Commission staff working document - Accompanying document to the Report from the Commission to the Council, the European Parliament and the European Economic and Social Committee - The operation of Directive 98/34/EC from 2006 to 2008 COM(2009)690
Date: 2009-12-21
Institutions: European Commission
Subjects: European standard, access to information, exchange of information, report, standard, standardisation, technical standard

EN 

EN 

 Error! Unknown document property name.  EN 

EUROPEAN COMMISSION 

Brussels, 21.12.2009 
SEC(2009) 1704 

COMMISSION STAFF WORKING DOCUMENT 

Accompanying document to the 

REPORT FROM THE COMMISSION TO THE COUNCIL, THE EUROPEAN 
PARLIAMENT AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE 

THE OPERATION OF DIRECTIVE 98/34/EC FROM 2006 TO 2008 

COM(2009)690 

EN 

 Error! Unknown document property name.  EN 

 
  
 
 
TABLE OF CONTENTS - ANNEXES 

Annex 1 – procedures for standardisation.................................................................................. 3 

1. 

Information procedure.................................................................................................. 3 

1.1. 

Role of ESOs ................................................................................................................ 3 

2. 

2.1. 

2.2. 

3. 

Mandates ...................................................................................................................... 3 

The consultation process.............................................................................................. 3 

Role of ESOs ................................................................................................................ 3 

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

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

CENELEC) 2006-2008 by state................................................................................... 4 

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

CENELEC) 1999-2008 by group of countries............................................................. 5 

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

Annex 5 Mandates 2006-2008 – total......................................................................................... 7 

Annex 6 Mandates by subject area ............................................................................................. 8 

Annex 7 Commission Decisions on formal objections 2006-2008 ............................................ 9 

Annex 8 Brief description of the notification procedure .......................................................... 11 

Annex 9 Developments in Court of Justice case-law on the matter 2006-2008....................... 13 

Annex 10  Application of the procedure 2006-2008: notifications of technical regulations 

submitted by the member states ................................................................................. 14 

10.1 

Volume of notifications during the 2006-2008 period............................................... 15 

10.2 

Breakdown by country ............................................................................................... 16 

10.3 

Breakdown by sector.................................................................................................. 20 

10.4 

Commission reactions: comments and detailed opinions 2006-2008 (Articles 8(2) 
and 9(2) of the Directive)........................................................................................... 23 

10.5 

Commission reactions: blockages 2006-2008 (Articles 9(3) and 9(4) of the Directive)24 

10.6  Member State reactions.............................................................................................. 25 

10.7 

Urgency Procedure (Article 9(7) of the Directive) .................................................... 26 

10.8 

Follow-up to Commission reactions .......................................................................... 29 

Annex 11  Application of the procedure 2006-2008: participation of EFTA countries 

signatory to the EEA Agreement, of Switzerland and of Turkey .............................. 30 

Annex 12 – Internet consultations 2006-2008 ......................................................................... 31 

 
 
 
 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 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, 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.  

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 
consulted for opinion also. Once a draft Commission Decision is ready, this is consulted with 
the Committee. After receiving a positive opinion, the Decision is processed further. 

EN 

3 

EN 

 
ANNEX 2 

BREAKDOWN  OF  NEW  NATIONAL  STANDARDISATION  ACTIVITIES  FROM 

NOTIFICATIONS (CEN AND CENELEC) 2006-2008 BY STATE 

Country 

2006 

2007 

2008 

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 
RU 
SE 
SI 
SK 
UK  

CEN 
CENELEC 
From EU-15 

From EU-12 

From EFTA 

TOTAL 

357 
6 
na 
27 
na 
23 
503 
8 

16 
190 
10 
238 
3 
11 
3 
0 
107 
0 
19 
14 
1 
64 
20 
69 
13 
32 
9 
6 
45 
127 

1905 
16 

1638 

236 

47 
1921 

219 
50 
25 
34 
0 
55 
450 
9 

10 
131 
11 
243 
2 
11 
1 
0 
132 
0 
18 
18 
0 
56 
19 
65 
1 
150 
14 
28 
19 
153 

