COMMISSION STAFF WORKING DOCUMENT Accompanying the document 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  SWD(2022) 297 final  COMMISSION STAFF WORKING DOCUMENT     Accompanying the document 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 {COM(2022) 481 final}  
 
 
TABLE OF CONTENTS – ANNEXES 

Annex 1 – Brief description of the notification procedure ......................................................... 2 

Annex 2- Case-law on the Single Market Transparency Directive in 2016-2020 ...................... 6 

Annex 3 – Application of the procedure between 2016-2020: notifications submitted by the 

Member States ............................................................................................................ 10 

3.1 Volume of notifications during 2016-2020 ......................................................................... 12 

3.2 Breakdown by country ........................................................................................................ 13 

3.3 Breakdown by sector ........................................................................................................... 16 

3.4 Commission reactions: comments and detailed opinions (DO) issued on notifications from 
2016 to 2020 (Articles 5(2) and 6(2) of the Single Market Transparency Directive) 17 

3.5 Commission reactions: postponement of the adoption of a notified draft in 2016 - 2020 

(Articles 6(3) and 6(4) of the Single Market Transparency Directive) ...................... 24 

3.6  Member States’ reactions ................................................................................................... 25 

3.7 Urgency procedure (Article 6(7) of the Single Market Transparency Directive) ............... 28 

3.8 Follow-up to Commission reactions ................................................................................... 31 

3.9 Positive examples, showcasing the impact of the Single Market Transparency Directive. 31 

3.10 Impact assessments ........................................................................................................... 34 

3.11 Most common barriers removed ....................................................................................... 34 

Annex 4 – Application of the procedure in 2016-2020: participation of EFTA countries 

signatory to the EEA agreement, of Switzerland and of Turkey ................................ 36 

Annex 5 – Online consultations between 2016 and 2020 ......................................................... 38 

 
 
 
ANNEX 1 – BRIEF DESCRIPTION OF THE NOTIFICATION PROCEDURE  

This annex gives a general overview of the notification procedure for products and indicates 
the specific procedural rules that apply to information society services. For a more detailed 
description of the procedure, please refer to the information brochure Guide to the procedure 
for  the  provision  of  information  in  the  field  of  technical  regulations  and  of  rules  on 
Information 
https://ec.europa.eu/growth/tools-
databases/tris/en/the-20151535-and-you/being-informed/guidances/vademecum/. 

available 

services, 

Society 

at 

Legal bases 

Introduced  in  1984  by  Directive  83/189/EEC1,  the  notification  procedure  in  the  field  of 
technical  regulations  has  gradually  been  extended  to  all  industrial,  agricultural  and  fishery 
products. In 1998, Directive 83/189/EEC was repealed and codified by Directive 98/34/EC2. 
Directive  98/34/EC  was  in  turn  amended  by  Directive  98/48/EC3  in  order  to  extend  the 
notification  procedure  to  information  society  services,  with  the  adaptations  needed  to  take 
account of the demands of the sector. In 2015, Directive 98/48/EC was repealed and replaced 
by Directive (EU) 2015/15354 with the aim of codifying it after the adoption  of Regulation 
(EU) No 1025/20125. 

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 their transparency, clarity 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  their  businesses  to  the  new  rules,  reducing  the  cost  of 
accessing the regulations and applying them correctly. 

Obligation to notify and standstill period 

Article  5(1)  of  Directive  (EU)  2015/1535  (the  Single  Market  Transparency  Directive) 
stipulates  that  the  EU  Member  States  must  inform  the  Commission  of  any  draft  technical 
regulation  prior  to  its  adoption.  Simple  transposing  an  EU  act  does  not  require  prior 
notification,  unless  the  national  authorities  adopt  national  provisions  that  go  beyond  mere 

1  

2 

3 

4  

5  

Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the 
field of technical standards and regulations, OJ L 109, 26.4.1983, p. 8. 
Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the 
provision of information in the field of technical standards and regulations, OJ L 204, 21.7.1998, p. 37. 
Directive 98/48/EC of the European Parliament and of the Council of 20 July 1998 amending Directive 98/34/EC 
laying down a procedure for the provision of information in the field of technical standards and regulations, OJ L 
217, 5.8.1998, p. 18. 
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. 
Regulation  (EU)  No 1025/2012  of  the  European  Parliament  and  of  the  Council  of  25 October  2012  on  European 
standardisation,  amending  Council  Directives  89/686/EEC  and  93/15/EEC  and  Directives  94/9/EC,  94/25/EC, 
95/16/EC,  97/23/EC,  98/34/EC,  2004/22/EC,  2007/23/EC,  2009/23/EC  and  2009/105/EC  of  the  European 
Parliament  and  of  the  Council  and  repealing  Council  Decision  87/95/EEC  and  Decision  No 1673/2006/EC  of  the 
European Parliament and of the Council, OJ L 316, 14.11.2012, p. 12. 

2 

 
 
 
 
 
 
 
 
                                                 
automatic compliance with EU acts and that contain technical regulations within the meaning 
of  the  Single  Market  Transparency  Directive  (Article  7  of  the  Single  Market  Transparency 
Directive). It is the Member States’ prerogative to decide whether or not to notify. 

Starting from the date of notification of a draft technical regulation, a three-month standstill 
period  –  during  which  the  notifying  Member  State  cannot  adopt  the  technical  regulation  in 
question – enables the Commission and the other Member States to examine the notified text 
and to respond appropriately. The only derogation from this rule is linked to the nature of the 
measure in question: for technical regulations linked to fiscal or financial measures, there is 
no standstill period. This also applies to technical regulations that have to be adopted urgently 
(see below). 

The  Commission  observes  that  national  measures  are  often  misclassified  as  a  ‘fiscal  or 
financial  measure’  in  the  meaning  of  the  Single  Market  Transparency  Directive  when  they 
contain any fiscal or financial measures not linked to technical regulations.  In order to help 
Member States to correctly classify these measures, the Commission has provided them with 
some  guidelines  on  the  definition  and  notification  of  ‘fiscal  or  financial  measures’  for  the 
purposes of the Single Market Transparency Directive. 

Possible reactions and consequences 

Where it emerges that the notified drafts may create obstacles to the free movement of goods 
or the free provision of information society services (Articles 34-36, 49 and 56 of the Treaty 
on  the  Functioning  of  the  European  Union  (TFEU))  or  that  they  are  not  in  line  with  EU 
secondary legislation, the Commission and the other Member States may submit a  detailed 
opinion  to  the  Member  State  that  has  notified  the  draft  (Article  6(2)  of  the  Single  Market 
Transparency  Directive).  The  detailed  opinion  has  the  effect  of  extending  the  three-month 
standstill period by an additional 3 months (only 1 additional month in the case of technical 
regulations related to information socicety services). The Commission and the Member States 
can also make comments on a notified draft (Article 5(2) of the Single Market Transparency 
Directive).  Comments  are  usually  sent  when  the  notified  draft  text  raises  issues  of 
interpretation or needs to be complemented with some arrangements for its implementation. 
The Commission and the Member States can also give an overall assessment of the measure, 
having  regard  to  the  general  principles  of  EU  law  and  policies,  or  inform  the  notifying 
Member State of its future obligations with regard to EU acts to be adopted or implemented. 
Unlike  detailed  opinions,  comments  do  not  extend  the  three-month  standstill  period.  The 
Commission can also block a draft for 12 months (which could be extended to 18 months) if 
EU harmonisation work is envisaged or already underway in the same field (Article 6(3) to 
(5) of the Single Market Transparency Directive). 

If a detailed opinion is issued, the Member State concerned shall inform the Commission of 
the  action  it  intends  to  take  in  response  to  the  detailed  opinion.  The  Commission  then 
comments  on that action (Article 6(2) of the Single Market Transparency  Directive).  In the 
case  of  comments,  the  Single  Market  Transparency  Directive  does  not  lay  down  any  legal 
obligation for the Member State that receives the comments to indicate what follow-up action 
it intends to take. 

Urgency procedure 

3 

 
 
 
 
 
 
 
 
Article 6(7)  of  the  Single  Market  Transparency  Directive  describes  the  urgency  procedure, 
designed to allow the immediate adoption of a national draft, subject to a closed list of certain 
conditions that must be clearly indicated upon notification. The aim of the urgency procedure 
is to enable a notifying Member State faced with serious and unforeseeable circumstances to 
immediately  adopt  the draft technical  regulation  in  question, without having to  wait for the 
expiry of the three-month standstill period. The Commission decides on the justification for 
the urgency procedure  as soon as possible. If the request  to  apply the urgency procedure is 
accepted by the Commission, the three-month stanstill period does not apply and the notified 
text  can  be  adopted.  Nevertheless,  any  examination  of  the  substance  of  the  text  can 
subsequently be carried out, as part of infringement proceedings for breaching EU law. 

Confidential notifications 

According to Article 5(4) of the Single Market Transparency Directive information supplied 
upon  notification  shall  not  be  confidential  except  at  the  express  request  of  the  notifying 
Member State6. Any such request shall be supported by reasons.  

Although the Directive does not provide elements to interpret how the term ‘confidential’ in 
Article  5(4)  should  be  understood,  it  is  apparent  that  the  ultimate  objective  of  the  Single 
Market Transparency Directive is to prevent barriers to the free movement of goods and the 
provision  of  information  society  services,  namely  by  guaranteeing  a  high  level  of 
transparency  in  the  single  market.  Therefore,  when  implementing  the  Single  Market 
Transparency  Directive,  Member  States  have  to  interpret  exceptions  to  the  transparency 
principle  in  a  restrictive  manner.  The  Commission  is  committed  to  carefully  monitoring 
Member  States’  use  of  confidential  notifications  under  Article  5(4)  of  the  Single  Market 
Transparency Directive, and to taking the necessary measures if it suspects that provision is 
being abused.  

The confidentiality of information supplied upon notification has to be explicitly justified by 
the  notifying  Member  State  with  grounded  arguments,  in  line  with  the  proportionality 
principle. A clear distinction should be made between:  

(i) 

(ii) 

cases in which the need for confidentiality is inherent to the substance of the 
draft legislation (e.g. the fight against terrorism);  
other  cases  in  which  economic  grounds  are  used  to  justify  confidentiality, 
including  copyright  protection,  frequently  used  as  justification  by  Member 
States.  

