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i!r Tir COMMISSION OF THE EUROPEAN COMMUNITIES 
Brussels, 13.05.1998 
COM( 1998) 291 final 
REPORT FROM THE COMMISSION TO THE COUNCIL 
'AND THE EUROPEAN PARLIAMENT 
#•(! EFFICIENCY AND ACCOUNTABILITY IN 
EUROPEAN STANDARDISATION 
UNDER THE NEW APPROACH 

CONTENTS 
INTRODUCTION: THE NEED FOR CONSTANT REVIEW 1 
I. THE SPECIFIC FEATURES OF THE NEW APPROACH IN RELATION TO 
STANDARDISATION ? 2 
The Relationship Between the New Approach and Standardisation 2 
The Need for Accountability 4 
The Role of National Standards Bodies 4 
The Use of Publicly Available Specifications (PAS) 5 
II. THE SEARCH FOR EFFICIENCY 6 
The concept of Efficiency 6 
Timetable for the Standardisation Procedure. 8 
III. PROPOSALS FOR IMPROVING THE EFFICIENCY OF THE EUROPEAN 
STANDARDISATION SYSTEM 9 
Management of the standardisation process. 9 
The role of public authorities 11 
A Single European Standardisation Body, or More Competition? 12 
Improving Awareness 13 
Financial Support to European Standardisation 14 
IV. CONCLUSIONS 15 
Annex: Progress in standardisation programmes 16 
INTRODUCTION: THE NEED FOR CONSTANT REVIEW 
1. European standards play a vital role in the proper functioning of the Single 
Market. At its November 1997 meeting, the Council for the Internal Market 
asked the Commission to "prepare a report on the efficiency of European 
standardisation, in co-operation with the European and national standards 
organisations, and with the appropriate European-level committees". During 
subsequent discussions, and in particular at the occasion of the informal 
meeting of Ministers for the Internal Market held in Cambridge in February 
1998, it was agreed that the Report should focus on the New Approach. 
This Report was produced in response to that request. It was prepared in close 
collaboration with Member States, European and national standards bodies and 
other interested parties. 
2. Efficiency in European standardisation has been brought to political attention 
at various occasions in the recent past. In its Action Plan for the Single 
Market1, the Commission noted that considerable progress has been made in 
the area of standardisation, but that there is no room for complacency. In its 
Communication on "the impact and effectiveness of the Single Market"2, the 
Commission noted that "some problems have been experienced due to delays 
in the delivery of standards, but that the standards bodies have made great 
strides in adapting to the surge in demand put upon them. The onus will be on 
European industry, if it wants the harmonised standards, to provide sufficient 
resources to finish the job." 
3. A recent report prepared by Denmark3 and presented to the Internal Market 
Council highlighted the fact that a significant number of standards for the New 
Approach has still to be delivered and that the average development time for 
standards remains too long in most cases. The Commission welcomes the 
initiative taken by Denmark, as it allows for verifying where further progress 
can be made. 
4. This Report describes the relationship between the New Approach and 
standardisation, and emphasises the need for accountability in standardisation. 
It then indicates how efficiency can be assessed, and formulates a number of 
proposals for improving efficiency. Its conclusions are that 
> the basic concepts of the New Approach and of European standardisation 
have proved their validity for the development of the Single Market, 
CSE(971)lfinalof4June 1997. 
COM(96)520 final of 30 October 1996. 
The European standardisation work: analysis and recommendations for efficiency initiatives. 
Report prepared for the Danish Agency for Trade and Industry, October 1997. 
1 b 
> the management of the standardisation process and transparency can be 
improved, which is a task mainly for the European standards bodies, 
> standardisation as a voluntary system has its limitations and public 
authorities have the responsibility to create incentives and a framework in 
which standards can be developed in an efficient way. 
I. THE SPECIFIC FEATURES OF THE NEW APPROACH IN RELATION TO 
STANDARDISATION 
The Relationship Between the New Approach and Standardisation 
5. The principles of the New Approach to technical harmonisation and standards 
were laid down in 1985 (OJEC C 136 of 4.6.1985). 
