COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 07.07.2000
COM(2000) 429 final

REPORT FROM THE COMMISSION TO THE COUNCIL, THE EUROPEAN

PARLIAMENT AND THE ECONOMIC AND SOCIAL COMMITTEE

THE OPERATION OF DIRECTIVE 98/34/EC FROM 1995 TO 1998

 CONTENTS

REPORT FROM THE COMMISSION TO THE COUNCIL, THE EUROPEAN

PARLIAMENT AND THE ECONOMIC AND SOCIAL COMMITTEE: THE OPERATION
OF DIRECTIVE 98/34/EC FROM 1995 TO 1998 ................................................................. 1

1. SUMMARY ................................................................................................................ 6

2. INTRODUCTION ....................................................................................................... 6

3. PART I: THE INFORMATION PROCEDURE FOR STANDARDS .......................... 9

3.1. Introduction ........................................................................................................... 9

3.2. Brief description of the procedure .......................................................................... 9

3.3. Operation of the information procedure from 1995 to 1998 .................................. 10

3.4. Trends in standardisation activities....................................................................... 11

3.5. Quality of the notifications from the national standardisation bodies .................... 12

3.6. Use of the information received through the procedure ........................................ 12

3.7. Information on standardisation activities in general.............................................. 14

3.8. Programming and standardisation mandates......................................................... 15

3.9. Action to improve the procedure .......................................................................... 16

3.10. Conclusions ......................................................................................................... 16

4. PART II: THE NOTIFICATION PROCEDURE FOR TECHNICAL RULES WITHIN

THE EUROPEAN COMMUNITY ............................................................................ 18

4.1. Introduction ......................................................................................................... 18

4.2. Description of the procedure ................................................................................ 19

4.2.1. Brief description of the procedure applicable to technical rules set up by

Directive 98/34/EC..................................................................................... 19

4.2.2. Changes made by Directive 94/10/EC to the procedure set up by Directive

83/189/EEC................................................................................................ 20

4.3. Application of the procedure................................................................................ 21

4.3.1. Volume of notifications .............................................................................. 21

4.3.1.1. General trend.............................................................................................. 21

4.3.1.2. Breakdown by country................................................................................ 22

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 4.3.1.3. Breakdown by sector .................................................................................. 23

4.3.2. Use of the emergency procedure................................................................. 24

4.3.3. Commission reactions................................................................................. 25

4.3.3.1. General trend.............................................................................................. 25

4.3.3.2. Detailed opinions........................................................................................ 25

4.3.3.3. Comments .................................................................................................. 28

4.3.3.4. Intention to propose, adopt or present to the Council a proposal for a binding
Community act - standstill decision ............................................................ 29

4.3.4. Reactions of the Member States.................................................................. 30

4.3.5. Handling of infringements .......................................................................... 30

4.3.6. Subsequent procedure................................................................................. 30

4.3.6.1. Meetings of the Committee set up by Directive 98/34/EC........................... 30

4.3.6.2. Package meetings ....................................................................................... 31

4.3.6.3. Meetings with the central units of the Member States ................................. 32

4.3.6.4. Ad hoc meetings......................................................................................... 32

4.4. Factors which contributed to the high number of notifications.............................. 32

4.4.1. Various factors ........................................................................................... 32

4.4.2. Court of Justice case-law ............................................................................ 32

4.4.2.1. Judgments declaring a Member State to have failed to fulfil its obligations. 33

4.4.2.2. Judgments in cases referred for a preliminary ruling ................................... 34

4.4.3. The Dutch operation to catch up on unnotified technical rules .................... 35

4.5. Action to improve transparency and provide businesses with more information ... 35

4.6. Conclusions and prospects ................................................................................... 37

5. PART III: EXCHANGE OF INFORMATION ON TECHNICAL RULES BETWEEN

THE COMMUNITY AND THE EFTA COUNTRIES............................................... 38

5.1. Introduction ......................................................................................................... 38

5.2. Description of the procedure ................................................................................ 38

5.3. Application of the procedure................................................................................ 39

5.3.1. Volume of notifications and breakdown by sector ...................................... 39

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 5.3.2. Reactions.................................................................................................... 40

5.3.2.1. Community comments on EFTA notifications ............................................ 40

5.3.2.2. EFTA comments on Community notifications ............................................ 41

5.4. Conclusions and prospects ................................................................................... 41

6. ANNEXES ................................................................................................................ 42

6.1. Table I - Breakdown of new standardisation activities started each year between
1991 and 1998 ..................................................................................................... 43

6.2. Table II a - Breakdown of new standardisation activities started in 1995 .............. 44

6.3. Table II b - Breakdown of new standardisation activities started in 1996.............. 45

6.4. Table II c - Breakdown of new standardisation activities started in 1997 .............. 46

6.5. Table II d - Breakdown of new standardisation activities started in 1998.............. 47

6.6. Table III a - Breakdown by country of new national standardisation activities

notified in 1995.................................................................................................... 48

6.7. Table III b - Breakdown by country of new national standardisation activities

notified in 1996.................................................................................................... 49

6.8. Table III c - Breakdown by country of new national standardisation activities

notified in 1997.................................................................................................... 50

6.9. Table III d - Breakdown by country of new national standardisation activities

notified in 1998.................................................................................................... 51

6.10. Table IV a - Top ten subsectors for new national standardisation activities in 199552

6.11. Table IV b - Top ten subsectors for new national standardisation activities in 199653

6.12. Table IV c - Top ten subsectors for new national standardisation activities in 199754

6.13. Table IV d - Top ten subsectors for new national standardisation activities in 199855

6.14. Table V - Application of Article 4 (requests to participate in national

standardisation activities and requests to draw up a European standard) ............... 56

6.15. Table VI a - Standardisation work entrusted to the European standardisation bodies

in 1995................................................................................................................. 57

6.16. Table VI b - Standardisation work entrusted to the European standardisation bodies

in 1996................................................................................................................. 59

6.17. Table VI c - Standardisation work entrusted to the European standardisation bodies

in 1997................................................................................................................. 61

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6.18. Table VI d - Standardisation work entrusted to the European standardisation bodies
in 1998................................................................................................................. 63

6.19. Table VII - Number of notifications of technical rules from each Member State
from 1995 to 1998 ............................................................................................... 65

6.20. Table VIII - Percentage of notifications of technical rules from each Member State
from 1995 to 1998 ............................................................................................... 66

6.21. Table IX - Breakdown by sector of drafts notified by the Member States of the
European Union (1995)........................................................................................ 67

6.22. Table X - Breakdown by sector of drafts notified by the Member States of the
European Union (1996)........................................................................................ 68

6.23. Table XI - Breakdown by sector of drafts notified by the Member States of the
European Union (1997)........................................................................................ 69

6.24. Table XII - Breakdown by sector of drafts notified by the Member States of the
European Union (1998)........................................................................................ 70

6.25. Table XIII - Comments on drafts notified by Norway and Switzerland in 1995 .... 71

6.26. Table XIV - Breakdown by sector of drafts notified by Norway and Switzerland in
1995..................................................................................................................... 72

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

THE OPERATION OF DIRECTIVE 98/34/EC FROM 1995 TO 1998

1. SUMMARY

This report on the application of Directive 98/34/EC1 from 1995 to 1998 is intended 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 (brief description of the
procedure, statistical analysis, quality of notifications and use made of the information,
requests to European standardisation bodies to draw up standards); the notification procedure
for technical rules within the European Community (how the procedure has developed,
information exchanged, reactions from the Commission and the Member States, subsequent
procedure, factors which contributed to the increase in the number of drafts notified, action
taken to provide businesses with more information); and the procedure for the exchange of
information on technical rules between the Community and the EFTA countries.

This report describes the role of Directive 98/34/EC during the period in question, and the
way in which it prevents barriers to intra-Community trade. It reflects the results of the
dialogue between the Commission and the Member States, and among the Member States,
and of the establishment of an information network linking European and national
standardisation bodies.

This report is intended to raise awareness of this procedure in the European Union and to
encourage businesses to make greater use of the procedure set up by the Directive.

2. INTRODUCTION

1. This report on the application of Directive 98/34/EC from 1995 to 1998 is intended
to inform the European Parliament, the Council and the Economic and Social
Committee in accordance with Article 11 of Directive 83/189/EEC, as amended by
Directives 88/182/EEC and 94/10/EC and consolidated by Directive 98/34/EC.

2. The purpose of Directive 98/34/EC is to prevent the appearance of barriers to intra-

Community trade; this basic instrument for the completion of the internal market has
fulfilled its purpose by initiating a dialogue between the Commission and the
Member States, by promoting cooperation among the Member States, and by setting
up an information network linking European and national standardisation bodies.

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Directive 83/189/EEC was amended by Directives 88/182/EEC and 94/10/EC and then consolidated by
Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a
procedure for the provision of information in the field of technical standards and regulations (OJ L 204,
21.7.1998, page 37). The latter entered into force on 5 August 1998 and repealed the earlier Directives.
For the sake of simplicity, this report therefore refers to Directive 98/34/EC rather than to Directive
83/189/EC.

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3. The changes made to the Directive, in particular those made during the period
covered by this report, and the case-law of the Court of Justice have contributed to
this result and have enhanced the transparency, dialogue, preventive approach and
reciprocal control which characterised the system from the start.

4. The report on the operation of this instrument from 1995 to 1998 is divided into three
parts.

4.1. The information procedure for standards

After a brief description of the procedure for standards, this section explains how it
worked from 1995 to 1998 and analyses the statistics. It also discusses the quality of
the notifications, the use made thereof, 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.

4.2. The notification procedure for technical rules within the European Community

This section describes how the procedure established by Directive 98/34/EC for
national technical regulations has developed. It examines the information flows,
including the various reactions from the Commission and the Member States, the
possible further procedures, and the results. Particular attention is paid to the factors
which contributed to the increase in the number of drafts notified and to the action
taken to provide businesses with more information.

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

The Agreement on the European Economic Area (EEA Agreement) entered into
force in 1994. It incorporates the provisions of Directive 98/34/EC in an adapted
form. Although the Swiss Confederation is not a party to the EEA Agreement, it
continues to participate in the exchange of information with the Community by
voluntarily following the practice introduced by the Agreement between the Member
States of EFTA and the European Economic Community laying down a procedure
for the exchange of information in the field of technical regulations.2

2
Council Decision 90/518/EEC of 24 September 1990 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, OJ L 291, 23.10.1990. This Agreement was concluded for a period of two
years and expired on 1 November 1992. It was extended for the period from November 1992 to
December 1993 by bilateral agreements in the form of exchanges of letters.

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This section analyses the exchange of information between these countries and the
Community.

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3. PART I: THE INFORMATION PROCEDURE FOR STANDARDS

3.1. Introduction

5. 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 1995 to 1998 and analyses the statistics. It also
discusses the quality of the notifications, the use made thereof, 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.

3.2. Brief description of the procedure

6. In practice, the information procedure for standards began on 1 January 1985. Since
the adoption of Directive 94/10/EC amending Directive 83/189/EEC, the notification
obligation has applied exclusively to new standardisation work started. It no longer
applies to other updates to the national standardisation programmes, namely drafts
for public scrutiny 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
Central Secretariats of CEN and 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 (Central Secretariats, Technical Boards, etc.) and by the Commission
departments.

Appropriate annual contracts were concluded between the European Commission

and CEN and CENELEC on technical operation of the information procedure for
standards.

7. 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 both Central Secretariats. In fact, ETSI is not made up of
national standardisation bodies, as defined 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.

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

3.3. Operation of the information procedure from 1995 to 1998

8. As stated in the previous report, as early as 1993 CEN introduced the simplified
procedure proposed by the Commission in 1992 and on which Directive 94/10/EC
was based. This simplification has enabled the CEN Central Secretariat 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.

In October 1996 CEN introduced the ICS classification for the notifications, the
ISO’s international classification of the various fields - of industry in particular -
covered by the standards. By 1998 the ICS classification had already been added to
around 22% of notifications.

Since the beginning of 1993 the full texts of draft standards for public scrutiny have
been exchanged, case by case, by mutual agreement between the bodies concerned in
the spirit of the participation provided for by Article 3 of Directive 98/34/EC.

9. 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.

As a result of CENELEC’s special 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.

At the express request of the Commission in December 1996, CENELEC confirmed

that the combined procedure described above was working well, and also confirmed
the commitment shown by its members. However, it is regrettable that the
information from the Vilamoura procedure is not released outside, as it is 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.

10. The statistics published in the CEN and CENELEC annual reports supply an
overview of the standardisation activities notified from 1995 to 1998.

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

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

– breakdown by country;

– breakdown by sector and subsector.

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

– the pre-1993 statistics take no account of the relatively high number of new
activities notified directly at the public scrutiny stage; moreover, these late
notifications were contrary to CEN/CENELEC regulations;

– 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.

The accession of three new Member States on 1 January 1995 complicates the
comparison of statistics from before and after that date.

The statistics set out in the annexes disregard notifications from France for
regularisation purposes in the course of 1995. The number of such regularisations
was estimated from the information received from AFNOR (62% of the total of
1 342).

