REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE ON THE OPERATION OF DIRECTIVE (EU) 2015/1535 FROM 2014 TO 2015
Date: 2017-12-19
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: access to information, approximation of laws, exchange of information, free movement of goods, information society, legislative drafting, mutual recognition principle, single market, technical regulations, trade restriction

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 19.12.2017  COM(2017) 788 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE ON THE OPERATION OF DIRECTIVE (EU) 2015/1535 FROM 2014 TO 2015 {SWD(2017) 465 final}  
 
 
Table of Contents 

INTRODUCTION ...................................................................................................................... 3 

1.  Developments 2014-2015 ................................................................................................... 5 

1.1.  Use of the notification procedure within the context of "Better regulation" and to 
improve competitiveness ......................................................................................................... 5 

1.2.  Use of the notification procedure to boost mutual recognition ................................... 5 

1.3. 

Improvements to the notification procedure ................................................................ 5 

1.4. 

Jurisprudence on the Single Market Transparency Directive ..................................... 6 

2.  Application of the notification procedure ........................................................................... 7 

2.1.  Effectiveness: general overview .................................................................................. 7 

2.2.  Use of the urgency procedure .................................................................................... 17 

2.3.  Notification of "fiscal or financial incentive measures" ............................................ 18 

2.4.  Follow-up to Commission reactions .......................................................................... 18 

2.5.  Follow-up to the notification procedure .................................................................... 18 

2.6. 

Structured exchanges with the Member States .......................................................... 19 

2.7.  Requests for access to documents issued under the Single Market Transparency 
Directive ............................................................................................................................... 20 

2.8.  Transparency ............................................................................................................. 20 

3.  Conclusion ........................................................................................................................ 21 

1 

 
 
 
EXECUTIVE SUMMARY 

This  report  analyses  the  application  of  one  of  the  cornerstones  of  the  internal  market  from 
2014 to 2015: the notification procedure laid down by Directive (EU) 2015/15351 (hereinafter 
referred  to  as  the  "Single  Market  Transparency  Directive").  The  report  highlights  the 
important  contribution of  the  notification  procedure  to  the functioning of  the  Single  Market 
and to the implementation of the Better Regulation policy2.  

Directive  (EU)  2015/1535  was  adopted  on  9  September  2015  and  repealed  and  replaced 
Directive 98/34/EC. Since Directive 98/34/EC had been substantially amended several times 
(notably  to  include  Information  Society  services  and  to  remove  technical  standards  from  its 
scope), a decision was taken to codify it in the interest of clarity. 

The  notification  to  the  Commission  of  national  technical  regulations  prior  to  their  adoption 
has  continued  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 including in certain emerging sectors and improving the quality of national 
technical  regulations  -  in  terms  of  transparency,  legibility  and  effectiveness  -  in  non-
harmonised  or  partly  harmonised  areas.  The  greater  clarity  in  the  legal  framework  of  the 
Member States can help economic operators to adapt to the new rules and thus reduce the cost 
of accessing the regulations and apply them correctly. This is possible also thanks to the fact 
that technical regulations notified to the Commission are translated into 23 official languages 
of the EU3. 

1 

2 

3  

Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying 
down a procedure for the provision of information in the field of technical regulations and of rules on 
Information Society services (codification; OJ L 241, 17.9.2015, p. 1–15). 
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 Smart Regulation in the European 
Union;  COM(2010)543  and  COM(2016)  615  final,  Better  Regulation:  Delivering  better  results  for  a 
stronger Union.  
Irish translation is not available.  

2 

 
 
                                                            
INTRODUCTION 

The notification procedure for national technical regulations allows the Commission and the 
Member States of the EU to examine before adoption the technical regulations Member States 
intend  to  introduce  for  products  (industrial,  agricultural  and  fishery)  and  for  Information 
Society  services  (see  Annex  1  of  the  Commission  Staff  Working  Document  accompanying 
this Report). 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 3).  

The main purpose of the notification procedure is to prevent the creation of new barriers to 
the  internal  market  before  they  have  been  put  in  place  and  have  produced  any  negative 
effects.  

The internal market is one of the Commission's 10 priorities and the Commission considers a 
better  functioning  Single  Market  as  an  engine  for  building  a  stronger  EU  economy  and 
"Europe’s best asset in times of increasing globalisation".4 For this reason, together with the 
Member States the Commission endeavours to unlock the full potential of the Single Market 
"so that citizens, business and public authorities can access goods and services for the best 
quality,  price  or  service".5  As  stated  in  the  Single  Market  Strategy,  "[T]he  Single  Market  is 
arguably  among  European  Union’s  greatest  achievements"6  and  the  Commission  considers  it  a 
priority  to  remove  remaining  regulatory  and  non-regulatory  barriers  to  the  Single  Market  for 
goods and services. The European Commission has decided to give the Single Market a new 
boost  with  a  number  of  ambitious  and  pragmatic  actions  in  key  areas  for  the  EU  internal 
market  such  as  circular  economy,  collaborative  economy,  the  Digital  Single  Market,  the 
Capital Market Union and taxation.  

In  its  Communication  "Upgrading  the  Single  Market:  more  opportunities  for  people  and 
business"7  the  Commission  has  stressed  that  "[g]oods  generate  around  75 %  of  intra-EU 
trade [and that in] 2014, trade in goods between EU Member States was valued at EUR 2 900 
billion", thus highlighting the important role played by trade in goods in the general context of 
trade in the Single Market (intra-EU trade in goods represented 20.6% of EU GDP in 2015). 
The  need  to  strengthen  the  free  movement  of  goods  and  to  provide  businesses  a  more 
predictable  regulatory  framework  is  reiterated  in  the  Commission  staff  working  document 
accompanying  this  Communication.  The  Single  Market  Transparency  Directive  contributes 
directly or indirectly to several follow-up initiatives of the Single Market Strategy.  

Given the centrality of the Single Market Transparency Directive in the proper functioning of 
the  Single  Market  for  goods  and  for  Information  Society  services,  this  report  is  adopted 
together with the "Goods Package". The aim of the package is to boost the Single Market and 
exploit its full potential by reinforcing trust in the Single Market for the benefit of all, citizens 
and business. Specifically, initiatives will be presented to make  mutual recognition function 
better and to enhance the enforcement of common EU product safety rules. 

The Single Market Transparency Directive is the most open and transparent instrument of the 
Single  Market.  It  is  a  unique  system  which  prevents  the  emergence  of  new  barriers  to  the 

4  
5  

6  

7  

https://ec.europa.eu/priorities/sites/beta-political/files/juncker-political-guidelines-speech_en_0.pdf 
See President Juncker's Political Guidelines, A New Start for Europe: My Agenda for Jobs, Growth, 
Fairness and Democratic Change. Political Guidelines for the next European Commission, 
https://ec.europa.eu/priorities/internal-market_en. 
A Single Market Strategy for Europe - Analysis and Evidence Accompanying the document Upgrading 
the Single Market: more opportunities for people and business, SWD/2015/0202 final. 
See  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 - Upgrading the Single Market: 
more opportunities for people and business, COM(2015) 550 final. 