Any  general  argument  on  economic  grounds put forward by the notifying Member State  to 
substantiate the need for confidentiality is rejected by default. 

Communication of final texts 

6   

On  this  aspect  see  the  conclusions  of  the  European  Ombudsman  in  the  recent  Case  2204/2018/TE: 
https://www.ombudsman.europa.eu/en/news-
document/en/126600?utm_source=some_EO&utm_medium=tw_organic&utm_campaign=TRIS_database 

4 

 
 
 
 
 
 
 
 
 
 
                                                 
 
At  the  end  of  the  notification  procedure,  the  Member  States  are  obliged  to  inform  the 
Commission  when  the  final  texts  have  been  adopted  or  to  indicate  if  the  notified  draft  has 
been  abandoned,  in  order  to  allow  the  procedure  to  be  closed  (Article 5(3)  of  the  Single 
Market  Transparency  Directive).  However,  over  the  reference  period  only  2  514  final  texts 
(i.e.  151  in  2016,  596  in  2017,  492  in  2018,  550  in  2019  and  725  in  2020)  were 
communicated  to  the  Commission,  out  of  3  553  notifications  received  (i.e.  for  71%  of  the 
notifications  received  in  the  reference  period  a  final  text  was  communicated  to  the 
Commission)7. 

Technical Regulations Standing Committee 

The  Standing  Committee  mentioned  in  Article  2  of  the  Single  Market  Transparency 
Directive,  comprising  representatives  appointed  by  the  Member  States,  is  chaired  by  a 
Commission  representative.  The  Committee  meets  twice  a  year  and  serves  as  a  forum  for 
discussing all issues concerning the application of the Single Market Transparency Directive. 

Application of the notification procedure to information society services 

The  notification  procedure  also  applies  to  information  society  services,  with  the  following 
adaptations:  

a)  if  a  detailed  opinion  is  issued,  the  total  extended  standstill  period  is  4  months, 
instead of the 6 months stipulated for products (see above);  
b)  the  Commission  can  only  block  the  draft  if  the  subject  of  the  draft  is  already 
covered by a proposal presented by the Commission to the European Parliament and 
the  Council  and  if  the  notified  text  contains  provisions  that  do  not  comply  with  the 
Commission’s proposal;  
c)  the  urgency  procedure  can  be  invoked  under  specific  circumstances  additional  to 
those applicable to products.  

The simplified procedure 

European  Free  Trade  Association  (EFTA)  countries  that  are  contracting  parties  to  the 
Agreement  on  the  European  Economic  Area  (EEA),  namely  Norway,  Iceland  and 
Liechtenstein,  apply  the  notification  procedure  with  the  necessary  adaptations8:  they  notify 
their drafts through the EFTA Surveillance Authority and can comment on the drafts notified 
by  EU  Member  States.  On  the  other  hand,  EU  Member  States  can  comment  on  the  draft 
technical  regulations  notified  by  the  three  countries  that  are  contracting  parties  to  the  EEA 
Agreement. 

Switzerland (which is part of the EFTA, but applies the EEA Agreement) also participates in 
the system. It submits its drafts to the Commission and can make or receive comments on the 
notified drafts on the basis of an informal agreement on the exchange of information in the 
field of technical regulations.  

7          Data extrapolated on 15 July 2021. 
8 

See point 1 of Annex II, Chapter XIX, to the EEA Agreement. 

5 

 
 
  
 
 
 
 
 
 
 
                                                 
Turkey  participates  in  the  procedure  in  the  same  way  as  the  EFTA  countries  that  are 
contracting parties to the EEA Agreement. The decision to include Turkey in the notification 
system  was  taken  in  1997  as  part  of  the  implementation  of  the  final  phase  of  the  Customs 
Union between Turkey and the European Community. 

ANNEX 2- CASE-LAW ON THE SINGLE MARKET TRANSPARENCY DIRECTIVE IN 2016-2020 

In  the  reference  period  the  Court  of  Justice  of  the  European  Union  (CJEU)  issued  several 
judgments  referring  to  the  Single  Market  Transparency  Directive  that  help  to  clarify  some 
aspects of the Directive. 

Definition of a technical regulation 
As regards the definition of a technical regulation, in Case C-62/19, Star Taxi app9, the CJEU 
argued  that  in  order  to  be  qualified  as  a  ‘technical  regulation’  under  the  Single  Market 
Transparency  Directive,  a  national  measure  concerning  information  society  services  should 
not only be considered a rule on information society services as defined in Article 1(1)(e) of 
the Single Market  Transparency Directive, but  also be binding  de jure (by law)  or de facto 
(by dint of circumstances), in particular, for the provision of the service concerned or its use, 
in a Member State or a significant part of it.  

In Case C-275/19, Sportingbet and Internet Opportunity Entertainment10, the CJEU clarified 
that national legislation stating that the right to  operate games of chance is reserved  for the 
State  and  may  be  exercised  only  by  undertakings  that  are  established  as  public  limited 
companies, to which the Member State concerned awards the corresponding concession, and 
which lays down the conditions and zones for exercising that activity, does not amount to a 
‘technical regulation’ within the meaning of that provision. In the same case, the CJEU also 
concluded  that  national  legislation  which  states  that  the  exclusive  right  to  operate  certain 
games of chance awarded to a public entity for the entire national territory is to include such 
operations on the internet constitutes a ‘technical regulation’ within the meaning of the first 
of  those  provisions,  and  the  failure  to  communicate  that  regulation  to  the  European 
Commission makes that legislation unenforceable against individuals.  

In  Case  C-137/17,  Van  Gennip  and  Others11,  the  CJEU  stated  that  an  authorisation 
requirement  for  the  transport  and  storage  of  certain  pyrotechnic  articles,  as  a  condition  for 
their  sale,  ‘does  not  constitute  a  requirement  in  respect  of  the  product  concerned,  but  for 
potential  buyers  and,  indirectly,  for  economic  operators  selling  pyrotechnic  articles’. 
Therefore, it cannot be considered a technical regulation.  
In Case C-613/14, James Elliott Construction12, the CJEU concluded that national provisions 
specifying,  unless  the  parties  agree  otherwise,  implied  contractual  terms  concerning  the 

9           Judgment of 3 December 2020, Star Taxi app, Case C-62/19, EU:C:2020:980. 

  10           Judgment of 22 October 2020, Sportingbet and Internet Opportunity Entertainment, Case C-275/19, EU:C:2020:856. 

11  
12  

Judgment of 26 September 2018, Van Gennip and Others, Case C-137/17, EU:C:2018:771. 
Judgment of 27 October 2016, James Elliott Construction, Case C-613/14, EU:C:2016:821. 

6 

 
 
 
 
 
 
                                                 
merchantable  quality  and  fitness  for  purpose  of  the  products  sold,  are  not  ‘technical 
regulations’.  

In accordance with  settled case-law13, the CJEU restated in  Case C-303/15,  M.and S.14 that 
national measures merely laying down conditions governing the establishment or provision of 
services by undertakings, such as national provisions requiring a license to operate a gaming 
casino  for  the  organisation  of  roulette  games,  card  games,  dice  games  and  gaming  on 
machines,  do  not  constitute  technical  regulations  within  the  meaning  of  the  Single  Market 
Transparency Directive.  

Furthermore,  with  respect  to  the  notion  of  a  technical  regulation,  in  Case  C-727/17,  ECO-
WIND  Construction15,  the  CJEU  clarified  that  in  order  to  be  included  in  the  scope  of  the 
category  ‘other  requirements’,  a  requirement  should  lay  down  conditions  capable  of 
significantly  influencing  the  composition,  nature  or  marketing  of  a  product.  On  the  other 
hand, in order to fall within the category of ‘laws, regulations or administrative provisions of 
the Member States prohibiting the manufacture, importation, marketing or use of a product’, 
a measure’s scope should clearly go beyond a limitation to certain uses of a product and not 
be  confined  to  a  mere  restriction  of  its  use.  That  category  is  particularly  intended  to  cover 
national  measures  that  leave  no  room  for  any  use  that  could  reasonably  be  made  of  the 
product concerned other than a purely marginal one. 

Fiscal measures  

In Case C-711/19, Admiral Sportwetten and Others16, the CJEU ruled that a national tax rule 
that puts in place taxation of the operation of betting terminals does not constitute a ‘technical 
regulation’  within  the  meaning  of  the  Single  Market  Transparency  Directive.  On  the  other 
hand,  according  to  the  Court,  tax  legislation,  which  is  not  accompanied  by  any  technical 
specification  or  any  other  requirement  with  which  it  is  purportedly  intended  to  ensure 
compliance, cannot be considered as a ‘de facto technical regulation’. 

Judgments on rules on services 

Regarding  the  definition  of  ‘rules  on  services’  as  laid  down  in  Article  1.1(e)  of  the  Single 
Market Transparency Directive, and in particular whether or not a rule is specifically aimed 
at  information  society  services,  in  Case  C-255/16,  Falbert17,  the  CJEU  concluded  that  a 
national measure that imposes sanctions in the event of advertising for unauthorised gaming, 
lotteries  or  betting,  constitutes  a  technical  regulation  if  it  is  clear  from  the  ‘preparatory 
works’  for  that  provision  of  national  law  that  its  object  and  purpose  was  to  extend  a  pre-
existing  prohibition  on  advertising  to  online  gaming  services,  which  it  is  for  the  national 
court to determine.  

   Judgment of 13 October 2016, M. and S., Case C-303/15, EU:C:2016:771. 

See, to that effect, Ince (see below, footnote 3), paragraph 76 and the case-law cited therein. 

13  
14  
15          Judgment of 28 May 2020, ECO-WIND Construction, Case C-727/17, EU:C:2020:393.  
16          Judgment of 8 October 2020, Admiral Sportwetten and Others, Case C-711/19, EU:C:2020:812. 
17  
Judgment of 20 December 2017, Falbert and Others, Case C-255/16, EU:C:2017:983. 

