EN  Error! Unknown document property name.  EN 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 DIRECTIV E 98/34/EC FROM 2006 TO 2008 
 
COM(2009)690 
 
  
 
TABLE OF CONTENTS - ANNEXES 
Annex 1 – procedures for standardisation.................................................................................. 3 
1. Information procedure.................................................................................................. 3 
1.1. Role of ESOs ................................................................................................................ 3 
2. Mandates .................................................................................................................... .. 3 
2.1. The consultation process .............................................................................................. 3 
2.2. Role of ESOs ................................................................................................................ 3 
3. Formal objections......................................................................................................... 3 
Annex 2 Breakdown of new national standardisat ion activities from notifications (CEN and 
CENELEC) 2006-2008 by state................................................................................... 4 
Annex 3 Breakdown of new national standardisat ion 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 Ju stice case-law on the matter 2006-2008....................... 13 
Annex 10 Application of the pr ocedure 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: comm ents and detailed opinions 2006-2008 (Articles 8(2) 
and 9(2) of the Directive)........................................................................................... 23 
10.5 Commission reactions: blockages 2006-2008 (Ar ticles 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 
EN 3 EN 
  ANNEX 1 – PROCEDURES FOR STANDARDISATION  
1. INFORMATION PROCEDURE  
1.1. Role of ESOs 
The NSBs, which are members of CEN and CE NELEC (including bodi es from the EFTA 
countries), send the necessary information to the CEN Management Centre and the Central 
Secretariat of CENELEC. The in formation 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 member s of CEN and CENELEC and to ETSI.  
Within the Commission, DG Enterprise and In dustry 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 li mited to receiving and 
examining the information submitted by CEN and CENELEC members via the secretariats of 
these two bodies..  
2. M
ANDATES  
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 consulta tion, firstly informally 
with the standardisation bodies, stakeholders an d Member States through sectoral committees 
or expert groups and then formally with th e 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 manda tes 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 Te chnical Board level. In practice, as mandates 
are discussed with the ESOs prior to their bei ng 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 th e ESOs, or any combination of them, as the 
work envisaged requires.  It is common for the ESOs to request co-f unding for the mandated work following acceptance 
– by means of action grants – although the issu ance of the mandate itself does not mean 
funding will necessarily be available and th e request for funding must undergo a thorough 
evaluation process by the Commission services.  
3. F
ORMAL OBJECTIONS  
The procedure begins with the formal object ion either being received by the Commission 
through the Permanent Representation or be ing 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 r eady, this is consulted with 
the Committee. After receiving a positive opin ion, the Decision is processed further. 
EN 4 EN 
 ANNEX 2 B REAKDOWN OF NEW NATIONAL STANDARDISATION ACTIVITIES FROM  
NOTIFICATIONS (CEN  AND CENELEC)  2006-2008  BY STATE  
Country 2006 2007 2008 Total 
AT 357 219 219 795 
BE 6 50 50 106 
BG na 25 25 50 
CH 27 34 14 75 
CY na 0 0 0 
CZ 23 55 56 134 
DE 503 450 448 1401 
DK 8 9 9 26 
EE 16 10 10 36 
ES 190 131 129 450 
FI 10 11 11 32 
FR 238 243 242 723 
GR 3 2 0 5 
HU 11 11 11 33 
IE 3 1 1 5 
IS 0 0 0 0 
IT 107 132 133 372 
LU 0 0 0 0 
LT 19 18 18 55 
LV  14 18 18 50 
MT 1 0 0 1 
NL 64 56 56 176 
NO 20 19 19 58 
PL 69 65 65 199 
PT 13 1 1 15 
RU 32 150 150 332 
SE 9 14 14 37 
SI 6 28 28 62 
SK 45 19 19 83 
UK  127 153 145 425 
     
CEN 1905 1904 1835 5644 
CENELEC 16 20 56 92 
From EU-15 
1638 1472 1458 4568 
From EU-12 
236 399 400 1035 
From EFTA 
47 53 33 133 
TOTAL 1921 1924 1891 5736 
 
EN 5  EN ANNEX 3 B REAKDOWN OF NEW NATIONAL ST ANDARDISATION ACTIVITIES FROM  
NOTIFICATIONS (CEN  AND CENELEC)  1999-2008  BY GROUP OF COUNTRIES  
 
