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 2002 to 2005 {SEC(2007) 350}
Date: 2007-03-21
Institutions: European Commission
Subjects: EC Directive, European standard, access to information, application of EU law, exchange of information, technical regulations, technical standard

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 21.3.2007 
COM(2007) 125 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 2002 TO 2005 

{SEC(2007) 350} 

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TABLE OF CONTENTS 

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 2002-2005 ........................................................................ 4 

Conclusion ................................................................................................................... 5 

Mandates ...................................................................................................................... 5 

Operation of the mandating process 2002-2005 .......................................................... 5 

Trends in mandates ...................................................................................................... 6 

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

Formal objections......................................................................................................... 8 

Operation of the procedure 2002-2005 ........................................................................ 8 

Conclusion ................................................................................................................... 8 

PART II: TECHNICAL REGULATIONS ................................................................................ 9 

1. 

1.1. 

1.2. 

1.3. 

2. 

2.1. 

2.2. 

2.3. 

2.4. 

2.5. 

2.6. 

Developments 2002-2005 ............................................................................................ 9 

Geographical coverage................................................................................................. 9 

Use of the procedure within the context of “better regulation” ................................. 10 

Improvements in managing the procedure................................................................. 10 

Application of the notification procedure .................................................................. 11 

Effectiveness: general overview ................................................................................ 11 

Use of the urgency procedure .................................................................................... 12 

Follow-up to Commission reactions .......................................................................... 13 

Dialogue with the Member States .............................................................................. 13 

Infringements against the Directive ........................................................................... 13 

Conclusion ................................................................................................................. 13 

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EXECUTIVE SUMMARY 

This report analyses the application of the procedures laid down by Directive 98/34/EC1 (“the 
Directive”)  for  standardisation  and  technical  regulations  from  2002-2005.  The  report 
highlights the important contribution of standardisation and the notification procedure to make 
the internal market work by improving the national regulatory environment2. 

The  standardisation  part  consists  of  the  information  procedure  on  standards,  Commission 
requests  to  the  European  Standards  Organisations  for  standardisation  work  (mandates)  and 
formal  objections  against  standards.  Each  of  these  activities  has  proved  to  be  an  important 
element  in  the  functioning  of  the  internal  market.  The  information  procedure  has  brought 
transparency in standardisation at national and thus also European level and has encouraged 
National  Standards  Bodies  to  continue  to  take  initiatives  to  the  European  level,  in  turn 
promoting 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,  both  in  the  areas  of  goods  and  of  Information  Society 
Services,  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.  The  preventive  and  dialogue-based  approach  characterising  the  notification 
procedure  was  particularly  useful  in  preparing  the  enlargement  of  the  internal  market  to  10 
new Member States in 2004. The notification procedure has also been an important tool for 
guiding national regulatory activity in certain emerging sectors and for 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  access  markets  and  to 
apply new regulations easily. 

PART I: STANDARDISATION 

1. 

INTRODUCTION 

This section describes the standardisation3 part of the Directive covering three main activities, 
the  information  procedure  on  standards,  Commission  requests  to  the  European  Standards 

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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).  
See  Action  plan  for  improving  the  regulatory  environment,  COM(2002)  278  final.  See  also  Better 
Regulation for Growth and Jobs in the European Union, COM(2005) 97 final. 
For more information on European standardisation policy see: 
http://ec.europa.eu/enterprise/standards_policy/index_en.htm 

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Organisations  (ESOs4)  for  standardisation  work  (mandates5)  and  formal  objections  against 
standards  primarily  under  New  Approach  directives6,  gives  statistics  for  2002-2005  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 National Standardisation Bodies (NSBs; as recognised under the 
Directive). 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 2002-2005 

The  procedure  has  continued  to  operate  successfully  from  2002  to  2005.  From  the  reports 
provided  by  CEN  and  CENELEC  each year, it is possible to see that the annual average of 
national measures notified continued to drop from previous reports. The 1995-1998 average 
was 1922 per year and for 1999-2001 was 1587 per year. For this reporting period the annual 
average is 1537 (Annex 2). However, the figures for individual years show the effect of the 
new CEN and CENELEC members from the EU-10.  

Annex 3 gives a breakdown by state of the notifications. The sectoral breakdown (Annex 4) 
shows  that  it  is  the  construction  sector  in  the  broadest  sense  that  dominates  the  national 
notifications,  with  structures,  buildings  and  construction,  concrete  and  metal  structures  all 
featuring regularly in the  top  ten  areas for notifications.  Other significant areas are those of 
food products and water quality. 