3.4. Trends in standardisation activities

12. Bearing these reservations in mind, a number of comments can be made on the trends
in international, European and national standardisation based on Tables I, II, III and
IV annexed to this report.

– The total number of new activities launched at these three levels has remained
stable since 1993 at around 4 500, after two years of rapid growth in 1991 and
1992.

– At national level, the number of new initiatives averaged 1 620 per year from
1995 to 1998, down from 2 000 per year from 1992 to 1994. The proportion of
very specific work within this number held steady at around 95%.

– The number of new initiatives at European level has fallen sharply since 1993
in comparison with the two previous years in both the electrical and non-
electrical sectors.

– At international level, the downward trend is continuing (average of 1 122

initiatives per year compared with 2 189 per year from 1992 to 1994).

– Tables IIIa to IIId show that on average 50% of new national activities were
from Germany and France. In 1998 the figure for France was in line with the
share of notifications from the other top three Member States (i.e. 10%).

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 – The top ten subsectors for national activities are shown in Tables IVa to IVd.
They show a high level of activity in the fields of aeronautics and chemicals in
1995. In 1996 and 1997 new national activities focused mainly on foodstuffs
and small machine tools. Foodstuffs remained the leading sector in 1998.

3.5. Quality of the notifications from the national standardisation bodies

13. In its previous reports the Commission indicated that there were still problems with
the notification deadlines and the intrinsic quality of the information supplied. The
Commission insisted on additional efforts at national and European level to remedy
this situation. Since the start of the report period (1995/98) such efforts have been
made, 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.

14. First, 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 published
in May 1995. This also explained how one member could participate in another
member’s activities. A month later a training seminar was held for all correspondents
to exchange experience. This was followed up by bilateral contacts on notifications
of dubious quality. A help desk was set up within the Central Secretariat to deal with
questions from suppliers of data.

15. Despite these measures, around 20% of notifications were still submitted late in
1998, compared with 23% in 1994. The main improvement is that in 1998 only 14%
of these late notifications were received at 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.

16. The description of the draft is still not sufficiently precise, although there was some
improvement between 1995 and 1998. In 1995 some 55% of notifications contained
no description other than the title. By 1998 this percentage was down to around 31%,
which is still high. These were principally notifications from the United Kingdom,
France, Finland and Austria. The other main inaccuracies in the notifications were
misclassification of the sector of activity, although there was improvement on this
point between 1995 and 1998. Also, the Commission departments have doubts about
whether some of the new activities are not linked to European or international work.

17. 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, and the lower volumes
involved, the quality of notifications from CENELEC members can be considered
satisfactory at least.

3.6. Use of the information received through the procedure

18. The 1992-94 report recommended a study of the dissemination at national level of
the information gleaned from the procedure, as no detailed information was available
on this subject. In May 1995 the CEN Central Secretariat sent a survey to its
correspondents. Several national bodies replied. It emerged that in Denmark a fee is

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 charged for subscribing to the monthly register and that notifications are examined
mainly by the standardisation body. In Germany the information is circulated to 60
or so relevant trade associations which are responsible for disseminating it to their
members. In France systematic dissemination and broad consultation of industry are
the striking 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.

19. 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. Table V 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;

– with one or two exceptions, requests to draw up European standards are non-
existent.

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

20. 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.
In 1997 this procedure was applied to 33 notifications, of which 14 were transferred
to European level and 5 others were left to be developed at national level, with the
participation of one or more other countries. In 1998 just 13 notifications were made
under this procedure, 3 of which were taken up at European level.

21. 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.

Within the CEN Central Secretariat, 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, 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 number of cases queried was cut from 16 in
1996 to 2 in 1997 because of a lack of resources.

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

– The simplification of the procedure brought about by Directive 94/10/EC has

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

13
 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 believes that further measures could be taken to make more
efficient use of the information at national level. Despite the great efforts made
by the CEN Central Secretariat, 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.

3.7. Information on standardisation activities in general

23. 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.

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.

24. At the start of 1995 a study was made of the knowledge and information needs of
small and medium-sized enterprises in Europe, with particular regard to
standardisation. This Euromanagement study was funded by the Commission and
conducted by AFNOR, the French standardisation body.

It highlighted the enormous difficulties encountered by SMEs in gaining access to

information on standardisation. To remedy this situation, in July 1996 the
Commission launched a profile- and awareness-raising programme. This evolving
programme was designed in close cooperation with the three European
standardisation bodies based on an agreement between them and the Commission.
The biggest project in this programme is the INES project started in 1997 and part-
funded by the Commission, which is intended, inter alia, to open up access to various
CEN documents via the Internet. Other forms of information were also produced
between 1995 and 1998 including a video, a brochure and a series of articles for
publications for SMEs.

25. At the request of the Commission, in 1998 the three standardisation bodies started
the computer work needed to establish a shared web site. 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.

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 This shared site will also provide easy access to the individual sites of the three
European standardisation bodies and to the Commission sites, where, amongst other
things, the full text of the Directives concerned and particulars of the harmonised
standards implementing them can be found. The address of this shared site is:
http://www.NewApproach.org.

26. At the same time the three European standardisation bodies continued to issue a
number of publications explaining their present activities, describing standards
adopted and listing national standards transposing European standards. They also
started their own project to set up a website.

27. The PERINORM information service, distributed monthly on CD-ROM, contains

bibliographic references for adopted standards as well as for standards at the public
scrutiny stage. It covers several countries as well as CEN and CENELEC at
European level and ISO and IEC at international level. The Commission financed
subscriptions to this service for several dozen Euro Information Centres, considered
to be those most affected by this field and covering a wide geographical area.

Other CD-ROMs are available on the market containing, inter alia, the full text of
international, CEN and CENELEC standards.

3.8. Programming and standardisation mandates

28. Pursuant to Article 6(3) of the Directive, the Standing Committee expressed
favourable opinions on 33, 18, 21 and 18 mandates in 1995, 1996, 1997 and 1998
respectively. 26 of these 90 mandates were to implement “new approach” Directives.
Others were principally in support of other Community policies (see Tables VIa,
VIb, VIc and VId in the Annex).

In 1996, 1997 and 1998 several key mandates were issued under the Directive on
Construction Products.

– Eleven mandates were issued on information technology and

telecommunications in 1995.

– Seven requests were made for standardisation in the field of consumer

protection policy.

– Eight mandates were given, principally to CEN, in support of Directives on the

environment.

– Eleven mandates concerned energy policy (reduction of consumption and

alternative sources).

– There were two requests for standardisation relating to transport policy.

This shows that the Commission is turning increasingly to standardisation to

implement various Community policies, as it had announced in its Communication
of 30 October 1995 on the broader use of standardisation in Community policy
(COM (95) 412 final).

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3.9. Action to improve the procedure

29. In the case of standardisation, Directive 94/10/EC introduced a highly simplified

procedure compared with the arrangements in Directive 83/189/EEC, thereby
making it possible to examine the quality of notifications more closely.

30. Several measures were taken by the CEN Central Secretariat, mainly in 1995, to
improve the quality of the data notified: 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 Central Secretariat 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.

31. CEN’s analysis of the quality of notifications submitted from 1995 to 1998, 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. A strict quality
assurance system must therefore be maintained and any new action in this field is
welcome. Potential measures include more frequent reports on the quality of the data
received and detailed examination of the most frequent and most serious problems.
The objective is to take targeted action, for example country by country.

32. 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.

33. With regard to the use made of the information, the current dissemination system
must be reviewed. The introduction of new technologies for notifications and for
disseminating the consolidated information must be envisaged to facilitate
communications 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 the 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 relevant sectors in the information from the procedure for
standards. European or national awareness-raising measures for these sectors could
also be envisaged.

3.10. Conclusions

34. The approximately 25% reduction in the number of new national standardisation
activities since 1993, compared with the previous period, was confirmed. The first

16
 reason for this was the simplified procedure introduced by Directive 94/10/EC,
which requires only strictly new national activities to be notified. The second reason
for this reduction was an actual fall in new national initiatives. The level of such
activity is still high, above all in Germany. Over the report period, an average of
1 620 national initiatives per year were started compared with 1 900 at European
level. Foodstuffs, construction products and small machine tools were the main fields
concerned.

35. The various measures taken by the CEN Central Secretariat, 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.

36. 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 seem insufficient to use this
procedure to verify the standstill declared when a standardisation mandate is issued.
The information procedure for standards is, therefore, not efficient enough. The 1995
questionnaire showed that only a few countries actively disseminate the information.
General dissemination in user-friendly form is needed. Examination of the benefits
and relevance of this procedure to the individual parties is also desirable. However, it
must be stressed that removal of this mechanism for monitoring national activities
could create new, significant risks of disruption of the internal market. It is up to all
parties concerned to consider the usefulness of this procedure and ways of
reinforcing it if it remains in place, but also the consequences were it to be removed.

17
4. PART II: THE NOTIFICATION PROCEDURE FOR TECHNICAL RULES
WITHIN THE EUROPEAN COMMUNITY

4.1. Introduction

37. In the early 1980s the Commission took advantage of the judgment of the Court of
Justice in the “Cassis de Dijon” case to launch a new policy to complete the internal
market resting on three pillars:

– acceptance in each Member State of products legally manufactured in the rest

of the Community (“mutual recognition”);

– harmonisation restricted to major economic sectors, particularly those affecting

health, safety and the environment;

– a preventive approach to the monitoring of national regulations.

Since 1984 Directive 83/189/EEC3 has obliged the Member States of the European
Union to notify the Commission and the other Member States of all draft technical
rules relating to products before they are adopted in national law; this procedure was
extended to cover the rules affecting the information society from 5 August 1999.

38. This revolutionary system has retained 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.

The procedure has been amended a number of times: first in 1988 (by Directive
88/182/EEC4), then in 1994 (by Directive 94/10/EC5), mainly to extend its scope.
Since then it has covered all products, both agricultural and industrial, and a wide
variety of rules.

The procedure for the notification of technical rules was consolidated by Directive
98/34/EC,6 which repealed the earlier Directives. The consolidated Directive entered
into force on 10 August 1998.

Directive 98/34/EC was in turn amended by Directive 98/48/EC,7 which extended

the procedure to information society services from 5 August 1999.

3
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, 26.4.1983.
4
Council Directive 88/182/EEC of 22 March 1988 amending Directive 83/189/EEC laying down a
procedure for the provision of information in the field of technical standards and regulations, OJ L 81,
26.3.1988.
5
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, 19.4.1994.
6
Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a
procedure for the provision of information in the field of technical standards and regulations, OJ L 204,
21.7.1998.
7
Directive 98/48/EC of the European Parliament and of the Council of 20 July 1998 amending Directive
98/34/EC laying down a procedure for the provision of information in the field of technical standards
and regulations, OJ L 217, 5.8.1998.

18
4.2. Description of the procedure

4.2.1. Brief description of the procedure applicable to technical rules set up by Directive
98/34/EC

39. 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 rule 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.

– If there is no reaction from the Member States and the Commission, the
notifying Member State can adopt the draft regulation as soon as the three-
month standstill period has passed.

– 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.

– 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 notification. 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.

40. 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 the
emergency procedure is justified.

19
41. 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.

42. 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.

4.2.2. Changes made by Directive 94/10/EC to the procedure set up by Directive

83/189/EEC

43. Directive 94/10/EC, which applies from 1 July 1995, materially amended the
notification procedure for the second time. The amendments were intended to clarify
certain terms, to adapt the Directive to practical needs, and to extend its scope.

For the sake of consistency, the scope of the Directive was extended in two respects:
(i) the concept of “technical specification”, which Directive 88/182/EEC had already
extended to include production methods and procedures for agricultural products,
foodstuffs and medicinal products, was extended to include production methods and
processes in general (Article 1(2)); (ii) the Community legislator added the new
concept of “other requirement”, meaning a requirement other than a technical
specification (Article 1(3)).

44. “Other requirements” include all specifications which can be imposed on a product
during its life cycle, from conditions of use to the management or disposal of the
waste it generates, for the purpose of protecting, in particular, consumers or the
environment. The “other conditions” listed in the Directive (“conditions of use,
recycling, reuse or disposal”) are given merely as examples. Other similar measures
must therefore also be notified, provided they can significantly influence the
composition or nature of the product or its marketing. This amendment closed up a
whole series of loopholes which allowed Member States to avoid the preventive
monitoring of certain technical rules which might affect the marketing or use of
products.

45. A new subparagraph of Article 1(9) gives three examples of “de facto technical
regulations” whose classification as technical regulations had previously been
disputed. To avoid impinging on the fiscal autonomy of the Member States, and to
ensure the flexibility inherent in voluntary agreements, there are specific standstill
arrangements for certain de facto technical regulations. Thus the Community
legislator has exempted notified fiscal and financial measures from the standstill
requirement; voluntary agreements are subject to a reduced standstill period of four
months.

In practice, the number of notifications of fiscal and financial measures designed to

encourage compliance with a technical specification by means of financial incentives
is increasing.