7 

 
 
 
 
 
 
 
 
 
 
                                                 
Furthermore,  in  Star  Taxi  app18,  the  CJEU  stated  that  a  service  consisting  of  putting  taxi 
passengers  directly  in  contact,  by  means  of  an  electronic  application,  with  taxi  drivers 
constitutes an ‘information society service’ where that service is not inextricably linked to the 
taxi transport service so that it does not form an integral part of that transport service. 

In  a  similar  vein,  in  Case  C-320/16,  Uber  France19,  the  CJEU  ruled  that  a  provision  of 
national  law  that  lays  down  criminal  penalties  for  the  organisation  of  a  system  putting 
customers  in  contact  with  persons  carrying  passengers  by  road  for  remuneration  using 
vehicles with fewer than 10 seats, without being authorised to do so, concerns a ‘service in 
the  field  of  transport’  insofar  as  it  applies  to  an  intermediation  service  that  is  provided  by 
means  of  a  smartphone  application  and  forms  an  integral  part  of  an  overall  service  the 
principal element of which is the transport service. Such a service is excluded from the scope 
of application of the Single Market Transparency Directive.  

More  specifically,  in  Case  C-390/18,  Airbnb  Ireland20,  the  CJEU  concluded  that  an 
intermediation service which, by means of an electronic platform, is intended to connect, for 
remuneration, potential guests with professional or non-professional hosts offering short-term 
accommodation services, while also providing a certain number of services ancillary to that 
intermediation  service,  must  be  classified  as  an  ‘information  society  service’.  The  CJEU 
clarified that, unlike the ‘Uber type’ intermediation services, Airbnb Ireland does not exercise 
such a decisive influence over the conditions for the provision of the accommodation services 
to  which  its  intermediation  service  relates,  particularly  since  Airbnb  Ireland  does  not 
determine, directly or indirectly, the rental price charged, still less does it select the hosts or 
the  accommodation  put  up  for  rent  on  its  platform.  Uber,  however,  exercises  decisive 
influence  over  the  conditions  under  which  transport  services  are  provided  by  the  non-
professional drivers using the application made available to them by that company. 

Additionally, in  relation  to  the interpretation  of the notion of  ‘rules on services’, the CJEU 
concluded  that  a  measure  that  prohibits  only  commercial  operators  of  search  engines  and 
commercial  service  providers  that  similarly  publish  content  from  making  newspapers  or 
magazines or parts thereof (excluding individual words and very short text excerpts) available 
to  the  public,  constitutes  a  ‘technical  regulation’  within  the  meaning  of  the  Single  Market 
Transparency Directive, notably a rule on information society services, the draft of which is 
subject to prior notification to the Commission21.  

Obligation to notify regional measures 

In  Case  C-336/14,  Ince22,  the  CJEU  clarified  that  the  draft  version  of  regional  legislation 
which  maintains  in  force,  throughout  the  region  concerned,  the  provisions  of  legislation 
common  to  the  various  regions  of  a  Member  State  that  has  expired,  is  subject  to  the 
notification  obligation,  insofar  as  that  regional  draft  version  contains  technical  regulations. 
As  a  result,  failure  to  comply  with  that  obligation  renders  those  regulations  unenforceable 

18          See Star taxi app (see above, footnote 9). 
19  
20  
21  
22  

Judgment of 10 April 2018, Uber France, Case C-320/16, EU:C:2018:221. 
Judgment of 19 December 2019, Airbnb Ireland, Case C-390/18, EU:C:2019:1112. 
Judgment of 12 September 2019, VG Media, Case C-299/17, EU:C:2019:716. 
Judgment of 4 February 2016, Ince, Case C-336/14, EU:C:2016:72. 

8 

 
 
 
 
 
 
 
                                                 
against individuals. Such an obligation is not called into question by the fact that the common 
legislation  had  previously  been  notified  to  the  Commission  at  a  draft  stage  because  the 
temporal and territorial scope of the regional draft differs from the common legislation. 

Sanction of unenforceability 

In  Case  C-144/16,  Município  de  Palmela23,  the  CJEU  ruled  that  the  sanction  of 
unenforceability  of  a  technical  regulation  that  has  not  been  notified  applies  only  to  that 
technical regulation and not to the entire legislative text containing it.  

Failure of a Member State to fulfill its obligations  

In Case C-514/19, Union des industries de la protection des plantes24, the CJEU clarified that 
the  communication,  under  Article  5  of  Directive  (EU)  2015/1535,  of  a  national  measure 
prohibiting the use of certain  active substances falling within the scope  of Regulation  (EC) 
No 1107/2009 on the placing of plant protection products on the market25 must be regarded 
as the official  provision  of information  on the need to  take emergency measures  within the 
meaning  of  Article  71(1)  of  that  regulation,  where:  that  communication  contains  a  clear 
presentation  of  the  evidence  showing,  first,  that  those  active  substances  are  likely  to 
constitute  a  serious  risk to  human  or  animal  health  or  to  the  environment  and,  second,  that 
that risk cannot be satisfactorily controlled without the adoption, as a matter of urgency, of 
the  measures  taken  by  the  Member  State  concerned,  and  where  the  European  Commission 
failed to  ask  that Member State whether that communication must be treated as the official 
provision of information under Article 71(1) of that Regulation.  

Access to documents in relation to the Single Market Transparency Directive procedure 

As  regards  the  requests  for  access  to  documents  concerning  the  detailed  opinions  issued  in 
the framework of the Single Market Transparency Directive, thanks to the CJEU judgment in 
Case C-331/15 P, France v Schlyter26, access to such documents has been facilitated. 

On 29 December 2011, the French authorities notified to the Commission, in the context of 
the  Single  Market  Transparency  Directive,  a  draft  Order  relating  to  the  content  and 
submission  conditions  of  the  annual  declaration  of  nanoparticle  substances  (notification 
2011/673/F). On 30 March 2012, the Commission delivered a detailed opinion, extending the 
initial standstill period by 3 additional months. On 16 April 2012, during the standstill period, 
Mr  Carl  Schlyter  requested  access  to  the  detailed  opinion  in  question.  The  Commission 
rejected that request by letter dated 7 May 2012. Mr Schlyter then submitted a confirmatory 
application  asking  the  Commission  to  reconsider  its  position.  On  27  June  2012,  the 
Commission  rejected  Mr  Schlyter’s  confirmatory  application.  On  6  September  2012,  Mr 
Schlyter  sought  an  annulment,  before  the  General  Court  of  the  European  Union,  of  the 
decision of the Commission of 27 June 2012 refusing access to its detailed opinion.  

Judgment of 1 February 2017, Município de Palmela, Case C-144/16, EU:C:2017:76. 

23  
24         Judgment of 8 October 2020, Union des industries de la protection des plantes, Case C-514/19, EU:C:2020:803. 
25        See footnote 36. 
26  

Judgment of 7 September 2017, France v Schlyter, Case C-331/15 P, EU:C:2017:639.  

9 

 
 
 
 
 
 
   
 
 
 
                                                 
In  its  judgment  of  16  April  2015,  Schlyter  v  Commission27,  the  General  Court  held, 
principally,  that  a  detailed  opinion  delivered  by  the  Commission  in  the  context  of  the 
procedure  laid  down  in  the  Single  Market  Transparency  Directive  does  not  fall  within  the 
scope of an investigation for the purposes of the third indent of Article 4(2) of Regulation No 
1049/2001  regarding  public  access  to  European  Parliament,  Council  and  Commission 
documents28,  and  that  disclosing  such  a  detailed  opinion  during  the  standstill  period  would 
not  necessarily  adversely  affect  the purpose of that  procedure.  The General  Court  therefore 
annulled the decision of the European Commission not to give access to the detailed opinion 
to Mr Schlyter during the standstill period.  

France appealed the decision of the General Court in order to have its judgment set aside, in 
which it had annulled the decision of the European Commission refusing, during the standstill 
period,  access  to  its  detailed  opinion  concerning  the  draft  Order  relating  to  the  content  and 
submission conditions of the annual declaration of nanoparticle substances. 

In its judgment, the CJEU stressed that the general requirement underlying the Single Market 
Transparency Directive is transparency. However, the requirement of transparency does not 
prevent  the Commission,  in  light  of the circumstances of  a particular case, from  relying on 
the third indent of Article 4(2) of Regulation 1049/2001, ‘in order to deny access to a detailed 
opinion delivered by itself or a Member State when it is able to demonstrate that access to the 
detailed  opinion  in  question  would  specifically  and  actually  undermine  the  objective  of 
preventing a technical regulation that is incompatible with EU law from being adopted’.  

ANNEX  3  –  APPLICATION  OF  THE  PROCEDURE  BETWEEN  2016-2020:  NOTIFICATIONS 

SUBMITTED BY THE MEMBER STATES 

Annexes 3.1,  3.2  and  3.3  give  a  statistical  overview  of  the  development  of  the  number  of 
draft  technical  regulations  notified  by  the  Member  States  from  2016  to  2020,  and  of  their 
breakdown by Member State and by sector. In accordance with Article 8 of the Single Market 
Transparency  Directive,  ‘statistics  concerning  communications  received’  as  part  of  the 
notification procedure are published once a year in the Official Journal C series29. 

Reactions  to  the  notified  drafts  –  in  the  form  of  comments  or  detailed  opinions  from  the 
Commission or a Member State, or of blockages on the part of the Commission – are set out 
in Annexes 3.4, 3.5 and 3.6. 

Annex 3.7  presents  the  requests  to  apply  the  urgency  procedure  that  the  Member  States 
addressed  to  the  Commission  pursuant  to  Article 6(7)  of  the  Single  Market  Transparency 
Directive. 

27  
28  

29  

T‑402/12, EU:T:2015:209. 
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. 
For 2016: OJ C 162, 23.5.2017, p. 4. 
For 2017: OJ C 372, 15.10.2018, p. 3. 
For 2018: OJ C 402, 28.11.2019, p. 1. 
For 2019: OJ C 343, 15.10.2020, p. 1. 
For 2020: OJ C 334, 20.08.2021, p.1. 

10 

 
 
 
 
 
 
 
                                                 
  
    
    
 
Annex 3.8  shows  the  action  taken  by  Member  States  in  response  to  the  Commission’s 
reactions. 

