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 1999 to 2001
Date: 2003-05-23
Institutions: European Commission
Subjects: Cenelec, ETSI, European Committee for Standardisation, application of EU law, exchange of information, national law, report, standardisation, technical regulations

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 23.5.2003
COM(2003) 200 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 1999 TO 2001

   
EXECUTIVE SUMMARY

The present report presents the results of the application of Directive 98/34/EC laying down a
procedure for the provision of information in the field of technical regulations and standards
and of rules on information society services. It covers the period 1999 to 2001. It is divided
into  three  parts:  the  information  procedure  for  standards,  the  notification  procedure  for
technical regulations and finally, the annexes referring to standards and technical regulations.

The  report  provides  an  assessment  of  the  role  of  Directive  98/34/EC  during  the  period  in
question. It is intended to raise awareness of these procedures set up by the Directive and to
encourage businesses to make even more use of it.

1.

STANDARDS

The  procedure,  in  the  field  of  standards,  is  designed  to  monitor  the  new  standardisation
activities  introduced  by  the  national  standardisation  bodies  (as  recognised  under  Directive
98/34/EC).  This  report  gives  a  brief  description  of  the  procedure  in  the  field  of  standards,
provides an assessment and proposes improvements.

The  report  concludes  that  it  would  be  useful  to  examine  the  value  and  direct  and  indirect
usefulness  of  this  procedure  for  the  different  players  on  the  market.  It  is  first  up  to  all  the
parties concerned to  consider  these  aspects and make  an assessment. However,  it  should  be
noted  that  it  is  highly  likely  that  the  absence  of  the  mechanism  for  monitoring  national
activities could  again create  the  danger  of  disruption  on  the  internal  market.  Therefore,  this
procedure  must  certainly  be  continued,  but  it  is  necessary  to  allocate  greater  resources  to  it
and to strengthen it at European and national levels in order to increase its effectiveness.

One  further  question  that  could  be  asked  concerns  the  legal  framework.  European
standardisation has developed considerably since the procedure was set up in 1983. There has
been  a  massive  movement  of  expert  resources  from  national  to  European  level  since  then.
European standardisation  now covers a  wide variety  of  fields  which  were previously  within
the scope of national standards.  It may  also be assumed that the standardisation bodies  now
automatically  check  whether  their  national  standardisation  intentions  should  be  submitted
directly  at  European  or  even  international  level.  It  would  therefore  be  useful  to  consider
reducing  the  legal  framework  of  the  information  procedure  for  standards  when  Directive
98/34/EC is revised.

1.

TECHNICAL REGULATIONS

By setting up a notification procedure for national technical  regulations, Directive 98/34/EC
has created a genuine observatory for the internal market, since it allows the Commission, the
Member States and economic operators to find out about national regulatory initiatives.

This  report  provides  a  brief  description  of  the  procedure  in  the  field  of  technical  rules,  the
information exchanged, and the reactions of the Commission and the Member States. It also
includes the results achieved, infringements of Directive 98/34/EC and case law in this area,
the measures taken to improve the functioning of the procedure and, finally, its application at
international level.

3

Looking to the future, the notification procedure could be extended both as regards contents
and  geographical  coverage.  Since  services  play  an  increasingly  important  role  in  our
economies,  the  Commission  has  undertaken  to  begin  studying  the  suitability  of  extending
Directive 98/34/EC  to  services  other  than  those  of  the  information  society.  This  appears
particularly  necessary  since  the  Commission  has  already  noted  in  its  analysis  of  drafts
covering several high technology sectors such as genetic treatment and the use of stem cells,
that  the  Member  States  are  increasingly  linking  the  processing  and  handling  of  products  to
requirements imposed on service providers.

The other challenge for Directive 98/34/EC is enlargement. A first step has already been taken
with  Turkey,  which  has  had  the  possibility  since  1  January  2001  of  participating  in  the
notification procedure under a simplified arrangement. Given the importance of the Directive
for the creation of an enlarged internal market, the Commission is currently studying ways of
including the participation of candidate countries  in the  notification  procedure  prior  to  their
accession, on the lines of the EFTA countries.

4

TABLE OF CONTENTS

EXECUTIVE SUMMARY...................................................................................................... 3

1.

2.

Standards ...................................................................................................................... 3

Technical regulations ................................................................................................... 3

Introduction .............................................................................................................................. 9

1.

2.

3.

General overview ......................................................................................................... 9

Standards ...................................................................................................................... 9

Technical regulations ................................................................................................... 9

Part I: Information procedure for standards ...................................................................... 11

1.

2.

2.1.

2.2.

3.

3.1

3.2

3.3

4.

4.1

4.2

5.

5.1

5.2

5.3

5.4

6.

6.1

6.2

6.3

7.

8.

Introduction................................................................................................................ 11

Brief description of the procedure.............................................................................. 11

Role of CEN and CENELEC ..................................................................................... 11

Role of ETSI .............................................................................................................. 11

Operation of the information procedure from 1999 to 2001...................................... 12

Handling of notifications ........................................................................................... 12

Statistics ..................................................................................................................... 12

Trends in new standardisation activities .................................................................... 13

Quality of the notifications from the national standardisation bodies ....................... 14

CEN............................................................................................................................ 14

CENELEC.................................................................................................................. 14

Use of the information received through the procedure............................................. 14

Dissemination of information .................................................................................... 14

Application of Article 4 of Directive 98/34/EC......................................................... 15

Application of Article 7 of Directive 98/34/EC......................................................... 15

Conclusions regarding the use of information ........................................................... 16

Information on standardisation activities in general .................................................. 16

Need for information by all the parties concerned..................................................... 16

Websites promoted by the Commission..................................................................... 16

Information products of European standardisation bodies......................................... 17

Programming and standardisation mandates.............................................................. 17

Action to improve the procedure................................................................................ 17

5

8.1

8.2

8.3

9.

Improvements at European level................................................................................ 17

Improvements at national level regarding notifications............................................. 18

Improvement at national level regarding the dissemination of information .............. 18

Conclusions and prospects ......................................................................................... 18

Part II : The information procedure for technical regulations.......................................... 20

1.

2.

2.1.

2.2.

3.

3.1.

3.2.

3.3

3.4.

3.5.

4.

4.1

4.2.

4.3.

4.4.

5.

5.1.

5.2.

5.3.

5.4.

5.5.

6.

6.1.

6.2.

7.

Introduction................................................................................................................ 20

Brief description of the procedure.............................................................................. 20

General presentation of procedure 98/34/EC in the field of products ....................... 20

Specific features of the procedure for the information society services sector.......... 21

statistical overview..................................................................................................... 24

Volume of notifications ............................................................................................. 24

Breakdown by country ............................................................................................... 24

Breakdown by sector.................................................................................................. 25

Breakdown by reaction .............................................................................................. 27

Use of the emergency procedure................................................................................ 28

Risks of barriers to the internal market detected through the notification procedure 29

General picture ........................................................................................................... 29

Incompatibility of notified drafts with Articles 28 and 30 and Articles 43 and 49 of
the EC Treaty ............................................................................................................. 31

Incompatibility of notified drafts with secondary legislation .................................... 32

Analysis of the reactions of the Member States......................................................... 34

Results........................................................................................................................ 35

Follow-up to detailed opinions .................................................................................. 36

Follow-up to comments ............................................................................................. 36

Drafts withdrawn........................................................................................................ 37

“Blocking” of national initiatives .............................................................................. 37

Identification of harmonisation needs........................................................................ 39

Handling of infringements ......................................................................................... 39

Infringements in the field of products........................................................................ 39

Infringements in the information society services sector........................................... 39

Court of Justice case-law ........................................................................................... 40

7.1.

Judgements on procedural matters ............................................................................. 40

6

7.2.

8.

8.1.

8.2.

8.3.

9.

9.1.

9.2.

9.3.

9.4.

10.

Judgements concerning the field of application of the Directive and definition of
concepts...................................................................................................................... 41

Action to improve the procedure................................................................................ 43

Transparency.............................................................................................................. 43

Meetings of the Committee set up by Directive 98/34/EC ........................................ 44

Package meetings ....................................................................................................... 45

International aspects of the notification procedure .................................................... 46

The exchange of information on technical rules between the Community and the
EFTA countries. ......................................................................................................... 46

Turkey ........................................................................................................................ 49

Enlargement ............................................................................................................... 49

Council of Europe ...................................................................................................... 49

Conclusions and prospects ......................................................................................... 49

Part III: Annexes .................................................................................................................... 52

1.

1.1.

1.2.

1.3.

1.4

1.5.

1.6.

1.7.

1.8

1.9.

annexes regarding standardisation ............................................................................. 53

Breakdown of new standardisation activities started each year between 1991 and
1998............................................................................................................................ 53

Breakdown of new standardisation activities started in 1999.................................... 54

Breakdown of new standardisation activities started in 2000.................................... 55

Breakdown of new standardisation activities started in 2001.................................... 56

Breakdown by country of new national standardisation activities notified in 1999 .. 57

Breakdown by country of new national standardisation activities notified in 2000 .. 58

Breakdown by country of new national standardisation activities notified in 2001 .. 59

Top ten subsectors for new national standardisation activities in 1999..................... 60

Top ten subsectors for new national standardisation activities in 2000..................... 61

1.10.

Top ten subsectors for new national standardisation activities in 2001..................... 62

1.11

Application of Article 4 (requests to participate in national standardisation activities
and requests to draw up a European standard)........................................................... 63

1.12.

Standardisation work entrusted to the European standardisation bodies in 1999...... 64

1.13.

Standardisation work entrusted to the European standardisation bodies in 2000...... 66

1.14.

Standardisation work entrusted to the European standardisation bodies in 2001...... 68

2.

Annexes concerning technical regulations................................................................. 69

7

2.1.

2.2.

2.3

2.3.

2.3.

2.4.

2.5.

2.5.

2.5.

2.6.

2.7.

2.8.

Number of notifications of technical rules from each Member State from 1999 to
2001............................................................................................................................ 69

Percentages of notifications of technical rules from each Member State from 1999 to
2001............................................................................................................................ 70

Breakdown by sector of drafts notified by the Member States of the European Union
(1999) ......................................................................................................................... 71

Breakdown by sector of drafts notified by the Member States of the European Union
(2000) ......................................................................................................................... 72

Breakdown by sector of drafts notified by the Member States of the European Union
(2001) ......................................................................................................................... 73

Number of notifications compared with number of times emergency procedure
invoked by sector between 1999 and 2000 ................................................................ 74

Comparison between notifications and reactions by sector (only detailed opinions
and comments) - 1999................................................................................................ 75

Comparison between notifications and reactions by sector (only detailed opinions
and comments) - 2000................................................................................................ 76

Comparison between notifications and reactions by sector (only detailed opinions
and comments) - 2001................................................................................................ 77

Follow-up to the detailed opinions delivered by the Commission (only finalised
procedures) on notifications in 1999 and 2000 .......................................................... 78

Breakdown by sector of drafts notified by Iceland, Norway and Switzerland between
1999 and 2001............................................................................................................ 79

Comments on drafts notified by Iceland, Norway and Switzerland in the 1999-2001
period ......................................................................................................................... 80

8

Introduction

1.

GENERAL OVERVIEW

The purpose of this report on the application of Directive 98/34/EC1 from 1999 to 2001 is to
inform  the  European  Parliament,  the  Council  and  the  Economic  and  Social  Committee,  in
accordance with Article 11 of the Directive.

It  is  divided  into  three  parts:  the  information  procedure  for  standards,  the  notification
procedure  for  technical  regulations  and  finally,  the  annexes  referring  to  standards  and
technical regulations.

The  report  provides  an  assessment  of  the  role  of  Directive  98/34/EC  during  the  period  in
question. It is intended to raise awareness of these procedures set up by the Directive and to
encourage businesses to make even more use of it.

2.

STANDARDS

The  procedure,  in  the  field  of  standards,  is  designed  to  monitor  the  new  standardisation
activities  introduced  by  the  national  standardisation  bodies  (as  recognised  under  Directive
98/34/EC). 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.

Despite the fact that only limited use is made of any of these systems, it should be stressed
that the very existence of the procedure has constrained national initiatives and to some extent
changed  the  approach  of  the  national  standardisation  bodies.  Human  resources  are
increasingly being concentrated on European work rather than national activities.

This report provides a brief description of the procedure in the field of standards, provides an
assessment and proposes improvements.

3.

TECHNICAL REGULATIONS

By setting up a notification procedure for national technical  regulations, Directive 98/34/EC
has created a genuine observatory for the internal market, since it allows the Commission, the
Member States and economic operators  to  find  out  about  the  regulatory  initiatives  taken  by
Member  States.  The  Directive  is  also  in  line  with  the  efforts  of  the  Council,  the  Member
States  and  the  Commission  to  improve  the  quality  of  legislation  at  both  Community  and
national  levels.  The  Directive  has  therefore  made  a  tangible  contribution  to  improving
national  law-making.  Prior  analysis  of  draft  national  rules  and  regulations  prevents  many
barriers to trade before they can have a negative effect. Likewise they allow the Commission
to identify the areas where there is a real need for harmonisation.

1

Directive  98/34/EC  of  the  European  Parliament  and  of  the  Council  of  22  June  1998,  amended  by
Directive 98/48/EEC 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. In this
report,  the  references  to  the  provisions  of  Directive  98/34/EC  refer  to  the  version  of  the  Directive  as
amended by Directive 98/48/EC.

9

                                                
Looking to the future, the notification procedure could be extended both as regards substance
and  geographical  coverage.  As  regards  substance,  account  could  be  taken  of  services  other
than those relating to the information society because services play an increasingly important
role in our economies. As for geographical coverage, the enlargement of the European Union
requires this to be increased.

This  report  provides  a  brief  description  of  the  procedure  in  the  field  of  technical  rules,  the
information  exchanged,  the  reactions  of  the  Commission  and  the  Member  States.  It  also
includes the results achieved, infringements of Directive 98/34/EC and case law in this area,
the measures taken to improve the functioning of the procedure and, finally, its application at
international level.

10

Part I: Information procedure for standards

1.

INTRODUCTION

This section reports on the information procedure for standards established by Articles 2 to 7
of  Directive  98/34/EC.  These  provide  for  the  national  standardisation  bodies  to  notify  the
Commission,  the  European  standardisation  bodies  and  the  other  national  standardisation
bodies of any new subjects for which they have decided to prepare or amend a standard. After
a brief description of the procedure, this section explains how it worked from 1999 to  2001
and analyses the statistics.  It also discusses  the quality of  the  notifications,  the use made of
them,  and  the  mandates  given  to  the  European  standardisation  bodies,  i.e.  the  European
Committee  for  Standardisation  (CEN),  the  European  Committee  for  Electrotechnical
Standardisation  (CENELEC)  and  the  European  Telecommunications  Standards  Institute
(ETSI). This section ends with details of improvements which have been or could be made.

2.

BRIEF DESCRIPTION OF THE PROCEDURE

2.1.

Role of CEN and CENELEC

The  information  procedure  for  standards  began  in  practice  on  1  January  1985.  Since  the
adoption  of  Directive  94/10/EC2,  amending  Directive  83/189/EEC3,  the  notification
obligation concerns only new standardisation activities. It no longer applies to other updates
to the national standardisation programmes, namely drafts for public enquiry or the adoption
of national standards.

The national  standardisation bodies, which are members of  CEN  and  CENELEC  (including
bodies  from  the  EFTA  countries),  send  the  necessary  information  to  the  CEN  Management
Centre  (CEN/CMC,  previously  known  as  the  CEN  Central  Secretariat)  and  the  Central
Secretariat  of  CENELEC.  The  information  gathered  is  sent  periodically  to  the  Commission
and  to  all  members  of  CEN  and  CENELEC,  who  are  responsible  for  distributing  it  to  the
sectors concerned in order to sound out their reactions. The information is also examined by
the relevant authorities within CEN and CENELEC (CEN/CMC and the Central Secretariat of
CENELEC, Technical Boards, etc.) and by the Commission departments.

Appropriate annual contracts were signed between the European  Commission  and  CEN and
CENELEC for the technical operation of the information procedure for standards.

2.2.

Role of ETSI

The European Telecommunications Standards Institute (ETSI) automatically takes part in the
information procedure for standards. In practice, however, its role is limited to receiving and
examining the information submitted by CEN and CENELEC members via the secretariats of
these two bodies. In fact, ETSI is not made up of national standardisation bodies, as defined

2

3

Directive 94/10/EC of the European Parliament and the Council of 23 March 1994 materially amending
for the second time Directive 83/189/EEC laying down a procedure for the provision of information in
the field of technical standards and regulations, OJ L 100 of 10.02.1996.
Council  Directive  83/189/EEC  of  28  March  1983  laying  down  a  procedure  for  the  provision  of
information in the field of technical standards and regulations OJ L 109 of 26.04.1983.

11

                                                
in  Article  1  of  Directive  98/34/EC.  Information  on  draft  national  technical  specifications  in
the  field  of  telecommunications  is  channelled,  in  principle,  either  via  the  information
procedure  for  technical  regulations  in  the  case  of  legislation,  or  via  CEN  and  CENELEC
members  in  the  case  of  voluntary  measures.  As  mentioned  in  the  previous  report,  it  can  be
assumed that national standardisation activities in the field of telecommunications should be
limited, since the ETSI programmes cover a wide range of subjects, all of which are covered
by the internal standstill rule.

In  practice,  this  section  of  the  report  therefore  focuses  solely  on  activities  notified  by  CEN
and CENELEC members listed in Annex II to Directive 98/34/EC.

3.

3.1

OPERATION OF THE INFORMATION PROCEDURE FROM 1999 TO 2001

Handling of notifications

As stated in the  previous report, CEN already  started  using  a  simplified  procedure  in  1993.
This is the procedure provided for in the proposal made by the Commission in 1992, on which
Directive 94/10/EC was based. This simplification has enabled the CEN Management Centre
to  exert  closer  control  over  the  flow  of  information  and  to  examine  the  presentation  and
content  of  certain  notifications  in  greater  detail.  It  has  also  made  it  possible  to  obtain  full,
realistic statistics on new activities.

Since the beginning of 1993 the full texts of draft standards have been exchanged for public
enquiry on a case by case basis and by mutual agreement between the bodies concerned. This
is in the spirit of the participation provided for by Article 3 of Directive 98/34/EC.

CENELEC  has  been  concentrating  on  its  internal  procedure,  known  as  the  "Vilamoura"
procedure, followed, where appropriate, by the information procedure laid down by Directive
98/34/EC.  The  Vilamoura  procedure  requires  each  CENELEC  member  to  notify  every
standardisation  activity  wanted  and/or  planned  as  early  as  possible,  even  at  a  preliminary
stage.  A  reaction  within  three  months  from  just  one  other  member  is  enough  to  activate  a
standstill period, which only the highest technical authority within CENELEC (the Technical
Board) can lift. Only if this authority finds it inappropriate to work at European level will it
authorise the notified activity at national level, which then becomes a national initiative under
the terms of Directive 98/34/EC.  Notifications  of  these  initiatives are  then  distributed  every
quarter to the larger circle of participants named in Directive 98/34/EC.

However, it is regrettable that the information from the Vilamoura procedure is not released
outside, as is the case in the procedure introduced by the Directive, but is circulated mainly
among  CENELEC  members.  Compilation  of  all  the  notifications  in  a  single  register  would
improve transparency and is, therefore, one possibility to explore.

3.2

Statistics

The  statistics  published  in  CEN  and  CENELEC  annual  reports  supply  an  overview  of  the
standardisation activities notified from 1999 to 2001.

As a result of CENELEC's Vilamoura procedure, and the fact that CENELEC covers only the
electrotechnical  sector,  the  number  of  notifications  from  its  members  under  Directive
98/34/EC has remained fairly low. The statistics in this report are therefore principally for the
activities of CEN members.