3 

 
                                                            
Single  Market  by  putting  the  focus  on  transparency,  dialogue,  prevention  and  better 
regulation. Not only it provides that Member States participate on an equal footing with the 
Commission in this procedure, but it also enables stakeholders themselves to have access to 
all  national  technical  regulations  under  preparation,  which  are  translated  in  23  official 
languages of the EU. Economic operators can therefore anticipate the creation of obstacles to 
trade  and,  by  taking  an  active  role  in  the  notification  process,  can  concretely  prevent 
unnecessary and costly administrative burdens from affecting their business. 

The  Single  Market  Transparency  Directive  also  plays  an  important  role  in  the  compliance 
dialogue  meetings  with  Member  States8,  which  are  part  of  the  culture  of  compliance  and 
smart  enforcement  work  strand  of  the  Single  Market  Strategy9.  The  Commission  sees  these 
meetings  as  an  opportunity  for  a  dialogue  to  improve  transposition,  implementation  and 
application of EU law. The dialogues are also an occasion to discuss together with Member 
States how to proactively address the challenges of EU law enforcement. In this context, the 
dialogue  under  the  Single  Market  Transparency  Directive,  combined  with  other  indicators, 
enables the Commission to better identify the problematic sectors and structural problems in 
the Member States.  

Taking  into  account  the role  of the Single  Market  Transparency  Directive  in  preventing  the 
creation of barriers on the single market of goods, in the framework of the Services Package 
the  Commission  recently  presented  a  legislative  proposal  for  a  self  standing  notification 
instrument in the area of services. This aims to modernise the existing notification procedure 
under  the  Services  Directive10  and  will  allow  for  more  upstream  verification  of  the 
justification  and  proportionality  of  new  national  regulations  potentially  restricting  the  free 
movement  of  services  as  well  as  addressing  compliance  through  the  dialogue  with  the 
Member States before the proposed legislation has been adopted11. 

Given  its  wide  scope,  which  covers  all  products,  industrial,  agricultural  and  fishery,  and 
Information  Society  services,  the  Single  Market  Transparency  Directive  also  helps  in 
promoting  the  free  movement  of  goods  and  services  in  emerging  sectors  of  the  digital 
economy and for preventing the creation of barriers to trade in the EU Digital Single Market. 
The  Single  Market  Transparency  Directive  notification  procedure  helps  to  create  a  stronger 
and  more  connected  Digital  Single  Market.  With  respect  to  the  collaborative  economy,  the 
Single  Market  Transparency  Directive  seeks  to  prevent  the  adoption  by  Member  States  of 
unjustified and disproportionate market access requirements.12 

8  

9  

10  

11  

12  

Compliance  dialogue  are  structured  /  strategic  meetings  with  Member  States  organised  on  a  regular 
basis to take stock of the state of the Single Market integration in that Member State, in particular the 
state of play of transposition and ongoing infringement proceedings. 
See  paragraph  "Ensure  a  culture  of  compliance  and  smart  enforcement  to  help  deliver  a  true  Single 
Market" of the Single Market Strategy, http://ec.europa.eu/growth/single-market/strategy_en. 
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 
See  Proposal  for  a  directive  on  the  enforcement  of  the  Directive  2006/123/EC  on  services  in  the 
internal  market,  laying  down  a  notification  procedure  for  authorisation  schemes  and  requirements 
related to services, COM(2016) 821. 
See  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  European  agenda  for  the 
collaborative economy, COM(2016) 356 final. 

4 

 
 
                                                            
1. 

1.1. 

DEVELOPMENTS 2014-2015 

Use of the notification procedure within the context of "Better regulation" and to 
improve competitiveness 

Already in its 2002 Communication "Better regulation for growth and jobs in the EU"13 the 
Commission  highlighted  that  the  preventive  control  mechanism  established  by  the  Single 
Market Transparency Directive contributes to improving the quality of national regulations on 
products and Information Society services. The cooperation between the Commission and the 
Member  States  within  the  context  of  the  notification  procedure  aims  to  ensure  a  clearer 
regulatory framework for economic operators. 

In  the  framework  of  the  Commission’s  action  plan  to  simplify  and  improve  the  regulatory 
environment14,  Member  States  have  been  invited  to  submit  impact  studies  (or  their 
conclusions)  together  with  notified  drafts  technical  regulations  under  the  Single  Market 
Transparency Directive, where such studies have been carried out internally. By carrying out 
these  impact  studies,  Member  States  are  encouraged  to  reflect  in  advance  on  the  most 
appropriate  instrument  to  be  used,  and  the  Commission  can  better  check  the  necessity  and 
proportionality of the measures proposed. In  the reporting period,  Member States submitted 
impact studies in relation to 356 notifications (almost 25% of the total of notifications). This 
represents  a  slight  increase  compared  to  the  previous  two  years,  when  Member  States 
submitted  314  impact  studies  out  of  1439  notifications  (approximately  22%  of  the  total  of 
notifications). 

1.2. 

Use of the notification procedure to boost mutual recognition 

The  Single  Market  Transparency  Directive  contributes  to  better  mutual  recognition.  The 
evaluation of national regulations, before their adoption, in the light of Articles 34-36 TFEU 
and of the mutual recognition principle and the recommendations of the Commission to insert 
a  single  market  clause  clause  in  notified  draft  national  rules,  where  necessary,  helps  in 
reducing  the  risk  of  these  rules  raising  regulatory  barriers  to  trade.    This  preventive 
mechanism  could  be  complemented  by  a  corrective  mechanism,  in  case  authorities,  when 
taking decisions based on national rules in individual cases, misapply the principle of mutual 
recognition. For this reason, the report is adopted together with the “Goods package”, which 
contains  a  Single  Market  Strategy  follow-up  initiative  to  give  a  major  boost  to  mutual 
recognition  in  the  area  of  goods.  It  aims  to  introduce  the  use  by  economic  operators  of  a 
voluntary  mutual  recognition  declaration  and  to  facilitate  the  smooth  implementation  of  the 
mutual  recognition  principle.  This  should  ensure  that  national  regulations  do  not  create 
unjustified barriers to trade through their full life cycle. 

1.3. 

Improvements to the notification procedure 

One  of  the  objectives  of  the  Single  Market  Transparency  Directive  is  to  inform  economic 
operators,  including  small  and  medium-sized  enterprises  (SMEs),  in  advance  of  planned 
technical  regulation  in  the  Member  States,  to  allow  them  to  make  their voices  heard  and  to 
adapt early their activities to future technical regulations.15 The high number of contributions 
on notifications sent by stakeholders shows that this right of scrutiny is used extensively and 
helps the Commission and national authorities to detect barriers to trade.  

In  an  ever-evolving  effort  towards  transparency  and  efficiency,  in  2015  the  Commission 
worked  on  a  new  functionality  on  the  Technical  Regulation  Information  System  (TRIS) 

13 
14 
15  

See supra, footnote 2. 
See supra, footnote 2. 
See whereas clause number 7 of the Single Market Transparency Directive. 

5 

 
 
                                                            
website.16 This new functionality was put in place in June 2016 and allows any person to use 
the  TRIS  website  to  submit  contributions  on  any  notification  during  the  standstill  period 
provided for under Article 6 of the Single Market Transparency Directive. 