20
 The fact that a public authority must be a contracting party to voluntary agreements
for them to be covered by the Directive has left the Member States a degree of
discretion in determining whether or not they are obliged to notify such measures. In
reality, it is exceptional for a State to sign a voluntary agreement; so, in spite of their
obvious impact on the free movement of goods, many voluntary agreements fall
outside the scope of the procedure set up by the Directive.

46. The standstill period imposed when a binding Community act is proposed
(Article 9(3), (4) and (5)) was extended, as the mechanism established by the original
version had produced highly unsatisfactory results. Thus the twelve-month standstill
period, starting on the date of notification of the draft, can be extended to eighteen
months where the Council adopts a common position during the initial twelve-month
period. Thanks to this change, the percentage of cases in which the legislator adopted
a binding Community act before the end of the extended standstill period quadrupled
compared with the 1992-94 period.

47. Another change concerns the transparency of the information procedure: the
definitive text of a technical regulation, which previously had to be communicated
only at the express request of another Member State or the Commission, must now
always be communicated (Article 8(3)). This change facilitates the last stage of the
procedure, i.e. the final monitoring of the adopted texts.

The same concern for transparency prompted the Community legislator to amend the
provisions on the confidentiality of the information communicated under the
procedure. Pursuant to Article 8(4), information supplied as part of a compulsory
notification is no longer confidential except at the express request of the notifying
Member State. The new Article 12 requires the Member States to refer to the
Directive either in the definitive text of a technical rule or on the occasion of its
adoption.

48. Other major changes to the Directive include the obligation to submit a risk analysis
in certain cases (Article 8(1)); the requirement to notify significant changes to a
previously notified draft (Article 8(1)); the introduction of a single contact point for
notifications under different procedures (Article 8(5)); the automatic lapsing of the
extended standstill period when the relevant binding Community act is adopted
(Article 9(6); the need for a “serious and unforeseeable” risk to justify recourse to the
emergency procedure and the Commission ruling on whether recourse to the
procedure is justified (Article 9(7)); certain exceptions to the notification
requirements (Article 10(1).

4.3. Application of the procedure

4.3.1. Volume of notifications

4.3.1.1. General trend

49. Table VII in the Annex shows that the Commission received 439 draft technical
regulations in 1995, 523 in 1996, 900 in 1997 and 604 in 1998. If we exclude 1997 -
which we will discuss later - we can see that there is a general upward trend in the
number of notifications received each year (an increase of 37% between 1995 and
1998). The extremely high number of notifications in 1997 was due to the “catch-up”
operation by the Dutch authorities following the judgment of the Court of Justice in

21
 the “CIA Security International” case: the Dutch authorities notified 227 draft
technical regulations with a view to their readoption. Even disregarding these Dutch
notifications, there was a remarkable growth in the number of notifications in 1997,
probably due to three factors: the accession of Austria, Finland and Sweden to the
European Union; the entry into force of Directive 94/10/EC, which extended the
scope of Directive 83/189/EEC; and the judgment in the “CIA Security” case, which
prompted Member States to apply the Directive with greater care.

Apart from these factors, the large number of notifications is explained by the nature
of the notified drafts. Many consisted of partial technical adaptations of existing
technical rules which had already been notified. The degree of Community
harmonisation varies from sector to sector. In some fields, such as foodstuffs, there is
only partial harmonisation. In others, harmonisation is nearing completion, for
example telecommunications, where the new Directive 99/5/EC of 9 March 1999 on
radio equipment and telecommunications terminal equipment applies to radio
equipment from 8 April 2000. The transport sector is covered by numerous
international conventions. Standardisation work has still not been completed in a
number of sectors, such as construction products where, in the absence of
harmonised European standards, the Member States continue to legislate at national
level to lay down product requirements.

4.3.1.2. Breakdown by country

50. Figure 1 (and Table VIII in the Annex) shows that from 1995 to 1998 most draft
rules were notified by the Netherlands, Germany, Austria and the United Kingdom.
Unlike previous years, Germany, the United Kingdom and France no longer account
for the majority of notifications. In 1995, 1996, 1997 and 1998 the joint share of
these Member States fell to between 24% and 48%. On the other hand, there was a
marked increase in the number of notifications from Austria and the Netherlands. In
1997, for the first time, Austria (106) and the Netherlands (341 or 114) notified more
draft technical regulations than Germany (99), the United Kingdom (71) and France
(51). There was a particularly marked increase in the number of drafts notified by
Belgium and Denmark in 1997 and 1998.

22
51. Figure 1

Notifications by Member State

1995-1998

350

300

250
Notifications

1995
200 1996
150 1997
1998
100

50

n
s

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ai

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Member States

4.3.1.3. Breakdown by sector

52. A breakdown by sector (see Figure 2 and Tables IX to XII in the Annex) shows that,
as was also the case in 1992-94, more than 75% of notifications received from 1995
to 1998 concerned the following five sectors: telecommunications (17.3%),
agriculture and foodstuffs (17.2%), transport (16.1%), mechanical engineering
(16.6%), and building and construction (12.1%). Transport is becoming increasingly
important, and even topped the list for the first time in 1997, while mechanical
engineering topped the list in 1998. The dominance of telecommunications noted in
1993 and 1994 continued in 1995 (27.1%), but weakened in 1996 (14.5%), 1997
(16.2%) and 1998 (14.4%). Mechanical engineering, which had been declining (from
23.5% in 1995 to 13.9% in 1997), recovered in 1998 to 17%, while building and
construction was stable (between 11% and 14%).

53. In terms of national preferences the situation changed very little: building and
construction was, as usual, dominated by notifications from Germany and Austria
(32.8% and 19.7% respectively of all notifications in this sector); agriculture and
foodstuffs were the leading sector in the Netherlands, which accounted for 37.3% of
all notifications in this sector; traditionally this sector has also been important in Italy
(30.5% of Italian notifications) and France (20.5% of French notifications).

Pharmaceuticals seem to be of particular interest to France and the United Kingdom,

which together contributed 41.7% of notifications in this sector. France was also the
source of a quarter of all notifications in the leisure goods sector. The Netherlands
accounted for a remarkable proportion of notifications in the environment and
transport sectors (41.9% and 35.4% respectively), the latter accounting for 29.4% of
all Greek notifications.

23
 Mechanical engineering, still dominated by German notifications (almost a quarter of
all notifications in this sector and a quarter of all German notifications), also appears
to be important in Finland (35.4% of Finnish notifications).

Telecommunications accounted for 38.9% of Danish notifications, 30.9% of Belgian

notifications, 28.7% of Austrian notifications and 21.9% of German notifications.

54. Figure 2

Notifications from the Member States by sector 1995-1998

200
180
160
140
120
Notifications

1995
1996
100
1997
80 1998

60
40
20
0
ls

s
s

t
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ffs
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pm
ag
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ee
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ei
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Sectors

4.3.2. Use of the emergency procedure

55. From 1995 to 1998, the Member States invoked the emergency procedure 131 times.
Measures notified under the emergency procedure between 1995 and 1998 accounted
for some 5% of all notifications.

The temporary increase in the number of measures notified under the emergency
procedure in 1996 (40 cases) was due to the BSE crisis, during which the United
Kingdom used the procedure in 24 cases. Another area in which urgency was
invoked several times was the transport of cash: in 1997 the urgency criteria were
considered to have been satisfied in five cases concerning Belgium, compared with
one case, also concerning Belgium, accepted in 1996 and one other in 1998. Other
areas in which urgency was invoked include plant-based products or preparations,
child safety (banning of foods mixed with objects, pseudo-toys, lighters shaped like
mobile telephones, decorative objects and dangerous products which are attractive to
children, play and recreation areas), the fuel supply system, vehicle identification in
order to reduce pollution and equipment used to detect radar and laser equipment in
vehicles.

24
56. Between 1992 and 1994 the Commission considered that the use of the emergency
procedure was justified in 25% of cases. This figure rose sharply to 33% in 1995,
80% in 1996, 68% in 1997 and 52.7% in 1998.

The United Kingdom and Belgium (34 notifications each) and France (23
notifications) accounted for more than 70% of all notifications under the emergency
procedure.

4.3.3. Commission reactions

4.3.3.1. General trend

57. The percentage of notifications eliciting a reaction from the Commission is falling. In
1992, 1993 and 1994, the Commission reacted to 60% of notifications; in 1995,
1996, 1997 and 1998 the Commission reacted to 49.7%, 63.1%, 46.5% and 38.5% of
notifications respectively, giving an average of 49.4%. These reactions take the form
of comments, detailed opinions or the announcement of the intention to propose a
directive (see Figure 3). It is not uncommon for a notification to elicit several
reactions from the Commission,

Figure 3

Number of reactions by type 1995-1998

300
250
Number

200 1995
1996
150
1997
100
1998
50
0
8.2 MS 8.2 EC 8.2 9.2 MS 9.2 EC 9.3 9.4
EFTA

Type of reaction

Key
8.2: comments
9.2: detailed opinion
9.3 and 9.4: standstill

4.3.3.2. Detailed opinions

(i) Statistics

58. From 1995 to 1998, the Commission delivered 360 detailed opinions regarding
notified drafts. The downward trend in the percentage of drafts which elicit a detailed
opinion from the Commission continued. In 1990 and 1991, the Commission had
delivered a detailed opinion in respect of 37% of drafts; In 1992, 1993 and 1994, this
rate was 31%, and for the period covered by this report it was 14.6%.

25
 (ii) Reasons:

Article 28 of the EC Treaty and the principle of mutual recognition

59. The absence of provisions ensuring compliance with the principle of mutual
recognition continued to be the point that the Commission raised most frequently in
the detailed opinions which it delivered regarding drafts notified by the Member
States in 1995, 1996 and 1997. 6% of drafts notified in 1995 (29 cases) elicited a
detailed opinion on the grounds of violation of the principle of mutual recognition. In
1996 (56 cases) and 1997 (92 cases), this rate increased to about 10%, while in 1998
(27 cases) it fell to 4.5%.

60. However, the way this question is approached has changed. Years of experience of
the notification procedure have given the Member States a good understanding of the
principle of mutual recognition. As a result - as is shown also by the rather low rate
of detailed opinions compared with the number of measures notified - the
Commission can now more frequently than in the past simply ask the Member States,
in the comments it makes, largely for educational purposes, to make improvements
to the clauses which they have drafted to apply the principle of mutual recognition.

The Commission now draws the Member States’ attention to the need to provide
businesses with precise and full information so that they can take advantage of the
rights conferred on them by Articles 28 et seq. of the Treaty. Thus, for example, the
Member States generally notify draft technical specifications which form part of
more general rules governing type-approval or checks on product conformity. Insofar
as these general rules provide for the acceptance of products legally manufactured
and/or marketed in the other Member States, the notified draft technical
specifications are already covered by the mutual recognition provided for in the basic
rules. For the sake of clarity and legal certainty, the Commission asks the Member
States, where appropriate, to summarise or refer to the provisions of the basic rules
on mutual recognition in notified drafts. The Commission also regularly reminds the
national authorities that the principle of mutual recognition also applies to tests, to
certificates attesting that products conform to national rules and to the national
bodies authorised to issue such certificates.

61. The Commission asks the Member States not only to ensure mutual recognition of
products from other Member States providing a level of protection of the legitimate
interests at stake equivalent to that provided for in the notified drafts, but also to
make sure that the technical requirements for products are reasonable. It is not
enough for the Member States to accept products from other Member States which
are “equivalent” to theirs. Insofar as such acceptance is based on a finding of
equivalence to the national requirements, it is important to ensure that the national
requirements are not themselves excessive, as otherwise products which satisfy the
legitimate objectives of the rules of the Member State of destination (health
protection, safety, etc.) would still face unjustified barriers to access to that country’s
market.

Thus in some cases the Commission sets the level of protection which it considers
reasonable by reference to the solutions which it adopts in its harmonisation
proposals, after consulting experts.

26
62. The Commission has also had occasion to deliver detailed opinions regarding other
requirements which are liable to create barriers to trade not directly linked to mutual
recognition. These include import authorisation requirements, excessive marking
requirements, rules making the use of quality descriptions subject to criteria linked to
origin, or requirements relating to certain type-approval procedures (e.g. the
requirement to have a representative established in the Member State in which the
product is to be marketed in order to have access to such a procedure).

Secondary legislation

63. One of the grounds on which the Commission delivers detailed opinions is failure of
a notified draft to comply with a Community directive or regulation which main
purpose is to abolish obstacles to the free movement of goods.

Twelve detailed opinions were based on infringement of Directive 89/336/EEC on

electromagnetic compatibility in 1995, eleven in 1996, two in 1997 and four in 1998.
In 1995, five detailed opinions were based on infringements of each of the following
Directives: 73/23/EEC on low-voltage equipment, 87/404/EEC on simple pressure
vessels and 91/263/EEC on telecommunications terminal equipment, whereas all
three Directives together only gave rise to five detailed opinions in 1996 and 1997. In
1998, two detailed opinions were based on infringements of Directive 98/13/EC on
telecommunications terminal equipment.

