REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE ON THE OPERATION OF THE SINGLE MARKET TRANSPARENCY DIRECTIVE FROM 2016 TO 2020
Date: 2022-09-23
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: EU Member State, approximation of laws, coronavirus disease, epidemic, exchange of information, free movement of goods, information society, single market, technical regulations, trade restriction

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 23.9.2022  COM(2022) 481 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE ON THE OPERATION OF THE SINGLE MARKET TRANSPARENCY DIRECTIVE FROM 2016 TO 2020 {SWD(2022) 297 final}  
 
 
Contents 

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

1.  Developments 2016-2020 ................................................................................................... 4 

1.1. 

Improvements to the notification procedure ................................................................ 4 

1.2.  Use of the notification procedure within the context of ‘better regulation’ and mutual 
recognition .............................................................................................................................. 5 

2.  Application of the notification procedure ........................................................................... 5 

2.1 

Effectiveness: general overview .................................................................................. 5 

2.2  Use of the urgency procedure .................................................................................... 12 

2.3  Notification of ‘fiscal or financial measures’ ............................................................ 12 

2.4 

Follow-up to Commission reactions .......................................................................... 13 

2.5 

Follow-up to the notification procedure .................................................................... 13 

Structured  exchanges  with  the  Member  States,  EEA-EFTA  countries,  Switzerland 
2.6 
and Turkey ............................................................................................................................ 13 

2.7 

Transparency ............................................................................................................. 15 

3.  Conclusion ........................................................................................................................ 15 

1 

 
 
 
EXECUTIVE SUMMARY 

This  report  is  drafted  and  submitted  in  compliance  with  Article  8  of  Directive  (EU) 
2015/15351  (the  ‘Single  Market  Transparency  Directive’).  It  analyses  the  results  of  the 
application of one of the cornerstones of the single market from 2016 to 2020: the notification 
procedure laid down by the Single Market Transparency Directive. The report highlights the 
notification procedure’s important contribution to the functioning of the single market and to 
implementing the Better Regulation guidelines and toolbox2, as well as its pivotal role during 
the COVID-19 pandemic.  

Notifying  the  Commission  of  national  technical  regulations  before  their  adoption  has 
continued to be an important tool to address the emergence of barriers to trade, with the aim 
to prevent them.  It has also continued to be a good channel to ensure cooperation between the 
Commission  and  the  Member  States  and  among  the  Member  States  themselves.  This  is 
particularly important in critical and unforeseen circumstances such as during the COVID-19 
pandemic. Also, technical regulations are notified to the Commission and the final texts of the 
notified measures are translated into 23 official languages of the EU3.  

Additionally,  the  implementation  of  the  Single  Market  Transparency  Directive  requires  the 
Commission  to  follow  up  and  monitor  all  notifications  raising  concerns  as  to  their 
compatibility  with  EU  law.  In  that  context,  the  Commission  pays  particular  attention  to 
measures having the highest impact on the single market4.  

1 

2 

3  
4  

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, OJ L 241, 17.9.2015, p. 1. 
Action plan for improving the regulatory environment, COM(2002) 278. See also Better Regulation for 
Growth  and  Jobs  in  the  European  Union,  COM(2005)  97;  Implementing  the  Community  Lisbon 
programme:  A  strategy  for  the  simplification  of  the  regulatory  environment,  COM(2005)  535;  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 Better Regulation: Delivering better results for a stronger Union, COM(2016) 615.  
Irish translation is not available.  
https://ec.europa.eu/info/sites/info/files/communication-enforcement-implementation-single-market-
rules_en_0.pdf  

2 

 
 
                                                           
INTRODUCTION 

As ‘an engine for building a stronger and fairer EU economy’,  the single market is a key part 
of the Commission’s six priorities for 2019-20245. The single market has improved prosperity 
and opportunities for businesses and the public in Europe. A well-functioning single market 
stimulates competition and trade, improves efficiency, raises quality and helps  reduce prices 
for businesses and consumers6. 

As part of the Commission’s March 2020  new industry strategy package7, a communication 
on  barriers8  and  an  action  plan  on  single  market  enforcement9  were  adopted  to  further 
improve  competitiveness  and  facilite  the  integration  of  companies  of  all  sizes  in  EU  and 
global value chains. Action 10 of the Commission action plan on single market enforcement 
refers  to  the  Single  Market  Transparency  Directive.  In  that  context,  ‘in  line  with  the  more 
strategic  approach  for  the  Commission’s  enforcement  actions,  the  implementation  of  the 
Single Market Transparency Directive is built on four axes:   

(i) 

(ii) 

(iii) 

(iv) 

Member  States  notify  to  the  Commission  all  draft  technical  regulations  
concerning  goods and information  society  services;   
the  Commission  follows  up  on  all  notifications  raising  concerns  as  to  the  their  
compatibility  with  EU  law;   
in  calibrating its follow-up, the Commission pays particular attention to  measures  
having  the  highest  impact on the single market;  
the Commission monitors legislation which was subject to a Commission reaction  
under  the  Single  Market  Transparency  Directive  and  which,  in  the  absence  of 
appropriate adjustments, may give rise to infringement proceedings’.  

The Commission puts a clear focus on prevention and enforcement in relation to cases  with 
the most significant impact on the single market economically or in some other way.  

The Single Market Transparency Directive aims to prevent the emergence of new barriers in 
the  single  market  by  focusing  on  transparency,  dialogue,  prevention  and  better  regulation. 
Member  States  can  participate  on  an  equal  footing  with  the  Commission  in  this  procedure. 
Stakeholders have access to both national technical regulations under preparation and the final 
texts  of  the  notified  measures,  translated  in  23  official  languages  of  the  EU.  Therefore, 
economic  operators  can  anticipate  the  creation  of  obstacles  to  trade  and  avoid  unnecessary 
and costly administrative burdens affecting their business. 