National Notifications
0500100015002000
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
EU-15 EU-10 EU-2
 
 
 
 
EN 6  EN ANNEX 4 S ECTORAL BREAKDOWN OF NOTIFICATIONS  
2006 2007 2008 
CEN 
Building and construction - 
Structures 115 115 Building and construction – 
Structures 135 Food products 192 
Water quality and water supply 73 Surgical instruments 126 Building and constructin - 
Structures 123 
Building and construction - 
Undetermined 70 Food products 78 Building and constructin - Fire 
protection 77 
 Building and construction - Fire 
protection 57 Air quality 77  Aerospace 71 
Food products 55 Waterproofing materials 59 Building and construction – 
Undetermined 67 
Small tools 39 Road Building and Maintena nce 54 Road Building and Maintenance 55 
Furniture 38 Building and construction – 
Undetermined 52 Fasteners 47 
Road Building and Maintenance 35 Building and construction – Fire 
protection 51 Small tools 46 
Building and construction - 
Thermal matters 34 Petroleum products 36 Light alloys 45 
Chemicals and chemical 
engineering 30 Water quality and water supply 35 Water quality and water supply 39 
 
 
EN 7  EN 
 ANNEX 5 M ANDATES 2006-2008  – TOTAL  
Type 2006 2007 2008 Total 
After formal objection (New Approach) 4 2 0 6 
Amendments (New Approach) 4 0 1 5 
New Approach mandates 5 7 2 14 
Mandates under other legislation 7 5 9 21 
Mandates under Community policy 4 6 6 16 
Total 24 20 18 62 
 
 
EN 8  EN 
 ANNEX 6 M ANDATES BY SUBJECT AREA  
Subject 2006 2007 2008 Total 
Services 1 0 0 1 
ICT 0 1 1 2 
Energy 2 1 1 4 
Transport 3 1 1 5 
Environment 2 2 3 7 
Consumer protection 4 0 4 8 
Other 0 6 5 11 
New Approach 12 9 3 24 
Total 24 20 18 62 
 
 
EN 9  EN 
 ANNEX 7 C OMMISSION DECISIONS ON FORMAL OBJECTIONS 2006-2008 
  Standard Directive  Decision Date Decision number O.J. 
Reference 
1 EN 143:2000 -“Respiratory protective device – 
Particle filters - Requirements, testing, marking” 89/686/EEC  
Personal Protective Equipment  Presumption of conformity 
partially withdrawn 16.03.2006 2006/216/EC L 080/76 
17.03.2006 
2 EN 13000 - Cranes 98/37/CE 
Machinery Presumption of conformity 
partialy withdrawn 24.11.2005 2006/731/EC L 299/26 
28.10.2006 
3 EN 13683 :2003 - Garden equipment - Integrally 
powered shredders/chippers 98/37/CE 
Machinery Non publication of the 
reference on the OJ 24.11.2005 2006/732/EC L 299/29 
28.10.2006 
4 EN ISO 14122-4 - Safety of machinery - 
Permanent means of access to machinery - Part 4: 
Fixed ladders (ISO 14122-4:2004) 98/37/CE 
Machinery Non publication of the 
reference on the OJ 24.11.2005 2006/733/EC L 299/30 
28.10.2006 
5 EN 848-3 - Safety of woodworking machines - 
One side moulding machines with rotating tool - Part 3 : numerical control boring machines and 
routing machines 98/37/CE 
Machinery Presumption of conformity 
partially withdrawn 02.03.2006 2006/704/EC L 343/102 
08.12.2006 
6 EN 10080:2005 – Steel for the reinforcement 
of concrete 89/106 
Construction Products Presumption of conformity 
withdrawn 15.09.2006 2006/893/EC L 291/35 
21.10.2007 
7 EN 71-1:2005 - Hemispheric toys - 5.12 first 
indent (former A 10) 88/378/EEC Toys Presumption of conformity 
partially withdrawn 25.09.2006 2007/184/EC L 85/7 
27.03.2007 
8 EN 71-1:2005 - Suction cups - 8.4.2.3 (former A 
11) 88/378/EEC Toys Presumption of conformity 
partially withdrawn 25.09.2006 2007/224/EC L 96/18 
11.04.2007 
 
