COMMISSION STAFF WORKING PAPER […]
Date: 2011-12-07
Institutions: European Commission
Subjects: European standard, economic support, exchange of information, information society, technical standard

EUROPEAN COMMISSION 

Brussels, 7.12.2011 
SEC(2011) 1509 final 

COMMISSION STAFF WORKING PAPER 

[…] 

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 IN 2009 AND 2010 

{COM(2011) 853 final} 

 
 
 
 
  
 
 
TABLE OF CONTENTS – ANNEXES 

Annex 1   Procedures for standardisation ..............................................................................…..  2 

1. 

1.1. 

2. 

2.1. 

2.2. 

3. 

Information procedure.................................................................................................  2 

Role of ESOs...............................................................................................................  2 

Mandates .....................................................................................................................  2 

The consultation process.............................................................................................  2 

Role of ESOs...............................................................................................................  2 

Formal objections........................................................................................................  3 

Annex 2  Breakdown of new national standardisation activities from notifications (CEN and 

CENELEC) in 2009 and 2010 by State ......................................................................  4 

Annex 3  Breakdown of new national standardisation activities from notifications (CEN and 

CENELEC) from 1999 to 2010 by group of countries ...............................................  5 

Annex 4  Sectoral breakdown of notifications ...........................................................................  6 

Annex 5  Mandates from 2006 to 2010 – total ...........................................................................  7 

Annex 6  Commission Decisions on formal objections in 2009 and 2010.................................  8 

Annex 7  Brief description of the notification procedure ...........................................................  10 

Annex 8  Developments in Court of Justice case-law on the matter in 2009 and 2010 .............  12 

Annex 9  Application of the procedure in 2009 and 2010: notifications of technical regulations  

submitted by the member states ..................................................................................  13 

9.1 

9.2 

9.3 

9.4 

9.5 

9.6 

9.7 

9.8 

Volume of notifications during the 2009-2010 period................................................  14 

Breakdown by country ................................................................................................  15 

Breakdown by sector...................................................................................................  18 

Commission reactions: comments and detailed opinions in 2009 and 2010 (Articles 8(2) 
and 9(2) of the Directive)............................................................................................  20 

Commission reactions: blockages in 2009 and 2010 (Articles 9(3) and 9(4) of the 
Directive) ....................................................................................................................   21 

Member State reactions...............................................................................................  22 

Urgency Procedure (Article 9(7) of the Directive) .....................................................  23 

Follow-up to Commission reactions ...........................................................................  25 

Annex 10  Application of the procedure in 2009 and 2010: participation of EFTA countries 

signatory to the EEA Agreement, of Switzerland and of Turkey ...............................  26 

Annex 11  Internet consultations in 2009 and 2010 .....................................................................  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 

2.1. 

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.  

2.2. 

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 

2 

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 

3 

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ANNEX 2 

BREAKDOWN  OF  NEW  NATIONAL  STANDARDISATION  ACTIVITIES  FROM 
NOTIFICATIONS (CEN AND CENELEC) IN 2009 AND 2010 BY STATE 

Country 

2009 

2010 

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 

196 
30 
12 
38 
2 
70 
424 
8 
9 
208 
3 
277 
0 
7 
4 
0 
123 
0 
3 
33 
0 
59 
17 
14 
0 
45 
21 
11 
29 
159 

205 
32 
31 
24 
1 
53 
368 
1 
18 
196 
0 
221 
464 
7 
9 
0 
265 
0 
44 
11 
1 
62 
15 
27 
0 
2 
18 
8 
26 
138 

401 
62 
43 
62 
3 
123 
792 
9 
27 
404 
3 
498 
464 
14 
13 
0 
388 
0 
47 
44 
1 
121 
32 
41 
0 
47 
39 
19 
55 
297 

CEN 
CENELEC

From EU-
15 

From EU-
12 

From 
EFTA 

1769 
99 

1512 

2190 
57 

1979 

3959 
156 

3491 

235 

229 

464 

55 

39 

94 

TOTAL 

1802 

2247 

4049 

EN 

4 

EN 

 
 
 
 
 
 
 
 