The New Approach deals 
with large families of 
products (e.g. machinery, 
construction products, 
toys, packaging, etc), or 
with horizontal risks 
(e.g. electro-magnetic 
compatibility). It defines 
the essential requirements 
that products must meet 
when they are put on the 
market, but it does not 
indicate the technical 
means by which to meet the requirements. With the exception of the 
Construction Products Directive, New Approach directives leave 
manufacturers the choice of technology. The New Approach directives, 
therefore, allow for a high degree of technological flexibility. 
To facilitate the marketing of products, the New Approach foresees the use of 
European standards as a fast track to meet essential requirements. 
Compliance with such standards remains voluntary, but provides definite 
advantages to manufacturers who place products on the market. New Approach and New Approach-like directives 
have been adopted, covering a range of products as 
diversified as toys, construction products, 
electro-magnetic compatibility, machinery, 
telecommunications terminal equipment, satellite 
earth station equipment, medical devices, 
packaging, etc. 
Products covered represent 17% of 
intra-Community trade. 
A list is attached in Annex* 
r Products meeting standards have a presumption of conformity with the 
essential requirements of the directives. 
> In most New Approach directives, standards permit a wider choice of 
conformity assessment procedures for manufacturers. For instance, 
compliance with European standards can allow a manufacturer to declare 
conformity with the Directive without third party intervention. 
Standardisation is, by its nature, a voluntary process carried out within 
independent organisations. Parties will only participate in the process if they 
perceive a value in doing so. The incentive to develop standards is mainly an 
economic one. Standards are adopted on the basis of consensus, defined by 
standards organizations as the absence of sustained objection from major 
parties. Compliance with standards remains voluntary. 
The New Approach has, however, added a new dimension to standardisation. 
> Standards bodies are not entirely free to decide what standards to develop. 
They are required to meet essential requirements of large legislative 
programmes, to develop a coherent set of standards that cover aspects of 
the public interest, such as safety. The standards themselves must remain 
flexible enough to allow for technological progress while, at the same 
time, providing a sufficiently precise level of specification to ensure 
smooth implementation of the directives. 
> The New Approach also introduced institutional changes. Responsibility 
for presenting European standards as "harmonised" standards under the 
New Approach has been given to the European standards organisations. 
At the same time, public authorities have committed themselves to not 
insisting on approving the technical content of such standards; no positive 
decision is required by which authorities approve the standards, even if 
previously such technical aspects were subject of regulation. 
7. In certain areas, where the market is not sufficiently interested in European 
standardisation, the pproach taken by the European legislator has not itself 
given rise to a sufficiently strong incentive to develop standards at the 
European level. The policy objective of the free movement of goods should 
not be delegated to the voluntary standardisation level, as standardisation can 
only solve technical questions. 
> For instance, the Construction Product Directive (CPD) does not create a 
sufficiently strong incentive to elaborate so-called European harmonised 
standards. As long as no such standards exist, national technical regulation 
continues to exist, and Member States can even adopt new regulation. 
Consequently, if the market is not prepared to elaborate standards, the free 
movement of construction products is not guaranteed by harmonisation 
and remains governed by the principles of the Treaty. 
> Another often-cited example of the "failure" of the European 
standardisation system is the case of plugs and sockets. These are 
excluded from the scope of the Low Voltage Directive, and no 
standardisation mandate has ever been given to CENELEC. Given the 
existence of vested national interests, it is unlikely that on a mere 
voluntary basis standardisation will take place. If harmonization of plugs 
and sockets should take place, a political decision is likely to be required. 
The Need for Accountability 
8. The New Approach charges European standards organisations to elaborate 
technical specifications the use of which provides a presumption of conformity 
with legal 
The General Guidelines for Cooperation and the Council 
Resolution on the Role of European Standardisation reflect 
principles of accountability in: 
> 
> 
> requirements. 
This can only be 
justified if the 
standardization 
system is truly 
open and 
transparent, if 
the standard is 
supported by all 
major interested 
parties, and if 
the standard is 
applied in a 
uniform way 
throughout the 
Community. 
These 
requirements are 
referred to as the 
accountability of 
European standardisation. Principles of accountability have been laid down in 
the General Guidelines for Co-operation between CEN and CENELEC and the 
European Commission, adopted in 1984 (currently under revision) and in the 
Council Resolution of 18 June 1992 on the role of European standardisation in 
the European economy (C 173 of 9.7.1992). 
