COMMISSION STAFF WORKING DOCUMENT Accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE THE OPERATION OF DIRECTIVE 98/34/EC FROM 2011 TO 2013
Date: 2015-07-17
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: EU law - national law, European Committee for Standardisation, access to information, application of EU law, free movement of goods, single market, standardisation, trade restriction

EUROPEAN 
COMMISSION 

Brussels, 17.7.2015  
SWD(2015) 137 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 

THE OPERATION OF DIRECTIVE 98/34/EC FROM 2011 TO 2013 

{COM(2015) 338 final} 

EN 

   EN 

 
 
 
 
  
 
 
TABLE OF CONTENTS – ANNEXES 

Annex 1 – Procedures for standardisation ..................................................................................1 

1. 

Information procedure ..................................................................................................1 

1.1. 

Role of ESOs .................................................................................................................1 

2. 

2.1. 

2.2. 

3. 

Mandates.......................................................................................................................1 

The consultation process ..............................................................................................1 

Role of ESOs .................................................................................................................1 

Formal objections .........................................................................................................2 

Annex 2 – Breakdown of new national standardisation activities from notifications  

    (CEN and CENELEC) in 2011 and 2012 by state....................................................3 

Annex 3 – Sectoral breakdown of notifications..........................................................................4 

Annex 4 – Mandates from 2006 to 2012 – total .........................................................................6 

Annex 5 – Commission Decisions on formal objections in 2011 and 2012 ...............................7 

Annex 6 – Brief description of the notification procedure .........................................................8 

Annex 7 – Developments in Court of Justice case-law on the matter 2011-2013 ....................10 

Annex 8 – Application of the procedure between 2011-2013: notifications of technical  

    regulations submitted by the member states ...........................................................11 

8.1 

8.2 

8.3 

8.4 

8.5 

8.6 

8.7 

8.8 

Volume of notifications during the 2011-2013 period ...............................................12 

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

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

Commission reactions: comments and detailed opinions in 2011, 2012 and 2013  
(articles 8(2) and 9(2) of the directive) .......................................................................19 

Commission reactions: blockages in 2011, 2012 and 2013 (articles 9(3) and 9(4) 
of the directive)...........................................................................................................20 

Member States reactions.............................................................................................21 

Urgency Procedure (Article 9(7) of the Directive) .....................................................22 

Follow-up to Commission reactions ...........................................................................24 

Annex 9 – Application of the procedure in 2011-2013: participation of efta countries 

    signatory to the eea agreement, of switzerland and of turkey ................................25 

Annex 10 – Internet consultations 2011-2013 ..........................................................................27 

 
 
ANNEX 1 – PROCEDURES FOR STANDARDISATION 

1. 

INFORMATION PROCEDURE 

1.1. 

Role of ESOs 

The  NSBs,  which  are  members  of  CEN  and  CENELEC  (including  bodies  from  the  EFTA 
countries),  send  the  necessary  information  to  the  CEN  Management  Centre  and  the  Central 
Secretariat of CENELEC. The information gathered is sent monthly (except in the summer and over 
the end of year period) by CEN and quarterly by CENELEC to the Commission (DG Enterprise and 
Industry), all the members of CEN and CENELEC and to ETSI.  

Within the Commission, DG Enterprise and Industry disseminates both the regular returns and the 
annual reports of CEN and CENELEC to the relevant services.  

ETSI takes part in the information procedure, although its role is limited to receiving and examining 
the  information  submitted  by  CEN  and  CENELEC  members  via  the  secretariats  of  these  two 
bodies. 

2. 

MANDATES 

1.2. 

The consultation process 

The Commission requests the political and technical endorsement of its policy in a particular area 
from  the  Member  States.  This  is  achieved  by  means  of  a  consultation,  firstly  informally  with  the 
standardisation  bodies,  stakeholders  and  Member  States  through  sectoral  committees  or  expert 
groups  and  then  formally  with  the  Member  States  through  the  Standing  Committee.  The 
consultation  process  is  co-ordinated  by  DG  Enterprise  and  Industry.  The  Committee  gives  its 
opinion on the draft mandate, an opinion that is fully respected by the Commission services and that 
is acted upon wherever reasonable and possible. Following this consultation – and any amendment 
arising from it – the mandates are forwarded to the relevant ESOs for acceptance.  

1.3. 

Role of ESOs 

The ESOs may accept the mandate as issued by the Commission services, or indeed not accept it if 
they so wish, by a decision made at Technical Board level. In practice, as mandates are discussed 
with  the  ESOs  prior  to  their  being  issued,  refusal  is  very  rare  and  mandates  are  usually  only  not 
accepted if the work is outside the scope of the ESO. 