12

The  statistics  on  new  work  reflect  the  latest  trends  in  standardisation  activities.  These
statistics can be examined from three complementary angles:

– 

– 

– 

breakdown  by  level  (national,  European  or  international)  and  activity  trends  at  each
level;

breakdown by country;

breakdown by sector and sub-sector.

As indicated in previous reports, the statistics must be interpreted with some caution for the
following reasons:

– 

– 

a  new  activity  launched  at  European  level  might  cover  a  much  wider  field  than  an
activity at national level;

because  of  different  working  methods  not  all  CEN  and  CENELEC  members  notify
new standardisation work at the same stage.

3.3

Trends in new standardisation activities

Bearing  these  reservations  in  mind,  a  number  of  comments  can  be  made  on  the  trends  in
international,  European  and  national  standardisation  based  on  the  tables  in  Annexes  1.1  to
1.10 of this report.

– 

– 

– 

– 

– 

– 

The total number of new initiatives launched for all of these three levels has stabilised
since  1999  at  around  3  815  units  compared  with  the  average  of  4  664  units  for  the
1995-1998 period covered by the previous report.

At national level, the number of new initiatives averaged 1 400 per year from 1999 to
2001,  down  from  1  620  per  year  in  the  1995-1998  period.  The  proportion  of  very
specific  work  within  this  number  held  steady  at  around  98%.  On  average,  30%  of
notifications were declared as revisions or amendments to existing national standards.

The  number  of  new  initiatives  at  European  level  fell  considerably  from  1998
compared with the previous two years. It averaged at 1 587 per year in the 1999-2001
period, whereas in the 1995-1998 period the average was 1 922 per year.

At  international  level,  the  downward  trend  is  also  continuing:  an  average  of
828 initiatives  per  year  for  the  years  1999/2001  compared  with  1.122  for  the  years
1995/1998.

Tables 1.5 to 1.7 (see annexes) show  that on  average  30% of new national  activities
were  in  Germany.  There  was  also  a  relatively  high  number  of  new  initiatives  in
Austria.

The  top  ten  sub-sectors  for  national  activities  are  shown  in  tables  1.8  to  1.10.
Foodstuffs remained the leading sector  for new national standardisation initiatives in
each financial  year. The Commission is of the opinion that European standardisation
should  be  increased  in  this  field.  National  activities  remain  important  in  the
construction sector. Given that there are several standardisation mandates in this field
for European initiatives, application of the standstill rule is debatable.

13

4.

4.1

QUALITY OF THE NOTIFICATIONS FROM THE NATIONAL STANDARDISATION BODIES

CEN

In  its  previous  reports  the  Commission  indicated  that  there  were  still  problems  with
notification deadlines and the intrinsic quality of the information supplied. The Commission
insisted on several occasions that further effort should be made at national and European level
to  remedy  this  situation.  Since  1995  such  efforts  have  been  made  systematically,  bringing
with them an improvement in the quality of notifications. This progress, which has not always
been  easy,  is  the  fruit  of  constant  efforts  by  the  CEN  Central  Secretariat  and  its  national
correspondents.

First, in 1995 the CEN Central Secretariat clearly defined the internal rules necessary to keep
notifications accurate, clear and reliable in a user's guide for its members. This also explained
how one member could participate in another member's activities. Other measures followed,
particularly in the 1995-1998 period, such as the creation of a help desk in the CEN central
unit  to  provide  help  on  any  issue  regarding  the  units  of  CEN  members  responsible  for
notifying new subjects.

Despite these measures, around 22% of notifications were still submitted late in 1999. In 2000
and 2001 this figure improved (falling to 16% and 15% respectively). However, for this group
of  late  notifications,  there  was  a  reduction  in  the  possibilities  of  intervention  by  the  parties
concerned.  For  example,  in  2001,  around  one  third  of  late  notifications  were  not
communicated until the end of the public scrutiny stage. Further efforts are essential to avoid
jeopardising  the  principles  of  the  information  procedure  laid  down  in  the  Directive.  In
particular, late notification can hinder direct participation in the work of other standardisation
bodies and the submission of comments at an early stage.

Precise descriptions of drafts are also lacking. In 1998 some 31%  of notifications  contained
no description other than the title. In the 1999-2001 period this had increased to an average of
36%. These were principally notifications from Austria, France and the United Kingdom. The
number of other quality-related problems found first fell in 1999 and 2000 (88 and 66 cases
reported respectively) then rose considerably in 2001 (136 cases). The inaccuracy of the data
mainly consisted of wrong classification of the sector/sub-sector of activity.

4.2

CENELEC

No detailed analysis similar to the analysis by the CEN Central Secretariat is available from
CENELEC.  However,  bearing  in  mind  the  internal  Vilamoura  procedure,  with  its  relatively
strict  rules  on  notification,  the  quality  of  notifications  from  CENELEC  members  can  be
considered good.

5.

5.1

USE OF THE INFORMATION RECEIVED THROUGH THE PROCEDURE

Dissemination of information

The Commission does not have accurate, up-to-date information on the national dissemination
of information on notifications, despite the reminders it gave to CEN members on 17 January
2002  and  13  June  2002  at  the  meetings  of  the  enlarged  Committee  set  up  by  Directive
98/34/EC.  Consequently  the  only  conclusions  that  can  be  drawn  are  those  of  the  survey
launched  by  the  CEN  Management  Centre  in  1995.  It  emerged  that  in  Denmark  a  fee  is
charged for subscribing to the monthly register and that notifications are examined mainly by

14

the standardisation body. In Germany, as the German standards institution (DIN) confirmed in
January 2002, the information is circulated to 60 or so relevant trade associations which are
responsible  for  disseminating  it  to  their  members.  In  France,  systematic  dissemination  of
information  and  broad  consultation  of  industry  are  the  main  features.  The  Italian
standardisation body disseminates the data to its industries and affiliates. Its technical staff are
also  kept  informed  of  the  activities  notified  sector  by  sector.  In  Portugal  the  information  is
passed  on  to  members  of  the  standardisation  organisation,  but  in  Sweden  and  the  United
Kingdom there seems to be only marginal interest in the information.

5.2

Application of Article 4 of Directive 98/34/EC

As  was  also  highlighted  in  previous  reports,  application  of  Article  4  of  the  Directive,  i.e.
involvement  in  national  activities  and  requests  to  draw  up  European  standards,  remains
marginal. The table in Annex 1.11 confirms these observations:

– 

– 

– 

the  number  of  comments  made  by  the  standardisation  bodies  remains  very  low  in
comparison with the number of notifications received;

requests to participate in other members' activities even seem to be decreasing;

requests  to  draw  up  European  standards  are  non-existent  apart  from  three  cases  in
1999  and  two  requests  in  2000.  It  is  not  clear  precisely  how  these  requests  were
followed up.

It can therefore once again be  concluded  from these statistics that the mechanisms provided
by Article 4 of the Directive in practice are not being used.

In  the  electrotechnical  sector,  allowance  should  be  made  for  application  of  the  Vilamoura
procedure.  This  provides  for  at  least  the  same  type  of  participation  in  each  new  initiative
launched  by  a  member  as  allowed  by  Article  4  of  Directive  98/34/EC.  This  procedure  was
used in the case of 40 and 35 notifications in 1999 and 2000 respectively. Of these, 17 and 6
initiatives respectively were transferred to European level, while 20 and 27 were developed at
national  level  with  the  participation  of  one  or  more  other  countries.  In  2001  just  18
notifications were made under this procedure, 7 of which were taken up at European level.

5.3

Application of Article 7 of Directive 98/34/EC

Application  of  the  standstill  rule  in  Article  7  of  Directive  98/34/EC  was  monitored  at  two
levels, by CEN/CENELEC and by the Commission.

At the  CEN Management Centre, some  notifications are periodically examined by technical
experts. No statistics are available on the number of cases handled, but it could be useful to
submit them to the Commission.

The Commission departments continued to examine the notifications received. This was both
to  monitor  the  standstill  in  cases  where  mandates  had  been  given  to  the  European
standardisation bodies and to examine whether it would be appropriate to transfer the notified
activity  to  European  level.  The  Commission  queried  29  notifications,  which  concerned  the
fields of construction, machines and personal protective equipment.

15

5.4

Conclusions regarding the use of information

To close this section on the use made of the information received, two remarks can be made:

– 

– 

6.

6.1

The  simplification  of  the  procedure  brought  about  by  Directive  94/10/EC  has,  since
1998,  created  the  conditions  required  for  more  efficient  use  of  the  information,  by
considerably  reducing  the  volume  of  data  and  concentrating  on  the  relevant
information.  However,  this  simplification  has  improved  neither  the  dissemination  of
the  information  at  national  level  nor  the  application  of  Article  4.  Use  of  the
information  seems  to  depend,  above  all,  on  the  general  attitude  of  CEN  members  to
the information procedure. For example, France has a policy of active dissemination of
the information gathered;

The Commission reiterates its opinion that further measures are needed to make more
efficient use of the information at national level. Despite the great efforts made by the
CEN Management Centre, systematic, tenacious efforts are still needed, particularly to
improve the notifications at source. Dissemination of the information at national level
could be improved by using advanced technologies and demonstrating the benefits of
this procedure to industry. For example, the notifications could be put on a website, if
possible with unrestricted, free access. There could also be a module on the website to
collect comments or requests for information by the parties concerned. The collection
- and if possible the evaluation of the comments - could be carried out by the national
body of the country of origin of the comments. In this case, the role of coordination at
national level by the CEN members could be maintained.

INFORMATION ON STANDARDISATION ACTIVITIES IN GENERAL

Need for information by all the parties concerned

Information on new national standardisation activities is only part of the mass of information
on standardisation activities. There is also the more general question of information about the
national standards adopted and all standardisation in progress or completed at European  and
international levels.

An effort is still needed to improve information and to take greater account of the interests of
consumers and environmental protection when standards are drawn up.

As  it  has  indicated  on  several  occasions,  the  Commission  considers  it  necessary  to  give  all
sectors  concerned  access  to  appropriate  information  on  standardisation  activities  on
reasonable  terms.  Accessibility  and  transparency  should  be  basic  characteristics  of  the
standardisation  system.  Constant  efforts  should  be  made  at  national  and  European  level  to
meet the information requirements of all interested parties.

6.2

Websites promoted by the Commission

At  the  request  of  the  Commission,  in  1998  the  three  standardisation  bodies  started  the
computer  work  needed  to  establish  a  shared  website.  This  single  gateway  on  the  Internet
should allow all outside users access to information on standardisation activities in progress
or already completed at European level under the "New Approach" Directives.

16

The  shared  site  will  also  provide  easy  access  to  each  of  the  sites  of  the  three  European
standardisation  bodies  and  the  Commission  sites.  The  full  text  of  the  Directives  concerned
and  the  references  of  the  harmonised  standards  implementing  the  Directives  are  already  on
these  sites,  along  with  other 
is:
http://www.NewApproach.org.  The  site  is  a  great  success,  as  the  access  statistics  reveal:
around  9  000  different  people  a  month  visit  the  site  and  about  40  000  pages  a  month  are
consulted.  The  site  giving  the  references  of  the  harmonised  standards  published  in  the  OJ
regarding  the  New  Approach  Directives  is  also  enjoying  great  success.  The  address  is:
http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/index.html

information.  The  address  of 

this  shared  site 

6.3

Information products of European standardisation bodies

The three European standardisation bodies have continued to issue a number of publications
(on  paper  and  in  electronic  format)  explaining  their  present  activities,  describing  standards
adopted  and  listing  national  transpositions.  They  have  also  each  created  their  own  Internet
site, with automatic pointers to their members' sites.

7.

PROGRAMMING AND STANDARDISATION MANDATES

Pursuant  to  Article  6(3)  of  Directive  98/34/EC,  the  Standing  Committee  set  up  under  the
Directive expressed  favourable opinions on 24, 16 and  7  mandates  in  1999,  2000  and  2001
respectively. A large number (27) of these 47 mandates concern the implementation of New
Approach  Directives,  in  particular  Directive  89/106/EEC  relating  to  construction  products.
Various  other  standardisation  mandates  have  also  been  issued  to  support  other  Community
policies (see Annexes 1.12 to 14):

– 

– 

– 

– 

Seven  requests  were  made  for  standardisation  in  the  field  of  consumer  protection
policy.

Six  mandates  concerned  energy  policy  (reduction  of  consumption  and  alternative
sources).

Four  mandates  were  given,  principally  to  CEN,  in  support  of  Directives  on  the
environment.

There  was  also  a  special  mandate  in  2001  concerning  technologies  for  humanitarian
demining.

This  summary  shows  that  the  Commission  is  making  increasing  use  of  standardisation  to
implement the different Community policies. This approach whereby broader use is made of
standardisation in the various Community policies is further confirmed by the Conclusions of
the Council of 1 March 2002 (OJ of 15 March 2002 - paragraph three of the Conclusions).

8.

8.1

ACTION TO IMPROVE THE PROCEDURE

Improvements at European level

In the field of standardisation, Directive 94/10/EC considerably simplified the procedure laid
down  in  Directive  83/189/EEC  (these  texts  were  consolidated  by  Directive  98/34/EC).  This
made  it  possible  to  control  the  volume  of  notifications  and  consequently  process  them  and
examine their quality and content.

17

Several  measures  have  been  taken  by  the  CEN  Management  Centre,  mainly  since  1995,  to
improve the quality of the data notified. These include the establishment of detailed rules, an
awareness-raising  seminar  and  establishment  of  a  central  quality  assurance  system.  CEN's
annual reports systematically examine in detail the quality of the notifications received, thus
allowing  an  extremely  useful  quality  assessment.  It  is  not  known  if  specific  measures  have
been taken at national level to improve quality. However, it must be stressed that the action
taken  by  the  CEN  Management  Centre  would  not  have  borne  fruit  without  the  active
cooperation of CEN members. CENELEC's Vilamoura procedure is quite strict on the quality
of data, however limited the volume.

CEN's analysis of the quality of notifications submitted from 1999 to 2001, together with the
assessment of the use made of the information collected during this period,  show,  however,
that progress on quality  has been relatively  slow.  In particular, a reduction in the quality of
notifications in 2001 shows that great vigilance is required. A strict quality assurance system
must  therefore  be  constantly  applied  and  any  new  action  in  this  field  is  welcome.  Possible
measures,  which  were  already  proposed  in  the  previous  report,  include  more  frequent
reporting  on  the  quality  of  the  data  received.  A  detailed  examination  could  be  made  of  the
problems  most  frequently  encountered  and  those  which  are  of  greatest  importance.  This
should allow targeted action, either by country or according to the nature of the problem, such
as the project description.

8.2

Improvements at national level regarding notifications

At national level, it  is  primarily  a  matter  for  the  Member  States  to  take  measures  to  enable
their national standardisation body to  comply fully with  the obligations  imposed in  the new
rules  laid  down  in  the  Directive  and  with  the  rules  established  within  the  European
standardisation bodies.

The  national  bodies,  in  turn,  should  examine  the  need  to  revise  and  adapt  their  notification
systems, with particular emphasis on quality and timely submission. The analysis once again
confirms persistent weaknesses on this point.

8.3

Improvement at national level regarding the dissemination of information

With regard to the use made of the information, the current dissemination system still needs to
be reviewed. The introduction  of new  technologies  based  on  websites  both  for  notifications
and  for  disseminating  the  consolidated  information  must  be  envisaged  to  facilitate
communication and make the information more attractive. The Commission also recommends
that the information on new activities of CENELEC members should form an integral part of
CEN information.  This does not require the  two  systems to be  integrated  or  the  CENELEC
procedure to be adapted, but it will provide a full overview for potential users and make the
CENELEC procedure more transparent for outsiders.

Revision of CEN's current dissemination system should also generate renewed interest on the
part of all the sectors interested in the information from the standards procedure. European or
national awareness-raising measures for these sectors could also be envisaged.

9.

CONCLUSIONS AND PROSPECTS

The reduction in the number of new national standardisation activities has continued. The first
reason for this was the simplified procedure introduced years ago, which requires only strictly
new national activities to be notified. The second reason for this reduction was an actual fall

18

in  new  national  initiatives.  However,  the  level  of  such  activity  is  still  high,  above  all  in
Germany. Over the report period, an average of 1 400 national initiatives per year were started
compared with 1 587 at European level. For all the CEN members, the fields where there is
still  a  high  level  of  national  standardisation  are  foodstuffs,  construction  products  and
aeronautics.

The various measures taken by the  CEN Management  Centre, in  close cooperation  with  the
national  standardisation  bodies,  have  improved  the  quality  of  notifications,  but  less  than
expected. Constant efforts and resources are needed to ensure data quality.  This  quality  is a
sine  qua  non  for  better  use  of  the  information  and  can  be  promoted  by  applying  new
technologies  to  improve  communications  and  the  presentation  of  the  information  collected.
Targeted measures regarding quality assurance would also be appropriate.

Use  of  the  information  gathered  under  Article  4  of  Directive  98/34/EC  remains  marginal,
particularly  participation  in  national  activities  and  requests  to  transfer  activities  to  the
European level. Moreover, the resources applied for using this procedure in order to verify the
standstill  declared  when  a  (European)  standardisation  mandate  is  issued  seem  insufficient.
The  information  procedure  for  standards  is  not,  therefore,  proving  to  be  directly  efficient.
Furthermore, the last questionnaire on this subject showed that only a few countries actively
disseminate  the  information.  General  dissemination  in  user-friendly  form  is  needed.
Combined  with  a  system  for  collecting  comments  and  requests,  this  should  increase  the
effectiveness of the procedure in the field of standards.

It  would  also  be  useful  to  examine  the  value  and  direct  and  indirect  usefulness  of  this
procedure for the different players on the market. It is first up to all the parties concerned to
consider these aspects and make an assessment. However, it should be noted that it is highly
likely that the absence of the mechanism for monitoring national activities could again create
the danger of disruption on the internal market. On this basis, this procedure must certainly be
continued,  but  greater  resources  need  to  be  allocated  to  it  to  strengthen  it  at  European  and
national levels in order to increase its effectiveness.

One  further  question  that  could  be  asked  concerns  the  legal  framework.  European
standardisation has developed considerably since the procedure was set up in 1983. There has
been  a  massive  movement  of  expert  resources  from  national  to  European  level  since  then.
European standardisation  now covers a  wide variety  of  fields  which  were previously  within
the scope of national standards. It may also be assumed that standardisers now automatically
check  whether  their  national  standardisation  intentions  should  be  submitted  directly  at
European  or  even  international  level.  It  would  therefore  be  useful  to  consider  reducing  the
legal  framework  of  the  information  procedure  for  standards  when  Directive  98/34/EC  is
revised.

19

Part II : The information procedure for technical regulations

1.

INTRODUCTION

The  following  pages  describe  how  the  information  procedure  established  by  Directive
98/34/EC  for  technical  regulations  has  developed.  This  system,  which  was  set  up  in  1983
under Directive 83/189/EEC, has maintained all its originality. It prevents the creation of new
barriers to trade within the internal market and emphasises transparency, dialogue, preventive
measures and mutual control.

Since  5  August  1999,  the  procedure  set  up  by  Directive  98/34/EC  has  been  extended  to
information society services4. In future, the Directive will play an even greater role with the
enlargement  of  the  European  Union.  In  this  respect,  the  Directive  could  prove  a  decisive
instrument for ensuring that enlarged internal market operates smoothly.

2.

BRIEF DESCRIPTION OF THE PROCEDURE

The  following  description  of  the  98/34/EC  procedure  is  divided  in  two  parts.  The  first
provides  a  general  presentation  of  the  procedure  in  the  field  of  products,  while  the  second
describes  the  specific  details  of  the  rules  on  information  society  services;  the  procedure  for
this sector differs slightly from that applicable to products.