Other detailed opinions were based on infringements of other secondary legislation,

particularly in the fields of foodstuffs (6 in 1995, 10 in 1996, 16 in 1997 and 6 in
1998) and vehicles.

The Commission also received 46 notifications concerning packaging and packaging

waste during this period. The Netherlands notified 9 drafts and Denmark 5, while
Finland, France, Spain and Sweden each notified 4 drafts.

The Commission considered ten of these drafts (including eight in 1996) to be

contrary to Directive 94/62/EC on packaging and packaging waste, Article 16 of
which provides that before adopting such measures the Member States must notify
the drafts of measures which they intend to adopt to the Commission under the
procedure set up by Directive 98/34/EC. If the proposed measure is also a technical
matter within the meaning of Directive 98/34/EC, the Member State concerned may
indicate, when following the notification procedures referred to in Directive
94/62/EC, that the notification is equally valid for Directive 98/34/EC.

In order to ensure the smooth operation of this procedure, the Commission has set up
a single contact point for the notification of all such drafts. The Committees set up by
Directives 98/34/EC and 94/62/EC were informed of this single contact point in
1995.

64. The upward trend in the number of detailed opinions based on complaints other than
violation of the principle of mutual recognition in 1992, 1993 and 1994 was reversed
in the period 1995-98. The percentage of detailed opinions relating to subjects other
than mutual recognition fell from 63% in 1994 to 61% in 1995, 46.2% in 1996,
21.4% in 1997 and 30% in 1998.

27
 (iii) Further action:

65. The second subparagraph of Article 9(2) of the Directive requires the Member State
to which a detailed opinion is addressed to inform the Commission of “the action it
proposes to take on such detailed opinions. The Commission shall comment on this
reaction.”

66. The Member State must indicate whether it intends to abandon the draft text, to
justify its adoption, or to amend it to make it conform to Community law. The
Commission’s reaction must indicate whether the Member State’s reply is
satisfactory, i.e. whether it eliminates all possibility of infringement of Community
law. To ensure that this dialogue proceeds smoothly, the Commission regularly
enters a list of notifications in respect of which the Member States have not provided
a reply on the agenda of the Committee set up by Directive 98/34/EC for discussion.

The way in which the national authorities respond to the detailed opinions delivered
by the Commission has improved since 1995, to the extent that the Member States
responded to virtually all detailed opinions relating to drafts notified in 1998. Less
than 10% of such responses required further discussion between the Commission and
the Member State concerned.

4.3.3.3. Comments

(i) Statistics:

67. From 1995 to 1998, the Commission made comments on 33% of all notifications.
This percentage is significantly lower than from 1992 to 1994 (46%) and in 1990 and
1991 (42%).

(ii) Reasons:

68. In general, the comments made by the Commission give an overall political or legal
assessment of the measure, express its position on the subject, or remind Member
States of their obligations, e.g. under an infringement proceeding or an earlier
notification.

69. The Commission has in particular made comments reminding the Member States of
their obligation under Article 12 of the Directive. Following the judgment in the CIA
Security International case, the compulsory reference to the Directive either in the
text of a technical regulation or at the time of its publication has assumed crucial
importance for the protection of the rights of individuals. The Commission has
therefore systematically asked for such a reference to be made.

The Commission also chose to make comments where it considered a more stringent
reaction entailing the extension of the standstill period to be inappropriate. In
addition to cases of incomplete mutual recognition clauses, this concerned cases
where the binding Community act had already been adopted, but did not yet apply,
and cases where such an act was unlikely to be adopted within eighteen months, the
maximum standstill period on account of a Community harmonisation initiative.

Comments were also used to complain about texts which were already in force and
which were either referred to in the notified draft or formed its legal basis. The

28
 notification procedure provides the Commission with an opportunity to discover such
texts and to assess their effects on the Community.

The Commission also made comments to inform the Member States about
standardisation work being carried on by the European standardisation bodies in the
field in question. In such cases the Commission’s reaction has to be limited to
comments, as this type of “European harmonisation” does not prevent the Member
States from adopting technical rules on the same subject, even if such rules
inevitably hamper the work of the European harmonisation bodies.

Fairly often during the 1995-98 period, the Commission had to remind the Member
States in its comments that the principle of “mutual recognition” derived from
Article 28 of the EC Treaty, as interpreted by the Court of Justice, also applies to
products originating in EFTA Member States which are contracting parties to the
Agreement on the European Economic Area.

4.3.3.4. Intention to propose, adopt or present to the Council a proposal for a binding
Community act - standstill decision

70. When the Commission applies Article 9(3) and (4) of the Directive, the Member
State cannot adopt its draft until one year after the date of notification. As this period
proved to be too short — between 1992 and 1994, the Community act on account of
which a standstill had been imposed was adopted before the end of the standstill
period in only six cases — Directive 94/10/EC modified the procedure slightly: the
standstill period starts on the date of notification and, to compensate for the
cumbersome nature of the cooperation and co-decision procedures, is automatically
extended by six months when the Council adopts a common position. The new
procedure made it possible to adopt a binding Community act before the end of the
standstill period in 10 cases (6 in 1995, 4 in 1996, none in 1997 or 1998). This is
equivalent to 38% of the cases in which Article 9(3), (4) or (5) is applied —
compared with 9% in the period from 1992 to 1994 — which shows how useful the
amendments made in this respect by Directive 94/10/EC are.

71. From 1995 to 1998, the Commission applied Article 9(3), (4) or (5) of Directive
98/34/EC in 30 cases. The Commission imposed a standstill in ten cases in 1995,
twelve in 1996, four in 1997 and four in 1998.

Most (7) of the standstill periods imposed in 1995 were due to the future Directive
96/98/EC on marine equipment, which was adopted on 20 December 1996. The other
standstill periods imposed in 1995 concerned foodstuffs (2) and articles of precious
metals (1). In 1996, standstill periods were imposed on six national drafts because
they were covered by Community drafts which eventually resulted in the adoption of
Directive 96/98/EC on marine equipment and Directive 98/18/EC on passenger
ships. Other drafts concerned fuel quality (auto-oil programme), buses, pesticide
residues (draft amendment of Directive 91/414/EEC on plant protection products)
and the transport of live animals. In 1997, there were two drafts concerning fuel
quality, one concerning ecological farm products and one concerning recreational
craft. In 1998 a standstill period was imposed on two draft national regulations on
account of the Regulation on the marketing standards for olive oil, then under
preparation, which was adopted one week after the end of the standstill period;
another standstill period was imposed on a draft relating to inland navigation and the
last concerned ecological foodstuffs.

29
 Seven of the ten cases in which Article 9(3), (4) and (5) of the Directive applied
concerned transport in 1995, and eleven out of twelve in 1996.

4.3.4. Reactions of the Member States

72. Some 41% of notified drafts elicited comments from other Member States in 1995,
36% in 1996, 29% in 1997 and 42% in 1998. Some 18% of notifications elicited
detailed opinions in 1995, 26% in 1996, 14% in 1997 and 18% in 1998.

73. The fields which elicited the most detailed opinions from other Member States in
1995 and 1996 were the environment, followed by mechanical engineering, electrical
engineering, and motor vehicles. In 1997, most objections concerned the
environment and chemicals, followed by foodstuffs and construction. In 1998, the
environment and chemicals again prompted the most reactions, followed by
foodstuffs.

4.3.5. Handling of infringements

74. Between 1995 and 1998, the Commission initiated 103 infringement proceedings for
failure to comply with Directive 98/34/EC, either for failing to notify draft measures
or for adopting them before the end of the standstill period. The Commission was
informed of the national measures either by the private body which it had
commissioned to hunt out national technical rules adopted in violation of Directive
98/34/EC, or by businesses affected by them. To allow businesses to find out about
notified texts and the dates of the initial standstill period, the Commission publishes
the titles of notified national drafts and the corresponding standstill periods in the
Official Journal of the European Communities each week.

75. In line with the Commission’s position, repeatedly expressed at meetings of the
Committee (see point 4.3.6.1 below) and at bilateral meetings between the
Commission and the central units in the Member States responsible for applying the
procedure (see point 4.3.6.3 below), the majority of Member States abandon the
disputed act and/or notify a new draft. During the reference period, this solution
allowed the infringement proceeding to be terminated in virtually all cases. The
Court of Justice delivered judgments in four cases (C-273/94, C-289/94, C-279/94
and C-145/97, see point 4.4.2.1 of this report). From 1992 to 1994, nine cases were
brought before the Court.

4.3.6. Subsequent procedure

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

76. The Committee set up by Article 5 of Directive 98/34/EC (consisting of

representatives appointed by the Member States and chaired by a representative of
the Commission) discussed points of general interest and specific points of interest to
certain parties.

The Committee met thirteen times between 1995 and 1998 (four in 1995, four in
1996, three in 1997 and two in 1998), which, due to budgetary constraints, was
markedly less than the sixteen meetings held between 1992 and 1994. They
discussed inter alia practical and budgetary aspects of the implementation of the

30
 procedure set up by Directive 98/34/EC, the action to be taken to enhance
transparency, and possible amendments to the Directive.

77. Discussions on the practical aspects of the way the procedure is implemented
covered the degree of transposition of Directive 94/10/EC; the final drafting of the
new Vade mecum, which forms the basis for cooperation between the central units
and the Commission; solutions to the problem of overlapping procedures (single
point of contact); the handling of notifications in the field of pharmacopoeia; the
electronic transmission of notifications and messages; the obligation to reply to
detailed opinions; and the obligation to automatically send the definitive texts. The
main budgetary aspect discussed was the cost of translations.

78. The Committee devoted a great deal of time to discussing measures to enhance the
transparency of the procedure set up by Directive 98/34/EC, including the
preparation of a brochure explaining the notification procedure to a wide audience8,
the possible publication in the Official Journal of summaries of notified drafts,
together with explanatory notices, and the action taken following the judgment in the
CIA Security case (explanations given at “package meetings” in the Member States;
invitation to the Member States to ask the Commission for its opinion on whether or
not a planned national measure needed to be notified; sending to the Member States
of the particulars of texts which appeared prima facie to contain technical rules, for
comment). The Technical Regulation Information System (TRIS) website was also
discussed and at the time of drafting this report the website is up and running and can
be consulted at http://europa.eu.int/comm/enterprise/tris.
79. The future development of the notification procedure was discussed during debates
about the participation of Turkey and the Central and Eastern European countries in
the information exchange system and the introduction of a transparency mechanism
for the information society. The latter came into being on 20 July 1998, following the
adoption of Directive 98/48/EC. The Committee also discussed the transposition of
the Directive.

80. The Committee served as a forum for discussions of the relationship between
Article 28 of the EC Treaty and Article 16 of Directive 89/106/EEC on construction
products, and on Decision No 3052/95/EC of the European Parliament and of the
Council establishing an information procedure on measures derogating from the
principle of the free movement of goods.9

81. The Committee also discussed individual notified drafts and the problems raised by
their application.

4.3.6.2. Package meetings

82. The practice of holding “package meetings” introduced a few years ago has enabled
the Commission to maintain contacts with the national authorities responsible for
drawing up technical regulations. The topics discussed at these meetings include

8
This brochure is published by the Office for Official Publication of the European Communities in all
official Community languages : ISBN 92-828-2786-0.
9
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, 30.12.1995, p.1).

31
 notifications by the country concerned, links with infringement proceedings based on
EC Treaty provisions relating to the free movement of goods, and developments
relating to the operation of the Directive. At these package meetings the Commission
was able to discuss the consequences of the judgment in the CIA Security case with
the Member State authorities.

4.3.6.3. Meetings with the central units of the Member States

83. The Commission made an effort to continue a dialogue with the national authorities
responsible for applying Directive 98/34/EC during the period 1995-98. These
meetings took place at the meetings of the Committee set up by the Directive or at
the package meetings referred to above. They enabled the Commission to terminate
numerous infringement proceedings which it had initiated for failure to comply with
the notification requirement laid down in the Directive. They also provided an
opportunity to discuss the practical problems which can arise in the application of the
procedure and enabled the central units to meet representatives of the Commission
departments responsible for managing the Directive.

4.3.6.4. Ad hoc meetings

84. The Commission actively investigates certain dossiers which it suspects may infringe
Community law and which may give rise to disputes between Member States and
businesses, or between Member States. Ad hoc meetings, organised by the
Commission, have helped the parties concerned to reach agreement on the disputed
points. During the period covered by this report, meetings were held concerning
fields as varied as wrecked cars, satellite television, advertising of tobacco products,
ro-ro ferries, weights and measures, etc.

4.4. Factors which contributed to the high number of notifications

4.4.1. Various factors

85. The high number of notifications between 1995 and 1998 cannot be attributed
exclusively to the accession of Austria, Finland and Sweden. The entry into force of
Directive 94/10/EC and the rich case-law of the Court of Justice were the main
factors which led the Member States to notify more than 2 400 draft technical rules
to the Commission.