The  notification  procedure  for  national  technical  regulations  under  the  Single  Market 
Transparency  Directive  allows  the  Commission  and  the  Member  States  to  examine,  before 
their adoption, the technical regulations any Member State intends to introduce for products 
(industrial,  agricultural  and  fishery)  and  information  society  services  (see  Annex  1  to  the 
Commission  staff working  document  accompanying this report).  The procedure  applies  in  a 
simplified manner to European Free Trade Association (EFTA) states which are parties to the 
Agreement on the European Economic Area (EEA), to Switzerland, and to Turkey (see Annex 
4).   

5  
6  
7  
8  
9  

https://ec.europa.eu/info/strategy/priorities-2019-2024/economy-works-people/internal-market_en 
https://ec.europa.eu/commission/presscorner/detail/en/fs_20_427 
https://ec.europa.eu/commission/presscorner/detail/en/ip_20_416 
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM%3A2020%3A0093%3AFIN  
See footnote 4. 

3 

 
                                                           
The Single Market Transparency Directive also plays a key role in the ‘country knowledge’ 
dialogue  meetings  with  Member  States  and  stakeholders10.  Such  meetings  are  part  of  the 
single  market  strategy’s  efforts  to  ensure  a  culture  of  compliance  and  smart  enforcement11. 
The  Commission  sees  these  meetings  as  an  opportunity  for  dialogue  to  improve  the 
implementation  of  the  Single  Market  Transparency  Directive.  In  this  context,  the  dialogue 
under  the  Directive,  combined  with  other  indicators,  enables  the  Commission  to  better 
identify the problematic sectors and structural problems in the Member States.  

This  report  drafted  and  submitted  in  compliance  with  the  Single  Market  Transparency 
Directive  is  a  snapshot  of  its  operation  from  2016  to  2020  both  from  a  qualitative  and 
quantitative angle.  

In 2020, the notification procedure under the Single Market Transparency Directive played a 
crucial role in the management of the COVID-19 pandemic and contributed to a coordinated 
approach to the health crisis throughout the EU. The spread of the virus caused the disruption 
of  global  supply  chains.  During  the  pandemic,  the  integrity  of  the  single  market  and,  more 
broadly, the preservation of production and distribution value chains  ensuring  the necessary 
supplies  to  our  health  systems  were  jeopardised.  The  Directive  provided  a  framework 
allowing Member States to act in a coordinated way.  

1. 

DEVELOPMENTS 2016-2020 

With  3 553  notifications  received  in  the  5-year  period  2016-2020  (see  Annex  3.1),  the 
dialogue  that  unfolded  in  the  context  of  the  Single  Market  Transparency  Directive 
demonstrated a good level of participation by the Member States, which issued 243 detailed 
opinions and 475 comments (see Annex 3.6). This was coupled with frequent reactions by the 
Commission  on  the  notified  technical  regulations,  notably  212  detailed  opinions  and  816 
comments issued by the Commission (see Annex 3.4). The highest number of reactions of the 
Commission  and  the  EU  Member  States  concerned  agriculture,  fishing  and  foodstuffs  and 
construction products.  

The  introduction  of  new  IT  tools  over  the  reference  period,  as  described  in  the  paragraphs 
below,  facilitated  economic  operators’  participation  in  the  Single  Market  Transparency 
Directive procedure. 

The  case-law  of  the  Court  of  Justice  of  the  European  Union  (CJEU)  shed  light  on  some 
interpretative  conundrums  of  the  Single  Market  Transparency  Directive.  These  included  the 
definition  of  technical  regulations,  the  classification  of  new  intermediation  services  in 
emerging sectors related to collaborative economy models, the right of access to documents in 
relation  to  the  Single  Market  Transparency  Directive  procedure  and  the  penalty  for  non-
notification12. 

1.1. 

Improvements to the notification procedure 

One  of  the  Single  Market  Transparency  Directive’s  objectives  is  to  inform  economic 
operators,  including  small  and  medium-sized  enterprises,  in  advance  of  planned  technical 
regulations  before  their  adoption  by  the  Member  States.  This  allows  economic  operators  to 
make  their  voices  heard  and  to  adapt  their  activities  in  good  time  to  future  technical 

10  

11  

12  

The ‘country knowledge’ dialogue consists in structured meetings with the national authorities involved 
in the notification procedure in each EU Member State and with national stakeholders. 
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. 
See  Annex  2  for  further  details  on  CJEU  case-law  on  the  Single  Market  Transparency  Directive  in 
2016-2020.  

4 

 
                                                           
regulations13.  The high number of contributions  on notifications sent  by stakeholders  shows 
that this right of scrutiny is exercised extensively and is helping the Commission and national 
authorities to detect barriers to trade.  

In  an  ever-evolving  effort  towards  transparency  and  efficiency,  in  2015  the  Commission 
worked  to  develop  a  new  function  on  the  Technical  Regulation  Information  System  (TRIS) 
website14.  This  function  was  put  in  place  in  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.  From  2016-2020,  the 
Commission received 1 618 contributions via this function (144 in 2016, 421 in 2017, 175 in 
2018, 281 in 2019 and 597 in 2020). 

1.2. 

Use  of  the  notification  procedure  within  the  context  of  ‘better  regulation’  and 
mutual recognition 

In  its  Communication  Better  regulation  for  growth  and  jobs  in  the  EU15,  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. 

The Single Market Transparency Directive also contributes to better mutual recognition. The 
mutual recognition principle, which derives from the case-law of the CJEU on Articles 34 to 
36  TFEU,  ensures  market  access  for  goods  that  are  not,  or  are  only  partly,  subject  to  EU 
harmonisation legislation. It guarantees that any good lawfully marketed in one Member State 
can  in  principle  be  sold  in  another.  The  assessment  of  national  regulations  before  their 
adoption helps minimise the risk that these rules raise unjustified regulatory barriers to trade, 
notably in the light of the mutual recognition principle. This is because the Commission can: 
(i) correct the text of the single market clauses in drafts notified by the Member States under 
the  Single  Market  Transparency  Directive  procedure;  and  (ii)  recommend  that  the  Member 
States insert the single market clause in notified draft national measures when it is missing in 
the notified drafts.    