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

Due to the enlargement on 1st May 2004 the NSBs of the ten new Member States became full 
members  of  CEN  and  CENELEC  and  the  notifications  increased  gradually  during  the 
reporting period (see Annex 3). From 2003 to 2005 the number of notifications from the EU-
15 has shown an upward trend. The addition of the EU-10 has caused overall figures to rise 
further. Post-enlargement, the contribution of the new Member States is 15-20% of the total 
of notified national initiatives. These Member States are already applying the procedure and 
contributing to the national work of standardisation in Europe.  

Through  the  publishing  of  national  standardisation  initiatives,  the  information  procedure 
encourages all stakeholders to consider the possibilities for extending the work to European 
level. In this way, the information procedure encourages the NSBs to bring their initiatives to 
European level, thus promoting the internal market and European harmonisation.  

In the new area of standardisation for services, the number of national initiatives notified is 
rather high (although not featuring in the annual top ten). This has led to an examination of 

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EN (European Committee for Standardisation), CENELEC (European Committee for Electrotechnical 
Standardisation) and ETSI (European Telecommunications Standards Institute).  
Mandates are requests representing an invitation to ESOs that may be accepted under certain conditions. 
For Directives under the New Approach see www.newapproach.org  

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those  areas  by  the  Commission  services,  for  example  when  preparing  the  standardisation 
mandate  on  customer  call  centres  towards  the  end  of  2005.  There  were  already  several 
initiatives  identified  at  national  level  in  this  area  and  these  were  drawn  together  as  far  as 
possible when drawing up the mandate. 

2.2. 

Conclusion 

The number of national initiatives notified under the information procedure is still significant. 
As in the sector of services, the notifications can be monitored to encourage standardisation 
work  to  be  brought  to  European  level  wherever  possible,  thus  encouraging  European 
harmonisation.  

The EU-10 are already playing their expected role in the information procedure, so it can be 
seen that the system should function well for the future. 

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 2002-2005 

In the reporting period, a total of 55 mandates were issued to the ESOs, with 10 amendment 
mandates  in  the  construction  sector  in  addition  to  this  (see  Annex  5).  As  with  previous 
reporting periods, a large number of the mandates concerned  New Approach directives  (20, 
plus the 10 amendments). Of the mandates issued, 46 were standardisation mandates, 8 were 
programming mandates and 1 was a study mandate.  

The Standing Committee set up pursuant to Article 5 of the Directive (‘the Committee’) was 
consulted  twice  on  standards  under  the  General  Product  Safety  Directive  (2001/95/EC) 
without  a  mandate,  the  references  of  which  would  be  published  in  the  OJ  to  give  a 
presumption of conformity with that Directive. 

The mandating process is now well-established and functions well. The informal consultation 
carried  out  before  the  documents  are  circulated  to  the  Committee  members  means  that  a 
mandate normally has consensual agreement before the formal consultation starts.  

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-REHS (European Trade 
Union  Institute  –  Research,  Education,  Health  and  Safety)  were  well-integrated  into  the 
process  by  the  end  of  the  reporting  period.  This  brings  greater  transparency  to  the  informal 
consultation.

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Database of mandates 

In order to increase transparency further, DG ENTR has developed a database of mandates. It 
contains the mandates with the numbering series M/xxx. This database was made accessible 
to the public through the internet in 2005 at: 

http://ec.europa.eu/enterprise/standards_policy/mandates/index.htm 

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. The progress of the mandated 
work is followed up by the sectoral services of the Commission. In certain cases, the ESOs 
request funding for the mandated work and subventions can be granted subject to the priority 
of the work and the appropriate evaluations.  

3.2. 

Trends in mandates 

The number of mandates issued has shown an increasing trend. 

The subject matter for mandates continues to broaden. Whilst many are still issued for New 
Approach directives, the percentage has fallen in relative terms since the last reporting period, 
from 57% to 36%. Mandates in other policy areas continue to be important (see Annex 6), in 
particular environment where 12 mandates were issued, but also transport (5) and consumer 
protection (4). 

Mandates in support of environmental legislation and policy 

One-fifth  of  the  mandates  issued  2002-2005  concerned  the  environment.  From  biowaste  to 
biofuels, waste from electronic equipment to energy-using products, this demonstrates the role 
that the Commission believes standards can play in this important policy area.  

This  has  been  emphasised  in  the  Commission  Communication  on  the  integration  of 
environmental aspects into European standardisation (COM (2004) 130 final), which stressed 
the role that standardisation can play in advancing the Commission’s policy of protecting the 
environment and sustainable development. 

