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 2006-2008 SEC(2009)1704
Date: 2009-12-21
Institutions: European Commission
Subjects: European standard, access to information, exchange of information, report, standard, standardisation, technical standard

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 21.12.2009 
COM(2009)690 final 

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 2006-2008 

SEC(2009)1704 

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TABLE OF CONTENTS 

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 ............................................ 1 

Executive summary .................................................................................................................... 3 

PART I: STANDARDISATION ............................................................................................... 3 

1. 

2. 

2.1 

2.2 

3. 

3.1 

3.2 

3.3 

4. 

4.1 

4.2 

Introduction .................................................................................................................. 3 

Information procedure.................................................................................................. 4 

Operation of the procedure from 2006 to 2008............................................................ 4 

Conclusion.................................................................................................................... 4 

Mandates ...................................................................................................................... 4 

Operation of the mandating process 2006-2008 .......................................................... 4 

Trends in mandates ...................................................................................................... 5 

Conclusion.................................................................................................................... 6 

Formal objections......................................................................................................... 7 

Operation of the procedure from 2006 to 2008............................................................ 7 

Conclusion.................................................................................................................... 7 

PART II: TECHNICAL REGULATIONS ................................................................................ 8 

1. 

1.1 

1.2 

Developments 2006-2008 ............................................................................................ 8 

The notification procedure in an enlarged internal market .......................................... 8 

Use of the procedure within the context of “Better regulation”................................... 8 

1.2.1 

Improvements in managing the 98/34 procedure......................................................... 9 

2. 

2.1 

2.2 

2.3 

2.4 

2.5 

2.6 

Application of the 98/34 procedure.............................................................................. 9 

Effectiveness: general overview .................................................................................. 9 

Use of the urgency procedure .................................................................................... 11 

Follow-up to Commission reactions .......................................................................... 11 

Dialogue with the Member States .............................................................................. 11 

Infringements against the Directive ........................................................................... 12 

Conclusion.................................................................................................................. 12 

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EXECUTIVE SUMMARY 

This report analyses the application between 2006 and 2008 of the procedures laid down by 
Directive 98/34/EC1 for standardisation and technical regulations. It highlights their important 
contribution  to  the  implementation  of  better  regulation  and  to  the  functioning  of  the  single 
market.  

The  standardisation  part  consists  of  the  information  procedure  on  standards,  Commission 
requests  to  the  European  Standards  Organisations  (ESOs2)  for  standardisation  work 
(“mandates”) and formal objections against standards. They have proved to be an important 
element  in  the  functioning  of  the  single  market.  The  information  procedure  has  brought 
transparency in standards and has encouraged National Standards Bodies (NSBs) to continue 
to  take  initiatives  to  promote  European  harmonisation.  Formal  objections  have  enabled 
Member  States  and  the  Commission  to  ensure  that  standards  meet  the  goals  of  regulation 
when  used  for  the  purposes  of  “New  Approach”  legislation.  Mandates  have  provided  the 
means  by  which  the  relationship  between  the  Commission  services  and  standardisers  is 
determined; the interface between the policy level and its technical expression. 

In the field of technical regulations, the notification to the Commission of national technical 
regulations prior to their adoption has proved to be an effective instrument of prevention of 
barriers  to  trade  and  of  cooperation  between  the  Commission  and  the  Member  States  and 
among  the  Member  States  themselves  as  well  as  improving  the  regulatory  framework. 
Moreover, at the end of 2008, this procedure showed to be useful in preventing the emergence 
within  the  internal  market  of  protectionist  measures  which  might  have  been  proposed  by 
Member States in the context of the economic and financial crisis.3 The notification procedure 
has  also  been  an  important  tool  for  guiding  national  regulatory  activity  in  emerging  sectors 
and  improving  the  quality  of  national  technical  regulations  -  in  terms  of  increased 
transparency,  readability  and  effectiveness  -  in  non-harmonised  or  partly  harmonised  areas. 
The  greater  clarity  in  the  legal  framework  of  each  Member  State  has  helped  economic 
operators to reduce the cost of accessing the regulations and applying them correctly. 

