COMMISSION STAFF WORKING DOCUMENT REFIT EVALUATION Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on the mutual recognition on goods lawfully marketed in another Member State
Date: 2017-12-19
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: EU Member State, administrative cooperation, exchange of information, free movement of goods, goods and services, market approval, mutual recognition principle, single market, technical rule

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 19.12.2017  SWD(2017) 475 final  COMMISSION STAFF WORKING DOCUMENT REFIT EVALUATION Accompanying the document Proposal for a Regulation of the European Parliament and of the Council  on the mutual recognition on goods lawfully marketed in another Member State {COM(2017) 796 final} - {SWD(2017) 471 final} - {SWD(2017) 472 final} - {SWD(2017) 476 final} - {SWD(2017) 477 final}  
 
 
1. 

2. 

2.1 

2.2 

2.3 

2.3.1 

2.3.2 

3. 

4. 

4.1 

4.2 

4.3 

5. 

6. 

6.1 

6.2 

6.3 

7. 

7.1 

7.1.1 

7.1.2 

7.1.3 

7.1.4 

Contents 

CONTEXT ................................................................................................................... 7 

BACKGROUND TO THE MUTUAL RECOGNITION PRINCIPLE AND 
REGULATION ............................................................................................................ 8 

Baseline 

Objectives of the mutual recognition principle and Regulation 

Description of the mutual recognition principle and Regulation 

The mutual recognition principle and its tools 

The Mutual Recognition Regulation 

8 

10 

10 

10 

11 

EVALUATION QUESTIONS .................................................................................. 14 

METHOD ................................................................................................................... 14 

External studies 

Desk research 

Stakeholders consultation 

15 

15 

15 

LIMITATIONS AND ASSESSMENT OF ROBUSTNESS OF FINDINGS ........... 16 

IMPLEMENTATION STATE OF PLAY ................................................................. 19 

Implementation of the mutual recognition principle 

Application of Regulation (EC) No 764/2008 

Compliance with the Regulation (EC) No 764/2008 

19 

20 

24 

ANSWERS TO THE EVALUATION QUESTIONS ............................................... 24 

Effectiveness: Evaluating to what extent mutual recognition achieved its objectives24 

Facilitating free movement of goods in the non–harmonised area through mutual 
recognition 

Increasing awareness of the mutual recognition principle 

Ensuring legal certainty when using the mutual recognition principle 

Improving administrative cooperation between national authorities (Mutual 
Recognition Regulation) 

24 

29 

33 

37 

39 

7.1.5 

Conclusion on effectiveness 

7.2 

7.2.1 

7.2.2 

7.2.3 

Efficiency: Measuring the cost effectiveness of the mutual recognition principle and 
Regulation 

42 

Costs for public authorities 

Costs for businesses 

Some practical illustrations at sectorial level 

1 

42 

45 

49 

 
 
7.2.4 

7.2.5 

7.2.6 

7.2.7 

7.2.8 

7.2.9 

7.3 

7.4 

7.5 

8. 

Costs for the Commission 

Benefits for national authorities 

Benefits for businesses 

Benefits for consumers 

Comparing costs and benefits 

Conclusion on efficiency 

Coherence: how mutual recognition fits in the other EU policies 

Relevance: assessing the continuous need for mutual recognition 

EU added value: Evaluating what mutual recognition brings to the EU 

58 

58 

59 

60 

60 

62 

62 

66 

68 

CONCLUSION .......................................................................................................... 71 

ANNEX 1: PROCEDURAL INFORMATION ....................................................................... 73 

ANNEX 2: STAKEHOLDER'S CONSULTATION ............................................................... 77 

OBJECTIVES OF THE CONSULTATION ............................................................. 77 

Consultation methods and tools 

77 

RESULTS OF THE CONSULTATION ACTIVITIES ............................................. 77 

Meetings of the Mutual Recognition Consultative Committee 

Stakeholder conference of 17 June 2016 

2.2.1  Main meeting 

2.2.2  Workshops 

2.3 

Public Consultation 

2.3.1  How stakeholders see mutual recognition and its potential shortcomings 

2.3.2 

2.3.3 

2.3.4 

Functioning of the Mutual Recognition Regulation 

Assessment of communication when using Mutual Recognition 

Priorities to improve Mutual Recognition 

2.3.5  Options 

Surveys carried out by the external contractors 

Other contributions received (position papers or e-mail) 

77 

79 

79 

79 

80 

80 

81 

82 

82 

82 

82 

84 

FEEDBACK TO STAKEHOLDERS ........................................................................ 84 

ANNEX 3: METHODS AND ANALYTICAL TOOLS USED IN PREPARING THE 
EVALUATION ........................................................................................................................ 86 

1. 

LITERATURE REVIEW AND ANALYSIS OF PUBLICLY AVAILABLE 
STATISTICS ............................................................................................................. 86 

2 

1. 

1.1 

2. 

2.1 

2.2 

2.4 

2.5 

3. 

 
 
1.1 

2. 

3. 

3.1 

3.2 

3.3 

4. 

The macro context 

86 

EXPLORATORY INTERVIEWS WITH COMMISSION OFFICIALS AND 
REPRESENTATIVES OF EUROPEAN BUSINESS ASSOCIATIONS ................. 87 

SURVEYS TARGETING DIFFERENT STAKEHOLDERS AFFECTED BY THE 
MUTUAL RECOGNITION PRINCIPLE ................................................................. 87 

National business and sector organisations (umbrella organisations targeting a broad 
87 
range of sectors) 

Companies 

National product contact points 

88 

89 

QUALITATIVE INTERVIEWS ............................................................................... 89 

ANNEX 4: OVERVIEW OF THE ASSESSED LITERATURE AND CASE LAW ............. 91 

1. 

2. 

LITERATURE ........................................................................................................... 91 

RECENT CASE LAW OF THE CJEU ON MUTUAL RECOGNITION ................ 95 

ANNEX 5: RESULTS OF THE PUBLIC CONSULTATION ............................................... 99 

1. 

2. 

3. 

6. 

7. 

TYPE OF RESPONDENTS ...................................................................................... 99 

HOW STAKEHOLDERS SEE MUTUAL RECOGNITION AND ITS POTENTIAL 
SHORTCOMINGS .................................................................................................. 101 

FUNCTIONING OF THE MUTUAL RECOGNITION REGULATION .............. 103 

ASSESSMENT OF COMMUNICATION WHEN USING MUTUAL 
RECOGNITION ...................................................................................................... 108 

PRIORITIES TO IMPROVE MUTUAL RECOGNITION .................................... 109 

ANNEX 6: CASE STUDIES 2016 ........................................................................................ 111 

1. 

1.1 

1.2 

1.3 

1.4 

1.5 

2. 

2.1 

MANUFACTURE OF OTHER FOOD PRODUCTS: FOOD SUPPLEMENTS ... 111 

Introduction 

Background 

Stakeholders involved 

111 

111 

113 

Practices and trends identified and main issues related to the application of Mutual 
Recognition 

113 

Conclusions 

118 

PRODUCTS IN CONTACTS WITH DRINKING WATER .................................. 118 

Introduction 

118 

3 

 
 
2.2 

2.3 

2.4 

2.5 

3. 

3.1 

3.2 

3.3 

3.4 

Background 

Stakeholders involved 

119 

122 

Practices and trends identified and main issues related to the application of Mutual 
Recognition 

122 

Conclusions 

125 

FOOD CONTACT MATERIALS ........................................................................... 125 

Introduction 

Background 

Stakeholders involved 

125 

126 

128 

Practices and trends identified and main issues related to the application of Mutual 
Recognition 

128 

ANNEX 7: OVERVIEW OF NOTIFICATIONS .................................................................. 130 

1. 

2. 

3. 

OVERVIEW NOTIFICATIONS REGULATION (EC) NO 764/2008 .................. 130 

OVERVIEW OF MEMBER STATES ANNUAL REPORTS ................................ 132 

OVERVIEW INQUIRIES RECEIVED BY PCPS .................................................. 136 

ANNEX 8: RESULTS OF THE EXTERNAL EVALUATION PERFORMED BY DTI, 
TECHNOPOLIS, E&Y AND VVA CONSULTING (2015) ................................................. 139 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

STAKEHOLDER’S VIEWS ON WHETHER THE MUTUAL RECOGNITION 
PRINCIPLE HAS ACHIEVED ITS OBJECTIVES................................................ 139 

AWARENESS OF THE PRINCIPLE AMONG ENTERPRISES, STRATEGIES 
CONCERNING MUTUAL RECOGNITION, AND COST OF INSUFFICIENT 
APPLICATION OF THE PRINCIPLE ................................................................... 142 

AWARENESS AND APPLICATION OF THE PRINCIPLE BY THE MEMBER 
STATES ................................................................................................................... 155 

MARKETS AND SECTORS WITH THE MOST PROBLEMS ............................ 177 

TYPOLOGY OF OBSTACLES .............................................................................. 187 

CONCLUSIONS: EFFECTIVENESS AND EFFICIENCY ................................... 190 

RECOMMENDATIONS ......................................................................................... 196 

ANNEX 9: SHORT COMPANY CASES ............................................................................. 201 

ANNEX 10: OVERVIEW OF DIRECTIVE EU 2015/1535 (TRIS) .................................... 216 

EXECUTIVE SUMMARY .................................................................................................... 219 

4 

 
 
PART I: STANDARDISATION ........................................................................................... 220 

1. 

2. 

2.1 

2.2 

3. 

3.1 

3.2 

3.3 

4. 

4.1 

4.2 

5. 

INTRODUCTION ................................................................................................... 220 

INFORMATION PROCEDURE ............................................................................. 220 

Operation of the procedure from 2011 to 2012 

Conclusion 

220 

221 

MANDATES ........................................................................................................... 221 

Operation of the mandating process 2011-2012 

Trends in mandates 

Conclusion 

221 

222 

222 

FORMAL OBJECTIONS ........................................................................................ 223 

Operation of the procedure from 2011 to 2012 

Conclusion 

223 

223 

NEW LEGISLATIVE FRAMEWORK ................................................................... 223 

PART II: TECHNICAL REGULATIONS ............................................................................ 224 

DEVELOPMENTS 2011-2013 ................................................................................ 224 

Use of the procedure within the context of “Better regulation” 

Use of the procedure to improve competitiveness 

Improvements in managing the 98/34 procedure 

225 

225 

226 

APPLICATION OF THE 98/34 PROCEDURE ...................................................... 227 

Effectiveness: general overview 

Use of the urgency procedure 

Notification of ‘fiscal or financial incentive measures’ 

Follow-up to Commission reactions 

Follow-up to the notification procedure 

Dialogue with the Member States 

Requests for access to documents issued under Directive 98/34 

227 

230 

230 

231 

231 

231 

232 

232 

2.9  

Conclusion 

ANNEX 11: SUMMARIES OF THE MEETINGS OF THE CONSULTATIVE “MUTUAL 
RECOGNITION COMMITTEE” .......................................................................................... 234 

1. 

MINUTES OF THE FIRST MEETING OF THE CONSULTATIVE ‘MUTUAL 
RECOGNITION COMMITTEE’ HELD IN BRUSSELS ON 4 MARCH 2009 .... 234 

5 

1. 

1.1 

1.2 

1.3 

2. 

2.1  

2.3  

2.4 

2.5 

2.6 

2.7 

2.8 

 
 
2. 

3. 

4. 

5. 

6. 

7. 

8. 

MINUTES OF THE SECOND MEETING OF THE CONSULTATIVE ‘MUTUAL 
RECOGNITION COMMITTEE’ HELD IN BRUSSELS ON 19 NOVEMBER 2010
 .................................................................................................................................. 235 

MINUTES OF THE THIRD MEETING OF THE CONSULTATIVE ‘MUTUAL 
RECOGNITION COMMITTEE’ HELD IN BRUSSELS ON 30 NOVEMBER 2011
 .................................................................................................................................. 238 

MINUTES OF THE 4TH MEETING OF THE CONSULTATIVE ‘MUTUAL 
RECOGNITION COMMITTEE’ HELD IN BRUSSELS ON 7 DECEMBER 2012
 .................................................................................................................................. 239 

MINUTES OF THE 5TH MEETING OF THE CONSULTATIVE ‘MUTUAL 
RECOGNITION COMMITTEE’ HELD IN BRUSSELS ON 6 DECEMBER 2013
 .................................................................................................................................. 241 

MINUTES OF THE 6TH MEETING OF THE CONSULTATIVE ‘MUTUAL 
RECOGNITION COMMITTEE’ HELD IN BRUSSELS ON 5 DECEMBER 2014
 .................................................................................................................................. 243 

MINUTES OF THE 7TH MEETING OF THE CONSULTATIVE ‘MUTUAL 
RECOGNITION COMMITTEE’ HELD IN BRUSSELS ON 2 DECEMBER 2015
 .................................................................................................................................. 245 

MINUTES OF THE 8TH MEETING OF THE CONSULTATIVE ‘MUTUAL 
RECOGNITION COMMITTEE’ HELD IN BRUSSELS ON 25 OCTOBER 2016
 .................................................................................................................................. 248 

ANNEX 12: STUDY OF THE DANISH BUSINESS ASSOCIATION ............................... 251 

1. 

2. 

3. 

4. 

5. 

6. 

EXECUTIVE SUMMARY ...................................................................................... 251 

INTRODUCTION ................................................................................................... 252 

METHODOLOGY ................................................................................................... 253 

MAIN FINDINGS ................................................................................................... 254 

CASE EXAMPLES ................................................................................................. 255 

POLICY RECOMMENDATIONS – THE WAY FORWARD… .......................... 257 

6 

 
 
 
 
 
 
 
1.  CONTEXT 

Obstacles  to  the  free  movement  of  goods  within  the  single  market  can  be  eliminated  by 
harmonising national legislation or through the principle of mutual recognition.  

Mutual  recognition  is  seminal  for  the  proper  functioning  of  the  single  market  for  goods.  It 
consists of a principle, embedded in Articles 34 and 36 of the Treaty on the Functioning of the 
European  Union  (TFEU),  and  further  elaborated  on  in  the  case  law,  and  in  a  legal  act, 
Regulation  (EC)  No  764/2008  (the  Mutual  Recognition  Regulation),  defining  the  practical 
modalities of its implementation.  

If a business is lawfully selling a product in one Member State, it should be able to sell it in 
other  Member  States  without  adapting  it  to  the  national  rules  of  that  Member  State,  even 
when there are no common European rules on how the product has to be manufactured (rules 
on  i.e.  characteristics  of  the  product,  size,  composition,  etc.).  The  right  to  sell  a  product 
lawfully marketed in another Member State1 can be refused only when the Member State of 
destination  has  diverging  product  requirements  whose  mandatory  imposition  is  justified  by 
the  need  to  protect  a  certain  public  interest,  and  those  requirements  are  necessary  and 
proportionate for achieving that objective. This is the principle of mutual recognition in the 
field of goods. Annex 4 contains an overview of the relevant case law on the basis of which 
the principle was elaborated.  

The  practicalities  of  how  mutual  recognition  works  in  practice  are  defined  by  the  Mutual 
Recognition Regulation. The Regulation introduces procedural guarantees to ensure on one 
hand that businesses can easily invoke their right to mutual recognition, and on the other hand 
that  Member  States  use  their  right  to  deny  mutual  recognition  in  the  light  of  the 
proportionality principle.  

In December 2013, the Conclusions on Single Market Policy, adopted by the Competitiveness 
Council, recalled that to improve framework conditions for businesses and consumers in the 
Single  Market,  all  relevant  instruments  should  be  appropriately  employed,  including 
harmonisation and mutual recognition2. The Commission was therefore requested to report to 
the  Council  on  the  sectors  and  markets  where  the  application  of  the  principle  of  mutual 
recognition is economically most advantageous, but where its functioning remains insufficient 
or problematic.  

In response to the indications that the functioning of the principle might not be optimal, and 
taking  into  account  the  request  of  the  Council,  the  application  of  the  principle  of  mutual 
recognition  was  subject  to  an  external  evaluation3,  part  of  the  REFIT  agenda  in  20144.  Its 
objective  was  to  assess  the  functioning  of  the  principle,  in  terms  of  efficiency  and 
effectiveness.  Among  the  shortcomings  identified  the  external  evaluation  pointed  out  the 
limitations of the Mutual Recognition Regulation and recommended several ways forward to 
improve  its  application.  These  conclusions  triggered  the  need  to  evaluate  the  Mutual 

1     
2  

3  

4  

Applies also to EEA products 
Conclusions  on  Single  Market  Policy,  Competitiveness  Council  meeting;  Brussels  2  and  3  December  2013: 
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/intm/139846.pdf       
European Commission, Study commissioned to Technopolis Group (2015): ‘Evaluation of the application of the principle of mutual 
recognition  in  the  field  of  goods,’  ENTR/172/PP/2012/FC  –  LOT  4  carried  out  between  April  2014  and  May  2015: 
http://ec.europa.eu/growth/single-market/goods/free-movement-sectors/mutual-recognition/index_en.htm.   
Scoreboard  Regulatory  Fitness  and  Performance  Programme  (REFIT):  State  of  Play  and  Outlook,  SWD(2014)192; 
http://ec.europa.eu/smart-regulation/docs/com2014_368_en.pdf  

7 

 
 
                                                            
Recognition  Regulation,  and  to  complement  the  evaluation  of  the  mutual  recognition 
principle.  

This evaluation will assess the functioning of mutual recognition in the field of goods, i.e. the 
mutual recognition principle and the Mutual Recognition Regulation. According to the 'Better 
Regulation  Guidelines5,  evaluations  are  an  essential  step  to  managing  and  revising  the 
existing body of EU legislation and policies and should precede the impact assessment, in line 
with  the  "evaluate  first"  principle.  This  evaluation  will  assess  to  what  extent  mutual 
recognition has achieved its original objectives in term of effectiveness, efficiency, relevance, 
coherence,  and  EU  value-added.  Its  findings  should  feed  into  the  impact  assessment  of  the 
planned initiative on achieving higher and better mutual recognition, called upon in the Single 
Market Strategy,  Upgrading  the Single Market: more opportunities for people and  business, 
adopted on 28 October 20156, and one of the main objectives of the 2017 Commission Work 
Programme7.  This initiative, called "the Goods package", aims to give citizens and businesses 
the  assurance  that  the  Single  Market  protects  and  empowers  them.  People  need  to  be 
confident that products available on the market can be trusted, their rights as consumers are 
not undercut, and businesses need to be confident that they can sell their products throughout 
the EU and that competition is fair. Therefore, the Commission is proposing, on the one hand, 
to strengthen the implementation of EU harmonisation legislation by supporting compliance 
and enforcement and on the other, to give a major boost to mutual recognition in the area of 
goods.  The  initiative  has  been  linked  to  the  REFIT  programme8  due  to  the  impacts  the 
malfunctioning  of  mutual  recognition  has  on  the  functioning  of  the  internal  market.  The 
evaluation  will  therefore  examine  the  extent  to  which  the  legal  framework  for  mutual 
recognition is fit for purpose and delivers its intended benefits while avoiding undue costs. 

2. 

BACKGROUND TO THE MUTUAL RECOGNITION PRINCIPLE AND REGULATION 

1.1  Baseline 

The principle of mutual recognition, stemming from Articles 34-36 TFEU and elaborated on 
the basis of case law, requires that, notwithstanding technical differences between the national 
rules that apply throughout the EU, the Member State of destination may not prohibit the sale 
on its territory of products that are lawfully marketed in other Member States, even if those 
were  manufactured  in  accordance  with  different  technical  rules.  The  only  possibility  for 
Member  States  to  deny  market  access  for  products  lawfully  marketed  in  another  Member 
States is on the basis of overriding interests linked to the protection of public interest such as 
protection  of  health,  consumers,  environment,  etc.  Therefore,  the  application  of  mutual 
recognition is not automatic. It can be lawfully denied if Member States demonstrate that, by 
not  complying  with  its  own  national  rules,  a  product  lawfully  marketed  in  another  Member 
State would endanger the protection of a given the public interest. Mutual recognition aims to 
facilitate the free movement of goods, where there are no EU harmonised rules governing the 
marketing of products or parts thereof, while maintaining a high level of protection of public 
interests. It is particularly relevant for innovative products, where businesses need to rely on 

5  
6  

http://ec.europa.eu/smart-regulation/guidelines/index_en.htm 
Communication from Commission to the European Parliament, the Council, the European Economic and Social Committee and the 
Committee of the Regions, Upgrading the Single Market: more opportunities for people and business, COM 2015 550/2 
http://ec.europa.eu/atwork/key-documents/index_en.htm 

7  
8            The aim of the REFIT programme is to ensure that EU laws are fit for purpose and deliver their intended benefits for citizens, 

businesses and society while removing red tape and lowering costs. It also aims to make EU laws simpler and easier to understand. 

              REFIT pays particular attention to small businesses, which can be disproportionately affected by the burden of implementing EU 

rules. 

8 

 
 
                                                            
existing national rules or deal with the absence of such rules in order to launch new products 
on the market.  

Applying  the  mutual  recognition  principle  also  consists  of  scrutinising  national  technical 
rules, in order to identify those undermining free movement of goods. This was done mainly 
by: 

 

 

Requiring  the  insertion  of  a  so  called  "mutual  recognition  clause"  in  the  new  national 
technical  regulations,  when  those  are  notified  to  the  Commission  via  Directive  (EU) 
2015/15359   

Dealing with complaints and infringements of free movement of goods as guaranteed by 
Articles 34-36 TFEU 

Yet, the application of the mutual recognition principle in practice was challenging since its 
introduction by the Court of Justice in 197910. Already in 1996, the Commission highlighted 
in a communication to the Parliament and the Council11 the difficulties of applying the mutual 
recognition  principle  in  practice.  These  concerns  were  reiterated  again  in  a  Commission 
Working  Document  in  199812,  and  in  a  communication  from  199913.    Furthermore,  the 
surveys  carried  out  in  2002  for  the  second  biennial  report  on  the  functioning  of  mutual 
recognition14  indicated  that  about  35%  of  businesses  reported  problems  with  mutual 
recognition,  and  about  50%  of  them  decided  to  adapt  their  products  to  the  rules  of  the 
Member State of destination. Furthermore, about 25% of the complaints received in the area 
of  free  movement  of  (non  -harmonised)  goods  related  to  mutual  recognition,  and  market 
access  for  products  constituted  one  of  the  most  important  problems  registered  by  SOLVIT. 
The  Commission  analysed  the  reasons  for  this  in  200715  and  reached  the  following 
conclusion:  The  lack  of  awareness  about  the  mutual  recognition  principle,  the  legal 
uncertainty about the scope of the principle and the burden of proof, the risk for enterprises 
that  their  products  will  not  get  access  to  the  foreign  market  or  that  they  will  have  to  be 
withdrawn  from  the  market  of  the  destination Member  State,  and the absence  of a  dialogue 
between  competent  authorities  in  different  Member  States  prevents  the  achievement  of  free 
movement  of  goods  in  the  non-harmonised  area16.  Following  this  analysis,  it  was  estimated 
that,  depending  on  the  product,  the  differences  between  technical  rules  in  different  national 
markets,  combined  with  the  need  for  multiple  testing  and  certification,  may  constitute 
between 2% and 10% of overall production costs17. However, the 2007 analysis was based on 
a  very  theoretical  methodology  to  estimate  macroeconomic  impacts,  such  as  estimates  as  a 
percentage of increase in GDP. As these estimates could not be verified ex post, the findings 
of  the  2007  analysis  were  not  considered  reliable  enough  to  be  used  as  a  basis  for  the 
evaluation. 

9  

10  
11  

12  
13  

14  
15  
16  

17  

Directive (EU) 2015/1535 laying down a procedure for the provision of information in the field of technical regulations and of rules 
on Information Society services, OJ L 241, 17.9.2015, p.1 
C-120/78 "Cassis de Dijon" 
The impact and effectiveness of the Single market, Communication from the Commission to the European Parliament and the 
Council, 30 October 1996 http://ec.europa.eu/internal_market/economic-reports/docs/single_en.pdf 
SWD on the application of the mutual recognition principle, SEC(1998) 242 
Communication from the Commission to the Council and the European parliament, Mutual recognition in the context of the follow-
up to the Action Plan for the Single Market, COM(1999)299 final 
COM(2002)419final of 23.7.2002 
Commission staff working document COM(2007) 36 Final of 2007 
Communication on mutual recognition COM(1999)2999 Final, first and second biennial report on the application of the principle of 
mutual  recognition,  SEC(1999)1106  of  13  July  1999  and  COM(2002)419  Final  of  23  July  2002,  Commission  staff  working 
document COM(2007) 36 Final of 2007 
See footnote 15 

9 

 
 
                                                            
The adoption of Regulation (EC) No 764/2008 (‘the Mutual Recognition Regulation’) was a 
response to  the  suboptimal  application  of  the  principle  of  mutual  recognition  in  the  field  of 
goods,  mainly  aimed  at  addressing  the  issues  identified  and  establishing  a  procedural 
framework to minimise the possibility that national technical rules create unlawful obstacles 
to the free movement of goods between Member States.  

1.2  Objectives of the mutual recognition principle and Regulation 

The objective of the mutual recognition principle is to guarantee free movement of goods in 
the internal market, in the absence of harmonised rules. The principle allows goods to move 
freely, despite the existence of different and potentially divergent national technical rules. As 
for  the  Mutual  Recognition  Regulation,  it  aimed  to  increase  awareness  of  the  mutual 
recognition  principle,  ensuring  legal  certainty  for  national  authorities  and  businesses  and 
improving administrative cooperation between national authorities. 

1.3  Description of the mutual recognition principle and Regulation 

This section describes the different components of mutual recognition.  

1.3.1 The mutual recognition principle and its tools 

The  mutual  recognition  principle  applies  in  the  area  of  products  that  are  not  subject  to  EU 
common rules (non - harmonised products) or to aspects of products falling outside the scope 
of such legislation (partially harmonised products). It allows a product lawfully marketed in a 
Member  State  to  be  sold  in  other  Member  State,  despite  the  fact  that  this  product  complies 
with  different  technical  rules.  Exceptions  to  this  principle  are  justified  on  grounds  of  the 
protection of public morality or public security, the protection of health and life of humans, 
animals  or  plants,  provided  for  under  Article  36  TFEU  or  on  the  basis  of  overriding 
requirements of general public importance recognised by the case law of the Court of Justice, 
and  also  that  they  are  proportionate  to  the  aim  pursued.  The  mutual  recognition  principle 
would  apply  in  the  area  of  childcare  articles,  textiles,  decorative  articles,  furniture,  lighters, 
cooking  accessories,  etc.  The  principle  applies  to  the  marketing  of  the  whole  product,  or  to 
aspects  of  it,  if  it  is  a  partially  harmonised  product.  For  example,  textiles:  the  content  of 
chemicals  that  may  be  present  in  textiles  is  harmonised,  but  the  lengths  of  the  cords  for 
children's textiles (to avoid strangulation risks) is left to national discretion (and thus subject 
to  mutual  recognition).  Mutual  recognition  also  applies  to  a  number  of  non-consumer 
products.  For  example,  while  certain  measuring  instruments  such  as  taximeters  or  water 
meters  are  subject  to  EU  harmonisation  legislation,  others  such  as  radars  for  speed 
measurement or breathalysers for estimating blood alcohol content are not. 

 

The mutual recognition clause  

The  clause  is  one  of  the  tools  allowing  for  the  correct  application  of  the  mutual 
recognition  principle.  In  its  2002  Communication  on  the  application  of  the  mutual 
recognition  principle18,  the  Commission  recommends19  the  insertion  of  a  mutual 
recognition clause in national technical rules notified under Directive (EU) 2015/1535, 
to  give  the  concerned  economic  operators  a  precise  and  clear  understanding  of  their 

18  

19  

Commission interpretative communication on facilitating the access of products to the markets of other Member States: the practical 
application of mutual recognition, 2003/C 265/02 
The insertion of the clause is not considered as mandatory for Member States 

10 

 
 
                                                            
rights  and  obligations  with  regards  to  the  application  of  that  rule  to  their  products 
lawfully marketed in other Member States. In practice, the clause refers to the mutual 
recognition principle and procedural guaranties of the regulation; it expressly mentions 
that products lawfully marketed in other Member States are allowed to enter the market 
despite not fully complying with this national technical regulation.  

 

Complaints and infringements related to Articles 34-36 TFEU 

The  Commission  monitors  whether  Member  States  comply  with  the  EU  law  and 
whether  their  national  rules  undermine  the  free  movement  of  goods.  To  ensure  that 
internal market rules are respected and applied correctly in the area of non-harmonised 
goods, the Commission follows up complaints based on alleged breaches of Article 34 
which cannot be justified.  

1.3.2 The Mutual Recognition Regulation  

The Regulation lays down the rules and procedures to be followed by the national authorities 
of  a  Member  State  when  taking  or  intending  to  take  a  decision,  in  accordance  with  the 
national  technical  rules,  which  would  hinder  the  free  movement  of  a  product  lawfully 
marketed in another Member State and subject to Article 34 TFEU. Therefore, the Regulation 
only  applies  when  national  authorities  intent  to  restrict  market  access,  and  not  before.  It 
applies when: 

a. 

b. 

c. 

d. 

e. 

f. 

national authorities intend to take an administrative decision, 

concerning a product lawfully marketed in another Member State, 

concerning a product or aspects of a product which are not subject to harmonised EU 
legislation, 

addressed to economic operators, 

based on a national technical rule, and  

has a restrictive effect on the product, namely that it will be: 

i. 

prohibited from being placed on the market, 

ii.  modified  or  subject  to  additional  testing  before  it  can  be  placed  or  kept  on  the 

market, or 

iii.  withdrawn from the market 

This  means  that  the  Regulation  does  not  apply  to  prior  authorisation  procedures,  as  the 
requirement that the placing of a product on the market is subject to prior authorisation is not 
a  technical  rule  within  the  scope  of  the  Regulation.  However,  the  decision  to  deny  prior 
authorisation  merely  because  the  product  does  not  comply  with  the  national  rules  in  the 

11 

 
 
Member States having the prior authorisation procedure is a decision within the scope of the 
Regulation20.  

 

Assessment by Member States of the need to apply a technical rule and information to 
the economic operator 

The mutual recognition principle is not automatically applied. It is not an obligation on 
Member  States,  but  a  right  which  can  be  invoked  by  economic  operators  wishing  to 
trade  their  products  in  the  internal  market.  Member  States  may  decide  that  the 
application  of  a  national  technical  rule,  to  the  detriment  of  mutual  recognition,  is 
necessary, based on the need to protect a given public interest. However, the Regulation 
places the burden of proof on the national authorities intending to deny market access. 
A  written  notice  has  to  be  sent  to  the  economic  operator,  informing  him  about  their 
intention to deny market access, and specifying the technical rule on which the decision 
is based, and the supporting technical or scientific evidence which makes the decision 
justified  and  proportionate.  The  economic  operator  has  the  right  to  submit  comments. 
Any decision denying market access taken after receiving comments from the economic 
operator shall be notified to him, and shall state the grounds on which it is based, the 
technical  or  scientific  evidence  supporting  the  decision  and,  when  applicable,  the 
reasons for rejecting the economic operator's arguments. The decision shall also indicate 
the remedies available under national law in order to challenge the decision.  

 

Product Contact Points 

Economic  operators  may  wish  to  know  about  the  applicable  national  rules  before 
entering  a  market.    The  Regulation  contains  the  obligation  on  Member  States  to 
establish Product Contact Points in their territories. The Product Contact Points provide, 
upon  request,  information  on  the  technical  rules  applicable  to  a  specific  product,  the 
contact details of the competent authorities in charge of supervising the implementation 
of the technical rule in question and the remedies available in case of dispute between 
the economic operator and the competent authority.  

 

The list of products which might be subject to mutual recognition 

Mutual recognition does not apply to products fully or to those aspects partially covered 
by EU harmonisation legislation. To facilitate the identification of products to which the 
mutual recognition principle may apply, the Regulation introduced an obligation for the 
Commission to put in place a non-exhaustive list of products which are not subject to 
EU harmonisation legislation.  

 

Reporting obligations  

Under the Regulation, every decision denying market access, as well as the grounds on 
which  it  is  based,  has  to  be  individually  notified  by  the  Member  States  to  the 

20  

See recital 12 of the Mutual Recognition Regulation  

12 

 
 
 
 
                                                            
Commission,  in  addition  to  notifying  the  economic  operator.  Additionally,  Member 
States have to send the Commission on a yearly basis a report on the application of the 
Regulation.  

Table 2-1: Intervention logic mutual recognition  

OUTCOMES 

IMPACTS 

EXTERNAL 
FACTORS 

NEEDS 

ACTIONS 

Mutual recognition 
principle 

Mutual recognition 
clause 

Complaints and 
infringements 

Regulation 764/2008 

OBJECTIVES 

GENERAL 
AND 
SPECIIFC 

Free 
movement of 
goods in the 
non-
harmonised 
area 

Awareness 
about mutual 
recognition 

Products 
lawfully 
marketed in 
one Member 
States can be 
more easily 
sold in another 

Remove 
barriers to 
trade of 
products 
lawfully 
marketed 
in one 
Member 
State 

Procedures for 
assessing and 
denying / restricting 
market access 

Legal 
certainty 

Reduction of 
information 
costs 

Product Contact 
Points 

Administrative 
cooperation 

List of products to 
which mutual 
recognition may 
apply 

Reporting 

Complementary 
actions 

Guidance documents 
on the application of 

Avoid 
duplication of 
tests/ 
additional 
testing 

13 

Better 
functioning of 
the internal 
market 

More choices 
for consumers 
at lower prices 

More 
opportunities 
for businesses 

Decentralized 
national 
administrations 
impeding the 
functioning of the 
product contact 
points network 

Perception of some 
national authorities 
that their own 
national rules are 
generally better than 
those of other 
Member States 

Perception of 
businesses that 
national rules must 
apply regardless of 
mutual recognition 

Tendency of 
businesses  to avoid 
any problems by 
complying with 
national rules 
without questioning 
them 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the mutual 
recognition principle 
to specific sectors 

Conferences, 
seminars and round 
tables on the 
application of the 
principle 

3. 

EVALUATION QUESTIONS  

In order to assess the functioning of mutual recognition in the field of goods and to evaluate 
whether  the  mutual  recognition  principle  and  the  Regulation  are,  in  effect,  on  course  to 
achieve their objectives, the following questions were used to guide the analysis: 

  Effectiveness: To what extent have the mutual recognition principle and the Regulation 
been effective in meeting, or moving towards, the defined objectives (i.e. to what extent 
have  they  contributed  to  facilitating  free  movement  of  goods?  To  what  extent  has  the 
Regulation contributed to achieving its objectives such as increasing awareness on the 
mutual  recognition  principle?  To  what  extent  has  legal  certainty  been  increased  for 
businesses  and  authorities  as  a  result  of  the  Regulation?  To  what  extent  has  the 
administrative  cooperation  been  improved  as  a  result  of  the  Regulation?  What  are  the 
factors that influenced the achievements and to what extent?) 

  Efficiency:  What  are  the  costs  of  the  mutual  recognition  principle  and  of  the 
Regulation?    What  are  the  benefits  of  the  mutual  recognition  principle  and  of  the 
Regulation?  To  what  extent  are  the  regulatory  costs  (including  administrative  burden) 
proportionate to the benefits achieved?  

  Coherence  with  other  policies:  To  what  extent  is  mutual  recognition  consistent  with 

other policy actions at EU and national level? 

  Relevance:  To  what  extent  is  the  mutual  recognition  principle  and  of  the  Regulation 
still  relevant  to  its  stakeholders?  How  well  do  the  objectives  (still)  correspond  to  the 
current needs within the EU?  

  EU added value: What is the additional value resulting from the Regulation, compared 
to what could be achieved by Member States at national and/or regional levels? To what 
extent do the issues addressed by the Regulation continue to require action at EU level? 
What would be the most likely consequences of repealing the Regulation? 

4.  METHOD 

The approach was designed in several steps, in order to ensure collection of both qualitative 
and  quantitative  data  from  the  relevant  audience.  First,  a  study  on  the  functioning  of  the 
mutual  recognition  principle  was  carried  out  by  an  external  consultant.  On  the  basis  of  its 
results,  an  evaluation  of  the  functioning  of  the  mutual  recognition  principle  and  Regulation 
was conducted by the Commission's services, using the evidence from the above mentioned 
external  evaluation  and  complemented  by  desk  research,  stakeholders  consultation  and  a 

14 

 
 
 
study  on  the  impacts  of  revising  the  Mutual  Recognition  Regulation.  The  evaluation  covers 
the  time  period  between  the  entry  of  the  Regulation  into  force  on  13  May  2009  and  31 
December  2016.  In  terms  of  geographical  coverage,  the  evaluation  covers  the  EU  Member 
States  and  the  EFTA  states  that  are  contracting  parties  to  the  Agreement  on  the  European 
Economic Area (EEA)21.     

1.4 

External studies 

The application of the principle of mutual recognition was subject to an external evaluation22. 
Its aim was to evaluate the application of the mutual recognition principle by Member States, 
in order to identify shortcomings and to present possible ways of enhancing the application of 
the principle. Thus, the study did not evaluate the Regulation specifically, but looked from a 
broader  perspective  at  the  impacts  of  an  insufficient  application  of  mutual  recognition  on 
economic  operators  and  the  internal  market.  Furthermore,  the  study  focused  on  the 
effectiveness  and  efficiency  aspects  only,  as  these  are  the  most  relevant  with  regard  to  the 
mutual recognition principle, which stems directly from the Treaty and the jurisprudence. The 
evaluation  was  based  on  a  combination  of  data  sources  and  data  collection  tools,  which 
included a literature review, statistical data, web-based surveys among different target groups 
and in-depth interviews with Member States and relevant stakeholders.  

Additionally, a study was launched in 2016 in order to estimate the market value of current 
intra-EU  trade  in  non-harmonised  products  falling  under  the  mutual  recognition  principle. 
Furthermore, the study looked into the magnitude of the problem triggered by the potentially 
suboptimal functioning of mutual recognition and its significance. This was done by analysing 
the  intra-EU  trade  for  harmonised  goods  compared  to  non-harmonised  goods  and  their 
evolution  over  the  last  10  years.  The  study  was  conducted  between  September  2016  and 
March 2017.  

1.5 

 Desk research 

Desk  research  was  conducted  for  the  purpose  of  the  evaluation  of  the  mutual  recognition 
principle  and  Regulation,  by  the  contractors  in  the  framework  of  the  external  studies 
mentioned  under  4.1  and  by  the  Commission's  services.    Available  literature  on  the  topic, 
annual  reports  from  the  Member  States  as  well  as  all  notifications23  received  between  2009 
and 2016 were scrutinised. Also, the Commission services examined the complaints received 
from  economic  operators  concerning  a  malfunctioning  of  mutual  recognition  and  the  draft 
national  regulations  notified  on  the  basis  of  Directive  (EU)  2015/1535.  The  desk  research 
involved  case  studies  in  sectors  where  the  application  of  mutual  recognition  is  problematic.  
The literature review comprised a review of existing business and academic literature on the 
non-harmonised  areas  in  the  EU  internal  market.  Annex  4  contains  a  full  overview  of  the 
assessed literature, and a summary of the notifications and annual reports received.  

1.6 

Stakeholders consultation 

Stakeholders consultation performed by the consultants 

21  
22  

23  

Iceland, Liechtenstein and Norway 
European Commission, Study commissioned to Technopolis Group (2015): ‘Evaluation of the application of the principle of mutual 
recognition in the field of goods,’ ENTR/172/PP/2012/FC – LOT 4 carried out between April 2014 and May 2015: 
http://ec.europa.eu/growth/single-market/goods/free-movement-sectors/mutual-recognition/index_en.htm. 
Notifications of national administrative decisions denying or restricting market access, on the basis of article 6 of the Regulation 

15 

 
 
                                                            
In  the  framework  of  the  external  study  mentioned  under  4.1,  four  different  surveys  were 
launched on 9 October 2014 and completed on 5 January 2015. These were a company survey 
(199  participants),  a  survey  of  national  business  associations  and  of  national  sector 
associations (20 participants), and a product contact point survey (26 participants). Following 
the  survey,  qualitative  interviews  with  national  business  associations  and  Product  Contact 
Points in each Member State were also carried out. The objective of the qualitative interviews 
was  to  shed  more  light  on  the  implementation  of  the  mutual  recognition  principle  in  the 
Member States, in particular with respect to ‘sensitive’ areas such as notification practices (or 
lack  thereof).  The  interviews  were  conducted  with  the  same  person  who  responded  to  the 
survey, to the extent possible. 

For  the  purposes  of  the  second  study  mentioned  under  4.1,  an  online  survey  was  launched 
between  December  2016  and  January  2017.  10024  respondents  accessed  the  survey  (40 
businesses, 38 national authorities, and 22 business associations). In parallel with the launch 
of  the  survey,  the  research  team  started  contacting  selected  stakeholders  for  in-depth 
interviews  on  the  application  of  the  mutual  recognition  principle  across  Europe.  The  team 
carried out 25 interviews in order to gather more fine-grained and detailed information about 
the implementation of mutual recognition.  

Annex  2  provides  a  full  overview  of  the  stakeholders'  consultation  performed  by  the 
consultants.  

Stakeholders consultation performed by the Commission 

During the 8th meeting of the Consultative Committee on mutual recognition which took place 
on 25 October 2016, the preliminary findings on the functioning of mutual recognition were 
presented and discussed with Member States representatives.  

An online public consultation was carried out from the 1st of June until the 30th of September 
2016.  153  replies  were  received,  representing  91  companies,  45  national  authorities  and  17 
citizens. The consultation was made available to the general public, and aimed to gather data 
on  how  stakeholders  perceive  mutual  recognition  and  its  potential  shortcomings,  on  the 
functioning  of  the  Mutual  Recognition  Regulation  (effectiveness,  efficiency,  coherence, 
relevance and EU added value), on the communication between mutual recognition users and 
on the possible options of achieving an increased and better mutual recognition. The results of 
the public consultation can be found in Annex 5.  

A stakeholders' event was organised on 17 June 2016, to identify the main issues relating to 
the functioning of mutual recognition and to identify possible ways forward. 144 participants 
attended the event, representing businesses (62), national authorities (60) and others (22). The 
minutes of the event can be found in Annex 2.   

5. 

LIMITATIONS AND ASSESSMENT OF ROBUSTNESS OF FINDINGS 

Assessing the magnitude of the difficulties linked to the functioning of mutual recognition and 
its actual and potential impacts on stakeholders is not straightforward. Indeed, several factors 
are making the evaluation of the application of mutual recognition a difficult exercise.  

24   However, only half of them answered the questionnaire to an extent that may be considered satisfactory 

16 

 
 
                                                            
First,  mutual  recognition,  when  it  is  working  properly,  is  invisible;  this  is  because  it  is 
impossible to monitor when and how many times goods are allowed to enter a market on the 
basis  of  the  mutual  recognition  principle.  Only  the  number  of  products  for  which  market 
access has been denied can be estimated, on the basis of the monitoring tools in place by the 
Regulation  (notification  of  administrative  decisions  denying  market  access  and  annual 
reports).  However,  this  doesn't  represent  the  full  picture  of  the  situation,  as  only  6  Member 
States  are  notifying  decisions  to  deny  market  access25.  The  complaints  received  and  the 
divergences noticed between the annual reports and notifications show that not all decisions 
taken are being notified to the Commission.  

It  is  possible  to  estimate,  based  on  intra  EU  trade  statistics,  the  number  of  non-harmonised 
products lawfully marketed in one Member State and placed on the market of other Member 
States.  However,  this  doesn't  show  how  many  products  were  marketed  on  the  basis  of  the 
mutual  recognition  principle.      This  is  because  businesses  may  decide,  on  commercial 
grounds, not to use mutual recognition, and to align their products with the existing national 
rules in the Member States where they want to market their products. Some large companies 
choose to design and produce products fitting the highest requirements, and thus complying 
with all national technical rules.  

Second, the results of the stakeholders' consultation might need to be treated with caution, as 
the  consultations,  targeted  or  opened,  were  not  representative  of  different  sectors,  Member 
States and company types.  

The  surveys  carried  out  in  2014-2015  by  the  external  consultant  registered  a  low  rate  of 
responses. 199 businesses and 20 national or sectoral associations participated in the survey. 
The  businesses  survey  did  not  result  in  a  representative  sample.  There  was  a  significant 
geographical bias with respect to the geographical coverage. Companies from Portugal (36), 
the  UK  (22)  and  Lithuania  (21)  were  significantly  overrepresented,  while  there  were  no 
responses from 9 EU Member States or from any of the EEA countries. Also, large companies 
were  overrepresented  in  the  survey,  while  small  companies  were  underrepresented.  29%  of 
the participating companies were large companies with more than 250 employees, while they 
represent around 1% of the EU's company population26.  26% were medium-sized companies 
with  50  to  250  employees  and  27%  are  small  companies  with  10  to  49  employees.  Micro 
companies  with  less  than  10  employees  accounted  for  18%.  Also,  the  business  associations 
had generally not put a high priority on responding to the survey, which can be either because 
they  don't  monitor  issues  related  to  mutual  recognition,  or  because  their  members  don't 
approach them in relation to these issues. Only a minority of sectors and Member States were 
represented  in  the  survey.  As  regards  the  survey  targeting  PCPs,  its  main  limitation  came 
from  the  fact  that  PCPs  are  only  the  interface  between  business  and  national  authorities  in 
charge of applying the mutual recognition principle. Thus, they are not always familiar  with 
the practicalities of the application of the mutual recognition principle, and they don't always 
have insight as regards the denial of market access for certain products. Furthermore, not all 
PCPs  across  the  EU  participated  in  the  survey.  PCPs  from  Austria,  Bulgaria,  France, 
Germany, Italy and Spain did not submit any responses to the survey, but, with the exception 
of  Italy,  they  were  subsequently  interviewed.    PCPS  from  Portugal  and  Romania  were 
represented  twice  (as  they  have  several  PCPs),  and  out  of  the  EEA/EFTA  countries, 
Liechtenstein and Norway participated. More details are provided in the synopsis report.  

25  
26  

See for more details section 7.1 
http://ec.europa.eu/growth/smes_en 

17 

 
 
                                                            
As  regards  the  public  consultation  carried  out  by  the  Commission,  it  gathered  153  replies 
only.    Businesses  actively  participated  (91)  but  without  reaching  a  representative  sample; 
large  companies  were  overrepresented  (19%),  while,  as  mentioned  previously,  they  only 
represent  1%  of  the  EU's  company  population.  Also,  when  asked  to  quantify  the  costs  and 
benefits of the Regulation, most businesses indicated that such estimation is impossible. Only 
a  few  replied  (between  11%  and  26%  depending  on  the  questions),  and  the  replies  contain 
considerable variations. This is why case studies were used in order to complement the lack of 
accurate  information  on  costs  and  benefits.    Member  States  were  represented  in  the 
consultation  by  both  PCPs  (13)  and  other  authorities  (32),  but  without  reaching  a  good 
geographical  balance:  no  replies  were  received  from  Cyprus,  Denmark,  Finland,  France, 
Greece, Ireland, Luxembourg, Malta and UK27.   

The overview of the notifications of draft national technical rules for the assessment of their 
compatibility  with  EU  law  by  the  Commission  under  Directive  2015/1535  provides  some 
insight on the sectors where a high regulatory activity at national level can be observed, and 
where the use of mutual recognition is more relevant28. From 2011 to 2013, 2114 notifications 
were received (675 in 2011, 734 in 2012 and 705 in 2013). The construction sector saw the 
highest number of notifications, with many measures related to energy efficiency of buildings 
and  concrete  structures,  road  pavements  and  constituent  materials,  fire  safety  of  buildings. 
Construction  was  followed  by  agricultural  products,  foodstuffs  and  beverages  (food 
hygiene,  the  composition  and  labelling  of  foodstuffs  and  beverages,  food  packaging, 
minimum  price  for  alcoholic  beverages,  composition  and  marketing  of  alcoholic  and  non-
alcoholic  beverages).    Notifications  were  also  received  in  the  telecommunications  sector 
(radio equipment and telecommunications terminal equipment, radio interfaces, hardware and 
software for the collection, management and use of data gathered by electronic mechanisms 
installed  on  board  vehicles  (black  box))  and  in  the  environment  sector  (packaging  and 
packaging  waste,  recyclable  products,  processing  of  biodegradable  waste).  This  information 
was used in order to identify sectors where numerous national technical rules exists or were 
introduced, in order to see if market access problems can be linked with important regulatory 
activity. However, the use of this information is limited and should be treated with caution, as 
many  issues  related  to  compatibility  with  EU  law  are  solved  before  the  adoption  of  the 
national rule, during the stand still period. Furthermore, the assessment performed under this 
Directive  links  to  the  compatibility  of  the  national  rule  with  EU  law,  while  the  Mutual 
Recognition Regulation covers the application of a national rule to a specific individual case. 
Thus,  while  the  national  rule  is  compatible  with  EU  law,  its  application  in  a  specific 
individual case  may  be  incompatible.  Therefore,  the  notifications  alone  cannot  be used  as  a 
good proxy for estimating the number of market access denials in specific sectors.  

All  these  factors  make  the  precise  measuring  of  the  mutual  recognition  principle  and 
Regulation's  effect  quite  challenging.  The  contributions  received  following  the  various 
surveys  and  consultations  carried  out  did  not  allow  a  statistically  representative  result  to  be 
reached.  However,  the  stakeholders'  consultation  was  very  wide,  and,  together  with  the 
multitude of information sources used, it allows a strong indicative picture of the functioning 
of mutual recognition to be gathered, reliable enough to be used as a basis for further decision 
making. 

27  

28  

Some of these Member States choose sending a position paper instead of participating in the public consultation, e.g. Denmark and 
France 
Latest  report  available:  http://ec.europa.eu/growth/tools-databases/tris/en/the-20151535-and-you/being-informed/reports/report-to-
the-european-parliament-2011-2013/ 

18 

 
 
                                                            
Furthermore,  it  is  necessary  to  draw  lessons  from  the  lack  of  reliable  data  on  mutual 
recognition in order to be able, in the future, to better assess the impacts of the functioning of 
the principle on free movement of goods. In order to do so, is it appropriate to reflect on more 
reliable monitoring tools, such as a better information collection tool, preferably an IT tool, to 
facilitate  the  collection  of  data,  as  well  as  relying  on  existing  surveys  at  EU  level  such  on 
which the Commission could rely to collect data on how well the mutual recognition principle 
performs.  

6. 

IMPLEMENTATION STATE OF PLAY  

1.7 

Implementation of the mutual recognition principle  

In addition to the Regulation, two main tools were used for facilitating the implementation of 
the  mutual  recognition  principle:  the  mutual  recognition  clause  and  the  management  of 
complaints.   

The mutual recognition clause 

It  has  been  a  longstanding  Commission  policy29  to  insist  on  the  insertion  of  a  mutual 
recognition  clause  in  the  technical  rules  of  Member  States30.  During  2012  and  2014  for 
example, 2168 draft national rules were notified, and only 205 contained a mutual recognition 
clause.  When  inserted,  the  clause  is  often  unclear  or  not  very  detailed.  This  shows  that 
national  authorities  are  reluctant  towards  mutual  recognition,  or  that  they  lack  awareness  in 
particular  regarding  the  benefits  it  could  achieve.  Therefore,  they  tend  not  to  follow  the 
Commission's recommendations in this area.  

Complaints  

Between 2009 and 2016, economic operators complained 195 times about a misapplication of 
the mutual recognition principle.   

Member State31 

2010 

2011 

2012 

2013 

2014 

2015 

2016 

Total 

1 

1 

1 

1 

Austria  

Belgium  

Bulgaria 

Czech Republic  

Denmark  

Estonia 

Finland 

France 

1 

1 

1 

6 

2 

3 

1 

1 

7 

1 

1 

1 

1 

1 

4 

7 

3 

3 

2 

1 

6 

1 

4 

28 

1 

1 

3 

29  
30  
31  

Communications COM (1999) 299, COM (2002)419, COM (2003)200 and C (2003)3944 
See section 2.3.1 
Where the misapplication of the mutual recognition principle is reported 

19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                            
Germany  

Greece 

Hungary 

Italy 

Latvia 

Lithuania 

Malta 

The Netherlands  

Poland  

Portugal  

Romania 

Slovenia 

Slovakia 

Spain 

Sweden  

UK 

4 

2 

7 

2 

1 

10 

7 

1 

1 

16 

2 

1 

4 

2 

1 

1 

1 

1 

3 

2 

1 

2 

10 

3 

2 

1 

2 

1 

2 

1 

2 

1 

3 

1 

1 

2 

3 

6 

1 

1 

5 

2 

1 

5 

1 

4 

1 

1 

1 

2 

1 

1 

1 

3 

1 

3 

5 

4 

3 

25 

1 

5 

2 

4 

38 

4 

8 

2 

5 

17 

8 

17 

The  sectors  where  most  of  the  complaints  were  registered  are  food,  construction  products, 
labelling and precious metals.  

Most concerned sectors 

Food (e.g. food supplements, vitamins) 

Construction products 

Labelling (including food labelling) 

Precious metals 

30 

17 

21 

6 

1.8  Application of Regulation (EC) No 764/2008 

This  section  describes  the  implementation  of  the  different  components  of  the  Regulation, 
since  its  entry  into  force  on  13  May  2009.  The  effects  of  the  implementation  are  further 
assessed in section 7. 

Establishing Product Contact Points (PCPs) 

20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PCPs have been established in all EU Member States. Their list was initially published in the 
OJ32 and is regularly updated and available online on the Commission's website33.  

The  Regulation  left  the  set-up  of  PCPs  to  the  discretion  of  Member  States,  thus,  their 
organisation  and  function  vary  significantly.  Most  Member  States  have  a  single  PCP, 
responsible  for  all  inquiries  related  to  non-harmonised  products.  In  a  few  Member  States34, 
the  PCP  is  split  between  a  general  one  and  a  construction  products  specific  one.  Other 
Member States35 have PCPs in 6-7 different ministries. In almost all Member States, the PCP 
(or the co-ordinator, where there are several PCPs) is located within the ministry responsible 
for  industry/business  and  the  internal  market,  often  as  part  of  a  group  or  team  dealing  with 
internal  market  policy. Only  in  Slovenia  the  PCP  is  located  in  an  independent  institute  (the 
Slovenian  Institute  for  Standardisation).  A  few  PCPs  handle  queries  (or  part  of  queries) 
themselves.  In  Malta,  the  PCP  is  responsible  for  all  communication  with  companies. 
However, this setup is unique to Malta (and difficult, if not impossible, to handle in a larger 
Member  State),  and  in  most  cases  queries  from  economic  operators  are  passed  on  to  the 
responsible ministry, department or directorate or,  occasionally, the relevant local authority. 
In  Italy,  there  is  an  appointed  PCP,  however,  economic  operators  must  contact  the  relevant 
ministry in charge of their product and receive their answer from this authority – without the 
PCP  being  involved.  The  way  replies  are  being  provided  to  economic  operators  also  varies 
from one Member State to another. Very often, the responsible authority replies directly to the 
company  making  the  query.  Thus,  the  PCP  has  little  insight  on  the  outcome  of  the  queries. 
Sometimes, national authorities provide answers to companies via the PCP.  

Establishing the list of products to which mutual recognition may apply 

Article  12  (4)  required  the  publication  of  a  non-exhaustive  list  of  products  which  are  not 
subject  to  EU  harmonisation  legislation  by  the  Commission.  This  task  proved  to  be  very 
challenging,  as  there  is  no  correspondence  between  the  nomenclature  under  which  products 
are  classified  in  the  different  existing  databases  and  the  scope  of  the  different  pieces  of 
harmonised  legislation.    On  the  basis  of  the  existing  Commission's  Export  Helpdesk 
database36 it was possible to extract an indicative, non-exhaustive list of products not covered 
by any piece of EU legislation. This list is available online on the Commission's website on 
mutual  recognition37.  However,  the  list  was  not  regularly  updated,  thus  does  not  take  into 
account  repealed  or  newly  adopted  legislation  since  2009.  Furthermore,  it  does  not  provide 
any  information  on  those  products  which  are  only  partially  covered  by  harmonisation 
legislation, and where mutual recognition may apply with respect to those aspects not covered 
by the harmonisation legislation.  

Notifications from Member States 

According  to  the  Regulation,  Member  States  shall  notify  the  Commission  every  time  they 
take an administrative decision denying or restricting market access. In the period between the 
entry  of  the  Regulation  into  force  on  13  May  2009  and  31  December  of  2016,  the 
Commission  has  received  3918  notifications,  originating  from  6  notifying  Member  States. 

32  
33  
34  
35  
36  
37  

OJ C 185 of 7.08.2009, p. 6-12 
https://ec.europa.eu/growth/single-market/goods/free-movement-sectors/mutual-recognition/contacts-list_en 
Estonia, Latvia and Poland  
Romania, Portugal and the Netherlands 
http://exporthelp.europa.eu/thdapp/index.htm 
https://ec.europa.eu/growth/single-market/goods/free-movement-sectors/mutual-recognition/products-list_en 

21 

 
 
                                                            
The  number  of  notifications  received  in  2015  amounts  to  447,  in  line  with  the  activity 
registered the year before (466 notifications in 2014).   For 2016, the number of notifications 
increased: 646 notifications were registered. The measures notified relate mainly to precious 
metals. Some notifications concern food supplements, fertilisers, energy drinks and vitamins. 
Annex 7 contains an overview of all notifications received.  

The yearly reports from Member States 

The Regulation requires Member States to submit a report every year on the application of the 
Regulation.  However,  despite  the  Commission's  efforts  to  insist  on  the  fulfilment  of  this 
obligation,  not  all  Member  States  are  communicating  the  reports  as  requested  by  the 
Regulation. For example, in 2016, only 2338 Member States submitted annual reports, while 
20 reports were received in 2015 and 21 in 2014.  

Identifying  recurrent  problems  and  monitoring  the  application  of  the  Mutual  Recognition 
Regulation on the basis of the annual reports is not straightforward. This is because the data 
received is not homogeneous or comprehensive enough to be considered as usable input. The 
Regulation sets out minimum information to be provided in the annual reports, i.e. the number 
of  decisions  denying  or  restricting  market  access  and  the  grounds  on  which  they  are  based, 
and leaves to the discretion of Member States the additional information they might consider 
useful  to  report.  This  leads  to  considerable  variations  as  regards  the  content  of  the  reports 
received.    The  Commission  suggested  a  template  to  be  followed  by  Member  States  but  this 
template is not widely used.  

The reports highlight the main issues encountered by Member States when applying mutual 
recognition,  in  particular  with  regards  to  the  lack  of  awareness,  the  poor  administrative 
cooperation and the difficulties related to the concept of "lawfully marketed".  

As regards awareness, almost all Member States highlighted in their annual reports the need 
for additional awareness raising campaigns and trainings, as many economic operators are not 
aware  of  mutual  recognition  and  how  it  functions.  Training  and  information  campaigns  are 
also considered useful and suggested for officials within Member States dealing directly with 
national technical rules, as this could have a positive impact  on the way they apply mutual 
recognition with regard to products lawfully marketed in other Member States.    

The lack of administrative cooperation is also a recurrent issue most Member States reported 
on. It is difficult to identify, within a Member State, the responsible authority responsible for 
a  specific  product.  Difficulties  are  underlined  also  with  regards  to  communication  with 
authorities  in  other  Member  States.  Some  Member  States  report  that  they  receive  late  and 
unclear answers39. Even when not reporting on specific problems encountered, Member States 
are  calling  for  more  administrative  cooperation40.  The  reports  also  underline  the  limitations 
encountered by PCPs when exercising their activities. Often, they receive questions which are 
not within their remit, such as questions related to affixing the CE marking, which relates to 
the application of harmonisation legislation. They are also affected by the complexity of the 
questions  they  receive,  the  variety  of  products  covered  by  mutual  recognition  and  language 
limitations.  

38  
39  
40  

Slovenia, the Netherlands, Malta, Italy and Luxembourg did not submit annual reports in 2016 
e.g. Romania, Slovenia, annual report 2015 
e.g. France, Sweden, annual reports 2015 

22 

 
 
                                                            
The sectors where the application of mutual recognition is reported as being more problematic 
for  both  Member  States  and  businesses  are  fertilisers,  food  labelling,  food  supplements 
(interpretation  of  various  national  authorisation  procedures),  construction  products  (role  of 
autonomous  certifying  bodies,  gold-plating,  national  quality  marks  and  standards)  and 
hallmarks (recognition of certificates).  

Annex 7 contains an overview of all the annual reports received. 

The telematic network  

Article 11 of the Regulation foresees that the Commission may establish a telematics network 
concerning the exchange of information between PCPs and/or the competent authorities of the 
Member  States.  The  possibility  of  establishing  this  telematic  network  was  discussed  for  the 
first time during the meeting of the Mutual Recognition Consultative Committee in 2014. The 
Commission suggested, for facilitating notifications and communication among PCPs, the use 
of the Internal Market Information tool (IMI)41. During the 2015 meeting of the Consultative 
Committee, they agreed on launching a pilot project for testing the use of IMI. However, this 
decision was postponed in the light of the adoption of the Single Market Strategy calling for 
higher  and  better  mutual  recognition  by  revisiting  the  Mutual  Recognition  Regulation. 
Member  States  considered  that  the  choice  of  the  IT  tool  for  supporting  notifications  and 
communication  should  be  made  after  the  revision  of  the  Regulation,  and  in  line  with  the 
changes to be made, in order to be able to choose the most appropriate IT tool.   

Meetings of the Consultative Committee on Mutual Recognition  

A Consultative Committee, established under the Regulation, assists the Commission. There 
is no obligation as regards how many times the Committee should meet. Usually, one meeting 
per year is organised. During the 8th meetings held, the Commission and the representative of 
the Member States and from EEA/EFTA (since 2011) have discussed matters relating to the 
application of this Regulation. The main topics discussed have been the guidance documents, 
the  role  of  Product  Contact  Points,  and  ways  forward  in  improving  the  application  of  the 
mutual  recognition  principle.  Member  States  also  raised  the  difficulties  encountered  during 
the application of the Regulation, such as the problematic concept of "lawfully marketed", the 
lack  of  awareness  about  mutual  recognition  and  the  lack  of  appropriate  communication 
among PCPs.  

Annex 12 provides an overview on the functioning of the Committee and issues discussed.  

Guidelines, awareness raising campaigns and information  

A  series  of  guidance  documents  offering  practical  information  on  the  application  of  the 
Regulation  to  particular  issues  (e.g.  the  concept  of  "lawfully  marketed",  hallmarks,  food 
supplements, etc.) have been prepared by the Commission with the input of the members of 
the consultative committee. These guidance documents are indicative, not legally binding, and 
have  been  made  public  on  the  Commission's  website  on  mutual  recognition42.  Annex  4 
contains an overview of all guidance documents published.  

41  
42  

http://ec.europa.eu/internal_market/imi-net/index_en.htm  
http://ec.europa.eu/growth/single-market/goods/free-movement-sectors/mutual-recognition/ 

23 

 
 
                                                            
Since  2009,  the  Commission  has  organised  or  taken  part  in  numerous  seminars  on  mutual 
recognition in the internal market and the application of the mutual recognition principle. The 
main participants were businesses from areas most often impacted by mutual recognition and 
academia. 

1.9  Compliance with the Regulation (EC) No 764/2008 

During the period covered by this evaluation, no formal infringement procedures specifically 
related  to  the  application  of  the  Mutual  Recognition  Regulation  were  yet  launched.  Issues 
related  to  the  lack  of  notifications  or  submission  of  annual  reports  where  addressed  with 
Member States during the meetings of the Consultative Committee43.  

7.  ANSWERS TO THE EVALUATION QUESTIONS 

1.10  Effectiveness: Evaluating to what extent mutual recognition achieved its objectives 

The  general  objective  of  the  mutual  recognition  principle  and  Regulation  was  to  facilitate 
free movement of goods in the non-harmonised area. Over the period from 2008 and 2014, 
around  0.89  million  enterprises  were  operating  within  non-harmonised  sectors,  representing 
more  than  50%  of  the  total  number  of  active  enterprises  in  the  manufacturing  economy44.  
Around  87%  of  the  enterprises  operating  within  the  non-harmonised  sectors  are  micro 
enterprises  (i.e.  with  less  than  9  employees)  and  around  11%  are  small  and  medium 
enterprises  (i.e.  with  a  number  of  employees  between  50  and  250)45.  In  terms  of  turnover, 
non-harmonised  sectors  represent  a  significant  contribution  to  the  economy,  i.e.  enterprises 
operating  within  non-harmonised  sectors  contribute  to  around  20%  of  the  total  value  of 
market  sales  of  manufacturing  sectors.    Furthermore,  the  value  on  intra  EU  exports  of  non-
harmonised products represented the 18% of the value of intra EU exports.  

Additionally, the Regulation had the following specific objectives: 

 

 

 

To increase awareness about the mutual recognition principle ,  

To ensure legal certainty when using the mutual recognition principle,  

To  improve  administrative  cooperation  among  national  authorities  when  applying  the 
mutual recognition principle  

1.10.1  Facilitating  free  movement  of  goods  in  the  non–harmonised  area  through  mutual 

recognition 

The results of the public consultation carried out between June and September 201646 show 
that the mutual recognition principle and the Regulation had limited effects in facilitating free 
movement of goods in the non-harmonised area.  

43  
44   

45  

46  

See annex 12 
Around  2  million  active  enterprises  are  operating  under  Section  C  of  NACE  classification  named  Manufacturing.  The 
correspondence between the list of NACE DIGIT-3 codes and the way they have been considered in the analysis (i.e. harmonised or 
non/partially harmonised) can be found in annex 5 
These figures have been computed for the period 2011 – 2013 since the enterprise statistics by size class for aggregates of activities 
(NACE rev.2) are only available for this period. 
See annex 5 

24 

 
 
                                                            
In general, the majority of companies wishing to sell products in another Member State check 
the  applicable  rules  in  that  Member  State.  If  these  rules  prevent  them  from  selling  their 
product as such, most of them adapt it.  

Figure 7-1: Public consultation 2016  

no

yes

Do you check rules before entering a market?

5,40% 

Do you adapt your product if the rules prevent you from selling it
as such?

13,00% 

94,50% 

86,00% 

Several  situations  make  businesses  adapt  their  products.  First,  they  can  decide  to  do  so 
immediately after the examination of the applicable national rules in the Member State where 
they want to sell their product, either because the business is not aware about the possibility of 
invoking mutual recognition to enter the market without adapting the product, or because the 
business  don't  trust  mutual  recognition,  and  prefer  not  to  use  it  at  all47.  Secondly,  they  can 
decide to adapt the product after receiving an administrative decision denying market access, 
mainly because it's too long and costly to challenge such decision. Lastly, the choice of not 
using  mutual  recognition  can  also  be  solely  based  on  strategic  reasons,  thus  unrelated  to 
awareness or trust in mutual recognition. For example, certain businesses prefer designing a 
product which fits all existing requirements in all Member States, and have the guarantee that 
they can penetrate any market without further modifications.  

Furthermore,  the  2016  public  consultation  shows  that  68%  of  the  respondents  tried  to  use 
mutual recognition to enter a new market, but half of them faced market access denial. More 
specifically,  75%  of  micro  enterprises,  80%  of  small  enterprises  and  71%  of  medium 
enterprises  tried  to  use  mutual  recognition,  and,  respectively,  62%,  53%  and  71%  of  them  
had their market access denied. In principle, national authorities can deny market access only 
when they have  diverging product  requirements  whose  mandatory  imposition is  justified  by 
the  need  to  protect  a  certain  public  interest,  and  those  requirements  are  necessary  and 
proportionate for achieving that objective. In practice, the stakeholders' feedback shows that 
market  access  denial  is  automatic,  because  national  authorities  are  not  aware  of  mutual 
recognition  or  they  find  that  applying  it  to  the  detriment  of  their  own  rules  results  in  legal 
uncertainty. Thus, they feel more confident in applying their national rules and ignore mutual 
recognition. Only 15% indicated that market access was not denied.  

Figure 7-2: Public consultation 2016  

47  

31% had not used mutual recognition, mainly because they don't know about it (15%) or because they don't trust it (4%) 

25 

 
 
 
                                                            
Have you used mutual recognition for entering a market?

68% 

32% 

0% 

When using mutual recognition, was market access
denied?

53% 

15% 

32% 

yes

no

No answer

A recent study carried out by the Danish Business Association48 also confirms the findings of 
the 2016 public consultations. This study shows that businesses are still experiencing barriers 
to free movement of products in the Single Market. 24 out of the 35 businesses interviewed by 
the association experienced problems with the application of the mutual recognition principle 
and  Regulation,  especially  in  certain  sectors,  such  as  construction  products,  food  contact 
materials,  products  in  contact  with  water  and  innovative  products.  According  to  this  study, 
this  is  due  to  the  fact  that  Member  States  apply  national  requirements49  on  products 
characteristics,  including  requirements  relating  to  product  testing  and  documentation,  to  the 
detriment  of  mutual  recognition.  This  results  in  businesses  having  to  retest  or  modify  the 
products or giving up on marketing the products in certain cases.  

Example: Upholstered furniture– a well-known obstacle for exports to the UK 

Special  requirements  in  the  UK  for  upholstered  furniture  –  even  for  garden  furniture  – 
require  that  a  special  range  of  products  have  to  be  developed  for  the  UK.  Due  to  fire 
protection public interests, foam and textiles must be treated with flame resistant chemicals. 
These flame resistant chemicals, for environmental public protection reasons, are restricted 
in entering other markets.  

The  consequence  for  one  specific  company  is  that  they  need  to  have  a  double  stock  of 
furniture  (binding  capital  of  abt.  150,000  euro).  There  are  extra  initial  costs  for  each 
product (abt. 50,000 euro per type), for which reason they have been forced to reduce the 
product range in the UK by abt. 25 p.c.  

Example: Export of environmentally friendly, innovative product hindered by national 
regulation 

Some years ago, a small Danish manufacturer developed an intelligent solution for efficient 
pest control, completely without the use of poison. Since then, the products are in demand 
by an increasing number of countries around the world. The system monitors rodent activity 
and protects against rats entering the building or gaining a foothold in the area. 

The product nevertheless meets many national obstacles in the form of national legislation 

48  

49  

See annex 13 -  based on qualitative telephone interviews with company executives and relevant technical managers from 35 
member companies, covering many different sectors 
Even if these national requirements are justified by the need to protect a given public interest, they may not always be necessary and 
proportionate.   

26 

 
 
 
 
 
 
                                                            
aimed at animal protection (e.g. in Sweden and Germany). These national rules banning the 
use of electricity on animals de facto block the marketing of the products, even if they are 
proved to be both efficient and better than poison which remains in nature.  
The findings of the surveys carried out during 2014-201550 are similar and point in the same 
direction.  One  third  of  the  respondents  among  businesses  believe  that  mutual  recognition 
doesn’t  work  well  in  practice.    The  reasons  identified  during  the  interviews  are  related  to 
additional tests that national authorities require, to the detriment of mutual recognition. One of 
the  examples  provided  relates  to  water  taps51,  where  in  2014  several  companies  stated  that 
additional  different national tests are required, to the detriment of mutual recognition, in  17 
Member  States;  the  differences  related  not  only  to  the  testing  required,  but  also  to  what 
needed precisely to be tested: in certain Member States components needed to be tested, while 
in others the testing referred to the whole product.   

Figure  7-3:  Company  survey:  In  your  view,  how  well  does  the  mutual  recognition 
principle work in practice? 

Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015, carried out by DTI 

The  survey  among  national  business  and  sector  associations  showed  that  25-35%  of  the 
respondents  perceive  the  objectives  to  be  partly  reached  (see  Figure  7-4),  because  mutual 
recognition functions better in certain areas than in others. For example, a Belgian company 
with less than 10 employees in the precious metals sectors52 explained that mutual recognition 
functions  in  an  average  way,  and  that  it  contributed  to  lowering  trade  barriers  for  certain 
categories  of  goods  which  can  be  sold  without  any  further  adaptations.  A  small  company 
active  in  the  construction  area53  (with  40%  of  its  exports  falling  into  the  scope  of  mutual 
recognition) considered that mutual recognition works "badly" and that it did not lower trade 
barriers at all. This company gave  up entering a market 3 times,  due to  the additional costs 
triggered by the request to modify or retest its products.  

Figure  7-4:  Business  and  sector  association  survey:  To  what  extent  has  the  mutual 
recognition principle achieved its objectives? 

50  
51  
52  
53  

External evaluation of the mutual recognition principle 2014-2015 
External evaluation of the mutual recognition principle 2014-2015, case studies, case study 2, 4, 8 
External evaluation of the mutual recognition principle 2014-2015, case studies, case study 16 
External evaluation of the mutual recognition principle 2014-2015, case studies, case study 12 

27 

 
 
 
                                                            
Source:  Questionnaire  survey among  national  business  and  sector  associations, running  from  9  October  2014  to  5  January 
2015, carried out by DTI 

The perception of businesses  that mutual recognition  doesn't  function  properly  is confirmed 
by  the  replies  provided  by  national  authorities  during  the  2016  public  consultation.  When 
national  authorities  check  if  products  available  on  their  market  and  coming  from  another 
Member State comply with the national rules they are enforcing, only 46% verify if they are 
already lawfully marketed in the Member State of origin, meaning that they take into account 
the  potential  application  of  mutual  recognition  of  these  products54.  The  others  directly 
conform to the applicable national rules, without looking into the potential application of the 
mutual recognition principle and Regulation.   This can be because they are not well aware of 
the practicalities of applying mutual recognition, or because they simply prefer applying their 
own national rules, with whose cultural and historical backgrounds they are well acquainted.    

The  input  submitted  in  the  annual  reports  on  the  application  of  the  mutual  recognition 
Regulation  goes  in  a  similar  direction:  while  Member  States  recognise  the  potential  of  the 
principle  and  Regulation  in  terms  of  achieving  their  objective,  they  also  believe  that  in 
practice  many  difficulties  stop  these  objectives  being  fulfilled.  These  difficulties,  which 
mainly  refer  to  the  lack  of  awareness  and  understanding  about  how  the  principle  should  be 
applied and legal uncertainty, will be further assessed in the following sections.   

The  perception  of  PCPs55  in  the  surveys  carried  out  during  2014-2015  was  more  positive. 
Around half of them indicated in the survey that the objectives have been either completely 
reached or close to completely reached. The other half perceived the objectives as being partly 
reached, and a few PCPs said that there is quite a long way to go in terms of lowering trade 
barriers in the internal market. However, these results have to be treated with caution, as the 
PCPs, depending on how they are organised at national level, are mostly the interface between 
businesses invoking their right to mutual recognition and national authorities exercising their 
right  to  apply  their  own  national  rules.  Most  of  them  are  only  providing  information  to  a 
specific request, and/or establish a contact between the business and the competent authority; 
they don't monitor the application of the mutual recognition principle, and don't have a lot of 
knowledge about the outcome of a case once it has left the remit of their competence56.  

54  
55  

56  

This doesn't mean that they allow market access automatically  
During  this  survey,  only  PCPs  were  interviewed.  the  survey  did  not  reach  national  authorities  granting  or  denying  mutual 
recognition   
See section 6.2 and 7 for a more detailed assessment of PCPs  

28 

 
 
 
                                                            
This is also supported by the number of complaints received relating to the application of the 
mutual recognition principle. Since 2010, 195 complaints relating to a misapplication of the 
mutual recognition principle were registered.  

With regards to the Regulation specifically, the results of the public consultation carried out in 
201657  show  that  very  few  economic  operators  consider  that  it  is  easier  to  sell  products  in 
other Member States since the Regulation entered into force. The majority consider that the 
Regulation has not improved the situation in terms of facilitating free movement of goods, or 
don't  know,  either  because  they  don't  use  mutual  recognition  or  they  don't  sell  products 
abroad58. 

Figure 7-5: Public consultation 2016 

Is it easier to sell products in another national market since the Mutual Recognition Regulation is in 
force?  

26% 

30% 

24% 

3% 

15% 

I don't know because I don't use mutual
recognition

yes

no

The  2016  public  consultation,  the  stakeholders'  consultation  performed  in  2014  and  the 
evidence submitted by the Danish business association all point to the same direction. Overall, 
stakeholders  consider  that  despite  the  existence  of  the  principle  and  the  adoption  of  the 
Regulation,  free  movement  of  goods  in  the  non-harmonised  area  still  remains  problematic. 
Businesses are still facing difficulties with regards to market access, despite the fact that their 
products are already lawfully marketed in other Member States. Thus, they often adapt their 
products or give up entering on a new market.  

1.10.2  Increasing awareness of the mutual recognition principle  

One of the specific objectives of the Regulation was to increase awareness about the mutual 
recognition principle. The stakeholders' consultation and the desk research performed by the 
Commission  services  show  that  there  are  businesses  and  national  authorities  still  unaware 
about the mutual recognition principle and Regulation. Lack of awareness about the principle 
triggers lack of awareness about how this principle should be applied or the conditions under 
which  mutual  recognition  could  be  denied.  It  also  triggers  lack  of  awareness  about  the 
Regulation as well; as the Regulation enters into play once mutual recognition is denied, by 
issuing  an  administrative  decision  and  notifying  it  to  the  economic  operator  and  to  the 
Commission.  

Figure 7-6: Public consultation 2016 

57  
58  

See annex 5 
15% replied other, but did not specify what they meant by it  

29 

 
 
 
                                                            
How much do you know about the Mutual Recogntion Regulation? 

71% 

40% 

32% 

22% 

Member States Businesses

8,70% 

0% 

I am fully aware

I am partially aware

I only found out about it now

Surveys  carried  out  in  200459  and  201460show  a  low  level  of  awareness  about  mutual 
recognition  among  businesses.  In  2004,  46%  of  the  respondents  declared  awareness  about 
mutual recognition; 54 % of the companies interviewed in 2014 declared not knowing about it 
or having heard of it but not being familiar with the details. The public consultation carried 
out in 201661 shows however a significantly higher level of awareness; 7% of the respondents 
declared  being  aware  of  mutual  recognition.  The  differences  in  the  declared  level  of 
awareness  can  be  explained  by  the  fact that  the consultation  process  was  different (targeted 
surveys versus open consultation).   

The  level  of  awareness  about  mutual  recognition  among  national  authorities  is  mixed.  The 
results  of  the  public  consultation  carried  out  in  2016  shows  that  when  national  authorities 
check if products available on their market coming from another Member State comply with 
the national rules they are enforcing, 53% verify if they are already lawfully marketed in the 
Member  State  of  origin  while  46%  don’t.  Thus,  those  not  checking  if  products  are  already 
lawfully marketed elsewhere take for granted the fact that their national rules are applicable, 
and  take  measures  against  economic  operators,  asking  them  to  align  their  products.  Some 
Member  States  organised  at  national  level  such  campaigns,  mostly  for  authorities,  and 
considered them very useful.   

In order to increase awareness of the mutual recognition principle, the Regulation put in place 
Product  Contact  Points  (PCPs)62.  Most  of  the  businesses  (73%)  replying  to  the  2016  public 
consultation  declared  that  they  have  never  contacted  a  PCP  in  order  to  obtain  information 
about  the  applicable  national  rules  and  the  mutual  recognition  principle,  mostly  (46%) 
because they are not aware of them. 

In the period between the entry into force of the Regulation on 13 May 2009 and today63, the 
Product Contact Points received 8024 questions from economic operators.  

59  
60  

61  
62  
63  

Survey carried out in the framework of the impact assessment supporting the proposal for the Mutual Recognition Regulation 
European Commission, Study commissioned to Technopolis Group (2015): ‘Evaluation of the application of the principle of mutual 
recognition  in  the  field  of  goods,’  ENTR/172/PP/2012/FC  –  LOT  4  carried  out  between  April  2014  and  May  2015: 
http://ec.europa.eu/growth/single-market/goods/free-movement-sectors/mutual-recognition/index_en.htm. 
See annex 5 
See section 6.2 
Requests received in 2016 are not taken into account, as these will be reported by Member States in the 2017 reports 

30 

 
 
 
                                                            
2010-201164 

1402 

2012 

1439 

2013 

1826 

2014 

1793 

2015 

1564 

The PCPs that were most contacted are France and the Czech Republic, followed by Slovakia.  

Figure 7-7: Most contacted PCPs 

Slovakia

82 
115 

135 

134 

Czech Republic

272 

France

416 

434 

325 

498 

325 

581 

375 

2015

2014

2013

2012

2010-2011

However, the number of questions indicated above is only indicative and does not constitute 
an accurate picture of all questions received or treated by the PCPs.  This is because not all 
Member  States  are  indicating  in  their  annual  reports  the  number  of  questions  received  and 
treated by the PCPs. In 2010-2011, 2012 and 2014, 17 Member States indicated the number of 
questions received by the PCPs. 19 Member States supplied this information in 2013 and 16 
Member  States  supplied  this  information  in  2015.  Also,  with  regard  to  the  number  of 
questions  received,  it  is  not  certain  that  the  number  indicated  covers  questions  related  to 
mutual recognition only. Some Member States are reporting those questions related to mutual 
recognition  only,  while  others  are  reporting  all  questions  received,  even  when  outside  the 
remit of the PCPs.  A few Member States65 conducted national surveys on the usefulness of 
the PCPs, and the results show that economic operators are globally satisfied with the services 
provided by the network, which are considered useful.  

In general, the main issues underlined by economic operators in relation to PCPs are the long 
delays  for  receiving  an  answer,  the  quality  of  the  answer  or  even  the  absence  of  it.  These 
issues are also highlighted by the Member States in their annual reports. Some Member States 
indicated that the 15 day deadline set out by the Regulation is difficult to meet, although most 
of  the  time  respected.  According  to  the  information  submitted  in  the  annual  reports,  these 
delays  are  caused  by  the  wide  range  of  products  (or  aspects  of)  falling  under  the  scope  of 
mutual recognition as well as the increasing number of applicable national rules, which makes 
it  difficult  to  easily  identify  the  responsible  persons  having  the  necessary  expertise.  The 
decentralisation  of  certain  Member  States  administration  and  the  fact  that  most  often  the 
necessary  competences  are  distributed  between  different  ministries  add  to  these  difficulties. 
Very  often,  the  PCPs  have  to  send  the  inquiry  to  the  local  responsible  officer.  Last  but  not 
least, language issues, especially when technical language is involved, add further delays and 
contributes to the sometimes low quality of the answers provided. Some good practices were 
also highlighted by Member States in their annual reports as regards the functioning of PCPs. 
Slovakia for example indicated that an expert network was put in place to support the work of 
the PCP. Furthermore, the PCP is located in the same department dealing with Directive (EU) 

64  
65  

The reporting in annual since 2012   
See annual reports from SE 2015, DE and FR 2013 

31 

 
 
 
                                                            
2015/1535, thus aware of all national regulations notified to the Commission and subject to 
the application of the mutual recognition principle.  