1904 
20 

1472 

399 

53 
1924 

219 
50 
25 
14 
0 
56 
448 
9 

10 
129 
11 
242 
0 
11 
1 
0 
133 
0 
18 
18 
0 
56 
19 
65 
1 
150 
14 
28 
19 
145 

1835 
56 

1458 

400 

33 
1891 

795 
106 
50 
75 
0 
134 
1401 
26 

36 
450 
32 
723 
5 
33 
5 
0 
372 
0 
55 
50 
1 
176 
58 
199 
15 
332 
37 
62 
83 
425 

5644 
92 
4568 

1035 

133 

5736 

EN 

4 

EN 

 
 
 
 
 
 
ANNEX 3 

BREAKDOWN 

OF 

NEW 

NATIONAL 

STANDARDISATION 

ACTIVITIES 

FROM 

NOTIFICATIONS (CEN AND CENELEC) 1999-2008 BY GROUP OF COUNTRIES 

National Notifications

2000

1500

1000

500

0

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

EU-15 EU-10 EU-2

EN 

5 

EN 

 
 
 
 
 
 
ANNEX 4 

SECTORAL BREAKDOWN OF NOTIFICATIONS  

2006 

2007 
CEN 

2008 

Building and construction - 
Structures 115 

115 

Building and construction – 
Structures 

135 

Food products 

Water quality and water supply 

Building and construction - 
Undetermined 
 Building and construction - Fire 
protection 

Food products 

Small tools 

Furniture 

Road Building and Maintenance 

Building and construction - 
Thermal matters 
Chemicals and chemical 
engineering 

73 

70 

57 

55 

Surgical instruments 

Food products 

Air quality 

Waterproofing materials 

126 

78 

Building and constructin - 
Structures 
Building and constructin - Fire 
protection 

77 

 Aerospace 

59 

Building and construction – 
Undetermined 

39 

Road Building and Maintenance 

54 

Road Building and Maintenance 

38 

35 

34 

30 

Building and construction – 
Undetermined 
Building and construction – Fire 
protection 

52 

Fasteners 

51 

Small tools 

Petroleum products 

36 

Light alloys 

Water quality and water supply 

35  Water quality and water supply 

192 

123 

77 

71 

67 

55 

47 

46 

45 

39 

EN 

6 

EN 

 
 
 
ANNEX 5 

MANDATES 2006-2008 – TOTAL 

Type 

2006 

2007 

2008 

Total 

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 

6 

5 

14 

21 

16 

62 

EN 

7 

EN 

 
 
 
 
ANNEX 6 

MANDATES BY SUBJECT AREA 

Subject 

Services 

ICT 

Energy 

Transport 

Environment 

Consumer protection 

Other 

New Approach 

Total 

2006 

2007 

2008 

Total 

1 

0 

2 

3 

2 

4 

0 

12 

24 

0 

1 

1 

1 

2 

0 

6 

9 

0 

1 

1 

1 

3 

4 

5 

3 

20 

18 

1 

2 

4 

5 

7 

8 

11 

24 

62 

EN 

8 

EN 

 
 
 
 
ANNEX 7 

COMMISSION DECISIONS ON FORMAL OBJECTIONS 2006-2008 

Standard 

Directive  

Decision 

Date 

Decision number 

1  EN 143:2000 -“Respiratory protective device – 

Particle filters - Requirements, testing, marking” 

2  EN 13000 - Cranes 

3  EN 13683 :2003 - Garden equipment - Integrally 

powered shredders/chippers 

4  EN ISO 14122-4 - Safety of machinery - 

Permanent means of access to machinery - Part 4: 
Fixed ladders (ISO 14122-4:2004) 

5  EN 848-3 - Safety of woodworking machines - 

One side moulding machines with rotating tool - 
Part 3 : numerical control boring machines and 
routing machines 