EN 10  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 97/23/EC Pressure 
Equipment Publication of the 
reference on the OJ 13.11.2008 2009/111/EC L 48/13 
19.02.2009 
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 Non publication of the 
reference on the OJ 13.11.2009 2009/140/EC L 40/33 
11.02.2010 
 
EN 11 EN ANNEX 8 B RIEF DESCRIPTION OF TH E NOTIFICATION PROCEDURE  
This annex gives a general over view of the notificat ion procedure for products and indicates 
the specific procedural characteristics that apply to Inform ation Society services. For a more 
detailed description of th e 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 proce dure in the field of 
technical regulations has gradually been extended to all in dustrial, agricultural and fishery 
products. In 1998, Directive 83/189/EEC was repeal ed and codified by  Directive 98/34/EC2, 
which in turn was ame nded 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/E C (hereinafter "the Directive" ) stipulates that the Member 
States shall inform the Commission of any draf t technical regulation prior to its adoption. The 
simple transposition of a Community act do es not require prior notification, unless the 
national authorities adopt national provisions that go beyond mere compliance with 
Community acts and that contain technical regu lations within the meaning of the Directive 
(Article 10 of the Directive).  Starting from the date of no tification of the draft, a three-month standstill period – during 
which the notifying Member Stat e cannot adopt the technical re gulation 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 appl ies to technical regulations that  have to be a dopted urgently 
(see below).  
Possible reactions and consequences 
 
Where it emerges that the notified drafts are liable to create ba rriers 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, th e Commission and the other Member States may 
submit a detailed opinion  to the Member State that has prepar ed the draft (Article 9(2) of the 
Directive). The detailed opinion has the eff ect of extending the st andstill period by an 
additional three months. The Commission a nd the Member States can also make comments  
about a notified draft that appears to comp ly 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 wo rk is due to be unde rtaken or is already 
underway in the same field (Article 9(3) to (5)). 
                                                
 
1 Directive of 28 March 1983, OJ L 109/8 of 26.4.1983  
2 O L 204/37 of 21.7.1998.  
3 O L 217/18 of 5.8.1998.  
 
EN 12 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 reac tion (Article 9(2)). With re gard to the comments, even 
though the Directive does not lay down any lega l 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 pro cedure a genuine instrument of dialogue. 
 
Urgency procedure 
 
Article 9(7) of the Directive describes an emer gency procedure, which is designed to allow 
the immediate adoption of a nationa l 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, th e protection of animals 
or the preservation of plants' ). The aim of the emergency pro cedure is to enable a notifying 
Member State faced with serious or unforeseea ble circumstances immediately to adopt the 
draft technical regulation, w ithout 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 procedur e 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 fo r 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 a dopted 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 chaire d by a representative of the Commission. In its 
‘Technical standards and regulations’ confi guration, the Committee meets regularly and 
constitutes a forum for discussing all issues conn ected with the application of the directive. 
 
Application of the 98/34 procedure to Information Society services  
The 98/34 procedure also applies to Inform ation 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, inst ead 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 proposa l 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 circ umstances stipulated for products ( 'serious and 
unforeseeable circumstances' ) but also 'for urgent reasons ...rel ating to public safety'.   
 
The simplified procedure  
 
EN 13 EN EFTA  countries that are contr acting parties to the Agreem ent on the European Economic 
Area (‘EEA’), namely Norway, Iceland and Liecht enstein, 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. Th e 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 ap plies the 98/34 proce dure on a voluntary basis 
following an informal agreement to exchange info rmation 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 participat e in the notification 
system was taken in 1997 as part of the impl ementation of the final phase of the Customs 
Union between Turkey and the European Community.  
ANNEX 9 D EVELOPMENTS 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 th e other under the preliminary ruling procedure 
(Article 234 of the EC  Treaty). The common f eature of these judgmen ts: they clarify the 
notion of technical regulation an d the obligation to notify, and confirm th e Court’s previous 
case-law regarding the unenforceability of techni cal regulations not notified prior to their 
adoption.  It should be pointed out that , like the other Court judgments on the notification procedure, 
these judgments can be consulted on the following website: http://curia.europa.eu/jcms/jcms/Jo1_6308/ ). 
 