Overall, the PCPs network is considered by Member States in their annual reports as a useful 
tool,  having  the  potential  to  help  economic  operators  in  obtaining  information  about  the 
applicable  national  rules  and  the  mutual  recognition  principle.  Member  States  consider 
however  that  it  needs  to  be  further  strengthened.  In  their  annual  reports,  they  call  on 
enhancing administrative cooperation, and integrating the PCPs into a wider network, in order 
for them to gain the expertise and to reply more efficiently to the inquiries they received. This 
view  is  also  shared  by  businesses,  as  58%  of  the  respondents  indicated  in  the  2016  public 
consultation that PCPs are a useful tool, despite the fact that only 7% of them considered their 
experience with PCPs as satisfactory.  

The  Regulation  had  a  limited  effect  in  increasing  awareness  about  the  mutual  recognition 
principle,  mainly  due  to  the  suboptimal  functioning  of  the  PCPs.  This  makes  it  difficult  for 
businesses to know when mutual recognition can be used for entering a market and what their 
rights are. Most stakeholders agreed however that PCPs are a very useful tool,  with a lot of 
potential. They need however to be strengthened in terms of administrative cooperation and 
network, in order to be efficient as regards their objectives.  

Additionally, one of the objectives of the mutual recognition clause referred to in section 2.3.1 
was  to  make  authorities  and  economic  operators  aware  of  the  mutual  recognition  principle. 
During  the  PCPs  survey  carried  out  in  2014,  only  28%  of  the  respondents  indicated  that  a 
mutual  recognition  clause  is  included  systematically  in  all  relevant  national  rules66.  The 
overview67 of the draft national technical regulations notified between 2012 and 2014 shows a 
poor use of the mutual recognition clause: 

2012 

2013 

2014 

Total 

755 

MRC68 
inserted 

Total 

MRC inserted 

Total 

MRC inserted 

69 

728 

79 

685 

57 

When  inserted,  the  clause  sometimes  lacks  clarity  or  is  not properly  implemented.  Many  of 
the  comments  and  detailed  opinions  the  Commission  issued,  when  assessing  draft  national 
regulations in the framework of Directive (EU) 2015/1535, relate to a wrong wording of the 
mutual recognition clause: 

Table 7-1: Overview of comments and detailed opinions in the framework of Directive 
(EU) 2015/1535- 2015 and 2016  

201569 

Total 

Absence of MRC 

MRC wrongly 

Non 

66  

67  
68  

8%  replied  that  MRCs  are  not  used  at  all,  20%  replied  that  MRCs  are  included  in  few  rules,  and  44%  replied  that  MRCs  are 
included in more than half of the adopted national rules.   
Carried out  internally by the Commission services 
Mutual recognition clause 

32 

 
 
 
                                                            
Comments 

Detailed opinions 

27 

11 

6 

4 

201671 

Total 

Absence of MRC 

worded 

related to 
the MRC70 

12 

2 

9 

5 

MRC wrongly 
worded 

Non 
related to 
the MRC 

Comments 

Detailed opinions 

35 

14 

18 

3 

11 

8 

6 

3 

Therefore,  the  mutual  recognition  clause  has  not  shed  sufficient  light  on  when  mutual 
recognition is applicable. Despite the regular recommendations by the Commission to insert 
the  clause  in  draft  national  legislation  notified  following  Directive  (EU)  2015/153572,  or  to 
redraft it in order to ensure clarity, its use is still poor. 

1.10.3  Ensuring legal certainty when using the mutual recognition principle  

Another  specific  objective  of  the  Regulation  is  to  ensure  legal  certainty  when  using  the 
mutual recognition principle. The Regulation tried to address the lack of legal certainty by: 

(1) 

 Introducing  the  principle  according  to  which  the  burden  to  demonstrate  that  the 
product does not meet the necessary requirements relies with the national authorities  

(2)   Establishing a non-exhaustive list of products to which mutual recognition might apply 

(3)  

Introducing an obligation to notify administrative decisions denying market access 

Clarity of the concept "lawfully marketed"  

The  main  value  of  the  Regulation  was  to  place  the  burden  of  proof  on  the  national 
authorities that intend to deny market access. This was justified by the uncertainties regarding 
who has to demonstrate that a product lawfully marketed in a Member State can be marketed 
in another Member State. The objective was to reduce the risk of seeing market access denied, 
by  allowing  communication  between  the  businesses  and  the  national  authorities  in  order  to 
prevent problems of free movement of goods. In practice, however, the outcome is not very 
positive.  Placing  the  burden  of  proof  on  Member  States  did  not  have  any  added  value  as 
regards the lack of clarity in the concept of "lawfully marketed", which triggers the possibility 
for  economic  operators  to  invoke  the  mutual  recognition  principle  to  sell  their  products  in 
other  Member  States.  This  is  because  the  Regulation  only  indicates  who  has  the  burden  of 
proof, without defining the concept of "lawfully marketed", nor the kind of evidence needed 
to demonstrate that a product was lawfully marketed. Furthermore, there is no jurisprudence 
from  the  Court  of  Justice  on  this  concept.  Thus,  businesses  report that  Member  States  have 

69  
70  
71  
72  

776 notifications were received in 2015; 44 concerned Information services 
Other issues related to incompatibility with EU law were raised, such as e.g. proportionality issues 
756 notifications were received in 2016, the number of notifications on information services in unknown today 
OJ L 241, 17.9.2015, p. 1–15 

33 

 
 
                                                                                                                                                                                          
different requirements as regards the evidence to be submitted in order to demonstrate that a 
product  is  "lawfully  marketed".  The  Commission  has  provided  guidance73  on  this  topic, 
explaining the meaning of the "lawfully marketed" concept and what type of evidence can be 
requested  or  accepted  in  order  to  demonstrate  it.  According  to  this  guidance,  any  piece  of 
evidence such as a product invoice, product label, catalogue with evidence of a date, sale or 
tax records, registrations, licences, notifications to/from the authorities, certifications, extracts 
from public records, etc. should be deemed suitable to demonstrate the actual marketing of the 
product  in  another  Member  State.  Despite  this  guidance,  Member  States  in  their  annual 
reports  and  businesses  in  their  contributions  report  that  the  concept  remains  problematic. 
Economic  operators  declared  for  example  that  if  a  product  invoice  is  sufficient  in  one 
Member State, very often it will not be considered as sufficient evidence in another Member 
State,  who  will  require  additional  evidence.    The  first  report  on  the  application  of  the 
Regulation74 underlines that the difficulty of demonstrating that a product has been lawfully 
marketed in another Member State is one of the issues where close and regular monitoring is 
necessary.  National  authorities  need  a  stronger  and  clearer  framework  for  being  able  to 
determine  whether  or  not  a  product  is  lawfully  marketed  and  to  allow  market  access  to 
products coming from other Member States despite the fact that they do not fully comply with 
their national technical rules.  

The difficulties raised by the concept of "lawfully marketed" were also discussed during the 
stakeholders' event held in June 2016 "Single market for products: fresh ideas to unleash full 
potential"75. A specific workshop was dedicated to a more practical approach for proving and 
assessing  lawful  marketing  of  products  in  other  Member  States.  During  this  workshop, 
business  representatives  described  the  problems  they  often  encounter  when  trying  to 
demonstrate  that  a  product  is  lawfully  marketed  in  a  Member  State,  especially  in  terms  of 
what  is  understood  and  accepted  as  evidence.  In  order  to  bring  more  clarity  and  facilitate 
market access, the participants focused on what is really needed as evidence to demonstrate 
the lawfulness of the marketing of a product and listed those elements considered necessary 
(e.g.  name  of  the  manufacturer  and  contact  details,  the  market(s)  where  the  product  is 
marketed,  and  the  regulations  and  standards  it  complies  with.  Participants  concluded  that 
standardising the type of information to be provided to national authorities in support of the 
demonstration of the lawfulness of the marketing of the product would have positive impacts 
on legal certainty when using mutual recognition.  

Businesses replying to the 2016 public consultation identified the difficulty of demonstrating 
the lawfulness of a product as an obstacle to mutual recognition.   

Table 7-2: Public consultation 2016 – Ranking of obstacles –Businesses  

Ranking of obstacles by order of importance  

Difficult for businesses to challenge a national decision denying market access 

Insufficient communication between national authorities of different Member States 

62% 

46% 

73  
74  

75  

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52013DC0592 
Communication  from  the  Commission  to  the  European  Parliament  and  the  Council,  First  report  on  the  application  of  Regulation 
(EC) No 764/2008, OJEU C (2012) 292 final 
See annex 2  

34 

 
 
 
                                                            
Lack of awareness about mutual recognition   

Difficult to obtain information about whether mutual recognition applies to a specific product and 
thus to assess if mutual recognition can be used or not for a specific product 

Other 

Slow/inefficient communication between businesses and national authorities 

Difficult to demonstrate to authorities in other Member States that a product is lawfully sold in a 
Member State 

Insufficient communication between national authorities within the same Member State 

35% 

32% 

29% 

27% 

26% 

21% 

Stakeholders predominantly agreed76 that standardising the type of information to be provided 
would facilitate demonstrating that a product is lawfully marketed in a Member State.  

Clarity concerning the products to which mutual recognition apply 

Before  the  adoption  of  the  Regulation,  it  was  difficult  for  both  economic  operators  and 
national  authorities  to  know  with  certainty  when  a  product  falls  into  the  scope  of  mutual 
recognition77.  The  Regulation  required  the  Commission  to  publish  a  non-exhaustive  list  of 
products  which  are  not  subject  to  EU  harmonisation  legislation  and  to  which  mutual 
recognition might apply, as a mean to improve legal certainty when trying to use the mutual 
recognition  principle.  More  information  on  the  list  is  available  in  section  6.2.  In  2015,  for 
example, the web-page hosting the product list received 2655 visits, and 59% of them left the 
page  immediately,  without  trying  to  use  the  list.  However,  during  the  public  consultation 
carried  out  in  2016,  68%  of  Member  States  and  51%  of  businesses  declared  that  the  list  is 
useful  and  necessary,  but  needs  to  be  updated  and  made  more  user-friendly.  These  findings 
point to the fact that stakeholders agree with the usefulness of having such a list, but that the 
list in its current state is not reliable.  

Transparency of administrative decisions  

The  obligation  to  notify  every  administrative  decision  denying  market  access  was  also 
intended  to  bring  more  legal  certainty  for  economic  operators  when  invoking  their  right  to 
mutual recognition. In the period between the entry into force of the Regulation on 13 May 
2009 and today, the Commission has received 3918 notifications. All notifications received 
come from 6 Member States, and one Member State, namely Portugal, accounts for around 
80%  of  the  notifications  received.  Most  of  notifications  refer  to  precious  metals,  and  some 
relate to foodstuff, fertilisers, food additives and electrical equipment. This doesn't mean that 
the  precious  metals  area  is  the  only  area  where  the  obligation  to  notify  is  respected  by 
Member  States.  The  fact  that  most  of  notifications  relate  to  one  category  of  products,  i.e. 
precious metals, could be explained by the reluctance of Member States to apply the mutual 
recognition  principle  in  an  area  where  many  of  them  have  permanent  and  long-time 
established  control  bodies  specifically  devoted  to  assessing  hallmarking  and  control  of 
precious  metals.  This  generated  several  infringement  procedures,  and  the  Court  of  Justice 

76  
77  

75% of Member States and 80% of businesses  
See Impact assessment 2007 

35 

 
 
                                                            
underlined  in  several  rulings78  that  Member  States  have  to  respect  the  free  movement  of 
precious  metals  on  the  basis  of  the  mutual  recognition  principle.  Because  of  the  abundant 
jurisprudence  of  the  Court  on  these  issues,  national  authorities  became  over  time  well 
acquainted with the application of the principle in this area, and with the obligation to notify 
contained in the Regulation.  

Additionally,  there  are  discrepancies  between  the  number  of  notifications  received  by  the 
Commission  and  the  number  of  administrative  decisions  indicated  by  Member  States  in  the 
annual reports. For example, some Member States are indicating in their annual reports that a 
certain  number  of  administrative  decisions  have  been  taken,  while  these  have  never  been 
notified  to  the  Commission.  Other  Member  States  are  reporting  that  no  administrative 
decisions have been taken, while complaints received show the contrary79. This points to the 
fact  that  Member  States  are  not  always  notifying  the  Commission  administrative  decisions 
denying  or  restricting  market  access.  This  issue  has  been  often  addressed  in  the  Mutual 
Recognition  Consultative  Committee80;  representatives  from  Member  States  considered  that 
the lack of notifications could be justified by the fact that inspectors performing controls on 
the market and taking these decisions lack awareness about the Regulation and its obligations 
and thus don't know that the decisions they are taking should be notified to the Commission. 
Some  Member  States  reported81  that  information  campaigns  and  trainings  have  been 
organised in order for their staff to get familiar with the Regulation; however these are more 
isolated cases, and don't allow drawing a conclusion of the effectiveness of these initiatives in 
terms of complying with the obligations of the Regulation.  

Difficulty to challenge administrative decisions denying market access  

The  Regulation  foresees  that  when  an  administrative  decision  denying  or  restricting  market 
access  is  notified  to  the  economic  operator,  it  shall  mention  the  legal  remedies  available  at 
national  level  allowing  challenging  this  decision.  Economic  operators  reported  that  national 
remedies  usually  consist  in  long  and  costly  court  proceedings.  During  the  2016  public 
consultation, they ranked this as the main obstacle to relying on mutual recognition:  

Table 7-3: Public consultation 2016  

Ranking of obstacles by order of importance  

Difficult for businesses to challenge a national decision denying market access 

62%82 

As  court  proceedings  are  very  time  consuming  and  expensive  for  businesses,  they  prefer 
adapting  their  products  or  renouncing  to  enter  the  market.    This  is  supported  by  the  2016 
public consultation, which shows that when market access (and mutual recognition) is denied, 
businesses rely rarely on the national remedies available to them:  

78  

79  
80  
81  
82  

The main cases being C-220/81 Criminal proceedings against Timothy Frederick Robertson and others, C-293/93 Criminal 
proceedings against Ludomira Neeltje Barbara Houtwipper, C-30/99 Commission v. Ireland 
See annex 7 
See annex 12  
See annex 7 
62% of respondents ranked this obstacle as being the most important one 

36 

 
 
 
 
                                                            
Figure  7-8:  2016  Public  consultation:  Did  you  challenge  the  decision  denying  market 
access?  

47% 

4,40% 

10% 

6,50% 

4,40% 

14% 

11% 

2% 

No answer

No, I prefer giving up the market

No, I prefer to aling on national rules

yes, still waiting for the results

Yes, but unsuccesfully and then gave up the
market
Yes, but unsuccesfully and then I aligned
with national rules
Yes, unsuccesfully

Yes, succesfully

To further underline this issue, during the 2016 public consultation, one business association  
indicated  that    in  the  area  of  drinking  water  installations  they  are  aware  of  more  than  100 
cases where national authorities denied market access and required the products to be adapted 
to  the  different  national  requirements;  one  company  tried  to  challenge  the  administrative 
decisions  denying  market  access,  which  resulted  in  a  two  years  lawsuit  (still  ongoing); 
another indicated that because the only way to challenge these decisions is having a long and 
costly lawsuit in  their  national law, they prefer to adapt the product  or  give up entering the 
market.  

Beyond  the  Regulation,  the  insertion  of  mutual  recognition  clauses83  in  the  draft  notified 
national  regulations84  also  aimed  to  increase  the  level  of  legal  certainty.    However,  the 
impacts of this policy in terms of legal certainty are limited.  

The  tools  put  in  place  by  the  Regulation  had  a  limited  effect  on  increasing  legal  certainty 
when using the mutual recognition principle. The lack of legal certainty appears to remain a 
major  obstacle  to  unleashing  the  full  potential  of  the  principle,  and  the  main  reason  why 
Member States and businesses are reluctant towards mutual recognition.    

1.10.4  Improving  administrative  cooperation  between  national  authorities 

(Mutual 

Recognition Regulation) 

Before the adoption of the Regulation, dialogue between the national authorities of different 
Member States was very difficult, mostly due to the lack of a common address book /network.  
The Regulation tried to remedy to this problem by introducing the Product Contact Points and 

83   
84  

See section 6.1 
See section 6.2.1 

37 

 
 
 
 
 
                                                            
the  telematic  network85.  Despite  this,  administrative  cooperation  remains  suboptimal,  for 
various reasons. Many Member States highlighted, in their annual report, the difficulties PCPs 
have to identify and contact the responsible authorities in their own administration in order to 
reply to requests received from economic operators. Some Member States managed over the 
years  to  put  in  place  a  network  of  experts,  but  the  variety  of  products  covered  by  mutual 
recognition and national legislation involved, as well as the different internal organisation in 
certain  Member  States  make  this  task  very  difficult.  Also,  there  is  a  lack  of  administrative 
cooperation  between  PCPs.  The  absence  of  a  network,  allowing  rapid  communication  and 
exchange  of  information  delays  the  work  of  the  PCP  when  replying  to  a  request  from 
economic operators. Many are complaining about the absence of reply from their colleagues 
from other  Member States,  or about long  delays to  receiving an answer. Often, the answers 
received are of low quality as regards the information transmitted86. 

During the survey carried out in 2014, the interviewed PCPs indicated the main problems with 
regard to administrative cooperation: 

Figure 7-9: 2016 public consultation 

Main issues related to administrative cooperation 

67 

47 

73 

Lack of information on whom to contact on
another Member State

Unduly long response time

No response at all

One  PCP  indicated  that  sometimes  the  delay  for  receiving  a  reply  is  40-50  working  days. 
Another indicated that the intervention of the Commission was necessary in order to obtain a 
reply. 

Additionally,  the  administrative  cooperation  between  PCPs  is  also  undermined  by  the 
difficulty  of  communicating  in  a  common  language,  especially  when  technical  terms  are 
involved.    This  issue  is  almost  unanimous  among  PCPs,  and  was  raised  in  the  surveys, 
interviews, in the annual reports as well as during the meetings of the Consultative Committee 
on mutual recognition.  

The majority of those economic operators who contacted a PCP preferred not to assess if their 
experience was satisfactory or not.  

Figure 7-10: Public consultation 2016  

Was your experience satisfactory? 

7% 

21% 

72,50% 

Yes

No

85  
86  

Article 11 of the Regulation 
See annex 7 

38 

 
 
 
 
                                                            
If not, what was the reason? 

79,10% 

3% 

0% 

4,40% 

13,10% 

Long delays

Language problems

Member  States  consider  communication  with  authorities  within  their  own  country  as  good, 
while communication with authorities from other Member States is rather average or poor. As 
regards  communication  between  national  administrations  and  businesses,  the  assessment  by 
authorities  is  quite  mixed  between  good,  average  and  poor.  The  main  reasons  for  poor 
communication  are  related  to  the  lack  of  knowledge  about  mutual  recognition,  language 
issues and the absence of an appropriate IT tool to facilitate communication.  

Figure 7-11: Public consultation 2016 

How do you asses communication when applying mutual recognition? 

57% 

33% 

2% 

20% 

35% 

28% 

35% 

28% 

15% 

Communication with authoritiesin the
same MS

Communication with authorities from
other MS

Communication between authorities
and businesses

Good

Average

Poor

What are the main causes of poor communication? 

51% 

20% 

20% 

22% 

Lack of awareness

Language problems

As  regards  the  telematic  network  foreseen  by  the  Regulation,  its  creation  was  discussed 
several  times  with  representatives  from  Member  States  during  the  meetings  of  the  Mutual 
Recognition Consultative Committee without being finalised87.  

1.10.5  Conclusion on effectiveness 

Overall, the findings of the evaluation show that the principle and the Regulation did not meet 
their objectives. Businesses are still encountering numerous obstacles to the free movement of 
products lawfully marketed in another Member States. During the 2016 public consultation, 
they  ranked  as  the  main  obstacle  in  difficulty to  challenge  administrative  decisions  denying 
market  access,  followed  by  insufficient  administrative  cooperation  and  lack  of  awareness 
about mutual recognition.  

The  tools  put  in  place  by  the  Regulation  in  order  to  ensure  awareness,  i.e.  the  PCPs,  had  a 
limited effect, mainly due to their suboptimal functioning. Businesses still don't know when 
mutual recognition can be used for entering a market and what their rights are. Furthermore, 
the  mutual  recognition  clause  has  not  shed  sufficient  light  on  when  mutual  recognition  is 
applicable.  Despite  the  regular  recommendations  by  the  Commission  to  insert  the  clause  in 
draft  national  legislation  notified  following  Directive  (EU)  2015/153588,  or  to  redraft  it  in 
order to ensure clarity, its use is still poor. 

87  
88  

See section 6.2.2 
OJ L 241, 17.9.2015, p. 1–15 

39 

 
 
 
 
 
                                                            
The tools put in place by the Regulation had also a limited effect on increasing legal certainty 
when using the mutual recognition principle. The lack of legal certainty appears to remain a 
major  obstacle  to  unleashing  the  full  potential  of  the  principle,  and  the  main  reason  why 
Member States and businesses are reluctant towards mutual recognition.    

As regards administrative cooperation, it still needs to be enhanced in order to facilitate the 
application of the mutual recognition principle.  

The weak use of the principle of mutual recognition and the limited impacts the Regulation 
had  in  achieving  the  foreseen  objectives  of  ensuring  free  movement  of  goods  in  the  Single 
Market points to the fact that there is a lot of potential to be unleashed. Estimating accurately 
the magnitude of this unleashed potential is not straightforward, due to the complex nature of 
mutual  recognition  and  the  wide  variety  of  products  to  which  it  applies.  However,  several 
elements indicate that the suboptimal use of mutual recognition triggers significant costs and 
that improving its functioning would bring significant benefits. The comparison of the value 
of the intra EU exports with domestic consumption89 shows that for harmonised products the 
value of intra EU exports is 55% of domestic consumption, while for the non-harmonised and 
partially  harmonised  goods  it  represents  only  35%.  A  study  done  for  the  European 
Parliament90 tried to estimate the magnitude of the impact that non-tariff barriers to trade have 
on the internal market. It concluded that a reduction of such barriers could lead to an increase 
in intra-EU trade of more than 100 billion EUR per year. 

Therefore, in terms of priorities  for the Commission  to remedy to  the ineffectiveness  of the 
regulation, national authorities and citizens ranked first the need to increase awareness of the 
mutual  recognition  principle,  while  businesses  stressed  their  need  for  effective  remedies  to 
take  action  against  decisions  denying  market  access.  If  the  consultation  did  not  result  in  a 
representative  sample  of  sectors,  company  type  and  Member  States,  it  provides  however  a 
good  indication  of  areas  where  the  scope  of  mutual  recognition  can  be  improved. 
Furthermore,  the  difficulties  in  terms  of  gathering  useful  data  on  the  functioning  of  mutual 
recognition  needs  to  be  addressed,  in  order  to  get  a  clearer  picture  of  how  the  principle 
functions and its impacts on the free movement of goods.  

Table 7-4: 2016 public consultation  

Ranking of priorities by businesses 

Ensure  that  businesses  have  effective  remedies  at  their  disposal  to  take  action  against  decisions 
denying mutual recognition when needed 

Increase legal certainty for businesses when using mutual recognition to sell products abroad 

Ensure  that  the  procedures  are  duly  followed  when  decisions  denying  market  access  are  taken  by 
national authorities 

Increase effectiveness of mutual recognition to facilitate access to the internal market 

72% 

67% 

65% 

64% 

89   
90  

Value of production-value of extra EU exports +value of intra EU imports  
The  Cost  of  Non-  Europe  in  the  Single  Market,  'Cecchini  Revisited',  An  overview  of  the  potential  economic  gains  from  further 
completion of the European Single Market, CoNE 1/2014 
http://www.europarl.europa.eu/RegData/etudes/STUD/2014/510981/EPRS_STU(2014)510981_REV1_EN.pdf 

40 

 
 
                                                            
  
Facilitate  communication  between  all  actors  involved  in  mutual  recognition  (business,  national 
authorities, European Commission) 

Increase general awareness of the mutual recognition principle 

Table 7-5: 2016 Public consultation  

Ranking of priorities by Member States 

Increase general awareness of the mutual recognition principle 

Ensure  that  the  procedures  are  duly  followed  when  decisions  denying  market  access  are  taken  by 
national authorities 

Ensure  that  businesses  have  effective  remedies  at  their  disposal  to  take  action  against  decisions 
denying mutual recognition when needed 

Increase effectiveness of mutual recognition to facilitate access to the internal market 

Increase legal certainty for businesses when using mutual recognition to sell products abroad 

Facilitate  communication  between  all  actors  involved  in  mutual  recognition  (business,  national 
authorities, European Commission) 

Table 7-6: 2016 public consultation  

Ranking of priorities by citizens 

Increase general awareness on the mutual recognition principle 

Increase  legal  certainty  for  businesses  when  using  mutual  recognition  to  sell 
products abroad 

54% 

52% 

51% 

42% 

40% 

35% 

33% 

31% 

64% 

52% 

Ensure  that  businesses  have  effective  remedies  at  their  disposal  to  take  action 
against decisions denying mutual recognition when needed 

47% 

Increase  effectiveness  of  mutual  recognition  to  facilitate  access  to  the  internal 
market 

41% 

Ensure that the procedures are duly followed when decisions denying market access 
are taken by national authorities 

35% 

Facilitate  communication  between  all  actors  involved  in  mutual  recognition 
(business, national authorities, European Commission) 

23% 

41 

 
 
 
1.11  Efficiency:  Measuring  the  cost  effectiveness  of  the  mutual  recognition  principle 

and Regulation 

One of the Commission's priorities is to make  EU law simpler and to reduce administrative 
burdens.  These  objectives  refer  specifically  to  costs  associated  with  reporting  and 
administrative  burdens,  and  costs  related  to  the  implementation  of  the  mutual  recognition 
principle  and  Regulation.  Measuring  the  efficiency  of  the  principle  and  Regulation  means 
evaluating  to  what  extent  the  costs  generated  by  using  the  principle  and  the  Regulation  are 
proportionate to the benefits it achieved. Relevant stakeholders were consulted on this topic. 

1.11.1  Costs for public authorities 

The Regulation, by nature, is  directly applicable; thus,  no particular costs were  incurred for 
transposing or integrating the requirements in national law. The PCPs generated specific costs 
for Member States.  With regards to the principle, the main costs are generated by its incorrect 
application.  The  analysis  below  therefore  looks  into  specific  costs  generated  particularly  by 
the PCPs, and at costs linked to the activity of national authorities other than PCPs, involved 
in the implementation of the principle and Regulation.  

Costs related to the implementation and functioning of the PCPs  

National authorities incurred costs related to implementing their obligation to establish PCP 
(putting them in place and having them functioning on an annual basis). Most of the time, the 
PCP has been integrated in an already existing department dealing with internal market issues. 
Based on the annual reports91, one person on average is fulfilling the task of PCP. This is the 
case for example in France, Sweden, Ireland, Greece, the Netherlands, Bulgaria and Poland. 
In cases where the function of PCP is available in several ministries, such as in Romania or 
Portugal,  several  persons  (5-8)  have  PCP  related  tasks  among  their  portfolio.  Estimates  of 
labour costs for PCPs can be made by taking into account the costs of Full Time Equivalents 
(FTEs)  necessary  to  perform  the  required  tasks  every  year.  As  detailed  information  on  the 
salary costs of administrative staff employed PCP is not available, an estimate has been made 
based on the Eurostat data (period 2010-2011) on the gross annual salaries for employees in 
national public administrations, as shown in the table below: 

Table 7-7: Gross annual salaries for employees in the public administration Eurostat 

GEO/TIME 

N of staff 

2010 

Belgium 

Czech Republic 

Denmark 

Germany  

Estonia 

1 

592 

2 

2 

1 

40124 Euro 

12786 Euro 

Information not available 

Information not available  

2011 

40921 Euro 

12850 Euro 

11541 Euro 

11944 Euro 

91  
92  

See annex 7 
For all issues related to internal market information, so we can assume that one person fulfils the tasks of PCP 

42 

 
 
 
 
                                                            
Ireland 

Greece 

Spain 

France 

Netherlands 

Portugal 

Romania 

Slovakia 

Sweden 

1 

2 

0.5 

1 

1 

8 

8 

0.5 

1 

Information not available 

Information not available 

29541 Euro 

29069 Euro 

Information not available 

46988 

Information not available 

7675 

11648 

38954 

47450 

7417 

11060 

41963 

PCPs reply to inquiries from economic operators within the limits set out by the Regulation, 
and it is necessary, very often, to communicate in English. Most Member States (25)93 have 
online portals providing information on the role of PCPs and mutual recognition. 18 Member 
States  provide  this  information  (sometimes  partially)  in  English.  The  availability  of  online 
information generates costs related to creating the website and keeping it up-to-date; however, 
these are easily counterbalanced by the potential reduction of the number of "basic" inquiries 
PCPs  would  have  to  deal  with  in  the  absence  of  such  online  information.  The  number  of 
inquiries received by PCPs varies from one Member State to another. Some Member States 
(France,  Czech  Republic,  Belgium,  Hungary  and  Sweden)  registered  a  high  number  of 
requests,  while  others  had  very  little.  For  example,  in  2015,  out  of  the  22  annual  reports 
received,  16  only  indicate  the  number  of  inquiries  received.  The  number  of  questions 
received amounted to 1645. The most active Member States are France, Czech Republic and 
Belgium, followed closely by Hungary and Sweden. 

Figure 7-12: PCPs activity 2015  

93  

See "Screening Report on Member States Product Contact Points and Product Contact Points for Construction", Ecorys, 2016 

43 

 
 
 
 
 
 
                                                            
31 

19 

37 

91 

100 

18 

217 

9 

40 

7 

25 

110 

86 

31 

87 

656 

France

Romania

Portugal

Spain

Belgium

Lithuania

Latvia

Ireland

Bulgaria

Czech Republic

Greece

Hungary

Poland

Slovakia

Slovenia

The fact that some PCPs receive a higher number of inquiries can be explained by the fact that 
these are big attractive and / or  more difficult markets, or  that promotion of PCPs has been 
more efficient. The low numbers registered in certain Member States can be also explained by 
the  fact  that  requests  are  not  properly  registered  and  monitored,  or  reported  to  the 
Commission.  For  example,  some  Member  States  are  indicating  in  their  annual  reports  an 
increase  of the number  of inquiries received by the PCPs, while the actual number of these 
inquiries was never communicated.94   

Costs  related  to  assessing  products  lawfully  marketed  in  another  Member  State  and 
notifying decisions restricting or denying market access 

Other  costs  supported  by  national  authorities95  are  those  related  to  assessing  if  a  product 
lawfully marketed in a Member State can be placed on their market on the basis of the mutual 
recognition  principle.  This  assessment  is  followed,  depending  on  its  outcome,  by  the 
obligation to notify economic operators and the Commission of their decisions restricting or 
denying market access. The assessment of the notifications and annual reports received by the 
Commission  between  2009  and  2016  show  that  only  a  few  Member  States  are  notifying 
administrative  decisions  to  the  Commission.  This  makes  it  impossible  to  calculate  the  costs 
related to this obligation, as the Commission does not have any accurate knowledge about the 
actual  number  of  administrative  decisions  taken  over  the  last  6  years,  as  these  were  not 
notified.  More  precise  information  exists  at  sectorial  level.  For  example,  in  the  area  of 

94  
95  

For a full overview of the number of inquiries received by the PCPs see annex 7  
These costs are related to national authorities other than PCPs 

44 

 
 
 
                                                            
fertilisers, the costs on national authorities to assess if fertilisers lawfully marketed in a single 
Member State can be placed on their market has been estimated at EUR 420 00096.  

Lastly, there are costs related to the obligation to send an annual report to the Commission on 
the application of the Regulation. This obligation did not incur any of the ordinary costs.  

Some Member States promoted the Regulation via awareness raising campaigns and training 
activities. However, these costs appear marginal, and are not considered burdensome for the 
Member States.  

Generally,  during  the  public  consultation,  national  authorities  ranked the  costs linked  to  the 
implementation of the regulation as average costs. Additionally to the choices provided by the 
consultation, authorities also indicated additional costs linked to the absence of an updated list 
of products to which mutual recognition may apply. This implies that they have to spend more 
time checking if a product is subject to harmonised rules or not. Some consider that additional 
costs are triggered by the administrative procedures, seen as long and time consuming.  

Figure 7-13: Public consultation 2016 

Costs for national authorities related to the implementation of the Mutual Recognition, ranked by their 
importance on a scale from 1 to 5, 1 being the lowest and 5 the highest.  

44% 

35% 

31% 

8% 

11% 

13% 

13% 

22% 

17% 

2% 

31% 

22% 

22% 

15% 

8% 

Establishing and ensuring the functioning
of Product Contact Points (infrastructure
and IT)

Recurrent costs related to the functioning
of the Product Contact Points, including
translation costs (staff only)

The obligation of the Member State of
destination to notify a decision denying
market access and the accompanying
procedural safeguards

1

2

3

4

5

1.11.2  Costs for businesses 

Generally,  there  are  no  major  costs  involved  for  businesses  when  applying  the  Regulation. 
Insignificant  costs  may  relate  to  economic  operators  getting  to  know  the  Regulation  and 
becoming familiar with the procedures it puts in place. 

The  main  costs  incurred  (transaction  and  adaptation  costs)  are  due  to  the  suboptimal 
application of the mutual recognition principle. According to information provided during 
the 2016 public consultation, the following costs have been identified:  

High costs are triggered by the need to adapt the products to the applicable national rules, 
when  mutual  recognition  is  either  denied  or  not  used  for  penetrating  the  market.  These 
adaptation  costs  are  estimated  to  be97  between  1000  and  150  000  Euro  per  product  and  per 

96  

97  

According to the survey on administrative costs carried out in the "Fertilisers Study", the costs for competent authorities to analyse 
requests for mutual recognition of national fertilising products have been estimated to be 0.2 FTEs x 28 x EUR 75 000 = EUR 420 
000 (B.40) for the whole EU.  
26% of respondents indicated an estimate of the costs incurred, the other choose not to reply or indicated that such estimation is 
impossible 

45 

 
 
 
                                                            
 
market. High costs are also related to delays in entering a market, estimated98 between 3000 
and  500  000  Euro  per  product  and  per  market,  and  to  lost  opportunities,  when  businesses 
renounce  entering  the  market  because  of  different  national  rules  requiring  the  adaptation  of 
the products. On average, the latest are estimated99at between 10 000 and 500 000 Euro per 
product and per market. The estimation of the adaptation costs appears to the lower than the 
estimation of costs linked to lost opportunities and delayed entry to the market. This may be 
due  to  the  specific  profile  of  the  respondents  to  the  public  consultations  that  were  able  to 
provide  estimates,  as  testing  costs  can  vary  significantly  from  one  product  to  another.  The 
variety of products and how this translates in terms of costs is also highlighted later on (see 
table  7-8).      Finally,  the  costs  related  to  challenging  administrative  decisions  denying 
market access are considered less important, mainly because few economic operators choose 
to do so. The estimate100 is between 10 000 and 100 000 Euro per product and per market.  

Figure 7-14: Public consultation 2016 

54% 

53% 

Costs in case mutual recognition has been denied 

52% 

38% 

29% 

Highly important

18% 

18% 

21% 

19% 

21% 

20% 

7% 

4% 

7% 

15% 

2% 

Costs related to aligning
products on national rules

Costs caused by the
delayed entry on the
market

Costs related to the
challenge before courts

Costs related to lost
opportunities

Relatively important

Of little importance

I don't know

Costs are also related in assessing if mutual recognition can be used to sell products in another 
Member  State.  Very  few  economic  operators  (2%)  are  outsourcing  this  assessment,  while 
26%  are  doing  it  internally.  46%    are  doing  both,  depending  on  the  product.  The  lack  of 
additional  information  does  not  allow  an  estimate  of  the  actual  costs  incurred  to  be  made 
when the assessment of whether or not mutual recognition can be used is outsourced. When 
done  internally,  economic  operators  spend  on  average  54  hours  doing  the  assessment; 
however, the number of hours indicated varies from one company to another. Most indicated 
only  a  few  hours  (less  than  10)  while  two  indicated  spending  more  than  500  hours  on  this. 
The average cost per hour is 78 Euro. When trying to demonstrate that a product is already 
lawfully marketed in  a Member State, businesses  indicate that the average  number of hours 
spent is 16, and the average cost per hour is 76 Euro. 

98  

99  

100  

20% of respondents indicated an estimate of the costs incurred, the other choose not to reply or indicated that such estimation is 
impossible 
13% of respondents indicated an estimate of the costs incurred, the other choose not to reply or indicated that such estimation is 
impossible 
11% of respondents indicated an estimate of the costs incurred, the other choose not to reply or indicated that such estimation is 
impossible 

46 

 
 
 
                                                            
These  results  confirm  the  findings  of  the  external  study  carried  out  in  2015101,  where 
businesses  underlined  transaction  and  adaptation  costs  as  being  very  significant.  They 
perceived testing as being costly – more than 40% of them have rated testing as being a very 
significant cost. The testing costs vary considerably, depending on the sector and the product, 
but some examples from different sectors are provided in Figures 7-18. Internal company staff 
time  and  administrative  costs  are  perceived  to  be  very  significant  by  32%  and  30%  of  the 
companies,  respectively.  In  the  interviews  carried  out  by  the  contractor,  many  companies 
mentioned that these types of costs naturally follow the testing costs and are therefore closely 
related  to  the  issue  of  Member  States  demanding  additional  tests.  Lastly,  around  26%  of 
businesses  perceive  the  adaptation  of  products  to  local  technical  requirements  to  be  a  very 
significant  cost.  Furthermore,  it  is  interesting  that  for  all  four  categories,  over  half  of  the 
companies perceive the costs as either very significant or significant.  

Figure  7-15:  Company  survey:  What  are  the  typical  cost  items  involved  and  how 
significant are they?102 

Note: N=28-31 (not all companies answered all questions) 

With  regards  to  the  costs,  the  survey  and  the  subsequent  interviews  carried  out  by  the 
contractor  revealed  the  same  wide  range  of  costs  as  during  the  2016  public  consultation, 
depending  on  the  different  sectors.  Similarly,  few  economic  operators  were  able  to  put  a 
figure on the costs faced due to the incorrect application of the mutual recognition principle. 
Of those that provided estimates, the costs ranged from 0.5% of the annual turnover, to 20% 
of the turnover. This is mainly due to the variety of products covered by mutual recognition.  
Table  7-8  summarises  some  of  the  characteristics  of  the  companies  that  provided  cost 
estimates. 

Table 7-8: Overview of the businesses that provided estimates for the costs of adapting 
or retesting products 

101  
102  

See annex 6 
Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015, carried out by DTI 

47 

 
 
 
                                                            
Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015, and interviews, carried out 
by DTI 

The variety of costs is mainly due to the fact that mutual recognition covers a wide range of 
products, with different characteristics and degrees of complexity. The two examples below 
show  the  diversity  of  costs  that  businesses  may  incur  depending  on  the  products  they  are 
selling:  

Example: water taps 

In  the  area  of  water  taps,  migration  of  chemical  substances,  odour  flavour  and  noise  are 
regulated at national level, and thus subject to mutual recognition. National rules in this area 

48 

SectorSize of companyKnowledge of MR principlePercentage of export goods falling under MR principleCosts of adaptation or retest (percentage of yearly turnover or euros)Articles of precious metalsSmallyes, but not in detail10010Childcare productsSmallno1050,000 EURChildcare productsLargeyes, but not in detail901Childcare productsMicrono510Childcare ProductsSmallno500,3Childcare productsMediumyes, but not in detail5Company originates from MS where national rules are stricterConstruction productsLargeyes700,5Construction productsMediumyes202Construction productsSmallyes4010Construction productsLargeyes10Testing costs, see caseConstruction productsMediumyes, but not in detail752,000-9,000 EUR/testConstruction productsSmallyesTailor-made products, agree on terms with clientConstruction, retailLargeyes50,000-100,000 EUR/testElectrical productsMediumno207Electrical productsLargeyes, but not in detail102FertilisersLargeyes520FertilisersSmallyes5010Fertilisers and potting soilLargeyes601FoodLargeyes1-55FoodLargeyes800,1Food additives and food supplementsLargeyes, but not in detail605Garments for childrenMediumyes, but not in detail100,2Medical devices and technical aidsLargeyes, but not in detail5020Paper industry, packaging for foodstuff etc.Largeyes1000,0025Production of metal devicesMediumyes, but not in detail51Sports equipmentLargeyesDocument and testing costs, see also caseLargeyes5010 yes305 
 
 
 
vary significantly, and one company indicated that for each product in the category of taps 
the  certification  and  testing  costs  are  up  to  €50,000.  In  addition,  the  cost  of  getting  a  new 
composition approved (to be used for the production of water taps) is between €50,000 and 
€100,000. Another company cited testing costs for a single component of approx. €2,000 and 
for  the  final  product  approx.  €8000-9000.  In  addition,  tests  can  be  rather  time-consuming. 
For instance, a test to determine whether the component or final product contains nickel takes 
up to 18 weeks.103 

Example: Food contact materials  

In  the  area  of  food  contact  materials,  a  company  producing  paper  that  comes  into  contact 
with food had to re test the paper already lawfully marketed upon the request of the Italian 
authorities. The cost of the testing was 700 Euro (per test), considered by the company as not 
a major cost, but rather as an unnecessary cost. 104 

1.11.3  Some practical illustrations at sectorial level 

Fertilisers 

The EU fertiliser product market is an economic sector that has between EUR 20 billion and 
EUR 25 billion in annual turnover and approximately 100 000 jobs105. It is partly covered by 
harmonising  legislation106  regulating  inorganic  fertilisers,  leaving  the  other  fertilising 
materials regulated at national level. Thus, intra-EU movement of national fertilisers should 
be covered by the principle of mutual recognition, but most Member States expressed strong 
reluctance in accepting mutual recognition due to environmental and human health concerns, 
socio-economic aspects, and alleged administrative burden and introduced prior authorisation 
procedures107. 

The  ex-post  evaluation  of  the  Fertilisers  Regulation  and  the  implications  of  the  entry  into 
force of the Mutual Recognition Regulation for the fertilising products sector108 found that in 
2009,  the  year  of  entry  into  force  of  MRR,  an  annual  average  of  no  more  than  5  to  10 
fertilising products had been placed on the market under the application of the procedures for 
mutual  recognition  in  most  Member  States.  Since  then,  the  yearly  reports  of  the  Member 
States  on  the  implementation  of  the  Regulation  show  that  20  Member  States  out  of  27 
specifically mentioned issues relating to fertilising products. They are reported as one of the 
product categories for which economic operators submit many information requests to PCPs, 
which means that there is a significant interest in intra-EU trade, but that economic operators 
are uncertain about the requirements applicable in different Member States. 

National producers often lack knowledge about the legal situation in other Member States and 
are unsure whether they should adapt their products to the requirements of the Member State 

103  
104  
105  
106  

107  

108  

See external evaluation of the mutual recognition principle - case studies 2 and 4 
See external evaluation of the mutual recognition principle -  case study 1 
See http://ec.europa.eu/enterprise/sectors/chemicals/files/fertilizers/final_report__23jan2012_en.pdf 
Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers, OJ L 304, 
21.11.2003, p. 1 
See also the guidance document on the application of the Mutual Recognition Regulation to prior authorisation procedures, 2010: 
http://ec.europa.eu/growth/single-market/goods/free-movement-sectors/mutual-recognition/index_en.htm   
Available at: http://ec.europa.eu/growth/sectors/chemicals/specific-chemicals/index_en.htmas 

49 

 
 
                                                            
of destination by modifying the product (which means additional costs) or if they can rely on 
Mutual  Recognition  procedures  (which  may  cause  delay  in  accessing  the  market  and  create 
costs in the prior authorisation procedure in some Member States). 109110 

In order to solve the recurrent issues faced by economic operators in the area of fertilisers, an 
optional  harmonisation  solution  was  preferred  for  fertilising  products  that  have  not  been 
harmonised.   

Food supplements 

Food  supplements111  are  concentrated  sources  of  nutrients  (or  other  substances)  with 
nutritional and physiological effect, marketed by business operators in the food sector. Such 
goods can be sold in “dose” form, such as pills, tablets and capsules, and could contain: 

 

 

 

Nutrients (vitamins and minerals); 

Botanicals;112 

Other substances (e.g. amino acids). 

The three main issues linked to mutual recognition113 are: 

 

 

 

Maximum levels of vitamins and minerals114 

Substances other than Vitamins and Minerals115 

Botanicals and botanical preparation116 

Information  collected  from  stakeholders  shows  a  very  heterogeneous  picture  of  the 
application of mutual recognition in the sector, with many issues faced by companies, relating 
to  both  differences  in  national  procedures/requirements  and  to  the  specific  nature  of  the 
various  products  included  in  the  sector.  On  the  former,  different  Member  States  follow 
different procedures and rules, in addition to a very dissimilar recognition and application of 
the principle, creating issues and obstacles companies may have to deal with when trying to 
enter a new market and often culminating in having different products for different countries.   
On the latter, stakeholders highlight the complexity of a sector with many different products, 
ingredients and their combinations, under different levels of controls and requirements among 

109  

110  

See the Commission Staff Working Document - Impact Assessment accompanying the Proposal for a Regulation of the European 
Parliament  and  of  the  Council  laying  down  rules  on  the  making  available  on  the  market  of  CE  marked  fertilising  products  and 
amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 (COM(2016) 157 final) 
See  the  Commission  Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  laying  down  rules  on  the  making 
available on the market of CE marked fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009, 
(COM(2016) 157 final). 
See annex 13 for the full case study on food supplements  
Plant parts, concentrated sources of plants or their extracts or derivatives with a physiological effect. 
Food Supplement Europe (2016), Input into the REFIT of the Mutual Recognition Regulation 764/2008. 

111  
112  
113  
114   Many Member States established national maximum levels for the amounts of vitamins and minerals in food supplements, while 
others preferred not to have specific maximum levels. The existence of particularly low levels applied in certain Member States, 
together with the large differences between the levels applied for the same substances across the EU, make it extremely difficult for 
companies to manufacture one single product for whole of the EU 
Some Member States apply positive lists115 with specific conditions to their use. In addition, some Member States may consider 
certain ingredients as for medicinal use only 
Botanicals are used in a wide variety of food supplements. Many Member States have positive lists, including conditions of use. The 
content of these lists differ widely, and certain botanicals are banned in different Member States because of medicinal status, while 
they are widely marketed as food supplements in others. 

116  

115  

50 

 
 
                                                            
Member States, making it difficult to have a uniform and clear picture of the whole sector and 
the possible strategies to overcome barriers.117  

Different countries, different rules 

Since the sector is not fully harmonised and limitedly regulated at EU level,118 companies and 
their products are subject to national legislation and mutual recognition. The main issues for 
companies arise from:  

 

 

 

Different  classification  of  ingredients  or  substances:  as  already  mentioned,  some 
products  may  be  classified  as  food  supplements  by  a  Member  State,  while  another 
country  –  sometimes  the  very  neighbour  –  can  consider  them  medicines,  therefore 
creating completely different requirements, rules and procedures to be followed for their 
marketing;  

Different  levels  of  ingredients  or  substances  allowed.  One  of  the  most  (and  most 
differently)  regulated  elements  is  the  level  of  ingredients  (e.g.  vitamins,  minerals  and 
other substances) allowed in a specific products at national level. Member States tend to 
have their own levels that apply to the same products, creating problems for companies 
which need to adapt their products and formulas to comply; 

Terminology  and  labels:  It  may  happen  that  terms  and  labels  are  not  uniformly 
accepted  across  Europe  (e.g.  probiotic).  This  requires  companies  to  change  and  adapt 
labels and packaging if it is the case.  

In addition, it appears that there is not full uniformity in the national systems in place, with 
few  Member  States119  that,  unlike  the  others,  do  not  rely  on  a  notification-based  system, 
which,  according  to  stakeholders,  may  tend  to  constitute  a  sort  of  pre-market  authorisation 
instead of a procedure to simply notify national authorities about the products to be marketed 
and register information on labels.  

In  the  end,  what  emerges  is  that  there  is  not  a  real  issue  of  complexity  of  procedures,  but 
rather  the  co-existence  of  many  different  rules,  requirements  and  practices  at  national  level 
that help companies investing time and resources to learn and cope with them, especially in 
countries with high levels of restrictions.120 However, since most of the companies present in 
this sector are SMEs, resources and time become crucial elements for their survival.   

The application of mutual recognition  

Stakeholders  find  the  application  of  mutual  recognition  to  be  difficult  in  the  complex 
environment  described  above.  They  underline  how  national  authorities  tend  to  focus  on 

117  

118  

119  
120  

This is particularly true for botanical products: while the use of botanicals and other derived preparations need to be compliant with 
requirements of Regulation (EC) No 178/2002, stakeholders underlined how no real steps forward seem to have been made to 
clarify the framework, without a centralised authorisation procedure – which would be extremely helpful – for the use of botanicals 
or to determine the classification of botanicals as either medicines or food supplements. This, as well as the large differences among 
Member States in the definition of botanicals and lists of products/ingredients which are allowed or not, create an uncertain and 
difficult environment for companies to operate. 
Some exceptions include the Regulation (EC) No 1924/2006 on nutrition and health claims, or Directive 2002/46/EC, with a list of 
substances that can be used for food supplement production, but whose implementation and monitoring is entrusted to the individual 
Member States. 
AT, NL, SE, SI and UK.  
Such as AT, DE, FI, HR, SE. 

51 

 
 
                                                            
national  legislation  when  deciding,  without  taking  into  account  other  EU  Member  States 
certifications  or  proof  of  the  fact  that  the  product  is  already  lawfully  marketed  in  another 
Member State.  

In addition, existing instruments meant to favour the application of mutual recognition – such 
as Product Contact Points – are not really instrumental in helping companies, given their role 
of as information hubs, with no real consultative or assessing capabilities and tasks.  

Companies  emphasise  how  the  main  reason  used  by  national  authorities  to  delay  or  even 
block a product from being marketed in a Member State concerns the existence of potential 
safety issues and the need for the authorities to protect the consumers, which cannot be easily 
challenged by companies.  Sometimes, however, companies report a lack of transparency in 
the reason for denial.  

In this regard, stakeholders suggest how the fact the burden of proof is on companies  – and 
not on national authorities – when demonstrating that a product is not dangerous, may limit 
their action and ability to challenge a decision, considering the time and resources needed.  

Companies  may  see  also  a  potential  effort  of  national  authorities  not  to  allow  (or  delay) 
foreign  companies  in  entering  the  local  market  in  order  to  reduce  competition  for  national 
companies.  

Considering the potential expenses and (considerable) use of time and resources to challenge 
a decision taken by national authorities through judicial procedures, sometimes such option is 
not considered by companies. According to stakeholders, this can be due to: 

 

 

 

Resources needed, as mentioned. For a company – especially an SME – such resources 
needed can be high to discourage it from pursuing such a way. For instance, an Italian 
SME active in the area of food supplement suggested how, on average, costs for lawyers 
and  appealing  procedures  can  amount  to  around  EUR  20,000  per  product,  but  other 
stakeholders provided more extreme examples; 

Uncertainty  of  the  final  outcome  of  the  procedure,  which  can  result  in  another  and 
definite loss for the company; 

Preference not to antagonise national authorities, which will be crucial for the approval 
of the many other products that a company in this sector usually has and tries to market. 

In light of these difficulties, stakeholders tend to:  

 

Adapt the product to the national requirements. Clearly this decision also entails some 
costs.  

o 

o 

An Italian SME indicated how adapting the product to sell it as a medicine could 
be virtually unbearable for an SME in terms of time and costs (with the need to 
develop a complete dossier, with testing, clinical tests and documentation), easily 
amounting to thousands of EUR.  

Adapting a product to different limits of ingredients or substances can also require 
some effort from the company, since it requires a new technological development, 

52 

 
 
with lab costs and feasibility studies. Such costs can be important for an SME (at 
least  EUR30-50,000  in  each  case),  not  considering  the  potential  impact  on  the 
production lines, which need to be differentiated even for a single ingredient. This 
strategy is not likely to repay when the targeted market is too small not to justify 
such investments. 

 

 

Not entering the market at all, when companies realise that costs and efforts will not 
lead to a positive solution or, even if it is the case, they will be too high to be sustained. 
In  this  case  it  can  be  very  difficult  to  estimate  the  costs  and  potential  losses  for 
companies, but there is no doubt that this can result in losing money as well as possible 
damages to the company’s image and reputation, especially after a judicial procedure; 

Trying to look for a “least common denominator” among a group of Member States, 
which  can  have  similar  rules  and  requirements  and  targeting  this  group  with  a  single 
product that would easily comply with all different national regulations. 

Products in contacts with drinking water121 

Considering the available information, it is possible to estimate the total turnover of the sector 
as between 40 and 43 billion per annum,122 while the number of companies operating can be 
estimated at around 7,000 units, with a heterogeneous distribution among small medium and 
large enterprises.123 

Tests  and  certifications  concerning  the  products  in  contact  with  drinking  water  come  under 
several categories: mechanical, hygienic and audits. The cost-spread for these certifications as 
well  as  statutory  audits  are  different  among  EU  Member  States.  In  Germany,  for  example, 
audit costs amount to a figure around 14% of the total costs for tests and certifications, while 
in other countries like U.K., Netherlands and France such a cost is around 1% of the total.124 

Water taps are among the products whose commercialization is more problematic, according 
to  stakeholders.  Water  taps  segment  covers  about  35%  of  the  entire  turnover  of  companies 
active in the area of products in contacts with drinking water.  

Stakeholders revealed how the application of mutual recognition with regard to these products 
is  seriously  deficient  currently,  thus  creating  limitations  to  both  competition  among 
businesses and availability of products for consumers in the EU single market. The main issue 
stems  from  the  absence  of  comprehensive  EU  harmonised  requirements  on  such  products. 
Article  10  of  Directive  98/83/EC  (Drinking  Water  Directive)125  requires  Member  States  to 
verify that the materials and substances used in the treatment and distribution systems are not 
present in drinking water “in concentrations higher than is necessary for the purpose of their 
use and do not, either directly or indirectly, reduce the protection of human health”.  

121  
122  

123  
124  
125  

See annex 13 for the full case study on products in contact with drinking water  
Eurostat data for product categories is not specific to drinking water contact products, some estimation based on expert evaluation 
are available thanks to data and document collection 
Panteia, Economic Effects of Article 10 of the Drinking Water Directive, 2016 
Figawa, Member Survey, 2016 
Concerning the quality assurance of treatment, equipment and materials in contact with drinking water. 

53 

 
 
                                                            
The  implementation  and  monitoring  measures  are  left  to  the  Member  States,  which  have 
established their own national test and certification bodies126 to assure the quality of materials 
and  to  issue  licences  for  the  sale  of  products  in  contact  with  drinking  water.  Each  body 
assesses  the  conformity  of  materials  and  products  in  contact  with  water  for  human 
consumption against specific requirements and criteria that vary at national level (for example 
as  regards  the  compliance  of  products  with  a  specific  composition  or  the  effects  of  the 
materials on the microbiological growth in the water). 

This  framework  creates  the  conditions  for  double  or  multiple  testing  of  products  in  contact 
with  drinking  water in  the  EU  market.  Companies  willing to  obtain  a licence  for  marketing 
their product in a single Member State have to comply with all the national test criteria and 
requirements  as  defined  in  the  law  and  by  the  relevant  test  and  certifications  bodies  in  that 
Member State. However, when they want to market that same product in other Member State, 
they are typically required to repeat those same tests by the relevant bodies in each individual 
Member State they want to enter, as Member States not only have different test criteria, but 
also  do  not  recognise  each  other’s  tests.  This  practice  does  result  in  an  expensive  and  time 
consuming reiteration of activities for businesses, which are forced to repeat tests and acquire 
certifications  several  times  in  the  EU  market,  into  higher  final  prices  for  consumers  and  – 
more  importantly  for  our  analysis  –  into  the  infraction  of  mutual  recognition  principle.  As 
pointed  out  by  a  representative  of  one  of  the  largest  European  manufacturer  of  hydraulic 
accessories and components, it is currently not possible for a business to market its products 
in more than a few countries127 at the same time in Europe, mainly due to additional testing 
and certifications that have to be done in each Member State requiring it. In some instances, 
the cost of additional testing may even exceed the cost of initial testing and certification.  

As an example, the interviewee reported that, in the context of EUR 2 million project aiming 
to  sell  a  single  hydraulic  product  in  15  EU  Member  States,  the  total  cost  for  the  initial 
certification  of  such  product  amounted  to  EUR  35,000,  while  cost  the  double  testing  in  a 
single  country  (FR)  was  EUR  38,000.  Similarly,  for  a  large  project  worth  EUR  60  million 
concerning  the  renewal  of  product  present  on  the  market  for  a  long  time,  interviewed 
stakeholder expects the costs for initial certifications (estimated at around EUR 1 million) to 
double  when  trying  to  market  the  product  in  all  the  28  Member  State  due  to  additional 
certification. 

Moreover,  companies  have  to  deal  with  the  auditors  of  the  different  national  certification 
bodies  who  periodically  conduct  audit  visits  concerning  the  quality  certifications  already 
acquired.  The  current  cost  reported  by  the  interviewed  stakeholder  for  managing  all  these 
certifications  (which  are,  for  drinking  water  only,  around  1,350)  is  around  EUR  2.3  million 
per year. Remarkably, all of these costs faced by businesses are passed on to consumers via 
final prices. 

126  

127  

FIGAWA  reports  the  following  list  of  national  test  and  certification  bodies:  Österreichische  Vereinigung  für  das  Gas-  und 
Wasserfach (AT), BELGAQUA (BE), Sekretariatet for byggevarer godkendt til drikkevand (DK), VTT Expert Services (FI), Centre 
Scientifique  et  Technique  du  Bâtiment  (FR),  Deutscher  Verein  des  Gas-  und  Wasserfaches  (DE),  National  Institute  of 
Environmental Health (HU), Ministerio della Salute (IT), Kiwa NL (NL), Państwowy Zakład Higieny (PL), Instituto Nacional de 
Saude (PT), Institut Za Varovanje Zdravja Republike Slovenije (SI),  Asociación Española de Normalización y Certificación (ES), 
Kiwa Swedcert (SE),  Schweizerischer Verein des Gas- und Wasserfaches (CH), Water Regulations Advisory Scheme (UK). 
The countries mentioned by the interviewee in these respect are AT, DE, and NL. Indeed, the interviewee stated that initial product 
certifications are sought and obtained in these MS, as the laboratories having the necessary technical instrumentation and know-how 
for  complex  (mechanical  and  hygiene)  testing  are  mainly  settled  there.  Moreover,  the  interviewee  company  has  a  preference  for 
German speaking countries due to the absence of language barrier in interacting with test and certification bodies. 

54 

 
 
                                                            
The  problem  of  double  and  additional  testing  is  particularly  acute  in  some  countries. 
Stakeholders  mentioned  how  Member  States  such  as  Spain,  France,  UK,  and  in  general  the 
Scandinavian countries, can be seen as the most problematic in this respect. Businesses may 
find double testing not only expensive in terms of fees to be paid to repeat the same test in 
different Member States, but also extremely time consuming. The time that elapses between 
the registration for tests and the certification of approval typically can span from six up to 12 
months, and may even reach 24 months in more complex circumstances. For companies, this 
obviously results in foregone profits due to the delayed market access. 

Crucially,  when  businesses  make  the  point  of  mutual  recognition  in  dealing  with  national 
authorities  in  other  MS,  the  latter  typically  refer  to  the  application  of  the  relevant  national 
norms and legislation, rather than EU Legislation.  

From  the  point  of  view  of  businesses,  there  is  a  generalized  lack  of  awareness  (if  not 
deliberate  disregard)  of  the  mutual  recognition  principle  by  national  test  and  certification 
bodies.  

Moreover, interviewees  reported  “cherry  picking”  by  national  authorities,  as  some  tests  and 
certifications presented by businesses can be accepted by some MS, while other tests shall be 
repeated. Businesses are simply asked to comply with national requirements and test criteria, 
even though their products underwent to the same testing in other countries.  

However, businesses are reluctant to bring national authorities to court to see the principle of 
mutual recognition applied. There are two main reasons behind this. First, businesses do not 
want to see their long-lasting relationship with national authorities jeopardised just to seek the 
application  of  mutual  recognition  to  a  single  product.  In  other  words,  they  prefer  avoiding 
confrontation with national authorities and complying with national requirements by repeating 
tests,  mainly  because  they  are  concerned  about  being  treated  unfavourably  in  the  future. 
Second,  businesses  are  concerned  that,  in  absence  of  harmonised  rules  at  EU  level  on 
hygienic testing, the enforcement of mutual recognition with respect to materials and products 
in contact with drinking water may start a “race to the bottom” among producers with regards 
to  the  quality  of  products,  a  fact  which  is  expected  to  negatively  impact  the  safety  of 
consumers. Finally, interviewed business associations also reported how among its members 
there  is  a  problem  of  awareness  about  mutual  recognition.  While  companies  dealing  with 
products  in  contact  with  drinking  water  are  aware  of  and  well-versed  in  relevant  legislation 
such  as  Regulation  (EU)  No  305/2011  (Construction  Products  Regulation)  or  Directive 
98/83/EC (Drinking Water Directive), are less aware about the possibility of benefiting from 
mutual recognition. 

Food contact material128 

Food contact materials (FCM), including food packaging, are only partially harmonized at the 
EU level and subject both to extensive national regulation and to extended practical scrutiny 
by the competent authorities, which may be partially justified by the potential impact of these 
products on public safety and more precisely public health. 

The food and drink industry in general is the EU's biggest manufacturing sector in terms of 
jobs and value added. The EU boasts an important trade surplus in trade in food and EU food 

128     See annex 13 for the full case study  

55 

 
 
                                                            
specialities are well appreciated overseas. In the last 10 years, EU food and drink exports have 
doubled, reaching over €90 billion and contributing to a positive balance of almost 30 billion. 
The FCM sector in particular has an approximate annual turnover of €100 billion.  

The range of non-harmonised aspects of the FCM industry was recently examined through a 
2016  JRC  Study  on  the  European  regulatory  and  market  situation  of  non-harmonised  food 
contact materials.129 The Study found that due to the lack of harmonisation of materials listed 
under the framework regulation the sector was subject to mutual recognition.  Specifically, the 
study  highlighted  a  lack  of  detail  in  relation  to  requirements  and  quality  assurance  towards 
declaration of compliance and supporting documents, certification where applicable, basis for 
enforcement and sanctions. Tellingly, the Study argued that this was a hurdle for competent 
authorities  as  well,  rather  than  only  for  economic  operators.  Indeed,  FCM  is  an  industry  in 
which  the  Member  States  have  a  complementary  authority,  allowing  them  to  exercise  a 
certain margin of discretion, but only within the limitations permitted by the FCM Regulation, 
the  procedural  norms  established  in  relation  to  EFSA130,  and  the  logic  of  the  Mutual 
Recognition  Regulation.  From  a  Member  State  perspective,  the  mirror  image  of  this 
competence is the need to be relatively specific in relation to the criteria and processes that 
they apply to make their decisions. This can be problematic in practice. 

At the national level, requirements on declarations of conformity to be provided by economic 
operators  and  supporting  documents  lack  guidance  and  associated  quality  criteria.  Self-
regulation can address this to some extent by providing additional sectorial guidelines, but it 
is unclear whether these are known and applied in particular by SMEs.  

National measures on specific materials are mainly based on lists of authorised substances and 
corresponding  restrictions.  Close  to  8,000  substances  were  found.  Some  materials  are 
regulated  by  more  than  10  Member  States  (metal,  glass)  and  some  only  by  a  few  (wood). 
National  rules  for  ceramics,  glass  and  metals/alloys  cover  about  15  heavy  metals  and  ban 
substances  such  as  barium  and  mercury.  There  are  between  100  and  over  5,000  substances 
authorised for each category  of the other  materials.  Only 15-35 %  of substances considered 
nationally are in the lists that EFSA reported as being adequately risk assessed. 

There  is  a lack  of  concerted  strategies  for  the monitoring  of  various  FCMs  among  Member 
States. This can be perceived as a grey area for the systematic assurance of food safety. The 
level of non-compliance is not greater overall for non-harmonised materials, but it is prevalent 
for their imports. Enforcement also suffers from lack of standards or test methods. 

To economic operators, the lack of transparency and accessibility on applicable requirements, 
rules and procedures is the key challenge: when moving from one Member State to the next, it 
is challenging to identify (a) whether national rules exist; (b) who the competent authority is; 
(c)  what  the  applicable  requirements  for  their  specific  FCMs  are;  and  (d)  whether  the  MR 
Regulation is a satisfactory solution.  

The interrelationship between the FCM Regulation and the Mutual Recognition Regulation is 
not  clear  to  economic  operators.  In  practice,  there  is  significant  familiarity  with  the  FCM 
Regulation as such and with applicable rulesets in major markets, but economic operators are 

129  

Non-harmonised 
JRC; 
https://ec.europa.eu/jrc/en/publication/eur-scientific-and-technical-research-reports/non-harmonised-food-contact-materials-eu-
regulatory-and-market-situation-baseline-study  

contact  materials 

and  market 

the  EU: 

regulatory 

situation, 

2016, 

food 

in 

see 

130      European food and safety authority  

56 

 
 
                                                            
insufficiently  aware  of  the  principles  and  scope  of  application  of  the  Mutual  Recognition 
Regulation and its ability to facilitate compliance with specific national rules. As noted in the 
2016 study, this lack of clarity “leads industries to seek external legal advice, which adds to 
costs  and  may  result  in  lengthier  authorisation  processes  and  delayed  market  access.  It  can 
also result in a greater focus on certification and accreditation systems at industrial level”. 

Road circulation of mobile machinery 

The  mobile  machinery  industry131  consists  of  a  series  of  products  across  sectors  (such  as 
agricultural machinery (excl. tractors), construction machinery, garden equipment, municipal 
equipment). The total production value in the EU amounted to €10.3bn in 2013132. Despite the 
existence  of  a  number  of  EU  harmonisation  measures  applying  to  mobile  machinery133,  the 
road approval aspect of mobile machinery is not subject to EU harmonisation and thus mutual 
recognition  should  apply.  However,  mobile  machines  are  still  facing  a  series  of  different 
requirements  across  EU  Member  States  when  requesting  road  approval  causing  costs  for 
manufacturers, authorities, users and citizens. 

The absence of harmonised requirements for the road circulation of mobile machinery in the 
EU has led to these specific problems: 

-  

-  

Different  requirements  for  road  circulation  of  mobile  machinery  are  applicable  in 
different  Member  States.  Road  approval  is  necessary  as  required  by  the  relevant 
Member  States.  This  procedure  causes  direct  costs  (administrative  burdens  for 
manufacturers and regulatory charges – such as third party testing and other inspection 
activities)  and  indirect  costs  to  industry  (time  delays  in  the  introduction  of  new 
products,  reduced  product  innovation  etc.)  as  well  as  indirect  costs  to  others 
(administrative  costs  for  MS  governments,  administrative  burdens  for  dealers,  time 
delay in delivery etc.). 

Compliance  costs  related  to  non-harmonised  requirements  are  causing  direct  industry 
costs (additional logistics, administrative translation, additional manufacturing & design 
costs)  which  cause  indirect  industry  costs  (higher  product  prices,  barriers  to  market 
entry etc.). Based on the market power of the industry such costs may be further passed-
on  to  downstream  clients  (in  the  form  of  increased  prices  or  different  prices  across 
Member States, differentiated access to machines); 

Costs  caused  by  the  application  of  the  different  national  requirements consist  of  both  direct 
and indirect costs. Direct costs for the industry to comply with existing legislation add up to 
€90 m in the EU. This corresponds to 1.3% of their turnover. Indirect industry costs were also 
identified,  such  as  time  delays  on  the  introduction  of  products,  reduced  innovation,  higher 
product prices or barriers to entry as well as reduced choice for consumers and administrative 
burdens for national administrations. Barriers to market entry are impacting above all SMEs 
who consider it too challenging to enter new Member States markets and to comply with their 
specific rules, more than other firms. 

131   Mobile  machinery  refers  to  any  self-propelled  mobile  machine  or  vehicle,  with  a  maximum  design  speed  higher  than  6  km/h, 

132  

133  

the  EU  harmonisation  of 

running on tyres and that is not intended for carrying passengers or goods on public roads 
Study  on 
ENTR/172/PP/2012/FC/Lot1. http://ec.europa.eu/DocsRoom/documents/17786/attachments/1/translations/en/renditions/native 
Amongst others: NRMM Directive 97/68/EC, Outdoor Noise Equipment Directive 2000/14/EC, Machinery Directive 2006/42/EC, 
Regulation (EU) No 167/2013 

road  circulation  of  mobile  machinery  –  FWC 

requirements 

the 

the 

for 

57 

 
 
                                                            
1.11.4  Costs for the Commission  

The  main  costs  incurred  by  the  Commission  are  related  to  managing  the  implementation  of 
the  Mutual  Recognition  Regulation  and  to  the  handling  of  notifications,  complaints  and 
infringements in the area of Articles 34-36 TFEU. These costs can be estimated on the basis 
of  Full  Time  Equivalents  (FTEs),  for  which  a  yearly  gross  salary  of  kEUR  60  has  been 
assumed, to which also 25% of overhead was added (75 000). It was assumed that one FTE 
corresponds to approximately 220 effective working days. Additionally, there are the costs of 
organising  the  Mutual  Recognition  consultative  committee,  estimated  on  the  basis  of  the 
number of experts participating and the amounts of travelling fees reimbursed.  

Mutual Recognition Regulation 
(per year) 

Notifications, complaints and 
infringements (per year) 

Mutual Recognition consultative 
committee (per year) 

1 FTE – EURO 75 000 

3 FTEs – EURO 225 000 

EURO 9700 

1.11.5  Benefits for national authorities  

There are several benefits of mutual recognition for the national authorities. 

First,  mutual  recognition  brings  regulatory  benefits134.  These  regulatory  benefits  are 
perceived  in  the  sense  of  ‘better  regulation’.  The  mutual  recognition  principle  respects 
Member  States'  regulatory  autonomy  and  diversity,  as  different  coexisting  national  rules 
should  be  considered  as  equivalent  while  at  the  same  time  ensuring  that  in  cases  where 
consumer  safety  or  health  is  at  stake,  derogations  apply.  Also,  it  avoids  unnecessary 
harmonisation at EU level, by allowing free movement of goods for products which are not 
always designed and manufactured according to identical rules.  

Second,  strategic  benefits135  can  be  achieved,  as  the  functioning  of  the  internal  market  is 
enhanced without adding any new EU legislation. Economic operators are supposed to have 
access to new markets while this access was hindered /blocked before the existence of mutual 
recognition.  

Finally, economic welfare136 is another benefit, as mutual recognition aims to facilitate free 
movement  of  goods,  thus  enhancing  competition,  providing  more  and  better  choices  to 
consumers and offering new opportunities to businesses.   

Further to the benefits of mutual recognition mentioned above, the Regulation was expected 
to bring certain benefits, in terms of increased awareness of the mutual recognition principle, 
and  better  information  on  the  applicable  rules in  the  Member  States  where  the  products  are 
lawfully  marketed,  allowing  for  a  smoother  application  of  the  mutual  recognition  principle. 
The expected benefits deriving from the obligation to notify administrative decisions denying 
market access was supposed to discipline national authorities when applying the principle, as 

134  
135  
136  

Pelkmans (2012): Mutual recognition: economic and regulatory logic in goods and services 
Pelkmans (2012): Mutual recognition: economic and regulatory logic in goods and services 
Pelkmans (2012): Mutual recognition: economic and regulatory logic in goods and services 

58 

 
 
 
                                                            
they  have  to  justify  why  market  access  is  refused.  National  authorities  agreed,  fully  or 
partially, with the benefits the Regulation brings. 

Figure 7-16: Public consultation 2016- Member States views  

Below are listed the main benefits the Mutual Recognition Regulation was expected to 
have.  Based on your experience, to what extent do you consider them to be realised? 

48% 

28% 

17% 

4% 

31% 

26% 

26% 

15% 

44% 

48% 

20% 

20% 

15% 

20% 

22% 

8% 

Better information on
national rules

Justification of
administrative decisions
denying market access

Reduced risk to see market
access denied

Increased awareness

I fully agree

I partially agree

I desagree

I dont know

1.11.6  Benefits for businesses  

The main benefit that the mutual recognition principle and Regulation were expected to bring 
were  an  easier  access  to  the  market  of  other  Member  States;  economic  operators  may 
exploit economies of scale by expanding into new geographical markets. Such changes should 
be reflected in gains in competitiveness and productive efficiency, and should thus contribute 
to the restoration of profit margins. In addition, it should foster innovation; the economies of 
scale are crucially important for innovative firms that spend a large fixed cost in research and 
development (R&D) and need a large internal market to cover these costs137. Furthermore, in 
order  to  launch  innovative  new  products  on  the  market,  businesses  need  to  rely  on  existing 
national  rules  or  deal  with  the  absence  of  such  rules;  a  correct  application  of  the  mutual 
recognition principle would not only facilitate free movement of innovative/new products but 
could also increase a number or innovative products to be placed on the market138.  

Following a proper application of the mutual recognition principle, the risk for enterprises that 
their products will not gain access to - or will have to be withdrawn from - the market of the 
Member  State  of  destination  would  in  many  cases  be  reduced.  A  proper  application  of  the 
mutual recognition principle would also imply less need for multiple testing and certification, 
and Member States would recognise products lawfully marketed in another member State and 
therefore not require additional testing. Additionally, the Regulation has additional potential 
benefits,  as  it  is  supposed  to  increase  awareness  of  the  principle  and  to  facilitate  access  to 
information about the applicable national rules.  

In terms of benefits that the Regulation brings, the perceptions of businesses are quite mixed:   

Figure 7-17: Public consultation 2016 

137  

138  

See  OECD  Economic  Surveys:  European  Union  2014,  Thematic  Chapter  Reinvigorating  the  EU single  market:  http://www.oecd-
ilibrary.org/economics/reinvigorating-the-eu-single-market_5jxx3d3hk437-en.  
The Innobarometer 2016  shows that the main barriers to commercialisation identified by business (including regulatory barriers) 
confirm in particular the relevance of the Single Market Strategy to give a boost to innovation performance 

59 

 
 
 
                                                            
 
Below are listed the main benefits the Mutual Recognition Regulation was expected to have.  Based on 
your experience, to what extent do you consider them to be realised? 

30% 

26% 

32% 

38% 

14% 

26% 

28% 

15% 

36% 

13% 

41% 

16% 

21% 

12% 

31% 

13% 

Better information on
national rules

Justification of
administrative decisions
denying market access

Reduced risk to see market
access denied

Increased awareness

I fully agree

I partially agree

I desagree

I dont know

1.11.7  Benefits for consumers 

In the case of an optimal functioning of mutual recognition, consumers would have access to 
a  wider  variety  of  products,  and  would  enjoy  lower  prices,  due  to  the  economies  of  scale 
made by the manufacturers. Furthermore it can be assumed that consumers would also benefit 
in terms of public interest protection, as a product lawfully marketed in another Member State 
would be allowed in their own Member State only if it satisfactorily fulfils the same public 
interest protection requirements139.  

This is also supported by a recent study carried out by the European Parliament140, where the 
benefits of removing remaining barriers to intra EU trade are evaluated. Although the study 
does not directly estimate the effects on consumers, the study points out that it is expected that 
EU consumers will benefit from a wider variety of supplies available for their consumption in 
line with increased bilateral trade flows. Furthermore, rising trade flows increases competitive 
pressure  on  domestic  producers  of  goods  and  leads  to  lower  prices  for  given  products.  The 
study estimates that a reduction in barriers to intra-EU trade could lead to increases in trade 
between Member States of a magnitude of more than 100 billion EUR annually. 

1.11.8  Comparing costs and benefits  

There  are  certain  administrative  costs  resulting  directly  from  the  Regulation.  For  national 
authorities,  the  main  costs  relate  to  implementing  the  PCPs  network  and  deciding  if  mutual 
recognition  can  be  applied  or  not.  For  businesses,  these  relate  to  getting  familiar  with  the 
Regulation.  

The  main  costs  involved  are  rather  due  to  the  suboptimal  application  of  mutual  recognition 
than to the application of the Regulation as such.  

Member States 

Businesses 

BENEFITS 
Regulatory 

COSTS 
Implementing 

BENEFITS 
Easier access to 

COSTS 
Information 

Consumers 
BENEFITS 
Wider variety 

Commission 
COSTS 
Mutual Recognition 

139  

140  

BIS  publication  (2014)  Measuring  the  benefits  to  UK  consumers  from  the  creation  of  the  European  Single  Market,  How  theory 
suggests the Single Market should create consumer benefits, mentions that "One main goal of the Single Market is the delivery of 
benefits to consumers, including access to goods and services at lower prices and higher quality and larger product variety." These 
are  expected  to  be  delivered  via:  "trade  liberation  (…),  stronger  competition  (…),  faster  product  innovation  (…)  and  costs 
reductions from legal and regulatory harmonisation." 
See "The costs of non- Europe", study of the European parliamentary research service: 
http://www.europarl.europa.eu/EPRS/EPRS_STUDY_536353_CoNE_Single_Market_I.pdf  

60 

 
 
 
                                                            
 
(better 
regulation, 
regulatory 
autonomy and 
diversity, no 
unnecessary 
harmonisa-tion) 

Strategic 
(enhanced 
functioning of 
the Single 
Market) 

Economic 
welfare 
(enhanced 
competition and 
more 
opportunities) 

and functioning 
of Product 
Contact Points 
EURO 7417-
47450141 

Assessment of 
products and 
notification of 
decisions 
denying market 
access 
EURO 420 000 
e.g. fertilisers 
sector) 

Reporting on 
the 
implementation 
if the 
Regulation 

new markets 
(opportunities) 

Lower 
production costs 
( no need to 
retest/adapt) 

Better access to 
information on 
applicable rules 

(on the 
applicable rules 
in the Member 
State of 
destination) 
10-500 hours 

Adaptation 
EURO 1000-
150 000142 
Delayed entry 
on the market 
EURO 3000-
500 000143 

Lost 
opportunities 
EURO 
40 000-500 
000144 

of supply 
available 

Regulation (per year) 
1 FTE – EURO 75 000 

Notifications, 
complaints and 
infringements (per year) 
3 FTEs – EURO 225 
000 

Lower prices 

Mutual Recognition 
consultative committee 
(per year) 
EURO 9700 

It is not possible to compare costs and benefits in a reliable way. The costs observed cannot 
be estimated globally, because of the variety of products and sectors involved, and because of 
the  lack  of  precise  data  related  to  the  occurrence  of  market  denial.  The  2016  public 
consultation  provides  the  perception  of  stakeholders  as  to  whether  or  not  costs  are 
proportionate to the benefits. The results show that while Member States tend to consider that 
the costs of the Regulation (which include the costs of the suboptimal functioning of mutual 
recognition) are proportionate with the benefits it generates, businesses mostly disagree.  

Figure 7-18: Public consultation 2016 

Would you agree or disagree with the following statement: "these costs are acceptable and 
proportionate to the benefits the Mutual Recognition Regulation brings in terms of facilitating market 
access? 

Businesses

9% 

Member States

2% 

35% 

35% 

54% 

62% 

I don't know

I desagree

I agree

This  perception  can  be  justified  by  the  fact  that  businesses  reported  important/  significant 
costs  while  they  did  not  really  observe  the  expected  benefits,  due  to  the  suboptimal 
functioning of mutual recognition. As the 2016 public consultation shows, 87% of businesses 
adapt their products instead of relying on mutual recognition. The costs incurred by national 
authorities were considered normal costs that are usually incurred in enforcing legislation, and 
thus proportionate with the benefits expected.  

141      Based on Gross annual salaries for employees in public administration Eurostat 
142  
143  
144  

Per product and per market 
Per product and per market 
Per product and per market 

61 

 
 
 
                                                            
1.11.9  Conclusion on efficiency  

Overall, it can be concluded that the suboptimal use of mutual recognition creates additional 
costs  on  businesses  and  prevents  them  from  taking  advantage  of  the  benefits  that  mutual 
recognition  might  bring.  Due  to  the  difficulty  of  gathering  accurate  data  on  mutual 
recognition,  it  was  not  possible  to  establish  the  global  costs  incurred  by  businesses.  But 
sectorial  evidence  and  the  results  of  the  different  surveys  and  consultations  carried  out, 
although not representative show that the costs are significant.   

A better functioning mutual recognition would reduce the costs incurred by businesses when 
they are obliged to adapt their products or to give up entering a market, while allowing all of 
the benefits listed above. A study done for the European Parliament145 shows that a reduction 
of barriers to trade could lead to an increase in intra-EU trade of more than 100 billion EUR 
per  year.  The  fact  that  mutual  recognition  does  not  function  well  is,  de  facto,  a  regulatory 
burden  triggering  barriers  to  trade.  Therefore,  any  efforts  to  improve  the  functioning  of 
mutual  recognition  would  result  in  simplifications  for  businesses,  e.g.  easier  access  to 
markets.    The  remaining  costs  (information  costs  and  costs  related  to  implementing  the 
Regulation) would become negligible in the light of the full benefits achieved.  