The mandates can be addressed to any one of the ESOs, or any combination of them, as the work 
envisaged requires.  

It is common for the ESOs to request co-funding for the mandated work following acceptance – by 
means  of  action  grants  –  although  the  issuance  of  the  mandate  itself  does  not  mean  funding  will 
necessarily be available and the request for funding must undergo a thorough evaluation process by 
the Commission services.  

EN 

1 

EN 

 
 
 
 
 
 
3. 

FORMAL OBJECTIONS 

The procedure begins with the formal objection either being received by the Commission through 
the Permanent Representation or being launched by the Commission itself. The documents are then 
circulated  to  the  Committee,  and  normally  a  Member  State  expert  group  is  also  consulted  for  its 
opinion. Once a draft Commission Decision is ready, the Committee is consulted. After receiving a 
positive opinion, the Decision is processed further. 

EN 

2 

EN 

 
 
 
 
 
 
 
ANNEX  2  –  BREAKDOWN  OF  NEW  NATIONAL  STANDARDISATION  ACTIVITIES  FROM 

NOTIFICATIONS (CEN AND CENELEC) IN 2011 AND 2012 BY STATE 

Country 

2011 

2012 

Total 

AT 
BE 
BG 
CH 
CY 
CZ 
DE 
DK 
EE 
ES 
FI 
FR 
GR 
HU 
IE 
IS 
IT 
LU 
LT 
LV 
MT 
NL 
NO 
PL 
PT 
RO 
SE 
SI 
SK 
UK 

173 
10 
8 
28 
0 
34 
343 
2 
15 
184 
16 
231 
0 
57 
8 
0 
99 
0 
30 
7 
0 
35 
18 
21 
0 
25 
22 
2 
23 
131 

211 
7 
1 
17 
0 
63 
353 
6 
14 
246 
7 
244 
1 
53 
20 
0 
93 
0 
7 
14 
4 
135 
12 
62 
0 
65 
27 
4 
25 
103 

384 
17 
9 
45 
0 
97 
696 
8 
29 
430 
23 
475 
1 
110 
28 
0 
192 
0 
37 
21 
4 
170 
30 
83 
0 
90 
49 
6 
48 
234 

Country 

CEN 
CENELEC

EU-15 

2011 

1458 
64 

1476 

2012 

1693 
101 

1765 

Total 

3151 
165 

3241 

EFTA 

46 

29 

75 

TOTAL 

1522 

1794 

3316 

EN 

3 

EN 

 
 
 
 
 
 
 
 
 
ANNEX 3 – SECTORAL BREAKDOWN OF NOTIFICATIONS  

2011 

2012 

CEN (Subsectors with more than 50 Notifications) 

Food products 

122  Food products  

Building and construction – Structures 

96 

Petroleum products  

Building and construction – Undetermined  

67 

Building and construction – Structures 

Petroleum products 

59 

Fire protection 

Services - Undetermined 

52 

Building and construction – Undetermined 

Mechanical Engineering - Fasteners  

51 

Shipbuilding and maritime structures 

150 

101 

93 

79 

73 

53 

EN 

4 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
2011 

2012 

CENELEC (Subsectors with more than 5 Notifications) 

Electrical accessories 

16 

Telephony, telegraphy for IT 

Electric cables 

Electrical installations in buildings  

Undetermined 

9 

7 

6 

Electric rotating machines 

Electric cables 

Electrical installations in buildings 

Electrical accessories 

Undetermined 

16 

13 

11 

9 

6 

5 

EN 

5 

EN 

 
 
 
 
 
 
 
 
 
 
ANNEX 4 – MANDATES FROM 2006 TO 2012 – TOTAL 

Type 

2006 

2007 

2008 

2009 

2010 

2011 

2012 

After formal objection (New 
Approach) 

Amendments (New Approach) 

New Approach mandates 

Mandates under other legislation 

Mandates under Community policy 

4 

4 

5 

7 

4 

2 

0 

7 

5 

6 

0 

1 

2 

9 

6 

Total 

24 

20 

18 

0 

4 

5 

10 

2 

21 

0 

0 

4 

12 

4 

20 

0 

0 

5 

9 

5 

1 

8 

8 

7 

0 

19 

24  

EN 

6 

EN 

 
 
 
 
 
 
 
ANNEX 5 – COMMISSION DECISIONS ON FORMAL OBJECTIONS IN 2011 AND 2012 

Standard 

Directive  

Decision

Date 
Decision 

Decision 
number 

O.J. Reference 
decision 
publication 

Date of 
reception 

Days to 
close the 
case 
(aprox) 