The judgment in the CIA Security case, which confirmed the Commission’s position
on the inapplicability of technical rules adopted in violation of Directive
83/189/EEC, demonstrated the importance of the information procedure and helped
raise awareness of it. The operation undertaken by the Dutch Government in the
summer of 1997 to catch up with notifications of technical rules was undoubtedly a
result of this judgment. This operation resulted in a substantial rise in the number of
notifications in 1997.

4.4.2. Court of Justice case-law

86. Between 1995 and 1998, the Court of Justice delivered eight judgments concerning
Directive 98/34/EC: four in response to Commission requests for rulings that a
Member State had violated its obligations under Community law and four in
response to references for preliminary rulings from national judges. These judgments

32
 essentially concern the concept of a “technical rule”; they clarify the scope of the
obligation to notify and the consequences of any failure to notify.

4.4.2.1. Judgments declaring a Member State to have failed to fulfil its obligations

87. The judgment of 11 January 1996 (Case C-273/94, Commission v Netherlands

[1996] ECR I-31) concerned a Dutch regulation which added an alternative
production method to the existing Dutch legislation on margarine. The Court seized
this opportunity to dismiss the widely held view that a technical rule whose purpose
or effect was to liberalise trade did not need to be notified. The legislation in
question established a new technical rule and as such it was subject to the Directive,
even though the new rule constituted a relaxation of the existing rules.

88. The necessary link between the technical specification and the marketing of the
products concerned, and the scope of the exception regarding transposition measures,
were clarified in the judgment of 17 September 1996 (Case C-289/94 Commission v
Italy [1996] ECR I-4405). In this case, the Italian Government refused to notify
provisions on the quality of waters in which molluscs are raised on the grounds that
these measures were intended to transpose certain provisions of Community law and
that they concerned only the waters and not the molluscs raised in them.

The Court dismissed both arguments, because the rules in question were very closely
linked to the marketing of the product, as only goods produced in accordance with
the provisions could be marketed, so compliance with the provisions had a direct
impact on the marketing of the molluscs. The Court ruled that the exception
regarding transposition measures did not apply, because the scope of the national
rules in question was far narrower than the scope of the Community rules.

89. In its judgment of 16 September 1997 (Case C-279/94 Commission v Italy [1997]
ECR I-4743), the Court made three points concerning the definition of a technical
rule. A provision prohibiting the marketing and use of a substance is a technical
regulation, and this was already the case before the clarification made by Directive
94/10/EC. However, a regulation imposing limits on the concentration of asbestos
fibres in the air does not define a characteristic required of a product, and does not in
principle fall within the definition of a technical specification; nevertheless, this does
not rule out the possibility of establishing that such a regulation may have
consequences as regards the characteristics of a product. Finally, the Court reiterated
that a technical regulation is subject to the notification procedure only if it is new, i.e.
it must produce distinct legal effects in relation to the previously existing
arrangements.

With regard to the procedure, the Court ruled that the notification and standstill
obligations do not always go together: the full text of the measure must be notified,
but only the technical regulations which it contains are subject to the standstill
period.

90. In its judgment of 7 May 1998 (Case C-145/97 Commission v Belgium [1998] ECR
I-2643), the Court ruled that pursuant to Article 8 of the Directive, the Member
States must communicate not only the draft text containing technical regulations, but
also the text of the basic legislative or regulatory provisions principally and directly
concerned. The aim of this provision is to enable the Commission to have as much

33
 information as possible in order to enable it to exercise as effectively as possible the
powers conferred on it by the Directive.

4.4.2.2. Judgments in cases referred for a preliminary ruling

91. The judgment of 30 April 1996 (Case C-194/94 CIA Security International SA v
Signalson SA and Securitel SPRL [1996] ECR I-2201) is without doubt the most
important judgment delivered by the Court during the period covered by this report.
In this judgment, the Court agreed with the assertion made by the Commission in its
communication of 1986 that a breach of the obligation to notify renders the technical
regulations inapplicable so that they may not be enforced against individuals.

The Court based this conclusion on the fact that Articles 8 and 9 of the Directive are
precise (in that the technical rules must be notified before they are adopted) and
unconditional, and must therefore be interpreted as meaning that individuals may
rely on them before national courts. Comparing the procedure established by
Directive 83/189/EEC with a simple information procedure, the Court stressed that
the aim of the Directive is not simply to inform the Commission, but to eliminate or
restrict obstacles to trade, to inform other States of technical regulations envisaged
by a State, to give the Commission and the other Member States time to react and to
propose amendments for lessening restrictions to the free movement of goods arising
from the envisaged measure, and to afford the Commission time to propose a
harmonising directive. The Court concluded that breach of the obligation to notify
constitutes a substantial procedural defect such as to render the technical regulations
in question inapplicable to individuals. Where an individual correctly relies on the
breach of such an obligation before the national court, the latter must decline to apply
a national technical regulation which has not been notified.

92. In addition to these very important clarifications, the Court ruled that the Directive
does not apply to rules laying down conditions governing the establishment of firms,
nor to rules which merely serve to enable technical regulations to be adopted.

93. In its judgment of 20 June 1996 (Joined Cases C-418/93, C-419/93, C-420/93,
C-421/93, C-460/93, C-461/93, C-462/93, C-464/93, C-9/94, C-10/94, C-11/94,
C-14/94, C-15/94, C-23/94, C-24/94 and C-332/94 [1996] ECR I-2975), the Court
found that the obligation to notify does not apply to national regulations which do
not lay down the characteristics required of a product but are confined to regulating
the closing times of shops.

94. The judgment of 20 March 1997 (Case C-13/96 Bic Benelux SA v Belgian State
[1997] ECR I-1755) concerned a marking to be placed on products informing the
consumer that they are subject to environmental tax. The Court seized this
opportunity to stress that the underlying purpose of a national measure has no
bearing on whether or not that measure constitutes a technical regulation.
Consequently, the fact that a national measure does not implement a technical
standard which may itself constitute a barrier to the free movement of goods or was
adopted in order to protect the environment does not mean that the measure cannot
be a technical regulation. Since the marking in issue was intended to inform the
public of the effects of a product on the environment, like any other quality label, the
Court concluded that it could not be regarded as exclusively a fiscal accompanying
measure.

34
95. In the judgment of 16 June 1998 (Case C-226/97 Lemmens [1998] ECR I-3711), the
question arose as to whether provisions applying to a product (breath-analysis
apparatus) when used by a particular user (the police) for a specific purpose (breath
analysis) must be notified. The Court ruled that certain measures may impose, in
respect of a product intended for a particular group of users, technical specifications
whose content depends on the specific objective pursued by that group. Where these
specifications are too remote in terms of their relationship with the production and
marketing of the product, they cannot be classified as technical regulations.
However, where the technical specifications must be complied with in order to sell
the product to a major user of that product on the market in question, they constitute
technical regulations; that was the case here.

96. The Court also ruled that the Directive applies equally to regulations which fall
within the scope of criminal law; its scope is not limited to products intended to be
used otherwise than in connection with the exercise of public authority.

4.4.3. The Dutch operation to catch up on unnotified technical rules

97. Following the judgment in the CIA Security International case, the Dutch
Government drew up a list of national regulations which should perhaps have been
notified to the Commission pursuant to Directive 83/189/EEC. Of the 400 dossiers
which it announced, the Dutch Government unilaterally withdrew 96, and it
withdrew a further 77 following discussions with the Commission departments under
a “prenotification” exercise (verification of the need to notify the texts in question).
Of the 227 texts thus notified, 70 were considered unimportant, and the rest were
considered important. The notifications covered a wide range of fields, from gaming
machines to judges’ robes; most drafts concerned sea transport, metrology,
agriculture or motor vehicles. The exercise showed that a large number of texts
which had been adopted without passing through the filter of Directive 83/189/EEC
contained provisions which were contrary to Community law; these provisions were
corrected under this operation.

4.5. Action to improve transparency and provide businesses with more information

98. The Directive has fulfilled its purpose as an instrument of transparency by providing
information to all parties concerned by technical rules, i.e. companies, Member
States and the Commission. The amending Directives have merely enhanced this task
of ensuring transparency and information.

However, businesses which can find out about initiatives taken in the countries in
which they market or wish to market their products and which could, therefore, help
to eliminate barriers to the free movement of goods at source, or at least adapt their
products to the new requirements in good time, still do not take full advantage of the
possibilities open to them. While certain European federations are now aware of the
advantages of the information procedure, the involvement of individual companies,
and particularly small and medium-sized companies, in the examination of notified
drafts still seems too marginal.

99. With a view to increasing transparency and the availability of information to

European citizens, the Commission has made available a number of sources of
information:

35
 Each year the Commission publishes in the Official Journal statistics on notifications
received, reactions to such notifications and infringement proceedings for failure to
comply with the obligations resulting from the Directive.10

Each week the Commission publishes in the Official Journal the titles of draft
national technical regulations which have been notified to it under the notification
procedure and the dates on which the initial three-month standstill period laid down
in the Directive ends for each notified draft. Where the Commission considers the
emergency procedure to be justified, this information is also published in the Official
Journal. Publication of this list is intended primarily to allow individuals to find out
about notifications and to check that technical regulations which they are required to
comply with have indeed been notified in advance.

With the same concern for transparency, the Commission has taken great care to
ensure that the Member States fulfil their obligations under Article 12 of the
Directive. A technical regulation not containing a reference to Directive 98/34/EC
may give rise to doubts as to whether it was notified in draft form and, following the
Court’s judgment in the CIA Security case, as to its applicability once adopted.

Press releases intended to inform the public of infringement proceedings against

technical regulations adopted in breach of the Directive are published regularly.
Individuals can rely on this information before a national authority in support of the
principle that a technical regulation adopted in breach of Directive 98/34/EC is
unenforceable.

100. To make it easier for businesses to access national technical regulations and draft
technical regulations, the Commission has studied the possibility of setting up a
website on the notification procedure for national technical regulations. This site will
provide access to general information about Directive 98/34/EC. Drafts notified since
July 1995 by the Member States of the European Community and by EFTA States
which are members of the European Economic Area will also be available on this
site. It will be a valuable tool providing information on technical regulations planned
or adopted in all the Member States. The objective will be to ensure that Directive
98/34/EC creates full transparency and is an effective tool for eliminating at source
barriers to the smooth operation of the internal market. It will also help to strengthen
the dialogue between businesses, the Member States and the Commission in the field
of technical regulations.11

In order to raise awareness of the Directive, the Commission has produced a

brochure containing an article-by-article commentary explaining the information
procedure clearly in simple layman’s language to the business circles concerned, the
general public, and the Member States. This brochure, 12 which has been translated
into all the official languages of the European Union, will also be available on the
TRIS website.

10
Statistics for 1995 published in OJ C 309, 18.10.1996, p. 2.
Statistics for 1996 published in OJ C 311, 11.10.1997, p. 2.
Statistics for 1997 published in OJ C 281, 10.9.1998, p. 3.
Statistics for 1998 published in OJ C 228, 11.8.1999, p. 7.
11
At the time of drafting this report, the Technical Regulation Information System (TRIS) website is up
and running and can be consulted at http://europa.eu.int/comm/enterprise/tris.
12
ISBN 92-828-2786-O.

36
4.6. Conclusions and prospects

101. The years 1995, 1996, 1997 and 1998 saw a substantial rise in the number of
notifications, even discounting the Dutch catch-up operation in 1997. This is partly
due to the accession of three new Member States in 1995, but also to the amendment
of the Directive and the case-law of the Court of Justice. Telecommunications,
agriculture and foodstuffs, transport, mechanical engineering and construction
continued to account for the bulk of notifications during this period.

102. During this period, the total number of Commission detailed opinions fell, due to the
improved quality of the national texts notified, which are more in line with
Community law. This demonstrates the didactic nature of the Directive, which has
resulted in notified texts being drafted with increasingly regard for Community rules.
While the Member States have become accustomed to paying greater heed to the
principle of mutual recognition, the Commission has still had to act to ensure
compliance with the provisions of the Directives on electromagnetic compatibility,
low-voltage equipment, telecommunications terminal equipment, and packaging and
packaging waste.

103. In its Communication to the Council and the European Parliament on mutual
recognition in the context of the follow-up to the action plan for the single market
(COM(1999) 299 final) of 16 June 1999, the Commission confirmed the importance
which it attaches to Directive 98/34/EC as an instrument for promoting mutual
recognition and preventing the creation of obstacles to the free movement of goods
and, since August 1999, information society services.

In response to this Communication, the Council itself called on the Member States to
develop appropriate measures in order to provide economic operators and citizens
with an effective framework for mutual recognition, inter alia by implementing the
notification procedure. The Council also invited the Commission to take the
appropriate measures and initiatives in this field, relying as much as possible on
administrative cooperation.

104. Directive 98/34/EC has been supplemented by the application from 1 January 1997
of the procedure for the exchange of information on national measures derogating
from the principle of the free movement of goods within the Community set up by
Decision No 3052/95/EC of the European Parliament and of the Council.