6  EN 10080:2005 – Steel for the reinforcement 

of concrete 

89/686/EEC  
Personal 
Protective 
Equipment  

98/37/CE 
Machinery 

98/37/CE 
Machinery 

98/37/CE 
Machinery 

98/37/CE 
Machinery 

89/106 
Construction 
Products 

7  EN 71-1:2005 - Hemispheric toys - 5.12 first 

88/378/EEC Toys 

indent (former A 10) 

8  EN 71-1:2005 - Suction cups - 8.4.2.3 (former A 

88/378/EEC Toys 

11) 

EN 

Presumption of conformity 
partially withdrawn 

16.03.2006 

2006/216/EC 

Presumption of conformity 
partialy withdrawn 

24.11.2005 

2006/731/EC 

Non publication of the 
reference on the OJ 

Non publication of the 
reference on the OJ 

24.11.2005 

2006/732/EC 

24.11.2005 

2006/733/EC 

Presumption of conformity 
partially withdrawn 

02.03.2006 

2006/704/EC 

Presumption of conformity 
withdrawn 

15.09.2006 

2006/893/EC 

Presumption of conformity 
partially withdrawn 

Presumption of conformity 
partially withdrawn 

25.09.2006 

2007/184/EC 

25.09.2006 

2007/224/EC 

O.J. 
Reference 

L 080/76 
17.03.2006 

L 299/26 
28.10.2006 

L 299/29 
28.10.2006 

L 299/30 
28.10.2006 

L 343/102 
08.12.2006 

L 291/35 
21.10.2007 

L 85/7 
27.03.2007 

L 96/18 
11.04.2007 

9 

EN 

 
 
 
  
9  EN 12929-2:2004 - Safety requirements for 

cableway installations designed to carry persons 
— General requirements — Part 2: Additional 
requirements for reversible bicable aerial 
ropeways without carrier truck brakes 

200/9/EC 
cableway 
installations 
designed to carry 
persons 

Presumption of conformity 
non withdrawn 

26.11.2008  Decision in the 
communication 
C(2008)7289  

No 
published 

10  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 

11  EN 3-9:2006 - Portable fire extinguishers — Part 

9: Additional requirements to EN 3-7 for 
pressure resistance of CO2 extinguishers 

97/23/EC Pressure 
Equipment 

Publication of the 
reference on the OJ 

13.11.2008 

2009/111/EC 

L 48/13 
19.02.2009 

97/23/EC Pressure 
Equipment 

Non publication of the 
reference on the OJ 

13.11.2009 

2009/140/EC 

L 40/33 
11.02.2010 

EN 

10 

EN 

 
 
 
ANNEX 8 

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 the 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  Community  act  does  not  require  prior  notification,  unless  the 
national  authorities  adopt  national  provisions  that  go  beyond  mere  compliance  with 
Community  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 28-30, 43 and 49 of 
the EC Treaty) or to secondary legislation, the Commission and the other Member States may 
submit a detailed opinion to the Member State that has prepared 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 the Member States can also make comments 
about  a  notified  draft  that  appears  to  comply  with  Community  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 Community harmonisation work is due to be undertaken or is already 
underway in the same field (Article 9(3) to (5)). 

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 

11 

EN 

 
 
 
 
 
 
                                                 
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  emergency  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 emergency 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  three-month  standstill.  The 
Commission decides on the justification for the emergency procedure as soon as possible. If 
the request to apply the emergency procedure is accepted by the Commission, the time limit 
for  the  98/34  procedure  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 Community 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 emergency 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 

EN 

12 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
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.  The  same  kind  of  reaction  is 
provided  for  the  entire  European  Community  to  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 9 

DEVELOPMENTS  IN  COURT  OF  JUSTICE  CASE-LAW  ON  THE  MATTER  2006-
2008  

The two Court of Justice judgments delivered on the Directive during the 2006-2008 period 
are  presented  below  in  chronological  order:  the  first  of  them  was  delivered  following 
proceedings for failure to fulfil an obligation launched by the Commission against a Member 
State  (Article 226  of  the  EC  Treaty)  and  the  other  under  the  preliminary  ruling  procedure 
(Article 234  of  the  EC  Treaty).  The  common  feature  of  these  judgments:  they  clarify  the 
notion of technical regulation and the obligation to notify, and confirm the Court’s previous 
case-law  regarding  the  unenforceability  of  technical  regulations  not  notified  prior  to  their 
adoption. 

