EUROPEAN COMMISSION 
Brussels, 1.6.2011 
SEC(2011) 671 final 
  
COMMISSION STAFF WORKING PAPER 
IMPACT ASSESSMENT 
Accompanying document to the 
Proposal for a 
 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on European Standardisation and amending Council Directives 89/686/EEC and 
93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 
2004/22/EC, 2007/23/EC, 2009/105/EC and 2009/23/EC 
{COM(2011) 315 final} 
{SEC(2011) 672 final}  
 
EN 1   EN Disclaimer:  
This report only commits the Commission’s servi ces involved in its pr eparation and does not 
prejudge the final form of any deci sion to be taken by the Commission. 
TABLE OF CONTENTS 
1. Procedural issues and consulta tion of interested parties.............................................. 4 
1.1. Identification ............................................................................................................ .... 4 
1.2. Organisation and timing............................................................................................... 4 1.3. Consultation of the IAB ............................................................................................... 4 1.4. Consultation and expertise ........................................................................................... 4 2. Policy context and key concepts .................................................................................. 5 2.1. Policy context............................................................................................................ ... 5 
2.2. Standardisation: key concepts...................................................................................... 5 2.3. The relevance of standards and Europ ean standardisation as policy tools .................. 6 
2.4. The cost of European standardisation .......................................................................... 8 3. Problem definition and subsidiarity ............................................................................. 8 3.1. Problems with respect to standa rdisation at European level........................................ 8 
3.1.1. Problem 1: the process for adopting European standards requested by the 
Commission is not fast enough .................................................................................... 8 
3.1.2. Problem 2: Underrepresentation of SMEs a nd societal stakeholders in the European 
standardisation process .............................................................................................. 14 
3.1.3. Problem 3: “Fora and Consortia Standards” cannot currently be referenced in public 
procurement of ICT.................................................................................................... 17 
3.2. How would the problem evolve , all things being equal?........................................... 19 
3.3. Simplification and update potential ........................................................................... 20 3.3.1. Procurement of existing standards ............................................................................. 20 3.3.2. Simplification of the financing of European standardisation..................................... 20 3.3.3. National standards for services .................................................................................. 21 3.3.4. European standards for services................................................................................. 22 3.4. Subsidiarity .............................................................................................................. .. 23 
4. Objectives.................................................................................................................. . 24 
4.1. General policy objectives........................................................................................... 24 
 
EN 2   EN 4.2. Specific objectives ..................................................................................................... 24  
5. Policy options............................................................................................................. 2 4 
5.1. Policy options for problem 1: the process for adopting European standards requested 
by the Commission is not fast enough ....................................................................... 24 
5.2. Policy options for problem 2: Under-re presentation of SMEs and societal 
stakeholders in the European standardisation process ............................................... 25 
5.3. Policy options for problem 3: “Fora and Consortia Standards” cannot currently be 
referenced in public procurement of ICT................................................................... 26 
5.4. Discarded options....................................................................................................... 27  
6. Analysis of impacts.................................................................................................... 27 6.1. Problem 1: the process for adopting European standards requested by the 
Commission is not fast enough .................................................................................. 27 
6.1.1. Policy Option 1.0: Base-line scenario........................................................................ 27 6.1.2. Policy Option 1.A: specify deadlines on th e delivery of European standards........... 27 
6.1.3. Policy Option 1.B: create a European Agen cy for Standards that would manage the 
standard-setting process. ............................................................................................ 30 
6.1.4. Policy Option 1.C: transparent and simplif ied procedures for harmonised standards 
and other European standards requested by the Commission.................................... 32 
6.2. Problem 2: Involvement of SMEs and so cietal stakeholders in the European 
standardisation process .............................................................................................. 33 
6.2.1. Policy Option 2.0: base-line scenario (i.e . the financial contribution to SME and 
societal stakeholder representation) ........................................................................... 33 
6.2.2. Policy Option 2.A: Facilitate direct public  representation of SMEs and societal 
stakeholders within the European  standardisation organisations............................... 33 
6.2.3. Policy Option 2.B: Grant voting rights to  organisations repr esenting SMEs and 
societal stakeholders within the Euro pean standardisation organisations.................. 35 
6.2.4. Policy Option 2.C: Strengthen the position of organisations representing SMEs and 
societal stakeholders within the ESOs by providing for the possibility of an operating 
grant .......................................................................................................................... . 36 
6.3. Problem 3: “Fora and Consortia Standards” cannot currently be referenced in public 
procurement of ICT.................................................................................................... 37 
6.3.1. Policy option 3.0: base-line scenario ......................................................................... 37 6.3.2. Policy Option 3.A: Revive the implemen tation of the mechanisms of Council 
Decision 87/95/EEC concerning public proc urement and the policy dialogue. ........ 37 
6.3.3. Policy Option 3.B: Allow for the referenci ng of “Fora and Consortia Standards”.... 38 
 
EN 3   EN 6.3.4. Policy Option 3.C: Grant Selected Privat e fora and consortia the Status of 
Recognized Entities under Directive 98/34/EC. ........................................................ 41 
7. Comparing the options ............................................................................................... 44 7.1. Problem 1: the process for adopting European standards requested by the 
Commission is not fast enough .................................................................................. 44 
7.2. Problem 2: Underrepresentation of SMEs a nd societal stakeholders in the European 
standardisation process .............................................................................................. 45 
7.3. Problem 3: “Fora and Consortia Standards” cannot currently be referenced in public 
procurement of ICT.................................................................................................... 46 
7.4. Preferred options ........................................................................................................ 4 7 
7.5. Choice of legal instrument ......................................................................................... 48 8. Monitoring and Evaluation ........................................................................................ 48 9. ANNEXES ................................................................................................................. 50 9.1. ANNEX 1 – CONSULTATION AND EXPERTISE ................................................ 50 9.2. ANNEX 2 – ECONOMIC ASPECTS OF STANDARDS IN THE EU.................. 115 9.3. ANNEX 3 – EUROPEAN STANDARDISATION ORGANISATIONS ............... 120 9.4. ANNEX 4 – SECONDARY EU LAW USING EUROPEAN STANDARDS ....... 143 
9.5. ANNEX 5 – DISCARDED OPTIONS.................................................................... 161 9.6. ANNEX 6 – EXISTING STUDIES ON PR OBLEMS OF SMEs IN EUROPEAN 
STANDARDISATION............................................................................................ 180 
9.7. ANNEX 7 – GLOBAL FORA AND CONS ORTIA IN THE FIELD OF ICT ....... 185 
9.8. ANNEX 8 – SME TEST.......................................................................................... 191 9.9. ANNEX 9 – CONCLUSIONS AND RECOMMENDATIONS OF THE 
EXTERNAL EVALUATION OF THE CONT RIBUTION OF EU FINANCING OF 
STANDARDISATION TO THE FULFILMENT  OF POLICY OBJECTIVES OF 
THE COMMISSION ............................................................................................... 193 
 
EN 4   EN 1. P ROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES  
1.1. Identification 
Lead DG: Enterprise and Industr y – WP reference: 2010/ENTR/021. 
1.2. Organisation and timing  
The Impact Assessment Steering Group wa s set up on 17 December 2009 and met 5 
times between 7 January and 13 December 2010. It was chaired by DG ENTR and staff from Directorates-General ENTR , INFSO, COMP, SANCO, MARKT, DIGIT, 
RTD and SG participated and contribut ed to the discussions of the Group.  
1.3. Consultation of the IAB 
The Impact Assessment Board delivered  its opinion on 11 February 2011. It 
recommended a number of clarifications with  respect to the scope of the options and 
recommended to demonstrate better the ex istence of the identified problems. The 
opinion requested greater clarity on option 3B addressing the problem of fora and 
consortia standards. The Board also asked to better assess the impacts of all the 
policy options, including by examining possibl e synergies and trade-offs between the 
three options. Finally, the different positi ons of the stakeholde rs should be better 
reflected in the main text of the IA report. 
The clarifications with respect to the scope  of the options were added to problems 1 
and 2, and the existence of the identified problems was elaborated in greater detail, 
inter alia through the additio n of a few examples and a new Annex 5 which outlines 
the discarded options. A more detailed governance structure was added to the 
assessment of option 3B (fora and consortia standards). Th e impacts of all the policy 
options was reorganised and possible syne rgies and trade-offs between the three 
options were added in the assessment a nd the comparison sections. The different 
positions of the stakeholders are now reflect ed in the assessment of the options and 
Annex 1, which sets out the results of th e consultation process, was complemented 
by more precise information on th e outcome of the consultation. 
1.4. Consultation and expertise 
This impact assessment builds on the external expertise
1 and a very broad 
consultation of stakeholders, a detailed ove rview of which can be found in Annex 1. 
The Commission’s minimum sta ndards have all been met. 
                                                 
1 The most important reports used for the purposes of this impact assessment are outlined in Annex 1 and 
can be consulted on http://ec.europa.eu/enterprise/policies/european-standards/standardisation-
policy/policy-review/index_en.htm . The other external expertise is mentioned in the footnotes of this 
document. 
 
EN 5   EN 2. P OLICY CONTEXT AND KEY CONCEPTS  
2.1. Policy context 
In its EUROPE 2020 strategy for smart,  sustainable and inclusive growth2, the 
Commission highlights the necessity to improve the method of standard setting 
and the use of standards in Europe  to leverage European and international 
standards for the long-term competitiven ess of European industry and for the 
achievement of important policy goals in areas such as e-government, e-health or e-accessibility. This initiative implements the Europe 2020 Flagship Initiatives on the Innovation Union
3, Industrial Policy4, a Digital Agenda for Europe5, a Resource 
Efficient Europe6 and the Single Market Act7, as well as the Disability Strategy 
2010-20208. It is part of a CWP 2011 Strategic initiative. 
On 21 October 2010, the European Parliament adopted a report on the future of 
European standardisation9 according to which the review of European 
standardisation should preserve its many su ccessful elements, remedy its deficiencies 
and strike the right balance between th e European, national and international 
dimensions. Furthermore, it recognises that  interoperability is  a key to innovation 
and competitiveness, especially in the ICT sector.  
2.2. Standardisation: key concepts  
Standardisation within the EU relies on voluntary cooperation  amongst businesses, 
users, public authorities and other intere sted parties (consumers, NGOs and other 
stakeholders). In Europe, th is voluntary cooperation is managed by independent 
organisations which are subject to WTO-criteria10 and ideally leads to agreement 
between the participants on the adoption of  a standard. Standardisation agreements 
have as their primary objective the defini tion of technical or quality requirements 
with which current or future products, production processes, services or methods 
may comply11. Certain parts of the economy ha ve their own standards, e.g. 
accounting and transport services12, which fall outside the scope of this impact 
                                                 
2 COM(2010)2020. 
3 COM(2010)546. 
4 COM(2010)614. 
5 COM(2010)245. 
6 COM(2011)21. 
7 COM(2011)206. 
8 COM(2010)636. 
9 A7-0276/2010. 
10 See Annex 3. 
11 See point 257 of the Guidelines on the applicability of Article 101 of the Treaty on the Functioning of 
the European Union to horizontal co-operation agreements [C(2010) 9274/2], OJ C ….  
12 For example, the International Accounting Standards (IAS) and International Financial Reporting 
Standards (IFRS) and related interpretations (SIC/IFRIC) issued by the International Financial 
Reporting Interpretations Committee have a worldwide impact. Standards are issued by an international 
private organisation called the International Accounting Standards Board (IASB) and must go through 
due process of endorsement before becoming part of EU law in accordance with Regulation (EC) No 
1606/2002 of the European Parliament and of the Council on the application of international accounting 
standards. In the transport sector, the Convention on International Civil Aviation, signed in Chicago on 
7 December 1944 (the Chicago Conv ention), to which all Member States are parties, provides for 
minimum standards to ensure the safety of civil aviation and environmental protection relating thereto. 
 
EN 6   EN assessment. Standards are not regulations . Standards are voluntary13 while 
regulations are obligatory a nd have the force of law. 
This document only concerns the European st andardisation system in which the three 
European standardisation or ganisations CEN, CENELEC and ETSI play a key role, 
and the standards for interoperability in the field of ICT. The definitions used for the 
purpose of this impact assessment are also set out in Annex 3. 
2.3. The relevance of standards and European standardisation as policy tools 
Standards and standardisation are very effective policy tools for the EU . 
Although standards and standardisation have much wider benefits for the European 
economy14, they are used as policy instruments to ensure, inter alia, the functioning 
of the single market, the interoperability of networks and systems, in particular in the 
field of ICT, a high level of consumer  and environmental protection, and more 
innovation and social inclusion. 
Standards are indispensable in the digita l society to ensure the interoperability 
of networks and systems, espe cially in the field of ICT . In a digitally driven 
society, ICT solutions are used in any econo mic sector as well as in our daily lives. 
ICT solutions, applications and services ha ve to be able to communicate with each 
other; they should be interoperable. Interoperability requires standards .  
European standards play a very important part in the functioning of the internal 
market for industrial products. European standards replace national and often 
conflicting standards which, as such, may cr eate technical impediments to a national 
market. European standards can, for the purpose of this impact assessment, be divided into 2 categories:  
• European standards developed at the request of the Commission
, on the basis of a 
so-called “mandate” in which the ESOs are requested to draw up technical 
specifications of a normative nature that meet the requirements set out in the mandate. These standards can be subdivided into 2 subcategories: 
– Harmonised standards which ensure th at products meet the essential 
requirements set out in EU legisl ation. Compliance with a European 
“harmonised” standard guarantees the required level of safety of products. However, use of harmonised standards is stil l voluntary and a 
manufacturer may use any other tec hnical solution whic h demonstrates 
that his product meets the essential requirements. The percentage of 
European standards that are harmonis ed standards has increased in the 
last two decades from 3.55% to 20 % in 2009. This shows the increasing 
                                                                                                                                                        
 
Technical standards developed by specialised organisations constitute the backbone of the railway and 
maritime sector.  
13 The TBT Agreement defines a standard as a documen t “approved by a recogni zed body, that provides, 
for common and repeated use, rules, guidelines or characteristics for products or related processes and 
production methods, with which compliance is not mandatory . It may also include or deal exclusively 
with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, 
process or production method.” A more detailed overview can be found in Annex 5. 
14 See Annex 2. 
 
EN 7   EN importance of standards as an  instrument to accompany EU 
legislation15. 
– Other European standards to  support European policies; 
• The remaining European standards  are adopted outside EU legislation on the 
initiative of undertakings, NSBs or other stakeholders, or at the request of the 
Commission.  
The percentage of the European standa rds portfolio mandated by the Commission 
has increased in the last two decades fr om 18% in 1999 to 34% in 2009. Despite this 
increase, the large majority of European standards remains industry–initiated , 
indicating that these instruments mainly respond to the needs of the industry and are 
mainly privately driven.  
Even if EU legislation did not refer to European standards, the mere existence of 
standards is trade-enhancing  because of their cost-decreasing effect and the 
reduction of information asymmetries between the supply and the demand sides, especially in the case of cross-border tran sactions. Several econometric studies have 
established a clear connection at a macroeconomic level between standardisation 
in the economy, productivity growth, trade and overall economic growth . The 
economic benefit of standardisation can va ry significantly be tween different EU 
countries. Studies show that the impact of standards on annual GDP growth could 
rage from 0.3 to 1 percentage point
16. For Germany this impact is estimated at 1% of 
the gross national product, for France at  0.8% and for United Kingdom only at 0.3%. 
There are no studies on aggreg ated impact on the EU level. 
The effectiveness of standards and standard isation as policy tools for the EU implies 
that European policymakers have a strong in terest in an effective and efficient 
standardisation system  which provides a flexible and transparent platform for 
consensus building between all participan ts and which is financially viable. 
Therefore, a specific legislative framework gov erning European standardisation 
has been developed over the years and current ly consists of the following pieces of 
legislation:  
(1) Directive 98/34/EC17 sets up the cooperation between the three ESOs (CEN, 
CENELEC and ETSI), the NSBs and the Commission. It contains, inter alia, 
a procedure in the field of sta ndards designed to monitor the new 
standardisation activities introduced by the NSBs. Systems have been set up 
mainly to allow other bodies to comment, participate in the work or request that an initiative be taken at European level.  
                                                
 
15 Detailed figures can be found in Annex 3 while Annex 4 contains an overview of EU legislation using 
European standards as a means to presume co nformity with the essential requirements. 
16 Swann G.M.P., “The Economics of Standardization: An Update’, Report for the UK Department of 
Business, Innovation and Skills (BIS), 2010. 
17 Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998, laying down a 
procedure for the provision of information in the field of technical standards and regulations and of 
rules on Information Society services (OJ L 204 of 21.07.1998), as amended by Directive 98/48/EC (OJ 
L 217 of 05.08.1998).  
 
EN 8   EN (2) Decision No 1673/2006/EC18 establishes the ru les concerning EU 
contribution to the financing of Eur opean standardisation to support the 
implementation of specific policies, meas ures, actions and EU legislation. It 
specifies the bodies and the standard isation activities eligible for EU 
financing, as well as the financing arrangements.  
(3) In the case of IT equipment, and in  support of interope rability, specific 
provisions are included in  Council Decision 87/95/EEC19 requiring Member 
States to ensure that in public proc urement orders reference is made to 
European or international standards.  
2.4. The cost of European standardisation20 
The cost of the creation of standards within the ESOs  was approximately 3,000 
million euro in 2009. The approximate cost of  creating one standard is estimated at 
approximately €1,000,000. This includes the co sts of experts, the organisation of 
meetings, travel etc.  
The ESOs point out that this cost is  financed primarily by industry  (93-95%) 
followed by national governments (around 3-5%) and the European Commission/EFTA contribution (around 2%).The fact that industry bears most of the 
cost of the system, together with the voluntar y character of standard s, reflects its high 
interest in standards and implies that the benefits outweigh the cost. Therefore, for society as a whole, the cost of creating st andards is minimal compared to the benefit 
for the economy, even erring on the si de of caution regarding the data. 
3. P
ROBLEM DEFINITION AND SUBSIDIARITY  
3.1. Problems with respect to standardisation at European level 
The use of standards and European standardis ation as policy tools is a success story. 
Their contribution to the achievement of th e internal market and as instruments for 
interoperability is tremendous. However, public consultations and the report of the 
European Parliament indicated that cert ain problems need to be addressed. 
3.1.1. Problem 1: the process for adopting European standards requested by the 
Commission is not fast enough 
In a rapidly changing world and society, esp ecially in sectors characterized by very 
short product lives and development cycles , standards must keep pace with rapid 
technological development. Some stakeholders argue th at the entire process of 
creating European standards is too slow21, although complaints about slowness of 
                                                 
18 Decision No 1673/2006/EC of the European Parliament and of the Council of 24 October 2006 on the 
financing of European standardisation, OJ L315, 15.11.2006. 
19 Council Decision 87/95/EEC of 22 December 1986 on standardisation in the field of information 
technology and telecommunications, OJ L36, 7.2.1987 
20 See Annex 3 for more details. 
21 See the report of the European Parliament on the Future of European Standardisation [A7-0276/2010].  
 
EN 9   EN standardisation may be less relevant fo r technologies with long lead times for 
development and redeployment22.  
At the moment, the development time  of CEN and CENELEC deliverables is 
between 36 and 21.5 months, depending on the type of procedure23, with a 
complementary tolerance of 9 months for all these deliverables. Production of a CEN 
Workshop Agreement or a Technical Spec ification typically takes only 12 – 24 
months and can take as litt le as 5-6 months. As regard s ETSI, the typical time frame 
is 24 to 36 months. Although the duration of the process could still shorten slightly 
within CEN/CENELEC so that they would be  similar to those of ETSI, at a certain 
point it becomes difficult to make fu rther progress without  jeopardising some 
fundamental principles of the standard-set ting process, especially the principle of 
consensus. However, these periods do not  take into account the time between the 
identification of the need for a non-mandated standard by interested parties and the date when the ESOs actually start worki ng on the standard. It should be underlined 
that the Commission has little or no infl uence on the time needed for developing a 
European standard which was not mandated by it.  
Therefore, this impact assessment will only focus on the speed of the development of 
the European standards mandated by the Commission , of which the entire 
development process can be much longer than  the periods set out above. It took more 
than 10 years, for example, to adopt a co mmon test procedure for cement, and about 
15 years for the harmonised product standa rd and the standard on conformity 
evaluation of cement. 
For the European standards mandated by the Commission, there are four main stages 
in the development process:  
(1) The first stage
, the preparation of the mandate  and the positive opinion of the 
committee  set up under Directive 98/34/EC, usually takes between 6 to 12 
months. In addition, planning requests fo r European standards and EU policy 
objectives are not always communicated  sufficiently clearly to the ESOs. 
Until now, this has been done in a variety of ways and at a variety of different levels, for example through the manda tes and different work programmes 
addressed to the ESOs
24.  
(2) The second stage , the acceptance of the mandate  by the ESO and the start of 
work  on the standard, is fairly variable. Under open mandates25, work on a 
                                                 
22 Sherif M.H., « When is Standardization slow ? », in The International Journal of IT Standards and 
Standardisation Research, 2003, vol. 1., issue 1, pp. 19-32. 
23 36 months for EN’s developed in accordance with th e normal enquiry procedure and Formal Vote track, 
23.5 months for EN’s developed in accordance w ith the shorter “Unique Acceptance Procedure” and 
21.5 months for Technical Specifications and Technical Reports. 
24 The Commission developed a rolling “Action Plan for European standardisation” in conjunction with 
European Free Trade Association (EFTA), th e ESOs, the NSBs and the Member States: 
http://ec.europa.eu/enterprise/policies/european -standards/standardisation-policy/implementation-
action-plan/index_en.htm . This action plan is complemented by an “ICT Standardisation Work 
Programme: http://ec.europa.eu/enterprise/sectors/ict/standards/work-programme/index_en.htm .  
25 Open mandates mean that the ESOs may, during standardisation work, add or modify to a certain extent 
the subjects referred to in the programme submitted, after having informed the Commission services 
and, in the event of a major am endment, the Standing Committee. 
 
EN 10   EN new standard can start immediately or , in some cases, a few years after 
acceptance of the mandate. The number of mandates issued and average response times vary between ETSI and CEN/CLC and so have been shown separately in the two tables below. ETSI reported a total of 17 mandates issued over the past three years (with between 0 and 9 per year). In the two 
years where mandates were issued, the average time for ETSI Board acceptance was 3 months (average times are for ETSI board acceptance). CEN/CLC reported a total of 64 mandates issued over the past three years, 
with average response times each year varying between 10.4 and 13.6 months. 
ETSI Mandates issued Average response time 
(months) 
2007 8 3 
2008 0 n/a 
2009 9 3 
CEN/CLC Mandates issued Average response time 
(months) 
2007 22 10.4 
2008 21 13.6 
2009 21 12.3 
 The current procedures employed for consulting on and responding to EC mandates and the average timeframes take n to implement each step are shown
 in the tables below. 
Procedures - ETSI Average 
time 
(wks) Notes 
1. Comments on 
draft mandate via membership 5 Varies between 4 and 6 weeks 
2. 98/34 adopted 
mandate for ETSI Board approval 6 Maximum 
3. Response to EC 3 Varies between 2 and 4 weeks depending on 
the need for further consultation 
4. Phase 1: work programme 30 Varies between 24 and 36 weeks (minimum) 
depending on size and complexity of tasks or need for financial support and coordination with other ESOs/SDOs 
5. Phase 2: Development of standards Variable Very variable, depending on complexity and 
contractual issues (EC grant agreement when 
required). EN development requires at least 1.5 years where the mandate task is relatively clear and there are no interdependencies with 
 
EN 11   EN work from elsewhere 
 
Procedures – CEN/CLC Average 
time (wks) Notes 
1. Analysis of the mandate in 
CCMC, consultation of the competent technical body (if any) and/or  important stakeholders, elaboration of a proposal for Technical Board (BT) decision 5.9 Average timeframe for 2009, 
excluding two exceptional cases (which would take the average timeframe to 9.7 weeks) 
2. Formal decision process by correspondence in BT 6   
(3) The third stage  is the development of the standard itself  as described above. 
For this stage, the average period in years between the date of acceptance of the work and the date of publication of the standard was as follows: 
Average duration (in years) fo r drafting mandated standards 
Publication 
year CEN CENE
LEC ETSI 
2005 6.20 3.45 1.08 
2006 5.46 3.23 1.55 
2007 4.37 2.85 1.83 
2008 2.92 3.84 1.87 
2009 2.42 2.34 1.79 
 Two factors determine the length of  this stage. On one hand, the above-
mentioned principle of consensus c onstitutes a crucial factor. Broad 
involvement of the large number of inte rested parties increases the risk of 
deadlock and stalemate: while one partic ipant rejects all or part of a proposed 
standard, it cannot be ratifie d. Participants may not manage to agree, given the 
range of vested interests, or some ma y wish to delay (or even prevent) the 
appearance of a standard long enough to prepare for it. The standard-setting 
approach aims at bringing together the different participants gradually. On the 
other hand, the availability of technical experts could in some cases be used as 
a deliberate strategy to block or delay technical work in a committee. 
 
EN 12   EN Relatively long timescales are therefor e inherent in th is stage of the 
standardisation process26. 
(4) The duration of the fourth stage , namely the publication of the reference of 
the harmonised standard in the OJ and the objection procedure , varies very 
widely. It depends primarily on the di versity of procedures. None of the 
directives specifies when publication should take place and there are important differences betw een objection procedures
27. Thus, the entire 
process for mandated standards can eas ily take 3 years and often much 
longer. 
The internal processes within CEN were revised , especially as regards the time 
taken to develop European standards. Histor ically much of the standardisation work 
carried out under New Appro ach Directives took many years to complete, with some 
individual standards taking as long as a decade to reach the market. Through various 
communications and ongoing dialogue with  the ESOs, the Commission sought to 
encourage revisions to processes that mi ght shorten these development times. CEN 
implemented a range of changes to its processes to enable such improvement, with a very clear and marked effect, as demonstrat ed in the box below. This illustrates, for 
example, that the 248 harmonised sta ndards published by CEN in 2003 took an 
average of almost eight years to produ ce (from acceptance of the work item to 
publication of the standard in the Offi cial Journal) while the 329 harmonised 
standards published to 31 December 2008 took an average of less than three years.  
 
 
                                                 
26 Borraz O., « Governing Standards : The Rise of Standardization Processes in France and in the EU », in 
Governance : An International Journal of Policy, Administration, and Institutions, Vol. 20, No. 1, 
January 2007, pp. 57-84. 
27 A detailed overview can be found in Annex 4. 
 