1.12  Coherence: how mutual recognition fits in the other EU policies 

Several initiatives relevant for mutual recognition have been identified:  

Directive  (EU)  2015/1535  laying  down  a  procedure  for  the  provision  of  information  in 
the  field  of  technical  regulations  and  of  rules  on  Information  Society  services146.  The 
Directive contributes to ensuring higher and better mutual recognition by requiring Member 
States  to  notify  the  Commission  and  each  other  of  any  draft  ‘technical  regulations’  for 
products  before  they  are  adopted  in  national  law,  with  a  view  to  boosting  transparency  and 
control  with  regard  to  those  regulations.  Since  national  technical  regulations  might  create 
unjustified barriers to trade between Member States, notification in draft form and subsequent 
evaluation of their content in the light of the mutual recognition principle help to diminish this 
risk.  As  for  the  relationship  between  the  Directive  and  the  Regulation,  they  have  differing 
objectives. The Directive seeks to prevent trade barriers in the form of ‘technical regulations’ 
before  they  are  adopted,  by  enabling  the  Commission  and  Member  States  to  verify  that  the 
technical rule is compatible with EU law. The Regulation applies after a ‘technical rule’ has 
been  adopted;  it  seeks  to  ensure  that  any  authorities  taking  decisions  based  on  such  rules 
apply  the  principle  of  mutual  recognition  correctly  in  individual  cases.  The  two  acts  are 
applied  at  different  stages  in  the  life  cycle  of  a  technical  rule.  While  the  Directive  is  a 
preventive  mechanism  which  precedes  the  adoption  of  a  technical  rule,  the  Regulation  is  a 
corrective measure once the rule is in force, ensuring on a case by case basis that the rule is 
being applied correctly. On the basis of the above, it appears that there is no incoherence or 
duplication between the mutual recognition principle / Regulation and the Directive. Rather, 
the analysis carried out shows several synergies. The main synergy which can be highlighted 
relates  to  the  inclusion  of  a  mutual  recognition  clause  in  the  draft  technical  regulations 
notified  to  the  Commission.    Other  synergies  relate  to  flagging  sectors  and  areas  where 

145  

146  

The  Cost  of  Non-  Europe  in  the  Single  Market,  'Cecchini  Revisited',  An  overview  of  the  potential  economic  gains  from  further 
completion of the European Single Market, CoNE 1/2014 
http://www.europarl.europa.eu/RegData/etudes/STUD/2014/510981/EPRS_STU(2014)510981_REV1_EN.pdf 
OJ L 241, 17.9.2015, p. 1–15 

62 

 
 
                                                            
  
Member  States  tend  to  regulate  intensively,  and  where  challenges  may  arise  in  terms  of 
applying the mutual recognition principle.   

Directive 2001/95/EC on General Product Safety147 (including the RAPEX148 mechanism) 
ensures  that  products  placed  on  the  EU  market  are  safe.  The  directive  applies  to  non-
harmonised consumer products. The Regulation also operates in the non-harmonised area, but 
do  not  apply  to  measures  taken  under  Directive  2001/95  and  concerning  products  posing  a 
risk  to  the  health  and  safety  of  consumers.  The  Regulation  applies  where  the  competent 
authorities  of  a  Member  State  intend  to  prohibit  the  marketing  or  use  of  a  non-harmonised 
consumer  product,  lawfully  marketed  in  another  Member  State,  on  the  basis  of  a  technical 
rule and for reasons other than a risk to the health and safety of consumers. This is the case, 
for  example,  when  a  product  is  not  allowed  to  be  marketed  for  reasons  based  on  the 
denomination,  size,  composition  or  packaging,  or  for  environmental  reasons.  The  analysis 
carried out on the coherence between these two legal instruments suggests that certain specific 
administrative  decisions  are  excluded  from  the  scope  of  the  Regulation,  while  others  are 
covered.  Furthermore  the  analysis  did  not  result  in  finding  any  clear  explanation  of  the 
rationale for the differentiation and that this differentiation could generate a risk of confusion 
among national authorities and economic operators.   

The relationship between the Directive and the Regulation is addressed in article 3.2 a) of the 
Regulation,  on  the  basis  of  which  it  appears  that  the  Regulation  does  not  apply  to  the 
following administrative decisions: 

 

 

 

 

temporary  ban  on  the  supply,  the  offer  to  supply  or  the  display  for  however  long  is 
needed  for  the  various  safety  evaluations,  checks  and  controls  for  any  product  that 
could be dangerous (article 8(1)(d) of the GPSD); 

ban  on  the  marketing  and  introduction  of  the  accompanying  measures  required  to 
ensure the ban is complied with for dangerous product: (article 8(1)(e) of the GPSD); 

order  for  or  organisation  of  the  actual  and  immediate  withdrawal,  and  alert  to 
consumers  of  the  risks  presented;  order  for  or  coordination  –  or,  if  appropriate, 
organisation  together  with  producers  and  distributors  –  of  the  recall  from  consumers 
and the destruction  of any dangerous product already on the market (article 8(1)(f) of 
the GPSD); 

any of the measures mentioned above as well as the requirement to mark with clearly 
worded and easily comprehensible warnings on the risks, to make the marketing subject 
to  prior  conditions  to  make  the  product  safe  and  to  order  that  persons  to  whom  the 
product  could  pose  risks  are  given  warning  in  good  time  and  in  an  appropriate  form 
including the publication of special warnings, for products posing a serious risk (article 
8(3) of the GPSD). 

Furthermore, the Regulation does not apply to certain measures, such as the organisation of 
appropriate safety checks on the safety properties of any product, the request of all necessary 
information  from  the  parties  concerned  and  the  decision  to  take  samples  of  products  and 

147  
148  

OJ L 11, 15.1.2002, pp. 4-17 
Rapid Alert System established under Directive 2001/95 on General Product Safety  

63 

 
 
                                                            
 
subject them to  safety  checks (Article 8(1)(a) of the GPSD), as  these are not administrative 
decisions taken on the basis of a technical rule in the sense of article 2 of the Regulation.  

A contrario, the Regulation would apply to the following administrative decisions:  

 

the  requirement  to  mark  with  clearly  worded  and  easily  comprehensible  warnings  on 
the  risks,  to  make  the  marketing  subject  to  prior  conditions  to  make  the  product  safe 
and to  order that persons to whom the product could pose risks are  given warning in 
good time and in an appropriate form including the publication of special warnings, for 
products that could pose a risk in certain conditions and for products that could pose 
risks for certain persons (article 8(1) (b) and (c) of the GPSD).  

Regulation (EU) No 305/2011 on construction products149 sets up Products Contact Points 
for  Construction  (PCPCs).    Article  10  of  The  Regulation  requires  each  Member  State  to 
nominate  a  Product  Contact  Point  for  Construction  in  order  to  "provide  information,  using 
transparent and easily understandable terms, on the provisions within its territory aimed at 
fulfilling  basic  requirements  for  construction  works  applicable  for  the  intended  use  of  each 
construction  product”. 
  The  Mutual  Recognition  Regulation,  and  in  particular  the 
requirements  related  to  Product  Contact  Points  (PCPs)  complements  coherently  the  PCPCs. 
The  objective  of  the  PCPCs  is  very  similar  with  the  objective  of  the  PCPs  under  mutual 
recognition; furthermore, many construction products belong to the non-harmonised area. The 
importance  of  the  construction  sector  both  in  terms  of  variety  and  complexity  of  products 
covered and number of active economic operators justify the existence of a specific PCP for 
construction  products.  Nevertheless,  in  numerous  Member  States,  the  PCPC  and  the  PCP 
have been merged, in order to offer a "one single entry point" for businesses. Thus, it appears 
that  that  there  is  no  incoherence  or  duplication  between  the  mutual  recognition  principle  / 
Regulation and the Construction Products Regulation. Rather, the analysis carried out shows 
synergies between the two and guidelines150 have been published for maintaining consistency 
between PCPs and CPCPs. 

The  SOLVIT  network151  is  a  service  provided  by  the  national  administration  in  each  EU 
Member State, and in Iceland, Liechtenstein and Norway. It helps business when their rights 
are breached by public authorities in another EU Member State, by aiming to find a solution 
within 10 weeks. Thus, SOLVIT may be used, as an alternative, by businesses when facing a 
national decision denying or restricting market access on the basis of the mutual recognition 
principle.  

The proposal for an EU Single Digital Gateway152 is expected to introduce a new obligation 
to provide information on national product rules online on a website, instead of upon request 
like  currently.  Member  States  will  need  to  provide  a  summary  of  the  applicable  rules  for 
product categories, but may also refer to the assistance services for more detailed information 
tailored to specific products. This follows good practices already adopted by many Member 
States.153  It  is  expected  that  having  access  to  the  information  online  will  facilitate  the 
accessibility and awareness of the role of PCPs and of national product rules by businesses. In 

149  
150  
151  
152 
153   

OJ L 88, 4.4.2011, p. 5–43 
Study performed by Ecorys (final version and link not available) 
http://ec.europa.eu/solvit/what-is-solvit/index_en.htm  
 http://ec.europa.eu/DocsRoom/documents/22761  
For example,  good  practices  on  how  to  provide  product  information  can  be  found  in  Austria,  France,  Denmark  and  the  UK.  See 
Annex 12 of the Evaluation. 

64 

 
 
                                                            
addition, this initiative is expected to improve the functioning of PCPs by setting out quality 
criteria and the obligation to provide information online.  

EU  harmonisation  legislation  and  mutual  recognition  are  fully  complementary.  Free 
movement of goods in the internal market is ensured through EU common rules on products 
(EU  harmonisation  legislation)  and  the  principle  of  mutual  recognition.  EU  harmonisation 
legislation  sets  out  common  requirements  on  how  a  product  has  to  be  manufactured,  which 
includes rules on i.e. characteristics of the product, size, composition, etc. Its aim is not only 
to  eliminate barriers to the free movement of goods in the single market, but  also to  ensure 
that only safe and otherwise compliant products find their way onto the EU market, in such a 
way that honest economic operators can benefit from a level playing field, thus promoting at 
the  same  time  an  effective  protection  of  EU  consumers  and  professional  users  and  a 
competitive single  market.  The  adoption  of  EU  common  rules  prevents  Member  State  from 
regulating  those  technical  aspects  of  products  and  products  complying  with  such  rules  are 
guaranteed free movement across the single market. However, EU harmonisation legislation 
covering every product and aspect of product  is neither a feasible nor a desirable objective. 
Adopting EU common rules is a costly and time consuming process, where a balance needs to 
be struck between different approaches and should be reserved for those products and aspects 
of products where there are significant barriers to the free movement across the Single Market 
which  cannot  be  addressed  otherwise.    Where  there  are  no  EU  common  rules,  or  when 
products are only partially covered by EU common rules, Member States remain free to adopt 
national technical rules laying down requirements to be met by those products, such as rules 
relating to designation, form, size, weight, composition, presentation, labelling or packaging. 

The results of the 2016 public consultation confirm the analysis carried out above. There is a 
consensus among stakeholders as regards the coherence of the Regulation with regard to other 
EU pieces of legislation. Most of the respondents are not aware about any overlaps between 
the Regulation and other initiatives/legislation/policies. A minor part of respondents indicated 
that  there  are  some  overlaps  linked  to  SOLVIT154,  RAPEX155,  ICSMS156  and  Regulation 
765/2008  on  market  surveillance157.  However,  the  analysis  of  their  individual  replies  shows 
that their perception is due to a misunderstanding of the EU legislation identified rather than 
to real overlaps.  

Figure 7-19: Public consultation 2016 

154   
155  
156  
157  

http://ec.europa.eu/solvit/index_en.ht  
See above 139  
Internet-supported information and communication system for the pan-European market surveillance 
OJ L 218/30, 13.08.2008 

65 

 
 
                                                            
Are you aware of any overlaps between the regulation and other EU initiatives? 

84% 

71% 

70% 

28% 

29% 

15% 

Yes

7.3.1 Conclusion on coherence 

No

Member States

Businnesses

Citizens

Overall,  the  internal  analysis  carried  out,  confirmed  by  the  results  of  the  2016  public 
consultation  show  that  there  does  not  seem  to  be  any  contradiction  between  mutual 
recognition  and  other  EU  policies  for  achieving  the  internal  market  and  facilitating the  free 
movement  of  goods  in  the  EU.  Rather,  the  mutual  recognition  principle  and  the  Regulation 
complement and are coherent with a number of initiatives in this area, as described above.  

1.13  Relevance: assessing the continuous need for mutual recognition  

Mutual  recognition  is  "one  of  the  most  appreciated  innovations  of  the  EU"158,  as  it  aims  to 
achieve a deep market integration while respecting diversity and regulatory autonomy among 
Member States. It is seen as an alternative to harmonisation, when the latest is not necessary, 
justified  and  proportionate.  However,  the  application  of  the  mutual  recognition  principle  in 
practice proved to be  very challenging.  The adoption of the Mutual Recognition Regulation 
aimed  to  enhance  and  improve  the  application  of  the  mutual  recognition  principle  and  thus 
reduced some of the costs incurred by businesses.  

To what extent is mutual recognition still relevant to its stakeholders?  

Businesses  still  encounter  problems  when  trying  to  sell  in  Member  State  products  lawfully 
marketed in another Member State. Member States need to retain their regulatory autonomy 
and diversity while supporting the competitiveness of their economic operators and allowing 
them easy access to markets. Whenever there are national technical rules, there will be a need 
to ensure the mutual recognition of those in order to guarantee the free movement of goods. A 
recent study159 shows that around 0.99 million enterprises160 were operating within the non-
harmonised area, representing more than 50% of the total number of active enterprises in the 
manufacturing  economy.  At  EU28  level,  more  than  8  million  persons  are  employed  in  the 
non-harmonised area, representing around 31% of all persons employed in the manufacturing 
sector). Furthermore, the (average) annual value of intra EU exports 161of non-harmonised (or 

158  

159  
160  
161  

"Mutual  recognition:  economic  and  regulatory  logic  in  goods  and  services",  Bruges  European  Economic  Research  Papers,  2012, 
Jacques Pelkmans 
Study on the cost and benefits of the revision of the Mutual recognition Regulation (EC) No 764/2008, February 2017 
Over the period 2012-2014 
Over the period 2008-2015 

66 

 
 
 
                                                            
partially  harmonised)  goods  has  been  equal  to  €335  billion,  while  the  contribution  of 
enterprises in the non-harmonised (or partially harmonised) area  is around 20% of the total 
value of market sales of manufacturing sectors (€1, 158 billion out of €5, 690 billion).  

Furthermore, mutual recognition is particularly relevant for supporting innovation.  In the area 
of new innovative products, there are no European harmonised rules, and businesses need to 
rely  on  existing  rules/standards  at  national  level,  or  even  to  deal  with  the  absence  of  such 
rules.  Mutual  recognition  is  the  only  alternative  for  businesses  wishing  to  market  their 
new/innovative  products  in  other  Member  States.  Recent  data162  shows  that  more  than  two 
thirds of EU companies have introduced at least on innovation since 2013, and four in ten EU 
companies  have  introduced  new  or  significantly  improved  products.  For  the  majority  of 
companies, innovative goods accounts for between 1% and 25% of their turnover (67%) while 
a  further  17%  say  that  they  account  for  more  than  26%  of  their  turnover.  The  relevance  of 
mutual  recognition  in  this  area  is  also  supported  by  the  fact  that  57%  of  EU  companies 
consider that the cost and complexity of meeting regulations or standards is a problem for the 
marketing  of  innovative  goods,  and  for  48%  this  is  one  of  the  reason  why  they  have  not 
introduced innovative goods on the market since 2013. Furthermore, 18% of those that have 
not  introduced  innovative  products  on  the  market  believe  that  further  support  in  relation  to 
how to meet regulations and standards is needed.  

Lastly,  mutual  recognition  is  an  alternative  to  harmonisation.  In  order  to  be  cost  effective, 
harmonisation can be used only in sectors where the divergence of technical rules poses too 
many  problems  to  permit  a  proper  application  of  the  mutual  recognition  principle.  
Furthermore,  mutual  recognition  can  achieve  similar  results  to  harmonisation  with  the 
advantage of not triggering transition costs (as harmonisation does, which forces companies to 
comply  with  new  harmonised  requirements  that  are  likely  to  be  different  from  the  prior 
national requirements).  

Thus, mutual recognition remains a very relevant issue for stakeholders across the EU, as the 
solutions it brings have the potential to address the needs of businesses and Member States. 
This is also supported by the fact that during the consultation process163, stakeholders showed 
a high interest in mutual recognition.  

How  well  do  the  objectives  set  out  in  the  Regulation  (still)  correspond  to  the  current  needs 
within the EU?  

Mutual  recognition  remains  a  much  appreciated  tool  for  achieving  free  movement  of  goods 
while respecting Member States regulatory autonomy and diversity. The Regulation captured 
well  the  practical  difficulties  of  the  application  of  the  mutual  recognition  principle;  these 
difficulties  remain  valid  and  improving  the  application  of  the  principle  is  still  an  objective 
which corresponds to the current need of stakeholders to rely on a smooth functioning of the 
internal market. This is confirmed by the results of the 2016 public consultation which shows 
that most of the tools put in place by the Regulation are still useful and necessary.   

Figure 7-20: Public consultation 2016: are the tools put in place by the Regulation still 
useful and necessary? 

162  
163  

Innobarometer 2016 – EU business innovation trends  
See annex 2 

67 

 
 
                                                            
Are these tools still useful and necessary?  

84% 

80% 

75% 

82% 

82% 

76% 

64% 

58% 

68% 

58% 

58% 

51% 

Member States

Businnesses

Citizens

PCPs

Obligation to notify

Product list

Guidelines

Since  the  introduction  of  the  principle  and  the  entry  into  force  of  the  Regulation,  the 
traditional way goods are being sold changed. Data164 shows that more and more products are 
being sold online; in the future, more and more products will be sold online, and the number 
of online cross border transactions will increase. However, the way products are being made 
available  to  consumers  (in  shops  or  online)  has  no  impact  on  the  fact  that  these  products 
should  comply  with  the  applicable  rules  and  benefit  from  the  free  movement  principle. 
Economic operators are entitled to invoke their right to mutual recognition regardless of how 
they  intend  to  sell  their  products,  provided  that  they  are  lawfully  marketing  them  in  one 
Member  State.  What  might  be  impacted  is  the  Member  States  capacity  to  conduct  market 
controls and check those products which are sold online. Currently, market control procedures 
are  more  adapted  to  the  classic  selling  methods  (shops),  but  it  is  expected  that,  due  to  the 
increase of online sales, market control procedures will evolve in order to better capture those 
products sold online.  

7.4.1 Conclusion on relevance  

The  evaluation  shows,  that,  overall,  mutual  recognition  remains  particularly  relevant  for 
businesses,  which  still  encounter  obstacles  to  free  movement  of  goods,  and  for  Member 
States,  who  still  need  to  retain  their  regulatory  autonomy.  Mutual  recognition  remains  also 
relevant for innovative products, where there is a need to rely on existing national rules or to 
deal  with  their  absence.  Furthermore,  mutual  recognition  remains  an  alternative  to 
harmonisation,  which  can  be  used  only  where  it  is  cost  efficient,  due  to  a  very  important 
divergence of technical rules. This conclusion justifies the need for a continued effort to refine 
and improve the functioning  of mutual recognition and achieve full potential of the internal 
market.    

1.14  EU added value: Evaluating what mutual recognition brings to the EU 

What  is  the EU  added  value  of  mutual  recognition  for  stakeholders?  To  what  extent  do  the 
issues addressed by the mutual recognition provisions continue to require action at EU level?  

164  

http://ec.europa.eu/eurostat/statistics-explained/index.php/E-commerce_statistics 

68 

 
 
 
                                                            
Following the stakeholders' consultation165, there is a general consensus among stakeholders 
that  mutual  recognition  brings  added  value  to  the  EU.  It  gives  the  possibility  to  market  in 
other  Member  States  products  already  lawfully  marketed  elsewhere,  while  maintaining 
Member  States'  regulatory  autonomy  and  diversity.  It  is  widely  acknowledged  that  the 
objectives  it  sets  out  can  be  met  only  by  acting  at  EU  level.  Throughout  the  consultation 
process, stakeholders were almost unanimous as regards the necessity of having an EU legal 
instrument  for  achieving  more  and  better  mutual  recognition.  This  is  because  mutual 
recognition only applies in cross border situations where an economic operator would like to 
trade in other Member States a product already lawfully marketed in a Member State. Action 
by  Member  States  alone  cannot  solve  problems  associated  with  the  application  of  the 
principle  of  mutual  recognition  across  the  single  market.  To  be  effective,  the  application  of 
the principle needs to be based on harmonised procedures to be applied equally by all national 
authorities.  Only  such  harmonised  procedures  can  guarantee  that  national  authorities  will 
apply  the  principle  in  the  same  manner,  thus  allowing  companies  to  benefit  from  an  equal 
treatment  regardless  of  the  country  where  they  try  to  market  their  product.  Leaving  the 
procedural  aspects  of  the  application  of  the  mutual  recognition  principle  to  each  Member 
State  would  weaken  the  principle  by  dismantling  the  modus  operandi  into  28  different  and 
possibly contradictory procedures. 

Figure 7-21: Public consultation 2016 – EU added value of mutual recognition  

European common procedures on mutual recognition guarantee equal treatment of businesses, 
regardless  of where they want to sell their products 

17% 

I don't agree

26% 

8% 

I agree

76% 

67% 

84% 

Citizens

Businnesses

Member States

165  

See annex 2 

69 

 
 
 
                                                            
European common procedures on mutual recognition guarantee that national authorities apply the 
principle in the same manner European common procedures on mutual recognition guarantee that 
national authorities apply the principle in the same manner  

I don't agree

29% 

35% 

15% 

I agree

64% 

52% 

68% 

Citizens

Businnesses

Member States

What would be the most likely consequences of repealing the mutual recognition provisions? 

The  mutual  recognition  principle  arises  from  articles  34-36  TFEU  and  has  been  further 
developed on the basis of the Court's jurisprudence. It cannot be repealed as such. In case of 
repealing  the  Regulation,  the  mutual  recognition  principle  would  continue  to  apply.  This 
means  that  economic  operators  would  no  longer  have  any  procedural  guarantees  in  case 
market access is denied.  They would no longer have access to PCPs, when information on the 
applicable  national  rules  is  needed.  Generally,  businesses  and  national  authorities  would  be 
reluctant to apply the mutual recognition principle alone, as they were before the adoption of 
the Regulation, in the absence of harmonised procedural guarantees. They would follow, de 
facto, the applicable national rules. In principle, this would mean going back to the baseline as 
it existed before the adoption of the Regulation.   

Figure 7-22: Public consultation 2016 

The absence of European common procedures on mutual recognition would weaken the principle by 
dismantling its application into 28 different and possibly contradictory procedures and undermine the 
internal market 

I don't agree

11% 
4% 
8% 

I agree

76% 

85% 

82% 

7.5.1 Conclusion on EU added value  

70 

Citizens

Businnesses

Member States

 
 
 
 
The  evaluation  shows  that  there  is  a  high  consensus  among  stakeholders  that  mutual 
recognition  brings  added  value  to  the  EU,  as  it  allows  free  movement  of  goods  already 
lawfully  marketed  in  one  Member  State  while  respecting  Member  States  regulatory 
autonomy.  Repealing  the  Regulation  would  mean  depriving  businesses  of  any  procedural 
guarantees when invoking the mutual recognition principle.  

8.  CONCLUSION 

There  is  a  general  consensus  among  stakeholders  that  mutual  recognition  in  the  fields  of 
goods has the potential to bring added value to the EU. It gives the possibility to market  in 
other Member States products already lawfully marketed elsewhere. However, the evaluation 
of the mutual recognition principle shows that it is not functioning as it should. The majority 
of  businesses  wishing  to  sell  products  in  another  Member  State  declare  that  they  check  the 
applicable  rules  in  that  Member  State,  and,  if  these  rules  prevent  them  from  selling  the 
product,  they  don’t  rely  on  the  principle  of  mutual  recognition  but  most  of  them  adapt  the 
product  to  those  rules.  Where  businesses  try  to  rely  on  the  principle  of  mutual  recognition, 
national authorities often deny market access to those products.  

Whilst  the  Regulation  was  adopted  to  facilitate  the  application  of  the  principle  of  mutual 
recognition, generally, the evaluation shows that only few economic operators consider that it 
is easier to sell products in other Member States since the Regulation entered into force.  

The  Regulation  had  a  very  moderate  effect  with  regards  to  the  objectives  settled,  mainly 
because the procedural requirements it put in place proved to be insufficient to ensure an easy, 
reliable and user-friendly application of the mutual recognition principle. It had limited effects 
in  raising awareness  of the mutual  recognition principle;  still many economic operators and 
national  authorities  are  not  fully  aware  of  the  principle  and  its  practical  implications,  and 
stakeholders,  throughout  the  consultation  process,  were  unanimous  with  regards  to  the 
necessity  to  continue  efforts  in  raising  awareness.  Member  States  and  citizens  consider  that 
this should be the Commission's first priority, while businesses ranked fourth. 

Legal  certainty  remains  an  issue  and  makes  users  reluctant  towards  mutual  recognition. 
Businesses ranked the need to increase legal certainty when using mutual recognition as the 
second  priority  for  the  Commission.  The  evaluation  shows  that  the  lack  of  knowledge  as 
regards  the  scope  of  mutual  recognition  makes  economic  operators  reluctant  to  use  the 
principle for entering new markets. Determining if a product might benefit from the mutual 
recognition  principle  is  not  straightforward,  as  mutual  recognition  applies  to  a  very  wide 
range  of  products,  i.e.  products  or  aspects  of  products  which  are  not  covered,  fully  or 
partially, by EU harmonisation legislation. Also, there are many uncertainties when it comes 
to  demonstrating  that  products  have  been  lawfully  marketed  in  a  given  Member  States. 
Furthermore, the difficulty to challenge administrative decisions that deny or restrict market 
access  has  been  pointed  out  as  a  reason  for  not  relying  on  mutual  recognition.  Businesses 
ranked this as being the main obstacle to using mutual recognition, and the first priority for 
the Commission; they were supported by Member States, who ranked this as the third priority. 
Although the actual number of administrative decisions denying or restricting market access 
is  unknown,  the  evaluation  of  the  functioning  of  mutual  recognition  shows  that  economic 
operators  are  often  faced  with  such  administrative  decisions.      Administrative  cooperation 
remains limited, despite the fact that the PCPs network, even if not used at its full capacity, is 
judged useful my most stakeholders. Member States called on improving the current system, 

71 

 
 
by  integrating  PCPs  in  a  wider  network  in  order  to  gain  expertise  and  by  enhancing 
administrative cooperation.  

Stakeholders  consulted  throughout  the  evaluation  were  unable  to  quantify  the  cost-saving 
brought by the principle and Regulation. A study done for the European Parliament166 tried to 
estimate  the  magnitude  of  the  impact  that  non-tariff  barriers  to  trade  have  on  the  internal 
market.  It  concluded  that  a  reduction  of  such  barriers  could  lead  to  an  increase  in  intra-EU 
trade of more than 100 billion EUR per year. While the concept of non-tariff barriers in the 
paper  is  broader  (including  not  only  lack  of  mutual  recognition  or  harmonisation  but  also 
discriminatory  procedures  and  less  favourable  tax  or  subsidy  treatment),  it  provides  an 
indication that the problem of mutual recognition not working well in practice is economically 
significant.  Due to  the ineffective application of the principle of mutual  recognition, goods 
lawfully marketed in one Member State are generally not being sold in another Member State 
without adaptations to national rules. This leads to barriers to free movement of goods; in the 
absence  of  harmonisation  legislation,  a  single  market  for  goods  is  thus  far  from  being 
achieved.  Economic  operators  are  not  benefitting  fully  from  the  internal  market  and  their 
existing rights. National authorities rely on their own national rules which may undermine the 
free movement of goods.  The qualitative input received during the consultation process also 
points into the direction that mutual recognition, when working optimally, has the potential to 
reduce costs and generate benefits.   

Throughout the consultation process, stakeholders were almost unanimous with regards to the 
necessity of enhancing the existing tools for achieving higher and better mutual recognition.  

166  

The  Cost  of  Non-  Europe  in  the  Single  Market,  'Cecchini  Revisited',  An  overview  of  the  potential  economic  gains  from  further 
completion of the European Single Market, CoNE 1/2014  
http://www.europarl.europa.eu/RegData/etudes/STUD/2014/510981/EPRS_STU(2014)510981_REV1_EN.pdf  

72 

 
 
 
 
                                                            
ANNEX 1: PROCEDURAL INFORMATION 

In December 2013, the Conclusions on Single Market Policy, adopted by the Competitiveness 
Council, recalled that to improve the framework conditions for businesses and consumers in 
the  Single  Market,  all  relevant  instruments  should  be  appropriately  employed,  including 
harmonisation and mutual recognition. The Commission was therefore requested to report to 
the  Council  on  the  sectors  and  markets  where  the  application  of  the  principle  of  mutual 
recognition is economically most advantageous, but where its functioning remains insufficient 
or problematic.  

In  response  to  the  Council  request  and  the  indications  that  the  functioning  of  the  principle 
might not be optimal, the application of the principle of mutual recognition was subject to an 
external  evaluation167.  Its  objective  was  to  assess  the  functioning  of  the  application  of  the 
principle and identify the shortcomings and on this basis, to identify possible ways to improve 
its application. The evaluation of the principle of mutual recognition was part of the REFIT 
agenda  in  2014.  This  exercise  did  not  include  a  full  ex-post  evaluation  of  the  Mutual 
Recognition Regulation but provided some indications on its current performance. 

Thus,  the  purpose  of  this  exercise  is  to  have  a  full  ex-post  evaluation  of  the  Mutual 
Recognition Regulation, in order to assess the main difficulties encountered and follow-up on 
the implementation of the Single Market Strategy with respect to mutual recognition, and in 
particular on the proposal to revisit the application of the principle of mutual recognition and 
the implementation of the Mutual Recognition Regulation with a the view to ensuring higher 
and  better  mutual  recognition.  This  initiative  is  part  of  the  Commission's  2017  Working 
Programme168.   

An Inter-Service Steering Group (ISSG) chaired by DG GROW was set up in October 2015 
and  with  the  participation  of  the  following  Directorates  General:  Legal  Service  of  the 
Commission (LS), Secretariat General (SG), DG Agriculture and Rural Development (AGRI), 
DG  Economic  and  Financial  Affairs  (ECFIN),  DG  Energy  (ENER),    DG  Environment 
(ENV),  DG  Justice  and  Consumers  (JUST),  DG  For  Mobility  and  Transport  (MOVE),  DG 
Health  and Food  Safety  (SANTE),  DG  Taxation  and  Customs  Union  (TAXUD),  DG  Trade 
(TRADE),  DG  Maritime  Affairs  and  Fisheries  (MARE).  The  ISSG  met  in  total  nine  times 
(29/01/2016,  07/03/2016,  21/04/2016,  29/09/2016,  28/11/2016,  27/01/2017,  13/02/2017, 
27/02/2017 and 06/03/2017). 

The Regulatory Scrutiny Board (RSB) of the European Commission assessed a draft version 
of  the  present  evaluation  and  issued  its  positive  opinion  on  07/04/2017.  The  Board  made 
several recommendations to further improve the report. Those were addressed in the revised 
report as follows: 

RSB recommendations 

Modification of the report 

(B) Main considerations 

The Board gives a positive opinion, but 
considers that the report should be improved 
with respect to the following key aspects: 

167  
168  

http://ec.europa.eu/DocsRoom/documents/13381    
COM(2017)710 Final 

73 

 
 
                                                            
(1) There is scope to improve the description 
and the relative importance of the main 
problems encountered in the application of 
the mutual recognition principle and the 
corresponding Regulation. Why do the key 
instruments put in place by the Regulation 
not deliver? 

(2) While being a REFIT evaluation, it does 
not clearly estimate existing regulatory 
burdens on companies or public 
administrations, or the potential for cost 
savings. 

This recommendation has been addressed 
thorough the text, by adding relevant data 
collected during the study supporting the 
impact assessment on the revision of the 
Mutual Recognition Regulation.   

Clarifications on the REFIT aspects have 
been added in sections 7.1.5 and 7.2.9 of the 
SWD.  

(3)  The  report  does  not  provide  clear 
conclusions 
the  Mutual 
on  whether 
Recognition  Regulation  remains  relevant  or 
not, or on the extent to which there is scope 
to remedy its ineffectiveness. 

The conclusions have been amended 
accordingly; see more specifically sections 
7.1.4, 7.1.5, 7.2.9, 7.3.1, 7.4.1, 7.5.1 and 8 of 
the SWD.  

(C) Further considerations and 
recommendations for improvement 

(1) Effectiveness and magnitude of the 
problem 

The report gives indications that the 
application of the mutual recognition 
principle and the related Regulation do not 
work properly. However, it does not provide 
robust evidence to show the extent of the 
problem. It should use information from the 
parallel draft impact assessment to estimate 
the magnitude of the problem (with the 
necessary caveats). In particular, it should 
further assess bottlenecks of the main 
delivery mechanisms: Contact 
Points in the national administrations, 
Commission database, mutual recognition 
clause in technical specifications. The report 
should differentiate between technical 
difficulties, lack of resources for 

The problems have been completed with 
useful data collected during the study 
supporting the impact assessment on the 
revision of the Mutual Recognition 
Regulation (more specifically, see section 
7.1 of the SDW). Explanations on the 
robustness of the data collected during the 
public consultations have been added in 
section 5 and 7.1.4 of the SWD.  

74 

 
 
 
 
 
 
 
 
 
 
enforcement, lack of awareness and political 
reluctance. 

The presentation of the results of the open 
public consultation should mention that they 
are not statistically representative. The report 
should better explain why it considers that 
the replies provide a reliable basis to 
substantiate the assessment. 
(2) Baseline 

The baseline should analyse how the 
situation would have evolved without the 
Regulation. 
It should show to what extent the observed 
evolution correspond to the estimates 
foreseen in the 2007 impact assessment 
accompanying the Regulation. It should also 
show to what extent the objectives of the 
Regulation were attained or not. 

(3) Efficiency 

The report should quantify costs and benefits 
as much as possible and identify the 
unnecessary regulatory burden. This is 
particularly important given the REFIT 
dimension. 
The report should clearly indicate the efforts 
made to obtain quantified data. The 
evaluation should compare figures against 
other estimates available (from statistics, 
studies, etc.) to show their robustness. 
(4) Relevance 

The report should discuss in this section how 
the lack of effectiveness of mutual 
recognition (both the principle and the 
Regulation) has no apparent major negative 
effects on the goods markets. In particular, 
the report should assess the relevance of the 
main measures of the Regulation, given their 
lack of effectiveness. The report should 

Information on the 2007 impact assessment 
was added in section 2.1 of the SWD. 

This recommendation has been addressed by 
amending sections 7.1.5 and 7.2.9 of the 
SWD.  

This recommendation has been addressed by 
amending sections 7.4 and 7.4.1 of the SWD. 

75 

 
 
 
 
 
 
 
 
 
 
 
The conclusions have been amended 
accordingly; see more specifically sections 
7.14, 7.1.5, 7.2.9 and 8 of the SWD. The 
collection of data for improving monitoring 
has been addressed in section 5 of the SWD. 

better analyse how new developments in e-
commerce affect mutual recognition and its 
application. 
(5) Conclusions 

The evaluation should present clear 
conclusions and underpin the statements with 
evidence. It should elaborate on the 
applicability of the mutual recognition 
principle, on whether the related Regulation 
remains relevant and to what extent there is 
scope to improve its effectiveness. It should 
also assess the usefulness and functioning of 
the main elements of the Regulation, for 
instance of the Product Contact Points or of 
the mutual recognition clause. 
The overall conclusions (e.g. on 
effectiveness and efficiency) should be 
consistent with the findings of previous 
sections. The report should present the 
limitations of the available evidence more 
transparently. 
The report should draw lessons from the 
suboptimal functioning of the monitoring 
and reporting framework. It should further 
explain how the DG would collect more 
reliable data for monitoring purposes. 

76 

 
 
 
 
 
 
 
 
 
 
 
ANNEX 2: STAKEHOLDER'S CONSULTATION 

1.  OBJECTIVES OF THE CONSULTATION  

The  'Single  Market  Strategy'  (COM(2015)550  of  28.10.2015)  highlights  the  need  to 
strengthen  the  single  market  for  goods  in  the  field  of  mutual  recognition.  This  principle 
allows  products  lawfully  marketed  in  a  Member  State  and  not  subject  to  European 
harmonisation legislation to  enjoy the right  of free movement, despite a lack of compliance 
with the national technical rules of the Member State of destination. However, the principle is 
not  yet  used  at  its  full  potential  as  shown  in  a  recent  evaluation  of  the  mutual  recognition 
principle.  

To improve the application of the mutual recognition principle, the Commission will present 
an EU-wide Action Plan to raise awareness of the principle of mutual recognition. The plan 
will  also  include  specific  actions  to  be  taken  for  sectors  in  which  mutual  recognition  could 
achieve the greatest increase in EU competitiveness (e.g. construction). The Commission will 
also  investigate  the  need  for  a  revision  of  Regulation  (EC)  No  764/2008  to  ensure  a  better 
application among businesses and national authorities. The objective of the consultation was 
therefore  to  seek  stakeholders'  views  on  the  current  and  future  application  of  Mutual 
Recognition.   

1.1  Consultation methods and tools 

The  members  of  the  Mutual  Recognition  Consultative  Committee169  were  asked  to 
provide  their  feedback  during  their  latest  meetings  on  2  December  2015  and  25  October 
2016. 

A  public  consultation  in  all  EU  official  languages  has  been  published  on  a  consultation 
website hosted on Europa. The consultation has run from June to September 2016.  

The  public  consultation  has  been  supplemented  by  a  stakeholder  conference  organised  by 
the Commission on 17 June 2016.  

2.  RESULTS OF THE CONSULTATION ACTIVITIES 

2.1  Meetings of the Mutual Recognition Consultative Committee 

The consultative “Mutual Recognition Committee” held its seventh and eighth meetings on 2 
December  2015  and  25  October  2016  respectively.  The  Committee's  members  are 
representatives  of  Member  States  dealing  with  mutual  recognition  issues.  The  Commission 
presented  the  envisaged  actions  for  raising  awareness  of  mutual  recognition  and  asked  for 
feedback  and  input  on  these  actions.  Member  States  welcomed  the  activities  presented  and 
stressed the importance of awareness raising in relation to a correct application of the mutual 
recognition  principle.    The  Commission  presented  also  a  preliminary  analysis  of  the  main 
problems generated by the suboptimal functioning of mutual recognition, as identified in the 
framework of the ongoing evaluation.  The delegates  agreed that  mutual recognition should 
not  be  only  a  right  that  economic  operators  may  invoke,  but  also  a  principle  that  national 
authorities should apply.  Furthermore, the Commission presented the preliminary options for 
improving  mutual  recognition  and  asked  for  feedback  from  the  delegations.  Some 

169  

The  members  of  this  Committee  are  the  national  authorities  responsible  for  mutual  recognition  in  the  28  Member  States  and  in 
Iceland, Liechtenstein, Norway, Switzerland and Turkey.  Representatives of other third parties or other experts may be invited to 
participate on a specifc topic, on a case by case basis. 

77 

 
                                                            
representatives  were  not  convinced  that  there  are  benefits  in  fully  revising  the  Regulation, 
whilst all of them agreed that some adjustments are necessary and that many of the problems 
can be solved with the actions foreseen in the Action Plan.  

The participants also supported the option to clarify the scope of the Regulation, and mainly 
the  mutual  recognition  principle,  thus  articles  34-36  TFEU,  where  guidelines  are  more 
appropriate to achieve this objective. The Commission also proposed having a clearer mutual 
recognition  clause,  such  as  a  standard  model,  which  could  be  adapted  to  particular  cases, 
would be proposed, for systematic integration in new national technical rules.  Another point 
discussed was the need for an updated and user friendly product database.  

The Commission presented then the possible introduction of a declaration of compliance with 
the  technical  rules  of  the  Member  State  where  the  product  is  being  lawfully  marketed,  to 
facilitate the access of this product to the market of the other Member States.  The declaration 
would offer a presumption of compliance for the economic operator; this presumption could 
be rebutted by national authorities, who would be tasked with proving non-compliance. Some 
Member  States  considered  that  this  option  would  introduce  a  significant  administrative 
burden  on  economic  operators  but  market  surveillance  authorities  would  welcome  such 
declaration, as it would facilitate their tasks.  

Another point discussed was the introduction of incentives for national authorities to ensure 
that they comply with the obligation to notify administrative decisions denying or restricting 
mutual recognition. More transparency for these decisions would be an incentive for Member 
States  to  apply  the  mutual  recognition  principle,  as  it  would  render  less  acceptable  the 
absence of notifications or the lack of a proper justification in supporting the administrative 
decisions  to  be  notified.  Using  an  IT  tool  for  allowing  Member  States  to  notify  would  also 
give all notifications  more visibility. Furthermore, the Commission  examines the possibility 
of  creating  a  new  fast  track  mechanism  which  would  be  an  alternative  to  the  costly  and 
lengthy  court  procedures  currently  available.  It  would  be  inspired  by  the  "safeguard 
procedure"  operating  in  the  area  of  products  covered  by  Union  harmonisation  legislation, 
which allows a Member State or the Commission to intervene in order to challenge a national 
decision which is considered to potentially breaching EU law. The fast track appeal procedure 
would  be  very  quick  (no  longer  than  3  months),  and  free  of  charge  for  businesses,  as  any 
other  complaint  they  may  address  to  the  Commission.  The  option  of  a  system  of  prior 
authorisation to placing products on the market was presented afterwards. Products lawfully 
marketed  in  the  market  of  one  Member  State  would  be  placed  on  the  market  of  another 
Member State only after a prior examination of the product by the receiving Member State. 
Many  Member  States  expressed  their  opposition  to  this  option,  as  it  would  hinder  the  free 
movement of goods.   

Another point of discussion was the option of ensuring free movement of goods guaranteed 
by  compliance  with  European  standards.  This  implies  the  recognition,  by  the  Commission, 
and  after  consultation  of  Member  States,  of  certain  European  standards  in  the  area  of  non-
harmonised goods via implementing acts. This option refers only to already existing European 
standards  and  not  to  mandating  the  developments  of  new  ones.    Member  States  considered 
that focusing on essential requirements is more beneficial than using standards.  

Additionally,  the  Commission  sought  the  Member  States'  opinions  on  the  option  of 
strengthening of the role of the Product Contact Points in order to provide information on all 
applicable rules for all products. Member States supported this option as the Product Contact 
Points lack resources and staff. The Commission proposed also the integration of the Product 

78 

 
Contact Points in a wider network, e.g. the Single Digital Gateway. Delegations consider that 
the Single Digital Gateway initiative is not advanced enough in order to able to provide input 
on this option.  

Another option presented was the harmonisation of certain basis requirements. Member States 
were  strongly  against  this  option,  since  partial  harmonisation  only  for  the  sake  of  free 
movement does not bring benefits proportionate to the level red tape it adds.   

2.2  Stakeholder conference of 17 June 2016 

A stakeholders' event was organised on 17 June 2016, to identify the main issues relating to 
the functioning of mutual recognition and to identify possible ways forward. 144 participants 
attended  the  event,  representing  businesses  (62),  national  authorities  (60)  and  others  (22), 
such as consumer organisations, representatives of trade unions. The detailed minutes of this 
conference can be found at: http://ec.europa.eu/DocsRoom/documents/17963. 

2.2.1 Main meeting 

Knut  Sauerbier,  responsible  for  product  compliance  and  IP  at  BRITA,  explained  how 
mutual  recognition  functions  for  businesses  by  providing  the  example  of  drinking  water 
treatment.  

Camilla  Hjermind,  Head  of  Division  of  International  Relations  of  the  Danish  Business 
Authority  of  the  Ministry  of  Business  and  Growth  presented  the  practical  difficulties 
encountered while applying the principle of mutual recognition.  

Jacques Pelkmans, Senior Fellow at CEPS in Brussels and visiting Professor at the College 
of Europe, outlined the main problems faced with mutual recognition, one of the EU's greatest 
innovation.  

Following the three presentations, the floor was given to the participants at the conference to 
discuss the topics.  

2.2.2 Workshops 

Workshop 1: Proving and assessing lawful marketing of products in other Member States: a 
more practical approach 

The  first  workshop  was  held  on  the  topic  of  proving  and  assessing  the  lawful  marketing  of 
products in another Member State. The participants were to discuss a more practical approach 
on  this  issue.  The  workshop  gathered  around  30  participants  and  had  a  balanced 
representation of national authorities, businesses and associations.  

Workshop 2: How to make mutual recognition a practical tool for businesses 

The  second  workshop  discussed  how  to  make  mutual  recognition  a  practical  tool  for 
businesses. The workshop involved 46 stakeholders. Participation was well balanced among 
national  authorities,  businesses,  associations  and  Commission  services.  The  workshop  was 
moderated by Annette Dragsdahl, Senior Adviser at the Confederation of Danish Industry.  

79 

 
2.3  Public Consultation 

153  replies  were  received  during  the  public  consultation.  Businesses  were  strongly 
represented (91), followed by Member States authorities (45), and citizens (17). This includes 
respondents  that  did  not  want  their  replies  published:  16  businesses,  9  authorities  and  one 
citizen. The remainder of the respondents agreed to have their response published either fully 
or anonymously. All replies are included in the statistics.  

45  authorities  from  Member  States  replied  to  the  public  consultation.  31%  are  Product 
Contact  Points,  the  rest  are  other  authorities  involved  in  this  area.  Among  the  group  of 
citizens  there  are  two  consumer  organisations.  Individual  companies  (44)  and  business 
organisations (44) were equally represented, while only 3 chambers of commerce replied to 
the consultation. In terms of company size, the responses are roughly balanced between small 
and large170 companies.  

In terms of activity sectors, manufacturing is the most represented sector (46%), followed 
by  wholesale  and  retail  trade  (13%),  agriculture,  forestry  and  fishing  (8%)  and  water 
supply (6%).  

The  geographical  representation  is  quite  well  balanced  for  businesses.  As  for  national 
authorities, 18 Member States and Norway participated in the public consultation. No replies 
were received from Cyprus, Denmark, Finland, France, Greece, Ireland, Luxembourg, Malta 
and UK. The majority of consumers chose not to indicate their country of establishment.  

The numbers and percentages used to describe the distribution of the responses to the public 
consultation derive from the answers provided under the EU-Survey tool. 

2.3.1 How stakeholders see mutual recognition and its potential shortcomings 

The  majority  of  responding  companies  wishing  to  sell  products  in  another  Member  State 
check the applicable rules in that Member State, and, if these rules prevent them from selling 
the product, most of them adapt it. This happens despite the fact that 70% of them are fully 
aware of the mutual recognition principle. More than half of the businesses responding tried 
to use mutual recognition to enter a new market. Among them, half had their market access 
denied, and only 2% challenged this decision successfully.  

35%  replied  that  they  do  not  rely  on  mutual  recognition  to  enter  a  new  market,  mainly 
because they do not know about it (15%) or because they do not trust it (4%).  

When  national  authorities  check  if  products  available  on  their  market  and  coming  from 
another Member State comply with the national rules they are enforcing, 53% verify if they 
are already lawfully marketed in the Member State of origin while 46% do not.  

Despite  the  indicated  high  level  of  awareness  about  mutual  recognition,  the  majority  of 
respondents consider that awareness-raising remains necessary. 

170  

Enterprises  can  be  classified  in  different  categories  according  to  their  size;  for  this  purpose  different  criteria  may  be  used  (e.g. 
number of persons employed, employees, balance sheet total, investments, ...), but the one most common in a statistical context is 
number  of  persons  employed  :  small  and  medium-sized  enterprises,  abbreviated  as  SMEs:  fewer  than  250  persons  employed  (
  SMEs  are  further  subdivided  into:  micro  enterprises:  fewer  than  10  persons  employed;  small  enterprises:  10  to  49  persons 
employed; medium-sized enterprises: 50 to 249 persons employed); large enterprises: 250 or more persons employed. 

80 

 
                                                            
With regards to the obstacles to the functioning of mutual recognition, businesses identified 
the  lack  of  quick  remedies  for  challenging  national  decisions  denying  market  access  as  the 
highest  one,  followed  by  insufficient  communication  among  authorities.  52%  of  the 
respondents faced such obstacles themselves.  

2.3.2 Functioning of the Mutual Recognition Regulation 

Effectiveness: to what extent has the Regulation achieved its objectives?  

The majority of respondents are aware of the Regulation, and consider that most of the tools 
put in place are useful and still necessary. As regards whether or not the Regulation has met 
its objective, the feeling is mixed among businesses and national authorities. Generally, very 
few economic operators consider that it is easier to sell products in other Member States since 
the Regulation entered into force. The majority consider that the Regulation has not improved 
the situation, or do not know, either because they do not use mutual recognition or they do not 
sell products abroad.  

Efficiency: costs and benefits of the Regulation  

As  regards  the  costs  of  implementing  the  Regulation,  national  authorities  ranked  them  as 
average.  On  top  of  the  choices  provided  by  the  consultation,  authorities  also  indicated 
additional  costs  linked  to  the  absence  of  an  updated  list  of  products  to  which  mutual 
recognition may apply. Some consider that additional costs are triggered by the administrative 
procedures,  seen  as  long  and  time-consuming.  Despite  the  costs,  national  authorities  agree, 
fully or partially, that the Regulation brings benefits in terms of facilitating market access.  

With  regards  to  businesses,  the  main  costs  incurred  are  triggered  by  the  need  to  adapt  the 
products to the applicable national rules, when mutual recognition is either denied or not used 
for penetrating the market. These costs are estimated171 on average at 23 000 Euro per product 
and per market. High costs are also related to delays in entering a market, estimated172 at 115 
000  Euro  per  product  and  per  market,  and  to  lost  opportunities,  when  businesses  relinquish 
entering  a  market  because  of  different  national  rules  that  require  adapting  the  products.  On 
average,  the  latest  are  estimated173  at  136  000  Euro  per  product  and  per  market.  The  costs 
related to challenging administrative decisions denying market access are considered as less 
important,  mainly  because  few  economic  operators  choose  to  do  so.  The  estimates174  are 
around 32 000 Euro per product and per market. There are however considerable variations in 
the answers.  

Costs  were  also  related  to  assessing  if  mutual  recognition  can  be  used  to  sell  products  in 
another  Member  State.  Very  few  economic  operators  (2%)  are  outsourcing  this  assessment, 
while 26% are doing it internally. 46%  are doing both, depending on the product.  

In terms of benefits that the regulation brings, the perception of responding businesses is quite 
mixed.  While  Member  States  tend  to  consider  that  the  costs  of  the  Regulation  are 
proportionate to the benefits it generates, businesses mostly disagree with only 9% agreeing.  

171  

172  

173  

174  

26% of respondents indicated an estimate of the costs incurred, the other choose not to reply or indicated that such estimation is 
impossible 
20% of respondents indicated an estimate of the costs incurred, the other choose not to reply or indicated that such estimation is 
impossible 
13% of respondents indicated an estimate of the costs incurred, the other choose not to reply or indicated that such estimation is 
impossible 
11% of respondents indicated an estimate of the costs incurred, the other choose not to reply or indicated that such estimation is 
impossible 

81 

 
                                                            
Coherence 

There is a consensus among respondents as regards the coherence of the Regulation. Most of 
the  respondents  are  not  aware  of  any  overlaps  between  the  Regulation  and  other 
initiatives/legislation/policies. The overlaps indicated by those replying positively are linked 
to Solvit, RAPEX, ICSMS and Regulation 765/2008 on market surveillance.  

EU added value  

The European added value of the mutual recognition rules is also strongly underlined by the 
respondents.  Most  of  them  agree  that  having  a  common  set  of  rules  guarantees  equal 
treatment, and that relying on national rules only would undermine the internal market.  

2.3.3 Assessment of communication when using Mutual Recognition 

Most  of  the  responding  businesses  have  never  contacted  a  Product  Contact  Point  to  obtain 
information  on  the  applicable  product  rules,  mainly  because  they  are  not  aware  of  their 
existence.  Among  those  having  contacted  Product  Contact  Points,  it  is  quite  difficult  to 
identify their level of satisfaction or the reasons behind it.  

Responding  Member  States  consider  the  communication  with  authorities  within  their  own 
country  as  good,  while  communication  with  authorities  from  other  Member  States  is  rather 
average or poor. As regards communication between national administrations and businesses, 
the  assessment  by  authorities  is  quite  mixed  between  good,  average  and  poor.  The  main 
reasons  for  poor  communication  relate  to  the  lack  of  knowledge  about  mutual  recognition, 
language issues and the absence of an appropriate IT tool to facilitate communication.  

2.3.4 Priorities to improve Mutual Recognition 

Stakeholders  have  different  views  with  regards  to  the  Commission's  priorities  as  regards  to 
mutual  recognition.  If  businesses  rank  the  need  for  effective  remedies  as  being  the  highest 
priority,  Member  States  and  citizens  opt  in  favour  of  increasing  awareness  of  mutual 
recognition.  

2.3.5 Options 

All  options  put  forward  for  making  mutual  recognition  easier  to  apply  and  more  reliable 
received a high level of support among respondents.  

As to what would be the most appropriate alternative to mutual recognition, the majority of 
respondents  agree  that  harmonisation  is  the  most  appropriate  tool  to  use  when  mutual 
recognition does not work properly.  

2.4  Surveys carried out by the external contractors 

In the framework of the external study evaluating the functioning of the mutual recognition 
principle175  ,  four  different  surveys  were  launched  on  9  October  2014  and  completed  on  5 
January 2015. These were a company survey (199 participants), a survey of national business 
associations and of national sector associations (20 participants), and a product contact point 

175  

http://ec.europa.eu/DocsRoom/documents/13381 

82 

 
                                                            
survey (26 participants). Following the survey, qualitative interviews with  national business 
associations and Product Contact Points in each Member State were also carried out.  

The findings of the surveys and interviews show that the application of the mutual recognition 
principle is challenging. Stakeholders outlined that there are still barriers to free movement of 
lawfully marketed goods due to additional requirements and tests existing in certain Member 
States. The lack of knowledge and awareness about mutual recognition was also pointed out  
as being problematic, as companies and national authorities do not know when and how the 
principle should be applied, in particular with regard to the type of products falling under the 
scope  of  mutual  recognition  and  to  the  type  of  documentation  to  be  required  for 
demonstrating  that  a  product  has  been  already  lawfully  marketed.  Poor  communication  and 
cooperation among national authorities has also been pointed out as a weakness, contributing 
to  the  poor  functioning  of  mutual  recognition.  In  terms  of  efficiency,  many  businesses 
declared  having  to  carry  out  additional  tests  at  the  request  of  the  Member  States  on  the 
territory of which they are trying to sell their products.  

In  the  framework  of  the  study  assessing  the  costs  and  benefits  of  the  different  options 
envisaged for improving mutual recognition, a survey and interviews were carried out by the 
external contactor. The stakeholder consultation focused not only on the current functioning 
of  mutual  recognition  –  and  its  main  issues  –  but  also  on  how  to  revise  the  Regulation, 
through  the  policy  options  proposed  by  the  Commission.  Targeted  surveys  and  interviews 
allowed an understanding of the stakeholders’ point of view about the Policy Options. With 
respect to the obstacles to the implementation of MR National authorities highlight that: the 
wide  scope,  size  and  fragmentation  of  the  market  falling  under  mutual  recognition  and  the 
presence  of  many  different  national  legislations  may  create  difficulties  in  having  clear, 
structured and smooth procedures to apply mutual recognition; products falling in areas where 
partial harmonisation and/or some EU standards exist create difficulties for authorities, since 
a mix of national and EU rules may apply, requiring more effort from their side to check and 
decide; a certain lack of communication exists also across Member States. This may result in 
difficulties for a national body to understand why a product was lawfully marketed in another 
Member  State  and  what  relevant  rules  apply,  without  investigating  and  asking  for  further 
information or clarification.   Businesses  highlighted  several  obstacles  as  well,  in  particular 
relating  to  the  interaction  with  national  authorities,  especially  in  terms  of  obtaining  easy 
access  to  information,  concerning  mainly  relevant  legislation  and  procedures  in  place 
especially because of language barriers, proving that the product is already lawfully marketed 
in  another  Member  State  since  National  Authorities  require  different  information  and 
evidence.  The  time  required  to  receive  a  response  from  the  national  authorities  has  a 
significant impact in delaying the entry into the market or even discouraging them to enter. 
Considering  the  issues  highlighted  by  stakeholders  both  economic  operators  and  national 
authorities agree that measures to improve the MR Regulation have to be taken. Within each 
category of stakeholder, preferences and opinions about the feasibility and priority of policy 
options (and sub-options) seem to be heterogeneous. While among National Authorities there 
is quite a spread consensus about the need for intervention, either through soft-law or hard-
law instruments, economic operators appear to be more cautious on the  effectiveness of the 
proposed options in avoiding delayed market access and reducing costs for them. However, 
economic  operators  and  national  authorities  appear  to  be  in  favour  of  mixing  different  sub-
options, rather than the adoption of a single, full policy option. 

83 

 
2.5  Other contributions received (position papers or e-mail) 

Several  interested  parties  submitted  separate  position  papers,  many  of  which  revealed  that 
indeed national technical rules are being used as a basis to deny mutual recognition and that 
no  effective  mechanisms  exist  for  businesses  to  question  national  decisions  denying  mutual 
recognition.  For  this  reason,  they  consider  that  more  ambition  is  needed  to  improve  trust 
among  Member  States  and  the  improvement  of  transparency  of  national  decisions  will 
alleviate this lack of trust.  

Concerning  the  principle  of  mutual  recognition,  some  stakeholders  mentioned  that  it  could 
further be strengthened by the introduction of a presumption of conformity to independently 
tested products. They argue that the Commission should provide a conformity assessment by 
independent  third  parties  as  a  precondition  for  a  corresponding  presumption  of  conformity 
with regard to the product marketed in another member state because they are not involved in 
the design, manufacture, supply, repair or maintenance of the item to be assessed.  

The  scope  of  the  Mutual  Recognition  Regulation  should  be  clarified,  better  structures  for 
proportionality assessments should be put in place, and an informal set-up could ensure better 
sharing of best practices among Member States. Also, dissuasive means should be introduced 
to  ensure  that  Member  States  notify  according  to  their  obligations  in  the  Regulation. 
Moreover, effective remedies must be available to businesses in order for them to get quicker 
clarity  on  decisions  taken  against  their  products  on  the  Single  Market,  including  enhanced 
transparency to see the decisions. In addition, the Product Contact Points should be optimised 
and give businesses easy access to information about national decisions and technical rules. 
Also,  there  is  an  overall  need  to  redeem  trust  and  strengthen  cooperation  among  Member 
State authorities across the Single Market.  

One proposal, made by some stakeholders, is that the notification of article 2.1 administrative 
decisions (Regulation (EC) No 764/2008) is brought together with the procedure used in the 
harmonised  sectors.  The  Commission  should  also  consider  other  measures  in  order  to 
integrate the non-harmonised and harmonised goods sector not only in the practical level but 
also in the policy level still fully respecting the principle of mutual recognition.  

The  lack  of  trust  between  competent  authorities  should  be  overcome  and  national  decisions 
should become more transparent. A Quick Assessment Procedure, allowing for an evaluation 
of decisions denying market access without a binding decision, is a potential tool that can lead 
to  better understanding of the Mutual Recognition principle and improve the functioning of 
the current Regulation. 

3. 

FEEDBACK TO STAKEHOLDERS 

Mutual  recognition  is  essential  to  the  Single  Market  for  goods.  Nevertheless,  its  use  is 
suboptimal,  generating  lost  business  opportunities,  less  competition  and  higher  prices  for 
consumers.  It  needs  to  be  further  improved  to  reduce  barriers  to  the  free  movement  of 
products lawfully marketed in one or several Member States. 

The consultation processes provided a wide range of views regarding the implementation of 
the  Regulation  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.  These  findings  will  underpin  the  forthcoming  Action  Plan  to  raise 

84 

 
awareness  on  the  mutual  recognition  principle  and  to  create  a  "mutual  recognition  culture", 
and the revision of the Regulation. 

Soft law instruments to improve the functioning of mutual recognition: This option refers to 
the  adoption  of  an  action  plan  containing  non-legislative  measures  to  further  boost  the 
application of the  mutual recognition principle. This  option would not  include a revision of 
the Regulation, and therefore the PCP network and the procedure to be followed by national 
authorities for denying market access would remain as they are today. The action plan would 
contain,  in  particular,  the  following  measures:  Awareness  raising  and  training;  A  clearer 
mutual recognition clause and Exchange of officials in the area of mutual recognition.  

Minimum legislative changes to Regulation (EC) No 764/2008 to improve the functioning of 
mutual  recognition:  Under  this  option,  containing  several  complementary  sub-options,  the 
Regulation  would  be  revised;  the  changes  to  be  introduced  would  address  all  the  drivers 
identified while allowing for more flexibility on the use of the mutual recognition principle. 
In particular, the following changes would be introduced in the Regulation: Free movement of 
goods  guaranteed  by  compliance  with  European  standards;  Transparency  for  administrative 
decisions denying market access and Enlarging the Product Contact Points. 

Comprehensive  legislative  changes  to  Regulation  (EC)  No  764/2008  to  improve  the 
functioning  of  mutual  recognition:  Under  this  option,  comprehensive  regulatory  changes 
would  be  made  to  the  current  legislation.  In  particular,  the  following  changes  would  be 
introduced  in  the  Regulation:  Clarifying  the  scope  of  mutual  recognition;  Declaration  of 
compliance;  Fast  track  appeal  procedure  and  Strengthening  the  Product  Contact  Points  and 
the cooperation between relevant authorities. 

Voluntary  prior  authorisation  to  placing  on  the  market:    Under  this  option,  the  suboptimal 
functioning of the mutual recognition principle would be addressed by intervening in a pre-
marketing  phase  to  prevent  obstacles  to  free  movement  of  goods  rather  than  in  a  post-
marketing  phase  as  it  is  the  case  today.  By  introducing  a  system  of  prior  authorisation  to 
placing  products  on  the  market,  economic  operators  would  have  confirmation  that  their 
products can have market access in the Member State of destination on the basis of the mutual 
recognition principle before actually entering that market.  

The soft law option could be combined with any of the other legislative options (options 3, 4 
or 5). Options 3, 4 and 5 would be mutually exclusive. 

The option relating to repealing the Mutual Recognition Regulation has been discarded at an 
early  stage.  The  Evaluation  has  concluded  that,  despite  its  current  shortcomings,  the 
Regulation  remains  relevant  and  that  common  procedures  for  the  application  of  mutual 
recognition are still necessary. Also, the option of proposing further harmonisation measures 
on  specific  basic  requirements  of  products  has  been  discarded.  Adopting  EU  harmonisation 
legislation on specific products or aspects of products which appear particularly problematic, 
where  this  is  justified,  necessary  and  proportionate  is  always  possible.  However,  adopting 
harmonisation  measures  which  would  cover  certain  aspects  of  all  products  (such  as 
traceability requirements) is not likely to address the current problem drivers and the current 
situation is expected to be maintained, i.e. obstacles for companies in getting access to new 
markets, implying costs related to re-testing, lost markets and opportunities, etc. 

85 

 
 
ANNEX 3: METHODS AND ANALYTICAL TOOLS USED IN PREPARING THE EVALUATION 

This  section  sets  out  the  methodological  approach  that  has  been  applied  to  the  evaluation 
objectives and the corresponding task requirements.  

The  methodology  has  combined  desk  research,  focusing  on  existing  textual  and  statistical 
sources,  with  a  survey  and  qualitative  interviews.  This  mix  has  allowed  the  team  to 
triangulate the results of the different analytical steps. The figure below presents an overview 
of the work carried out in the project. 

Overview of work 

Source: DTI, Technopolis, EY and VVA Consulting 

1.  LITERATURE REVIEW AND ANALYSIS OF PUBLICLY AVAILABLE STATISTICS 

The literature review comprised a review of existing business and academic literature on the 
non-harmonised  areas  in  the  EU  internal  market.  Annex  A  contains  a  full  overview  of  the 
assessed  literature.  In  addition,  the  evaluation  team  has  assessed  and  analysed  publicly 
available statistics from e.g. Eurostat and the OECD. This review aimed at gaining an initial 
overview of possible barriers and issues involved in the application of the mutual recognition 
principle as well as providing a good understanding of the available types of data, which were 
discussed in further detail during the surveys and qualitative interviews. 

1.1  The macro context  

The Eurostat database provided data on the macroeconomic context, including: 

 

 

 

 

 

increases or decreases in intra-EU trade in terms of sectors and markets; 

unemployment rate; 

inflation; 

EU exports by sector; and 

EU imports by sector. 

By  using the  above-mentioned  quantitative  context  measures  as  a  point of departure, it was 
investigated if Member States with a high share of cases/issues relating to the application of 
the mutual recognition principle shared a similar macroeconomic context. Clearly,  the crisis 

86 

 
 
dynamics  were  unleashed  by  factors  that  had  nothing  to  do  with  mutual  recognition  (or  the 
application thereof), but the macroeconomic factors will be used to investigate if authorities in 
countries  hit  particularly  hard  by  the  crisis  behave  in  a  different  way  with  regards  to  the 
application  of  the  mutual  recognition  principle  for  certain  product  categories.  Among  the 
questions posed were, ‘Do some of the Member States that were hit particularly hard by the 
financial  crisis  tend  to  find  it  harder  to  apply  the  principle?’  ‘Do  high  levels  of  e.g. 
unemployment affect the application of the principle among Member States?’ By integrating 
the quantitative Eurostat indicators into the evaluation, the team seeks to shed light on these 
kinds of questions. 

2. 

EXPLORATORY  INTERVIEWS  WITH  COMMISSION  OFFICIALS  AND  REPRESENTATIVES 
OF EUROPEAN BUSINESS ASSOCIATIONS 

The  evaluation  team  has  conducted  ten  exploratory  interviews  with  or  received  written 
feedback  from  Commission  officials  and  representatives  of  European  business  associations.  
The aim of these exploratory interviews was to gather information on the application of the 
mutual recognition principle and cross-European information on the challenges regarding the 
application  of  the  mutual  recognition  principle  and  the  areas  where  the  problems  are  most 
pronounced. The interviews took place between August 2014 and December 2014.  

3. 

SURVEYS  TARGETING  DIFFERENT  STAKEHOLDERS  AFFECTED  BY  THE  MUTUAL 
RECOGNITION PRINCIPLE  

The  objective  of  the  questionnaire  surveys  was  to  collect  quantitative  information  on  the 
application of the mutual recognition principle in the Member States. Four different surveys 
were launched on 9 October 2014 and completed on 5 January 2015. These were a company 
survey, a survey of national business associations176, a survey of national sector associations, 
and  a  product  contact  point  survey.  The  surveys  for  the  business  and  sector  associations 
contained almost identical questions. In the subsequent analysis, these are grouped together.  

The  company  survey  and  the  survey  of  national  business  organisations  and  national  sector 
organisations were conducted in English, French, German and Spanish. 

3.1  National business and sector organisations (umbrella organisations targeting a 

broad range of sectors)  

This  survey  aimed  to  gain  a  broad  picture  of  the  burdens  and  costs  that  enterprises  may 
experience and identifying areas where problems may exist. The team contacted one business 
association  per  Member  State.  The  business  associations  have  generally  not  put  a  high 
priority  on  responding  to  the  survey,  which  is  interpreted  as  a)  the  associations  are  not 
monitoring the subject, or b) that enterprises rarely approach their business associations with 
these kinds of issues. However, the business associations that have answered the survey and 
many of those that have participated in an interview have provided us with valuable input and 
company  examples.  The  same  impression  applies  to  the  national  sector  organisations.  In 
addition, Business Europe has  approached numerous business associations  for their input to 
the evaluation, and some associations may have felt that this input was sufficient. 

The  national  sector  organisations  represent  the  sectors  in  which  the  majority  of  decisions, 
requests for information and complaints arise (as indicated in the Terms of Reference). Some 

176  

”National  business  associations”  are cross-sector associations,  typically  functioning  as national  umbrella organisations for sector-
specific associations etc. 

87 

 
                                                            
of these sectors were covered by the national business organisations. The sector associations 
that received the survey represented food, construction, fertilisers, automobiles, and electrical 
products in the Member States. The questionnaire used here closely resembles the one used 
for the above-mentioned business organisations.  

For both national business and sector organisations, only a minority of sectors and Member 
States  are  represented  in  the  surveys.  All  received  weekly  reminders  to  participate  in  the 
survey  and  the  business  associations  were  also  contacted  by  telephone.  The  participating 
organisations are represented by 10 national business associations, five sector associations in 
the food industry and three sector organisations representing the railway sector (the latter are 
all at the EU Level). 

3.2  Companies  

The company survey was requested by the client during the inception phase of the evaluation. 
Due to budget and time constraints, the outreach of the survey was limited. In order to carry 
out  the  company  survey  with  only  a  limited  budget,  the  national  business  and  sector 
organisations were asked to disseminate the survey questionnaire to their individual member 
companies  to  the  extent  possible.  Thus,  it  has  not  been  possible  to  control  any  bias  in  the 
sample with respect to: 

 

 

 

country representation; 

sector representation; and 

company size. 

Because  business  associations  sent  out  the  questionnaires,  it  was  not  possible  for  the 
contractor to follow up with companies to ensure a greater response rate. It should be noted, 
however,  that  many  business  associations  have  been  very  cooperative  in  sending  out  the 
survey to their individual members. 

As  expected,  the  survey  did  not  result  in  a  representative  sample,  and  all  results  should  be 
interpreted with this in mind. Nevertheless, the responses do provide some indication of how 
companies  perceive  the  application  of  the  mutual  recognition  principle  and  of  the  potential 
costs  for  companies  in  Member  State  that  do  not  comply  with  the  mutual  recognition 
principle. 

In total, 447 companies have accessed the online survey. Of these, 199 companies completed 
the survey, either fully or partially. The majority of participating companies only completed 
the survey partially.  

With  respect  to  geographical  coverage,  there  is  significant  geographical  bias,  which  was 
unavoidable due  to  the constraints described above. Companies  from  Portugal (36), the UK 
(22) and Lithuania (21) are significantly overrepresented in the survey,  while there were no 
responses from nine EU Member States or from any of the four EFTA countries (cf. above for 
details). 

the  survey,  while  small  companies  are 
Large  companies  are  overrepresented 
underrepresented.  Large  companies  only  make  up  around  1%  of  the  EU’s  company 

in 

88 

 
population.177.  However,  in  this  survey,  29%  of  the  participating  companies  were  large 
companies  with  more  than  250  employees,  26%  were  medium-sized  companies  with  50  to 
250 employees and 27%  were small companies with  10 to 49 employees. Micro companies 
with less than 10 employees accounted for 18%. 

3.3  National product contact points 

The aim of the survey among product contact points was to help identify issues in the legal 
framework, to  gain an understanding of whether there are some sectors  that are particularly 
‘problematic’ in the country in question, and areas where further dialogue with other product 
contact points and the Commission, etc., might be necessary.  

The  product  contact  points  (or  the  co-ordinator,  where  there  are  several  product  contact 
points)  are  typically  located  within  the  ministry  responsible  for  industry/business  and  the 
internal market. The product contact points have a coordinating function (at least with respect 
to notifications) and are thus in the best position to have an overview of the application of the 
mutual recognition principle in their country. Other Member State authorities responsible for 
applying the mutual recognition principle in their field have a narrower domain (e.g. sectoral, 
or  regional).  This  means  that  none  of  these  authorities  will  have  a  good  overview  of  the 
general  (cross-sectoral,  national)  situation  pertaining  to  the  application  of  the  mutual 
recognition principle in the Member State.  

Not all product contact points across Member States participated in the product contact point 
survey (cf. the footnote to). In general, the team put much effort into ensuring a high level of 
response from all survey target groups. The team followed up with phone calls to the product 
contact  points  and  national  business  associations  to  gain  a  higher  response  rate  and  set  up 
qualitative  interviews.  For  the  vast  majority  of  product  contact  points,  this  approach  was 
successful. However, for the business associations, the response rate in the survey remained 
rather low.  

Explanations for the relatively low response may be: 

 

 

 

 

 

that business and sector organisations do not monitor mutual recognition closely;  

that  companies  do  not  approach  the  business  and  sector  associations  when  they 
experience problems; 

that business associations have already given input to Business Europe; 

that companies are not concerned with the mutual recognition principle; or  

that  companies  experience  problems  with  the  free  movement  of  goods  in  the  internal 
market,  but  do  not  link  these  problems  to  the  principle  of  mutual  recognition  and 
therefore do not know that their problem falls within this area. 

4.  QUALITATIVE INTERVIEWS 

Following  the  survey,  the  evaluation  team  carried  out  qualitative  interviews  with  national 
business associations and product contact points in each Member State. The objective of the 
qualitative interviews was to shed more light on the implementation of the mutual recognition 

177  

E.g. http://ec.europa.eu/enterprise/policies/sme/facts-figures-analysis/index_en.htm  

89 

 
                                                            
principle  in  the  Member  States,  in  particular  with  respect  to  ‘sensitive’  areas  such  as 
notification practices (or lack thereof). The interviews were conducted with the same person 
who responded to the survey, to the extent possible (in a few cases the interview was referred 
to a colleague). 

The  evaluator  has  been  in  contact  with  product  contact  points  in  all  Member  States  except 
Italy. As for the Italian product contact point, the team was informed by the contacts at the 
Italian  Ministry  (provided  by  the  Commission)  that  they  do  not  deal  with  the  mutual 
recognition  topic,  and  that  they  were  not  aware  of  other  authorities  in  Italy  that  we  could 
contact. 

The  evaluator  has  repeatedly  contacted  business  associations  in  all  Member  States  and 
approached them for an interview. Some business associations monitor the application of the 
mutual  recognition  principle  closely,  and  they  have  provided  us  with  valuable  insights  into 
the problems and the benefits of the mutual recognition principle. Others do not monitor the 
application of the principle closely and/or have not heard about problems from their members, 
but agreed to an interview. The last (small) group of business associations did not monitor the 
application  of  the  mutual  recognition  principle,  had  not  heard  about  problems  in  the  field 
from their members, and consequently did not feel that they were in a position to contribute. 
In these cases, we have attempted to contact sector associations that may provide insight into 
the  field,  but  in  some  cases,  it  was  not  possible  to  identify  a  sector  association  either  that 
could provide information, as the mutual recognition principle was not monitored.  

The companies have been asked to put a figure on the cost of the incorrect application of the 
mutual recognition principle for their company. Very few companies have been able to do so. 
The main reason seems to be that companies adapt their products to the requirements from the 
Member State in question and test their products/withdraw from the particular market/do not 
enter the market. They do not spend time on calculating what the costs of the situation might 
be.  Similarly,  none  of  the  business  associations  that  we  have  interviewed  have  these  cost 
figures, either because they have not asked the companies specifically about this, or because 
the companies cannot put a figure on it. 

90 

 
  
 
 
ANNEX 4: OVERVIEW OF THE ASSESSED LITERATURE AND CASE LAW 

1.  LITERATURE  

 

 

BIS  publication  (2011):  The  economic  consequences  for  the  UK  and  the  EU  of 
completing the Single Market 

BIS publication (2013) : Optimal Integration in the Single market: A Synoptic Review  

  Moïsé,  E.  2013.  The  impact  of  trade  facilitation  on  developing  countries.  GREAT 

Insights, Volume 2, Issue 8. November 2013. Maastricht: ECDPM 

  M.  Vancauteren  and  D.  Weiserbs,  ULC  :Intra-European  Trade  of  Manufacturing 

Goods: An extension of the gravity model 

 

 

 

 

 

Natalie  Chen  and  Dennis  Novy,  International  Trade  Integration:  A  Disaggregated 
Approach, 2009, CEP Discussion Paper No 908 

Business Europe (2014): Position paper: Evaluation of the application of the principle 
of mutual recognition mutual recognition principle of goods 

CSES (2014): Evaluation of the Internal Market Legislation for Industrial Products 

Copenhagen Economics (2012): Delivering a stronger single market 

Laurens Ankersmit, What if Cassis de Dijon were Cassis de Quebec? The assimilation 
of goods of third countries origin in the internal market, Common Market Law Review 
50: 1387-1410,2013 

  Markus  Mostl,  Preconditions  and  limits  of  mutual  recognition,  Common  Market  Law 

Review 47:405-436, 2010 

 

 

 

Christine  Janssens  (2013):  The  principle  of  mutual  recognition  mutual  recognition 
principle in EU law 

Kerber  and  Van  den  Bergh,  Mutual  Recognition  Revisited:  Misunderstandings, 
Inconsistencies, and Suggested reinterpretation, Kyklos, Vol.61, 2008, No. 3, 447-465 

HM  Government  UK  (2013):  Review  of  the  Balance  of  Competences  between  the 
United Kingdom and the European Union - The Single Market 

  Mattera, The principle of mutual recognition and respect for national, regional and local 

identities and traditions, Kostoris and Schiopa (Eds.) 

  Weiler, Mutual recognition, functional equivalence and harmonisation in the evolution 

of the European commun market and the WTO, Kostoris and Schiopa (Eds.) 

  Mattera,  The  principle  of  mutual  recognition  in  the  European  integration  process, 

Palgrave Macmillan, 2005, pp. 1-24  

 

Amstrong, Mutual recognition, Barnard and Scott(Eds.) 

91 

 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amstrong,  The  law  of  the  single  European  market:  unpacking  the  premises,  Hart 
Publishing, 2002, pp. 225-267 

Patrick  A.  Messerlin  (2011)  The  European  Union  single  market  in  goods:  between 
mutual recognition and harmonisation, Australian journal of International Affairs, 65:4, 
410-435 

Davies,  Is  mutual  recognition  an  alternative  to  harmonisation:  lessons  on  trade  and 
tolerance of diversity from the EU, Bartels and Ortino (Eds.),  

Davies, regional trade agreements and the WTO legal system, OUP, 2006, pp. 265-280 

Bartels, The legality of  the EC  mutual recognition clause under  WTO  law, Journal of 
International Economic law, 2005, 691-720 

Toulemonde,  A  welfare  analysis  of  the  principle  of  mutual  recognition,  European 
Economic review 60, 2013,1-16 

OECD  (2013):  International  Regulatory  Co-operation:  Addressing  Global  Challenges, 
OECD Publishing. 

OECD  (2013):  Trends  in  international  regulatory  co-operation,  in  International 
Regulatory Co-operation: Addressing Global Challenges, OECD Publishing. 

Orgalime  (2014):  Position  paper:  Suggestions  for  improving  the  application  of  the 
mutual recognition principle 

Pelkmans, Jacques (2012): Mutual Recognition: economic and regulatory logic in goods 
and services 

Pelkmans, Jacques (2011): the case for “more Single Market” 

Pelkmans,  Jacques  (2010): Mutual  Recognition:  rationale, logic and application in the 
EU internal goods market 

Pelkmans,  Jacques  (2003):  Mutual  Recognition  in  Goods  and  Services:  An  economic 
perspective 

Pelkmans, J., (2011), the case for “more Single Market” 

Pelkmans,  J.,  Correia  de  Brito,  A.  (2015),  Transatlantic  MRAs:  Lessons  for  TTIP?, 
CEPS Special Report, no. 101, March, Brussels 

Pelkmans,  J.,  Labory  S.,  Majone,  G.  (2000),  Better  EU  regulatory  quality:  assessing 
current initiatives and new proposals 

Pelkmans J., Correia de Brito, A., Enforcement in the single market, Brussels 

Schmidt, Susanne (2008): Mutual Recognition – a new mode of governance 

92 

 
 

 

 

 

 

 

Commission report COM(2001)736 of 7 December 2001, “Economic Reform : Report 
on the functioning of Community product and capital markets” 

Commission Staff Working Paper SEC(2001)1993 of 7 December 2001, “Statistical and 
technical  annex  to  the  “Report  on  the  functioning  of  Community  product  and  capital 
markets;  

“Technical  barriers  to  trade”,  Volume  1  of  Sub-series  III  (“Dismantling  of  Barriers: 
Technical Barriers to Trade”), Single Market Review, Luxembourg, 1998;  

Hagemejer J. and Michalek Jan J., “The Significance of Technical Barriers to Trade for 
Poland and other CEECs Acceding to the EU: Reconsidering the Evidence”, Emergo – 
Journal of Transforming Economies and Societies, 2004, v. 11, No 1, p. 36;  

Brenton P. Sheehy J. and Vancauteren M., “Technical Barriers to Trade in the European 
Union:  Data,  Trends  and  Implications  for  Accession  Countries”,  Journal  of  Common 
Market Studies, 2001, No 39, p. 241;  

Fabienne Ilzkovitz, Adriaan Dierx, Viktoria Kovacs and Nuno Sousa, « Steps towards a 
deeper  economic  integration:  the  internal  market  in  the  21st  century  “,  European 
Economy, Economic Papers, No. 271. January 2007 

 

Rodrigue, J.P. et al. (2016), The Geography of Transport Systems, Routledge 

European Council conclusions 

 

 

 

Cardiff European Council, 15/16 June 1998: Presidency Conclusions 

Council resolution of 28 October 1999 on mutual recognition (2000/C 141/02) 

Competitiveness  Council  meeting;  Brussels,  2  and  3  December  2013:  Conclusions  on 
Single Market Policy 

The Mutual Recognition Regulation 

 

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 

Communications and other Commission documents 

 

 

European Commission (2007): Accompanying document to the Proposal for a directive 
of the European Parliament and of the Council laying down procedures relating to the 
application of certain national technical rules to products lawfully marketed in another 
Member State and repealing Decision 3052/95/EC Impact assessment 

European  Commission  (2012):  First  report  on  the  application  of  Regulation  (EC)  No 
764/2008 2008 - COM(2012) 292 final 

93 

 
 

 

 

 

 

 

 

European Commission interpretative communication of 3 October 1980, concerning the 
consequences  of  the  judgment  given  by  the  court  of  Justice  on  20  February  1979  in 
Case 120/78 (‘Cassis de Dijon’) 

European Commission  COM(1999)299  final: Mutual recognition  in  the context of the 
follow up to the Action Plan  for the Single Market  - on the application of the  mutual 
recognition principle, based on a detailed analysis of the cases of incorrect application 
of mutual recognition handled by the Commission 

European  Commission  (2002):  Second  biennial  Report  on  the  Application  of  the 
Principle of Mutual Recognition in the Single Market 

European  Commission  (1999):  Commission  Staff  Working  Paper:  First  Report  on  the 
application of the principle of mutual recognition in product and services markets 

European  Commission  (1998):  Document  du  travail  des  services  de  la  Commission: 
L’application du principe de reconnaissance mutuelle 

European Commission (2014): Restarting the EU’s Growth Engine – A new start for the 
Internal Market 

Evaluation  of  the  Application  of  the  Principle  of  Mutual  Recognition  in  the  Field  of 
Goods, Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs 
2015 

Commission guidance documents  

 

 

 

 

 

European Commission (2010): Guidance document: the relationship between Directive 
98/34/EC and the Mutual Recognition Regulation 

http://ec.europa.eu/DocsRoom/documents/5801/attachments/1/translations 

European  Commission  (2013):  Commission  Working  Document:  Guidance  document. 
The  concept  of  ‘lawfully  marketed’  in  the  Mutual  Recognition  Regulation  (EC)  No 
764/2008 

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52013DC0592 

European Commission (2010): Guidance document: The relationship between Directive 
2001/95/EC and the Mutual Recognition Regulation 

http://ec.europa.eu/DocsRoom/documents/5807/attachments/1/translations 

European  Commission  (2010):  Guidance  Document:  The  application  of  Mutual 
Recognition Regulation to prior authorisation procedures 

http://ec.europa.eu/DocsRoom/documents/5822/attachments/1/translations 

European  Commission  (2010):  Guidance  Document:  The  application  of  Mutual 
Recognition Regulation to narcotic drugs and psychotropic substances 

http://ec.europa.eu/DocsRoom/documents/5821/attachments/1/translations 

94 

 
 

 

 

 

 

European  Commission  (2010):  Guidance  Document:  The  application  of  Mutual 
Recognition Regulation to food supplements 

http://ec.europa.eu/DocsRoom/documents/13481/attachments/1/translations 

European  Commission  (2010):  Guidance  Document:  The  application  of  Mutual 
Recognition Regulation to non-CE marked construction products 

http://ec.europa.eu/DocsRoom/documents/5881/attachments/1/translations 

European  Commission  (2010):  Guidance  Document:  The  application  of  Mutual 
Recognition Regulation to fertilisers and growing media 

http://ec.europa.eu/DocsRoom/documents/5825/attachments/1/translations 

European  Commission  (2010):  Guidance  Document:  The  application  of  Mutual 
Recognition Regulation to articles of precious metals 

http://ec.europa.eu/DocsRoom/documents/5806/attachments/1/translations 

European  Commission  (2010):  Guidance  Document:  The  application  of  Mutual 
Recognition Regulation to weapons and firearms 

http://ec.europa.eu/DocsRoom/documents/5824/attachments/1/translations 

2.  RECENT CASE LAW OF THE CJEU ON MUTUAL RECOGNITION 

CJEU, Case C-227/06 Commission v Belgium, ECLI:EU:C:2008:160 

By requiring economic operators wishing to market construction products,  which have been 
lawfully  manufactured  and  /  or  marketed  in  another  Member  State,  in  Belgium  to  obtain 
national conformity marks, Belgium has failed to fulfil its obligations under Articles 34 and 
36 TFEU (ex 28 EC and 30 EC). 