2.1.

General presentation of procedure 98/34/EC in the field of products

Pursuant  to  Article  8(1)  of  Directive  98/34/EC,  the  Member  States  are  required  to
communicate to the Commission any draft technical regulation.

The notifying Member State may not adopt the technical regulation for three months from the
date  of  notification  of  the  draft  to  the  Commission.  This  standstill  period  allows  the  other
Member States and the Commission to examine the notified draft and to react appropriately.
The  outcome  of  this  consultation  procedure  between  the  notifying  Member  State,  the  other
Member States and the Commission determines the fate of the draft technical rule.

The following cases may arise:

– 

– 

4

The Member States and/or the Commission do not wish to give a reaction. In this case,
the notifying Member State can adopt the draft regulation as soon as the three-month
standstill period has elapsed.

If  another  Member  State  and/or  the  Commission  makes  comments  pursuant  to
Article 8(2)  of  the  Directive,  the  notifying  Member  State  must  take  such  comments
into  account  as  far  as  possible  in  the  subsequent  preparation  of  the  technical
regulation.

It  was  extended  under  Directive  98/48/EC  of  the  European  Parliament  and  of  the  Council  of  20  July
1998 amending Directive 98/34/EEC laying down a procedure for the provision of information in the
field of technical standards and regulations, OJ L 217 of 05.08.1998.

20

                                                
– 

– 

Where  a  Member  State  and/or  the  Commission  considers  that  the  draft  measure
envisaged  may  create  obstacles  to  the  free  movement  of  goods,  it  may  deliver  a
detailed  opinion  as  provided  for  in  Article  9(2)  of  the  Directive.  In  this  case,  the
Member  State  concerned  must  postpone  the  adoption  of  the  measure  for  six  months
from the date of notification and must inform the Commission of the action it proposes
to take in response to the detailed opinion.

Where  the  Commission  announces  its  intention  to  propose  or  adopt  a  binding
Community act in the field concerned by the notified draft, or where it finds that the
notified  draft  concerns  a  matter  which  is  covered  by  a  proposal  for  a  binding
Community act presented to the Council, Article 9(3) and (4) of the Directive requires
the notifying Member State to postpone the adoption of the technical rule for twelve
months from the date of its communication. Article 9(5) of the Directive provides for
this  standstill  period  to  be  extended  to  eighteen  months  if  the  Council  adopts  a
common  position  during  that  twelve-month  period.  Such  extended  standstill  periods
automatically lapse if the Commission withdraws its proposal or decides not to make a
proposal, or when the Community act has been adopted.

Article 9(7)  of  the Directive  allows  national  measures  to  be  adopted  immediately  in  certain
urgent cases. If a Member State wishes to adopt a technical rule for urgent reasons occasioned
by  serious  and  unforeseeable  circumstances  relating  to  the  protection  of  public  health  or
safety, the protection of animals or the preservation of plants, it can ask for this procedure to
apply and is not required to observe the standstill requirement. The notification must state the
reasons  which  warrant  the  urgency  of  the  measures  taken,  and  the  Commission  then  rules
whether application of the emergency procedure is justified.

Article 8(3)  provides that the definitive text  of  the  regulation  must  be  communicated  to  the
Commission without delay.

The Commission plays a decisive role in the procedure. It is responsible for distributing to the
Member States not only the notified drafts but also the other messages circulating between the
Commission  and  the  Member  States  or  among  the  Member  States.  It  also  provides
translations of these texts in order to facilitate the smooth operation of the procedure.

The Standing Committee of representatives of the Member States (set up by Article 5 of the
Directive) is an advisory body which meets about four times a year. It plays an important part
in supervising the procedure and examining the various issues arising from the notifications.

2.2.

Specific features of the procedure for the information society services sector

Directive 98/48/EC, which has been  applicable since 5  August 1999,  substantially  extended
the scope of Directive 98/34/EC. Given the rapid development of information society services
and  the  national  regulatory  activity  accompanying  this  development,  it  has  been  considered
appropriate to also introduce a notification system for this type of service5

.

5

For further information on the application of the notification procedure to information society services,
see the recent Commission report entitled "Evaluation of the application of Directive 98/34/EC in the
field  of  information  society  services"  COM(2003) 69  final  of  13.2.2003,  and  the  Vade  mecum  to
Directive 98/48/EC (http://europa.eu.int/comm/enterprise/tris/vade9848/index_en.pdf).

21

                                                
Field of Application

According  to  Article  1(2)  of  Directive  98/34/EC  (as  amended  by  Directive  98/48/EC)  the
services  concerned  are  "any  service  normally  provided  for  remuneration,  at  a  distance,  by
electronic means and at the individual request of a recipient of services". Consequently radio
broadcasting  services  and  the  television  broadcasting  services  referred  to  in  Article  1a)  of
Directive 89/552/EEC on the pursuit of television broadcasting services are excluded from the
field of application because they are  not  provided at the individual request of  a  recipient  of
services.

There  are  certain  exceptions  to  this  field  of  application  (Article  1(2)  and  (5)  of  Directive
98/34/EC).  The  Directive  does  not  apply  to  rules  on  matters  covered  by  Community
legislation  on  telecommunications  services,  as  defined  by  Directive  90/387/EEC  on  the
establishment  of 
the
implementation of open network provision, or to the rules on matters covered by Community
legislation on financial services. Finally, the rules on regulated markets, within the meaning
of Directive 93/22/EEC on investment services in the securities field, are excluded from the
notification  obligation  (for  this  sector  all  that  remains  is  the  obligation  to  communicate  the
texts adopted).

telecommunications  services 

internal  market  for 

through 

the 

It should therefore be borne in mind that telecommunications services and financial services
are  not,  as  such,  excluded  from  the  field  of  application  of  Directive  98/34/EC.  Some
exceptions have simply been provided for in the terms laid down because in these two fields,
a large number of matters are being harmonised and fall within a regulatory framework which
is already sufficiently  well-defined at Community level. The  exclusion of regulated markets
lies in the need to adopt without delay regulatory instruments which deal with on-line services
relating  to  highly  mobile  and  very  fluid  financial  markets,  where  situations  may  change
suddenly and unpredictably.

Article  1(5)  of  Directive  98/34/EC  defines  rules  on  services  as  "a  requirement  of  a  general
nature relating to the taking-up and pursuit of service activities within the meaning of point 2
[information  society  services],  in  particular  provisions  concerning  the  service  provider,  the
services and the recipient of services, excluding any rules which are not specifically aimed at
the services defined in that point".

The  concept  of  a  "requirement  of  a  general  nature"  therefore  implies  the  exclusion  of
measures which, instead of laying down abstract and general requirements, are of direct and
individual concern to certain specific recipients, such as administrative or judicial decisions in
individual cases (e.g. the granting of licences to one or more specific operators).

A rule is not "specifically" aimed at the services concerned when it "affects such services only
in an implicit or incidental manner" (second indent, fifth subparagraph of Article 1(5)). The
Directive  therefore  requires  notification  of  regulatory  drafts  which,  given  their  grounds,
content  and  purpose,  directly  and  openly  concern,  entirely  or  in  part,  information  society
services.  It  is  therefore  not  only  regulatory  texts  which  as  a  whole  deal  with  information
society services that are covered, but also regulations of which only a part (an article or even a
paragraph) deals with an information society service (see second indent, fifth subparagraph of
Article 1(5). As is the case for technical rules, rules on de facto compulsory services are to be
notified.

22

The  following  are  examples  of  measures  likely  to  constitute  rules  on  information  society
services:

– 

– 

– 

– 

– 

– 

measures concerning the conditions of access to an on-line activity;

measures concerning the conditions for exercising an on-line activity;

measures concerning the provider of on-line services;

measures concerning the provision of on-line services;

measures concerning the receiver of on-line services;

measures  concerning  de  facto  mandatory  services  (e.g.  a  rule  referring  to  non-
regulatory texts or a  professional code of practice for  the  supply  of  services  on  line,
compliance with which confers a presumption of conformity; a voluntary agreement to
which  a  public  authority  is  a  contracting  party  and  the  aim  of  which  is  compliance
with the rules on services; etc.).

Rules of procedure

The rules of procedure applicable to draft rules on information society services broadly follow
those applicable to draft rules on products. However, there are certain differences:

– 

– 

– 

First,  as  regards  detailed  opinions  (Article  9  (2)),  these  may  be  issued  if  the
Commission  or  a  Member  State  consider  that  the  draft  "may  create  obstacles  to  the
free  movement  of  services  or  to  the  freedom  of  establishment  of  service  operators
within  the  internal  market".  In  the  case  of  rules  on  products,  the  Member  State
concerned  must  postpone  the  adoption  of  its project  for  six  months  from  the  date  of
communication. In the case of rules on services, this is reduced to four months.

Secondly,  although  in  the  product  sector  Member  States  are  obliged  to  postpone  the
adoption  of  a  draft  technical  regulation  for  twelve  months  if  the  Commission
announces its intention to propose or adopt a binding Community act or if it finds that
the  draft  concerns  a  matter  which  is  covered  by  a  proposal  for  a  Community  act
presented to the Council (Article 9(3) and (4)), in the case of regulations on services, a
standstill  period  of  twelve  months  is  possible  only  in  the  second  scenario
(Article 9(4)). Furthermore, the standstill period is possible only if the notified project
contains provisions which do not comply with the Commission's proposal  (recital 23
of Directive 98/48/EC).

Thirdly,  the  emergency  procedure  (Article  9  (7))  may  be  applied  for  regulations  on
information society  services,  not only  "for  urgent  reasons  occasioned  by  serious  and
unforeseeable  circumstances  relating  to  the  protection  of  public  health  or  safety,  the
protection of animals or the preservation of plants" (the same circumstances as those
already  laid  down  for  products),  but  also  "for  urgent  reasons  occasioned  by  serious
and unforeseeable circumstances relating to […] public policy, notably the protection
of  minors".  Finally,  the  urgency  clause  for  information  society  services  may  also  be
invoked  for  regulations  on  financial  services,  "for  urgent  reasons  occasioned  by
serious circumstances relating to the protection of the security and the integrity of the
financial system, notably the protection of depositors, investors and insured persons."

23

3.

STATISTICAL OVERVIEW

The  following  chapter  provides  a  statistical  overview  of  the  trends  in  the  number  of
notifications  received  and  their  breakdown  by  Member  State  and  sector.  Data  will  also  be
presented on the different types of reaction (i.e. comments, detailed opinions and “blocking”).
One  final  point  will  deal  with  the  use  of  the  urgency  procedure  provided  for  in  Directive
98/34/EC.

3.1.

Volume of notifications

The table in Annex 2.1 shows that the Commission received 591 draft technical regulations in
1999, 751 in 2000 and 530 in 2001. The general trend in the number of notifications received
each year by the Commission is upward from 1999 to 2000 (+24.3%). However, in 2001 the
number  dropped  mainly  as  a  result  of  the  considerable  reduction  in  the  number  of  drafts
notified in the telecommunications sector (from 186 in 2000 to 47 in 2001). This was because
the Member States had already notified a large number of radio interfaces in 2000, following
the  entry  into  force  of  Directive  99/5/EC  on  radio  equipment  and  telecommunications
terminal equipment.6

Generally speaking, a spate of "re-regulation" is apparent in the Member States, mainly as a
result of technological  advances and the desire to  increase  controls  in  the field of health, in
particular regarding foodstuffs (in dubio pro dubio).

3.2.

Breakdown by country

Figure 1 (and  Table  2.2  in the  Annex) shows that from 1999 to 2001 most draft rules  were
notified by the Netherlands and Austria. In 2000, there was a marked increase in the number
of  notifications  from  Denmark  and  the  United  Kingdom  (Denmark:  43  in  1999  and  114  in
2000;  UK  49  in  1999  and  95  in  2000).  The  increase  in  the  number  of  notifications  by
Denmark and the United Kingdom that year is mainly due to the increase in notifications in
the  telecommunications  and  transport  sectors.  In  2001,  however,  the  statistics  are  more
similar again to those of 1999: the Netherlands  returns to  first place  (with 98 notifications),
while  France  and  Germany  remain  among  the  four  countries  which  notify  the  most  drafts
(with 55 and 50 notifications respectively). One trend has continued since 1999, namely the
large number of notifications sent by Austria (69 in 1999, 138 in 2000 and 75 in 2001).

6

These  interfaces  should  be  notified  to  the  Commission  under  Article  4  of  Directive  99/5/EC  of  the
European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications
terminal equipment and the mutual recognition of their conformity, OJ L 91 of 7.04.1999.

24

                                                
Figure 1

Notifications by Member State

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3.3

Breakdown by sector

A breakdown by sector (see Figure 2 and the three tables in Annex 2.37) shows that, as in the
1995-98 period, most notifications received between 1999 and 2001 concerned the following
five  sectors:  agricultural  products  and  foodstuffs  (18.9%),  telecommunications  (15.9%),
transport  (15.2%),  building  and  construction  (14.7%),  and  mechanical  engineering  (6.7%).
However,  for  the  first  time  since  1992,  these  five  sectors  account  for  under  75%  of  total
notifications,  mainly  because  of  the  growing  importance  of  the  environment  (5.9%  of  total
notifications between 1999 and 2001).

7

In these figures and tables, the health/medical equipment sector essentially covers medical devices.

25

 
                                                
Figure 2

Notifications by the Member States by sector 1999-2001

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Although,  in  percentage  terms,  the  agricultural  products  and  foodstuffs  sector  varied  in  the
1999-2001  period  (from  21.1%  in  1999  to  16.9%  in  2000,  then  back  to  19.1%  in  2001)  it
remained  at  a  high  level  in  terms  of  the  total  number  of  notifications  (125,  127  and  108
notifications  in  1999,  2000  and  2001  respectively)  and  even  took  the  lead  in  2001.  After
dropping  back  between  1996  and  1998,  telecommunications  grew  considerably,  taking  the
lead in 2000; it then fell back again in 2001. The  transport sector remained  stable  at a high
level.  The  building  and  construction  sector  rose  considerably  in  percentage  terms  (12.3%,
14.5% and 18.7% in 1999, 2000 and 2001 respectively). Mechanical engineering however fell
sharply (from 10.3% in 1999 to 4.4% in 2001), following a short upturn in 1998 (17%).

26

 
 
 
 
 
 
 
 
 
 
This  confirms  that  in  the  1999-2001  period,  the  Member  States  mainly  legislated  to  take
account  of  technological  advances  and  to  increase  controls  in  the  foodstuffs  sector.  Safety
needs have also been apparent in the transport sector.

Alongside  the  technological  progress,  the  procedure  has  been  started  in  the  information
society  services  sector:  23  drafts  were  notified  in  this  field  in  2000  and  25  in  20018.  They
covered  complex  subjects  such  as  electronic  signatures,  the  combating  of  computer-related
crime, electronic commerce, the protection of minors in communications and domain names.
These are sectors in which technological and legal advances fully justify the introduction of
an  effective  prior  information  mechanism,  administrative  partnership  and  monitoring,
particularly with a view to ensuring fundamental freedoms and rights.

3.4.

Breakdown by reaction

As  a  general  rule  there  was  a  reduction  in  the  percentage  of  notifications  that  provoked  a
reaction on the part of the Commission. The reactions were in the form of comments, detailed
opinions  or  announcements  of  intention  to  propose,  adopt  or  present  a  Community  act  (see
Figure 3). A notification quite often caused a combination of reactions by the Commission.

Figure 3

3 00

2 50

2 00

1 50

1 00

50

0

Key

8.2 :

9.2 :

Numbe r of reactions by type 1999-2001

199 9

200 0

200 1

8 .2 MS

8 .2 EC

9 .2 MS

9 .2 EC

9.3

9.4

comments

detailed opinion

9.3 + 9.4: blocking

8

It is difficult to compare with 1999, since Directive 98/48/EC,  which extended Directive 98/34/EC to
information society services did not apply until 5 August 1999.

27

                                                
For the 1995, 1996, 1997 and 1998 period, the rate of reactions by the Commission amounted
to 49.7%, 63.1%, 46.5% and 38.5% respectively. The trend continued in 1999 when the rate
fell to 34.2%. Although the total figure had slightly increased in 2000 to 39.8%, the types of
reaction should be looked at.

In 2000, the Commission made comments on 32.2% of the  notifications received  compared
with  26.2%  in  1999  and  27%  in  1998;  it  sent  detailed  opinions  on  only  6.5%  in  2000
compared with 7.2% in 1999, producing an average of 6.8% (the rate had been 14.6% for the
1995-1998  period  and  31%  for  the  1992-1994  period).  This  drop  may  be  the  result  of  the
Commission's information efforts over a number of years in the Member States.

An improvement in the quality of the technical regulations notified is also visible in the total
number of detailed opinions delivered by the Member States; this fell from 15.7% of notified
drafts in 1999 to 12.6% in 2000.

On  the  other  hand,  for  2001,  the  trend  towards  a  constant  improvement  in  the  quality  of
legislation ceases to become apparent. The number of reactions by the Commission increased
considerably.  It  delivered  detailed  opinions  on  11.7%  of  the  notifications  received  (the
average between 1999 and 2000 was 6.8%). It also sent comments on 27.7% of notifications.
The Member States, for their part, delivered detailed opinions from 16.9% of the notifications
(compared with 12.6% in 2000).

This  trend  appears  to  be  due,  among  other  things,  to  the  fact  that  the  Member  States  are
attempting  to  take  into  account  technological  developments  by  proposing  new  legislation
which  is  increasingly  complex  and,  therefore,  creates  obstacles  to  the  free  movement  of
products and the free provision of information society services.

From 1999 to 2001, the Commission applied Article 9(3) to (5) of Directive 98/34/EC in 31
cases. These provisions oblige a Member State to observe a standstill period starting from the
time  the  draft  is  communicated,  if  the  Commission  announces  its  intention  to  propose  or
adopt a binding Community act in accordance with Article 249 (ex Article 189) of the Treaty,
or it announces its finding that the draft concerns a matter covered by such a proposal. There
were 4 such standstill periods in 1999, 8 in 2000 and  19 in 2001. Of the 31  applications of
Article  9(3),  (4)  or  (5)  of  Directive  98/34/EC,  14  concerned  the  agricultural  products  and
foodstuffs sector.

3.5.

Use of the emergency procedure

From  1999  to  2001,  the  Member  States  invoked  the  emergency  procedure  103  times.  The
measures notified in this way accounted for 5.4% of total notifications. This is about the same
number as in the 1995 to 1998 period.

Urgency  was  invoked  mainly  in  the  agricultural  and  foodstuffs  sector  (52  times)  and  in  the
transport  sector  (14  times),  followed  by  the  chemical  industry  (7  times).  If  the  number  of
notifications by sector is compared with the number of times urgency is invoked (see Table
2.4 annexed), the sectors where proportionally greater use is made of this procedure are health
and  medical  equipment  (21.4%),  followed  by  agri-foodstuffs  (14.5%),  then  pharmaceutical
products (9.4%) and information society services (8.5%).

28

It can be seen that urgency is invoked mainly in fields which directly concern the protection
of  health  or  where  there  is  rapid  technological  change  resulting  in  a  problem  of  public
security  (information  society  services),  particularly  in  the  period  following  11  September
2001.

The Commission considered that the use of the emergency procedure was justified in 15 cases
in  1999,  13  cases  in  2000  and  24  cases  in  2001,  resulting  in  an  average  acceptance  rate  of
50.5%. The rate of acceptance has therefore steadily fallen since 1996 (from 80% in 1996 to
68%  in  1997  and  52.7%  in  1998).  There  are  many  complex  reasons  for  this  drop.
Nevertheless, it is clear that particularly in the agricultural and foodstuffs sector (over 50% of
the  total  number  of  urgent  cases)  that  the  Member  States  have  invoked  urgency  in  matters
which were already regulated exhaustively at Community level.