 
ANNEX 3 

   BREAKDOWN  OF  NEW  NATIONAL  STANDARDISATION  ACTIVITIES  FROM  NOTIFICATIONS (CEN  AND CENELEC)  FROM 

1999 TO 2010 BY GROUP OF COUNTRIES 

National Notifications

2500

2000

1500

1000

500

0

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

EU-15 EU-10 EU-2

EN 

5 

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ANNEX 4 

 SECTORAL BREAKDOWN OF NOTIFICATIONS  

2009 

2010 

CEN 

Building and construction – Structures  

183  Building and construction – Structures 

591 

Food products 

70 

Building and construction – Fire protection 

Building and construction – Undetermined  

66 

Food products 

Mining 

61 

Services - Undetermined 

Building and construction – Fire protection 

54 

Health, environment and medical equipment - 
Undetermined 

Road Building and Maintenance  

44  Water quality and water supply  

Non-metallic materials - Undetermined  

42 

Building and construction - Undetermined 

 Aerospace 

Optics  

Road safety 

41 

Petroleum products 

39  Air quality 

38  Mechanical engineering - Fasteners 

75 

62 

58 

56 

51 

50 

46 

44 

40 

EN 

6 

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ANNEX 5 

MANDATES FROM 2006 TO 2010 – TOTAL 

Type 

2006

2007 

2008 

2009 

2010 

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 

EN 

7 

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ANNEX 6 

COMMISSION DECISIONS ON FORMAL OBJECTIONS IN 2009 AND 2010 

Standard 

Directive  

Decision

Date 
Decision 

Decision 
number 

O.J. Reference 
decision 
publication 

Date of 
reception 

Days to 
close the 
case 
(aprox) 

EN 3-9:2006 - Portable fire 
extinguishers — Part 9: 
Additional requirements to 
EN 3-7 for pressure 
resistance of CO2 
extinguishers 
EN 3-8:2006 - Portable fire 
extinguishers - Part 8: 
Additional requirements to 
EN 3-7 for the construction; 
resistance to pressure and 
mechanical tests for 
extinguishers with a 
maximum allowable 
pressure equal to or lower 
than 30 bar 
EN 12312-9:2005 - Aircraft 
ground support equipment - 
Specific requirements - Part 
9: Container/Pallet loaders 

1 

2 

3 

97/23/EC 
Pressure 
Equipment 

Non publication of 
the reference in the 
OJ 

10/02/2009 C(2009) 666 

L 48/13 
19.02.2010 

06/07/2007  574 

97/23/EC 
Pressure 
Equipment 

Publication of the 
reference in the OJ 

10/02/2009 C(2009) 739 

L 40/33 
11.02.2010 

06/07/2007  574 

2006/42/EC 
Machinery 

publication with a 
restriction  

11/03/2009

C(2009) 
1551 

L 067/85 
12.3.2009 

19/10/2005  1222 

EN 

8 

EN 

 
 
 
 
  
 
4 

5 

6 

7 

EN ISO 4869-4:2000 
Acoustics - Hearing 
protectors - Part 3: 
Measurement of insertion 
loss of ear-muff type 
protectors using an acoustic 
test fixture 

EN 353-1:2002 Personal 
protective equipment against 
falls from height – Part 1: 
Guided type fall arresters 
including a rigid anchor line 

89/686/EEC  
Personal 
Protective 
Equipment  

Presumption of 
conformity 
withdrawn 

89/686/EEC  
Personal 
Protective 
Equipment  

non-withdrawal of 
the reference of 
standard  

18/03/2010

C(2010) 
1599 

L 69/20 
19.3.2010 

05/11/2008  493 

19/03/2010

C(2010)1619 
final 

L 75/27 
23.3.2010 

29/10/2008  500 

EN 71-1:2005 – 5.12 
Fillings (rembourrage) 

88/378/EEC 
Toys 

non-withdrawal of 
the reference of 
standard  

09/06/2010

C(2010)3571 
final 

non published 

15/05/2006  1464 

EN 71-8:2003/A2:2005 – 
Swings 

88/378/EEC 
Toys 

Presumption of 
conformity partially 
withdrawn 

24/06/2010

C(2010)4156 
final 

non published 
(but mentioned 
in the list 
published on 
OJEU C 236/3 
01.09.2010) 

19/04/2006  1505 

EN 

9 

EN 

 
 
 
 
ANNEX 7 

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 
effect of extending the standstill period by an additional three months. The Commission and 

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. 

EN 

10 

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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 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 

EN 

11 

EN 

 
 
 
 
 
 
 
 
 
 
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  not  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 8 

DEVELOPMENTS  IN  COURT  OF  JUSTICE  CASE-LAW  ON  THE  MATTER  IN  2009 
AND 2010  

During the 2009-2010 period one Court of Justice judgment has been delivered on Directive 
98/34/EC. 