PART I: STANDARDISATION 

1. 

INTRODUCTION 

This  section  describes  the  standardisation  part  of  the  Directive  covering  the  information 
procedure on standards, Commission requests to ESOs for standardisation work (mandates4) 

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Directive  98/34/EC  of  the  European  Parliament  and  of  the  Council  of  22  June  1998,  laying  down  a 
procedure  for  the  provision  of  information  in  the  field  of  technical  standards  and  regulations  and  of 
rules on Information Society services (OJ L 204 of 21.07.1998), as amended by Directive 98/48/EC (OJ 
L 217 of 05.08.1998). 
CEN (European Committee for Standardisation), CENELEC European Committee for Electrotechnical 
Standardisation) and ETSI (European Telecommunications Standards Institute). 
Communication from the Commission to the European Council – A European Economic Recovery Plan 
26 November 2008, COM(2008) 800 final. 
Mandates are requests representing an invitation to ESOs that may be accepted under certain conditions. 

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and  formal  objections  against  standards  primarily  under  New  Approach  directives,  gives 
statistics for 2006-2008 and provides analysis of the functioning of this part of the Directive. 

2. 

INFORMATION PROCEDURE 

The  procedure  in  the  field  of  standards  is  designed  to  monitor  the  new  standardisation 
activities introduced by the NSBs. Systems have been set up mainly to allow other bodies to 
comment,  participate  in  the  work  or  request  an  initiative  to  be  taken  at  European  level  (see 
Annex 1). 

2.1 

Operation of the procedure from 2006 to 2008 

The procedure has continued to operate successfully. It follows from the reports provided by 
CEN and CENELEC each year that the annual average of national measures notified remains 
stable.  Annex  3  displays  figures  from  1991  showing  an  increase  of  notifications  at  each 
enlargement. 

The sectoral breakdown (Annex 4) shows that it is the construction sector which dominates 
the  national  notifications.  Other  significant  areas  are  food  products,  water  quality  and  road 
building and maintenance. 

The  information  disseminated  under  the  procedure  continues  to  give  rise  to  requests  for 
information by the Commission services, as well as queries regarding the standstill (Article 7) 
arising either from notifications or other sources. 

2.2 

Conclusion 

information  procedure  still  plays  an 

The 
in  encouraging  national 
standardisation bodies to bring their initiatives to European level. Enlargement has led to an 
increase in notifications from new Member States, which will stabilise and even fall as they 
become more fully integrated, thus following the trend led by older Member States.  

important  role 

3. 

MANDATES 

Standardisation  “mandates”  are  a  well-established  Commission  tool  to  obtain  technical 
specifications that support European legislation and/or policy. They are a request to the ESOs 
for  standardisation  work  and  provide  a  reference  framework  for  that  work  (see  Annex  1). 
They  are  indispensable  in  cases  where  standards  support  legislation,  for  example  in  the 
context of the New Approach Directives. 

3.1 

Operation of the mandating process 2006-2008 

A total of 62 mandates were issued to the ESOs. The number of mandates concerning New 
Approach Directives has fallen compared to the previous period (Annex 5).  

The  mandating  process  functions  well.  The  informal  consultation  carried  out  before  the 
Committee  means  that  a  mandate  has  normally  consensual  agreement  before  the  formal 
consultation. 

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The  European  standardisation  stakeholders  –  ANEC  (European  association  for  the  co-
ordination  of  consumer  representation  in  standardisation),  ECOS  (European  Environmental 
Citizens Organisation for Standardisation), NORMAPME (European Office of Crafts, trades 
and  Small  and  Medium-sized  Enterprises  for  Standardisation)  and  ETUI(European  Trade 
Union Institute ) were well-integrated into the process by the end of the reporting period. This 
brings greater transparency to the informal consultation. 