4.

RISKS  OF  BARRIERS  TO  THE  INTERNAL  MARKET  DETECTED  THROUGH  THE
NOTIFICATION PROCEDURE

A  general  picture  of  these  barriers  may  be  obtained  from  a  statistical  overview  and  a  more
specific description  of the problems  posed in relation to Articles  28  and  30  and  Articles  43
and 49 of the EC Treaty, and in relation to secondary legislation.

4.1

General picture

A  comparison  between  the  number  of  notifications  per  sector  and  the  reactions  of  the
Commission or the Member States results in the following conclusions for 1999 (see also the
first table of Annex 2.5):

– 

– 

The sectors for which the Commission and the Member States delivered most detailed
opinions  are those of health and medical equipment, followed by  chemical  products,
household and leisure equipment and agricultural products and foodstuffs.

If the comments and detailed opinions are taken into account as a whole for 1999, in
first place appears health and medical equipment, followed by chemical products, the
environment and agricultural products and foodstuffs.

The  situation  is  similar  for  2000  (see  the  second  table  in  Annex  2.5),  although  information
society services appear for the first time:

– 

– 

The areas in which most detailed opinions were delivered by the Commission and the
Member  States  were,  in  first  place,  household  and  leisure  equipment,  followed  by
information  society  services,  agricultural  products  and  foodstuffs  and,  finally,  health
and medical equipment.

Looking  again  at  detailed  opinions  and  comments  as  a  whole,  health  and  medical
equipment appear in first place, followed by chemical products, agricultural products
and foodstuffs and, finally, household and leisure equipment.

The  situation  is  similar  for  2001,  although  for  the  first  time  miscellaneous  products  are  of
significance (see also the third table of Annex 2.5).

– 

The areas in which most detailed opinions were delivered by the Commission and the
Member  States  were  health  and  medical  equipment,  followed  by  chemical  products,
miscellaneous products, and building and construction.

29

– 

If  an  analysis  is  carried  out  again  of  detailed  opinions  and  comments  as  a  whole,
health and medical equipment appear in first place, followed by chemical products, the
environment, and, finally, miscellaneous products.

This  comparison  leads  to  the  conclusion  that  most  barriers  occur  in  the  following  sectors:
health  and  medical  equipment,  chemical  products,  and  agricultural  products  and  foodstuffs.
Conversely, the sectors with the fewest problems are pharmaceuticals and transport.

Another basis for comparison by which to gain an overview is the type of legal basis invoked
by the Commission in its detailed opinions. In 1999 the situation was as follows: 9

– 

– 

17 detailed opinions were delivered on the basis of secondary legislation (6 of which
on the basis of Directive 89/336/CEE10 relating to electromagnetic compatibility);

30 detailed opinions were addressed to the Member States on the basis of Articles 28
and 30 of the EC Treaty (21 of which because of the absence of the mutual recognition
clause or because of an inadequate clause and 9 because the measure was considered
disproportionate to the objective pursued).

For 2000:

– 

– 

– 

17 detailed opinions were delivered on the basis of secondary legislation;

29 detailed opinions were based on Articles 28 and 30 of the EC Treaty (18 of which
because of the absence of the mutual recognition clause or because  of  an inadequate
clause  and  11  because  the  measure  was  considered  disproportionate  to  the  objective
pursued);

10 detailed opinions were addressed to the Member States on the basis of Articles 43
and 49 of the EC Treaty (these concerned information society services).

For 2001:

– 

– 

33  detailed  opinions  were  sent  to  the  Member  States  on  the  basis  of  secondary
legislation  (6  of  which  on  the  basis  of  Directive  73/23/EEC11  on  low-voltage
equipment and 5 on the basis of Directive 97/23/EC12 on pressure equipment);

30 detailed opinions were based on Articles 28 and 30 of the EC Treaty (20 of which
because of the absence of the mutual recognition clause or because  of  an inadequate
clause and 10 because the measure was considered disproportionate).

In total 67 detailed opinions (40.4%) were based on secondary legislation and 99 (59.6%) on
Articles  28  and  30  and  Articles  43  and  49  of  the  EC  Treaty.  This  shows  that  although  the
notification  procedure  does  not  apply  to  the  measures  by  which  the  Member  States  comply
with  binding  Community  acts  which  result  in  the  adoption  of  technical  specifications  or  to
regulations  on  services  (see  the  first  indent  of  Article  10(1)  of  Directive  98/34/EC),  the
notified texts often concern, directly or indirectly, secondary Community legislation.

9

10

11

12

A detailed opinion may have more than one legal basis, which explains why the figures often add up to
more than the total number of detailed opinions delivered each year.
OJ L 139 of 23.05.1989.
OJ L 77 of 26.03.1973.
OJ L 181 of 9.07.1997.

30

                                                
4.2.

Incompatibility of notified drafts with Articles 28 and 30 and Articles 43 and 49
of the EC Treaty

An examination of the detailed opinions addressed by the Commission to the Member States
on the basis of Articles 28 and 30 of the EC Treaty shows that, with a few exceptions, most of
the  barriers  to  trade  identified  are  related  to  the  principle  of  mutual  recognition  and  the
drafting of clauses whose presence in notified drafts is a condition sine qua non for the correct
application of this principle.

In the field of pharmaceuticals and medical equipment, the Commission has delivered only a
few detailed opinions concerning mutual recognition clauses, either because the subject was
covered by a directive (in particular Directive 93/42/EC on medical devices) or the complaint
concerned certain discriminatory procedures regarding parallel imports of medicinal products.

In the environment and chemical products sector, mutual recognition clauses cannot apply in
all cases. For drafts where such clauses are necessary, the Commission noted in some cases
that the clauses laid down were inadequate, since they were limited to certain standards, made
European  standards  compulsory  or  were  subject  to  certain  preconditions  (e.g.  that  the
reference  of  the  standard  of  another  Member  State  should  be  included  in  an  official  State
publication). In addition, some drafts were deemed  contrary to  Article 28  of the EC Treaty,
since they created barriers disproportionate to the objectives sought. In this respect, the failure
to provide scientific data (an  infringement of  Article 8(1)  of  Directive  98/34/EC)  to  support
certain prohibitions in the chemical sector made it difficult for the Commission in many cases
to analyse the proportionality of the proposed measures.

The drafts notified in the agricultural field were rarely in breach of Article 28 of the Treaty
and only occasionally concerned the problem of mutual recognition, other than for secondary
aspects (use of specific equipment, etc.). In the foodstuffs sector, problems arose particularly
in  relation  to  the  addition  of  vitamins  and  minerals  to  foodstuffs.  Some  Member  States
refused to add mutual recognition clauses, arguing that the addition of vitamins and minerals
at certain levels could cause problems for human health. These problems should, nevertheless,
be solved with the adoption of the draft regulation on fortified foods which the Commission is
currently drawing up and publication of which is expected this year.

In  the  field  of  information  society  services,  the  notifications  showed  that  often  the  Member
States  make  the  same  requirements  as  those  already  fulfilled  by  the  service  provider  in  the
Member State of origin. This was considered by the Commission as contrary to the principles
of  free  movement  of  services  and  freedom  of  establishment  (Articles  43  and  49  of  the  EC
Treaty). It is useful to note that national initiatives have emerged in a new area, namely that of
domain  names  (on  the  Internet).  In  this  respect,  it  is  clear  that  the  Member  States  are
beginning  to  adapt  their  legislation  to  technological  developments.  The  Commission  has
intervened to ensure that this development is consistent throughout the Member States and to
thus prevent the creation of barriers to the performance of cross-border activities.

The  detailed  opinions  sent  by  the  Commission  in  the  construction  sector  often  refer  to  the
request  for  the  inclusion  of  mutual  recognition  clauses  in  fields  considered  by  the  Member
States  as  pertaining  to  safety  or  personal  protection  (e.g.  fire  protection,  amusement  parks,
playgrounds,  old  people's  homes,  etc.).  In  this  sector  problems  of  mutual  recognition  often
arise because Member States intend to make European or national standards compulsory.

31

As  regards  mechanical  engineering,  problems  of  mutual  recognition  arise  particularly  as
regards electronic taxi meters. Since a proposal for a directive on this type of taxi meter was
submitted by the Commission on 15  September 2000 (COM(2000) 566 final),  the  problems
raised by these notifications should be settled in the future.

The  majority  of  detailed  opinions  addressed  to  the  Member  States  regarding  transport
concerned  the  absence  or  poor  drafting  of  the  mutual  recognition  clause.  In  this  field,  the
Commission pointed out that the principle of mutual recognition applied not only to technical
manufacturing specifications, but also to the control procedures applicable to the products.

Often the Member States believe that they do not have to include a mutual recognition clause
in notified texts if they refer  to standards.  On several occasions, the Commission has stated
that, where a European standard is compulsory, a mutual recognition clause for products from
other Member States of the European Union and from the EFTA countries that belong to the
European Economic Area must be included in the text.

One particular case of mutual recognition concerned the transposition of certain regulations of
the Economic Commission for Europe of the United Nations (ECE/UN) in the field of motor
vehicles. Under Article 6 of Council Decision 97/836/EC13, by which the Community acceded
to  the  agreement  governing  the  drafting  of  ECE/UN  regulations,  the  Member  States  may
subscribe to ECE/UN regulations by which the Community is not yet bound. In this case they
are  obliged  to  include  a  mutual  recognition  clause,  since  otherwise  vehicles  from  other
Member States which have not yet subscribed to the ECE/UN regulation could be prevented
from  entering  the  markets  of  the  Member  States  which  have  already  subscribed.  This
obligation was mentioned by the Commission in several notifications.

In  the  field  of  energy,  few  drafts  were  the  subject  of  Commission  reactions  on  the  basis  of
Articles 28 and 30 of the EC Treaty (given the application of Directive 96/92/EC14 concerning
the internal market in electricity). These reactions mainly concerned the conditions of access
to the national electricity network of other Member States.

Since  most  notifications  in  the  field  of  telecommunications  are  related  to  the  fact  that  the
requirements  go  beyond  what  is  laid  down  in  Directive  89/336/EEC  on  electromagnetic
compatibility or in Directive 99/5/EC15 on radio equipment and telecommunications terminal
equipment,  the  question  of  mutual  recognition  clauses  rarely  arises  as  these  additional
requirements  have  in  most  cases  been  considered  by  the  Commission  as  incompatible  with
these directives.

4.3.

Incompatibility of notified drafts with secondary legislation

In  the  field  of  pharmaceuticals  and  medical  equipment,  it  was  the  drafts  on  medical
equipment  that  gave  rise  to  most  reactions.  The  problems  were  often  due  to  incorrect
interpretation of Directive 93/42/EC16 concerning medical devices, as amended by  Directive
98/79/EC17. This is also why in certain cases the Commission pointed out that drafts were not
notifiable  in  relation  to  Directive  98/34/EC  but  should  have  been  notified  according  to
specific articles of Directive 93/42/EC.

13

14

15

16

17

OJ L 346 of 17.12.1997.
OJ L 27 of 30.01.1997.
OJ L 91 of 7.04.1999.
OJ L 169 of 12.07.1993.
OJ L 331 of 7.12.1998.

32

                                                
In the environment and chemical products sector, the Commission drew the Member States'
attention to the incompatibility of notified drafts with certain directives and regulations. Most
such cases concerned incompatibility with waste directives, such as Directive  91/689/EEC18
on hazardous waste and Directive 75/442/EC19 on waste. Similarly, a notification concerning
the  recovery,  recycling,  regeneration  and  destruction  of  halons,  chlorofluorocarbons  and
hydrochlorofluorocarbons  was  deemed  contrary  to  Regulation  (EC)  No  2037/200020  on
substances that deplete the ozone layer.

Agricultural products and foodstuffs is a heading under which appear drafts covering a wide
variety  of  subjects,  ranging  from  combating  bovine  spongiform  encephalopathy  to  the
regulatory size of a  grain of rice.  The Commission's reactions to  "agricultural"  notifications
generally concern the incorrect application of a directive concerning human or animal health,
phytosanitary  products,  animal  welfare,  seeds  and  seedlings,  ornamental  plants,  or  a
regulation related to  the  common  organisation of  markets.  The  Member  States  often  invoke
the  precautionary  principle  to  justify  measures  which  go  beyond  what  is  laid  down  in
Community legislation. In these cases, the Commission has systematically requested the data
used by the Member States to justify the invoking of this principle.

There are a large number of notifications for the construction sector, but during the reference
period  there  were  not  many  reactions  by  the  Commission  in  relation  to  Directive
89/106/EEC21 relating to  construction products. Most of  the  reactions in  this  sector  concern
mutual recognition clauses (see point 4.2 above).

As  regards  information  society  services,  a  first  problem  concerns  notifications  in  which  the
Member  States  do  not  confine  themselves  -  under  the  terms  of  Article  10  of  Directive
98/34/EC22  –  to  simply  transposing  Directive  1999/93/EC23  on  electronic  signature  and
Directive 2000/31/EC24  on  electronic  commerce.  The  notification  procedure  has  made  it
possible to check whether the Member States impose additional charges compared with those
provided  for  under  the  Directives.  In  most  cases,  in  its  detailed  opinions  and  comments  on
these  two  Directives  the  Commission  focused  on  defending  the  free  movement  of  services
and  freedom  of  establishment.  This  gave  it  the  opportunity  to  have  the  idea  respected  that
information  society  services  cannot  be  obstructed  beyond  what  is  allowed  under  the
Directives.

The  second  category  of  detailed  opinions  delivered  by  the  Commission  concerns  the
protection  of  personal  data  in  relation  to  the  management  of  information  society  services.
Through  its  detailed  opinions,  the  Commission  has  allowed  the  development  of  adequate
protection of the processing of personal data throughout the Member States, referring to the
European  Convention  on  Human  Rights  and  Community  directives  on  the  protection  of
personal data.

Finally, this Directive prevents the Member States from extending the field of application of
their national drafts beyond their borders, for instance in the domain names sector.

18

19

20

21

22

23

24

OJ L 377 of 31.12.1991.
OJ L 194 of 25.07.1975.
OJ L 244 of 29.09.2000.
OJ L 40 of 11.02.1989.
See  also  the  Canal  Satellite  Digital  judgement  of  22  January  2002  -  C-390/99,  point  48,  not  yet
published in the reports of cases before the Court.
OJ L 13 of 19.01.2000.
OJ L 178 of 17.07.2000.

33

                                                
The  drafts  notified  by  the  Member  States  in  the  field  of  mechanical  engineering  and
household  equipment  generally  give  rise  to  difficulties  regarding  the  mutual  recognition
clause. Nevertheless, there were also problems regarding the correct application of Directive
73/23/EEC  on  low  voltage  equipment  and  Directive  97/23/EC  on  pressure  equipment.  The
problems  encountered  in  this  field  often  arose  from  the  fact  that  the  Member  States  made
national  or  European  standards  compulsory  although  these  two  Directives  allow  economic
operators the option of using other technical solutions if they meet the essential requirements
that they define.

In  the  field  of  transport,  the  Commission  has  received  a  large  number  of  notifications
regarding  motor  vehicles.  However,  few  of  these  have  raised  serious  problems.  As  regards
transport  by  sea  and  inland  waterway,  the  Commission  delivered  detailed  opinions  for
incompatibility  with  Directive  97/70/EC25  on  the  safety  of  fishing  vessels  and  Directive
82/714/EEC26 on inland waterway vessels.

In  the  field  of  energy,  the  Commission  noted  that  some  technical  rules  contained  in  the
regulations  on  the  management  of  networks  in  the  Member  States  were  discriminatory  and
therefore  in  breach  of  Directive  96/92/EC  on  the  internal  market  in  electricity,  which  lays
down that minimum technical design and operational requirements for the connection to the
system of generating installations, distribution systems, interconnector circuits and direct lines
must ensure the interoperability of systems and be objective and non-discriminatory.

Most of the notifications in the field of telecommunications concern interface requirements for
terminal  equipment.  The  Commission  reactions  generally
radiocommunications  and 
concentrated on the fact that the notified drafts laid down additional requirements which were
not  provided  for 
in  Directive  89/336/EEC  on  electromagnetic  compatibility  and
Directive 99/5/EC  on  radio  equipment  and  telecommunications  terminal  equipment  and  the
mutual  recognition  of  their  conformity.  The  Commission  also  noted  that  some  drafts  made
European or international standards compulsory, thus contravening these two New Approach
directives.

4.4.

Analysis of the reactions of the Member States

An examination of the detailed opinions which the Member States exchange shows that as a
general rule they react on similar points to those raised by the Commission (for example, by
invoking  Articles  28  and  30  of  the  EC  Treaty  as  regards  the  environment  and  by  invoking
Directives 73/23/EEC and 97/23/EC as regards mechanical engineering).

Nevertheless, there is one big difference between the reactions of the Commission and those
of  the  Member  States:  often  the  Member  States  require  certain  technical  amendments  to
notified  drafts  (in  all  the  areas  analysed  below)  whereas  the  Commission  calls  for  the
inclusion of a mutual recognition clause. The Member States appear to call for these technical
amendments  to  ensure  that  the  notified  drafts  are  as  closely  in  line  as  possible  with  the
technical requirements of their own legislation.

In  the  field  of  pharmaceuticals  and  medical  equipment,  the  Member  States  have  mainly
delivered  detailed  opinions 
the  notified  drafts  with
the 
Directive 93/42/EEC on medical devices.

incompatibility  of 

for 

25

26

OJ L 34 of 9.02. 1998.
OJ L 301 of 28.10.1982.

34

                                                
In the environment and chemical products sector, the Member States reacted in particular to
the  prohibitions  on  the  sale  and/or  manufacture  of  certain  chemical  substances.  In  their
reactions, the Member States considered, on the basis of Articles 28 and 30 of the Treaty, that
these prohibitions were disproportionate, since in their opinions other less restrictive measures
were  possible;  in  some  cases  they  considered  the  scientific  data  provided  by  the  Member
States  that  submitted  the  notification  as  inadequate.  Some  drafts  were  also  considered
contrary to Directive 94/62/EC27 on packaging and packaging waste.

In  the  agricultural  products  and  foodstuffs  sector,  a  large  number  of  detailed  opinions
concerned  the  incompatibility  of  the  notified  drafts  with  certain  agricultural  and  foodstuffs
directives. In non-harmonised fields, in some cases (for instance the addition of vitamins and
minerals to  foodstuffs) the  introduction of  a  mutual recognition clause  was  requested  in  the
detailed opinions.

In  the  construction  sector,  the  Member  State  which  had  made  the  notification  was  often
requested to  introduce  a  mutual  recognition  clause  in  order  to  ensure  the  free  movement  of
goods. In some cases the notifying Member State is also requested to introduce a reference to
harmonised standards in implementation of Directive 89/106/EEC on construction products.

In  the  field  of  information  society  services,  the  Member  States  did  not  issue  any  detailed
opinions  in  the  1999-2001  period,  which  appears  to  have  been  due  to  the  fact  that  the
administrative departments responsible for technical files in the Member States were not used
to making use of the possibilities offered by the notification procedure in the field of services
and  probably  had  not  yet  drawn  up  well-defined  positions  on  issues  relating  to  a  new,
developing sector such as that of information society services.

As regards the mechanical engineering sector a large part of the detailed opinions are based
on  Directive  97/23/EC  on  pressure  equipment  and  Directive  73/23/EEC  on  low  voltage
equipment.

In the field of transport, a small number of notifications led the  Member States  to  deliver a
detailed opinion. They generally called for technical adaptations in their detailed opinions.

The energy sector  gave  rise to virtually no  reactions  on the part  of  the  Member States.  The
few reactions that did occur concerned ensuring the interconnection of electricity systems.