2. 

2.1 

APPLICATION OF THE NOTIFICATION PROCEDURE 

Effectiveness: general overview  

► Volume of notifications and sectors involved 

From 2016 to 2020, the Commission received 3 553 notifications (700 in 2016, 676 in 2017, 
666 in 2018, 657 in 2019 and 854 in 2020)16.  

Marked differences have been noticed in the number of notifications among Member States, 
with  some carrying out  on average more than 50 notifications per  year  and others  notifying 
less than 10 per year (see Annex 3.2). While this gap can be partly explained with reference to 
the  way  the  state  organisation  is  structured  in  different  countries  (e.g.  presence  of 

13  
14  
15 
16  

See Recital 7 of the Single Market Transparency Directive. 
http://ec.europa.eu/growth/tools-databases/tris/en/ 
See supra, footnote 2. 
See Annex 3.1. These figures do not include notifications from  EFTA countries that are signatories of 
the EEA Agreement (Norway, Lichtenstein and Iceland),  or notifications from Turkey or Switzerland. 
In  the  reporting  period,  the  Commission  received  232  notifications  by  these  countries  (124  by 
EFTA/EEA countries, 74 by Turkey and 34 by Switzerland). See Annex 4 for more information about 
these notifications.  

5 

 
                                                           
regional/local authorities with regulatory powers), by lack of awareness or by a higher/lower 
degree of regulatory activity, this wide discrepancy raised doubts as to whether there has been 
full  compliance  with  the  notification  obligations.  Analysis  showed  that  in  2017,  2018  and 
2019  almost  all  Member  States  did  not  notify  nor  re-notify  draft  technical  regulations. 
However,  the  vast  majority  of  Member  States  had  relatively  low  numbers  of  non-notified 
drafts, equal to or below 10 per year. 

A correlation between the size of the Member States and the number of notifications can be 
observed in Annex 3.2 (Table 1), with the biggest Member States notifying in general more 
than the medium-sized  and small  ones. This  can  be partly explained  by  a higher number of 
regional and local authorities that 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  certain  bigger  Member  States  and  bigger  Member  States  with  a 
centralised structure notified more than Member States with a decentralised structure.  

As in the previous reporting period, the highest number of notifications over 2016-2020 
concerned the construction sector, followed by the notifications in the area of agricultural 
products, fishery, aquaculture and other foodstuffs.  

Numerous  notifications  were  also  made  in  the  area  of  information  society  services,  in  the 
environmental  and  chemical  sectors  (mainly  on  packaging  and  packaging  waste,  plastic 
products,  fertilisers,  plant  protection  products  containing  glyphosate  or  neonicotinoids, 
emission  standards,  cosmetic  products  containing  microplastics)  and  transport  (e.g.  on 
electric  vehicles,  special  equipment  for  passenger  vehicles  and  taxis,  snow  mobiles, 
e-scooters, ships and recreational craft, drones) (see Annex 3.3).  

► Issues addressed by the Commission in its reactions 

In  the  non-harmonised  areas,  i.e.  those  in  which  national  measures  in  the  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 connected to the 
information society) TFEU, the Commission’s reactions were intended to draw  the Member 
States’ attention to potential non-justified obstacles to trade after assessing the necessity and 
the  proportionality  of  the  measure  in  line  with  the  case-law  of  the  Court  of  Justice  of  the 
European Union.  

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

 

In 2016-2020, Member States notified 765 draft technical regulations in the field of 
construction  (131  in  2016,  181  in  2017,  139  in  2018,  158  in  2019  and  156  in 
202017). These drafts concerned all types of construction products,  including 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, and 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 

17  

See Annex 3.3. 

6 

 
                                                           
mainly under Regulation (EU) No 305/2011 laying down harmonised conditions for 
the marketing of construction products18.  

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)19  and  Directive  92/42/EEC  on  efficiency 
requirements for new hot-water boilers fired with liquid or gaseous fuels20. 

Technical  regulations  relating  to  buildings’  energy  efficiency  were  assessed  under 
Directive  2012/27/EU  on  energy  efficiency21,  Directive  2010/31/EU  on  the  energy 
performance of buildings22 and Directive 2009/125/EC establishing a framework for 
the setting of ecodesign requirements for energy-related products23. 

The  Commission  also  assessed  draft  legislation  concerning  requirements  for 
motorway  communications  equipment.  The  draft  notified  was  examined  under 
Directives 1999/5/EC24, 2006/95/EC25 and 2004/108/EC26. 

 

On  agricultural  products,  fishery,  aquaculture  and  other  foodstuffs,  from  2016 
to 2020 Member States notified 693 draft technical regulations (145 in 2016, 106 in 
2017, 146 in 2018, 161 in 2019 and 135 in 202027). The areas covered by these drafts 
included, for instance, 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  were  examined  under  the  TFEU 
provisions  on  the  free  movement  of  goods  and  Regulation  (EU)  No  1151/2012  on 
quality schemes for agricultural products and foodstuffs28.  

18  

19  

20  

21  

22  

23  

24  

25  

26  

27  
28  

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. 
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. 
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. 
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. 
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. 
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. 
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 91, 7.4.1999, p. 10.  
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, 27.12.2006, p. 10. 
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, 
31.12.2004, p. 24.  
See Annex 3.3. 
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. 

7 

 
 
                                                           
During  the  relevant  period,  the  Commission  examined  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  foodstuffs29, 
Regulation (EC) No 853/2004 laying down specific hygiene rules for food of animal 
origin30  and  Regulation  (EC)  No  854/2004  laying  down  specific  rules  for  the 
organisation  of  official  controls  on  products  of  animal  origin  intended  for  human 
consumption31. 