The  practice  of  giving  a  follow-up  to  all  the  mandate  consultations  to  the  Committee  by 
means of an updated list has continued throughout the period. 

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3.2 

Trends in mandates 

The  subject  matter  for  mandates  continues  to  broaden.  The  proportion  of  the  number  of 
mandates issued for the New Approach Directives is 38%, very similar to the last reporting 
period. Mandates in other policy areas continue to be numerous (see Annex 6), in particular 
consumer protection and the environment, but also transport and energy. 

Mandates in support of lead markets 

Two  mandates  were  issued  since  the  beginning  of  the  lead  market  initiative  in  2007.  These 
mandates  concern  bio-based  products  and  demonstrate  the  extent  to  which  the  Commission 
believes in the potential role of standards in this important policy area. 

Standards in support of legislation 

Mandates were issued in support of a broad spectrum of legislation, proving the importance 
conferred to the model. Some examples include: legislation on cosmetics, vehicle repairs and 
maintenance,  food  products,  animal  feed  and  general  product  safety,  as  well  as  the 
environment. The number of mandates supporting new areas of European policy has doubled 
compared to the previous reporting period. Some examples are the mandates onsupply chain 
security, accessibility to the built environment or the space industry programme. 

The first mandate supporting the eco-design Directive was issued at the end of 2008. This was 
highlighted in the communication from the Commission on the integration of environmental 
aspects into European standardisation (COM(2004) 130 final), which emphasised the role that 
standards can play to develop the Commission’s policy in terms of environmental protection 
and sustainable development. 

The  number  of  mandates  supporting  legislation  outside  the  New  Approach  (see  Annex  5) 
remains large (some 35% overall) and shows that this model has been adopted across a broad 
range of Commission services. 

In  2006  a  mandate  on  the  relationship  with  costumers  contact  centers  was  issued.  Service 
sector is a new growing area for standardisation. This trend for the use of mandates in support 
of legislation outside the New Approach and in new areas of policy reflects the situation that 
European standardisation is increasingly used in support of the better regulation policy. This 
has  been  recognised  and  encouraged  by  the  Commission’s  Communication  of  2004  on  the 
role of European standardisation in the framework of European policies and legislation5. 

3.3 

Conclusion 

The process of mandating is well-established, but care must be taken to ensure it continues to 
operate smoothly. To this end, the informal consultation of all the relevant parties prior to the 
Committee consultation is essential and should continue. 

To improve transparency in the functioning of the Committee, the Commission services have 
from  2006  invited  the  European  standardisation  stakeholders,  ANEC,  ECOS,  ETUI  and 
NORMAPME, to participate in its enlarged meeting. 

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COM(2004) 674 final of 18.10.2004. 

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For the sake of transparency the services of the Commission will consider the possibility of 
organising  a  written  procedure  inspired  by  internet  forums.  The  objective  will  be  to  ensure 
that  all  committee  members  can  read  the  observations  of  the  other  members,  rendering  this 
type of consultation similar to that held at the Committee meeting. 

The  process  of  mandating  has  proved  to  be  instrumental  in  enlarging  the  role  of 
standardisation  in  new  areas  of  EU  legislation  and  policy.  This  is  also  reflected  by  the  fact 
that a number of new EU legislative acts refer to the Directive. 

4. 

FORMAL OBJECTIONS 

The  New  Approach  directives  contain  safeguards  for  cases  where  a  harmonised  standard 
cannot enable products to meet the essential requirements of the directives concerned. When 
such cases occur, the Member States or the Commission may introduce a formal objection to 
the standard in question on which the Committee is consulted (see Annex 1). 

4.1 

Operation of the procedure from 2006 to 2008 

The number of objections raised by the Commission during the reporting period has been low 
(11).  In  only  two  cases,  the  Decision  was  to  maintain  the  presumption  of  conformity;  in  9 
cases, it was fully or partially withdrawn (see Annex 7). 