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 

Judgment of 26 October 2006, Case C-65/05, Commission versus Hellenic Republic 
(JO C 326 of 30 December 2006, page 8)  

In  the  field  of  games  of  chance,  the  judgment  Commission  v  Hellenic  Republic  stated  that 
national measures prohibiting the use of all electric, electromechanical and electronic games, 
including  all  computer  games,  on  all  public  or private  premises  apart  from  casinos,  and  the 
use  of  games  on  computers  in  undertakings  providing  internet  services,  and  making  the 
operation  of  such  undertakings  subject  to  the  issue  of  a  special  authorisation,  must  be 
considered technical regulations in the meaning of Directive 98/34/EC. 

In addition, the judgment has a bearing on the issue of urgency provided for by the Directive.   
In fact, the Court adds (logically) that the obligation to notify cannot be called into question 
by the need to adopt national legislation urgently in order to deal rapidly and directly with a 
social problem.  

4 

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

EN 

13 

EN 

 
 
 
 
 
 
 
                                                 
Judgment of 8 November 2007, Case C-20/05, Schwibbert 
(JO C 315 of 22 December 2007, page 4)  

In  its  most  recent  judgment,  Schwibbert,  the  Court  provides  another  example  of  a  technical 
regulation notifiable under the Directive.  In this instance, it concerned the obligation to affix 
the distinctive sign « SIAE » to compact discs of works of figurative art for the purposes of 
marketing them in Italy. 

The Court clarifies that this obligation constitutes a technical regulation which, if not notified 
to the Commission, cannot be invoked against an individual (Judgment CIA Security). 

ANNEX 10 

APPLICATION  OF  THE  PROCEDURE  2006-2008:  NOTIFICATIONS  OF 

TECHNICAL REGULATIONS SUBMITTED BY THE MEMBER STATES 

Annexes 10.1, 10.2 and 10.3 give a statistical overview of the development of the number of 
draft technical regulations notified by the Member States between 2006 and 2008, 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 10.4 to 10.6. 

Annex 10.7  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 10.8  shows  the  action  taken  by  the  Member  States  in  response  to  the  Commission’s 
reactions. 

5 

For  2006:  OJ  C  151/10  of  5.7.2007;  for  2007:  OJ  C  132/7  of  30.5.2008;  for  2008:  OJ  C  131/3  of 
10.06.2009.  

EN 

14 

EN 

 
 
 
 
 
 
 
 
                                                 
10.1 

VOLUME OF NOTIFICATIONS DURING THE 2006-2008 PERIOD 

Figure 1 

The statistics in figure 1 show that the Member States notified to the Commission 668 draft 
regulations in 2006, 710 in 2007 and 601 in 2008. 

EN 

15 

EN 

 
 
10.2 

BREAKDOWN BY COUNTRY 

Figure 2 

Notifications by Member State

250

200

150

100

50

0

2008
2007
2006

Austria

Belgium

Cyprus
Bulgaria
Czech Republic
Denmark

Estonia

Finland

Germany
France

Greece

Hungary

Ireland

Italy

Latvia
Lithuania
Luxembourg

Malta
Netherlands

Poland

Portugal

Romania

Slovakia

Slovenia

Sweden
Spain
United Kingdom

During the 2006-2008 period, two Member States each notified more than 200 draft technical 
regulations:  they  were  Germany  (212)  and  the  Netherlands  (205).  A  group  of  five  other 
countries  (Sweden,  France,  United  Kingdom,  Austria  and  Belgium)  come  next  with  a  total 
number of notifications of between 100 and 160. As far as the two “new” Member States are 
concerned,  Bulgaria  and  Romania  submitted  33  notifications  (10  and  23  respectively) 
between 2007 and 2008.   