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, electromech anical 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 b earing on the issue of urgency pr ovided for by the Directive.   
In fact, the Court adds (logica lly) that the ob ligation 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 Agreemen t, which includes Article 8(2) of the Directive  
 
EN 14 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 th is 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 ). 
 
A
NNEX 10 A PPLICATION 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 overvi ew of the development of the number of 
draft technical regulations not ified by the Member States between 2006 and 2008, and of their 
breakdown by Member State and by sector. It sh ould be pointed out that, in accordance with 
Article 11 of the Directive, ‘statistics concer ning communications received’ as part of the 
notification procedure are pub lished once a year in the O fficial Journal, C series5. 
 The reactions to the notified drafts – in the fo rm of comments or detailed opinions from the 
Commission or the Member States, or of bl ockages 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 15 EN 10.1 V OLUME OF NOTIFICATIONS DURING THE 2006-2008  PERIOD  
Figure 1 
 
The statistics in figure 1 show that the Me mber States notified to the Commission 668 draft 
regulations in 2006, 710 in 2007 and 601 in 2008. 
 
EN 16 EN 10.2 B REAKDOWN BY COUNTRY  
Figure 2 
Notifications by Member State
050100150200250
Austria
Belgium
Bulgaria
Cyprus
Czech Republic
Denmark
Estonia
Finland France
Germany
Greece
Hungary
IrelandItaly
Latvia
Lithuania
LuxembourgMalta
NetherlandsPolandPortugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom2008
2007
2006
 
During the 2006-2008 period, two Member States each notified more than 200 draft technical 
regulations: they were Germany (212) and th e Netherlands (205). A group of five other 
countries (Sweden, France, Unite d Kingdom, Austria and Belgium)  come next with a total 
number of notifications of be tween 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 17 EN Table 1 – Number of notifications of tec hnical regulations submitted by the Member 
States from 2006 to 2008 
Member States  2006 2007 2008 
Austria  42 48 36 
Belgium  28 48 32 
Bulgaria  - 4 6 
Cyprus  1 0 0 
Czech Rep.  21 24 35 
Denmark  24 38 22 
Estonia  8 11 5 
Finland  18 39 31 
France  57 58 45 
Germany  77 83 52 
Greece  5 4 7 
Hungary  15 12 12 
Ireland  6 14 16 
Italy 20 20 18 
Latvia  10 8 10 
Lithuania  2 6 8 
Luxembourg  2 2 2 
Malta  7 0 0 
Netherlands  71 63 71 
Poland  48 50 21 
Portugal  7 3 2 
Romania  - 5 18 
Slovakia  9 12 15 
Slovenia  11 8 3 
Spain  70 35 41 
Sweden  50 64 54 
 
EN 18 EN United Kingdom  59 51 39 
Total EC  668 710 601 
 
EN 19 EN Table 2 – Percentages of notifications subm itted by the Member States from 2006 to 
2008 
Member States  2006 2007 2008 
Austria  8,3% 9,9% 6,5% 
Belgium  5,5% 9,9% 5,7% 
Bulgaria 0,0% 0,8% 1,1% 
Cyprus  0,2% 0,0% 0,0% 
Czech Rep. 4,1% 4,9% 6,3% 
Denmark  4,7% 7,8% 3,9% 
Estonia  1,6% 2,3% 0,9% 
Finland  3,5% 8,0% 5,6% 
France  11,2% 11,9% 8,1% 
Germany  15,2% 17,1% 9,3% 
Greece  1,0% 0,8% 1,3% 
Hungary  3,0% 2,5% 2,2% 
Ireland  1,2% 2,9% 2,9% 
Italy 3,9% 4,1% 3,2% 
Latvia  2,0% 1,6% 1,8% 
Lithuania  0,4% 1,2% 1,4% 
Luxembourg  0,4% 0,4% 0,4% 
Malta  1,4% 0,0% 0,0% 
Netherlands  14,0% 13,0% 12,7% 
Poland  9,4% 10,3% 3,8% 
Portugal  1,4% 0,6% 0,4% 
Romania 0,0% 1,0% 3,2% 
Slovakia  1,8% 2,5% 2,7% 
Slovenia  2,2% 1,6% 0,5% 
Spain  13,8% 7,2% 7,4% 
Sweden  9,8% 13,2% 9,7% 
United Kingdom  11,6% 10,5% 7,0% 
 