1 

2 

EN 15947, Pyrotechnic 
articles - Fireworks, 
Categories 1, 2 and 
3 

EN 15947, Pyrotechnic 
articles - Fireworks, 
Categories 1, 2 and 
3 

2007/23/EC 

Publication of the 
reference in the OJ 
with a restriction 

28/07/2011  C(2011)5310

L197/23 
29.07.2011 

20/09/2010  300 

2007/23/EC 

Publication of the 
reference in the OJ 
with a restriction 

28/07/2011  C(2011)5310

L197/23 
29.07.2011 

27/09/2010  300 

EN 

7 

EN 

 
 
 
  
 
 
ANNEX 6 – BRIEF DESCRIPTION OF THE NOTIFICATION PROCEDURE 

This annex gives a general overview of the notification procedure for products and indicates 
the specific procedural characteristics 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 standards and regulations 
and  of  rules  on  Information  Society  services,  available  on  the  following  website: 
http://ec.europa.eu/enterprise/tris. 

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, 
which  in  turn  was  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. 

Obligation to notify and  standstill period 

Article  8(1)  of  Directive  98/34/EC  (hereinafter  "the  Directive")  stipulates  that  the  Member 
States shall inform the Commission of any draft technical regulation prior to its adoption. The 
simple transposition of a European Union act does not require prior notification, unless the 
national authorities adopt national provisions that go beyond mere compliance with European 
Union acts and that contain technical regulations within the meaning of the Directive (Article 
10 of the Directive). 

Starting from the date of notification of the draft, 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  to  this  rule  is  linked  to  the  nature  of  the  measure  in 
question:  for  technical  specifications  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). 

Possible reactions and consequences 

Where it emerges that the notified drafts are liable to create barriers to the free movement of 
goods or to the free provision of Information Society services (Articles 34-36, 49 and 56 of 
the  Treaty  on  the  Functioning  of  the  European  Union)  or  to  secondary  legislation,  the 
Commission  and  the  other  Member  States  may  submit  a  detailed  opinion  to  the  Member 
State that has notified the draft (Article 9(2) of the Directive). The detailed opinion has the 

1 
2 
3 

Directive of 28 March 1983, OJ L 109/8 of 26.4.1983 
O L 204/37 of 21.7.1998. 
O L 217/18 of 5.8.1998. 

8 

 
 
 
 
 
 
 
 
 
 
                                                 
effect of extending the standstill period by an additional three months. The Commission and 
the  Member  States  can  also  make  comments  about  a  notified  draft  that  appears  to  comply 
with  European  Union  law  but  that  requires  clarification  in  its  interpretation  (Article 8(2)). 
The  Commission  can  also  block  a  draft  for  a  period  of  12  months  if  European  Union 
harmonisation  work  is  due  to  be  undertaken  or  is  already  underway  in  the  same  field 
(Article 9(3) to (5)). 

In  the  event  of  a  detailed  opinion  being  issued,  the  Member  State  concerned  informs  the 
Commission of the action that it intends to take in response to the detailed opinion, and the 
Commission  comments  on  that  reaction  (Article 9(2)).  With  regard  to  the  comments,  even 
though the Directive does not lay down any legal obligation for the Member State receiving 
the  comments  to  indicate  what  follow-up  action  it  intends  to  take,  the  Member  States  are 
inclined to respond, thus making the procedure a genuine instrument of dialogue. 

Urgency procedure 

Article 9(7) of the Directive describes an urgency procedure, which is designed to allow the 
immediate adoption of a national draft, subject to a closed list of certain conditions that must 
be  clearly  indicated  at  the  time  of  notification  (‘serious  and  unforeseeable  circumstances 
relating  to  the  protection  of  public  health  or  safety,  the  protection  of  animals  or  the 
preservation of plants'). The aim of the urgency procedure is to enable a notifying Member 
State  faced  with  serious  or  unforeseeable  circumstances  immediately  to  adopt  the  draft 
technical  regulation,  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-monthe  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 breach of European Union law. 

Communication of final texts 

At the end of the 98/34 procedure, the Member States are bound to inform the Commission of 
final texts as soon as those texts have been adopted and to indicate cases in which the notified 
draft has been abandoned, in order to allow the 98/34 procedure to be closed (Article 8(3) of 
the Directive). 

‘Technical standards and regulations’ committee 

The Standing Committee laid down in Article 5 of the Directive consists of representatives 
appointed by the Member States and is chaired by a representative of the Commission. In its 
‘Technical  standards  and  regulations’  configuration,  the  Committee  meets  regularly  and 
constitutes a forum for discussing all issues connected with the application of the Directive. 