Through  the  reporting  period,  mandates  have  been  issued  to  support  a  broad  range  of 
legislation.  This  includes  legislation  on  the  European  single  sky,  cosmetics,  intermodal 
loading units and road  tolls,  conventional rail systems,  foodstuffs,  animal  feeds  and  general 
product safety, as well as the environment. 

The number of mandates supporting legislation outside the New Approach (see Annex 5) is 
large (some 50% overall) and shows that this co-regulatory model has been adopted across a 
broad range of the Commission services.  

The breadth of legislative areas shows the commitment to the co-regulatory model provided 
by standardisation. The use of such a model encourages a regulatory approach which does not 
inflate  the  Community  acquis  with  overly  detailed  rules  through  leaving  to  industry  and 
interested  parties  the  task  of  developing  standards  that  can  give  technical  expression  to 
legislation, thus following the principles of better regulation.  

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Mandates  have  also  increasingly  been  used  to  support  new  areas  of  European  policy. 
Examples  include  the  study  mandate  on  hydrogen  fuel  cells,  the  programming  mandate  on 
crime risk in products and services and the standardisation mandate on film archiving. 

A mandate was issued for the first time in 2003 for standardisation in the service sector. This 
was followed by two more mandates in 2005, with another being consulted at the Committee 
meeting at the end of the reporting period. This is a new growth area for national, European 
and  international  standardisation.  The  process  of  mandating  links  here  to  the  information 
procedure, as initiatives on service standardisation at national level were examined in drawing 
up the mandate on customer contact centres (see point 2.1 above). 

These trends for the use of mandates in support of legislation outside the New Approach and 
in  new  areas  of  policy  reflect  the  situation  that  European  standardisation  is  increasingly 
used in support of the Commission’s better regulation policy. This has been recognised in, 
and indeed encouraged by, the Commission Communication of 2004 on 'The role of European 
standardisation in the framework of European policies and legislation'7. 

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  relevant  parties  prior  to  the 
Committee consultation is essential and should be reinforced.  

To improve transparency in the functioning of the Committee, the Commission services are 
also actively considering the possibility of inviting the European standardisation stakeholders, 
ANEC, ECOS, ETUI-REHS and NORMAPME, to participate in its enlarged meeting. 

In order to improve transparency the consultations by written procedure will be opened up so 
that  all  Committee  members  can  see  the  comments  of  the  others,  making  this  kind  of 
consultation similar to a consultation carried out during the meeting of the Committee. 

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. 

Vademecum on European standardisation 

The procedure of handling mandates, formal objections against harmonised standards and the 
publication of the references of harmonised standards are all contained within the Vademecum 
on European standardisation, along with a number of other relevant documents.  

The  Commission  consulted  the  Committee  and  other  interested  parties  on  the  Vademecum 
prior to its publication.  

The Vademecum is published on the Europa website at: 

http://ec.europa.eu/enterprise/standards_policy/vademecum/index.htm  

7 

COM(2004) 674 final of 18.10.2004. 

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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 for the details of 
the procedure). 

4.1. 

Operation of the procedure 2002-2005 

The number of objections that have given rise to Commission Decisions during the reporting 
period  has  been  low  (8).  In  5  cases  the  Decision  was  to  maintain  the  presumption  of 
conformity; in 3 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, 
construction products and medical devices.  

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 2002-2005  

The  notification  procedure  for  national  technical  regulations  (“the  procedure”)  allows  the 
Commission  and  the  Member  States  of  the  EU  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  Member  States  which  are  signatories  to  the  Agreement  on  the  European 
Economic Area and to Switzerland and Turkey (see Annex 12). 

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  Member  States  to  ascertain  the  degree  of  compatibility  of  notified  drafts  with 

Community legislation, including directives.  

•  The  active  participation  of  the  Member  States  in  assessing  notified  drafts  has,  over  the 
years,  enabled  the  establishment  of  an  effective  dialogue  between  them  and  the 
Commission. 

•  All interested parties, including consumers, are promptly  informed  of national  regulatory 
initiatives and economic operators can adapt their activities in good time to future technical 
regulations. 

1.1. 

Geographical coverage  

The  procedure  made  an  important  contribution  to  ensure  the  respect  of  the  internal  market 
rules  during  the  enlargement  of  the  EU.  The  dialogue  established  since  2002  with  the 
applicant countries led to the introduction of a simplified procedure giving these countries the 
administrative capacity, technical structure and knowledge needed to apply the Directive even 
before the date of accession (see Annex 10). 

Moreover, to ensure that the Directive was correctly transposed, seminars were organised in 
some  of  these  countries  to  study  the  procedure  and  to  discuss  the  measures  already  put  in 
place by the national authorities.  