EN 20 EN 10.3 B REAKDOWN BY SECTOR  
Figure 3 
 
 
Building and construction  are constantly increasing and repr esent 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 notificati ons). Between 2006 and 
2008, two other sectors gr ew significantly: telecommunications (221 notifications)  and 
transport (215 notifications). Information Society services represent on average 5,3% of the 
total number of notifications. 
 
EN 21  EN 
 Tables 3 and 4 – Breakdown by sector of  the drafts notified by the Member Stat es of the European Union in 2006 and 2007 
Sectors 2006  Sectors 2007 
Building and construction 104 15,6% Building and construction 145 20,4% 
Foodstuffs and agricultural products 96 14,4% Foodstuffs and agricultural products 111 15,6% 
Chemicals 15 2,2% Chemicals 30 4,2% 
Pharmaceuticals 18 2,7% Pharmaceuticals 23 3,2% 
Domestic and leisure equipment 18 2,8% Domestic and leisure equipment 31 4,4% 
Mechanical engineering 85 12,7% Mechanical engineering 55 7,7% 
Energy, ores, wood 45 6,7% Energy, ores, wood 26 3,7% 
Environment, packaging 51 7,6% Environment, packaging 64 9,0% 
Health, medical equipment 11 1,6% Health, medical equipment 7 1,0% 
Transport 75 11,2% Transport 71 10,0% 
Telecommunications 86 12,9% Télecommunications 81 11,4% 
Miscellaneous products 30 4,5% Miscellaneous products 29 4,1% 
Information Society services 34 4,9% Information Society services 37 5,2% 
 
EN 22  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 19,3% 
Foodstuffs and agricultural products 91 15,1% 
Chemicals 12 2,0% 
Pharmaceuticals 36 6,0% 
Domestic and leisure equipment 31 5,2% 
Mechanical engineering 42 7,0%  
Energy, ores, wood 29 4,8% 
Environment, packaging 54 9,0% 
Health, medical equipment 5 0,8% 
Transport 69 11,5% 
Télecommunications 54 9,0% 
Miscellaneous products 27 4,5% 
Information Society services 35 5,8% 
 
EN 23  EN 10.4 C OMMISSION REACTIONS : COMMENTS AND DETAILED OPINIONS 2006-2008  
(ARTICLES  8(2)  AND 9(2)  OF THE DIRECTIVE ) 
Table 7 
Year Comments Detailed opinions 
2006 154 61 
2007 136 66 
2008 128 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 num ber of 668 notifications 
(10.9%); in 2007, 66 detailed opini ons on the total number of 710 notifications (9.29%). On 
the 601 notifications of 2008 the Commission issu ed 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 24  EN 10.5 C OMMISSION REACTIONS : BLOCKAGES 2006-2008  (ARTICLES  9(3)  AND 9(4)  OF THE 
DIRECTIVE ) 
During the 2006-2008 period, the Co mmission requested a 12-m onth postponement of the 
adoption of 22 draft regulations notified by th e Member States, because they concerned a 
subject on which Community harmonisation wo rk had already been announced or was 
underway. 
 
Table 8 
Standstills 
Year 
Announcement of a 
Community text (Article 9(3))Presentation to the Council of a 
Community text (Article 9(4)) Total 
2006 1 2 3 
2007 7 4 11 
2008 5 3 8 
 