EN 13   EN ETSI and CENELEC also  improved the efficiency of their core activities and 
operations in order to shorten procedures. W ithin ETSI, for example, new IT 
applications were developed and staffi ng levels around key Technical Body support 
roles were increased. Many of the functions  of the Central Secretariat of CENELEC 
are directed specifically towards areas of work requested by the Commission or 
otherwise required by the Commission as a result of its administrative requirements 
(e.g. handling mandates for standardisa tion work, establishing contracts and 
preparing financial quotations, managing the New Approach consultants, etc). 
A comparative analysis of the more informal  processes adopted in the ICT-sector by 
global fora and consortia such as OASI S, OMG, W3C, ETSI, and ISO/IEC/JTC1 
reveals that, if these bodies seek consensu s, the speed of their processes (from the 
start of work on a new item until completion) does not differ much (typically between 12 and 24 months, but in extreme cases  as little as 6 months) and formal and 
informal procedures tend to  converge over time, as the latter increasingly get market 
recognition and legitimacy
28. The success of the informal  standardisation processes 
in the field of ICT owes much not only to its speed, but also to the search for extreme 
simplicity, with a strong pr eference for solutions taken from concrete industry 
practice, in order to ensure  high levels of interoperability. The main difference 
between ESOs and informal standardisation bodi es in the ICT-sector is that the latter 
do not require a formal national ratification pr ocedure and that draf t specifications or 
standards are usually made available for co mment over the internet at an early draft 
stage. However, formal voting remains restricted to Members.  
The main negative consequence  of a slow standard-setting process for all European 
standards is that conflicti ng national standards continue to exist, which may create 
technical barriers in the supply chain or barri ers to trade if the national standard is 
used as a protectionist instrument. Another consequence is that, in the specific case 
of harmonised standards, businesses cannot use the relevant sta ndard to confer a 
presumption of conformity and must de monstrate compliance with the essential 
requirements in accordance with the confor mity assessment module set out in the 
applicable EU legislation. In both cases, businesses are prevented from saving costs 
incurred due to fragmentation of the in ternal market or conformity assessment 
procedures. Conflicting nationa l standards or the absence of harmonised standards 
lead to higher transaction costs and hi gher per-unit costs cause d by the need to 
produce divergent batches. Industry reacts to  this situation by establishing informal 
standardisation channels for the rapid de velopment of technical specifications to 
ensure interoperability which gain an inte rnational reach. In a ddition, the absence of 
a European standard could lead to safety ri sks. The development of a safety standard 
for portable ladders, for example, took an extremely long period of some 10 years. 
According to estimates (IDB database, 2009)  within the EU the yearly accidents 
related to ladders amount to 413,000 and 25%  of the recorded accidents involved 
elderly people.  
                                                 
28 Simcoe T., “Delay and de jure standardizati on: exploring the slowdown in Internet standards 
development” in Greenstein S. and Stango V., Standards and Public Policy, Cambridge, 2007. See also 
Annex 7 for a comparative table. 
 
EN 14   EN 3.1.2. Problem 2: Underrepresentation of SMEs and societal stakeholders in the European 
standardisation process 
Several studies showed that SMEs encounter  a series of problems with respect to 
standards and st andardisation29. During the public consultation, 69% of respondents 
declared that the participation of SMEs  in European standardisation should be 
reinforced. One of the most important problems, according to many stakeholders,  is 
that SMEs are in general under-represented in standardisation activities , in 
particular at European level.  
Indeed, standard-setting is a labour-inten sive and time-consuming activity and, for 
the most part, only large businesses and government agencies specialising in standards issues can afford to allow one individual to spend a significant amount of 
his/her time attending standard -setting meetings. For sma ller businesses, where job 
descriptions are broader, the fixed cost of participation may simply be too high. 
According to a study prepared at  the request of the Commission
30, the four most 
important barriers to access by SMEs  to the standardisation process  are: (a) the 
amount of time required; (b) the travel and subsistence costs; (c) the cost of 
participating in technical committees (fee) and (d) the cost of becoming a member of 
a standardisation body (fee). Th e amount of time is considered to be the greatest 
barrier.  
While SMEs are generally quite well represented in the technical committees of the 
NSBs, it is rare for SMEs and their represen tatives to form part  of the delegations 
that participate directly in the Technical Committees and Working Groups of the 
ESOs. In theory, participation in the standardisation activities of CEN and CENELEC is open to all interested stake holders via the NSBs  but meetings at 
European level involve a considerable burde n in terms of time and travel costs for 
SMEs
31.  
Standards have a broad impact on society . Often they relate to the safety and well-
being of citizens, the effici ency of networks, the envir onment and other public policy 
fields. Many standards increase safety fo r consumers while others have a direct 
environmental impact. Minimum safety st andards are used to solve imperfect 
information problems. By conveying info rmation about the negative effects of 
products, they allow customers to avoid pr oducts that might harm them, the public, 
or the environment, and they allow regulators to exclude unsafe products from the market. These standards allow buyers to c onfirm that products and processes have 
the characteristics they want without the additional transaction costs of independent 
testing. Standards are graduall y playing a new role in so ciety. Standardisation is 
evolving from a technical di scussion on facilitating exch anges and adding value to 
the organizations, to the provision of a normative framework for economic operators 
in environmental, social or economic issues.  
                                                
 
29 For further details, see Annex 6. 
30 http://ec.europa.eu/enterprise/policies/european-
standards/files/standards_policy/ access_to_standardisation/doc/access_ to_standardisation_study_eim_e
n.pdf .  
31 http://ec.europa.eu/enterprise/policies/sme/ma rket-access/standardisation/index_en.htm#h2-5 .  
 
EN 15   EN Although standards play a major role in society, the opinion of  relevant societal 
stakeholders is not sufficiently integr ated in the standardisation process32 in the 
EU. Many perceive standards as a technical matter of relevance to the internal 
workings of a product or service, but whic h do not concern them directly. Because of 
this asymmetric informati on, these societal stakehol ders often underestimate the 
importance of standards to their interests a nd that leads some to avoid involvement in 
the process.  
In order to address the problem of insuffi cient representation of SMEs and societal 
stakeholders in standardisation activities, financial contributions  are paid, inter alia, 
under the following programmes: 
– The Entrepreneurship and Innovation programme33 supports SME involvement in 
the field of European standardisation. EU  financial support for the representation 
of SMEs in standardisation at European level increased from an annual amount of 
€700,000 to €1 million in 2008 and €2.1 million fr om 2009. This money is used to 
promote SMEs’ participation and defence of  their interests in standardisation and 
to improve their information about, and us e of, European standards. According to 
an external evaluation, the Commission’s intervention scheme for the period 2002 to 2008 directly addressed this need by providing the resources and mechanisms for direct participation of SME represen tatives in the technical bodies of the 
ESOs
34. 
– The programme of Community action in the field of consumer policy35 includes 
financial contributions to European consumer organisations representing 
consumer interests in the development of standards for products and services at 
EU level. In 2009, the grant amounted to about €1,460,000 and to €1,386,000 in 2010. The programme covers the period from 31 December 2006 to 31 December 
2013. 
– Grants are paid under the LIFE+-Programme
36 to strengthen the participation of 
NGOs in the European standardisation pr ocess in order to ensure balanced 
stakeholder representation and the systematic integration of environmental aspects. In 2009, the grant am ounted to approximately €185,000.  
– The participation of trade uni ons in the development of technical standards is also 
partly financed by the EU budget since many standards have an impact on the 
health and safety of workers, for exampl e through the design of work equipment. 
                                                
 
32 See also the report of the Eu ropean Parliament on the Future of European Standardisation [A7-
0276/2010].  
33 Decision No 1639/2006/EC of the European Parliament and of the Council of 24 October 2006 
establishing a Competitiveness and Innovation Fr amework Programme (2007 to 2013), OJ L310, 
9.11.2006. 
34 http://ec.europa.eu/enterprise/ policies/sme/files/craft/craft-
priorities/doc_stand/evaluation_mainreport_en.pdf .  
35 Decision No 1926/2006/EC of the European Parliament and of the Council of 18 December 2006 
establishing a programme of Community action in the field of consumer policy (2007-2013), OJ L404, 30.12.2006. 
36 Regulation (EC) No 614/2007 of the European Parliament and of the Council of 23 May 2007 
concerning the Financial Instrument for the Environment (LIFE+), OJ L149, 9.6.2007. 
 
EN 16   EN The criteria for eligibility fo r these grants, the conditions for their use and the 
type of financial contributions available vary widely . Some organisations receive 
grants for actions while others  also receive operating gran ts. The principle of gradual 
decrease for operating grants which are not fl at-rate grants pursua nt to Article 113 of 
the Financial Regulation, applies to  some but not a ll beneficiaries. 
Organisations representing SMEs and soci etal stakeholders at European level  
can, under certain conditions, become associ ate members of CEN which allows them 
to participate, without voting rights, in the General Assembly, open sessions of the 
Administrative Board, Technical Board, Sect or Activities and the CEN Certification 
Board. As a member of the Technical Boar d, an Associate Member can also apply 
for and hold the secretariat of Technical Committees and participate in Technical 
Committees (TCs) and Subcommittees, upon request, as an observer. Associate Members can also receive documentation fo r all meetings for which requests for 
participation have been granted. A similar system exists in CENELEC. However, the 
absence of voting rights in CEN and CEN ELEC prevents organi sations representing 
SMEs and societal stakeholders having a mo re decisive influence on technical work. 
The role of observer diminishes the influe nce of the participant in the technical 
discussion on a standard and in the final decisions that will be taken about the 
standard. The lack of voting rights mean s that these organisations are not as 
influential as they should be and can onl y carry arguments if they have strong 
evidence to back up their claims. 
Although the national delegation principle wi thin the ESOs cont ains a number of 
checks and balances designed to produce st andards without anti-competitive effects, 
the most negative consequence  of the problem of insuffici ent participation of SMEs 
and societal stakeholders is that particip ants in standardisation may influence the 
results of the process, get the know-how and technical understanding relating to these 
results and implement the standard before it is publicly available.
37 As a result, the 
participating undertakings will most likel y have a head start and therefore a 
significant competitive advantage in the relevant downstream markets38. In an 
industry where lead time is a crucial factor , active participation in standardisation 
thus confers an appreciable competitiv e advantage vis-à-vi s non-participating 
competitors. If participation in the standard-setting process is not open in the sense that it does not allow all competitors (and/or stakeholders) in the market affected by the standard to take part in  choosing and elaborating the st andard, the risks of a likely 
restrictive effect on compet ition will exist by excluding certain companies from the 
ability to influence the choice and elaborat ion of the standard. The greater the likely 
market impact of the standard and the wide r its potential fields of application, the 
                                                
 
37 In the Commission decision No 87/69/EEC in Case IV/31.458, X/Open Group , OJ L35, 6.2.1987, p. 36-
43, the Commission considered that even if the standards adopted were made public, the restricted 
membership policy had the effect of preventing non- members from influencing the results of the work 
of the group and from getting the know-how and technical understanding relating to the standards which the members were likely to acquire. In addition, non-members could not, in contrast to the 
members, implement the standard before it was adopted (see paragraph 32). The agreement was 
therefore in these circumstances seen to constitute a restriction under Article 101(1). 
38 Koenig C. and Trias A., “Some standards for standa rdisation: a basis for harmonisation and efficiency 
maximisation of EU and US antitrust control of the standard-setting process”, European Intellectual 
Property Review, 2010, v. 32, n. 7, pp. 320-331. 
 
EN 17   EN more important it is to allow equa l access to the standard-setting process39. These 
negative consequences hit SMEs especially  when a harmonised standard would not 
take into account the need s of manufacturing SMEs40. In that case, the 
competitiveness of the SME would be affected  since it would either have to alter its 
production processes, or use the conform ity assessment module laid down in the 
relevant directive which often entails the intervention of a conformity assessment body. 
3.1.3. Problem 3: “Fora and Consortia Standards ” cannot currently be referenced in 
public procurement of ICT.  
In the field of ICT, many standards ensuri ng interoperability were not developed by 
the ESOs but by global fora and consortia. This applies particularly in the case of 
Internet and World Wide Web related standards . A few, such as MPEG, issued 
by DVB, are subsequently published by formal standardisation organisations such as 
ISO standards
41. Since the 1980s, global fora and consortia , such as IETF, W3C 
and OASIS have emerged as world-leading ICT standards development organisations 
primarily covering the Internet and Web domains42. Mostly due to a lack of highly 
specialized expertise, the traditional sta ndard-setting organisations do not cover the 
ICT domain and so a major part of global ICT standardisation work is currently done 
outside the formal European or inte rnational standard isation system.  
The number of “Fora and Consortia Standards” used today on a global scale is 
impressive . They are used for browsing the Worl d Wide Web for business or social 
purposes, sending e-mails or engaging in a ny form of electronic collaboration. For 
wireless communication, the IEEE 802.11 standard on WiFi is used; the 
identification of internet resources is ba sed on URI (Unified Re source Identifier) set 
by IETF; the transport layer of internet communication, TCP/IP is defined by IETF; 
HTML and XML are set by W3C; audio a nd video signals are compressed following 
the MPEG standards published by DVB a nd ISO; the Web Accessibility guidelines 
for disabilities are set by W3C and OASIS has the expertise in technical standards for web services
43.  
Referencing of standards in public procurement  can be an important means of 
fostering innovation while providing public auth orities with the tools needed to fulfil 
their tasks, especially in lead markets44 such as e-health. Public procurement of a 
                                                 
39 See the Guidelines on the applicability of Article 101 of the Treaty on the Functioning of the European 
Union to horizontal co-operation agreements, OJ C11 of 14.1.2011, p. 1. 
40 See, for example, the judgment of 12 May 2010 in Case T-432/05, EMC Development AB  v. 
Commission , not yet reported, where the applicant basical ly argued that this had been the case. The 
applicant submitted that European standard EN197- 1 “was designed, thanks to the close cooperation 
between Cembureau and CEN/TC 51, to favour existing major cement producers in the market” (point 68 of the judgement).  
41 Van Eecke P., Truyens M., “Standardization in the European Information and Technology Sector: 
Official Procedures on the Verg e of Being Overhauled”, 5 Shidler J. L. Com. & Tech. 11 (2009), 
available at http://www.lctjournal.washingt on.edu/vol5/a11VanEecke.html .  
42 For a detailed description, see Annex 7. 
43 Jakobs K., « ICT Standardisation – Co-ordinating the Diversity » in: Innovations in NGN: Future 
Network and Services, 2008. K-INGN 2008. First ITU-T Kaleidoscope Academic Conference, Geneva, 
2008. 
44 Communication: A lead market initiative for Europe - COM(2007) 860. 
 
EN 18   EN certain value has to comp ly with Directive 2004/18/EC45 which differentiates 
between formal standards and other techni cal specifications for which a description 
of functional requirements is addi tionally requested. At the moment, referring to 
“Fora and Consortia Standards” in public procurement which is subject to 
Directive 2004/18/CE is only possible in exceptional circumstances46. Since “Fora 
and Consortia Standards” do not, as such, f it into any of the categories of standards 
to which public authorities may refer in  their calls for tenders, cautious public 
authorities will refrain from referring to these standards. The consequence is that the 
ITC that they are procuring may not be interoperable with IT C purchased by other 
authorities. This difficulty often prevents public authorities from defining their ICT 
strategies and architectures, including cross-border interope rability between 
organisations47.  
Although the public sector is  by far the largest procur er of ICT services and 
applications, especially software48 Fora and Consortia Standards have not found 
their way into the available European ICT standardisation “catalogue ” produced 
by the ESOs. For instance Internet or Web technologies cannot be  referenced since 
those technologies and the related appli cations and services are not covered by 
European standards. In fact, the “busin ess models” of CEN and CENELEC either 
envisage revenues from sales of standards or the full reimbursement of standard 
development costs. Both models are hardly  compatible with the practices of some 
major fora and consortia which typically envisage free distribution of standards 
                                                 
45 Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the 
coordination of procedures for the award of public works contracts, public supply contracts and public 
service contracts, OJ L134, 30/04/2004, p. 114 – 240. 
46 Article 23(3)(a) of Direc tive 2004/18/EC specifies that technical specifications in public procurement to 
which the Directive applies, must be formulated eith er by reference to techni cal specifications defined 
in Annex VI and, in order of preference, to national standards transposing European standards, European technical approvals, comm on technical specifications, interna tional standards, other technical 
reference systems established by the European standardisation bodies or - when these do not exist - to 
national standards, national technical approvals or national technical specifications relating to the design, calculation and execution of the works and use of the products. Each reference shall be 
accompanied by the words "or equi valent"”. According to Annex VI  a "standard" means a technical 
specification approved by a recognised standardising body for repeated or continuous application, compliance with which is not compulsory and which is an international, a European or a national 
standard. A "European technical a pproval" means a favourable techni cal assessment of the fitness for 
use of a product for a particular purpose, based on the fulfilment of the essential requirements for 
building works, by means of the inherent characteristics of the product and the defined conditions of 
application and use. European technical approvals are issued by an approval body designated for this purpose by the Member State. A "Common technical specification" means a tec hnical specification laid 
down in accordance with  a procedure recognised by the Member States which has been published in the 
Official Journal of the European Union while a "technical reference" means any product produced by European standardisation bodies, other than official standards, according to procedures adopted for the 
development of market needs. 
47 Commission White Paper “Modernising ICT Standardisation in the EU - The Way Forward”, 
COM(2009)324. 
48 With market revenues of over €200 billion in Europe  and growth rates of betw een 6% and 8%, software 
is the largest and the fastest-growing segment of  the information and communication technologies 
(ICT) market The European software industry is a significant contributor to the European economy and 
a key driver of innovation and change. Spending on software and related services is worth around €258 
billion to the European economy, or around 2.6% of  GDP4. The software indust ry creates tax revenues, 
is a major source of high-value jobs, and has do wnstream multiplier effects throughout the economy 
(Source: report of an Industry Expert Group to DG INFSO “Towards a European Software Strategy” 
March 2009) 
 
EN 19   EN online and cover costs through relatively high membership fees. In addition, ESOs 
may be unwilling to endorse or rubberstam p standards developed by third parties and 
be responsible for their main tenance while global fora a nd consortia may not see any 
added value in transposing their deliverabl es, already broadly implemented at global 
level, into a formal regional standard.  
This situation has a range of negative impacts. During the public consultation, 
77% of respondents recognised this as a problem49. Indeed, European public 
authorities are not in a position to refer to  and thus exploit the potential of innovative 
ICT technologies which slows down the implementation of pu blic goals in areas such 
as e-health, e-accessibility, e-government. Mo reover, the European Digital single 
market cannot be realised as Member Stat es will select their own solutions (which 
may not be interoperable with other Memb er States) and thus block the digital 
market for instance for content related matte rs. In the field of eHealth services, for 
example, a study carried out for the Commission by Empirica GmbH in 2008 on 
“ICT standards in the health sector: curren t situation and prospects” painted a bleak 
picture, finding a lack of well-devel oped e-health standards for particular 
applications and concrete use cases, and conflicting standards, versions and 
implementations, i.e. a lack of standard s that are widely used, implying that 
standards often conflict and interoperability problems often occur. Many of the 
conflicting standards are pr oprietary. There may also be different or flawed 
implementations of the same standard that are not interoperable. In some cases even different versions of the sa me standard may conflict. For health service providers, 
this situation may imply that computerised  systems remain stand-alone and unable to 
exchange data with each other in-house or  externally. The lack of ICT systems 
interoperability and of wi dely accepted standards directly implies compromised 
quality of healthcare and unn ecessarily high costs for the health systems. To the 
extent that EU Member States seek cross-bo rder health services and, in the long run, 
an internal market for health services, su ch interoperability problems need to be 
solved at the EU or international level. The work to harmonise eHealth standards is 
further complicated by the number of standa rds developing organisations active in 
the area, not only the ESOs and ISO, but also Fora and Consortia such as IHTSDO 
for terminology, HL7 for electronic messa ging, DICOM for digital healthcare 
imaging, openEHR for eHealth records and IHE for interoperable systems. 
3.2. How would the problem evolve, all things being equal? 
As regards the speed of the European stan dard-setting process, the figures set out 
above show that the duration of the pro cess could still shorte n slightly within 
CEN/CENELEC to equate to those of ETS I. However, it is likely to become 
increasingly difficult to make furt her progress without jeopardising some 
fundamental principles of the standard-set ting process, especially the principle of 
consensus.  
Little or no evolution can be expected  in relation to the other problems. 
                                                
 
49 See Annex 1 and the report of the European Parlia ment on the Future of European Standardisation [A7-
0276/2010]. 
 
EN 20   EN 3.3. Simplification a nd update potential 
At the moment, the co-existence of three different legal instruments on European 
standardisation (Decisions 87/95/EEC and 1673/2006/EC and Directive 98/34/EC) 
creates a number of ambiguities. These issu es are listed below and could be easily 
rectified if the legal framework is revised. 
3.3.1. Procurement of existing standards 
At the moment, Decision No 1673/2006/EC sp ecifies that EU financing will be 
provided: 
– in the form of grants without a call for proposals, to European standardisation 
bodies to carry out the produc tion and revision of European  standards or any other 
standardisation product which is necessary  and suitable for the implementation of 
Community policies and legislation and complementary activities set out in 
Article 3 of the Decision; or  
– in the form of grants after a call for proposals, or by public procurement 
procedures, to other bodies to carry out , in collaboration with the European 
standardisation bodies, the performance of  preliminary or ancillary work in 
connection with European standardisa tion, such as studies, programmes, 
evaluations, comparative analyses, research work, laboratory work, inter-laboratory tests and conformity evaluation work. 
The procurement of existing standards by the Commission is not expressly 
mentioned in the Decision. Yet, procuring standards is possible under Chapter V of the Financial Regulation
50. Resolving this legal ambiguity would not have any 
budgetary impact. 
3.3.2. Simplification of the financi ng of European standardisation 
The evaluation of the Community financing of standardisation51 suggests that a shift 
to a radically simpler, faster and more stab le arrangement is nece ssary to increase the 
efficiency of financial support and ensure that it is fully ut ilised - and indeed 
extended - in future. It recommends that the Commission seek to identify a significantly simpler and less bureaucratic set of arrangements in the medium term, and that in the interim the administrative requirements and financial controls be defined as clearly as possible and th en applied fairly, proportionately and 
consistently across the various contracts. 
In its proposal for the recast of the Financ ial Regulation applicable to the general 
budget of the European Union
52, the Commission pointed out that the currently 
applicable rules on grants have proved insu fficient to alleviate the administrative 
                                                 
50 Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation 
applicable to the general budget of the European Communities, OJ L248, 16.9.2002. 
51 Evaluation of the Contribution of Community Financing of Standardisation to the Fulfilment of Policy 
Objectives of the Commission, submitted by GHK/Technopolis on 30 June 2009. http://ec.europa.eu/enterprise/dg/files/evaluation/2009-06-30__final_report_and_appendices_en.pdf
. Its 
main conclusions can be found in Annex 9. 
52 COM(2010)260 of 28.5.2010. 
 
EN 21   EN burden imposed on oper ational services and beneficiaries. According to the proposal, 
this administrative burden prevents se rvices from using thei r resources on policy 
objectives and on timely delivery, while it crea tes excessive red tape for beneficiaries. It 
has two direct causes: excessive similarity between procurement and grant rules/procedures, although the objectives ar e different (acquisition vs. support) ; and the 
fact that controls for grants  focus on real costs (real-cost based grant) rather than on 
expected results (deliv erables) of projects. 
This proposal for the recast of the Financial Regulation intends to shift the Union 
scheme towards a performance-based system, based on the definition of agreed indicators and objectives (outputs and outcomes), and to proceed to a robust 
simplification of lump sums (lump sums, sta ndard scales of unit costs and flat rates), 
clearly disconnected from a ny verification of actual costs of implementation. Under 
this new system, the Commission would be ab le to establish lump sums, scales of 
unit costs and flat rates on the basis of a provisional budget submitted by the 
applicant taking into acc ount its internal accounti ng practices, including only 
acceptable cost categories, whic h are consistently applied to similar operations by the 
applicant. In parallel, the proposal indicates that the real-cost regime,  maintained as 
the default regime , should be reviewed (clarification of  various types of costs, costs 
actually incurred, in kind contributions, profit).  
The rules on the financing of European st andardisation could be aligned with these 
simplifications in the recast  of the Financial Regulation. 
3.3.3. National standards for services 
Articles 2 to 4 of Directive 98/34/EC  establish cooperation between the 
standardisation bodies and the Co mmission for standards on products
53. This 
cooperation includes the exchange of in formation on national standardisation 
initiatives so that NSBs are encouraged to bring their initiatives to European level, 
thus promoting the internal market and European harmonisation. Formally speaking, 
this cooperation does not apply to standards on services which are not included in the 
scope of the Directive.  
Importance of services for the economy has steadily increased over time in most 
OECD countries. This process known as "tertiarization" does not only mean that 
services occupy increasing shares of GDP but  also that they pl ay an increasingly 
important role in intermediate inputs fo r manufacturing, and high- tech manufacturing 
in particular. The tendency of knowledge  intensive business services firms to 
develop new services as part of a produc t package that includes physical, tangible 
                                                 
53 According to Article 1(6) of the Directive, a stan dard is a technical specification approved by approved 
by a recognised standardisation body for repeated or  continuous application, with which compliance is 
not compulsory and which is an international, European or national standard. A technical specification 
is defined as a “specification contained in a document which lays down  the characteristics required of 
a product such as levels of quality, performance, safety or dimensions, including the requirements 
applicable to the product as regards the name under which the product is sold, terminology, symbols, 
testing and test methods, packaging, marking or  labelling and conformity assessment procedures”  as 
well as “production methods and processes used in respect of agricultural products as referred to 
Article 38(1) of the Treaty, products intended for human and animal consumption, and medicinal 
products as defined in Article 1 of Directive 65/65/EEC, as well as production methods and processes 
relating to other products, where these have an effect on their characteristics.”  
 