Other notifications concerned the labelling of foodstuffs. The Commission assessed 
their  compatibility  with  Regulation  (EU)  No  1169/2011  on  the  provision  of  food 
information  to  consumers32,  in  particular  with  the  provisions  on  nutritional 
declarations, or other sector-specific provisions on consumer information33.  

 

In  the  information  society  services  sector,  Member  States  notified  255  measures 
(58 in 2016, 43 in 2017, 34 in 2018, 57 in 2019 and 63 in 202034), with the bulk of 
notifications concerning draft legislation affecting electronic commerce, social media 
and  online  platform  operators,  net  neutrality  and  media  pluralism,  fake  news  and 
online  hate  speech,  as  well  as  other  rules  on  information  society  services  falling 
within the scope of Directive 2000/31/EC (‘the e-Commerce Directive’)35 and rules 
related  to  audiovisual  media  services  falling  within  the  scope  of  Directive  (EU) 
2018/1808 (the revised Audiovisual Media Services Directive)36.   

29  

30  

31  

32  

33  

34  
35  

36  

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. 
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. 
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.  Regulation  (EC)  No  854/2004  was  repealed  by 
Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official 
controls and other official activities performed to ensure the application of food and feed law, rules on 
animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 
999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 
652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council 
Regulations  (EC)  No  1/2005 and  (EC)  No  1099/2009  and Council  Directives  98/58/EC,  1999/74/EC, 
2007/43/EC,  2008/119/EC  and  2008/120/EC,  and  repealing  Regulations  (EC)  No  854/2004  and  (EC) 
No  882/2004  of  the  European  Parliament  and  of  the  Council,  Council  Directives  89/608/EEC, 
89/662/EEC,  90/425/EEC,  91/496/EEC,  96/23/EC,  96/93/EC  and  97/78/EC  and  Council  Decision 
92/438/EEC (Official Controls Regulation), OJ L 95, 7.4.2017, p. 1.  
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. 
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. 
See Annex 3.3. 
Directive 2000/31/EC of the European Parliament and of the  Council of 8 June 2000 on certain legal 
aspects  of  information  society  services,  in  particular  electronic  commerce,  in  the  Internal  Market 
(‘Directive on electronic commerce’), OJ L 178, 17.7.2000, p. 1. 
Directive  (EU)  2018/1808  of  the  European  Parliament  and  of  the  Council  of  14  November  2018 
amending Directive 2010/13/EU on the coordination of certain provisions laid down by law, regulation 
or  administrative  action  in  Member  States  concerning  the  provision  of  audiovisual  media  services 
(Audiovisual Media Services Directive) in view of changing market realities, OJ L 303, 28.11.2018, p. 
69. 

8 

 
 
 
                                                           
Other  Commission  reactions  were  issued  in  relation  to  notified  draft  measures 
concerning rules on information society services focusing on electronic identification 
and trust services falling under the scope of Regulation (EU) 910/2014 (the ‘eIDAS 
Regulation’)37 and the free flow of non-personal data as regulated under Regulation 
(EU)  2018/180738.  There  were  also  notifications  on  digital  data  privacy, 
cybersecurity, data retention, electronic invoicing, copyright, telecom and electronic 
communications  (including  5 G),  safer  internet  for  kids,  e-books,  online  gambling 
and in several cases linked, in explicit or in ancillary terms, to the free movement of 
services  and  freedom  of  establishment  (Articles  49  and  56  TFEU,  as  well  as  the 
Services  Directive39),  to  consumer  rights  under  Directive  2011/83/EU40,  to  the 
protection  of  personal  data  under  the  General  Data  Protection  Regulation  (EU) 
2016/67941, and to the freedom of expression and the freedom to conduct a business 
as enshrined in the Charter of Fundamental Rights of the European Union.  

In the chemicals sector, the Commission received 167 notifications (32 in 2016, 32 
in 2017, 28 in 2018, 27 in 2019 and 48 in 202042), regarding areas such as biocidal 
products,  plant  protection  products  and  products  falling  within  the  scope  of 
Regulation 
the  Registration,  Evaluation, 
Authorisation  and  Restriction  of  Chemicals  (‘REACH’)43,  which  were  mainly 
examined under the Biocidal Products Regulation44, Regulation (EC) No 1107/2009 
concerning  the  placing  of  plant  protection  products  on  the  market45  and  under 
REACH. 

(EC)  No  1907/2006  concerning 

In the  environmental sector, the Commission examined 206 draft measures (55 in 
2016,  39  in  2017,  28  in  2018,  33  in  2019  and  51  in  202046).  Some  notified  drafts 
concerned  packaging  waste  and  disposable  plastic  products  and  raised  problems  of 
compatibility  with  Directive  94/62/EC  on  packaging  and  packaging  waste47  (for 

Regulation  (EU)  No  910/2014  of  the  European  Parliament  and  of  the  Council  of  23  July  2014  on 
electronic  identification  and  trust  services  for  electronic  transactions  in  the  internal  market  and 
repealing Directive 1999/93/EC, OJ L 257, 28.8.2014, p. 73. 
Regulation (EU) 2018/1807 of the European Parliament and of the Council of 14 November 2018 on a 
framework for the free flow of non-personal data in the European Union, OJ L 303, 28.11.2018, p. 59. 
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. 
Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer 
rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament 
and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European 
Parliament and of the Council, OJ L 304, 22.11.2011, p. 64. 
Regulation  (EU)  2016/679  of  the  European  Parliament  and  of  the  Council  of  27  April  2016  on  the 
protection of natural persons with regard to the processing of personal data and on the free movement of 
such data, and repealing Directive 95/46/EC (General Data Protection Regulation), OJ L 119, 4.5.2016, 
p. 1. 
See Annex 3.3. 
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. 
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. 
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, OJ L 309, 24.11.2009, p. 1. 
See Annex 3.3. 
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. 