From 1 May 2004, all the new Member States have been able to fully apply the procedure and 
translations of notified drafts have been available in the 20 official languages of the EU.  

The  initiative’s  success  is  shown  by  the  number  of  notifications  from  the  10  new  Member 
States: 64 between 1 May 2004 and 31 December 2004 and 196 in 2005 (26.5% of the total 
number of notifications from the 25 Member States). 

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1.2. 

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

Following the Commission’s action plan to simplify and improve the regulatory environment8 
several  initiatives  have  been  taken  in  the  framework  of  the  notification  procedure  over  the 
reporting period. To ensure that comprehensive information is available when notified drafts 
are examined and to facilitate their understanding and evaluation, Member States have been 
invited  to  submit  impact  studies  (or  their  conclusions)  together  with  notified  drafts,  where 
such  studies  have  been  carried  out.  Analysing  these  impact  studies  also  encourages  the 
Member States to reflect in advance on the most appropriate instrument to be used.  

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 have 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 

•  the  possibility  of  accessing  all  regulations  in  a  given  sector  through  the  publication  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 or regulating the exercise of on-line activities. 

1.3. 

Improvements in managing the procedure 

The  Commission  conducted  various  campaigns  during  2002-2005  to  increase  transparency 
and  dialogue  with  the  national  authorities.  Firstly,  the  operation  of  the  TRIS  (“Technical 
Regulations Information System”) database was improved so that, since 2002, all documents 
have  been  sent  electronically  in  a  standardised  format.  Secondly,  Member  States  must 
mention  in  the  notification  message  any  impact  studies  which  have  been  carried  out  (see 
paragraph  1.2  above).  Finally,  they  are  also  required  to  indicate  whether  their  drafts  may 
affect  international  trade  and  must  therefore  be  notified  under  the  WTO’s  TBT  and/or  SPS 
Agreements.  This  information  allows  the  Commission  to  connect  the  Community  and 
international dimensions of notified drafts, to assess their implications better and to defend the 
interests of European industry within the WTO more effectively. 

The Commission ensures public access to the notified drafts, in the 20 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: the monthly number of searches increased from 4 459 in 2003 to 11 109 in 
2005 (see Annex 13). 

To allow interested parties to respond effectively to the competent authorities, a mailing list 
system  was  introduced  in  2003.  Based  on  a  simple  on-line  registration,  draft  regulations 
notified  by  Member  States,  in  the  respective  areas  of  interest,  are  sent  automatically  by  e-

8 

See supra, footnote 2 

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mail. The number of registrations has increased (420 subscribers at the end of 2003 and 1 300 
at the end of 2005). 

2. 

APPLICATION OF THE NOTIFICATION PROCEDURE 

2.1. 

Effectiveness: general overview 

► Volume of notifications and sectors involved 

Between 2002 and 2004 (EU-15) the total number of notified drafts fell slightly compared to 
the  previous  period  (1 487  as  opposed  to  1 872  between  1999  and  2001)  -  around  500 
notifications  per  year.  Enlargement  (EU-25)  contributed  to  an  increase  in  the  number  of 
notifications to 739 in 2005. 

One  of  the  factors  explaining  the  high  number  of  drafts  notified  by  Member  States  is  the 
effect  of  the  case-law  of  the  Court  of  Justice  since  the  “CIA  Security  International”9 
judgment,  namely  the  unenforceability  against  third  parties  of  technical  regulations  not 
notified in advance to the Commission (for recent case-law, see Annex 9). 

As  in  the  past,  agricultural  products  and  foodstuffs  is  the  sector  which  saw  the  highest 
number of notifications during the reporting period. The subjects covered included labelling 
of foodstuffs, food supplements, traceability and the origin of products and also measures on 
the  co-existence  of  GMOs  with  conventional  and  organic  crops.  Notifications  increased 
significantly in the telecommunications, transport, construction and, particularly in 2005, 
energy  and  mechanical  engineering  sectors.  In  the  field  of  Information  Society  services, 
the  notifications  mainly  concerned  electronic  signature,  electronic  commerce  and  domain 
names (see Annexes 11.1 to 11.3). 

► Issues examined 

In  non-harmonised  areas  subject  to  compliance  with  Articles  28  to  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.  In  addition,  the  Commission  invited  Member  States  to  insert  a  mutual 
recognition  clause 
interpretative 
technical 
communication on compliance with the mutual recognition principle in the product sector10. 

in  each  draft 

regulation 

following 

its 

9 
10 

Case C-194/94 CIA Security International SA v Signalson SA and Securitel SPRL [1996] ECR I-2201. 
Facilitating the access of products to the markets of other Member States: the practical application of 
mutual recognition (2003/C 265/02), OJ C 265/2 of 04.11.2003. 