EN 22   EN goods is a prominent feature of what has been coined a "convergence process". This 
process encompasses manufacturing firms whic h have also begun to offer services as 
part of package including bot h the physical product as well as services. High-tech 
products are, for example, often sold in  combination with maintenance services. 
The output of manufacturing st ill consists to the largest extent of manufactured 
products. Service output of ma nufacturing, however, grows quite fast and displayed 
annual growth rates of 5 to 10 % fo r the period 1995-2005. Service output of 
manufacturing was growing in all Member  States but the Czech Republic between 
2000 and 2005 which is the latest available ye ar of data. Taking into account that the 
latest recession hit manufacturing industrie s relatively harder than services, the 
shares of service output of  manufacturing is likely to  have increased further. 
In general, the delineation between servic es and goods is becoming less relevant in 
the reality of the internal market. In pract ice, it is not always possible to clearly 
distinguish standards on products fr om standards on services. Many product 
standards have a service com ponent while standards on se rvices often also partly 
relate to products. Therefore, most NSBs notify their intentions  about all new or 
amended standards in accordance with the in ternal rules of the ESOs, irrespective of 
their scope and despite the current absen ce of an obligation to notify envisaged 
service and process standards54. However, this de-facto situ ation is not foolproof: if, 
for example, a NSB deliberately chooses not  to notify its plans for a new national 
service or process standard to protect th eir national market, the other NSBs and the 
ESOs will remain unaware of these plans so that the matter cannot be discussed in view of a possible initiative  for a European standard.  
The public consultation shows that most re spondents were in favour of including 
service standards in the sc ope of Directive 98/34/EC
55 or its possible successors. Just 
over half (58%) of the NSBs stated that there would be no additional administrative 
workload or cost associated with the notif ication of service sta ndards, and a further 
quarter (25%) stated that the costs would be  negligible or insigni ficant. The lack of 
additional administrative costs are explained by the fact that notification is current 
practice for most NSBs and many are not de veloping significant numbers of national 
service standards anyway.  
3.3.4. European standards for services 
European standards on services are al ready covered by Decision No 1673/2006/EC 
on the financing of European standard isation. The older Directive 98/34/EC, 
however, only applies to standards on pr oducts and the consultative committee of 
representatives of Member States set up by Article 6 of the Directive cannot formally 
propose that the Commission ask the ESOs to draw up a European standard on 
                                                 
54 See reports on the implementation of Directive 98/34/EC : COM(2009)690 and SEC(2009)1704, 
COM(2007)125 and SEC(2007)350, and COM(2003)200. See also http://www.cen.eu/boss/Support/Support%20proce sses%20-%20Index/notifpr oc/Pages/default.aspx
. 
and http://portal.etsi.org/nso/handbook.asp .  
55 It should be noted, however, that articles 8 to 10 of Directive 98/34/EC, i.e. the provisions concerning 
the notification of draft technical regulations, have no bearing to standardisation. Therefore, these 
articles as well as other articles of the Directiv e concerning the notification of draft technical 
regulations fall outside the scope of this impact assessment. 
 
EN 23   EN services (Article 6( 3)). In theory, the Committee s hould not even be consulted for 
such requests (Article 6(4)). 
Correspondingly, the Commission addresse d Programming Manda te M/340 in the 
field of services to CEN, CENELEC and ETSI in 2003, in whic h it requested the 
delivery of a programme of standardisation work in support to the Internal Market 
for services, giving priority to areas where intra-community  trade already existed or 
was desirable. In July 2005, the Commi ssion addressed the Second Programming 
Mandate M/371, in the field of services to  CEN which resulted in 11 feasibility 
projects. Other mandates, for example, rela te to postal services  (mandates M/312 and 
M/428), cinematographic works (mandate M/365), business-support services to 
SMEs (mandate M/370), customer-contac t services (mandate  M/378) and supply 
chain security (mandate M/419).  
However, Article 26(5) of the “Services Directive”56 obliges the Member States, in 
cooperation with the Commission, to en courage the development of voluntary 
European standards with the aim of f acilitating compatibility between services 
supplied by providers in different Member States, information to the recipient and 
the quality of service provision.  
Consequently, there is a case for aligni ng and simplifying the procedures for all 
mandates to ESOs, regardless of their subj ect-matter, by including the possibility to 
ask ESOs to draft European standards on services into the legal text. There was 
general support for this possibili ty in the general consultation.  
3.4. Subsidiarity 
European standardisation supports European  legislation establishing the Single 
Market  (see Annex 4) and contributes to incr easing the competitiv eness of European 
industry. The harmonisation of standards at European level overcomes technical 
barriers to trade which could be caused by c onflicting national sta ndards. Therefore, 
this impact assessment only examines prob lems and policy options  that relate to 
standardisation at European level.  Correspondingly, measures to improve 
standardisation at national level are not considered.  
All problems outlined above  concern primarily the func tioning of the internal 
market . Consequently, any legislative prop osal with respect to European 
standardisation would have to be based on Article 114 TFEU, which is the legal basis 
of all directives referred to in Annex 4. The proportionality of the options will be 
assessed later in this report. 
                                                 
56 Directive 2006/123/EC of the European Parliame nt and of the Council of 12 December 2006 on 
services in the internal market, OJ L376, 27.12.2006. 
 
EN 24   EN 4. O BJECTIVES  
4.1. General policy objectives 
This initiative aims at increasing th e contribution of standards and European 
standardisation to a better functioning internal market , stimulating growth and 
innovation and fostering the competitiveness of EU enterprises, especially SMEs.  
4.2. Specific objectives 
(1) Reduce the time taken by the standardis ation process for st andards developed 
at the request of the Commission; 
(2) Ensure that SMEs and societal stakehol ders are adequately represented in the 
standardisation process, es pecially for standards deve loped at the request of 
the Commission; 
(3) Broaden the use of ICT standards and t hus enhance interope rability through a 
more integrated European public proc urement market for ICT products and 
services, especially in c onnection with the establishment of an “e-Internal 
Market”; 
(4) Remove ambiguities in th e existing legal framework. 
5. P OLICY OPTIONS  
Each policy option listed below (with the exception of the baselin e options) would be 
accompanied by the simplification measures analysed above.  
5.1. Policy options for problem 1: the process for adopting European standards 
requested by the Commission is not fast enough 
• Option 1.0  is the baseline option  against which the remaining options are 
assessed, namely the current situation as described above.  
• Policy Option 1.A : specify deadlines for the delivery of European standards , 
for example in the grant agreements and in the mandates.   
• Policy Option 1.B : create a European Agency for Standards  that would manage 
the standard-setting process. The agency  would merge and re place the existing 
ESOs. The agency would act as a secretariat for European standardisation while the national delegation principle would be  upheld. It would be responsible for 
developing European standards, in  close cooperation with NSBs.  
• Policy Option 1.C
: transparent and simplified procedures for harmonised 
standards and other European standards requested by the Commission . The 
first element would consist of a more  organised regular annual programming 
cycle which might help ESOs to bette r respond to new and ongoing priorities. 
Secondly, mandates would not require the individual favourable opinion of the 
committee but comments of the representa tives of the Member States on the 
subject of the individual mandates woul d be sought when the work programme 
 
EN 25   EN was discussed. Thirdly, ESOs would be obliged to answer any standardisation 
request from the Commission (i.e. a mandate) within two calendar months. 
Finally, the procedure for objecting to harmonised standards would also be 
shortened. 
5.2. Policy options for problem 2: Under- representation of SMEs and societal 
stakeholders in the European standardisation process  
• Option 2.0  is the baseline option  against which the remaining options are 
assessed. It does not propose any new measur es compared to the current situation. 
It is described above. 
• Policy Option 2.A : Facilitate direct representation of SMEs and societal 
stakeholders within the ESOs . This would include the amendment of the voting 
arrangements and an extension of the number and the formal rights of “Associated Members” in CEN
57 and “Cooperating Partners” in CENELEC58. Since 
administrations, administrative bodies, NS Bs, network operators, manufacturers 
and users can already be members of ETSI59, in the case of ETSI only amendment 
of the voting arrangements would be necessary.  
• Option 2.B : Grant voting rights to organ isations representing SMEs and 
societal stakeholders within the Europ ean standardisation organisations. This 
would include the amendment of the voti ng arrangements and an extension of the 
number and the formal rights of “Associated Members” in CEN60 and the 
“Cooperating Partners” in CENELEC61. Since administrations, administrative 
bodies, National Standards Organizations, network operators, manufacturers and 
users can already be members of ETSI62, in the case of ETSI only an amendment 
of the voting arrangements would be n ecessary whereby these organisations 
would play a more prominent role in the technical work. 
• Option 2.C : Strengthen the position of organ isations representing SMEs and 
societal stakeholders within the ESOs by providing for the possibility of an 
operating grant.  A more active role for organi sations representing SMEs and 
societal stakeholders in the technical work  of the standardisation process could be 
ensured if separate organisations repres enting SMEs, the interests of consumers 
                                                 
57 Associate Members of CEN are organizations represen tative, at European level, of social and economic 
interests, the statutes of which are governed by European legislation, or by the national legislation of 
one of the CEN national Members' countries, and whic h comply with other conditions mentioned in the 
Statutes of CEN (Article 6.3).  
58 Cooperating Partners of CENELEC are independ ent European or international organizations 
representing, with a sufficient de gree of representativity within th eir defined area of competence, a 
sector or subsector of th e electrotechnical field.  
59 Article 6.1 of the Statutes of ETSI. 
60 Associate Members of CEN are organizations represen tative, at European level, of social and economic 
interests, the statutes of which are governed by European legislation, or by the national legislation of one of the CEN national Members' countries, and whic h comply with other conditions mentioned in the 
Statutes of CEN (Article 6.3).  
61 Cooperating Partners of CENELEC are independ ent European or international organizations 
representing, with a sufficient de gree of representativity within th eir defined area of competence, a 
sector or subsector of th e electrotechnical field.  
62 Article 6.1 of the Statutes of ETSI. 
 
EN 26   EN and environmental considerations and a nother defending social  interests could 
benefit from an operating grant. This possibility would have to be introduced in the legislation concerning the financing of  European standardisation which would 
provide for a more transparent and fina ncially sound system of supporting these 
organisations, by clearly setting out the criteria for the financial support by the 
EU.  
5.3. Policy options for problem 3: “Fora and Consortia Standards” cannot currently 
be referenced in public procurement of ICT.  
• Option 3.0
 is the baseline option  against which the remaining options are 
assessed. It does not propose any new measur es compared to the current situation. 
It is described above. 
• Policy Option 3.A : Revive the implementation of  the mechanisms of Council 
Decision 87/95/EEC  concerning public procurement and the policy dialogue. 
Public authorities could be reminded about the exis ting legislation and its 
implications for the use of standards in public tenders, including the need to notify 
exceptions when referring to non-European technical specifications. This could be 
done through a communication from the Commission to the Member States.  
• Policy Option 3.B : Allow for the referencing of “Fora and Consortia 
Standards” in public procurement of ICT . The objective is to expressly allow 
referencing of “Fora and Consortia St andards” in public procurement for 
interoperability purposes in those areas where no appropriate European standards 
are available, e.g. in the Internet domain, or in domains where a fora and consortia 
specification has much broader market accep tance than an ESO standard e.g IEEE 
WiFi specifications compared to the ETSI Hyperlan standard. To help public authorities use the best available standa rds, it would be necessary to identify 
certain requirements or attributes to which the standardisation process and the 
standard comply. These attributes e.g. openness, transparency, balance, 
stakeholder involvement, IPR policies, w ould ensure that the standards respect 
public policy objectives and societal needs. Complian ce with these attributes 
would be assessed with the help of a “consultative platform” that would be 
composed of, inter alia, representati ves from Member States, ESOs, ISOs,  the 
most relevant private fora and cons ortia, SMEs, industry, and consumer 
organizations.  
• Policy Option 3.C
: Grant selected private fora and consortia the Status of 
Recognized Entities under Directive 98/34/EC . Directive 98/34/EC puts in 
place an information and co-ordin ation mechanism between national 
standardisation bodies and ‘recognised’ European standardis ation entities to 
harmonise the production of standards at the European level. ‘Recognised’ bodies 
have a right of information and consultation on national standardisation activities to prevent the development of nationa l standards already available in the 
European catalogue, unless they are specifically mandated by national 
governments.  
 
EN 27   EN 5.4. Discarded options 
During the public consultation, stakeholders raised several other issues, which were 
not retained for further analysis in this impact assessment report. These issues are listed in Annex 5. As a consequence of the consultation, some options were refined.  
6. A
NALYSIS OF IMPACTS  
None of the options has impacts on fundamental  rights, the number and the quality of 
jobs, technological developments, develo ping countries, public  health or public 
authorities. 
6.1. Problem 1: the process for adopting European standards requested by the 
Commission is not fast enough 
6.1.1. Policy Option 1.0: Base-line scenario 
As described above. It serves as a refe rence against which the other options are 
assessed. 
6.1.2. Policy Option 1.A: specify deadlines on the delivery of European standards.  
The advantage  of this option is that European standards would be available after a 
fairly short period. The assumption is that  ESOs would accept shorter deadlines and 
that they could persuade technical expert s willing to spend more time on developing 
a standard. The positive economic benefits of the earlier availability of a standard 
can be deducted from the relation betw een standards portfolio and growth. 
According to the AFNOR study63 "the positive variation in the stock of standards of 
1% induces an increase of 0.12% in the growth of  the TFP (Total Factor 
Productivity). Thus the c onclusion that earlier availability of sta ndards would lead to 
more standards on the market and result  in more growth. Faster standard 
development may have a positive impact on competitiveness as businesses could in addition save costs thanks to the "defragmen tation" of the internal market and to the 
simplification of conformity assessment pr ocedures. Shorter standard development 
may also encourage innovation and new technologies. 
Financial incentives  to encourage ESOs to speed up the process are a necessary part 
of this option, as well as financial sanctions in case of late delivery. The financial incentive is a valuable elemen t of this option, especially in  the light of the financial 
simplification referred to above. Indeed, if one would shift the financing scheme 
towards a more performance-ba sed system, based on the defin ition of agreed indicators 
and objectives (outputs and ou tcomes) and a simplification of  lump sums, the speed of 
the standard-setting process for standards elab orated at the request of the Commission 
should be taken into consideration. 
However, there are some disadvantages lin ked to this option. Firstly, the obligatory 
deadlines and corresponding financial conseque nces for failure to deliver can only be 
                                                
 
63 The economic impact of standardis ation. Technological change, stan dards growth in France, AFNOR, 
June 2009. 
 
EN 28   EN applied to standards mandated by the Comm ission, which are a small percentage of 
the total (34%). A drawback of this option is that ESOs may decline requests  for 
new items for standardisation, in particular  for technically complex or contentious 
issues. Facing deadlines may encourage so me NSOs to avoid standardisation at 
European level so that ther e would be fewer European st andards and more, probably 
conflicting, national standard s on the same subject.  
Secondly, deadlines for Europ ean standards could have a negative impact on the 
quality of the standard . Time can only be gained by reducing consensus and 
correspondingly curtailing (or avoiding) one of the intermediate consultation stages. 
The objective of the need for a consensu s and a broad consulta tion is mainly to 
protect the standardisation process from be ing influenced by the private commercial 
interests of vendors or users, thus ensuring that it leads to sta ndards that serve the 
public interest. A standard founded on a broad consensus following a sufficient 
consultation had a number of positive effect s on the market for which the standards 
are destined, for example it means that asymmetries in the cost of access to 
information are reduced, entry barriers ar e lowered, price-performance calculation is 
simpler, and the ability of suppliers to impose switching costs is also reduced64.  
Thirdly, deadlines for all European standard s and the production of at least the same 
number of standards in le ss time could lead to increased costs (more frequent 
meetings for example).  
Estimated annual costs of workin g groups of creation of new 
standards (euros)  
 3 year process 
Experts costs (1 meeting /6 days/month*10 
experts*600 euro) 432,000 
Laboratory costs 400,000 
Travel costs 86,400 
Total  918,400  
Number of working groups (CEN/CENELEC) 1,704 
Estimated active working groups (35%of total 
existing wg) 596 
Cost 35% working groups CEN/CENELEC 547,733,760 
Cost ETSI (estimated of the basis of number of 
deliverables) 2,306,247,411 
                                                 
64 David, P.A., and Shurmer, M. "Formal standards- setting for global telecommunications and information 
services. Towards an institutional regime transformation?" Telecommunications Policy (20:10) 1996, 
pp 789-815. 
 
EN 29   EN Number of annual deliverables 
(CEN/CENELEC/ETSI) 3,069 
Total costs  2,853,981,171  
Cost per deliverable  929,938  
On the one hand, this option would result in an estimated additional annual cost  per 
standard of around €150,000 to €200 ,000 if standards were to be  finalised in 2 years. 
According to the current share of standard cr eation costs, this would translate into an 
additional cost per standard for the Commission of €3,000 to € 4,000, for national 
governments of €4,500 to €6,000 and for i ndustry of €142,000 to 190,000. On the 
other hand, if one assumes that the releva nt working group meets on a more or less 
permanent basis and starts new work when a consensus is reached on the previous 
topic, this option would necessarily result in the development of  more standards 
which has positive economic effects. The increase in speed would only be possible 
if industry and other stakeholders agree to share the additiona l cost or if the 
Commission finances it.  
Unless specific measures are taken, d eadlines for European standards would 
necessarily have a negative impact on the involve ment of SMEs and societal 
stakeholders . In other words, this option would worsen the problem of the lack of 
involvement of SMEs and societal stake holders. The willingness of businesses, and 
especially SMEs, to take part in standa rdisation activities would be reduced since 
they would have to use their scarce sta ndardisation resources in a shorter and 
therefore more labour-intensive period.  
During the consultation process , ETSI highlighted that standardisation is a 
voluntary activity and it is not realistic for the EC to expect that financial support 
will immediately bring all the necessary stakeholders to the table. 86% of 
respondents in the public consultation do not wish to have the EU’s financing of 
standardisation subject to conditions of speed  of delivery. This is true for each one of 
our six categories of stake holders (80% of citizens; 92% of companies; 84% of 
industry associations; 65% of public aut horities; 90% of European and national 
standards bodies and 92% of public intere st organisations) and for the 19 SMEs as 
well (in this case, the percentage of replie s indicating an opposition is even equal to 
100%). Respondents perceived the time needed for the standard-setting and definition process as reasonable in most cas es. Increasing speed is often perceived as 
having a negative impact on the quality of th e outcome of the process. If, however, a 
need emerges to further speed up the proc ess, respondents say that possible speed-
related conditions in EU financing would not improve  the situation. As an 
alternative, they suggest increasing the use of IT solutions in working methods, tools 
and processes of National and European Sta ndards Bodies. Some re plies also suggest 
concentrating resources and efforts only on the development of those standards 
which are relevant for market players. 
 
EN 30   EN 6.1.3. Policy Option 1.B: create a European Agency for Standards that would manage the 
standard-setting process.  
Work in European standardisation is alr eady done at European level by the ESOs, 
CEN, CENELEC and ETSI. This option w ould merge the three ESOs into one 
agency that would develop European standards. 
The advantage  of this option is that the agency would be supervised by the 
European legislator and that it would beco me more difficult to decline mandates for 
European standards. The creation of a new European standardisation agency would probably mean that requests for harmonised standards would be ha ndled as a priority. 
Furthermore, it would seem a priori logical to suppose that the smaller the number of 
European organisations dealing with st andardisation, the lower the level of 
duplication of administrative resources and expenses would be, and the greater the 
cost-efficiency. If one prefers more integrat ed standards covering different sectors, it 
would also seem logical to replace the curren t sectoral approach with an integrated 
approach whereby all European standards w ould be drafted under the auspices of one 
single body which would pool all the av ailable expertise. In addition, the 
participation of SMEs in the standardis ation process could be improved. A single 
European standardisation agency could also lead to faster standard development. In 
this case, the positive effects would be si milar as described above for option 1. A. 
However, this option has a number of consid erable drawbacks. It requires, above all, 
close cooperation with the NSBs  to make it viable. An agency on European 
standardisation could not operate without th eir support. An agency  could not provide 
the level of expertise  necessary to perform effectiv ely the tasks of a technical 
committee. It is commonly held that expert s from industry and ot her stakeholders are 
better placed to provide the ri ght level of technical knowledge. An agency that would 
replace and merge the existing ESOs would be likely to face the same challenges as 
nowadays, namely that the actual work in the technical committees is done by experts delegated by the NSOs which would have corresponding voting rights. 
Therefore, consensus between the experts would still be necessary , regardless 
whether the work was done under the auspices  of an ESO or an agency. Moreover, a 
speedily elaborated specification could st ill face a negative vote by members who 
considered that the proposed standard di d not fulfil the necessary requirements.  
This option would certainly lead to substantial additional costs for the EU-budget . 
The Commission currently contributes around 47% of the total income of the three 
ESOs (€44,000,000), which covers part of the ESOs’s secretariat staff costs, some 
consultancy costs as well as activities such as translation of standards, visibility 
actions to promote EU standards and prelimin ary or feasibility studies for standards. 
This contribution amounted to 21.2 million euro in 2009. The rest of the ESOs income is mainly financed by members´ fees and contributions. ESOs currently employ 208 permanent staff. The costs of the current system are shown in the following table: 
 
EN 31   EN 
 
It has to be kept in mind that the number of standards mandated by the 
Commission is a fairly small proportion of the total deliverables issued by ESOs . 
The Commission issues around 20 mandates per year. For each mandate we can count from 1 up to more than 100 standard s produced. However, the great majority 
of European standards remain industry–ini tiated and financed. The total number of 
deliverables issued by ESOs in 2009 was around 3,000.  
The assumption is that standardisation work would continue to be carried out as it is 
under the current system, where most of the costs of the experts developing the 
standards would be financed by the private sector. If the ESOs were merged and transformed into an EU executive agency, it is likely that the EU budget would 
have to generate the total income of the agency , including the part currently 
financed by other parties mainly through fees . The assumption is th at there would not 
be payment of fees by stakeholders in orde r to facilitate participation by SMEs and 
societal stakeholders. If the agency was of a size comparable to the EACI or the ERCEA
65, this would lead to an additional a nnual cost for the EU  budget of at least 
€20,000,000.  
There would be a negative impact in term s of costs, while positive impacts in terms 
of improvement of the quality of the standardisati on process are not clear. It is also 
questionable whether standardisation activ ities, in which the main players are 
private, should be performed by a public EU agency, particularly while the current 
structure seems to be responding to industry needs.  
During the consultation , all three ESOs said that they  expect that the creation of a 
new agency will make the ESS more complex. They reported that a new organisation would result in more meetings, additional co sts, a lack of clar ity over the boundaries 
                                                
 
65 Executive Agency for Competitiveness and Innovation  (EACI): EU contribution: €15,000,000 - staff: 
152; Education, Audiovisual and Culture Executive Agency (EACEA): EU contribution: €46,000,000 - staff: 412; European Research Council Executive Agency (ERCEA): EU contribution: €32,000,000- 
staff: 330; Trans-European Transport Network Executive Agency (TEN-T EA): EU contribution: 
€9,000,000 - staff: 99. 
 
EN 32   EN between the EC and the new agency and more difficult coordination amongst 
stakeholders at different levels. ETSI repor ted that it could see no benefits to the 
proposed approach. 
6.1.4. Policy Option 1.C: transparent and simplif ied procedures for harmonised standards 
and other European standards re quested by the Commission.  
A more organised regular a nnual programming process woul d increase the workload 
of the services of the Co mmission but would have a general positive impact . It 
would enable ESOs to an ticipate upcoming requests and shorten the acceptance 
process. The second part of this option, i. e. the replacement of the favourable opinion 
on individual mandates by a general discus sion on the overall EU standardisation 
work programme would offer an equivale nt level of transparency vis-à-vis 
representatives of Member States. The main difference is that the consultation would 
be part of a more general consultation on overall standardisation planning and the 
choice of priorities. The th ird part of this option woul d oblige the ESOs to answer 
any standardisation request from the Commission (i.e. a mandate) within two 
calendar months. The last part of this op tion consists of shortening and streamlining 
the various procedures for objections66 which would offer the advantage that 
harmonised standards would be more rapidl y available on the market for use by 
businesses.  
This option would have a positive impact  on the internal market and the 
competitiveness of businesses (including SMEs) by reducing the overall period of standardisation by up to 1 year, while ha ving no negative impacts or supplementary 
costs. This acceleration in the standardisa tion process would come from shortening 
the period for issuing mandates by appr oximately 6 months (by removing the 
separate consultation of the committee) whil e another 6 months could be cut at the 
end of the process through efficiency  gains when object ions are raised. 
Competitiveness advantage for businesses w ould come from benefiting earlier from 
the presumption of conformity granted to those using such harmonised standards. It 
is however impossible to quantify this posit ive impact as it can only be estimated 
once the subject of the standard, the tur nover of the businesses concerned and the 
cost of conformity assessment of their pr oducts in the absence of a standard are 
known. 
Although this option has an overall positive impact without any negative impacts, the 
main disadvantage  is that it would only apply to harmonised standards and 
standards developed at the re quest of the Commission, so it  would have no impact on 
the speed of other European standardisati on work. In addition, it would lead to an 
additional workload of the Commission a nd corresponding admini strative costs of 
about €250,000 per year. 
During the consultation  of January-February 2010, CEN/CLC reported that a two-
month timeframe for responding is achievable and at no additional cost. ETSI reported that a two-month time frame for responding was not achievable. Instead, 3 
months is the minimum possible timeframe du e to the need to coordinate with the 
other ESOs and other involved SDOs and to consult with the ETSI Board before 
                                                
 
66 A detailed overview can be found in Annex 4. 
 
EN 33   EN acceptance (although this would be depende nt on the reaction of the technical 
organisation and board of ETSI to a speci fic request). Achieving this timeframe 
would probably not incur any additional financial costs. ETSI reported that the following changes would be necessary for the ESOs to be able to respond to mandates within in a shorter timeframe: firstly, a stronger and earlier consultation on the mandate drafting process to ensure that the community has a better understanding of what is needed, which can accelera te the ESO acceptance process; secondly, 
improvements to the presentation of content and clarity of purpose of draft mandates, 
and thirdly, a simplification of the contra ctual process for grant agreements that 
presently require at least 9 months. ETS I reported that there would be no cost 
implications associated with these cha nges, nor any other implications. CEN/CLC 
reported that the BT formal approval could be further shortened in order to be able to 
respond to mandates within a shorter ti meframe. CEN/CLC did not report any 
associated cost implications to this cha nge. CEN/CLC also highlighted that some of 
the delays are due to factors outside the co ntrol of the ESOs, but that instead reside 
with the Commission.  
6.2. Problem 2: Involvement of SMEs and so cietal stakeholders in the European 
standardisation process 
6.2.1. Policy Option 2.0: base-line scenario (i .e. the financial contribution to SME and 
societal stakeholder representation) 
As described above. It serves as a refe rence against which the other options are 
assessed. 
6.2.2. Policy Option 2.A: Facilitate direct representation of SMEs and societal 
stakeholders within the Europe an standardisation organisations  
Long term direct participat ion of technically aware st aff of individual SMEs and 
societal stakeholders in the meetings and discussions of a technical committee allows 
this staff to build a reputation within th e standardisation organisations. In addition, 
staff can work directly to influence the process.  
Participation in the standa rdisation process requires a strong technical 
understanding of proposed standards and their context . In addition, participants 
need to be prepared to commit up front to  substantial investments of the time and 
energy necessary to follow ongoing internal  discussions about the subject of the 
future standard. Many questions are m oving targets – discu ssions can progress 
quickly and the challenges presented when a standard is proposed may evolve just as 
quickly. Also, the relative value of a c ontribution is frequently judged by the 
contributor’s willingness to follow-up and finds workable answers to questions raised. Furthermore, long-term commitment to the standards development process is 
necessary. 
On-going and active participation in a technical committee or working group 
requires a very significant commitment of time . The generally accepted guideline 
is that meaningful participation in any technical committ ee or working group 
requires a baseline of approximately 20%  of a person’s working hours (1 day of 
work and meetings per week plus tri- or  semi-annual conferences ). The average costs 
of participation can hardly be  calculated given the wide ra nge of size, scope and level 
 