9 

 

 

37  

38  

39  

40  

41  

42  
43  

44  

45  

46  
47  

 
                                                           
example with regard to the requirements for banning lightweight plastic carrier bags) 
and  Directive  (EU)  2019/904  on  the  reduction  of  the  impact  of  certain  plastic 
products on the environment48 (for example as regards the definitions of ‘plastic’).   

The  notification  procedure  also  allowed  the  Commission  to  intervene  in  sectors  where 
harmonisation  was  envisaged  or  under  way  at  EU  level  and  thus  prevented  Member  States 
from introducing divergent national measures. Pursuant to Articles 6(3) and 6(4) of the Single 
Market  Transparency  Directive,  the  Commission  requested  the  notifying  Member  States  to 
postpone the adoption of notified draft  technical  regulations for 12 months from the date of 
notification  in  the  fields  of  organic  production  of  plants,  animals  and  aquaculture  products 
and  foodstuffs  (notification  2018/190/BG),  organic  production  of  rabbit  meat  (notification 
2018/219/E), organic broiler quails (notification 2018/666/F) and disposable plastic products 
(notifications 2018/665/B and 2019/9/UK).  

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

During the reporting period, the Single Market Transparency Directive proved to be effective 
in  numerous  cases  as  the  national  authorities  redrafted  the  notified  drafts  according  to  the 
Commission’s  recommendations  or  withdrew  them.  A  case  in  point  was  the  notification 
concerning  a  draft  decree  obliging  car  drivers  residing  in  Italy  and  transporting  with  them 
children  under  4  years  of  age  to  use  specific  car  seat  reminder  alarm  devices  that  prevent 
minors from being left behind in the vehicle. In its detailed opinion, the Commission pointed 
out  that  several  requirements  of  the  notified  draft  were  in  conflict  with  EU  harmonisation 
rules and with the free movement of goods (Articles 34-36 TFEU). This was due to the lack 
of  evidence  for:  (i)  the  proportionality  of  the  requirement  concerning  the  prior  approval 
procedure for car seat reminder alarm devices lawfully manufactured in other Member States; 
and  (ii)  the  obligation  to  equip  those  devices  with  an  automatic  communication  system  for 
sending  messages  or  calls  via  mobile  wireless  communication  networks  to  at  least  three 
different phone numbers. The Commission highlighted that the ‘prior authorisation procedure’ 
obliging  ‘accredited  bodies’  to  apply  for  recognition  to  the  Italian  Directorate-General  for 
Motor Vehicles could be in conflict with the principle of free provision of services within the 
Union (Article 56 TFEU). The Italian authorities redrafted the proposed decree according to 
the  Commission’s  remarks,  while  ensuring  that  the  notified  draft  measure  could  attain  the 
objective of children’s safety.  

Similarly, in 2016, 2017 and 2018, the Commission received several notifications concerning 
the characteristics and specific equipment of unmanned aircraft (drones). In its reactions, the 
Commission recalled the ongoing harmonisation process at EU level and invited the Member 
States  concerned  to  cooperate  to  establish  an  EU  regulatory  framework  applicable  to 
unmanned aircraft which would ensure a high level of safety with regard to the operation of 
such  aircraft  and  make  it  possible  to  manage  the  associated  risks  relating  to  safety,  the 
protection of privacy and of personal data. The Member States concerned complied with the 
Commission’s  recommendations,  as  expressed  in  the  comments  and  detailed  opinions,  or 
withdrew the notified drafts49. 

In  2020,  at  the  outset  of  the  COVID-19  pandemic,  some    Member    States    adopted    or  
prepared national  measures  affecting  the  free movement of  personal  protective equipment 
such  as  protective  glasses,  facemasks,  gloves,  surgical  overalls  and  gowns,  and  the  free 
movement  of  medicines.  These  measures  risked  preventing  such  essential  goods  from  

48  

49  

Directive (EU) 2019/904 of the European Parliament and of the Council of 5 June 2019 on the reduction 
of the impact of certain plastic products on the environment, OJ L 155, 12.6.2019, p. 1. 
See Annex 3.9 for additional examples. 

10 

 
                                                           
reaching  those  who  needed  them  most,  notably  healthcare  workers,  field  intervention  teams 
and patients in affected areas all across Europe. They created domino effects, with Member 
States taking measures to mitigate the impact of measures taken by other Member States. In a  
short time span, restrictions spread to an increasing range of products, starting with  personal 
protective  equipment  and  extending  to  medicines.  Such  measures  disrupted  logistics  and 
distribution chains and encouraged stockpiling responses in the supply chain. Ultimately, such 
measures reintroduced internal borders at a time where solidarity between Member States was 
the  most  needed.  The  Commission  urged  Member  States  to  notify  such  measures  via  the 
Single Market Transparency Directive mechanism and provided guidance on how to do this. 
The measures notified to the Commission were assessed as a matter of high priority and the 
Commission supported Member States in correcting those measures that could have hindered 
the free movement of essential goods in the single market50. The experience of the COVID-19 
pandemic  demonstrated  the  relevance  of  the  Single  Market  Transparency  Directive 
procedures, including the urgency procedure (see paragraph 2.2), while it also offered useful 
lessons  for future tackling of adverse single market  effects  caused by  emergency situations. 
Where the measures were notified after their adoption, as was the case for approximately 150 
COVID-19-related notifications in 2020, the notification mechanism offered by the Directive 
meant that the information and peer-review benefits could still be harnessed during the crisis 
thanks to the TRIS communication platform, where Member States could get acquainted with 
the COVID measures adopted by other Member States.  

► Most commonly tackled barriers  

One  of  the  purposes  of  the  Single  Market  Transparency  Directive  is  to  detect  areas  where 
recurrent  obstacles  to  the  free  movement  of  goods  and  the  freedom  to  provide  information 
society  services  arise  and,  as  a  result,  to  identify  the  need  to  intervene  with  harmonisation 
measures aimed at ensuring a smoother functioning of the single market51. In the period under 
analysis, the Commission identified several recurrent barriers in the notified draft measures. 
These  included  the  lack  of  the  single  market  clause,  misleading  and  unclear  provisions  that 
could  have been interpreted and applied as market  restrictions  or repetition of provisions of 
EU regulations, the issue of mandatory standards, and additional test methods52. 