11 

 
 
 
 
3.1 Volume of notifications during 2016-2020  

Figure 1: Number of Notifications 

Figure 1 shows that the Member States notified  700 draft regulations in 2016, 676 in 2017, 
666 in 2018, 657 in 2019 and 854 in 2020 to the Commission. 

900

800

700

600

500

400

300

200

100

0

700

676

666

657

854

2016

2017

2018

2019

2020

12 

 
 
 
 
 
 
 
3.2 Breakdown by country 

Figure 2: Notifications by Member State 

Notifications by Memebr State 

450
400
350
300
250
200
150
100
50
0

2016
2019

2017
2020

2018

During  the  2016-2020  period,  the  three  Member  States  that  notified  the  highest  number  of  draft  technical  regulations  were  France  (396), 
Germany (323) and Austria (258). They are followed by eight other Member States (The Netherlands, Sweden, Denmark, Finland, Belgium, the 
United Kingdom, Poland, the Czech Republic), with a total number of notifications between 162 and 235. At the other end of the spectrum, the 
three Member States that notified the lowest number of draft technical regulations were Cyprus (7), Portugal (19) and Luxembourg (35). 

13 

 
 
 
  
Table 1 – Number of notifications of technical regulations submitted by the Member 
States from 2016 to 2020 

Member States 
Austria 
Belgium 
Bulgaria  
Croatia 
Cyprus  
Czech Republic  
Denmark 
Estonia  
Finland 
France 
Germany 
Greece 
Hungary  
Ireland 
Italy 
Latvia  
Lithuania  
Luxembourg 
Malta 
Netherlands 
Poland 
Portugal 
Romania  
Slovakia  
Slovenia  
Spain 
Sweden 
United Kingdom 
Total  

2016 
34 
30 
14 
18 
2 
38 
34 
14 
43 
80 
63 
8 
31 
11 
40 
8 
7 
3 
10 
45 
28 
3 
6 
12 
20 
19 
33 
46 
700 

2018 
68 
42 
18 
7 
0 
46 
26 
14 
48 
48 
54 
14 
9 
2 
23 
7 
15 
2 
14 
32 
28 
2 
8 
15 
7 
30 
54 
33 
666 

2019 
59 
23 
7 
6 
1 
29 
37 
10 
13 
56 
57 
16 
13 
11 
31 
4 
11 
16 
3 
49 
62 
6 
9 
23 
12 
18 
40 
35 
657 

2020 
57 
38 
25 
6 
1 
28 
72 
13 
41 
141 
84 
6 
26 
7 
21 
8 
19 
13 
6 
63 
21 
1 
20 
14 
10 
26 
69 
18 
854 

Total 
258 
168 
71 
44 
7 
162 
190 
62 
171 
396 
323 
122 
103 
37 
134 
33 
57 
35 
37 
235 
165 
19 
52 
99 
54 
123 
231 
165 
3553 

2017 
40 
35 
7 
7 
3 
21 
21 
11 
26 
71 
65 
78 
24 
6 
19 
6 
5 
1 
4 
46 
26 
7 
9 
35 
5 
30 
35 
33 
676 

14 

 
 
 
 
 
 
 
Table 2 – Percentage of notifications submitted by the Member States from 2016 to 2020 

Member States 

Austria 
Belgium 
Bulgaria  
Croatia 
Cyprus  
Czech Republic  
Denmark 
Estonia  
Finland 
France 
Germany 
Greece 
Hungary  
Ireland 
Italy 
Latvia  
Lithuania  
Luxembourg 
Malta 
Netherlands 
Poland 
Portugal 
Romania  
Slovakia  
Slovenia  
Spain 
Sweden 
United Kingdom 

2016 

4.9% 
4.3% 
2.0% 
2.6% 
0.3% 
5.4% 
4.9% 
2.0% 
6.1% 
11.4% 
9.0% 
1.1% 
4.4% 
1.6% 
5.7% 
1.1% 
1.0% 
0.4% 
1.4% 
6.4% 
4.0% 
0.4% 
0.9% 
1.7% 
2.9% 
2.7% 
4.7% 
6.6% 

2017 

2018 

5.9% 
5.2% 
1.0% 
1.0% 
0.4% 
3.1% 
3.1% 
1.6% 
3.8% 
10.5% 
9.6% 
11.5% 
3.6% 
0.9% 
2.8% 
0.9% 
0.7% 
0.1% 
0.6% 
6.8% 
3.8% 
1.0% 
1.3% 
5.2% 
0.7% 
4.4% 
5.2% 
4.9% 

10.2% 
6.3% 
2.7% 
1.1% 
0.0% 
6.9% 
3.9% 
2.1% 
7.2% 
7.2% 
8.1% 
2.1% 
1.4% 
0.3% 
3.5% 
1.1% 
2.3% 
0.3% 
2.1% 
4.8% 
4.2% 
0.3% 
1.2% 
2.3% 
1.1% 
4.5% 
8.1% 
5.0% 

2019 

9.0% 
3.5% 
1.1% 
0.9% 
0.2% 
4.4% 
5.6% 
1.5% 
2.0% 
8.5% 
8.7% 
2.4% 
2.0% 
1.7% 
4.7% 
0.6% 
1.7% 
2.4% 
0.5% 
7.5% 
9.4% 
0.9% 
1.4% 
3.5% 
1.8% 
2.7% 
6.1% 
5.3% 

2020 
6.7% 
4.4% 
2.9% 
0.7% 
0,1% 
3.3% 
8.4% 
1.5% 
4.8% 
16.5% 
9.8% 
0.7% 
3.0% 
0.8% 
2.5% 
0.9% 
2.2% 
1.5% 
0,7% 
7,4% 
2,5% 
0,1% 
2,3% 
1,6% 
1,2% 
3,0% 
8,1% 
2,1% 

2016-
2020 
7.26% 
4.73% 
2.00% 
1.24% 
0.20% 
4.56% 
5.35% 
1.75% 
4.81% 
11.15% 
9.09% 
3.43% 
2.90% 
1.04% 
3.77% 
0.93% 
1.60% 
0.99% 
1.04% 
6.61% 
4.64% 
0.53% 
1.46% 
2.79% 
1.52% 
3.46% 
6.50% 
4.64% 

15 

 
 
 
 
 
 
 
 
 
 
3.3 Breakdown by sector 

Figure 3: Breakdown by sector of the drafts notified by Member States of the EU from 2016 to 2020 

765

693

167

152

196

206

205

255

112

159

155

165

323

900

800

700

600

500

400

300

200

100

0

16 

 
 
 
Figure 4: Breakdown by sector in 2016 

Figure 6: Breakdown by sector in 2018  

146

139

28

34 39

28

44

57

34

24 30

61

2

160
140
120
100
80
60
40
20
0

Figure 5: Breakdown by sector in 2017 

Figure 7: Breakdown by sector in 2019  

17 

 
  
 
 
 
 
Figure 8: Breakdown by sector in 2020 

156

135

48

46

38

51

52

87

63

57

77

18

26

180

160

140

120

100

80

60

40

20

0

18 

 
 
 
Figure 9: Percentage per sector of the drafts notified by the Member States of the EU from 2016 to 2020 

Transport; 9%

Agriculture; 20%

Chemicals; 5%

Construction; 22%

Telecoms; 5%

Pharmaceuticals and 
Cosmetics; 4%

Mechanics; 5%

Information Society 
Services; 7%

Healthcare, Medical 
Equipment; 3%

Goods and 
Miscellaneous Products; 
6%

Environment; 6%

Energy, Minerals, 
Wood; 6%

Domestic and Leisure 
Equipment; 4%

19 

 
 
 
Figure 10: Breakdown by sector in 2016 

Figure 12: Breakdown by sector in 2018  

Figure 11: Breakdown by sector in 2017 

 Figure 11: Break down  

9%

4%

4%

22%

9%

5%

0%

7%

4%

21%

4%

6%

5%

Figure 13: Breakdown by sector in 2019  

20 

 
 
 
 
 
 
Figure 14: Breakdown by sector in 2020  

Telecoms; 3%

Pharmaseuticals and 
Cosmetics; 7%

Mechanics; 2%
Information 
Society 
Services; 7%

Healthcare, Medical 
Equipment; 10%

Transport; 9%

Agriculture; 16%

Chemicals; 6%

Construction; 18%

Environmen
t; 6%

Goods and 
Miscellaneous 
Products; 6%

Domestic and Leisure 
Equipment; 5%

Energy, Minerals, 
Wood; 4%

21 

 
 
3.4  Commission  reactions:  comments  and  detailed  opinions  (DO)  issued  on 
notifications  from  2016  to  2020  (Articles  5(2)  and  6(2)  of  the  Single  Market 
Transparency Directive) 

200

180

160

140

120

100

80

60

40

20

0

Figure 15: Commission reactions to notifications from 2016 to 2020 

189

184

154

155

134

60

34

40

38

40

2016

2017

2018

2019

2020

Comments

DO

The number of comments made by the Commission decreased from 154 in 2016 to 134 
in 2020.  

The number of detailed opinions issued by the Commission from 2016-2020 decreased. 
In  2016,  the  Commission  issued  60  detailed  opinions  on  the  total  of  700  notifications 
(8.5%). In 2017 it issued 34 on the total of 676 (5.0%). In 2018 it issued 40 on the total of 
666 (6%). In 2019 it issued 38 on the total of 657 (5.7%). In 2020 it issued 40 on the total 
of 854 (4.6%). 