Similarly in the field of telecommunications, there were virtually no reactions by the Member
States. The detailed opinions delivered by the Member States in this area mainly stressed the
incompatibility  of  notified  drafts  with  Directive  99/5/EC  on  radio  equipment  and
telecommunications terminal equipment.

5.

RESULTS

The  results  achieved  and  hence  the  effectiveness  of  the  procedure  introduced  by
Directive 98/34/EC  can  be  analysed  in  particular  through  the  follow-up  carried  out  by  the
Member  States  to  the  detailed  opinions  and  comments  made,  including  the  withdrawal  of
drafts by the Member States. The effectiveness of the Directive also lies in the possibility of
imposing a standstill period on national drafts as provided for by Articles 9(3), (4) and (5) of

27

OJ L 365 of 31.12.1994.

35

                                                
the  Directive.  It  may  also  be  analysed  in  terms  of  the  real  needs  for  harmonisation  at
Community level that have been identified.

5.1.

Follow-up to detailed opinions

An analysis of the follow-up given by the Member States to the detailed opinions delivered by
the Commission  under  the  notification  procedure  shows  the  effectiveness  of  this  procedure.
Below are a few indicative figures. They only concern the cases in which the procedure has
been completed, that is, where the Member State has stated that a follow-up would be given to
the  detailed  opinions  delivered  by  the  Commission  and  where  the  Commission  has  in  turn
commented on the Member State's reply28.

Years 1999 and 2000:

Year

1999

2000

Total number of finalised
procedures

Positive Commission
position

Negative Commission
position

29

26

24

18

5

8

The figures show that initially in 84.2% of cases a solution in accordance with internal market
rules  could  be  found.  In  addition,  of  the  15.8%  of  cases  (13  notifications)  where  the
Commission  did  not  give  a  positive  response,  according  to  the  information  sent  to  the
Commission by the Member States, only 5 of the 13 drafts in question were adopted.

Of these five notifications, following the amendments finally made by the Member States, the
Commission  was  of  the  opinion  that  in  three  cases  the  texts  in  question  were  no  longer  in
breach of  Community law.  In the  remaining two cases,  the  Commission was of  the  opinion
that the text was still in breach of Community law and consequently announced the possible
opening of infringement proceedings on the basis of Article 226 of the Treaty. In other words,
of the 55 drafts that were considered to be in breach of internal market rules at the beginning
of the procedure, only two texts (i.e. 3.6%) were adopted with contents that, according to the
Commission, continued to infringe those provisions.

An analysis by sector (see table 2.6 of the annex) shows that the areas where there appeared to
be the most problems in terms of the follow-up given to the Commission's detailed opinions
are the agri-foodstuffs sector, pharmaceuticals and the environment.

Given the small number of procedures that have been finalised for notifications in 2001, it is
not yet possible at this stage to produce an analysis for that year.

5.2.

Follow-up to comments

In  the  case  of  the  comments  made  by  the  Commission  or  the  Member  States  on  notified
drafts, Directive 98/34/EC does not lay down an obligation for the Member State addressed to
state  how  it  intends  to  react  to  the  comments.  Nevertheless,  Member  States  often  say  what
action  they  intend  to  take.  The  positive  results  achieved  by  the  notification  procedure  may,

28

These  figures  do  not  include  notifications  which  were  shelved  because  a  notifying  Member  State
withdrew a draft. See point 5.3 of this report for an analysis of withdrawn drafts.

36

                                                
therefore, also be measured in terms of the number of responses that the Member States make
to  the  comments,  which  demonstrates  the  intensity  of  the  dialogue  and  the  transparency
achieved.

For 1999 and 2000, of the 852 comments made by the Commission and the Member States,
510 received a response by the Member States, i.e. a response rate of 60%. In 1999, the rate
was 63% and in 2000 it was 57%. This difference may be explained mainly by the fact that in
some cases the Member States carry out a detailed study on how to follow up the comments;
it therefore cannot be ruled out that responses may yet be received in 2002 on the notifications
for 2001. This is why an analysis of the follow-up given to the comments on notifications in
2001 would produce a false image at this stage.

As  regards  the  content  of  responses  to  comments,  generally  speaking  Member  States  take
account of the comments made by the Commission and the other Member States.

5.3.

Drafts withdrawn

The results achieved via Directive 98/34/EC may also be analysed on the basis of the drafts
withdrawn by the Member States. From a statistical point of view, in 1999 out of a  total of
591 notifications, 29 were withdrawn by the Member States (4.9%) in 2000 out of a total of
751 notifications 54 (7.2%) were withdrawn and in 2001 out of a total of 530 notifications, 24
(4.5%) were withdrawn.

A  breakdown  of  withdrawals  by  sector  for  the  years  1999  to  2001  shows  that  they  were
mainly  in  the  telecommunications,  transport  and  construction  sectors.  The  drafts  withdrawn
are broken down as follows:

57 telecommunications; 10 transport; 10 construction; 9 agricultural products and foodstuffs;
6  energy  and  minerals;  5  chemical  products;  2  environment; 2  miscellaneous;  1  mechanical
engineering, 1 pharmaceuticals; 1 information society services.

An  analysis  of  these  withdrawals  shows  first  that  they  were  due  to  the  fact  that  comments
and/or detailed opinions had been sent or discussions had been held with the Commission.

As  regards  content,  the  Member  States  withdrew  their  notifications  in  most  cases  because
they incorrectly applied Community directives (such as Directive 99/5/EC on radio equipment
and  telecommunications  terminal  equipment,  Directive  95/16/EC29  on  lifts,  Directive
97/70/EC  on  the  safety  of  fishing  vessels,  Directive  96/92/EC  on  common  rules  for  the
internal  market  in  electricity,  etc).  In  other  cases,  the  drafts  were  withdrawn  following  an
announcement  by  the  Commission  of  a  Community  draft  covering  the  same  field  (e.g.  the
proposal  for  a  Directive  on  the  restriction  of  the  use  of  certain  hazardous  substances  in
electrical and electronic equipment or the proposal for a directive on measuring instruments).
In some specific cases, following a  dialogue which took place in accordance with Directive
98/34/EC, the Member State felt it more appropriate to submit a new draft.

5.4.

“Blocking” of national initiatives

The results achieved may also be measured on the basis of the application of paragraphs 3 to
5 of Article 9 of Directive 98/34/EC, which obliges the Member States to observe a standstill
period  of  one  year  (or  up  to  eighteen  months)  from  the  time  when  the  drafts  are

29

OJ L 213 of 7.09.1995.

37

                                                
communicated  to  the  Commission.  As  a  result,  Directive  98/34/EC  has  promoted
harmonisation  at  Community  level  by  preventing  the  adoption  of  national  measures  which
could have frozen the position of some Member States while  common solutions were being
sought:

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

Eight  drafts  were  blocked  because  the  Commission  had  submitted  a  proposal  for  a
regulation on the animal-health requirements applicable to non-commercial movement
of pet animals (COM(2000) 529 final).

Two drafts were blocked because they dealt with a subject covered in the proposal for
a Decision amending Decision 91/516/EEC establishing a list of ingredients whose use
is  prohibited  in  compound  feedingstuffs.  This  amendment  was  adopted  on  5  April
2000 (Decision 2000/285/EC).

Two  drafts  were  blocked  because  a  Community  proposal  on  food  supplements  was
being drawn up (COM(2000) 222 final). This Directive was adopted on 10 June 2002
(Directive 2002/46/EC).

One  draft  was  blocked  because  of  work  on  a  proposal  for  a  regulation  on  fortified
foods.

One  draft  was  blocked  because  the  draft  regulation  on  the  labelling  of  fishery  and
aquaculture products30 was invoked.

Work 
(COM(2000) 566 final) led to the blocking of six drafts.

a  Directive 

proposal 

the 

for 

on 

on  measuring 

instruments

Three  drafts  had  been  blocked  on  the  basis  of  a  proposal  for  a  Directive  amending
Directive  2001/83/EC  on  the  Community  code  relating  to  medicinal  products  for
human (COM(2001) 404 final).

A blocking was imposed on two drafts because they were covered by a proposal for a
directive on the restriction of the use of certain hazardous substances in electrical and
electronic equipment (COM(2000) 347 final).

A blocking was imposed on one draft because a Community draft amending Directive
92/61/EEC  relating  to  the  type-approval  of  two  or  three-wheel  motor  vehicles  was
being drawn up (COM(1999) 276 final).

One national draft was blocked because it was covered by a Community draft that led
to Directive 2000/31/EC on electronic commerce.

This  list  shows  that  certain  Community  drafts  have  given  rise  to  the  blocking  of  several
national  drafts  (e.g.  the  proposal  for  a  directive  on  measuring  instruments);  indeed  some
Member States were considering legislating in this field (which proves the value of European
harmonisation)  and  it  was  therefore  particularly  useful  to  prevent  the  adoption  of  national
laws, which were often diverging and could have hampered the Council's discussions.

30

Adoption by the comitology procedure, which is why there is no COM number.

38

                                                
5.5.

Identification of harmonisation needs

The  Directive  also  makes  it  possible  to  identify  the  real  needs  for  harmonisation  at
Community  level.  On  the  basis  of  the  notification  procedure,  harmonisation  proceedings
began  concerning,  for  instance,  the  restriction  on  the  use  of  phthalates,  heavy  metals,  the
labelling  of  the  caffeine  content  of  non-alcoholic  drinks,  fortified  foods,  food  supplements
and compound feedingstuffs.

In  the  field  of  information  society  services,  there  was  a  plethora  of  national  legislative
initiatives in the field of domain names (Internet) which could require consideration regarding
the need for possible harmonisation.

6.

HANDLING OF INFRINGEMENTS

Between 1999 and the end of 2001, the Commission initiated 20 infringement proceedings for
failure to comply with Directive 98/34/EC, either for failing to notify national measures or for
adopting them before the end of the standstill period. The Commission was either informed of
the national legislation by the economic operators concerned or its own services discovered it.

In  line  with  the  Commission's  position,  repeatedly  expressed  at  meetings  of  the  Committee
(see point 8.2 below), at bilateral meetings and at "package" meetings (see point 8.3 below),
the  majority  of  Member  States  abandon  the  disputed  text  and/or  notify  a  new  draft  which,
after undergoing the notification procedure, is adopted and at the same time the disputed text
is repealed. During the reference period, this solution allowed the infringement proceedings to
be  terminated  in  virtually  all  cases.  Problems  continued,  nevertheless,  in  the  field  of
information  society  services  (see  point  6.2  below).  At  the  end  of  2001,  a  total  of  16
infringement proceedings were still in progress for breach of Directive 98/34/EC.

6.1.

Infringements in the field of products

Following the judgement of 30 April 1996 on CIA Security International31, which confirmed
the  position  defended  by  the  Commission  in  its  communication  86/C  245/0532  on  the
inapplicability of the technical regulations adopted in breach of the notification obligation, the
Member  States  have  started  notifying  their  draft  technical  regulations  as  a  matter  of  course
and  the  Commission  has  been  able  to  stop  the  systematic  opening  of  infringement
proceedings.

There are consequently only a few ongoing infringements in the field of products.

6.2.

Infringements in the information society services sector

Since  5  August  1999,  regulations  on  information  society  services  have  to  be  notified  under
Directive 98/34/EC. In this sector, the number of texts adopted by the Member States without
notification  is  still  high  at  the  moment.  In  2000  and  2001,  the  Commission  opened  7
infringement proceedings for failure to observe the notification procedure.

31

32

C-194/94, ECR p.I-2201. For further information on this judgement, see the Commission report on the
operation of Directive 98/34/EC from 1995 to 1998, COM(2000) 429 final, of 7 July 2000, points 91
and 92.
OJ No C 245/4 of 1 October 1986.

39

                                                
The  legislation  adopted  by  the  Member  States  can  be  classified  in  two  categories:  that
regulating  fields  covered  by  Community  directives  and  that  regulating  the  non-harmonised
areas.

The first category refers mainly to regulations concerning electronic signatures and electronic
commerce. As regards the second category of texts, these concern electronic communication,
the  electronic  transmission  of  documents  and  telecommunications  services  other  than  those
covered by Directive 89/552/EEC. These are also texts concerning Internet domain names and
national measures aimed at creating a legal framework for the use of electronic billing.

To  clarify  the  problems  regarding  the  application  and  interpretation  of  Directive 98/48/EC,
the  Commission  considered  it  important  to  set  up  dialogue  with  the  Member  States  based
mainly  on  bilateral  meetings.  Following  these  meetings,  the  Commission  was  able  to
terminate  the  infringement  proceedings,  since  the  national  authorities  had  withdrawn  the
disputed texts.

7.

COURT OF JUSTICE CASE-LAW

the  Court  of  Justice  delivered  eight 

Between  1999  and  2001, 
judgements  on
Directive 98/34/EC, six of which were in response to references for preliminary rulings from
national courts and two following infringement proceedings by the Commission. Apart from
this  distinction  concerning  the  type  of  proceedings,  there  are  two  categories  of  judgement:
those  dealing  with  procedural  matters  and  those  concerning  the  field  of  application  of  the
Directive and the definition of its concepts.

7.1.

Judgements on procedural matters

Unenforceability of a technical regulation

In  this  context,  mention  should  first  be  made  of  the  judgement  of  the  Court  of  Justice  of
26 September 2000, Unilever,33
 in which the Court extended the conclusions of its judgement
CIA  Security  International  to  the  failure  to  observe  the  standstill  period  provided  for  in
Directive 98/34/EC.In the case CIA Security International, the Court had already stated that
failure to observe the notification obligation made the technical regulation unenforceable. In
the Unilever judgement, it stated that adoption of a measure which had been notified, but for
which  the  deadlines  laid  down  in  Directive  98/34/EC  had  not  been  observed,  also  rendered
the technical regulations it contained unenforceable.

The  case  in  question  concerned  a  draft  Italian  law  regulating  labelling  indicating  the
geographical origin of different types of olive oil. This draft law had been properly notified.
The  Commission  had  then  applied  a  standstill  period  of  one  year  in  accordance  with
Article 9(3)  of  the  Directive,  since  the  draft  covered  a  field  in  which  it  intended  to  begin
harmonisation work. Without waiting for the end of the standstill period, Italy had adopted its
draft.

33

C-443/98, ECR p. I-7535.

40

                                                
The  Court's  judgement  is  particularly  significant  since  it  concerned  a  dispute  between  two
companies.  The  company Central  Food, which had ordered  the  olive  oil  from  Unilever,  did
not accept delivery, arguing that the products were not labelled in accordance with Italian law.
Unilever,  on  the  other  hand,  invoked  the  fact  that  Italy  had  not  observed  the  deadlines
provided  for  in  the  notification  procedure.  The  Court  stressed  that  "Whilst  it  is  true  that  a
directive cannot of itself impose obligations on an individual and cannot therefore be relied on
as such against an individual, that case-law does not apply in proceedings between individuals
where  non-compliance  with  Article  8  or  Article  9  of  Directive  83/189,  which  constitutes  a
substantial  procedural  defect,  renders  a  technical  regulation  adopted  in  breach  of  either  of
those articles inapplicable".

Link between detailed opinions and notice

As regards procedure, mention should also be made of the Court Order of 13 September 2000,
Commission v. Netherlands34
 which gave details regarding the link between detailed opinions
within the meaning of Directive 98/34/EC and notice issued on the basis of Article 226 of the
EC Treaty under infringement procedures.

The  Order  concerned  a  decree  concerning  the  treatment  of  bivalve  molluscs  from  foreign
waters, which had been adopted by the Dutch authorities, without amendment of the notified
draft  despite  the  Commission's  detailed  opinion.  Following  the  adoption  of  the  text,  the
Commission sent the Dutch authorities a reasoned opinion on the basis of Article  169  (now
226)  of  the  EC  Treaty,  since  the  disputed  regulation  was,  in  its  opinion,  in  breach  of
Article 30 and 36 (now Article 28 and 30) of the EC Treaty.

The Commission was of the opinion that a detailed opinion within the meaning of Article 9(1)
of Directive 83/189/EEC (now 98/34/EC) constituted formal notice, meeting the requirements
of Article 169 of the Treaty (now Article 226 EC) and that it was therefore possible to move
on  immediately  from  a  detailed  opinion  to  a  reasoned  opinion.  In  the  Order,  the  Court  of
Justice specified that a detailed opinion cannot be considered as the equivalent of a letter of
formal notice, as the Member State to which it is addressed cannot have infringed Community
law, since the measure exists only in draft form.

This  judgement  was  confirmed  by  the  Court  in  its  judgement  of  15  February  2001,
Commission v. France, on national legislation concerning rubber materials and rubber articles
entering into contact with foodstuffs, food products and beverages35.

Since then, the Commission has increased the monitoring of texts adopted after notification,
in  order  to  begin  infringement  proceedings  immediately  if  there  is  a  breach  of  Community
law (very rare infringements, as was seen in point 5.1).

7.2.

Judgements concerning the field of application of the Directive and definition of
concepts

Exemptions provided for in Article 10 of Directive 98/34/EC

Several  judgements  have  clarified  the  exemption  provided  for  in  the  first  indent  of
Article 10(1) of Directive 98/34/EC, according to which Member States do not have to notify

34

35

C-341/97, ECR p. I-6611.
C-230/99, ECR 2001, p. I-1169.

41

                                                
the texts by which they comply with binding Community acts which result in the adoption of
technical specifications or rules on information society services.

In the joint case Albers, Van den Berkmortel and Nuchelmans36, the Court was of the opinion
that  by  adopting  rules  prohibiting  the  administration  of  clenbuterol  to  fattening  cattle,  the
Netherlands  had  honoured  its  obligations  pursuant  to  Directive  86/469/EEC  concerning  the
examination of animals and fresh meat for the presence of residues and was therefore exempt,
under Article 10 of the Directive, from the notification obligation.

On  the  other  hand,  in  the  Unilever  judgement  (see  point  7.1  above)  the  Court  stated  that
Article 10 of the Directive could not be invoked when a provision of a directive allowed the
Member  States  sufficiently  wide  room  for  manoeuvre.  This  was  the  case  here.  Italy  had
submitted that Directive  79/112/EEC relating to  the  labelling of foodstuffs required that the
place of origin or provenance of the product be indicated on the label in cases where omission
of such information would be liable to mislead consumers as to the real origin or provenance
of  the  foodstuff.  According  to  the  Court,  this  provision  is  drafted  in  general  terms,  which
leave  sufficient  room  for  manoeuvre  for  it  to  be  concluded  that  national  rules  on  labelling
relating to the origin of olive oils cannot be regarded as national provisions conforming to a
binding  Community  act  within  the  meaning  of  the  first  indent  of  Article  10(1)  of  Directive
83/189.

This restrictive interpretation of the first indent of Article 10(1) was confirmed by the Court
in the Canal Satellite Digital judgement37.

Concept of technical regulation and technical specification

In the Colim judgement38 of 3 June 1999, the Court emphasised that although the obligation
to give certain information  on  a product  to  the consumer via  labelling on  the  product  or  by
attaching  documents  (instructions  for  use  and  guarantee  certificate)  constitutes  a  technical
regulation within the meaning of the Directive, this is not the case for the obligation to give
this information in a certain language. "Unlike the first obligation, which concerns the product
directly,  the  second  is  intended  merely  to  specify  the  language  in  which  the  first  must  be
carried  out."  The  case  in  question  concerned  the  Belgian  Law  on  Trade  Practices  and
Consumer Information and Protection.