However, when taking into account the notification of new objections, the number of formal 
objections  is  on  the  rise.  The  main  areas  are  under  the  directives  on  machinery,  toys  and 
pressure equipment. 

In a number of cases, problems of the compatibility of standards have been discussed in the 
Committee and have given rise to requests for amendment of harmonised standards without 
the necessity for a formal objection. 

4.2 

Conclusion 

Although  the  process  from  receiving  the  objection  to  issuing  of  the  Decision  is  quite  time-
consuming, the procedure in general has worked adequately. 

In a similar way to the mandates, and for the sake of transparency, the Commission will make 
decisions on formal objections public in a consolidated way, and make available an updated 
table of the actions in relation to the formal objections to the Committee at each meeting. 

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PART II: TECHNICAL REGULATIONS 

1. 

DEVELOPMENTS 2006-2008 

The notification procedure (“the procedure”) allows the Commission and the Member States 
to  examine  preventively  the  technical  regulations  Member  States  intend  to  introduce  for 
products (industrial, agricultural and fishery) and for Information Society services (see Annex 
8).  It  applies  in  a  simplified  manner  to  the  EFTA  States  which  are  signatories  to  the 
Agreement on the European Economic Area and to Switzerland and Turkey (see Annex 11). 

The major benefits of the procedure 

•  It  allows  new  barriers  to  the  internal  market  to  be  detected  even  before  they  have  any 

negative effects, thus avoiding long and costly infringement proceedings.  

•  It  allows  the  detection  of  protectionist  measures  which  might  be  drawn  up  by  Member 

States under exceptional circumstances, such as an economic and financial crisis. 

•  It  allows  Member  States  to  ascertain  the  degree  of  compatibility  of  notified  drafts  with 

Community legislation, including directives.  

•  Over  the  years,  the  active  participation  of  the  Member  States  in  assessing  notified  drafts 

has generated an effective dialogue between them and the Commission. 

•  Economic operators can make their voices heard and can adapt their activities in good time 
to  future  technical  regulations.  This  right  of  scrutiny  is  used  extensively  by  economic 
operators, helping the Commission and national authorities to detect any barriers to trade. 

1.1 

The notification procedure in an enlarged internal market  

The  procedure  made  an  important  contribution  to  the  smooth  functioning  of  the  internal 
market during the enlargement of the EU to include 10 “new” Member States in 2004. The 
positive results of this, observed in 2005, have since been confirmed by the receipt from these 
10  Member  States  of  122  notifications  in  2006,  131  notifications  in  2007  and  109 
notifications in 2008.  

Furthermore, the procedure extended to Bulgaria and Romania (EU-27). The 2 new Member 
States  provided  themselves  with  the  administrative  capacity,  technical  structure  and 
knowledge necessary for the application of the Directive: 33 drafts notified between 1 January 
2007 and 31 December 2008.  

Once  again,  the  Directive  has  shown  that  it  is  an  effective  tool  in  ensuring  the  smooth 
functioning of the internal market for both products and information society services.  

1.2 

Use of the procedure within the context of “Better regulation”  

Following the Commission’s action plan to simplify and improve the regulatory environment, 
several  initiatives  have  been  taken  in  the  framework  of  the  notification  procedure  over  the 
reporting  period.  Member  States  have  been  invited  to  submit  impact  studies  together  with 

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notified  drafts.  These  impact  studies  encourage  Member  States  to  reflect  in  advance  on  the 
most appropriate instrument to be used, and allow the Commission to check the necessity of 
the  measures  proposed,  taking  into  account  any  barriers  to  the  functioning  of  the  internal 
market.  

The Commission also intensified its efforts in line with better regulation principles to ensure 
the clarity and consistency of the notified drafts and to identify any unnecessarily complex or 
onerous procedures that need to be simplified to help economic operators while guaranteeing 
a high level of protection for public health, consumers and the environment.  