Application of the 98/34 procedure to Information Society services 

The  98/34  procedure  also  applies  to  Information  Society  services,  with  the  following 
adaptations:  a)  in  the  event  of  a  detailed  opinion  being  issued,  the  total  standstill  period  is 
four  months  from  the  date  of  the  communication,  instead  of  the  six  months  stipulated  for 

9 

 
 
 
 
 
 
 
 
 
 
 
products;  b)  the  Commission  can  only  block  the  draft  for  a  maximum  of  12  months  if  the 
subject  of  the  draft  is  already  covered  by  an  EU  Council  proposal  and  if  the  notified  text 
contains provisions that do not comply with the proposal drafted by the Commission; c) the 
urgency procedure can be invoked not only under the circumstances stipulated for products 
('serious and unforeseeable circumstances') but also 'for urgent reasons ... relating to public 
safety'.  

The simplified procedure 

EFTA  countries  that  are  contracting  parties  to  the  Agreement  on  the  European  Economic 
Area  (‘EEA’),  namely  Norway,  Iceland  and  Liechtenstein,  apply  the  98/34  procedure  with 
the necessary adaptations4: they notify their drafts via the EFTA Surveillance Authority and 
can  comment  on  the  drafts  notified  by  the  27  Member  States.  On  the  other  hand  the  entire 
European Union can comment on drafts notified by the three countries signatory to the EEA 
Agreement. 

Switzerland  (which  is  part  of  EFTA,  but  which  does  apply  the  EEA  Agreement)  also 
participates  in  the  system.  This  country  applies  the  98/34  procedure  on  a  voluntary  basis 
following  an  informal  agreement  to  exchange  information  in  the  field  of  technical 
regulations: it submits its drafts to the Commission and can make and receive comments on 
the notified drafts.  

Turkey,  which  transposed  the  Directive  in  2002,  participates  in  the  procedure  in  the  same 
manner  as  the  EFTA  countries.  The  decision  to  have  Turkey  participate  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 7 – DEVELOPMENTS IN COURT OF JUSTICE CASE-LAW ON THE MATTER 2011-2013 

During  the  reporting  period  the  European  Court  of  Justice  (ECJ)  delivered  two  important 
judgements concerning Directive 98/34/EC. 

judgment  was  rendered  on  14  April  2011 

The  first 
in  case  C-42/10,  Vlaamse 
Dierenartsenvereniging  and  Janssens.  According  to  the  judgement,  national  provisions 
concerning the pet passport and its use as proof of identification and registration as well as 
the use of self-adhesive stickers to amend the identity details of the owner and the animal, on 
the  one  hand,  and  those  relating  to  the  determination  of  a  unique  number  for  pets,  on  the 
other, do not constitute technical regulations in the meaning of Directive 98/34/EC. 

The second judgment was rendered on 19 July 2012 in case C-213/11, Fortuna and Others. 
In this case the ECJ decided that national provisions, which could have the effect of limiting, 
or  even  gradually  rendering  impossible,  the  running  of  gaming  on  low-prize  machines 
anywhere  other  than  in  casinos  and  gaming  arcades  are  capable  of  constituting  ‘technical 

4 

Annex II, Chapter XIX, point 1 to the EEA Agreement, which includes Article 8(2) of the Directive 

10 

 
 
 
 
 
 
 
 
                                                 
regulations’ in so far as it is established that those provisions constitute conditions which can 
significantly influence the nature or the marketing of the product concerned. 

It  should  be  pointed  out  that,  like  the  other  Court  judgments  on  the  notification  procedure, 
these 
website: 
consulted 
http://curia.europa.eu/jcms/jcms/Jo1_6308/). 

judgments 

following 

can 

the 

on 

be 

ANNEX  8  –  APPLICATION  OF  THE  PROCEDURE  BETWEEN  2011-2013:  NOTIFICATIONS  OF 

TECHNICAL REGULATIONS SUBMITTED BY THE MEMBER STATES 

Annexes 8.1,  8.2  and  8.3  give  a  statistical  overview  of  the  development  of  the  number  of 
draft  technical  regulations  notified  by  the  Member  States  between  2011  and  2013,  and  of 
their breakdown by Member State and by sector. It should be pointed out that, in accordance 
with  Article  11  of  the  Directive,  ‘statistics  concerning communications  received’  as  part  of 
the notification procedure are published once a year in the Official Journal, C series5. 