The  judgement  of  the  Court  of  16  November  2000  in  the  Donkersteeg  case39  dealt  with
whether  a  national  law  requiring  every  farmer  to  have  the  pigs  on  his  holding  vaccinated
against  Aujeszky's  disease  was  a  technical  regulation.  According  to  the  Court,  this  law  is  a
technical specification within the meaning of the Directive, as the vaccination is linked to the
actual production of the agricultural product concerned and therefore defines a procedure in
the  production  of  that  product.  Nevertheless,  it  is  not,  according  to  the  Court,  a  technical
regulation within the meaning of the Directive, since to be classified as a technical regulation,
the  observance  of  these  technical  specifications  must,  according  to  the  Directive,  be
compulsory de jure or de facto. However, the  Dutch decree  in  question  did  not  impose  any
restriction on either the marketing or use of the products concerned when, in contravention of
the provision, the pigs had not been vaccinated.

36

37

38

39

C-425/97, ECR 1999, p. I-2947.
C-390/99, not yet published in European Court Reports.
C-33/97, ECR 1999, p. I-3175.
C-37/99, ECR 2000, p. I-10223.

42

                                                
The  judgement  of  the  Court  of  12  October  2000  in  the  Snellers  case40  concerned  the
authorisation of a vehicle  for  use on the public highway. The matter concerned Dutch  rules
determining the date on which a vehicle was first authorised for use on the public highway.
According to the Court, these could not constitute technical specifications within the meaning
of the Directive, since such specifications have to refer to the product as such. However, the
Dutch  rules  simply  defined  criteria  for  determining  the  date  on  which  a  vehicle  was  first
authorised for use on the public highway and did not define any characteristic required of the
product, i.e. the vehicle, as such.

In  its  judgement  of  8  March  2001  on  the  van  der  Burg  case41,  the  Court  clarified  the
relationship  between  publicity  and  technical  regulation.  The  case  concerned  a  Dutch  decree
prohibiting  commercial  advertising  for  transmitting  equipment  of  a  non-approved  type.  The
question was whether such a prohibition constituted a technical regulation within the meaning
of the Directive. The Court stated that the relationship between an advertising ban such as the
one in question and technical regulations to be satisfied by the transmitting equipment was not
sufficient  for  the  prohibition  to  be  classified  as  a  technical  specification  and  hence  as  a
technical  regulation.  The  Court  emphasised  that  the  decree  merely  prohibited  a  marketing
method,  without  laying  down  the  characteristics  required  of  a  product,  in  this  case
transmitting equipment.

8.

ACTION TO IMPROVE THE PROCEDURE

The Commission has carried out a variety of measures to improve the notification procedure.
These  concern  on  the  one  hand  improving  the  access  of  businesses  to  the  information
provided by the procedure and on the other improving the exchange of information between
the Commission and the Member States.

8.1.

Transparency

To  improve  the  access  of  economic  operators  to  draft  technical  regulations,  in  2000  the
Commission created an Internet site on the notification procedure42. This site provides access
to  information  on  the  drafts  notified  by  the  EU  Member  States  since  1984  and  on  the
measures  communicated  by  the  EFTA  members  of  the  European  Economic  Area.  It  also
provides explanations on how the procedure works and provides access to the case law of the
Court of Justice in this area. The purpose of the site is to ensure that Directive 98/34/EC fully
fulfils its role as regards transparency and eliminating barriers to the smooth operating of the
internal market.

To publicise the new Internet site and provide information on the notification procedure, the
Commission has published a brochure providing a brief explanation of the objectives  of the
procedure and how it works. The brochure also contains the addresses of the national bodies
responsible for the procedure in their country.

Since the new Internet site was created, the Commission has noted a considerable increase in
the  number  of  comments  made  by  economic  operators.  It  intends  to  further  improve  the
information  provided  to  these  operators  in  order  to  ensure  maximum  transparency  of  the

40

41

42

C-314/98, ECR 2000, p. I-8633.
C-278/99, ECR 2001, p. I-2015.
The  site,  which  is  called  TRIS  (Technical  Regulations  Information  System),  can  be  consulted  at  the
following address: http://europa.eu.int/commm/enterprise/tris.

43

                                                
notified drafts. It is essential for businesses to know about them, on the one hand in order to
adapt their products in advance to new national regulations and on the other so that they can
alert  their  governments  and  the  Commission  to  any  unjustified  barriers  which  would  result
from the adoption of the drafts.

8.2.

Meetings of the Committee set up by Directive 98/34/EC

Eleven meetings of the Committee set up under Article 5 of Directive 98/34/EC (composed of
representatives appointed by the Member States and chaired by a Commission representative)
took place between 1999 and  2001.  Discussions  concentrated on the various aspects set out
below.

Improving the exchange of information

As regards the practical aspects of implementing the procedure, discussions were held on the
progress made in transposing Directive 98/48/EC and on the drawing up of the Vade-mecum
on  cooperation  between  the  central  units  and  the  Commission  departments  regarding  this
Directive,  the  electronic  transmission  of  notified  drafts  and  messages  and  the  obligation  to
reply to detailed opinions and to systematically submit the final texts. Discussions were also
held on the creation of an electronic system (extranet) which provides the Member States with
direct access to the Commission database on the operation of Directive 98/34/EC. At the time
this  report  was  written,  this  system  had  been  created,  which  should  greatly  facilitate
communication between the Commission and the Member States regarding the procedure.

Impact studies

The  Committee  also  examined  the  value  of  adding  impact  studies  to  notified  drafts.  The
discussion  related  to  the  Lisbon  European  Council  of  March  2000,  which  had  asked  the
Commission, the Council and the Member States to "set out - by 2001 - a strategy for further
coordination  action  to  simplify the regulatory  environment at both national and  Community
level".

The Member States  responded  to  this  by  setting up a high-level  advisory  group  (commonly
known  as  the  Mandelkern  Group),  which  presented  a  report  on  the  simplification  of  the
regulatory environment to the Laeken European Council in December 2001. The report stated,
in relation to impact assessments, there was: "Agreement by all Member States that from June
2002  they  will  submit  the  relevant  national  RIA  [Regulatory  Impact  Assessment],  where  it
exists, alongside regulation notified to the Commission and other Member States".

The  Commission  responded  to  this  appeal  in  its  Communication  of  5  December  2001
"Simplifying and improving the regulatory environment" (COM(2001) 726 final) which was
presented  at  the  Laeken  European  Council.  In  the  Communication,  the  Commission  stated
that it "expected, in accordance with the recommendations of the Mandelkern Group, that the
Member  States  would  systematically  append  to  the  regulations  notified  to  the  Commission
and the other Member States the relevant national statutory impact assessment each time such
an assessment had been made".

The Laeken Council stressed in its conclusions that it "welcomes the final report by the high
level advisory group (Mandelkern Group) on the quality of regulatory arrangements and the
Commission communication on regulatory simplification, […]".

44

The  Committee  members  subsequently  agreed  that  these  impact  studies  would  be  sent
together  with  the  notified  drafts  each  time  they  were  carried  out.  The  studies  could  be
submitted  either  as  such  or  in  the  form  of  a  summary.  The  inclusion  of  such  studies  with
notified drafts should:

– 

– 

– 

encourage  Member  States  to  think  at  the  earliest  possible  stage  in  the  legislative
process about the most appropriate instrument to use;

make the legislation of the Member States easier to understand and

make  evaluation  of  the  notified  drafts  by  the  Member  States  and  the  Commission
easier.

Decision 3052/95/EC

The  Committee  also  served  as  a  forum  for  the  discussion  of  questions  regarding  Decision
No 3052/95/EC  of  the  European  Parliament  and  of  the  Council  concerning  an  information
procedure  on  measures derogating  from the principle of  the free movement of  goods43. The
implementation of this decision was also debated on several occasions.

Access to documents

Finally, the Committee  also  dealt  with  the  question  of  access  to  the  comments  and  detailed
opinions of the Member States and those of the Commission following the entry into force of
Regulation  1049/2001  on  public  access  to  European  Parliament,  Council  and  Commission
documents on 3 December 2001. Discussions on this matter are still in progress.

Future development of the procedure

The future developments of the notification procedure were dealt with during the discussions
on the participation of Turkey and the candidate countries in the information exchange system
(see point 9). The candidate countries have been attending Committee meetings as observers
since October 2001 (Turkey has been associated in the work of the Committee since 199944).
The Committee also discussed the accession of the Community to the Moscow Convention on
Information and  Legal Cooperation concerning  "Information  Society  Services"  (see  point 9)
and the possibilities of extending the procedure to services other than those of the information
society.

8.3.

Package meetings

The  practice  of  holding  "package  meetings"  (meetings  in  the  capitals  to  discuss  a  large
number  of  cases  with  the  ministers  concerned)  has  enabled  the  Commission  to  maintain
contacts  with  the  national  authorities  responsible  for  drawing  up  technical  regulations.  The
drafts notified by the country concerned are discussed at these meeting as are the changes to
be made to them to make them comply with internal market rules, infringements of Directive
98/34/EC and developments concerning the functioning of the procedure. At these meetings,

43

44

Decision  No  3052/95/EC  of  the  European  Parliament  and  of  the  Council  of  13  December  1995
establishing  a  procedure  for  the  exchange  of  information  on  national  measures  derogating  from  the
principle of the free movement of goods within the Community, OJ L 321 of 30.12.1995.
See Decision No 2 of the EC-Turkey Association Council of 8 March 1999 concerning the extension of
the list of committees referred to in Annex 9 to Decision No 1/95 on implementing the final phase of
the Customs Union, OJ L 72 of 18.3.1999.

45

                                                
the Commission departments have also had the opportunity to discuss the development of the
case  law  of  the  Court  with  Member  State  authorities,  in  particular  the  consequences  of  the
Unilever judgement (see point 7.1. above).

9.

INTERNATIONAL ASPECTS OF THE NOTIFICATION PROCEDURE

The notification procedure is not limited to the Member States of the EU but also applies to
EFTA  countries  and,  recently,  to  Turkey.  The  Commission  is  also  currently  studying  the
possibility of the participation of the candidate countries in the procedure before accession.

9.1.

The exchange of information on technical rules between the Community and the
EFTA countries.

Since Austria, Finland and Sweden acceded to the Community, the simplified procedure for
the exchange of information  on technical regulations between  the Member States of the  EC
and EFTA (originally set up in 1990 by an agreement between the Community and the EFTA
members45) has applied between the Member States of the Community on the one hand and
Iceland, Liechtenstein, Norway, and, on a voluntary basis, Switzerland, on the other. Annex II
to the Agreement on the EEA includes Directive 98/34/EC, amended as appropriate.

Since  1  March  2001,  Directive  98/48/EC,  which  extends  the  notification  procedure  to
information society services, also applies to EFTA members of the EEA.46

Description of the procedure

Since 1994, the exchange of information between the Member States of the Community and
the Member States of EFTA has taken place via the Commission and the EFTA Surveillance
Authority set up by the Agreement on the EEA.

There  is  a  three-month  standstill  period,  during  which  the  notifying  State  cannot  adopt  the
text, starting on the date of receipt of the draft regulation by the EFTA Surveillance Authority
(for  notifications  from  EFTA  Member  States)  or  the  Commission  (for  notifications  from
Community  Member  States).  The  EFTA  Surveillance  Authority  and  the  Community  may
make  comments  on  the  draft  technical  regulations  notified  under  this  procedure.  The
Commission  draws  up  comments  on  behalf  of  the  Community,  in  consultation  with  the
Member States, and communicates them to the EFTA Surveillance Authority, which forwards
them to its Member States.

The  Agreement  contains  no  provisions  regarding  the  extension  of  the  standstill  period.  The
only  possibility  for  continuing  the  procedure  once  comments  have  been  made  is  to  hold
regular  consultations  on  the  comments  made  by  all  contracting  parties  or  to  call  ad  hoc
additional meetings to discuss specific cases.

45

46

Council  Decision  90/518/EC  concerning  the  conclusion  of  an  Agreement  between  the  European
Economic  Community,  on  the  one  hand,  and  the  Republic  of  Austria,  the  Republic  of  Finland,  the
Republic of Iceland, the Kingdom of Norway, the Kingdom of Sweden and the Swiss Confederation, on
the other, laying down a procedure for the exchange of information in the field of technical regulations
of 24 September 1990, OJ L 291 of 23.10.1990.
Decision of the EEA Joint Committee No 16/2001 of 28 February 2001 amending Annex II (Technical
regulations,  standards,  testing  and  certification)  and  Annex  XI  (Telecommunication  services)  to  the
EEA Agreement, OJ L 117 of 26.04.2001.

46

                                                
Volume of notifications and breakdown by sector

Between 1999 and 2001, the Commission received 97 notifications from the EFTA Member
States, whereas between 1995 and 1998, the  figure  amounted  to  149.  Norway  submitted  45
notifications,  Switzerland  38  and  Iceland  14  (see  figure  4).  If  the  number  of  EFTA
notifications  is  compared  with  the  number  of  Community  notifications  for  the  1995-1998
period and the 1999-2001 period, the ratio remains virtually unchanged (EFTA notifications
equal to 6% of total Community notifications for the 1995-1998 period, compared with 5.1%
for the 1999-2001 period).

Number of notifications by EFTA countries 1999-2001

1999

2000

2001

Figure 4

18

16

14

12

10

8

6

4

2

0

Iceland

Norway

Switzerland

A  breakdown  by  sector  shows  that  the  trend  observed  in  1997  has  continued  (see  table  2.7
annexed). In 1997, agricultural products and foodstuffs for the first time took the lead in terms
of the number of notifications. In the 1999-2001 period, notifications in this sector made up
35%  of  the  total  number.  In  contrast,  the  number  of  notifications  in  the  field  of
telecommunications, which is the second biggest sector, continued to fall. As a result, in the
1999-2001 period, this sector represented only 16.5% of the notifications.

The importance of the agricultural products and foodstuffs sector reflects an identical trend at
Community level, namely a spate of "re-regulation" in the Member States, resulting from the
various crises in this sector. The EFTA  countries on the other  hand  notified  far  fewer radio
interfaces47 than the Member States.

The first three notifications by EFTA countries concerning information society services also
took place in 2001.

47

These  interfaces  must  be  notified  to  the  Commission  in  accordance  with  Directive  99/5/EC  of  the
European Parliament and of the Council EC of the European Parliament and of the Council of 9 March
1999  on  radio  equipment  and  telecommunications  terminal  equipment  and  the  mutual  recognition  of
their conformity, OJ L 91 of 7.04.1999.

47

                                                
Community comments on EFTA notifications

In the 1999-2001 period, the Community made comments on 56 (57.7%)  notifications from
EFTA (see table 2.8 annexed), which is slightly up on the 1995-1998 period (50.3%).

The  comments  sent  by  the  Community  to  the  EFTA  members  of  the  European  Economic
Area  Agreement  mainly  concerned  problems  of  compatibility  with  secondary  Community
legislation, 
in  particular  Directives  98/95  (genetically  modified  seed),  88/388/EEC
(movement  of  flavourings),  99/71/EC  (pesticide  residues  on  foodstuffs),  77/99/EEC  (health
marking  of  meats),  99/5/EC  (telecommunications  terminal  equipment),  96/98/EC  (marine
equipment)  and  Directive  2000/31/EC  (electronic  commerce  and  other  information  society
services).

In  other  comments,  the  attention  of  these  countries  was  drawn  to  the  aspects  of
proportionality  and  the  obligation  to  include  and  apply  in  their  technical  regulations  the
mutual  recognition  clauses  required  in  order  to  prevent  the  creation  of  technical  barriers  to
trade  and  to  ensure  the  observance  of  Articles  11  to  13  of  the  Agreement.  In  this  respect
mention  was  made  of  the  case  law  of  the  Court  of  Justice  of  22  October  1998  in  the  case
Commission  versus  France48,  in  which  the  Court  stressed  the  obligation  for  the  Member
States to include a mutual recognition clause in legislation on non-harmonised fields.

In  its  comments,  the  Commission  also  referred  to  ongoing  work  at  Community  level:
amendment of Directive 98/18/EC on passenger ships, Decision 91/516/EEC on feedingstuffs
(amendment  adopted  on  5  April  2000  in  Decision  2000/285/EC),  Directive  94/52/EC  on
environmental 
supplements
the  Community 
(COM(2000) 222 final)  adopted  on  10  June  2002.  The  ongoing  work  within  European
standardisation  bodies  and  certain  international  agreements  (SOLAS  Convention  and  IMO
circular) were also mentioned.

protection 

draft 

food 

and 

on 

As regards the notifications from Switzerland, the Community drew the attention of the Swiss
authorities  to  certain  differences  in  approach  between  Swiss  legislation  and  Community
legislation, in  particular  as  regards  foodstuffs  (labelling  of  origin  of  foodstuffs,  flavourings,
etc.) and telecommunications (Directive 99/5/EC on telecommunication terminal equipment).

Comments by EFTA on Community notifications

Three  Community  notifications  gave  rise  to  comments  by  the  EFTA  surveillance  authority
(2 in 1999, 0 in 2000 and 1 in 2001).

The comments mainly concerned the possible barriers that the drafts in question could create
regarding  products  legally  manufactured  in  EFTA  countries  (e.g.  a  Dutch  notification  on
bivalve molluscs).

Conclusions and outlook

In  the  years  1999  to  2001  the  number  of  notifications  remained  at  the  same  level  as  in  the
1995-1998 period. The biggest sector is agricultural products and foodstuffs. The reasons for
the  reactions  of  the  Community  regarding  drafts  notified  by  EFTA  countries  remained  the
desire to ensure that these countries  observe Community legislation. There has always been
excellent cooperation regarding the procedure.

48

C-184/96, ECR 1998, p. I-6197.

48

                                                
In  the  near  future,  a  modus  vivendi  must  be  found  for  Switzerland  to  participate  too  in  the
exchange  of  information  on  information  society  services.  So  far  it  has  participated  in  the
notification procedure on an informal basis.

9.2.

Turkey

Since 1 January 2001, Turkey has participated in the notification procedure in the same way
as EFTA countries. The decision for Turkey to participate in the notification  procedure was
taken  in  1997  during  the  introduction  of  the  final  phase  of  the  customs  union  between  the
Community  and  Turkey49.  A  single  period  of  standstill  of  three  months  applies,  with  no
possible extension. Turkey may make comments on the Member States' drafts and vice-versa.
On  the  other  hand,  there  is  no  system  of  exchange  provided  for  between  Turkey  and  the
EFTA countries.

9.3.

Enlargement

Given  the  importance  of  the  Directive  for  the  smooth  functioning  of  the  enlarged  internal
market, the Commission is currently studying ways for the candidate countries to participate
in  the  notification  procedure  prior  to  their  accession,  along  the  same  lines  as  the  EFTA
countries and Turkey.

9.4.

Council of Europe

The Community  will  soon  accede to  the Convention  on  Information and  Legal Cooperation
concerning  information  society  services  of  the  Council  of  Europe50.  The  Convention  was
open  for  signature  in  Moscow  on  4  and  5  October  2001.  It  incorporates  part  of  Directive
98/34/EC in the field of information society services. The aim is to increase transparency and
the knowledge of all the member countries of the Council of Europe and the observer states
regarding  the  national  regulations  planned  in  connection  with  information  society  services,
with the possibility of the mutual transmission of comments on notified drafts.

10.

CONCLUSIONS AND PROSPECTS

During the reference period of this report, work took place on the subject of governance.  In
relation  to  this,  openness,  participation  and  efficiency  were  highlighted  as  principles  to  be
applied to guarantee the quality of regulations, proportionality and subsidiarity51.

As  an  instrument  of  transparency  and  partnership  at  the  service  of  the  internal  market,
Directive 98/34/EC reflects these different principles, as this report shows.

First,  openness.  Businesses,  Member  States  and  Commission  departments  have  received
information  on  over  1800  draft  technical  regulations  notified  during  this  period.  The
information has been presented in a way suited to needs and in all the official languages.