CJEU, Case 88/07 Commission v Spain, ECLIEU:C:2009:123 

By withdrawing from the market products based on medicinal herbs lawfully produced and/or 
marketed  in  another  Member  State,  under  an  administrative  practice  consisting  in 
withdrawing from the market any product based on medicinal herbs not included either in the 
annex  of  the  an  Order  on  the  creation  of  a  special  register  of  medicinal  herb-based 
preparations or the annex of an Order establishing the list of plants sale of which to the public 
is prohibited or restricted because of their toxicity, other than a preparation the constituents of 
which are exclusively one or more medicinal herbs or whole parts of such herbs, or crushed or 
powdered  parts  of  such  herbs,  on  the  ground  that  that  product  is  deemed  to  be  a  medicinal 
product marketed without the requisite marketing authorisation, Spain has failed to fulfil its 
obligations  under  Articles  34  and  36  TFEU  (ex  28  EC  and  30  EC)  and  Articles  1  and  4  of 
Decision No 3052/95/EC of 13 December 1995 establishing a procedure for the exchange of 
information  on  national  measures  derogating  from  the  principle  of  the  free  movement  of 
goods within the Community. 

95 

 
 
CJEU, Case C- 132/08 Lidl, ECLI:EU:C:2009:281 

Member States cannot, under Directive 1999/5/EC of 9 March 1999 on radio equipment and 
telecommunications  terminal  equipment  and  the  mutual  recognition  of  their  conformity, 
require  a  person  who  places  radio  equipment  on  the  market  to  provide  a  declaration  of 
conformity  even  though  the  producer  of  that  equipment,  whose  head  office  is  situated  in 
another Member State, has affixed the ‘CE’ marking to that product and issued a declaration 
of conformity in its regard. 

Where  a  matter  is  regulated  in  a  harmonised  manner  at  Community  level,  any  national 
measure  relating  thereto  must  be  assessed  in  the  light  of the  provisions  of  that  harmonising 
measure and not in that of Articles 34 and 36 TFEU (ex 28 EC and 30 EC).  

CJEU, Case C-100/08 Commission v Belgium. ECLI:EU:C:2009:537 

By  making  the  import,  possession  and  sale  of  birds  born  and  bred  in  captivity  that  were 
legally  marketed  in  another  Member  States  subject  to  restrictive  conditions  requiring 
economic operators to alter the specimen marking to respond to the specific requirements of 
Belgian law and by not allowing the marking accepted in other Member States or certificates 
issued (in  accordance  with  Regulation (EC)  No  338/97  on  the  protection  of  species  of  wild 
fauna and flora by regulating trade) and by denying traders the ability to obtain exemptions 
from the prohibition to hold European native birds legally marketed in other Member States, 
Belgium has failed to fulfil its obligations under Article 34 TFEU (ex 28 EC). 

CJEU, Case C-333/08 Commission v France, ECLI:EU:C:2010:44 

By  laying  down,  for  processing  aids  and  foodstuffs  whose  preparation  involved  the  use  of 
processing  aids  from  other  Member  States  where  they  are  lawfully  manufactured  and/or 
marketed,  a  prior  authorisation  scheme  not  complying  with  the  principle  of  proportionality, 
France has failed to fulfil its obligations under Article 34 TFEU (ex 28 EC). 

CJEU, Case C-142/09 Vincent Willy Lahousse, ECLI:EU:C:2010:694 

Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two or three-
wheel  motor  vehicles,  and  Directive  2002/24/EC  of  18  March  2002  relating  to  the  type-
approval  of  two  or  three-wheel  motor  vehicles  and  repealing  Directive  92/61  are  to  be 
construed as meaning that, where a vehicle or a component or separate technical unit thereof 
does  not  qualify  for  the  type-approval  procedure  established  by  those  directives,  on  the 
ground  that  it  does  not  come  within  their  scope,  the  provisions  of  those  directives  do  not 
prevent a Member State from introducing, in its domestic law and in relation to such vehicle, 
component or separate technical unit, a similar mechanism for recognising the checks carried 
out  by  other  Member  States.  In  any  event,  such  legislation  must  comply  with  EU  law,  in 
particular Articles 34 TFEU and 36 TFEU. 

96 

 
 
 
 
 
CJEU, Case C-484/10 Ascafor and Asidac, ECLI:EU:C:2012:113 

Articles  34  TFEU  and  36  TFEU  must  be  interpreted  as  meaning  that  the  requirements  laid 
down  in  Spanish legislation  for  official  recognition  of  certificates  demonstrating  the  quality 
level of reinforcing steel for concrete granted in a Member State other than Spain constitute a 
restriction on the free movement of goods. Such a restriction may be justified by the objective 
of the protection of human life and health, provided the requirements laid down are not higher 
than the minimum standards required for the use of reinforcing steel for concrete in Spain. In 
such a case, it is for the referring court to ascertain — where the entity granting the certificate 
of  quality  which  must  be  officially  recognised  in  Spain  is  an  approved  body  within  the 
meaning  of  Council  Directive  89/106/EEC  of  21  December  1988  on  the  approximation  of 
laws, regulations and administrative provisions of the Member States relating to construction 
products,  as  amended  by  Council  Directive  93/68/EEC  of  22  July  1993  —  which  of  those 
requirement  go  beyond  what  is  necessary  for  the  purposes  of  attaining  the  objective  of  the 
protection of human life and health. 

CJEU, Case, C-171/11 Fra.bo, ECLI:EU:C:2012:453 

Article 34 TFEU (ex 28 EC) must be interpreted as meaning that it applies to standardisation 
and certification activities of a private-law body, where the national legislation considers the 
products  certified  by  that  body  to  be  compliant  with  national  law  and  that  has  the  effect  of 
restricting the marketing of products which are not certified by that body. 

CJEU, Case C-150/11 Commission v Belgium, ECLI:EU:C:2012:539 

By  requiring  systematically  the  production  of  a  vehicle’s  certificate  of  conformity  for  the 
purpose of a roadworthiness test prior to the registration of a vehicle previously registered in 
another  Member  State  (in  addition  to  production  of  a  certificate  of  registration)    and  by 
making  such  vehicles  subject  to  a  roadworthiness  test  prior  to  their  registration  due  to  a 
change in ownership, without taking into account the results of the roadworthiness test carried 
out  in  another  Member  State,  Belgium  has  failed  to  fulfil  its  obligations  under  Article  4  of 
Council Directive 1999/37/EC of 29 April 1999 on the registration documents for vehicles, as 
amended  by  Council  Directive  2006/103/EC  of  20  November  2006,  and  under  Article  34 
TFEU. 

CJEU, Case C-385/10 Elenca, ECLI:EU:C:2012:634 

Articles  34  TFEU  to  37  TFEU  must  be  interpreted  as  precluding  national  provisions  which 
automatically make the marketing of construction products, originating from another Member 
State, subject to the affixing of CE marking. 

97 

 
 
 
 
 
 
CJEU, Case C-481/12 UAB Juvelta, ECLI:EU:C:2014:11 

Article 34 TFEU must be interpreted as precluding national legislation under which, for it to 
be permissible for them to be sold on the market of a Member State, articles of precious metal 
imported from another Member State, in  which they are authorised to be put  on the market 
and  which  have  been  stamped  with  a  hallmark  in  accordance  with  the  legislation  of  that 
second  Member  State,  must,  where  the  information  concerning  the  standard  of  fineness  of 
those  articles  provided  in  that  hallmark  does  not  comply  with  the  requirements  of  the 
legislation  of  that  first  Member  State,  be  stamped  again,  by  an  independent  assay  office 
authorised  by  that  first  Member  State,  with  a  hallmark  confirming  that  those  articles  have 
been inspected and showing their standard of fineness in accordance with those requirements. 

CJEU, Case C-423/13 Vilniaus Energija, ECLI:EU:C:2014:2186 

Article 34 TFEU and Directive 2004/22/EC of 31 March 2004 on measuring instruments must 
be interpreted as precluding national legislation and practice according to which a hot-water 
meter  which  satisfies  all  the  requirements  of  that  Directive  and  is  connected  to  a  remote 
(telemetric) data-transmission device is to be regarded as a measuring system and, as a result, 
cannot be used for its intended purpose so long as it has not been subject, together with that 
device, to a metrological verification as a measuring system.  

Competent national authorities may not, in any event, unnecessarily require technical analyses 
where those analyses have already been carried out in another Member State and their results 
are available to those authorities or may, at their request, be placed at their disposal (see, to 
that  effect,  Commission  v  Portugal,  ECLI:EU:C:2005:669,  paragraph  46  and  the  case-law 
cited). 

CJEU, Case C-354/14 Capods Import-Export, ECLI:EU:C:2015:658 

Article  34  TFEU  and  Article  31(1)  and  (12)  of  Directive  2007/46/EC  of  5  September  2007 
establishing a framework for the approval of motor vehicles and their trailers, and of systems, 
components  and  separate  technical  units  intended  for  such  vehicles  (Framework  Directive) 
must  be  interpreted  as  not  precluding  national  legislation,  which  makes  the  marketing  in  a 
Member State of new spare parts for road vehicles subject to the application of an approval or 
homologation procedure in that Member State, provided that that legislation also lays down 
exceptions  such  as  to  ensure  that  parts  lawfully  produced  and  marketed  in  other  Member 
States  are  exempted  or,  failing  this,  that  the  parts  in  question  are  capable  of  posing  a 
significant  risk  to  the  correct  functioning  of  systems  that  are  essential  for  the  safety  of  the 
vehicle or its environmental performance and that that approval or homologation procedure is 
strictly necessary and proportionate in relation to the objectives of protection of road safety or 
of protection of the environment. 

The  conditions  for  proving  that  such  parts  have  already  been  approved  or  homologated  or 
constitute original parts or parts of matching quality are governed, in the absence of European 
Union  rules  on  the  matter,  by  the  law  of  the  Member  States,  subject  to  the  principles  of 
equivalence and of effectiveness. 

98 

 
 
 
ANNEX 5: RESULTS OF THE PUBLIC CONSULTATION 

1.  TYPE OF RESPONDENTS 

153  replies  were  received  during  the  public  consultation.  Businesses  were  strongly 
represented (91), followed by Member States authorities (45), and citizens (17). This includes 
respondents  that  did  not  want  their  replies  published:  16  businesses,  9  authorities  and  one 
citizen. The remainder of the respondents agreed to have their response published either fully 
or anonymously. All replies are included in the statistics. 

Type of respondents 

11% 

29% 

59% 

Bussinesses

Member States authorities

Citizens

45  authorities  from  Member  States  replied  to  the  public  consultation.  31%  are  Product 
Contact Points, the rest are other authorities.  

Among the group of citizens there are two consumer organisations.  

Individual  companies  (44)  and  business  organisations  (44)  were  equally  represented,  while 
only  3  chambers  of  commerce  replied  to  the  consultation.  In  terms  of  company  size,  the 
responses are roughly balanced between small and large companies.  

Businesses representation 

3% 

48% 

48% 

Company size 

8% 

15% 

16% 

7% 

99 

Individual companies

Business organisations

Chambers of commerce

micro
small
medium
large

 
 
 
 
In terms of activity sectors, manufacturing is the most represented sector (46%), followed 
by  wholesale  and  retail  trade  (13%),  agriculture,  forestry  and  fishing  (8%)  and  water 
supply (6%).  

The  geographical  representation  is  quite  well  balanced  for  businesses.  As  for  national 
authorities, 18 Member States and Norway participated in the public consultation. No replies 
were received from Cyprus, Denmark, Finland, France, Greece, Ireland, Luxembourg, Malta 
and UK. The majority of consumers chose not to indicate their country of establishment.  

Authorities 

20,00%

18,00%

16,00%

14,00%

12,00%

10,00%

8,00%

6,00%

4,00%

2,00%

0,00%

40,00%

35,00%

30,00%

25,00%

20,00%

15,00%

10,00%

5,00%

0,00%

Business 

100 

 
 
 
Consumers 

100,00%
90,00%
80,00%
70,00%
60,00%
50,00%
40,00%
30,00%
20,00%
10,00%
0,00%

The numbers and percentages used to describe the distribution of the responses to the public 
consultation derive from the answers provided under the EU-Survey tool. Other submissions 
of stakeholders to the public consultation, such as position papers and contributions by email, 
have  been  taken  into  account  when  describing  and  analysing  the  views  of  stakeholders,  but 
without being considered for the statistical representation. 

2.  HOW  STAKEHOLDERS  SEE  MUTUAL  RECOGNITION  AND 

ITS 

POTENTIAL SHORTCOMINGS 

The  majority  of  companies  wishing  to  sell  products  in  another  Member  State  check  the 
applicable  rules  in  that  Member  State,  and,  if  these  rules  prevent  them  from  selling  the 
product, most of them adapt it. This happens despite the fact that 70% of them are fully aware 
of the mutual recognition principle. More than half of the businesses responding tried to use 
mutual recognition to enter a new market. Among them, half had their market access denied, 
and only 2% challenged this decision successfully.  

35% replied that they don't rely on mutual recognition to enter a new market, mainly because 
they don't know about it (15%) or because they don't trust it (4%).  

Do you check rules before entering a market?

94,50% 

5,40% 

Do you adapt your product if the rules prevent you from
selling it as such?

86% 

13% 

Have you used mutual recognition for entering a market?

68% 

31% 

yes

no

When using mutual recognition, was market access denied?

52% 

15% 

Did you challenge the denial of market access?

36,50% 

14% 

101 

 
 
 
When  national  authorities  check  if  products  available  on  their  market  and  coming  from 
another Member State comply with the national rules they are enforcing, 53% verify if they 
are already lawfully marketed in the Member State of origin while 46% don’t.  

Despite  the  indicated  high  level  of  awareness  about  mutual  recognition,  the  majority  of 
respondents consider that awareness-raising remains necessary: 

Do you know that a product lawfully marketed in one Member State must, in principle, 
be admitted in another Member State? 

93% 

70% 

70% 

95% 

88% 

84% 

Member States

Businesses

Citizens

23% 

17% 

6% 

I am fully aware

I am partially aware

Awareness raising is necessary

With regards to the obstacles to the functioning of mutual recognition, businesses identified 
the  lack  of  quick  remedies  for  challenging  national  decisions  denying  market  access  as  the 
highest  one,  followed  by  insufficient  communication  among  authorities.  By  order  of 
importance, obstacles have been ranked as follows:  

Ranking of obstacles by order of importance  

Difficult for businesses to challenge a national decision denying market access 

Insufficient communication between national authorities of different Member States 

Lack of awareness about mutual recognition   

Difficult to obtain information about whether mutual recognition applies to a specific product and 
thus to assess if mutual recognition can be used or not for a specific product 

Other 

Slow/inefficient communication between businesses and national authorities 

Difficult to demonstrate to authorities in other Member States that a product is lawfully sold in a 
Member State 

Insufficient communication between national authorities within the same Member State 

62% 

46% 

35% 

32% 

29% 

27% 

26% 

21% 

102 

 
 
 
52%  of  the  respondents  faced  such  obstacles  themselves.  Most  of  the  examples  provided 
relate  to  national  authorities  insisting  on  applying  the  national  rules  at  the  cost  of  mutual 
recognition, very often in relation to food legislation or fertilisers.  

3. 

FUNCTIONING OF THE MUTUAL RECOGNITION REGULATION 

Effectiveness: to what extent has the Regulation achieved its objectives? 

The majority of respondents are aware of the Regulation, and consider that most of the tools 
put in place are useful and still necessary. As regards whether or not the Regulation has met 
its objective, the feeling is mixed among businesses and national authorities.  

How much do you know about the Mutual Recogntion Regulation? 

71% 

64% 

40% 

32% 

22% 

23% 

Member States
Businesses
Citizens

8,70% 

5% 

0% 

I am fully aware

I am partially aware

I only found out about it now

Are these tools still useful and necessary?  

84% 

80% 

75% 

64% 

58% 

58% 

68% 

58% 

51% 

82% 

82% 

76% 

PCPs

Obligation to notify

Product list

Guidelines

No, the objectives of the Regulation have not been achieved 

52% 

29% 

8% 

47% 

60% 

15% 

17% 

15% 

17% 

Legal certainty

Administrative cooperation

Reduced risk of denied market access

Member States

Businnesses

Citizens

Member States

Businnesses

Citizens

103 

 
 
 
 
I don't know if  the objectives of the Regulation have been achieved 

29% 

17% 

13% 

18% 

17% 

20% 

17% 

8% 

10% 

Member States

Businnesses

Citizens

Legal certainty

Administrative cooperation

Reduced risk of denied market access

Yes, the objectives of the Regulation have been partially achieved 

57% 

64% 

53% 

26% 

29% 

31% 

17% 

23% 

17% 

Member States

Businnesses

Citizens

Legal certainty

Administrative cooperation

Reduced risk of denied market access

Yes, the objectives of the Regulation have been fully achieved 

29% 

20% 

17% 

17% 

3% 

11% 

2% 

11% 

5% 

Legal certainty

Administrative cooperation

Reduced risk of denied market access

Member States

Businnesses

Citizens

Generally,  very  few  economic  operators  consider  that  it  is  easier  to  sell  products  in  other 
Member  States  since  the  Regulation  entered  into  force.  The  majority  consider  that  the 
Regulation has not improved the situation, or don't know, either because they don't use mutual 
recognition or they don't sell products abroad.  

Is it easier to sell products in another national market since the Mutual Recognition 
Regulation is in force?  

24% 

25% 

28% 

yes

no

I don't know

104 

 
 
 
 
 
Efficiency: costs and benefits of the Regulation 

As  regards  the  costs  of  implementing  the  Regulation,  national  authorities  ranked  them  as 
average.  On  top  of  the  choices  provided  by  the  consultation,  authorities  also  indicated 
additional  costs  linked  to  the  absence  of  an  updated  list  of  products  to  which  mutual 
recognition may apply. Some consider that additional costs are triggered by the administrative 
procedures,  seen  as  long  and  time-consuming.  Despite  the  costs,  national  authorities  agree, 
fully or partially, that the Regulation brings benefits in terms of facilitating market access.  

Costs for national authorities related to the implementation of the Mutual Recognition, 
ranked by their importance on a scale from 1 to 5, 1 being the lowest and 5 the highest.  

35% 

31% 

44% 

22% 

22% 

22% 

8% 

13% 

11% 

13% 

17% 

2% 

31% 

15% 

8% 

1

2

3

4

5

Establishing and ensuring the functioning
of Product Contact Points (infrastructure
and IT)

Recurrent costs related to the functioning
of the Product Contact Points, including
translation costs (staff only)

The obligation of the Member State of
destination to notify a decision denying
market access and the accompanying
procedural safeguards

Below are listed the main benefits the Mutual Recognition Regulation was expected to 
have.  Based on your experience, to what extent do you consider them to be realised? 

48% 

28% 

17% 

4% 

44% 

48% 

31% 

26% 

26% 

20% 

20% 

20% 

15% 

15% 

I fully agree

22% 

I partially agree

8% 

I desagree

I dont know

Better information on
national rules

Justification of
administrative decisions
denying market access

Reduced risk to see market
access denied

Increased awareness

With  regards  to  businesses,  the  main  costs  incurred  are  triggered  by  the  need  to  adapt  the 
products to the applicable national rules, when mutual recognition is either denied or not used 
for  penetrating  the  market.  These  costs  are  estimated178  on  average  to  be  23  000  Euro  per 
product  and  per  market.  High  costs  are  also  related  to  delays  in  entering  a  market, 
estimated179  at  115  000  Euro  per  product  and  per  market,  and  to  lost  opportunities,  when 

178  

179  

26% of respondents indicated an estimate of the costs incurred, the other choose not to reply or indicated that such estimation is 
impossible 
20% of respondents indicated an estimate of the costs incurred, the other choose not to reply or indicated that such estimation is 
impossible 

105 

 
 
 
                                                            
 
 
businesses  relinquish  entering  a  market  because  of  different  national  rules  that  require  the 
products  to  be  adapted.  On  average,  the  latest  costs  are  estimated180  at  136  000  Euro  per 
product  and  per  market.  The  costs  related  to  challenging  administrative  decisions  denying 
market  access  are  considered  to  be  less  important,  mainly  because  few  economic  operators 
choose to do so. The estimates181 are around 32 000 Euro per product and per market. There 
are however considerable variations in the answers.  

Costs where mutual recognition has been denied 

54% 

53% 

52% 

38% 

18% 

18% 

7% 

21% 

19% 

21% 

20% 

4% 

7% 

29% 

Highly important

15% 

2% 

Relatively important

Of little importance

I don't know

Costs related to aligning
products on national rules

Costs caused by the
delayed entry on the
market

Costs related to the
challenge before courts

Costs related to lost
opportunities

Costs  were  also  related  to  assessing  if  mutual  recognition  can  be  used  to  sell  products  in 
another  Member  State.  Very  few  economic  operators  (2%)  are  outsourcing  this  assessment, 
while 26% are doing it internally. 46%  are doing both, depending on the product. The lack of 
additional  information  does  not  allow  an  estimate  of  the  actual  costs  incurred  when  the 
assessment of whether or not mutual recognition can be used is outsourced to be made. When 
done  internally,  economic  operators  spend  on  average  54  hours  doing  the  assessment; 
however, the number of hours indicated varies from one company to another. Most indicated 
only  a  few  hours  (less  than  10)  while  two  indicated  spending  more  than  500  hours  on  this. 
The average cost per hour is 78 Euro. When trying to demonstrate that a product is already 
lawfully  marketed  in  a  Member  State,  businesses  indicate that the average  amount  of  hours 
spent is 16, and the average cost per hour is 76 Euro.  

In terms of benefits that the regulation brings, the perception of businesses is quite mixed:   

Below are listed the main benefits the Mutual Recognition Regulation was expected to 
have.  Based on your experience, to what extent do you consider them to be realised? 

30% 

14% 

26% 

28% 

26% 

32% 

15% 

36% 

21% 

13% 

41% 

12% 

38% 

16% 

31% 

13% 

Better information on
national rules

Justification of
administrative decisions
denying market access

Reduced risk to see market
access denied

Increased awareness

I fully agree

I partially agree

I desagree

I dont know

180  

181  

13% of respondents indicated an estimate of the costs incurred, the other choose not to reply or indicated that such estimation is 
impossible 
11% of respondents indicated an estimate of the costs incurred, the other choose not to reply or indicated that such estimation is 
impossible 

106 

 
 
 
                                                            
 
 
While Member States tend to consider that the costs of the Regulation are proportionate to the 
benefits it generates, businesses mostly disagree with only 9% agreeing.  

Would you agree or disagree with the following statement: "these costs are acceptable 
and proportionate to the benefits the Mutual Recognition Regulation brings in terms of 
facilitating market access? 

Businesses

9% 

Member States

2% 

Coherence 

35% 

35% 

54% 

62% 

I don't know

I desagree

I agree

There is a consensus among stakeholders as regards the coherence of the Regulation. Most of 
the  respondents  are  not  aware  of  any  overlaps  between  the  Regulation  and  other 
initiatives/legislation/policies.  The  overlaps  indicated  by  those  replying  yes  are  linked  to 
Solvit, RAPEX, ICSMS and Regulation 765/2008 on market surveillance.  

Are you aware of any overlaps between the regulation and other EU initiatives? 

28% 

29% 

15% 

Yes

EU added value 

84% 

71% 

70% 

No

Member States

Businnesses

Citizens

The European added value of the mutual recognition rules is also strongly underlined by the 
respondents.  Most  of  them  agree  that  having  a  common  set  of  rules  guarantees  equal 
treatment, and that relying on national rules only would undermine the internal market.  

European common procedures on mutual recognition guarantee equal treatment of 
businesses, regardless  of where they want to sell their products 

I don't agree

17% 

26% 

8% 

I agree

76% 

67% 

84% 

107 

Citizens

Businnesses

Member States

 
 
 
 
European common procedures on mutual recognition guarantee that national 
authorities apply the principle in the same manner European common procedures on 
mutual recognition guarantee that national authorities apply the principle in the same 
manner  

29% 

35% 

15% 

I don't agree

I agree

52% 

64% 

68% 

Citizens

Businnesses

Member States

The absence of European common procedures on mutual recognition would weaken 
the principle by dismantling its application into 28 different and possibly contradictory 
procedures and undermine the internal market 

I don't agree

11% 

4% 
8% 

I agree

76% 

85% 

82% 

Citizens

Businnesses

Member States

4.  ASSESSMENT  OF  COMMUNICATION  WHEN  USING  MUTUAL 

RECOGNITION 

Most  of  the  businesses  have  never  contacted  a  Product  Contact  Point  (PCP)  to  obtain 
information  on  the  applicable  product  rules,  mainly  because  they  are  not  aware  of  their 
existence.  Among  those  having  contacted  Product  Contact  Points,  it  is  quite  difficult  to 
identify their level of satisfaction or the reasons behind it.  

Have you ever contacted a PCP? 

27% 

72% 

Yes

No

What was the reason for not contacting a PCP? 

46% 

1% 

25% 

Language problems

Other

I am not aware about them

108 

 
 
 
 
 
Member  States  consider  communication  with  authorities  within  their  own  country  as  good, 
while communication with authorities from other Member States is rather average or poor. As 
regards  communication  between  national  administrations  and  businesses,  the  assessment  by 
authorities  is  quite  mixed  between  good,  average  and  poor.  The  main  reasons  for  poor 
communication  are  related  to  the  lack  of  knowledge  about  mutual  recognition,  language 
issues and the absence of an appropriate IT tool to facilitate communication.  

How do you asses communication when applying mutual recognition? 

57% 

33% 

2% 

35% 

28% 

35% 

28% 

20% 

15% 

Good

Average

Poor

Communication with authoritiesin the
same MS

Communication with authorities from
other MS

Communication between authorities
and businesses

What are the main causes of poor communication? 

51% 

20% 

20% 

22% 

Lack of awareness

Language problems

Lack of IT tools

Other

5. 

PRIORITIES TO IMPROVE MUTUAL RECOGNITION 

Stakeholders have different views with regards to the possible priorities with regard to mutual 
recognition. If businesses rank the need for effective remedies as being the highest priority, 
Member States and citizens opt in favour of increasing awareness of mutual recognition.  

Ranking of priorities by businesses 

Ensure that businesses have effective remedies at their disposal to take action against decisions 
denying mutual recognition when needed 

Increase legal certainty for businesses when using mutual recognition to sell products abroad 

Ensure that the procedures are duly followed when decisions denying market access are taken by 
national authorities 

Increase effectiveness of mutual recognition to facilitate access to the internal market 

Facilitate  communication  between  all  actors  involved  in  mutual  recognition  (business,  national 
authorities, European Commission) 

Increase general awareness of the mutual recognition principle 

72% 

67% 

65% 

64% 

54% 

52% 

109 

 
 
 
 
 
Ranking of priorities by Member States 

Increase general awareness of the mutual recognition principle 

Ensure that the procedures are duly followed when decisions denying market access are taken by 
national authorities 

Ensure that businesses have effective remedies at their disposal to take action against decisions 
denying mutual recognition when needed 

Increase effectiveness of mutual recognition to facilitate access to the internal market 

Increase legal certainty for businesses when using mutual recognition to sell products abroad 

Facilitate  communication  between  all  actors  involved  in  mutual  recognition  (business,  national 
authorities, European Commission) 

Ranking of priorities by citizens   

Increase general awareness on the mutual recognition principle 

Increase legal certainty for businesses when using mutual recognition to sell products abroad 

Ensure that businesses have effective remedies at their disposal to take action against decisions 
denying mutual recognition when needed 

Increase effectiveness of mutual recognition to facilitate access to the internal market 

Ensure that the procedures are duly followed when decisions denying market access are taken by 
national authorities 

Facilitate  communication  between  all  actors  involved  in  mutual  recognition  (business,  national 
authorities, European Commission) 

51% 

42% 

40% 

35% 

33% 

31% 

64% 

52% 

47% 

41% 

35% 

23% 

110 

 
 
 
 
 
ANNEX 6: CASE STUDIES 2016 

The  case  studies  below  were  carried  out  in  the  framework  of  the  Study  on  the  costs  and 
benefits  of  the  revision  of  the  Mutual  Recognition  Regulation  (September  2016-February 
2017).   

1.  MANUFACTURE OF OTHER FOOD PRODUCTS: FOOD SUPPLEMENTS 

1.1 

Introduction 

Food supplements are concentrated sources of nutrients (or other substances) with nutritional 
and physiological effect, marketed by business operators in the food sector. 

Such goods can be sold in “dose” form, such as pills, tablets and capsules, and could contain: 

Nutrients (vitamins and minerals); 

Botanicals;182 

Other substances (e.g. amino acids). 

The  main  rules  for  the  marketing  of  these  products  by  manufacturers  are  laid  down  in 
Directive 2002/46/EC, in which implementation and monitoring is entrusted to the individual 
Member States. 

The  Directive  includes  a  list  of  substances  that  may  be  used  for  the  production  of  food 
supplements, and was amended several times over recent years.183 

During  the  first  round  of  interviews,  stakeholders  –  both  from  business  associations  and 
national  authorities  –  highlighted  how  this  sector  still  constitutes  one  of  the  main  “grey 
areas”, where EU and national rules collide and combine, and where national authorities have 
the largest autonomy and room for manoeuvre in decision making and acceptance/denial on 
market entry.  

Stakeholders underlined how this type of product suffers from a poor implementation of the 
principle of Mutual Recognition across the EU. Different MS authorities provide diverse and 
heterogeneous procedures and requirements to access the market, which are often difficult for 
companies to deal with. 

1.2  Background  

The reference legislation on food supplements is harmonized to a limited extend, and provides 
a relatively loose regulatory framework based, as mentioned, on Directive 2002/46/EC. 

The Directive provides a list of vitamins and minerals which may be used in the manufacture 
of food supplements, but it does not give information on the levels that these substances could 
have within the products, nor on any mix with botanicals or other substances. This creates a 
legal vacuum around which the "puzzle" of the food supplements industry rotates. 

182  
183  

Plant parts, concentrated sources of plants or their extracts or derivatives with a physiological effect. 
Commission Regulation (EU) 2015/414, Commission Regulation (EU) No 119/2014, Commission Regulation (EU) No 1161/2011, 
Commission Regulation (EC) 1170/2009, Commission Directive 2006/37/EC 

111 

 
                                                            
The coverage of this gap is de facto left to the Member States, which identify heterogeneous 
solutions  that  lead  to  various  safety  standards  of  products,  levels  of  ingredients  as  well  as 
their classification.  

The three main issues that have to do with the mutual recognition184 are: 

Maximum  levels  of  vitamins  and  minerals.  Many  Member  States  established  national 
maximum levels for the amounts of vitamins and minerals in food supplements, while others 
preferred  not  to  have  specific  maximum  levels.  The  existence  of  particularly  low  levels 
applied  in  certain  Member  States,  together  with  the  large  differences  between  the  levels 
applied for the same substances across the EU, make it extremely difficult for companies to 
manufacture one single product for whole of the EU; 

Substances other than Vitamins and Minerals. Some Member States apply positive lists185 
with specific conditions to their use. In addition, some Member States may consider certain 
ingredients for medicinal use only; 

Botanicals  and  botanical  preparation.  Botanicals  are  used  in  a  wide  variety  of  food 
supplements.  Many  Member  States  have  positive  lists,  including  conditions  of  use.  The 
content  of  these  lists  differ  widely,  and  certain  botanicals  are  banned  in  different  Member 
States  because  of  medicinal  status,  while  they  are  widely  marketed  as  food  supplements  in 
others. 

Stakeholders  involved  (i.e.  businesses  and  consumers)  call  for  greater  transparency  of  the 
rules:186  consumers  push  on  the  rise  of  the  levels  of  consumer  protection  in  Europe  while 
companies are more interested in an increased harmonization of the rules, dictated especially 
by the costs to obtain certifications to export to other European countries. 

Businesses,  in  order  to  facilitate  their  export,  also  try  to  create  selling  strategies  of  the 
products  that,  by  modifying  the  labelling  of  these  from  "food  supplement"  to  "medical 
device", may guarantee them an easier, faster and less expensive access to the market. This 
could  be  possible  because,  in  the  current  legal  environment,  the  same  product  can  be  –  for 
example – considered to be a botanical food supplement in one EU country and as an herbal 
medicine in another one.187 This option, however, can entail some other costs for companies 
when labelling a product as “medicine”.  

Considering  the  market,  it  is  estimated  that  approximately  20%  of  consumers  in  several 
European  countries  use  at  least  one  type  of  food  supplement,  with  big  variations  between 
North and South, (northern populations making more extensive usage).188 

It is difficult, however, to have a clear picture of the market size. The entire market in recent 
years  has  been  estimated  to  be  worth  EUR  11  billion  in  Europe,189  and  apparently  has  a 
growing trend, with a good share (around 20%) represented by botanicals.  

184  
185  

186  

187  
188  
189  

Food Supplement Europe (2016), Input into the REFIT of the Mutual Recognition Regulation 764/2008. 
A “positive list” is an official register where all elements (or substances or products) allowed in the county are listed. It is opposite 
to a “negative list”, which contains all elements (or substances or products) not allowed in the country.  
Food  Supplements  Europe,  (2016)  Input  into  the  REFIT  of  the  Mutual  Recognition  Regulation  764/2008;  BEUC  (2016),  Food 
Supplements. 
BEUC (2016), Food Supplements – Challenges & risks for consumers. 
Ibidem. 
Euromonitor data 2014. 

112 

 
                                                            
With respect to the individual Member States, the biggest market is Italy, with a turnover of 
EUR  3bn,  with  around  25%  –  EUR  300/400  million  –  coming  from  products  that  use 
botanicals.190 

1.3  Stakeholders involved 

Stakeholder category 

Organisation191 

Description 

Business Association 

FoodSupplementsEurope 

Business 

French SME 

Business 

Italian SME 

Business 

Dutch subsidiary of a 
multinational company 

International  association  working  to  promote 
issues  related  to  the  industry  of  the  food 
supplement  in  Europe.  Members  include  other 
associations active at national level 

SME founded in 2003 with over 130 employees 
– all based in France – and turnover of over EUR 
30 m in 2016 

SME  founded  in  the  1980s  to  produce  and 
commercialise  food  supplements.  Around  30 
employees and turnover of more than EUR 15 m 
in 2016 

Holland-based  subsidiary  of  a  multinational 
company  founded  in  1947.  Established  over  25 
years  ago  and  with  annual  turnover  of  around 
EUR 15 m in the BeNeLux area 

1.4  Practices and trends identified and main issues related to the application of 

Mutual Recognition192  

Information collected from stakeholders show a very heterogeneous picture of the application 
of  mutual  recognition  in  the  sector,  with  many  issues  faced  by  companies,  relating  to  both 
differences  in  national  procedures/requirements  and  to  the  specific  nature  of  the  various 
products included in the sector. 

On the former, as already mentioned, different Member States follow different procedures and 
rules,  in  addition  to  a  very  dissimilar  recognition  and  application  of  the  principle,  creating 
issues and obstacles companies may have to deal with when trying to enter a new market and 
often culminating in having different products for different countries.   

On the latter, stakeholders highlight the complexity of a sector with many different products, 
ingredients and their combinations, under different levels of controls and requirements among 
Member States, making it difficult to have a uniform and clear picture of the whole sector and 
the possible strategies to overcome barriers.193  

Different countries, different rules 

190  
191  
192  
193  

Stakeholders input. 
In some cases, stakeholders have asked for not disclosing their contact details.  
Please consider that the following sections are based on inputs collected from businesses and business associations. 
This is particularly true for botanical products: while the use of botanicals and other derived preparations need to be compliant with 
requirements  of  Regulation  (EC)  No  178/2002,  stakeholders  underlined  how  no  real  steps  forward  seem  to  have  been  made  to 
clarify the framework, without a centralised authorisation procedure – which would be extremely helpful – for the use of botanicals 
or to determine the classification of botanicals as either medicines or food supplements. This, as well as the large differences among 
Member  States  in  the  definition  of  botanicals  and  lists  of  products/ingredients  which  are  allowed  or  not,  create  an  uncertain  and 
difficult environment for companies to operate. 

113 

 
                                                            
Since  the  sector  is  not  fully  harmonised  and  regulated  to  a  limited  extent  at  EU  level,194 
companies  and  their  products  are  subject  to  and  need  to  comply  with  extensive  national 
legislation.  In  this  regard,  three  main  areas  have  been  highlighted  by  stakeholders,  where 
main issues for companies arise:  

Different  classification  of  ingredients  or  substances:  as  already  mentioned,  some  products 
may be classified as food supplements by a Member State, while another country – sometimes 
its'  very  neighbour  –  can  consider  them  medicines,  therefore  with  completely  different 
requirements, rules and procedures to be followed for their marketing;  

Different levels of ingredients or substances allowed. One of the most (and most differently) 
regulated  elements  is  the  level  of  ingredients  (e.g.  vitamins,  minerals  and  other  substances) 
allowed in a specific product at national level. Member States tend to have their own levels 
that apply to the same products, creating problems for companies which need to adapt their 
products and formulas to comply; 

Terminology  and  labels:  It  my  happen  that  terms  and  labels  are  not  uniformly  accepted 
across  Europe  (e.g.  probiotic).  This  requires  companies  to  change  and  adapt  labels  and 
packaging if it is the case.  

In addition, it appears there is not complete uniformity in the national systems in place, with 
few  Member  States195  that,  unlike  the  others,  do  not  rely  on  a  notification-based  system, 
which,  according  to  stakeholders,  may  tend  to  constitute  a  sort  of  pre-market  authorisation 
instead of a procedure to simply notify national authorities of the products to be marketed and 
register information on labels.  

In  the  end,  what  emerges  is  that  there  is  not  a  real  issue  of  complexity  of  procedures,  but 
rather  the  co-existence  of  many  different  rules,  requirements  and  practices  at  national  level 
that  make  companies  investing  time  and  resources  to  learn  and  handle  them,  especially  in 
those  countries  with  high  level  of  restrictions.196  However,  since  most  of  the  companies 
present in this sector are SMEs, resources and time become crucial elements for their survival.   

The application of mutual recognition  

Stakeholders  find  the  application  of  mutual  recognition  to  be  difficult  in  the  complex 
environment described above.  

Stakeholders  underline  how  national  authorities  tend  to  focus  on  national  legislation  when 
deciding, without taking into account other EU MS-certifications or proof of the fact that the 
product is already lawfully marketed in another MS.  

In addition, existing instruments meant to favour the application of mutual recognition – such 
as Product Contact Points – are not really instrumental in helping companies, given their role 
as information hubs, with no real consultative or assessing capabilities and tasks.  

Companies  emphasise  how  the  main  reason  used  by  national  authorities  to  delay  or  even 
block  a  product  from  being  marketed  in  another  Member  State  concerns  the  existence  of 

194  

195  
196  

Some exceptions include the Regulation (EC) No 1924/2006 on nutrition and health claims, or Directive 2002/46/EC, with a list of 
substances that can be used for food supplement production, but whose implementation and monitoring is entrusted to the individual 
Member States. 
AT, NL, SE, SI and UK.  
Such as AT, DE, FI, HR, SE. 

114 

 
                                                            
potential safety issues and the need for the authorities to protect the consumers, which cannot 
be  easily  challenged  by  companies.    Sometimes,  however,  companies  report  a  lack  of 
transparency in the reason for denial.  

In this regard, stakeholders suggest how the fact the burden of proof is on companies  – and 
not on national authorities – when demonstrating that a product is not dangerous, may limit 
their action and ability to challenge a decision, considering time and resources needed.  

Companies  may  see  also  a  potential  effort  of  national  authorities  not  to  allow  (or  delay) 
foreign  companies  in  entering  the  local  market  in  order  to  reduce  competition  for  national 
companies.  

Considering the potential expenses and (considerable) use of time and resources to challenge 
a decision taken by national authorities through judicial procedures, sometimes such option is 
not considered by companies. According to stakeholders, this can be due to: 

Resources  needed,  as  mentioned.  For  a  company  –  especially  an  SME  –  such  resources 
needed can be so high to discourage it from pursuing such way. For instance, an Italian SME 
active  in  the  area  of  food  supplement  suggested  how,  on  average,  costs  for  lawyers  and 
appealing procedures can amount to around EUR 20,000 per product, but other stakeholders 
provided more extreme examples (see Box below); 

Uncertainty of the final outcome of the procedure, which can result in another and definite 
loss for the company; 

Preference not to antagonise national authorities, which will be crucial for the approval of the 
many other products that a company in this sector usually has and tries to market. 

In the light of these difficulties, according to stakeholders, other possible options include: 

Adapting  the  product  to  the  national  requirements.  Clearly  also  this  decision  entails  some 
costs.  

o 

o 

An  Italian  SME  indicated  how  adapting  the  product  to  sell  it  as  a  medicine  could  be 
virtually unbearable for an SME in terms of time and costs (with the need to develop a 
complete  dossier,  with  testing,  clinical  tests  and  documentation),  easily  amounting  to 
thousands of EUR.  

Adapting a product to different limits of ingredients or substances can also require some 
effort  from  the  company,  since  it  requires  a  new  technological  development,  with  lab 
costs and feasibility studies. Such costs can be important for an SME (at least EUR30-
50,000  in  each  case),  not  considering  the  potential  impact  on  the  production  lines, 
which need to be differentiated even for a single ingredient. This strategy is not likely to 
repay when the targeted market is too small not to justify such investments. 

Not entering the market at all, when companies realise that costs and efforts will not lead to 
a positive solution or, even if it is the case, they will be too high to be sustained. In this case it 
can be very difficult to estimate the costs and potential losses for companies, but there is no 
doubt  that  this  can  result  in  losing  money  as  well  as  possible  damages  to  the  company’s 
image and reputation, especially after a judicial procedure; 

115 

 
Trying  to  look  for  a  “least  common  denominator”  among  a  group  of  MS  which  can  have 
similar rules and requirements and therefore targeting them with a single product that would 
easily comply with all different national regulations. 

The box below presents more in details some of the experiences highlighted by stakeholders 
in different EU Member States.  

Box 6-1: Examples of positive and negative experiences with mutual recognition in EU 
MS 

Belgium 

Stakeholders underline how the Belgian case is one of the hardest for them to deal with, with 
so many difficulties in entering this market that – sometimes – leave them to no choice other 
than not marketing the product.  

A French SME finds that in recent years the marketing of products have become increasingly 
difficult.  While  for  some  basic  products  (e.g.  ginseng)  there  is  no  specific  interpretation 
needed by Belgian authorities and the scrutiny can be quite fast and straightforward, for other, 
more complex products, after dealing with many questions and requests for clarification, the 
company  saw  its  requests  for  notification  and  marketing  to  be  refused  by  the  Belgian 
authorities.  Authorities  did  not  accept  the  brand  under  which  the  product  was  marketed, 
which was, however, already lawfully marketed in at least another MS. Without any specific 
explanation  given  about  the  interpretation  that  led  to  this  decision,  the  company  is  still 
expecting a definitive response after more than 2 years. Over EUR 10,000 and months have 
been  spent  by  the  company,  waiting  to  be  in  front  of  a  court  to  challenge  the  decision. 
Considering the turnover for the same product in similar markets, the company can assume to 
have  a  potential  loss  of  turnover  between  EUR  200,000  and  500,000  for  not  entering  the 
Belgian market.  

A  Holland-based  subsidiary  of  an  international  company  decided  not  to  further  pursue  the 
entrance on the Belgian market with a product already lawfully marketed in another MS. The 
issue  related  to  a  product  which,  despite  being  accepted  in  other  MS  and  proved  not 
dangerous,  had  higher  levels  of  ingredients  than  those  allowed  by  the  Belgian  law.  The 
decision  not  to  enter  the  market  was  taken  after  that  for  months  the  company  tried  to  get 
access to the market also through the support of SOLVIT and product contact points, without 
any success. The company estimates around EUR 100,000 spent in law suits.  

Netherlands 

The  same  Holland-based  company  faced  a  similar  case  in  Netherlands,  when  trying  to 
introduce a product onto the market through mutual recognition.  

While  no issues  were  apparently  faced  in  the  first  few  years,  in  2013, after  a  change  in  the 
Dutch law, the company started seeing its requests delayed and eventually denied, under the 
motivation  that  the  products  was  considered  unsafe  for  local  consumers,  since  the  level  of 
some ingredients was higher than the maximum level allowed in the country. Despite proving 
that  the  product  was  already  lawfully  marketed  in  another  MS  and  that  was  not  to  be 
considered unsafe,197 the company decided to challenge the decision in front of a Dutch court 

197  

The company specified how they submitted a proof of safety (considering the lists of products by EFSA, indicating that they could 
not find any suggestion that the product was unsafe in its components up to the level that was present in the product), evidence that 

116 

 
                                                            
since no further explanation was given by national authorities. After two years, with no final 
decision,  the  company  decided  to  market  the  product  anyway,  on  the  basis  of  the  evidence 
they already provided. A late reaction of the national authorities, which seized the products, 
brought the company back to a national court, which decided that the fault was to be ascribed 
to  national  authorities,  for  not  reacting  sooner  in  stopping  a  product,  and  providing  a 
motivation.  However,  such  decisions  was  not  decisive  for  the  company,  since  it  put  the 
company in the position of starting the whole process to put the product into the market once 
again.  

The  company  reported  legal  expenditures  for  around  EUR  90,000,  plus  the  time  and  effort 
needed  to  reach  a  final  verdict.  In  addition,  around  EUR  500,000  of  potential  loss  (in 
consumer  price)  were  considered  for  2016  only,  due  to  the  impossibility  to  market  the 
product.  

Spain 

While mutual recognition is difficult to implement in many countries, Spain is considered as 
one of the most positive examples. Companies encounter very few obstacles in entering the 
market – for both types of products and levels of ingredients, as long as they can prove that 
the  product  is  already  lawfully  marketed  in  another  MS.  A  French  SME  reported  how  the 
process, including a declaration by the Spanish distributor and the presentation of another MS 
notification  of  the  validity  of  the  product,  took  around  2-3  months  and  no  more  than  EUR 
1,000 for a single product, quite the opposite of many other Member States.198  

Other MS 

Baltic Countries represent an interesting example of how the same product can be considered 
very  differently  across  –  in  this  case  neighbouring  –  countries.  An  Italian  SME  saw  its 
product being approved and lawfully marketed in Lithuania, while blocked in Estonia, under 
the motivation that it was considered as a medicine by the local authorities. The same product 
is  still  under  review  in  Latvia,  with  a  consultation  among  authorities  whether  it  should  be 
considered as a food supplement or not.  

Germany is considered a highly regulated market, with one of the most stringent control and 
regulation systems. Issues are particularly related to plants and botanical products, which can 
be often considered medicines, with the need for companies to change the formula or some 
ingredients of their product. Such changes may cost around EUR 5,000 per product to a SME 
– and become very expensive if the company has to make changes to several products at once 
– plus additional time and costs to obtain a new certification, carry out new checks on quality 
and the need to require a new notification from the MS where the company is based.199  

Notwithstanding such general difficulties, stakeholders highlighted also as the situation seems 
to  be  –  slightly  and  slowly  –  improving  with  some  positive  signals  from  Member  States  in 
terms of application of mutual recognition. Member States appear to start drawing common 
rules and similar requirements (e.g. FR and IT in the field of botanical products), easing the 

the product was lawfully marketed and largely sold in another EU MS, a formal letter of approval from a scientists  – also part of 
EFSA  –  and  requesting  a  Dutch  Research  Institute  to  draft  a  report  on  the  possible  unsafety  of  the  components,  leading  to  no 
indications in this sense.  
Stakeholders specified, nonetheless, how it is likely that time and costs vary heavily for different products.  
Stakeholders underlined how German authorities  may  require a new notification for the  modified product, to be produced by the 
original Member State, even if the product is not going to be marketed in such country.  

198  
199   

117 

 
                                                                                                                                                                                          
work  of  companies,  while  other  countries,  originally  very  difficult  to  enter  (e.g.  SI),  start 
accepting mutual recognition, even if at a very slow pace.  

1.5  Conclusions  

Despite  the  heterogeneity  of  cases  and  requirements  across  the  EU  that  could  create  some 
very different situations for companies, stakeholders seem to generally agree on the fact the 
mutual recognition is not working properly in the sector.  

Complexity of products, intricacy and differences in national requirements, scarce knowledge 
or  disposition  of  national  authorities  in  considering  mutual  recognition  do  not  facilitate  the 
situation  of  companies,  which,  as  a  paradox,  may  find  easier  to  export  food  supplements 
outside  the  EU  than  across  our  internal  borders,  often  spending  more  resources  in  fighting 
decisions from authorities than their actual competitors.  

And while a full harmonisation of the sector would probably solve many issues but it would 
probably be the hardest path to follow, changes seem to be definitely needed to improve the 
actual situation.  

The  main  issue  that  companies  highlight  is  an  unbalanced  situation  between  them  –  which 
have the burden of proof– and national authorities, which can too easily delay or deny market 
access  without  a  full  and  clear  explanation  and  little  burden  afterwards.  In  addition,  open-
ended procedures gives no real room for manoeuvre to companies when a decision is taken by 
national  authorities,  together  with  a  general  scarce  attitude  of  national  authorities  in 
considering the principle.  

The complexity of the sector, however, may require specific attention to measures and options 
to be implemented.  

These  are  all  elements  that  need  to  be  addressed  in  order  to  improve  the  situation  and 
facilitate a better application of mutual recognition. 

2. 

PRODUCTS IN CONTACTS WITH DRINKING WATER 

2.1 

Introduction 

The legislation of the European Union (EU)  provides to  Member States (MS) a set of rules 
concerning  the  production  and  commercialization  of  products  which  are  in  contact  with 
drinking water.200 

Such  measures  are  due  to  be  transposed  by  each  MS:  Directive  98/83/EC  (Drinking  Water 
Directive)  established  that  it  is  up  to  individual  MS  to  take  all  the  necessary  measures  to 
ensure that materials and products in contact with drinking water do not generate any negative 
effect on human health. 

However,  the  transposition  and  implementation  of  this  provision  by  national  legislators 
resulted in the emergence of a multitude of country-specific requirements, with MS pursuing 
the  same  objective  (ensuring  an  adequate  level  of  safety  for  consumers)  through  diverse 
provisions and test criteria, and different levels of stringency of rules.  

200  

Directive 98/83/EC, Drinking Water Directive 

118 

 
                                                            
This  multitude  of  different  national  requirements  creates  a  particularly  challenging 
environment for manufacturers in the sector, also in the application of mutual recognition.   

Companies  are  subject  to  a  series  of  time-consuming  and  complex  activities  necessary  to 
obtain  the  certifications,  and  it  conveys  an  overall  increase  in  costs  that  inhibits  their 
propensity in trying to have access to new markets. 

During  the  previous  phase  of  the  study,  all  categories  of  stakeholders  highlighted  the 
importance of this sector, and the need for intervention to a generally poor implementation of 
mutual recognition.  

Particular emphasis will be placed on Water Taps, which represent one of the core products in 
the sector, with several stakeholders involved highlighting that the commercialization of this 
type of product in Europe remains quite challenging. 

2.2  Background 

The  manufacturing  sector  of  products  in  contact  with  drinking  water  spreads  in  a  wide  and 
articulated range. 

A list can be summarized into the following categories:201 

Safety and Protection valves, 

Water treatment machineries, 

Water Taps, 

Pipes and fittings, and 

Tanks and pumps 

Overall, the market demand for this kind of products can be seen as driven by a multiplicity 
of factors such as:  

The need to replace installed systems at the end of their lifecycle;  

Provide for expansions to public networks for new buildings;  

The trend towards a sophistication in terms of design (shape and external characteristics) and 
performances (water efficiency, control of leakage and reduction of costs). 

Considering  available  information,  it  is  possible  to  estimate  the  total  turnover  of  the  sector 
between 40 and 43 billion per annum,202 while the number of companies operating can be 
estimated at around 7,000 units, with a heterogeneous distribution among small medium and 
large enterprises.203 

201  

202  

203  

Figawa, Effects of Article 10 of the EU Drinking Water Directive on test and certification costs for products in contact with drinking 
water, 2016 
Eurostat data for product categories is not specific to drinking water contact products, some estimation based on expert evaluation 
are available thanks to data and document collection 
Panteia, Economic Effects of Article 10 of the Drinking Water Directive, 2016 

119 

 
                                                            
In terms of Net Sales on the European Market the central and northern European countries are 
leaders,  with  Germany,  Switzerland  and  Nordic  countries  on  top,  while  companies  from 
third countries (e.g. Far East, Middle East and Africa) together with the Iberian Peninsula (ES 
and PT) are instead at the bottom,204 as shown in the figure below.  

Figure 6-1: Net Sales of Products in contact with Drinking Water (2015) 

Author’s elaboration based on stakeholder input 

All these products may be hazardous to human health, and therefore must comply with certain 
safety requirements.  

Tests and certifications concerning the products that come into contact with drinking water 
fall mainly under two categories: mechanical and hygienic,205 as presented in the following 
figure. 

Figure 6-2: Test and Certifications 

Author’s elaboration based on stakeholder input 

The  cost-spread  for  these  certifications  as  well  as  statutory  audits  is  different  among  EU 
Member States. 

204  
205   Mechanical  tests  are  related  to  issues  like  pressure  fluctuation,  closure,  deformation,  while  hygienic  tests  are  related  to  the 

Data and information provided by Stakeholders 

possibility that there is a release of substances in the water. 

120 

 
 
 
                                                            
In  Germany,  for  example,  audit  costs  amount  to  a  figure  around  14%  of  the  total  costs  for 
tests and certifications, while in other countries like U.K., Netherlands and France such a cost 
is around 1% of the total.206 

Figure 6-3: Total Costs for Certifications 

Author’s elaboration based on stakeholder input 

Water Taps 

Water taps are among the products whose commercialization is more problematic, according 
to  stakeholders.  Water  taps  are  basically  valves  used  to  control  the  release  of  water. 
Unfortunately  there  is  a  limited  availability  in  terms  of  industry  sector  data,  and  databases 
cannot reach the level of granularity needed. 

For this reason, to estimate the key variables useful to give a clear representation of the target 
market,  a triangulation of the information provided by different stakeholders involved in the 
analysis, together with interviews with stakeholders and Eurostat data has been implemented. 

Therefore, following figures can be estimated about the segment of the sector that is linked to 
the production of taps and valves in contact with drinking water, presented in the following 
table.207 

Table 6-1: Estimated data on water taps in the EU 

Variable 

Turnover  (EUR mln) 

N. of Enterprises  

2012 

14,768 

1403 

2013 

14,864 

1378 

2014 

15,074 

1393 

Therefore, it could be estimated that the water taps segment covers about  35% of the entire 
turnover. Plastic plates, sheets, tubes and profiles follow immediately with an average figure 

206  
207  

Figawa, Member Survey, 2016 
Eurostat, Annual detailed enterprise statistics for industry (NACE Rev. 2, B-E) – C2814 Manufacture of other taps and valves 

121 

 
 
                                                            
of EUR 11.398 million. At the end of the list, we can find tanks, reservoirs and containers of 
metal (less than EUR 500,000). 

Four  member  states  are  of  particular  interest  in  the  current  analysis:  France,  Germany, 
Netherlands  and  Great  Britain.  These  countries  are  the  promoters  of  an  initiative,  started  in 
2011,  which  aims  to  harmonize  the  tests  for  the  hygienic  suitability  of  products  in  contact 
with  drinking  water.  This  agreement  was  launched  after  the  failure  of  the  European 
Acceptance Scheme in 2006.208 

These countries all together generate on average 50% of the sector turnover in Europe, and 
they host around one third of the total number of enterprises. 

Table 6-2: Estimated data for the 4MS 

Variable 

4MS Turnover  

(EUR mln) 

2012 

7,4935 

4MS N. of Enterprises  

423 

2.3  Stakeholders involved  

2013 

8,073 

406 

2014 

7,628 

419 

Stakeholder category 

Organisation 

Description  

Business Association 

FIGAWA 

Business 

Geberit 

German  association  based  in  Cologne,  whose 
members are businesses related to gas and water 
sector.  The  association  promotes  technological 
development  in  the  industry  and  try  to  improve 
cooperation  between  the  German  organizations 
and  international  bodies  for  the  development  of 
rules and regulations. 

Multinational  company  based  in  Switzerland 
with  over  10,000  employees  and  125  years  of 
activity.  80% of  the  turnover  (over  EUR2bn per 
year) is generated in the EU. 

2.4  Practices and trends identified and main issues related to the application of 

Mutual Recognition  

Interviews with stakeholders representing manufacturers of products and materials in contact 
with  drinking  water209  revealed  how  currently  the  application  of  mutual  recognition  with 
regard  to  these  products  is  seriously  deficient,  thus  creating  limitations  to  both  competition 
among businesses and availability of products for consumers in the EU single market. 

The  main  issue  stems  from  the  absence  of  comprehensive  EU  harmonised  requirements  on 
such products. Article 10 of Directive 98/83/EC (Drinking Water Directive)210 requires MS to 

208  

209  

210  

This  project  intended  to  create  a  unique  European  system  to  assess  hygienic  aspects  of  products  in  contact  with  drinking  water, 
source: http://www.ceir.eu 
E.g.  pipes,  pumps,  taps,  valves,  fittings,  water  heaters,  catering  equipment,  seals,  etc.;  and  materials  such  as  elastomers,  metals, 
plastics, etc. 
Concerning the quality assurance of treatment, equipment and materials in contact with drinking water. 

122 

 
                                                            
verify that the materials and substances used in the treatment and distribution systems are not 
present in drinking water “in concentrations higher than is necessary for the purpose of their 
use and do not, either directly or indirectly, reduce the protection of human health”. This was 
related  to,  for  instance,  in  terms  of  the  concentration  of  substances  leaking  from  such 
materials, or the breeding of pathogenic microorganisms upon them.  

However, as already mentioned, the implementation and monitoring measures are left to the 
MS,  which  have  established  their  own  national  test  and  certification  bodies211  to  assure  the 
quality  of  materials  and  to  issue  licences  for  the  sale  of  products  in  contact  with  drinking 
water.  Each  body  assess  the  conformity  of  materials  and  products  in  contact  with  water  for 
human consumption against specific requirements and criteria that vary at national level (for 
example as regards the compliance of products with a specific composition or the effects of 
the materials on the microbiological growth in the water). 

This  framework  creates  the  conditions  for  double  or  multiple  testing  of  products  in  contact 
with  drinking water in  the EU  market. Companies  willing to obtain  a licence for marketing 
their product in a single MS have to comply with all the national test criteria and requirements 
as  defined  by  in  the  law  and  by  the  relevant  test  and  certifications  bodies  in  that  MS. 
However,  when  they  want  to  market  that  same  product  in  other  MS,  they  are  typically 
required to repeat those same tests by the relevant bodies in each individual MS they want to 
enter, as MS not only have different test criteria, but also do not recognise each other’s tests. 
This  practice  does  result  into  an  expensive  and  time  consuming  reiteration  of  activities  for 
businesses, which are forced to repeat tests and acquire certifications several times in the EU 
market, into higher final prices for consumers and – more importantly for our analysis – into 
the infraction of mutual recognition principle enshrined in Regulation (EC) 764/2008. In fact, 
on the basis such a principle, a MS may not prohibit the sale on its territory of products which 
are  lawfully  marketed  in  another  MS,  even  where  those  products  were  manufactured  in 
accordance with technical rules different from those to which domestic products are subject. 
The current situation is especially difficult for SMEs which may not be able, due to limited 
resources, to fulfil the different test and certification requirements imposed in each MS. 

As pointed out by a representative of one of the largest European manufacturer of hydraulic 
accessories and components, it is currently not possible for a business to market its products 
in more than few countries212 at the same time in Europe, mainly due to additional testing and 
certifications  that  shall  be  taken  in  each  MS  requiring  so.  In  some  instances,  the  cost  of 
additional testing may even exceed the cost of initial testing and certification. As an example, 
the interviewee reported that, in the context of EUR 2 million project aimed at selling a single 
hydraulic  product  in  15  EU  MS,  the  total  cost  for  the  initial  certification  of  such  product 
amounted  to  EUR  35,000,  while  cost  the  double  testing  in  a  single  country  (FR)  was  EUR 
38,000.  Similarly,  for  a  large  project  worth  EUR  60  million  concerning  the  renewal  of 
product present on the market for a long time, interviewed stakeholder expects the costs for 
initial certifications (estimated at around EUR 1 million) to double when trying to market the 
product in all the 28 MS due to additional certification. 

211  

212  

FIGAWA  reports  the  following  list  of  national  test  and  certification  bodies:  Österreichische  Vereinigung  für  das  Gas-  und 
Wasserfach (AT), BELGAQUA (BE), Sekretariatet for byggevarer godkendt til drikkevand (DK), VTT Expert Services (FI), Centre 
Scientifique  et  Technique  du  Bâtiment  (FR),  Deutscher  Verein  des  Gas-  und  Wasserfaches  (DE),  National  Institute  of 
Environmental Health (HU), Ministerio della Salute (IT), Kiwa NL (NL), Państwowy Zakład Higieny (PL), Instituto Nacional de 
Saude (PT), Institut Za Varovanje Zdravja Republike Slovenije (SI),  Asociación Española de Normalización y Certificación (ES), 
Kiwa Swedcert (SE),  Schweizerischer Verein des Gas- und Wasserfaches (CH), Water Regulations Advisory Scheme (UK). 
The countries mentioned by the interviewee in these respect are AT, DE, and NL. Indeed, the interviewee stated that initial product 
certifications are sought and obtained in these MS, as the laboratories having the necessary technical instrumentation and know-how 
for  complex  (mechanical  and  hygiene)  testing  are  mainly  settled  there.  Moreover,  the  interviewee  company  has  a  preference  for 
German speaking countries due to the absence of language barrier in interacting with test and certification bodies. 

123 

 
                                                            
Moreover,  companies  have  to  deal  with  the  auditors  of  the  different  national  certification 
bodies  who  periodically  conduct  audit  visits  concerning  the  quality  certifications  already 
acquired.  The  current  cost  reported  by  the  interviewed  stakeholder  for  managing  all  these 
certifications  (which are, for drinking water only, around 1,350)  is  around EUR 2.3  million 
per year. Remarkably, all of these costs faced by businesses are passed on to consumers via 
final prices. 

The  problem  of  double  and  additional  testing  is  particularly  acute  in  some  countries. 
Stakeholders mentioned how MS such as ES, FR, UK, and more in general the Scandinavian 
countries,  can  be  seen  as  the  most  problematic  in  this  respect.  Businesses  may  find  double 
testing not only expensive in terms of fees to be paid to repeat the same test in different MS, 
but  also  extremely  time  consuming.  The  time  that  elapses  between  the  registration  for  tests 
and the certification of approval typically can span from six up to 12 months, and may even 
reach 24 months in more complex circumstances. For companies, this obviously results into 
foregone profits due to the delayed market access. 

Crucially,  when  businesses  make  the  point  of  mutual  recognition  in  dealing  with  national 
authorities  in  other  MS,  the  latter  typically  refer  to  the  application  of  the  relevant  national 
norms and legislation, rather than EU Legislation.  

From  the  point  of  view  of  businesses,  there  is  a  generalized  lack  of  awareness  (if  not 
deliberate  disregard)  of  the  mutual  recognition  principle  by  national  test  and  certification 
bodies.  

Moreover,  interviewees  reported  “cherry  picking”  by  national  authorities,  as  some  tests  and 
certifications presented by businesses can be accepted by some MS, while other tests shall be 
repeated. Businesses are simply asked to comply with national requirements and test criteria, 
even though their products underwent the same testing in other countries.  

However, businesses are reluctant to bring national authorities to court to see the principle of 
mutual recognition applied.  

As emerged in the interviews, there are two main reasons behind this. First, businesses do not 
want to see their long-lasting relationship with national authorities jeopardised just to seek the 
application  of  mutual  recognition  to  a  single  product.  In  other  words,  they  prefer  avoiding 
confrontation  with  national  authorities  and  complying  with  national  requirements  by 
repeating tests, mainly because they are concerned of being treated unfavourably in the future. 
Second,  businesses  are  concerned  that,  in  absence  of  harmonised  rules  at  EU  level  on 
hygienic testing, the enforcement of mutual recognition with respect to materials and products 
in contact with drinking water may start a “race to the bottom” among producers as regards 
the quality of products, a fact which is expected to negatively impact the safety of consumers. 
Finally,  interviewed  business  association  reported  how  also  among  its  members  there  is  a 
problem  of  awareness  about  mutual  recognition.  While  companies  dealing  with  products  in 
contact  with  drinking  water  are  aware  of  and  well-versed  in  relevant  legislation  such  as 
Regulation  (EU)  No  305/2011  (Construction  Products  Regulation)  or  Directive  98/83/EC 
(Drinking  Water  Directive),  are  less  aware  about  the  possibility  of  benefiting  from  mutual 
recognition. 

124 

 
 
 
Box 6-2: European Drinking Water (EDW) 

Founded in 2015, the European Drinking Water (EDW, formerly ICPCDW) is a consortium 
of  25  European  trade  associations  representing  industries  which  manufacture  and  supply 
products  and  materials  used  in  drinking  water  applications  and  connected  to  municipal 
drinking water supplies within the EU. 

The  coalition  is  open  to  any  relevant  business  association  and  has  a  horizontal  structure, as 
each member has equal rights to participate in and give its contribution to EDW meetings and 
activities.  Members  elect  the  chairman  of  the  consortium  and  may  withdraw  from  it  at  any 
time. 

EDW purpose is to address the current lack of EU harmonised regulatory requirements for the 
conformity  of  products  and  materials  used  in  applications  involving  contact  with  drinking 
water.  The  mission  is  to  discuss  and  define  a  harmonized  scheme  for  requirements  and 
conformity assessment of products and materials used in drinking water applications that can 
be accepted in all EU Member States. 

2.5  Conclusions 

Stakeholders  highlighted  how  the  actual  application  of  mutual  recognition  to  products  in 
contact with drinking water needs to be improved. The absence of a harmonized scheme of 
requirements  for  products  and  materials  accepted  by  all  MS  caused  a  fragmentation  of  the 
internal market in terms of quality marks and certifications across MS, as well as an impact 
on the level of consumer protection. 

More  importantly,  the  lack  of  awareness,  mind-set  or  willingness  by  national  authorities  to 
apply  mutual  recognition  in  this  sector,  combined  with  companies  reluctance  to  challenge 
them  in  front  of  a  court,  depict  a  situation  in  which  businesses  are  unable  to  sell  lawfully 
marketed products in a large number of EU MS at the same time.  

On the opposite side, businesses have to deal with the costs of double testing and additional 
certifications  and  the  foregone  profits  due  to  delayed  market  entry,  as  they  have  to  wait 
several months being allowed entering the market of other MS. 

3. 

FOOD CONTACT MATERIALS 

3.1 

Introduction 

The present case study will examine a specific category of materials and articles intended to 
come into contact with food (food contact materials or FCMs), namely food packaging. This 
case  study  was  identified  in  prior  stages  of  the  study  as  being  relevant,  both  by  competent 
authorities  as  by  economic  operators,  due  to  the  complexity  of  applying  the  Mutual 
Recognition Regulation 764/2008 to this context. This is principally due to the fact that food 
contact materials (including food packaging) are only partially harmonized at the EU level. In 
addition,  the  non-harmonised  aspects  of  food  contact  materials  are  often  subject  both  to 
extensive national regulation and to extended practical scrutiny by the competent authorities, 
which is justified by the potential impact on public safety and more precisely public health. 

The  case  study  therefore  has  the  objective  of  understanding  the  magnitude  of  the  costs  and 
limitations  to  trade  due  to  the  actual  suboptimal  application  of  mutual  recognition  to  food 

125 

 
contact-material,  and  the  impact  of  available  policy  options  to  address  the  issue.  This  will 
provide further detail on the practical considerations and barriers that economic operators and 
competent authorities face when bringing products to the market, with the added element that 
any technical rules imposed by competent authorities are more likely to be linked (or linkable) 
to  a  public  interest,  specifically  the  protection  of  health.  Given  that  competent  authorities 
must, under Article 6.1 of the Regulation, specify technical or scientific evidence to the effect 
that  “the  intended  decision  is  justified  on  one  of  the  grounds  of  public  interest  set  out  in 
Article  30  of  the  Treaty  or  by  reference  to  other  overriding  reasons  of  public  interest”,  the 
application of the Regulation to food packaging can be particularly relevant when assessing 
the policy options available to the legislator. 

3.2  Background  

The food and drink industry in general is the EU's biggest manufacturing sector in terms of 
jobs and value added. The EU boasts an important trade surplus in trade in food and EU food 
specialities  are  well  appreciated  overseas.  In  the  last  10  years,  EU  food  and  drink  exports 
have doubled, reaching over €90 billion and contributing to a positive balance of almost 30 
billion. The FCM sector in particular has an approximate annual turnover of €100 billion.  

Apart from the Mutual Recognition Regulation, the FCM sector is more specifically regulated 
through  the  Food  Contact  Materials  Regulation  (EC)  No  1935/2004.  This  Regulation 
establishes the principle of safety assessment and management, specifically regarding the risk 
of transfer of chemicals from such materials into foods. Some of these contact materials are 
covered by EU legislation, specifically active and intelligent materials (which are not inert by 
design), ceramics, plastics, and regenerated cellulose. The materials covered only by national 
measures  are  adhesives,  printing  inks,  coatings,  glass,  ion  exchange  resins,  waxes,  metals, 
cork, wood, paper and board, silicones, rubber, textiles and combinations of materials.213 

The FCM Regulation explicitly foresees a complementary role for the Member States, which 
are  allowed  under  Article  5  of  that  Regulation  to  maintain  or  adopt  national  provisions  in 
relation  to  FCMs,  in  the  absence  of  specific  measures  adopted  under  the  Regulation  itself. 
Furthermore, the European Food Safety Authority (EFSA) is explicitly granted the authority 
to  adopt  specific  measures  aiming  at  protecting  public  health  (i.e.  to  evaluate  the  safety  of 
specific FCMs), which it does with some frequency.214 

Thus,  food  packaging  is  subject  to  a  relatively  complex  regulatory  framework.  The  main 
principles are set out at the EU level via the FCM Regulation, which explicitly covers some 
materials  but  leaves  others  within  the  remit  of  the  Member  States.  A  producer  of  food 
packaging  must  therefore  follow  a  specific  procedure215  towards  the  national  competent 
authority216  if no rules are available at EU level; and the national competent authority must 
forward  such  requests  for  authorisation  to  EFSA  for  EU  level  scrutiny.  Decisions  may  be 
made  at  the  national  level,  but  only  insofar  as  topics  have  not  been  harmonised  at  the  EU 
level, and always taking into account the provisions of EU law, including the MR Regulation. 
Since  specific  guidelines  are  available  at  the  EU  level  on  how  FCMs  must  be  tested  and 

213  
214  

215  
216  

See http://ec.europa.eu/food/safety/chemical_safety/food_contact_materials/legislation_en  
See  http://www.efsa.europa.eu/en/topics/topic/food-contact-materials,  and  specifically  http://www.efsa.europa.eu/en/science/food-
ingredients-and-packaging for decisions on food packaging 
Illustrated here: http://www.efsa.europa.eu/sites/default/files/applications/apdeskapplworkflowfcm.pdf  
Published here: https://ec.europa.eu/food/sites/food/files/safety/docs/cs_fcm_auth_ref_en.pdf  

126 

 
                                                            
assessed (by the European Reference Laboratory for Food Contact Materials EURL-FCM)217, 
in principle similar decisions should be made by the various Member States.  

The  sector  itself  is  relatively  complex  and  multi-layered,  comprising  various  types  of 
economic  operators  that  interact  to  provide  food  packaging.  The  ‘Industrial  guidelines  on 
traceability of materials and articles for food contact’218 distinguish between  

 

 

 

 

the processing of starting materials by the converters and producers; 

use of empty packaging by distributors or fillers; 

distribution  of  finished  articles  such  as  kitchenware/tableware  by  distributors  or 
retailers; 

sale to end consumers of filled packaging by distributors or retailers. 

The range of the non-harmonised aspects of the FCM industry was recently examined through 
a 2016 JRC Study on the European regulatory and market situation of non-harmonised food 
contact  materials.219  The  Study  found  that  this  sector  suffered  a  lack  of  harmonisation  of 
materials listed under the framework regulation and that it was “the object of issues in mutual 
recognition”.  Specifically,  the  study  highlighted  a  lack  of  detail  in  relation  to  requirements 
and  quality  assurance  towards  declaration  of  compliance  and  supporting  documents, 
certification where applicable, basis for enforcement and sanctions. 

Tellingly,  the  Study  argued  that  this  was  a  hurdle  for  competent  authorities  as  well,  rather 
than  only  for  economic  operators.  Indeed,  FCM  is  an  industry  in  which  the  Member  States 
have a complementary authority, allowing them to exercise a certain margin of discretion, but 
only  within  the  limitations  permitted  by  the  FCM  Regulation,  the  procedural  norms 
established in relation to EFSA, and the logic of the MR Regulation. From a Member State 
perspective,  the  mirror  image  of  this  competence  is  the  need  to  be  relatively  specific  in 
relation  to  the  criteria  and  processes  that  they  apply  to  make  their  decisions.  This  can  be 
problematic in practice.  

From  the  economic  operators’  perspectives,  the  guidance  which  is  available  from  the 
competent authorities is often described as being too generic and high-level to allow them to 
prepare  authorisation  requests  with  a  sufficient  degree  of  predictability.  Access  to  national 
level legislation and the interpretative documents created by competent regulators in relation 
to  the  application  of  the  legislation  was  often  described  as  lacking,  both  on  the  nature  of 
substances  considered,  the  types  of  restrictions  and  numerical  values  imposed.  Ambiguities 
on  this  point  were  seen  as  impeding  mutual  recognition,  both  for  regulators  and  economic 
operators.  

Competent  authorities  are  available  in  all  Member  States  under  the  FCM  Regulation. 
However, for this case study it is worth underlining that the competences and activities of the 
authorities  diverge  relatively  widely,  and  can  vary  depending  on  the  substances  involved, 
with not all substances being covered in all Member States. Even when competent authorities 
for  a  given  substance  are  available  in  multiple  Member  States,  their  FCM  schemes  and 

217  
218  
219  

See https://ec.europa.eu/jrc/en/eurl/food-contact-materials  
See http://www.apeal.org/wp-content/uploads/2015/04/1.-Industrial-Guidelines-Traceability-Jan2006.pdf  
Non-harmonised 
JRC; 
https://ec.europa.eu/jrc/en/publication/eur-scientific-and-technical-research-reports/non-harmonised-food-contact-materials-eu-
regulatory-and-market-situation-baseline-study  

contact  materials 

and  market 

the  EU: 

regulatory 

situation, 

2016, 

food 

in 

see 

127 

 
                                                            
specific  requirements  for  the  authorisation  of  substances  are  not  the  same.  EFSA  acts  as  a 
mitigating factor on this point by establishing and supporting a Member State network220 to 
facilitate share dating needs further follow-up activities comparing national protocols. 

As noted in the introduction, for this case study the main role of the Member State (or rather 
of  its  competent  authority)  under  the  FCM  Regulation  is  to  act  as  a  contact  point  for 
economic  operators  that  wish  to  submit  requests  for  authorisation  for  specific  substances  to 
EFSA, and as a regulator with subsidiary competences (i.e. when the EU has not intervened to 
harmonise  specific  products)  by  applying  national  legislation,  criteria  and  procedures  to 
determine whether FCMs are safe, taking into account both the FCM Regulation and the MR 
Regulation.  

3.3  Stakeholders involved 

The following stakeholders have been contacted:  

 

 

 

 

Crown Europe, a manufacturer of packaging products and technology (including cans, 
closures,  wrappings  and  tins).221  It  is  a  significant  economic  operator  in  this  market, 
active  in  40  countries,  employing  over  23,000  people  and  net  sales  of  $9.1  billion 
annually. 

APEAL, the Association of European Producers of steel for packaging222, a federation 
of the four major producers of steel for packaging (Arcelor Mittal, ThyssenKrupp, Tata 
Steel, and US Steel Kosice). APEAL represents 95% of the total European production 
of  steel  for  packaging,  and  the  production  of  up  to  4.8  million  tonnes  of  steel  for 
packaging per year (equivalent to 42 billion steel cans). 

European Carton Makers Association (ECMA),223 the International Network of Folding 
Carton  Organisations,  representing  carton  businesses,  national  carton  associations  and 
suppliers  to  the  carton  industry.  ECMA  represents  500  carton  producers  in  nearly  all 
countries  in  the  European  Economic  Area.  Around  70%  of  the  total  carton  market 
volume in Europe, and a current workforce of about 45,000 people are represented. 

European Printing Ink Association (EuPIA),224 founded in 2003 as a division of CEPE, 
the  European  Council  of  the  Paint,  Printing  Ink  and  Artists'  Colours  Industry.  EuPIA 
represents  the  interests  of  the  European  manufacturers  of  printing  inks  and  related 
products. 

3.4  Practices and trends identified and main issues related to the application of 

Mutual Recognition 

Based  on  the  currently  available  information,  the  following  practices  and  trends  can  be 
highlighted:  

 

At  the  national  level,  requirements  on  declarations  of  conformity  to  be  provided  by 
economic  operators  and  supporting  documents  lack  guidance  and  associated  quality 

220  

221  
222  
223  
224  

See  the  Food  Ingredients  and  Packaging  (FIP)  Scientific  Network  on  Food  Contact  Materials  (FCM);  available  at 
http://www.efsa.europa.eu/sites/default/files/assets/fipnonplasticsnetworklist.pdf  
See http://www.crowncork.com/about-crown  
See www.apeal.org/about-us/  
See http://www.ecma.org/about-ecma/  
See http://www.eupia.org/index.php?id=2  

128 

 
                                                            
 

 

 

 

criteria. Self-regulation can address this to some extent by providing additional sectorial 
guidelines, but it is unclear whether these are known and applied in particular by SMEs.  

National  measures  on  specific  materials  are  mainly  based  on  lists  of  authorised 
substances and corresponding restrictions. Close to 8,000 substances were found. Some 
materials  are  regulated  by  more  than  10  MSs  (metal,  glass)  and  some  only  by  a  few 
(wood).  National  rules  for  ceramics,  glass  and  metals/alloys  cover  about  15  heavy 
metals and ban substances such as barium and mercury. There are between 100 and over 
5,000 substances authorised for each category of the other materials. Only 15-35 % of 
substances considered nationally are in the lists that EFSA reported as being adequately 
risk assessed. 

There is a lack of concerted strategies for the monitoring of various FCMs among MSs. 
This can be perceived as grey area for the systematic assurance of food safety. The level 
of  non-compliance  is  not  greater  overall  for  non-harmonised  materials,  but  it  is 
prevalent  for  their  imports.  Enforcement  also  suffers  from  lack  of  standards  or  test 
methods. 

To  economic  operators,  the  lack  of  transparency  and  accessibility  on  applicable 
requirements,  rules  and  procedures  is  the  key  challenge:  when  moving  from  one 
Member State to the next, it is challenging to identify (a) whether national rules exist; 
(b)  who  the  competent  authority  is;  (c)  what  the  applicable  requirements  for  their 
specific FCMs are; and (d) whether the MR Regulation is a satisfactory solution.  

The interrelationship between the FCM Regulation and the MR Regulation is not clear 
to  economic  operators.  In  practice,  there  is  significant  familiarity  with  the  FCM 
Regulation  as  such  and  with  applicable  rulesets  in  major  markets,  but  economic 
operators are insufficiently aware of the principles and scope of application of the MR 
Regulation and its ability to facilitate compliance with specific national rules. As noted 
in  the  2016  study,  this  lack  of  clarity  “leads  industries  to  seek  external  legal  advice, 
which  adds  to  costs  and  may  result  in  lengthier  authorisation  processes  and  delayed 
market  access.  It  can  also  result  in  a  greater  focus  on  certification  and  accreditation 
systems at industrial level”. 

129 

 
 
 
ANNEX 7: OVERVIEW OF NOTIFICATIONS 

1.  OVERVIEW NOTIFICATIONS REGULATION (EC) NO 764/2008 

Since the entry into force of the Regulation, the Commission received  3918 notifications of 
administrative decisions taken pursuant to article 6.2. These are notifications of administrative 
decisions  taken  on  the basis  of  a  national  rule,  and  denying  or  restricting  market  access  for 
products lawfully marketed in another Member State. The table below offers an overview of 
the number of notifications received per year (in 2009, notifications were sent only as from 
July, after the entry into force of the Regulation).  