The reactions to the notified drafts – in the form of comments or detailed opinions from the 
Commission  or  the  Member  States,  or  of  blockages  on  the  part  of  the  Commission  –  are 
illustrated in Annexes 8.4 to 8.6. 

Annex 8.7  refers  to  the  requests  to  apply  the  urgency  procedure  that  the  Member  States 
addressed to the Commission pursuant to Article 9(7) of the Directive. 

Annex 8.8  shows  the  action  taken  by  the  Member  States  in  response  to  the  Commission’s 
reactions. 

5  

For 2011: OJ 2012/C 160/05 of 6 June 2012; for 2012:  OJ 2013/C 165/07 of 11.06.2013 ; for 2013: OJ 
2014/C 145/06 of 15 May 2014 

11 

 
 
 
 
 
 
 
 
                                                 
8.1 

Volume of notifications during the 2011-2013 period 

Figure 1: Number of Notifications

2013

2012

2011

675

705

734

The statistics in Figure 1 show that the Member States notified 675 draft regulations in 2011, 
734 draft regulations in 2012 and 705 draft regulations in 2013 to the Commission. 

12 

 
 
 
 
8.2 

Breakdown by country 

Figure 2: Notifications by Member States

225
200
175
150
125
100
75
50
25
0

a

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r
t
s
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A

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S

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U

2013
2012
2011

During  the  2011-2013  period,  three  Member  States  which  notified  the  highest  number  of  draft  technical  regulations  were  Austria  (187), 
Germany (180) and France (169). A group of five other countries (Denmark, Italy, Netherlands, Sweden, Spain and United Kingdom) come next 
with a total number of notifications of between 103 and 143.  

13 

 
 
 
 
 
 
 
 
 
 
Table 1 – Number of notifications of technical regulations submitted by the Member 
States in 2011, 2012 and 2013 

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 

2011 

2012 

2013 

59 
25 
12 
0 
26 
29 
39 
16 
23 
57 
57 
15 
27 
6 
48 
3 
9 
4 
2 
43 
37 
5 
41 
28 
8 
27 
40 
48 
734 

63 
27 
16 
1 
2 
30 
34 
12 
29 
49 
61 
12 
38 
8 
34 
5 
17 
16 
2 
41 
27 
5 
12 
33 
9 
47 
33 
42 
705 

65 
19 
11 
0 
1 
22 
38 
9 
23 
63 
62 
13 
28 
10 
29 
6 
5 
4 
5 
41 
27 
5 
22 
35 
10 
39 
30 
53 
675 

14 

 
 
 
 
Table 2 – Percentage of notifications submitted by the Member States in 2011, 2012 and 
2013 

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 

2011 (%) 

2012 (%) 

2013 (%) 

8.0% 
3.4% 
1.6% 
0.0% 
3.5% 
4.0% 
5.3% 
2.2% 
3.1% 
7.8% 
7.8% 
2.0% 
3.7% 
0.8% 
6.5% 
0.4% 
1.2% 
0.5% 
0.3% 
5.9% 
5.0% 
0.7% 
5.6% 
3.8% 
1.1% 
3.7% 
5.4% 
6.5% 

8.9% 
3.8% 
2.3% 
0.1% 
0.3% 
4.3% 
4.8% 
1.7% 
4.1% 
7.0% 
8.7% 
1.7% 
5.4% 
1.1% 
4.8% 
0.7% 
2.4% 
2.3% 
0.3% 
5.8% 
3.8% 
0.7% 
1.7% 
4.7% 
1.3% 
6.7% 
4.7% 
6.0% 

9.6% 
2.8% 
1.6% 
0.0% 
0.1% 
3.3% 
5.6% 
1.3% 
3.4% 
9.3% 
9.2% 
1.9% 
4.1% 
1.5% 
4.3% 
0.9% 
0.7% 
0.6% 
0.7% 
6.1% 
4.0% 
0.7% 
3.3% 
5.2% 
1.5% 
5.8% 
4.4% 
7.9% 

15 

 
 
8.3 

Breakdown by sector 

Table  3:  Breakdown  by  sector  of  the  drafts  notified  by 
the Member States of the European Union in 2011 

Figure 3: Percentage of the sectors of the drafts notified by the 
Member States of the European Union in 2011 

Sectors 

Construction 
Agriculture, Fishing and 
Foodstuffs 
Transport 
Telecoms 
Environment 
Mechanics 
Goods and Miscellaneous 
Products 
Energy, Minerals, Wood 
98/48/EC Services 
Domestic and Leisure Equipment 
Chemicals 
Pharmaceuticals and Cosmetics 
Health, Medical Equipment 
Total 

