  decisions  to  restrict  the  marketing  of  products,  fine-tuning 
authorities  powers  notably  in  relation  to  on-line  sales  imports  from  third  countries, 
recovery of costs of controls for products found to be non-compliant;  

stricter obligations for mutual assistance and legal presumption that products found to 
be noncompliant in Member State A are also non-compliant in Member State B; 

Member  States'  enforcement  strategies  setting  out  national  control  activities  and 
capacity  building  needs  and  an  EU  Product  Compliance  Network  providing  an 
administrative  support  structure  to  peer  review  Member  States'  performance 
coordinate and help implementing joint enforcement activities of Member States.  

The  measures  underlying  the  preferred  option  were  rated  highly  favourable  across  the 
different categories of respondents in the public consultation. Stakeholders concur on the need 
for  much  stronger  coordination,  more  resources  and  efficient  use  of  resources  for  market 
surveillance  and  more  effective  tools  to  improve  the  enforcement  framework  for  controls 
within the Single Market and on imports into the EU. A more pro-active approach to prevent 
non-compliance  by  providing  information  and  assistance  to  economic  operators  is  also 
supported by stakeholders. On a more detailed level some variations occur between the views 
of authorities and businesses on the most appropriate form of the digital compliance system or 
the specific powers and sanctions; these concerns have been integrated in the assessment. 

More  information  on  the  different  options,  on  those  retained  and  on  the  views  of  the 
stakeholders can be found in the Impact Assessment.  

7