22 

 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 3 – Number of comments and detailed opinions issued by the Commission on 
Member States’ notifications for the period 2016-202030  

2016 

2017 

2018 

2019 

2020 

s
t
n
e
m
m
o
C

d
e
l
i
a
t
e
D

n
o
i
n
i
p
O

s
t
n
e
m
m
o
C

d
e
l
i
a
t
e
D

n
o
i
n
i
p
O

s
t
n
e
m
m
o
C

d
e
l
i
a
t
e
D

n
o
i
n
i
p
O

s
t
n
e
m
m
o
C

d
e
l
i
a
t
e
D

n
o
i
n
i
p
O

s
t
n
e
m
m
o
C

d
e
l
i
a
t
e
D

n
o
i
n
i
p
O

Austria 
Belgium 
Bulgaria 
Croatia 
Cyprus 
Czech Republic 
Denmark 
Estonia 
Finland 
France 
Germany 
Greece 
Hungary 
Ireland 
Italy 
Latvia 
Lithuania 
Luxembourg 
Malta 
Netherlands 
Poland 
Portugal 
Romania 
Slovakia 
Slovenia 
Spain 
Sweden 
United Kingdom (before 2021) 

1 
1 
0 
2 
1 
2 
1 
2 
0 
1 
3 
5 
0 
2 
2 
0 
0 
5 
1 
7 
3 
5 
0 
0 
0 
2 
0 
1 
5 
4 
1 
2 
4 
0 
0 
0 
0 
3 
2 
3 
4 
0 
2 
1 
0 
0 
1 
1 
0 
3 
5 
2 
2 
1 
0 
5 
Totals per reaction type  154  60  189  34  184  40  155  38 

0 
1 
4 
1 
0 
1 
0 
1 
2 
2 
0 
10 
1 
0 
2 
0 
2 
0 
1 
0 
0 
1 
1 
1 
2 
6 
1 
0 

9 
6 
0 
1 
1 
6 
6 
1 
3 
19 
14 
70 
5 
0 
5 
0 
0 
0 
1 
5 
3 
2 
2 
17 
1 
6 
5 
1 

25 
13 
1 
2 
0 
23 
2 
5 
25 
12 
7 
3 
1 
1 
6 
1 
3 
1 
10 
2 
7 
1 
1 
3 
2 
7 
13 
7 

20 
5 
1 
1 
0 
4 
8 
0 
3 
11 
8 
4 
3 
7 
10 
1 
3 
0 
1 
3 
35 
1 
0 
3 
5 
3 
5 
10 

13 
6 
4 
7 
0 
7 
7 
3 
4 
16 
22 
3 
2 
1 
12 
0 
0 
1 
4 
8 
6 
0 
0 
6 
9 
4 
3 
6 

0 
1 
0 
1 
0 
2 
1 
1 
1 
2 
2 
2 
2 
0 
5 
2 
0 
0 
1 
1 
0 
0 
2 
1 
0 
7 
0 
0 

9 
7 
2 
2 
0 
1 
13 
1 
3 
21 
23 
0 
2 
3 
4 
3 
4 
3 
1 
4 
6 
0 
4 
2 
1 
6 
7 
2 
134 

0 
0 
8 
0 
0 
0 
2 
0 
0 
13 
4 
0 
2 
0 
0 
0 
3 
0 
1 
1 
0 
1 
0 
0 
0 
4 
1 
0 
40 

Totals per year 
Total number of reactions 

214 

223 

224 
1028 

193 

174 

30   

This table refers to comments and detailed opinions issued by the Commission on Member States’ notifications 
during  the  period  2016-2020.  The  table  therefore  includes  reactions  in  the  first  3  months  of  2021,  as  those 
reactions relate to notifications from 2020.  

23 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.5 Commission reactions: postponement of the adoption of a notified draft in 2016-
2020 (Articles 6(3) and 6(4) of the Single Market Transparency Directive) 

For notifications from the period 2016-2020, the Commission requested a twelve-month 
postponement of the adoption of five draft technical regulations notified by the Member 
States,  because  they  concerned  a  matter  on  which  EU  harmonisation  work  had  already 
been announced or was underway. 

Table 4 – Postponements of notifications from 2016 to 2020 

2016 

2017 

2018 

2019 

2020 

0 

0 

0 

0 

0 
Article 6(3)*           
3 
Article 6(4)**         
Article 6(4)**        
1 
1 

0 

0 

* Article 6(3): postponement when the Commission announces its intention to propose or 
adopt  a  directive,  regulation  or  decision  on  the  matter  covered  by  a  notified  technical 
regulation. 
** Article 6(4): postponement when the Commission announces its finding that the draft 
technical regulation concerns a matter covered by a proposal for a directive, regulation or 
decision presented to the European Parliament and the Council. 

24 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.6  Member States’ reactions 

Table 5 – Comments and detailed opinions issued by the Member States on noifications from 
2016 to 2020 (Articles 5(2) and 6(2) of the Single Market Transparency Directive) 

Austria 
Belgium 
Bulgaria 
Croatia 
Cyprus 
Czech Republic 
Denmark 
Estonia 
Finland 
France 
Germany 
Greece 
Hungary 
Ireland 
Italy 
Latvia 
Lithuania 
Luxembourg 
Malta 
Netherlands 
Poland 
Portugal 
Romania 
Slovakia 
Slovenia 
Spain 
Sweden 
United Kingdom 
TOTALS 

2017 

2020 

2019 

2018 

2016 

TOTALS 
COM  DO  COM  DO  COM  DO  COM  DO  COM  DO  COM  DO 
16 
3 
11 
1 
0 
18 
4 
2 
3 
17 
14 
7 
12 
0 
31 
2 
2 
0 
6 
10 
15 
16 
7 
10 
1 
28 
1 
6 
243 

24 
3 
0 
0 
0 
5 
5 
3 
4 
5 
10 
0 
3 
0 
19 
1 
0 
0 
0 
0 
16 
1 
0 
1 
4 
16 
22 
0 
142 

9 
0 
0 
2 
0 
3 
4 
0 
2 
3 
16 
0 
6 
0 
16 
0 
0 
0 
2 
1 
13 
1 
0 
3 
4 
18 
10 
5 
118 

60 
3 
1 
2 
0 
11 
16 
5 
8 
14 
46 
3 
16 
0 
66 
2 
1 
0 
5 
3 
60 
3 
6 
10 
14 
62 
44 
14 
475 

1 
1 
2 
0 
0 
5 
3 
1 
0 
1 
1 
2 
0 
0 
15 
0 
2 
0 
1 
4 
1 
5 
2 
0 
0 
6 
0 
0 
53 

2 
1 
2 
0 
0 
3 
0 
0 
0 
2 
1 
1 
0 
0 
1 
0 
0 
0 
2 
1 
2 
5 
1 
1 
0 
3 
0 
2 
30 

5 
0 
2 
0 
0 
3 
1 
0 
2 
7 
8 
2 
1 
0 
4 
0 
0 
0 
3 
4 
6 
3 
2 
7 
1 
14 
1 
2 
78 

14 
0 
1 
0 
0 
2 
5 
2 
0 
2 
8 
0 
4 
0 
9 
1 
0 
0 
1 
1 
6 
1 
1 
1 
3 
6 
3 
3 
74 

4 
0 
1 
0 
0 
1 
0 
0 
0 
5 
3 
0 
7 
0 
6 
2 
0 
0 
0 
1 
5 
1 
0 
1 
0 
5 
0 
2 
44 

6 
0 
0 
0 
0 
1 
2 
0 
1 
3 
6 
2 
1 
0 
12 
0 
0 
0 
1 
0 
17 
0 
2 
1 
1 
9 
6 
6 
77 

4 
1 
4 
1 
0 
6 
0 
1 
1 
2 
1 
2 
4 
0 
5 
0 
0 
0 
0 
0 
1 
2 
2 
1 
0 
0 
0 
0 
38 

7 
0 
0 
0 
0 
0 
0 
0 
1 
1 
6 
1 
2 
0 
10 
0 
1 
0 
1 
1 
8 
0 
3 
4 
2 
13 
3 
0 
64 

25 

 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
Figure  16  –  Comments  and  detailed  opinions  issued  by  each  Member  State  on  notifications 
from 2016 to 2020 (Articles 5(2) and 6(2) of the Single Market Transparency Directive) 

60

46

66

31

60

62

44

28

16

11

18

11

16

3

3

1

2

1

0

0

4

5

2

17

14

14

16

12

7

3

8

3

0

0

2

2

2

1

0

0

6

5

10
3

15 16

7

6

3

14

10

10

1

1

14

6

70

60

50

40

30

20

10

0

Comments

Detailed Opinions

Figure 17 – Comments and detailed opinions issued by Member States on notifications from 
2016 to 2020 (Articles 5(2) and 6(2) of the Single Market Transparency Directive) 

142

53

78

74

77

44

38

64

30

118

160

140

120

100

80

60

40

20

0

2016

2017

2018

2019

2020

Comments

Detailed Opinions

26 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table  6  –  Number  of  reactions  (comments,  detailed  opinions  and  decisions  to  postpone  the 
adoption of a draft31) issued by Member States and the Commission to notifications from 2016 
to 2020 by sector 

e
r
u
t
l
u
c
i
r
g
A

s
l
a
c
i
m
e
h
C

n
o
i
t
c
u
r
t
s
n
o
C

e
r
u
s
i
e
L
d
n
a
c
i
t
s
e
m
o
D

t
n
e
m
p
i
u
q
E

d
o
o
W

,
s
l
a
r
e
n
i
M

,
y
g
r
e
n
E

t
n
e
m
n
o
r
i
v
n
E

s
u
o
e
n
a
l
l
e
c
s
i

M
d
n
a

s
d
o
o
G

s
t
c
u
d
o
r
P

l
a
c
i
d
e
M

,
e
r
a
c
h
t
l
a
e
H

t
n
e
m
p
i
u
q
E

s
e
c
i
v
r
e
S
y
t
e
i
c
o
S
n
o
i
t
a
m
r
o
f
n
I

s
c
i
n
a
h
c
e

M

d
n
a

s
l
a
c
i
t
u
e
c
a
m
r
a
h
P

s
c
i
t
e
m
s
o
C

s

m
o
c
e
l
e
T

t
r
o
p
s
n
a
r
T

S
M

r
e
p
l
a
t
o
T

Austria 
33 
Belgium 
2 
Bulgaria 
5 
Croatia 
1 
Cyprus 
0 
Czech Republic 
10 
Denmark 
14 
Estonia 
5 
Finland 
6 
France 
15 
Germany 
28 
Greece 
4 
Hungary 
20 
Italy 
53 
Ireland 
0 
Latvia 
2 
Lithuania 
1 
Luxembourg 
0 
Malta 
0 
Netherlands 
9 
Poland 
26 
Portugal 
6 
Romania 
3 
Slovakia 
16 
Slovenia 
15 
Spain 
74 
20 
Sweden 
United Kingdom (before 2021)  10 
Commission 
Totals per sector 