The national authorities have been encouraged to consider the following aspects in particular: 

•  the  wording  of  drafts:  clarity,  consistency,  transparency  and  legal  certainty  in  the 

application of the texts; 

•  the possibility of accessing all regulations in a given sector through the publication both on 

paper and on-line of consolidated versions of the texts; 

•  the 

identification  of  procedures 

imposing  unnecessarily  complex  and  onerous 
administrative burdens on economic operators, particularly when placing a product on the 
market. 

•  1.2.1 

Improvements in managing the 98/34 procedure  

The Commission conducted various campaigns to increase transparency and dialogue with the 
national authorities. The operation of the TRIS (“Technical Regulations Information System”) 
database  has  seen  continuous  improvement  and  a  new  version  should  be  launched  by  early 
2010  at  the  latest,  which  will  reduce  the  processing  time  of  notifications  and  will  allow 
connection  between  TRIS  and  national  databases.  Since  2007  the  Commission  has 
reformulated point 7 of the notification message to clarify whether, in the context of the “one-
stop shop”, a notification made under the Directive may be considered valid under another EU 
legislative act.  

The Commission ensures public access to the notified drafts, in the 23 official languages of 
the EU, and to the essential information on the conduct of the procedure through the website 
http://ec.europa.eu/enterprise/tris. A constant increase in the number of on-line consultations 
has  been  observed:  from  2006  to  2008  the  number  of  searches  rose  by  7.5%  to  reach 
approximately 140,000 searches in 2008 (see Annex 12). 

2. 

APPLICATION OF THE 98/34 PROCEDURE 

2.1 

Effectiveness: general overview  

► Volume of notifications and sectors involved 

Between  2006  and  2008,  the  total  number  of  notified  drafts  (1,979)  increased  compared  to 
1,782  between  2003  and  2005.  Enlargement  (EU-27)  contributed  to  this  increase.  Certain 
weaknesses  were  observed  in  the  implementation  of  some  Member  States’  commitment  to 
notify draft technical regulations (see Annex 10.2). 

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The construction sector saw the highest number of notifications. Many related to measures 
taken  by  Member  States  in  order  to  make  buildings  more  energy  efficient.  Agricultural 
products and foodstuffs followed. In this sector, measures were related to food hygiene, to 
the  co-existence  of  genetically  modified  organisms  with  conventional  crops,  to  the 
composition  and  labelling  of  foodstuffs.  Notifications  increased  significantly  in  the 
telecommunications and transport sectors. Several notifications were received in the games 
of  chance  sector  (on-line  gambling),  the  chemicals  sector  (dangerous  substances  and 
phytopharmaceutical products) the environment (reduction in the use of plastic bags, waste 
and the quality of biofuels) (see Annexes 10.1 to 10.3). 

► Issues examined 

In the non-harmonised areas, subject to compliance with Articles 28-30 (free movement of 
goods)  and  43  and  49  (right  of  establishment  and  freedom  to  provide  services)  of  the  EC 
Treaty,  the  Commission’s  reactions  were  intended  to  warn  Member  States  of  potential 
obstacles to trade which could be created by an unnecessary measure disproportionate to the 
objective  pursued.  The  Commission  continued  to  invite  Member  States  to  insert  mutual 
recognition clauses into each draft technical regulation.  

In  harmonised  areas,  the  reactions  were  intended  to  ensure  that  national  measures  were 
necessary, justified and compatible with EU secondary legislation. 

•  Notifications  in  the  area  of  construction  were  analysed  principally  under  Directive 
89/106/EEC on construction products and the harmonised standards adopted in the context 
of this Directive as well as Directive 2002/91/EC on the energy performance of buildings.  