2016

2015

2014

2013

2012

2011

2010

2009

Notifications 2009-2016  

646 

447 

466 

434 

474 

328 

314 

No Notifications

809 

The  analysis  of  the  notifications  received  shows  the  following:  only  certain  Member  States 
are  notifying:  Portugal,  Denmark,  UK,  Spain  and  Sweden  and  Belgium.  However,  certain 
Member States are reporting in their annual reports administrative decisions denying market 
access,  without  ever  notifying  these  to  the  Commission.  In  2009,  the  Commission  received 
314  notifications.  The  Member  States  notifying  were  Portugal,  Denmark  and  UK.    All 
notifications concerned precious metals, with the exemption of those from the UK, related to 
furniture. In 2010, a higher number of notifications were observed. The Commission received 
809 notifications. The Member States notifying were Portugal, Denmark, the UK and Spain.  
Most notifications concerned, again, precious metals. Some notifications were received in the 
food and fertilizers area. Administrative decisions have been taken without being notified to 
the Commission. For example one Member State mentions in its yearly report to have issued 
a written notice as well as a decision for “products increasing yield”; these decisions were not 
notified  to  the  Commission.  From  2011,  the  number  of  notifications  stabilised;  the 
Commission received 474 notifications, with only two Member States notifying, Portugal and 
Denmark.  Most notifications concerned precious metals. Some notifications were received in 
the  area  of  food  supplements  (e.g.  addition  of  folic  acid  in  certain  food).  Administrative 
decisions  denying  market  access  are  mentioned  by  certain  Member  States  in  their  annual 
reports,  but  not  notified  to  the  Commission.  In  2012,  the  Commission  received  434 
notifications.  Member  States  notifying  were  Portugal,  Denmark,  Belgium  and  Spain.    Most 
notifications  concerned  precious  metals.  Other  sectors  concerned  were  fertilisers,  food 

130 

 
 
supplements,  food  additives  (e.g.  addition  of  caffeine  in  energy  drinks),  and  vitamins  (e.g. 
addition of vitamin B in energy drinks). In 2013, the Commission received 328 notifications. 
Member  States  notifying  were  Portugal,  Denmark,  Belgium  and  Spain.    Most  notifications 
concerned  precious  metals,  fertilisers,  food  supplements.  A  slightly  lower  number  of 
notifications  were  registered  during  2013,  without  any  reliable  explanation.    Administrative 
decisions are mentioned in the annual reports but never notified to the Commission:  at least 
one  case  concerning  a  negative  administrative  decision  was  received  through  SOLVIT 
(fertilizers),  60  decisions  were  adopted  by  a  regional  authority  (solar  panels,  car  pieces, 
sanitary  tap  ware),  30  decisions  affecting  TV  sets,  2  affecting  fertilizers  and  24  articles  of 
precious  metals.  20  cases  were  kit  cars  were  denied  market  access  were  also  taken  and  not 
notified. In 2014, the Commission received 466 notifications. Member States notifying were 
Portugal,  Denmark,  UK,  the  Netherlands  and  Spain.   Most notifications  concerned precious 
metals. Notifications were also received in the area of food: vitamins (e.g. levels of vitamin D 
  Other 
&A),  food  additives  (caffeine 
in  chocolate),  childcare  articles  (playpens). 
administrative  decisions  are  mentioned  by  yearly  reports  but  not  notified 
the 
to 
Commission225;  in  one  case,  the  adoption  of  460  administrative  negative  decisions  is 
highlighted  in  the  annual  reports,  and  none  was  notified  to  the  Commission.  In  2015,  the 
Commission  received  447  notifications.  Member  States  notifying  were  Portugal,  Denmark, 
Belgium  and  Spain.    Most  notifications  concerned  precious  metals.  Notifications  were  also 
received in the area of fertilisers, energy drinks and food supplements.  Some Member States 
mention, in their annual reports, a certain number of administrative decisions taken following 
Article  6  (2)  of  the  Regulation226,  while  these  decisions  have  not  been  notified  to  the 
Commission.  In  2016, the Commission  received 646 notifications.  Member States notifying 
were  Portugal,  Denmark,  UK,  Belgium  and  Spain.    Most  notifications  concerned  precious 
metals.  Notifications  were  also  received  in  the  area  of  vitamins  (e.g.  iron,  acid  folic),  food 
supplements  and  furniture.  Some  discrepancies  appear  between  the  annual  reports  and  the 
notifications.  

As  regards  the  sectors  concerned  by  these  notifications,  the  analysis  shows  that  precious 
metals is the most concerned sector. The fact that most of notifications relate to one category 
of  products,  i.e.  precious  metals,  could  be  explained  by  the  reluctance  of  Member  States  to 
apply  the  mutual  recognition  principle  in  an  area  where  many  of  them  have  permanent  and 
long-time established control bodies specifically devoted to assessing hallmarking and control 
of precious metals. This generated several infringement procedures, and the Court of Justice 
underlined  in  several  rulings227  that  Member  States  have  to  respect  the  free  movement  of 
precious  metals  on  the  basis  of  the  mutual  recognition  principle.  For  example,  certain 
Member States require a compulsory marking of the product, by the Authorised Assay Office 
to indicate that it has been satisfactorily assayed (the nature of the metal and its standard of 
fineness),  and  did  not  accept  marking  by  an  Authorised  Assay  Office  in  another  Member 
State. The Court rules that member States cannot prohibit the marketing of precious articles 
that  have  been  hallmarked  by  an  independent  body  in  another  Member  State228.  Because  of 
the abundant jurisprudence of the Court on these issues, national authorities became over the 
time well acquainted with the application of the principle in this area, and with the obligation 
to notify contained in the Regulation. This is particularly the case of Portugal, accounting for 
80% of all notifications received, as all of the decisions notified concern precious metals.  

225  
226  
227  

228  

4 cases observed 
545 in one case and 32 in another case 
The  main  cases  being  C-220/81  Criminal  proceedings  against  Timothy  Frederick  Robertson  and  others,  C-293/93  Criminal 
proceedings against Ludomira Neeltje Barbara Houtwipper, C-30/99 Commission v. Ireland 
C-293/93 Criminal proceedings against Ludomira Neeltje Barbara Houtwipper 

131 

 
                                                            
2.  OVERVIEW OF MEMBER STATES ANNUAL REPORTS 

Overview 2010 

25229 Member States submitted annual reports for their activity in 2010.  

As these are the first reports after the application of the Mutual Recognition Regulation from 
13 May 2009, they do not bring much information as many Member States underlined it was 
too early to draw effective conclusion on the implementation of the Regulation.  

Some difficulties are already reported as regards certain categories of products, i.e. fertilizers 
and  textiles.  Most  of  the  requests  received  concern  precious  metals,  food  supplements  and 
additives, fertilizers and construction products.  

Moreover,  Member  States  raised  the  importance  of  PCPs,  and  that  economic  operators  are 
still not very aware about their existence (e.g. Portugal reports 25 annual inquiries received, 
and  consider  that  the  low  volume  of  inquiries  is  due  to  the  lack  of  awareness about  PCPs). 
Language issues with regards to PCPs are already mentioned by certain Member States.   

The  reports  also  mentioned  that  raising  awareness  about  mutual  recognition,  guidelines  and 
organising trainings remains necessary in order to ensure a smooth application of the mutual 
recognition  principle  (e.g.  Slovakia,  Romania,  Spain,  and  the  Netherlands).  Some  Member 
States  (e.g.  Germany)  raised  the  difficulties  encountered  at  national  levels  as  regards  the 
notification of administrative decisions restricting market access, due to the important number 
of national authorities involved.   

Overview 2011 

For the period May 2010 to December 2011, 24230 Member States submitted annual reports. 
There are disparities with regards to the content of the reports submitted; while some reports 
are  very  detailed  and  contain  useful  information  for  assessing  the  functioning  of  mutual 
recognition (e.g. France, Belgium, the Netherlands), other are just brief summaries informing 
on the absence of decisions for which a notification should be made (e.g. Slovenia, Estonia).   

The  Member  States'  yearly  reports  on  the  implementation  of  mutual  recognition  mention 
general  issues  with  the  implementation  of  the  mutual  recognition  principle,  in  particular 
language  and  access  to  information  as  well  as  scope  issues.  PCPs  encounter  difficulties  as 
they  often  need  translation  in  order  to  deal  with  the  requests  received.  The  questions  they 
have to deal with are often very complex, and relate to a wide category of products.  

Some Member States point to the lack of administrative cooperation, and suggest the use of 
IMI  for  enhancing  the  way  national  administrations  communicate  among  them  (e.g.  Spain, 
France, Sweden, and the Czech Republic).  

The  lack  of  awareness  about  mutual  recognition  is  highlighted  in  numerous  reports,  and 
awareness  raising  campaigns  and  trainings  are  suggested  by  Member  States  in  order  to 
address this problem (e.g. Spain, France, the Netherlands, and Denmark).  

7  Member  States  mentioned  having  issues  with  products  subject  to  prior  authorisation 
procedures, and required guidance from the Commission on this issue.  

229  
230  

Cyprus and Poland did not submit annual reports  
Cyprus, Malta and Bulgaria did not submit annual reports 

132 

 
                                                            
As regards problematic sectors, several Member States (12) listed fertilising products as one 
of  the  products  for  which  they  received  the  most  queries,  and  highlighted  the  particular 
obstacles  faced  for  a  smooth  application  of  mutual  recognition  to  fertilising  products  (e.g. 
Belgium, Austria). Food is also a sector that Member States considered as problematic. 

Overview 2012 

25231 Member States submitted annual reports.  

The  problematic  sectors  pointed  out  in  the  annual  reports  are  construction  products,  food, 
fertilisers and prior authorisation procedures. In the construction products area, Belgium notes 
an increase in the number of inquiries received, and underlines that the number of questions in 
this  area  accounts  for  44%  of  the  total  number  of  questions  received.  This  assessment  is 
shared by Germany, the Czech Republic, and Italy. With regards to fertilisers in particular, 20 
Member  States  listed  fertilising  products  as  one  of  the  products  for  which  they  received 
queries  through  their  PCPs.  Seven  Member  States  specifically  listed  fertilising  products  as 
being  a  difficulty  for  the  smooth  application  of  the  MRR.  Further,  10  Member  States 
mentioned having issues with products subject to prior authorisation procedures. Difficulties 
are also raised as regards the concept of "lawfully marketed" (e.g. Slovakia).  

Member  States  are  also  raising  the  issue  of  poor  administrative  cooperation;  for  example, 
Denmark  points  out  that  slow  replied  from  PCPs  are  unsatisfactory  for  economic  operators 
and risk undermining cooperation among authorities.  Some Member States suggest putting in 
place  a  network  of  PCPs  to  enhance  cooperation  and  communication  (e.g.  France,  Czech 
Republic).  

The annual reports are also indicating a certain number of administrative decisions denying or 
restricting  market  access  that  were  taken  at  national  level,  without  being  notified  to  the 
Commission (e.g. Poland reports 22 decisions and 19 written notices).  

The  preventive  effect  of  the  Regulation  is  pointed  out  as  being  one  of  the  benefits  the 
Regulation brings (e.g. Slovakia, Bulgaria). This is because the principle has to be applied on 
a case by case basis, thus obliging national authorities to asses each individual case.  

The  lack  of  awareness about  mutual  recognition  is  often  mentioned  by  Member  States,  and 
some  suggest  awareness  raising  campaigns  as  a  useful  means  to  address  this  issue  (e.g. 
France, Slovakia).   

Overview 2013 

All  Member  States  submitted  annual  reports.  There  are  disparities  as  regards  the  content  of 
the reports submitted; while some reports are very detailed and contain useful information for 
assessing  the  functioning  of  mutual  recognition  (e.g.  France,  Belgium,),  other  are  just  brief 
summaries  informing  on  the  absence  of  decisions  for  which  a  notification  should  be  made 
(e.g. Malta, Greece, Estonia).   

11  Member  States  highlight  the  lack  of  awareness  about  mutual  recognition  and  the  poor 
administrative  cooperation  among  authorities.  They  suggest  guidance  and  awareness  raising 
campaigns in order to remedy this problem, as well as enhancing administrative cooperation.  

231   Malta and Cyprus did not submit annual reports.  

133 

 
                                                            
As  regards  PCPs,  the  difficulties  due  to  the  wide  range  of  products  covered  by  mutual 
recognition  are  pointed  out.  Internal  coordination  is  needed  in  order  to  be  able  to  reply  to 
economic  operators  within  the  deadlines,  or  an  expert  network  to  support  the  PCPs  (e.g. 
Bulgaria).  Furthermore,  PCPs  are  also  receiving  questions  outside  the  scope  of  their 
competences, and are complaining about language issues, as replies and questions need to be 
translated (e.g. Romania, Spain, Lithuania, France).  

As regards problematic sectors, the food sector is mentioned by several Member States (e.g. 
Spain, Denmark) as well as fertilisers (10 Member States reported problems in this area, e.g. 
Belgium,  Austria,  Portugal).  Articles  of  precious  metal  and  construction  products  ('new 
problems'  highlighted:  the  role  of  autonomous  certifying  bodies,  gold-plating,  non-
acceptance of CE marked products, national quality marks and standards) continue to remain 
problematic.  

As  regards  notifications,  Slovenia  suggests  putting  in  place  a  database  to  share  the 
notifications  received  by  the  Commission.  As  during  precedent  years,  administrative 
decisions  denying  or  restricting  market  access  are  being  taken  at  national  level  (e.g.  30 
decisions mentioned by Hungary in its annual reports) but not notified to the Commission.  

Estonia mentioned difficulties as regards the identification of the applicable legal framework 
for  some  products,  and  the  Czech  Republic  mentions  difficulties  as  regards  prior 
authorisations.  

Overview 2014 

25  Member  States  have  submitted  the  yearly  report.    There  are  disparities  as  regards  the 
content  of  the  reports  submitted;  while  some  reports  are  very  detailed  and  contain  useful 
information  for  assessing  the  functioning  of  mutual  recognition  ,  other  are  just  brief 
summaries informing on the absence of decisions for which a notification should be made.   

As  regards  notifications,  some  negative  decisions  are  mentioned  by  yearly  reports  but  not 
notified to Commission (4 cases noted). In one case, the adoption of 460 negative decisions is 
highlighted while none was notified.  

The majority of issues underlined by Member States on the basis of notifications and requests 
for  information  concern  a  few  specific  categories  of  goods:  articles  of  precious  metals, 
foodstuffs, food additives and food supplements, fertilisers and construction products.  

Other difficulties highlighted are related to the  PCPs. Their role and identity are not widely 
known  among  economic  operators  and  administrations  (even  national  ones).  Furthermore, 
linguistic difficulties were pointed out, as PCPs need often to translate inquiries and replies. 
Some  Member  State  indicated  that  certain  PCPs  are  extremely  difficult  to  contact,  by 
economic  operators,  other  PCPs  or  researchers.  Finally,  the  deadlines  are  considered  too 
stringent, but nevertheless, mostly respected everywhere.  

Difficulties  still  remain  as  to  demonstrate  that  a  product  has  been  lawfully  marketed  in 
another  Member  State,  even  after  the  Commission  adopted  a  guidance  document  on  these 
issues.  Other  difficulties  relate  to  economic  operators  '  understanding  of  “harmonised”  and 
“non-harmonised” areas, and thus on when the principle of mutual recognition may be used.   

As regards the impacts of the Regulation, they are generally estimated as positive by Member 
States.  Benefits  are  highlighted  for  economic  operators  and  administrations  too,  as  they  are 

134 

 
for  example  less  burdened  with  requests  for  conformity  assessment.  Member  States  tend  to 
consider in their reports that the Regulation has great preventive importance, and the highest 
added value is estimated in terms of information provided to enterprises (especially SMEs) by 
the PCP as regards existing national technical requirements.  

As regards suggestions for improving the application of the regulation, Member States refer 
to  information  and  dissemination  activities,  in  order  to  u-increase  awareness,  more  contacts 
with  and  between  PCPs,  in  order  to  enhance  administrative  cooperation,  and  common 
procedures and best practices.  

Overview 2015 

22  Member  States  submitted  annual  reports.  Generally,  identifying  recurrent  problems  and 
monitoring the application of the Mutual Recognition Regulation on the basis of the annual 
reports remains not straightforward. This is because the data received is not homogeneous or 
comprehensive  enough  to  be  considered  as  usable  input,  and  the  template  suggested  by  the 
Commission is still not widely followed by Member States.  

Template reporting 

Application 

Sectors 

PCP 

Assessment 

Impact 

AOI 

The  number  of  decisions  taken  in  the  period,  the 
authorities involved and the legal basis on which they 
were taken 

An  analysis  of  types  of  products  and/or  sectors  in 
which the Regulation was applied most often 

Information  on  the  structure  and  functioning  of  the 
PCP  (contact  details,  roles  performed,  staffing, 
number and nature of inquiries, etc.) 

Any difficulties experienced – proposals  
possible improvements 

for 

Impacts of the Regulation on the practical functioning 
of the mutual recognition principle 

Any other possible element worth mentioning 

On the basis of the available information, the main difficulties identified relate to: 

The  "lawfully  marketed"  concept:  the  reports  mention,  despite  guidance  from  the 
Commission,  difficulties  in  assessing/demonstrating  that  a  product  has  been  lawfully 
marketed  in  a  given  Member  State.  Clarifications  are  required  so  as  to  improve  the  current 
situation and bring more legal certainty.  

Lack  of  awareness  about  mutual  recognition:  this  is  a  predominant  issue  highlighted  in  the 
reports, and Member States are almost unanimously calling for awareness-raising campaigns, 
to  increase  the  level  of  knowledge  about  what  mutual  recognition  is  and  how  it  works  in 
practice.  

Poor  administrative  cooperation  and  communication:  the  reports  mention  the  lack  of  cross-
border cooperation among authorities, and that some Product Contact Points are very difficult 

135 

 
to contact. Most reports underline the need for better cooperation among authorities, allowing 
for swift communication.   

Prior authorisation procedures: differences in perception and interpretation relating to existing 
authorisation procedures in different Member States are also widely mentioned in the reports. 
However,  the  lack  of  details  does  not  allow  a  clear  understanding  of  why  this  is  a problem 
and how it should be addressed.   

The  sectors  where  the  application  of  mutual  recognition  is  more  problematic  are  fertilisers, 
food  labelling,  food  supplements  and  hallmarks.  In  particular,  food  supplements  are 
considered  as  a  very  problematic  area  for  the  application  of  mutual  recognition  and 
harmonisation is recommended to facilitate the free movement of goods.  

As regards the activity of PCPs, the number of questions received during 2015 amounted to 
1645.  Out  of  the  22  annual  reports  received,  16  only  indicate  the  number  of  inquiries 
received.  The  other  Member  States  mention  the  activity  of  PCPs,  without  indicating  the 
number  of  questions  they  received.  The  most  active  Member  States  are  France,  Czech 
Republic and Belgium, followed closely by Hungary and Sweden.  

The reports highlight the limitations PCPs encounter when exercising their activities. Often, 
they  receive  questions  which  are  not  within  their  remit.  They  are  also  affected  by  the 
complexity  of  the  questions  they  receive,  the  variety  of  products  covered  by  mutual 
recognition and language limitations. This affects the quality of the reply, and also the timely 
provision of information to economic operators; the strict deadlines for replying to economic 
operators  are  difficult  to  meet,  although  mostly  adhered  to.  More  and  better  administrative 
cooperation,  supported  by  an  IT  tool  for  communication  and  translation  purposes,  is 
suggested  as  a  remedy  to  these  issues.  Several Member  States  point  out  the  low  number  of 
inquiries received by the PCPs, linked to the lack of awareness about the service they provide. 
Increasing awareness and providing a visual identity for PCPs could constitute an appropriate 
way of addressing this issue. Some Member States indicate that offering online information 
about mutual recognition and certain problematic sectors helped in optimising the functioning 
of the PCPs. 

Only  a  few  Member  States  provided  input  on  the  impacts  of  the  Mutual  Recognition 
Regulation  on  free  movement  of  goods.  Generally,  the  Regulation  is  considered  useful  as  a 
pre-emptive instrument, as well as having the potential to facilitate free movement of goods. 
However,  adjustments,  especially  in  terms  of  awareness,  legal  certainty  and  administrative 
cooperation, are necessary in order for this potential to be fully realised.  

3.  OVERVIEW INQUIRIES RECEIVED BY PCPS 

During 2010/2011, PCPs received 1402 inquiries. This number is based on the annual reports 
where Member States provided information on the number of questions received. The sectors 
accounting for most of the questions are fertilisers and foodstuff. The most active PCPs are 
France, Czech Republic, Slovakia and Germany.  

136 

 
581 

2010/2011 

325 

29  34  23  12  86  34  23  14  24  10  19 

134 

16 

25  13 

Number of Q received

During  2012,  PCPs  received  1439  inquiries.  This  number  is  based  on  the  annual  reports 
where Member States provided information on the number of questions received. The sectors 
accounting for most of the questions are fertilisers and foodstuff. The most active PCPs are 
France, Czech Republic, Slovakia and Germany.  

375 

2012 

325 

52  38  17  30 

97  75 

17  53  14  35  17 

100  135 

13 

Number of Q received

During 2013, PCPs received1826 inquiries. This number is based on the annual reports where 
Member  States  provided  information  on  the  number  of  questions  received.  The  sectors 
accounting for most of the questions are fertilisers, construction products and foodstuff. The 
most  active  PCPs  are  France,  Czech  Republic,  Slovakia,  Hungary,  Belgium  and  Germany. 
Some Member States received a very low amount of questions, e.g. Ireland, Portugal.  

416 

325 

2013 

272 

91 

31 

10  48 

140 

83 

20  41  10 

100 115 

24  14 

71 

Number of Q received

During 2014, PCPs received1793 inquiries. This number is based on the annual reports where 
Member  States  provided  information  on  the  number  of  questions  received.  The  sectors 
accounting for most of the questions are fertilisers, construction products and foodstuff. The 
most active PCPs are France, Czech Republic and Belgium. Some Member States received a 
very low amount of questions, e.g. Ireland, Portugal.  

137 

 
 
 
 
498 

434 

2014 

96 

26  84  93  160 

51  12 

100  82  33  10  52  20  21  21 

Number of Q received

During 2015, PCPs received1546 inquiries. This number is based on the annual reports where 
Member  States  provided  information  on  the  number  of  questions  received.  The  sectors 
accounting for most of the questions are fertilisers, construction products and foodstuff. The 
most active PCPs are France, Czech Republic and Belgium. Some Member States received a 
very low amount of questions, e.g. Ireland, Bulgaria.  

656 

2015 

87  31  86  91  110  40  9 

217 

100  37  19  10  31  25  18 

Number of Q received

138 

 
 
 
 
 
ANNEX  8:  RESULTS  OF  THE  EXTERNAL  EVALUATION  PERFORMED  BY  DTI, 
TECHNOPOLIS, E&Y AND VVA CONSULTING (2015) 

This chapter presents the results – findings – of the evaluation. It is mainly based on primary 
data  collected  through  surveys  and  interviews  (cf.  Chapter  3  for  more  details  on  the 
methodologies  used),  some  secondary  (statistical)  data  from  various  sources,  and 
supplemented with insights from the literature review and from position papers received from 
EU-level business associations.  

The chapter begins with an  overall question, i.e. ‘to what extent  has the  mutual  recognition 
principle achieved its objectives?’ (section 5.1) The stakeholders’ views on this are discussed 
before  the  chapter  proceeds  to  analyse  more  specific  aspects  of  the  mutual  recognition 
principle and its application. 

Section  5.2  takes  the  perspective  of  the  enterprises,  i.e.  ‘to  what  extent  do  European 
enterprises know and understand the mutual recognition principle? Which strategies do they 
employ  when  exporting  to  other  Member  States,  what  are  the  costs  to  companies  if  the 
principle  is  not  fully  applied  by  the  Member  States,  and  are  the  administrative  burdens  of 
(non-)application of the mutual recognition principle proportionate?’ 

This is followed by section 5.3 taking the perspective of the Member States, i.e. ‘how well do 
Member State administrations know and understand the mutual recognition principle, and do 
they  apply  the  principle  correctly?’  This  section  also  covers  the  more  technical  aspects  of 
Member  States’  application  of  the  principle  –  notification  practices,  use  of  technical  rules, 
mutual  recognition  clauses  and  prior  authorisation  procedures,  as  well  as  the  dialogue 
between the Member States (product contact points).  

Section 5.4 takes a crosscutting perspective, seeking to identify in which markets and which 
sectors problems are found most commonly. 

Finally, section 5.5 summarises some of the key findings into a ‘typology of obstacles’ to full 
application of the mutual recognition principle.  

1.  STAKEHOLDER’S  VIEWS  ON  WHETHER  THE  MUTUAL  RECOGNITION  PRINCIPLE  HAS 

ACHIEVED ITS OBJECTIVES  

According  to  Regulation  (EC)  No.  764/2008,  the  objectives  of  introducing  the  mutual 
recognition principle are as follows: 

 

 

 

ensuring the free movement of goods within the internal market; 

lowering remaining trade barriers in the internal market; and 

promoting trade in goods among EU Member State. 

From  the  three  surveys  with  the  product  contact  points,  the  national  business  and  sector 
associations  and  the  companies,  it  can  be  seen  that  there  are  stakeholders  who  perceive  the 
mutual recognition to have, or nearly have, reached its stated objectives. However, there are 
also a substantial number of stakeholders, who think that the mutual recognition principle still 
has some way to go before it has achieved its objectives.  

139 

 
In the product contact point survey, the respondents are generally positive. Around half of the 
product contact points think that the objectives have been either completely reached or close 
to completely reached. The other half perceive the objectives to be partly reached, and a few 
product  contact  points  say  that  there  is  quite  a  long  way  to  go  in  terms  of  lowering  trade 
barriers in the internal market (see Figure 8-1).  

Figure  8-1:  Product  contact  point  survey:  To  what  extent  has  the  mutual  recognition 
principle achieved its objectives? 

Source: Questionnaire survey among PCPs, running from 9 October 2014 to 5 January 2015, carried out by DTI 

The  company  survey  reveals  that  among  the  companies  that  know  about  the  mutual 
recognition  principle,  there  is  a  slightly  negative  perception  of  how  the  mutual  recognition 
principle  works  in  practice.  While  one-fourth  believes  that  it  works  as  intended,  more  than 
one-third thinks the opposite and states that the principle works badly in practice as illustrated 
in Figure 8-2. The interviews with companies show that the main reason for stating that the 
mutual  recognition  principle  works  badly  has  to  do  with  additional  tests  that  national 
authorities ask the companies to perform, even though the mutual recognition principle should 
apply. 

Figure  8-2:  Company  survey:  In  your  view,  how  well  does  the  mutual  recognition 
principle work in practice? 

Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015, carried out by DTI 

140 

 
 
 
 
 
The  survey  among  national  business  and  sector  associations  shows  that  around  40%  of  the 
respondents  believe  that  the  objectives  either  have  been  completely  reached  or  are  close  to 
being  completely  reached.  25-35%  of  the  respondents  perceive  the  objectives  to  be  partly 
reached, and around 25-30% of the respondents believe that there is still quite a long way to 
go before the objectives have been reached (see Figure 8-3). 

Figure  8-3:  Business  and  sector  association  survey:  To  what  extent  has  the  mutual 
recognition principle achieved its objectives? 

Source:  Questionnaire  survey  among  national  business and  sector  associations, running  from  9 October  2014  to  5  January 
2015, carried out by DTI 

There are indications from the survey and the interviews that the mutual recognition principle 
is  not  applied  to  a  satisfying  extent.  The  Danish  Business  Association  is  one  of  the  few 
business associations that actively monitor its members’ problems within the area of mutual 
recognition.  The  association  estimates  that  20%  of  its  members  experience  problems  with 
incorrect application of the mutual recognition principle. However, the figure is relatively old 
(from  2007).  The  Danish  business  association  is  carrying  out  a  new  survey  of  its  members, 
but  the  results  are  not  ready  yet.  In  addition, the  Spanish  business  association  has  a  project 
called ‘Online for the identification of problems of Spanish companies in the European Single 
Market’.  It  aims  to  1)  collect  information  on  the  main  problems,  which,  despite  the 
implementation of the Single Market, hinder the activity of Spanish companies, and 2) seek 
solutions to these problems in collaboration with the competent authorities of the National or 
Community Administrations. According to the Spanish business association, one of the main 
obstacles refers to the incorrect application of the mutual recognition principle. 

Positive  aspects  of  the  mutual  recognition  principle  are  mentioned  in  the  interviews. 
Companies state that when mutual recognition works well, they are able to manufacture one 
version  of  their  product  only  and  sell  it  on  different  markets,  thus  lowering  the  costs.  In 
addition, one company has found it easier to challenge ‘local wish lists’ from customers and 
distributors  blamed  on  local  regulations.  Where  there  is  malfunctioning  of  the  principle 
(experienced by approx. 35% of the companies), this is mainly perceived to be related to the 
application of the principle. 

Overall,  the  mutual  recognition  principle  in  itself  works  well  as  a  legal  concept  to  help 
stimulate  trade.  The  literature,  the  questionnaire  surveys  and  the  interviews  all  point  in  the 
direction  that  it  is  not  in  the  legal  text  as  such,  but  rather  in  its  application  that  challenges 

141 

 
 
 
arise. In addition, the legislation sometimes proves difficult to understand for both companies 
and  Member  State  authorities.  This  means  that  there  are  various  challenges  associated  with 
the  application  of  the  principle,  which  need  to  be  addressed.  A  2012  study  by  Copenhagen 
Economics  also  found  that  according  to  the  SOLVIT  and  TRIS  databases  wrongful 
application of the legislation exists within the area of goods covered by mutual recognition.232  

The impact assessment of the mutual recognition regulation estimated that perfect operation 
of  mutual  recognition  inside  the  EU  would  produce  a  maximum  increase  of  EU  GDP  by 
1.8%. Furthermore, it was estimated that the failure to properly apply the principle of mutual 
recognition  reduced  trade  in  goods  in  the  internal  market  by  up  to  10%  or  €150  billion.233 
Although the Mutual Recognition Regulation has created a better functioning internal market, 
there are still areas where the mutual recognition principle is nor applied properly, and thus, 
there are still potentially benefits to be gained. The nature and extent of the challenges will be 
investigated in this analysis. 

2.  AWARENESS  OF  THE  PRINCIPLE  AMONG  ENTERPRISES,  STRATEGIES  CONCERNING 
MUTUAL RECOGNITION, AND COST OF INSUFFICIENT APPLICATION OF THE PRINCIPLE  

This section takes the perspective of the enterprises, i.e. how well do they know the principle, 
do they use it in practice, and what are the costs to companies if the principle is not properly 
applied  by  the  Member  States?  Finally,  the  question  is  asked  whether  the  administrative 
burdens of (non-) application of the mutual recognition principle are proportionate. 

Awareness and knowledge of the principle among enterprises 

There  seems  to  be  a  lack  of  awareness  of  the  principle  of  mutual  recognition,  particularly 
among  enterprises.  The consequence  is  that  enterprises  and competent  (regional)  authorities 
often take national technical rules for  granted. Enterprises then adapt their products to local 
requirements,  or  get  them  retested,  thereby  incurring  added  costs  and  requiring  additional 
time, or they may even completely refrain from entering the new market.234 This is supported 
by input from the Member States’ Consultative Committee to the Commission that shows that 
there  are  still  uncertainties  concerning  how  to  handle  the  mutual  recognition  principle.235 
Moreover,  most  enterprises  cannot  afford  a  lengthy  process  discussing  back  and  forth  with 
Member State authorities, so they try to either solve the problem quickly or withdraw from a 
market.  

The  awareness  and  knowledge  of  the  principle  of  mutual  recognition  among  enterprises  is 
somewhat  mixed.  The  large  companies  exporting  to  other  Member  States  seem  mostly  to 
have  at  least  some  awareness  and  understanding  of  the  principle.  Often,  they  have  a  legal 
department, which, among other things, focuses on the mutual recognition principle. From the 
perspective of the product contact points, more than 40% of the product contact points think 
that most (above 75%) large companies seeking to market a product in another Member State 
know and understand the mutual recognition principle. A third of the product contact points 
think  that  50-75%  of  large  companies  know  and  understand  the  principle.  For  SMEs,  the 
situation is very different. More than a third of the product contact points assess that among 

232  
233  

234  
235  

Copenhagen Economics (2012): Delivering a stronger single market 
European  Commission  (2007):  Accompanying  document  to  the  Proposal  for  a  directive  of  the  European  Parliament  and  of  the 
Council  laying  down  procedures  relating  to  the  application  of  certain  national  technical  rules  to  products  lawfully  marketed  in 
another Member State and repealing Decision 3052/95/EC Impact assessment 
 Interview with DG ENTR 
For instance: European Commission (2010): Minutes of the second meeting of the consultative “Mutual Recognition Committee”, 
held in Brussels on 19 November 2010 and European Commission (2011): Minutes of the third meeting of the consultative “Mutual 
Recognition Committee”, held in Brussels on 30 November 2011 

142 

 
                                                            
SMEs  seeking  to  market  a  product  in  another  Member  State,  less  than  25%  know  and 
understand the mutual recognition principle, while 40% of product contact points believe that 
only between 25% and 50% of SMEs know and understand the principle (cf. Figure 8-4).  

The experiences reported by the participating business organisations (both in the survey and 
in  the  interviews)  are  consistent  with  the  assessment  of  the  product  contact  points,  i.e.  that 
small companies generally do not have the same degree of awareness and basic understanding 
of the mutual recognition principle and clauses compared to large enterprises. 

Asking  companies  directly  about  this,  the  company  survey  shows  that  about  75%  of  the 
companies  participating  in  the  survey  either  know  what  the  principle  of  mutual  recognition 
means or have heard of it, but are not familiar with its details (See Figure 8-4). 

Figure 8-4: Company survey: Do you know about the principle of mutual recognition? 

Note: N = 164. 
Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015, carried out by DTI 

The  company  survey  confirms  the  experience  of  the  product  contact  points  and  business 
organisations,  i.e.  that  large  companies  have  a  much  greater  degree  of  awareness  of  the 
principle  than  small  companies  do.  It  is  a  bit  surprising  that  many  micro  companies  have  a 
good understanding of the principle, see Figure 8-5 below. 

There  is  no  obvious  explanation  for  this  phenomenon.  There  may  be  a  bias  in  the  sample 
meaning  that  micro  companies  that  take  the  trouble  to  answer  the  survey  may  be  more 
familiar  with  and  interested  in  the  mutual  recognition  principle  than  micro  companies  as  a 
whole. However, such a bias may of course also apply to the other company segments.  

143 

 
 
 
 
 
 
 
 
Figure 8-5: Company survey: Do you know about the principle of mutual recognition? 
Micro (<10), Small (10-49), Medium (50-250) and Large (>250) companies 

Note: N = 164. 
Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015, carried out by DTI 

The companies in the survey were asked whether they have exported to other Member States - 
i.e. whether they have been in a position where the mutual recognition principle could apply. 
The  majority  of  the  companies  in  the  survey,  close  to  75%,  have  sold  goods  in  another 
Member  State  over  the  last  three  years.  This  is  consistent  with  the  share  of  companies  that 
have  heard  about  the  mutual  recognition  principle.  However,  for  most  of  the  non-exporting 
companies, their decisions not to sell their goods in other EU  countries were not influenced 
by concerns about the potential problems in meeting the technical rules applicable in other EU 
countries, and the decision not to export was related to other issues.236 

Awareness of the principle among business associations 

In the survey of business associations and in the subsequent interviews, it became clear that 
many business associations did not monitor the principle and consequently could not provide 
input to the evaluation. One the one hand, the business associations sometimes conclude that 
since  they  do  not  hear  about  the  problem  of  mutual  recognition  from  their  members,  the 
problem with less than full application of the mutual recognition principle cannot be a major 
problem. On the other hand, as an Austrian business association puts it, “You need to monitor 
the application of the mutual recognition principle in order to know if there are problems.” 

Furthermore, the interviews also indicated that many business associations do not know much 
about  the  mutual  recognition  principle,  the  main  reason  being  that  they  do  not  receive 
complaints  from  their  members  and  therefore  do  not  focus  on  the  area.  However,  more 
information on the subject could potentially push some business and sector associations to be 
more  aware  of  the  application  of  the  mutual  recognition  principle  and  actively  investigate 
they  experience  problems.  The  Commission  could 
among 
advantageously  inform  the  business  associations  about  the  mutual  recognition  principle.  A 
concrete suggestion from the Austrian business association was to use EEN to distribute such 
information, organise seminars on the subject, etc. 

their  members  whether 

236  

This specific indication is based on a very small number of answers (N = 23) and must be interpreted with this in mind. 

144 

 
 
 
 
                                                            
Enterprise strategy and experience with mutual recognition when entering other 
Member State markets 

Companies may choose different strategies when entering the market of other Member States, 
all of which affect the resources that they have to spend before the product can be marketed. 
The main strategies are: 

 

 

 

 

examining technical rules in the destination market; 

adapting their products to specific requirements/rules in the destination market; 

retesting  their  products  as  a  result  of  requirements  from  customers  and/or  authorities; 
and  

relying on the principle of mutual recognition for products already marketed in another 
Member State. 

As  shown  in  Figure  8-6,  two-thirds  of  the  companies  participating  in  the  company  survey 
check if their products meet the applicable technical rules before entering a new EU market. 
A  minority  of  them  do  not  experience  any  additional  requirements  for  their  products. 
However,  one-third  of  the  companies  do  not  check  if  additional  technical  rules  apply  when 
entering a new EU market, probably because they trust that the mutual recognition principle 
works as intended. 

Figure 8-6: Company survey: When entering a new EU country, have you taken any of 
the following steps related to meeting technical rules applicable in that country? 

33% 

45% 

22% 

I have done nothing to check if my
products meet the technical rules
applicable in the destination EU
country

Examined the applicable technical
rules in the destination EU country, but
there were no additional requirements
as compared to my domestic market

Examined the applicable rules in the
destination EU country

Note: N = 86. 
Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015, carried out by DTI 

For the companies  that have  examined the applicable rules in  the destination  Member State 
and  judged  that  actions  had  to  be  taken237,  60%  adapted  their  product(s)  to  local  technical 
requirements,  22%  retested  their  products,  and  19%  took  ‘other  steps’.  The  other  steps 
(extracted from the open answers to the survey) primarily included doing both of the above 
and sometimes refraining from entering the market of the Member State in question.  

237  

37 companies answered this question 

145 

 
 
                                                            
Textbox 8-1 

[We usually] check our product with national authorities, and nine out of 10 times we are told 
that we need to adapt our product to local requirements. 

Medium-sized company, construction sector (company survey) 

(Particularly experiences problems in France and Germany) 

The  business  associations  were  also  asked  about  how  the  companies  prepare  for  entering  a 
new  market.  They  also  pointed  to  the  spending  of  resources  on  examining  the  applicable 
technical rules in the destination Member State as a very frequent choice. Thus, two-thirds of 
business  associations  responded  that  this  was  very  frequently  or  frequently  done  by 
companies. Almost half of the business associations also see businesses frequently refraining 
from entering the market at all. 

Figure 8-7: Business and sector association survey: Companies may apply one or more 
of  the  following  strategies  when  entering  a  new  market  (within  the  internal  market). 
How do they react? Rank from 1-4, where 1 is the highest priority and 4 is the lowest 

Source: Questionnaire survey among national business and sector associations, running from 
9 October 2014 to 5 January 2015, carried out by DTI 

However, in the personal interviews stated, retesting was the issue indicated most frequently 
by  the  business  associations  as  a  major  cost  element.  It  was  also  a  requirement  that  the 
companies often faced, particularly because Member States require that testing of the product 
is  done  in  the  destination  Member  State  or  by  specific  laboratories  (which  may  include 
laboratories outside the Member State in question). The statement from a business association 
in the text box below supports this.  

Textbox  8-2:  On  company  strategies  when  met  with  national  technical  requirements 
although mutual recognition should apply 

Their strategy depends on how big  the company is. The big companies can either choose to 
retest, if the market is important to them, or they may be big enough to say “we know the law” 
and  they  challenge.  They  dare  to  take  the  fight.  Small  companies  adapt,  depending  on  how 
important  the  market  is  or  on  how  many  markets  they  operate.  They  cannot  challenge  it 

146 

 
 
because  they  cannot  afford  it,  and  they  fear  the  authorities  and  cannot  afford  to  take  the 
conflict.  Therefore,  when  they  call  us  they  want  to  be  anonymous  when  we  take  the  matter 
further. It is dangerous for them. 

National business association, Northern European Member State 

When asked why these steps were taken, more than 40% of the companies answered that they 
simply  assumed  it  was  necessary,  as  they  did  not  know  if  the  mutual  recognition  principle 
applied  to  their  product.  Almost  a  third  took  such  steps  because  they  were  required  for 
acceptance  in  the  local  market  and  did  not  check  whether  the  mutual  recognition  principle 
could  apply.  Nearly  29%  relied  on  the  principle,  but  it  turned  out  that  it  did  not  work  in 
practice,  meaning  that  the  companies  believed  that  they  had  the  legal  right  to  introduce  the 
products, but the national authorities still asked for testing or adaptation.  

Figure 8-8 Company survey: Why did you take these steps related to meeting technical 
rules? 

Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015, carried out by DTI 

In addition to lack of awareness of the mutual recognition principle among companies, many 
of  the  steps  that  companies  think  they  need  to  take  when  entering  another  Member  State 
market  boil  down  to  ‘legal  uncertainty’  due  to  differences  in  testing  methods,  use  of  prior 
authorisation  procedures,  because  the  legislation  is  difficult  to  understand,  or  because  the 
authorities  in  the  destination  Member  State  do  not  apply  the  legislation  correctly.  In  the 
company  survey,  more  than  half  of  the  companies  rank  legal  uncertainty  concerning  the 
understanding  of  the  mutual  recognition  principle/legislation  as  the  first  or  second  most 
important barrier to an effective functioning of the mutual recognition principle. 

147 

 
 
 
 
Figure  8-9:  Company  survey:  What  are  the  obstacles  to  effective  mutual  recognition? 
Rank from 1-4 

Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015, carried out by DTI 

A  concrete  example  of  national  requirements  forcing  companies  to  adapt  or  withdraw  their 
products is the case of bisphenol A in France.  

Textbox 8-3: Bisphenol A in France 

Bisphenol A is a plastic softener, which is forbidden in baby products, but allowed in other 
plastic  products.  France  has  been  looking  to  extend  the  ban  on  bisphenol  A  to  other  plastic 
products,  and  certain  other  plastic  products  were  included  in  the  ban  on  1  January  2015. 
Companies may then choose to adapt all of their products to the requirements of the French 
market, or just the ones that they want to market in France. In any case, this has a substantial 
economic impact on the companies. The costs may be indirect, as companies may decide to 
withdraw  their  products  or  market  other  products  without  bisphenol  A.  It  can  also  affect 
competition in the sense that competition is lower in the French market due to fewer products 
without bisphenol A being marketed, which may again affect consumers. 

Source: Interview with Eurocommerce 

The  product  contact  points  were  also  asked  about  companies’  strategies  with  respect  to 
technical rules, and their answers indicate that based on their experience companies do indeed 
spend resources on examining technical rules and adapting to the requirements of the Member 
State(s)  where  they  want  to  market  their  products.  When  they  do  this  it  is  due  to  a  lack  of 
awareness  of  the  mutual  recognition  principle.  The  majority  of  the  product  contact  points 
(59%)  report that  this occurs between 10%  and 50%  of  the time,  while  14%  of  the  product 
contact points report that companies from other Member States do this between 50% and 75% 
of  the  time.  This  is  particularly  pronounced  in  the  construction  product  industry  and  in  the 
food and food additives industries. 

Regarding the product contact points’ experience with enterprises from other Member States 
adapting  their  products  to  local  requirements  due  to  lack  of  awareness  of  the  mutual 
recognition principle, 45% of the product contact points reported that companies from other 
Member  State  adapt  their  products  less  than  10%  of  the  time,  35%  of  the  product  contact 
points stated that this occurred between 10% and 50% of the time, while 20% reported that it 
happened  more  the  50%  of  the  time.  Again,  it  was  found  that  product  adaptation  is 

148 

 
 
particularly pronounced within the construction product industry, though the majority of the 
product contact points were not able to identify the sectors in which this occurred.  

With respect to how often enterprises from other Member State have their products retested, 
due  to  lack  of  awareness  of  the  mutual  recognition  principle,  none  of  the  product  contact 
points reported that this is the case in more than 50% of the time, whereas 55% of the product 
contact  points  indicated  that  this  is  the  case  in  only  less  than  10%  of  the  time.  Again,  the 
construction  product  industry  was  pointed  out  as  the  sector  where  this  problem  is  most 
widespread by some product contact points, but the majority of product contact points was not 
able to pinpoint any sectors where the problem is particularly pronounced. 

When asked how often enterprises from other Member States simply refrain from entering the 
market at all, due to the lack of awareness of the mutual recognition principle, 90% of product 
contact  points  reported  that  they  see  this  happening  less  than  25%  of  the  time,  while  the 
remaining  10%  experience  this  between  25%  and  75%  of  the  time.  Most  product  contact 
points have not been able to indicate which sectors are particularly exposed to this problem. 

Costs  to  the  companies  resulting  from  less  than  full  application  of  the  mutual 
recognition principle 

The  companies  that  decided  to  take  steps  to  meet  local  technical  requirements,  such  as 
retesting and/or adapting the products, indicate that there are significant costs associated with 
the  administrative  burden,  retesting  of  products  and  the  actual  adaptation  of  the  product  as 
shown in the Figure 8-10 below. 

Figure  8-10:  Company  survey:  What  are  the  typical  cost  items  involved  and  how 
significant are they? 

Note: N=28-31 (not all companies answered all questions) 
Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015, carried out by DTI 

The companies that have answered this question particularly perceive testing as being costly – 
more  than  40%  of  the  companies  have  rated  testing  as  being  a  very  significant  cost.  The 
testing costs vary considerably, depending on the sector and the product, but some examples 
from different sectors are provided in Table 8-1. 

149 

 
 
Internal company staff time and administrative costs are perceived to be very significant by 
32%  and  30%  of  the  companies,  respectively.  In  the  company  interviews,  many  companies 
mentioned that these types of costs naturally follow the testing costs and are therefore closely 
related to the issue of Member States demanding additional tests. Lastly, around 26% of the 
companies  perceive  the  adaptation  of  products  to  local  technical  requirements  to  be  a  very 
significant  cost.  Furthermore,  it  is  interesting  that  for  all  four  categories,  over  half  of  the 
companies perceive the costs as either very significant or significant.  

The company survey and the subsequent interviews revealed a rather wide range of costs in 
different  sectors.  The  costs  are  presented  in  Table  8-1.  Few  companies  were  able  to  put  a 
figure  on  the  costs  they  face  because  of  the  incorrect  application  of  the  mutual  recognition 
principle.  Of  those  that  provided  estimates,  the  costs  ranged  from  0.5%  of  the  annual 
turnover,  to  20%  of  the  turnover.  Table  8-1  summarises  some  of  the  characteristics  of  the 
companies that provided cost estimates. 

Table 8-1: Overview of the companies that provided estimates for the costs of adapting 
or retesting products 

Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015, and interviews, carried out 
by DTI 

150 

SectorSize of companyKnowledge of MR principlePercentage of export goods falling under MR principleCosts of adaptation or retest (percentage of yearly turnover or euros)Articles of precious metalsSmallyes, but not in detail10010Childcare productsSmallno1050,000 EURChildcare productsLargeyes, but not in detail901Childcare productsMicrono510Childcare ProductsSmallno500,3Childcare productsMediumyes, but not in detail5Company originates from MS where national rules are stricterConstruction productsLargeyes700,5Construction productsMediumyes202Construction productsSmallyes4010Construction productsLargeyes10Testing costs, see caseConstruction productsMediumyes, but not in detail752,000-9,000 EUR/testConstruction productsSmallyesTailor-made products, agree on terms with clientConstruction, retailLargeyes50,000-100,000 EUR/testElectrical productsMediumno207Electrical productsLargeyes, but not in detail102FertilisersLargeyes520FertilisersSmallyes5010Fertilisers and potting soilLargeyes601FoodLargeyes1-55FoodLargeyes800,1Food additives and food supplementsLargeyes, but not in detail605Garments for childrenMediumyes, but not in detail100,2Medical devices and technical aidsLargeyes, but not in detail5020Paper industry, packaging for foodstuff etc.Largeyes1000,0025Production of metal devicesMediumyes, but not in detail51Sports equipmentLargeyesDocument and testing costs, see also caseLargeyes5010 yes305 
 
Two relevant cases were identified within the area of water tap production. This product is 
particular  because  the  tap  is  in  contact  with  drinking  water,  and  the  product  is  therefore 
classified as a product having contact with food. EN standards cover mechanical, functional 
and  physical  requirements  for  taps  and  hoses.  However,  the  use  of  positive  material  lists, 
substance  migration,  noise,  odour,  flavour  or  appearance  of  the  water  is  still  regulated  by 
national testing or certification requirements. Taps are only mentioned in the Drinking Water 
Directive (DWD, 98/83/EC) where EU Member States have to ensure that materials used in 
the  distribution  of  drinking  water  do  not  release  substances  in  concentrations  higher  than 
necessary for the purpose of their use. This means that all Member States can (and do) apply 
their own rules, and the testing procedures vary among the Member States. The approaches of 
Member States differ when it comes to national certification systems. The existence and the 
role of national regulatory bodies and toxicity committees also vary. Often competences fall 
within different authorities. One of the companies has calculated that for each product in the 
category of taps the certification and testing costs are up to €50,000. In addition, the cost of 
getting a new composition approved (to be used for the production of water taps) is between 
€50,000  and  €100,000  (see  Case  4).  The  other  company  cited  testing  costs  for  a  single 
component of approx. €2,000 and for the final product approx. €8000-9000. In addition, tests 
can  be  rather  time-consuming.  For  instance,  a  test  to  determine  whether  the  component  or 
final product contains nickel takes up to 18 weeks (see Case 2). 

Much work has been done to try to secure a common testing system but, so far, the Member 
States  have  not  been  able  to  agree  on  this.  The  prioritisation  of  product  requirements  is 
different,  as  is  sometimes  the  jurisdiction  of  competences.  However,  a  group  of  Member 
States  has  undertaken  some  positive  steps:  Germany,  the  UK,  the  Netherlands  and  France 
have agreed on a common positive list of materials. 

In theory, the mutual recognition principle should apply to this area. However, it is clear from 
the cases that in reality it does not, as Member States require that national tests be carried out 
before accepting the taps on the markets. One company perceives the request for national tests 
as a market protection measure, an observation that is further strengthened by the fact that a 
working  group  under  CEN  (consisting  of  company  representatives)  has  failed  to  find  a 
solution to the problem of requiring national tests (see Case 2 for further information). 

Even though certification and test requirements are different in different countries, the basic 
purpose  and  parameters  are  similar.  Irrespective  of  the  reasoning  behind  the  request  for 
national tests, the tests result in significant costs for companies.  

Another example has to do with paper products, which come in contact with food. Here, the 
company in question experiences that their Italian customers require the product to be tested 
according  to  Italian  standards.  The  company  perceives  this  request  to  be  due  to  lack  of 
knowledge. One test costs around €700, which the company does not see it as a major cost 
rather as an unnecessary and perhaps a bit annoying cost (see Case 1). 

Within  the  area  of  construction  products,  companies  still  feel  that  the  mutual  recognition 
principle is not necessarily respected. The Construction Products Regulation (305/2011) has 
replaced  the  Construction  Products  Directive  (89/106/EE).  This  regulation  aims  to  prohibit 
the  use  of  conflicting  national  marks  of  declaration  of  performance  and  ensure  that  any 
product  that  is  CE  marked  is  freely  allowed  onto  the  market  in  the  EEA  without  further 

151 

 
testing.  Mutual  recognition  applies  to  non-CE  marked  products  in  the  non-harmonised  area 
only.238 

Several  companies  mention  that  there  is  a  specific  problem  in  Germany.  As  a  Commission 
case  from  2011  shows,  the  German  standardisation  body  is  so  dominant  on  the  market  in 
terms of drawing up standards, certifying  products,  etc., that distribution of products  on the 
German  market  is  virtually  impossible  without  conforming  to  this  institute’s  standards, 
although the mutual recognition principle may apply.239 Moreover, the issue was mentioned 
in the literature in 2012, where a Danish flooring company experienced that for products sold 
in Germany, the relevant authority Deutsches Institut für Bautechnik requires more stringent 
tests.  In  addition  to  the  CE  label,  additional  health  and  environmental  impacts  of  products 
need to be tested and monitored by an external, German party. This has led to a significant 
increase  in  costs  for  the  company,  i.e.  first  due  to  the  requirement  for  additional  external 
monitoring;  second,  because  the  German  Institute  did  not  accept  the  Danish  testing  results 
produced  to  obtain  the  Danish  Indoor  Label,  which  forced  the  company  to  undertake 
additional testing in Germany. In addition, it has also led the company to limit the number of 
products it offers in the German market as additional testing is counted in millions of Danish 
kroner per product.240  

Another  company  experienced  that  as  long  as  construction  products  are  not  harmonised, 
Member  States  have  a  tendency  to  require  national  approvals  or  even  extra  tests.  Germany 
and Belgium are highlighted as Member States where the company has experienced this. 

Another (Portuguese) company acknowledges  that outside the harmonised area and in areas 
where  there  is  no  CE-marking,  Member  States  have  different  requests  for  certification  and 
tests. Since the company produces tailor-made products, all terms and conditions are agreed 
with  customers  before  producing.  However,  in  public  tenders  it  can  be  problematic  that 
Member  States  have  different  rules,  because  there  may  be  rules/requests  for  tests  that  the 
company cannot foresee and take into account, since they do not know the national markets 
well  enough.  If  they  were  selling  standard  products  (in  non-harmonised  areas  with  no  CE-
marking), the differences between Member State would have been a greater issue (see Case 
10). 

The food and food  supplement sectors, particularly with respect to  food enrichers such as 
vitamins, is another area where companies experience many national rules. According to the 
product contact point and company interviews, Member States like Denmark and Spain have 
rather  strict  rules  with  respect  to  the  maximum  amount  of  vitamins  and  minerals  present in 
food and food supplements, whereas other countries, such as the UK, have less strict rules or 
even, in some cases, rules for including particular enrichers such as iron in wheat. The amount 
of vitamins and minerals is not (yet) harmonised, whereas the types of vitamins and minerals 
permitted for use in food and food supplements are harmonised by Directive 2002/46/EC.241  

One large company provides an example from Denmark, which is one of the countries where 
the  rules  for  enriched  food  (with  added  vitamins  and  minerals)  are  strict.  In  some  areas, 
Denmark  has  special  rules  justified  by  food  safety.242  Danish  policy  is  to  not  let  enriched 

238  

239  
240  
241  
242  

European  Commission  (2011):  Guidance  document  -  The  application  of  the  Mutual  Recognition  Regulation  to  non-CE  –marked 
construction products 
Case C-171/11 – Reference for a preliminary ruling of 30.3.2011 
Copenhagen Economics (2012): Delivering a stronger single market 
European Commission (2010): Guidance Document - The application of the Mutual Recognition Regulation to food supplements 
see also TRIS notification 2014/203/DK, where it is highlighted that “The Danish Veterinary and Food Administration finds that, in 
the  interests  of  protecting  human  health,  there  is  a  need  for  national  regulation  until  common  rules  have  been  introduced” 
http://ec.europa.eu/growth/tools-databases/tris/en/search/?trisaction=search.detail&year=2014&num=203 

152 

 
                                                            
foodstuffs onto the market (by keeping the tolerated level of enrichers close to zero), unless 
special permission is given by the Danish Veterinary and Food Administration (which rarely 
happens  according  to  the  company  in  question).  Enriched  foodstuffs  are  thus  effectively 
blocked from the Danish  market, and the mutual recognition principle is  not  applied in  this 
area. The company in question has chosen not to contest the rule since the policy is very firm, 
and Denmark is such a small market that it is not worth the cost of having the policy tested. 
The  company  simply  refrains  from  marketing  the  products  in  question  in  Denmark.  It  is 
estimated that this product type could amount to 5% of annual sales (i.e. foregone revenues), 
see Case 8 for further information. 

The above-mentioned company as well as the Spanish product contact point call for further 
harmonisation  in  the  area  of  enriched  food  and  food  supplements.  The  Spanish  product 
contact  point  stated  that  as  the  rules  on  food  enrichers  and  food  supplements  (vitamins, 
minerals)  are  stricter  in  Spain  than  in  other  Member  State,  it  is  difficult  for  the  mutual 
recognition  principle  to  function  properly  in  this  sector.  Spain  has,  for  instance,  prior 
authorisation  procedures  in  this  area  to  ensure  that  foreign  companies  comply  with  the 
national  legislation.  The  situation  is  quite  resource  consuming,  both  for  the  companies,  but 
also for the product contact points. However, it may be challenging to harmonise the allowed 
amounts  of  vitamins  and  minerals  in  food,  as  the  acceptable  levels  appear  to  differ 
considerably in various Member States. 

Product  classification  differences  can  also  cause  problems.  Within  the  area  of  fertilisers, 
companies  typically  experience  barriers  because,  as  mentioned  above,  there  are  different 
classifications  of  products  as  fertilisers  in  different  Member  States.  Within  the  area  of 
fertilisers,  Commission  services  estimate  that  the  current  situation  in  the  market,  where 
fertilisers  are  categorised  very  differently  in  different  Member  States,  costs  economic 
operators around 26 million euros in total on a yearly basis. These costs stem from placing a 
new product on the market. By listing the authorised ingredients, the Commission estimates 
that the costs for economic operators will be reduced to around 1 million euros.243  

Another  example  (but  in  a  different  sector)  was  mentioned  in  the  case  of  a  French  sports 
equipment company that had to withdraw certain exercise products from the German and UK 
market, as they resembled a weapon and therefore were classified as a weapon in these two 
countries. The strategy for economic operators in this type of case was withdrawal from the 
market, resulting in missed market opportunities (see Case 9). 

Proportionality of the administrative burdens 

The  typical  administrative  burdens  associated  with  the  implementation  of  the  principle  of 
mutual  recognition  mainly  affect the companies seeking  to  export  products into  a particular 
market. These burdens are closely related to the requirement from different Member States for 
national  tests,  even  though  the  mutual  recognition  principle  should  apply.  As  previously 
discussed,  Member  States  sometimes  use  the  derogations  allowed  under  the  mutual 
recognition  principle  (protection  of  public  health,  safety,  etc.)  without  substantial 
justifications. In principle, the Member States are only allowed to use the derogations under 
strict conditions, but in reality, the reasons for establishing technical rules are not always well 
justified. 

243  

Information provided by Commission services 

153 

 
                                                            
This means that if the mutual recognition principle was functioning efficiently, the companies 
would not be subject to the burden of having to adapt or retest their products. These burdens, 
imposed  on  companies  from  the  incorrect  application  of  the  mutual  recognition  principle, 
cannot be justified, but the problem is that the only alternative that companies feel that they 
have  would  be  a  court  case,  which  is  both  too  costly  and  takes  too  long.  The  burdens  of 
carrying  out  the  alternative  would  then  be  even  greater.  Several  companies  have  stated  that 
they  do  not  consider  discussing  the  fairness  of  the  technical  rules  with  Member  State 
authorities as an option (too costly and takes too long), and simply just follow the demands. 
In a few cases, if the market is small, the company has chosen not to enter that market. 

Product contact points also experience that administrative burdens exist, which again is due to 
incorrect  application  of  the  mutual  recognition  principle  or,  sometimes,  the  lack  of  trust 
between  Member  States.  For  instance,  within  the  area  of  fertilisers,  some  Member  State 
authorities have expressed strong concerns to the Commission that their administrations might 
be overwhelmed if many fertilising materials lawfully placed on the market in other Member 
States with different technical requirements were to be placed on their markets over a short 
period. National authorities would not be able to react within the period provided for by the 
Mutual  Recognition  Regulation.  Member  States  are  concerned  that  this  could  lead  to  a 
situation  where  products  lawfully  marketed  in  another  Member  State  would  be  marketed  in 
their  territories  as  well,  without  giving  the  receiving  Member  State  any  impact  on  the 
parameters  used  for  the  assessment  of  their  potential  risks  for  health  and  the  environment. 
There  are  also  concerns  that  inappropriate  or  low  quality  products  will  enter  the  market.244 
These  concerns  may  have  to  do  with  the  different  classifications  of  fertilisers  in  different 
Member States mentioned in the product contact point interviews, but also that the Member 
States do not put sufficient trust in each other’s regimes. 

The  product  contact  point  survey  revealed  that  the  product  contact  points  perceive  that 
administrative and regulatory burdens particularly exist for companies as illustrated in Figure 
8-8. 

Figure  8-11:  Product  contact  point  survey:  Are  there  administrative  and  regulatory 
burdens for the following stakeholders? 

Source: Questionnaire survey among PCPs, running from 9 October 2014 to 5 January 2015, carried out by DTI 

When it comes to the proportionality of the burdens, around one-fourth of the product contact 
points  find  the  burdens  not  to  be  proportionate  at  all,  neither  for  Member  State  authorities, 

244  

Information on fertilisers provided by the Commission services 

154 

 
 
                                                            
companies  nor for conformity assessment bodies. However, it is important to underline that 
the burdens are a result of the incorrect application of the mutual recognition principle, and 
not a result of the implementation of the principle as such.245  

Figure 8-12: Product contact point survey: Are the burdens considered proportionate? 

Source: Questionnaire survey among PCPs, running from 9 October 2014 to 5 January 2015, carried out by DTI 

The  requirements  for  the  product  contact  points  are  relatively  limited.  Under  Regulation 
764/2008 (Art. 10), the product contact points are required to inform economic operators of 
the  technical  rules  applicable  to  specific  types  of  products,  contact  details  of  the  relevant 
competent  authorities,  and  available  solutions  for  resolving  potential  disputes  between  the 
competent  authorities  and  the  economic  operators.  In  addition,  product  contact  points  are 
required  to  respond  to  the  economic  operator  within  15  working  days,  but  in  practice,  this 
obligation is often transferred to the competent authority. The competent authority is clearly 
requested to answer the questions from the economic operators and to notify the Commission 
and the economic operator about any refusals of market access within 20 working days (Art. 
6.2).  The  main  administrative  burden  identified  in  the  product  contact  point  interviews 
associated with the implementation of the mutual recognition principle is that answers to the 
economic operators and/or to the other product contact points must be translated into English. 
This  can  be  difficult  for  competent  authorities  not  used  to  communicating  in  English,  and 
burdensome for the product contact points if the answer contains many technical terms. The 
possibility of establishing an electronic system for exchanging information between product 
contact  points  was  already  mentioned  in  the  Mutual  Recognition  Regulation,  and  as 
mentioned earlier (section 0), the IMI system could be a means to limiting this burden. 

3.  AWARENESS AND APPLICATION OF THE PRINCIPLE BY THE MEMBER STATES 

While  the  previous  section  took  the  perspective  of  the  companies,  this  section  takes  the 
perspective  of  the  Member  States,  their  knowledge  and  understanding  of  the  mutual 
recognition  principle,  and  whether  the  principle  is  applied  correctly  by  the  Member  States. 
The  section  covers  issues  such  as  notification  practices,  use  of  technical  rules,  mutual 
recognition  clauses  and  prior  authorisation  procedures,  as  well  as  the  dialogue  between 
particularly product contact points in the different Member States. We begin with setting the 

245  

Unavoidable  costs  are  to  check  whether  the  mutual  recognition  principle  applies.  In  addition,  certain  costs  may  be  unavoidable 
when  the  technical  rules  of  the  Member  State  of  destination  comply  with  Articles  28  to  30  EC  Treaty  (European  Commission 
(2007):  Accompanying  document  to  the  Proposal  for  a  directive  of  the  European  Parliament  and  of  the  Council  laying  down 
procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and 
repealing Decision 3052/95/EC Impact assessment) 

155 

 
 
                                                            
  
framework by taking a brief look at how the product contact point system is organised in the 
Member States.  

Organisation of the product contact point system in the Member States 

The product contact point is the contact for the economic operator for questions pertaining to 
the application of the mutual recognition principle. Regulation 764/2008 states that “Member 
States shall designate Product Contact Points in their territories and shall communicate their 
contact  details  to  the  other  Member  States  and  to  the  Commission.”  At  the  request  of  an 
economic operator, the product contact points shall within 15 days provide information on: 

 

 

 

the  technical  rules  applicable  to  a  specific  type  of  product  in  the  Member  State  in 
question; 

the contact details of the competent authorities within the Member State: and 

the remedies generally available in the Member State in the event of a dispute between 
the competent authorities and an economic operator. 

Finally,  the  product  contact  points  in  the  different  Member  States  are  expected  to  work 
together to solve potential issues for economic operators246. The detailed set-up of the product 
contact point function is left to the Member State. 

The  organisation  and  function  of  the  product  contact  points  vary  significantly  between 
Member States. Most Member States – both large and small – have a single product contact 
point, which is responsible for all queries regarding product-related EU legislation, including 
the Construction Products Regulation. In a few Member States (Estonia, Latvia and Poland), 
the  product  contact  point  function  is  split  between  a  general  product  contact  point  and  a 
product  contact  point  specifically  for  construction  products.  In  a  small  number  of  Member 
States  (the  Netherlands,  Portugal  and  Romania),  the  product  contact  points’  responsibilities 
are divided between 6-7 sector ministries or inspectorates.  

In almost all Member States, the product contact point (or the co-ordinator, where there are 
several product contact points) is located within the ministry responsible for industry/business 
and the internal market, often as part of a group or team dealing with internal market policy. 
Only in Slovenia is the product contact point placed in an independent institute (the Slovenian 
Institute for Standardisation).  

A  few  product  contact  points  handle  queries  (or  part  of  queries)  themselves.  In  Malta,  the 
product  contact  point  is  responsible  for  all  communication  with  companies,  meaning  that 
companies  receive  all  answers  from  one  authority.  However,  this  setup  is  unique  to  Malta 
(and difficult, if not impossible, to handle in a large Member State), and in most cases queries 
from economic operators are passed on to the responsible ministry, department or directorate 
or,  occasionally,  the  relevant  local  authority.  This  is,  for  instance,  sometimes  the  case  in 
Germany,  where  the  responsible  authority  for  the  product  is  often  found  at  Länder  level.  A 
rather extreme version of the decentralised setup can be found in France and Italy, where the 
product  contact  point  is  not  a  central  unit  in  charge  of  the  mutual  recognition  concept,  but 
simply  the  contact  point  towards  the  Commission.  As  mentioned,  in  the  case  of  Italy,  the 
appointed  product  contact  point  claims  not  to  deal  with  the  mutual  recognition  topic  at  all. 

246  

Regulation  (EC)  No  764/2008  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 

156 

 
                                                            
This means that there is no single contact point for economic operators in Italy. Rather, they 
must  contact  the  relevant  ministry  in  charge  of  their  product  and  receive  their  answer  from 
this authority – without the product contact point being involved.  

The responsible authority either replies directly to the company making the query, or passes 
the decision or answer back to the product contact point, which then communicates with the 
company.  The  first  model,  where  the  responsible  authority  replies  directly  to  the  company 
without  involving  the  product  contact  point,  appears to  be the  most  widespread  solution.  In 
these  cases,  the  product  contact  point  may  have  little  information  on  the  outcome  of  the 
queries, as decisions can be notified directly by the competent authority without informing the 
product contact point (or not notified at all). The effects of this decentralised setup is analysed 
in further detail in section 5.3.3. 

Although  it  was  not  a  specific  question  in  the  interviews,  a  few  product  contact  points 
provided examples of the volume of queries received, which ranged from 15-20 a year up to 
approx.  100  a  year.  The  figures  provided  in  these  examples  seem  rather  low  and  could 
indicate  that  many  companies  bypass  the  product  contact  point  and  go  directly  to  the 
responsible ministries or authorities. However, there is no evidence to support this hypothesis 
further.  In  many  cases,  construction  products  and  food  additives  are  the  areas  where  most 
queries are made. Both national and foreign companies use the product contact point system. 
In  some  countries  (such  as  the  Czech  Republic),  enquiries  mainly  come  from  national 
companies,  whereas  in  other  Member  State  such  as  Cyprus,  the  enquiries  are  mainly  from 
foreign companies. 

Awareness and knowledge of the principle among national administrations 

The product contact points were asked about their view of different stakeholders’ knowledge 
and understanding of the principle. Figure  shows the answers. 

Figure  8-13:  Product  contact  point  survey:  Based  on  your  experience  as  a  product 
contact  point,  what  percentage  of  the  main  stakeholder  groups  know  and  understand 
the mutual recognition principle? 

Source: Questionnaire survey among PCPs, running from 9 October 2014 to 5 January 2015, carried out by DTI 

As  for  knowledge  of  the  mutual  recognition  principle  among  authorities  in  the  Member 
States, the general assessment of the product contact points is  that most national authorities 
are aware of and understand the principle of mutual recognition (third row in Figure 8-11). In 
the  qualitative  interviews,  the  knowledge  of  the  mutual  recognition  principle  among 

157 

 
 
authorities  and  enterprises  was  discussed  too.  80%  of  the  product  contact  points  report  that 
the  majority  of  national  authorities  are  relatively  well  versed  in  the  mutual  recognition 
principle.247  However,  the  interviews  showed  that  there  are  uncertainties  among  national 
authorities, which are sometimes rooted in the fact that some national authorities are more in 
touch  with  the  mutual  recognition  principle  than  others  are.  Those  national  authorities  that 
seldom get queries within their area are sometimes not very familiar with the principle. In one 
Member State, the product contact  point stated that most of the authorities are not aware of 
the principle and do not know how to use it, which clearly is problematic. The product contact 
point of the Member State in question acknowledged the need for informing more about the 
mutual  recognition  principle,  preferably  with  the  support  of  the  European  Commission.  In 
addition,  the  Spanish  product  contact  point  reports  that  companies  lack  information  on  the 
principle of mutual recognition and that in their opinion more information and dissemination 
activities are needed. 

Several  product  contact  points  address  the  need  for  additional  awareness  campaigns,  as  the 
relevant authorities also need to be kept informed about any developments within the field of 
mutual  recognition.  In  Member  States  where  the  product  contact  point  has  carried  out  such 
information campaigns, the knowledge of the mutual recognition principle and its application 
among  the  relevant  authorities  increases,  although  economic  operators  have  not  evaluated 
whether there is a real effect of these campaigns. Where the need for awareness campaigns is 
recognised but not acted upon, the reason is invariably a lack of resources for such activities.  

In some Member States, there are specific areas where uncertainties arise, such as in the non-
harmonised  part  of  construction  products.  Ireland  has  assigned  a  specific  technical  rules 
coordinator in each government department, which helps to reduce uncertainty. However, it 
should also be mentioned that not all product contact points seem to have a thorough insight 
into the level of knowledge in the national authorities, simply because they are not contacted 
with questions from the relevant authorities, and they are not actively investigating whether 
the  relevant  authorities  understand  the  mutual  recognition  principle  well  enough.  In  other 
words,  the problem  lies  in  the  lack of  communication/exchange  of  information  between  the 
product  contact  points  and  the  relevant  authorities.  While  this  seems  to  be  the  situation  in 
some  Member  States,  other  product  contact  points  indicate  in  the  personal  interviews  that 
they  make  an  effort  to  inform  regional  and  local  authorities  about  the  functioning  of  the 
mutual recognition principle.  

Although  the  product  contact  points  generally  perceive  the  knowledge  among  national 
authorities  to  be  fairly  high,  the  qualitative  interviews  reveal  that  companies  sometimes 
experience that a) the national authorities cite ‘health’ or ‘safety’ as a reason for not allowing 
a product on the market without justifying it further and b) the authorities do not easily accept 
innovative  products.  As  can  be  seen  from  Figure  ,  21%  of  the  companies  in  the  company 
survey  perceive  the  lack  of  knowledge  or  correct  application  of  the  mutual  recognition 
principle by authorities to be the greatest obstacles to effective mutual recognition. 

247  

80% of the PCPs state that more than 50% of all national authorities know and understand the mutual recognition principle 

158 

 
 
 
 
                                                            
Figure 8-14: Company survey: What are the obstacles to effective mutual recognition? 
Rank from 1-4 

Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015, carried out by DTI 

As  an  example,  one  company  experienced  a  situation  where  their  application  regarding 
fortification with iron in breakfast cereals was accepted, while the production of a cereal bar 
using  the  same  fortified  cereals  was  perceived  as  a  different  case,  and  had  to  be  looked  at 
again without automatically guaranteeing mutual recognition. This example may indicate that 
the competent authorities act in a rather rigid manner, an issue that is also raised by several 
business associations and the Swedish product contact point. This will be discussed in more 
detail in the following. 

The  surveyed  product  contact  points  also  perceive  a  rather  large  share  of  the  conformity 
assessment bodies to be well aware of the mutual recognition principle. However, at least one 
company example shows that although the conformity assessment bodies may be aware of the 
principle  of  mutual  recognition,  it  is  not  always  accepted.  Germany  has  regional  rules  for 
approval of construction products falling outside of the harmonised area. In October 2014, the 
Commission  notified  that  Germany  must  not  ask  for  additional  stamps  or  approvals248,  but 
companies  still  face  problems  with  it.  The  same  company  has  also  experienced  issues  with 
product types (surface coatings) where tests are not required in their home country, but they 
are required in Germany. In practice, the company tests its products in Germany, as the test 
facilities cannot be found in their home country because a test is not required there. Testing 
costs  amount  to  approx.  €7,000  per  product,  and  the  tests  need  to  be  repeated  on  a  regular 
basis. 

The situation is considerably different at the regional (and local) levels where around half of 
the product contact points assess that less than 50% of the regional authorities in their country 
are aware of the mutual recognition principle. If they are not directly involved in queries, this 
is not necessarily problematic. However, if they are, it is clearly problematic with regard to a 
proper application of the mutual recognition principle. 

248  

http://ec.europa.eu/growth/tools-databases/newsroom/cf/itemdetail.cfm?item_id=7860&lang=en 

159 

 
 
 
 
                                                            
Notification practices 

The relevant authorities are notifying the decisions not to allow a product on the market to the 
Commission. In addition, the product contact points report once a year to the Commission on 
the  application  of  the  mutual  recognition  principle  and  meet  once  a  year  in  the  mutual 
recognition  consultative  committee  to  discuss  the  matter.  The  notes  from  meetings  in  the 
consultative committee revealed that there are apparent discrepancies between the number of 
notifications received by the Commission and the number of decisions made by the Member 
State authorities reported in the annual reports. In 2012, there were at least 51 cases where the 
decision not to allow a product into the market was not communicated to the Commission.249 
There may be several reasons for this. One is that in some Member States with a decentralised 
administrative  structure,  regional  or  local  bodies  adopt  negative  decisions  that  are  notified 
neither to the central government (which prepares the annual reports) nor to the Commission. 
Another reason is that there still seems to be some misunderstandings as to the scope of the 
Mutual  Recognition  Regulation  as  well  as  to  its  relationship  with  other  pieces  of  EU 
legislation. Thus, several negative decisions that were adopted by some Member States do not 
seem to have been considered to be among those decisions referred to in Article 2(1) of the 
Mutual Recognition Regulation and therefore not communicated to the Commission.250 

In the interviews, the product contact points were asked whether it sometimes happened that 
negative decisions were not notified to the Commission. However, almost all product contact 
points  stated  either  that  no  refusals  had  been  made  at  all  or  that  all  refusals  were  notified. 
Three  product  contact  points  stated  that  they  did  not  monitor  this  issue,  because  the 
authorities  making  the  decision  to  refuse  a  product  entry  to  the  market  do  not  notify  the 
product  contact  point.  However,  they  ask  for  information  once  a  year  when  preparing  the 
yearly reports on the application of the mutual recognition principle to the Commission. Only 
one product contact point admitted that in one or two cases refusals had been made without 
notifying  the  Commission.  When  asked  what  it  would  take  for  their country  to  notify  more 
refusals, most product contact points were consistently of the opinion that there is no need for 
improvement, since everything is notified or no refusals have been made. One product contact 
point suggested that notification should be made a legal obligation, supported by a system of 
relevant sanctions.  

However,  adding  to  this  picture  is  the  decentralised  structure  of  the  product  contact  point 
system  discussed  above.  Although  the  product  contact  points  receive  a  yearly  update  when 
they are to report to the Commission on the notifications, the decentralised system favoured 
by  many  Member  State  poses  a  risk  that  inconsistencies  appear,  and  this  can  be  an 
explanation for the discrepancies explained above. In some Member States, such as Germany, 
the responsibility for notifications is at the regional (Länder) level, meaning that all competent 
authorities at this level can adopt decisions according to Regulation 764/2008 and would then 
need  to  notify  the  Commission.  In  addition,  even  in  areas  where  the  ECJ  has  delivered  an 
unequivocal judgment, national administrations often still fail to apply the principle of mutual 
recognition  correctly.  Janssens  (2013)  suggests  that  this  is  due  to  weak  monitoring  of  ECJ 
case law in several Member State.  

Some  product  contact  points  receive  a  copy  of  the  decision/answer  or  are  otherwise  kept 
informed about the decisions made. Other product contact points, such as the one in Belgium, 

249  

250  

Note: ‘At least’ because the UK reported ‘several’ cases. These were not communicated to the Commission; some of them at least 
because  they  allegedly  took  place  within  the  framework  of  an  informal  dialogue  with  the  economic  operators.  European 
Commission working document (2012): Yearly reports on the application of Regulation (EC) No 764/2008 
European Commission (2012): Yearly reports on the application of Regulation (EC) No 764/2008-2012 

160 

 
                                                            
are in  charge of sending out  all  decisions.  In  the Czech Republic, the product contact point 
has  a  network  of  experts  at  each  relevant  authority,  and  the  product  contact  point  works  in 
close  cooperation  with  these.  In  Poland,  there  is  frequent  communication  with  the  relevant 
authorities, thus keeping the product contact point updated on any cases. In Portugal, where 
the product contact point function is divided between seven ministries, each product contact 
point has to report about the questions received and copy written answers to the Portuguese 
Institute for Quality, which then keeps track of queries. According to one of the Portuguese 
product  contact  points,  this  provides  a  very  good  overview  of  the  situation  in  the  country 
regarding the application of the mutual recognition principle. A simpler version of this system 
could  be  that  the  relevant  authorities  copy  the  product  contact  point  on  the  final 
communications with the economic operators, and that the product contact point has to record 
this information in a database as one of its obligations. 

Use of technical rules  

According to the Mutual Recognition Regulation, Member States may put technical rules in 
place  but  these  must  be  justified  (cf.  section  4.2).  However,  Member  States  sometimes 
mistake  safety  for  quality.  For  example,  Member  States  present  mutual  recognition  clauses, 
which state that a product should be allowed, “provided the product offers a similar level of 
protection  as  the  products  in  the  Member  State.”  This  statement  is  not  compatible  with  EU 
law,  as  it  should  not  specify  a  ‘similar  level’  –  the  product  is  either  safe  or  not  safe.  If  a 
product from country X is already safe, but the product in country Y is safer, it is not a valid 
reason  for  excluding  the  product  from  country  X.251  Business  organisations  have  indicated 
that  Member  States  use  these  barriers  too  often.252  They  are  not  necessarily  perceived  as 
intentional  attempts  to  keep  a  product  out  of  the  market,  but  rather  as  problems  with  fully 
understanding  the  application  of  the  mutual  recognition  principle.  For  instance,  innovative 
products  that  do  not  easily  fit  into  pre-defined  boxes  of  what  a  product  can  do  can  pose 
problems. In these instances, it is often  seen that the national authorities demand extra tests 
that  are  not  necessary,  since  the  product  is  already  approved  in  its  home  country.253  Three 
business associations stated that the Member State authorities tend to be risk averse and act in 
a  cautious  manner,  thus  making  it  difficult  for  companies  with  innovative  products  to  enter 
markets in other Member States even though they are proven safe in their home country.  

Along  these  lines,  the  interviews  with  the  national  business  associations  and  the  position 
papers  received  from  Business  Europe254  and  Orgalime255  revealed  that  national  technical 
barriers are often perceived to be unjustified. Sometimes, Member States do not provide the 
necessary justification when introducing a national technical regulation – a requirement that is 
clearly stated in Art. 8 of Directive 98/34 governing the notification procedure. According to 
several  business  associations,  Member  States  also  often  cite  general  ‘safety  reasons’  or 
‘health reasons’ – even when these are too vague to justify a new national rule.  

To analyse the number of new technical regulations that are being proposed in the Member 
States,  which  potentially  can  create  barriers  in  the  Internal  Market,  the  TRIS  database  was 
investigated. TRIS (Technical Regulation Information System) is part of the 98/34 procedure, 
which aims to prevent creating barriers in the internal market before they materialise. Member 
States notify their legislative projects regarding products and Information Society services to 

251  
252  
253  
254  
255  

Interview with DG ENTR 
Interview with Eurocommerce 
Interview with DI, the Danish Business Association 
Business Europe (2014): Position Paper: Evaluation of the application of the principle of mutual recognition of goods 
Orgalime (2014): Position Paper: Suggestions for improving the application of the mutual recognition principle 

161 

 
                                                            
the Commission, which analyses these projects in the light of EU legislation. Member States 
participate on an equal footing with the Commission in this procedure and are able to issue 
their  opinions  on  the  notified  drafts.  Thus,  TRIS  helps  stakeholders  to  be  informed  of  new 
draft  technical  regulations.  It  also  allows  Member  State  to  participate  in  the  98/34 
procedure.256 

Data from the TRIS database shows that in 2014 the Member States submitted 685 new draft 
technical  regulations.  Table  8-2  shows  an  overview  of  the  draft  technical  regulations 
submitted the last three years. 