EN 34   EN of technical complexity of standards. Ev en generalizations should be taken with a 
pinch of salt. The cost depends, of course, on a number of factor s including the size 
and complexity of the work to be done, th e availability of existing work upon which 
the standard can be based, the number and quality of resources available to 
contribute to developing the solution, etc. The individual components of cost that go 
into developing and setting or approving a standard include membership dues or participation fees paid by participants to the standards organization, costs associated 
with salaries and support for technical re sources (people) invol ved, travel costs for 
committee meetings and overhead costs. Me mbership dues are a relatively minor 
cost of participating in standards work, compared to the cost of participation. A 
hypothetical technical committee consisting of  10 engineers working for three years 
to develop a specification, and devoting each  an average of 20% of their working 
time to the project could easily come to  a total € 1,000,000 given the cost of an 
engineer, including salary, benefits, office sp ace and equipment, trav el costs etc. (see 
details under option 1.A). Furthermore, th is covers just the work involved in 
developing the standard.  
The second phase would include costs associated with  the approval of the work, 
including public and member reviews and voting . This could add hundreds or 
possibly thousands of hours of additional work by technical people, increasing the 
costs even further. There are no precise estimates of these a dditional costs but, 
depending on the complexity of the review ing process, they could amount to a 
significant share of the original developm ent costs. Finally and most importantly 
there are the ‘lost opportuni ty’ costs of not doing something else that can be 
particularly relevant for SMEs. At company level, this could be as simple as having 
an engineer working on standardisation rather than on the company’s own R&D 
project or other activities.  
Although such direct participat ion is clearly the most eff ective way for an individual 
SME to have an impact on a particular standard proposal, the sheer number of 
technical committees and working groups impedes  direct public representation to 
a large extent. For example, CEN had 1939 Technical Bodies in 2009, namely 292 
active Technical Committees, 33 active CEN Workshops, 62 Sub-committees and 
1395 Working Groups. At the end of 2008, there were 338 active CENELEC 
Committees, Sub-Committees, Task For ces and Working Groups. ETSI had 27 
technical committees/ETSI Projects, 6 Industry Specification Groups and a few 
Partnership Projects an d Special Committees.  
At a more general level, one could expect that the indivi dual participation of SMEs 
would lead to an ineffective distribution of information to the SMEs that are not participating in the standardisation proce ss. Finally, this opti on would inflate the 
number of participants in the standardisa tion process so that it would be likely to 
have a negative impact on the speed of th e standard-setting process. This would 
cause additional difficulties for problem 1 above.  
Although this option is not expected to ha ve any consequences for the EU budget, it 
would be very costly for the participants, inefficient and ineffective for all parties 
concerned. 
During the consultation  process, many respondents emphasized the importance of 
the principle of national de legation. In this respect, CEN and CENELEC said that 
 
EN 35   EN moving away from this principle would require modification of all internal 
regulations and dramatically change th e way the ESO works. There would be 
fundamental issues to be solved around new processes and procedures and such a radical change would incur heavy costs. Concerns were also expressed about the 
implications for balanced representati on and a fragmentation of the European 
standardisation system. 
6.2.3. Policy Option 2.B: Grant voting rights to  organisations repr esenting SMEs and 
societal stakeholders within the Eu ropean standardisati on organisations  
Organisations representing SMEs and soci etal stakeholders can, under certain 
conditions, become associate members  of CEN which allows them to participate, 
without voting rights, in the General Asse mbly, open sessions of the Administrative 
Board, Technical Board, Sector Activities  and the CEN Certification Board. As a 
member of the Technical Bo ard, an Associate Member can  also apply for and hold 
the secretariats of Technical Committees and participate in Technical Committees (TCs) and Subcommittees, upon request, as an  observer. A similar system exists in 
CENELEC. In ETSI, represen tative organisations are or dinary members and they do 
have a vote, but given that there are 20,000 weighted votes in ETSI and each of the 
comparable activities gets one of these, the voting rights are somewhat symbolic.  
Granting voting rights to a very limited numb er of representative organisations on 
technical work within  CEN would have a very positive impact  on the involvement 
of SME and societal stakehol ders. Other delegations with voting rights would have to 
take into account the views expressed by delegates of SMEs and societal 
stakeholders. No negative impacts  could be identified. This option seems entirely 
compatible with the principle of national delegation, especially if voting rights were 
granted to a very limited number of Eur opean organisations re presenting SMEs and 
societal stakeholders on the technical as pects of the standard. This option is not 
expected to have any cons equences for the EU budget. 
However, granting voting rights to organi sations other than NSBs needs to be 
negotiated and agreed with the members of the ESOs, so the feasibility of this 
option is uncertain . Furthermore, it may entail the payment of a higher membership 
fee which would increase the cost of this  option for organisations representing SMEs 
and societal stakeholders. This may m ean a slight increase in the financial 
contribution paid by the EU to the costs incurred by organisations representing SMEs 
and societal stakeholders at European level.  
During the public consultation , 69% of respondents declare that, even if the national 
delegation principle already guarantees a good level of involvement, the participation 
of consumer organisations, environmental NGOs, trade unions and social partners, 
and SMEs within standardisation bodies and committees should be further promoted. 
This is true for 78% of c itizens; 58% of companies and 65% of industry associations. 
The majority of public aut horities (97 %) European an d national standards bodies 
(90%) and in the case of NGOs/environmen t/consumer/public interest organisations 
(93%). are in favour of further participat ion. Favourable replies are in the majority 
(71%) also in the case of the 19 SMEs. Stakeholders also suggested modifying the voting procedures within standardisation bodies in order to further stimulate the 
setting-up of mixed groups. 
 
EN 36   EN 6.2.4. Policy Option 2.C: Strengthen the position of organisations representing SMEs and 
societal stakeholders within the ESOs by providing for the possibility of an operating 
grant 
An important advantage of this option is that these organisati ons have access to a 
larger pool of expertise and knowledge than individual SMEs or societal 
stakeholders. Moreover, these organisations are much more effective at exchanging 
information to their members: individual SM Es and societal stakeholders would be 
less effective in exchange information with other interested SMEs and societal stakeholders, in the absence of a specia lised network and dedicated resources.  
The assumption is that the current level of  EU financing would be maintained. EU 
financial support for the representation of SM Es in standardisation at European level 
amounts to approximately €2,000,000 pe r year. The financial support to 
organisations representing consumers and en vironmental concerns in standardisation 
varies respectively around €1,320,000 and €185,000 per year. 
Unlike a grant for an action, which helps to  co-finance a one-off action over a given 
period (which has a budget specific to th at action irrespectiv e of the body's other 
activities) an operating grant  is broader based: its pur pose is to provide financial 
support for the existence and functioning of a body over a period that is equivalent to 
its accounting period to enable it to carry out a set of activities. Operating grants are 
intended to cover the normal operating expe nses which enable a body to have an 
independent existence and to implement a range of activities that correspond to the 
pursuit of its statutory objectives, which mu st contribute to the development and 
implementation of an EU policy. In practice, the costs which are likely to be eligible 
are those relating to staff costs, general ad ministrative expenditure necessary for the 
running of the body (or overheads), and expens es linked to its no rmal activities as 
approved in the work programme drawn up for the purposes of the grant. In view of 
the nature of the grant, the body's entire budget is involved, unless the body has developed several areas of activity one or more of which are not connected with the 
activities for which the Commission wi shes to provide financial support. 
The positive aspect  of this option is that it provide s for the possibility of continuous 
support to organisations representing SMEs and societal stakeholders so that they 
could consolidate their role in the standardisation process. The other positive aspect is that the possibility of an operating gran t contains a strong impetus for ESOs to 
continue considering these organisations as solid partners in the standardisation process so that the opinions of these orga nisations are adequately taken into account 
during the technical work on European st andards. By strengthening the financial 
instrument to ensure that the objective of correct SME and societal stakeholder 
representation is met, the financial suppor t and the objectives of the EU would be 
clearly linked so that financing would be deployed purposefully in pursuit of specific 
objectives (such as SME and societ al stakeholders’ representation). 
In principle, if operating grants are re newed they should be gradually reduced 
according to the principle of degressivity . The basic philosophy of operating grants 
is that they should provide temporary suppo rt for an organisati on to allow it to 
achieve financial independence in the longer term. However,  this degressivity would 
contradict the EU policy under which the pos ition of SMEs and societal stakeholders 
must be strengthened in order to ensu re the inclusiveness of the European 
 
EN 37   EN standardisation system. In ad dition, it seems likely that more and more European 
standards will be developed in the future so that the workload of organisations 
representing SMEs and societal stakeholders  in the European standardisation system 
will increase. These organisations have a pe rmanent role which is essential for EU 
activities and policies because of the context in which they operate and their statutory 
objectives. Therefore, this option would re quire an exception to the degressivity 
principle in the basic act unde rlying the award of the grants . Furthermore, this option 
requires that the budgetary amounts which are currently scat tered over several 
budgetary lines would be at least ma intained by the budgetary authority. 
No negative aspects could be identified. This option is not expected to have any other 
consequences for the EU budget than those outlined above. 
As already set out above, 69% of respondents of the public consultation  declare that 
the participation of consum er organisations, environmental NGOs, trade unions and 
social partners, and SMEs within standa rdisation bodies and committees should be 
further promoted. A minority of respondents (l arge companies, main ly) is against the 
option of financially supporti ng the less represented stakeholders, since they consider 
that this could be viewed as a discrimina tory measure in relation to other actors. 
6.3. Problem 3: “Fora and Consortia Standa rds” cannot currently be referenced in 
public procurement of ICT. 
6.3.1. Policy option 3.0: bas e-line scenario 
As described above. It serves as a refe rence against which the other options are 
assessed. 
6.3.2. Policy Option 3.A: Revive th e implementation of th e mechanisms of Council 
Decision 87/95/EEC concerning public pr ocurement and the policy dialogue.  
Under this option, Fora and Consortia Sta ndards could be considered as “common 
technical specifications” under Article 1(2)  of Council Decision 87/95/EEC, i.e. a 
technical specification drawn up with a view to uniform application in all the 
Member States. There c ould be two situations: 
(1) The Fora and Consortia Standard is not similar to an existing standard or 
functional specification . Strictly speaking, Fora a nd Consortia Standards do 
not fall within the scope of Decisi on 87/95/EEC, as set out in Article 3. 
Therefore, these Fora and Consortia st andards would have to be transformed 
into a European standard, following the procedures of the Decision, so that 
they can be used in public procurement.  
(2) The Fora and Consortia St andard is similar to an  existing standard or 
functional specification . In that case, Article 5(3) of the Decision allows 
Member States to take account of speci al circumstances which may justify the 
use of standards and speci fications other th an those provided for in the 
Decision where an existing standard or  functional specification would be 
technically inadequate for its purpose. In that case, contracting authorities 
would have to apply the formalities set out in Article 5(5). Moreover, the Commission could recognise Fora in acco rdance with point 3 of the Annex to 
 
EN 38   EN the Decision, which provides for the “determination of the most efficient 
methods of ensuring th e rapid application of  […] technical specifications 
within the context of the present Decision”  in the public procurement sector. 
Neither situation is satisfactory. The fo rmer leads to supplementary charges, 
responsibilities and costs for ESOs that would have to transform the Fora and 
Consortia Standard into a Eu ropean standard. A substantia l part of the costs would 
have to be borne by the Commission. In add ition, the ESOs would be responsible for 
the regular review and update of the standard. This would lead to an extra 
administrative burden for ESOs and an  additional cost for the EU-budget . 
The most important problem with the latter situation is the lack of legal certainty . 
Firstly, it is difficult to determine if Article 5 of the Decision would apply since the circumstances referred to in Article 5(3)  no longer correspond to the technological 
reality on the market. Therefore, this possibility may require a very broad 
interpretation of the provisions of Decision 87/95/EEC. S econdly, the question 
would remain whether the provisions of the Decision were still compatible with the general provisions of Direct ive 2004/18/EC which obliges contracting au thorities to 
formulate technical specifications either by  reference to standa rds or equivalent 
documents or in terms of performance or f unctional requirements, provided that such 
parameters are sufficiently precise to allo w tenderers to determine the subject-matter 
of the contract and to allo w contracting authorities to award the contract. Thirdly, 
this possibility would mean that contrac ting authorities would have to apply the 
formalities set out in Article 5(5) which were not conceived for cases like this. Due 
to this legal uncertainty, the impacts on the internal market, SMEs, public 
authorities, consumers and innovation would be minimal . However, there would 
be no budgetary impacts. 
The advantage  of this option is that no legisl ative change is required and the 
corresponding administrative costs for the EU legislator and the Member States 
could be avoided.  
During the public consultation , only 3% of respondents considered that the 
provisions of Decision 87/95/EEC are a sufficient legal basis for allowing 
contracting authorities to use Fora and C onsortia Standards for the purpose of public 
procurement. 
6.3.3. Policy Option 3.B: Allow for the referencing of “Fora and Consortia Standards”  
The main advantage of this option  is that the possibility of referencing selected 
Fora and Consortia Standards  for procurement purposes on a firm legal basis is 
expected to counter the te ndency towards market fragmentation and to have a 
positive impact on the internal market, especially for businesses delivering goods or services complying with these Fora a nd Consortia Standards. Correspondingly, the 
referencing of Fora and Consortia Standards  can be expected to enhance the 
competitiveness of enterprises, with the creation of a competitive advantage for businesses concerned, in particular the Eu ropean ICT industry. Also, the fact that 
these specifications are officially endorse d would reassure ente rprises about their 
stability and provide an incentive to invest. 
 
EN 39   EN SMEs are expected to benefit in two main ways . First, the refere ncing of Fora and 
Consortia Standards  would reduce information costs, as it would be easier for 
operators to ascertain what specifications were available for their products. Second, 
the availability of a broad range of rec ognized Fora and Cons ortia Specifications  
would create new business opportunities for SME, as they could build on existing 
protocols and procedures and innovate  with lower costs and diminished 
technological and market assessment risks.  In standardised a nd modular markets, 
SMEs would have greater oppo rtunities to provide add- ons and applications. The 
impact of this option on innovation would probably be marginal.  
This option would also have positive indirect impacts on consumers , considering 
the proliferation of high-tech consumer electronic products th at exhibit network 
effects. In markets with network effects,  the benefit to consumers of joining a 
network depends on the number of other consumers who join. This has several implications for competition in network markets. Firstly, expectations of consumers regarding the expected future size of a network are critical in determining the 
adoption of network products. Thus consum er expectations that one technology will 
become predominant may indeed lead to that effect. Secondly, competition in markets with network effects is likely to  lead to standardisation on a single 
technology. In other words, the long-term co-existence of  competing incompatible 
specifications is unlikely. This is because a small initial advantage will likely influence consumer expectations about the adoption of a particular Fora and 
Consortia Specification. This in turn w ill lead to more consumers adopting the 
technology. Because the value of the product increases with the number of adopters, 
the value of the network in creases to future adopters
67 Widely accepted markets 
specifications help consolidate a larger  customer base (as opposed to offering 
products/support based on disparate proprie tary technologies). The same effect 
occurs for end-users since vendors are pooled together, which increases competition and drives prices down, producing better qua ntity and quality of end-user options
68. 
These positive impacts, however, could have corresponding risks , in particular as 
regards competition and intellectual property rights. An important risk, for example, 
is that Fora and Consortia Standards  could contain proprietary technologies, whereby 
a factual monopoly in a technology would resu lt in a factual monopoly in the market 
for services and products based on the tec hnology. This would then favour the single 
supplier of th at technology69. However, the same situation applies with regard to 
ESO standards which can also contain pr oprietary technologies and an analogous 
approach is therefore needed.  
Therefore, this option requires additional safeguards  to address these risks: 
(1) Firstly, the “Fora and Consortia standards”  would need to fulfill a 
number of predefined criteria . These criteria would be inspired by the 
Commission’s White Paper on “Modernisi ng ICT Standardisation in the EU – 
                                                 
67 Gandal N., “Compatibility, Standardization, & Network Effects: Some Policy Implications”, 2002, 
http://www.tau.ac.il/~gandal/netpolicy.pdf . 
68 Vomin V.F. and Pedersen M.K., “Open Standards and their early adoption: Implications for the 
Government Policy”, 2006, http://www.itst.dk/it-arkitektur-og- standarder/standardisering/abne-
standarder/baggrundsrapporter/OStEA_Delphi_report3_Final1.pdf .  
69 See Annex 7. 
 
EN 40   EN The Way Forward”70, and would be selected  and assessed by the 
Commission. For example, it would be n ecessary that the Fora and Consortia 
Standards at least observe FRAND IPR policies, as is the case with the ESOs, or operate on a royalty free basis.  
(2) Secondly, the selection process w ould have to be done with the assistance 
from stakeholders through a consultative “Platform”  consisting of a very 
wide range of stakeholders and intere sted parties and wi thout recourse to 
remunerated external expertise. The obj ective of the “platform” would be to 
help evaluate, inter alia, the openness of the standards development process, 
the quality of the Fora and Consortia Standards, the implemented IPR policies  
and the vendor and platform neutrality of their work produ ct. The “platform” 
should guarantee that all stakeholders ar e fairly represented,  that appropriate 
criteria are enacted, and that trustw orthy results are made available.  
Therefore, this policy option would not entail  any outlays from the EU budget  
except the budget for running the platform which could be estimated at about 
€120,000 per year during the first 2 years (start-up phase) and €60,000 per year during the following years. 
This impact of this option on public  authorities would be very positive . 
Referencing to Fora and Consortia Standards  in public procurement is expected to 
lead to greater competition among supplie rs, products and services, and this should 
translate into lower costs.  
At the moment, it is impossible to quantify the consequences of this option for 
several reasons: 
(1) There is no comprehensive repository in the public domain of all existing 
private and public Fora and Consortia Standards  currently in use. Looking at 
the ICT-sector, approximately 70,000 st andards were developed in the ICT 
industry between the eighties and 2004
71 (more than four times the total 
number of ISO standards at the same  date and roughly 10% of the entire 
PERINORM database grouping official national and intern ational standards 
worldwide). If the same growth patterns had been maintained over the last five years – considering that each year some 3,000 new ICT specifications appear - this figure would likely have increased to anywhere between a total 
80,000 and 90,000 specifications. Furtherm ore, considering that the 3GPP 
project alone resulted in over 14,000 specifications, some  practitioners 
believe that the total figure is now closer to 100,000 units.  
(2) It is impossible to calculate the fina ncial savings enabled by this option. In 
theory, one could attempt to calcula te them on the basis of econometric 
                                                
 
70 A list of possible attributes is set out in point 2.1 of the Commission’s White Paper on “Modernising 
ICT Standardisation in the EU – The Way Forward”, COM(2009)324 of 3.7.2009. It should be noted 
that, for those standard-setting agreements which ri sk creating market power, the Guidelines on the 
applicability of Article 101 of the Treaty on the F unctioning of the European Union to horizontal co-
operation agreements [C(2010)9274 of 14.12.2010] set out the conditions under which such agreements 
would normally fall outside the scope of Article 101(1) TFEU. 
71 See WTO, World Trade Report, 2005 
 
EN 41   EN estimates of the premium price commanded by control of proprietary 
standards enabling network effects in the software market in the past which were found as high as 18% - 46% of costs. Public procurement is deemed to account for a total 14% of to tal ICT expenditure in Eu rope that is currently 
estimated at around € 670 billion. The software market is an estimated € 60-70 bn (of which an estimated 16-20% pr ocured in public markets) which 
extends to exceed €200 bn if related cons ulting services are included, as these 
are usually bundled to the provision of software. In  practice, however, there 
are too many uncertainties in this model to come to solid estimates. 
Other intangible benefits  include the fact that enhanced standardisation for 
interoperability purposes has the potential to  speed up the adoption of IT solutions in 
the public sector and allow the provision of better se rvices throug h diversified 
channels. Referencing to Fo ra and Consortia Standards can hasten the conception 
and integration of information systems. Th e reduction of delays due to the adoption 
of common norms and standard s allows a quicker implementation of online services. 
Better interoperability decreases on a case by case basis the costs of 
misunderstanding, the cost of operating se mantic transformations, the costs of 
establishing platforms to transport and translate date, the cost of developing 
interfaces between applications, the cost of  maintaining developments and settings 
and configurations which are parameters known to influence investment decisions.  
The public consultations  gave very mixed results on this option. In one consultation, 
the large majority of respondents are against the possibility to refer to the documents 
developed by fora and cons ortia in legislation and publ ic policies. However, the 
positive replies to this question came mainly from companies and associations working in the ICT domain. In  the other consu ltation, most res pondents were in 
favour of this option. 
6.3.4. Policy Option 3.C: Grant Selected Priv ate fora and consortia the Status of 
Recognized Entities under  Directive 98/34/EC.  
The impacts of this option depend on a numb er of external factors, such as the 
willingness of the selected fora and consor tia to be recognised and to submit to 
controls with respect to the WTO-criter ia on standardisation. Fora and consortia 
might be reluctant to apply for recognition due  to the additional cost of accreditation, 
its periodical renewal (e.g. cost for internal audit
72) and the costs related to 
compliance with the process requirements  and considerations  regarding their 
“independence”. In case of recognition, fora  and consortia would have to comply 
with certain procedural aspects of form al standardisation which may slow down 
future standard development.  
Obviously, these fora and consortia are subject to competition law  to the extent that 
they can be considered to be an undertaki ng or an association of  undertakings within 
the meaning of Articles 101 and 102 TFEU73. In that case, one should assess, under 
                                                 
72 The magnitude of audit costs is di fficult to determine, as no real eq uivalent of the accreditation system 
envisaged by this option appears to exist. However, based on parameters referred to the American National Standards Institute (ANSI), one could envisa ge a figure in the order of US$ 10,000 to US$ 
15,000 (between around 7.000 to 11.000 €) 
73 See judgment of 12 May 2010 in Case T-432/05, EMC Development AB v. Commission. 
 
EN 42   EN Article 101(1) TFEU, whether an agreemen t between undertakings, which is capable 
of affecting trade between Member States, has an anti-competitive object or actual or potential restrictive effects on competiti on. In addition, one should then determine , 
under Article 101(3) TFEU, which only becomes relevant when an agreement is found to be restrictive of co mpetition within the meaning of Article 101(1), the pro-
competitive benefits produced by that agreement and to assess whether those pro-competitive effects outweigh the restrictive effects on competition
74.  
The recognition of private fora and consortia would pose some notable governance 
and co-ordination problems . In general terms, the ar eas of overlap between the 
various recognised standardis ation organisations would in crease coordination costs. 
Based on some conservative estimates, the largest fora and consortia would have to withdraw, as a result of the recognition, from 3% to 5% of  their standard portfolios, 
with cumulative effects lead ing to a total possible 10%- 30% as long as their number 
increases. It is unclear whether recogn ition would produce negative effects on fora 
and consortia in terms of reduced room  for manoeuvre and thus possible lost 
opportunities.  
Private fora and consortia usually have  sizeable membership fees, which could 
discourage SME participation in the standardisation process and represent 
discrimination . The costs for a European SME of participating as a member in a 
given private standardisation project can easily increase by 50% to 100% annually as 
compared to the prevailing practice within an  ESO. The size of this additional burden 
tends to decrease the higher the number of  projects an SME is interested in, but 
certainly represents a barrier for niche pr oducers with very speci fic interests. This 
explains previous research findings that it is generally ICT SME with a broad IPR 
portfolio that tend to follow standardisat ion, including the works of the private fora 
and consortia. Membership dues are in any case a relatively minor cost of 
participating in standards work, compared to the cost of participation in standardisation activities. A ll in all the number of SME that have enough resources 
to take part into ICT standardisation activities is very unlikely to exceed a few hundred across Europe. The main compe titive advantage these SME without IPR 
could draw from the participation in a sta ndard developing organi zation relates to the 
information value of such participation with regard to the latest technological 
developments and the transient competitive edge this can provide. To this end, a crucial distinction should be made in the degree of “openness” between those private 
consortia that make draft specifications available for comment very early in the 
standardization phase and therefore do not di scriminate as far as access to strategic 
knowledge is concerned and those who give  this possibility to members only. 
Finally, the consolidation and concentratio n process of consortia activities in ICT 
standardisation decreases the variety of options, especia lly for small- and medium-
sized enterprises, to join consortia. Their relative influence in the reduced number of 
(probably larger) consortia will probabl y also be lower. On the other hand, 
monitoring consortia activitie s will be easier through concentration on a smaller 
number of consortia, which have not shifted the focus of their activities. In total, small and medium-sized enterprises woul d face increased challenges in actively 
participating in consortia, but fewer problem s in passively observing their activities. 
                                                
 
74 See Guidelines on the applicability of Article 101 of the Treaty on the Functio ning of the European 
Union to horizontal co-operation agreements [C(2010)9274 of 14.12.2010].  
 