M                    

2011 

166 

113 

66 
58 
42 
41 

40 

33 
32 
32 
28 
15 
9 
675 

16 

 
 
 
 
 
 
Table  4:  Breakdown  by  sector  of  the  drafts  notified 
by the Member States of the European Union in 2012 

Figure 4: Percentage of the sectors of the drafts notified by 
the Member States of the European Union in 2012 

sector of th
M                

10.5

4.2

4.9

1

6.3

eSectors 

Construction 
Agriculture, Fishing and 
Foodstuffs 
Telecoms 
Transport 
Goods and Miscellaneous 
Products 
Environment 
Mechanics 
Pharmaceuticals and Cosmetics 
98/48/EC Services 
Energy, Minerals, Wood 
Domestic and Leisure Equipment 
Chemicals 
Health, Medical Equipment 
Total 

2012 

188 

146 

77 
60 

46 

43 
36 
31 
30 
29 
22 
19 
7 
734 

8.2

4.1

19.9

98/48/EC Services

Agriculture, Fishing and
Foodstuffs

Chemicals

Construction

Domestic and Leisure
Equipment

Energy, Minerals ,Wood

2.6

Environment

Goods and Miscellaneous
Products

25.6

Health, Medical Equipment

Mechanics

Pharmaceuticals and
Cosmetics

Telecoms

Transport

5.9

4

3

17 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 5: Breakdown by sector of the drafts notified by the 
Member States of the European Union in 2013 

Figure 5: Percentage of the sectors of the drafts notified by the 
Member States of the European Union in 2013 

Tab3: Breakdown by sector of the drafts notified by the M                     

Sectors 
Construction 
Agriculture, Fishing and 
Foodstuffs 
Telecoms 
Environment 
Transport 
Goods and Miscellaneous 
Products 
Mechanics 
98/48/EC Services 
Energy, Minerals, Wood 
Domestic and Leisure Equipment 
Chemicals 
Pharmaceuticals and Cosmetics 
Health, Medical Equipment 
Total 

2013 
158 

134 

70 
56 
42 

40 

37 
37 
35 
29 
29 
28 
10 
705 

6

5.2

9.9

98/48/EC Services

Agriculture, Fishing and
Foodstuffs

Chemicals

Construction

19

Domestic and Leisure
Equipment

Energy, Minerals ,Wood

Environment

4.1

Goods and Miscellaneous
Products

Health, Medical Equipment

7.9

5

4.1

22.4

Mechanics

Pharmaceuticals And
Cosmetics

Telecoms

Transport

4

5.2

1.4

5.7

18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.4 

Commission reactions: comments and detailed opinions in 2011, 2012 
and 2013 (articles 8(2) and 9(2) of the directive) 

Figure 6: Commisson Reactions to Notifications in 2011, 2012 and 
2013

160
140
120
100
80
60
40
20
0

2011

2012

2013

Comments 

Detailed Opinions

2011

130

51

2012

145

64

2013

150

93

The number of comments made by the Commission increased from 130 in 2011 to 145 in 
2012 and to 150 in 2013. 

The number of detailed opinions issued by the Commission during the period in question 
increased  between  2011  and  2012:  51  detailed  opinions  in  2011  on  the  total  number  of 
675  notifications  (7.5%)  and  in  2012,  64  detailed  opinions  on  the  total  number  of  734 
notifications (8.7%).  

The percentage of detailed opinions increased to the level of 13.1% in 2013 (93 detailed 
opinions were issued by the Commission on the total number of 705 notifications). 

19 

 
 
 
 
 
 
 
 
8.5 

Commission reactions: blockages in 2011, 2012 and 2013 (articles 9(3) 
and 9(4) of the directive) 

During the 2011-2013 period, the Commission requested a 12-month postponement of the 
adoption of 12 draft regulations notified by the Member States, because they concerned a 
subject  on  which  Union  harmonisation  work  had  already  been  announced  or  was 
underway. 

Table 6 

Year 

2011 
2012 
2013 

Standstills (Blockages) 

Announcement of a 
Community text 
(Article 9(3)) 
2 
2 
4 

Presentation to the Council of 
a Community text 
(Article 9(4)) 
1 
2 
1 

Total 

3 
4 
5 

20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.6 

Member States reactions 

Table 7 - Comments and detailed opinions issued by the Member States 2011, 2012 
and 2013 (Articles 8(2) and 9(2)) 

2011 

2012 

2013 

Comments 

Detailed 
Opinions 

Comments 

Detailed 
Opinions 

Comments 

Detailed 
Opinions 

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 
UK 
Total 

6 
1 
0 
0 
0 
7 
2 
0 
4 
12 
34 
0 
1 
0 
16 
0 
2 
0 
3 
4 
4 
3 
4 
15 
5 
11 
1 
11 
146 