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In  harmonised  areas,  the  reactions  were  intended  to  ensure  that  national  measures  going 
beyond the simple transposition of directives were justified and compatible with Community 
law. 

•  Since 2004, several Member States have 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 light of Directive 2001/18/EC (deliberate release of 
GMOs),  these  texts  have  provided  examples  of  regulatory  solutions  for  other  Member 
States. 

•  In 2004,  several  drafts  aimed at introducing blind spot  mirrors  for lorries demonstrated 
the need to speed up the entry into force of common rules in an area already harmonised at 
Community level by Directive 2003/97/EC. 

•  This is also true for drafts on substances used as ingredients in food supplements which 

are only partly harmonised at Community level. 

•  An  analysis  of  the  intense  regulatory  activity  at  national  level  in  the  games  of  chance 
sector,  in  which  there  are  no  common  rules,  has  highlighted  aspects  of  free  movement 
within the internal market and national public policy. 

•  Since 2003 there have also been many 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. 

► Reactions 

The Commission issued 293 detailed opinions, which represents 12.7% of the total number of 
drafts  notified  over  the  reporting  period  (2 290).  In  the  1999-2001  period,  the  figure  was 
8.2%.  For  their  part,  the  Member  States  issued  275  detailed  opinions.  Of  1 563  comments, 
802  were  made  by  the  Commission  and  761  by  the  Member  States  (see  Annexes  11.4  and 
11.6).  

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 Annex 11.5). 

2.2. 

Use of the urgency procedure 

From a total of 2 290 notifications, the Member States made 99 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 
to be justified in 49 cases (see Annex 11.7). 

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2.3. 

Follow-up to Commission reactions 

This is the main indicator for assessing the commitment of the Member States to compliance 
with their obligations  under the  procedure. For 2002-2005, 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 84.7% over the period) and gradually improved 
(78.5%  in  2002  increasing  to  87%  in  2005).  The  responses  were  mainly  satisfactory  (an 
average  of  60.6%  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 11.8). 

2.4. 

Dialogue with the Member States  

The regular meetings of the Committee allowed views to be exchanged on points of general 
interest and also on specific aspects of the procedure. Between 2003 and the accession, the 10 
new Member States participated in the Committee’s work as observers. 

The discussions particularly concerned the enlargement of 1 May 2004, the possible extension 
of  the  Directive  to  services  other  than  Information  Society  services,  public  access  to 
documents relating to the 98/34 procedure following the entry into force of Regulation (EC) 
No 1049/2001,  the  impact  studies  for  notified  drafts  and  the  overlap  between  the  procedure 
and other Community notification procedures (“one-stop shop”).  

“Package meetings” and seminars were also held in the Member States, thus allowing direct 
dialogue between the Commission and national authorities involved in the procedure. In 2005, 
a conference involving about 200 participants from the Member States and European industry 
provided an opportunity to find out the expectations of those involved in the procedure and to 
discuss improvements in its effectiveness. 

2.5. 

Infringements against the Directive  

The infringement proceedings (Article 226 of the EC Treaty) brought against Member States 
were related to the breach of their obligation to notify technical regulations at a draft stage, in 
accordance  with  the  Directive.  The  number  of  these  proceedings  remained  low  during  the 
period in question: three in 2002, three in 2003, two in 2004 and four in 2005. The outcome 
of the infringement proceedings was that the unnotified national regulations were repealed by 
the Member States. All these proceedings have been closed. 

2.6. 

Conclusion 

Between  2002  and  2005,  the  utility  of  the  procedure  has  been  fully  confirmed  in  terms  of 
effectiveness,  transparency  and  administrative  cooperation.  Moreover,  the  high  number  of 
draft  technical  regulations  notified  by  Member  States  in  accordance  with  the  Directive 
contributes  to  ensure  a  correct  application  of  Community  legislation  through  a  preventive 
approach. 

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The  networking  approach  and  the  high  degree  of  cooperation  between  the  Commission  and 
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 
the need to supplement or reinforce these to be detected. 

The intense work undertaken to ensure that the 10 applicant countries would comply with the 
obligations  arising  from  the  Directive  on  their  accession  to  the  EU  has  helped  ensure  the 
correct operation of the enlarged internal market.  

Extending  the  enterprise  policy  dimension  remains  a  priority  in  the  application  of  the 
procedure.  Notified  drafts  are  already  available  electronically,  free  of  charge  and  in  all  the 
official languages of the EU. Efforts will continue to provide economic operators with a legal 
framework that is as clear as possible without any regulatory excesses. 

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