► Reactions 

The  Single  Market  Transparency  Directive  allows  for  a  formal  and  structured  exchange  of 
information  between  the  Member  States  and  the  Commission  and  among  Member  States, 
when assessing notified drafts. The intensity of this exchange of information is proven 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 subsequent exchange of messages (see 
Annexes  3.4,  3.5,  3.6  and  3.8).  This  exchange  of  information  provides  the  Member  States 
with  the  possibility  to  ascertain  the  degree  of  compatibility  of  the  notified  drafts  with  EU 
legislation.  The  Commission  met  regularly  at  expert  level  during  the  reporting  period  with 
representatives  of  the  Member  States  to  clarify  outstanding  issues,  when  necessary,  and 
requested  supplementary  information  from  Member  States  to  clarify  the  scope  of  notified 
technical regulations. 

In  the  period  considered,  the  Commission  issued  212  detailed  opinions  (60  in  2016,  34  in 
2017, 40 in 2018, 38 in 2019 and 40 in 2020), which represent 5.9% of the total number of 

50  

51  
52  

Communication from the Commission to the European Parliament, the European Council, the Council, 
the European Central Bank, the European Investment Bank and the Eurogroup – Coordinated economic 
response to the COVID-19 Outbreak, COM(2020) 112. 
See Recital 15 of the Single Market Transparency Directive. 
See Annex 3.11 for additional details on the most common barriers removed. 

11 

 
                                                           
drafts  notified  by  the  Member  States  over  the  reporting  period.  For  their  part,  the  Member 
States issued 243 detailed opinions (78 in 2016, 44 in 2017, 38 in 2018,  30 in 2019 and 53 in 
2020). Out of the 1 291 comments issued during the reporting period, 816 were made by the 
Commission (154 in 2016, 189 in 2017, 184 in 2018, 155 in 2019 and 134 in 2020) and 475 
by the Member States (118 in 2016, 74 in 2017, 77 in 2018, 64 in 2019 and 142 in 2020) (see 
Annexes 3.4 and 3.6). In five cases, the Commission invited the Member States concerned to 
postpone  adoption  of  the  notified  technical  regulations  for  1  year  from  the  date  of  their 
receipt,  because  there  was  EU  harmonisation  work  announced  or  under  way  in  the  area 
covered by the notified drafts (see Annex 3.5). 

Looking by sector at the number of reactions (comments, detailed opinions and Commission 
decisions to postpone adoption of a draft) issued by each Member State and the Commission 
in  the reporting period,  we  can  gain further insight  into the Member States’ participation  in 
the  dialogue  triggered  by  the  notifications  and  on  the  specific  interests  of  certain  Member 
States  whose  reactions  are  more  concentrated  in  specific  sectors  (see  Annex  3.6,  Table  6). 
Italy,  Spain,  Austria  and  Poland are among the  most active Member States. Analysis of the 
reactions per Member State and by sector shows that Austria, Spain and Italy take a particular 
interest  in the agriculture, fishery  and foodstuffs sector. Most of the reactions issued by the 
Commission concern the construction and agricultural sectors. 

Thanks to the access to all notifications and to the messages exchanged within the dialogues, 
Member States can use the Single Market Transparency Directive to draw on the ideas of their 
partners. These can be used to solve common problems regarding technical regulations and to 
understand when a draft technical regulation could be in breach of EU law.  

2.2 

Use of the urgency procedure 

Member  States  may  request  the  Commission  to  assess  their  proposal  to  invoke  the  urgency 
procedure  provided  for  in  Article  6(7)  of  the  Single  Market  Transparency  Directive  if,  in 
order to respond to an urgent and unforeseeable situation they are obliged to adopt technical 
regulations  immediately  and  do  not  have  time  to  wait  for  the  3-month  standstill  period  to 
consult  the  Commission  and  the  other  Member  States  beforehand.  If  the  Commission,  after 
reviewing the reasons brought forward by the Member State concerned, accepts the urgency 
procedure, the standstill period of 3 months does not apply and the measure can be adopted 
immediately53. It typically takes the Commission several working days after the notification to 
decide  whether  it  accepts  the  reasons  brought  forward  by  the  Member  State  concerned  and 
allows it to adopt the technical regulations immediately. 

Out of a total of 3 553 notifications, Member States made 346 requests to apply the urgency 
procedure  to  notified  drafts  (51  in  2016,  34  in  2017,  35  in  2018,  39  in  2019  and  187  in 
2020)54. The use of the urgency procedure was refused for cases in which the justification was 
not  sufficiently  established  or  was  based  on  purely  economic  grounds  or  national 
administrative  delays,  as  well  as  in  cases  for  which  no  unforeseeable  circumstances  were 
demonstrated. The urgency  procedure  was deemed justified in  283  cases  (41 in  2016, 28 in 
2017,  21  in  2018,  29  in  2019  and  164  in  2020).  These  cases  concerned  in  particular 
psychotropic substances, control of narcotics, the fight against terrorism, firearms, infection of 
bees,  biocidal  products,  prohibition  of  products  that  are  harmful  to  health,  pyrotechnic 
articles,  medicines  (critical  medicines/substances  necessary  for  the  treatment  of  COVID-19 
patients),  protective  equipment,  masks,  medical  devices  and  in  vitro  medical  devices, 
disinfectants and alcohols needed for their production (see Annex 3.7). 

53  
54  

See Annex 1 for further details on the urgency procedure. 
See Annex 3.7. 

12 

 
                                                           
2.3 

Notification of ‘fiscal or financial measures’ 

Under the Single Market Transparency Directive, Member States have to provide notification 
of  ‘fiscal  and  financial  measures’,  i.e.  technical  regulations  linked  to  fiscal  or  financial 
measures affecting the consumption of products or services by encouraging compliance with 
such technical regulations. The peculiarity of such measures is that the standstill period does 
not apply (Article 7(4) of the Single Market Transaprency Directive). 