5 
0 
0 
0 
0 
1 
0 
0 
0 
7 
1 
3 
1 
1 
5 
0 
0 
0 
10 
4 
0 
4 
0 
1 
0 
3 
0 
2 
48 

9 
2 
1 
0 
0 
6 
1 
0 
1 
11 
4 
2 
1 
1 
10 
0 
0 
1 
5 
2 
1 
2 
2 
2 
0 
16 
0 
5 
85 

5 
0 
0 
6 
0 
6 
2 
0 
2 
15 
27 
1 
0 
2 
14 
0 
0 
0 
2 
1 
10 
1 
7 
3 
3 
13 
2 
8 
130 

11 
1 
0 
0 
0 
6 
0 
0 
0 
5 
2 
0 
1 
0 
9 
0 
1 
0 
6 
8 
1 
1 
1 
6 
0 
9 
0 
4 
72 

7 
2 
2 
0 
0 
23 
1 
0 
3 
17 
57 
0 
7 
1 
23 
0 
0 
0 
1 
3 
6 
4 
5 
11 
9 
22 
1 
4 
209 

21 

 
 
 
 
 
 
 
 
 
 
 
8.7 

Urgency Procedure (Article 9(7) of the Directive) 

Table 8 - Requests to apply the urgency procedure received in 2011, 2012 and 2013 

2011 

2012 

2013 

Austria 
Belgium 
Bulgaria 
Croatia 
Cyprus 
Czech R. 
Denmark 
Estonia 
Finland 
France 
Germany 
Greece 
Hungary 
Ireland 
Italy 
Latvia 
Lithuania 
Luxembourg 
Malta 
Netherlands 
Poland 
Portugal 
Romania 
Slovakia 
Slovenia 
Spain 
Sweden 
UK 
Total 

Requests 

4 
0 
0 
0 
0 
1 
1 
0 
1 
1 
0 
1 
3 
1 
1 
0 
0 
0 
0 
2 
2 
0 
1 
2 
0 
2 
3 
0 
26 

Favourable
opinion 
4 
0 
0 
0 
0 
0 
1 
0 
1 
0 
0 
0 
1 
1 
1 
0 
0 
0 
0 
2 
2 
0 
1 
0 
0 
1 
3 
0 
18 

Requests 

0 
3 
1 
0 
0 
2 
0 
1 
7 
1 
1 
5 
2 
0 
0 
0 
0 
0 
0 
2 
1 
1 
0 
0 
0 
0 
8 
0 
35 

Favourable
opinion 
0 
0 
0 
0 
0 
2 
0 
1 
6 
1 
1 
2 
2 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
8 
0 
23 

Requests 

0 
1 
0 
0 
0 
8 
0 
1 
1 
1 
1 
0 
2 
0 
0 
1 
0 
0 
0 
2 
0 
1 
2 
0 
0 
1 
4 
0 
26 

Favourable
opinion 
0 
0 
0 
0 
0 
2 
0 
1 
1 
1 
1 
0 
2 
0 
0 
0 
0 
0 
0 
1 
0 
1 
1 
0 
0 
0 
4 
0 
15 

Table 8 provides an overview of the number of requests to apply the emergency procedure, by 
Member State and by year; it also shows the number of requests to which the Commission gave 
a favourable opinion.   

22 

 
 
 
 
 
 
 
 
Table 9 - Breakdown by sector of the requests to apply the urgency procedure in 2011, 2012 and 2013 