105. In future, the role of the Directive will also be stressed in the field of services, in the
context of the information society.

106. With a view to enlargement, the applicant countries have shown a keen interest in
Directive 98/34/EC and are willing to incorporate it into their domestic legal
systems. Thus the Directive could play its didactic role for the free movement of
goods within the internal market by encouraging the national authorities to become
more Community-minded.

107. Turkey is now associated with the work of the committee set up by Directive
98/34/EC, and its experts started attending meetings in 1999.

37
5. PART III: EXCHANGE OF INFORMATION ON TECHNICAL RULES
BETWEEN THE COMMUNITY AND THE EFTA COUNTRIES

5.1. Introduction

108. The Agreement between the Member States of EFTA and of the EEC laying down a
procedure for the exchange of information in the field of technical regulations
entered into force in November 1990 (Council Decision 90/518/EEC13) for an initial
period of two years. The Agreement accordingly expired on 1 November 1992. The
Agreement on the European Economic Area (EEA), which takes over the notification
procedure with arrangements similar to those of the previous Agreement, did not
enter into force until 1 January 1994; in the interval, the Agreement concluded by
Council Decision 90/518/EEC was extended by means of bilateral agreements in the
form of an exchange of letters.

In order to avoid any barriers to trade between the Member States of the two groups,
the 1990 Agreement established a link between the information procedure based on
Directive 98/34/EC and the equivalent procedure between the EFTA countries.

The Agreement on the EEA, which has applied since 1 January 1994, includes
Directive 83/189/EEC, amended as appropriate, in Annex II, Part XIX.

109. The Community and Switzerland have continued to apply the information exchange
procedure since the entry into force of the Agreement on the EEA, even though the
Swiss Confederation is not a signatory to the Agreement.

110. 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 EEC and EFTA 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. The number of notifications under this system has
accordingly declined.

5.2. Description of the procedure

111. During 1992 and 1993, all messages relating to the information procedure between
the Member States of the Community and the Member States of EFTA were
exchanged between the Commission of the European Communities and the EFTA
Council. Since 1994, the exchange of information between the Member States of the
Community and the Member States of EFTA has gone via the Commission and the
EFTA Surveillance Authority set up by the Agreement on the EEA.

112. 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

13
Decision of 24 September 1990, published in OJ L 291, 23.10.1990.

38
 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.

5.3. Application of the procedure

5.3.1. Volume of notifications and breakdown by sector

113. Figure 4 and Table XIII in the Annex show that the accession of Austria, Finland and
Sweden has considerably reduced the number of notifications from EFTA countries.
Between 1995 and 1998, the Commission received 149 draft technical regulations
from EFTA Member States, compared with 344 in 1992, 1993 and 1994. Eighty-one
notifications were from Norway, 62 from Switzerland and 6 from Iceland.

Figure 4

Number of notifications by EFTA countries 1995-

1998

40
30 1995
1996
20 1997

10 1998

0
Iceland Norway Switzerland

A breakdown by sector (Figure 5 and Table XIV in the Annex) shows that
telecommunications was the most important sector during this period, as was also the
case in 1992-94; in 1995, 70% of all notifications concerned telecommunications;
this figure was still 62% in 1996. There was a drop in notifications in this sector in
1997 (just three notifications, or less than 10%), rising slightly to 12% in 1998.
Agricultural products and foodstuffs was the leading sector in 1997, accounting for
37.5% of all notifications. In 1998, this sector and transport each accounted for 28%
of notifications.

39
 Figure 5

Notifications by EFTA countries by sector 1995-1998

30

25

20 1995
1996
15
1997
10 1998

5.3.2. Reactions

5.3.2.1. Community comments on EFTA notifications

114. From 1995 to 1998, the Community made comments on 75 EFTA notifications
(50%), which represents a slight fall on the 66% of EFTA notifications which
prompted the Community to make comments from 1992 to 1994. These comments
were the subject of a consultation procedure with the Community Member States.

115. Notifications made by Austria, Sweden and Finland in 1994 for which the standstill
period ended after 1 January 1995, i.e. after the date of accession of these States to
the European Union, were treated as notifications from Member States. This means
that the notifications could, in principle, elicit a detailed opinion from the
Commission or from other Member States. The Commission delivered 15 detailed
opinions early in 1995 relating to notifications from the new Member States.
Notifications from new Member States were also the subject of one detailed opinion
and six comments from existing Member States.

116. The comments made by the Community concerned above all problems of
compatibility with Community secondary legislation, in particular Directives
73/23/EC (low-voltage equipment), 77/535/EEC (methods of sampling and analysis
for fertilisers), 89/106/EEC (construction products), 89/336/EEC (electromagnetic
compatibility) and 91/263/EEC (telecommunications terminal equipment).

117. Other comments drew the attention of the EFTA countries to aspects of
proportionality and/or the need to include in their technical regulations the mutual
recognition clauses needed to avoid creating technical barriers to trade and to ensure
compliance with Articles 11, 12 and 13 of the Agreement on the European Economic
Area; However, only 10% of EFTA notifications prompted a reaction from the
Community regarding these aspects. This sharp fall is evidence of a trend towards an
effective mutual recognition system in relations with the EFTA countries.

In its comments, the Community also referred to work in progress at Community

level (future Directives 96/98/EC on marine equipment and 98/18/EC on passenger
ships) or within the European standardisation bodies, and to international agreements

40
 (Stockholm Agreement and SOLAS Convention). Other comments referred to
Community provisions relating to the labelling of animal feedingstuffs containing
genetically modified organisms or the provisions of the Agreement on the EEA
pursuant to which the contracting parties are to examine any difficulties that might
arise in their trade in agricultural products and endeavour to seek appropriate
solutions. The Community also referred to the obligation pursuant to Article 12 of
Directive 98/34/EC to refer to the Directive when a technical regulation is published.

5.3.2.2. EFTA comments on Community notifications

118. EFTA commented on four Community notifications in 1995, three in 1996, four in
1997 and one in 1998. The new Member States made five comments early in 1995.

Most of the EFTA comments referred to the standardisation work of the European
bodies. They also referred to legislation in force in certain EFTA countries, to their
intention to apply international agreements (such as the Stockholm Agreement
concerning specific stability requirements for ro-ro passenger ships) and to barriers
which the drafts might create to trade in products legally manufactured in one or
more EFTA countries (e.g. the Dutch notification on sustainable wood for the wood
industry). They also supported initiatives taken by the authorities of the Member
States (as in the case of the French notification limiting the sound levels of personal
stereos).

5.4. Conclusions and prospects

119. The 1995-98 period was marked by a fall in the number of notifications compared
with the 1992-94 period, due to the accession of Austria, Finland and Sweden to the
Community. Telecommunications remained the main sector. Community reactions to
drafts notified by the EFTA countries continued to be motivated by the desire for
these countries to abide by the provisions of Community law. Cooperation under the
procedure was excellent.

41
6. ANNEXES

42
6.1. Table I - Breakdown of new standardisation activities started each year between 1991 and 1998

CEN/CENELEC members in the EU

Year 1991 1992 1993 1994 1995 1996 1997 1998

Level No % No % No % No % No % No % No % No %

a. National
activities

a.1 Connected
241 2.4 542 5.2 109 1.7 119 23.5 74 1.4 62 1.4 71 1.5 49 1.1
with European
or
international
activities

a.2 Specific* 1952 19.1 1744 16.5 2019 31.3 1511 29.8 1839 35.4 1531 34.3 1356 28.1 1497 35.8

a.3 Total
2193 21.5 2286 21.4 2128 33.0 1630 32.2 1913 36.8 1593 35.7 1427 29.6 1546 36.9
(a.1 + a.2)

b. European
5887 57.6 5014 47.5 2466 38.2 1985 39.8 2091 40.3 1643 36.8 2270 47.2 1684 40.2
activities

c. International
2130 20.9 3252 30.8 1860 28.8 1454 28.6 1190 22.9 1223 27.4 1116 23.2 958 22.9
activities

d. Total
10210 100 10552 100 6454 100 5069 100 5194 100 4459 100 4813 100 4188 100
(a + b + c)

Source: Notifications to the CEN/CENELEC.

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

43
6.2. Table II a - Breakdown of new standardisation activities started in 1995

CEN/CENELEC members in the EU

Non-electrical
Non-electrical Electrical Total share
Field
(1) (2) (3) = (1) + (2) (1) x 100
(3)
Level No % No % No % %
a. National
activities
a.1 Connected with
74 1,9 0 0 74 1,4 100
European or
international
projects
a.2 Specific* 1823 46,5 16 1,3 1839 35,4 99,2
a.3 Total
1897 48,4 16 1,3 1913 36,8 99,2
(a.1 + a.2)
b. European
1291 33,0 800 62,6 2091 40,3 61,7
activities
c. International
728 18,6 462 36,1 1190 22,9 61,2
activities
d. Total
3916 100 1278 100 5194 100 75,4
(a + b + c)
Source: Notifications to the CEN/CENELEC.

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

44
6.3. Table II b - Breakdown of new standardisation activities started in 1996

CEN/CENELEC members in the EU

Non-electrical
Non-electrical Electrical Total share
Field
(1) (2) (3) = (1) + (2) (1) x 100
(3)
Level No % No % No % %
a. National
activities
a.1 Connected
with European 62 1,9 0 0 62 1,4 100
or
international
projects
a.2 Specific* 1514 46,1 17 1,4 1531 34,3 98,9
a.3 Total
1776 48,0 17 1,4 1593 35,7 98,9
(a.1 + a.2)
b. European
911 27,8 732 62,1 1643 36,8 55,4
activities
c. International 64 ,9
794 24,2 429 36,5 1223 27,4
activities
d. Total
3281 100 1178 100 4459 100 73,6
(a + b + c)
Source: Notifications to the CEN/CENELEC.

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

45
6.4. Table II c - Breakdown of new standardisation activities started in 1997

CEN/CENELEC members in the EU

Non-electrical
Non-electrical Electrical Total share
Field
(1) (2) (3) = (1) + (2) (1) x 100
(3)
Level No % No % No % %
a. National
activities
a.1Connected
with 68 1,9 3 0,2 71 1,5 95,8
European or
international
projects
a.2Specific* 1345 36,9 11 1,0 1356 28,1 99,2
a.3Total
1413 38,8 14 1,2 1427 29,6 99,0
(a.1 + a.2)
b. European
1558 42,8 712 60,9 2270 47,2 68,6
activities
c. International
673 18,4 443 37,9 1116 23,2 60,3
activities
d. Total
3644 100 1169 100 4813 100 75,7
(a + b + c)
Source: Notifications to the CEN/CENELEC.

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

46
6.5. Table II d - Breakdown of new standardisation activities started in 1998

CEN/CENELEC members in the EU

Non-electrical
Non-electrical Electrical Total share
Field
(1) (2) (3) = (1) + (2) (1) x 100
(3)
Level No % No % No % %
a. National
activities
a.1 Connected
with 49 1,5 0 0,0 49 1,1 100,0
European or
international
projects
a.2 Specific* 1487 45,0 10 1,1 1497 35,8 99,3
a.3 Total
1536 46,5 10 1,1 1546 36,9 99,3
(a.1 + a.2)
b. European
1077 32,5 607 69,0 1684 40,2 64,0
activities
c. International
695 21,0 263 29,9 958 22,9 72,5
activities
d. Total
3308 100 880 100 4188 100 79,0
(a + b + c)
Source: Notifications to the CEN/CENELEC.

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

47
6.6. Table III a - Breakdown by country of new national standardisation activities notified in 1995

Field Non-electrical Electrical Total

Country No % No % No %
a. DE 468 24,4 3 18 471 24,4
b. FR 564 29,5 2 13 566 29,3
c. UK 313 16,3 5 31 318 16,5
d. IT 216 11,3 0 0 216 11,2
e. ESP 125 6,5 0 0 125 6,5
f. Other EU 211 11,0 6 38 217 11,2
countries
g. EU total 1897 99,1 16 100 1913 99,1
h. EFTA 18 0,9 0 0 18 0,9
countries
i. Grand total 1915 100 16 100 1931 100
(g+h)
Sources: Notifications to the CEN/CENELEC.

Notes:

1. 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.

2. 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. The figures for France (AFNOR) exclude 778 notifications for “regularisation” purposes. This number of regularisations has been
estimated at 62% of the total number of notifications.

48
6.7. Table III b - Breakdown by country of new national standardisation activities notified in 1996

Field Non-electrical Electrical Total

Country No % No % No %
a. DE 466 29,1 6 31,6 472 29,2
b. FR 212 13,3 1 5,3 213 13,2
c. UK 166 10,4 0 0 166 10,3
d. IT 237 14,8 0 0 237 14,6
e. ESP 168 10,5 0 0 168 10,4
f. Other EU 327 20,4 10 53,0 337 20,8
countries
g. EU total 1576 98,5 17 89,5 1593 98,4
h. EFTA 24 1,5 2 10,5 26 1,6
countries
i. Grand total 1600 100 19 100 1619 100
(g+h)
Sources: Notifications to the CEN/CENELEC.