76 
6 
12 
3 
0 
29 
20 
7 
11 
31 
60 
10 
28 
97 
0 
4 
3 
0 
11 
13 
75 
19 
13 
20 
15 
90 
45 
20 
333  35  246  54  30  55  49  14  59  42  17  26  68  1028 
711  45  315  94  43  78  119  29  76  68  39  44  85  1746 

8 
0 
0 
0 
0 
5 
0 
0 
0 
0 
0 
0 
0 
1 
0 
0 
0 
0 
0 
0 
11 
0 
0 
1 
0 
0 
0 
0 

1 
0 
0 
0 
0 
1 
0 
0 
0 
0 
12 
0 
0 
2 
0 
0 
0 
0 
0 
0 
1 
0 
0 
0 
0 
1 
0 
0 

12 
0 
0 
0 
0 
0 
1 
0 
1 
1 
2 
0 
0 
2 
0 
2 
0 
0 
8 
0 
4 
0 
0 
0 
0 
3 
2 
2 

7 
4 
0 
0 
0 
3 
3 
1 
3 
3 
7 
0 
2 
7 
0 
0 
0 
0 
0 
0 
17 
4 
1 
0 
0 
5 
0 
2 

0 
0 
1 
0 
0 
1 
0 
0 
0 
0 
0 
1 
0 
1 
0 
0 
0 
0 
0 
0 
0 
3 
1 
0 
0 
1 
6 
0 

1 
0 
0 
0 
0 
0 
0 
0 
0 
0 
5 
0 
1 
4 
0 
0 
0 
0 
0 
1 
1 
0 
0 
0 
0 
0 
8 
1 

4 
0 
0 
0 
0 
0 
0 
0 
0 
1 
1 
0 
0 
3 
0 
0 
0 
0 
0 
0 
8 
0 
0 
0 
0 
0 
0 
0 

2 
0 
0 
0 
0 
1 
0 
0 
0 
0 
2 
0 
1 
2 
0 
0 
0 
0 
0 
0 
1 
0 
1 
0 
0 
0 
0 
0 

3 
0 
0 
1 
0 
1 
0 
1 
1 
0 
0 
0 
2 
2 
0 
0 
1 
0 
0 
0 
1 
0 
0 
0 
0 
0 
0 
0 

0 
0 
0 
0 
0 
1 
1 
0 
0 
4 
0 
0 
0 
7 
0 
0 
0 
0 
0 
0 
2 
0 
0 
0 
0 
5 
2 
1 

2 
0 
0 
0 
0 
1 
0 
0 
0 
0 
0 
0 
0 
5 
0 
0 
0 
0 
3 
1 
1 
0 
0 
0 
0 
0 
4 
0 

3 
0 
6 
1 
0 
5 
1 
0 
0 
7 
3 
5 
2 
8 
0 
0 
1 
0 
0 
2 
2 
6 
7 
3 
0 
1 
3 
4 

31  

Detailed  opinions  with  comments  were  counted  as  one  reaction,  that  is,  as  a  detailed  opinion.  If  the  same 
reaction concerned more than one notification, it was counted as multiple reactions. 

27 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.7 Urgency procedure (Article 6(7) of the Single Market Transparency Directive) 

Table 7 – Requests to apply the urgency procedure received from 2016 to 2020 

2016 

2017 

2018 

2019 

2020 

Totals 

s
t
s
e
u
q
e
R

e
c
n
a
t
p
e
c
c
A

s
t
s
e
u
q
e
R

e
c
n
a
t
p
e
c
c
A

s
t
s
e
u
q
e
R

e
c
n
a
t
p
e
c
c
A

s
t
s
e
u
q
e
R

e
c
n
a
t
p
e
c
c
A

s
t
s
e
u
q
e
R

e
c
n
a
t
p
e
c
c
A

s
t
s
e
u
q
e
R

e
c
n
a
t
p
e
c
c
A

Austria 
1 
1 
Belgium 
2 
0 
Bulgaria 
1 
1 
Croatia 
0 
0 
Cyprus 
0 
0 
Czech Republic 
2 
0 
Denmark 
0 
0 
Estonia 
5 
5 
Finland 
5 
5 
France 
5 
5 
Germany 
3 
2 
Greece 
0 
0 
Hungary 
10  10 
Ireland 
1 
0 
Italy 
1 
1 
Latvia 
1 
1 
Lithuania 
0 
0 
Luxembourg 
0 
0 
Malta 
0 
0 
Netherlands 
2 
0 
Poland 
0 
0 
Portugal 
1 
0 
Romania 
1 
1 
Slovakia 
1 
1 
Slovenia 
0 
0 
Spain 
1 
0 
7 
Sweden 
7 
United Kingdom (before 2021)  1 
1 

3 
11 
5 
0 
0 
6 
12 
11 
21 
77 
15 
3 
23 
4 
5 
7 
0 
0 
0 
4 
7 
0 
11 
5 
2 
3 
44 
4 
TOTALS  51  41  34  28  35  21  39  29  187  164  346  283 

0 
0 
1 
0 
1 
1 
0 
0 
0 
0 
1 
1 
0 
0 
0 
0 
2 
2 
0 
0 
1 
1 
11 
0 
1 
1 
0 
0 
0 
0 
1 
1 
0 
0 
0 
0 
0 
0 
0 
0 
1 
1 
0 
0 
0 
0 
0 
0 
0 
0 
2 
1 
11  10 
2 
2 

2 
12 
3 
0 
0 
8 
12 
4 
7 
71 
10 
1 
11 
1 
3 
3 
0 
0 
0 
3 
3 
0 
11 
3 
2 
5 
12 
0 

2 
9 
3 
0 
0 
5 
12 
3 
7 
68 
7 
1 
9 
0 
3 
3 
0 
0 
0 
3 
3 
0 
7 
3 
2 
2 
12 
0 

3 
19 
6 
0 
1 
11 
14 
12 
21 
81 
21 
16 
26 
6 
5 
7 
0 
0 
0 
6 
8 
1 
15 
5 
2 
10 
46 
4 

0 
0 
0 
0 
0 
0 
0 
1 
3 
4 
3 
0 
1 
3 
1 
1 
0 
0 
0 
0 
2 
0 
1 
1 
0 
0 
8 
0 

0 
3 
1 
0 
1 
0 
0 
2 
4 
0 
3 
3 
2 
1 
0 
1 
0 
0 
0 
1 
1 
0 
2 
0 
0 
1 
7 
1 

0 
2 
0 
0 
0 
0 
0 
2 
4 
0 
2 
2 
2 
1 
0 
1 
0 
0 
0 
1 
1 
0 
2 
0 
0 
0 
7 
1 

0 
1 
0 
0 
0 
0 
2 
1 
3 
5 
4 
1 
2 
3 
1 
1 
0 
0 
0 
0 
3 
0 
1 
1 
0 
1 
9 
0 

Table  7  provides  an  overview  of  the  number  of  requests  to  apply  the  urgency  procedure,  by 
Member State and by year. It also shows the number of requests on which the Commission gave 
a favourable opinion.   

28 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 18 – Member States’ requests to apply the urgency procedure and percentage of 
favorable opinions given by the Commission between 2016 and 2020 

90

80

70

60

50

40

30

s
t
s
e
u
q
e
R

f
o

r
e
b
m
u
N

20

10

0

a
t
l
a

M

s
u
r
p
y
C

a
i
t
a
o
r
C

a
i
n
a
u
h
t
i

L

g
r
u
o
b
m
e
x
u
L

95% 100%

92%

86% 88%

83%

73%

67%

58%

55%

30%

19%

0%

l
a
g
u
t
r
o
P

n
i
a
p
S

e
c
e
e
r
G

d
n
a
l
e
r
I

m
u
i
g
l
e
B

s
d
n
a
l
r
e
h
t
e
N

c
i
l
b
u
p
e
R
h
c
e
z
C

y
n
a
m
r
e
G

a
i
n
a
m
o
R

a
i
r
a
g
l
u
B

k
r
a
m
n
e
D

y
r
a
g
n
u
H

d
n
a
l
o
P

a
i
n
o
t
s
E

e
c
n
a
r
F

n
e
d
e
w
S

a
i
r
t
s
u
A

d
n
a
l
n
i
F

y
l
a
t
I

a
i
v
t
a
L

a
i
k
a
v
o
l
S

a
i
n
e
v
o
l
S

100,00%

90,00%

80,00%

70,00%

60,00%

50,00%

40,00%

30,00%

20,00%

10,00%

0,00%

s
n
o
i
n
i
p
o

e
l
b
a
r
u
o
v
a
f

f
o

e
g
a
t
n
e
c
r
e
P

…
m
o
d
g
n
i
K
d
e
t
i
n
U

Number of Requests

Pecentage of favourable opinions

29 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 8 – Breakdown by sector of requests to apply the urgency procedure from 2016 to 2020 

t
n
e
m
p
i
u
q
E
e
r
u
s
i
e
L
d
n
a
c
i
t
s
e
m
o
D
0 
0 
0 
1 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
2 
2 