In the case Lars Sandström (Judgment of 15 April 2010, Case C-433/05, OJ C 148 of 5 June 
2010, p.2) the Court of Justice clarifies the concept of significant alteration of the draft for the 
purposes of the third subparagraph of Article 8.1 of the Directive. 

It  stated  that  "an  amendment  made  to  a  draft  technical  regulation  already  notified  to  the 
European  Commission,  pursuant  to  the  first  subparagraph  of  that  provision,  and  which 
contains, in relation to the notified draft, merely a relaxation of the conditions of use of the 
product  in  question  and  which,  therefore,  reduces  the  possible  impact  of  the  technical 
regulation  on  trade,  is  not  a  significant  alteration  of  the  draft  for  the  purposes  of  the  third 
subparagraph of that provision and need not be notified beforehand to the Commission". 

It  should  be  pointed  out  that,  like  other  Court  of  Justice  judgments  on  the  notification 
procedure, this judgment can be consulted on the following website: 

http://curia.europa.eu/jcms/jcms/Jo1_6308/). 

4 

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

EN 

12 

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ANNEX 9 

APPLICATION  OF  THE  PROCEDURE  IN  2009  AND  2010:  NOTIFICATIONS  OF 
TECHNICAL REGULATIONS SUBMITTED BY THE MEMBER STATES 

Annexes 9.1, 9.2 and 9.3 give a statistical overview of the development of the number of draft 
technical regulations notified by the Member States in 2009 and 2010, 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 9.4 to 9.6. 

Annex 9.7  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 9.8  shows  the  action  taken  by  the  Member  States  in  response  to  the  Commission’s 
reactions. 

5 

For 2009: OJ C 164/3 of 24.06.2010; for 2010: OJ C 147/07 of 18 May 2011  

EN 

13 

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9.1 

VOLUME OF NOTIFICATIONS DURING THE 2009-2010 PERIOD 

Figure 1 

2010 

2009 

The statistics in figure 1 show that the Member States notified to the Commission 708 draft 
regulations in 2009 and  817 in 2010. 

EN 

14 

EN 

 
 
 
 
 
 
9.2 

BREAKDOWN BY COUNTRY 

Figure 2 

During the 2009-2010 period, the two Member States which notified the most draft technical 
regulations  were  France  (155)  and  Germany  (120).  A  group  of  three  other  countries 
(Netherlands, United Kingdom and Spain) come next with a total number of notifications of 
between 100 and 117.  

EN 

15 

EN 

 
 
 
 
 
Table  1  –  Number  of  notifications  of  technical  regulations  submitted  by  the  Member 
States in 2009 and 2010 

Member States  

2009 

2010 

Austria 

Belgium 

Bulgaria 

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  

43 

51 

 8 

1 

26 

34 

15 

31 

56 

64 

9 

20 

8 

31 

15 

9 

1 

9 

67 

20 

9 

 14 

16 

14 

52 

31 

54 

708 

48 

31 

5 

6 

26 

45 

5 

34 

99 

56 

7 

10 

9 

41 

12 

8 

63 

12 

50 

42 

7 

41 

14 

7 

47 

40 

52 

817 

EN 

16 

EN 

 
 
 
Table 2 – Percentages of notifications submitted by the Member States in 2009 and 2010 

Member States 

Austria 

Belgium 

Bulgaria 
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 

2009 

6.1% 

7.2% 

1.1% 

0.1% 

3.7% 

4.8% 

2.1% 

4.4% 

7.9% 

9.0% 

1.3% 

2.8% 

1.1% 

4.4% 

2.1% 

1.3% 

0.1% 

1.3% 

9.5% 

2.8% 

1.3% 

2.0% 

2.3% 

2.0% 

7.3% 

4.4% 

7.6% 

2010 

5.9% 

3.8% 

0.6% 

0.7% 

3.2% 

5.5% 

0.6% 

4.2% 

12.1% 

6.9% 

0.9% 

1.2% 

1.1% 

5.0% 

1.5% 

1.0% 

7.7% 

1.5% 

6.1% 

5.1% 

0.9% 

5.0% 

1.7% 

0.9% 

5.8% 

4.9% 

6.4% 

EN 

17 

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9.3 

BREAKDOWN BY SECTOR 

Figure 3 

Building and construction are constantly increasing and represent the sector with the highest 
number of notifications during the period in question (354 notifications). They are followed 
by the foodstuffs and agricultural products sector (224 notifications). In 2009 and 2010, the 
transport sector grew (178 notifications). Information Society services represent on average 
5.5% of the total number of notifications. 