Notes:

1. 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.

2. 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.

49
6.8. Table III c - Breakdown by country of new national standardisation activities notified in 1997

Field Non-electrical Electrical Total

Country No % No % No %
a. DE 404 28,0 6 40,0 410 28,1
b. FR 25 17,4 2 13,3 254 17,4
c. UK 152 10,5 0 0 152 10,4
d. IT 173 11,8 1 6,7 174 11,9
e. ESP 123 8,5 1 6,7 124 8,5
f. Other EU 309 21,4 4 26,6 313 21,4
countries
g. EU total 1413 97,8 14 93,3 1427 97,7
h. EFTA 32 2,2 1 6,7 33 2,3
countries
i. Grand total 1445 100 15 100 1460 100
(g+h)
Sources: Notifications to the CEN/CENELEC.

Notes:

1. 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.

2. 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.

50
6.9. Table III d - Breakdown by country of new national standardisation activities notified in 1998

Field Non-electrical Electrical Total

Country No % No % No %
a. DE 518 32,7 7 70,0 525 33,0
b. FR 174 11,0 0 0 174 10,9
c. UK 160 10,1 0 0 160 10,0
d. IT 161 10,2 0 0 161 10,2
e. ESP 168 10,6 0 0 168 10,5
f. Other EU 355 22,4 3 30,0 358 22,4
countries
g. EU total 1536 97,0 10 100 1546 97,0
h. EFTA 47 3,0 0 0 47 3,0
countries
i. Grand total 1583 100 10 100 1593 100
(g+h)
Sources: Notifications to the CEN/CENELEC.

Notes:

1. 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.

2. 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. CS: Czech Republic.

51
6.10. Table IV a - Top ten subsectors for new national standardisation activities in
1995

SUBSECTORS Number of new activities

(EU + EFTA)

Code Name

T02 Aeronautics 264(*)

C99 Chemical products - 75(*)

miscellaneous

N05 Textiles 64

C01 Foodstuffs 58

I09 Small machine tools 56

I11 Machine tools 53

S09 Water quality and water 51

supply

B02 Construction 44

B99 Building - miscellaneous 44

aspects

N03 Oil products 39

T03 Road vehicles 40

Total - 788

Source: Notifications to the CEN/CENELEC.

Notes:
1. In 1995 the top two subsectors in the electrical engineering sector were:
- electricity cables (code W08): 6 new drafts
- electrical accessories (code W11): 2 new drafts.
2. In the absence of more detailed figures, the totals given are for the EU plus the EFTA
countries.
( )
* Estimate for subsectors T02 and C99, excluding the notifications for regularisation
purposes from France.

52
6.11. Table IV b - Top ten subsectors for new national standardisation activities in
1996

SUBSECTORS Number of new activities

(EU + EFTA)

Code Name

C01 Foodstuffs 119

I09 Small machine tools 66

T01 Shipbuilding and offshore 64

structures

S09 Water quality and water 58

supply

T02 Aeronautics 53

B03 Concrete 43

B01 Fire protection 42

I19 Nuclear energy 33

N03 Oil products 33

M01 Steel 29

S99 Health - miscellaneous 29

Total 569

Source: Notifications to the CEN/CENELEC.

Notes:
1. In 1996 the top two subsectors in the electrical engineering sector were:
- electricity cables (code W08): 7 notifications
- telecommunications cables and wires (code V08): 3 notifications.
2. In the absence of more detailed figures, the totals given are for the EU plus the EFTA
countries.

53
6.12. Table IV c - Top ten subsectors for new national standardisation activities in
1997

SUBSECTORS Number of new activities

Name
(EU + EFTA)
Code

C01 Foodstuffs 66

I09 Small machine tools 52

T03 Road vehicles 50

B01 Fire protection 49

B99 Building - miscellaneous 44

aspects

I05 Steel tubes 43

S09 Water quality and water 38

supply

B02 Construction 37

B27 Waterproof materials 33

T02 Aeronautics 31

Total 443

Source: Notifications to the CEN/CENELEC.

Notes:
1. In 1997 the top two subsectors in the electrical sector were:
- switching and control systems (code W06): 5 notifications
- electrical accessories (code W11): 3 notifications.
2. In the absence of more detailed figures, the totals given are for the EU plus the EFTA
countries.

54
6.13. Table IV d - Top ten subsectors for new national standardisation activities in
1998

SUBSECTORS Number of new activities

(EU + EFTA)

Code Name

C01 Foodstuffs 61

T01 Shipbuilding and offshore 61

structures

I19 Nuclear energy 58

S09 Water quality and water 49

supply

I05 Steel tubes 47

S08 Air quality 47

B02 Construction 39

B25 Gas distribution installations 37

T03 Road vehicles 33

N02 Solid fuels 32

Total 464

Source: Notifications to the CEN/CENELEC.

Notes:
1. In 1998 the top two subsectors in the electrical sector were:
- fibre optics (code V28): 4 notifications
- overhead electric lines (code W04): 2 notifications.
2. In the absence of more detailed figures, the totals given are for the EU plus the EFTA
countries and the Czech Republic (CS).

55
6.14. Table V - Application of Article 4 (requests to participate in national
standardisation activities and requests to draw up a European standard)

Year Requests for Comments Requests to Requests for a

information participate European
standard

1985 5 14 5 0

1986 8 16 10 1

1987 5 74 5 0

1988 0 67 15 0

1989 0 52 16 1

1990 20 78 7 0

1991 0 83 16 0

1992 0 52 5 0

1993 0 34 7 0

1994 5 74 7 1

1995 0 46 4 2

1996 0 63 8 1

1997 0 58 5 0

1998 0 29 3 2

Source: CEN/CENELEC.

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

56
6.15. Table VI a - Standardisation work entrusted to the European standardisation
bodies in 1995

1. Mandates related to New Approach Directives

– Directive 88/378/EEC: standardisation mandate for CEN in the field of organic

compounds in toys other than chemical toys.

– Directive 89/336/EEC, Directive 91/263/EEC and Directive 93/97/EEC

supplementing Directive 91/263/EEC: standardisation mandate for CEN,
CENELEC and ETSI in the field of electromagnetic compatibility
requirements.

– Directive 98/79/EC on in vitro diagnostic medical devices: programming

mandate for CEN and CENELEC.

2. Mandates in connection with the Directives on public procurement

– Directive 89/440/EEC: standardisation mandate for CEN and CENELEC in the

field of qualification of construction enterprises.

3. Mandates in connection with Community policy in the field of information

technology and telecommunications

– Corporate telecommunications networks.

– Work programme for aeronautical mobile satellite terminals.

– Multiple 64 kbits/s leased lines.

– General packet radio service on GSM.

– Work programme for electronic toll systems.

– Standards for integrated circuit cards for road toll collection.

– Standards for metal and optical fibre cables and for cabling systems.

– Standards for broadband ISDN/ATM-based networks and metropolitan

networks.

– Standards for frame relay.

– Standards for access networks.

– Standards for digital European cordless telecommunications (DECT).

– Standards for GSM and DCS 1800.

– Standards covering the elements involved in the terrestrial flight

telecommunications system (TFTS).

– Standards for trans-European trunked radio system (TETRA).

57
 – Standards for mobile satellite services.

– Report on the numbering of telecommunications services.

– Standards for sound, picture and data coding.

– Standards for managing the various elements in a telecommunication

management network (TMN).

– Standards for the universal mobile telecommunications system (UMTS).

– Standards for software interfaces to information and communications

technologies services.

4. Mandates in connection with other Community policies.

4.1. Consumer protection policy

– Directive 92/59/EEC on general product safety: standardisation mandate

for CEN in the field of consumer safety - bunk beds.

4.2. Environmental policy

– Directive 94/55/EC on the transport of dangerous goods: standardisation

mandate for CEN.

– Directive 94/62/EC on packaging and packaging waste: standardisation

mandate for CEN.

– - Directive 94/67/EC and Directive 89/369/EEC: standardisation mandate

for CEN for determination of the total emissions of certain heavy metals
into the air.

4.3. Energy policy

– Council Decision 93/500/EEC (ALTENER Programme): standardisation

mandate for CEN and CENELEC in the field of solar photovoltaic
energy systems and components.

– Directive 92/75/EEC: standardisation mandate for CEN and CENELEC

for the drafting and adoption of measurement standards for household
lighting sources.

– Directive 92/75/EEC: standardisation mandate for CEN and CENELEC

for the drafting and adoption of measurement standards for household
ovens.

– Directive 92/75/EEC: standardisation mandate for CEN and CENELEC

for the drafting and adoption of measurement standards for household
water heaters and hot-water storage appliances.

– SAVE and PACE Programmes: standardisation mandate for CEN and

CENELEC for the drafting and adoption of measurement standards for
ballasts for fluorescent lamps.

58
6.16. Table VI b - Standardisation work entrusted to the European standardisation
bodies in 1996

1. Mandates related to New Approach Directives

– Mandate for CEN and CENELEC in the field of construction products:

geotextiles.

– Mandate for CEN and CENELEC in the field of construction products: curtain
walling.

– Mandate for CEN and CENELEC in the field of construction products: fire
alarm and detection systems, fixed explosion suppression systems and
products.

– Mandate for CEN and CENELEC in the field of construction products: sanitary
appliances.

– Mandate for CEN and CENELEC in the field of construction products: fixed
road traffic installations.

– Mandate for CEN and CENELEC in the field of construction products:

structural timber products.

– Mandate for CEN and CENELEC for a study on the feasibility of, need for and
proposed form of a guideline concerning the selection of personal protective
equipment.

2. Mandates in connection with public procurement

– Mandate for CEN and CENELEC for standardisation in the field of equipment
and installations for the transmission and distribution of electricity.

3. Mandates in connection with Community policy in the field of information

technology and telecommunications

– Mandate for CEN in the field of postal services and equipment.

– Mandate for CEN, CENELEC and ETSI in the field of information technology,
consumer electronics and telecommunications: standards for ISDN packet
mode services.

– Mandate for CEN, CENELEC and ETSI in the field of information technology,
consumer electronics and telecommunications: standards for user access to
broadband ISDN networks and services.

59
4. Mandates in connection with other Community policies.

4.1. Consumer protection policy

– Standardisation mandate for CEN and CENELEC in the field of safety of

equipment for fairgrounds and amusement parks.

4.2. Policy on worker protection

– Mandate for CEN in the field of specifications for fire-resistant hydraulic

fluids used for power transmission (hydrostatic and hydrokinetic).

4.3. Environmental policy

– Mandate for CEN and CENELEC for the quality assurance of automated
measuring systems.

4.4. Transport policy

– Mandate for CEN, CENELEC and ETSI in the field of space technology.

– Mandate for CEN, CENELEC and ETSI in the field of air traffic
management equipment and systems.

4.5. Energy policy

– Mandate for CEN for the adoption of standards containing minimum

requirement specifications, including test methods for fatty acid methyl
esters (FAME) or biodiesel.

– Mandate for CEN and CENELEC for the adoption of measuring

standards and test methods for the power of electric motors.

60
6.17. Table VI c - Standardisation work entrusted to the European standardisation
bodies in 1997

1. Mandates related to New Approach Directives

– Mandate for CEN and CENELEC in the field of construction products: wood-
based panels.

– -Mandate for CEN and CENELEC in the field of construction products:

cements, building limes and other hydraulic binders.

– Mandate for CEN and CENELEC in the field of construction products:

reinforcing and prestressing steel for concrete.

– Mandate for CEN and CENELEC in the field of construction products:

masonry and related products.

– Mandate for CEN and CENELEC in the field of construction products:

horizontal complement for the evaluation of construction products and
elements in respect of their resistance to fire.

– Mandate for CEN and CENELEC in the field of construction products: waste
water engineering products.

– Mandate for CEN and CENELEC in the field of construction products:

floorings.

– Mandate for CEN and CENELEC in the field of in vitro diagnostic medical
devices.

2. Mandates in connection with public procurement

(No mandates)

3. Mandates in connection with Community policy in the field of information

technology and telecommunications

– Programming and standardisation mandate for CEN, CENELEC and ETSI in

the field of health care informatics.

– Mandate for CEN, CENELEC and ETSI in the field of road transport
telematics.

– Mandate for CEN, CENELEC and ETSI on European multicultural

specificities.

– Mandate for CEN, CENELEC and ETSI on geographic information systems.

– Mandate for CEN, CENELEC and ETSI on consumer interests in the field of
electronic commerce.

61
4. Mandates in connection with other Community policies.

4.1. Consumer protection policy

– Mandate for CEN in the field of consumer safety: feasibility study on

possible standardisation on fire resistance of nightwear.

– Mandate for CEN and CENELEC in the field of consumer safety: baby-
walkers.

– Mandate for CEN in the field of consumer safety: oil lamps.

– Mandate for CEN and CENELEC in the field of consumer safety: safety
of child care articles.

4.2. Environmental policy

– Mandate for CEN and CENELEC concerning the reference method for
the measurement of SO2, NOx, CO and O3 in ambient air.