Efficiency and accountability must be balanced. It is essential that all 
interested parties have the possibility of fully considering the substance of a 
draft and of expressing their views during the public inquiry, with associated 
comments taken into consideration, even if this has an impact of efficiency. 
Accountability determines to a large extent the role f national standards 
organisations and of the possible use of Publicly Available Specifications. 
The Role of National Standards Bodies institutional rules relating to questions such as 
membership of the standards organisations, access for 
European-based interest groups to policy setting 
activities, dialogue with the public authorities, etc.; 
the possibility for all interested parties to participate 
effectively in standardisation work, under fair 
conditions; 
the need to verify consensus through national public 
enquiry, the establishment of consensus through national 
representation, and, in certain countries, the need to 
make standards available in the national language; 
the obligation for national standards bodies to transpose 
European standards in an uniform way, and to withdraw 
conflicting national standards. 
Consensus is determined on the basis of national representation. National 
standards bodies thus play an essential role in expressing the national position 
and they will continue to play this role. In addition, national bodies are a link 
between market players, in particular SMEs, and European standardisation, 
and provide access to and advice on European standards, as well as secretarial 
support to Technical Committees. The Commission considers that national 
bodies are an essential part of the European standardisation system. 
However, national standards bodies should also project themselves as being 
part of a common European standardization system, serving common 
interests. This is particular true in their relations with international 
standardisation. 
Nevertheless, the possibility of providing secretariats for technical committees 
and similar bodies by European-level sectoral associations (such industrial 
federations) should be considered as an alternative to national standards 
bodies. This possibility should not affect the approval procedures, which 
remain with the national standards bodies. 
The Use of Publicly Available Specifications (PAS) 
10. Some Member States have suggested examining whether, in the absence of 
European standards, PAS adopted by private consortia of companies, or other 
documents of CEN, CENELEC and ETSI, can be used for the New Approach, 
even if they do not have the status of standards. The Commission considers 
that PAS and similar documents can play a useful role as input to the 
standardisation process. Where PAS reflect market practice, it may be useful 
to verify through the standardisation process whether that practice may meet 
with overall consensus and thus become a full-fledged standard. The 
Commission welcomes the procedures developed by CENELEC and ETSI to 
present PAS for approval as European standards. 
11. The advantage associated with the use of such documents is the greater speed 
with which they can be adopted, compared with standards. The difference in 
speed is due mainly to the absence of the need to seek a general consensus that 
is characteristic of the standardisation process. Consensus emerges only from 
those who consent to the initiative. For this reason, the direct use of PAS and 
similar documents under the New Approach has its limitations. 
PAS lack the democratic legitimacy and accountability offered by the 
standardisation process. Furthermore, the procedural guarantees on the 
implementation of such documents are less stringent compared with those 
applicable to standards. A number of practical questions would have to be 
resolved in order to give greater recognition to PAS under the New Approach, 
for example: Who could write PAS? Should PAS providers be formally 
"recognised"? By whom? Should PAS become a new category of 
specifications under Directive 83/189? Should public authorities approve 
individual PAS? Could there be conflicting PAS? How should workers, 
consumers, environmental interests and SMEs be involved in the elaboration 
of PAS? 
In any case, Directives would have to be modified in order to assimilate such 
documents to European standards. 
Thus, although shortcomings in accountability impede the direct use of PAS 
under the New Approach, the use of PAS as an input to the standardisation 
process offers interesting perspectives that CEN, CENELEC and ETSI should 
exploit. 
IL THE SEARCH FOR EFFICIENCY 
The Concept of Efficiency 
12. An efficient standardisation system should provide high-quality standards, 
deliver them in a timely fashion, and the standards themselves should be 
effectively used in the market. Efficient standardisation is, therefore, relevant 
to public authorities, industry and the social partners. 
• Public authorities are interested because standardisation is carried out 
within the policy framework of the internal market. Standards need to 
provide a sufficient degree of precision in order to allow the assessment of 
compliance with Community law. Conversely, the capacity of 
standardisation to complete the internal market affects the credibility of the 
public policy objective. Inevitably, criticisms of shortcomings in the 
standardisation system will be raised at the political level. A fair balance 
must, however, be maintained between efficiency and respect for the 
principles of accountability. 