EN 

18 

EN 

 
 
 
 
 
 
Tables 3 and 4 – Breakdown by sector of the drafts notified by the Member States of the European Union in 2009 and 2010 

2009 

132 

105 

18.6% 

14.8% 

21 

23 

23 

39 

40 

62 

9 

3.0% 

3.2% 

3.2% 

5.5% 

5.6% 

8.8% 

1.3% 

Sectors 

Building and construction 

Foodstuffs and agricultural products 

Chemicals 

Pharmaceuticals 

Domestic and leisure equipment 

Mechanical engineering 

Energy, ores, wood 

Environment, packaging 

Health, medical equipment 

Transport 

Telecommunications 

Miscellaneous products 

Information Society services 

Sectors 

2010 

Building and construction 

Foodstuffs and agricultural products 

222 

119 

27.2% 

14.6% 

Chemicals 

Pharmaceuticals 

Domestic and leisure equipment 

Mechanical engineering 

Energy, ores, wood 

Environment, packaging 

Health, medical equipment 

19 

23 

47 

46 

35 

47 

5 

64 

86 

51 

53 

2.3% 

2.8% 

5.8% 

5.6% 

4.3% 

5.8% 

0.6% 

7.8% 

10.5% 

6.2% 

6.5% 

114 

16.1% 

Transport 

70 

39 

31 

9.9% 

5.5% 

4.4% 

Telecommunications 

Miscellaneous products 

Information Society services 

EN 

19 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9.4 

COMMISSION  REACTIONS:  COMMENTS  AND  DETAILED  OPINIONS  IN 2009  AND 2010 
(ARTICLES 8(2) AND 9(2) OF THE DIRECTIVE) 

Table 7 

Year 

2009 

2010 

Comments 

Detailed opinions 

154 

108 

57 

48 

The  number  of  detailed  opinions  issued  by  the  Commission  during  the  period  in  question 
decreased: 57 detailed opinions in 2009 on a total number of 708 notifications (8.05%) and in 
2010, 48 detailed opinions on a total number of 817 notifications (5.87%).  

The number of comments made by the Commission also decreased: from 154 in 2009 to 108 
in 2010. 

Figure 4 

EN 

20 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
9.5 

COMMISSION REACTIONS: BLOCKAGES IN 2009 AND 2010 (ARTICLES 9(3) AND 9(4) 
OF THE DIRECTIVE) 

During  the  2009-2010  period,  the  Commission  requested  a  12-month  postponement  of  the 
adoption  of  11  draft  regulations  notified  by  the  Member  States,  because  they  concerned  a 
subject  on  which  Community  harmonisation  work  had  already  been  announced  or  was 
underway. 

Table 8 

Year 

2009 

2010 

Standstills 

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

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

3 

2 

3 

3 

Total 

6 

5 

EN 

21 

  EN 

 
 
 
 
 
9.6 

MEMBER STATES REACTIONS 

Table  9  –  Comments  and  detailed  opinions  issued  by  the  Member  States  in  2009  and 
2010 (Articles 8(2) and 9(2))  

2009 

2010 

Austria 
Belgium 
Bulgaria 
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 

Com. 
10 
3 
1 
0 
6 
3 
6 
9 
22 
12 
11 
6 
0 
24 
8 
1 
0 
1 
7 
4 
5 
4 
8 
3 
16 
4 
9 
183 

EN 

D.O. 
1 
3 
0 
0 
0 
1 
0 
1 
23 
8 
4 
0 
0 
18 
1 
0 
0 
4 
0 
3 
0 
1 
4 
0 
1 
0 
1 
74 

22 

Com. 
4 
8 
1 
3 
15 
12 
3 
6 
14 
10 
0 
2 
4 
14 
10 
3 
2 
2 
4 
15 
2 
9 
1 
2 
13 
10 
2 
171 

D.O. 
1 
3 
0 
1 
1 
0 
0 
1 
7 
8 
0 
0 
1 
14 
3 
0 
0 
0 
0 
2 
0 
3 
0 
0 
2 
1 
8 
56 

EN 

 
 
 
 
 
  