Contributors have the possibility to make their contribution confidential and available only to 
the Commission services. The new "Contributions" tool also provides a way to quickly and 
easily  gain  access  to  contributions  from  other  stakeholders  provided  they  have  not  been 
marked as confidential, giving more visibility to contributions also outside the Commission.   

All  contributions  submitted  through  this  new  mechanism  will  be  immediately  forwarded  to 
the  Commission's  competent  services,  representing  an  increase  in  the  efficiency  of  the 
contribution process. In the meantime, contributors receive an automatic acknowledgement of 
receipt through the Contribution Acceptance receipt sent by email.  

1.4. 

Jurisprudence on the Single Market Transparency Directive  

In the reference period the Court of Justice of the European Union (CJEU) issued two main 
rulings referring to the Single Market Transparency Directive and its obligations which help 
to clarify some aspects of the Directive and to better define some of its requirements. 
In case C-307/13 (Ivansson and Others),17 the Court stated that, if a change to the timetable 
for the implementation of a national measure is made and if this is significant in nature, the 
draft technical regulation is subject to the obligation of communication to the Commission, as 
laid  down  in  the  third  subparagraph  of  Article 5(1)  of  the  Single  Market  Transparency 
Directive  ("Member States  shall  communicate  the  draft  technical  regulation  again  to  the 
Commission […] if they make changes to the draft that have the effect of significantly altering 
its  scope,  shortening  the  timetable  originally  envisaged  for  implementation,  adding 
specifications or requirements, or making the latter more restrictive"). The Court added that a 
failure  to  observe  such  an  obligation  constitutes  a  procedural  defect  in  the  adoption  of  the 
technical  regulation  concerned,  and  renders  this  technical  regulation  inapplicable  and 
therefore unenforceable against individuals.  
In case C-98/14 (Berlington Hungary and Others)18 the Court ruled that a tax legislation such 
as  that  at  issue  which  is  not  accompanied  by  any  technical  specification  or  any  other 
requirement with which it is purportedly intended to ensure compliance, cannot be described 
as a "de facto technical regulation" (Article 1(f) of the Single Market Transparency Directive) 
and  that  the  concept  of  "de  facto  technical  regulations"  refers,  not  to  the  tax  measures 
themselves, but to the technical specifications or other requirements linked to them. 

The Court also stated that the provisions of national legislation that prohibit the operation of 
slot machines outside casinos constitute "technical regulations" within the meaning of Article 
1(f) of the Single Market Transparency Directive, the drafts of which must be communicated 
in accordance with the first subparagraph of Article 5(1) of the Single Market Transparency 
Directive. The Court held that "a national measure which restricts the organisation of certain 
games  of  chance  to  casinos  only  constitutes  a  ‘technical  regulation’,  within  the  meaning  of 

16  
17  

18  

http://ec.europa.eu/growth/tools-databases/tris/en/. 
The case was brought to the Court in the context of a request for a preliminary ruling concerning the 
interpretation of the third subparagraph of Article 8(1) of then Directive 98/34/EC, (OJ 1998 L 204, p. 
37) on the obligation to communicate to the Commission any changes to the drafts previously notified 
to the Commission under the above-mentioned Directive, that have the effect of significantly altering 
the scope of, shortening the timetable originally envisaged for implementation, adding specifications or 
requirements, or making the latter more restrictive. 
The  case  was  brought  to  the  Court  in  the  context  of  a  request  for  a  preliminary  ruling  concerning, 
amongst others, the interpretation Articles 1, 8 and 9 of then Directive 98/34/EC. The case concerned 
regulation in the areas of slot machines.  

6 

 
                                                            
Article [1(f)  of  the  Single  Market  Transparency  Directive],  in  so  far  as  it  can  significantly 
influence the nature or the marketing of the products used in that context". 

The Court also held that Articles 5 and 6 of the Single Market Transparency Directive, which 
illustrate the procedural steps of the notification procedure, "are not intended to confer rights 
on individuals, in such a way that their infringement by a Member State gives rise to a right 
of individuals to obtain from that Member State compensation for the damage suffered as a 
result of that infringement on the basis of EU law".  

These  judgements  provided  better  clarity  on  the  interpretation  of  Articles  1,  5  and  6  of  the 
Single  Market  Transparency  Directive  and  notably  on  the  notification  of  changes  to 
previously  notified  laws,  the  concept  of  technical  regulation  and  the  fact  that  procedural 
breaches  do  not  give  rise  to  compensation  claims.  This  will  help  Member  States  and  the 
Commission in better applying the Single Market Transparency Directive. 

2. 

APPLICATION OF THE NOTIFICATION PROCEDURE 

1.5. 

Effectiveness: general overview  

► Volume of notifications and sectors involved 

From 2014 to 2015, the Commission received 1382 notifications (655 in 2014, 727 in 2015)19. 
This represents a small decrease with respect to the previous two years (1484 notifications).  

Marked differences in the number of notifications among Member States have been noticed, 
with  some  Member  States  carrying  out  on  average  more  than  50  notifications  per  year  and 
others notifying less than 10 notifications per year. If this gap can be partly explained with a 
different  setting  of  the  State  organisation  (e.g.  presence  of  regional/local  authorities  with 
regulatory powers), lack of awarness or with a higher/lower degree of regulatory activity, this 
wide discrepancy raises doubts about the full compliance with the notification obligations by 
some  Member  States.  This  can  also  be  explained  by  the  fact  that  some  national  regulatory 
authorities  do  not  take  into  account  the  Single  Market  Transparency  Directive  notification 
process, and notably the required stand-still of three months, when planning their regulatory 
decision making process.  

19  

These  figures  do  not  include  notifications  from  EFTA  countries  which  are  signatories  of  the  EEA 
Agreement  (Norway,  Lichtenstein  and  Iceland),  Turkey  and  Switzerland.  In  the  reporting  period  85 
notifications were carried out by these countries (44 by EFTA/EEA countries, 22 by Turkey and 19 by 
Switzerland). Please see Annex 3 for more information about these notifications.  

7 

 
                                                            
A correlation between the size of the Member States and the number of notifications can be 
observed,  with  the  biggest  Member  States  notifying,  in  general,  more  than  the  medium  and 
small  ones.  This  can  be  partly  explained  with  a  higher  number  of  regional  and  local 
authorities  which have an obligation to notify their draft technical regulations. However, this 
is not always the case: for instance, in some cases medium-sized Member States notified more 
than some bigger Member States. 

As 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, and fire safety of 
buildings.  

Like  in  the previous  reporting  period,  this  sector  was  again followed  by  notifications  in  the 
area of agricultural products, fishery and aquaculture products and other foodstuffs. In 
this  category,  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,  quality  and  origin 
marks.   

8 

Member States20142015Austria3843Belgium2020Bulgaria613Croatia104Cyprus143Czech Republic2637Denmark2939Estonia1817Finland3437France4969Germany5061Greece78Hungary2422Ireland62Italy2920Latvia1521Lithuania48Luxembourg21Malta51Netherlands5944Poland2536Portugal722Romania2417Slovakia2335Slovenia86Spain2130Sweden3832United Kingdom6479Total655727 
 
 
Numerous notifications were also made 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)). 