• The interest of industry in the efficiency of standardisation arises first from 
the access that standards give to the market-place in regulated technical 
areas. Secondly, industry itself devotes substantial resources to 
standardisation and wishes to see the greatest possible return from its 
investment. 
• Workers, consumers and environment organisations are interested because 
standards quantify the level of protection that essential requirements are 
intended to provide. The accountability of the standardisation system and its 
capacity to deliver standards providing a high level of protection are 
therefore of prime importance to them. 
13. The first objective of European standards under the New Approach is, indeed, 
to meet the essential requirements of the Directives. Efficiency should, 
therefore in the first place be assessed on the basis of whether standards are 
adequate to meet them. It makes no sense to adopt a lot of standards if they 
are insufficient to give presumption of conformity. Industry is, in any case, 
primarily interested in the practical results of using standards rather than in the 
efficiency of the process. However, a cost-benefit analysis of European 
standardisation is still missing. The Commission stands ready to support 
initiatives to close this methodological gap. Such an analysis should also 
encompass benchmarking the impact of standardisation in Europe with 
standardisation in other regions of the world, including its effect on 
competitiveness. 
14. An analysis based on the number of standards adopted is simply not sufficient 
to assess efficiency, as the number does not reflect their impact. As an 
illustration of this point, the programmes of standards for New Approach 
Directives vary widely in size, independently of the economic impact of the 
Directives to which they refer. For instance, in each of the Machinery and 
Pressure Equipment areas, there are programmes of over 700 standards, whilst 
for the economically comparable area of medical devices, only 200 standards 
are foreseen. For the construction area, where a full programme is still under 
preparation, some 1500 standards are expected. 
15. As a pragmatic approach to improving efficiency, reference can be made to the 
reduction of delays that occur in the standardisation process. The chart that 
follows describes the stages of standardisation from elaboration of mandates to 
the transposition of European standards as national standards. It also shows 
the actors involved and indicates the average periods needed for each stage4. 
Although the nature of standardization is different in CEN, CENELEC and 
ETSI \ comparing the time taken for different stages of the standardisation 
process can, at any rate, be used as a benchmark to identify potential 
weaknesses and to compare methods. 
16. It may be concluded from the chart that: 
• Several actors are involved: the Commission, national authorities, the 
European standards organisations and the national standards organisations. 
Efforts to improve efficiency can be made by each of them. 
• Procedures related to the New Approach (e.g. agreement on the terms of 
mandates) and to standardisation itself (e.g. acceptance of a mandate, public 
enquiry, voting by national representation, and transposition of European 
standards at national level) in themselves take several months. These 
procedural periods are inherent in the system, even if improvements are 
possible. 
• Substantial differences exist between CEN, CENELEC and ETSI, covering 
an average standards elaboration period ranging from 24 to 75 months. The 
differences can be explained in part by differences in the standardising 
process, and may also indicate a potential scope for further reductions; 
however, determining the scope for such reductions will require a more 
detailed analysis. 
The periods indicated do not necessarily add up. Activities take place in parallel and in many cases 
standardisation mandates cover ongoing standardisation activities 
As an example, the making of technology-neutral specifications (the usual practice in CEN) is more 
difficult and time-consuming than selecting among available technologies (the usual practice in 
ETSI). Standardization in CENELEC is characterised by the high share of international standards 
adopted as European standards. 
Timetable for the Standardisation Procedure. 
Commission draws up a mandate, in consultation with 
83/189, and in construction CPD, Committee. 
Commission transmits mandate to European standards 
organisations (ESO) 
ESO accept the mandate 
ESO elaborate a (joint) programme 
Only in the case of the CPD: 