Table 8-2: Overview of draft technical regulations submitted to TRIS, 2012-2014 

2012 

2013 

2014 

Total 

With 
comments 

Incl. MR 
clause 

Total 

With 
comments 

Incl. MR 
clause 

Total 

With 
comments 

Incl. MR 
clause 

755 

227 

69 

728 

191 

79 

685 

224 

57 

Source: TRIS database, http://ec.europa.eu/growth/tools-databases/tris/da/search/ 

From  Table  8-2,  it  appears  that  the  total  number  of  draft  technical  regulations  submitted  to 
TRIS has decreased slightly over the past few years. Of the 685 draft technical regulations in 
2014, Member  States or  the  Commission had comments for 224 draft technical  regulations. 
Fifty-seven of these included the term ‘mutual recognition clause’, which is an indication that 
the technical regulation pertains to the Mutual Recognition Regulation. The sectors where the 
technical  regulations  are  found  differ  considerably,  but  the  sectors  with  the  most  draft 
technical  regulations  include  the  construction  sector  (67  cases),  foodstuffs  (39  cases),  and 
chemical  products  (21  cases).257  Although  many  of  these  undoubtedly  are  justified,  it  is 
potentially a very large number of new technical regulations that companies have to take into 
consideration to assess whether the mutual recognition principle applies or not. For instance, 
in 2014 Italy stated that all non-alcoholic fruit-flavoured beverages must contain no less than 
20 per cent natural fruit juice, stating health protection as the justification. Several objections, 
among others from the Commission, led to the amendment of this proposal.258  

The view across product contact points is quite varied, when asked about the extent to which 
Member States as a whole have limited their use of technical rules, and span the scale from 
‘not at all’ to ‘to a very high degree’. Views are similarly split when it comes to the extent to 
which  their  own  countries  have  limited  the  use  of  technical  rules  over  the  past  five  years 
(since the Mutual Recognition Regulation came into force in 2009 (see Figure 8-13).  

256  
257  
258  

http://ec.europa.eu/growth/tools-databases/tris/en/ 
http://ec.europa.eu/enterprise/tris/en/search/  
2014/316/I,  
http://ec.europa.eu/growth/tools-databases/tris/da/index.cfm/search/?trisaction=search.detail&year=2014&num=316&mLang=EN    

162 

 
 
 
 
                                                            
Figure  8-15:  Product  contact  point  survey:  The  effects  of  the  mutual  recognition 
principle as perceived by product contact points 

Source: Questionnaire survey among PCPs, running from 9 October 2014 to 5 January 2015, carried out by DTI 

Perhaps  the  most  striking  finding  from  Figure  8-13  is  that  about  one  in  five  of  the  product 
contact points did not know the answer to the question of whether their own Member State 
had limited the use of technical rules. The evaluator assigns this finding to the decentralised 
setup governing the mutual recognition principle identified in many Member States, which is 
true for at least three of the Member States that did not know the answer to this question (the 
rest  were  EFTA-countries).  A  requirement  that  the  product  contact  points  need  to  actively 
collect  this  information  would  probably  significantly  change  this  picture,  and  more 
importantly: it would help to ensure that the use of technical rules does not increase without 
good justifications. 

Application of the principle (administration towards companies) 

Another issue that emerges from the product contact point interviews is that there is a lack of 
clarity  concerning  what  kinds  of  documentation  the  companies  should  submit  to  document 
that their products are lawfully marketed in another Member State. One product contact point 
even states that clarification as to what ‘lawfully marketed’ means could be useful. While the 
concept  ‘lawfully  marketed’  is  not  defined  as  such  in  the  Mutual  Recognition  regulation 
itself, Regulation (EC) No 765/2008 defines the concepts of ‘making available and placing on 
the market’. ‘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  initial  making 
available of a product on the Union market. Thus, for products that are subject to the Mutual 
Recognition  Regulation,  the  Commission  considers  the  concept  of  ‘marketing’  to  mean  any 
supply  of  a  product  for  distribution,  consumption  or  use  in  another  Member  State  or  in  an 
EFTA state that is a contracting party to the EEA Agreement. ‘Lawful marketing’ is therefore 
perceived by the Commission as marketing in another Member State or an EFTA state that is 
a  contracting  party  to  the  EEA  Agreement  in  accordance  with  the  applicable  national 
legislation.259  

259  

European  Commission  (2013):  Commission  working  document:  Guidance  document.  The  concept  of  “lawfully  marketed”  in  the 
Mutual Recognition Regulation (EC) No. 764/2008 

163 

 
 
                                                            
Several  product  contact  points  point  out  that  the  lack  of  clarity  concerning  what 
documentation  companies  should  be  requested  to  submit  to  document  ‘lawful  marketing’ 
complicates  and  delays the  process both  for  companies  that  do  not  know  beforehand  which 
documentation  will  be  required  and  for  the  authorities  in  the  destination  Member  State. 
Several product contact points thus called for guidelines to help determine for each product 
(group)  what  kinds  of  documentation  will  be  needed  to  prove  the  companies’  claims. 
Regulation 764/2008  states  in  Article  4 that  companies  should  submit  ‘relevant information 
concerning  the  characteristics  of  the  product  or  type  of  product  in  question’  as  well  as 
‘relevant and readily available information on the lawful marketing of the product in another 
Member State’. The Mutual Recognition Regulation does not specify the means of evidence 
that  may  be  used  by  economic  operators  to  demonstrate  that  a  product  has  been  lawfully 
marketed in another Member State or in an EFTA state. This avoids imposing any additional 
administrative burden and does not limit in any way the means of evidence that an economic 
operator may present as part of the information mentioned by Article 4(b) to the authorities of 
the Member State of destination. In its guidance document260, the Commission states that to 
demonstrate  the  actual  marketing  of  the  product  in  another  Member  State,  or  in  an  EFTA 
state,  any  piece  of  evidence  should  be  deemed  suitable.  This  evidence  could  be  a  product 
invoice,  product  label,  catalogue  with  evidence  of  a  date,  sale  or  tax  records,  registrations, 
licences,  notifications  to/from  the  authorities,  certifications,  extracts  from  public  records, 
etc.261 Obviously, this limits the burdens on the economic operators that they do not need an 
official  statement,  which  is  intentional.  However,  it  also  leaves  the  product  contact  points 
with little guidance on when, for instance, a product invoice is sufficient proof that a product 
has  been  marketed  in  another  Member  State  in  accordance  with  the  applicable  national 
legislation.  This  may  again  lead  to  additional  administrative  burdens  on  companies  if  the 
product  contact  point  is  unsure  of  the  validity  of  the  documentation  and  asks  for  additional 
documentation to be supplied. 

Use of Mutual Recognition clauses 

Mutual recognition clauses refer to a clause in a particular national legislation clearly stating 
that  if  a  product  meets  the  conditions  set  out  by  the  destination  Member  State,  it  can  be 
marketed  in  that  Member  State.  An  example  of  a  mutual  recognition  clause  is  presented 
below: 

“The  application  of  this  law  is  subject  to  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 to subsequent amendments”.262 

Alternatively: 

 “The requirements of this law do not apply to products lawfully marketed and/or produced in 
other Member State or in Turkey or to products legally produced in EFTA states which are 

260  

261  

262  

European  Commission  (2013):  Commission  working  document:  Guidance  document.  The  concept  of  “lawfully  marketed”  in  the 
Mutual Recognition Regulation (EC) No. 764/2008 
European  Commission  (2013):  Commission  working  document:  Guidance  document.  The  concept  of  “lawfully  marketed”  in  the 
Mutual Recognition Regulation (EC) No. 764/2008 
European  Commission  (2010):  Guidance  document  –  the  relationship  between  Directive  98/34/EC  and  the  Mutual  Recognition 
regulation 

164 

 
                                                            
signatories to the EEA Agreement, provided that they provide a level of protection equivalent 
to that sought by this law”.263.  

In 1998, the European Court of Justice delivered an important judgement (the so-called foie 
gras  case).  The  judgement  states  that  a  Member  State  must  include  a  mutual  recognition 
clause  for  products  from  other  Member  States,  when  a  regulation  on  composition  and 
production methods  reserves the use of a certain trade description to  products, which meets 
the conditions set out by the destination Member State.264 

Many  of  the  Member  States  are  seeking  to  incorporate  mutual  recognition  clauses  in  their 
legislation. From the product contact point survey, it can be seen that in three quarters of the 
countries  whose  product  contact  points  participated  in  this  evaluation,  mutual  recognition 
clauses are incorporated in the majority or all relevant national legislation. Mutual recognition 
clauses  are  only  included  in  a  few  pieces  of  national  legislation  (Cyprus,  Greece,  Latvia, 
Lichtenstein, and Luxembourg) or not at all (the Netherlands) in about 1/4 of the countries. 

Figure  8-16:  Product  contact  point  survey:  To  what  extent  is  the  mutual  recognition 
principle  implemented  in  the  national  law  of  your  country  through  so-called  “mutual 
recognition clauses”? 

Source: Questionnaire survey among PCPs, running from 9 October 2014 to 5 January 2015, carried out by DTI 

When  the  national  authorities  implement  these  clauses,  the  aim  is  to  make  it  easier  for 
companies  and  authorities  to  navigate  on  the  internal  market.  The  introduction  of  mutual 
recognition  clauses  in  regulations  is  perceived  by  at  least  three  product  contact  points265  to 
render the mutual recognition principle more effective, and these product contact points call 
on  the  mutual  recognition  clauses  to  be  enforced.  Some  product  contact  points  are  actively 
encouraging the relevant authorities to implement such clauses, but this practise could be even 
more widespread than indicated. Thus, even though there are differences between the Member 

263  
264  

265  

Presentation by Katrin Hendrix, DG ENTR Unit C5, Elimination of technical barriers to trade – principle of mutual recognition 
European  Commission  (2003): Commission  interpretative  communication  on facilitating  the  access  of  products  to  the  markets  of 
other Member States: the practical application of mutual recognition (2003/C 265/02) 
“At  least”  because  the  question  did  not  specifically  address  mutual  recognition  clauses,  but  asked  what  would  render  the  mutual 
recognition principle more effective 

165 

 
 
                                                            
States  regarding  the  extent  to  which  the  mutual  recognition  principle  is  implemented  in 
national legislation through mutual recognition clauses, the majority of the Member States do 
have  such  clauses  and  several  see  them  as  an  effective  tool  towards  rendering  the  mutual 
recognition principle more effective.  

Use of prior authorisation procedures 

A prior authorisation procedure is an  administrative procedure established by the legislation 
of a Member State in accordance with which, before a product may be placed on that Member 
State's  market,  the  competent  authority  of  that  Member  State  must  give  formal  approval 
following an application.266  

Prior  authorisation  procedures  are  by  definition  a  barrier  to  trade.  The  Court  of  Justice  has 
repeatedly held that national legislation, which makes the marketing of products subject to a 
prior authorisation procedure, restricts the free movement of goods.267 Therefore, in order to 
be justified with regard to the fundamental principle of the free movement of goods within the 
internal market, a mandatory prior authorisation procedure should: 

 

 

pursue a public interest-objective recognised by EU law; and 

be  non-discriminatory  and  proportionate;  i.e.,  it  should  be  appropriate  to  ensure 
achievement of the aim pursued but not go beyond what is necessary in order to achieve 
that aim.268 

Prior authorisation procedures may be justified and proportional, but Member States may also 
use them to delay the approvals of products that are due to enter the market. An effect may be 
that SMEs or economic operators with products of low added value (such as fertilisers, which 
are usually marketed in nearby countries due to high transport costs) end up not entering the 
market.269  In  addition,  there  is  ample  anecdotal  evidence  of  national  authorities  demanding 
that a product be tested nationally.270 

In the survey, the following distribution on the use of prior authorisation procedures  can be 
seen: 

266  

267  

268  

269  
270  

European  Commission:  THE  APPLICATION  OF  MUTUAL  RECOGNITION  REGULATION  (EC)  764/2008  TO  PRIOR 
AUTHORISATION PROCEDURES, Draft Informal Guidance Document 
European  Commission:  THE  APPLICATION  OF  MUTUAL  RECOGNITION  REGULATION  (EC)  764/2008  TO  PRIOR 
AUTHORISATION PROCEDURES, Draft Informal Guidance Document. Judgments include: Judgment of the Court of Justice of 
22  January  2002,  Canal  Satélite  Digital  SL,  Case  C-390/99.,  paragraph  43.;  Judgment  of  the  Court  of  10  November  2005, 
Commission v Portuguese Republic, Case C-432/03., paragraph 52.; Judgment of the Court of 15 July 2004, Nicolas Schreiber, C-
443/02., paragraphs 49-50. 
European  Commission:  THE  APPLICATION  OF  MUTUAL  RECOGNITION  REGULATION  (EC)  764/2008  TO  PRIOR 
AUTHORISATION PROCEDURES, Draft Informal Guidance Document. 
Interview with DG ENTR 
Interview with Eurocommerce 

166 

 
 
 
 
 
 
                                                            
Figure  8-17:  Product  contact  point  survey:  To  what  extent  are  prior  authorisation 
procedures used in your country and for which sectors? 

Source: Questionnaire survey among PCPs, running from 9 October 2014 to 5 January 2015, carried out by DTI 

Overall, relatively few product contact points were able to answer this question. The number 
of  respondents  varies  between  ten  and  fifteen.  Only  ten  of  the  product  contact  points  were 
able  to  provide  an  overall  figure  on  the  use  of  prior  authorisation  procedures.  Of  these  ten 
product contact points, 80% state that the overall use of prior authorisation procedures is very 
low,  ranging  between  ‘not  at  all’  and  ‘to  a  low  degree’.  However,  it  is  clear  that  prior 
authorisation  procedures  are  especially  used  regarding  articles  of  precious  metals,  food 
additives and food supplements, foodstuffs, and fertilisers. While product contact points may 
not  be  aware  of  the  overall  use  of  Prior  Authorisation  Procedures,  they  do  know  a  few 
specific  sectors  where  it  is  used.  Again,  the  decentralised  structure  that  exists  in  many 
Member  States  is  an  explanatory  factor  for  this.  In  the  qualitative interviews,  some  product 
contact points stated that they had no knowledge of the matter since such procedures are  in 
the domain of the sector ministries and, apparently, any use of Prior Authorisation Procedures 
is not brought to the attention of the product contact point. 

In  the  interviews  carried  out  in  the Member  States,  seven  product  contact  points  stated  that 
they  do  not  know  about  the  situation,  and  four  product  contact  points  stated  that  Prior 
Authorisation Procedures are not used in their country. The majority of product contact points 
mentioned that such procedures are rarely used, and mostly in areas that affect human health 
and  safety.  The  types  of  products  that  were  most  frequently  indicated  by  product  contact 
points as being subject to these procedures are fertilisers (11 Member States), food and food 
additives  (four  Member  States),  construction  products  in  the  non-harmonised  area  (four 
Member  States),  medical  products  (three  Member  States),  automobile  spare  parts  (two 
Member States), precious metals (two Member States) and animal traps (two Member States). 
It should be kept in mind that as a relatively large part of the product contact points do not 
have a good overview of this, the actual use of prior authorisation procedures may be higher 
than stated here. 

According  to  the  qualitative  interviews  with  the  product  contact  points,  ‘fertilisers’  are  the 
sector where the prior authorisation procedures are most frequently used. Prior authorisation 
procedures concerning fertilisers are mainly used because the product is classified differently 

167 

 
 
in different Member States. For instance, in some Member States a fertiliser is classified as an 
herbicide  supplement,  whereas  in  other  Member  States,  the  same  product  is  classified  as  a 
fertiliser. The same is true for food supplements. Particularly the permitted amount of certain 
enrichers, such as vitamins and minerals, is larger in some Member States than in others. The 
Member  States  with  the  strictest  rules  therefore  often  feel  the  need  to  introduce  prior 
authorisation  procedures.  In  a  draft  impact  assessment  of  fertilisers  carried  out  by  the 
Commission, the same pattern can be identified.  

Nine product contact points state that in their Member States, prior authorisation procedures 
are  applied  within  this  area,  and  the  yearly  reports  of  the  Member  States  on  the 
implementation  of  the  mutual  recognition  principle  show  that  20  Member  States  out  of  27 
specifically mentioned issues relating to fertilisers. In addition, fertilisers are reported as one 
of the product categories for which economic operators submit many information requests to 
product  contact  points,  which  means  that  economic  operators  are  uncertain  about  the 
requirements  applicable  in  the  different  Member  States.  In  February  2010,  DG  ENTR 
published  a guidance document on the application of the Mutual  Recognition  Regulation  to 
prior  authorisation  procedures.271  However,  as  stated  above,  the  yearly  reports  on  the 
implementation of the mutual recognition principle do not show that this guidance document 
has  eased  the  difficulties  of  economic  operators  in  this  regard  within  the  area  of  fertilisers, 
particularly  because  there  are  still  problems  with  what  constitutes  a  fertiliser.  The  different 
definitions  in  different  Member  States  result  in  almost  all  Member  States  perceiving  the 
Mutual  Recognition  Regulation  as  not  having  the  potential  to  create  a  functioning  internal 
market for fertilisers272. 

Companies  were  asked  to  rank  the  obstacles  to  effective  mutual  recognition.  Here,  prior 
authorisation procedures and differences in testing methods were ranked second. 

Figure 8-18: Company survey: What are the obstacles to effective mutual recognition? 
Rank from 1-4 

Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015, carried out by DTI 

271  

272  

http://ec.europa.eu/enterprise/policies/single-market-goods/free-movement-non-harmonised-sectors/mutual-
recognition/index_en.htm 
Information on fertilisers provided by the Commission services 

168 

 
 
 
                                                            
Differences in testing methods 

According to an interview with (the then) DG MARKT, a common problem witnessed by the 
Commission is that products falling under the scope of the mutual recognition regulation are 
not accepted in other Member States due to the requirement to be tested again. In many cases, 
this can be difficult to resolve, as Member States claim that they need the testing for public 
health or safety reasons. However, as shown in section 4.1.4, the reasons are not always well 
justified. From a business perspective, the experience is that economic operators faced with 
this  type  of  problem  resolve  the  problem  quickly  by  carrying  out  the  necessary  tests,  or 
withdraw from the market. Businesses can generally not afford lengthy cases and potentially 
lose money  in the process.273 One company stated that they are aware that the concerns are 
not always well enough justified, but that court cases can take many years, which companies 
cannot afford to wait for. There is also the issue of court case costs for companies.  

With respect to testing, most of the answers from the product contact points fall in one of two 
categories:  1)  those  that  do  not  know  the  answer  to  this  question,  as  they  lack  insight  into 
other Member States’ testing procedures (around 40% of the product contact points), and 2) 
those  that  accept  the  tests  from  other  Member  States  (around  half  of  the  product  contact 
points). Many product contact points highlight that the testing methods used in their country 
conform to European standards and are thus generally not different from those used in other 
Member States. However, this is contradicted by findings from the company survey and the 
company cases, which show that for approx. 60% of the companies, testing costs are either a 
‘very significant’ or a ‘significant cost’. 

Clearly, there are instances where national tests are required by the destination Member State. 
Two  aspects  stand  out  from  the  interviews.  One  is  when  a  non-accredited  laboratory  has 
tested  the  product.  Here,  the  tests  sometimes  need  to  be  repeated,  or  companies  have  to 
provide evidence that the test is performed by an equivalent of an accredited body, which puts 
a higher burden of proof on the companies. The other issue is related to the first issue and has 
to do with outdated legislation. In a specific example from Sweden, the maritime authorities 
had rules for testing the level of emissions from ships (NOx) but the rules were outdated. This 
implied that tests by bodies accredited according to the regulation had to be accepted, but also 
that tests from bodies that had been accredited according to an international agreement should 
be accepted, and also tests from non-accredited bodies (but with additional evidence that the 
bodies had competences equivalent to accredited bodies).  

Closely related to the issue of outdated legislation is that some administrators apply the rules 
directly and do not  consider the mutual  recognition  principle. Often, they only  change their 
administrative  processes  if  the  regulation  is  changed.  The  Swedish  product  contact  point 
perceives the issue of outdated legislation and its routine application (i.e. without considering 
the mutual recognition principle) to be a problem all over the EU. We do not have additional 
evidence on this from the product contact point interviews, but anecdotal evidence from the 
company  interviews  and  the  interviews  with  business  associations  suggests  that  it  can  be 
particularly difficult for innovative products to gain immediate acceptance in other Member 
States,  although  they  are  considered  safe  in  the  home  Member  State.  As  an  example,  one 
company  produces  a  tap  water  system  with  pipes  installed  in  the  wall,  but  in  at  least  one 
Member  State  the  rule  is  that  the  pipes  need  to  be  visible,  despite  the  fact  that  it  has  been 
proven  in  numerous  tests  that  the  pipes  in  the  system  do  not  leak.  This  is  an  example  of  a 
product  that  does  not  comply  with  legislation  that  was  adopted  before  the  innovative  idea 

273  

Interview with Eurocommerce 

169 

 
                                                            
came onto the market. Business associations and companies have seen examples of Member 
State  authorities  acting  in  a  precautionary  manner  and  simply  applying  the  old  legislation, 
even though the innovative product should be covered by the mutual recognition principle.  

The companies may also experience barriers related to testing if a standardisation/test body is 
so dominant on the market that even though the company is not legally required to conform to 
its standards, in practice it is impossible to market products on the market without doing so. 
This issue is explained in more detail below. 

Textbox 8-4: The case of Italian copper fittings (construction product) in Germany 

In 2011, an Italian company, manufacturing and selling copper fittings, took a case to court in 
Germany.  In  2000,  the  Italian  company  has  been  granted  a  water  industry  certificate 
necessary for operating on the German market for five years. However, in 2005, amendments 
were made to the certification process, including a 3000-hour test. Subsequently, the Italian 
company’s certificate was cancelled, since the company had not produced the said test. The 
company found this cancellation unlawful and saw it as a protectionist measure, and took the 
case to court since the case law of the European Court of Justice had so far not produced any 
reliable assessment. In short, the company was not successful in its claim, mainly because the 
conditions laid down by the European Commission with respect to the lawful drawing-up of 
technical  standards  was  fulfilled,  and  that  the  3000-hour  test  was  not  introduced  for 
discriminatory reasons. In addition, companies were given the opportunity to take part in the 
standardisation  process.  However,  the  Court  and  the  Commission  consider  it  highly 
problematic if a standardisation body is  so dominant  on the  market in  terms of  drawing up 
standards,  certifying  products,  etc.,  that  distribution  of  products  on  the  market  is  virtually 
impossible without conforming to this institute’s standards, particularly when producers are 
free to develop other standards or products. In essence, this is a problem of a dominant player 
on  the  market,  which  forces  the  companies  to  adapt  to  its  standards,  although  the  mutual 
recognition principle may apply. The Court called for further clarification on this issue, and it 
is still not clear what legal steps (if any) could be taken to solve this issue. 

Source: ECJ: Case C-171/11 – Reference for a preliminary ruling of 30.3.2011 

Communication among product contact points and between product contact points and 
the Commission 

Another  challenge  related  to  the  application  of  the  mutual  recognition  principle  is  the  slow 
communication  between  product  contact  points  that  is  sometimes  encountered.  In  a 
Commission report from 2012 regarding yearly reports on the application of Regulation (EC) 
No  764/2008-2012,  the  example  was  presented  of  the  Danish  product  contact  point  staff  in 
some  instances  having  to  ask  for  the  Commission’s  assistance  in  order  to  receive  answers. 
Slow  replies  are  unsatisfactory  (and  potentially  costly)  for  businesses  and  risk  undermining 
the cooperation between authorities in the product contact point network. The French product 
contact point mentioned similar issues in the 2012 report. However, it is also clear from the 
report that there are great differences in product contact point response times. Moreover, the 
Polish product contact point indicated the need for exchanges  of experience, good practices 
and broad discussions  on the subject  of the operation of the product  contact points, and the 
practical application of the provisions of the 'goods package' among those directly involved in 

170 

 
the activities of the product contact points.274 This also indicates a need to debate whether the 
communication in the product contact point system could be improved.  

The product contact point survey indicated that barriers to dialogue with other Member States 
do exist, but also that not all product contact points experience this.  

Figure  indicates that the main problems are unduly long response times from other Member 
States and lack of response/information not granted by other product contact points. One out 
of  four  product  contact  points  stated  that  there  were  no  problems  with  delays,  while  the 
remainder reported some or significant problems with unduly long response times from other 
Member  States.  When  asked  whether  information  is  sometimes  not  granted  or  no  answer 
provided,  two-thirds  of  the  product  contact  points  reported  some  or  significant  problems 
regarding this issue. 

Figure 8-19: Product contact point survey: Do barriers to dialogue with other Member 
States  exist?  (For  instance  in  connection  with  requests  for  information  on  specific 
products) 

Source: Questionnaire survey among PCPs, running from 9 October 2014 to 5 January 2015, carried out by DTI 

The  interviews  with  product  contact  points  provided  similar  indications.  Some  product 
contact points have little dialogue with other Member States and can therefore not report any 
problems,  whereas  other  product  contact  points  have  only  experienced  good  dialogue  with 
fast  and  accurate  answers.  However,  eight  product  contact  points  highlight  problems  with 
either  unsatisfactory  response  times  by  some  Member  States,  and/or  information  that  is  not 
sufficient to help the economic operators. 

The product contact points that mentioned unsatisfactory response times by some Member 
States  gave  different  examples  of  this.  One  product  contact  point  stated  that  sometimes  the 
wait  is  40-50  days  for  a  response  from  another  Member  State,  rather  than  the  15  working 
days, which is the normal time allowed within the product contact point network. Sometimes, 
according  to  another  product  contact  point,  it  can  take  a  long  time  for  the  product  contact 
points  even  to  confirm  that  they  have  received  the  question.  Another  product  contact  point 
states that sometimes the communication is excellent and answers are received within a few 
days, but that there are also cases where getting in contact is very difficult:  

274  

European Commission (2012): Yearly reports on the application of Regulation (EC) No 764/2008-2012 

171 

 
 
                                                            
“I would say that 20% of the cases are handled in a rather bad manner. One has to ask 
over and over again, and still it is not certain that they will answer at all”.  

The  feeling  among  those  product  contact  points  that  commented  on  this  issue  is  that  the 
majority  of  the  dialogue  is  effective  and  timely,  but  that  a  few  Member  States  repeatedly 
contribute to significant delays. However, none of the interviewees wanted to identify these 
Member States.  

Two product contact points question the 15 working days, which as mentioned above is the 
time  allowed  product  contact  points  to  answer  a  request.  They  find  it  difficult  to  answer 
within  that  period,  typically  if  the  request  needs  to  be  distributed  to  local  authorities  with 
limited  knowledge  of  English.  Then  it  is  often  the  duty  of  the  product  contact  point  to 
translate  the  answer  into  English,  which  can  take  some  time  as  the  technical  wording  in  an 
area outside of the product contact point’s competence can cause problems. 

In addition, some product contact points have experienced issues with the  language and/or 
quality  of  the  reply.  It  appears  that  some  product  contact  points  reply  in  their  national 
language  and/or  link  to  the  national  legislation  in  their  original  language.  Others  send  a 
general answer that is not concrete enough for the product contact points asking the question 
to  advise  the  companies  adequately.  The  quality  of  the  information  varies,  and  one  product 
contact  point  has  experienced  receiving  contradicting  information.  Another  product  contact 
point states that problems such as these obviously delay the process for the companies. The 
product  contact  points  in  question  cannot  always  help  the  companies  in  an  optimal  way,  as 
they  cannot  read  and  communicate  the  relevant  regulation  to  the  company.  As  a  result,  the 
companies  perceive  the  response  time  from  the  product  contact  point  to  be  slow  and  the 
service  level  to  be  inadequate.  In  that  way,  it  becomes  even  more  difficult  for  the  product 
contact  points  to  communicate  enquiries  and  issues  regarding  market  access,  national 
requirements, etc.  

Some  product  contact  points  have  called  for  a  translation  tool  for  authorities  to  be  able  to 
process  the  requests  more  effectively  when  the  question  or  the  answer  is  provided  in  a 
language not understood by the other party. Clearly, there needs to be some kind of quality 
control  of  such  a  translation  tool  to  ensure  that  the  translation  is  correct.  The  Commission 
could  assist  with  this,  particularly  if  the  IMI  system  were  to  be  used  for  communication 
among the product contact points, as discussed below.  

The  IMI  system  is  one  of  the  systems  discussed  in  the  literature,  which  might  be  used  as  a 
communication  tool  for  the  national  authorities.  The  system,  its  possibilities  and  possible 
limitations are discussed in Textbox . 

Textbox 8-5: The IMI system 

 

The IMI system has been in operation since 2008. It is a tool that allows authorities to 
communicate  with  each  other  and  in  some  cases  with  the  Commission.  The  system 
offers  different  flexible  workflows.  It  allows  competent  authorities  to  communicate 
with each other on a one-on-one basis, or the competent authorities can communicate, 
for example, a piece of legislation to a number of other partners. Shared repositories can 
also be put into the system. 

 

Since  IMI  is  for  competent  authorities,  it  could  be  used  as  a  communication  platform 
for  product contact points. In addition, the  ministries under which the product  contact 

172 

 
Textbox 8-5: The IMI system 

points are established are often already using the IMI. However, a legal basis is required 
for cooperation/communication between product contact points. Therefore, the annex of 
the  IMI  Regulation  would  need  to  be  amended  to  include  a  reference  to  this  legal 
provision.  

Two features of the IMI system are particularly interesting for the national authorities, 
i.e. the multilingual approach and the security issue. The IMI system has a high level of 
traceability and security - features that are important to the authorities. With respect to 
the language issue, if a German national authority wants to ask a question, it can do so 
in  German,  and,  e.g.,  a  Portuguese  authority  can  answer  in  Portuguese.  However,  as 
stated above, to ensure high quality in the translation, it is important that the translation 
be  carried  out  either  by  a  translator  or,  if  carried  out  automatically,  be  checked  by  a 
translator.  Currently,  the  system  only  provides  an  automatic  translation,  which  is  not 
likely to be sufficient for questions of a regulatory nature.  

In  the  Mutual  Recognition  Regulation,  there  are  two  articles  where  the  IMI  system 
could be of use: 

1.  Network of  product  contact  points  –  the IMI system  can  work  as  a  communication 
platform  for  the  product  contact  points,  when  they  need  to  communicate  to  assist 
economic operators. 

2. Obligation to notify (Art. 6) - at present, notifications are sent to the Commission by 
e-mail. A more transparent and structured solution for notifications could be to use the 
IMI  system.  Moreover,  the  IMI  system  could  be  used  as  a  way  of  storing  the 
notifications.  Art.  6  obliges  product  contact  points  to  notify  both  companies  and  the 
Commission, but for the time being, only the Commission can be notified via IMI. 

DG  GROW  is  looking  at  expanding  the  system  in  the  future  by  offering  a  separate 
mechanism  by  which  external  actors  like  companies  can  interact  with  the  IMI  back 
office. It will be a different system, as due to security reasons IMI needs to be kept as a 
tool  for  public  administration  only,  but  the  proposed  new  system  would  be  connected 
with relevant features of the IMI system.  

 

 

 

 

 

Lastly, it is important to note that the IMI is about cooperation and the use of the system is 
not  obligatory,  which  means  that  Member  States  need  to  agree  to  use  the  IMI  system. 
Therefore, it is important to sound out the Member States to see if there is a need for such a 
system, and a willingness to use it. 

Source: Interview with DG MARKT and http://ec.europa.eu/internal_market/imi-net/about/index_en.htm 

In the survey, the product contact points were also asked about dialogue with the European 
Commission. Nine product contact points (41%) have at some point engaged in dialogue with 
the Commission concerning the mutual recognition principle (apart from the yearly meetings 
in the Mutual Recognition Committee and the yearly reports that have to be submitted to the 
Commission), but only to a limited extent (maximum three cases in the last three years). 

173 

 
 
Figure  8-20:  Product  contact  point  survey:  Have  you  engaged  in  dialogue  with  the 
European Commission concerning the mutual recognition principle? 

Source: Questionnaire survey among PCPs, running from 9 October 2014 to 5 January 2015, carried out by DTI 

There are a few explanations for the rather limited dialogue with the Commission. First, the 
product  contact  points  report  to  the  Commission  once  a  year  on  the  situation  regarding  the 
application of the mutual recognition principle, and they have a yearly meeting in the Mutual 
Recognition  Committee.  It  may  be  that  the  product  contact  points  believe  that  this 
communication  is  sufficient  for  them  to  inform  the  Commission  of  any  shortcomings. 
Secondly,  a  great  number  of  product  contact  points  do  not  see  any  problems  with  the 
communication, or are not aware of any problems in the dialogue, and therefore may not see 
the need to interact with the Commission. For the latter group, the decentralised structure in 
many  Member  States  can  be  the  reason  for  product  contact  points  not  being  aware  of  any 
issues, and therefore not communicating with the Commission. 

Legal uncertainty 

Literature  shows that stakeholders  frequently face  legal uncertainties regarding the scope of 
the application of the principle of mutual recognition.275 It is often unclear to which categories 
of products mutual recognition applies, and since the principle of mutual recognition is based 
on the case law of the European Court of Justice, the legislation on mutual recognition does 
not and cannot contain a comprehensive list of products or aspects of products to which the 
principle  should  apply.  Consequently,  enterprises  as  well  as  national  administrations  need 
extensive  knowledge  of  EU  law  in  order  to  establish  whether  the  principle  of  mutual 
recognition applies to a specific product or aspects of it.276  

Findings from the literature review show that there is some uncertainty about how and when 
to apply the mutual recognition principle in practice. Businesses, product contact points and 
national administrations have all mentioned this issue.277 For instance, the Spanish product 

275  

276  
277  

First  Report  on  the  application  of  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: 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0292:FIN:EN:PDF.  
ToR Evaluation of the application of the principal of mutual recognition in the field of goods. 
European Commission (2012): First Report on the application of 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. The information comes from the yearly reports on the 
application of the Mutual Recognition Regulation that Member States are required to submit to the Commission under Article 12(1) 
of the mutual recognition Regulation. The reports must include information on the number of written notices sent pursuant to Article 
6(1) and the types of products concerned; sufficient information concerning any decisions taken pursuant to Article 6(2), including 
the grounds on which those decisions were based and the types of products concerned; and the number of decisions taken pursuant 
to Article 6(3) – intended negative decisions finally not adopted, and the types of products concerned. 

174 

 
 
                                                            
 
contact point reported in the 2012 Annual report that companies lack information on the 
principle of mutual recognition, and that in their opinion more information and dissemination 
activities are needed.278  

In  the  product  contact  point  interviews  conducted  by  the  evaluation  team  it  was  found  that 
approx. 50% of the product contact points state that the national authorities may not be fully 
aware  of  the  application  of  the  mutual  recognition  principle(cf.  section  0  where  this  was 
discussed  in  more  detail).  However,  in  the  interviews  it  is  also  mentioned  that  the  product 
contact  points  and  the  national  authorities  sometimes  experience  difficulties  with  the 
application of the mutual recognition principle, particularly in the non-harmonised part of the 
construction sector and with food supplements. As mentioned above, the problem exists in the 
area of food supplements, the problem because of the differences in the amounts of enrichers 
that the Member States will allow in their food, and therefore there are very different national 
rules.  These  will  prevail  until  the  amounts  of  vitamins  allowed  in  food  supplements 
potentially are harmonised.279 

Means or actors that render certain aspects of mutual recognition more (or less) 
effective than others 

The product contact points were asked if they could provide examples of means or actors in 
the system that contribute to making mutual recognition work more effective or less effective 
– in other words, good practices, or bad practices. This section concludes on some of the key 
issues that were identified in the previous analysis. 

Lack of awareness 

As discussed above, both in lack of awareness among companies and among some Member 
State authorities is an important barrier to effective implementation of the mutual recognition 
principle.  Several  product  contact  points  call  for  awareness  campaigns  directed  at  different 
target groups to increase the effectiveness of the mutual recognition principle. Some product 
contact points call for the assistance of the Commission to carry out information campaigns, 
also because it would expand the reach of the information and, in one instance, because the 
product  contact  point  has  difficulties  in  financing  the  information  campaigns.  However,  in 
other  Member  States,  product  contact  points  undertake  seminars  and  training  (e.g.  Cyprus, 
Denmark, Lithuania, Slovakia, Slovenia, and Sweden). In Croatia, the interaction between the 
Mutual  Recognition  Regulation  and,  for  example,  Directive  98/34  is  explained  regularly  to 
the competent authorities. The product contact point, which is also the Croatian 98/34 Central 
Unit,  performs  regular  educational  seminars  and  meetings  with  authorities  and  business 
associations. In Denmark, the product contact point has developed a guide on the use of the 
principle of mutual recognition that can be accessed on its website. 

Lack of trust 

The  personal  interviews  with  the  business  associations  revealed  that  there  are  examples  of 
Member States putting up barriers when requirements in one Member State are not equivalent 
to  those  of  the  destination  Member  State.  These  Member  States  require  equivalence  of 
requirements, which is very different from recognition of requirements, and this is a problem. 
Lack  of  trust  in  other  Member  States’  procedures,  interpretations  and/or  requirements  - 
possibly due to a lack of understanding of each other’s working practices – are often cited as 

278  
279  

European Commission (2012): Yearly reports on the application of Regulation (EC) No 764/2008-2012 
European Commission (2010): Guidance Document - The application of the Mutual Recognition Regulation to food supplements 

175 

 
                                                            
leading  to  these  situations.  This  lack  of  trust  can  also  result  in  authorities  taking  a  very 
restrictive  view  of  the  mutual  recognition  principle.  Whereas  the  main  rule  is  that  products 
should be sold freely and only be stopped in extraordinary circumstances, in practice lack of 
trust  can  result  in  authorities  taking  the  opposite  perspective,  i.e.  looking  at  the  safety 
aspects/consumer interests with the free movement aspect as a secondary consideration. This 
can increase the use of prior authorisation procedures and/or different testing methods, which 
again  can  create  legal  uncertainty.  In  its  position  paper  from  2014  produced  for  this 
evaluation, Orgalime suggests that an improvement in the market surveillance in all Member 
States is a key factor in improving trust and thereby improving the functioning of the mutual 
recognition  principle.  Increased  and  better  market  surveillance  is  expected  to  reduce  the 
duplication of conformity assessment controls by authorities  (as the level of trust is  raised), 
which in turn benefits the economic operators.  

In one case, the lack of trust reached all the way to companies. The perception of the product 
contact point in question was that companies know the mutual recognition principle very well 
and simply state that they are allowed to put the product on the market. Likewise, the product 
contact  point  believed  that  companies  are  ‘misusing’  the  mutual  recognition  principle  by 
putting  their  product  first  on  a  market  where  it  is  easy  to  be  accepted  and  then  using  the 
mutual recognition principle to put their products on other markets. However, this is exactly 
what  the  mutual  recognition  principle  should  do,  i.e.  ensure  that,  in  principle,  products  that 
are  lawfully  marketed  in  one  Member  State  must  be  admitted  to  the  market  of  any  other 
Member  State.  Again,  the  lack  of  trust  in  other  Member  States  is  perceived  to  be  the  main 
reason  behind this statement. If this lack of trust  did  not  exist, the accusation  of companies 
‘speculating’ in where to market their products first would not exist either. However, it also 
demonstrates  a  lack  of  understanding  of  the  reasoning  behind  the  mutual  recognition 
principle. 

Organisation of the product contact point function 

Another  issue  emerging  from  the  interviews  with  the  product  contact  points  concerns  the 
organisation of the product contact point and other internal market functions in the Member 
State administrations.  The  evaluator  has  no  means  objectively  to  assess the  effectiveness  of 
one set-up vs. another with respect to, e.g., response times or the correctness with which the 
mutual  recognition  principle  is  applied.  However,  comparing  remarks  from  the  different 
product contact points, it seems that grouping together related functions such as  the product 
contact  point,  the  contact  point  for  construction  products,  and  staff  working  with  other 
internal  market  issues,  seems  to  create  good  dynamics  and  increase  the  pool  of  knowledge 
available  to  the  product  contact  point.  This  could  be  an  example  of  good  practice.  A  very 
different model for organising the product contact point function is found in a small minority 
of  Member  States  where  the  product  contact  point  function  is  divided  between  several 
ministries,  departments,  or  other  units,  with  one  coordinating  product  contact  point.  The 
advantage  of  such  a  system  is  that  the  individual  product  contact  points  may  have  better 
insight  into  the  specifics  of  their  domain.  The  effectiveness  of  such  a  set-up  depends  very 
much  on  the  details,  in  particular  whether  the  lack  of  a  single  entry  point  for  companies  is 
balanced with good guidance on where to direct inquiries. In one of the Member States with 
this type of organisation, the view of the interviewed business association of the system was 
negative, since it was seen as confusing for companies. Table 8-3 presents an overview of the 
different set-ups in different Member States. 

176 

 
 
Table 8-3: Overview of the different product contact point setups in Member States 

Single contact point for 
practically all product-
related EU legislation 

PCP incorporated in a 
wider team dealing with 
Single Market policy 

PCP responsibility 
divided among several 
ministries 

Examples of Member 
States: Malta 

Examples of Member 
States: Denmark, UK 

Examples of Member 
States: Portugal 

Source: PCP interviews 

One PCP, several 
national/regional 
authorities with 
product 
responsibility 

Examples of Member 
States: Germany, 
Italy, France 

In Denmark and the UK, the product contact points have been incorporated in a wider team in 
the  relevant  ministry/authority  dealing  with  the  Single  Market  policy.  This  means  that  all 
questions regarding rules and regulations related to the functioning of the Internal Market can 
be  answered  by  the  same  authority,  which  simplifies  matters  for  the  economic  operators. 
Along  these  lines,  Orgalime  suggests  in  its  position  paper280  that  the  product  contact  point 
function  could  be  strengthened,  for  instance,  by  incorporating  product  contact  points, 
SOLVIT, EEN and other supportive structures into a single contact point at national level. 

A  good  practice  emerging  from  the  product  contact  point  interviews  is  that  product  contact 
point functions are better informed about the outcome of the queries, which they pass on to 
other authorities in their country, would appear to be preferable to product contact points that 
do not receive a copy of the answer/decision or are otherwise not informed of the outcome. 
While  having  an  overview  of  what  actually  happens  when  a  query  is  made  may  not  be  a 
precondition  for  an  effective  system,  at  least  an  overview  can  contribute  to  identifying  any 
bottlenecks  or  other  problems  in  the  system,  which  is  the  basis  for  addressing  any  such 
problems.  

4.  MARKETS AND SECTORS WITH THE MOST PROBLEMS 

Sectors with the most problems 

The  minutes  of  the  second  meeting  of  the  consultative  Mutual  Recognition  Committee 
indicate  that  in  2010  and  2011  the  product  types  that  received  the  most  inquiries  or  were 
subject  to  notifications  were  articles  of  precious  metal,  foodstuffs,  food  additives  and  food 
supplements, automotive spare parts, construction products and fertilisers.281 The latest report 
published  by  the  Commission  (2012)  on  the  application  of  the  mutual  recognition  principle 
highlighted that  the  majority  of  decisions,  requests  for  information  and  complaints  received 
by  the  national  administrations  also  concern  specific  categories  of  goods.  In  addition  to 
precious  metals282,  foodstuffs,  food  additives  and  food  supplements,  construction  products, 

280  
281  

282  

Orgalime (2014): Position paper: Suggestions for improving the application of the mutual recognition principle 
European  Commission  (2010):  Minutes  of  the  second  meeting  of  the  consultative  “Mutual  Recognition  Committee”,  held  in 
Brussels  on  19  November  2010  and  European  Commission  (2011):  Minutes  of  the  third  meeting  of  the  consultative  “Mutual 
Recognition Committee”, held in Brussels on 30 November 2011. 
However,  this  is  a  very  specific  case  involving  hallmarking  of  jewelry,  where  a  Member  State  allowed  hallmarking  done  by 
companies in China and other Member State would not accept this as hallmarking. Source: Interview with DG MARKT, DG ENTR. 

177 

 
                                                            
fertilisers,  and  automobile  spare  parts  as  mentioned  above,  the  report  now  also  mentioned 
electrical products and spring water.283  

The  Commission’s  yearly  reports  on  the  application  of  the  Mutual  Recognition  Regulation 
(2008-2012)  shows  that  problems  regarding  construction  products  and  food  and  foodstuffs 
seem to be a recurring issue. For instance, in Belgium, two major categories account for some 
65%  of  all  queries,  i.e.  construction  products  (44%)  and  consumer  products284  (21%).  This 
suggests that there is still a relatively high level of uncertainty and/or problems in relation to 
these  two  types  of  products  in  the  non-harmonised  sectors.  The  situation  in  Poland  follows 
this  pattern,  with  the  majority  of  the  queries  falling  under  construction  products  (42%)  and 
consumer products285 (12% on average). Subjects that recurred were how to document that a 
product has been lawfully placed on the market, CE marking, labelling, and the relationship 
between  the  Construction  Products  Regulation  and  mutual  recognition  procedures.  Many  of 
the answers to these issues can be found in the Commission’s guidelines on the application of 
the  mutual  recognition  principle.  Other  examples  are  seen  in  Latvia,  which  had  inquiries 
and/or  notifications  regarding  fertilisers,  textiles,  foodstuffs,  and  construction  products;  in 
Denmark,  which  particularly  had  queries  regarding  construction;  and  in  the  Netherlands, 
where  there  were  inquiries  within  the  construction  products,  (spring)  water,  cosmetics, 
fertilisers and biocides, and food supplements sectors.286 However, as the subsequent product 
contact point interviews showed, queries do not necessarily mean that there are problems with 
the application of the mutual recognition principle. For instance, 70% of the queries in Spain 
are related to construction products, but since a large part of the area is harmonised, the issues 
do  not  arise  in  this  area.  Rather,  the  problems  are  within  the  area  of  food  and  food 
supplements, as national Member State rules differ considerably within this area. 

The  Commission’s  Enterprise  Europe  Network  (EEN)  carries  out  an  SME  survey  (still 
pending)  in  all  Member  States  asking,  among  other  things,  if  and  where  SMEs  have 
experienced  problems  with  doing  business  in  Europe.  Around  21%  of  the  reported  cases 
(1648  out  of  7817),  concerned  problems  related  to  free  movement  of  goods  in  the  internal 
market.  The  sectors  with  the  most  problems  related  to  the  free  movement  of  goods  were 
foodstuffs  (15%),  construction  products  (9%),  machines  (8.5%),  and  agricultural  products 
(6%).287  

Food and construction products are also the sectors highlighted in the company interviews. As 
mentioned  in  section  4.2.3,  it  is  particularly  enriched  food  and  the  amount  of  vitamins  and 
minerals  allowed  (within  the  food  sector);  water  taps  in  contact  with  food  (within 
construction)  as  well  as  the  rather  specific  issue  in  the  construction  sector  of  the  lack  of 
respect of the mutual recognition principle, particularly in Germany. 

283  

284  
285  
286  
287  

European Commission (2012): First Report on the application of 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. The information comes from the yearly reports on the 
application of the Mutual Recognition Regulation that Member States are required to submit to the Commission under Article 12(1) 
of the Mutual Recognition Regulation. The reports include at least the information on the number of written notices sent pursuant to 
Article  6(1)  and  the  type  of  products  concerned;  sufficient  information  concerning  any  decisions  taken  pursuant  to  Article  6(2), 
including the grounds on which those decisions were based and the type of products concerned; and the number of decisions taken 
pursuant to Article 6(3) – intended negative decisions finally not adopted, and the type of products concerned. 
Not specified further in the reports 
Not specified further in the reports 
European Commission (2012): Yearly reports on the application of Regulation (EC) No 764/2008-2012 
EEN  Database,  SME  survey,  http://ec.europa.eu/yourvoice/ipm/forms/dispatch?form=smefeedback&lang=en  (accessed  mid-
January 2015) 

178 

 
                                                            
Data from the SOLVIT288 database also provides evidence of some areas where challenges to 
the  free  movement  of  goods  occur.  Generally,  businesses  tend  to  account  for  a  very  small 
number  of  SOLVIT  cases,  compared  with  the  number  of  cases  submitted  by  private 
individuals. In 2013, there were only 132 closed cases submitted by businesses, amounting to 
9% of all cases. Moreover, very few SOLVIT cases involved the free movement of goods. In 
2013,  SOLVIT  only  had  30  cases  (2%  of  all  cases  in  2013)289  within  the  area  of  free 
movement of goods.290 Previous SOLVIT reports and an analysis by the Centre for European 
Policy Studies291 suggest that the low representation of businesses has to do with the fact that 
businesses prefer to have more legal certainty than SOLVIT can provide. Another reason is 
that  proving  that  a  particular  national  restrictive  measure  is  unjustified  calls  for  technical 
expertise and formal powers that SOLVIT centres do not have.292 

Of the cases that SOLVIT received regarding the free movement of goods, some of the cases 
that could not be informally resolved include the following:293 

Textbox 8-6: Examples of unsolved SOLVIT cases 

 

 

 

 

 

Labelling  to  show  that  a  food  product  contains  nuts.  The  Member  State  concerned 
rejected the argument that given the small quantity of nuts in the product, the wording 
'contains traces of nuts' would be sufficient to protect consumers. The problem could not 
be resolved through SOLVIT. 

Certification  of  solar  panels.  A  Member  State  insisted  on  certification  by  a  national 
body, as it did not accept another Member State’s certification (required to qualify for a 
grant). The applicants decided to go to court. 

Difficulty  with  importing  fertilisers.  Products  from  another  Member  State  were  not 
recognised  as  fertilisers,  as  the  authority  concerned  interpreted  the  word  'fertilisers' 
differently.  The  case  was  closed  because  it  could  not  be  informally  resolved,  and  the 
Commission started its own informal procedure against the country concerned. 

Transit of defence products through a Member State. The country of origin considered 
the transit licensing procedure to be disproportionate. Given its political sensitivity, the 
case could not be informally resolved. 

Acceptance of hallmarking by an organisation accredited by another Member State. This 
is  generally  also  a  politically  sensitive  matter,  and  it  was  impossible  for  the  SOLVIT 
centres to resolve this case informally. 

  Marketing of nutrition supplements. These products were marketed legally in many EU 
countries, but one Member State required them to be registered as medicinal products, 
refusing to let them be marketed as nutrition supplements. It was not possible to find an 
informal solution. 

 

The proportion of alcohol in a canned drink. These drinks were legally marketed in one 

288  

289  
290  
291  
292  
293  

SOLVIT  is  a  service  provided  by  the  national  administration  in  each  EU  country  and  in  Iceland,  Liechtenstein  and  Norway. 
SOLVIT  offers  assistance  when  your  EU  rights  as  a  citizen  or  as  a  business  are  breached  by  public  authorities  in  another  EU 
country and you have not (yet) taken your case to court. Source: http://ec.europa.eu/solvit/what-is-solvit/index_en.htm  
http://ec.europa.eu/internal_market/scoreboard/performance_by_governance_tool/solvit/index_en.htm  
http://ec.europa.eu/internal_market/scoreboard/performance_by_governance_tool/solvit/index_en.htm    
Pelkmans and de Brito (2012): Enforcement in the EU Single Market, Centre for European Policy Studies 
http://ec.europa.eu/internal_market/scoreboard/performance_by_governance_tool/solvit/index_en.htm 
http://ec.europa.eu/internal_market/scoreboard/performance_by_governance_tool/solvit/index_en.htm  

179 

 
                                                            
Member State, but the alcohol content meant they could not be sold in another Member 
State  because  of  the  latter’s  national  legislation.  As  the  national  law  was  undergoing 
reform  at  the  time,  the  relevant  authorities  were  unable  to  resolve  the  problem 
informally. 

 

Registration of a certain type of trailer. The authorities of one Member State refused to 
register certain trailers. This made it impossible to sell them in that country. The issue 
was already under discussion in formal EU meetings between the authorities responsible 
for  vehicle  registration,  so  SOLVIT  was  unable  to  provide  a  solution.  The  matter  was 
further taken up bilaterally between the respective authorities. 

When discussing the SOLVIT cases with the then DG MARKT, the interviewee particularly 
recalls  problems  in  the  ‘grey  areas’,  for  instance,  with  respect  to  food  additives  (the  issue 
being  whether  these  should  be  considered  as  food  or  vitamins/medicines),  general  food 
products  (for  instance,  does  it  contain  nuts,  which  may  be  considered  important  in  some 
countries and not in others). Particularly the first issue with vitamins and minerals in food is 
also  an  area  that  has  repeatedly  been  highlighted  by  product  contact  points  and  companies 
alike. 

Another particular problem voiced by DG MOVE has to do with ship classification. A ship 
needs  to  be  certified  by  a  recognised  classification  society.  Some  products  fall  under  the 
marine equipment directive and are thereby harmonised, but many types of equipment, such 
as  engines, do not  fall under that directive and are thus  non-harmonised. This  can lead to  a 
situation where, for instance, a ship engine is built into different ships, but has to be inspected 
by  four  or  five  different  classification  societies,  depending  on  which  is  responsible  for  the 
classification  as  a  whole.  This  creates  extensive  administrative  burdens  for  the  economic 
operator.294 However, this particular problem was only mentioned in one interview with the 
Commission and not highlighted by any economic operators. 

The  business  associations  particularly  highlight  fertilisers,  construction  products  and 
foodstuffs  as  sectors  where  issues  regarding  the  application  of  the  mutual  recognition 
principle are particularly pronounced, but many are not able to point to specific sectors (see  

Figure ).  

294  

Interview with DG MOVE 

180 

 
 
 
 
 
 
 
 
 
                                                            
Figure 8-21: Business and sector association survey: Are there some sectors/subsectors 
where this problem is particularly pronounced? Please indicate which ones 

Source:  Questionnaire  survey  among  national  business and  sector  associations, running  from  9 October  2014  to  5  January 
2015, carried out by DTI 

Fertilisers were also mentioned in the product contact point interviews and in the SOLVIT-
cases  above.  As  mentioned  previously,  prior  authorisation  procedures  are  often  used  for 
fertilisers as the product is classified differently in different Member States.  

In  the  company  survey,  the  sectors  represented  by  respondents  are  particularly  construction 
products  (42),  nursery  and  childcare  products  (25),  electrical  products  (15),  foodstuffs  (15), 
and  articles  of  precious  metals  (12).  Obviously,  these  are  also  the  problematic  sectors 
identified  in  the  company  survey.  However,  the  evaluation  team  has  experienced  that 
companies  mostly  participate  in  surveys  if  they  either  see  a  benefit  from  it  or  feel  that  the 
subject  needs  to  be  addressed.  It  is  therefore  also  interesting  that  the  sector  ‘Nursery  and 
childcare  products’  is  relatively  well  represented.  From  the  interviews,  it  seems  that  the 
challenges in this sector are similar to the ones experienced in the food sector, i.e. that certain 
Member States put up stricter rules than others do. One company interview revealed that the 
UK  put  up  specific  standards  for  the  flammability  of  baby  sleeping  bags,  citing  safety  as  a 
reason.  This  clearly  protects  UK  producers  that  respect  these  standards,  but  also  limits  the 
market for producers from other EU Member States. 

The  product  contact  point  survey  revealed  that  the  sectors  where  product  contact  points 
believe  that  enterprises  most  often  spend  resources  examining  the  technical  rules  are 
construction (nearly 45%), food and food additives/supplements (around 50%), and articles of 
precious metals and fertilisers (approx. 20% each).295 The same sectors are predominant when 
it comes to the product contact points’ perception of the sectors in which economic operators 
most often adapt their products to local requirements. Problems with retesting of products are 
mainly  perceived  to  be  within  the  construction  and  food/food  additives  and  supplements 
sectors.  

295  

The percentages do not add up to 100 as the respondents were able to select more than one sector 

181 

 
 
                                                            
When  it  comes  to  the  companies  refraining  from  entering  a  foreign  market,  the  product 
contact points perceive these problems to be most pronounced within the sectors of fertilisers, 
food/food additives and food supplements, and construction products. 

To sum up, the sectors where the literature review, surveys and interviews most consistently 
point to problems with the application of the mutual recognition principle are: 

 

 

 

the non-harmonised area of construction where no CE-marking applies (for instance in 
the area of water taps);  

a general issue with construction products where the mutual recognition principle is not 
respected,  particularly  in  Germany  (an  infringement  case  have  been  launched  by  the 
Commission296); and  

the area of enriched food where Member States tolerate different levels of vitamins and 
minerals.  

Another  area  frequently  mentioned  is  fertilisers,  where  the  Member  States  have  different 
definitions  of  what  constitutes  a  fertiliser  as  described  in  section  0.  Finally,  nursery  and 
childcare  products  (different  standards  in  different  Member  State)  and  ship  classification 
(demand for national tests) have emerged from the survey and the interviews respectively as 
sectors with problems in applying the mutual recognition principle.  

The  economic  importance  of  the  construction  products  and  food  sectors  is  considerable. 
Construction  products  are  a  large  market,  with  a  total  (EU-28)  turnover  in  2012  of  approx. 
770  million  euros.  Moreover,  in  2012,  approx.  1.6  million  persons  were  employed  in  this 
sector.297  

In the food sector, the total (EU-28) turnover in 2013 was approx. one billion euros and the 
sector  employed  315,000  persons.298  The  sector  was  growing  slightly,  with  food  and  drink 
industry production in the EU increasing by 0.43% in Q4 of 2014.299 

For fertilisers, the total (EU-28) turnover is 390 million euros, and the sector employs around 
10,000 people.300 Thus, the sector is of less economic importance in the EU than construction 
and food, but it is also one of the sectors with the greatest problems in reaching a common 
decision on what constitutes a fertiliser. 

Markets with the most problems 

As  can  be  seen  from  the  company  survey,  the  three  largest  national  markets  in  the  EU  – 
Germany,  France  and  the  United  Kingdom  –  clearly  stand  out  in  terms  of  the  frequency  of 
obstacles encountered by the surveyed companies. 

296  
297  

298  
299  

300  

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:62013CA0100 
Eurostat  SBS:  Annual  detailed  enterprise  statistics  for  construction  (Electrical,  plumbing  and  other  construction  installation 
activities, Electrical installation, Plumbing, heat and air conditioning installation, and Other construction installation), and Annual 
detailed  enterprise  statistics  for  industry  (Manufacture  of  bricks,  tiles  and  construction  products,  in  baked  clay,  Manufacture  of 
concrete  products  for  construction  purposes,  Manufacture  of  plaster  products  for  construction  purposes,  and  Manufacture  of 
machinery for mining, quarrying and construction) 
Eurostat SBS: Annual detailed enterprise statistics for industry (NACE Rev. 2, B-E), Manufacture of food products 
FoodDrinkEurope, 
_Q4_of_2014.pdf 
Eurostat SBS: Annual detailed enterprise statistics for industry (NACE Rev. 2, B-E), Manufacture of basic chemicals, fertilisers and 
nitrogen compounds, plastics and synthetic rubber in primary forms 

http://www.fooddrinkeurope.eu/uploads/publications_documents/FoodDrinkEurope_Economic_Bulletin_-

182 

 
                                                            
Figure  8-22:  Company  survey:  In  which  national  markets  have  you  experienced 
obstacles? 

Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015, carried out by DTI 

This does not necessarily indicate that obstacles to mutual recognition are more widespread in 
these markets compared to other national markets. It could simply reflect the fact that these 
markets  are  the  largest  in  the  EU  and  that  many  companies  export  to  these  markets  and, 
consequently,  there  are  more  opportunities  for  companies  to  have  experienced  obstacles  in 
terms of mutual recognition. As the interviewed companies also participated in the survey, the 
Member  States  in  which  these  companies  experience  problems  are  obviously  the  same  as 
those presented in the figure above. 

The survey among national business and sector associations shows a similar picture. France, 
Germany  and  the  UK  are  still  the  markets  where  problems  most  frequently  occur  for  the 
business  and  sector  associations’  members,  but  also  Italy,  the  Netherlands  and  Sweden  are 
mentioned as Member States where economic operators frequently experience problems. 

183 

 
 
 
 
 
 
 
Figure 8-23: Business and sector association survey: In which national markets do your 
members experience barriers due to prior authorisation or testing? 

Source:  Questionnaire  survey  among  national  business and  sector  associations, running  from  9 October  2014  to  5  January 
2015, carried out by DTI 

Although the number of business and sector associations being able to answer this question is 
rather low, the indications in this table are similar to the ones found in the company survey. 

Influence of macro-economic aspects on application of mutual recognition 

By  using  macro  data301  from  the  Eurostat  database,  the  team  investigated  if  Member  States 
with a high share of cases/issues related to the application of the mutual recognition principle 
share  a  similar  macroeconomic  context.  The  company  survey  indicated  that  Germany 
followed  by  France  and  the  United  Kingdom  were  the  Member  States  where  the  largest 
number of companies across the EU experienced obstacles related to the application of mutual 
recognition. The common denominator for these countries is that they are the largest intra-EU 
importers  measured  in  terms  of  imports  in  €  millions.  Belgium,  the  fourth  largest  intra-EU 
importer, is also mentioned as  being among the countries where  relatively many companies 
experience problems. As could be seen in the tables presented in section 4.5, it was clear that 
none  of  the  Member  States  stood  out  in  terms  of  trade  pattern,  although  some  clearly 
experienced higher levels of intra-EU trade than others did. 

However, it should also be noted that the culture in different Member States might influence 
whether  economic  operators  experience  problems.  For  instance,  in  Germany,  the  interviews 

301  

Increases or decreases in intra-EU trade in terms of sectors and markets, EU export by sector, EU import by sector, Unemployment 
rate, EU direct investments, Inflation, Consumer activity 

184 

 
 
                                                            
indicate  that  at  least  in  the  construction  sector,  the  German  authorities  seem  to  favour  their 
own national tests and perceive them to be superior to other Member States’ tests.  

Other countries indicated as troublesome in this context by the survey participants are Poland, 
Italy and Spain. Part of the explanation in a macro context could be that these countries have 
experienced  particularly  severe  economic  problems  in  the  wake  of  the  financial  crisis 
(especially Spain and Italy). However, many countries with high unemployment rates are not 
mentioned in the company survey to be problematic in a mutual recognition context, so it is 
not possible to draw a correlation. For an overview of the unemployment and inflation rates in 
all Member States see Figure 8-24 and Figure 8-25. 

185 

 
Figure 8-24: Unemployment rates by Member State, 2014 

Source: Eurostat 

Figure 8-25: Inflation rate by Member State, 2014 

Source: Eurostat 

186 

 
 
 
The  product  contact  points  were  also  asked  whether  they  believed  that  macro-economic 
aspects influenced the application of the mutual recognition principle in the Member States – 
for instance, whether the economic crisis may have led to a certain degree of protectionism in 
the home market. However, in general, the product contact points did not believe that this was 
the  case  –  at  least  not  for  their  own  countries.  A  few  product  contact  points  remarked  that 
there  might  be  an  increased  number  of  companies  from  the  Member  States  that  are  most 
severely  affected  by  the  crisis  trying  to  enter  other  markets,  i.e.  exporting  their  way  out  of 
problems  in  their  domestic  market.  This  is  for  instance  seen  in  Italy.  However,  the  product 
contact  points  did  not  generally  believe  that  this  affected  the  way  the  mutual  recognition 
principle was applied. 

The business associations were also asked this question, but most did not have any opinion. 
Only  two  business  associations  (one  from  the  North  Europe  and  one  from  South  Europe) 
mentioned  that  they  suspected  a  certain  degree  of  protectionism  in  some  markets  after  the 
crisis. However, this is very difficult to detect and often disguised as public support schemes 
or  public  procurement  with  specific  objectives  (such  as  environmental,  safety,  health,  etc., 
concerns),  resulting  in  requirements  that  tend  to  favour  the  Member  State’s  domestic 
producers.  

In sum, it cannot be concluded that macro-economic aspects have a significant impact on the 
application  of  the  mutual  recognition  principle.  Rather,  the  application  (or  lack  thereof)  is 
founded  in  Member  State  traditions  with  respect  to  tests,  inertia  in  national/regional 
administrations  towards  handling  new  products  that  do  not  fit  the  pre-defined  boxes  of 
legislation (particularly if these products come from other Member State) and lack of trust in 
the administration of other Member States. 

5. 

TYPOLOGY OF OBSTACLES 

The above analysis has identified a number of obstacles, which are summed up in Table 8-4. 

Table 8-4: Overview of sectors and types of obstacles 

Sectors 

Types of obstacles 

Lack of 
trust 

Lack of 
know-
ledge of 
MR 
principle – 
competent 
authorities 

Difficultie
s for 
companies 
challengin
g non-
application 
of MR 

Lack of 
know-
ledge of 
MR 
principle – 
compa-
nies 

Insufficien
t dialogue 
among 
PCPs 

X 

X 

Construc-
tion – 
water taps 

Construc-
tion - non-
harmonise
d area in 
general 

Difference
s in 
Member 
State 
national 
standards 

Lack of 
accep-
tance of 
MR 
principle 

Request 
for 
national 
tests in the 
area of 
MR 
principle 

X (general 
issue) 

X (particu-
larly DE) 

187 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sectors 

Types of obstacles 

X (general 
issue, but 
e.g. DK, 
ES have 
strict 
standards) 

X 

X (UK 
have strict 
rules) 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

Enriched 
food 

Fertilisers 

Ship 
classifica-
tions 

Nursery 
and 
childcare 
products 

Innovative 
products 
(different 
sectors) 

Across 
sectors 

The different types of obstacles are discussed in more detail below. 

Lack of trust 

The  Member  States’  lack  of  trust  in  each  other’s  procedures,  interpretations  and/or 
requirements - possibly due to a lack of understanding of each other’s working practices - is 
often  cited as  leading  to  authorities  taking  a  very  restrictive  view  of  the  mutual  recognition 
principle. This means that products are not allowed in other Member States on the grounds of 
safety  and/or  consumer  interests  in  instances  where  the  mutual  recognition  principle  should 
apply,  and  can  potentially  lead  to  Member  States  increasing  their  use  of  prior  authorisation 
procedures. 

Lack of knowledge of mutual recognition principle – competent authorities 

This  obstacle  is  related  to  competent  authorities  acting  in  a  cautious  manner  and  simply 
applying  the  old  legislation,  even  though  an  innovative  product  should  be  covered  by  the 
mutual  recognition  principle.  This  means  that  it  can  be  particularly  difficult  for  innovative 
products to gain immediate acceptance in other Member States, although they are considered 
safe in the home Member State. 

Difficulties for companies in challenging non-application of mutual recognition 

Several  companies  have  stated  that  although  they  are  positive  that  the  mutual  recognition 
principle applies to their product, they do not insist on this towards the competent authorities. 
The main reason is that it is perceived to be a costly and lengthy process to test if the mutual 

188 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
recognition principle applies, in terms of money and loss of market share if the process takes 
too long. This is particularly true for SMEs, but large companies are also hesitant to take this 
step. In addition, as the mutual recognition principle is based on case law, more court cases 
would give a clearer overview of how to apply the principle for Member State authorities but 
as mentioned above, companies are unwilling to take cases to court.  

Lack of knowledge of mutual recognition principle – companies 

The lack of awareness of mutual recognition by companies implies that companies often do 
not  know  with  which  obligations  they  need  to  comply,  or  which  rights  can  be  upheld  in 
certain  product  areas.302  Thus,  before  entering  a  market,  companies  may  check  the  national 
requirements and adapt their products accordingly, without checking/knowing that the mutual 
recognition  principle  could  apply.  Better  knowledge  may  result  in  companies  being  able  to 
avoid these costs (depending on how firm the Member State authority is on the demands and 
how  costly  it  would  be  for  the  company  to  test  if  the  principle  applies).  This  is  a  general 
problem across sectors. 

Slow and insufficient dialogue among product contact points 

The  evaluation  has  shown  that  the  dialogue  between  competent  authorities  and  between 
competent  authorities  and  the  Commission  is  too  slow  and  incomplete  at  times.  This  can 
result  in  companies  getting  the  information  later  than  the  15  working  days  defined  in  the 
Mutual Recognition Regulation, and companies can perceive the information that they receive 
as incomplete and unhelpful. This too is a general problem across sectors. 

Request for national tests in the area of the mutual recognition principle 

In non-harmonised areas where the mutual recognition principle should apply, the evaluation 
has shown examples of Member States still demanding national tests. There are indications in 
this  evaluation  that  it  is  sometimes  done  because  the  Member  States  do  not  trust  the 
procedures  in  other  Member  States,  and  sometimes  for  market  protection  reasons.  An 
example is found within the area of water taps. Examples of costs incurred by the companies 
include  the  cost  of  getting  approval  of  a  new  composition  to  be  used  for  the  production  of 
water  taps  (€50,000  to  €100,000),  testing  costs  for  a  component  (approx.  €2,000)  and  for  a 
final product (€8,000-9,000). In addition, the tests can take up to four to six months. A similar 
situation has arisen in the shipping sector, where a ship needs to be certified by a recognised 
classification society. Some products, such as engines, are not harmonised and fall under the 
mutual recognition principle. However, the principle is not always respected, meaning that a 
ship  engine  may  have  to  be  inspected  by  four  or  five  different  classification  societies, 
depending  on  which  is  responsible  for  the  classification  as  a  whole.  This  creates  extensive 
administrative burdens for the economic operator303, without being able to put a figure on that 
cost. 

Differences in Member States’ national standards 

This  type  of  obstacle  is  an  issue  in  the  food  and  food  supplement  sectors,  especially  with 
respect  to  food  enrichers  such  as  vitamins  and  minerals.  The  obstacle  arises  when  certain 
Member States have strict rules justified by the national food administrations. The amount of 
vitamins  and  minerals  is  not  (yet)  harmonised  whereas  the  types  of  vitamins  and  minerals 

302  
303  

Position paper – Business Europe 
Interview with DG MOVE 

189 

 
                                                            
permitted  for  use  in  food  and  food  supplements  have  been  harmonised  by  Directive 
2002/46/EC304. This means that the Member States can set very low levels (close to zero %) 
of the vitamins and minerals allowed, in effect blocking enriched foodstuff as is the situation 
in Denmark. Examples of actions taken by economic operators are to refrain from marketing 
the products in question in Denmark. Denmark is perceived to be such a small market that it is 
not  worth  the  cost  of  having  the  policy  tested.  It  is  estimated  that  this  product  type  could 
amount to 5% of annual sales of the company in Denmark (i.e. foregone revenues). Similar 
examples of certain Member States putting up strict rules have identified in the nursery and 
childcare sector. The challenges in this sector are similar to the ones experienced in the food 
sector. 

Lack of acceptance of the mutual recognition principle because of established national 
standards 

This problem is quite specific to the construction products sector and is particularly prevalent 
in Germany. However, as Germany is a large market with imports from many other Member 
States, this is of great importance to the entire construction products sector. The main problem 
lies in the German standardisation body being so dominant on the market in terms of drawing 
up standards, certifying products, etc., that distribution of products on the German market is 
virtually  impossible  without  conforming  to  this  institute’s  standards.305  In  essence,  this  is  a 
problem of a dominant player on the market forcing companies to adapt to its standards. This 
means that companies are not able to apply the mutual recognition principle on the German 
market.  Instead  they  are  instead  forced  to  have  their  product  tested  according  to  German 
standards. 

6.  CONCLUSIONS: EFFECTIVENESS AND EFFICIENCY 

The  conclusions  will  address  the  effectiveness  and  efficiency  of  the  mutual  recognition 
principle based on the findings of the study as far as possible.  

The recommendations primarily focus on two main areas: 

  What, if anything, can be done to render mutual recognition more effective as a means 

to achieve its stated objectives?  

 

How can any barriers to effective mutual recognition be overcome? 

these 

As 
recommendations to these questions together. 

two  questions  are  closely  interlinked, 

the  evaluation  team  presents 

the 

Effectiveness 

Effectiveness of the application of the mutual recognition principle is the extent to which the 
objectives of the mutual recognition principle have been achieved or whether there has been 
significant progress towards them, what successes and difficulties have been identified, and to 
what extent the chosen solutions have proved appropriate. In order to determine effectiveness, 
the  study  also  examined  whether  any  external  factors  have  had  a  significant  negative  or 
indeed  positive  impact  on  inter-EU  trade  flows,  with  the  aim  of  isolating  the  effects  of  the 

304  
305  

European Commission (2010): Guidance Document - The application of the Mutual Recognition Regulation to food supplements 
ECJ: Case C-171/11 – Reference for a preliminary ruling of 30.3.2011 

190 

 
                                                            
mutual  recognition  principle  from  other  factors.  In  the  present  evaluation,  the  following 
evaluation questions have been examined with respect to effectiveness: 

 

To  what  extent  has  the  mutual  recognition  principle  achieved  each  of  its  stated 
objectives as a mechanism and means?306 

  What are the barriers to effective mutual recognition? 

 

Are  there  any  aspects/means/actors  that  render  certain  aspects  of  mutual  recognition 
more or less effective than others, and – if so – what lessons can be drawn from this? 
How were the objectives achieved? 

These questions are addressed below. 

The extent to which the mutual recognition principle as a mechanism and means has achieved 
its stated objectives 

According  to  Regulation  (EC)  No.  764/2008,  the  objectives  of  introducing  the  mutual 
recognition principle are as follows: 

 

 

 

ensuring the free movement of goods within the internal market; 

lowering remaining trade barriers in the internal market; and 

promoting trade in goods among EU Member State. 

The overall conclusion is that the mutual recognition principle is still not fully achieving its 
objectives.  The  findings  from  the  literature  review,  the  questionnaire  surveys  and  the 
interviews all point in the direction that it is not from the legal text as such, but rather in its 
application  that  challenges  arise.  In  the  product  contact  point  survey  and  the  business  and 
sector  association  survey,  around  half  of  the  respondents  state  that  the  principle  has  largely 
achieved  its  objectives,  whereas  the  other  half  find  that  there  is  still  some  way  to  go, 
particularly  regarding  the  application  of  the  principle.  The  company  survey  reveals  that 
among  the  companies  that  know  about  the  mutual  recognition  principle,  more  respondents 
think that the principle works poorly in practice (one-third of the respondents) than those who 
think that it works as intended (one-fourth).  

The  TRIS307  database  shows  that  in  2014  there  were  close  to  700  notifications  of  new 
technical rules. Although the number has been decreasing over the past three years, it is still a 
high  number  of  potential  new  technical  rules  for  economic  operators.  Some  of  them  are 
undoubtedly justified, but it is a large number of notifications, which can indicate that there 
might be problems with the application of the mutual recognition principle. 

306  

307  

The  aim  of  the  regulation  is  to  strengthen  the  functioning  of  the  internal  market  by  improving  the  free  movement  of  goods 
(Regulation  (EC)  No  764/2008,  Art.  1)  by  applying  a  mutual  recognition  clause  in  national  legislation,  establish  procedures  in 
Member State that limits the use of technical rules, and increase the knowledge of the n among economic operators and citizens. 
TRIS  stands  for  the  Technical  Regulation  Information  System  and  helps  businesses  to  be  informed  about  new  draft  technical 
regulations and allows them to participate in the 98/34 procedure, a procedure allows the Commission and the Member States of the 
EU to examine the technical regulations Member States intend to introduce for products (industrial, agricultural and fishery) and for 
Information 
and 
http://ec.europa.eu/growth/tools-databases/tris/en/about-the-9834/the-aim-of-the-9834-procedure/) 

(http://ec.europa.eu/growth/tools-databases/tris/en/ 

adoption. 

services 

Society 

before 

their 

191 

 
 
                                                            
Barriers to effective mutual recognition 

The  evaluation  shows  that  there  are  still  significant  barriers  towards  meeting  the  goal  of 
ensuring free movement of goods within the internal market as well as the goal of promoting 
trade of goods between EU Member States. The typical barriers are: 

 

 

 

 

 

 

 

 

Lack of trust in the authorities (including market surveillance) of other Member States, 
which leads to some Member State administrations adding requirements (such as extra 
tests) which are not in accordance with the mutual recognition principle. 

Lack  of  knowledge  of  the  application  of  the  mutual  recognition  principle  among 
competent  authorities,  particularly  concerning  innovative  products,  where  it  is  not 
always clear to the competent authorities under which categories these products fall and 
if the mutual recognition principle applies. 

Difficulties  for  companies  in  determining  if  the  mutual  recognition  principle  applies. 
Currently, enterprises and business associations perceive the process of verifying if the 
mutual  recognition  principle  applies  to  be  too  slow  and  costly.  This  means  that 
companies often refrain from standing on their right and simply abide by the demands 
from the Member State in question. 

Companies’  lack  of  awareness  of  the  mutual  recognition  principle,  which  results  in 
companies checking the national requirements and adapting their products accordingly 
before  entering  a  market  without  checking/knowing  that  the  mutual  recognition 
principle might apply.  

Difficulties for product contact points and economic operators alike to determine what 
documentation  companies  should  (be  requested  to)  submit  to  document  that  their 
product  is  lawfully  marketed  in  another  Member  State.  The  Commission  has  issued  a 
guidance  document,  stating  that  to  demonstrate  the  actual  marketing  of  the  product  in 
another  Member  State,  or  in  an  EFTA  state,  any  piece  of  evidence  should  be  deemed 
suitable.308  Obviously,  this  limits  the  burdens  on  the  economic  operators  that  they  do 
not need an official statement, which is intentional. However, it also leaves the product 
contact points with little guidance on when, for instance, a product invoice is sufficient 
proof that a product has been marketed in another Member State in accordance with the 
applicable national legislation. This may again lead to additional administrative burdens 
on companies if the product contact point is unsure of the validity of the documentation 
and asks for additional documentation to be supplied.  

The dialogue between competent authorities and between competent authorities and the 
Commission  is  too  slow  and  incomplete  at  times,  not  infrequently  resulting  in  delays 
and incomplete and unhelpful information to the economic operators. 

Request for national tests in the area of mutual recognition principle. For instance, this 
is seen within water taps and ship classification, and it appears to be a cross-European 
issue in both sectors. 

Differences in Member States’ national definitions and standards. This obstacle is seen 
in several sectors, including foodstuff, fertilisers, and nursery and childcare products. 

308  

European  Commission  (2013):  Commission  working  document:  Guidance  document.  The  concept  of  “lawfully  marketed”  in  the 
Mutual Recognition Regulation (EC) No. 764/2008 

192 

 
                                                            
 

Lack  of  acceptance  of  the  mutual  recognition  principle  (particularly  an  issue  in  the 
construction  products  sector,  and  particularly  in  Germany  and  to  some  extent  in 
Belgium). 

Means or aspects rendering certain aspects of mutual recognition more or less effective than 
others 

Member State’ lack of trust in each other’s procedures, interpretations and/or requirements is 
an  important  barrier to  a  better  functioning  of  the  mutual  recognition  principle.  The  lack  of 
trust  can  imply  that  authorities  are  taking  a  restrictive  view  of  the  products  that  can  be 
allowed onto the market of the Member State in question and thereby they do not apply the 
mutual recognition principle the way it was intended. This can result in an increase in prior 
authorisation procedures and/or tests, which increases the costs for economic operators. 

Lack  of  awareness  among  companies  and  among  some  Member  State  authorities  is  an 
important  barrier  to  effective  implementation  of  the  mutual  recognition  principle.  Several 
product  contact  points  call  for  awareness  campaigns  directed  at  different  target  groups  to 
increase  the  effectiveness  of  the  mutual  recognition  principle.  Some  product  contact  points 
call for the assistance of the Commission to carry out information campaigns, also because it 
would  expand  the  reach  of  the  information.  In  some  Member  States,  product  contact  points 
perform  seminars  and  training  for  competent  authorities  and  sometimes  for  business 
associations. In Denmark, the product contact point has developed a guide on the use of the 
principle of mutual recognition that can be accessed on its website. 

There  are  indications  in  the  evaluation  that  grouping  together  related  functions  such  as  the 
product  contact  point,  the  contact  point  for  construction  products,  SOLVIT,  EEN,  and  staff 
working with other internal market issues appears to create good dynamics and increases the 
pool of knowledge available to the product contact point. This could be an example of good 
practice which is found in Denmark and the UK. This means that all questions regarding rules 
and regulations related to the functioning of the Internal Market can be answered by the same 
authority, which simplifies matters for the economic operators.  

A  good  practice  emerges  from  the  product  contact  point  interviews.  A  system  in  which 
product contact points are better informed about the outcomes of the queries that they pass on 
to  other  authorities  in  their  country  would  appear  to  be  preferable  to  a  system  in  which 
product  contact  points  do  not  receive  a  copy  of  the  answer/decision  or  are  otherwise  not 
informed  of  the  outcome.  While  having  an  overview  of  what  actually  happens  when  an 
inquiry is made may not be a precondition for an effective system, at least an overview can 
contribute to identifying any bottlenecks or other problems in the system, which is the basis 
for addressing any such problems.  

Efficiency 

Efficiency arises from the relationship between the resources applied and the results achieved. 
Thus,  the  analysis sets  out  to  answer  if  the  effects  obtained  are  reasonable  compared  to  the 
costs  (administrative  burdens,  etc.).  In  this  context,  the  evaluation  questions  enquire  as  to 
whether the desired impacts have been  achieved, at what cost, and if this represents  a good 
return  (economic,  social  or  scientific)  on  the  costs  involved.  In  the  present  evaluation,  the 
following efficiency evaluation questions were posed: 

 

To what extent have the effects been achieved at a reasonable cost? 

193 

 
 

the 
To  what  extent 
implementation  of  the  principle  of  mutual  recognition  considered  proportionate  for 
stakeholders and other relevant actors (Member State authorities, etc.)? 

the  administrative  and  regulatory  burden  created  by 

is 

  What  aspects  of  mutual  recognition  are  the  most  efficient  or  inefficient,  especially  in 
terms of resources that are mobilised by stakeholders during the different phases of the 
process? 

  What good practices can be identified? 

 

 

How can costs/administrative burden be reduced? 

To  what  extent  can  measures  be  taken  to  improve  the  positive  effect  of  mutual 
recognition on the free movement of goods and what measures would these be? 

The first four evaluation questions will be concluded upon below. The last two questions, i.e. 
how  costs/administrative  burdens  can  be  reduced  and  what  can  be  done  to  improve  the 
positive  effect  of  mutual  recognition  on  the  free  movement  of  goods,  are  addressed  in  the 
recommendations. 

As  mentioned  above  very  few  companies  have  been  able  to  give  an  indication  of  the  costs 
associated  with  the  improper  functioning  of  the  mutual  recognition  principle.  Likewise,  the 
business associations do not have a good overview of the costs either (cf. section 3.4). Section 
5.2.3 and the company cases provide some examples of the costs incurred by companies, but 
they should be viewed as examples only. 

The extent to which the effects have been achieved at a reasonable cost 

In  theory,  if  the  mutual  recognition  principle  works  perfectly,  the  effects  of  the  principle 
should be achieved without companies having to carry out an assessment of national technical 
rules (if the companies’ products do not fall under the exemptions to the mutual recognition 
principle).  