BE 

AT 
R F R  F  R  F  R  F R F R F R F R F R F R F R F  R  F R F R F R F R F R F R F R F R F  R  F 

EL  HU 

LV  NL 

PT  RO 

FR  DE 

DK 

BG 

CZ 

EE 

SK 

PL 

SE 

ES 

IT 

IE 

FI 

98/48/EC 
Services 
Agr. Fishing 
and Foodstuffs 

Chemical 

Construction 

Domestic and 
Leisure Equip. 
Energy, Min, 
Wood 

Environment 

Goods & Misc. 
Products 
Health, Medi. 
Equipment 

Mechanics 

Pharmac. and 
Cosmetics 

Telecoms 

Transport 

Total 

0

0

3

0

0

0

0

0

0

0

1

0

0

4

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 0

0 0

0 0

0 0

0 0

0 0

0 1

0  0  0 

0 0  0  1  0  4 

3 0

0 0

0 0

0 1

0 0

0 0

0 1

0  0  0 0

0 1

0 4

2 0

0 0

0 0

0 0

0 1

0  0  0 

3 3  0  0  0  3 

0 1

1 1

1 1

1 0

0 0

0 0

0 1

1  1  1 0

0 0

0 1

0 0

0 0

0 2

2 0

0 0

0  6  6 

0 0  0  0  0  0 

0 0

0 0

0 0

0 1

1 0

0 0

0 0

0  0  0 0

0 0

0 1

1 0

0 0

0 0

0 2

0 0

0  0  0 

0 0  0  0  0  0 

0 0

0 0

0 0

0 0

0 0

0 3

0 0

0  0  0 0

0 0

0 0

0 0

0 1

0 0

0 0

0 0

0  0  0 

0 0  0  0  0  1 

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 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 0

0 0

0 0

0  0  0 0

0 0

0 0

0 0

0 0

0 1

0 0

0 0

0  3  3 

0 0  0  0  0  0 

0 0

0 0

0 0

0 1

1 0

0 2

2 0

0  0  0 1

1 0

0 0

0 1

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

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  0  0 

0 1  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 0

0 0

0 0

0 0

0 0

0 0

0  0  0 

1 0  0  0  0  3 

1 0

0 1

1 8

7 0

0 2

2 0

0 4

4  0  0 0

0 0

0 0

0 2

2 1

1 0

0 0

0 1

1  6  6 

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 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 0

0 0

0 0

0 0

0 1

0 1

0  0  0 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0  0  0 

4 4  0  1  0   11  4 1

1 2

2 9

8 3

2 2

2 6

2 7

5  1  1 1

1 1

0 6

3 3

2 2

1 3

2 2

0 3

1  15  15 

R:  Requests     F: Favorable Opinions 

Table 9, which gives a sectoral breakdown of the requests to apply the urgency procedure received by the Commission during the 2011-2013 
period, shows that the application of this exceptional procedure was invoked mainly in the pharmaceutical and cosmetics sector (29 requests) and 
in the chemicals sector (23). 

23 

 
 
 
 
 
 
8.8 

Follow-up to Commission reactions 

Table  10  shows  that,  in  2011,  the  recipient  Member  States  responded  to  47  of  the  51  detailed 
opinions issued by the Commission (92,1%) and that 23 responses were deemed satisfactory by 
the Commission (46%).  

In 2012, they responded to 59 of the 64 detailed opinions (92.1%); 27 were satisfactory (45.7%).  

In 2013, they responded to 73 of the 93 detailed opinions (75.2); 39 were satisfactory (53,4 %). 

 Table 10 

Year 

2011 
2012 
2013 

Detailed 
Opinions 
51 
64 
93 

Responses from 
the MS 
47 
59 
73 

Satisfactory 

Closures 

23 
27 
39 

9 
6 
7 

Table 11 

Year 

Comments 

2011 
2012 
2013 

130 
145 
150 

Responses from 
MS 
83 
93 
79 

Table 11 shows that, in 2011, the recipient Member States responded to 83 of the 130 comments 
issued by the Commission (63,8 %) and in 2012, they responded to 93 of the 145 (64.1 %). In 
2013 they responded to 79 of the 150 (52.6 %).  

24 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX 9 – APPLICATION  OF  THE  PROCEDURE  IN 2011-2013:  PARTICIPATION  OF  EFTA  COUNTRIES  SIGNATORY  TO  THE  EEA  AGREEMENT,  OF 

SWITZERLAND AND OF TURKEY 

Table 12 – Number of notifications from EFTA countries and comments issued to them by the European Union 

2011 

2012 

2013 

Notifications  Comments   Notifications  Comments   Notifications  Comments  

A
T
F
E

Iceland 

Liechtenstein 

Norway 

6 

1 

6 

4 

0 

6 

4 

2 

4 

1 

2 

0 

3 

0 

13 

1 

0 

5 

EN 

25 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table  13  –  Number  of  notifications  submitted  by  Switzerland  and  Turkey  and  comments  issued  to  them  by  the  Commission  or  the 
Member States 

2011 

2012 

2013 

Notifications  Comments  Notifications Comments  Notifications Comments 

Switzerland

Turkey 

7 

2 

2 

0 

11 

0 

2 

0 

7 

6 

1 

0 

Table 14 – Number of comments from EFTA, Switzerland and Turkey regarding the notifications from the Member States 

2011 

2012 

2013 

EFTA 

Switzerland

Turkey 

0 

0 

0 

1 

0 

0 

0 

0 

0 

EN 

26 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX 10 – INTERNET CONSULTATIONS 2011-2013 

EN 

27 

EN