EN 43   EN Consequently, larger companies are more likely to gain by their active 
standardisation engagements. 
In any event, this option would require carefu l scrutiny of the procedural 
guarantees offered by the fora and consortia , as part of the selection process. A 
key characteristic of some c onsortia is that the commerci al considerations of their 
members play an overt role in influencing standard development, whereas in the case 
of traditional standardisation bodies such motivations, even if not necessarily less 
significant, are more covert. Therefore, although such consor tia often follow the 
same rules as the official standardisation bodies, the rules are adapted to the interests 
of the community that the consortia se rve. For example, although the consensus 
principle is often part of the private standard consortia voting system, the range of 
actors involved is much smaller, hence limiting the array of technical and commercial interests involved in developing the standard. Participation can be also 
strictly controlled and limited to a particular  category of actors, whereas transparency 
can be restricted to the members of a part icular community. In addition, the lack of 
official status means that there is no need  to follow strictly al l the stages in the 
bureaucratic process, in the same way that standardisation bodies must. At the same 
time, it also means that such organisations have to account only to their members. Consequently, consensus is easier to achie ve and standard development is quicker. 
At the same time, the access to standards use as well as standardisation process can 
be severely restricted, and the benefits are more than often unequally distributed 
among the members. Furthermore, there is a risk that a broad recognition of fora and 
consortia would lead to the opposite result to that which European standardisation 
aims to achieve. European standardisation ai ms inter alia at eliminating conflicting 
standards, through cooperation and coordi nation. However, fora and consortia 
develop standards in similar or even iden tical fields so that  the likelihood of 
conflicting standards would increase. 
This option would entail additional costs for the fora and consortia , especially in 
demonstrating compliance with WTO-criteri a and in particular for the process 
requirements and considerations regarding their “independence”. In case of recognition, the fora and consortia would have  to comply with th e procedural aspects 
of formal standardisation and would have  to fulfil the duties of a recognized body. 
Neither of these aspects adds value to the content and quality of the standard. It would also require additional resources from the EU budget  since it would be 
reasonable for organisations complying with a ll criteria to be entitled to benefit from 
a financial contribution from the EU.  
This option was not supported in the consultation process. Respondents highlighted 
that further fragmentation of the European  standards landscape would place a greater 
time, cost and effort burden on stakeholders (especially weaker ones) to be able to 
monitor, follow and / or participate in relevant standards de velopment activities, 
which would lead to more scattered, less  effective stakeholde r participation and 
ultimately more situations where sta ndards are developed without relevant 
stakeholder involvement. Ther e were also concerns, esp ecially from stakeholder 
organisations, about the operational imp lications of an expanded system. In 
particular, their concerns relate to (i) barriers to accessing other F&C (higher fees, 
less appropriate tools/processes) , (ii) the strength of certain  interest groups in other 
F&C and opportunities for private parties to manipulate standardisation outcomes for 
their own interests, (iii) the increasing di fficulty in delivering a single coherent 
 
EN 44   EN standardisation response to a market need, risk of conf licting standards / 
requirements and greater difficulties in co mplying with them, and (iv) decreased 
legitimacy, respect for and trust in th e formal standardisation process. 
7. C OMPARING THE OPTIONS  
The policy options for the three problem ar eas are compared below according to the 
criteria of effectiveness (i.e. to what extent they fulfil the specific objectives), efficiency (i.e. at which costs they do so ) and coherence with other EU policies. 
Given the qualitative nature of the imp act assessment, the following scores were 
chosen for illustrative purposes: low, medium and high. 
7.1. Problem 1: the process for adopting European standards requested by the 
Commission is not fast enough 
COMPARISON OF THE OPTIONS FOR PROBLEM 1 
OPTIONS EFFECTIVENESS EFFICIENCY 
Policy Option 1.0: Base-line 
scenario N.A N.A 
Policy Option 1.A: specify 
deadlines on the delivery of European standards HIGH : very positive 
economic benefits. In some cases, ESOs could decline 
requests for new items for 
standardisation, in particular for technically complex or contentious items. Possible negative impacts on the consensus about the content 
of the standard, unless 
specific measures are taken to ensure involvement of SMEs and societal stakeholders. HIGH : the increase of the 
costs of carrying out the work at a faster speed is 
moderate compared with the 
very positive economic benefits. 
Policy Option 1.B: create a European Agency for 
Standards that would 
manage the standard-setting process LOW : the possible benefits 
of a closer supervision by 
the European legislator and 
a more efficient overall structure in 1 organisation would be outweighed by the need for expertise, 
consensus and respect for 
the common principles about standardisation. Faster development of EU standards would reduce costs linked to the 
fragmentation of the internal 
market and to conformity assessment procedures. LOW : This would lead to an 
additional annual cost for 
the EU budget of at least 
€20,000,000. The extra cost for the EU budget related to a standardisation agency could be higher than the 
current cost.  
 
EN 45   EN Gains could be smaller than 
for option 1.C as the speed gained through this option is 
less clear. No support in the 
public consultation. 
Policy Option 1.C: transparent and simplified procedures for harmonised standards and other European standards 
requested by the 
Commission HIGH : the overall period 
for the standardisation work could be reduced with 1 year so that the harmonised or any other standard requested 
by the Commission could be 
available to businesses much earlier. Businesses would benefit earlier from the presumption of conformity granted to those using such 
harmonised standards No 
negative impacts on ESOs which supported the idea. HIGH : no extra costs could 
be identified.  
Consequently, options 1.A (provided that specific measures are taken to ensure 
involvement of SMEs and societal stakeholders) and  1.C are clearly dominant from the 
perspective of effectiveness and efficiency. 
7.2. Problem 2: Underrepresentation of SMEs and societal stakeholders in the 
European standardisation process 
COMPARISON OF THE OPTIONS FOR PROBLEM 2 
OPTIONS EFFECTIVENESS EFFICIENCY 
Policy Option 2.0: base-line 
scenario (i.e. the financial 
contribution to SME and 
societal stakeholders  
representation N.A. N.A. 
Policy Option 2.A: Facilitate 
direct public representation of SMEs and societal stakeholders within the European standardisation 
organisations MEDIUM : the most 
effective, but also most time and resource intensive, approach. It requires a strong technical understanding of 
proposed standards and their 
context and a very significant commitment of time. Negative impact on information exchange with other interested SMEs and 
societal stakeholders. Strong 
concerns of interested parties with respect to principle of national delegation. Negative impact on problem LOW : Membership dues are 
in any case a relatively minor cost of participating in standards work, compared to the cost of participation. 
Risk of fragmentation.  
 
EN 46   EN 1 (trade-off and coherence 
problem). 
Policy Option 2.B: Grant voting rights to organisations representing 
SMEs and societal 
stakeholders within the European standardisation organisations MEDIUM : the effectiveness 
is high but moderated by the uncertainty about the 
feasibility of this option. 
Support during the public consultation. HIGH : Some organisations 
representing SMEs and societal stakeholders already 
participate, as an associate 
member or equivalent in CEN and CENELEC, or as members in ETSI. Voting rights could strengthen the 
position of these 
organisations.  
Policy Option 2.C: 
Strengthen the position of organisations representing SMEs and societal stakeholders within the ESOs by providing for the 
possibility of an operating 
grant HIGH : strong impetus to 
encourage ESOs to ensure that the opinions of organisations representing SME and societal stakeholders s are adequately 
taken into account during the 
technical work on European standards. Positive impact on information exchange with other interested SMEs and 
societal stakeholders. Large 
support during the consultation. HIGH : The possibility of 
continuous financial support would consolidate the position of representing organisations in the ESOs, provided that an exception to 
the principle of degressivity 
was granted and the current level of funding maintained.  
Thus, option 2.C is clearly dominant from  the perspective of effectiveness and 
efficiency. 
7.3. Problem 3: “Fora and Consortia Standa rds” cannot currently be referenced in 
public procurement of ICT. 
COMPARISON OF THE OPTIONS FOR PROBLEM 3 
OPTIONS EFFECTIVENESS EFFICIENCY 
Policy option 3.0: base-line 
scenario N.A N.A. 
Policy Option 3.A: Revive 
the implementation of the 
mechanisms of Council 
Decision 87/95/EEC concerning public procurement and the policy dialogue LOW : absolute lack of legal 
certainty. No support during 
the consultation process. LOW : extra administrative 
burden for ESOs and an 
additional cost for the EU-
budget  
Policy Option 3.B: Allow for 
the referencing of “Fora and 
Consortia Standards” HIGH : this option would 
have a general positive 
impact. Although some 
concerns were expressed HIGH : the cost-
effectiveness of this measure 
is optimal if these standards 
are selected and assessed on 
 
EN 47   EN during the consultation, the 
ICT businesses expressed their full support. the basis of predefined 
criteria or attributes and following consultation of 
interested parties  
Policy Option 3.C: Grant 
Selected Private fora and 
consortia the Status of Recognized Entities under Directive 98/34/EC MEDIUM : depends on a 
number of external factors 
which are difficult to assess. Important negative side-effects on SME and stakeholder participation in 
the standardization process 
(trade-off and coherence difficulties for problem 2). Little support during the consultation. LOW : costly procedures, 
notable governance and 
coordination problems. 
Therefore, option 3.B is clearly dominant fr om the perspectives of effectiveness and 
efficiency. 
7.4. Preferred options 
Consequently, it is suggested that the following options be retained: 
• The combination of policy Options 1.A (deadlines on the delivery of European 
standards) and 1.C (Transparent and simplified procedures for harmonised 
standards and other European stan dards requested by the Commission); 
• Policy Option 2.C: Strengthen the position of organisations representing SMEs 
and societal stakeholders within the ESOs  by providing for the possibility of an 
operating grant; 
• Policy Option 3.B: Allow for the referencing of “Fora and Consortia 
Specifications”. 
None of these options has negative side-effects. The three preferred options have all a positive impact on competitiveness, while 
options 1.A and 1.C having the strongest impact. 
– Options 1.A and 1.C: In the case of shor ter and more transparent process for 
development of harmonised standards, businesses can use the presumption of 
conformity due to the compliance with th e standard early on and do not have to 
demonstrate compliance with essential requirements. Therefore businesses save costs and conflicting national standards could be avoided. 
– Option 2.C: SMEs are an important source of innovation. Maintaining and 
enhancing their participation con trib ute to the development of innovative 
standards and to mitigate risks of proprietary rights  
– Option 3.B: In as much as risks regarding proprietary technologies are mitigated, 
the referencing of Fora and Consortia St andards can be expected to enhance the 
 
EN 48   EN competitiveness of enterprises, in particular the European ICT industry thanks to 
their specific standardisa tion coverage and speed.  
7.5. Choice of legal instrument 
The suggested options as well as the simp lification items do not require amendment 
of the legislation of Member States. These items only concern the ESOs, the NSBs, organisations representing SMEs and societal  stakeholders, and th e EU Institutions. 
Therefore, a Directive would not be an appropriate instrume nt in this case. 
The legal instrument would have to be of general application, in particular for the 
part on the use of Fora and Consortia stan dards in procurement which would have to 
directly applicable in all Member States. In addition, the legislat ive instrument would 
contain a number of obligati ons that would be directly applicable to the ESOs, the 
NSBs, organisations representing SMEs  and societal stakeholders, and the 
Commission. Therefore, the mo st appropriate legal instru ment would be a regulation. 
8. M
ONITORING AND EVALUATION  
The Commission will publish an annual repo rt on the implementation of the entire 
regulation. This report will be partly ba sed on the information gathered by the 
Commission and the regular reporting by the ESOs, especially regarding the 
evolution of problems 1 and 2.  
The length of the European standard-setting process would be measured on the basis 
of the information about the length of th e actual standardisation process which the 
ESOs already annually provide  to the Commission, the prov isional date of issuing a 
mandate as indicated in the Commissi on work programme and the date of 
publication of the reference of the harmonise d standard in the OJ or the (partial) 
withdrawal following an objection, whiche ver the latest. However, it would be 
necessary to launch a further evaluation, at fa irly short notice, to assess if additional 
measures could be taken to make Europ ean standard setti ng (including for the 
European standards that are not requested  by the Commission) faster and more 
efficient. 
Organisations representing SMEs and societal  stakeholders would have to provide, as 
part of the annual reporti ng about the activitie s partly funded by the EU grant, 
detailed information about their activities in  the standardisation bodies as well as an 
evaluation of the extent to wh ich their points of view are actually taken into account 
in standardisation work. The reporting by the ESOs on the evolution of the problem 
of under-representation of SMEs and soci etal stakeholders in the European 
standardisation process might require a specific contribution from the NSBs, 
especially as regards the representation of SMES and societal stakeholders in mirror 
national standardisation committees and the actions in place at national level to 
support participation of SMEs and societal stakeholders. 
The references of the selected Fora and Consortia standards in  calls for tenders 
issued by public authorities will be gathered as an indicator for the evaluation of the solution to problem 3. 
 
EN 49   EN In addition, it would be appropriate to provide for a fuller evaluation of the 
functioning of the Regulation after a few year s. This would be pa rticularly relevant 
in measuring the evolution of problem 3 where the need to increase EU competitiveness by promoting the rapid adoption of pan-EU interoperable products and services in public procurement would require a further evaluation of the ICT 
standards used in public procurement and the uptake of e-Government services.  
By 2013 at the latest, an inde pendent review will be launched to measure and assess 
if the strategic objectives of the Strate gy on European standardisation are being 
achieved, as set out in the communication COM(2011)311. 
 
 
EN 50   EN 9. ANNEXES 
9.1. ANNEX 1 – CONSULTATION AND EXPERTISE 
9.1.1. Standardisation system – external studies 
In 2008, the Commission services co mmissioned a study to assess the “ Access to 
standardisation”75 The objective of the study was to evaluate to what extent the 
current European Standardisation System wa s open to participation by all necessary 
stakeholders. The study did not only evalua te the system as it is, but also how 
stakeholders themselves perceived it. The time required for participation, travel and 
subsistence costs as well as the fees were identified as the main barriers.  
Detailed barriers to participation by specifi c groups of stakeholders as mentioned by 
standardisation organisations are presented in Annex III. 
In January 2009 the Commission establis hed an independent expert group, the 
Expert Panel for the Review of the European Standardisation System 
(EXPRESS) , with the aim of making strategic recommendations regarding 
standardisation in Europe for the decade to come.  
The Panel was composed of 30 experts fr om European, national and international 
standards organisations, industry, SMEs, NGO s, trade unions, academia, fora and 
consortia and public authoritie s from EU Member States. 
EXPRESS delivered its report "Standardis ation for a competitive and innovative 
Europe: a vision for 2020"76to the European Commission in February 2010 
9.1.2. ICT – external studies 
In 2006, the Commission launched a study77 to analyse the current European ICT 
landscape and standard isation policy and to make recommendations for future 
development. The final report of the study was published in July 2007. Following a 
web-based public consultation on the resu lts, the comments received were published 
on the Europa website and discussed at an Open Meeting in February 2008 where 
broad support for policy changes was expressed. 
In order to support the a ssessment of likely impacts of policy options, DG ENTR 
contracted a study on “Futur e Standardisation Policy: Im pact Assessment of Policy 
Options” in January 2009. The final report was presented in January 201078.  
                                                 
75 http://ec.europa.eu/enterprise/policies/european-
standards/files/standards_policy/ access_to_standardisation/doc/access_ to_standardisation_study_eim_e
n.pdf 
76 http://ec.europa.eu/enterprise/policies/european-
standards/files/express/exp_384_express_report_final_distrib_en.pdf 
77 Study on “Specific Policy Needs for ICT Standardisation” by DLR Piper, Belgium 
78 Report presented by the Italian consultant Economisti Associati and published on the DG ENTR 
website 
 
EN 51   EN 9.1.3. Main stakeholders 
The main stakeholder groups are as follows: 
– International Standards Bodies – ISO, IEC, ITU 
– European Standards Organisations (E SOs) – CEN, CENELEC, ETSI. A more 
detailed description of ESOs is presented in Annex V  
– National Standards Bodies (NSBs) – wh ich are members of CEN and CENELEC 
– Member State Authorities (MSA) – Nationa l authorities from Member States of 
the European Standardisation System, in cluding EU Member States, plus EFTA 
countries and EU candidate countries.  They are represented on the Senior 
Officials Group for Standardisation (SOGS),  
– Third Countries National Standardisati on Organisations – American National 
Standards Institute (ANSI) 
– Fora and Consortia (FORA AND C ONSORTIA) – priv ate organisation 
developing standards outside the official ESOs system 
– Commission Services (EC) – responsible for European standardisation policy  
– Industry Associations(includi ng ICT, software and ICT solution using industries) 
– Societal stakeholders (consumer and e nvironmental organisations, unions, SME's 
and employers representatives) – ANEC, ECOS, ETUI, NORMAPME,  
– Companies (including SMEs) – standards' users 
– EFTA secretariat  
9.1.4. Results of the publication consu ltation on the Standardisation package 
9.1.4.1. Executive summary 
Within the scope of the Impact Assessmen t exercise concerning the reform of the 
European Standardisation System, this publ ic consultation was carried out between 
March 23rd and May 21st 2010. 
The aim of this consultation was to give  all standardisation stakeholders the 
possibility to express their views on th e current functioning of the European 
Standardisation System and on the po ssible improvements that could be 
implemented. 
Due to the high interest in standardisati on and a large publicity, this initiative has 
been very successful in te rms of number of replies. A total number of 483 answers 
from various categories and nationalities of  stakeholders were received. A detailed 
analysis of the respondents is pres ented in point 3 of this report. 
The 14 questions were grouped into 4 main topics: 
 
EN 52   EN • Adaptation of the European Standardisa tion System to the rapid evolution of 
technologies 
• Avoidance of the creation of new techni cal barriers to trade for products and 
services in the internal market 
• Adaptation of the European standardisati on system to new markets and societal 
challenges 
• Cost of standards 
As a summary of the replies, we can conc lude that, independently from the category 
of stakeholders (citizens, companies, i ndustry associations, public authorities, 
organisations of public interest, European and National Standards Bodies), there is a 
general satisfaction with th e current structure and f unctioning of the European 
standardisation system.  
Respondents clearly highlight that it is vital to preser ve the national delegation 
principle. In addition to this , they are not in favour of  opening up the process to new 
standardisation actors (e.g., fora and cons ortia) because of potential concerns in 
terms of the transparency and limited stakeholder involvement.  
Respondents also underline the beneficial i nputs and outcomes which derive from the 
public-private partnership nature of the system currently in place and they are 
concerned with any poten tial interference of Brussels-based authorities.  
Last but not least, from the replies that have been collect ed, a strong need emerges to 
further promote the importance of standards in general and to make standards more 
user-friendly and accessible, also in terms of purchasing price. 
In general, respondents showed their ap preciation for this public consultation 
initiative and the possibility they had to  express their views on the review of the 
European standardisation system. 
9.1.4.2. Respondents 
In the period from March 23rd 2010 to May 21st 2010, a total number of 483 replies 
were sent to the three functional mailboxe s for this public cons ultation (citizens, 
public authorities and orga nisations). The distributi on of replies amongst the 
different categories of stakeholders is as follows: 
 
EN 53   EN  
  Number of 
responses % of total 
respondents 
Citizens 68 14,1%
Companies (it includes 19 SMEs) 158 32,7%
ESOs & NSBs 29 6,0% 
Industry associations 162 33,5%
Organisations of public interest  (it includes 
NGOs, environmental and consumer associations and trade unions) 17 3,5% 
Public authorities 39 8,1% 
other categories 10 2,1% 
TOTAL 483   
In geographical terms, Germany is the biggest contributor with 213 replies. 
Other bigger contributors ar e as follows: France (58/ 483 - 15%), UK (25/483 - 5,2%) 
and Spain (17/483 - 3,5%) 
Out of the 10 categories of stakeholders reported above, the following six ones were 
selected for the purpose of this analysis: 
  Number 
of responses % of total 
respondents 
Citizens 68 14,1%
Companies 158 32,7%
ESOs & NSBs 29 6,0% 
Industry associations 162 33,5%
Organisations of public in terest (it includes NGOs, 
environmental and consumer associations and trade unions) 17 3,5% 
Public authorities 39 8,1% 
A breakdown of the results by these six categories will be provided for each 
question. 
 
EN 54   EN It must be mentioned that some of the replies present are si milar and/or often 
identical. For instance, this is the case of the 26 replies that were sent by companies 
belonging to the Saint Gobain Group, or the 21 replies that were sent by companies 
which are part of the German Industry Association VDMA. 
In those cases, each single reply is consid ered as an individual one, thus following 
the same policy that was adopted for the publication of the replies on the Europa 
website. Actually, it would be  unfair not to take into account the contribution of a 
single reply just because it comes from a group or just because a reference is made to 
the opinion of an association. 
It is true that this choice will give a cons iderable weight, in statistical terms, to the 
opinions of these associations or groups. However, it would be discriminatory to 
ignore the contribution of one of these replies – that, once again, come from 
individual entities - to this public consultation.  
9.1.4.3. Methodological approach 
The consultation document and the fourteen que stions it contains aimed at gathering 
stakeholders’ opinions and views on a potential review of the European 
Standardisation System. The final goal was to make stakeholders react to some 
propositions of change and suggest  possible alternative solutions. 
Open-ended questions were identified in the majority of cases as the most adequate 
means to accomplish this goal, since they allow respondents to make comments and observations supporting their position with  regard to one particular topic. 
An illustration of the results of this consultation with a breakdown by category of 
respondents will be presented in the following section of this document. No breakdown by country was undertaken sin ce it does not seem relevant for the 
purpose of this public consultation. 
Due to the large amount of replies, far beyond initial expectations, the need to 
facilitate analysis of th e responses imposed some me thodological constraints. The 
qualitative nature of this consulta tion was preserved and the opinions and 
suggestions expressed by stakeholders were  duly noted down and taken into account. 
At the same time, when feasible an attempt is made to provide a sort of quantitative/statistical analysis of the res ponses so as to make the main results of 
each question easier to access and comment on. 
Therefore, for some of the questions (1-2-3 -5-10) a “yes”/“no” or “not possible to 
define” analysis was carried out. For some other questions (4-6-7-8-9), where this 
analysis could not be conducted, a “trend analysis” was carried out. To be more 
precise, in addition to the qualitative analys is, each individual reply was classified 
according to the following three categories: 
• Category “No”: the reply denotes a general indication not to change or modify the 
system in place with regard to the speci fic issue explored through the question; 
• Category “Yes”: the reply de notes a general in dication to modify or change the 
system in pace with regard to the spec ific issue explored through the question; 
 
EN 55   EN • Category “Unclear/No possible to define”:  the respondent does not take a clear 
position on the possibility to change the system in place. 
The results of this quantitative analysis will not reflect the richness of the replies. 
Nevertheless, such statistical analysis  may provide a useful indication of 
stakeholders’ general attitude w ith regards to a specific topic. 
9.1.4.4. Results 
For each question, a summary table indicating the percentage of respondents - with a 
breakdown by the chosen six categories of stakeholders – is presented. Respondents’ 
views – in terms of Yes/No/NotDefined – ar e synthetically reporte d in the same table 
for those questions where this classificati on was possible (this is the case of question 
1-2-3-5-10). The percentages for this clas sification refer only to those respondents 
who actually provided a reply to the question. 
In order to provide the reader with the same ba ckground information that 
respondents could find in the consultation doc ument, the introductory paragraphs for 
each section of questions are provided in italics. 
Avoidance of the creation of new techni cal barriers to trade for products and 
services in the internal market  
The emergence of national service standards and alternative standardisation 
documents (like Publically Available Specifications) developed by National 
Standards Organisations (NSO) constitutes a ri sk of technical barriers to trade within 
the internal market. Since the 80’s, the Commission and the standardisation bodies 
(ESOs and NSOs) shall be informed – in th e field of products - of the new subjects 
for which NSOs have decided, by including them in their standards programme to prepare or amend a standard. The same pr ocedure could be envisaged for national 
programmes of service standards (includi ng process standards) and alternative 
standardisation documents. 
1) Do you think that service standards (inc luding process standards) and alternative 
standardisation documents should be included in the scope of Directive 98/34/EC or its 
successor? 
Services standards (including process standa rds) in the scope of Directive 98/34/EC 
or its successor: 
  Number of 
responses % on 
total % 
Yes % 
No % 
ND* 
All 411 85% 74% 20% 6% 
Citizens 51 75% 86% 10% 4% 
Companies 140 89% 75% 20% 5% 
ESOs & NSBs 29 100% 97% 0% 3% 
 
EN 56   EN Industry 
associations 137 85% 63% 33% 4% 
Organisations of 
public interest  
15 88% 47% 20% 33%
Public authorities 32 82% 97% 0% 3% 
*not possible to define 
Alternative standardisation documents in the scope of Directive 98/34/EC or its 
successor: 
  Number of 
responses % on 
total % 
Yes % 
No % 
ND
* 
All 411 85% 31% 61% 8% 
Citizens 51 75% 37% 59% 4% 
Companies 140 89% 41% 54% 5% 
ESOs & NSBs 29 100% 28% 48% 24%
Industry associations 137 85% 26% 69% 5% 
Organisations of 
public interest  
15 88% 13% 80% 7% 
Public authorities 32 82% 19% 75% 6% 
*not possible to define 
As the two tables above clearly show, res pondents generally split this question into 
two separate ones. 
On the one hand, most respondents are in favou r of including servi ce standards in the 
scope of Directive 98/34/EC or its possible successors. Th is is true for all the six 
categories of stakeholders and also for t hose 19 companies that registered as SMEs 
(75% is the percentage of “Yes” in thei r case, with just 19% of “No” replies). 
On the other hand, 61% of respondents ar e against the inclus ion of alternative 
standardisation documents. Actually, among all the categories, there is a general 
concern that these documents are the result of a process which does not reflect the views and opinions of all the relevant stakeholders. A more positive attitude towards the inclusion of alternative standardisati on documents can be seen in the case of 
companies and industry associatio ns working in the ICT field. 
 