A number of notifications concerned gambling products and services.  

Finally, a number of notifications related to the environment sector (mainly packaging and 
packaging waste, recyclable products, processing of biodegradable waste) (see Annex 2.3).  

► Issues addressed by the Commission in its reactions 

In  the  non-harmonised  areas  which,  in  absence  of  secondary  legislation,  are  subject  to 
compliance  with  Articles  34  to  36  (free  movement  of  goods)  and  49  and  56  (right  of 
establishment  and  freedom  to  provide  services)  TFEU,  the  Commission’s  reactions  were 
intended to draw Member States’ attention to potential obstacles to trade after assessing the 
necessity  and  the  proportionality  of  the  measure  in  line  with  the  case-law  of  the  Court  of 
Justice.  Thus  the  Commission  aimed  to  ensure  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.  

When national measures partially fall under  harmonised areas, the reactions were intended 
to ensure that national measures were compatible with EU secondary legislation. 

 

In 2014-2015 Member States notified 303 (151 in 2014 and 152 in 2015) 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 Regulation (EU) No 305/2011 laying down harmonised conditions 
for  the  marketing  of  construction  products  and  repealing  Council  Directive 
89/106/EEC20.  

The  Commission  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)21  and  Directive  92/42/EEC  on  efficiency 
requirements for new hot-water boilers fired with liquid or gaseous fuels22. 

Technical regulations relating to energy efficiency of buildings were assessed under 
Directive  2012/27/EU  on  energy  efficiency23,  Directive  2010/31/EU  on  the  energy 

20  

21  

22  

23  

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. 

9 

 
 
                                                            
performance of buildings24 and Directive 2009/125/EC establishing a framework for 
the setting of ecodesign requirements for energy-related products25. 

The  Commission  also  examinded  draft  legislation  concerning  requirements  for 
motorway  communications  equipment.  The  notified  draft  was  examined  under 
Directive 1999/5/EC26, Directive 2006/95/EC27 and Directive 2004/108/EC28. 

 

In  the  agricultural,  fishery  and  foodstuff  sectors,  from  2014  to  2015  Member 
States notified 266 (133 in 2014 and 133 in 2015) draft technical regulations. These 
drafts  concerned,  inter  alia,  materials  coming  into  contact  with  foodstuffs,  energy 
drinks, trans fats in food products, wine and spirits, quality marks for foodstuffs, the 
well-being of animals and the marketing of fur products. 

Certain Member States notified draft regulations setting up marks linking the quality 
of a product with its origin. These notifications have been examined under the Treaty 
provisions on the free movement of goods and Regulation (EU) No 1151/2012 of the 
European  Parliament  and  the  Council  on  quality  schemes  for  agricultural  products 
and foodstuffs.29  

During the relevant period, the Commission examined many notifications concerning 
the  hygiene  of  foodstuffs  and  issued  detailed  opinions  and  comments  concerning 
their compliance with Regulation (EC) No 852/2004 on the hygiene of foodstuffs30, 
Regulation (EC) No 853/2004 laying down specific hygiene rules for food of animal 
origin31  and  Regulation  (EC)  No  854/2004  laying  down  specific  rules  for  the 
organisation  of  official  controls  on  products  of  animal  origin  intended  for  human 
consumption32. 

Other notifications concerned the labelling of foodstuff and the Commission assessed 
their  compatibility  with  Regulation  (EU)  No  1169/2011  on  the  provision  of  food 
information  to  consumers,33  in  particular  with  the  provisions  on  nutritional 
declarations, or other sector-specific provisions on consumer information.34  

24  

25  

26  

27  

28  

29  

30  

31  

32  

33  

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. 
Directive  1999/5/EC  of  the  European  Parliament  and  of  the  Council  of  9  March  1999  on  radio 
equipment and telecommunications terminal equipment and the mutual recognition of their conformity, 
OJ L 91of 7.4.1999, p. 10–28.  
Directive 2006/95/EC of the European Parliament and of The Council of 12 December 2006 on the 
harmonisation of the laws of Member States relating to electrical equipment designed for use within 
certain voltage limits, OJ L 374 of 27.12.2006, , p. 10–19 
Directive 2004/108/EC of the European Parliament and of the Council  of 15 December 2004 on the 
approximation of the laws of the Member States relating to electromagnetic compatibility, OJ L 390 of 
31.12.2004, p. 24–37.  
Regulation  (EU)  No  1151/2012  of  the  European  Parliament  and  the  Council  on  quality  schemes  for 
agricultural products and foodstuffs, OJ L 343, 14.12.2012, p. 1–29. 
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. 
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 

10 

 
 
 
 
                                                            
 

 

 

 

In the Information Society services sector there were 69 (25 in 2014 and 44 
in  2015)  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. 

In  the  metrology  sector  there  were  67  notifications  (37  in  2014  and  30  in 
2015).  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  instruments35.  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  69  (33  in  2014  and  36  in 
2015)  notifications.  The  bulk  of  the  notifications  concerned  biocidal  products, 
fertilisers, plant protection products and products falling under the scope of REACH 
and  were  mainly  examined  under  Regulation  (EC)  No  1907/2006  concerning  the 
Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  ("REACH")36, 
the  Biocidal  Products  Regulation37  and  Regulation  (EC)  No  1107/2009  concerning 
the placing of plant protection products on the market38.  

In the environmental sector the Commission examined 86 (42 in 2014 and 44 
in  2015)  draft  regulations.  Some  notified  drafts  concerned  packaging  waste  and 
raised  both  problems  of  compatibility  with  the  EU  harmonised  legislation, 
particularly  Directive  94/62/EC  on  packaging  and  packaging  waste39  (for  example 
with  regard  to  the  requirements  for  banning  lightweight  plastic  carrier  bags),  and 
with Articles 34-36 TFEU, for the non-harmonised aspects (for instance with regard 

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. 
Regulation (EU) No 1379/2013 of the European Parliament and of the Council of 11 December 2013 on 
the  common  organisation  of  the  markets  in  fishery  and  aquaculture  products,  amending  Council 
Regulations  (EC)  No  1184/2006  and  (EC)  No  1224/2009  and  repealing  Council  Regulation  (EC)  No 
104/2000, OJ L 354, 28.12.2013, p. 1–21. 
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,  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. 
Regulation  (EU)  No  528/2012  of  the  European  Parliament  and  of  the  Council  of  22  May  2012 
concerning the making available on the market and use of biocidal products, OJ L 167, 27.6.2012, p. 1–
123. 
Regulation  (EC)  No  1107/2009  of  the  European  Parliament  and  of  the  Council  of  21  October  2009 
concerning  the  placing  of  plant  protection  products  on  the  market  and  repealing  Council  Directives 
79/117/EEC and 91/414/EEC, GU L 309 del 24.11.2009, p. 1–50. 
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. 

34  

35  

36  

37  

38  

39  

11 

 
  
 
 
 
 
                                                                                                                                                                                          
to  the  mutual  recognition  clause  or  the  use  of  national  standards  for  disposable 
plastic bags or disposable plastic cups, glasses and plates).   