Commission accepts programme 
Technical Committee (TC) elaborates draft standard 
ESO and national standards bodies (NSO) organise 
Public enquiry 6 
TC considers comments 
NSO vote/ESO ratify 6 
ESO transmit references to the Commission, 
Including: translation titles 
Commission publishes the reference 
NSO transpose European standard. 6-12 months 
2 months 
CEN: 2.5 months 
CLC: 6 months 
ETSI: 1-3 months 
CEN: 6-18 months 
CLC: 1-9 months 
ETSI: 6-12 months 
2 months 
CEN: 35 months 
CLC: 12-24 months 
ETSI: 15 months 
CEN: 6 months 
CLC: 6 months 
ETSI: 4 months 
CEN: 19 months 
CLC: 4 months 
ETSI: 5 months 
CEN: 4 months 
CLC: 7.5 months 
ETSI: 2 months 
CEN: 5 months 
CLC: 3 months 
ETSI: insufficient 
experience 
4 months 
CTR7: up to 18 months 
CEN: 12 months 
CLC: 12 months 
ETSI: 9-12 months 
6 Excluding secretarial handling in CEN, CENELEC and ETSI. 
7 Common Technical Regulation, adopted on the basis of ETSI European Standards. 
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120 140 III. PROPOSALS FOR IMPROVING THE EFFICIENCY OF THE EUROPEAN 
STANDARDISATION SYSTEM 
Management of the standardisation process. 
17. The management of the standardisation process is, in the first place, the 
responsibility of the European standards organisations and their members. 
CEN, CENELEC and ETSI have for a number of years been implementing a 
policy of increasing efficiency. As an illustration, since 1993, the average 
developme 
nt time for 
standards 
in ETSI 
has been 
reduced 
from 45 to 
28 
months. 
CENELE 
C has a 
developme 
nt time of 
between 
24 and 48 months. CEN has itself set a target of 47 months (in 1991 it needed 
135 months); at present it requires 75 months (see chart). What matters more 
than the average standards elaboration time is the definition of realistic time 
schedules in standardisation programmes, the capacity to respect them and the 
transparency in their implementation. 
Detailed reports prepared by CEN, CENELEC and ETSI, explaining the 
measures taken or intended to improve efficiency, and their position on the 
suggestions made by Ministers during their meeting in Cambridge in February 
1998, will be presented to Member States. Annual reviews should take place, 
in co-operation with the European standards organisations. 
18. Some Member States have suggested that CEN, CENELEC and ETSI should 
consider a more systematic use of voting by qualified majority to speed up the 
adoption of European standards. Under the rules of standardisation, standards 
are based on consensus, i.e. the absence of sustained objection from major 
parties. Consensus is the guiding principle leading up to the vote on a final 
proposal, based on national representation. A standard is adopted if a qualified 
majority of national votes is reached. 
Voting at an earlier stage will not necessarily speed up standardisation, but can 
do so in certain cases. Much will depend on the skills of the Chairman of a 
Technical Committee. Proceeding at an early stage to voting might hamper the 
standardisation process by making it more political. Diverging opinions might 
be made more visible, and arbitration between different interests may become 
more complicated. Furthermore, those who fear to be defeated may organise 
opposition to a standard. On the other hand, "voting or indicative voting can 
speed up the process, for instance where vested interests block progress and 
show no willingness to compromise, or where hidden commercial interests 
block progress. In such cases, voting can create transparency and unlock 
situations. The European standards bodies should carefully consider the 
possibility of speeding up the standardization process by having recourse to 
voting at an earlier stage. 
19. CEN and CENELEC should consider further opening their structures to 
representative European-based interested parties, such as workers, consumers, 
environmental interests and industry, allowing them to participate in strategic 
discussions and the elaboration of policy. In contrast to ETSI, in CEN and 
CENELEC policy decisions and strategic discussion remain limited to their 
Boards and national standards bodies. Especially in CEN, which covers a very 
broad number of industrial domains, there is no visible forum for the 
consultation of stakeholders on strategic aspects of standardisation. 
According to the organisations representing European consumers and 
European workers, improvements can be made in a number of national 
organisations, mainly as regards representation and clear procedures for 
establishing a national consensus. Environment organisations feel that they 
are not sufficiently represented in the standardisation process, which is 
considered to be mainly industry driven and market led. Their fear is increased 
in the light of the shift from national to European, international and informal 
standardisation levels. The Commission considers that the participation of all 
interested parties is important for consensus building and accountability. 
Possibilities for collective interests to participate in European standardisation 
in a balanced way should be the subject of further discussion and monitoring 
in the enlarged 83/189 Committee. 