0 

5 

e
r
u
t
l
u
c
i
r
g
A

s
l
a
c
i
m
e
h
C

n
o
i
t
c
u
r
t
s
n
o
C

0 
1 
0 
0 

2 
1 
0 
0 
2 
1 
11 
0 
2 
2 
1 
3 
1 
0 
0 
0 
1 
1 
3 

1 
2 
0 
0 

1 
3 
5 
16 
0 
5 
0 
1 
0 
0 
4 
0 
0 
0 
5 
0 
0 
0 
40 

0 
4 
0 
0 

0 
0 
0 
0 
0 
3 
3 
2 
0 
0 
0 
0 
0 
0 
1 
0 
0 
1 
1 

0 

0 

1 

32 

83 

16 

Austria 
Belgium 
Bulgaria 
Cyprus 
Czech 
Republic 
Denmark 
Estonia 
Finland 
France 
Germany 
Greece 
Hungary 
Ireland 
Italy 
Latvia 
Netherlands 
Poland 
Portugal 
Romania 
Slovakia 
Slovenia 
Spain 
Sweden 
United 
Kingdom 
(before 2021) 
Totals per 
sector 

d
o
o
W

,
s
l
a
r
e
n
i
M

,
y
g
r
e
n
E

t
n
e
m
n
o
r
i
v
n
E

s
u
o
e
n
a
l
l
e
c
s
i

M
d
n
a

s
d
o
o
G

s
t
c
u
d
o
r
P

s
e
c
i
v
r
e
S
y
t
e
i
c
o
S
n
o
i
t
a
m
r
o
f
n
I

s
c
i
n
a
h
c
e

M

t
n
e
m
p
i
u
q
E

l
a
c
i
d
e
M

,
e
r
a
c
h
t
l
a
e
H

0 
5 
1 
0 

3 
4 
0 
0 
45 
3 
0 
3 
0 
2 
0 
0 
2 
0 
1 
0 
1 
0 
0 

2 
2 
0 
0 

0 
0 
0 
0 
1 
0 
0 
4 
0 
0 
0 
0 
1 
0 
0 
0 
0 
2 
0 

s
c
i
t
e
m
s
o
C
d
n
a

s
l
a
c
i
t
u
e
c
a
m
r
a
h
P

0 
2 
4 
0 

5 
4 
6 
4 
22 
7 
0 
13 
4 
0 
1 
0 
3 
1 
7 
3 
0 
0 
0 

0 

86 

s

m
o
c
e
l
e
T

t
r
o
p
s
n
a
r
T

S
M

r
e
p
s
l
a
t
o
T

0 
0 
0 
0 

0 
0 
1 
1 
3 
0 
0 
1 
0 
0 
0 
0 
0 
0 
0 
0 
0 
1 
0 

1 

8 

0 
1 
0 
0 

0 
2 
0 
0 
1 
2 
0 
0 
0 
0 
0 
1 
0 
0 
0 
0 
0 
2 
0 

0 

9 

3 
19 
6 
1 

11 
14 
12 
21 
81 
21 
16 
26 
6 
5 
7 
6 
8 
1 
15 
5 
2 
10 
46 

4 

346 

0 
0 
0 
0 

0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 

0 

0 

1 

0 

0 

19 

70 

12 

0 
2 
0 
0 

0 
0 
0 
0 
6 
0 
1 
2 
0 
1 
1 
1 
0 
0 
1 
2 
0 
1 
0 

0 
0 
1 
0 

0 
0 
0 
0 
0 
0 
1 
0 
0 
0 
0 
0 
1 
0 
0 
0 
0 
0 
0 

0 

3 

0 
0 
0 
0 

0 
0 
0 
0 
1 
0 
0 
0 
0 
0 
0 
1 
0 
0 
0 
0 
0 
0 
0 

1 

3 

30 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table  8,  which  gives  a  sectoral  breakdown  of  the  requests  to  apply  the  urgency  procedure 
received  by  the  Commission  during  the  2016-2020  period,  shows  that  the  application  of  this 
exceptional procedure was invoked largely in the chemical sector (83 requests), but also in the 
healthcare  and  medical  equipment  sector  (70),  the  pharmaceutical  and  cosmetics  sectors  (86) 
and the agricultural sector (30). 

3.8 Follow-up to Commission reactions 

Table  9  shows  that,  in  2016,  the  recipient  Member  States  responded  to  57  of  the  60  detailed 
opinions issued by the Commission (95%) and that the Commission deemed 41 (72%) of those 
responses satisfactory.  

In 2017, they responded to 27 of the 34 detailed opinions (79%); 17 responses were satisfactory 
(63%).  

In  2018,  they  responded  to  33  of  the  40  detailed  opinions  (83%);  12  replies  were  satisfactory 
(36%). 

In  2019,  they  responded  to  36  of  the  38  detailed  opinions  (95%);  20  replies  were  satisfactory 
(44%). 

In  2020,  they  responded  to  34  of  the  40  detailed  opinions  (85%);  3  replies  were  satisfactory 
(9%). 

Table  9  –  Responses  from  the  Member  States  to  detailed  opinions  issued  by  the 
Commission each year 

Number of 
Commission DO 
Replies from MS 
% of Replies from 
MS 
Satisfactory replies 
% of satisfactory 
replies 

2016 

2017 

2018 

2019 

2020 

60 
57 

34 
27 

40 
33 

38 
36 

40 
34 

95% 
41 

79% 
17 

83% 
12 

95% 
16 

85% 
3 

72% 

63% 

36% 

44% 

9% 

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

 

  In 2018 and 2019 the Finnish authorities notified several measures on a new category of 
vehicles,  converted  from  an  existing  passenger  car  to  a  ‘car  tractor’,  with  their  speed 
limited  to  45  km/h  and  that  could  be  driven  with  a  ‘moped’  driving  licence.  The 
Commission  issued  comments  on  vehicle  classification  rules  and  the  compatibility  of 
the  notified  measures  with  the  rules  on  driving  licence  categories  and  the  minimum 

31 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 

 

 

driving age laid down in Directive 2006/126/EC on driving licences32. Finland deemed 
it appropriate to withdraw the notified measures at issue. 

  In  2019  Spain  notified  a  draft  royal  decree  introducing  a  voluntary  quality  mark  for 
agricultural machinery and providing for market access-related advantages to products 
bearing  the  quality  mark.  The  Commission  issued  a  detailed  opinion  because  the 
notified draft was in breach of Article 34 TFEU. By supporting the products bearing the 
Spanish  quality  mark,  the  notified  draft  created  an  advantage  for  domestic  products, 
compared to products that satisfied the applicable mandatory requirements in Spain, or 
equivalent requirements applicable in another Member State of the EU, but not bearing 
the Spanish quality mark. Following a dialogue between the Commission and Spain in 
the  context  of  the  Single  Market  Transparency  Directive,  Spain  amended  the  draft  in 
question in line with the Commission’s remarks. 

  In 2019 France notified a draft decree aimed at enhancing consumer information on the 
origin  of  honeys  and  laying  down  the  obligation  for  blends  of  honeys  packaged  in 
France to indicate the names of the countries of origin in descending order by weight. 
This name had to be highlighted when the corresponding quantity of honey constituted 
more than 20% of the weight of the product. The Commission issued a detailed opinion 
to  point  out  that  imposing  on  operators  packaging  honey  in  France  an  additional 
mandatory labelling requirement to indicate in descending order of weight the countries 
of  origin  and  to  highlight  the  name  of  the  country  from  which  the  honey  constituting 
more  than  20%  of  the  weight  comes  and  to  indicate  ‘More  than  20%’  or  ‘>20%’,  is 
contrary  to  Directive  2001/110/EC  on  honey33.  France  agreed  to  amend  the  notified 
draft  to  meet  the  requirements  of  Directive  2001/110/EC  in  the  context  of  this 
notification.   

  In 2018 the Czech Republic notified a draft measure on the introduction to, and supply 
of  construction  products  on,  the  market  and  the  use  of  construction  products  in 
buildings. The Commission issued a detailed opinion because the notified draft was in 
breach  of  Regulation  (EU)  No  305/2011  on  construction  products34  and  Article  34 
TFEU. Following a dialogue, the Czech Republic amended the draft in question in line 
with the Commission’s recommendations. 

In 2018 Spain notified a draft royal decree laying down zootechnical standards on the 
rearing, trade and entry into the EU of pure-bred breeding animals, hybrid breeding pigs 
and  their  reproductive  material,  and  updating  the  national  programme  for  the 
conservation, improvement and promotion of livestock breeds. The Commission issued 
a  detailed  opinion  because  the  notified  draft  was  in  breach  of  the  EU  provisions 
harmonised  by  the  Animal  Breeding  Regulation  (Regulation  (EU)  2016/101235). 
Following a dialogue, Spain amended the draft in line with the Commission’s remarks. 

32  

33  
34  

35  

Directive 2006/126/EC of the European Parliament and of the Council of 20 December 2006 on driving  licences, OJ L 
403, 30.12.2006, p. 18. 
Council Directive 2001/110/EC of 20 December 2001 relating to honey, OJ L 10, 12.1.2002, p. 47. 
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. 
Regulation  (EU)  2016/1012  of  the  European  Parliament  and  of  the  Council  of  8  June  2016  on  zootechnical  and 
genealogical conditions for the breeding, trade in and entry into the Union of purebred breeding animals, hybrid breeding 
pigs and the germinal products thereof and amending Regulation (EU) No 652/2014, Council Directives 89/608/EEC and 

32 

 
 
 
                                                 
 
 

 

 

 

 

 

  In  2018  Spain  notified  a  draft  decree  regulating  and  promoting  artisan  food.  The 
Commission  issued  a  detailed  opinion  because  the  notified  draft  was  in  breach  of 
Article  34  TFEU.  Following  a  dialogue,  Spain  amended  the  draft  in  line  with  the 
Commission’s remarks. 

  In  2018  the  Finnish  authorities  notified  a  draft  on  the  cross-border  distance  sales  of 
alcoholic  beverages  aimed  at  clarifying  the  provisions  applicable  to  retail  sales  of 
alcoholic  beverages  subject  to  approval.  The  Commission  issued  a  detailed  opinion 
pointing out that the measures in question were considered a quantitative restriction on 
the  free  movement  of  goods  under  Article  34  TFEU  because  they  favoured  distance 
sales  from  retailers  in  Finland  over  those  from  other  Member  States.  Such  measures 
were  not  justified  in  the  light  of  Article  36  TFEU.  The  Finnish  authorities  decided  to 
withdraw the draft.  

  In  2018  Spain  notified  a  draft  technical  regulation  aimed  at  ensuring  that  farmers 
produced  high-quality  and  healthy  agricultural  products  for  consumers  by  using 
environmentally friendly farming practices. The Commission issued comments on this 
notification, reminding Spain of the conditions for obtaining support from the EAFRD 
(European Agricultural Fund for Rural Development). The Spanish authorities took the 
Commission’s comments into account. 

In  2017  Austria  notified  a  total  ban  on  the  use,  for  professional  and  non-professional 
purposes,  of  plant  protection  products  containing  the  active  substance  glyphosate  in 
Carinthia.  The  Commission  issued  comments  because  the  draft  appeared  to  raise 
concerns in relation to the provisions on the authorisation of plant protection products 
contained in Regulation (EC) No 1107/2009 on the placing of plant protection products 
on the market36. The draft measure was not adopted. Instead, in 2018 Austria notified 
an amendment to the draft that no longer targeted a specific substance and limited non-
professional  users’  access  to  low-risk  products,  authorised  for  minor  gardening 
purposes.  The  revised  measure  was  aligned  with  other  similar  measures  notified  by 
other Member States to which the Commission had not reacted. 