EN 

16 

EN 

 
 
Table 1 – Number of notifications of technical regulations submitted by the Member 
States from 2006 to 2008 

Member States  

2006 

2007 

2008 

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 

42 

28 

 - 

1 

21 

24 

8 

18 

57 

77 

5 

15 

6 

20 

10 

2 

2 

7 

71 

48 

7 

 - 

9 

11 

70 

50 

48 

48 

4 

0 

24 

38 

11 

39 

58 

83 

4 

12 

14 

20 

8 

6 

2 

0 

63 

50 

3 

5 

12 

8 

35 

64 

36 

32 

6 

0 

35 

22 

5 

31 

45 

52 

7 

12 

16 

18 

10 

8 

2 

0 

71 

21 

2 

18 

15 

3 

41 

54 

EN 

17 

EN 

 
United Kingdom 

Total EC 

59 

668 

51 

710 

39 

601 

EN 

18 

EN 

 
Table 2 – Percentages of notifications submitted by the Member States from 2006 to 
2008 
Member States  

2008 

2006 

2007 

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 

8,3% 

5,5% 

0,0% 

0,2% 

4,1% 

4,7% 

1,6% 

3,5% 

11,2% 

15,2% 

1,0% 

3,0% 

1,2% 

3,9% 

2,0% 

0,4% 

0,4% 

1,4% 

14,0% 

9,4% 

1,4% 

0,0% 

1,8% 

2,2% 

13,8% 

9,8% 

11,6% 

9,9% 

9,9% 

0,8% 

0,0% 

4,9% 

7,8% 

2,3% 

8,0% 

11,9% 

17,1% 

0,8% 

2,5% 

2,9% 

4,1% 

1,6% 

1,2% 

0,4% 

0,0% 

13,0% 

10,3% 

0,6% 

1,0% 

2,5% 

1,6% 

7,2% 

13,2% 

10,5% 

6,5% 

5,7% 

1,1% 

0,0% 

6,3% 

3,9% 

0,9% 

5,6% 

8,1% 

9,3% 

1,3% 

2,2% 

2,9% 

3,2% 

1,8% 

1,4% 

0,4% 

0,0% 

12,7% 

3,8% 

0,4% 

3,2% 

2,7% 

0,5% 

7,4% 

9,7% 

7,0% 

EN 

19 

EN 

 
10.3 

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 (365 notifications). They are followed 
by  the  foodstuffs  and  agricultural  products  sector  (298  notifications).  Between  2006  and 
2008,  two  other  sectors  grew  significantly:  telecommunications  (221  notifications)  and 
transport (215 notifications). Information Society services represent on average 5,3% of the 
total number of notifications. 

EN 

20 

EN 

 
 
 
Tables 3 and 4 – Breakdown by sector of the drafts notified by the Member States of the European Union in 2006 and 2007 
Sectors 

Sectors 

2006 

Building and construction 

104 

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 

96 

15 

18 

18 

85 

45 

51 

11 

75 

86 

30 

34 

15,6%  
14,4%  
2,2%  
2,7%  
2,8%  
12,7%  
6,7%  
7,6%  
1,6%  
11,2%  
12,9%  
4,5%  
4,9%  

Building and construction 

Foodstuffs and agricultural products 

Chemicals 

Pharmaceuticals 

Domestic and leisure equipment 

Mechanical engineering 

Energy, ores, wood 

Environment, packaging 

Health, medical equipment 

Transport 

Télecommunications 

Miscellaneous products 

Information Society services 

145 
111 

30 

23 
31 

55 

26 
64 

7 

71 

81 

29 
37 

2007 

20,4% 

15,6% 

4,2% 

3,2% 

4,4% 

7,7% 

3,7% 

9,0% 

1,0% 

10,0% 

11,4% 

4,1% 

5,2% 

EN 

21 

EN 

 
 