EN 57   EN 2) Are you aware of specific cases where na tional service standards and alternative 
standardisation documents have caused technical barriers to trade? 
  Number of 
responses % 
on total% 
Yes % 
No % 
ND* 
 
All 401 83% 12% 75% 13%
Citizens 51 75% 8% 82% 10%
Companies 139 88% 9% 82% 9% 
ESOs & NSBs 28 97% 25% 71% 4% 
Industry 
associations 132 81% 11% 73% 16%
Organisations 
of public interest 14 82% 14% 86% 0% 
Public 
authorities 31 
79% 35% 35% 30%
*not possible to define 
Three quarters of respondents are not aw are of any specific cases where national 
service standards and altern ative standardisation documen ts have caused technical 
barriers to trade. A difference must be point ed out in the case of public authorities, 
where replies are equally split among thos e respondents who are aware of specific 
cases and those who are not.  
The cases of technical barriers men tioned in the replies have to do, inter alia , with 
integration requirements for migrant workers,  interoperability in the railway domain, 
medical equipments and technologies, educa tion of sport trainers and planning and 
building-related activities in the construc tion sector. The fiel ds of tourism, e-
government, e-health and labelling are also mentioned. 
It must be said that, in some of the “No”  replies, while replyi ng that they are not 
aware of specific barriers due to existing national standards and/or standardisation 
documents, some stakeholders point out th at the lack of harmonised standards does 
represent an impediment to the effective provision of a specific service. For instance, some concerns are raised about ticketi ng and booking procedures for cross-border 
transportation of passengers  in the railway sector. 
Adaptation of the European standardisat ion system to the rapid evolution of 
technologies  
 
EN 58   EN The traditional standardisation process lasts an average of 1 to 3 years. This pace 
very often does not correspond to the sp eed with which new technologies are 
developed, and some sectors have been reluct ant to ask the standards organisations to 
develop standards, even if such standard s would have contribu ted to extend their 
market or rationalise their processes. Others, especially th e ICT sector, have 
developed interoperability specifications in  fora and consortia, outside the ESOs as 
described in the Commission White Paper – Modernising ICT standardisation in the 
EU – the Way Forward. However, neither the current legal framework of European 
standardisation (Decision 87/95/EEC), nor the rules on public procurement allow 
referencing of such fora and consortia specifi cations in regulations of public policies. 
3) For areas other than Information and Comm unication Technology (ICT), should it be 
possible to refer to documents developed by fo ra and consortia in legislation and public 
policies? If it should, how should it be implemented? 
  Number of 
responses % on 
total % 
Yes % 
No % 
ND* 
All 421 87% 13% 83% 4% 
Citizens 52 76% 6% 87% 7% 
Companies 146 92% 13% 84% 3% 
ESOs & NSBs  
29 100% 10% 90% 0% 
Industry associations 143 88% 15% 81% 4% 
Organisations 
of public interest 13 76% 38% 62% 0% 
Public 
authorities 32 
82% 9% 81% 10%
*not possible to define 
As clearly emerges from the table, the la rge majority of res pondents are against the 
possibility to refer to the documents deve loped by fora and cons ortia in legislation 
and public policies. This is true also fo r the sub-category of the 19 SMEs, where the 
percentage of “No” replies is equal to 94%. 
Respondents recognise that these documents are already part of ICT standardisation 
and they generally say that they understand this inclusion because of the peculiarities 
of the sector. However, they oppose having th is option in the case of standardisation 
in general. Respondents explain their opposition by referring to the nature of the actors which produce these documents and to the procedures these actors follow in the standard development process. In pa rticular, responses tend to highlight the 
 
EN 59   EN following potentially problematic issues: th e small number of stakeholders involved 
in these fora and consortia, and the limited transparency of the internal processes and 
procedures. According to stak eholders, one of th e risks is the offi cial recognition of 
the decisions made by a small numb er of highly influential actors. 
The issues of transparency and limited st akeholder involvement are also mentioned 
in many of the replies which are in favour of  this inclusion. Actually, conformity to 
conditions of transparency and openness is often indicated as the key implementation 
requirement. 
In general, we observe that respondents a ppear quite open to the possibility of using 
these documents as a starting point for disc ussions in the standa rdisation processes 
within officially recognised standards development bodies.  
Finally, it must be said that many positive re plies to this question tend to come from 
companies and associations working in the ICT domain. This can be easily 
understood since the inclusion of documents  developed by fora  and consortia is 
already accepted as required for ICT standardisation.  
4) How could ESOs and NSOs be encouraged to accelerate their standards development 
process? Should for example the EU financ ing for standardisation be subject to 
conditions in terms of speed of delivery wh ilst maintaining the openness of the process? 
  Number of 
responses % on 
total 
All 416 86% 
Citizens 50 74% 
Companies 144 91% 
ESOs & NSBs 29 100% 
Industry associations 143 88% 
Organisations of public interest 13 76% 
Public authorities 31 79% 
The analysis of the main trends shows th at 86% of respondents do not wish to have 
the EU’s financing of standardisation subjec t to conditions of speed of delivery. This 
is true for each one of our six categories of stakeholders  (80% of citizens; 92% of 
companies; 84% of industry associations ; 65% of public authorities; 90% of 
European and national standa rds bodies and 92% of public  interest organisations) 
and for the 19 SMEs as well (in this case, the percentage of re plies indicating an 
opposition is even equal to 100%).  
 
EN 60   EN There is a general tendency to perceive the time needed for the standard-setting and 
definition process as reasonable in most cas es. Increasing speed is often perceived as 
having a negative impact on the quality of the outcome of the process. 
If, however, a need emerges to further sp eed up the process, respondents say that 
possible speed-related conditi ons in EU financing would not improve the situation. 
As an alternative, they suggest increasing the use of  IT solutions in working 
methods, tools and processes of National and European Standards Bodies. Some 
replies also suggest concen trating resources and efforts only on the development of 
those standards which are relevant for market players. 
Adaptation of the European standardisat ion system to new markets and societal 
challenges  
European standardisation has been deve loped on the model of the international 
standards organisations, to c ontribute to rationalisatio n of production, growth of 
labour productivity, opening of  markets and safety of products. Globalisation, new 
global challenges, “Better regulation” public policies, new societal demands as well 
as a growing share of services in the global economy and the boosting of innovation 
to resolve the current economic crisis request standardisation to adapt its traditional structures. 
Standards remain voluntary instruments. Thei r effect depends on th eir credibility and 
of the level of consensus that  they represent. The current diversification of the use of 
standards requires a broadening of the range of partners involved in the 
standardisation process, therefore more openness, transparency and balanced 
representation. 
Standards facilitate global trade and acce ss to markets. Standards need to be 
accessible to all users, and the availability of translations of standards can help disseminate new technologies.  
5) Should the WTO principles  of transparency, openness,  impartiality, consensus, 
efficiency, relevance and consistency
79 be integrated in the legal framework of European 
standardisation (especially in EU Directive 98/34/EC or in its successor)? How should 
this be implemented? 
  Number of 
responses % on 
total % 
Yes % 
No % 
ND* 
All 415 86% 32% 54% 14%
Citizens 50 74% 16% 74% 10%
Companies 143 91% 17% 61% 22%
                                                 
79 As approved in the Decision of  the Committee on principles for the development of international 
standards, guides and recommendations with relation to article 2, 5 and annex 3 of the WTO/TBT 
Agreement (G/TBT1/rev.8 23 may 2002). 
 
EN 61   EN ESOs & NSBs 29 100% 31% 48% 21%
Industry 
associations 140 86% 39% 51% 10%
Organisations 
of public interest 14 82% 79% 14% 7% 
Public 
authorities 33 
85% 61% 27% 12%
*not possible to define 
It can be observed that more than half of the respondents are ag ainst the integration 
of WTO principles of transparency; openne ss, impartiality, consensus, efficiency, 
relevance and consistency into the legal fr amework of European standardisation (the 
same trend can be observed in the case of the 19 SMEs, where the percentage of 
“Nos” amounts to 82%). Respondents tend to say that these principles are already 
followed and adopted by standards bodies at  both national and European level. The 
explicit inclusion of these principles within European legislative documents – 
respondents indicate - would just lead to  a multiplication of the numbers of actors 
involved in the European standardisation system and to the consequent official 
recognition of documents elaborated by organisms like fora and consortia. As 
already observed, the activity of these act ors and the documents they produce is 
generally criticised for a l ack of transparency, openness a nd balanced representation.  
It can be observed that percentages are diffe rent in the case of public authorities and 
NGOs/environment/consumer/public interest or ganisations. However, this difference 
can be explained by the fact that these cat egories of respondents appear to be more 
focused on the relevance of these principl e in itself and are therefore mainly in 
favour of their explicit inclusi on in legislation documents. 
6) How could the participation of Consum ers’ organisations, NGOs, Trade Unions and 
social partners, and SMEs be best promot ed? What should be the role of public 
authorities (European Commission and Member States) in supporting such a 
participation in a transparent, open, impa rtial, consensual, efficient, relevant and 
consistent European st andardisation system?  
  Number of 
responses % on 
total 
All 418 87% 
Citizens 49 72% 
Companies 143 91% 
ESOs & NSBs 29 100% 
 
EN 62   EN Industry associations 144 89% 
Organisations of public 
interest 15 88% 
Public authorities 32 82% 
The analysis of the main trends shows that  69% of respondents declare that, even if 
the national delegation princi ple already guarantees a good le vel of involvement, the 
participation of consumer organisati ons, environmental NGOs, trade unions and 
social partners, and SMEs within standardisation bodies and committees should be further promoted. This is tr ue for 78% of citizens; 58 % of companies and 65% of 
industry associations. The majority of public authorities (97 %) European and 
national standards bodies (90%) and in the case of NGOs/environment/consumer/public interest or ganisations (93%). are in favour of 
further participation. Favourable replies are in  the majority (71%) also in the case of 
the 19 SMEs. In the case of SMEs, this per centage may look lower than expected but 
is probably due to the fact that some SM Es have reported the opinion of the industry 
associations they are part of, and, as figur es show, industry associations tend to be 
already quite satisfied with the curren t level of stakehol der participation. 
Financial support to pa rticipation by public authori ties, reduced membership and 
participation fees and awareness raising ini tiatives are the most frequently suggested 
solutions in order to better promote the participation of cons umer organisations, 
NGOs, trade unions and social partners, and SMEs. Stakeholders also suggest 
modifying the voting procedures within sta ndardisation bodies in order to further 
stimulate the setting-up of mixed groups. A re vision of the list of  participants aiming 
at a further inclusion of under-represented ar eas of civil society, an increased use of 
IT tools and technologies and a comparison of best practice expe riences in Europe 
are also suggested. 
It must also be said that a minority of respondents (large companies, mainly) are 
against the option of financially supporting the less represented stakeholders, since 
this could be viewed as a discriminato ry measure in relation to other actors. 
7) How could the national standardisation or ganisations deepen their cooperation, and 
mutualise their activities? Could the following  tasks be shared amongst several national 
standards organisations? a) Management of the Secretariats of Technical Committees; b) Notification of new national standardisat ion projects, c) Promot ion/Sales of standards 
or d) Other? 
  Number of 
responses % on 
total 
All 383 79% 
Citizens 49 72% 
Companies 137 87% 
 
EN 63   EN ESOs & NSBs 29 100% 
Industry associations 126 78% 
Organisations of public 
interest 5 29% 
Public authorities 32 82% 
The analysis of the main trends shows th at three quarters of respondents (75%) are 
opposed to changes with rega rds to the current level of cooperation among the NSOs. 
Favourable replies are only 12% in the case of citizens; 8% for companies; 10% for 
industry associations; 13% for public auth orities; 3% for European and national 
standards bodies and 20% for public interest organisations). This is true for the 19 
SMEs as well, where 76% declare to be satisfied with the situation as it is. 
In order to understand this “n egative” attitude from respond ents, two things must be 
highlighted. 
First, respondents in gene ral declare that the level of cooperation among NSOs has 
already improved a lot. They also tend to af firm that the options suggested within the 
questions are already in place. 
Second, many stakeholders fear that the wa y the question is formulated indirectly 
supports - or encourages support for - the es tablishment of a Bru ssels-based form of 
control (even in the form of a single European standardisation body) of the 
standardisation process. In the eyes of these respondents,  this would generate more 
bureaucracy, costs, and might undermine the independence of standardisation actors. 
These concerns explain why many replie s stress the importance of the national 
delegation principle and call for the preser vation of the privat e-public partnership 
nature of the current standardisation system. 
Without prejudice to the national delegati on principle, how c ould the European 
Standards Organisations manage dire ctly, on a case by case basis, some 
standardisation activities, especially some Technical Committees? 
  Number of 
responses % on total 
All 394 82% 
Citizens 50 74% 
Companies 138 87% 
ESOs & NSBs 29 100% 
Industry associations 132 81% 
Organisations of 11 65% 
 
EN 64   EN public interest 
Public authorities 28 72% 
The analysis of the main trends shows that  about three quarters of respondents (76%) 
are opposed to the idea of having Europe an Standards Organisations manage 
directly, on a case by case basis, some sta ndardisation activities, especially some 
Technical Committees. The percentage of repl ies in favour is just  6% in the case of 
citizens; 22% for companies; 10% for industry associations; 4% for public 
authorities; 7% for European and national standards bodies and 36% - slightly higher 
than the average - for public interest organisa tions. This is true also in the case of the 
19 SMEs as well, where no one was in favour of this change. 
As was the case for question No. 7, the fear  of a potentially st rong interference of 
Brussels-based authorities in the European standardisation process, and a consequent 
potential prejudice to the national delegati on principle, justifies this opposition by 
respondents. 
8) What support should the European Co mmission provide to facilitate the use of 
European standards as a means to open glob al markets? What would be the operational 
means that the Commission should use? (Support  experts’ participation in international 
standardisation activities, translation of Eu ropean standards into extra-EU languages?) 
  Number of 
responses % on 
total 
All 397 82% 
Citizens 51 75% 
Companies 142 90% 
ESOs & NSBs 29 100% 
Industry associations 124 77% 
Organisations of public interest 14 82% 
Public authorities 32 82% 
Respondents tend to suggest the following meas ures to facilitate the use of European 
standards as a means to open global markets: supporting, also  in financial terms, the 
participation of European experts in international standardisation activities; promoting the use of European standards in international trade agreements and in the 
working groups of international trade or ganisations, and providi ng translations of 
European standards in non-EU languages. With regards to th is last measure, it must 
be said that a minority of stakeholders ar e opposed to it, since th ey believe that the 
English version is sufficient for use in inte rnational activities and that the European 
Commission should focus on guaranteeing the translation of sta ndards in all EU 
languages. 
 
EN 65   EN 9) Under which conditions do you think that  the European Commission could launch, on 
a case by case basis, calls for tenders, open  to the ESOs and to other organisations, to 
develop standards supporting EU policies and legislation? 
  Number of 
responses % on 
total % 
Yes % 
No % 
ND* 
All 408 84% 10% 83% 7% 
Citizens 49 72% 4% 86% 10%
Companies 143 91% 8% 86% 6% 
ESOs & NSBs 29 100% 0% 79% 21%
Industry associations 138 85% 13% 83% 4% 
Organisations of 
public interest 13 76% 46% 46% 8% 
Public authorities 30 77% 10% 83% 7% 
*not possible to define 
The analysis of the main trends shows that 83% of respondents are against the 
launch, on a case by case basis, of calls for tenders open to European Standards Bodies and other organisati ons aiming at developing st andards in support of EU 
policies and legislation. This is true for all categories of stakeholders (86% in the 
case of citizens and companies; 82% in  the case of SMEs; 83% of industry 
associations and public aut horities; 79% in the case of European and national 
standards bodies), with the exception of public interest organisations, where both 
negative and positive replies score the same (46%).  
As was the case for questions 1, 3 and 5, con cerns regarding a potential increase in 
the number of actors involved in the Europ ean standardisation process and that these 
new actors (fora and consortia.) may not gua rantee transparency and openness are the 
main reasons behind this strong opposition. 
These concerns are reflected also in the case of the favourable replies, where it is 
strongly highlighted that every potential cont ractor resulting from these calls must 
strictly ensure a balanced and transparent consultation process. 
10) What is, in your views, the most efficien t level of participation in the process of 
Standards Development: National, European or International? 
  Number of 
responses % on 
total 
All 416 86% 
 
EN 66   EN Citizens 49 72% 
Companies 143 91% 
ESOs & NSBs 29 100% 
Industry associations 142 88% 
Organisations of public 
interest 15 88% 
Public authorities 32 82% 
The analysis of the replies shows that there is a general tendency not to indicate a 
preference among the national, the European  and the international standardisation 
level in terms of efficiency. All levels are seen as equally important and their 
efficiency is perceived as  depending on the circumstan ces and factors taken into 
account. 
At a general level, it is worth underlin ing that many respondent s, even if they 
decided not to select it as the most efficient level of pa rticipation, took advantage of 
this question to strongly defend the importa nt role of the nati onal standardisation 
level. This level is seen as the one where the standardisation pro cess really starts and 
where all the actors, even the small ones, ar e involved and can ex ert their influence. 
Finally, in the case of those replies wher e a clear preference is  expressed, we can 
observe some interesting relations between the preferred level of standardisation and 
the business sector in which th e stakeholder is involved: for instance, operators of the 
construction sector tend to select the Eu ropean level as the most efficient one, 
whereas the preference goes to the global level for respondents operating in the ICT 
sector. 
11) In your opinion, is where is the major ad ded value in European standardisation with 
respect to national standardisation?” 
  Number of 
responses % on 
total 
All 406 84% 
Citizens 47 69% 
Companies 140 89% 
ESOs & NSBs 29 100% 
Industry associations 138 85% 
 
EN 67   EN Organisations of public 
interest 14 82% 
Public authorities 32 82% 
 
From the replies that were collected, it em erges that the development of harmonised 
standards, the removal of trade barriers a nd the creation of a single market represent 
by far the major added value of European standardisation. Companies and industry 
associations in particular benefit from a reduction of transaction costs, an increased level of interoperability a nd the development of a common technical language within 
the European market. 
Cost of standards
 
The costs of purchasing standards have been  identified as an important barrier to 
their use, especially by SMEs. Purchasing a full collection of standards is sometimes 
necessary to answer a call for tender, access specific markets or take full advantage of the benefits of the “New  Approach” regulation. Some st akeholders consider that 
the price of standard s – different in every National St andards Organisations - is too 
high with respect to their public interest function. 
12) What are, in your views, the most s erious barriers to the use of standards by 
enterprises: costs of standards (purchasing price)? Costs of operational 
implementation? Access to information? Knowledge of existing standards?
80 
  Number of 
responses % 
on total 
All 411 85% 
Citizens 51 75% 
Companies 145 92% 
ESOs & NSBs 26 90% 
Industry associations 143 88% 
Organisations of public interest 8 47% 
Public authorities 32 82% 
                                                 
80 These barriers have been identified in the Study « Access to Standardisation » - EIM March 2009, 
commissioned by the European Commission 
 
EN 68   EN The replies indicate that the lack of knowledge and awareness  about both the 
importance of the standardisation process a nd the content and fiel d of application of 
standards themselves represent the most se rious barrier to the use of standards. 
Stakeholders generally complain about the difficulty to access information about which standards to apply, the complexity of the technical la nguage used, and the 
large amount of standards (and updates) th at may concern one specific product. 
Both problems accessing information and the complexity of technical language 
contribute to making implementation costs  another key barrier to the application of 
standards. Stakeholders declare that some tr aining would be needed in order to help 
market players, above all the smaller one s, access information concerning standards 
and understand which specific regulations di rectly concern the products they produce 
and sell. 
Although the price of standards  – in a draft classification of  the most recurrent issues 
raised by respondents – ranks third after lack of knowledge and awareness  and 
implementation costs , it does emerge as another major barrier to the use of standards. 
The price is perceived as too high, above all by smaller operators. However, it must 
be pointed out that it is not the price itself that appears to be th e key issue. Actually, 
the problem is that for a sp ecific product more than on e standard is needed and 
previews of standards do not  often provide buyers with a clear idea of the relevance 
of specific standards to their needs (in other words, they may end up buying 
standards they do not really need). Furt hermore, compliance with standards is 
sometimes not a voluntary choice but de facto  a mandatory one. Therefore, actors 
have no option but to buy standards. 
Many respondents have the feeling they are paying for standards tw ice: firstly, they 
actually need to pay to be involved in the standardisation pr ocess; secondly, they 
need to pay to buy the outcome of the pro cess they have been directly involved in. 
Finally, respondents complain about the some times huge differences in the prices of 
the same standards among the different Nati onal Standards Bodies and the fact that 
they cannot choose where to  make their purchase.  
13) What could the standards organisations d o, in addition to their current practice, to 
facilitate the access to standards, especially by SMEs? 
  Number of 
responses % on 
total 
All 394 82% 
Citizens 43 63% 
Companies 140 89% 
ESOs & NSBs 27 93% 
Industry associations 139 86% 
 
EN 69   EN Organisations of public 
interest 7 41% 
Public authorities 32 82% 
It can be observed that re spondents generally took advantag e of this question to put 
forward their solutions to the i ssues raised in question No. 13. 
Concerning lack of knowledge and awareness , respondents suggest increasing the 
communication effort to promote the importance of standards and to illustrate the benefits these voluntary sta ndards generate for a compa ny. Standards bodies are also 
invited to adopt a more common technical language, to provide more user-friendly 
summaries and to make use of IT technologies and solutions (eg., simple email 
alerts) in order to keep ma rket players up-to-date with newly developed standards. 
Respondents also suggest emphasising the importance of standards and standardisation in general in e ducation programmes and seminars. 
In order to reduce implementation costs , different measures are recommended: 
further investment in training and workshops  (with the support of industry and trade 
associations), the provision of guidelines in the different nati onal languages and the 
adoption of more user-friendly langu age in the editing of standards. 
As far as the price of standards is concerned, many respondents observe that 
standards should id eally be free. At the same time, they are aware that the sale of 
standards is a vital part of standards bodies’ business model. Therefore, some 
“softer” measures are suggested in order to deal with this issue: 
– availability of mandatory standards at a reduced price when  bundles/packages of 
standards are bought; 
– free availability of the main  content of each standard for web consultation only; 
– free summaries in local languages so as to  limit the risk for companies to purchase 
standards they do not need; 
– specific cooperation agreements with a ssociations of SMEs aiming at making 
standards available at a cheaper price for this category of market players. 
The European Commission and public author ities in general are asked to give 
financial contributions to every measure help ing to make standards less expensive for 
companies and users in general. 
Still on the price of standards, two standards bodi es – DIN and DKE – are often 
mentioned as examples to be followed. Respondents were particularly satisfied with some initiatives undertaken by these two organisms, like the provision of free summaries in the local language and the sa le of bundles of standards at a reduced 
price. 
 
EN 70   EN 9.1.5. Detailed results of the public  consultation on ICT Standardisation 
9.1.5.1. Introduction 
In 2006, the Commission launched a review wi th a study to analyse the current EU 
ICT standardisation policy and bring fo rward recommendations for its future 
development. The study report was published in July 2007 and a web-based consultation followed. The comments received were published on the Europa website and an open conference was held in February 2008 to examine the study 
recommendations and those comments. 
As a result, it was decided to present a White Paper to ascertain the degree of 
consensus on the possible proposals for policy choices and specific measures that 
would help the European ICT standardisati on policy to better respond to industry and 
societal needs.  
An open consultation on the White Paper was launched on 3 July and closed on 15 
September 2009. Responses could be provi ded through the Commission’s web-based 
interactive policy making tool (IPM), thr ough a dedicated email address or by post.  
Following the wide publicity given to the consultation, especially through 
standardisation related committees and orga nisations, a total of 130 responses were 
received; 53 from industry or  business organisations, 27 fr om standardisation bodies, 
18 from individuals, 17 from public authorit ies and the rest from  research or other 
societal organisations. All of the respons es have been pub lished in full on the 
‘Europa’ website
81. 
The objective of the consultation was to ascertain the degree of consensus on the 
possible proposals for policy choices and specific measur es that would help the 
European ICT standardisation po licy to better respond to indu stry and societal needs.  
The White Paper discussed possible proposals in 6 main policy domains of European 
ICT standardisation policy:  
• Attributes of ICT standards associated  with EU legisla tion and policies  
• The use of ICT standards in public procurement  
• Fostering synergy between ICT resear ch, innovation and standardisation  
• Intellectual property righ ts in ICT standards 
• Integration of fora and consortia in  the ICT standardisation process  
• Enhancing the dialogue and part nership with stakeholders  
                                                 
81 http://ec.europa.eu/enterprise/sectors/ict/standards/extended/consultation_2009_en.htm .  
 
EN 71   EN While the overall response to all the pr oposals contained in the White Paper was 
broadly positive, most respondents provi ded extensive comments and additional 
input that will facilitate fu rther refinement of thinki ng on many of the issues.  
The proposed attributes for ICT standards to  be associated with  EU legislation and 
policies and the link between those attrib utes and WTO criteri a were very much 
welcomed. Some respondents suggested that  certain attribute definitions needed 
further clarification while others called for clear and transparent processes and 
procedures for evaluating the compliance of  specifications with the attributes. In 
addition, some felt that any future ICT st andardisation policy needed to cover the 
coherence  of standards. 
A need for more flexibility for public pr ocurement was widely supported as was the 
need for public procurement to be based on open and transparent processes allowing 
for fair competition. There was also br oad support for the compliance with the 
attributes as a means of identifying standa rds which could be referred to in public 
procurement activities. 
Although most respondents felt that gr eater synergy between ICT R&D and 
standardisation would benefit researchers and standardiser s alike, there was strong 
opposition to any mandatory requirements gove rning the relationship between those 
activities. Many respondents also pointed out that the strong business driver of 
standardisation was not always  present in R&D activities. 
With regard to the treatment of intellectual property rights (IPR) there was a large 
consensus that standards developing organi sations should set open, transparent, fair 
and predictable IPR policies which also take account of emerging business models. 
While many respondents felt that the use of ex-ante  declarations of maximum 
licensing rights was an option which should be  considered by each SDO in order to 
increase predictability, it should not become a mandatory approach.  
While better cooperation between fora a nd consortia and ESOs was supported, the 
majority of respondents (but not the nationa l standardisation orga nisations) were also 
of the opinion that the possibi lity of directly referencing specific fora and consortia 
deliverables in support of EU legislat ion or policy was needed as well. 
Finally, the creation of a multi-stakeholder platform, as an extension of SOGITS, 
was very widely welcomed. However, it was also felt that its co mposition, rules and 
procedures would need to be carefully and clearly defined.  
9.1.5.2. Questionnaire  
The White Paper discussed possible proposals in 6 main policy domains of European 
ICT standardisation policy:  
• Attributes of ICT standards associated  with EU legisla tion and policies  
• The use of ICT standards in public procurement  
• Fostering synergy between ICT resear ch, innovation and standardisation  
 
EN 72   EN • Intellectual property righ ts in ICT standards 
• Integration of fora and consortia in  the ICT standardisation process  
• Enhancing the dialogue and part nership with stakeholders  
Within each area, the White Paper raised a number of specific questions to identify 
the potential legislative or other changes which could be envisaged to help a new 
ICT standardisation policy to reach the obj ectives set, including interoperability 
goals. 
9.1.5.3. Respondents  
Of the 133 responses received, 1 arrived by post and the rest were evenly shared 
between the IPM tool and email.  
18 individuals responded and 112 answers we re made on behalf of organisations.  
The 112 answers on behalf of organisa tions were subdivided as follows: 
• 35 ICT service and product suppliers,  
• 27 standardisation organisations (10 in ternational organi sations, 9 national 
standardisation bodies, 4 European orga nisations and 4 US organisations),  
• 17 industry associations (cove ring users and producers), 
• 17 Member State pub lic authorities,  
• 6 organisations representi ng societal interests,  
• 5 organisations with a specific R&D focus, and 
• 3 SME associations. 
• 2 other organisations 
69 respondents supported all of the po ssible proposals alt hough most provided 
additional comments to explain their views.  
51 respondents did not agree with one or more of the possible proposals, again 
providing supporting justification. 
6 respondents focused on one particular issu e and did not reply to the rest of the 
questionnaire. 
4 responses were unclear. 
 
EN 73   EN Overview of responses per country
051015202530
ATBEBGCYCZDKFIFRDEELHUITLVMTNLPTROESSEUK
Non-EU
 
Responses were received from a total of 20 Member States however some of these 
responses were made on behalf of European or global companies and organisations. 
9.1.5.4. Attributes of ICT standards associat ed with EU legisl ation and policies  
One specific question was raised in the White Paper in this area: Do you agree that the attributes for standard s to be associated with EU legislation 
and policies should be integrated  in the future ICT standard isation policy as  set out in 
section 2.1 of the White Paper? 
 