20. Use of electronic means of communication is an important contributor to 
efficiency. In 1997, the Commission gave a contribution of 1.6MECU, 
covering 50% of costs of participating national CEN members, to the INES 
(CEN Internet Network for European Standardisation) project. INES intends 
to promote the use of modern tools of communication. INES covers four 
areas: Electronic Committee processes, Document Management Service, WEB 
Information Service, and Standards Deliveries Service. Electronic 
standardisation and such means of information dissemination already exist in 
ETSI and are being implemented in CENELEC. In this effort, no Community 
support was requested. However, co-operation should enhanced between 
CEN, CENELEC and ETSI. 
21. New Approach Directives state that presumption of conformity is linked to the 
use of "national standards transposing European standards". National 
standards bodies should be aware of the importance of European standards 
being presented to the market, and should therefore handle transposition with 
all necessary urgency. Transposition periods for European standards should 
be set as short as is reasonably possible and time limits should be better 
10 
respected. Delays in transposition by national standards bodies should not 
diminish the benefits of the New Approach for manufacturers. If such delays 
occur, and since European standards have to be transposed in a uniform way, 
a manufacturer can rely on any national standard transposing a European 
standard or directly on the European standard. 
22. The quality of standards and the efficiency of the process can be improved if 
the work in the European standards organisations is preceded or 
complemented with well-targeted pre-normative research actions. On the one 
hand, pre-normative research promotes the development of new standards 
while on the other hand the standards can better disseminate the results of 
research. As announced in its document "Research and standardisation"8, the 
Commission will continue promoting pre-normative research in close co­
operation with the European standards organizations and the economic 
operators involved in standardisation. 
The role of the public authorities 
23. Some Member States have suggested that mandates should be made more 
precise. Mandates have been agreed with Member States through the 
83/189 Committee. The only area where the work of mandating and 
programming is not yet completed is in construction, although all final 
mandates are expected by mid-1998. The elaboration of final mandates for the 
Construction Products Directive was in itself a difficult exercise, mainly due to 
the need to identify national technical specifications that should become 
subject of European standardisation. Therefore, the average time for their 
elaboration was much longer than for other areas. Similarly, the elaboration of 
standardization programmes by CEN is a long process. Where mandates are 
given, it is important to integrate essential issues, such as the protection of 
safety, health and environment. 
If in the course of standardisation work a need arises for more precise 
indications regarding the terms of the related mandates, the European 
standards organisations should raise that question with the Commission, who, 
in co-operation with the relevant Committees, will address such questions and 
clarify the mandate. Questions can also be raised directly in the various 
Committees and groups in which the European standards organisations are 
invited to participate. However, when interested parties cannot agree on 
technical specifications, the Commission should not be considered as a "court 
of appeal" to make technological choices. 
24. Standardisation programmes, containing priorities and timetables, have been 
examined by the 83/189 Committee and sectoral committees or expert groups 
11 
in place for all the New Approach directives8. The Commission and national 
authorities should reinforce the monitoring of progress in the implementation 
of programmes. Progress in standardisation under the New Approach will 
also be covered in the Internal Market Scoreboard. 
25. A recent survey by the Commission services has revealed that the operation of 
Community Committees and expert groups in several cases could be 
improved. The Commission intends to address the efficiency of Committees 
and expert groups in a Report to be further examined in collaboration with 
Member States. In the management of committees, sufficient periods should 
be left to Member States to adopt a national position, and national 
administrations should ensure that co-ordination amongst all interested 
national services takes place in due time. More electronic transmission of 
documents, as well as electronic consultations between the Commission and 
Member States, should take place, the more given the continual budgetary 
constraint on the operation of such Committees and expert groups. 
26. _. The participation of public authorities in the standardisation process 
raises the question of the balance between their different roles: on the one 
hand, they participate in the standards making process at the same level as 
industry, workers, consumers, SMEs, environment interests; on the other hand, 
they act as an authority with a duty to protect the public interest. Once public 
authorities have agreed on a mandate, the search for technical solutions should 
in principle be left to the interested parties. In certain areas such as 
environment, health and safety, the participation of public authorities on a 
technical level is important in the standardisation process. Efficiency can be 
improved if the technical expertise of public authorities is present at the level 
of working groups. Furthermore, when a mandate is given, public authorities 
should examine draft standards, particularly when submitted to public enquiry, 
in order to ensure that the draft standards meet the requested safety, health and 
environmental levels. 