During  the  period  2016-2020,  Member  States  notified  149  draft  measures  as  ‘fiscal  or 
financial measures’ (44 in 2016, 48 in 2017, 26 in 2018, 31 in 2019 and 45 in 2020)55.  

2.4 

Follow-up to Commission reactions 

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

From  2016  to  2020,  the  ratio  between  the  number  of  responses  by  the  Member  States  to 
Commission detailed opinions and the volume of detailed opinions issued by the Commission 
was  satisfactory,  but  could  be  further  improved  (an  average  of  87%  over  the  period). 
Satisfactory  responses  by  Member  States  accounted  on  average  for  45%  of  the  replies  (see 
Annex 3.8).  

In the period considered, the Member States withdrew 21756 draft technical regulations. In 30 
cases (4 in 2016, 13 in 2017, 9 in 2018, 2 in 2019 and 2 in 2020) the withdrawal followed the 
adoption  of  a  detailed  opinion  issued  by  the  Commission.  Reasons  for  these  withdrawals 
include:  (i)  the  notifying  Member  State’s  introduction  of  substantial  changes  to  the  draft 
technical regulation, which required a new notification (Article 5(1) of the Directive); and (ii) 
the  national  authorities’  simple  decision  not  to  go  ahead  with  adopting  the  draft  technical 
regulation. For other notified draft technical regulations the dialogue is still ongoing.  

2.5 

Follow-up to the notification procedure  

For  those  cases  in  which  the  potential  breaches  of  the  EU  internal  market  law  were  not 
entirely  removed  via  the  notification  procedure,  the  Commission  conducted  further 
investigations  (e.g.  on  plant  protection  products,  electronic  cigarettes,  tobacco).  The 
Commission  also  conducted  investigations  on  Member  States’  alleged  breaches  of  the 
notification obligation, for example, in relation to rules on taximeters, glass bottles for wine 
and  spirits,  advertising  equipment,  waste,  gambling,  gaming  machines,  fluorinated 
greenhouse  gas  emissions,  plastic  products,  furniture,  collaborative  economy,  etc.  In  such 
cases, the Commission  informed the concerned  national  contact  point for the Single Market 
Transparency  Directive  of  the  consequences  of  breaching  the  notification  obligation  and 
recalled the obligation to notify. 

2.6 

Structured exchanges with the Member States, EEA-EFTA countries, Switzerland 
and Turkey 

The  regular  meetings  of  the  Technical  Regulations  Standing  Committee  fostered  a  fruitful 
exchange of views on points of general interest and also on specific aspects of the notification 
procedure.  

As  regards  the  notification  procedure,  the  discussions  in  the  context  of  the  Technical 
Regulations Standing Committee meetings particularly concerned:  

55  
56  

See Annex 1 for further details on the ‘fiscal and financial measures’. 
Data extrapolated on 14 July 2021. 

13 

 
                                                           
the urgency procedure under the Single Market Transparency Directive;  

 
  access to documents of the Commission and confidential notifications;  
 
 

the notification procedure for the Swiss and EEA notifications;  
the obligation for Member States to communicate to the Commission the final text of a 
notified technical regulation;  

  developments  on  CJEU  jurisprudence  concerning  the  Single  Market  Transparency 

Directive; and  
the functioning of the one-stop shop mechanism. 

 

Based  on  requests  from  the  Member  States  or  on  the  initiative  of  the  Commission,  the 
Commission gave presentations in the Technical Regulations Standing Committee to provide 
clarification on some recurrent barriers or on new pieces of EU legislation. The presentations 
concerned:  

  Directive (EU) 2019/904 on the reduction of the impact of certain plastic products on 

 

the environment;  
the notification procedure under the Services Directive 2006/123/EC Regulation (EU) 
2018/1807 on the free flow of non-personal data in the EU;  
the General Data Protection Regulation (EU) 2016/679;  
the Road Safety Directives 2014/45/EU57, 2014/46/EU58 and 2014/47/EU59;  
restrictions on microbeads at EU level;  

 
 
 
  Directive 94/62/EC on packaging and packaging waste;  
 
the single market clause and Articles 34-36 TFEU. 

Several  Member  States  shared  their  best  practices  for  notifications  under  the  Single  Market 
Transparency Directive with the Standing Committee. 

Bilateral meetings were also held in many Member States as part of the ‘country knowledge’ 
missions. These meetings aimed to target specific single market needs of each Member State 
by means of a direct dialogue between the Commission and the national authorities, as well as 
through meetings with national stakeholders. In this context, the Commission visited several 
EU capitals60 and attended meetings with Member State authorities and national stakeholders. 
The main problems concerning implementation of the Single Market Transparency Directive 
at  national  level  as  identified  through  these  missions  concern  the  low  level  of  notifications 
(e.g.  in  Romania,  Lithuania  and  Portugal),  administrative  capacity  (e.g.  in  Bulgaria)  or 
coordination  issues  (e.g.  in  Italy,  Spain  and  Germany)  and  limited  knowledge  of  the  Single 
Market Transparency Directive by national administrations.  

Throughout  the  reference  period,  the  Commission  also  discussed  the  application  of  the 
Directive  in  the  compliance  dialogue  meetings  with  Member  States,  which  are  carrried  out 
following the commitment on the single market strategy. The Commission also regularly gave 
ad hoc technical seminars to the national authorities involved in the notification procedure. 