 Number of 
Responses % of total 
respondents % of 
Positive/Negative 
responses 
Positive 115 77% 96% 
Negative 5 3% 4% 
No answer/unclear  10 1% - 
Total 130 80% 100% 
To facilitate the use of the best available standards in support of EU legislation and 
policies, the White Paper proposed  that requirements be laid  down, in the form of the 
list of attributes, for such standards and th eir associated processes. Compliance with 
the attributes would help ensure that wider policy objectives as well as public interest 
expectations were met. 
 
EN 74   EN The vast majority of respondents welcomed  the suggestion to integrate the proposed 
set of attributes into the revised European  ICT standardisation policy and to use this 
set of requirements as a basis for evalua ting the eligibility of ICT standards for 
association with European le gal frameworks and policies. 
The link between the proposed set of attrib utes and the criteria set by WTO for 
International standardisation organisa tions was very much welcomed. Many 
respondents noted that the principles of openness, consensus, balance and 
transparency were already applied by the European standardisa tion bodies and by 
certain fora and consortia.  
Various respondents underlined the need to analyse the criteria thoroughly, 
especially those attributes that relate to  the standards themselves with a view to 
allowing them to be used for evaluating a specific standardisation deliverable in a given context. In particular, they felt that the attributes covering IPR policy 
requirements, relevance, technology ne utrality and quality needed careful 
consideration to make sure  they unambiguously related to any standardisation 
deliverables. 
Some respondents called for further clarif ication of the attributes defining the 
standardisation processes that led to a specific deliverable such as openness, 
consensus, and balance. 
Attention was also drawn to the fact that  organisations such as IETF, OASIS and 
W3C are widely perceived as being as open and transparent in their processes as the 
formal standardisation bodies while however, reaching co mpliance with the 
attributes by other means than those ap plied within formal standardisation. For 
example, participation in their activities  is usually open to any organisation or 
individual on the basis of direct membership. 
Several respondents furthermore stressed the need for adequate processes to ensure 
that consumer and SME expectations were me t using the attributes list, while others 
suggested adding “coherence” either to th e list of attributes  or as a general 
consideration in any revised legislation to  avoid any risk of duplicating, conflicting 
and competing standards. 
Nearly all respondents furthermore pointed to a need to define and implement clear 
assessment processes, including responsibilit ies and decision-making procedures, to 
evaluate compliance of standards with the attributes list. In that regard several relevant evaluation processes were cited such as the ARO process applied within ISO/IEC JTC1 and the CAMSS process deve loped in the context of the EIF.  
9.1.5.5. The use of ICT standards in public procurement  
Two specific questions were raised in the White Paper in this area: Do you agree that the public procuremen t provisions of Council Decision 87/95/EEC 
should be updated so that public authori ties can more easily ac quire ICT services, 
applications and products that fulfil their specific requirements and in particular an 
adequate level of interoperability? 
 
EN 75   EN  Number of 
Responses % of total 
respondents % of 
Positive/Negative responses 
Positive 115 77% 96% 
Negative 4 3% 4% 
No answer/don’t know 11 2% - 
Total 130 81% 100% 
Do you agree with the need to clarify that when they are defined within the context 
of ICT strategies, architectures and inter operability frameworks, the implementation 
of standardised interfaces can be made  a requirement in public procurement 
procedures, provided the principles of  openness, fairness, objectivity and non-
discrimination and the public proc urement directives are applied? 
 Number of 
Responses % of total 
respondents % of 
Positive/Negative responses 
Positive 112 74% 93% 
Negative 7 5% 7% 
No answer/don’t know 11 2% - 
Total 130 81% 100% 
Many respondents underlined the potential  impact of public procurement with 
respect to fast market take up of innova tive solutions. They also recognised the 
potential support to the furt her deployment of standard s via public procurement.  
Respondents largely highlighted the dramatic  evolution that has taken place in the 
ICT environment over the last decade, th e subsequent growth in the need for 
electronic data exchange between public administra tions and between those 
administrations and business and citizens.  In domains such as eGovernement, 
eLearning, eAccessibility and eHealth, inter operability was seen as a key issue in 
reaching policy objectives. 
Respondents therefore largely agreed with the suggestion that the public procurement 
provisions of Council Decision 87/95/EEC  should be updated so that public 
authorities can more easily acquire ICT serv ices, applications and products that fulfil 
their specific requirements and in particul ar an adequate level of interoperability. 
Most respondents furthermore agreed th at the requirements within given ICT 
architectures and strategies ar e such that public authoritie s may in specific cases need 
to impose specific interfaces in order to meet their interoperability objectives.  
 
EN 76   EN Many comments however stressed the need to respect the principles of openness, 
fairness, transparency and non-discrimina tions when referencing standards and 
specifications in public procurement. They therefore felt that the standards referred to in public procurement shoul d also comply with  the attributes set out in the White 
paper. 
Several respondents also highli ghted the impact of IPR issu es in public procurement, 
some of them arguing that IPR should at l east be made available at fair, reasonable 
and non-discriminating conditions, while othe rs argued that royalty-free conditions 
were needed in order to guarantee fair competition and support innovation. 
A few respondents were however of the opi nion that no additional flexibility was 
required in order to allow procurement of effective ICT services. They felt that the 
necessary levels of fair competition, ope nness and transparency can already be 
realised by adherence to the public procur ement legislation laid down by Directive 
2004/14 and by referring only to standards is sued by the recognise d standardisation 
organisations CEN, CENELEC and ETSI.  
9.1.5.6. Fostering synergy between ICT rese arch, innovation and standardisation  
Three specific questions were raised in the White Paper in this area: Do you agree that standardisation and rese arch stakeholders should be regularly 
consulted to ensure that relevant Europ ean research initiatives contribute most 
effectively to ICT standardisation activities? 
 Number of 
Responses % of total 
respondents % of 
Positive/Negative responses 
Positive 114 76% 94% 
Negative 6 5% 6% 
No answer/don’t know 10 1% - 
Total 130 81% 100% 
Do you agree that standardisers should adap t their procedures where necessary to 
ensure that contributions from resear ch organisations, consortia and projects 
facilitate the timely production of ICT standards? 
 Number of 
Responses % of total 
respondents % of 
Positive/Negative responses 
Positive 108 74% 92% 
Negative 12 7% 8% 
No answer/don’t know 10 1% - 
 
EN 77   EN Total 130 81% 100% 
Do you agree that Member States should si milarly consider regul ar consultation of 
standardisation and research stakeholders to ensure that relevant national research 
initiatives contribute most effectively to ICT standardisation activities? 
 Number of 
Responses % of total 
respondents % of 
Positive/Negative responses 
Positive 114 77% 96% 
Negative 6 3% 4% 
No answer/don’t know 10 1% - 
Total 107 80% 100% 
The general thrust of the suggestions put forward in the White Paper was accepted by 
respondents. They largely felt that the f acilitation of knowledge transfer between 
R&D and standardisation woul d certainly raise awareness of the potential benefits 
standardisation can provide. 
However, although respondents clearly suppo rt the idea of es tablishing regular 
dialogues between the R&D and standard isation communities, the majority 
expressed concern about the dangers of bur eaucratising such relationships and were 
firmly opposed to the introduction of any mandatory links between R&D projects 
and standardisation.  
Many respondents, mostly representing industr y, drew attention to the fact that the 
transfer of technology into standardisation is always a business decision. Moreover 
many R&D results do not automatically call for further standardisation efforts. Respondents feared that an institutiona l link between standardisation and R&D 
would lead to the publication of many stan dards with no direct business relevance 
and little prospect of implementation. 
The majority of respondents therefor e support dialogue between ETPs and 
standardisation at the planning phase of R& D initiatives and an increased exchange 
of information between both communities.  
On that basis most respondents saw no need for additional measures to improve 
standardisation processes or the procedur es of standards developing organisations. 
For formal organisations and fora and c onsortia alike, the R&D community already 
has sufficient opportunities to liaise with and participate in standa rdisation activities. 
With a few exceptions, most of the Member States do not appear to have major R&D 
initiatives that would be of interest with regard to IC T standardisation. Respondents 
in general were also of the opinion th at the dialogue betw een the Research 
community and standardisation at national level should be es tablished in an informal 
and non-bureaucratic manner.  
 
EN 78   EN 9.1.5.7. Intellectual property righ ts in standardisation  
One specific question was raised in the White  Paper in this area: do you agree that 
ICT standards developing organisations should, subject to competition law and respecting the owner’s IPR: 1) implement clear, transparent and balanced IPR policies which do not discriminate among di fferent business models, 2) ensure the 
effectiveness of procedures for IPR disclosu res, and 3) consider a declaration of the 
most restrictive licensing terms, possibl y including the (maximum) royalty rates 
before adoption of a standard as a potenti al route to providing more predictability 
and transparency? 
 Number of 
Responses % of 
responses % of 
Positive/Negative responses 
Positive 104 69% 88% 
Negative 16 10% 12% 
No answer/Unclear  10 2% - 
Total 130 81% 100% 
The IPR related suggestions triggered a la rge number of comments and contributions 
to the ongoing policy discussion on how to d eal with IPR in ICT standardisation. All 
respondents except one provided contributions on this topic. In fact a number of 
respondents only reacted to the IPR related proposals and to no other aspect of the 
White Paper.  
The majority of respondents agreed with th e problem analysis in the White Paper. 
IPR is perceived as one of the most critical  issues in ICT standardisation, especially 
when looked at in relation to the sugges tions made concerning public procurement 
and further cooperation with  fora and consortia. 
Respondents for the most part agreed th at ICT standard-developing organisations 
should take account of all stakeholde rs’ interests (IPR owners, standard 
implementers and end users) and implement clear and balanced IPR policies which do not discriminate and allow compe tition among different business models.  
Most respondents seem happy with the FR AND approach to IPR licensing, although 
several felt that it could be improved to provide more clarity, transparency and predictability. Some responde nts were of the opinion th at FRAND with no royalty-
free option was the only way to deal with IP R in standardisation, arguing that this 
would ensure the return on inve stment required to finance further research activities. 
The majority of respondents supportin g FRAND policies, how ever, supported the 
inclusion of royalty-free approaches, noting the deve lopment of other business 
models providing income to  support further R&D. Seve ral respondents felt that IPR 
should always be made availa ble on a royalty-free basis fo r standards associated with 
legal frameworks and/or public policies.  
 
EN 79   EN Many respondents drew attention to the f act that the fast evolution of ICT 
technologies and the subsequent increase in the number of patents in the ICT domain 
have dramatically increased the complexity  of monitoring the im plementation of IPR 
policies. Moreover, the time spent nego tiation on licensing arrangements was said by 
many to be out of step with the speed of evolution or innovation.  
Although many felt that there might be scope  for improving FRAND, the possibility 
of requiring a declaration of the most restrictive licensi ng terms, including 
(maximum) royalty rates before adoption of a standard, was not generally accepted 
as a route to providing more pred ictability and transparency.  
While the users of technologies broadly supported the proposal, technology providers 
generally have no wish to see such an a pproach become mandatory, arguing that it 
would prolong standardisation discussions a nd probably increase the royalties. Some 
technology providers and indus try associations however, co uld consider the inclusion 
of ex-ante  declarations of royalty rates on a voluntary basis. 
Most standard-developing organisations also  opposed the proposal . They were of the 
opinion that “commercial” discussions s hould not take place in standardisation 
organisations. A few though, could accept a vo luntary approach within their IPR 
policies and very few already e nvisaged such a possibility.  
Some respondents also drew at tention to the copyri ght issue, noting th at that the free 
availability of standards would increase accessibility and consequently the likelihood of implementation, especially in SMEs.  
9.1.5.8. Integration of fora and consortia in the ICT standardisation process 
Two specific questions were raised in the White Paper in this area: 1. Do you agree with enabling the refere ncing of specific fora and consortia 
standards in relevant EU legislation and policies subject to a positive evaluation of the standard and the foru m or consortium processes with regard 
to the attributes list as describe d in chapter 2.1 of the White Paper? 
 Number of 
Responses % of responses % of 
Positive/Negative responses 
Positive 104 69% 87% 
Negative 16 11% 13% 
No answer/don’t know 10 2% - 
Total 130 81% 100% 
2. Do you agree that better cooperation should be promoted between fora and 
consortia and ESOs on the basis of a pr ocess which would lead to standards 
issued by the ESOs? 
 
EN 80   EN  Number of 
Responses % of 
responses % of 
Positive/Negative responses 
Positive 110 73% 91% 
Negative 10 8% 9% 
No answer/don’t know 10 1% - 
Total 130 81% 100% 
The majority of respondents felt that the dynamics of the ICT sector and the growing 
need for interoperability solutions requi red fast and effective implementation of 
standards. They felt this was illustrated by the fact that in new and innovative 
domains, like the internet, several non-ES O standard-developing organisations such 
as IETF, OASIS and W3C have gained wi de market acceptance and are recognised 
as leaders in their specific domains.  
The majority of respondents therefore agr eed with the proposal to enable direct 
referencing of specific fora and consortia standards in relevant EU legislation and 
policies to help achieve interoperability obj ectives, subject to a positive evaluation of 
the standard and the related forum or consortium processes with regard to the attributes list. Respondents were  of the opinion that this would permit a balance to be 
achieved between public interest expect ations and market requirements.  
Many respondents provided additional comments  to highlight that the referencing of 
fora and consortia standards in Europ ean policies and legislation to ensure 
interoperability should focus primarily on existing specifications in technical 
domains that are not covered by the ESOs and for which the tech nical responsibility 
clearly belongs to the specific forum or cons ortium. In that context, the stakeholder 
platform and the Member States would have  a key role in monitoring the coherence 
of ICT standards and in ensuring that they  responded to identifie d public interest 
expectations, being compliant with the a ttributes as well as providing business 
relevance.  
16 respondents, including 9 national sta ndardisation bodies and CEN/CLC, opposed 
the possibility of directly referencing a ny fora or consortia specifications in 
legislation or policies. Th ese organisations believe th at the ESOs should keep a 
monopoly on standards for referencing in EU  legislation and policy referring to the 
success of the “New Approach” internal market/product safety legislation. A 
majority of respondents, however, supporte d the proposals made by the White Paper 
in relation to the revision of the Council  Decision 87/95 fostering the implementation 
of standards to achie ve interoperability. 
Moreover several national standards bodies  highlighted the range of existing 
processes which allow the transposition of fora and consortia specifications into European standards which, they say, make s the proposal for direct referencing 
superfluous. However, the implicit assump tion that fora and consortia would be 
willing to transfer their speci fications to ESOs was reject ed by several respondents.  
 
EN 81   EN In opposition to the national standards organi sations, most of the national authorities 
responding to the White Paper consulta tion generally welcome these proposals 
subject to clear and transp arent procedures for evaluating fora and consortia 
specifications. Several would also like to  see SMEs and consumer organisations 
being helped to participate in the activit ies of international standards developing 
organisations.  
Some respondents were of the opinion that fora and consortia fully complying with 
the attributes should be recognised as ESOs  and included as such in the annex of 
Directive 98/34/EC. Other res pondents feared that the strong industry focus in some 
fora and consortia may not afford sufficient  access to societal representation and ran 
the risk of producing specifications which were not technology neutral. 
A great many comments stressed the need  for differentiation between fora and 
consortia highlighting the gulf between  on the one hand, well-established 
organisations which have implemented a dvanced open, transparent and effective 
processes and which have a broad membersh ip and on the othe r hand, the “closed 
groups” which are not open to the participa tion of all stakeholde rs and often have a 
limited scope and set of objectives.  
A large majority of respondents agreed with the proposal to  promote better 
cooperation between fora and consortia a nd ESOs on the basis of a process which 
would lead to standards bei ng issued by the ESOs. Some added however, that such a 
cooperation process should be subject to cas e by case arrangements clearly defining 
all aspects of the cooperation and the rela ted responsibilities e.g. for maintenance, 
participation, visibility, publication and copyright. More over, since the cooperating 
organisations do not necessarily have iden tical IPR policies, an agreement on IPR 
issues prior to the start of the cooperation was critical.  
Several respondents, mainly industry and non-formal standards developing 
organisations, were opposed to such a 2 steps process. Not only is the process 
lengthy, but many fora and consortia see no added value since it focuses on 
procedural aspects and does not lead to a wider implementation of their 
specifications, which in most cases are already implemented at global level. 
In that regard several respondents noted the risk that successi ve processes could 
change the content of a specification whic h would be confusing; if change was 
excluded, it would at best be a duplic ation or rubber stamping which should be 
avoided. They also felt there was a danger of European isolation from global standardisation as other regions implemen ted the specifications immediately and do 
not transpose them into  national standards.  
9.1.5.9. Enhancing dialogue and partne rship with stakeholders  
Two specific questions were raised in the White Paper in this area: Do you agree with the establishment of  a permanent, multi-stakeholder, ICT 
standardisation policy platform (with a wider membership than the Member State SOGITS Committee previously established by Council Decision 87/95) to advise the 
Commission on all matters related to the European ICT standardisation policy and its effective implementation? 
 
EN 82   EN  Number of 
Responses % of 
responses % of 
Positive/Negative responses 
Positive 113 75% 93% 
Negative 7 5% 7% 
No answer/don’t know 10 1% - 
Total 130 81% 100% 
Do you agree that the ESOs and other ICT standard developing organisations should 
be invited to review the function and com position of the current ICTSB to make it 
more efficient? 
 Number of 
Responses % of 
responses % of 
Positive/Negative responses 
Positive 113 76% 97% 
Negative 4 2% 3% 
No answer/don’t know 13 3% - 
Total 130 81% 100% 
The overwhelming majority of respondents agreed with the proposal to extend the 
current Member States committee SOGI TS, set up by Council Decision 87/95, to 
allow the participation of all ICT standardisation stakeholders and transform it into a permanent multi-stakeholder ICT standardisation platform. A few respondents were of the opinion that such a platform s hould be set up and monitored by the ESOs. 
In their comments and contributions, res pondents underlined that the platform should 
enhance the dialogue on ICT standardisat ion policy between all stakeholders 
involved but the composition of the platform  was critical, and should be balanced, 
including SME and consumer representatives.  
Respondents agreed with the scope and task s set out in the White Paper and noted 
that the Member States must be able to  execute their responsibilities in accordance 
with the rules and procedures  of the Institutions. Commen ts underlined the need for 
the platform to focus on the implementation of ICT standards for Europe ensuring an 
adequate level of inter operability and coherence,  while balancing industry 
expectations with publ ic interest needs. 
With respect to the “ICTSB” successor, the majority of re spondents supported the 
proposal made by the White Paper. They fe lt that the ICTSB should be composed of 
relevant standards developi ng organisations and could be  hosted by the ESOs. They 
 
EN 83   EN also noted that the ICTSB should compleme nt the platform by coordinating standard 
setting to support policy orient ations set by the platform. 
9.1.6. Consultation of Member State Aut horities, European Standards Organisations, 
National Standards Bodies and Fora and Consortia  
During January-February 2010, Member St ate Authorities (MSA), European 
Standards Organisations (ESOs), National Standards Bodies (N SBs) and Fora and 
Consortia (F&C) were consulted with the assistance of the Technopolis Group. 
Each of the main groups of stakeholder cons ulted is listed in th e table below, with 
the number of organisations, representa tives or countries (depending on the 
stakeholder group) targeted in each and detail s of the coverage of responses received. 
The total response coverage was 96%, m eaning that only 5 of the 129 target 
organisations, representatives and countries  failed to provide a response within the 
time available. Full coverage was also ach ieved in 6 of the 9 stakeholder groups. 
Stakeholder Group  Targets Coverage Coverage 
(%) 
European Standardisation Organisations (ESO) Organisations 3 3 100% 
National Standards Bodies 
(NSB) Representativ
es 67 66 99% 
Member State Authorities 
(MSA) Countries 33 30 91% 
Fora and consortia (F&C) Organisations 6 6 100% 
Stakeholder Organisations 
(SH) Organisations 13 12 92% 
International Standards 
Organisations (ISO/IEC) Organisations 2 2 100% 
Total  124 119 96% 
Only the questions and replies that dire ctly or indirectly concern the problems 
outlined in this impact assessment are set out below. 
9.1.6.1. Objective 1 - Service st andards and alternative st andardisation deliverables 
Question 1.1: Make an obligation to ea ch National Standards Organisation to 
notify all national service standards. 
 
EN 84   EN The Commission wanted to understand the numbers of national service standards 
developed in the last five years, the propor tion of these that had been notified to the 
Commission on a voluntary basis, and th e costs and implications of a new 
requirement for all  national service standards to be notified in future. 
Replies by the NSBs:  
• The average number of service standa rds developed by each NSB over the last 
five years is around 15, an averag e of three per NSB per year.  
• 89% of the NSBs that responded currently  notify all of their new work items on 
service standards to the Commission, via CEN/CLC. 
• One responding NSB produces a large numbe r of service standa rds each year but 
does not currently notify these. Among the other  NSBs that responded the 
proportion of service standa rds notified on a voluntary basis over the past five 
years was 96%. 
• The majority of NSBs expect there to be either no (58%) or negligible (25%) 
additional costs were they to be required to notify all service standards in future. 
• The costs associated with a move to oblige all NSBs to notify all national service 
standards do not appear to be significant for ‘Member State’ NSBs but may be for 
those who do not currently notify (m ainly accession and EFTA countries). 
However, based on the available data it is  not possible to provide a firm estimate 
of those costs. The expected procedure and basis for calculation of costs would 
have to be more clearly defined before an accurate cost estimate could be provided. 
• There do not appear to be any signifi cant practical barriers or negative 
implications to adoption of this provision for the vast majority of NSBs. None 
argued against this provision. 
• The situation with regard to service standard development within ETSI NSOs is 
unclear and would need to be investigated further if the provision is expected to 
extend into the telecommunications sector. 
Replies by the ESOs:
 
• CEN/CLC do not expect there to be any significant costs or negative implications 
of the provision, although some adjust ment to IT systems and reporting 
procedures would be necessary. 
• ETSI indicated that there would be a sign ificant additional cost and workload but 
that these were difficult to identify accura tely as ETSI is currently unaware of the 
level of national service st andardisation in the ICT (telecommunications) sector 
and the nature and level of reporting expected by the EC. 
Replies by the MSAs:  
 
EN 85   EN • The majority of MSAs do not expect there to be any significant costs or practical 
implications associated with the adoption of this provision. 
• A small number do envisage (relatively minor) additional costs that may need to 
be provided by them to their NSBs in order to support the new notification 
requirements. 
• Additional detailed comments were provi ded by a small number of MSAs in 
relation to the possible le gal arrangements at European and national levels. 
Question 1.2: Open the possibility for the Commission to impose standstill on 
national service standards developmen t process and to request European 
Standards Bodies to develop European service standards. 
The Commission wanted to understand the additional workload for the Commission 
to review the notifications, impose standstill procedures  where necessary and issue 
an additional 10 mandates per annum. It al so wished to unders tand the additional 
workload for the ESOs and NSBs in eval uating and responding to those mandates, 
along with any practical imp lications of the provision. 
Replies by the ESOs:  
• ETSI foresees additional workload of ~140 person days per annum (costs of 
~€85,000) and CEN/CLC foresee additional workload of ~200 person days per annum (costs of ~€100,000). 
• These costs could increase if there is a need for c oordination among the ESOs or 
more widely (with other bodies) or if the mandates relate to particularly large or 
complex standardisation projects. 
• The stated costs do not include work following acceptance of the mandate (e.g. 
contracting, detailed planni ng, execution of the work). 
• The costs in dealing with the mandates would be higher if  EC financing is 
provided for the standardisation work, due  to the considerable administrative 
burden associated with the financial and administrative arrangements. If there is a 
need to establish new technical bodies to respond to the mandates this may also impose additional costs at ESO-level. 
Replies by the NSBs:
 
• Most NSBs could not provide an estimat e of costs as the work involved in 
responding to each mandate is very di fferent in nature and complexity. 
• Where NSBs could provide cost estimates, the average workload foreseen is an 
additional 95 person days (i.e. 9.5 per ma ndate) at an additional cost of €30k. 
There was, however, a broad range of es timates from a low of 40 days (4 per 
mandate) to a high of 160 days (16 per mandate). 
 
EN 86   EN • Several NSBs suggested that adoption of  this provision would not present any 
problems, and no significant practical implications were noted. 
Replies by the MSAs : 
• The majority of MSAs stated that th ere would be no si gnificant practical 
implications or costs to the MSAs  associated with this provision. 
• Some additional costs could be incurred by MSAs and NSBs if a greater body of 
European standardisation work is fores een (costs associated with discussion / 
coordination between Member States). 
• Some MSAs pointed out that nationa l standards development work might 
sometimes be useful as a precursor to Eu ropean standardisati on. Stopping it too 
early (through standstill) could have a negative impact in some cases. 
• Other comments urged caution in slowing down or interrupting standardisation 
activities at national level, so EU leve l activity should be initiated quickly 
following any standstill procedure. 
• The ESS already has good processes for identifying the appropriate level for 
standardisation activity (national, EU, Inte rnational) and so fu rther intervention by 
the Commission should be manage d carefully and efficiently. 
Question 1.3: Make an obligation to ea ch National Standards Organisation to 
notify all national standards and other normative documents. 
The Commission wanted to understand the costs and implications of extending 
notification procedures to a ll standardisation deliverables produced at national level. 
Replies by the NSBs : 
• The average number of new work items on national standardisation products (all 
types) developed by each NSB over the last five years is around 280, an average 
of 56 per NSB per year. There was a very significant range in the level of activity, with some NSBs developing no new work items and others pr oducing in excess of 
330 per year. 
• The likely number of notifications that  would have to be reviewed by the 
Commission is >2,000 per annum across all of the NSBs. However, roughly 80% 
of the new work items developed by th e NSBs are already being notified on a 
voluntary basis, so the addi tional number of work items notified may be in the 
order of 4-500 per annum. 
• Roughly half of the NSBs notify all new work  items as part of current practice so 
there are no significant practical implica tions or costs for these NSBs, although 
not all agree that this would be a positive development. 
• For those NSBs not currently  notifying all new work item s, the average additional 
administrative workload per annum was estim ated to be ~70 person days at a cost 
 
EN 87   EN of just over €33k. However the very broa d range of estimates provided suggest 
that the basis for calculating these costs may have been different in different 
NSBs and a more detailed or specific exerci se to arrive at a cost estimate may be 
warranted. 
• NSBs that provided data indicated that  the average additional workload per 
annum associated with making all draft st andardisation documents  available to the 
Commission would be in the order of 60 person days per NSB per annum, at a 
cost of ~€36k. Again, it appears that thes e cost estimates may be unreliable due to 
uncertainties as to the expected procedur es involved (e.g. physical documents vs. 
electronic, translated vs. not translated, made available at en quiry stage vs. other 
points in the process, etc.). 
• A small number of NSBs noted that there may be confidentiality / IPR issues 
associated with transfer of ‘private’ documents developed by industry consortia. 
• Some NSBs believe that extension of no tification procedures and introduction of 
the possibility of standstill for industr y specifications (PAS) would have a 
negative impact on the willingness of indus try groups to develop these ‘informal’ 
documents within the NSB ‘system’, affecting adversely the NSBs’ competitive position and causing industry to carry out a greater level of standardisation 
activity out of si ght of the NSBs. 
Replies by the ESOs: 
Both CEN/CLC and ETSI indica ted that it was difficult to 
calculate a reliable estimate of the additiona l costs of this provision (workload and €) 
at this stage. However, ETSI estimated that  the provision would require at least an 
additional 65-70 person days in year one and additional costs of ~€42,000, but that these costs may be lower in subsequent years once processes and IT tools have been set-up. CEN/CLC noted that IT developmen ts and additional reporting workload are 
foreseen 
Replies by the Stakeholder Organisations:
 
• The provision provoked a mixed response from stakeholders, with some 
suggesting that notification of all work items may help to improve transparency, 
reduce duplication of effort and enable a greater proportion of standardisation 
work to be harmonised at European or in ternational levels. This could serve both 
to minimise new barriers to trade, suppor t the internal market, reduce duplication 
of effort and improve the coherence betw een national, European and International 
standardisation. 
• Others, however, argued that the requireme nt for notification and the attendant 
threat of standstill might drive participan ts to develop their informal standards 
outside of the NSB system, reducing tran sparency and reduci ng the extent to 
which these documents can be developed through a broader and stronger consensual process. This may reduce th e number of actors involved in formal 
standardisation activities and may limit the extent to which informal standards developed first at national level could even tually be transferred to European level. 
 