The  notification  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  6(3)  and 
6(4)  of  the  Single  Market  Transparency  Directive,  the  Commission  has  requested  the 
notifying  Member  State  to  postpone  the  adoption  of  notified  draft  legislation  for  twelve 
months  from  the  date  of  notification  in  the  fields  of:  electronic  signatures,  electronic 
archiving,  electronic  recorded  delivery,  electronic  time-stamping  and  certification  services 
(notification 2013/584/B and 2013/585/B) and requirements for milk and milk products, ice 
creams and edible fats and oils (notification 2015/169/CZ).  

Thus,  the  Single  Market  Transparency  Directive  helps  to  avoid  the  fragmentation  of  the 
Single  Market  in  areas  where  harmonisation  is  envisaged  or  under  way  and  aims  to  give 
greater certainty and stability in the legal framework to the economic operators. 

►  Positive  examples,  showcasing  the  impact  of  the  Single  Market  Transparency 
Directive 

 

 

 

In  2014  the  Commission  issued  a  detailed  opinion  on  an  Italian  notification 
concerning a regional logo which linked the origin of a wide range of products with 
their quality. The Commission argued that this measure would have been contrary to 
Article 34 TFEU as it could have encouraged consumers to buy national products to 
the detriment of imported ones. Following a dialogue, the Italian authorities removed 
the  barrier  by  eliminating  the  reference  to  the  origin  of  the  products  covered  by  the 
notified draft. 

In 2014 Hungary notified a draft measure setting inspections to ensure that operators 
have  paid  VAT  on  wine  products  without  geographical  indication  marketed  in 
Hungary.  These  inspections  were  subject  to  the  payment  of  a  fee.  The  Commission 
issued  a  detailed  opinion  arguing  that  the  payment  of  a  VAT  inspection  fee  was 
contrary to Regulation (EU) No 1308/2013 establishing a common organisation of the 
markets  in  agricultural  products40.  Following  the  adoption  of  the  measure  by  the 
Hungarian  authorities,  the  Commission  started  an  investigation  which  was  finally 
closed  due to the fact that the contested  measure ceased to  have  effect from 31 July 
2017  (due  to  lack  of  extension  by  the  Hungarian  authorities).  The  notification 
procedure, therefore, proved useful in the identification of a barrier to trade which was 
eventually removed through an investigation. 

In  2015  the  French  authorities  notified  the  Commission  a  draft  measure  defining  a 
logotype  to  be  used  with  industrial  and  craft  products  protected  by  geographical 
indications.  The  Commission  issued  a  detailed  opinion  on  the  grounds  that 
establishing the logotype, which consisted of a blue and red outline around the initials 
"IG" [indication géographique – geographical indication], with the word "FRANCE", 
was liable to constitute a measure having equivalent effect under Article 34 TFEU. In 
particular, the Commission considered that this logotype underlining the French origin 
of the products concerned would go beyond the objective of authenticating the specific 
local  or  regional  origin  of  a  product  and  could  therefore  encourage  consumers  to 
purchase products bearing this logo, to the exclusion of products from other Member 

40  

Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 
establishing  a  common  organisation  of  the  markets  in  agricultural  products  and  repealing  Council 
Regulations  (EEC)  No 922/72,  (EEC)  No 234/79,  (EC)  No 1037/2001  and  (EC)  No 1234/2007,  OJ  L 
347, 20.12.2013, p. 671–854. 

12 

 
                                                            
 

 

States.  The French authorities took these  objections  on board and amended  the draft 
logotype in a manner with was consider acceptable by the Commission. 

In  2015  France  notified  a  draft  technical  regulation  setting  out  the  expected 
performance  of  personal  protective  equipment  (PPE)  used  to  protect  operators  and 
workers  from  synthesised  plant  protection  products  and  proposed  appropriate  tests. 
The  Commission  issued  a  detailed  opinion  expressing  its  concerns  on  the  mutual 
recognition clause contained in the notified draft. According to the notified draft, any 
other means could be used to demonstrate that suits comply with the essential health 
and safety requirements of Council Directive 89/686/EEC on the approximation of the 
laws  of  the  Member  States  relating  to  personal  protective  equipment41  (PPP 
Directive),  provided  that  these  means  guaranteed  the  same  level  of  protection  for 
operators and workers as the test conditions and information requirements described in 
the French draft. The Commission was of the opinion that this provision rendered in 
practice  the  test  conditions  and  information  requirements  of  the  notified  text 
mandatory,  in  breach  of  Article  4(1)  of  the  PPE  Directive:  "Member  States  may  not 
prohibit,  restrict  or  hinder  the  placing  on  the  market  of  PPE  or  PPE  components 
which  comply  with  the  provisions  of  this  Directive  and  which  bear  the  CE  marking 
attesting  their  conformity  to  all  the  provisions  of  this  Directive,  including  the 
certification  procedures  in  Chapter  II".  The  French  authorities  modified  the  text 
accordingly, addressing the concerns expressed by the Commission.  

In 2014 the United Kingdom notified a draft providing that motorway communications 
equipment  should  comply  with  the  Low  Voltage  Directive  (LVD)42,  the  Radio  & 
the 
Telecommunication  Terminal  Equipment  Directive 
Electromagnetic Compatibility Directive (EMC)44, and, in addition, with a number of 
harmonised voluntary standards. The Commission issued a detailed opinion reminding 
that if products fall within the scope of specific EU harmonising legislation providing 
for  the  CE  marking  (such  as  the  LVD,  EMC,  R&TTE),  they  shall  comply  with  that 
legislation  and  shall  not  be  subject  to  those  provisions  of  the  notified  draft  that 
regulate  the  same  risks.  The  United  Kingdom  modified  the  draft  by  removing  any 
requirement  to  comply  with  voluntary  harmonised  standards  under  CE  marking 
directives throughout the notified draft. 

(R&TTE)43, 

and 

► Most common tackled barriers  

One of the purposes of the Single Market Transparency Directive is to allow the identification 
of  areas  of  recurrent  obstacles  to  the  free  movement  of  goods  and  the  freedom  to  provide 
Information  Society  services  and  the  detection  of  harmonisation  needs  with  the  aim  of 
ensuring a smoother functioning of the single market45.  

41  

42  

43  

44  

45  

Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member 
States relating to personal protective equipment, OJ L 399, 30.12.1989, p. 18–38. 
Directive  2014/35/EU  of  the  European  Parliament  and  of  the  Council  of  26 February  2014  on  the 
harmonisation  of  the  laws  of  the  Member  States  relating  to  the  making  available  on  the  market  of 
electrical equipment designed for use within certain voltage limits, OJ L 96, 29.3.2014, p. 357–374. 
Directive  1999/5/EC  of  the  European  Parliament  and  of  the  Council  of  9  March  1999  on  radio 
equipment and telecommunications terminal equipment and the mutual recognition of their conformity, 
OJ L 091 , 07.04.1999 p. 10-28. 
Directive  2004/108/EC  of  the  European  Parliament  and  of  the  Council  of  15  December  2004  on  the 
approximation of the laws of the Member States relating to electromagnetic compatibility and repealing 
Directive 89/336/EEC, OJ L 390, 31.12.2004, p. 24–37. 
See recital number 15 of the Single Market Transparency Directive. 