 
 
Tables 5 and 6 – Breakdown by sector of the drafts notified by the Member States of the European Union in 2008 
Sectors 

2008 

Building and construction 

116 

Foodstuffs and agricultural products 

Chemicals 

Pharmaceuticals 

Domestic and leisure equipment 

Mechanical engineering 

Energy, ores, wood 

Environment, packaging 

Health, medical equipment 

Transport 

Télecommunications 

Miscellaneous products 

Information Society services 

91 

12 

36 

31 

42 

29 

54 

5 

69 

54 

27 

35 

19,3%  
15,1%  
2,0%  
6,0%  
5,2%  
7,0%  
4,8%  
9,0%  
0,8%  
11,5%  
9,0%  
4,5%  
5,8%  

EN 

22 

EN 

 
 
 
 
10.4 

COMMISSION  REACTIONS:  COMMENTS  AND  DETAILED  OPINIONS  2006-2008 
(ARTICLES 8(2) AND 9(2) OF THE DIRECTIVE) 

Table 7 

Year 

2006 

2007 

2008 

Comments 

Detailed opinions 

154 

136 

128 

61 

66 

52 

The number of detailed opinions issued by the Commission during the period in question did 
not vary significantly: 61 detailed opinions in 2006 on the total number of 668 notifications 
(10.9%); in 2007, 66 detailed opinions on the total number of 710 notifications (9.29%). On 
the 601 notifications of 2008 the Commission issued 52 detailed opinions, corresponding to 
8.65% of the total number.  

On the other hand, the number of comments made by the Commission decreased at a constant 
rate from 154 in 2006 to 128 in 2008. 

Figure 4 

EN 

23 

  EN 

 
 
 
 
 
10.5 

COMMISSION REACTIONS: BLOCKAGES 2006-2008 (ARTICLES 9(3) AND 9(4) OF THE 
DIRECTIVE) 

During  the  2006-2008  period,  the  Commission  requested  a  12-month  postponement  of  the 
adoption  of  22  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 

2006 
2007 
2008 

Standstills 

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

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

1 
7 
5 

2 
4 
3 

Total 

3 
11 
8 

EN 

24 

  EN 

 
 
10.6  MEMBER STATE REACTIONS 

Table 9 
(Articles 8(2) and 9(2)) 

Comments and detailed opinions issued by the Member States 2006-2008 

2006 

2007 

2008 

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 

Com. 
13 
3 

0 
12 
0 
1 
2 
14 
30 
0 
11 
0 
21 
4 
0 
0 
0 
8 
10 
2 

3 
6 
18 
4 

12 

174 

8 
2 

0 
0 
2 
1 
0 
2 
8 
0 
2 
0 
6 
0 
0 
1 
1 
2 
2 
1 

D.O.  Com. D.O. 
13 
1 
0 
0 
8 
0 
0 
5 
12 
42 
1 
4 
1 
22 
7 
0 
0 
0 
9 
6 
0 
1 
0 
5 
19 
1 

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

2 
0 
6 
0 

6 

52 

10 

167 

4 

39 

Com. 
13 
0 
0 
0 
5 
0 
0 
2 
16 
27 
2 
6 
1 
6 
3 
0 
0 
3 
3 
4 
1 
2 
2 
7 
18 
4 

10 

135 

D.O. 
5 
6 
0 
0 
0 
2 
1 
8 
12 
2 
1 
0 
1 
2 
0 
0 
0 
2 
2 
1 
0 
1 
0 
0 
3 
0 

2 

51 

EN 

25 

EN 

 
 
 
 
  
  
 
 
 
 