27. The Commission will take practical measures to improve the publication of 
references of European standards in the Official Journal, a condition for such 
standards to become effective under the New Approach. The electronic 
sending of titles and references for publication of references of European 
standards in the Official Journal is an important instrument to make further 
progress. In particular, CEN should accelerate the translation of titles of the 
standards into the Community languages. 
A Single European Standardisation Body, or More Competition? 
28. There have been suggestions that CEN and CENELEC should be merged. The 
Commission considers that CEN and CENELEC are independent 
8 Reports prepared by CEN, CENELEC and ETSI on the state of progress of European 
standardisation under New Approach directives are made available to Member States. 
12 
organizations and that a decision on a merger belongs to the CEN and 
CENELEC constituencies. In the Commission's opinion, it is unlikely that a 
merger at European level would improve efficiency unless it was matched by 
corresponding structural reorganisations at the national level. In many cases, 
the structure of CEN and CENELEC reflects corresponding national structure, 
and each organisation has its own constituency, its own fields of competence 
and own links to the international and national standardisation levels. Modern 
management tools, such as benchmarking, should be promoted amongst the 
European and the national standards organisations. 
29. Efficiency is not likely to be enhanced by the recognition of new standards 
bodies. New organisations would have to cope with the same tension between 
efficiency and accountability as CEN, CENELEC and ETSL As they would 
not be members of the international standards organisations ISO/IEC/ITU, 
they would not be in a position to represent Europe's interest at the 
international level, which is becoming increasingly important. 
Improving Awareness. 
30. It is necessary to bring standardisation and standards to the attention of 
market participants, in particular SMEs. This is mainly a task of the national 
standards organisations, national authorities and national federations 
representing industry. In order to give impetus to a European policy in this 
area, a Memorandum of Understanding was agreed in 1995 between the 
Commission and the European standards organisations. It aimed to improve 
policy on awareness. NORMAPME, who represents SMEs and craft interests 
in European standardisation, takes part in the implementation of this MoU. 
31. Progress reports on New Approach areas should be made available on the 
Internet by the European standards organisations. Links should be foreseen 
with information on directives, mandates, lists of references of European 
standards published for individual New Approach directives, lists of notified 
bodies and related information at the national level. 
32 In order to give a high visibility to the efficiency issue, the Commission 
envisages to organise a conference with all interested parties. Other questions 
that might be dealt with in such a conference are the relations with 
international standardisation and the relations with Central and Eastern 
European countries. 
13 
Financial Support to European Standardisation 
33. Financial support has been one of the main means by which the Community 
has promoted European standardisation. Since 1986, a total of 60 MECU has 
been committed to New Approach standardisation work at European level; 
amongst the most substantial beneficiaries are construction (21 MECU), 
machinery (17.8 MECU) and medical devices (10.3 MECU). For work under 
a large area such as the low-voltage directive, no financial support was 
requested. The average contribution requested for standards was gradually 
reduced from 50,000 to 30, 000 ECU. As a consequence of the progress of the 
work, the financial contribution to standardisation from the Commission has 
been continuously reduced over recent years. 
34. 20.000.000 
5 000.000 
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organisations concerning the implementation of contracts and the financial 
consequences to be drawn from delays will be intensified. Alternative ways of 
providing financial support will be developed if this would increase efficiency. 
Following a review of standardisation policy carried out in 1996 and 1997, 
policy for financial support has been adapted in order to emphasise the 
market-driven nature of standardisation: 
> Support is now provided mainly to contribute to maintaining a strong 
infrastructure for European standardisation. Consequently the Central 
Secretariats of CEN, CENELEC and ETSI are financially supported to 
ensure respectively 45%, 17% and 15% of their operational costs. 
> Particularly important is support for the current 17 New Approach 
Consultants, appointed by common agreement between the Commission 
and the European standards organisations. Their task is to verify as 
independent experts whether standards respect the essential requirements 
and the terms of the mandate. 
> Translation into the so-called "minority" languages absorbs a large 
amount of funds. Such funds are used mainly to support national standards 
14 
bodies in the translation of European standards for transposition as 
national standards. 
> Priority will be given, within the limits of budgets available, to 
standardisation work in new areas, such as protection of consumers and of 
the environment. 