In the present evaluation, the administrative burdens mentioned by the stakeholders primarily 
relate to incorrect (or non-)application of the principle. None of the burdens mentioned were a 
result of the implementation of the principle as such. 

In  addition, the requirements  for the product  contact points are relatively limited. The  main 
administrative  burden  identified  in  the  product  contact  point  interviews  associated  with  the 
implementation of the mutual recognition principle is that answers to the economic operators 
and/or to the other product contact points must be translated into English. This can be difficult 
for  competent  authorities  not  used  to  communicating  in  English  and  burdensome  for  the 
product  contact  points  if  the  answer  contains  many  technical  terms.  The  possibility  of 
establishing an electronic system for exchanging information between product contact points 
was already mentioned in the Mutual Recognition Regulation, and as mentioned earlier in the 
evaluation, the IMI system could be a way of limiting this burden. 

The extent to which the administrative burdens are considered proportionate 

The  typical  administrative  burdens  associated  with  the  implementation  of  the  principle  of 
mutual  recognition  mainly  concern  the  companies.  These  burdens  are  closely  related  to  the 

194 

 
requests  from  different  Member  States  that  national  tests  be  conducted,  even  though  the 
mutual recognition principle should apply. The burdens imposed on companies resulting from 
the  incorrect  application  of  the  mutual  recognition  principle  are  not  proportionate,  but  the 
problem is that the only alternative that companies feel that they have would be a court case, 
which  is  both  too  costly  and  takes  too  long.  The  burdens  of  choosing  the  alternative  would 
then be even greater than simply complying with the requirements. The evaluation shows that 
these costs are particularly pronounced for SMEs, as they lack the competences and financial 
ability to complain to the authorities or take the case to court.  

Most efficient/inefficient aspects of mutual recognition in terms of resources mobilised 

First, companies, in particular, find the requests for national tests in areas where the mutual 
recognition  principle  should  apply  to  be  a  resource-consuming  aspect  of  the  incorrect 
functioning  of  the  mutual  recognition  principle.  Such  costs  are  particularly  found  in  the 
construction  products  sector.  Direct  costs  of  retesting  can  run  from  a  few  hundred  euros  to 
tens  of  thousands,  depending  on  the  product.  Adding  to  this  is  the  time  that  the  company 
spends waiting for the test results, and the repetition of the tests that is frequently required. 

Second,  strict  rules  in  certain  Member  States,  particularly  within  the  area  of  enriched  food, 
close  the  markets  in  question  for  some  companies,  unless  they  are  willing  to  adapt  their 
products to local requirements. In some cases, where the markets are small (such as Denmark, 
the example given in the report), companies decide to withdraw from the market, but in large 
markets  companies  often  adapt  their  products.  For  enriched  foods,  this  requires  several 
production lines and can potentially be very costly (without any companies being able to put a 
figure on this). 

Third, the product contact points mostly find it difficult to point to specific aspects that impact 
the  efficiency  of  the  mutual  recognition  principle  in  terms  of  the  resources  required.  The 
procedure and the requirements depend very much on the product concerned. However, a few 
product  contact  points  point  to  prior  authorisation  procedures  in  general  as  being  the  most 
demanding in terms of resources. Several product contact points complain that there are not 
enough  resources  (personnel)  for  the  product  contact  point  function  as  such,  which  impacts 
the  efficiency  of  the  whole  process  by  creating  delays.  The  Commission  has  published  a 
number of guidelines on the application of the mutual recognition principle, but a number of 
product  contact  points  still  call  for  Commission  assistance  to  help  explain  the  principle  to 
national  authorities  and  economic  operators  alike,  primarily  due  to  the  above-mentioned 
resource issues.  

Good practices 

Several  product  contact  points  are  attempting  to  distribute  knowledge  on  the  application  of 
the  mutual  recognition  principle  to  competent  authorities  and  sometimes  to  business 
associations. This is done through seminars and training. In one case (Denmark), the product 
contact point has developed a mutual recognition manual. The logic behind this is that when 
competent  authorities  are  well  informed  about  the  application  of  the  mutual  recognition 
principle, companies are met with fewer groundless demands for retesting, etc., which limits 
the  burdens  on  companies.  Likewise,  as  outlined  above,  if  the  knowledge  about  internal 
market issues is pooled, the knowledge available to the product contact point is increased. In 
Denmark and the UK, the product contact points have been incorporated into a wider team in 
the  relevant  ministry/authority,  which  also  deals  with  the  Single Market  policy.  This  means 
that  all  questions  regarding  rules  and  regulations  related  to  the  functioning  of  the  Internal 

195 

 
Market  can  be  answered  by  the  same  authority,  which  simplifies  matters  for  the  economic 
operators. 

Some  product  contact  points  actively  follow  up  on  the  notifications  or  they  are  copied  in 
communications when decisions are sent to the companies and to the Commission. Ensuring 
that the product contact points are copied in the correspondence with the companies regarding 
this matter could be a way to ensure better transparency and that product contact points are 
informed  about  the  use  of  e.g.  prior  authorisation  procedures  without  increasing  the 
administrative burdens of the sector ministries. In addition, when product contact points are 
aware of the use of instruments, such as prior authorisation procedures, they have a chance to 
challenge the justifications of the uses and perhaps contribute to decreasing the use. This can 
lower the administrative burdens of companies. 

7.  RECOMMENDATIONS 

Better monitoring of the implementation of the mutual recognition principle 

The  product  contact  points  should  be  actively  involved  in  monitoring  the  actions  of  the 
competent  authorities.  The  product  contact  points  could  be  actively  monitoring  the  actions 
that the competent authorities take in the field of mutual recognition, advising the competent 
authorities  in  the  field  of  the  mutual  recognition  principle  or  holding  meetings  a  couple  of 
times a year where all relevant competent authorities meet and exchange experiences with the 
application  of  the  mutual  recognition  principle.  Some  product  contact  points  take  up  an 
active, coordinating role, but many product contact points do not. 

Recommendation 1 

The evaluator recommends that the product contact points be given a more active role in terms 
of monitoring the implementation of the mutual recognition principle, for instance, by being 
required to following up with competent authorities and coordinating actions. In some cases, 
this  would  also  necessitate  improved  overall  capacity  through  additional  funding,  improved 
knowledge, etc. 

Setting up a mechanism for easier demonstration of “lawful marketing” for economic 
operators 

The  evaluation  showed  that  several  product  contact  points  point  out  that  the  lack  of  clarity 
concerning  what  documentation  companies  should  be  requested  to  submit  to  document 
‘lawful marketing’ complicates and delays the process both for companies that do not know 
beforehand  which  documentation  will  be  required  and  for  the  authorities  in  the  destination 
Member State. Also, the situation may lead to additional administrative burdens on companies 
if  the  product  contact  point  is  unsure  of  the  validity  of  the  documentation  and  asks  for 
additional  documentation  to  be  supplied.  A  mechanism  to  make  it  easier  for  economic 
operators  to  demonstrate  that  the  products  that  they  market  have  previously  market  in  their 
home Member State could therefore advantageously be introduced. The mechanism could for 
instance  be  a  manual  (distributed  to  all  product  contact  points)  or  an  online  “mutual 
recognition encyclopaedia”. Both of these could be based on the already existing guidelines 
for the application of the mutual recognition principle. 

196 

 
 
Recommendation 2 

The  evaluation  team  recommends  to  introduce  a  mechanism,  that  makes  it  easier  for 
economic  operators  to  demonstrate  “lawful  marketing”  of  their  products  towards  other 
Member States. 

Better insight into the magnitude of the problem of incorrect application of the mutual 
recognition principle, particularly for SMEs 

The evaluation showed that many of the business and sector associations and product contact 
points  had  little  insight  into  the  magnitude  of  the  problem  of  incorrect  application  of  the 
mutual recognition principle. The companies also had difficulties in determining the level of 
cost incurred, and  the answers received from the companies varied considerably.  Thus, it is 
recommended  to  discuss  further  with  companies  (particularly  SMEs)  how  heavy  and 
unmanageable the incorrect application of the mutual recognition principle is. 

Recommendation 3 

The evaluation team recommend additional discussions with economic operators (particularly 
SMEs)  on  the  burdens  associated  with  incorrect  application  of  the  mutual  recognition 
principle. 

Improve dialogue among competent authorities 

The  evaluation  shows  that  the  dialogue  among  competent  authorities  works  well  in  many 
cases,  but  it  is  lacking  in  other  cases.  Two  important  barriers  to  an  effective  dialogue  (and 
thereby  obstacles  to  helping  companies  more  quickly)  are  slow  response  times  by  some 
Member States and answers in the national language. 

One  solution  to  the  language  issue,  which  may  in  turn  shorten  the  response  rates  (if  this 
problem  also  is  linked  to  language  issues),  could  be  to  use  the  IMI  system  of  the  mutual 
recognition  legislation.  One  relevant  aspect  of  the  IMI  system  is  its  multilingual  approach, 
meaning that Member States can post questions and answers in their national language. This 
could  potentially  resolve  some  of  the  issues  regarding  the  communication  between  the 
competent  authorities,  although  it  is  likely  that  further  development  of  the  system  and/or 
involvement of translators will be necessary. However, it is also important that the competent 
authorities  be  required  to  communicate  with  their  European  counterparts  so  that  they  can 
provide  good  advice  to  the  economic  operators.  The  15-day  time  limit  for  answering  an 
inquiry is already incorporated in the Mutual Recognition Regulation, but the product contact 
points  could  be  required  to  monitor  the  competent  authorities  better  and  offer  their  help,  if 
necessary.  

Recommendation 4 

The evaluation team recommends that to improve the dialogue between competent authorities, 
particularly with respect to the language issue, the Commission should look into whether the 
IMI system could be used as a communication tool. 

In  addition,  it  is  recommended  that  the  product  contact  points  be  required  to  monitor  the 
competent authorities more than now and offer assistance if necessary. This could be part of a 

197 

 
major revision of the product contact point setup. 

Ensure a better dialogue between the competent authorities and the Commission 

There  are  apparent  discrepancies  between  the  number  of  notifications  received  by  the 
Commission and the number of decisions made by the Member State authorities reported in 
the  annual  reports.  This  means  that  some  decisions  falling  under  the  Mutual  Recognition 
Regulation  appear  to  be  adopted  but  not  notified  to  the  Commission.  The  product  contact 
points do not always appear be informed of the decisions made by the relevant ministries or 
agencies. In some cases, once a request from a company has been passed on to the relevant 
ministry,  the  product  contact  point  does  not  hear  about  it  anymore.  Some  product  contact 
points actively follow up on the notifications, or see the correspondence when decisions are 
sent  to  the  companies,  while  others  only  receive  information  when  the  relevant  ministries 
send  it  to  them.  The  good  practice  of  staying  in  the  loop  ensures  that  the  product  contact 
points  know  about  the  notifications  sent  to  the  Commission,  without  imposing  large 
administrative  burdens  on  them.  It  is  therefore  important  that  the  product  contact  points  be 
required to be more active in following up on the requests that they receive from economic 
operators. 

In  addition,  there  are  indications  in  the  evaluation  that  grouping  together  related  functions 
such as the product contact point, the contact point for construction products, SOLVIT, EEN, 
and  staff  working  with  other  internal  market  issues,  seems  to  create  good  dynamics  and 
increase the pool of knowledge available to the product contact point. This would mean the 
same  authority  could  answer  all  questions  regarding  rules  and  regulations  related  to  the 
functioning  of  the  Internal  Market.  This  simplifies  matters  for  the  economic  operators.  In 
order to promote a more effective set-up of the product contact point function in the Member 
State a more detailed framework for the roles, rights and obligations vis-à-vis other national 
authorities and companies could be specified at EU level. 

Recommendation 5 

The evaluation team recommends that the product contact point systems in the Member States 
be  set  up  in  such  a  way  that  product  contact  points  are  informed  about  the  decisions,  for 
instance, by receiving copies of the decisions made by the competent authorities. This setup 
would  require  a  more  detailed  framework  on  the  role  of  product  contact  points  and  their 
obligations  vis-à-vis  competent  authorities.  We  therefore  recommend  the  introduction  of  a 
more  detailed  framework  for  the  set-up  and  functioning  of  the  product  contact  point  in  the 
Member State at EU level. 

In  addition,  it  is  recommended  to  group  functions  and  activities  related  to  Internal  Market 
issues  within  relevant  Member  State  administrations  to  create  better  dynamics  and  a  single 
access point for economic operators. 

Harmonisation of certain areas 

Particularly  in  the  areas  of  construction  products  (a  particular  problem  was  highlighted 
concerning water taps) and food enrichers, different Member States have different perceptions 
of appropriate standards and safety levels. 

Within  the  area  of  water  taps,  there  are  indications  from  companies  that  the  certifications 
asked  for  by  different  Member  States  are  not  that  different  content-wise,  but  the  Member 

198 

 
States  still  refuse  to  allow  a  product  on  the  market  that  has  not  been  tested  according  to 
national  standards.  This  could  indicate  that  the  certifications  serve  to  protect  the  national 
markets.  As  the  trust,  which  is  necessary  for  the  mutual  recognition  principle  to  function 
properly, is not present in this case, harmonisation could be a solution in this particular case.  

Within the area of enriched food, different policies exist which make a proper functioning of 
the  mutual  recognition  principle  difficult.  The  amount  of  vitamins  and  minerals  is  not  (yet) 
harmonised, whereas the types of vitamins  and minerals  permitted for use  in  food and food 
supplements are harmonised by Directive 2002/46/EC.309 This means that the Member States 
can set very low levels (close to 0%) of the vitamins and minerals allowed in effect blocking 
enriched  foods  in  their  markets.  The  Member  States  have  very  diverging  standards  for 
enriched food, and it is expensive for the companies to comply with this. However, since the 
standards  are  very  different  in  different  Member  States,  it  seems  unlikely  that  the  Member 
States can come to an agreement concerning a harmonised amount. The same may be true for 
fertilisers,  where  the  draft  impact  assessment  carried  out  by  the  Commission  shows  lack  of 
trust among the Member States. Moreover, that the perception of what constitutes a fertiliser 
varies greatly among Member States. 

Recommendation 6 

The  evaluation  team  recommends  investigating  whether  areas  exist  where  harmonisation 
would  limit  the  use  of  technical  rules  and  incorrect  application  of  the  mutual  recognition 
principle and thus ease the burdens on economic operators.  

Awareness-raising campaigns 

First,  the  analysis  shows  that  there  is  a  need  for  increasing  the  awareness  of  the  mutual 
recognition principle among companies and national and regional authorities. It is important 
that companies and authorities at all levels are well aware of the mutual recognition principle 
and  its  application  so  that  companies  can  stand  on  their  own  rights  and  national  authorities 
can guide the companies properly and reduce the use of national technical rules. In addition, 
the  analysis  shows  that  national  authorities/sector  ministries  or  agencies  sometimes  act 
cautiously and do not allow innovative products into the market that may not fit into existing 
rules, although the product is deemed safe on the home market. Awareness-raising campaigns 
could help guide the sector ministries and agencies. 

Finally, the analysis shows that the reasons for not applying the mutual recognition principle 
correctly  can  be  a  result  of  lack  of  awareness  of  the  application  of  the  mutual  recognition 
principle,  a  desire  for  high  standards  in  a  non-harmonised  area,  or  imposing  a  form  of 
protectionism. When the first option is the case, awareness-raising campaigns can potentially 
help in reducing the number of cases in which national technical rules are being imposed. 

Recommendation 7 

The  evaluation  team  recommends  carrying  out  awareness-raising  campaigns  aimed  at 
companies, regional and national authorities as well as business associations.  

The European Commission could play a role in awareness-raising campaigns among national 
and regional authorities. This could be done by: 

309  

European Commission (2010): Guidance Document - The application of the Mutual Recognition Regulation to food supplements 

199 

 
                                                            
Recommendation 7 

 

 

 

drafting training/information material;  

making  available  easy-to-understand  information  for  economic  operators  on  what 
mutual recognition is, how it is applied (providing specific examples), etc.; and  

participating  in  events  and  meetings  at  the  Member  State  level  (potentially  aimed  at 
sectors such as construction and food, where problems exist), partly to ensure that the 
mutual  recognition  principle  and  its  application  are  properly  explained,  and  partly  to 
show that incorrect application of the principle is a serious matter at the European level. 

Subsequently,  the  product  contact  points  could  be  in  charge  of  arranging  awareness-raising 
campaigns targeted at companies. 

Lastly, awareness-raising campaigns towards business and sector associations may contribute 
to increasing the knowledge of the mutual recognition principle among the associations and 
allow  them  better  to  spot  and  assist  companies  that  may  experience  difficulties  with  the 
application of the principle. A concrete suggestion is to use the EEN as a platform for this. 

In  addition,  the  awareness-raising  campaigns  could  also  potentially  help  reduce  the  legal 
uncertainties  that  many  companies  experience.  Improper  understanding  of  the  mutual 
recognition principle by companies may imply that the legislation is difficult to understand, 
which  then  creates  legal  uncertainty.  It  also  means  that  these  companies,  and  in  particular 
SMEs,  suffer  from  an  information  imbalance  vis-à-vis  the  competent  authorities  in  the 
Member  States.  Likewise,  if  authorities  in  other  Member  States  are  perceived  as  either  not 
knowing  the  mutual  recognition  principle  well  enough  or  not  applying  it  properly,  this  can 
increase the use of prior authorisation procedures and/or different testing methods, which in 
turn can create legal uncertainty. 

Sectors on which to focus 

The evaluation has shown that there are a number of sectors where action particularly could 
be taken. 

Particularly construction products (both the non-harmonised area in general and water taps) 
and  food,  particularly  the  area  of  enriched  food  are  areas  where  the  literature  repeatedly 
highlights  these  sectors  as  problematic,  and  the  evaluation  has  shown  indications  from 
companies  that  incorrect  application  of  the  mutual  recognition  principle  creates  costs  for 
companies.  As  mentioned  above,  the  economic  importance  of  the  construction  and  food 
sectors is considerable. 

Fertilisers, ship classifications, and nursery and childcare products are sectors where there are 
have been problems, but the indications of the extent of the economic burdens for companies 
are  less  clear  and  are  difficult  to  quantify  overall.  In  particular,  there  are  some  issues 
concerning a common understanding at EU-level of what constitutes a fertiliser.  

A  number  of  issues  cut  across  sectors  such  as  problems  with  innovative  products,  and  the 
application of the mutual recognition principle in these cases. 

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ANNEX 9: SHORT COMPANY CASES 

The  short  company  cases  were  developed  in  the  context  of  the  external  evaluation  of  the 
functioning of the mutual recognition principle performed in 2015 by DTI, Technopolis, EY 
and VVA Consulting. These cases are derived from the answers to the questionnaire survey 
for  companies,  and  in  some  cases,  they  are  supplemented  with  a  short  interview  with  the 
company.  

Company 1 

Company  1  is  a  large  Swedish  company,  active  in  the  paper  industry  (producing  packaging 
for foodstuffs, etc.). All of its exported products fall under the principle of mutual recognition. 
The company knows the principle of mutual recognition.  

When exporting, the company has taken the necessary steps to check the applicable rules in 
the  EU  destination  country.  In  some  cases,  the  company  has  had  to  retest  its  products.  In 
particular, this has occurred when its customers demanded that a specific test was carried out 
to  show  that  the  product  complied  with  the  national  legislation  (in  this  case,  the  Italian 
legislation  concerning  paper  in  contact  with  food),  despite  the  fact  that  the  paper  already 
complied with rules in the home Member State and in all other Member States. The company 
has  tried  to  raise  this  issue  with  their  Italian  customer,  but  both  the  customer  and  the 
company’s own sales office in Italy state that this has to be done as Italian legislation requires 
it.  The  company  perceives  this  demand  as  a  lack  of  knowledge  of  the  mutual  recognition 
principle. 

In  this  case,  the  additional  tests  were  the  result  of  companies  in  the  host  country  not  being 
aware  of  or  not  accepting  the  mutual  recognition  principle.  However,  the  retesting  costs 
quoted for Company 1 are perceived to be rather low. For the company, the costs have mainly 
involved internal staff time. One test amounts to approx. €700, and every product needs to be 
tested. In addition, if a chemical additive in a product is changed, the product needs to be re-
tested.  The  company  has  only  experienced  these  issues  in  Italy.  In  addition,  the  Italian 
authorities are not perceived as taking the necessary steps to ensure that the retesting demands 
by Italian customers actually comply with the mutual recognition principle. 

As  illustrated  by  the  example  of  exports  to  Italy,  the  mutual  recognition  principle  did  not 
work  in  practice  for  Company  1,  even  though  the  company  relied  on  it.  Nevertheless,  the 
company perceives that the mutual recognition principle in itself is working well, but it is not 
always applied properly. 

Source:  Questionnaire  survey  among  companies,  running  from  9  October  2014  to  5  January  2015  and  interview  with  the 
company 

Company 2 

Company 2 is a medium-sized Danish company. It works within the construction sector. 75% 
of  its  exported  products  fall  under  the  principle  of  mutual  recognition.  The  company  has 
exported products to other EU Member States in the last three years, and has heard about the 
principle of mutual recognition of goods, but is not familiar with the details of the principle.  

Before  entering  a  new  market,  the  company  has  examined  the  applicable  rules  in  the 
importing EU country. Afterwards, the company has retested its products. The costs related to 
these  applications,  which  include  administrative  fees,  testing  costs,  internal  company  staff 

201 

 
Company 2 

time, and adaptation of the product to local technical requirements, have been very high.  

However,  the  company  does  not  even  check  to  verify  if  the  mutual  recognition  principle 
applies, since in their area (water taps, which are classified as components related to drinking 
water and thereby products related to food), each of the Member States have their own tests 
and do not respect any of the tests carried out in other Member State.  

Within  the  company’s  sector,  EN  standards  cover  mechanical,  functional  and  physical 
requirements  for  taps  and  hoses.  However,  water  taps  are  only  mentioned  in  the  Drinking 
Water  Directive  (DWD,  98/83/EC)  where  EU  Member  States  have  to  ensure  that  materials 
used  in  the distribution of drinking  water do not  release substances in concentrations higher 
than  necessary  for  the  purpose  of  their  use.  This  means  that  all  Member  State  can  (and  do) 
apply their own rules, and the testing procedures vary among the Member State.  

Much work has been done to try to secure a common testing system; but so far, the Member 
States have not been able to agree on this. However, a group of Member States has undertaken 
some positive steps forward, and Germany, UK, the Netherlands and France have agreed on a 
common positive list of materials. 

In theory, the mutual recognition principle should apply to this area, but in reality it does not, 
as each Member States requires that national tests be carried out before accepting the taps on 
their  markets.  The  company  perceives  the  request  for  national  tests  as  a  market  protection 
measure. 

The  required  tests  result  in  significant  costs  for  companies.  Although  certification  and  test 
requirements are different in different countries, the basic purpose and parameters are similar. 
This causes duplication of efforts and costs. In some Member States, it is enough to show test 
certificates for each component, whereas in other Member States, the entire product needs to 
be  tested.  Testing  costs  for  a  component  is  approx.  €2,000  and  for  a  final  product  around 
€8,000-9,000. In addition, tests can be rather time-consuming. For instance, a test to determine 
whether the component or final product contains nickel takes up to 28 weeks. 

Thus, the company perceives the principle of mutual recognition to be functioning very badly, 
and  the  company  does  not  believe  that  the  mutual  recognition  principle  has  contributed  to 
lowering  trading  barriers.  The  two  largest  obstacles  to  a  better  functioning  of  the  mutual 
recognition  principle  are  the  lack  of  awareness  of  the  mutual  recognition  principle  among 
companies as well as the fact that the authorities do not know the mutual recognition principle 
well  enough  or  do  not  apply  it  correctly.  Both  obstacles  may  have  been  important,  but 
particularly  the  fact  that  the  national  authority  has  insisted  on  national  requirements  that  do 
not  comply  with  the  mutual  recognition  principle  is  important  in  this  case.  Company  2  has 
experienced  the  above-mentioned  obstacles  in  Austria,  Belgium,  Finland,  France,  Germany, 
the  Netherlands,  Sweden,  and  the  UK.  In  addition,  the  company  has  experienced  that 
insurance companies are not willing to insure houses where water taps are not tested according 
to national standards. The same is happening in Sweden. 

Source:  Questionnaire  survey  among  companies,  running  from  9  October  2014  to  5  January  2015  and  interview  with  the 
company 

202 

 
 
Company 3 

Company  3  is  a  large  Swedish  company  in  the  food  sector.  It  has  sold  goods  in  other  EU 
Member  States  for  the  past  three  years.  The  company  knows  the  principle  of  mutual 
recognition,  and  estimates  that  80%  of  its  exports  fall  under  the  principle  of  mutual 
recognition.  

Whenever the company has entered a new market, it has examined the applicable local rules 
and adapted its product to them. The cost of taking these steps amounts to 0.1% of the annual 
turnover. The  two  most  significant  costs in  this process are  internal  company staff time  and 
adaptation  of  the  product  to  local  technical  requirements.  The  adaptation  of  the  product  to 
local technical requirements mainly has to do with changing the language of the information 
stated on the package. In addition, in some Member State the kind of information required on 
the packaging differ. The company states that their clients confront them with these demands - 
not the authorities. Changing the language or information on the package amounts to € 1,000-
1,500, plus person hours (approx. 1 day). 

The company has experienced that the mutual recognition principle did not work in practice, 
even though the company relied on it. However, it is the application of the mutual recognition 
principle that did not work in practice, rather than the principle itself. According to Company 
3,  overall,  the  mutual  recognition  principle  works  ‘well’,  when  properly  applied,  and  the 
company has only experienced that it was not properly applied in the few instances mentioned 
above.  The  company  believes  that  mutual  recognition  has  lowered  trade  barriers  and 
comments:  ‘[The  principle]  makes  it  easier  to  challenge  local  "wish  lists"  and  differentiate 
"need  to  have"  from  "nice  to  have"’.  The  two  most  important  obstacles  to  effective  mutual 
recognition  are  legal  uncertainty  because  the  mutual  recognition  legislation  is  unclear 
(perceived in this case to be the application of the legislation) and that the authorities in other 
Member States do not know the principle well enough or do not apply the principle correctly. 
Company 3 has experienced these obstacles in Austria, Germany, and Greece. 

Source:  Questionnaire  survey  among  companies,  running  from  9  October  2014  to  5  January  2015  and  interview  with  the 
company 

Company 4 

Company 4 is a Swedish company, producing and selling furniture and other products for the 
home. The company is present in 18 Member States. Thus, harmonised product requirements 
are the key to being efficient and cost-effective in the production and distribution of products. 
The  company  has  experienced  problems  with  the  application  of  the  mutual  recognition 
principle within the area of water taps for kitchen and bathroom sinks. 

Water  taps  are  a  non-harmonised  product  category.  Therefore,  national  certifications  are 
required to place the products on national markets. EN standards cover mechanical, functional 
and  physical  requirements  for  taps  and  hoses.  However,  the  use  of  positive  material  lists, 
substance  migration,  noise,  odour,  flavour  or  appearance  of  the  water  are  still  regulated  by 
national testing or certification requirements. Taps are only mentioned in the Drinking Water 
Directive  (DWD,  98/83/EC  ).  EU  Member  States  have  to  ensure  that  materials  used  in  the 
distribution  of  drinking  water  do  not  release  substances  in  concentrations  higher  than 
necessary for the purpose of their use. This means that Member States can (and do) apply their 
own  rules,  and  the  testing  procedures  vary  among  the  Member  States.  The  approach  of 
Member States differs when it comes to national certification systems. The existence and the 

203 

 
Company 4 

roles  of  national  regulatory  bodies  and  of  toxicity  committees  are  also  different.  Often 
competences fall within different authorities. 

However, based on the company policy to use only materials with a lead content below 0.2%, 
it  has  very  few  options  to  choose  from  the  positive  list.  Company  4  calculates that for  each 
product in the taps category, the certification and testing costs are up to €50,000. In addition, 
the cost of getting a new composition approved (to be used for the production of water taps) is 
between €50,000 and €100,000. It is also a rather time-consuming  process, since the testing 
requires six months, as there is a bottleneck in the capacity for testing. 

At present, there are four different water efficiency labelling schemes in Europe. However, the 
company has not been able to adopt any of these labelling schemes, because their acceptance 
and recognition among consumers is limited by geography.  

The  types  of  costs  that  the  company  face  include  additional  costs  of  respecting  and 
aggregating 17 different certification schemes for the same product. 

Company 4 would benefit greatly from better application of the mutual recognition principle. 

Source: Interview with the company, written case on taps provided by the company 

Company 5 

Company 5 is a medium-sized company operating within the area of childcare products. The 
company  is  based  in  the  UK.  The  company  has  heard  about  the  principle  of  mutual 
recognition,  but  it  is  not  familiar  with  the  details  of  the  principle.  Approx.  5%  of  the 
company’s exports fall under the mutual recognition principle.  

The  company  has  a  mixed  view  of  the  mutual  recognition  principle.  The  principle  has  a 
positive  side.  Thus,  countries  asking  for  own  tests  and  standards  dramatically  increase  the 
companies’  stocks,  while  the  mutual  recognition  principle  helps  to  decrease  stocks  by 
reducing  inventories  and  facilitating  sales  efforts.  However,  the  company  representative 
believed that  the  principle may allow lower quality products  coming  into  the UK, while not 
complying  with  British  safety  standards.  The  British  nightwear  standard  is  one  of  the 
exemptions  under  the  mutual  recognition  principle.  This  prevents  other  EU  producers  from 
selling nightwear in the UK if they do not comply with British nightwear standards. However, 
with their main product, a baby sleeping bag, British standards for baby sleeping bags cannot 
prevent non-compliant products from coming into the UK. This will be a serious risk for the 
consumer. This is the negative side of the mutual recognition principle. 

However, as far as the company knows, certainly for childcare products, such as baby sleeping 
bags, British standards are higher than those in most EU countries are. The British authorities 
have imposed specific UK standards in the market for such products, citing child safety as a 
reason  (as  far  as  the  company  knows).  This  helps  the  British  company,  but  is  a  barrier  for 
producers  in  other  EU  countries.  Since  the  UK  rules  are  stricter  than  the  rules  in  other  EU 
Member State that the company sell to, if they just comply with UK standards they are on the 
safe side in most markets.  

Source:  Questionnaire  survey  among  companies,  running  from  9  October  2014  to  5  January  2015  and  interview  with  the 
company 

204 

 
Company 6 

Company  6  is  a  large  Danish  company  operating  in  the  construction  products  area.  The 
company  knows  the  mutual  recognition  principle  and  estimates  that  70%  of  its  exports  fall 
under the mutual recognition principle. 

When  the  company  has  entered  a  new  EU  market,  it  has  typically  examined  the  applicable 
rules in the destination Member State, and often it has had to retest its products. The company 
does  not  think  that  the  mutual  recognition  principle  works  well,  but  it  is  clear  that  it  is  the 
application of the principle, rather than the actual principle itself, that is the problem. 

The  company  has  a  rather  specific  problem  in  Germany,  where  most  of  its  obstacles  occur. 
Germany  has  regional  rules  for  approval  of  construction  products  falling  outside  of  the 
harmonised  area.  In  October  2014,  the  Commission  notified  that  Germany  must  not  ask  for 
additional  stamps  or  approvals310,  but  the  company  (claiming  not  to  be  the  only  one)  still 
experience  these  obstacles.  In  addition,  the  company  has  experienced  issues  with  product 
types  (surface  coatings)  where  tests  are  not  required  in  their  home  country,  but  they  are 
required in Germany. In practice, the company tests its products in Germany, as there are no 
test facilities in Denmark because a test is not required there. Testing costs amount to approx. 
€7,000 per product, and the tests need to be repeated on a regular basis. In addition, whenever 
there is a new chemical in the surface coatings (which sometimes can change if the supplier is 
changed), the test must be repeated too. 

The company is  currently investigating whether the test  results obtained in  Germany can  be 
used in France too, as there are similar requirements. This remains to be seen; otherwise, the 
tests may have to be repeated in France. 

Source:  Questionnaire  survey  among  companies,  running  from  9  October  2014  to  5  January  2015  and  interview  with  the 
company 

Company 7 

Company 7 is a large Danish company operating in the construction products sector. The 
company knows the mutual recognition principle and estimates that 10% of the company’s 
exports fall under the mutual recognition principle. 

When the company has entered a new market, the company has experienced that whether 
construction products are CE-marked or not, national approvals are necessary. This means that 
the company needs national approvals, which can require additional documentation, and in 
some instances, it needs to carry out additional tests. In particular, the company has 
experienced problems in Belgium and Germany, because there are national fire codes that the 
company must follow. 

The costs are particularly associated with obtaining the additional documentation, and in some 
instances  carrying  out  the  additional  tests.  This  means  that  legal  uncertainty  associated  with 
different  testing  methods  is  the  most  prominent  obstacle  towards  a  better  functioning  of  the 
mutual  recognition  principle  for  this  company.  The  costs  have  not  been  quantified  for  this 
case. 

Source:  Questionnaire  survey  among  companies,  running  from  9  October  2014  to  5  January  2015  and  interview  with  the 
company 

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Company 8 

Company  8  is  a  large  company  operating  in  the  food  sector,  headquartered  in  Switzerland. 
However,  the  two  respondents  to  the  survey  and  subsequent  interviewees  are  based  in 
Germany and Denmark. Between 1% and 5% of the company’s exports fall under the mutual 
recognition principle. Both interviewees knew the mutual recognition principle well. 

The  mutual  recognition  principle  is  perceived  to  work  to  an  average  extent.  However,  the 
company’s  issues  regarding  the  principle  are  primarily  related  to  the  application  of  the 
principle.  In  circumstances  where  the  mutual  recognition  principle  is  applied  properly  the 
principle  has  contributed  to  lowering  of  trade  barriers.  The  effect  is  that  the  company  can 
manufacture  the  same  product  for  different  Member  States  without  having  to  change  the 
recipe.  However  whether  the  principle  is  applied  properly  is  only  obvious  if  it  is  explicitly 
confirmed by authorities (e.g. in case of prior authorisation procedures which are not in place 
for the application of the mutual recognition principle in all Member States). However, if such 
procedures  exist  they  can  have  the  disadvantage  of  being  time  consuming  and  burdensome. 
The notion in Article 6(4) of Regulation 764/2008/EC according to which “the product shall 
be deemed to be lawfully marketed” does not work, if the national competent authorities do 
not start the time periods specified in Article 6(2) by sending a written notice that they intend 
to adopt a decision as referred to in Article 2(1). 

There  are  also  examples  of  cases  where  the  mutual  recognition  principle  should  apply  in 
theory, but where Member State authorities are not applying it properly. One example comes 
from Denmark, where the rules for enriched food (or rather, the level of vitamins and minerals 
in  food)  are  strict.  The  amount  of  vitamins  and  minerals  allowed  in  food  are  not  (yet) 
harmonised,  whereas  the  types  of  vitamins  and  minerals  permitted  for  use  in  food  and  food 
supplements are harmonised by Regulation 1925/2006/EC and Directive 2002/46/EC. In some 
areas, Denmark has special rules justified by food safety. Danish policy is not to let enriched 
foodstuffs onto the market (by keeping the tolerated level of enrichers close to zero), unless 
special permission is given by the Danish Veterinary and Food Administration. According to 
the company, enriched foodstuffs are thus effectively blocked from the Danish market, and the 
mutual recognition principle is not applied in this area. Company 8 has chosen not to contest 
the justification of the food safety concerns, since the policy is very firm, and Denmark is such 
a small market that it is not worth the cost and time of having the policy tested. The company 
simply refrains from marketing the products in question in Denmark. It is estimated that this 
product  type  could  amount  to  5%  of  annual  sales  (i.e.  foregone  revenues).  In  other,  more 
important  markets,  the  company  may  adapt  the  products  in  question  to  suit  the  national 
requirements. 

Another issue, which has now been resolved at least in Denmark, are the rules for tolerances 
in the declared amounts of vitamins and minerals in foodstuffs (natural variations occur so that 
the amounts contained in a specific product are allowed to fluctuate around a median value). 
The Danish tolerance rules were stricter than those of a number of other EU countries, which 
meant  difficulties  in  marketing  the  product.  The  company  discussed  whether  to  contest  the 
policy as  a matter  of principle, but recently the issue was solved by the  adoption of the EU 
Guidelines  on  Tolerances.  Although  such  guidelines  are  not  legally  binding  and  do  not 
constitute a legal harmonisation they were  accepted alongside with the national standards in 
Denmark.  

Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015 and two interviews with the 
company 

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Company 9 

Company 9 is a large French company operating within the sector of sports equipment. The 
respondents are well aware of the principle of mutual recognition. 

When  entering  a  new  market,  the  company  typically  examines  the  applicable  rules  in  the 
destination  Member  State  and  adapts  the  products  to  the  local  technical  requirements.  The 
company  does  so  because  its  strategy  is  to  conform  to  all  requirements  applicable  in  the 
countries where it operates to guarantee high product quality and safety to its customers. 

Nevertheless, the company has experienced problems with different classifications of products 
in different Member States. In two cases, the company had to withdraw certain gym products 
from  the  German  and  UK  markets  because  they  resembled  a  weapon.  Consequently,  the 
product  was  classified  as  a  weapon  in  these  two  countries.  The  company  has  local  legal 
advisors who can discuss with authorities and argue that the products conform to French law. 
However,  particularly  in  the  German  case,  the  advisor  told  them  that  the  German  law 
pertaining to weapons is so strong that the company could not do much about it. The strategy 
was to withdraw the product from the market, resulting in a missed market opportunity. The 
company needs to get its products on the market quickly, so there is no time for arguing with 
administrations about withholding products, etc. This means that the company just does what 
it  is  asked  to  do  by  the  administrations.  It  may  have  the  right  to  market  certain  products  in 
certain markets, but there is no time to check this. 

In addition, the company experienced a situation in Spain where a request from the Spanish 
government stated that to sell bicycles in Spain, a conformity assessment had to be attached to 
each  bicycle.  The  company’s  bicycles  conform  to  European  standards,  but  in  Spain,  the 
company’s legal advisor said that a 1998 decree had to be respected. 

According  to  the  company’s  many  countries  use  national  technical  rules,  and  since  this 
involves  quite  a  large  number  of  authorities,  it  appears  that  many  of  them  are  not  aware  of 
European  law.  Thus,  differences  in  testing  methods  as  well  as  authorities  in  other  Member 
State not correctly applying the mutual recognition principle are the two greatest obstacles to 
an effective functioning of the mutual recognition principle. 

Source:  Questionnaire  survey  among  companies,  running  from  9  October  2014  to  5  January  2015  and  interview  with  the 
company 

Company 10 

Company 10 is a small Portuguese company active in the construction sector. The respondent 
knows what the principle of mutual recognition means.  

Within  the  non-harmonised  area  of  construction  products,  there  are  clearly  different 
requirements  among  Member  States.  However,  Company  10  produces  tailor-made  products, 
which  means  that  terms  and  conditions  are  agreed  with  customers  before  the  products  are 
produced. They have a certification system (procedure for certifying their products), and send 
a  copy  of  this  to  the  customers.  Sometimes  there  are  small  differences  in  interpretations 
between  Portugal  and  Belgium,  for  instance,  but  they  are  resolved  during  the  contracting 
phase. Before they prepare a large product order, they reach an agreement on these issues with 
the customer. 

As the company produces customer-specific products, it is not such a big problem that there 

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Company 10 

are  different  rules  in  different  Member  States  in  the  non-harmonised  area.  They  can  handle 
any differences in the contracting phase. However, in public tenders it can be problematic that 
the Member States have different rules, because there may be rules/requests for tests that the 
company  cannot  foresee,  since  they  do  not  know  the  national  markets  well  enough,  and 
therefore cannot take these into account. 

If the company were selling standard products, mutual recognition would have been a greater 
issue. In Portugal, many companies within the construction sector produce products in serial 
batches.  Here,  the  CE  mark  is  often  used.  If  no  CE-mark  exists,  companies  must  be  more 
attentive to rules in other Member State. 

Source:  Questionnaire  survey  among  companies,  running  from  9  October  2014  to  5  January  2015  and  interview  with  the 
company 

The  following  cases  are  derived  from  the  survey  and  have  not  been  supplemented  with  an 
interview. 

Company 11 

Company 11 is a medium-sized Danish company operating in electrical products. It has sold 
goods  to  other  EU  Member  States  the  last  three  years  and  knows  the  principle  of  mutual 
recognition. Around 50% of its exports fall under mutual recognition.  

When  the  company  has  entered  a  new  market,  it  has  examined  the  applicable  rules  in  the 
destination EU country and adapted its product to the local requirements. The company is not 
able  to  state  the  cost  of  the  adaptation  to  these  local  requirements.  However,  the  company 
states  that  the  typical  costs  involved  are  administrative  costs,  testing  costs  and  internal  staff 
costs, and that they are all significant costs.  

The company has met local technical requirements, since it assumed it was necessary and did 
not think that mutual recognition would apply.  

The company states that mutual recognition works ‘well’, but it does not know whether it has 
lowered  any  trade  barriers.  Lack  of  awareness  among  companies  and  legal  uncertainty 
because the legislation is unclear are the two biggest obstacles to effective mutual recognition. 
The  company  has  experienced  these  obstacles  in  Germany  and  France.  It  happens 
approximately twice a year that the company decides not to enter a new market in the EU for 
legal reasons. Over the years, the number of decisions not to enter a new EU market for legal 
reasons has remained constant. 

Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015 

Company 12 

Company 12 is a small Belgium company operating in the construction products sector with 
40% of its exports covered by the mutual recognition principle. The company is well aware of 
the principle of mutual recognition.  

When  entering  a  new  market,  the  company  has  examined  the  applicable  rules  in  the 
destination EU country, and retested its product afterwards. The company stated that the costs 

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Company 12 

of these steps amount to approx. 10% of the company’s annual turnover. The costs that have 
been very significant involving administrative fees, testing costs, and internal company staff 
time.  

Although  the  company  states  that  it  is  well  aware  of  the  mutual  recognition  principle,  the 
company has retested its product, as it believed that this was required to adapt the product to 
local  requirements.  Thus,  it  did  not  check if  the  mutual  recognition  principle  applied  in  this 
case.  

This company believes that the principle works ‘badly’, and it does not know if it has helped 
to lower trade barriers. However, it is likely that it is not the principle itself that does not work 
well,  but  rather  the  understanding  of  the  principle  and  its  application.  This  is  seen  in  the 
company’s answers regarding the most important obstacles to the effective functioning of the 
mutual recognition principle. First, the company states that the legal uncertainty, in terms of 
the mutual recognition legislation being unclear, is a prominent obstacle. The second obstacle 
that  the  company  highlights  is  that  the  authorities  in  other  Member  States  do  not  know  the 
mutual recognition principle well enough or do not apply the principle of mutual recognition 
correctly. These obstacles have meant that on three occasions the company has decided not to 
enter another EU market. The costs of these decisions are not specified, but are in addition to 
the costs amounting to 10% of the company’s turnover as stated above. 

Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015 

Company 13 

Company 13 is a small company from the Netherlands involved in the production of metal 
devices. It has sold goods in other EU Member States within the last three years and it knows 
the  principle  of  mutual  recognition  well.  Around  25%  of  its  exports  fall  under  the  mutual 
recognition principle. 

The  company  has  done  nothing  to  check  if  its  products  meet  the  local  requirements  in  the 
destination  EU  Member  State  (and  has  not  subsequently  experienced  problems).  This 
company believes that the mutual recognition of goods principle works very well and that it 
has helped in lowering trade barriers. In answer to how the principle has lowered the trade 
barriers,  the  company  commented,  "In  the  past  in  our  sector,  all  countries  had  their  own, 
different requirements. Now there is just one applicable directive."  

The two greatest obstacles to effective mutual recognition are the lack of awareness of the 
principle  among  companies  and  the  fact  that  the  authorities  in  other  Member  State  do  not 
know or do not apply the principle correctly. The company has experienced these obstacles 
in Germany. 

Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015 

Company 14 

Company 14 is a medium-sized Spanish company selling children’s clothing. The company 
has sold goods in other EU Member States over the past three years. The company has heard 
of the principle  of  mutual recognition, and estimates  that  10%  of its exports  fall under the 

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Company 14 

principle of mutual recognition.  

When the company has entered a new market, it has typically examined the applicable rules 
and adapted its products to local requirements. These steps cost 0.2% of the annual turnover, 
meaning that the typical costs involved are not perceived by the company to be significant.  

The company adapted its products because it assumed that it was necessary, as the company 
did not know that the mutual recognition principle could apply. This means that even though 
the level of the costs (amounting to 0.2%  of the turnover) does  not appear to  be high,  and 
even though the company does not perceive the costs of adapting its products as significant, 
there might be costs that could be avoided if the mutual recognition principle were applied 
correctly.  

The  company  perceives  the  principle  of  mutual  recognition  to  be  working  in  an  ‘average’ 
way, and it does not know if the principle has helped in lowering trade barriers. The reason 
for  this  statement  is  perceived  by  the  evaluator  to  be  mainly  found  in  the  incorrect 
application  of  the  mutual  recognition  principle  and  not  in  the  principle  itself.  Also,  the 
company  lists  the  two  greatest  obstacles  to  effective  mutual  recognition  to  be  the  lack  of 
awareness of the mutual recognition principle among companies (including itself) and legal 
uncertainty because the mutual recognition legislation is unclear (or difficult to know when 
to apply). 

Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015 

Company 15 

Company 15 is a medium-sized Lithuanian company. The company produces stainless steel 
devices  to  be  used  in  the  food,  brewing,  milk,  alcohol,  chemical,  and  biofuel  industries.  It 
has sold goods to other EU Member States over the past three years. The company is aware 
of the mutual recognition principle, but does not know it in detail. The principle of mutual 
recognition applies to 5% of its exports.  

Whenever  the  company  has  entered  a  new  market,  it  has  examined  the  local  technical 
requirements  and  adapted  its  products  to  them.  The  requirements  and  the  costs that  follow 
this  adaptation  process  is  a  figure  corresponding  to  1%  of  the  company’s  annual  turnover. 
The two most significant costs to the firm are testing costs and administrative fees.  

The main reason for the company to adapt its products to the local requirements was that it 
thought it was required, and it did not know that the mutual  recognition principle could be 
applied. Whereas the company does know about the mutual recognition principle, but not in 
detail,  the  above  experience  suggests  that  a  higher  degree  of  awareness  of  the  principle 
internally in the company could potentially reduce the adaption costs. The company also lists 
lack  of  awareness  of  the  mutual  recognition  principle  among  companies  as  one  of  the 
greatest  obstacles  to  effective  functioning  of  the  mutual  recognition  principle.  However,  it 
should also be  noted that the company estimates  that  only  5%  of its exports  fall  under the 
mutual recognition principle. Hence, the adaptation and testing costs mainly reflect those of 
products outside the scope of the principle. 

Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015 

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Company 16 

Company 16 originates from Belgium and operates within the sector of precious metals. The 
company  has  less  than  10  employees,  and  100%  of  its  exports  fall  under  the  mutual 
recognition principle. The company exports to the UK in particular. Over the last three years, 
it has sold goods to other EU Member States. Company 16 is well aware of the principle of 
mutual recognition.  

When Company 16 exports, it examines the applicable rules in the destination EU country, 
and  afterwards  adapts  its  products  to  the  local  technical  requirements.  The  company 
estimates  that  the  costs  of  the  adaptation  process  correspond  to  approx.  10%  of  its  annual 
turnover. On a scale from 1 to 5 (1 being very costly), the administrative fees and adaptation 
of the product to local technical requirements are estimated to be at around 3. 

The company assumed that it had to adapt its goods to the local requirements, since it did not 
know (enough) about the principle of mutual recognition.  

Company 16 states that the mutual recognition principle operates in an ‘average’ way. It also 
believes that the mutual recognition principle has contributed to lowering the trade barriers 
as  ‘some  goods  can  now  be  sold  in  other  EU  countries  without  the  need  to  adapt  them  to 
national laws’.  

According to the company, the two greatest obstacles to a better functioning of the mutual 
recognition  principle  are  the  lack  of  awareness  of  the  principle  among  companies  and  the 
legal  uncertainty  related  to  prior  authorisation  procedures  or  different  testing  methods. 
Particularly  the  lack  of  awareness  among  companies  (including  their  own)  suggests  that  a 
better functioning of the mutual recognition principle has to do with the company’s need to 
better understand where the principle applies, rather than a malfunctioning of the principle 
itself.  In  addition,  the  legal  uncertainty  related  to  prior  authorisation  procedures  and/or 
different testing methods has to do with the national authorities’ application of the principle.  

As  100%  of  the  company’s  exports  fall  under  the  mutual  recognition  principle,  and  as  the 
costs  associated  with  adapting  the  company’s  products  correspond  to  around  10%  of  the 
company’s turnover, initially there are significant benefits to be reaped for this company by 
ensuring a better application of the principle. In addition, on 15 occasions, the company has 
decided not to market a product in another Member State, due to issues such as authorisation 
procedures. This figure has remained constant over the years. This means that there also may 
be significant economic benefits to be reaped by the company if it is able to sell products in 
new EU markets if the mutual recognition principle is applied properly. 

Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015 

Company 17 

Company  17  is  a  large  UK-based  company  that  produces  child  safety,  childcare  and  child 
use  articles.  Around  90%  of  its  exported  products  are  recognised  under  the  principle  of 
mutual  recognition,  and  it  has  exported  to  other  EU  Member  States  within  the  last  three 
years. The company has heard about the principle of mutual recognition, but it is not familiar 
with its details.  

When the company  has  entered a new  market, it examined and adapted its products to  the 
applicable  rules  in  the  destination  Member  State.  The  costs  of  this  adaptation  amount  to 

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Company 17 

around  1%  of  total  annual  turnover,  a  figure  that  is  perceived  to  be  quite  high,  as  the 
company  has  a  large  turnover.  The  cost  of  administrative  fees  has  been  very  significant. 
Testing costs, internal company staff  time, and adaptation of the product to local technical 
requirement have been rather costly too.  

The reason for adapting the products to  local requirements was that  the company was told 
that it was required. However, the company did not check if the mutual recognition principle 
applied.  

According to Company 17, the mutual recognition principle works poorly. The two biggest 
obstacles to effective mutual recognition are related to the authorities' lack of knowledge of 
the correct application of the principle and the legal uncertainty related to the lack of clarity 
of the mutual  recognition principle. In  addition, it is the evaluators’ understanding that the 
company’s  own  lack  of  knowledge  of  the  mutual  recognition  principle  plays  a  role  in  this 
assessment,  since  the  company  never  checked  whether  the  mutual  recognition  principle 
applied - even though it estimates that 90% of its exports fall under the principle. 

The company has experienced these obstacles in Austria, Belgium, Cyprus, Czech Republic, 
Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Malta,  Poland, 
Portugal, Romania, Spain, and Sweden. On five occasions, the company has decided not to 
market  its  product  in  another  Member  State,  particularly  due  to  issues  related  to  prior 
authorisation procedures or different testing methods. 

Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015 

Company 18 

Company 18 is a small German company active in the childcare products sector. In the last 
three years, the company has sold goods in other Member States. The company states that it 
does  not  know about the principle of  mutual  recognition. Nevertheless, it assumes  that  the 
mutual recognition applies to 50% of its export goods.  

When the company has entered a new market, it has examined and then adapted its products 
to  the  applicable  rules  in  the  destination  Member  State.  The  cost  of  taking  these  steps 
corresponds  to  approx.  0.3%  of  the  annual  turnover.  In  this  respect,  administrative  fees  as 
well as testing costs are very significant.  

Company 18 took these steps because it believed that it was required to do so, and therefore 
did not check if the mutual recognition principle applied. Moreover, it can be seen from the 
above statements that the company was also not familiar with/did not know about the mutual 
recognition principle. 

Despite  not  knowing  about  the  principle  of  mutual  recognition,  the  company  believes  that 
this  principle  works  badly  in  practice.  Given  the  above  statements,  this  is  most  likely 
because the company does not know the principle well. This is further supported by the fact 
that  the  company  believes  that  the  two  biggest  obstacles  to  an  effective  functioning  of  the 
mutual recognition principle are the lack of awareness of the principle among companies and 
the legal uncertainty, because the mutual recognition legislation is unclear. The company has 
run  into  obstacles  when  operating  in  France,  Poland,  Sweden  and  the UK.  Over  the  years, 
the company has decided not to enter a market approximately twice a year. Thus, there may 

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Company 18 

also be economic benefits to be reaped by the company being able to enter new markets, if 
its awareness of the application of the mutual recognition principle increases. 

Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015 

Company 19 

Company  19  is  a  large  German  company  operating  in  the  sectors  of  medical  devices  and 
technical assistance devices (such as wheelchairs). The company has sold goods in other EU 
Member  States  within  the  last  three  years.  Company  19  has  heard  about  the  principle  of 
mutual recognition, but it is not familiar with its details. The company estimates that 50% of 
its exports fall under the principle of mutual recognition. 

Each time the company has entered a new market, it has examined the applicable rules in the 
destination EU country and then adapted its product to local requirements. The costs of the 
steps  to  comply  with  the  local  requirements  amount  to  a  figure  corresponding  to  approx. 
20% of the company’s annual turnover. Administrative fees, testing costs, internal company 
staff  time,  and  adaptation  of  the  product  to  local  technical  requirements  are  all  very 
significant costs to the company.  

The  company  tried  to  rely  on  the  principle  of  mutual  recognition,  but  it  did  not  work  in 
practice, mainly because local authorities did not respect the mutual recognition principle.  

The company believes that the mutual recognition principle works in an ‘average’ way and 
does not know if it has helped in lowering trade barriers. The greatest obstacles to a better 
application of the mutual recognition principle are legal uncertainties due to issues of prior 
authorisation procedures and the fact that the authorities in other Member States do not know 
the principle well enough or do not apply the principle correctly. The company has primarily 
experienced obstacles in Sweden. On six occasions, it has decided not to enter another EU 
market  due  to  these  legal  issues.  Over  the  years,  the  company  has  more  and  more  often 
decided not to  enter another  EU market for legal  reasons.  Thus, in  addition  to the costs of 
adapting its product to local requirements, there are potentially benefits to be gained if the 
company  can  enter  new  markets  because  of  better  application  of  the  mutual  recognition 
principle particularly by Member State authorities. 

Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015 

Company 20 

Company  20  is  a  medium-sized  company  based  in  the  UK  operating  in  the  construction 
products sector. It has sold goods to other Member State the last three years. The company 
knows what mutual recognition means, and assumes that 20% of its export goods fall under 
the principle of mutual recognition.  

When  entering  a  new  EU  market  the  company  examines  the  local  technical  requirements, 
and comments, "[We] check the case with the national authorities, and nine out of 10 times 
we  need  to  adapt  to  the  local  requirements."  These  adaption  costs  amount  to  2%  of  the 
company’s  annual  turnover.  Especially  the  adaptation  to  local  requirements  accounts  for 
significant  costs.  Even though  the  company  relied  on  mutual  recognition,  the  principle  did 
not  work  in  practice,  potentially  because  the  national  authorities  did  not  know  the  mutual 

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Company 20 

recognition principle well enough or did not apply the principle correctly.  

In  this  company's  view,  the  principle  works  ‘badly’.  This  is  interpreted  as  referring  to  the 
application of the principle rather than the mutual recognition principle itself. However, the 
company  perceives  the  principle  as  having  helped  to  lower  trade  barriers,  just  not  in  its 
sector.  In  addition,  80%  of  the  company’s  exports  fall  outside  the  scope  of  the  mutual 
recognition principle, which means that the problem could be that the principle simply does 
not apply to most of the company’s products. 

The two largest obstacles to a better functioning of the mutual recognition principle are that 
the national authorities do not know about the mutual recognition principle or do not apply it 
correctly, and that there is legal uncertainty due to prior authorisation procedures. It therefore 
seems  that  the  lack  of  understanding  of  the  application  of  the  mutual  recognition  principle 
among national authorities is what constitutes some of the adaptation costs for the company. 
The  company  has  experienced  obstacles  in  France  and  Germany.  On  10  occasions,  the 
company has decided not to enter another EU market for legal reasons. Over the years, the 
times where the company has decided not to enter another EU market for legal reasons has 
decreased  slightly.  However,  there  might  still  be  benefits  to  be  obtained  here  for  the 
company as well. 

Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015 

Company 21 

Company 21 is small a German company working with childcare products. It has sold goods 
to other Member States for the past three years. The company states that it does not know 
about the principle of mutual recognition. Still, it assumes that 10% of its exports fall under 
the principle.  

When  entering  a  new  market,  the  company  examines  the  applicable  rules  and  adapts  its 
products to them. The costs of these adaptations are approx. €50,000 annually. The typical 
costs involved are administrative fees, testing costs, and adaptation to the local requirements, 
and they are all perceived to be very significant costs.  

The  reason  for  adapting  its  products  was  that  the  company  did  not  know  that  the  mutual 
recognition  principle  may  have  applied,  and  therefore  the  company  thought  that  it  had  to 
adapt its products to local requirements. 

According  to  Company  21,  the  mutual  recognition  principle  works  ‘very  badly’.  It  is  not 
necessarily  the  legislation  in  itself,  but  rather  that  the  company  did  not  know  about  the 
principle and that it may have been difficult to understand the legislation. Thus, the problem 
is  rather  a  lack  of  awareness  of  the  principle  than  the  principle  itself.  This  is  further 
supported by the fact that the company perceives the two greatest obstacles to an effective 
functioning  of  the  mutual  recognition  principle  to  be  lack  of  awareness  of  the  mutual 
recognition  principle  among  companies  and  legal  uncertainty  due  to  unclear  mutual 
recognition legislation. The company has experienced these obstacles in France and Sweden. 

Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015 

214 

 
Company 22 

Company 22 is a micro company based in the UK producing childcare products. It has sold 
goods in other EU Member States for the past three years. The company does not know the 
mutual  recognition  principle,  but  still  estimates  that  5%  of  its  exports  fall  under  the  mutual 
recognition of goods principle.  

When  the  company  enters  a  new  market  it  examines  local  requirements  and  often  ends  up 
retesting  the  product  or  adapting  it  to  local  requirements.  The  costs  of  these  requirements 
correspond to approx. 10% of the annual turnover. 

The typical costs, linked to testing and adaptation of the product to the local requirements, are 
very significant. The company assumed it was necessary to adapt to the local requirements as 
they did not know or check if the mutual recognition principle applied.  

According  to  the  company,  the  mutual  recognition  works  in  an  ‘average’  way.  The  two 
greatest  obstacles  to  an  effective  functioning  of  the  mutual  recognition  principle  are  lack  of 
awareness of the principle among companies, and that the authorities do not know the mutual 
recognition  principle,  or  do  not  apply  the  principle  correctly.  Company  23  has  experienced 
these  obstacles  in  Germany.  Thus,  better  awareness  and  application  of  the  principle  by 
companies  and  national  authorities  alike  could  potentially  reduce  the  adaptation  costs  for 
Company 23. However, it should also be kept in mind that only 5% of the company’s exports 
falls under the principle. Hence, the potential economic gains may be limited. 

Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015 

Company 23 

Company 23 is  a large, Portuguese company operating in  the fertiliser  sector. The company 
has sold goods to other EU Member States in the past three years. The company knows about 
the  mutual  recognition  principle.  About  5%  of  its  exports  fall  under  the  mutual  recognition 
principle.  

When entering a new market, Company 23 examines local requirements and adapts to them. 
The  adaptation  costs  amount  to  approx.  20%  of  the  company's  annual  turnover.  The  typical 
costs  involved  are  administrative  costs,  internal  company  staff  time,  and  adaptation  of  the 
product to local requirements. All of these are very significant costs.  

When  entering  a  new  market,  Company  23  has  tried  to  rely  on  the  mutual  recognition 
principle,  but  it  has  not  worked  in  practice.  This  is  probably  because  only  5%  of  the 
company’s  products  fall  under  the  mutual  recognition  principle.  In  addition,  the  company 
believes that the principle works very well and that it has helped to lower trade barriers. Thus, 
the  mutual  recognition  principle  may  function  well  in  practise,  and  the  costs  of  adapting  to 
local requirements may be related to the fact that few of the company’s products actually fall 
under the mutual recognition principle.  

The company has experienced obstacles in Bulgaria and Italy. On 20 occasions, the company 
has decided not to enter a new EU market for legal reasons. 

Source: Questionnaire survey among companies, running from 9 October 2014 to 5 January 2015 

215 

 
 
ANNEX 10: OVERVIEW OF DIRECTIVE EU 2015/1535 (TRIS) 

Directive  (EU)  2015/1535  was  adopted  on  9  September  2015  and  repealed  and  replaced 
Directive 98/34/EC. The Directive requires the Member States to notify the Commission and 
each other of any draft ‘technical regulations’ for products before they are adopted in national 
law, with a view to boosting transparency and control with regard to those regulations. Since 
national  technical  regulations  might  create  unjustified  barriers  to  trade  between  Member 
States, notification in draft form and subsequent evaluation of their content help to diminish 
this risk. 

There is a two-pronged procedure for this exchange of information:  

 

 

the  first  part  of  the  Directive  relates  to  the  European  standardisation  bodies  and  the 
procedures  for  information  on  new  national  initiatives  which  should  lead  to  the 
formulation of national standards, compliance with which is not compulsory; 

the second requires Member States to take part in a system of reciprocal transparency 
and  monitoring  of  draft  technical  regulation  within  the  meaning  of  the  Directive, 
compliance with which is compulsory and non-observance of which could impede the 
proper functioning of the single market. 

The Directive enables the Commission and the Member States to identify potential barriers to 
trade  and  take  action  to  ensure  that  they  are  either  not  brought  into  force,  or  are  made 
compatible with EU law. 

The Directive and the Regulation have differing objectives: 

a)   The  Directive  seeks  to  prevent  trade  barriers  in  the  form  of  ‘technical  regulations’ 
before they are adopted, by enabling the Commission and Member States to verify that 
the technical rule is compatible with EU law. 

b)   The Regulation applies after a ‘technical rule’ has been adopted; it seeks to ensure that 
any  authorities  taking  decisions  based  on  such  rules  apply  the  principle  of  mutual 
recognition correctly in individual cases. 

The two acts apply at different stages in the life cycle of a technical rule. While the Directive 
is a preventive mechanism which precedes the adoption of a technical rule, the Regulation is a 
corrective measure once the rule is in force, ensuring on a case by case basis that the rule is 
being applied correctly. 

To guarantee the transparency of national legislative initiatives and ensure that the Internal 

Market  functions  correctly,  Article  8  of  the  Directive  requires  Member  States  to  forward 
immediately to the Commission any draft technical regulation they plan to adopt, along with 
the grounds for the proposed measures. 

Generally, and if the proposed technical rule is considered justified, the Commission requests 

Member States to include in the notified text a ‘mutual recognition clause’, in the interests of 
transparency and legal certainty for national administrations and economic operators. 

216 

 
Nevertheless, even a national technical rule which has been notified under the Directive could 
still  create  barriers  to  the  free  movement  of  goods  since  it  has  to  be  implemented  by  the 
national  administration.  Any  misunderstanding  or  flawed  interpretation  by  the  competent 
authority might result in the rule being wrongly applied. Moreover, the technical rule might 
not  reflect  the  latest  technological  developments  and  product  innovation.  Thus,  a  rule  that, 
during  the  notification  procedure  under  the  Directive,  showed  no  risk  of  creating  trade 
barriers, can still throw up a barrier for a product which has been lawfully placed elsewhere in 
the internal market. In that event the Regulation should be applied on a case-by-case basis. 

In  the  light  of  the  Commission  interpretative  communication  on  the  practical  application  of 
mutual recognition6, Member States are still invited to insert into their draft national technical 
regulations mutual recognition clauses for products which have been lawfully manufactured 
and/or  marketed  in  another  Member  State  of  the  European  Union  or  in  Turkey,  or  lawfully 
manufactured in an EFTA State that is a contracting party to the EEA agreement. 

The  standard  mutual  recognition  clause  may  be  supplemented  by  a  reference  to  the 
applicability of the Regulation. 

The reference to the Regulation might be worded as follows: 

‘The application of this law is subject to 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 to subsequent amendments.’ 

From 2011 to 2013, the Commission received 2114 notifications (675 in 2011, 734 in 2012 
and 705 in 2013). 

The  construction  sector  saw  the  highest  number  of  notifications  over  the  reporting  period. 
Many  measures  related  to  energy  efficiency  of  buildings  and  concrete  structures,  road 
pavements  and  constituent  materials,  fire  safety  of  buildings.  Construction  was  again 
followed by agricultural products, foodstuffs and beverages. In this sector, several measures 
concerned  food  hygiene,  the  composition  and  labelling  of  foodstuffs  and  beverages,  food 
packaging, minimum  price  for  alcoholic  beverages,  composition  and  marketing  of alcoholic 
and non-alcoholic beverages. 

in 

the 

increased 

(radio  equipment  and 
telecommunications 
Notifications 
telecommunications  terminal  equipment,  radio  interfaces,  hardware  and  software  for  the 
collection, management and use of data gathered by electronic mechanisms installed on board 
vehicles  (black  box))  and  in  the  environment  sector  (packaging  and  packaging  waste, 
recyclable products, processing of biodegradable waste).  

sector 

Below,  the  latest  report  on  the  application  of  the  Directive  provides  more  details  on  its 
implementation on the ground.  

217 

 
218 

   EUROPEAN COMMISSION  Brussels, 17.7.2015  COM(2015) 338 final   REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE THE OPERATION OF DIRECTIVE 98/34/EC FROM 2011 TO 2013 {SWD(2015) 137 final}  
 
EXECUTIVE SUMMARY 

This  report  analyses  the  application  of  the  procedures  laid  down  by  Directive  98/34/EC311 
from  2011  to  2013  as  regards  technical  regulations  and  for  2011  and  2012  as  regards 
standards (the standardisation part of Directive 98/34/EC was repealed as of 1 January 2013 
by Regulation (EU) No 1025/2012 on European standardisation312, in order to better address 
future challenges in European standardisation). It highlights the important contribution of the 
notification procedure to the functioning of the single market and to the implementation of the 
Better Regulation policy313.  

The standardisation part consists of the information procedure on standards, the Commission 
requests  to  the  European  Standards  Organisations  (ESOs)314  for  standardisation  work 
(mandates), and formal objections against standards. Each of these activities has proved to be 
an important element in the functioning of the single market. The information procedure has 
brought  transparency  to  standards  at  national  and  thus  also  European  level  and  has 
encouraged  National  Standards  Bodies  (NSBs)  to  continue  to  take  initiatives  at  European 
level,  which  in  turn  promotes  European  harmonisation.  Formal  objections  have  enabled 
Member  States  and  the  Commission  to  ensure  that  standards  meet  the  goals  of  regulation 
when  used  for  the  purposes  of  ‘New  Approach’  legislation.  Mandates  have  provided  the 
means by which the relationship between the Commission services and standardisation bodies 
is determined; the interface between the policy level and its technical expression. 

In the field of technical regulations, the notification to the Commission of national technical 
regulations  prior  to  their  adoption  has  again  proved  to  be  an  effective  instrument  of 
prevention of barriers to trade and of cooperation between the Commission and the Member 
States  and  among  the  Member  States  themselves.  The  notification  procedure  has  been  an 
important  tool  for  guiding  national  regulatory  activity  in  certain  emerging  sectors  and 
improving the quality of national technical regulations - in terms of transparency, readability 
and effectiveness  - in non-harmonised or partly harmonised areas. The greater clarity in the 
legal  framework  of  the  Member  States  has  helped  economic  operators  reduce  the  cost  of 
accessing the regulations and applying them correctly. 

311 

312  

313 

314 

Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998, laying down a procedure for the provision of 
information  in  the  field  of  technical  standards  and  regulations  and  of  rules  on  Information  Society  services  (OJ  L  204  of 
21.07.1998), as amended by Directive 98/48/EC (OJ L 217 of 05.08.1998). 
Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, 
amending  Council  Directives  89/686/EEC  and  93/15/EEC  and  Directives  94/9/EC,  94/25/EC,  95/16/EC,  97/23/EC,  98/34/EC, 
2004/22/EC,  2007/23/EC,  2009/23/EC  and  2009/105/EC  of  the  European  Parliament  and  of  the  Council  and  repealing  Council 
Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council, OJ L 316, 14.11.2012, p. 12–
33. 
Action plan for improving the regulatory environment, COM(2002) 278 final. See also Better Regulation for Growth and Jobs in the 
European Union, COM(2005) 97 final; Implementing the Community Lisbon programme: A strategy for the simplification of the 
regulatory  environment,  COM(2005)  535  final;  A  strategic  view  of  Better  Regulation  in  the  European  Union,  COM(2006)  689; 
Second strategic review of Better Regulation in the European Union, COM(2008) 32, Third strategic review of Better Regulation in 
the European Union, COM(2009) 15 and Smart Regulation in the European Union; COM(2010)543.  
CEN (European Committee for Standardisation), CENELEC (European Committee for Electrotechnical Standardisation) and ETSI 
(European Telecommunications Standards Institute). 

219 

 
 
 
 
                                                            
PART I: STANDARDISATION 

1.  INTRODUCTION 

This  section  describes  the  operation  of  the  standardisation  part  of  Directive  98/34/EC 
covering three main activities: the information procedure on standards, Commission requests 
to the European Standards Organisations for standardisation work (mandates315), and formal 
objections  against  standards  supporting  New  Approach  Directives.  It  provides  and  explains 
statistics  for  the  period  2011-2012,  as  the  standardisation  part  of  Directive  98/34/EC  was 
repealed  as  of  1  January  2013  by  Regulation  (EU)  No  1025/2012  on  European 
standardisation. 

2. 

INFORMATION PROCEDURE 

The  information  procedure  in  the  field  of  standards  is  designed  to  monitor  the  new 
standardisation activities introduced by the NSBs (as recognised under Directive 98/34/EC). 
The notification system was set up mainly to allow other bodies to comment, participate in the 
work or request an initiative to be taken at European level (see Annex 1). 

2.1  Operation of the procedure from 2011 to 2012 

The  procedure  continued  to  operate  successfully  from  2011  to  2012.  From  the  reports 
provided  by CEN and  CENELEC  each year, it is  possible to  see that the annual average  of 
national measures remained relatively stable in 2011 and 2012. Annex 2 gives a breakdown of 
notifications by Member State. 

Comparing the statistics of 2011-2012 with the previous periods, the number of notifications 
made by the EU27 countries continued to be stable with between 1750 and 2000 notifications 
per year (not considering the exceptional situation in 2010). 

The sectoral breakdown (Annex 3) shows that the  construction sector, in its broadest  sense, 
continues  to  dominate  the  national  notifications  in  CEN.  Food  products  and  petroleum 
products  have  also  been  a  significant  area  in  CEN.  In  CENELEC,  electrical  accessories, 
electric cables, and electrical installations in buildings have been significant subsectors both 
in 2011 and 2012. 

The  information  disseminated  under  the  procedure  continued  to  give  rise  to  requests  for 
further  information  by  the  Commission  services,  as  well  as  queries  regarding  the  standstill 
(Article 7) arising either from notifications or other sources. 

Apart  from  the  rather  exceptional  situation  of  2010  the  number  of  notifications  has  been 
relatively stable, or even decreasing since 2006. This applies also to the Member States which 
joined the EU in 2004 and 2007 and could be interpreted as a sign of good integration in the 
system as the standardisation activity appears to be moving from the national to the European 
level. In general the procedure is well applied and works correctly.  

315 

Mandates are requests representing an invitation to ESOs that may be accepted under certain conditions. 

220 

 
 
                                                            
2.2  Conclusion 

information  procedure  still  plays  an 

The 
in  encouraging  national 
standardisation  bodies  to  bring  their  initiatives  to  the  European  level,  thus  encouraging  the 
single  market  and  European  harmonisation.  Notifications  from  EU  12  Member  States  are 
stable which can be considered as a good sign of their integration in the system.  

important  role 

As  of  1  January  2013,  the  standardisation  part  of  Directive  98/34/EC  was  repealed  by 
Regulation (EU) No 1025/2012 on European standardisation in order to better address future 
challenges  in  European  standardisation.  This  relates  in  particular  to  the  increased 
development of standards for services, the evolution of standardisation deliverables other than 
formal  standards,  and  increased  requirements  on  the  inclusiveness  of  the  European 
standardisation  system.  Regulation  (EU)  No  1025/2012  however  maintains  a  similar 
information procedure operated under Directive 98/34/EC, even though with minor changes. 

3.  MANDATES 

Standardisation  “mandates”  are  a  well-established  Commission  tool  to  obtain  technical 
specifications that support European legislation and/or policy. They are requests to the ESOs 
for  standardisation  work  and  provide  a  reference  framework  for  that  work  (see  Annex  1). 
They  are  indispensable  in  cases  where  standards  support  legislation,  for  example  in  the 
context of the 'New Approach' Directives. 

3.1  Operation of the mandating process 2011-2012 

In the reporting period, a total of 43 mandates were issued to the ESOs, with 8 amendment 
mandates.  The  ratio  of  amendments  is  relatively  higher  compared  to  that  of  previous  years 
(see Annex 4). Also the number of mandates concerning New Approach Directives (13, plus 
the 8 amendments) has increased compared to the previous period.  

The  mandating  process  functions  well.  The  informal  consultation  carried  out  before  the 
documents  are  circulated  to  the  members  of  the  Committee  on  Standards  and  Technical 
Regulations  means  that  a  mandate  normally  has  consensual  agreement  before  the  formal 
consultation starts. 

The  European  standardisation  stakeholders  –  ANEC  (European  association  for  the  co-
ordination  of  consumer  representation  in  standardisation),  ECOS  (European  Environmental 
Citizens Organisation for Standardisation), NORMAPME (European Office of Crafts, Trades 
and  Small  and  Medium-sized  Enterprises  for  Standardisation)  and  ETUI-REHS  (European 
Trade Union Institute – Research, Education, Health and Safety) were well-integrated into the 
process  during  the  reporting  period.  This  brings  greater  transparency  to  the  informal 
consultation. 

In order to increase transparency further, DG Internal Market, Industry, Entrepreneurship and 
SMEs maintains a database of mandates. It contains all mandates issued in the past with the 
numbering series M/xxx. This database is publicly accessible on the internet at: 

http://ec.europa.eu/growth/tools-databases/mandates/index.cfm?fuseaction=search.welcome 

221 

 
 
The  practice  of  giving  a  follow-up  to  all  the  mandate  consultations  to  the  Committee  on 
Standards  and  Technical  Regulations  by  means  of  an  updated  list  has  continued  throughout 
the period. 

3.2  Trends in mandates 

In the reporting period, mandates were issued in support of a broad spectrum of legislation. 
The most significant areas include legislation on construction products, ecodesign, consumer 
protection,  and  environmental  protection.  The  breadth  of  legislative  areas  shows  the 
importance conferred on the model. 

The subject matter for mandates continues to broaden. At the same time, mandates issued for 
the New Approach Directives are still very important, and their number has actually increased 
compared  to  the  previous  reporting  periods.  Mandates  in  other  policy  areas  continue  to  be 
numerous, in particular consumer protection and the environment. 

The number of mandates supporting legislation outside the New Approach (see Annex 4) has 
remained  relatively  high  compared  with  the  last  period  and  shows  that  this  co-regulatory 
model  continues  to  be  adopted  across  a  broad  range  of  EU  policies.  Mandates  supporting 
Directive 2009/125/EC (the Ecodesign Directive) have been a major contributor in this field. 

Six  mandates316  were  issued  during  the  period  2011–2012  in  support  of  the  Ecodesign 
Directive. These  mandates  are aimed at products such  as  household dishwashers, lamps, air 
conditioners, pumps or fans.  

This trend for the use of mandates in support of legislation outside the New Approach and in 
new areas reflects the situation that European standardisation is increasingly used in support 
of  the  better  regulation  policy.  This  has  been  recognised  in,  and  indeed  encouraged  by,  the 
Commission  Communication  of  2011  'A  strategic  vision  for  European  standards:  Moving 
forward  to  enhance  and  accelerate  the  sustainable  growth  of  the  European  economy  by 
2020'317. 

The number of mandates supporting European policy continued to drop and is for the second 
consecutive  time  slightly  inferior  compared  to  the  previous  reporting  period.  Nevertheless, 
amongst the five policy mandates are some key initiatives to promote interoperability such as 
the mandate on smart grids or the mandate on the space industry. 

No mandate for standardisation in the service sector was issued during this period.  

3.3  Conclusion 

The process of mandating is well-established and is today governed by Regulation (EU) No 
1025/2012.  The  informal  consultation  of  the  ESOs  and  all  interested  parties  (in  particular 
those  European  stakeholders  representing  the  users  of  future  standards)  prior  to  the 
consultation of the Committee on Standards and Technical Regulations is essential. 

To  improve  transparency  in  the  functioning  of  the  Committee  on  Standards  and  Technical 
Regulations,  the  Commission  services  continued  in  the  reporting  period  in  the  practice 

316 
317 

Mandates M481, M485, M488, M495, M498 and M500 make reference to the Directive 2005/32/EC 
COM(2011) 311 final of 01.06.2011. 

222 

 
 
                                                            
introduced in 2006 to invite the European standardisation stakeholders ANEC, ECOS, ETUI-
REHS and NORMAPME, to participate in its enlarged meeting. 

The  process  of  mandating  has  proved  to  be  instrumental  in  enlarging  the  role  of 
standardisation in new areas of EU legislation and policy.  

4. 

FORMAL OBJECTIONS 

The  New  Approach  directives  contain  safeguards  for  cases  where  a  harmonised  standard 
cannot enable products to meet the essential requirements of the directives concerned. When 
such cases occur, the Member States or the Commission may introduce a formal objection to 
the standard in question on which the Committee on Standards and Technical Regulations is 
consulted (see Annex 1 for the details of the procedure). 

4.1  Operation of the procedure from 2011 to 2012 

Compared  to  previous  years,  the  number  of  objections  that  have  given  rise  to  Commission 
Decisions has slightly decreased during the reporting period. Only one Decision was adopted 
by the Commission  which restricted the presumption  of conformity. This Decision however 
concerned two formal objections against an identical harmonised standard (see Annex 5).  

4.2  Conclusion 

The procedure in general has worked adequately. Compared to the previous reporting period, 
the process from receiving the objection to issuing the Decision was shortened significantly in 
2011 and 2012. 

In  a  similar  way  to  the  mandates,  and  for  the  sake  of  transparency,  the  Commission  makes 
decisions on formal objections public in a consolidated way, and makes an updated table of 
the actions in relation to the formal objections available to the Committee on Standards and 
Technical Regulations at each meeting. 

5.  NEW LEGISLATIVE FRAMEWORK 

As  of  1  January  2013,  the  standardisation  part  of  Directive  98/34/EC  was  repealed  by 
Regulation  (EU)  No  1025/2012  on  European  standardisation  which  introduced  significant 
changes  with  respect  to  the  information  procedure,  mandating  procedure  and  formal 
objections.  

A specific report on the implementation of the Regulation (EU) No 1025/2012 for the period 
from  2013  to  2015  will  be  presented  to  the  European  Parliament  and  to  the  Council  in 
accordance with Article 24(3) of the Regulation.  

223 

 
 
 
 
PART II: TECHNICAL REGULATIONS 

1.  DEVELOPMENTS 2011-2013 

The  notification  procedure  for  national  technical  regulations  (the  procedure)  allows  the 
Commission  and  the  Member  States  of  the  EU  to  examine  preventively  the  technical 
regulations  Member  States  intend  to  introduce  for  products  (industrial,  agricultural  and 
fishery) and for Information Society services (see Annex 6). It applies in a simplified manner 
to the European Free Trade Association (EFTA) Member States which are signatories to the 
Agreement  on  the  European  Economic  Area  (EEA)  and  to  Switzerland  and  Turkey  (see 
Annex 9). 

The major benefits of the procedure 

 

 

 

 

 

 

 

 

 

 

It  allows  new  barriers  to  the  internal  market  to  be  detected  before  they  have  any 
negative effects, thus avoiding long and costly infringement proceedings.  

It allows the detection of protectionist measures which might be drawn up by Member 
States under exceptional circumstances, such as an economic and financial crisis. 

It allows Member States to ascertain the degree of compatibility of notified drafts with 
European Union legislation.  

It  allows  an  effective  dialogue  between  Members  States  and  the  Commission  when 
assessing notified drafts.  

It is a benchmarking tool allowing Member States to draw on the ideas of their partners 
in order to solve common problems regarding technical regulations.  

It allows economic operators, including small and medium-sized enterprises (SMEs), to 
make  their  voices  heard  and  to  adapt  their  activities  in  good  time  to  future  technical 
regulations.  This  right  of  scrutiny  is  used  extensively  by  economic  operators,  helping 
the Commission and national authorities to detect any barriers to trade. 

It contributes to the application of the subsidiarity principle. 

It is a regulatory instrument which can be used to identify areas where harmonisation is 
necessary. 

It helps to improve the quality of national and EU regulations in line with the "Better 
regulation" approach. 

It  contributes  to  improving  competitiveness  of  enterprises  in  the  context  of  industrial 
policy.  

224 

 
 
1.1  Use of the procedure within the context of “Better regulation”  

In its Communication "Better regulation for growth and jobs in the EU"318 the Commission 
has  highlighted  that  the preventive  control  mechanism  established  by  Directive  98/34/EC  is 
crucial for improving national regulations on products and Information Society services. 

In  the  framework  of  the  Commission’s  action  plan  to  simplify  and  improve  the  regulatory 
environment319,  Member  States  have  been  invited  to  submit  impact  studies  (or  their 
conclusions) together with notified drafts, where such studies have been carried out internally. 
The analysis of these impact studies encourages the Member States to reflect in advance on 
the most appropriate instrument to be used, and allows the Commission to check the necessity 
and proportionality of the measures proposed.  

The  cooperation  between  the  Commission  and  the  Member  States  within  the  context  of  the 
98/34/EC notification procedure helps to improve the clarity and consistency of the notified 
draft national legislations. This cooperation will be intensified with a view to ensuring a clear 
and legible regulatory framework for economic operators while guaranteeing a high level of 
protection for public health, consumers and the environment. 

The national authorities are encouraged to consider the following aspects in particular: 

 

 

 

the  wording  of  drafts:  clarity,  consistency,  transparency  and  legal  certainty  in  the 
application of the texts; 

the possibility of accessing all regulations in a given sector through the publication both 
on paper and on-line of consolidated versions of the texts; 

the  identification  and  avoidance  of  procedures  imposing  unnecessarily  complex  and 
onerous  administrative  burdens  on  economic  operators,  particularly  when  placing  a 
product on the market. 