EN 25 EN 
 10.6 M EMBER STATE REACTIONS  
 
Table 9 Comments and detailed opinions issued by the Member States 2006-2008 
(Articles 8(2) and 9(2))  
  2006 2007 2008 
  Com. D.O. Com. D.O. Com. D.O. 
Austria 13 8 13 4 13 5 
Belgium 3 2 1 0 0 6 
Bulgaria   0 0 0 0 
Cyprus 0 0 0 0 0 0 
Czech Rep. 12 0 8 0 5 0 
Denmark 0 2 0 1 0 2 
Estonia 1 1 0 0 0 1 
Finland 2 0 5 0 2 8 
France 14 2 12 8 16 12 
Germany 30 8 42 6 27 2 
Greece 0 0 1 0 2 1 
Hungary 11 2 4 0 6 0 
Ireland 0 0 1 1 1 1 
Italy 21 6 22 5 6 2 
Latvia 4 0 7 0 3 0 
Lithuania 0 0 0 0 0 0 
Luxembourg 0 1 0 1 0 0 
Malta 0 1 0 3 3 2 
Netherlands 8 2 9 3 3 2 
Poland 10 2 6 0 4 1 
Portugal 2 1 0 1 1 0 
Romania   1 0 2 1 
Slovakia 3 2 0 0 2 0 
Slovenia 6 0 5 0 7 0 
Spain 18 6 19 2 18 3 
Sweden 4 0 1 0 4 0 
United 
Kingdom 12 6 10 4 10 2 
Total 174 52 167 39 135 51 
 
EN 26 EN 
 10.7 U RGENCY 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 0 0 0 0 0 0 
Belgium 3 2 4 1 0 0 
Bulgaria 0 0 0 0 0 0 
Cyprus 0 0 0 0 0 0 
Czech Rep. 0 0 0 0 0 0 
Denmark 0 0 0 0 0 0 
Estonia 1 0 0 0 0 0 
Finland 0 0 2 0 0 0 
France 8 0 3 3 3 0 
Germany 0 0 1 1 0 0 
Greece 1 0 0 0 0 0 
Hungary 0 0 1 0 1 0 
Ireland 0 0 0 0 1 0 
Italy 1 0 1 0 1 1 
Latvia 1 0 1 0 1 0 
Lithuania 0 0 0 0 0 0 
Luxembourg 0 0 0 0 0 0 
Malta 0 0 0 0 0 0 
Netherlands 1 1 1 0 2 1 
Poland 0 0 0 0 0 0 
Portugal 0 0 3 0 0 0 
Romania 0 0 1 0 1 0 
Slovakia 0 0 0 0 0 0 
Slovenia 0 0 0 0 0 0 
Spain 1 0 0 0 1 0 
 
EN 27 EN 
 Sweden 1 1 1 1 2 2 
United Kingdom  0 0 0 0 0 0 
Total 17 4 19 6 13 4 
 
EN 28  EN 
  
Table 10  provides an overview of the number of requests to apply the em ergency procedure, by Member State and by year; it also shows th e 
number of requests to which the Commissi on gave a favourable opinion (14 out of th e 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 th e requests to apply the urgency procedur e received by the Commission during the 2006-20 08 
period, shows that the application of this  exceptional procedure was invoked mainly in the foodstuffs a nd agricultural products  sector (11 
requests) and in the health and medical equipment sector (7). 
 
EN 29  EN 10.8 F OLLOW -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 Commissi on (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 sati sfactory (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* 
Year   
Detailed 
opinions 
 Responses from the Member States Satisfactory Closures 
2006 61 53 41 8 
2007 66 54 45 8 
2008 52 43 30 5 
*Data at 04/06/2009 
 
Table 13  
 
Year  
Observations COM 
  
Responses from the  
Member States 
 
2006 
  
154  
114 
 
2007 
  
136  
80 
 
2008 
  
128  
67 
 Table 13 shows that, in 2006 , the recipient Member  States responded to 114 of the 154 
observations issued by th e 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 30 EN 
 ANNEX 11 A PPLICATION 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. 
EC 
        
Norway  21 9 21 5 16 8 
Liechtenstein  1 0 1 0 0 0 EFTA  
Iceland 1 0 6  2 9 0 
 
Table 14 – Number of notifications submitte d 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 13 5 12 3 3 0 
 Turkey 19 15 2 1 5 2 
 
Table 15 – Number of comments from EFTA , Switzerland and Turkey regarding the 
notifications from the Member States 
 2006 2007 2008 
 EFTA 1 0 1 
 Switzerland 0 8 1 
 Turkey 0 1 0 
 
EN 31  EN ANNEX 12 – INTERNET CONSULTATIONS 2006-2008 
Figure 5