10.7 

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

Table 10 

Requests to apply the urgency procedure received 2006-2008 

YEAR 

2006 

2007 

2008 

COUNTRY 

Requests 

Favourable 
opinion 

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 

EN 

0 

3 

0 

0 

0 

0 

1 

0 

8 

0 

1 

0 

0 

1 

1 

0 

0 

0 

1 

0 

0 

0 

0 

0 

1 

0 

2 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

1 

0 

0 

0 

0 

0 

0 

0 

1 

0 

0 

0 

0 

0 

0 

3 

1 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

4 

0 

0 

0 

0 

0 

2 

3 

1 

0 

1 

0 

1 

1 

0 

0 

0 

1 

0 

3 

1 

0 

0 

0 

26 

0 

0 

0 

0 

0 

0 

0 

0 

3 

0 

0 

1 

1 

1 

1 

0 

0 

0 

2 

0 

0 

1 

0 

0 

1 

0 
0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

1 

0 

0 

0 

0 

1 

0 

0 

0 

0 

0 

0 

EN 

 
 
 
 
 
 
 
 
 
 
 
Sweden 

United Kingdom 

Total 

1 

0 

17 

1 

0 

4 

1 

0 

19 

1 

0 

6 

2 

0 

13 

2 

0 

4 

EN 

27 

EN 

 
 
Table 10 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 (14 out of the 49 made during the entire 2006-2008 period).  

Table 11 – Breakdown by sector of the requests to apply the urgency procedure 2006-2008. 

Table 11, which gives a sectoral breakdown of the requests to apply the urgency procedure received by the Commission during the 2006-2008 
period,  shows  that  the  application  of  this  exceptional  procedure  was  invoked  mainly  in  the  foodstuffs  and  agricultural  products  sector  (11 
requests) and in the health and medical equipment sector (7). 

EN 

28 

EN 

 
 
 
 
 
 
 
10.8 

FOLLOW-UP TO COMMISSION REACTIONS 

Table 12 shows that, in 2006, the recipient Member States responded to 53 of the 61 detailed 
opinions issued by the Commission (86.8%) and that 41 responses were deemed satisfactory 
by  the  Commission  (67,2%).  In  2007,  they  responded  to  54  of  the  66  detailed  opinions 
(81,8%);  45  were  satisfactory  (68,1%).  In  2008,  52  detailed  opinions  were  issued  by  the 
Commission.  Of  the  43  responses  from  the  Member  States  (82.6%),  30  were  deemed 
satisfatory by the Commission (57,6%). 

 Table 12* 

Detailed 
opinions 

Responses from the 
Member States 

Satisfactory 

Closures 

53 

54 

43 

41 

45 

30 

8 

8 

5 

Year  

2006 

2007 

61 

66 

2008 
*Data at 04/06/2009 

52 

Table 13 

Year 

Observations COM 

Responses from the  
Member States 

2006 

2007 

2008 

154 

136 

128 

114 

80 

67 

Table  13  shows  that,  in  2006,  the  recipient  Member  States  responded  to  114  of  the  154 
observations  issued  by  the  Commission  (74  %).  In  2007,  they  responded  to  80  of  the  136 
(58,8 %) and, in 2008, Member States responded to 67 of the 128 observations made by the 
Commission (52,3 %).  

EN 

29 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX 11 

APPLICATION  OF  THE  PROCEDURE  2006-2008:  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 Community 

2006 

2007 

2008 

Notifications  Com. EC 

Notifications  Com. EC 

Notifications  Com. 

Norway 

Liechtenstein 

A
T
F
E

Iceland 

21 

1 

1 

9 

0 

0 

21 

1 

6 

5 

0 

2 

16 

0 

9 

EC 

8 

0 

0 

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

2006 

2007 

2008 

Notifications 

Com.  

Notifications  Com.  

Notifications  Com.  

  Switzerland 

  Turkey 

13 

19 

5 

15 

12 

2 

3 

1 

3 

5 

0 

2 

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

2006 

2007 

2008 

  EFTA 

  Switzerland 

  Turkey 

1 

0 

0 

0 

8 

1 

1 

1 

0 

EN 

30 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX 12 – INTERNET CONSULTATIONS 2006-2008 

Figure 5 

EN 

31 

EN