13 

 
 
                                                            
In  this  respect,  the  Commission  identified  in  the  period  under  analysis  several  recurrent 
barriers in the notified draft legislation, of which the most pertinent ones are listed below.. 

Mutual recognition clauses  

The Commission reacted frequently to notifications of draft technical regulations in which the 
mutual recognition clause was not included or was not drafted in line with the standard laid 
down  in  the  "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). Some Member States justified the absence of the mutual recognition clause in their 
drafts  on  the  basis  of  the  inclusion  of  a  general  mutual  recognition  clause  in  the  basic 
legislation.  In  those  cases,  the  Commission  nonetheless  recommended  to  the  notifying 
Member  States  to  include  in  the  notified  drafts  a  direct  reference  to  the  mutual  recognition 
clause  in  the  basic  legislation  in  order  to  ensure  the  necessary  legal  certainty  for  business 
operators.  

Improper legal drafting technique - Repetition of provisions of EU Regulations 

One of the most frequent issues addressed by the Commission in the detailed opinions issued 
on the basis of EU regulations applicable in the food hygiene area, was a practice whereby the 
notified  draft  technical  regulations  repeated,  often  partially  and  in  an  incomplete  way,  the 
provisions  laid  down  in  the  applicable  EU  regulations.  According  to  the  Treaty  on  the 
Functioning  of  the  European  Union,  a  regulation  has  general  application,  is  binding  in  its 
entirety  and  is  directly applicable  in  all  Member  States  (Article  288  TFEU).  Thus,  Member 
States may not lay down rules in the area governed by directly applicable EU legislation, even 
identical ones, as they would interfere with the correct application of the EU legislation and 
cause uncertainty as to the complete application of the relevant EU law.  

Incorrect implementation of the exemptions provided for in the food hygiene regulations 

Several potential breaches have also been identified in respect of the implementation by the 
notifying  Member  States  of  the  exceptions  and the  flexibility  clauses  contained  in  the  three 
Regulations  (e.g.  Article  1(3)  and  (5)  and  Article  10(3)  of  Regulation  (EC)  No  853/2004 
laying  down  specific  hygiene  rules  for  food  of  animal  origin).  Member  States  wrongly 
implemented or went beyond what is allowed by these exemptions. 

Unjustified barriers related to Information Society services  

In the area of Information Society services the Commission identified recurrent problems in 
notified drafts concerning gambling. These  led to the issuance  of 14 detailed opinions (6  in 
2014  and  8  in  2015)  the  main  grounds  of  which  concerned  unjustified  or  disproportionate 
restrictions to the free provision of services and freedom of establishment under Articles 49 
and  56  TFEU.  For  example,  the  Commission  made  remarks  concerning  the  conditions  for 
granting the monopoly and licenses to gambling operators, the establishment requirements in 
a  given  Member  State  of  the  service  provider  or  of  its  ICT  infrastructure  or  regarding  the 
blocking of websites.  

Other recurring issues in the detailed opinions concerning gambling related to the compliance 
with  the  Data  Protection  Directive  95/46/EC,  restrictions  to  the  free  movement  of  goods 
(Article 34-36 TFEU) and breach of product–related secondary legislation such as Regulation 
(EC)  No  765/2008  on  marketing  of  products,  accreditation  and  market  surveillance,  the 
radio  equipment  and 
Machinery  Directive  2006/42/EC,  Directive  1999/5/EC  on 
telecommunications 
terminal  equipment,  Directive  2014/30/EU  on  Electromagnetic 
Compatibility  and  the  Low  Voltage  Directive  2014/35/EU.  For  example,  the  Commission 

14 

 
raised concerns regarding requiring CE marking, assessment by conformity assessment bodies 
or non-recognition of foreign conformity assessment bodies. 

Standards – making them mandatory, requring additional test methods  

Another  recurring  issue  is  a  practice  whereby  national  legislation  seeks  to  make  voluntary 
European harmonised standards compulsory by inserting them into national law.  

In this context, under the New Approach directives, only "essential requirements" listed in the 
harmonising Directives are mandatory. European harmonised standards are one of the ways of 
guaranteeing  the  presumption  of  conformity  with  the  mandatory  essential  requirements  and 
should thus remain voluntary. 

This practice by the Member States would create barriers to trade within the internal market 
since products complying with the essential requirements of New Approach Directives but not 
with  the  European  harmonised  standards,  could  not  freely  circulate  in  the  Member  State  in 
question.  

Moreover,  some  Member  States  intended  to  develop  and  to  require  additional  (non-
standardised)  test  methods  to  those  provided  for  by  harmonised  standards  while,  additional 
national  methods  cannot  be  imposed  by  Member  States  in  the  light  of  the  case  law  of  the 
CJEU as well as primary and secondary EU legislation. National (even voluntary) procedures 
linked to the verification/testing of characteristics not harmonised in harmonised standards are 
therefore not allowed.  

All of the above-mentioned recurrent practices have been discussed with the Member States 
in the framework of the Standing Committee of Technical Regulations, which meets twice per 
year.  In  addition,  these  recurrent  practices  will  be  also  discussed  in  the  context  of  bilateral 
compliance meetings with the Member States.  

► Reactions 

The  Single  Market  Transparency  Directive  allows  for  a  formal  and  structured  exchange  of 
information between the Members States and the Commission and among Members States to 
take  place  when  assessing  notified  drafts.  The  intensity  of  this  exchange  of  information  is 
demonstrated by the high number of reactions sent by the Commission and the Member States 
to  the  notifications  and  by  the  replies  of  the  notifying  Member  States  and  the  subsequent 
exchange of messages. Thanks to this exchange of information, the Member States have also 
the possibility to ascertain the degree of compatibility of notified drafts with European Union 
legislation.  When  necessary,  the  Commission's  services  also  meet  at  expert  level  with 
representatives of the Member States to clarify outstanding issues. The Commission can also 
send  to  the  Member  States  requests  for  supplementary  information  in  order  to  clarify  the 
scope of the notified technical regulations. 

The  intensity  of  this  dialogue  is  showed  in  the  table  below  which  indicates  the  number  of 
notifications per Member State for each year of the period considered and the comments and 
detailed opinion issued by the Commission regarding those notifications46. 

46  

This table uses a different methodology from the rest of the report for the calculation of the number of 
detailed  opinions  and  comments  issued  by  the  Commission.  While  the  rest  of  the  report  refers  to 
detailed opinions and comments issued in the course of the relevant period (2014 and 2015), the table 
refers  to  detailed  opinions  and  comments  issued  with  regard  to  notifications  carried  out  in  2014  and 
2015. Therefore, the table includes detailed opinions and comments issued in the beginning of 2016 for 
notifications  made  in  the  end  of  2015.  Likewise,  the  table  does  not  include  detailed  opinions  and 
comments issued in the beginning of 2014 for notifications made in the end of 2013. 