49

50

51

Decision  No  2/97  of  the  EC-Turkey  Association  Council  of  4  June  1997  establishing  the  list  of
Community  instruments  relating  to  the  removal  of  technical  barriers  to  trade  and  the  conditions  and
arrangements governing their implementation by Turkey, OJ L 191 of 21.07.1997.
Convention on Information and Legal Cooperation concerning "Information Society Services" ETS No.
180. For further information: http://conventions.coe.int/Treaty/EN/cadreprincipal.htm.
European Governance - A White Paper, COM(2001) 428 final, 25.07.2001, p. 12.

49

                                                
The creation of an Internet site (http://europa.eu.int/comm/enterprise/tris) contributed to this,
as did a new electronic communication system with the Member States and the Commission
departments.

A spate of re-regulation also took place, mainly as a result of technological advances and the
desire  to  increase  controls  in  the  fields  of  health  and  in  particular  food.  The  desire  of  the
Member States to respond to rapid technological development confirmed that it was entirely
worth extending the notification procedure to information society services.

Secondly, participation.  The analysis  of  notified drafts  led the Commission to  react  in  over
one  third  of  cases  between  1999  and  2001.  The  Member  States,  for  their  part,  reacted  in
almost half of the cases, which shows the intensity of the dialogue that has developed between
them.

In  2001,  there  was  a  difference  compared  with  previous  years  regarding  the  number  of
detailed  opinions  delivered  by  the  Commission.  Although  in  1999  and  2000  the  number
continued to fall as in previous years, there was an increase in 2001. This seems to be due to
the fact that the Member States, in order to keep pace with technological developments, are
proposing new laws which are increasingly complex and consequently the source of barriers
to  the  free  movement  of  products  and  the  free  movement  to  provide  information  society
services.

The  reactions  of  the  Commission  and  the  Member  States  are  to  a  large  part  due  to  the
intervention of businesses. Aware of the possibility of intervention in the national legislative
process provided by Directive 98/34/EC, many of them have reacted. They have emphasised
the trading problems that could be caused by certain national drafts, particularly in the sectors
of  drinks  packaging,  the  environment,  chemicals  and  foodstuffs,  thus  inducing  the
Commission and their governments to react to safeguard their competitiveness.

It  should  be  noted  that  although  the  notification  procedure  does  not  apply  to  measures  by
which  the  Member  States  comply  with  binding  Community  acts  which  lead  to  adoption  of
technical specifications or regulations regarding services, the drafts notified nevertheless very
often lead the Commission to react on the basis of secondary Community legislation.

Efficiency,  also.  Directive  98/34/EC  has  ensured  that  decisions  are  taken  at  the  most
appropriate level. As stated in this report, in almost thirty cases, the Directive has facilitated
harmonisation  at  Community  level  by  preventing  the  adoption  of  national  measures  which
would have  hardened  the  positions  of  certain  Member  States  while  common  solutions  were
being sought.

High among the  achievements of  the notification procedure  appears  the  improvement  of  the
quality  of  national  regulations.  By  means  of  the  prior  analysis  of  draft  texts,  the  Directive
prevents the creation of many barriers before they have a detrimental effect and thus makes a
tangible contribution to improving the law-making of the Member States.

The results achieved between 1999 and 2001 show that the Directive made it possible to meet
the  challenge  posed  by  the  new  wave  of  regulations.  By  providing  Member  States  with
examples  of  the  best  approaches  adopted  by  their  counterparts,  and  even  indicating  what
approaches  should  be  avoided,  the  notification  procedure  helped  improve  the  quality  of
national regulations. An analysis of the replies by the Member States to the detailed opinions
sent by the Commission and the subsequent dialogue shows that in almost all cases (96%), the

50

problems that would have arisen from the adoption of the drafts in their initial version were
removed.

Finally,  proportionality  and  subsidiarity  are  on  the  list  of  achievements.  By  improving  the
quality of national regulations, the notification procedure has made legislative intervention at
Community  level  less  often  necessary.  It  has  also  identified  sectors  where  intervention  at
European level appeared more appropriate.

Given  technological  developments,  particularly  in  the  scientific  field,  the  notification
procedure is increasingly becoming an instrument with which to identify emerging sectors so
that  the  best  solutions  can  be  found  for  them,  which  may  involve  a  combination  of  formal
rules with other more flexible ones.

Looking to the future, the notification procedure could be extended both as regards contents
and geographical coverage.

Since  services  play  an  increasingly  important  role  in  our  economies,  the  Commission  has
undertaken to begin studying the suitability of extending Directive 98/34/EC to services other
than  those  of  the  information  society52.  This  appears  particularly  necessary  since  the
Commission  has  already  noted  in  its  analysis  of  drafts  covering  several  high  technology
sectors  such  as  genetic  treatment  and  the  use  of  stem  cells,  that  the  Member  States  are
increasingly  linking  the  processing  and  handling  of  products  to  requirements  imposed  on
service providers.

The other challenge for Directive 98/34/EC is enlargement. A first step has already been taken
with  Turkey,  which  has  had  the  possibility  since  1  January  2001  of  participating  in  the
notification procedure under a simplified arrangement. The Commission is currently studying
ways of including the participation of candidate countries in the notification procedure prior
to  their  accession,  in  the  same  way  as  the  EFTA  countries,  given  the  importance  of  the
Directive for the creation of an enlarged internal market.

Concerned  both  with  enlargement  and  the  importance  of  information  society  services,  the
Convention on information and legal cooperation concerning information society services of
the Council of Europe incorporates, in part, Directive 98/34/EC in this field. Its purpose is to
increase transparency and the knowledge of all the Member States of the Council of Europe
and  the  observer  States  of  the  national  regulations  planned  in  connection  with  information
society services. The Community is soon to accede to this Convention.

Finally,  the  Commission  should  continue  emphasising  the  transparency  of  the  notification
procedure, in the light of the undertakings it made in the White Paper on Governance.

52

An  internal  market  strategy  for  the  services,  COM(2000)  888  final,  of  29.12.2000,  p.  16  and  the
Working  Programme  2001  of  the  Enterprise  DG,  second  part,  p.  82.  A  contract  for  the  provision  of
services will also soon be concluded in this respect jointly by the Enterprise DG and the Internal Market
DG as part of the internal market strategy for services mentioned.

51

                                                
Part III: Annexes

52

1.

ANNEXES REGARDING STANDARDISATION

1.1.

Breakdown of new standardisation activities started each year between 1991 and 1998

CEN/CENELEC members in the EU

Year

Level

a. National activities

a.1 Connected with
European or
international
activities

1994

1995

1996

1997

1998

1999

2000

2001

No

%

No

%

No

%

No

%

No

%

No

%

No

%

No

%

119

2,3

74

1,4

62

1,4

71

1,5

49

1,1

43

1,2

35

0,9

28

0,7

a.2 Specific*

1511

29,8

1839

35,4

1531

34,4

1356

28,1

1497

35,8

1262

35,6

1348

33,5

1483

38,3

a.3 Total (a.1 + a.2)

1630

32,2

1913

36,8

1593

35,7

1427

29,6

1546

36,9

1305

36,8

1383

34,4

1512

39,0

b. European activities

1985

39,2

2091

40,3

1643

36,8

2270

47,2

1684

40,2

1505

42,4

1707

42,4

1548

40,0

c. International

activities

1454

28,7

1190

22,9

1223

27,4

1116

23,2

958

22,9

739

20,8

935

23,2

811

21,0

d. Total (a + b + c)

5069

100

5194

100

4459

100

4813

100

4188

100

3549

100

4025

100

3870

100

Source: Notifications to CEN/CENELEC.

These  figures  could  be  overestimated  as  not  all  CEN/CENELEC  members  automatically  report  any  links  with  European  or  international

(*)
activities.

53

1.2.

Breakdown of new standardisation activities started in 1999

CEN/CENELEC members in the EU

Field

Level

a. National activities

a.1 Connected with
European or
international drafts

Non-electrical

(1)

No

43

%

1,6

a.2 Specific*

1226

44,3

a.3 Total

(a.1 + a.2)

1269

45,9

b. European activities

c. International

activities

d. Total

(a + b + c)

911

589

2769

32,9

21,2

100

Source: Notifications to CEN/CENELEC.

Electrical

(2)

Total

(3) = (1) + (2)

Non-electrical
share

(1) x 100

No

0

36

36

594

150

780

%

0

4,6

4,6

76,2

19,2

100

No

43

1262

1305

1505

739

3549

%

1,2

35,6

36,8

42,4

20,8

100

(3)

%

100

97,1

97,2

60,5

79,7

78,0

(*) These figures could be overestimated as not all CEN/CENELEC members automatically report any links with European or international activities.

54

1.3.

Breakdown of new standardisation activities started in 2000

CEN/CENELEC members in the EU

Non-electrical

(1)

Electrical

(2)

Total

(3) = (1) + (2)

Non-electrical
share

(1) x 100

Field

Level

a. National activities

a.1 Connected with
European or
international drafts

a.2 Specific*

a.3 Total

(a.1 + a.2)

No

35

1318

1353

b. European activities

1091

c. International

activities

d. Total

(a + b + c)

729

3173

%

1,1

41,5

42,6

34,4

23,0

100

No

0

30

30

616

206

852

%

0

3,5

3,5

72,3

24,2

100

No

35

1348

1383

1707

935

4025

%

0,9

33,5

34,4

42,4

23,2

100

(3)

%

100

97,8

97,8

63,9

78,0

78,8

Source: Notifications to CEN/CENELEC. (*) These figures could be overestimated as not all CEN/CENELEC members automatically report any links
with European or international activities.

55

1.4

Breakdown of new standardisation activities started in 2001

CEN/CENELEC members in the EU

Non-electrical

(1)

Electrical

(2)

Total

(3) = (1) + (2)

Non-electrical
share

(1) x 100

No

28

1467

1495

875

636

3006

%

1,0

48,8

49,8

29,1

21,1

100

No

0

16

16

673

175

864

%

0

1,9

1,9

77,9

20,2

100

No

28

1483

1511

1548

811

3870

%

0,7

38,3

39,0

40,0

21,0

100

(3)

%

100

98,9

98,9

56,5

78,4

77,7

Field

Level

a. National activities

a.1 Connected with
European or
international drafts

a.2 Specific*

a.3 Total

(a.1 + a.2)

b. European activities

c. International

activities

d. Total

(a + b + c)

Source: Notifications to CEN/CENELEC.

(*) These figures could be overestimated as not all CEN/CENELEC members automatically report any links with European or international activities.

56

1.5.

Breakdown by country of new national standardisation activities notified in 1999

Non-electrical

Electrical

Total

Field

Country

a. DE

b. ESP

c. FR

d. IT

e. AUS

f. UK

g. Other EU
countries

h. EU total

i.  EFTA  countries
+ CZ

No

385

150

229

98

182

84

141

1269

105

j. Grand total (h+i)

1374

Sources: Notifications to CEN/CENELEC.

%

28,0

10,9

16,7

7,2

13,2

6,1

10,3

92,4

7,6

100

No

12

4

2

1

2

12

3

36

1

37

%

32,4

10,8

5,4

2,7

5,4

32,5

8,1

97,3

2,7

100

No

397

154

231

99

184

96

144

1305

106

1411

%

28,2

10,9

16,4

7,0

13,0

6,8

10,2

92,5

7,5

100

Notes:

1. 

2. 

Comparisons  between  the  various  countries  must  be  made  with  some  caution,  since  the  exact  stage  at  which  a  new  draft  is  notified  by  the
INFOPRO system has not been harmonised.

These  figures  reflect  the  number  of  notifications  managed  by  the  central  unit.  Any  questions  relating  to  the  exact  number  of  new  activities
started at national level should be sent to the relevant national standardisation body.

3. 

CZ: Czech Republic.

57

1.6.

Breakdown by country of new national standardisation activities notified in 2000

Non-electrical

Electrical

Total

Field

Country

a. DE

b. ESP

c. FR

d. IT

e. AUS

f. UK

g. Other EU
countries

h. EU total

i.  EFTA  countries
+ CZ

No

406

158

207

120

171

144

151

1353

53

j. Grand total (h+i)

1406

Sources: Notifications to CEN/CENELEC.

Notes:

%

28,9

11,2

14,7

8,5

12,1

10,2

10,7

96,3

3,7

100

No

6

3

8

0

8

3

2

30

3

33

%

18,2

9,1

24,2

0

24,2

9,1

6,1

90,9

9,1

100

No

408

161

215

120

179

147

153

1383

56

1439

%

28,4

11,2

14,9

8,3

12,5

10,2

10,6

96,1

3,9

100

Comparisons  between  the  various  countries  must  be  made  with  some  caution,  since  the  exact  stage  at  which  a  new  draft  is  notified  by  the

1.
INFOPRO system has not been harmonised.

These  figures  reflect  the  number  of  notifications  managed  by  the  central  unit.  Any  questions  relating  to  the  exact  number  of  new  activities

2.
started at national level should be sent to the relevant national standardisation body.

3.

CZ: Czech Republic.

58

1.7.

Breakdown by country of new national standardisation activities notified in 2001

Non-electrical

Electrical

Total

Field

Country

a. DE

b. ESP

c. FR

d. IT

e. AUS

f. UK

g. Other EU
countries

h. EU total

i.  EFTA  countries
+ CZ

No

514

233

127

121

226

117

157

1495

76

j. Grand total (h+i)

1571

Sources: Notifications to CEN/CENELEC.

Notes:

%

32,7

14,8

8,1

7,7

14,4

7,5

10,0

95,2

4,8

100

No

3

2

7

1

0

2

1

16

1

17

%

17,6

11,8

41,2

5,9

0

11,8

5,9

94,1

5,9

100

No

517

235

134

123

226

119

158

1511

76

1587

%

32,6

14,8

8,4

7,8

14,2

7,5

10,0

95,3

4,7

100

Comparisons  between  the  various  countries  must  be  made  with  some  caution,  since  the  exact  stage  at  which  a  new  draft  is  notified  by  the

1.
INFOPRO system has not been harmonised.

These  figures  reflect  the  number  of  notifications  managed  by  the  central  unit.  Any  questions  relating  to  the  exact  number  of  new  activities

2.
started at national level should be sent to the relevant national standardisation body.

3.

CZ: Czech Republic

59

1.8

Top ten subsectors for new national standardisation activities in 1999

SUBSECTORS

Number of new activities

(EU + EFTA + CZ)

Code

C01

T02

B03

B01

N14

S09

N03

B02

B99

C02

Total

Name

Foodstuffs

Aeronautics

Concrete

Fire protection

Plastic tubes

Water quality and water supply

Oil products

Construction

Building - miscellaneous aspects

Paints and assimilated products

80

63

46

43

40

40

36

34

34

31

447

Source: Notifications to CEN/CENELEC.
Notes: In 1999 the top two subsectors in the electrical engineering sector were:

CZ: Czech Republic

- electricity cables (code W08): 11 new drafts
- electricity cables (code V07): 3 new drafts

60

1.9.

Top ten subsectors for new national standardisation activities in 2000

SUBSECTORS

Number of new activities

(EU + EFTA + CZ)

Code

C01

T02

N03

B02

S09

B99

H09

N05

B01

S99

Total

Name

Foodstuffs

Aeronautics

Oil products

Construction

Water quality and water supply

Building - miscellaneous aspects

Furniture

Textiles

Fire protection

Health - miscellaneous

73

47

44

41

41

38

36

36

30

29

415

Source: Notifications to CEN/CENELEC.

Notes:

In 2000 the top two subsectors in the electrical engineering sector were:
- electrical installations in buildings (code W27): 9 new drafts
- electricity cables (code W08): 7 new drafts

61

1.10.

Top ten subsectors for new national standardisation activities in 2001

SUBSECTORS

Number of new activities

(EU + EFTA + CZ)

Code

C01

B99

B03

S09

B02

F99

I09

T02

H99

B01

Total

Name

Foodstuffs

Building - miscellaneous aspects

Concrete

Water quality and water supply

Construction

Basic standards

Small tools

Aeronautics

Household goods

Fire protection

80

74

70

65

55

45

44

41

35

34

543

Source: Notifications to CEN/CENELEC.

Notes:

In 2001 the top two subsectors in the electrical engineering sector were:
- electronical devices (code V15): 3 new drafts
- alarm systems (code V21): 3 new drafts

62

1.11

Application  of  Article  4  (requests  to  participate  in  national  standardisation
activities and requests to draw up a European standard)

Year

1985

1986

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

Requests for
information

Comments

Requests to
participate

Requests for a
European
standard

14

16

74

67

52

78

83

52

34

74

46

63

58

29

5

8

5

0

0

20

0

0

0

5

0

0

0

0

50

24

14

5

10

5

15

16

7

16

5

7

7

4

8

5

3

4

6

1

0

1

0

0

1

0

0

0

0

1

2

1

0

2

3

2

0

Source : CEN

Notes:

1.

2.

3.

4.

In  the  absence  of  detailed  figures,  the  totals  given  are  for  the  EU  plus  the  EFTA
countries + CZ.
Not all requests for information or to participate and comments were reported to the
CEN Management Centre.
Following  a reminder by CEN/CENELEC, some comments dating  from 1985/1986
were entered in 1987.
From  1989  the  figures  are  primarily  for  CEN,  following  the  introduction  of  the
Vilamoura system in CENELEC.

63

1.12.

Standardisation work entrusted to the European standardisation bodies in 1999

1.

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

Mandates related to New Approach Directives

Mandate  for  CEN  and  CENELEC  concerning  the  execution  of  standardisation  work
for  harmonised  standards  on  thermal  insulating  products,  doors,  windows,  shutters,
gates  and  associated  hardware;  membranes;  precast  normal/  lightweight/  autoclaved
aerated concrete products.

Mandate  for  CEN  and  CENELEC  concerning  the  execution  of  standardisation  work
for harmonised standards on adhesives used in the construction industry.

Mandate  for  CEN  and  CENELEC  concerning  the  execution  of  standardisation  work
for  harmonised  standards  on  pipes,  tanks  and  piping  accessories  not  coming  into
contact with water intended for human consumption.

Mandate  for  CEN  and  CENELEC  concerning  the  execution  of  standardisation  work
for harmonised standards on products for concrete, mortar and grout.

Mandate  for  CEN  and  CENELEC  concerning  the  execution  of  standardisation  work
for harmonised standards on space heating appliances.

Mandate  for  CEN  and  CENELEC  concerning  the  execution  of  standardisation  work
for  harmonised  standards  on  thermal  insulation  products,  doors,  windows,  shutters,
gates  and  associated  hardware;  membranes,  precast  normal/  lightweight/  autoclaved
aerated  concrete  products;  chimneys,  flues  and  specific  products;  gypsum  products;
fire  detection  and  alarm  systems,  fixed  firefighting  installations,  smoke  and  fire
control devices and explosion suppression products.

Addendum  to  the  mandates  for  CEN  and  CENELEC  concerning  the  execution  of
standardisation  work  for  harmonised  standards  on  circulation  fixtures,  structural
support appliances and floor coverings.

Mandate  for  CEN  to  reviewing  the  harmonised  standard  EN  1384  “Helmets  for
equestrian  activities”  following  the  petition  in  the  European  Parliament  aiming  to
improve rider safety.

Mandate  for  CEN,  CENELEC  and  ETSI  with  a  view  to  preparing  an  EN  standard
similar  to  the  future  ISO  9001:2000  standard  for  application  in  the  regulatory  field
(application of modules, etc.)

Mandate for CEN, CENELEC and ETSI concerning the applicability of the Directive
on electromagnetic compatibility to aircraft.

Mandate for CEN, CENELEC and ETSI in the field of Directive 1999/5/EC on radio
equipment and telecommunications terminal equipment.

Mandate  in  the  field  of  construction  products:  horizontal  complement  to  the
standardisation  mandates  for  CEN  and  CENELEC  concerning  the  evaluation  of
construction products in respect of their reaction to fire.