> In order to assess the achievements of the past and to identify the future 
financial needs for the maintenance of an effective European 
standardisation system, the Commission invites CEN, CENELEC and 
ETSI to launch an independent evaluation of the financing of European 
standardisation. The results of the evaluation should be examined in 
collaboration with the Commission and Member States. 
IV. CONCLUSIONS 
1. European standardisation has had a difficult start, but has improved 
considerably. Nevertheless, the management of processes needs to be 
improved, notably by adopting better management techniques. More openness 
in strategic standardisation policy-making, (particularly in CEN, given its 
horizontal competence), will contribute to an increase in efficiency and 
accountability. 
2. CEN, CENELEC and ETSI are independent organisations. It is therefore their 
responsibility to ensure efficiency and respect for time schedules. 
3. Standardisation is a voluntary, consensus-driven process; standards cannot be 
imposed. In some cases, apparent failures of standardisation must be explained 
by the nature of standardisation itself. There are limits to the capacity of 
market participants to self-regulate. In the case where public interest is at 
stake, public authorities should create a sufficiently strong incentive for 
standardisation, or take other measures as appropriate. 
4. The Commission intends to hold regular reviews, together with Member States 
and European Standards Organisations, to examine measures for efficiency on 
the basis of reports prepared by CEN, CENELEC and ETSI. 
5. Transparency on progress should be improved. The standards organisations 
are invited to make reports on the progress of standardisation in New 
Approach areas available on the Internet, and to continually update them. 
6. A number of aspects, such as the an analysis of the impact of standards on the 
market, the working of sectoral committees and expert groups, the visibility of 
European standardisation, and the financing of European standardisation 
requires continuous follow-up, involving the co-operation of standards bodies, 
national authorities and the Commission. 
15 
ANNEXE 
PROGRESS STANDARDISATION ACTIVITIES IN THE FRAMEWORK OF THE NEW APPROACH {*) 
UNDER DEVELOPPMENT 
•UNDER APPROVAL 
GRATIFIED 
(*) excluding construction products, for which a standardisation programme is still under development. 
(**) including active implantable medical devices. 
M 
STANDARDISATION ACTIVITIES RELATED TO THE 
NEW APPROACH 
DIRECTIVE 
REFERENCES 
90/384/EEC< 
87/404/EEC 
88/378/EEC 
89/392/EEC 
89/686/EEC 
90/385/EEC 
93/42/EEC 
90/396/EEC AREAS 
Non-automatic weighing 
instruments 
Simple pressure vessels 
Safety of toys 
Safety of machinery 
Personal protective equipment 
Medical devices, including 
active implantable medical 
devices 
Gas appliances MANDATED 
1 
47 
10 
894 
300 
248 
91 RATIFIED 
1 
38 
6 
214 
159 
127 
45 UNDER 
APPROVAL 
5 
1 
370 
47 
60 
32 UNDER 
DEVELOPPME 
NT 
4 
3 
310 
94 
61 
14 
44-
93/15/EEC Explosive for civil uses 
94/9/EEC Potentially explosive 
atmospheres 
94/25/EEC Recreational craft 
95/16/EEC Lifts 
94/62/EC Packaging and packaging waste 
89/336/EEC Electromagnetic compatibility 
92/75/EEC Energy labelling 
91/263/EEC Telecommunication terminal 
equipment 
93/97/EEC Satellite earth station equipment 
89/106/EEC Construction products : 
97/23/EC Pressure equipment 
COM/96/0643 In vitro diagnostic medical 
final devices 
COM/97/0034 Railways equipment 
final 
COM/93/322 Precious metals 
final 51 
50 
49 
17 
21 
128 
5 
30 
8 
771 
22 
104 0 
5 
15 
4 
0 
79 
3 
25 0 
8 
11 
3 
0 
11 
1 
Overal programme under development 
280 
0 
12 
0 250 
4 
28 51 
37 
23 
10 
21 
38% 
1 
5 
241 
18 
64 
<4Z 


ISSN 0254-1475 
COM(98) 291 final 
DOCUMENTS 
EN 10 01 02 
Catalogue number : CB-CO-98-320-EN-C 
ISBN 92-78-36153-4 
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