15 

 
                                                            
In the period considered the Commission issued 141 detailed opinions (60 from 2014, 81 from 
2015),  which  represents  10.2%  of  the  total  number  of  drafts  notified  by  the  Member  States 
over  the  reporting  period.  This  figure  shows  a  10%  decrease  in  the  number  of  detailed 
opinions  issued  by  the  Commission  compared  to  the  previous  two  years.  For  their  part,  the 
Member  States    issued  131  detailed  opinions  (64  from  2014  and  67  from  2015),  which 
represents a decrease compared to the previous two years (157 detailed opinions). Of the 589 
comments issued during the reporting period (634 had been issued in the previous two years), 
352 were made by the Commission (161 in 2014 and 191 in 2015) and 237 by the Member 
States (112 in 2014 and 125 in relation to notifications from 2015) (see Annexes 2.4 and 2.6). 

The table below shows the number of reactions (comments and detailed opinions) issued by 
each Member State in the reporting period. The numbers in the table provide some indications 
on the participation of Member States in the dialogue triggered by the notification and on the 
specific  interests  of  some  Member  States  whose  reactions  are  more  contentrated  in  specific 
sectors. Austria, France, Germany, Italy, Poland, Spain and the United Kingdom are among 
the most active Member States. An analysis of the reactions per Member State and by sector 
shows  a  particular  interest  of  Austria,  France,  Italy,  Slovakia  and  Spain  for  the  agriculture, 

16 

NotificationsCommentsD.O.NotificationsCommentsD.O.Austria3810243141Belgium20322012Bulgaria6011314Croatia1021420Cyprus1452310Czech Republic264037116Denmark29633954Estonia18901732Finland342137132France4915569815Germany50656174Greece730833Hungary241052253Ireland621201Italy29742024Latvia15222132Lithuania437819Luxembourg200100Malta531110Netherlands591104452Poland25333682Portugal7422243Romania241131792Slovakia23723592Slovenia812611Spain21933084Sweden38613260United Kingdom649479104Total6551536272714182Member States20142015 
 
 
fishery  and  foodstuffs  sector;  of  Germany  for  the  telecoms  sector;  of  Poland  for  the 
mechanics sector; and of Malta for the domestic and leisure equipment sector (mostly linked 
with gambling machines). 

Thanks to the access to all notifications and to the messages exchanged within the dialogues, 
Member States can use the Single Market Transparency Directive as a benchmarking tool. It 
allows  them  to  draw  on  the  ideas  of  their  partners  in  order  to  solve  common  problems 
regarding technical regulations and to identify when a draft technical regulation could be in 
breach of EU law.  

In 3 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 2.5). 

1.6. 

Use of the urgency procedure 

Out of a total of 1382 notifications, the Member States made 76 (40 in 2014 and 36 in 2015) 
requests  to  apply  the  urgency  procedure  to  notified  drafts.  The  Commission  confirmed  the 
strict  conditions  required  by  the  Single  Market  Transparency  Directive  for  the  urgency 
porcedure to apply, 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 for 

17 

ConstructionAgriculture, Fisheries and FoodstuffsTransportEnergy, Minerals, WoodTelecomsMechanics98/48/EC ServicesEnvironmentDomestic And Leisure EquipmentPharmaceuticals And CosmeticsChemicalsGoods and Misc. ProductsHealth, Medical EquipmentAustria21011051332210Belgium0300000000000Bulgaria2000010100050Croatia0400000100000Czech Republic0800020000050Denmark0401000001000Estonia0300000000010Finland0203000100000France3903041101120Germany44103520008020Greece0000000000050Hungary0800010000120Ireland0200000000020Italy01120210100260Lithuania0000000000030Malta00000010100000Netherlands0100000000300Poland65100100200380Portugal0100000100050Romania1100010000050Slovakia01300000000070Slovenia0800000000000Spain32501000100070Sweden1311001100000United Kingdom2401010401260 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
cases  in  which  the  justification  was  not  sufficiently  established  or  was  based  on  purely 
economic  grounds  or  national  administrative  delay  as  well  as  in  cases  for  which  no 
unforeseeable circumstances were demonstrated. The urgency procedure was deemed justified 
in  60  cases  (29  in  2014  and  31  cases  in  2015),  in  particular  concerning  psychotropic 
substances,  control  of  narcotics,  medicinal  products,  fight  against  terrorism,  firearms, 
pesticides, infection of bees, prohibition of products that are harmful to health and fireworks 
(see Annex 2.7). 

1.7. 

Notification of "fiscal or financial incentive measures" 

According to the Single Market Transparency Directive, 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  2014-2015  Member  States  notified  70  (35  in  2014  and  35  in  2015)  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  the  Single 
Market Transparency Directive 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 shared with the Member States 
Guidelines on the definition and notification of "fiscal or financial measures" for the purposes 
of the Single Market Transparency Directive. 

1.8. 

Follow-up to Commission reactions 

According to Article 6(2) of the Single Market Tranpsarency Directive, Member States have 
to report on the action they propose to take in response to a detailed opinion. 

From 2014 to 2015, the ratio between the number of responses given by the Member States 
and the volume of detailed opinions issued by the Commission was satisfactory, but could be 
further improved (an average of 79% over the period). The number of completely satisfactory 
responses was in line with the previous two years (an average of 56% over the period 2014-
2015 in comparison with 54% over the period 2012-2013) (see Annex 2.8).  

In  the  period  considered  the  Member  States  withdrew  43  draft  technical  regulations.  In  12 
cases (7 in 2014 and 5 in 2015) the withdrawal followed the delivery of a reaction (detailed 
opinion  or  comments)  by  the  Commission.  Some  of  the  reasons  of  these  withdrawals  are, 
inter alia, the introduction by the notifying Member State of substantial changes to the draft 
technical  regulation  which  require  a  new  notification  (Article  5(1)  of  the  Single  Market 
Transparency Directive) or the simple decision of the national authorities not to go ahead with 
the adoption of the draft technical regulation.   

For other notified draft technical regulations the dialogue is still on-going.  

1.9. 

Follow-up to the notification procedure  

For  all  other  cases  in  which  the  potential  breaches  of  the  EU  internal  market  law  have  not 
been  entirely  removed  within  the  framework  of  the  notification  procedure,  the  Commission 
conducted  further  investigations  which  in  some  cases,  eventually  led  to  launching  a  pre-
infringement dialogue with the Member States (the so-called EU Pilot) and, in some cases, to 
infringement proceedings (Article 258 of the TFEU) on subjects such as sugar content for jam 
and marmalade and use of the reserved denomination "marmalade", quality and transparency 
of the supply chain for virgin olive oils, wine and spirits, labelling of beef meat in the context 

18 

 
of a regional quality system, online gambling, fuel quality, gas appliances, the safety of road 
barriers and packaging and packaging waste.  