64

– 

– 

2.

3.

4.

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

Mandate  in  the  field  of  construction  products:  horizontal  complement  to  the
standardisation  mandates  for  CEN  and  CENELEC  concerning  the  evaluation  of
construction products in respect of their resistance to fire.

Mandate for CEN and CENELEC concerning medical devices.

Mandates in connection with public procurement

(No mandates)

Mandates  in  connection  with  Community  policy  in  the  field  of  information
technology and telecommunications

(No mandates)

Mandates in connection with other Community policies.

4.1. Consumer policy

Mandate for CEN, CENELEC and ETSI in the field of consumer safety: ladders.

Mandate for CEN, CENELEC and ETSI in the field of the safety and user-friendliness
of products for people with special needs (the elderly or disabled).

Supplement to the existing mandate for CEN concerning the methods of analysis for
materials and articles intended to come into contact with foodstuffs.

Mandate  for  CEN,  CENELEC  and  ETSI  related  to  consumer  safety:  product
information.

Mandate for CEN, CENELEC and ETSI related to consumer safety: child safety .

4.2 Environmental policy

Mandate  for  CEN  for  establishing  a  standard  pertaining  to  a  fuel  quality  monitoring
system.

Mandate  for  CEN  related  to  measuring  methods  for  concentrations  of  particulate
matters with PM 2.5 in ambient air.

4.3 Energy policy

Mandate  for  CEN  and  CENELEC  for  drawing  up  and  adopting  measurement
standards for household gas ovens (document from the IRL delegation).

Mandate  for  CEN  and  CENELEC  relating  to  the  revision  and  extension  of  the
standard  EN  50294  "Methods  of  measurement  of  total  input  power  of  ballast-lamp
circuits".

Mandate for CEN and CENELEC regarding the methods for measuring the efficiency
of  ballast-lamp  circuits  for  discharge  lamps  and  the  efficiency  of  outdoor  discharge
lamp luminaries.

65

1.13.

Standardisation work entrusted to the European standardisation bodies in 2000

1.

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

2.

3.

Mandates related to New Approach Directives

Mandate  for  CEN  under  Directive  98/37/EC  relating  to  machines  with  a  view  to
revising standards EN 1726-1 and EN 1459 concerning the safety of industrial trucks.

Mandate  for  CEN,  CENELEC  and  ETSI  concerning  cableway  installations  designed
to carry persons.

Mandate  for  CEN  for  the  realisation  of  harmonised  standards  in  the  field  of
construction products: flat glass, profiled glass and glass block products.

Mandate for CEN relating to the revision of standard EN ISO 11681-2 on chainsaws
for tree-service.

Mandate  for  CEN  relating  to  the  revision  of  revision  of  standard  EN  703:1995  on
safety of agricultural machines/silage cutters.

Mandate  for  CEN,  CENELEC  and  ETSI  relating  to  the  safety  aspects  of  the
electromagnetic  fields  generated  by  certain  appliances  in  connection  with  Directive
73/23/EEC,  Directive  1999/5/EC  and  Council  Recommendation  1999/519/EC  of  12
July 1999.

Mandate  for  CEN  and  CENELEC  concerning  the  execution  of  standardisation  work
for harmonised standards on construction products in contact with water.

Mandate  for  CEN  and  CENELEC  concerning  the  execution  of  standardisation  work
for harmonised standards on construction products and in relation to fire performance.

Supplement  to  the  existing  mandate  for  CEN  and  CENELEC  concerning  the
performance  of  standardisation  work  on  harmonised  standards  for  heat  insulation
products.

Mandate for CEN relating to the revision of standard EN 795/1996 "Protection against
falls from a height – Anchorage devices – Requirements and testing".

Mandates in connection with public procurement

(No mandates)

Mandates  in  connection  with  Community  policy  in  the  field  of  information
technology and telecommunications

(No mandates)

4.

Mandates in connection with other Community policies.

4.1. Consumer policy

– 

Mandate for CEN on fire resistance of nightwear.

66

– 

Mandate  for  CEN  in  the  field  of  consumer  safety :  cords  and  ties  on  children’s
clothing.

4.2 Environmental policy

– 

Mandate for CEN relating to solid biofuels.

4.3 Energy policy

– 

– 

Mandate  for  CEN and  CENELEC  relating  to  definitions  and  measurements  methods
for stand-by losses of domestic appliances.

Mandate for CENELEC for the revision of standards for definitions and measurement
methods for the efficiency of oil-cooled and dry-type transformers.

4.3 Research policy

– 

Mandate for CEN, CENELEC and ETSI on technologies for humanitarian demining.

67

1.14.

Standardisation work entrusted to the European standardisation bodies in 2001

1.

– 

– 

– 

2.

3.

4.

– 

– 

– 

– 

Mandates related to New Approach Directives

Mandate for CEN relating to the revision of standard EN ISO 848-3:1999 "Safety of
woodworking machines".

Mandate for CEN for the revision of standards in the field of packaging and the waste
from packaging in the context of Directive 94/62/EC.

Mandate for CEN, CENELEC and ETSI concerning electromagnetic compatibility for
the telecommunications network in the context of Directive 89/336/EEC.

Mandates in connection with public procurement

(No mandates)

Mandates  in  connection  with  Community  policy  in  the  field  of  information
technology and telecommunications

(No mandates)

Mandates in connection with other Community policies.

4.1 Agriculture policy

Mandate  for  CEN  for  the  development  and  adoption  of  standards  for  animal  feed  in
connection with Directive 70/373/EEC.

4.2 Environmental policy

Mandate  for  CEN  for  standardised  measuring  methods  for  benzo(a)pyrene,  in
connection with Council Directive 96/62/EC.

4.3 Energy policy

Mandate  for  CEN  for  the  development  and  adoption  of  measurement  standards
relating to domestic appliances for the production of hot water and running on gas.

4.4 Internal market policy, aspects other than those related to the New Approach.

Mandate  for  CEN,  CENELEC  and  ETSI  for  the  development  and  adoption  of
standards in the postal field.

68

2.

2.1.

ANNEXES CONCERNING TECHNICAL REGULATIONS

Number of notifications of technical rules  from  each Member State  from 1999
to 2001

2000

39

114

83

20

23

30

13

7

26

7

122

138

5

29

95

751

2001

30

36

50

27

22

55

8

2

30

0

98

75

7

40

50

530

Member State

1999

Belgium

Denmark

Germany

Spain

Finland

France

Greece

Ireland

Italy

Luxembourg

Netherlands

Austria

Portugal

Sweden

United Kingdom

EC total

20

43

85

31

24

54

17

4

25

1

128

69

6

35

49

591

69

2.2.

Percentages  of  notifications  of  technical  rules  from  each  Member  State  from
1999 to 2001

Member State

Belgium

Denmark

Germany

Spain

Finland

France

Greece

Ireland

Italy

Luxembourg

Netherlands

Austria

Portugal

Sweden

United Kingdom

%

2000

5.2

15.2

11.0

2.7

3.1

4.0

1.7

0.9

3.5

0.9

16.2

18.4

0.7

3.9

12.6

%

2001

5.7

6.8

9.4

5.1

4.1

10.4

1.5

0.4

5.7

0

18.5

14.2

1.3

7.5

9.4

%

1999

3.4

7.3

14.4

5.2

4.1

9.1

2.9

0.7

4.2

0.2

21.6

11.7

1.0

5.9

8.3

70

2.3

Breakdown by sector of drafts notified by the Member States of the European Union (1999)

SECTOR

B

DK

D

E

FIN

F

GR IRL

Building and construction

Agricultural products and
foodstuffs

Chemical products

Pharmaceuticals

Household and leisure equipment

Mechanical engineering

Energy, minerals, wood

Environment, packaging

Health, medical equipment

Transport

Telecommunications

Miscellaneous

Information society services

2

2

1

3

0

5

0

2

1

1

3

0

0

10

10

7

3

1

0

2

1

6

0

11

2

0

0

6

1

5

0

26

0

3

0

10

22

1

1

3

6

3

2

3

1

1

1

0

5

3

0

3

2

0

3

1

0

2

3

0

0

7

2

4

0

1

8

8

3

0

5

5

3

1

9

8

3

0

2

7

1

0

0

2

1

0

0

3

0

0

1

TOTAL BY MEMBER STATE

20

43

85

31

24

54

17

3

1

0

0

0

0

0

0

0

0

0

0

0

4

I

0

12

2

1

1

5

0

1

0

1

1

0

1

25

L

NL

A

P

0

0

0

0

0

0

0

0

0

0

1

0

0

1

5

43

9

1

2

1

8

16

0

19

14

7

3

30

4

3

1

2

7

4

5

1

6

5

0

1

128

69

1

2

0

0

0

1

0

1

0

0

1

0

0

6

S

1

18

2

3

1

2

1

2

0

4

1

0

0

UK

EC
TOTAL

3

9

1

6

0

2

0

4

0

14

7

2

1

73

125

37

27

9

61

24

44

3

90

70

17

11

35

49

591

71

2.3.

Breakdown by sector of drafts notified by the Member States of the European Union (2000)

GR IRL

L

NL

A

P

S

UK

SECTOR

B

DK

D

E

FIN

Building and construction

Agricultural 
foodstuffs

products 

and

Chemical products

Pharmaceuticals

Household and leisure equipment

Mechanical engineering

Energy, minerals, wood

Environment, packaging

Health, medical equipment

Transport

Telecommunications

Miscellaneous

Information society services

0

7

2

0

5

4

1

1

0

5

6

5

3

26

17

4

2

1

1

4

2

3

1

22

47

0

1

9

0

2

0

2

2

0

0

6

42

0

3

1

7

0

0

2

4

1

1

0

4

0

0

0

5

4

3

0

0

3

0

1

0

5

1

0

1

F

4

12

3

2

0

1

1

1

2

3

0

0

1

2

4

1

1

0

0

3

0

0

2

0

0

0

TOTAL BY MEMBER STATE

39

114

83

20

23

30

13

72

I

1

10

2

0

0

1

1

2

0

4

2

0

3

26

0

0

0

0

0

0

0

0

0

0

5

1

1

7

0

0

0

0

0

0

2

0

0

2

0

0

3

7

6

54

12

0

0

5

8

13

0

13

2

5

4

39

1

3

0

0

7

3

5

2

31

43

3

1

122

138

0

5

0

0

0

0

0

0

0

0

0

0

0

5

EC
TOTAL

109

127

33

13

8

42

26

33

5

131

186

15

23

3

6

3

1

0

4

1

1

0

8

1

0

1

5

4

2

6

0

7

1

5

0

26

37

1

1

29

95

751

2.3.

Breakdown by sector of drafts notified by the Member States of the European Union (2001)

SECTOR

B

DK

D

E

FIN

F

GR IRL

Building and construction

Agricultural products and
foodstuffs

Chemical products

Pharmaceuticals

Household and leisure equipment

Mechanical engineering

Energy, minerals, wood

Environment, packaging

Health, medical equipment

Transport

Telecommunications

Miscellaneous

Information society services

3

5

0

1

3

1

3

3

0

6

0

3

2

3

8

0

1

3

1

2

3

0

8

4

2

1

12

9

2

6

0

2

1

8

0

2

1

2

5

5

6

2

0

1

5

0

1

1

1

0

3

2

5

0

0

1

0

1

1

0

0

4

2

2

6

11

6

0

9

1

3

6

1

0

3

11

2

2

TOTAL BY MEMBER STATE

30

36

50

27

22

55

1

1

0

0

0

0

2

1

0

3

0

0

0

8

1

0

0

0

0

0

0

1

0

0

0

0

0

2

I

5

5

0

0

0

4

5

0

1

5

2

1

2

30

L

NL

A

P

0

0

0

0

0

0

0

0

0

0

0

0

0

0

4

37

7

3

1

4

5

10

2

15

3

6

1

41

9

4

0

0

0

3

4

0

3

9

1

1

98

75

1

1

1

0

0

0

1

0

0

1

0

1

1

7

S

1

13

2

1

4

2

1

1

0

9

2

3

1

UK

EC
TOTAL

6

8

1

2

0

2

2

4

2

9

13

1

1

99

108

19

24

13

25

32

37

6

69

47

26

25

50

40

530

73

2.4.

Number of notifications compared with number of times emergency procedure
invoked by sector between 1999 and 2000

SECTOR

Total
number

% of total

No

% urgent
cases

of urgent cases

Building and construction

Agricultural  products  and
foodstuffs

Chemical products

Pharmaceuticals

Household 
equipment

and 

leisure

Mechanical engineering

Energy, minerals, wood

Environment, packaging

Health, medical
equipment

Transport

Telecommunications

Miscellaneous

Information 
services

society

281

360

89

64

30

128

82

114

14

290

303

58

59

4

52

7

6

1

6

1

3

3

14

0

1

5

1.4%

14.5%

7.9%

9.4%

3.3%

4.7%

1.2%

2.6%

21.4%

4.8%

0%

1.7%

8.5%

100%

100%

100%

100%

100%

100%

100%

100%

100%

100%

100%

100%

100%

74

2.5.

Comparison between notifications and reactions by sector (only detailed opinions and comments) - 1999

SECTOR

Number of
notifications

Detailed
opinion from
the
Commission

Detailed
opinion
from the
Member
States

Comments
(Commission
and Member
States)

% detailed
opinions in
relation to
number of
notifications*

% comments in relation
to number of
notifications*

Building and construction

Agricultural products and foodstuffs

Chemical products

Pharmaceuticals

Household and leisure equipment

Mechanical engineering

Energy, minerals, wood

Environment, packaging

Health, medical equipment

Transport

Telecommunications

Information society services

Miscellaneous

Total all sectors

73

125

37

27

9

61

24

44

3

90

70

11

17

2

12

3

2

3

2

3

1

0

8

6

1

0

1

31

22

2

3

4

4

7

8

6

0

0

5

35

84

55

8

3

39

16

37

3

46

60

10

12

4.1%

34.4%

67.6%

14.8%

66.7%

9.8%

29.2%

18.2%

266.7%

15.6%

8.6%

9.1%

29.4%

591

43

93

408

47.9%

67.2%

148.6%

29.6%

33.3%

63.9%

66.7%

84.1%

100%

51.1%

85.7%

91%

70.6%

*

These  percentages  are  explained  by 

the  fact  one  notification  can  receive  several  detailed  opinions  and/or  comments

75

2.5.

Comparison between notifications and reactions by sector (only detailed opinions and comments) - 2000

SECTOR

Number of
notifications

Detailed
opinion from
the
Commission

Detailed
opinion
from the
Member
States

Comments
(Commission
and Member
States)

% detailed
opinions in
relation to
number of
notifications*

% comments
in relation to
number of
notifications*

Building and construction

Agricultural products and foodstuffs

Chemical products

Pharmaceuticals

Household and leisure equipment

Mechanical engineering

Energy, minerals, wood

Environment, packaging

Health, medical equipment

Transport

Telecommunications

Information society services

Miscellaneous

Total all sectors

109

127

33

13

8

42

26

33

5

131

186

23

15

751

4

13

2

1

2

5

0

4

0

5

1

11

1

49

6

42

11

0

3

9

5

4

2

8

1

0

4

95

38

92

29

1

2

22

16

13

5

66

144

9

7

444

9.2%

43.3%

39.4%

7.7%

62.5%

33.4%

19.2%

24.2%

40%

9.9%

1.1%

47.8%

33.3%

34.8%

72.4%

87.9%

7.7%

25%

52.4%

61.5%

39.4%

100%

50.4%

77.4%

39.1%

46.7%

*

These percentages are explained by the fact one notification may be the subject of several detailed opinions and/or comments.

76

2.5.

Comparison between notifications and reactions by sector (only detailed opinions and comments) - 2001

SECTOR

Number
of
notificat
ions

Detailed
opinion from
the
Commission

Detailed
opinion
from the
Member
States

Comments
(Commission
and Member
States)

% detailed
opinions in
relation to
number of
notifications*

% comments
in relation to
number of
notifications*

Building and construction

Agricultural products and foodstuffs

Chemical products

Pharmaceuticals

Household and leisure equipment

Mechanical engineering

Energy, minerals, wood

Environment, packaging

Health, medical equipment

Transport

Telecommunications

Information society services

Miscellaneous

Total all sectors

99

108

19

24

13

25

32

37

6

69

47

25

26

24

6

2

1

4

3

3

3

1

2

7

4

2

530

62

20

15

9

0

1

5

3

13

3

5

2

0

11

87

45

53

16

12

8

14

13

35

8

16

45

15

19

299

44.4%

19.4%

57.9%

4.2%

38.5%

32%

18.7%

43.2%

66.7%

10.1%

19.1%

16%

50%

45.5%

49.1%

84.2%

50%

61.5%

56%

40.6%

94.6%

133.3%

23.2%

95.7%

31.9%

73.1%

*

These percentages are explained by the fact one notification may be the subject of several detailed opinions and/or comments.

77

2.6.

Follow-up to the detailed opinions delivered by the Commission (only finalised
procedures) on notifications in 1999 and 2000

SECTOR

Positive
position by
Commission

% positive
position by
Commission

Negative
position by
Commission

% negative
position by
Commission

Building and construction

Agricultural  products  and
foodstuffs

Chemical products

Pharmaceuticals

Household 
equipment

and 

leisure

Mechanical engineering

Energy, minerals, wood

Environment, packaging

Health, medical
equipment

Transport

Telecommunications

Miscellaneous

Information society
services

Total all sectors

3

9

3

1

4

2

3

2

-*

9

1

1

4

42

100%

60%

100%

33.3%

80%

100%

100%

66.7%

-*

90.9%

100%

100%

80%

84.2%

0

6

0

2

1

0

0

1

-*

2

0

0

1

13

0%

40%

0%

66.7%

20%

0%

0%

33.3%

-*

9.1%

0%

0%

20%

15.8%

No detailed opinion was delivered by the Commission in this field in 1999 or 2000.

78

2.7.

Breakdown  by  sector  of  drafts  notified  by  Iceland,  Norway  and  Switzerland
between 1999 and 2001

SECTOR

Iceland

Norway

Switzerland

Total for
sector

1999

2000

2001

1999

2000

2001

1999

2000

2001

1999

2000

2001

Building and
construction

Agricultural  products
and foodstuffs

Chemical products

Pharmaceuticals

Household and leisure
equipment

Mechanical
engineering

Energy, minerals,
wood

Environment,
packaging

Health, medical
equipment

Transport

Telecommunications

Miscellaneous

Information 
services

society

Total all sectors

0

2

1

0

0

0

0

0

0

1

0

0

0

4

0

4

0

0

0

0

0

0

0

0

0

0

0

4

0

5

0

0

0

0

0

0

0

0

0

0

1

6

1

5

1

0

1

2

0

0

0

3

1

0

0

0

1

1

1

0

0

0

1

0

2

8

1

0

0

3

2

0

0

5

1

0

0

0

3

0

2

0

8

3

1

0

2

0

1

0

1

0

1

0

14

15

16

17

0

1

1

1

0

1

0

1

0

1

3

0

0

9

0

5

1

3

0

0

1

0

0

1

1

0

0

1

15

5

1

1

4

0

1

0

5

1

1

0

0

6

2

2

0

1

0

2

0

3

11

1

0

0

13

3

3

0

5

2

0

0

1

4

0

3

12

35

28

34

79

Comments on drafts notified by Iceland, Norway and Switzerland in the 1999-
2001 period

2.8.

1999

Country

Notifications

EC comments

Iceland

Norway

Switzerland

Total

2000

4

14

17

35

1

8

9

18

Country

Notifications

EC comments

Iceland

Norway

Switzerland

Total

2001

4

15

9

28

2

7

6

15

Country

Notifications

EC comments

Iceland

Norway

Switzerland

Total

4

15

4

23

6

16

12

34

80