   In 2017 Hungary notified a measure  on a labelling obligation for dual use food chain 
products,  i.e.  products  placed  on  the  market  in  Hungary  with  different  ingredients  or 
with  a  different  ratio  of  ingredients  than  in  countries  outside  Hungary,  but  with  the 
same  name  and  appearance.  The  Commission  issued  a  detailed  opinion  because  it 
considered the notified draft was in breach of the free movement of goods principle as 
set out in Article 34 TFEU. Hungary decided to withdraw the measure in question. 

   In 2017 Germany notifed a complete ban on the importation, placement on the market 
and  sowing  of  certain  types  of  seeds  treated  with  particular  plant  protection  products. 
The Commission issued a detailed opinion because the proposed ban was in breach of 
applicable  EU  legislation  on  plant  protection  products,  pursuant  to  which  Member 
States may not prohibit the placement on the market or use of seeds treated with plant 

36  

90/425/EEC  and  repealing  certain  acts  in  the  area  of  animal  breeding  (Animal  Breeding  Regulation),  OJ  L  171, 
29.6.2016, p. 66. 
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 of 24.11.2009, p. 1. 

33 

 
 
 
                                                                                                                                                             
protection  products  authorised  for  such  use  in  at  least  one  Member  State.  Germany 
agreed to address the concerns the Commission had raised.  

3.10 Impact assessments 

In  line  with  the  Commission’s  action  plan  to  simplify  and  improve  the  regulatory 
environment37, the Member States of the EU have been invited to submit impact assessments 
(or  their  conclusions)  together  with  notified  draft  technical  regulations  under  the  Single 
Market  Transparency  Directive,  where  such  studies  have  been  carried  out  internally.  By 
carrying out  these impact  assessments, Member  States  are encouraged to reflect  in  advance 
on the most appropriate instrument to be used, and the Commission can in turn better assess 
the necessity and proportionality of the measures proposed. 

In  the  reporting  period,  Member  States  submitted  impact  assessments  for  898  notifications 
(25% of the total number of notifications).  

3.11 Most common barriers removed 

Mutual recognition clause  

The  Commission  frequently  reacted  to  notifications  of  draft  technical  regulations  in  which  the 
mutual  recognition  clause  was  not  included  when  needed,  or  was  not  drafted  in  line  with  the 
single  market  clause,  as  set  out  in  Commission  Communication  The  Goods  Package: 
Reinforcing trust in the single market (COM(2017) 787 of 19 December 2017). 

This preventive mechanism could be complemented by a corrective mechanism applicable if the 
national authorities, in taking decisions based on national rules in individual cases, misapply the 
principle of mutual recognition. Regulation (EU) 2019/515 on the mutual recognition of goods 
lawfully marketed in another Member State aims to give a major boost to mutual recognition in 
the  area  of  goods38.  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 trade barriers39. 

Improper legal drafting technique – Repetition of provisions of EU regulations 

One  of  the  most  frequent  issues  addressed  by  the  Commission  in  the  detailed  opinions  they 
issued, for example, on the basis of EU regulations applicable in the area of food hygiene and to 
plant  protection  products,  was  a  practice  whereby  the  notified  draft  technical  regulations 
repeated,  often  partially  and  in  an  incomplete  or  even  diverging  way,  the  provisions  of 
applicable EU regulations. According to Article 288 TFEU, a regulation has general application, 
is binding in its entirety and is directly applicable in all Member States. This means that Member 
States may not lay down rules in the area governed by directly applicable EU legislation, even if 

37  
38  

39  

Action plan for improving the regulatory environment, COM(2002) 278. 
Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March 2019 on the mutual recognition of 
goods lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008, OJ L 91, 29.3.2019, p. 1. 
https://ec.europa.eu/growth/single-market/goods/free-movement-sectors/mutual-recognition_en 

34 

 
 
 
 
 
 
 
                                                 
identical to EU rules, as they would interfere with the correct application of EU legislation and 
give rise to uncertainty about the complete application of the relevant EU law.  

Incorrect implementation of food hygiene regulation exemptions 

Several  potential  breaches  have  also  been  identified  in  the  implementation  by  the  notifying 
Member States of the exceptions and flexibility clauses in three food hygiene regulations:  

  Regulation (EC) No 852/2004 on the hygiene of foodstuffs  

  Regulation  (EC)  No  853/2004  laying  down  specific  hygiene  rules  for  food  of  animal 

origin  

  Regulation (EC) No 854/2004 laying down specific rules for the organisation of official 

controls on products of animal origin intended for human consumption.  

Member States wrongly implemented or went beyond what these exemptions allow. 

Unjustified barriers to information society services  

In  the  area  of  information  society  services,  the  Commission  identified  recurrent  problems, 
mainly concerning unjustified or disproportionate restrictions on the free provision of services in 
relation  to  the e-Commerce  Directive40, the revised Audiovisual  Media Services Directive, the 
free  flow  of  non-personal  data  Regulation41  and  the  eIDAS  Regulation  (EU)  910/201442. 
Unjustified  restrictions  were  also  addressed  explicitly  or  in  ancillary  terms  regarding  the  free 
movement  of  services  and  the  freedom  of  establishment  in  the  area  of  information  society 
activities  (Articles  49  and  56  TFEU,  as  well  as  Directive  2006/123/EC  on  services43)  and 
regarding  the  General  Data  Protection  Regulation44,  the  Consumer  Rights  Directive45,  the 
electronic invoicing Directive46, as well as the freedom of expression and the freedom to conduct 
a business. 

Standards – making them mandatory, requring additional test methods  

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

40  

41  

42  

43  

44  

45  

46  

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. 
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. 
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. 
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. 
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. 
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. 
Directive 2014/55/EU of the European Parliament and of the Council of 16 April 2014 on electronic invoicing in public 
procurement, OJ L 133, 6.5.2014, p. 1. 

35 

 
 
 
                                                 
 
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 mandatory essential requirements. They should 
therefore remain voluntary. 

The  practice,  mentioned  above,  followed  by  some  Member  States,  of  making  voluntary 
European  harmonised  standards  compulsory,  could  create  trade  barriers  in  the  single  market. 
This  is  because  products  complying  with  the  essential  requirements  of  the  New  Approach 
Directives,  but  not  with  European  harmonised  standards,  could  not  freely  circulate  in  the 
Member State in question.  

All  the  recurrent  practices  mentioned  above  were  discussed  with  the  Member  States  in  the 
Technical  Regulations  Standing  Committee,  set  up  in  accordance  with  Article  2  of  the  Single 
Market Transparency Directive. The Technical Regulations Standing Committee meets twice  a 
year, as stated in Article 3 of the Single Market Transparency Directive. The recurrent practices 
were also discussed in ‘Country knowledge’ meetings with the Member States.  

ANNEX  4  –  APPLICATION  OF  THE  PROCEDURE  IN  2016-2020:  PARTICIPATION  OF  EFTA 

COUNTRIES SIGNATORY TO THE EEA AGREEMENT, OF SWITZERLAND AND OF TURKEY 

Table  10  –  Number  of  notifications  from  EEA-EFTA  countries  and  comments  issued  on 
those notifications by the EU  

2017 

2018 

2016 
Not.  Com.  Not.  Com.  Not.  Com.  Not.  Com.  Not.  Com.  Not.  Com. 
Iceland 
6 
Liechtenstein  1 
Norway 
34 
Total 
41 

8 
23 
3 
8 
93 
20 
124  31 

8 
3 
17 
28 

6 
1 
11 
18 

2 
0 
18 
20 

1 
3 
13 
17 

1 
2 
6 
9 

2 
0 
3 
5 

1 
0 
0 
1 

3 
0 
4 
7 

1 
1 
5 
7 

Total 

2020 

2019 

Table 11 – Number of notifications from Switzerland and comments issued on notifications 
from Switzerland by the EU 

2017 

2016 
Not.  Com.  Not.  Com.  Not.  Com.  Not.  Com.  Not.  Com.  Not.  Com. 
1 

Total 

2020 

2018 

2019 

15 

5 

6 

8 

0 

4 

1 

2 

4 

34 

12 

Switzerland 

Table  12  –  Number  of  notifications  from  Turkey  and  comments  issued  on  notifications 
from Turkey by the EU 

2016 
Not.  Com.  Not.  Com.  Not.  Com.  Not.  Com.  Not.  Com.  Not.  Com. 

Total 

2020 

2018 

2019 

2017 

36 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Turkey 

15 

3 

17 

0 

26 

1 

9 

4 

7 

0 

74 

8 

Table  13  –  Comments  by  EEA-EFTA  countries,  Switzerland  and  Turkey  on  Member 
States’ notifications 

EEA-EFTA 
Switzerland 
Turkey 

2016 
0 
1 
0 

2017 
2 
0 
0 

2018 
0 
0 
0 

2019 
0 
1 
0 

2020 
0 
0 
0 

Total 
2 
2 
0 

37 

 
 
 
 
 
 
 
 
ANNEX 5 – ONLINE CONSULTATIONS 2016-2020 

Figure 17 – Online consultations between 2016 and 2020 

236.306

197.341

151.202

152.158

134.737

250.000

200.000

150.000

100.000

50.000

0

2016

2017

2018

2019

2020

In  the  period  in  question,  871  744  searches  were  carried  out  using  the  Technical  Regulation  Information  System  (TRIS)  website  (151  202  in 
2016, 134 737 in 2017, 152 158 in 2018, 197 341 in 2019 and 236 306 in 2020). 

38 

 
 
 
 
 
 
 
 
 
 
 
 
Figure 18 – Online consultations in 2016 

39 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 19 – Online consultations in 2017 

40 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 20 – Online consultations in 2018 

41 

 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 21 – Online consultations in 2019 

42 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 22 – Online consultations in 2020  

24.807

23.934

20.165

21.994

20.254

16.644

16.404

20.899

18.749

19.112

17.592

16.752

30.000

25.000

20.000

15.000

10.000

5.000

0

43