1.2  Use of the procedure to improve competitiveness 

In the framework of the EU 2020 strategy, a new approach of the industrial policy based on 
competitiveness analysis of legislation has been proposed. 

In this context, in the latest update of the Communication on Industrial Policy of 10 October 
2012 - Communication of the Commission to the European Parliament, to the Council, to 
the  European  Social  and  Economic  Committee  and  to  the  Committee  of  the  Regions  -  A 
stronger  European  industry  at  the  service  of  economic  growth  and  re-launch  -  COM 
(2012)582 final – the Commission underlined that: 

“Governance  and  regulatory  obstacles  to  the  Internal  Market  also  arise  from  policy  areas 
that  are  regulated  by  Member  States,  for  example  technical  rules,  refusals  to  apply  mutual 
recognition  and  mismatches  between  the  27  different  sets  of  taxation  rules.  An  upstream 
analysis  of  draft  technical  rules  can  prevent  the  emergence  of  regulatory  obstacles.  This  is 
precisely  the  objective  of  the  98/34  notification  procedure,  which  requires  draft  legislation 
containing technical rules on products and information society services to be communicated 

318 
319 

See supra, footnote 3. 
See supra, footnote 3. 

225 

 
 
                                                            
to  the  Commission  before  they  are  adopted.  The  preventive  nature  of  this  procedure  has 
avoided a large number of contraventions of free movement of goods rules. This notification 
procedure  can  also  be  used,  however,  to  improve  national  legislation  in  line  with  "Better 
Regulation"  principles  and  through  benchmarking.  Its  potential  can  be  further  exploited  by 
recommending  that  Member  States  use  competitiveness  proofing  in  the  context  of  national 
impact assessments.”. 

The  Communication  of  the  Commission  on  industrial  policy  makes  an  explicit  reference  to 
Directive  98/34/EC  which,  beside  to  its  role  as  an  instrument  for  prevention  of  obstacles to 
intra-EU  trade  has  the  task  to  encourage  Member  States  to  proceed  to  a  competitiveness 
analysis of national legislation. 

This  approach  was  endorsed  by  the  Committee  on  Industry,  Research  and  Energy  of  the 
European  Parliament  in  its  Report  of  18  December  2013  on  reindustrialising  Europe  to 
promote  competitiveness  and  sustainability  ((2013/2006(INI))  where  it  encouraged  further 
exploitation  of  the  potential  of  the  98/34  notification  procedure  and  suggested  that  the 
Member  States  introduce  competitiveness  proofing  in  impact  assessments  conducted  at  the 
drafting stages of national legislative processes, in the wider framework of the ‘Single Market 
Test’ called for in  Parliament’s resolution of 7 February 2013 with  recommendations  to the 
Commission on the governance of the Single Market. 

In this context, Member States, as of March 2014, have been invited to prepare on a regular 
basis  a  competitiveness  analysis  of  the  national  legislation  notified  under  the  scope  of  the 
procedure established by Directive 98/34/EC. 

1.3 

Improvements in managing the 98/34 procedure 

The  Commission  continued  conducting  various  campaigns  during  2011-2013  to  increase 
transparency  and  dialogue  with  the  national  authorities.  The  TRIS  (Technical  Regulations 
Information System) database has seen continuous improvement. 

the 

revamping  of 

The  Commission  worked  on 
the  TRIS  public  website, 
(http://ec.europa.eu/growth/tools-databases/tris/en/), to explain the 98/34 procedure in a more 
accessible way and to reach a wider audience, especially SMEs. The website ensures public 
access  to  the  notified  drafts,  in  the  23  official  languages  of  the  EU,  and  to  essential 
information  regarding  the  procedure.  A  constant  increase  in  the  number  of  on-line 
consultations has been observed: from 2011 to 2013 the number of searches rose by 10% to 
reach  approximately  212,000  searches  in  2013  (see  Annex  10).  More  than  4300  economic 
operators subscribed to the TRIS mailing list, which is a rise of 25% since 2010. 

In 2012-2013, the Commission also produced a video on the 98/34 procedure. The message 
was to explain in a simple and attractive way the functioning of the procedure and its benefits 
for enterprises, to encourage active participation by enterprises, especially SMEs, and explain 
how  they  can  make  best  use  of  the  existing  tools  (websites,  databases,  alert  systems).  This 
video  was  published  on  11  September  2013  and  is  accessible  using  the  following  link  - 
http://www.youtube.com/watch?v=ziuAklsNKdI.  It  has  been  promoted  on  social  networks 
and was viewed 2675 times by stakeholders since its publication. 

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2.  APPLICATION OF THE 98/34 PROCEDURE 

2.1   Effectiveness: general overview  

►   Volume of notifications and sectors involved 

From 2011 to 2013, the Commission received 2114 notifications (675 in 2011, 734 in 2012 
and 705 in 2013). 

Like in the previous reporting period, the construction sector saw the highest number of 
notifications  over  the  reporting  period.  Many  measures  related  to  energy  efficiency  of 
buildings  and  concrete  structures,  road  pavements  and  constituent  materials,  fire  safety  of 
buildings.  Construction  was  again  followed  by  agricultural  products,  foodstuffs  and 
beverages.  In  this  sector,  several  measures  concerned  food  hygiene,  the  composition  and 
labelling  of  foodstuffs  and  beverages,  food  packaging,  minimum  price  for  alcoholic 
beverages,  composition  and  marketing  of  alcoholic  and  non-alcoholic  beverages. 
Notifications 
(radio  equipment  and 
telecommunications  terminal  equipment,  radio  interfaces,  hardware  and  software  for  the 
collection, management and use of data gathered by electronic mechanisms installed on board 
vehicles  (black  box))  and  in  the  environment  sector  (packaging  and  packaging  waste, 
recyclable products, processing of biodegradable waste) (see Annex 8.3). 

telecommunications  sector 

increased 

the 

in 

►  

Issues examined 

In the non-harmonised areas, subject to compliance with Articles 34-36 (free movement of 
goods) and 49 and 56 (right of establishment and freedom to provide services) of the Treaty 
on  the  Functioning  of  the  European  Union  (TFEU),  the  Commission’s  reactions  were 
intended  to  draw  Member  States’  attention  to  potential  obstacles  to  trade  which  could  be 
created  by  an  unnecessary  measure  disproportionate  to  the  objective  pursued.  Thus  the 
Commission  ensured  compliance  with  these  principles  and  in  addition  continued  to  invite 
Member States to insert mutual recognition clauses into each draft technical regulation falling 
outside the harmonised area.  

In the harmonised areas, the reactions were intended to ensure that national measures were 
necessary, justified and compatible with EU secondary legislation. 

 

In  2011,  2012  and  2013  Member  States  notified  512  draft  technical  regulations in  the 
field  of  construction.  These  drafts  concerned  all  types  of  construction  products,  inter 
alia, bridge structures and concrete road structures, pitched roof coverings for buildings, 
fire-fighting and rescue equipment, thermal insulation, synthetic fill materials, concrete 
structures,  electrical  installations  on  and  in  concrete  structures,  metallic  materials  in 
contact with drinking water.  

In  particular,  the  Commission  examined  draft  technical  regulations  setting  additional 
technical requirements or tests for construction products impeding the free movement of 
products  labelled  with  the  CE  mark.  The  notified  drafts  were  examined  principally 
under  Directive  89/106/EEC  on  construction  products320  and  Regulation  (EU)  No 

320  

Council Directive 89/106/EEC of 21 December 1988 on the approximation of laws, regulations and administrative provisions of the 
Member States relating to construction products, OJ L 40, 11.2.1989, p. 12–26. 

227 

 
 
                                                            
305/2011  laying  down  harmonised  conditions  for  the  marketing  of  construction 
products and repealing Council Directive 89/106/EEC321.  

The Commission also examined draft legislation prohibiting the installation of fossil oil 
furnaces and natural gas furnaces in new buildings except when oil and gas furnaces use 
only renewable energy. The notified draft was examined under Directive 2009/142/EC 
on  gas  appliances  (GAD)322  and  Directive  92/42/EEC  on  efficiency  requirements  for 
new hot-water boilers fired with liquid or gaseous fuels323. 

Technical  regulations  relating  to  energy  efficiency  of  buildings  were  assessed  under 
Directive  2012/27/EU  on  energy  efficiency324,  Directive  2010/31/EU  on  the  energy 
performance  of  buildings325  and  Directive  2009/125/EC  establishing  a  framework  for 
the setting of ecodesign requirements for energy-related products326. 

 

In  the  foodstuffs  and  agricultural  sectors,  from  2011  to  2013  Member  States  notified 
393 draft technical regulations. These drafts concerned, inter alia, materials coming into 
contact  with  foodstuff,  energy  drinks,  trans  fats  in  food  products,  wine  and  spirits, 
labelling  of  foodstuff,  in  particular  nutritional  declarations,  quality  marks,  the  well-
being of fur animals and the marketing of fur products. 

Certain Member States notified draft regulations imposing restrictions on or prohibition 
of  food  packaging  containing  bisphenol  A  and  in  particular  packaging  for  foods 
intended for children between 0 and 3 years, as well as concerning health warning to be 
affixed  to  packaging  containing  bisphenol  A.  These  notifications  have  been  examined 
under  the  Treaty  provisions  on  the  free  movement  of  goods  and  Regulation  (EC)  No 
1935/2004 concerning materials and articles intended to come into contact with food.327  

During the relevant period the Commission examined many notifications concerning the 
hygiene  of  foodstuffs  and  issued  detailed  opinions  and  comments  on  the  basis  of 
Regulations  (EC)  No  852/2004  on  the  hygiene  of  foodstuffs328,  (EC)  No  853/2004 
laying down specific hygiene rules for food of animal origin329 and (EC) No 854/2004 
laying down specific rules for the organisation of official controls on products of animal 
origin intended for human consumption330. 

Other  notifications  concerned  the  labelling  of  foodstuff  and  the  Commission  assessed 
their compatibility with Directive 2000/13/EC on the approximation of the laws of the 

321  

322  

323  

324  

325  

326  

327  

328  

329  

330  

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 products and repealing Council Directive 89/106/EEC, OJ L 88, 4.4.2011, p. 5–43. 
Directive 2009/142/EC of the European Parliament and of the Council of 30 November 2009 relating to appliances burning gaseous 
fuels, OJ L 330, 16.12.2009, p. 10–27. 
Council  Directive  92/42/EEC  of  21  May  1992  on  efficiency  requirements  for  new  hot-water  boilers  fired  with  liquid  or  gaseous 
fuels, OJ L 167, 22.6.1992, p. 17–28. 
Directive 2012/27/EU of the European Parliament and of the Council of 25 October 2012 on energy efficiency, amending Directives 
2009/125/EC and 2010/30/EU and repealing Directives 2004/8/EC and 2006/32/EC, OJ L 315, 14.11.2012, p. 1–56. 
Directive 2010/31/EU of the European Parliament and of the Council of 19 May 2010 on the energy performance of buildings, OJ L 
153, 18.6.2010, p. 13–35. 
Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting 
of ecodesign requirements for energy-related products, OJ L 285, 31.10.2009, p. 10–35. 
Regulation  (EC)  No  1935/2004  of  the  European  Parliament  and  of  the  Council  of  27  October  2004  on  materials  and  articles 
intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC, OJ L 338, 13.11.2004, p. 4–17. 
Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs, OJ L 
139, 30.4.2004, p. 1–54. 
Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules 
for food of animal origin, OJ L 139, 30.4.2004, p. 55–205. 
Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the 
organisation of official controls on products of animal origin intended for human consumption, OJ L 139, 30.4.2004, p. 206–320. 

228 

 
 
                                                            
 

 

 

 

Member States relating to the labelling, presentation and advertising of foodstuffs331 and 
Regulation (EU) No 1169/2011 on the provision of food information to consumers.332 

In  the  Information  Society  services  sector  there  were  99  notifications.  Numerous 
notifications  were  in  the  area  of  gambling,  while  others  concerned,  inter  alia, 
copyright  in  the  digital  environment,  on  demand  audio-visual  media  services, 
electronic commerce, electronic signature and other trust services. 

Since 2011, Member States have notified a series of technical regulations concerning 
measuring  instruments.  These  drafts  concerned  various  types  of  measuring  devices 
such  as  gas,  electricity  and  heat  meters,  taximeters  or  prism  refractometers  and 
provided  for  specific  requirements  which  these  instruments  have  to  fulfil.  The 
notifications on gas, electricity and heat meters and taximeters were mainly analysed 
under  Directive  2004/22/EC  on  measuring  instruments333.  The  novelty  consisted  of 
projects  of  new  smart  metering  systems,  also  falling  under  Directive  2004/22/EC, 
which are quite complex due to the needs of the combination of engineering with IT 
and communication, data privacy and security aspects. 

In  the  chemicals  sector  the  Commission  received  76  notifications.  Some  of  them 
regarded the annual declaration of nanoparticle substances as well as draft legislation 
banning  the  import  and  sale  of  products  containing  certain  phthalates  intended  for 
indoor  use  or  which  may  come  into  contact  with  skin  or  mucous  membranes.  The 
notified  drafts  were  mainly  examined  under  Regulation  (EC)  No  1907/2006 
concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals 
(REACH)334.  

In  the  environment  sector  the  Commission  examined  141  draft  regulations.  Some 
notified  drafts  established  conditions  for  the  use  of  environmental  claims  on  plastic 
objects  and  packaging  while  others  prohibited  the  marketing  of  non-biodegradable 
shopping bags. These notifications have been mainly analysed in the light of Directive 
94/62/EC on packaging and packaging waste335. 

The  98/34  procedure  has  also  allowed  the  Commission  to  intervene  in  sectors  where 
harmonisation was envisaged or under way at European Union level and thus has prevented 
Member  States  from  introducing  divergent  national  measures.  Pursuant  to  Articles  9(3)  and 
9(4)  of  Directive  98/34/EC,  the  Commission  has  blocked  the  adoption  of  notified  draft 
legislation  for  twelve  months  from  the  date  of  notification  in  the  fields  of:  type-approval 
requirements  for  masses  and  dimensions  of  motor  vehicles and  their  trailers;  marketing  and 

331  

332  

333  

334  

335  

Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the 
Member States relating to the labelling, presentation and advertising of foodstuffs, OJ L 109, 6.5.2000, p. 29–42. 
Regulation  (EU)  No  1169/2011  of  the  European  Parliament  and  of  the  Council  of  25  October  2011  on  the  provision  of  food 
information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of 
the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, 
Directive  2000/13/EC  of  the  European  Parliament  and  of  the  Council,  Commission  Directives  2002/67/EC  and  2008/5/EC  and 
Commission Regulation (EC) No 608/2004, OJ L 304, 22.11.2011, p. 18–63. 
Directive  2004/22/EC  of  the  European  Parliament  and  of  the  Council  of  31  March  2004  on  measuring  instruments,  OJ  L  135, 
30.4.2004, p. 1–80. 
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), establishing a European Chemicals Agency, amending Directive 
1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council 
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, OJ L 396, 30.12.2006, p. 
1–849. 
European  Parliament  and  Council  Directive  94/62/EC  of  20  December  1994  on  packaging  and  packaging  waste,  OJ  L  365, 
31.12.1994, p. 10–23. 

229 

 
 
                                                            
use  of  explosives  precursors;  the  indication  of  the  origin  of  olive  oil  on  the  label  and  the 
methods for such indication; compounds terms for spirit drinks; electronic identification and 
trust  services  for  electronic  transactions;  fertilisers  allowed  in  organic  production.  Through 
this  type  of  intervention,  not  only  has  the  Commission  avoided  the  fragmentation  of  the 
market  in  areas  where  harmonisation  was  envisaged  or  under  way,  but  it  has  also  granted 
greater certainty and stability in the legal framework of Member States and of the European 
Union  to  the  benefit  of  economic  operators  and  of  the  competitiveness  of  European 
enterprises. 

► Reactions 

The  Commission  issued  detailed  opinions  in  relation  to  208  notifications,  which  represents 
9.8% of the total number of drafts notified by the Member States over the reporting period. 
This  figure  shows  a  29.2%  increase  in  the  number  of  detailed  opinions  issued  by  the 
Commission compared to the previous three years. For their part, the Member States issued 
205  detailed  opinions.  Of  the  910  comments  issued  during  the  reporting  period,  425  were 
made by the Commission and 485 by the Member States (see Annexes 8.4 and 8.6). 

In 12 cases, the Commission invited the Member States concerned to postpone the adoption of 
the notified regulations for one year from the date of their receipt because there was European 
Union harmonisation work under way in the area (see Annex 8.5). 

2.3   Use of the urgency procedure 

Out of a total of 2114 notifications, the Member States made 87 requests to apply the urgency 
procedure  to  notified  drafts.  The  Commission  confirmed  its  strict  interpretation  of  the 
exceptional  conditions  required  by  Directive  98/34/EC,  namely  serious  and  unforeseeable 
circumstances relating in particular to the protection of health and safety. As a result, use of 
the urgency procedure was refused where the justification was not sufficiently established or 
was  based  on  purely  economic  grounds  or  national  administrative  delay  as  well  as  in  cases 
where  no  unforeseeable  circumstances  were  demonstrated.  The  urgency  procedure  was 
deemed  justified  in  56  cases,  in  particular  concerning  psychotropic  substances,  control  of 
narcotics,  radioactive  waste,  infection  of  bees,  poisonings  caused  by  methanol  intoxication, 
explosive precursors, protection of cash transports, prohibition of products that are harmful to 
health, prohibition of the possession and use of fireworks not intended for private individuals. 
(see Annex 8.7). 

2.4  Notification of ‘fiscal or financial incentive measures’ 

According  to  Directive  98/34,  Member  States  have  to  notify  fiscal  and  financial  incentives, 
i.e.  technical  regulations  which  are  linked  to  fiscal  or  financial  measures  affecting  the 
consumption  of  products  or  services  by  encouraging  compliance  with  such  technical 
regulations. The specificity of such technical regulations is that the standstill period does not 
apply. 

During  the  period  2011-2013  Member  States  notified  112  draft  regulations  as  ‘fiscal  or 
financial measures’. The Commission observes that often national legislation is misclassified 
as  ‘fiscal  or  financial  measure’  in  the  meaning  of  Directive  98/34/EC  when  it  contains  any 
fiscal or financial measures but not the incentive to comply with such technical regulations. In 
order to help Member States to correctly classify these technical regulations the Commission 

230 

 
 
drafted Guidelines on the definition and notification of 'fiscal or financial measures' for the 
purposes of Directive 98/34/EC. 

2.5  Follow-up to Commission reactions 

From 2011 to 2013, the ratio between the number of responses given by Member States and 
the  volume  of  detailed  opinions  issued  by  the  Commission  was  satisfactory  (an  average  of 
86%  over  the  period).  This  percentage  is  the  main  indicator  used  to  assess  Member  States’ 
commitment  to  meeting  their  obligations  under  the  procedure.  The  number  of  completely 
satisfactory  responses  was  higher  in  comparison  with  the  previous  reporting  period  (an 
average of 48.4% over the period 2011-2013 in comparison with 32.5% over the period 2009-
2010) (see Annex 8.8), showing an increased compliance of Members States with the internal 
market  legal  framework  following  the  Commission's  reaction.  The  effect  of  Commission's 
reactions was even more remarkable in the case of notified draft technical regulations which 
were  withdrawn  following  the  delivery  of  a  detailed  opinion  (24  cases  for  the  reporting 
period). For other notified draft technical regulations the dialogue is still on-going. 

2.6  Follow-up to the notification procedure  

For all other cases where the potential breaches of the EU internal market law have not been 
entirely cleared within the framework of the 98/34/EC procedure, the Commission conducted 
further  investigations  which  in  some  cases,  eventually  led,  to  EU  Pilots  or  to  infringement 
proceedings  (Article  258  of  the  TFEU)  on  subjects  such  as  quality  and  transparency  of  the 
supply  chain  for  virgin  olive  oils,  taxation  of  food  products  with  high  sugar,  salt,  and/or 
caffeine content, environmental protection product charges, traditional food production, wine 
and  spirits,  banning  of  products  intended  for  indoor  use  which  contain  certain  types  of 
phthalates, products made of leather, hide and fur, minimum content of fruit juice that must be 
contained in non-alcoholic fruit-based beverages and plastic bags.  

Two  of  the  infringement  proceedings  brought  against  Member  States  during  the  reporting 
period were grounded on the breach of obligations under Directive 98/34/EC.  

2.7  Dialogue with the Member States  

The  regular  meetings  of  the  Committee  on  Standards  and  Technical  Regulations  allowed 
views  to  be  exchanged  on  points  of  general  interest  and  also  on  specific  aspects  of  the 
procedure.  

As  regards  technical  regulations,  the  discussions  particularly  concerned  the  role  of 
notifications  for  national  competitiveness  issues  and  competitiveness  proofing;  access  to 
documents of the Commission under Regulation (EC) No 1049/2001 regarding public access 
to  European Parliament, Council and Commission  documents336;  the obligation  for Member 
States to communicate to the Commission the final text of a notified technical regulation; and 
the  legal  consequences  of  the  delivery  of  a  detailed  opinion  under  Article  9(2)  of  Directive 
98/34/EC. 

The  Commission  made  presentations  concerning  Regulation  (EU)  No  1169/2011  on  the 
provision  of  food  information  to  consumers;  the  review  of  Regulation  (EC)  No  1907/2006 

336  

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 documents, OJ L 145, 31.5.2001, p. 43-48. 

231 

 
 
                                                            
(REACH);  the  Product  Safety  and  Market  Surveillance  Package;  the  evaluation  report  of 
Directive 2006/123/EC on services in the internal market337; the state of play of the internal 
market  in  the  construction  sector;  issues  related  to  technical  regulations  in  the  area  of 
renewable  energy  sources;  notifications  about  metrology  and  notifications  in  the  railway 
sector,  in  particular  notification  obligations    in  the  framework  of  Directive  2004/49/EC  on 
safety  on the  Community's  railways338    and  Directive  2008/57/EC  on  the  interoperability  of 
the rail system within the Community339.  

Guidelines on the definition and notification of 'fiscal or financial measures' for the purposes 
of  Directive  98/34/EC,  and  guidelines  on  the  “One-stop-shop  for  the  98/34  notification 
procedure and for the notification procedures laid down in specific EU rules” were presented 
by the Commission.  

Seminars  were  also  held  in  several  Member  States,  allowing  direct  dialogue  between  the 
Commission  and  the  national  authorities  involved  in  the  procedure  and helping  the latter  to 
become familiar with the highly technical elements of the procedure.  

2.8  Requests for access to documents issued under Directive 98/34 

From 2011 to 2013 the Commission received 272 requests for access to documents issued in 
the  framework  of  the  98/34  procedure.  The  major  part  of  them  concerned  detailed  opinions 
and  comments  delivered  by  the  Commission.  In  167  of  the  cases,  access  to  the  requested 
documents was given. In the other cases, access to documents was refused while the dialogue 
with the Member States, aimed at removing the potential obstacle to trade, was ongoing. 

2.9   Conclusion 

During  the  period  2011-2013,  the  usefulness  of  the  procedure  has  again  been  confirmed  in 
terms of effectiveness, transparency and administrative cooperation.  

The preventive and networking approach of the 98/34 procedure has substantially reduced the 
risk  of  national  regulatory  activities  being  carried  out  in  a  way  that  would  create  technical 
barriers  to  the  free  movement  of  goods  within  the  internal  market.  The  high  number  of 
detailed opinions and comments issued during the reporting period demonstrates that there is 
still a risk of fragmentation of the internal market for goods. On average 86% of the detailed 
opinions issued by the Commission during the period were replied to by the Member States 
concerned and dialogues followed to remove any incompatibility with EU law and ensure the 
free movement of goods within the internal market, thus avoiding infringement procedures.   

The 98/34 procedure has also confirmed its usefulness in providing the possibility to identify 
areas where harmonisation at EU level might be an option. 

When applying Directive 98/34/EC the Commission remains vigilant regarding the principle 
of better regulation and the need to sustain a favourable environment for the competitiveness 

337  

338  

339  

Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market, OJ L 
376, 27.12.2006, p. 36–68. 
Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety on the Community's railways and 
amending  Council  Directive  95/18/EC  on  the  licensing  of  railway  undertakings  and  Directive  2001/14/EC  on  the  allocation  of 
railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety  certification, OJ L 164, 
30.4.2004, p. 44–113. 
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 Community, OJ L 191, 18.7.2008, p. 1–45. 

232 

 
 
                                                            
of  the  European  economy.  Notified  drafts  continue  to  be  available  electronically,  free  of 
charge  and  in  all  the  official  languages  of  the  EU,  thus  providing  the  opportunity  for 
economic operators and other stakeholders to comment on them.  

Efforts  will  continue  in  order  to  ensure  a  clear  legal  framework  for  economic  operators 
aiming at enhancing the competitiveness of European enterprises in the EU and abroad, taking 
into account the links between the 98/34 procedure and that established by the Agreement on 
Technical  Barriers  to  Trade  (TBT)  in  the  context  of  the  World  Trade  Organisation  (WTO). 
Further promotion of the Directive and its stronger implementation  together with a stronger 
link  with  follow-up  policy  and  legislative  actions  are  crucial  in  order  to  fully  achieve  its 
objectives. 

233 

 
 
 
 
ANNEX 11: SUMMARIES OF THE MEETINGS OF THE CONSULTATIVE “MUTUAL RECOGNITION 
COMMITTEE” 

1.  MINUTES  OF  THE  FIRST  MEETING  OF  THE  CONSULTATIVE  ‘MUTUAL  RECOGNITION 

COMMITTEE’ HELD IN BRUSSELS ON 4 MARCH 2009 

The  consultative  “Mutual  Recognition  Committee”  was  set  up  by  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  (JO 
L218 of 13.8.2008, p. 21. 

The  committee  met  for  the  first  time  on  4  March  2009.  The  attendance  list  is  attached 
hereto. 

The following matters were discussed. 

RULES OF PROCEDURE 

The  Commission  presented  the  draft  rules  of  procedure  which  were  sent  to  delegates  in 
English,  French  and  German.  This  draft  corresponds  to  the  standard  text  of  the  rules  of 
procedure  which  was  approved  by  the  Commission  on  31  January  2001  (OJ  C  38, 
6.02.2001, p. 3). 

The  Commission  indicated  that  the  draft  rules  of  procedure  will  be  translated  into  all 
official  EU  languages  and  then  sent  to  the  members  of  the  committee  for  approval.  Any 
member of the committee who does not express his opposition or intention to abstain from 
voting on the draft rules of procedure within the time-limit laid down in the message shall 
be considered to have given his tacit agreement (written procedure). 

INDICATIVE LIST OF PRODUCTS 

The  Commission  presented  the  work  in  progress  with  respect  to  the  indicative  and  non-
exhaustive  list  referred  to  in  Article  12(4)  of  Regulation  (EC)  No  764/2008  (see 
attachment). 

PRODUCT CONTACT POINTS 

The Commission reminded all Member States of their obligation to designate Product Contact 
Points (PCP) in their territories and to communicate their contact details as stated in Article 9 
of the Mutual Recognition Regulation. 

The  Commission  invited  delegations  to  inform  the  committee  of  the  state  of  the  play 
regarding the establishment of their PCP. 

GUIDANCE DOCUMENTS 

The Commission presented a summary of the six draft guidance documents (see attachment): 

(1)  The application of the mutual recognition regulation to weapons and firearms 

(2)  The application of the mutual recognition regulation to articles of precious metals 

234 

 
 
(3)  The relationship between the Directive 98/34 and the mutual recognition regulation 

(4)  The application of the mutual recognition regulation to food supplements 

(5)  The relationship between the Directive 95/2001 an the mutual recognition regulation 

(6)  The application of the mutual  recognition regulation to narcotic drugs and psychoactive 

substances 

The chair clarified that these documents are not legally binding but just drafts that need to be 
improved with the contributions and expertise of the members of the Committee. 

ANY OTHER BUSINESS 

Contacts between committee members and the Commission 

The Commission explained that all future communications between the Commission and the 
committee  members  within  the  context  of  the  committee  will  go  via  CIRCA  (see 
http://circa.europa.eu/). 

The role of Product Contact Points under the forthcoming Construction Products 
Regulation 

Some delegations expressed their concerns about an IMCO amendment of the Commission’s 
proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  laying  down 
harmonised conditions for the marketing of construction products [COM(2008)311final]. This 
amendment seeks to broaden the role of Product Contact Points. 

CONCLUSION OF THE MEETING 

The  Commission  also  informed  the  committee  that  the  management  of  the  Mutual 
Recognition Regulation (EC) 764/2008 will be transferred to unit ENTR/C/2 with effect from 
1 May 2009. 

Finally, the Commission suggested that another meeting of the committee should be organised 
after  having  gained  some  experience  with  the  implementation  of  the  Regulation  in  the 
Member  States.  Consequently,  the  Commission  took  the  view  that  it  was  too  premature  to 
announce a date for the next meeting. 

2.  MINUTES OF THE SECOND MEETING OF THE CONSULTATIVE ‘MUTUAL RECOGNITION 

COMMITTEE’ HELD IN BRUSSELS ON 19 NOVEMBER 2010 

The  consultative  Mutual  Recognition  Committee  held  its  second  meeting  on  19  November 
2010. The attendance list and the PowerPoint presentations are attached hereto. 

The following matters were discussed. 

GUIDE TO THE APPLICATION OF THE TREATY PROVISIONS GOVERNING THE FREE MOVEMENT 
OF GOODS 

The Commission presented the updated 2010 version of the Guide to the application of Treaty 
provisions  governing  the  free  movement  of  goods,  prepared  and  drafted  by  Unit  C2  of  the 

235 

 
 
Directorate-General for Enterprise and Industry. The guide was distributed to the participants 
in their respective language. 

The Commission indicated that all Member States will be provided with links to the guide in 
all official languages340. 

GUIDANCE DOCUMENTS ON THE APPLICATION OF THE MUTUAL RECOGNITION REGULATION 

The Commission presented the final versions of the Guidance documents on the application of 
the MRR. The  documents  were  made available immediately after the meeting  in  all  official 
languages on the DG's homepage and links with access to these documents were sent to the 
Member States341. 

The seven guidance documents are the following: 

(1)  The application of the Mutual Recognition Regulation to weapons and firearms 

(2)  The application of the Mutual Recognition Regulation to articles of precious metals 

(3)  The relationship between Directive 98/34/EC and the Mutual Recognition Regulation 

(4)  The application of the Mutual Recognition Regulation to food supplements 

(5)  The relationship between Directive 2001/95/EC and the Mutual Recognition Regulation 

(6)  The application of the Mutual Recognition Regulation to narcotic drugs and psychotropic 

substances 

(7)  The application of the Mutual Recognition Regulation to prior authorisation procedures. 

The  Commission  pointed  out  that  these  documents  are  not  legally  binding  and  may  be 
amended in the course of time, especially as a result of the evolution of the case-law of the 
European Court of Justice. 

Guidelines in regard to the construction sector were proposed to be added but the Commission 
stressed that ongoing legislative procedures within that sector have to be finalised before such 
guidelines can usefully be prepared. 

DISCUSSION ON THE APPLICATION OF THE MUTUAL RECOGNITION REGULATION AND THE 
MEMBER STATES' REPORTS 

The Commission briefly presented the notifications received and the Member States' reports. 
The Commission proposed to report after the end of the calendar year and to organise training 
for the PCPs. 

The Commission drew inter alia attention to the following: 

  There are apparent discrepancies between the number of notifications received by the 

340 

341 

The  guide  is  available  in  all  language  versions  at  http://ec.europa.eu/enterprise/policies/single-market-goods/free-
movement-non-harmonised-sectors/index_en.htm 
The  guidance  documents  are  available  at  http://ec.europa.eu/enterprise/policies/single-market-goods/free-movement-non-
harmonised-sectors/mutual-recognition/ 

236 

 
 
                                                            
Commission and the number of decisions taken by the MS authorities reported on in 
the annual reports (some decisions falling within the MRR seem to be adopted, but not 
notified to the Commission); 

  products  most  often  concerned  are  articles  of  precious  metal,  foodstuffs,  food 

additives and food supplements, construction products and fertilisers; 

  difficulties  encountered  concern  inter  alia  the  interpretation  of  some  terms  used  in 
MRR  (eg.  “placing  on  the  market”  and  “lawful  marketing”,  “conditions  of  use”, 
“administrative  decisions”;  “economic  operator”),  the  identification  of  products,  the 
lack of established channels of communication among the competent authorities from 
MSs, no common linguistic regime. 

It was concluded that PCPs play an important and useful role in the application of the MRR 
and  that  there  is  increasing  awareness  of  the  mutual  recognition  principle  -  both  within 
national  administrations  and  by  economic  operators.  Economic  operators  should  be  able  to 
find  PCP’s  contact  details  easily  (web  pages,  e-mail)  and  the  channels  of  communication 
between national administrations could be reinforced. 

DATABASE IN REGARD TO PRODUCT CONTACT POINTS AND LIST OF PRODUCTS 

The  Commission  presented  the  database  in  regard  to  PCPs  and  the  list  of  products.  The 
Member States were asked to check their contact details by CIRCA. The document with the 
updated contact details will be translated into all the  official languages and published in the 
Official Journal. 

Internal Market Information System (Imi): State Of Play 

The Commission presented the internal market information system (IMI) and its possible role 
in the application of the MRR. The Commission concluded that the suggestion to expand the 
IMI system to cover the MRR seems to be a useful measure, but needs to be explored further. 

Any Other Business 

The  Commission  informed  the  committee  about  the  request  from  the  EFTA  secretariat  and 
some  EEA/EFTA  countries  to  participate  in  future  committee  meetings  and  proposed  that 
representatives of the EFTA secretariat and EEA/EFTA countries would be invited to the next 
committee meeting. No objections were raised to this proposal. 

Next Steps/Conclusion 

The  Commission  indicated  that  the  committee  should  continue  to  meet  annually  and 
suggested  that  reports  should  be  submitted  on  a  calendar-year  basis.  To  this  end,  the 
Commission  suggested  that  the  next  report  would  cover  the  period  from  May  2010  to  May 
2011 and then the Commission could request the supplementary report for the remaining part 
of  2011,  so  that  reporting  on  a  calendar-year  basis  would  be  possible  from  2012.  The 
Commission would inform the Member States more precisely about the reporting obligations 
in due time. 

237 

 
 
3.  MINUTES  OF  THE  THIRD  MEETING  OF  THE  CONSULTATIVE  ‘MUTUAL  RECOGNITION 

COMMITTEE’ HELD IN BRUSSELS ON 30 NOVEMBER 2011 

The  committee  held  its  third  meeting  on  30  November  2011.  The  attendance  list  and  the 
PowerPoint presentations are attached hereto. 

The following matters were discussed. 

PRESENTATION OF NEW GUIDANCE DOCUMENTS ON THE APPLICATION OF 
THE REGULATION 

The  Commission  presented  the  new  two  final  versions  of  the  Guidance  documents  on  the 
application of the MRR. The documents had been made available prior to the meeting in all 
official languages and will be soon published on the DG's homepage.  

Guide  to  the  application  of  the  mutual  recognition  regulation  to  non-CE-marked 
construction products 

The  Commission  presented  this  new  guidance  document  which  had  previously  been 
distributed to the participants in their respective languages. The Commission highlighted the 
new and most relevant issues related to the new Construction Products Regulation (CPR). 

Guide to the application of the Mutual Recognition Regulation to fertilisers and growing 
media 

The  Commission  presented  this  second  new  guidance  document  which  had  been  also 
previously  distributed  to  the  participants  in  their  respective  languages.  The  Commission 
presented general aspects related to the fertilisers sector.  

THE  APPLICATION  OF  THE  REGULATION  -  MEMBER  STATES'  REPORTS, 
NOTIFICATIONS 

The Commission briefly presented the Member States' reports and the notifications received. 

The Commission drew inter alia attention to the following: 

  There  are  evident  discrepancies  between  the  number  of  notifications  received  by  the 
Commission and the number of decisions taken by the MS authorities reported on in the 
annual  reports  (some  decisions  falling  within  the  MRR  have  been  adopted,  but  not 
notified to the Commission); 

  Products most  often concerned are articles of precious metal, foodstuffs, food additives 
and food supplements, automotive spare parts, construction products and fertilisers; 

  Difficulties  encountered  concern  inter  alia  the  actual  role  of  PCP,  the  alleged  lack  of 
clarity of the deadlines and steps of the procedure, and the difficulties to demonstrate that 
a product has been lawfully marketed in another MS; 

The perceived impact of the MRR is usually estimated as positive and with a great preventive 
importance. 

238 

 
 
There  have  been  several  re-occurring  requests  from  the  MS,  especially  that  of  additional 
information, training sessions and workshops for PCPs. 

The  Commission  informed  the  meeting  about  the  possible  revision  of  the  existing  guidance 
documents, indicating that even if open to receiving comments on them, the documents will 
not be revised in the immediate future. Some new guidance documents may be presented if 
suggestions received. 

INTERNAL MARKET INFORMATION SYSTEM (IMI) - UPDATE ON THE STATE 
OF PLAY 

The Commission presented information on the state of play of the Internal Market information 
system (IMI). The current proposal for an IMI Regulation was also discussed. 

The Commission is of the opinion that this option may be further explored. 

NEXT STEPS - THE PREPARATION OF THE COMMISSION’S REPORT IN 2012 

The Commission informed the meeting about its obligation of reviewing the application of the 
MRR during 2012. A report thereon will be submitted to the European Parliament and to the 
Council. 

The report by the Commission is expected during May 2012. 

From 2012 yearly reports will follow calendar years. 

ANY OTHER BUSINESS 

The  Commission  mentioned  that  EFTA  representatives  (EFTA  Surveillance  Authority  and 
Norway) are present for the first time in this committee meeting. It is expected that the MRR 
will be adopted soon under the EEA Agreement. 

4.  MINUTES  OF  THE  4TH  MEETING  OF  THE  CONSULTATIVE  ‘MUTUAL  RECOGNITION 

COMMITTEE’ HELD IN BRUSSELS ON 7 DECEMBER 2012 

The  committee  held  its  fourth  meeting  on  7  December  2012.  The  attendance  list  and  the 
PowerPoint presentations are attached hereto. 

The following matters were discussed: 

PRESENTATION  OF  THE  FIRST  REPORT  ON  THE  APPLICATION  OF 
REGULATION (EC) NO 764/2008 

The  Commission  presented  its  first  report  on  the  application  of  Mutual  Recognition 
Regulation 764/2008/EC (COM(2012) 292 final) adopted on 15 June 2012. 

The  report  confirms  that  the  Regulation  works  by  and  large  in  a  satisfactory  way  and  that 
there is no need for amendments at present. It also shows that that there are certain specific 
categories  of  products  where  the  difficulties  in  the  application  of  the  Regulation  seem  to 
concentrate,  such  as  articles  of  precious  metals,  foodstuffs,  food  additives  and  food 
supplements, construction products, fertilisers, automobile spare parts, and electrical products. 

239 

 
 
In  the  report's  conclusions,  the  Commission  proposes  that  close  and  regular  monitoring 
through  the  consultative  committee  on  mutual  recognition  takes  place  especially  on  the 
following areas: 

 

 

 

difficulties to demonstrate that a product has been lawfully marketed in another Member 
State; 

difficulties  in  identifying  which  legal  provisions  apply  and  which  are  the  relevant 
national authorities in charge; 

different  testing  methods  relied  upon  by  the  Member  States  and  their  possible 
compatibility through mutual recognition; and 

 

the role of prior authorisation procedures. 

THE  APPLICATION  OF  THE  REGULATION  -  MEMBER  STATES'  REPORTS, 
NOTIFICATIONS 

The Commission briefly presented the Member States' reports and the notifications received. 

The Commission drew inter alia attention to the following: 

 

 

 

 

 

the majority of issues (notifications + requests for information) concerning few specific 
categories of goods; 

difficulties highlighted by the MS; 

impact  of  the  Regulation  in  the  free  movement  of  goods  (underlining  its  pre-emptive 
importance); 

requests from the MS; and 

requests from the Commission. 

MS were then invited to make a tour de table with the view to share among members of the 
Committee the main issues raised in their national reports, notably difficulties encountered in 
applying  the  Regulation  and  how  they  were  addressed,  areas/products  most  concerned,  and 
the number of decisions taken by the MS authorities during the reporting period. 

THE LINK BETWEEN DIRECTIVE 98/34/EC AND REGULATION 764/2008 

Presentation attached. The Commission underlined the role of Directive 98/34  in preventing 
trade barriers under the form of ‘technical regulations’ before they are adopted, by enabling 
the Commission and MS to verify that the technical rule is compatible with EU law. 

SOLVIT 

Presentation  attached.  The  Commission  suggested  that  Product  Contact  Points  (PCP)  may 
advise companies to go to SOLVIT, if the concerned case falls under its competence (cross 
border element and related to a situation of improper application of a given national law). 

240 

 
 
NEXT STEPS 

The  Commission  reminded  the  conclusion  of  its  report  according  to  which  the  Regulation 
works by and large in a satisfactory way and that there is no need for amendments at present. 

The Commission highlighted that at this stage raising awareness is essential. Members of the 
Committee were invited to ensure a wide dissemination of information in order to reach end 
users:  citizens  and  economic  operators.  The  Commission  expressed  its  availability  to 
participate in national events, if need be. 

The Commission also insisted that notifications should be addressed to unit ENTR/C2. 

Furthermore representatives of MS were invited to update contact details for both committee 
members and PCP. 

The 2012 report by the MS is expected before 28 February 2013 

THE  PCP  WORKSHOP  (WITH  PARTICIPATION  OF  THE  MEMBERS  OF  THE 
PCP NETWORK) 

The  workshop  was  organized  following  suggestions  to  facilitate  PCPs  to  meet  among 
themselves and with the Commission with the aim of inter alia minimizing discrepancies in 
the number of notifications undertaken under the Regulation and the number of the decisions 
taken by Member States’ authorities. 

The following points were discussed: prior authorization, legally marketed in another member 
state,  Relation  between  GPSD  and  764/2008  ,  intention  to  adopt  a  decision,  decisions  by 
customs  authorities,  functioning  of  PCPs  and  the  Internal  Market  Information  System  data 
base (IMI). 

5.  MINUTES  OF  THE  5TH  MEETING  OF  THE  CONSULTATIVE  ‘MUTUAL  RECOGNITION 

COMMITTEE’ HELD IN BRUSSELS ON 6 DECEMBER 2013 

The  committee  held  its  fifth  meeting  on  6  December  2013.  The  attendance  list  and  the 
PowerPoint presentations are attached hereto. 

The following matters were discussed: 

ADOPTION OF THE NEW RULES OF PROCEDURE 

The  Commission  presented  the  draft  rules  of  procedure  which  were  sent  to  delegates  in 
English.  This  draft  corresponds  to  the  standard  text  of  the  rules  of  procedure  which  was 
approved  by  the  Commission  on  12  July  2011  (OJ  C  206,  12.7.2011,  p.  11-13).  The 
Commission also detailed the main changes as regards the existing rules of procedure. 

After announcing an agreed modification the rules of procedure were adopted. 

241 

 
 
 
 
 
PRESENTATION  OF  THE  COMMISSION'S  GUIDANCE  DOCUMENT  ”THE 
CONCEPT  OF  'LAWFULLY  MARKETED'  IN  THE  MUTUAL  RECOGNITION 
REGULATION (EC) NO 764/2008” 

The  Commission  presented  its  10th  guidance  document  on  the  application  of  the  Mutual 
Recognition  Regulation,  "The  concept  of  ‘lawfully  marketed’  in  the  Mutual  Recognition 
Regulation (EC) No 764/2008", adopted on 16 August 2013. 

This  guidance  document  offers  additional  precisions  on  the  concept  of  ‘lawful  marketing’, 
details the obligations for both enterprises and administrations under the Mutual Recognition 
Regulation,  and  takes  the  view  that  any  piece  of  evidence  should  be  deemed  suitable  to 
demonstrate the actual marketing of the product in another Member State or in an EFTA state 
that is a contracting party to the EEA Agreement. 

MEMBER STATES' REPORTS, NOTIFICATIONS 

MS  were  then  invited  to  a  tour  de  table  in  order  to  share  the  main  issues  raised  in  their 
national reports. 

The  Commission  then  briefly  presented  the  Member  States'  reports  and  the  notifications 
received during the reporting period and drew attention to the following main points: 

•  The  majority  of  notifications  and  requests  for  information  concern  a  few  specific 

categories of goods, 

•  Difficulties highlighted by the MS, 

• 

Impact  of  the  MRR  regarding  the  free  movement  of  goods  (underlining  its  preventive 
importance and the information role of the PCP), 

•  Requests from the MS, 

•  Requests from the Commission: 

a. 

Representatives of MS were invited to update contact details for both Committee 
members and Product Contact Points (PCP), whenever necessary. 

b.  As regards the next round of national reports, the Commission indicated that the 

2013 report is expected before 31 March 2014. 

MUTUAL RECOGNITION AND PRIVATE LAW BODIES 

The  Commission  has  identified  certain  situations  that  do  not  fall  under  the  scope  of  the 
Mutual Recognition Regulation but that nevertheless seem to cause problems with regard to 
free movement of (non-harmonised) products and with regard to the application of the mutual 
recognition principle. Several examples were discussed. 

The Commission called for continuing discussion on this area. 

The Commission raised the issue of the notification mechanism which should help preventing 
these problems. As it covers only standards, and only the national standardization bodies, this 
area is being further reflected upon. 

242 

 
 
NEXT  STEPS  -  THE  EVALUATION  OF  THE  PRINCIPLE  OF  MUTUAL 
RECOGNITION 

The Commission highlights the efforts of the LT Presidency to better enforce the principle of 
mutual recognition. 

The  principle  of  mutual  recognition  will  be  evaluated  during  2014  and  the  members  of  the 
committee  will be contacted,  among other  relevant  actors, by the contractor conducting this 
evaluation. 

The Commission was thanked for undertaking the revision of the principle. MS stressed that 
business  organizations  are  an  important  actor  and  that  not  only  administrations  should  be 
contacted. It was also stressed that there are still problems within the goods area and that the 
number  of  notifications  and  MS  notifying  may  be  too  low.  The  importance  of  awareness 
raising activities was underlined by several MS. 

6.  MINUTES  OF  THE  6TH  MEETING  OF  THE  CONSULTATIVE  ‘MUTUAL  RECOGNITION 

COMMITTEE’ HELD IN BRUSSELS ON 5 DECEMBER 2014 

The  committee  held  its  sixth  meeting  on  5  December  2014.  The  attendance  list  and  the 
PowerPoint presentations are attached hereto. 

The following matters were discussed: 

INTRODUCTION 

In the opening address, the Commission Director for "Single Market for Goods", outlined the 
timing of the ongoing evaluation of the application of the principle of mutual recognition (in 
this specific case, mutual recognition in  goods),  as well as the overall approach in mapping 
the situation, by identifying - with the view to presenting avenues for an improved application 
of the principle - both the markets/areas most affected by the incorrect application of mutual 
recognition,  and 
the 
the  problems  encountered.  The  main  message 
Competitiveness Council meeting of 4-5 December 2013, identifying: 

referred 

to 

• 

• 

• 

• 

the  further  use  and  application  of  the  mutual  recognition  principle  in  the  priorities  for 
enhancing the single market; 

the collective responsibility of all agents involved; 

the  importance  of  the  support  of  Member  States  both  during  the  evaluation  and  for  the 
correct application of mutual recognition; 

a  call  for  cooperation  between  Member  States,  and  between  Member  States  and  the 
Commission. 

The  important  role  of  Product  Contact  Points  (PCP)  as  the  first  interlocutor  for  economic 
operators was also underlined. 

243 

 
 
 
 
PRESENTATION OF THE ONGOING EVALUATION OF THE APPLICATION OF 
THE PRINCIPLE OF MUTUAL RECOGNITION IN THE FIELD OF GOODS 

The Commission's contractor for the evaluation of the application of the principle of mutual 
recognition  in  the  field  of  goods  (the  Danish  Technological  Institute)  presented  the  current 
state  of  the  exercise  and  the  preliminary  findings  of  the  ongoing  surveys  which  have  been 
tailor-made for national authorities and businesses. 

MEMBER STATES' REPORTS, NOTIFICATIONS 

The  Commission  presented  the  yearly  analysis  of  reports  and  Member  States'  notifications, 
indicating  the  need  to  make  the  reports  more  homogeneous  and  to  notify  the  Commission 
about  all  decisions  when  mutual  recognition  was  denied,  as  specifically  required  by  the 
Mutual  Recognition  Regulation.  Reference  was  made  to  several  decisions  denying  mutual 
recognition,  but  not  notified  by  the  concerned  Member  States  to  the  Commission. 
Discontinued  notifications  remain  a  recurrent  problem  in  the  application  of  the  Regulation. 
The  general  problem  of  lack  of  cooperation  between  PCP  was  also  underlined.  The 
Commission  reiterated  the  message  that  Member  States  are  the  ones  applying  mutual 
recognition,  hence  their  feedback  and  support  in  identifying  what  is  not  functioning  is 
essential. 

Next  year's  reports,  covering  the  application  of  the  Mutual  Recognition  Regulation  during 
2014, should be addressed to the Commission before 31 March 2015. 

The problem of non-notification of decisions was highlighted, and the need for interchange of 
best-practices mentioned. The needed for an IMI system was underlined. 

Member  States  were  then  invited  to  do  a  tour  de  table  with  the  view  to  sharing  among 
members of the Committee the main issues raised in their national reports. 

NEXT STEPS - THE USE OF THE INTERNAL MARKET INFORMATION SYSTEM 
(IMI)  FOR  NOTIFICATIONS,  ESTABLISHING  A  TELEMATIC  NETWORK,  AND 
STRUCTURED INFORMATION FROM THE PCP 

In  the  afternoon  session,  the  Commission  presented  a  demonstration  of  the  possible  use  of 
IMI for the Member States' notifications, and opened an introductory debate on establishing a 
telematic  network  of  PCP,  as  provided  for  in  Article  11  of  the  Mutual  Recognition 
Regulation. The Commission explained that extending the use of IMI to include the Mutual 
Recognition Regulation would require adoption of an implementing act. 

While  in  general  the  message  of  streamlining  the  framework  for  notifications  by  using  IMI 
was  well  received  by  the  MS  representatives,  they  also  referred  to  the  necessity  internal 
consultation  at  MS  level  before they  could accept.  The  Commission  explained  that  this  is  a 
first proposal, all Member States would have to accept the use of IMI before a decision could 
be  made.  Alternatively,  Member  States  were  invited  to  propose  other  means  to  improve  a 
current  situation  in  which  notifications  are  not  sent  to  the  Commission,  as  required  by  the 
Mutual  Recognition  Regulation.  A  note  on  IMI  use  for  the  notifications  under  the  Mutual 
Recognition Regulation will be sent shortly to all MS. 

244 

 
 
 
ANY OTHER BUSINESS AND CONCLUSION 

Some  experiences  of  promoting  mutual  recognition  and  single  market  instruments  were 
shared.  The  need  for  a  common  visual  identity  of  PCPs,  and  a  rationale  for  promotional 
activities to support a common single market tool was also underlined. 

As  regards  the  minutes  of  the  meeting,  in  accordance  with  Article  10(1)  of  the  Rules  of 
Procedure, a draft version of the minutes will be sent to the members of the committee within 
15  working  days.  The  members  of  the  committee  are  then  invited  to  send  any  written 
comments they may have on the minutes to the Chairperson. The committee shall be informed 
of those comments. 

In  accordance  with  Article  10(2) of the same Rules of Procedure, a summary report for the 
European Parliament would be drawn up under the auspices of the Chair, briefly describing 
each  item  on  the  agenda.  The  report  would  not  mention  the  individual  position  of  the 
members in the committee's discussions. 

The Commission concluded the meeting by thanking the members of the committee for their 
participation, and the interpreters for their work. 

7.  MINUTES  OF  THE  7TH  MEETING  OF  THE  CONSULTATIVE  ‘MUTUAL  RECOGNITION 

COMMITTEE’ HELD IN BRUSSELS ON 2 DECEMBER 2015 

The  consultative  “Mutual  Recognition  Committee”,  established  by  Article  13  of  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  (OJ  L218  of 
13.8.2008, p. 21) (MRR), held its seventh meeting on 2 December 2015. 

The agenda, the attendance list and the presentations are attached hereto. 

INTRODUCTION 

The  Commission  (COM)  welcomed  the  participants  and  presented  the  modalities  of  the 
meeting, including administrative and linguistic arrangements. The committee was then called 
to adopt the proposed draft agenda and the following agenda was adopted: 

(1)  Presentation of the Single Market Strategy and its implementation 

(2)  Options to achieve more and better mutual recognition in the single market for products 

(3)  Guidelines  for  improving  consistency  across  Member  States'  in  providing  information 

to businesses though PCPs and PCPCs. 

(4)  Member States' annual reports. 

(5)  The  potential  use  of  the  Internal  Market  Information  system  for  the  purposes  of  the 
Regulation (EC) 764/2008 on Mutual Recognition (Member States' notifications) 

(6)  Any other business 

245 

 
 
Delegates  included  also  representatives  from  the  Points  of Contact  for Products (PCPs)  and 
Points of Contact for construction products (PCPCs). 

PRESENTATION  OF  THE  SINGLE  MARKET  STRATEGY  AND 
IMPLEMENTATION 

ITS 

COM  presented  the  Single  Market  Strategy  (SMS)  including  an  outline  of  the  possible 
options initially considered for the strengthening of the application of the principle of mutual 
recognition. 

OPTIONS TO ACHIEVE MORE AND BETTER MUTUAL RECOGNITION IN THE 
SINGLE MARKET FOR PRODUCTS 

COM detailed the major problems identified as regards the proper application of the principle 
of mutual recognition1, those measures envisaged for its strengthening as well as the calendar 
and indicative initial options for the revision of the MRR. 

COM then presented an outline of the Single Digital Gateway (SDG) initiative. The initiative 
would aim at offering online the complete package of information and procedures necessary 
to  do  business  in  the  Single  Market,  covering  both  services  and  goods  and  a  better  inter-
linkage of the various existing portals and services on the EU and national level. 

It was underlined that we are still in a brainstorming phase and input is needed. It was asked 
about  the  stakeholder  workshop  envisaged  on  15  March  2016.  COM  replied  business 
stakeholders and Member States would be invited (three delegates per Member State). 

As regards possible options not yet mentioned for the improvement of mutual recognition, it 
was mentioned the possibility of revising the scope of the MRR, for instance making it also 
covering negative decisions addressed to end users. COM mentioned the additional possibility 
of  relying  on  standards.  The  issue of  problems  posed  by  national  standards  interacting  with 
EU standards was also raised, and it was requested more streamlined approaches treating the 
goods area as a whole. 

COM  proposed  Member  States  to  provide  input  on  any  other  additional  options  for  the 
revision of the MRR to be provided to COM before 15/12/2015. 

GUIDELINES FOR IMPROVING CONSISTENCY ACROSS MEMBER STATES' IN 
PROVIDING INFORMATION TO BUSINESSES THOUGH PCPS AND PCPCS. 

COM  presented  its  project  to  develop  guidelines  for  improving  consistency  of  online 
provision  of  information  by  PCPs  and  PCPCs,  with  the  support  of  an  external  assessor 
ECORYS.  Specific  issues  related  to  construction  products  to  continue  in  the  afternoon's 
session. 

External  Evaluation  of  the  Application  of  the  mutual  recognition  principle  in  the  field  of 
goods - final report: http://ec.europa.eu/DocsRoom/documents/13381 

MEMBER STATES' ANNUAL REPORTS 

In  the  afternoon's  session  COM  presented  the  analysis  of  the  yearly  reports  and  Member 
States' notifications, indicating the need to make the reports more homogeneous and to notify 

246 

 
 
the  Commission  about  all  decisions  when  mutual  recognition  was  denied,  as  specifically 
required by the Mutual Recognition Regulation. 

Next  year's  reports,  covering  the  application  of  the  Mutual  Recognition  Regulation  during 
2015, should be addressed to the Commission before 31 March 2016. 

THE  POTENTIAL  USE  OF  THE  INTERNAL  MARKET  INFORMATION  SYSTEM 
FOR  THE  PURPOSES  OF  THE  REGULATION  (EC)  764/2008  ON  MUTUAL 
RECOGNITION (MEMBER STATES' NOTIFICATIONS) 

COM referred to the presentation made at the last meeting and the note ("The potential use of 
the Internal Market Information system for the purposes of the Regulation (EC) 764/2008 on 
Mutual  Recognition")2  addressed  to  the  national  authorities,  requesting  their  feedback  by 
October this year. The proposal was supported by a majority of Member States who provided 
a response. 

COM then outlined the use of IMI for notifications under the MRR and addressed particular 
concerns raised by Member States in response to the note, clarifying that: 

a)  MS can opt to register all authorities that need to notify in IMI, or, can register central 
authorities that notify on behalf of other authorities, in which case the central authorities 
would be able to indicate the details of the authority that took a decision. 

b)  Notifications should be sent within a period of 20 working days from the expiry of the 
time limit for the receipt of comments from the economic operator (as per Article 6(2)). 
The relevant provisions of the MRR do not provide for any follow-up such as informing 
on  possible  challenges  and  appeal  procedures.  The  only  further  actions  that  would  be 
offered in IMI once a notification has been sent would be withdrawal and resubmission 
due to error. 

c) 

d) 

e) 

f) 

sharing  notifications  with  other  Member  States  through  IMI  would  be  left  to  the 
discretion of the sender. 

any exchange of comments on the notification would be limited to the sender and COM 
for the purposes of confirming completeness and correctness only. Other MS would not 
be able to comment. 

an  exchange  of  information  between  PCP's  would  not  be  included  due  to  mixed 
feedback from Member States. 

a  "free  text"  field  might  be  useful  to  provide  information  on,  for  instance,  products 
perceived as a risk to health or environment. 

COM indicated the main advantage of sharing notifications would be transparency, which in 
itself leads to better practices, motivating those authorities not yet notifying. 

In  view  of  the  generally  positive  position  of  the  committee  towards  the  use  of  IMI,  COM 
asked  whether  any  of  the  presents  had  any  fundamental  problem  with  the  use  of  IMI  for 
notifications under the MRR. In  view of the committee members in  the meeting  not  having 
any fundamental concern against the use of IMI, this is then considered as a positive response 
for  moving  on  to  an  IMI  pilot  project  for  the  notifications  under  the  Mutual  Recognition 

247 

 
 
Regulation  -  and  that  any  fundamental  concern  could  be  raised  as  comments  to  the 
committee's draft minutes. Member States will also be consulted in the IMI committee. 

ANY OTHER BUSINESS AND CONCLUSION 

Operative conclusions of the meeting: 

  As  regards  the  already  concluded  external  report  on  the  application  of  the  principle  of 
mutual recognition in the field of goods, the Commission would like to present it in the 
Council and will draft a Staff Working Document summarising it. 

 

Initial ideas on the options initially envisaged for the revision of the Mutual Recognition 
Regulation requested - indicative deadline for their reception by COM: 15/12/2015. 

  A  draft  for  an  optional  template  for  the  yearly  reports  of  the  Member  States  under  the 

Mutual Recognition Regulation to be sent to the Member States for comments. 

  Positive  response  for  moving  into  an  IMI  pilot  project  for  the  notifications  under  the 

Mutual Recognition Regulation. Member States will be consulted in the IMI committee. 

  As  regards  the  next  meeting  of  the  committee:  to  be  possibly  held  before  summer,  to 
discuss  and  assess  the  possible  options  for  the  revision  of  the  Mutual  Recognition 
Regulation. 

  Action  to  be  taken  by  COM  as  regards  metadata  of  the  list  with  PCP  contact  details 

(http://ec.europa.eu/growth/single-market/goods/free-movement-sectors/mutual-
recognition/contacts-list/index en.htm)  

As  regards  the  minutes  of  the  meeting,  in  accordance  with  Article  10(1)  of  the  Rules  of 
Procedure, a draft version of the minutes will be sent to the members of the committee before 
the  Christmas  break.  The  members  of  the  committee  are  then  invited  to  send  any  written 
comments they may have on the minutes to the Chairperson. The committee shall be informed 
of those comments. A final version of the minutes will then be distributed. 

In  accordance  with  Article  10(2) of the same Rules of Procedure, a summary report for the 
European  Parliament  would  also  be  drawn  up  under  the  auspices  of  the  Chair,  briefly 
describing each item on the agenda. The report would not mention the individual position of 
the members in the committee's discussions.  

The Commission concluded the meeting by thanking the members of the committee for their 
participation, and interpreters for their work. 

8.  MINUTES  OF  THE  8TH  MEETING  OF  THE  CONSULTATIVE  ‘MUTUAL  RECOGNITION 

COMMITTEE’ HELD IN BRUSSELS ON 25 OCTOBER 2016 

The  consultative  “Mutual  Recognition  Committee”,  established  by  Article  13  of  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  (OJ  L218  of 
13.8.2008, p. 21) (the Regulation), held its eight meeting on 25 October 2016. 

248 

 
 
INTRODUCTION 

The  Commission  (COM)  welcomed  the  participants  and  presented  the  modalities  of  the 
meeting, including administrative and linguistic arrangements. The committee was then called 
to adopt the proposed draft agenda and the following agenda was adopted: 

1.  Annual reports 

2. 

3. 

4. 

Results of the public consultation 

State of play of the evaluation of the Mutual Recognition Regulation 

The future of mutual recognition 

5.  AOB 

ANNUAL REPORTS (WD01) 

COM  presented  the  annual  activity  of  Member  States  in  2015  based  on  the  annual  reports 
submitted and on the administrative decisions notified. The presentation underlined the main 
difficulties encountered by Member States when applying mutual recognition and the impacts 
of  the  Regulation  on  free  movement  of  goods.  COM  highlighted  the  need  to  receive  from 
Member  States  reports  containing  data  homogeneous  and  comprehensive  enough  to  be 
considered  as  usable  input  for  monitoring  the  application  of  the  Regulation  and  identifying 
recurrent  problems.  This  can  be  achieved  by  using  the  template  suggested  by  COM.  Also, 
COM pointed out that not all administrative decisions restricting or denying market access are 
being notified and reiterated that national authorities are bound to notify to the Commission 
these decisions, as provided for under articles 6(2) and 7(2) of the Regulation. 

RESULTS OF THE PUBLIC CONSULTATION (WD02) 

COM  presented  the  results  of  the  public  consultation  carried  out  between  1.06.2016  and 
30.09.2016. A summary of all  contribution received following the stakeholders consultation 
(including  individual  contributions)  will  be  annexed  to  the  evaluation  of  the  functioning  of 
mutual  recognition  and  to  the  impact  assessment.  COM  indicated  that  the  results  will  be 
published on the COM website and annexed to the evaluation and impact assessment. 

PRELIMINARY  EVALUATION  OF  THE  FUNCTIONING  OF  MUTUAL 
RECOGNITION (WD03) 

COM  presented  an  overview  of  the  ongoing  evaluation  of  the  functioning  of  mutual 
recognition. COM explained that the evaluation covers the mutual recognition principle and 
Regulation, and looks at how effective, efficient, coherent relevant and with EU added value 
these are. COM explained that discrepancies appear between the annual reports indicating a 
certain  number  of  administrative  decisions  taken,  complaints  received  from  businesses  and 
the notifications received. 

THE FUTURE OF MUTUAL RECOGNITION: ACTION PLAN (WD04) 

COM  presented  actions  that  could  be  included  in  the  action  plan  for  raising  awareness  on 
mutual recognition and asked for feedback and input on these actions. 

249 

 
 
THE FUTURE OF MUTUAL RECOGNITION: PROBLEM DEFINITION (WD05) 

COM  presented  a  preliminary  analysis  of  the  main  problems  generated  by  the  suboptimal 
functioning of mutual recognition, as identified in the framework of the ongoing evaluation.   

THE FUTURE OF MUTUAL RECOGNITION: OPTIONS (WD06) 

COM  presented  the  preliminary  options  for  improving  mutual  recognition,  which  will  be 
considered  in  the  framework  of  the  impact  assessment,  and  asked  for  feedback  from  the 
delegations.  COM  asked  input  on  an  option  concerning  the  repeal  of  the  Regulation. 
Delegations don’t support such option.  

CONCLUSION 

The  Chair  welcomed  the  interesting  discussion  and  the  very  constructive  input  received 
during  the  meeting.  As  the  work  on  evaluation  the  functioning  of  mutual  recognition  and 
reaching  to  more  and  better  mutual  recognition  is  still  in  progress,  delegations  will  be  kept 
informed on this progress and asked for additional input, via CIRCA BC.  

Comments  on the documents submitted for discussion during the  meeting  should be sent to 
COM before 1.12.2016.  

The next meeting of the Committee will take place most probably in 2017, after the summer.   

250 

 
 
 
 
 
ANNEX 12: STUDY OF THE DANISH BUSINESS ASSOCIATION 

DI 

10 February 2016 

Breaking down barriers: Back to Basics, Please! 

A company survey on trade barriers in the Single Market 

1.  EXECUTIVE SUMMARY 

The  objective  of  this  survey  is  to  clarify  if  barriers  to  the  free  movement  in  the  Single 
Market,  identified  in  previous  DI-studies  (e.g.  from  2004,  2007  and  2012),  are  still 
existing and if new barriers have been created. 

The  survey  is  based  on  qualitative  telephone  interviews  with  company  executives  and 
relevant  technical  managers  from  35  DI  member  companies,  covering  many  different 
sectors.  

The  main  conclusions  are  that,  though  marketing  within  the  Single  Market  by  a  large 
to  be  relatively  easy  and 
majority  of 
straightforward,  those  who  experienced  barriers  ten  years  ago,  still  experience  the 
same degree of barriers today. 

the  companies  generally 

is  considered 

National  requirements  on  product  characteristics,  including  special  requirements  on 
documentation  and  testing,  have  the  consequence  that  companies  often  have  to  double 
test,  change  product  characteristics,  or  in  some  cases  give  up  marketing  products  in 
certain countries.  

Barriers are mainly found in the following product areas: 

 

 

 

 

Construction  products 
supplementary testing, environmental requirements) 

fire  protection 

(different 

rules, 

requirements 

for 

Products under the General Product Safety Directive (non-harmonised area) 

Products in contact with water 

Products in contact with foodstuffs 

  Medical products (different labelling requirements) 

251 

 
 
 
 
 
 

Innovative products, e.g. no standards available 

Also  at  country  level,  we  see  the  same  Member  States  as  previously  reported.  To  be 
mentioned  especially  are  countries  such  as  the  UK,  Germany,  Sweden,  Norway,  the 
Netherlands  and  Belgium.  It  should  be  taken  into  consideration,  however,  that  the 
survey  is  based  on  Danish  companies  and  therefore  barriers  are  typically  found  in 
countries that take the majority of Danish exports.  

Policy recommendations – The way forward 

Based  on  the  findings  of  the  survey,  DI  identifies  four  policy  recommendations  to  be 
considered  in  connection  with  the  follow-up  on  the  European  Commission’s  Single 
Market Strategy: 

 

 

 

 

European institutions to keep continuous and high focus on the well-functioning of 
the free movement in the Single Market 

The principle of mutual recognition should be better defined and consolidated   

The establishment of a ‘Quick Assessment Procedure’ 

New national technical regulations to be subject to an impact assessment 

The recommendations are further developed at the end of the paper. 

2. 

INTRODUCTION 

The  Single  Market  is  a  cornerstone  of  the  European  integration  project.  Designed  to 
allow  goods,  services,  capital  and  people  to  move  more  freely  across  national  borders, 
the  Single  Market  make  it  easier  for  businesses  to  import  and  export  their  products. 
However,  many  companies  still  face  a  variety  of  trade  related  barriers  that  limit   their 
potential for growth. This is a matter of growing concern, also giving rise to a certain 
surprise,  considering  that  several  Single  Market  strategies  and  action  plans  have  been 
launched in order to cope with the remaining barriers.  

During the years, DI has carried out surveys among our members to take the temperature 
of  the  Single  Market  as  experienced  by  businesses.  We  now  found  that  it  was  time  to 
make yet another survey to check the state of affairs, especially in the light of previous 
and present political actions to improve the free movement within the Single Market.  

Therefore,  the  objective  of  this  study  has  been  to  identify  and  map  some  of  the  trade 
barriers  that  companies  face  in  the  Single  Market.  A  large  majority  of  the  interviewed 
companies were also surveyed in previous similar studies conducted in 2004, 2007 and 
2012,  respectively.  An  important  focus  of  this  study  has  been  to  uncover  whether 
previously detected barriers still exist today and how companies cope in practice.  

The  survey  looks  at  the  Single  Market  and  the  free  movement  of  goods  as  well  as 
services. The area of goods has come far in terms of harmonising product requirements 
and  building  a  legal  foundation,  which  has  since  paved  the  way  for  the  service  sector. 
Today,  goods  and  services  are  often  interlinked,  and  barriers  in  one  sector  may  thus 
influence the total package. 

252 

 
 
3.  METHODOLOGY 

The survey is based on  qualitative telephone interviews with company executives and 
relevant  technical  managers  from  35  selected  DI  member  companies.  All  interviews 
followed a semi-structured interview guide to ensure a certain level of consistency in the 
conducted interviews while also providing the respondents with the opportunity to bring 
up new issues outside of the questionnaire. 

Roughly,  two  thirds  of  the  companies  (22  of  35)  are  SMEs  with  less  than  250 
employees, while the rest (13 of 35) are large enterprises with more than 250 employees. 

In the selection of companies to be included in the survey, a  maximum representation 
of different product/service areas was pursued.  

The  underlying  assumption  is  that  if  one  company  has  a  problem  due  to  national 
regulation, the same challenge will be experienced by other companies within the same 
product/service category. 

The  survey  includes  the  following  sectors:  construction  products,  machinery,  medical 
equipment,  foodstuff,  IT  equipment,  electrical  products,  maritime  equipment,  pressure 
equipment, consumer products such as furniture, tableware, bicycles and services.  

Almost all companies in this survey have experience in European-wide trade, although a 
few  have  chosen  no  longer  to  export  their  products  to  other  markets  due  to  different 
reasons. 

The  survey  builds  on  previous  studies  from  2004,  2007  and  2012  and  is  as  such  the 
latest set of results in a larger time-series study. 

Like the previous studies, this survey has sought to establish: 

- 

- 

Do  companies  feel  that  marketing  their  products  in  other  Single  Market  countries 
is easy and straightforward? 

Do  European  product/service  standards  exist  within  the  companies’  area  of 
activity? If so, do companies adhere to these standards? 

-  What are the types of  barriers that companies continue to  meet in daily business? 

How do companies tackle such barriers? 

Recalling the qualitative nature and scope of this survey, the aim is not to set up another 
highly  statistically  valid  analysis  of  the  current  situation  on  trade  barriers  wi thin  the 
Single  Market,  but  rather  to  illustrate  some  of  the  concrete  examples  of  the  challenges 
that companies continue to face.  

Consequently,  the  results  and  conclusions  of  this  survey  cannot  be  taken  to  apply 
universally  or  be  used  to  draw  statistical  generalisations.  However,  it  is  interesting  to 
note  that  the  main  findings  are  very  much  in  line  with  previous  Commission 
surveys. 

253 

 
 
4.  MAIN FINDINGS 

Confirming results from previous surveys: Barriers still exist! 

Overall,  the  product/service  areas  experiencing  barriers  and  administrative  burdens  are 
the  same  as  previously  detected.  Despite  several  initiatives  from  i.a.  the  Commission, 
not much seems to have changed in the last ten years. 

National regulation prevails over mutual recognition… 

24  out  of  35  companies  currently  experience  barriers  to  the  free  movement  on  some 
markets.  

Countries  such  as  the  UK,  Germany,  Sweden,  Norway,  the  Netherlands,  Belgium  and 
Poland are most frequently mentioned.  

The  typical  barriers  are:  Stricter  national  requirements  for  documentation,  testing  and 
administration, often due to special national regulation or different interpretation of EU -
rules. To some degree, also changes in product characteristics are needed.  

Barriers are mainly found in the following product areas: 

 

 

 

 

Construction  products 
supplementary testing, environmental requirements) 

fire  protection 

(different 

rules, 

requirements 

for 

Products under the General Product Safety Directive (non-harmonised area) 

Products in contact with water 

Products in contact with foodstuffs 

  Medical products (different labelling requirements) 

 

Innovative products, e.g. no standards available 

The  trend  of  an  increasing  demand  for  national  testing  and  new  requirements  for  e.g. 
labelling especially relates to environmental concerns. 

… Yet, Single Market trade is considered relatively easy 

On a positive note, when asked for the respondents’ overall experience, a large majority 
generally find it relatively easy and straightforward to market and sell their products and 
services in other EU countries. 

This is not surprising, as the basic principles and legislation for goods and services  are 
in place and have indeed been so for a number of years.  

Common  EU-regulation  is  preferred  as  the  basis  for  marketing  products  and  does 
make  life  easier  in  most  product  areas.  Furthermore,  the  study  confirms  that  European 
and international standards are followed to a wide extent.  

254 

 
 
In  spite  of  this  overall  positive  perception  of  trade  within  the  Single  Market,  many 
respondents,  however,  have  to  adapt  their products  and/or  marketing  strategies  to 
comply with different national requirements, an adaptation which should not be needed.  

Furthermore,  big  as  well  as  small  companies  point  to  the  increasing  number  of 
burdensome EU-regulation, such as e.g. environmental requirements, the construction 
product regulation and the RoHS. 

Generally, a vast majority of companies accept stricter requirements  if they are based on 
common  regulation,  while  additional  national  rules  or  different  national  application  in 
practice are considered a substantial burden. 

To ensure a level playing field, effective and more homogenous market surveillance 
is called for 

Across  almost  all  sectors,  companies  ask  for  a  more  frequent  and  especially  a  more 
homogenous  market  surveillance.  Companies  see  market  surveillance  as  a  means  to 
ensure a level playing field. 

In  particular  insufficient  compliance  of  performance  declarations  in  the  construction 
sector is mentioned in this context. 

Also  within  the  field  of  dietary  supplements,  inconsistent  surveillance  is  reported. 
Certain countries tend to focus more on non-safety related issues like labelling than on 
actual safety concerns. 

5.  CASE EXAMPLES  

Installation of steel chimneys complicated by national H&S training requirements  

An SME manufacturing and installing steel chimneys primarily within the Single Market 
has experienced that requirements for national training courses within health and safety 
for  workers  have  increased  considerably  and  differ  from  one  country  to  another.  T his 
hinders  flexibility  in  the  posting  of  workers  and  represent  a  considerable  increase  in 
costs.  A special challenge is experienced in Poland where the project manager must be 
on  site  during  the  complete  installation  phase.  This  complicates  supplies  and  increases 
costs.  

The certification process under the standard EN 1090 on welding poses severe problems 
for sub-suppliers. 

Wood burning stoves must find a balance between environmental requirements and 
energy efficiency  

An  SME  exports  wood  burning  stoves  and  accessories  to  all  European  countries  and 
ends up being squeezed between optimization of emission targets and energy efficiency 
–  requirements  that  are  going  into  opposite  directions.  New  labelling  requirements 
addressed to consumers are increasing, e.g. regarding energy efficiency. Irrespective of 
testing  results  according  to  the  Nordic  Swan  standard,  the  stoves  must  be  retested 
according to different national standards on several markets.  

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This means that launching a new type costs about ½ million DKK (corresponding to abt. 
70,000  euro)  alone  in  performing  tests.  To  this  come  annual  or  biannual  audits  from 
national  test  organizations,  amounting  to  abt.  5-6,000  euro  per  audit.  Additional  to  the 
actual  costs,  the  administration  of  such  different  testing  procedures  takes  a  lot  of  time 
and resources. 

CE-marked chipboards for construction and industry without free movement 

The  manufacturer  experiences  that  there  is  still  more  regulation,  e.g.  on  environmental 
characteristics.  Technical  documentation  often  has  to  be  adapted  to  local  tradition.  In 
Norway,  a  special  national  technical  approval  is  required.    National  regulation  often 
leads to new testing, which is considered to be mandatory. The company asks for more 
market surveillance as not all products on the market fulfill performance requirements.  

Acoustic  ceilings  –  covered  by  the  CPR  and  European  standards  but  also  by 
different national regulations 

A  large  company  has  decided  to  adapt  to  national  requirements,  but  nevertheless  point 
out that they have extra testing costs of around 60,000 euro without any added value and 
resulting in time delays for launching new products. The supplementary testing is caused 
by different national fire regulation requirements in e.g. the UK, Germany and Belgium; 
emission test requirements coming up in e.g. France, Belgium and Lithuania; and special 
national requirements on documentation, e.g. on waste disposal. 

Upholstered furniture – a well-known obstacle for exports to the UK 

Even if furniture is under the scope of the General Product Safety Directive and covered 
by European standards, special requirements in the UK for upholstered furniture  – even 
for garden furniture – means that a special range of products has to be developed for the 
UK.  Due  to  fire  protection,  foam  and  textiles  must  be  treated  with  flame  resistant 
chemicals, which for environmental reasons are not wanted on other markets.   

The  consequence  for  one  specific  company  is  that  they  need  to  have  a  double  stock  of 
furniture  (binding  capital  of  abt.  150,000  euro).  There  are  extra  initial  costs  for  each 
product  (abt.  50,000  euro  per  type),  for  which  reason  they  have  been  forced  to  reduce 
the product range in the UK by abt. 25 p.c.  

Export  of  environmentally  friendly,  innovative  CE-marked  product  hindered  by 
national regulation 

Some  years  ago,  a  small  Danish  manufacturer  developed  an  intelligent  solution  for 
efficient pest control, completely without the use of poison. Since then, the products are 
in demand by an increasing number of countries around the world. The system monitors 
rodent activity and protects against rats entering the building or gaining a foothold in the 
area. 

The  product  is  CE-marked  under  the  Low  Voltage  Directive,  but  nevertheless  meets 
many  national  obstacles  in  the  form  of  national  legislation  aimed  at  animal  protection 
(e.g. in Sweden and Germany). The de facto blocks the marketing of the products, even 
if they are proved to be both efficient and better than poison which remains in nature.   

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Different packaging requirements for pharmaceutical products 

Pharmaceutical  products  have  to  be  registered  in  each  Member  State  before  marketing. 
Member  States  have  different  requirements  as  to  the  information  that  must  be  or  is 
allowed  on  the  packaging.  This  makes  it  impossible  to  introduce  common  packaging, 
even where the same languages may be used. As an example, Finland requires a triangle 
in the ‘blue box’, but this is not allowed in Sweden. Belgium requires a bar code sticker 
on  the  packaging,  which  is  not  permitted  on  other  markets.  Italy  has  a  special  ‘bollini 
sticker’, and France requires two red lines on the blister cards. 

The  consequence  is  reduced  product  range  on  some  markets  and  a  higher  amount  of 
scraps.  

Also large companies suffer from burdensome regulations 

Even for a large company  – manufacturing many different types of products  – it seems 
difficult  to  stay  updated  on  new  regulations  and  requirements.  New  labelling 
requirements  to  the  effect  that  the  manufacturer’s  address  must  be  on  each  product  is 
mentioned  as  a  very  costly  new  requirement.  Different  interpretation  of  the  RoHS 
directive;  confusion  in  many  Member  States  (e.g.  Estonia,  Latvia,  Hungary  and 
Lithuania)  as  to  the  use  of  performance  declarations,  and  whether  or  not  a  product  is 
under the Construction Product Regulation – are other burdensome concerns in practice.  

For  products  in  contact  with  water,  many  different  rules  and  requirements  for  testing 
apply:  some  Member  States  want  testing  of  the  materials  used  (e.g.  Germany);  others 
want to test the final product (e.g. Denmark).  

6. 

 

POLICY RECOMMENDATIONS – THE WAY FORWARD… 

DI welcomes the 2015 Single Market Strategy and push for concrete action. 

The  European  institutions  should  keep  continuous  and  high  focus  on  the  well -
functioning  of  the  free  movement  in  the  Single  Market.  New  technologies  and 
developments  require  new  solutions.  Yet,  if  the  basics  are  not  in  place  and  well 
understood, then the foundation for the free movement is at stake.  

National  legislators  and  administrators  should  be  trained  in  basic  principles  to 
ensure  the  well-functioning  of  common  rules,  and  there  must  be  a  better 
coordination at European level.  

 

The  principle  of  mutual  recognition  should  be  better  defined  and  consolidated 
through a revision of EU-regulation 764/2008  laying down procedures relating to 
the application of certain national technical rules to products lawfully marketed in 
another Member State. 

Awareness of the principle of mutual recognition should be raised among national 
authorities, the judiciary and the business community. 

For the business community the awareness is not enough if businesses continue to 
stand  alone  in  their  assessment  of  their  right  to  market  their  product  on  a  new 

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market,  being  left  with  the  only  option  of  a  possible  costly  court  case  against 
market authorities. 

The  SOLVIT  system  should  be  reinforced,  but  experience  shows  that  it  cannot  solve 
cases  where  a  special  national  regulation  is  in  force,  not  respecting  the  mutual 
recognition principle.  

 

The  establishment  of  a  ‘Quick  Assessment  Procedure’  could  promote  better 
application  of  mutual  recognition  in  goods  and  services  and  would  improve  the 
transparency of national decisions. 

The  ‘Quick  Assessment  Procedure’  could  assess  whether  mutual  recognition 
should apply when a Member State exerts a national technical rule on a product or 
service that is already being lawfully marketed in another Member State.   

The  procedure  would  produce  a  non-binding  opinion.  This  could  give  the 
economic  operator  further  insight  before  contentious  proceedings  and  also  add 
transparency to national decisions (helping similar business sectors make informed 
choices).  It  would  demonstrate  particularly  problematic  areas  to  the  Commission 
and act as a deterrent to Member States.  

The procedure would be carried out by a forum of Member States on a rolling basis 
(e.g.,  represented  by  officials  responsible  for  the  Product  Contact  Points).  The 
forum  should  meet  quarterly  and  businesses  should  have  direct  access  for 
transmitting  specific  cases  of  conflicting  national  technical  rules  and  possible 
refusal of marketing of a lawfully marketed product in another Member State.  

 

New  national  technical  regulations  should  be  subject  to  an  impact  assessment 
with  respect  to  the  principle  of  free  movement,  and  their  justification  and 
proportionality  should  be  documented  and  based  on  special  conditions  of  the 
Member State in question.   

The  European  Commission  should  use  the  European  Semester  to  discuss  special 
national requirements with Member States creating barriers to the free movement.  

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