•  Several  Member  States  notified  drafts  on  the  co-existence  of  genetically  modified  crops 
with  conventional  and  organic  crops  and  on  the  control  of  accidental  contamination  by 
GMOs.  Analysed  in  the  light  of  Directive  2001/18/EC  (deliberate  release  of  GMOs), 
Regulation (EC) Nos. 1829/2003 on genetically modified food and feed and 1830/2003 on 
the traceability of food and feed products produced from GMOs and amending Directive 
2001/18/EC, these texts have provided examples of regulatory solutions for other Member 
States.  

•  On 1 January 2006, Regulation Nos. 852/2004 (hygiene of foodstuffs), 853/2004 (specific 
hygiene  rules  for  food  of  animal  origin)  and  854/2004  (official  controls  on  products  of 
animal  origin  intended  for  human  consumption)  entered  into  force.  These  regulations 
authorise Member States to take certain measures at national level, which were notified in 
the framework of the 98/34 procedure and subject to detailed opinions and/or observations.  

•  Several  Member  States  notified  drafts  concerning  health  claims  on  and  labelling  of 

foodstuffs, and the additives, colourings and preservatives contained therein.  

•  Equally  numerous  were  notifications  on  radio  interfaces,  a  sector  in  which  rapid 
technological development has resulted in increasingly complex national regulations likely 
to create barriers within the internal market. 

•  An  analysis  of  the  intense  regulatory  activity  at  national  level  in  the  non-harmonized 
games  of  chance  sector  has  highlighted  aspects  of  free  movement  within  the  internal 
market and national public policy. 

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•  The procedure  has  also  allowed  intervention  in  the  sectors  where  harmonisation  was 
envisaged  at  Community  level  and  has  prevented  Member  States  from  introducing 
divergent national measures.  

► Reactions 

The  Commission  issued  detailed  opinions  in  relation  to  179  notifications,  which  represents 
9.04%  of  the  total  number  of  drafts  notified  over  the  reporting  period  (1,979).  This  figure 
shows a fall compared to the previous reporting period, suggesting that the Member States are 
legislating increasingly with the Community in mind and taking into account the requirements 
of  an  effectively  functioning  internal  market.  For  their  part,  the  Member  States  issued  142 
detailed opinions. Of the 894 observations issued during the reporting period, 418 were made 
by the Commission and 476 by the Member States (see Annexes 10.4 and 10.6). 

In 22 cases, the Commission invited the Member States concerned to postpone the adoption of 
the notified regulations for one year from the date of their receipt, so as not to compromise 
Community harmonisation work underway in the area (see Annexes 10.5). 

In  addition,  the  Commission  drew  the  attention  of  the  Member  States  to  the  need  to  ensure 
compatibility  with  the  rules  of  the  Agreement  on  technical  barriers  to  trade  when  the 
measures concerned were also notified to the World Trade Organisation.  

2.2 

Use of the urgency procedure 

Out of a total of 1,979 notifications, the Member States made 49 requests to apply the urgency 
procedure  to  notified  drafts.  The  Commission  confirmed  its  strict  interpretation  of  the 
exceptional  conditions  required,  namely  serious  and  unforeseeable  circumstances  relating  in 
particular to the protection of health and safety. As a result, use of the urgency procedure was 
refused where the justification given was based on purely economic grounds or stemmed from 
an attempt to make up for national administrative delay. The urgency procedure was deemed 
justified in 14 cases (see Annex 10.7). 

2.3 

Follow-up to Commission reactions 

For 2006-2008, the ratio between the number of responses given by Member States and the 
volume of detailed opinions issued by the Commission was satisfactory (an average of 83.7% 
over  the  period).  This  percentage  is  the  main  indicator  used  to  assess  Member  States’ 
commitment to meeting their obligations under the procedure. The Commission observes that 
the  responses  were  mainly  satisfactory  (an  average  of  64.3%  over  the  period).  Continued 
dialogue  between  the  Commission  and  the  Member  States  involved  contributed  to  this  by 
allowing many cases to be resolved within a year of notification (see Annex 10.8). 