In  the  period  concerned,  the  Commission  also  started  EU  Pilot  cases  and  where  necessary, 
infringement  proceedings  concerning,  inter  alia,  the  breach  of  obligations  under  the  Single 
Market Transparency Directive. For all these cases, the Commission drew the attention of the 
national authorities to their duty to notify and to respect the standstill period provided for in 
Article 6(2) of the Single Market Transparency Directive. The Commission recalled that the 
CJEU  held  that  the  adoption  of  technical  regulations  in  breach  of  "the  obligation  to  notify 
constitutes  a  substantial  procedural  defect  such  as  to  render  the  technical  regulations  in 
question inapplicable to individuals". Consequently, individuals can resort to national courts 
which "must decline to apply a national technical regulation which has not been notified in 
accordance with the directive" (Case C-194/94 CIA Security International, paragraphs 44, 48 
and 54; Case-226/97 Lemmens, paragraph 33; Case C-303/04 Lidl Italia, paragraphs 23, 24).  

1.10. 

Structured exchanges with the Member States  

The regular meetings of the Single Market Transparency Directive Committee allowed views 
to be exchanged on points of general interest and also on specific aspects of the notification 
procedure.  

As regards technical regulations, the discussions particularly concerned the urgency procedure 
under  the  Single  Market  Transparency  Directive;  access  to  documents  of  the  Commission 
under  Regulation  (EC)  No  1049/2001  regarding  public  access  to  European  Parliament, 
Council  and  Commission  documents47  and  confidential  notifications;  the  obligation  for 
Member  States  to  communicate  to  the  Commission  the  final  text  of  a  notified  technical 
regulation;  developments  on  the  jurisprudence  of  the  CJEU  concerning  the  Single  Market 
Transparency Directive. 

Based on requests from the Member States and on the initiative of the Commission to provide 
clarification  on  some  recurrent  barriers  or  on  new  legislation,  the  Commission  made 
presentations concerning the notification procedure for the Swiss and the EEA notifications; 
technical regulations in the area of psychoactive substances; the proposal for a regulation on 
electronic  identification  and  trust  services  for  electronic  transactions  in  the  internal  market; 
the relation between REACH and the Single Market Transparency Directive; issues related to 
the  broadcasting  exemption  from  the  Single  Market  Transparency  Directive;  the  mutual 
recognition clause and Articles 34-36 TFEU; the Fuel Quality Directive48; the food hygiene 
package49; the Packaging and Packaging Waste Directive50; the notification procedure under 
Regulation (EU) No 1169/201151.  

47  

48  

49  

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. 
Directive  2009/30/EC  of  the  European  Parliament  and  of  the  Council  of  23  April  2009  amending 
Directive  98/70/EC  as  regards  the  specification  of  petrol,  diesel  and  gas-oil  and  introducing  a 
mechanism  to  monitor  and  reduce  greenhouse  gas  emissions  and  amending  Council  Directive 
1999/32/EC  as  regards  the  specification  of  fuel  used  by  inland  waterway  vessels  and  repealing 
Directive 93/12/EEC, OJ L 140, 5.6.2009, p. 88–113. 
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 

19 

 
  
                                                            
Several Member States made presentations on their best practices for notifications under the 
Single Market Transparency Directive. 

Seminars  were  also  held  in  several  Member  States,  allowing  direct  dialogue  between  the 
Commission  and  the  national  authorities  involved  in  the  notification  procedure  and  helping 
the latter to become familiar with the technical elements of the notification procedure.  

The  Commission  has  included  presentations  on  the  application  of  the  Single  Market 
Transparency  Directive  in  the  agendas  of  the  compliance  dialogue  meetings  with  Member 
States which are carrried out following the commitment in the Single Market Strategy.  

1.11.  Requests  for  access  to  documents  issued  under  the  Single  Market  Transparency 

Directive 

From 2014 to 2015 the Commission received 236 (98 in 2014 and 138 in 2015) requests for 
access  to  documents  issued  in  the  framework  of  the  Single  Market  Transparency  Directive. 
The  major  part  of  them  concerned  detailed  opinions  and  comments  delivered  by  the 
Commission.  In  68  of  the  cases,  access  to  the  requested  documents  was  given.  In  the  other 
cases,  access  to  documents  was  refused  or  partially  refused  while  the  dialogue  with  the 
Member States, aiming to remove the potential obstacle to trade, was ongoing. 

1.12. 

Transparency 

Transparency is a fundamental feature of the notification procedure. The TRIS public website 
is  the  window  that  ensures  stakeholders  are  constantly  informed  about  all  draft  technical 
regulations under preparation by Member States and that a dialogue between stakeholders and 
the Commission services takes place, thanks to the new contribution functionality mentioned 
in paragraph 1.3. 

The success of the TRIS public website is corroborated by numbers: 

  At the end of 2015 there were 5,196 subscribers to the TRIS mailing list compared to 

4,441 in 2013, with an increase of 17% in the two-year reporting period;  

  In  the  period  considered  244,736  searches  have  been  carried  out  through  the  TRIS 
public  website  compared  to  177,147  searches  in  the  period  2012-2013,  with  an 
increase of 38%; 

  Also, access to  notifications by the users has increased from 869,791 occurrences in 

2013 to 1,203,299 by the end of 2015, determining a specific increase of 38%. 

50  

51  

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 
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. 
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 Text with EEA relevance, OJ L 304, 22.11.2011, p. 18–63. 

20 

 
 
                                                                                                                                                                                          
3. 

CONCLUSION 

During  the  period  2014-2015,  the  usefulness  of  the  procedure  has  again  been  confirmed  in 
terms  of  transparency,  administrative  cooperation  and  prevention  of  techical  barriers  in  the 
internal market.  

The preventive and networking approach of the notification procedure, has 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 an internal market which is rapidly evolving, but is not yet 
delivering on its full potential. 

There is  still room  for improvement in  the application  of the procedure, namely concerning 
the  number  of  notifications  from  some  Member  States  and  their  compliance  with  the 
notification obligations. A higher number of notifications and a more active participation of 
Member States in the procedure would favour the prevention of new technical barriers and the 
identification of systemic issues in each Member State and across the EU. This would help the 
dialogue with the Commission and would facilitate a more targeted and effective approach to 
barriers to intra-EU trade. 

The  high  number  of  detailed  opinions  and  comments  issued  during  the  reporting  period 
demonstrates that there is an increasing risk of fragmentation of the internal market for goods. 
On  average  79%  of  the  detailed  opinions  issued  by  the  Commission  were  replied  to  by  the 
Member  States  concerned  and  dialogues  followed  to  remove  any  incompatibility  with  EU 
law, thus avoiding infringement procedures. 

The importance of the Single Market Transparency Directive is proved by the high interest of 
stakeholders in the notification procedure, as noted, inter alia, in the REFIT Platform opinion 
on  the  Directive52.  This  growing  interest  mirrors  the  effort to  improve  the  transparency  and 
the efficiency of the TRIS public website.    

The  notification  procedure  has  also  confirmed  its  usefulness  in  providing  the  possibility  to 
identify areas where harmonisation at EU level might be an option. 

When  applying  the  Single  Market  Transparency  Directive  the  Commission  remains  vigilant 
regarding the principle of better regulation and the need to sustain a favourable environment 
for  the  competitiveness  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 to enhance the competitiveness of European enterprises in the EU and abroad, taking 
into  account  the  links  between  the  notification  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 Single Market Transparency 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. 

52  

https://ec.europa.eu/info/files/refit-platform-recommendations-internal-market-xii6a-single-market-
transparency-directive_en 

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