57  

58  

59  

60  

Directive  2014/45/EU  of  the  European  Parliament  and  of  the  Council  of  3  April  2014  on  periodic 
roadworthiness tests for motor vehicles and their trailers and repealing Directive 2009/40/EC, OJ L 127, 
29.4.2014, p. 51. 
Directive 2014/46/EU of the European Parliament and of the Council of 3 April 2014 amending Council 
Directive 1999/37/EC on the registration documents for vehicles, OJ L 127, 29.4.2014, p. 129. 
Directive 2014/47/EU of the European Parliament and of the Council of 3 April 2014 on the technical 
roadside inspection of the roadworthiness of commercial vehicles circulating in the Union and repealing 
Directive 2000/30/EC, OJ L 127, 29.4.2014, p. 134. 
The  Commission  visited  Bulgaria,  Spain,  Poland,  Romania,  Italy,  France,  Germany,  Portugal,  Ireland 
and Lithuania. 

14 

 
 
 
                                                           
Turkey improved its participation in the notification procedure over the reference period. 

2.7 

Transparency 

2.7.1  Requests  for  access  to  documents  issued  under  the  Single  Market  Transparency 
Directive 
From 2016 to 2020 the Commission received 53161 requests for access to documents issued in 
the  context  of  the  Single  Market  Transparency  Directive.  Most  requests  concerned  detailed 
opinions and comments delivered by the Commission. In line with the latest developments in 
CJEU case-law (see Annex 2, Case C-331/15 P,  France v Schlyter), most of the  documents 
were disclosed. 

2.7.2 Participation of stakeholders 

Transparency is a fundamental feature of the notification procedure. The TRIS website, which 
is  publicly  available,  ensures  that  stakeholders  are  constantly  informed  about  all  draft 
technical  regulations  under  preparation  by  Member  States  and  that  a  dialogue  between 
stakeholders and the Commission takes place, thanks to the function enabling stakeholders to 
submit contributions on draft technical regulations. As already mentioned, between 2016 and 
2020, the Commission received 1 618 contributions via this functionality. Over the reference 
period, the Commission also started translating the final texts of the notified measures into all 
EU  languages.  The  translations  of  the  final  texts  are  available  on  the  TRIS  website  and 
provide additional transparency. 

The success of the TRIS website is confirmed by numbers:  

  At  the  end  of  2020  there  were  6 467  active  subscribers  to  the  TRIS  mailing  list, 
compared  to  5 196  at  the  end  of  2015,  marking  a  25%  increase  over  the  5-year 
reporting period.  

 

In  the  period  considered,  871 744  searches  were  carried  out  through  the  TRIS 
website  (151 202 in  2016, 134 737 in  2017, 152 158 in  2018, 197 341 in 2019  and 
236 306 in 2020), with an average of 174 349 searches per year62. 

  Access to notifications by users also increased, from 1 203 299 occurrencies by the 
end  of  2015  to  7 394 991  by  the  end  of  2020,  amounting  to  a  specific  increase  of 
514.6% over the whole reference period 2016-2020 compared with the end of 2015. 

3. 

CONCLUSION 

During the period 2016-2020, the effectiveness of the Single Market Transparency Directive 
procedure  was  confirmed  again  in  terms  of  transparency,  administrative  cooperation  and 
prevention of technical barriers in the single market. The notification procedure’s preventive 
and  networking  approach  reduced  the  risk  that  national  regulatory  activities  could  create 
technical  barriers  to  the  free  movement  of  goods  and  information  society  services.  In  that 
respect,  boosting  the  Member  States’  participation  in  the  Single  Market  Transparency 
Directive procedure, both in terms of notifications sent and of reactions to drafts notified by 
other Member States, demonstrates the joint ownership of the single market, which is a key 
objective for the Commission.  In 2020, during the  COVID-19 pandemic,  the Single Market 

61  

As there was no possibility to encode the lead Unit for access to document requests in the Commission 
databases during the period from 1.1.2018 to 1.10.2018, the figures concerning this period are based on 
a simulation  using the average percentage of requests for access to documents assigned to the Unit in 
charge of the  management of the Single Market Transparency Directive for the  years 2016, 2017 and 
2019.  
62           See Annex 5. 

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Transparency Directive procedure ensured that that the primary objective of protecting health 
and human life was pursued by national  measures in compliance with the single market rules. 
The Directive and its notification system supported Member States in this respect by ensuring 
transparency, synergies and, ultimately, European solidarity. 

The  Directive’s  importance  is  proven  by  stakeholders’  growing  interest  in  the  notification 
procedure  and  the  number  of  contributions  by  them  via  the  TRIS  website  in  the  reference 
period. This growing interest mirrors the effort to improve the transparency and the efficiency 
of the TRIS website.   

The  notification  procedure  has  also  confirmed  its  usefulness  in  providing  the  possibility  to 
identify areas where further harmonisation at EU level is necessary, such as harmonisation of 
packaging  labelling  for  disposal  of  waste.  Efforts  will  continue  to  ensure  a  clear  legal 
framework  for  economic  operators,  aiming  to  enhance  the  competitiveness  of  European 
enterprises in the EU and abroad, while taking into account the links between the notification 
procedure and the procedure established by the Agreement on Technical Barriers to Trade in 
the context of the World Trade Organization (WTO)63.  

The experience gained in these recent  years is essential to build up  this improved landscape 
for  the  implementation  of  the  Single  Market  Transparency  Directive.  To  achieve  the 
Directive’s  full  potential,  the  Commission  will  continue  to  incentivise  Member  States’ 
participation,  both  in  notifying  national  draft  technical  regulations  and  in  reacting  to  drafts 
notified by other Member States.  In its reactions, the Commission will put special emphasis 
on matters of significant importance to the single market and on those that serve in particular 
to  efficiently  address  bottlenecks  identified  in  the  context  of  the  recovery  and  green  and 
digital  transitions.  This  greater  focus  will  also  lead  to  the  appropriate  follow-up  to  the 
Commission reactions so that effective action is taken to prevent potential barriers from being 
put in place.  

63  

In the period concerned, the EU Member States, the EFTA Member States that are signatories to the EEA 
Agreement,  Switzerland  and  Turkey  flagged  363  notifications  in  the  TRIS  database  as  being  subject  to 
notification to the WTO under the Agreement on Technical Barriers to Trade. 

16