  
9.7 

URGENCY PROCEDURE (ARTICLE 9(7) OF THE DIRECTIVE) 

Table 10 – Requests to apply the urgency procedure received in 2009 and 2010 

YEAR 

2009 

2010 

COUNTRY 

Requests 

Favourable 
opinion 

Requests 

Favourable 
opinion 

Austria 
Belgium 
Bulgaria 

Cyprus 
Czech Rep. 
Denmark 
Estonia 
Finland 
France 
Germany 
Greece 
Hungary 
Ireland 
Italy 
Latvia 
Lithuania 
Luxembourg 
Malta 
Netherlands 
Poland 
Portugal 
Romania 
Slovakia 
Slovenia 
Spain 
Sweden 

United Kingdom 
Total 

2 
1 
0 
0 
0 
0 
0 
1 
0 
2 
0 
0 
0 
0 
0 
1 
0 
0 
0 
0 
3 
2 
0 
0 
3 
5 
0 
20 

EN 

2 
2 
0 
0 
0 
1 
0 
1 
4 
1 
0 
0 
2 
0 
0 
0 
0 
1 
0 
2 
0 
4 
0 
0 
6 
6 
0 
32 

2 
0 
0 
0 
0 
0 
0 
0 
0 
2 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
5 
0 
9 

23 

2 
2 
0 
0 
0 
1 
0 
1 
2 
1 
0 
0 
2 
0 
0 
0 
0 
0 
0 
2 
0 
2 
0 
0 
0 
5 
0 
20 

EN 

 
 
 
 
 
 
 
 
Table 10 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 to which the Commission gave a favourable opinion (29 out of the 52 made during the entire 2009-2010 period).  

Table 11 – Breakdown by sector of the requests to apply the urgency procedure in 2009 and 2010. 

Table 11, which gives a sectoral breakdown of the requests to apply the urgency procedure received by the Commission during the 2009-2010 
period, shows that the application of this exceptional procedure was invoked mainly in the pharmaceutical and cosmetics sector (15 requests) and 
in the goods and miscellaneous products sector (5). 

EN 

24 

EN 

 
 
 
 
 
 
 
 
 
 
9.8 

FOLLOW-UP TO COMMISSION REACTIONS 

Table 12 shows that, in 2009, the recipient Member States responded to 51 of the 57 detailed 
opinions issued by the Commission (89.5%) and that 20 responses were deemed satisfactory 
by  the  Commission  (39.2%).  In  2010,  they  responded  to  40  of  the  48  detailed  opinions 
(83.3%), 10 were satisfactory (25%).  

 Table 12* 

Year 

2009 

2010 

*Data at 04/06/2011 

Table 13 

Year 

2009 

2010 

Detailed 
opinions 

Responses from 
the Member 
States 

Satisfactory 

Closures 

57 

48 

51 

40 

20 

10 

4 

4 

Observations COM

Responses from the  
Member States 

154 

108 

105 

67 

Table  13  shows  that,  in  2009,  the  recipient  Member  States  responded  to  105  of  the  154 
observations issued by the Commission (68.2 %) and in 2010, they responded to 67 of the 108 
(62 %).  

EN 

25 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX 10 

APPLICATION  OF  THE  PROCEDURE  IN  2009  AND  2010:  PARTICIPATION  OF 
EFTA  COUNTRIES SIGNATORY TO THE EEA AGREEMENT, OF SWITZERLAND 
AND OF TURKEY 

Table 13 – Number of notifications from EFTA countries and comments issued to them 
by the European Union 

2009 

2010 

Notifications 

Com. EU 

Notifications 

Com. EU 

A
T
F
E

Norway 

Liechtenstein 

Iceland 

8 

6 

1 

5 

4 

1 

10 

8 

1 

0 

0 

0 

Table 14 – Number of notifications submitted by Switzerland and Turkey and comments 
issued to them by the Commission or the Member States 

2009 

2010 

Notifications 

Com. 

Notifications 

Com. 

  Switzerland 

  Turkey 

9 

3 

1 

2 

5 

2 

0 

2 

Table  15  –  Number  of  comments  from  EFTA,  Switzerland  and  Turkey  regarding  the 
notifications from the Member States 

  EFTA 

  Switzerland 

  Turkey 

EN 

2009 

2010 

0 

0 

0 

26 

0 

0 

0 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX 11 – INTERNET CONSULTATIONS IN 2009 AND 2010 

Figure 5 

EN 

27 

EN