– Mandate for CEN and CENELEC concerning the reference method for
the measurement of benzene in ambient air.

– Mandate for CEN and CENELEC concerning the reference method for
the measurement of Pb, Cd, As and Ni in ambient air.

4.3. Transport policy

(No mandates)

4.4. Energy policy

– Mandate for CEN and CENELEC for the designation of operational

modes and for the measurement methods related to the power
consumption of televisions, videocassette recorders, decoders and
satellite receivers.

62
6.18. Table VI d - Standardisation work entrusted to the European standardisation
bodies in 1998

1. Mandates related to New Approach Directives

– Mandate for CEN for the conversion of the Eurocodes from ENV prestandards
into European EN standards concerning the structural and geotechnical design
of buildings and civil engineering works.

– Mandate for CEN and CENELEC concerning the execution of standardisation

work for harmonised standards on structural metallic products and ancillaries.

– Mandate for CEN and CENELEC concerning the execution of standardisation

work for harmonised standards on internal and external wall and ceiling
finishes.

– Mandate for CEN and CENELEC concerning the execution of standardisation

work for harmonised standards on roof coverings, rooflights, roof windows and
ancillary products.

– Horizontal complement to the mandates for CEN and CENELEC concerning

the execution of standardisation work for the evaluation of construction
products in respect of their reaction to fire.

– Mandate for CEN and CENELEC concerning the execution of standardisation

work on road construction products.

– Mandate for CEN and CENELEC concerning the execution of standardisation

work for harmonised standards on aggregates.

– Mandate for CEN, CENELEC and ETSI for the elaboration and adoption of
standards for railway equipment, related to the interoperability of the trans-
European high-speed rail system.

2. Mandates in connection with public procurement

(No mandates)

3. Mandates in connection with Community policy in the field of information

technology and telecommunications

– Mandate relating to electronic signature.

– -Mandate relating to educational software.

– Standardisation mandate for CEN, CENELEC and ETSI for harmonised

standards for R-GSM terminals.

– Standardisation mandate for CEN, CENELEC and ETSI for harmonised

standards for the GSM cordless telephony system.

63
 – Mandate for the European standards bodies in the field of information and
communications technologies for elderly and disabled people.

4. Mandates in connection with other Community policies.

4.1 Consumer protection policy

– Mandate for CEN and CENELEC in the field of consumer safety related
to the safety of lighters.

4.2 Environmental policy

– Three mandates concerning a manual reference method allowing the

calibration of an automated system for measuring emissions of
substances.

4.3 Energy policy

– Standardisation mandate for CEN and CENELEC for the designation of

operational modes and for the measurement methods related to the power
consumption of audio systems.

– Standardisation mandate for CEN and CENELEC for the measurement

method for the determination of the efficacy of fluorescent lighting
luminaries.

– Standardisation mandate for CEN and CENELEC for the elaboration and
adoption of standards for the measurement methods for the determination
of the efficiency of individual air conditioners.

64
6.19. Table VII - Number of notifications of technical rules from each Member State
from 1995 to 1998

Member State 1995 1996 1997 1998

Belgium 26 17 59 50

Denmark 36 28 40 55

Germany 92 88 99 76

Spain 25 19 35 24

Finland 17 34 22 23

France 61 41 51 47

Greece 12 16 12 11

Ireland 1 4 3 1

Italy 31 27 31 32

Luxembourg 1 0 0 2

Netherlands 43 62 341 122

Austria 25 61 106 69

Portugal 5 19 7 11

Sweden 5 34 23 30

United 59 73 71 51
Kingdom

EC total 439 523 900 604

65
6.20. Table VIII - Percentage of notifications of technical rules from each Member
State from 1995 to 1998

Member State % % % %
1995 1996 1997 1998
Belgium 5,9 2,1 6,5 8,2

Denmark 8,2 5,3 4,4 9,1

Germany 20,9 16,8 11 12,5

Spain 5,6 3,6 3,8 3,9

Finland 3,8 6,5 2,4 3,8

France 13,8 7,8 5,6 7,7

Greece 2,7 3 1,3 1,8

Ireland 0,2 0,7 0,3 0,1

Italy 7 5,1 3,4 5,2

Luxembourg 0,2 - - 0,3

Netherlands 9,7 11,8 37,8 20,1

Austria 5,6 11,6 11,7 11,4

Portugal 1,1 3,6 0,7 1,8

Sweden 1,1 6,5 2,5 4,9

United 13,4 13,9 7,8 8,4

Kingdom

66
6.21. Table IX - Breakdown by sector of drafts notified by the Member States of the European Union (1995)

SECTOR B DK D E FIN F GR IRL I L NL A P S U EC TOTAL

K

Building and construction - 3 14 5 1 1 1 - 4 - - 11 3 - 6 49

Agricultural products and foodstuffs 5 - 3 4 - 3 4 - 11 - 16 3 1 - 8 58

Chemicals 1 1 1 - 1 - - - - - 1 2 - 2 - 9

Pharmaceuticals 3 - - 1 - 2 1 - - - - - - - 5 12

Household and leisure equipment - 1 1 - - 3 - - - - 2 1 - - 3 11

Mechanical engineering 3 5 45 6 8 7 - 1 10 - 4 3 - - 11 103

Energy, minerals, wood - - - 1 - - 1 - - - 1 - - - - 3

Environment, packaging - 1 - - 1 1 - - - 1 6 - - 1 - 11

Health, medical equipment - - - - - 3 - - - - - 1 - - - 4

Transport 2 9 2 3 3 8 3 - 3 - 5 3 - 1 11 53

Telecommunications 12 16 24 5 1 33 1 - 2 - 8 1 1 - 15 119

Miscellaneous - - 2 - 2 - 1 - 1 - - - - 1 - 7

TOTAL BY MEMBER STATE 26 36 92 25 17 61 12 1 31 1 43 25 5 5 59 439

67
6.22. Table X - Breakdown by sector of drafts notified by the Member States of the European Union (1996)

SECTOR B DK D E FIN F GR IRL I L NL A P S U EC TOTAL

K

Building and construction 1 3 28 6 4 4 2 1 1 - 5 11 - 2 9 77

Agricultural products and foodstuffs 2 5 5 1 1 10 5 1 8 - 27 7 6 - 26 104

Chemicals - 2 5 1 1 3 1 - 4 - 6 3 - 3 2 31

Pharmaceuticals 3 - 1 - 2 4 - - - - - - - 2 3 15

Household and leisure equipment - 2 1 - 2 1 - - - - 1 2 - - - 9

Mechanical engineering 5 5 11 6 13 8 - - 2 - 6 7 2 3 11 79

Energy, minerals, wood - - 1 - - - 1 - - - - - - 2 - 4

Environment, packaging 2 3 4 1 3 1 2 1 1 - 9 4 1 4 2 38

Health, medical equipment - - 1 - - - - - 1 - - - - - - 2

Transport - 4 11 2 5 1 5 - 7 - 8 12 - 11 17 83

Telecommunications 1 4 20 2 3 8 - 1 2 - - 15 10 7 3 76

Miscellaneous 3 - - - - 1 - - 1 - - - - - - 5

TOTAL BY MEMBER STATE 17 28 88 19 34 41 16 4 27 - 62 61 19 34 73 523

68
6.23. Table XI - Breakdown by sector of drafts notified by the Member States of the European Union (1997)

SECTOR B DK D E FIN F GR IRL I L NL A P S UK EC

TOTAL

Building and construction 1 1 26 7 5 3 2 1 1 - 15 28 - 4 2 96

Agricultural products and foodstuffs 7 6 4 8 1 11 4 0 11 - 81 7 - 1 25 166

Chemicals 1 1 3 3 - - 1 0 6 0 11 3 - 4 1 34

Pharmaceuticals - - 6 - - 4 - - 1 - 4 2 - 2 4 23

Household and leisure equipment - 1 0 2 0 3 - - - - 1 - - - 1 8

Mechanical engineering 11 3 26 5 6 8 - - 2 - 40 12 2 5 5 125

Energy, minerals, wood 1 - - 1 - 6 - - - - 2 - - - - 10

Environment, packaging 4 4 3 - 1 5 1 1 2 - 32 5 3 - 2 63

Health, medical equipment - - 1 - - - - - - - 1 - 1 - 1 4

Transport - 8 7 3 5 2 4 - 3 - 110 9 1 7 24 183

Telecommunications 33 16 23 6 3 7 - 1 4 - 9 38 - - 6 146

Miscellaneous 1 - - - 1 2 - - 1 - 35 2 - - - 42

TOTAL BY MEMBER STATE 59 40 99 35 22 51 12 3 31 - 341 106 7 23 71 900

69
6.24. Table XII - Breakdown by sector of drafts notified by the Member States of the European Union (1998)

SECTOR B DK D E FIN F GR IRL I L NL A P S UK EC

TOTAL

Building and construction 2 - 30 5 3 1 - - 5 - 14 9 - 1 6 76

Agricultural products and 9 4 6 1 1 15 2 - 7 - 35 2 5 4 7 98

foodstuffs

Chemicals 3 8 2 1 - 2 2 - 7 - 4 4 1 3 2 39

Pharmaceuticals - 1 2 - - 4 1 - 1 - 2 1 - 3 2 17

Household and leisure equipment 1 - - 1 - 1 - - - - - 1 1 1 - 6

Mechanical engineering 18 - 8 9 7 7 2 - 7 - 10 16 2 7 10 103

Energy, minerals, wood - 2 - 2 - 2 - - 1 1 5 4 - 1 2 20

Environment, packaging 8 2 3 1 2 2 1 1 1 1 18 2 - 1 - 43

Health, medical equipment - - 3 - - - - - - - 1 3 - - - 7

Transport 1 9 11 - 7 7 3 - 1 - 18 3 1 8 10 79

Telecommunications 1 26 11 3 3 2 - - 1 - 6 21 1 1 11 87

Miscellaneous 7 3 - 1 - 4 - - 1 - 9 3 - - 1 29

TOTAL BY MEMBER STATE 50 55 76 24 23 47 11 1 32 2 122 69 11 30 51 604

70
6.25. Table XIII - Comments on drafts notified by Norway and Switzerland in 1995

COUNTRY NOTIFICATIONS EC COMMENTS

Norway 8 6

Switzerland 16 8

TOTAL 24 14

Comments on drafts notified by Norway and Switzerland in 1996

COUNTRY NOTIFICATIONS EC COMMENTS

Norway 30 23

Switzerland 13 4

TOTAL 43 27

Comments on drafts notified by Iceland, Norway and Switzerland in 1997

COUNTRY NOTIFICATIONS EC COMMENTS

Iceland 1 1

Norway 11 5

Switzerland 20 6

TOTAL 32 12

Comments on drafts notified by Iceland, Norway and Switzerland in 1998

COUNTRY NOTIFICATIONS EC COMMENTS

Iceland 5 4

Norway 32 11

Switzerland 13 7

TOTAL 50 22

71
6.26. Table XIV - Breakdown by sector of drafts notified by Norway and Switzerland
in 1995

SECTOR NORWAY SWITZERLAND TOTAL FOR SECTOR

Pharmaceuticals - 1 1

Mechanical engineering 1 - 1

Energy, minerals, wood - 1 1

Health, medical equipment - 1 1

Transport 1 2 3

Telecommunications 6 11 17

TOTAL FOR COUNTRY 8 16 24

72
 Breakdown by sector of drafts notified by Norway and Switzerland in 1996

SECTOR NORWAY SWITZERLAND TOTAL FOR SECTOR

Building and construction 1 - 1

Foodstuffs 2 1 3

Chemicals 3 1 4

Pharmaceuticals - 2 2

Mechanical engineering - 3 3

Health, medical equipment - 1 1

Environment, packaging 1 - 1

Transport 1 - 1

Telecommunications 22 5 27

TOTAL FOR COUNTRY 30 13 43

73
 Breakdown by sector of drafts notified by Iceland, Norway and Switzerland in 1997

SECTOR ICELAND NORWAY SWITZERLAN TOTAL FOR SECTOR

D

Building and construction - - - -

Foodstuffs - 4 8 12

Chemicals - 2 2 4

Pharmaceuticals - - 2 2

Mechanical engineering - - 3 3

Health, medical equipment - - - -

Environment, packaging 1 1 3 5

Transport - 1 2 3

Telecommunications - 3 - 3

TOTAL FOR COUNTRY 1 11 20 32

74
 Breakdown by sector of drafts notified by Iceland, Norway and Switzerland in 1998

SECTOR ICELAND NORWAY SWITZERLAN TOTAL FOR SECTOR

D

Building and construction - - 3 3

Foodstuffs 3 5 6 14

Chemicals - 6 - 6

Pharmaceuticals - - - -

Household and leisure - 1 - 1

equipment

Mechanical engineering 1 - 1 2

Energy - - 2 2

Health, medical equipment - - - -

Environment, packaging 1 1 - 2

Transport - 13 1 14

Telecommunications - 6 - 6

TOTAL FOR COUNTRY 5 32 13 50

75