2.4 

Dialogue with the Member States 

The  regular  meetings  of  the  Committee  on  Standards  and  Technical  Regulations  allowed 
views  to  be  exchanged  on  points  of  general  interest  and  also  on  specific  aspects  of  the 
procedure.  

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Discussions particularly concerned the enlargement to Bulgaria and Romania, public access to 
documents  relating  to  the  98/34  procedure  pursuant  to  Regulation  (EC)  No  1049/20016the 
overlap  between  the  procedure  and  other  Community  notification  procedures  (“one-stop 
shop”),  the  developments  in  the  management  of  the  TRIS  database  and  Member  States’ 
obligations to respond to detailed opinions and communicate the definitive texts.  

Seminars  were  also  held  in  several  Member  States,  allowing  direct  dialogue  between  the 
Commission  and  the  national  authorities  involved  in  the  procedure  and  helping  the  latter  to 
become  familiar  with  the  often  highly  technical  elements  of  the  procedure.  In  addition,  a 
conference  to  mark  the  25th  anniversary  of  the  Directive  was  held  in  November  2008.  This 
event was an opportunity to showcase the performance of the 98/34 mechanism and discuss 
prospects  for  the  future,  including  how  to  better  use  the  mechanism  to  favour  the 
competitiveness  of  enterprises,  in  particular  SMEs.  It  was  also  a  chance  to  note  the 
expectations  of  the  economic  operators,  particularly  their  desire  to  have  access  to  the 
documents  exchanged  under  the  procedure.  On  the  same  day,  a  new  booklet  entitled 
“Preventing obstacles to trade in the internal market – Directive 98/34” was published in all 
the official languages of the EU and widely distributed in the Member States (ISBN 978-92-
79-09847-5). 

2.5 

Infringements against the Directive 

The  number  of  infringement  proceedings  (Article  226  of  the  EC  Treaty)  brought  against 
Member States for breach of obligations under the Directive remained low during the period 
in question: fourteen in 2006, nine in 2007 and five in 2008. 

2.6 

Conclusion 

Between  2006  and  2008,  the  utility  of  the  procedure  has  been  fully  confirmed  in  terms  of 
effectiveness,  transparency  and  administrative  cooperation.  The  fact  that,  in  relation  to  the 
number  of  technical  draft  regulations  notified,  the  number  of  infringement  proceedings 
remains minimal shows that the correct application of Community legislation can be ensured 
through  a  preventive  approach  and  the  close  partnership  between  the  Commission  and  the 
Member States as well as between the Member States themselves. 

This networking approach and the high degree of cooperation between the Commission and 
the Member States have also ensured that national regulatory activities have been carried out 
without creating technical barriers to trade and that Community harmonisation has occurred 
only  where  really  needed,  in  strict  compliance  with  the  subsidiarity  principle.  At  the  same 
time, in certain areas where harmonisation measures already exist, the procedure has allowed 
to detect the need to supplement or reinforce them. 

When  applying  the  98/34  directive  the  Commission  will  remain  vigilant  as  regards  the 
principles  of  better  regulation  and  the  need  to  sustain  a  favourable  environment  for  the 
competitiveness of the European economy. Therefore notified drafts continue to be available 
electronically, free of charge and in all the official languages of the EU. Moreover efforts will 
continue  to  provide  economic  operators  with  a  legal  framework  that  is  as  clear  as  possible, 

6 

Regulation  (EC)  no  1049/2001  of  the  European  Parliament  and  of  the  Council  of  30  May  2001 
regarding public access to European Parliament, Council and Commission documents (OJ L 145/43 of 
31.5.2001). 

EN 

12 

   EN 

 
                                                 
will continue to seek to avoid "goldplating" and provide with comments, aiming at enhancing 
the  competitiveness  of  European  enterprises  in  the  EU  and  abroad,  taking  into  account  the 
links  between  this  procedure  and  that  established  by  the  Agreement  on  technical  barriers  to 
trade (TBT) in the context of the World Trade Organisation (WTO).  

EN 

13 

   EN