EN 88   EN • Any implementation of this provision shoul d, in the view of stakeholders, be 
introduced carefully and gradually, and standstill only imposed in cases where 
there are clear and obvious benefits to acting at a European level. 
• Existing processes are already in place to decide the level at which it is most 
appropriate for a given document to be  developed. Not all national work has 
European level significance or sufficien t demand from other countries, and there 
is a danger that if European work is initiated too soon it  may fail while at the same 
time the Commission will have prevented nati onal level activity  from proceeding. 
This would obviously serve to curtail rath er than enhance standardisation activity. 
• Other possible negative implications iden tified by stakeholders include a slowing 
down of standards development wor k, reduced flexibility of formal 
standardisation to respond to local n eeds, fostering negative sentiments 
concerning the (increased) level of EU -level political control over national 
standardisation activity, and hamper ing innovation by requiring greater 
justification for new, industry-led initiatives. 
Replies by the MSAs:  
• Most MSAs stated that there would be no costs or practical implications to their 
own activities as a result of this provision. 
• Some MSAs expressed support for th e provision, on the grounds that full 
notification would enable all documents to be covered by the same legal 
framework. 
• Other MSAs argued against the provisi on, suggesting that it may reduce the 
number of cases where stakeholders use NSBs to support the development of their 
own ‘informal’ standards, reducing the level of oversig ht that NSBs can provide 
into new developments at national level. 
• It was also noted that notification may not be necessary in all cases (e.g. not 
necessary for best practice guides that  do not impose any requirements but are 
merely a support tool). 
Question 1.4: Open the possibility for th e Commission to impose standstill on all 
national standards and normative document development process and to 
request European Standards Bodies to develop European standards or 
normative documents. 
The Commission wanted to understand the additional workload for the Commission 
to review the notifications, impose standstill procedures  where necessary and issue 
an additional 10 mandates per annum. It al so wished to unders tand the additional 
workload for the ESOs and NSBs in eval uating and responding to those mandates, 
along with any practical imp lications of the provision. 
Because the questions surrounding this provision mainly related to the additional 
administrative costs and workload involve d in developing (E C) and responding to 
 
EN 89   EN (ESOs, NSBs) an additional 10 mandates per annum, the relevant answers have 
already been provided in re lation to Provision 2 above. These were as follows: 
• ETSI foresees additional workload of ~140 person days per annum (costs of 
~€85,000) and CEN/CLC foresee additional workload of ~200 person days per 
annum (costs of ~€100,000) although these co sts could increase if  there is a need 
for coordination among the ESOs or more  widely (with other bodies), if the 
mandates relate to particularly large or complex standardisation projects, if the mandate requires the setting up of new TCs/TBs or if Co mmission financing 
accompanies the mandates. The stated costs do not include work following 
acceptance of the mandate (e.g. contracti ng, detailed planning, execution of the 
work). 
• Most NSBs could not provide an estimat e of costs as the work involved in 
responding to each mandate is very different  in nature and complexity, but where 
estimates could be provided an additiona l workload of around 95 person days (i.e. 
9.5 per mandate) at an additional cost of €30k per NSB was envisaged. 
• Most MSAs do not foresee any significant a dditional costs but so me noted that the 
workload within their NSB would incr ease (and would have to be paid for 
somehow) and that increased notification would require greater levels of dialogue, 
information exchange and opinion sharing between Member States. 
NSBs and MSAs provided additi onal comments as follows: 
• NSBs reiterated concerns that the threat of possible standstill proceedings being 
imposed on ‘informal’ standard isation work might drive industry / stakeholders to 
develop these outside the formal standa rdisation system, leading to further 
fragmentation of the market and disc onnecting NSBs from informal national 
standardisation activity. 
• NSBs have extended their portfolios to embrace informal, low-consensus 
normative documents in order to remain connected to this activity and improve 
the basis on which such documents are produced. It is not always appropriate for these documents to be turned into nati onal or European standards, although this 
may be a natural consequence to their successful development and use on an 
informal basis (first). 
• The provision would be inequitable as it would impose requirements on NSBs in 
relation to informal documents that are not imposed on other fora and consortia 
(SDOs), thereby placing NSBs at a competitive disadvantage. 
• The provision may slow the development of informal standards and technical 
specifications, acting a s brake on innovati on, and may cause the EC to interfere 
in the production of tools that  serve a purely national need.rr 
9.1.6.2. Objective 2 – Improving access to harmonised standards 
Question 2.1: National Standards Bodies  to provide free access to Harmonised 
Standards supporting New Approach directives. 
 
EN 90   EN The Commission wished to understand the fina ncial implications of this provision for 
the operating budgets of the NSBs by unders tanding the scale of ‘lost’ income if 
European harmonised standards could no longe r be sold. It also wished to understand 
the implications from the perspective of ISO/IEC were European standards based on 
ISO/IEC documents to be made available for free. 
Replies by the NSBs : 
• In the vast majority of cases the NSBs were  not able to provide figures for the sale 
of European harmonised standards, and onl y just over half pr ovided figures on the 
revenues generated from the sale of all pr oducts containing standards. Figures for 
sale of standards could not be provided in most cases because NSBs’ information 
systems do not provide disaggreg ated data at this level. 
• For those that could provide data on th e sale of all standards documents, annual 
revenues average €3.8 million per NSB, broa dly in line with the figures provided 
by the Commission. 
• Grossed up annual sales figures for all products containing standards for all 40 
NSBs totalled just over €150 million per annum. 
• The annual ‘losses’ that would be incu rred by NSBs if harmonised standards 
would no longer be sold (i.e. would be  made available for free) cannot be 
calculated accurately, and only a minority of NSBs could provide any kind of 
estimate. However, based on the limited data  available we can estimate that NSBs 
would lose revenues of between 10% a nd 20% of their total operating budgets, 
equivalent to €50 - €100 million per annum in total across all 40 NSBs. However, even this very broad estimate is subject  to a high degree of uncertainty and the 
proportion of overall revenues lost may be below 10% in some cases and 
significantly more th an 20% in others. 
• NSBs pointed out that the ‘costs’ of this  provision would go far beyond a loss of 
income from the sale of European HS: 
– It would disrupt the existing busin ess model, requiring significant 
changes to business processes and operating procedures, based on the 
need to apply different funding m odels for different parts of the 
operations; 
– The change may create confusion on the part of industry as to why 
some standards are free while othe rs are not and may impact on the 
ability of NSBs to continue to charge the same amounts for non-
harmonised standards; 
– Neither the Commission nor the MSAs would be in a position in most 
cases to compensate the NSBs for these losses. 
• NSBs also stated that the provision would stand in cont ravention to the copyright 
rules of ISO and IEC and would not be pe rmissible under the terms of the Vienna 
and Dresden agreements. Attempts on the part of NSBs to provide free access to 
 
EN 91   EN European harmonised standards based on ISO/IEC standards would result in 
copyright infringements, may result in legal action, and may lead ISO/IEC to no 
longer make their standards available for adoption as European standards. This 
could lead to significant disconnecti on between European and International 
standardisation, with negative c onsequences at both levels. 
• NSBs also stated that there is insufficien t evidence to show that the purchase price 
of standards is a significant barrier to take up and use of standards by SMEs, and 
it is appropriate that tools that cost money to produce and add value to business 
operations should be charged for. Moreover,  other barriers to take-up (such as 
lack of information on standards, low awar eness of the benefits that they provide, 
the costs of meeting the requirements imposed by the standards, and so on) are shown to be more significant barriers for SMEs. Initiatives are underway to 
further address these problems. 
• Finally, NSBs confirmed that many step s have been taken to improve SMEs’ 
access to standards and to reduce the prices they have to pay. Standards represent 
good value for money and making them freel y available through the use of public 
subsidies would devalue them. 
Replies by ISO/IEC: 
ISO/IEC stated that the provisi on would compromise the entire 
ISO/IEC system, have a significant negative impact on operations and jeopardise the 
agreed established process by which the co sts of international standardisation are 
spread across stakeholders and users. In short, without this co mmercial sales activity 
the system could not continue in its curren t form or at its current levels. Specific 
additional points raised included: 
– ISO/IEC central offices get signifi cant revenues from the sale of 
standards and their operations woul d be jeopardised by the proposal 
– Most members of ISO/IEC, on whic h the system depends, rely on the 
sale of standards to finance their op erations. Without that income they 
could not support intern ational standardisati on at the same level 
– The provision would be in direct contravention of  the rules of ISO/IEC 
which place the commercial exploita tion of publications as fundamental 
to the financial integrity of their respective systems. ISO/IEC also stated that numerous studies have confirmed that the (purchase) price of standards is negligible in  relation to the value they add. They attract and 
reassure customers, demonstrate market leadership, create competitive advantage, develop and maintain best practice. It is therefore 
appropriate that users pay a nomi nal fee to purchase these business 
tools 
Replies by the MSAs: 
A small number of the MSAs provided comments, reaffirming 
the points expressed above, sp ecifically that they would not be in a position to 
compensate NSBs for the losses, that the financial model of the national, European and International standardisa tion systems would be jeopard ised, and that there is a 
lack of evidence that the provision would be effective. 
 
EN 92   EN Question 2.2: Member States or the Commi ssion to compensate losses generated 
for the budget of NSBs due to free access to Harmonised Standards. 
The Commission wished to understand whet her MSAs and or the Commission itself 
would be in a position to compensate NS Bs for the shortfalls in their operating 
budgets were European Harmonised Standard s to be made available for free. The 
Commission also wished to understand what  might be an appropriate basis for 
allocating any future compensation package. 
Replies by the MSAs:  
• The majority of the MSAs that responded indicated that they would not be willing 
and / or able to compensate NSBs for the losses. The main reasons related to: 
– The potential scale of the compensa tion package necessary, depending 
on the NSB in question, was estimat ed at anywhere between €180k per 
annum and €6 million per annum. MS As already provide significant 
financial support for standardisat ion and many envisaged that the 
current level of support may need to be doubled, something that is not feasible in the current economic clim ate which is placing considerable 
pressure on public finances; 
– Lack of adequate justification for th e provision that woul d give rise to 
this need, namely that there is  not a sufficient case for making 
harmonised standards available for free.  It was also mentioned that if 
the Commission is correct in its assumptions and that making HS 
available without charge would incr ease demand, then the scale of the 
compensation package required would also increase. However, many MSAs clearly do not feel that this change is necessary or appropriate. 
• Only one MSA indicated that they woul d be in a position to compensate their 
NSB for the losses. 
• Several MSAs were not able to provide a definitive response, mainly on the 
grounds that a more in depth analysis of  the likely costs and the political and 
practical consequences that this change  would bring would be  needed. Any final 
decision would have to be a political one and the MSAs were not in a position to 
pre-judge the outcome of that political process. 
• Some MSAs suggested that, in principl e, free access to harmonised standards 
would be beneficial in promoting the use of HS among SMEs and may provide a 
better implementation of New Approach  Directives, thereby improving the 
operation of the internal ma rket. Free access may also promote the wider adoption 
of European HS internationally, bringing trade benefits between Europe and the 
rest of the world. 
• However, a similar number of MSAs stat ed that free access would not lead to 
improvements in implementation, given th at the purchase costs are often very 
small in relation to the costs of implementation and given that the standards are still often not available in national langua ges. Some MSAs suggested that sorting 
 
EN 93   EN out the (lack of) translation of standa rds into national la nguages was a more 
significant barrier than their purchase pri ce, and that improved financing for this 
activity would be a more effective use of limited resources. 
• A small number of MSAs argued that fr ee access to HS would diminish their 
value and that users should recognise a nd value the benefits that the use of 
standards can bring. 
• Most MSAs were unable or unwilling to  specify an appropriate basis for a 
compensation package, either because th ey did not agree w ith the provision, 
would be unable to provide financial s upport, or believed th at the compensation 
package should be drawn up by a nd funded by the Commission. Where 
suggestions were given these were eith er based around past sales, future 
distribution volumes, the costs of the HS development process, or the costs of 
distribution / dissemination. No clear consensus emerged as to how any 
compensation package should be organised. 
Replies by the ESOs:  
• ETSI indicated that the provision was not re levant to it as all ETSI deliverables 
are already made freely available. 
• CEN/CLC indicated that because it doe s not sell standards any compensation 
package would have to be directed to the national members (NSBs/NCs). 
• CEN/CLC also stated that the private or semi-private (independent) status of the 
NSBs was important and that a greater re liance on public financing could distort 
the system and have (negative) repercus sions on the attitudes and behaviour of 
private stakeholders. 
• CEN/CLC indicated that any action that  impacted on the sustainability and 
financial robustness of its members coul d have a negative im pact on the central 
secretariat. 
• Finally, CEN/CLC pointed out that, give n the problems with the current EC 
financing system and the unwillingness of  many NSBs to participate in co-
financed mandated work, it is perhaps unrea listic to imagine that NSBs could be 
fully compensated for the losses through an  increase in this  type of funding. 
Replies by the NSBs:  
• Most NSBs stated that if HS were to be made freely available then the NSBs’ 
work to support their development could only be continued if the Commission or 
MSAs were in a position to provide full compensation for all the losses incurred. 
• A compensation package based on past sa les would not be feasible so should 
instead be based on 100% of the real costs of all work to support the development, 
implementation, revision and dissemina tion of HS going fo rward. This should 
include any administrative costs as sociated with accessing the funding. 
 
EN 94   EN • Several NSBs do not believe that the Commission or the MSAs would be in a 
position to provide such compensation. 
• Several NSBs also stated that such a change would diminish the important 
principle that standardisation should be an  industrial activity, and so indicated that 
reducing private contributions and increasi ng public ones woul d be a retrograde 
step. The current financing model is more  robust, appropriate and less open to 
political will and influence th an the one that might have to be adopted if HS were 
to be made freely available. 
• Regardless of whether an appropriate and workable compensation package could 
be achieved, this does not address the f undamental issue of ISO/IEC agreements 
and copyright rules which would have to be overcome before HS could be made 
freely available. 
9.1.6.3. Objective 3 – Improving stakeholder access to the standards development process 
Question 3.1: Request Member States to monitor and report on the balance of 
representation of stakeholders  in NSB mirror committees. 
The Commission wished to understand the costs to itself, to the NSBs and to the 
MSAs of the development and implementati on of a monitoring and reporting system 
designed to detail the balanc e of representation of up to 10 (defined) groups of 
stakeholder within national mirror committ ees. It also wished to understand any 
practical implications of the establishment of such a monitoring and reporting system. 
Replies by the NSBs:
 
• Half of the NSBs provided a cost estimate for the set-up and ongoing 
implementation of a new monitoring and reporting system. Based on these 
estimates the average cost per NSB to set up the system would be ~€112k, with 
the range of estimates running from €0 to €500k. The ongoing annual implementation costs are estimated at €75k per NSB per year, with the range of 
estimates running from €2k to €650k. It should be noted that because the system to be developed and implemented has not yet been defined in any detail the cost estimates are subject to a high degree of uncertainty. However, the total costs to 
the NSBs (i.e. across all 40) can be estimated at ~€4.5 million for initial set-up 
and €3 million for annual implementation. 
• It will be imperative for a detailed specification for the monitoring and reporting 
system to be defined and agreed at a Eu ropean level prior to implementation at 
national level. Some iteration may be require d so that differences in interpretation 
and in national structures can be resolved. 
• A significant minority of NSBs already monitor and report on the balance of 
stakeholder representation in their sta ndardisation committees, and the costs of 
complying with the Commission’s system could be relatively low if it mirrors that already in place. However, many NSBs exp ect that this would not be the case. 
 
EN 95   EN • A significant number of NSBs stated that the ‘concept’ of balanced representation 
would have to be defined. This may be di fficult or impossible to do intelligently, 
other than at the level of individual comm ittees in individual countries, as an 
‘appropriate’ balance will depend on the work programme of the committee in question, factored by the relevance of the issues to  the national st akeholder groups 
and also their willingness and ability to get involved. 
• National mirror committees are already ope n and making all relevant actors aware 
of the work and allowing all to participate leads to the achieved ‘balance’. It is not 
appropriate or feasible to enforce a remotely defined ‘idealised’ balance within national committees. For this  reason many NSBs fail to see the merits in a 
centralised (and potentially bu reaucratic) reporting system as it could (or should) 
not form the basis for corrective action. 
• Other actions to improve stakeholder access to standardisation (e.g. supporting 
financially stakeholder groups that are know n not to have as much representation 
as might be desirable) may be a more effective use of resources than a monitoring 
and reporting system. 
Replies by the MSAs:
 
• Most MSAs felt unable to provide an estimat e of their costs to install and maintain 
an annual monitoring and reporting system. 
• Ten MSAs provided an estimate of the costs, which were calculated at an average 
of €150k for initial set-up and an average of €40k per annum for ongoing 
implementation. However, one MSA provided very different estimates to the others and if this ‘outlier’ is removed th e average set-up costs would be estimated 
at €55k per MSA and ongoing implementa tion costs would be €22k per MSA per 
year. 
• MSAs confirmed that the balance of representation within national standardisation 
committees was an important issue and th ey should be (and are) vigilant in 
ensuring that this is achieved as much  as possible. Many MSAs place formal 
requirements on their NSBs in this regard. 
• While the principle and ambition underlyi ng the provision is important, several 
MSAs stated that this issue requires fu rther consideration. Th e very significant 
costs to the MSAs, NSBs and participants in implementing and maintaining the reporting system could be excessive, and disproportionate to the utility of the 
information provided. It is not clear how different levels  of participation would be 
judged and what an ideal ‘balance’ might look like. 
• More suitable ways forward may be to limit the requirement to committees 
dealing with mandated European standa rds only, to provide more effective 
support to under-represented stakeholder groups, and / or to ensure careful 
monitoring of complaints about the balance of participation or barriers to access to 
committees. 
 
EN 96   EN • MSAs also noted that the situation is sometimes different in smaller countries 
where there are insufficient numbers of na tional experts available to represent all 
groups in all committees 
The ESOs  did not identify any implications / costs to them as a result of this 
provision 
Question 3.2: NSBs to provide free access to national committees for SMEs, 
NGOs, consumer organisations and trade unions. 
The Commission wished to understand the curr ent scales of fees (tariffs) requested 
by NSBs for participation in standardisa tion committees for each type of committee 
and each type of participant. It also  requested information on the number of 
stakeholder groups / organisations paying those fees in each of the last five years and 
the total volume of revenues generated thr ough these charges. The Commission also 
wished to understand any other practical implications or costs of this provision. 
Replies by the NSBs:  
• Just over half of the NSBs do not charge  any fees for participation in national 
committees, although many are only able to  do this because they generate 
sufficient revenues form other sources (e.g. the sale of standards) to  cover their 
costs. 
• Among those that do charge fees there ar e many and various charging models in 
place, including different scales for diffe rent types of organisation, fixed uniform 
fees for all types of partic ipant, exclusions (i.e. free access) for some groups and 
not others, free access based on the paymen t of a membership fee, ‘entry’ fees 
payable only once, and so on. There are too many different charging models in 
place to summarise here. 
• None of the NSBs appear to differenti ate their charges based on the type of 
committee accessed or on the types of standards being developed within them. 
• Only ten (25%) of the NSBs provided da ta on the number of stakeholders paying 
fees, as most of the remainder do not  levy any charges. Just over 1,000 
organisations pay fees each year to each  of these NSB on average. The numbers 
ranged from a low of 34 per year for one  NSB to a high of almost 6,000 per year 
for another. 
• Only six NSBs could provide data on the volume of revenues generated. The total 
volume of fees generated annually across these six was €3.5 million, equivalent to 
just over €580k each per annum. The volume of revenues generated annually ranged from a low of €44k to a high of just over €1.4 million. 
• NSBs stated that the decisions as to wh ether to charge for access to committees, 
and how much to charge and on what basi s have been agreed at national level 
between the stakeholders involved. 
 
EN 97   EN • There are clear interdependencies between  the revenue streams employed within 
each NSB. Various mixes of public and private financing are employed depending 
on the national context, and within th e private revenues, a combination of 
membership fees, income from sale of standards, certification and other 
commercial activities are used in various configurations to en sure the financial 
stability of the NSB. Any moves by the Commission to remove one source of revenues would have to be addressed by a corresponding increase from another 
source. 
• Many NSBs charge reduced fees for minority stakeholder groups and SMEs 
although not all differentia te at these levels. 
• NSBs appear to be more supportive of the idea that minority stakeholder groups 
should be provided with free access than the idea that SMEs should participate for 
free. In some cases providing free access to SMEs would have a profound effect 
on income levels, and NSBs believe that it is appropriate for SM Es to contribute 
as they are one of the main users / benefi ciaries of the standardisation work (while 
consumers, NGOs, trade unions, etc. are not). 
• Several NSBs do not believe that charges for access to committees are a hindrance 
to involvement, as evidenced by the fact that recent moves to provide free access 
to certain committees has not resulted in greater levels of participation by minority stakeholder groups or SMEs. 
• NSBs also pointed out that various initiatives are underway to improve 
stakeholder participation in national committees without interfering with the 
NSBs’ business models. 
The ESOs
 did not identify any implications / costs to them as a result of this 
provision 
The MSAs  did not identify any implications / co sts to them as a result of this 
provision but several pointed out that stakeholder involvement and balanced 
representation is important. Ot hers pointed out that the co sts of providing free access 
would be high for their NSB and / or that they do not support the provision 
Question 3.3: Member States to ensu re that minority stakeholders are 
represented in all national standardisat ion committees, including by providing 
financial support for representati ve groups at national level. 
The Commission wished to understand (i) th e extent to which minority stakeholder 
groups (MSGs) at national level receive financial support to enable them to 
participate in standardisation; (ii) the m echanisms and charges in place at NSB-level 
for providing these groups with access to national committees ; (iii) the funding 
provided by MSAs to enable MSG participat ion; (iv) the nature of the reporting 
relationship between NSBs and the MSG funding bodies concerning their 
involvement in standardisation; and (v) the estimated costs to install and maintain a system of support for MSGs. The Commission also wished to understand any significant practical implications associated with this provision. 
 
EN 98   EN Replies by the NSBs:  
• Most of the NSBs stated that no direct  public financing is provided to enable 
MSGs to participate in national standard isation committees. In many cases this is 
because access is free.. 
• In around a third of the cases NSBs indicat ed that some support is provided, either 
through the ‘general’ funding of these gr oups, through the provision of travel and 
subsistence grants or through payments to  reduce the level of membership fees 
that have to be paid. 
• NSBs did not identify any ‘special’ mechanisms for providing MSGs with access 
to standardisation, and most  indicated that a princi ple of open and equitable 
access is applied to all groups. However,  funding provided to MSGs is known in 
some cases to enable free or reduced access to committees which otherwise would 
have to be paid for in full or at a higher rate. 
• Regardless of the financing / charging si tuation most NSBs relay information on 
new work items and new committees to MSGs to facilitate their access, with some 
proactive targeting in place. In some cases dedicated committees and IT tools 
have been installed in order to enha nce MSG access to st andardisation work. 
• The majority of NSBs stated that no sp ecial reporting procedures are in place 
between them and their MSAs with regard  to participation by MSGs, because no 
funding is provided to MSGs or no special distinction is made between them and 
other types of participant. In a minority of  cases special reporting is in place, with 
NSBs providing information on particip ation levels through annual reports, 
dedicated regular repor ts or ‘on request’. 
• Most NSBs were unable to pr ovide an estimate of the co sts of installing a system 
of support for MSGs at national level, and the small number that felt able came up 
with very different estimates, ranging  from a low of €2.4k to a high of €600k. 
• Several NSBs indicated that free access woul d not in and of itself be sufficient to 
guarantee MSG involvement and that payment of expert fees and travel and subsistence costs may be necessary also to ensure higher levels of involvement. 
• Some NSBs appear to believe that su ch support is appropriate while others 
disagree and argue instead that the principle of open and equitable access would 
be compromised by this kind of positive discrimination. 
• NSBs also pointed out that funding for pa rticipation would only address part of 
the problem, as MSGs often do not have  sufficient resources and systems to 
consult their members effectively. Therefore, while funding may enable 
representatives to attend it is not necessa rily the case that a ‘position’ can be 
adopted and carried forward to  standardisation meetings. 
Replies by the MSAs:
 
 
EN 99   EN • Roughly a quarter of the MSAs indicated that funding is provided to MSGs to 
support their participation in  standardisation, covering a range of different types 
of support targeted to speci fic groups. The nature and level of funding provided to 
MSGs varied, in some cases being allo cated to the NSB to enable MSG access 
and in other cases being a llocated directly to MSGs. The amounts allocated varied 
from €100k to €1.4 million per annum. 
• Most MSAs could not provide an estimate of the costs of installing and 
maintaining a system of support to MSGs at national level, as this ‘system’ of 
support has not yet been defined in a ny way. Around a third did attempt to 
provide an estimate, with these av eraging around €200k per MSG per year. 
However, the MSAs clearly envisaged very  different types and levels of support, 
ranging from a low of €2.4k to a high of  €1.1 million per MSG per annum. We 
therefore do not believe that it is possibl e to provide any kind of reliable estimate 
in the absence of some kind of standard sp ecification as to the nature of support to 
be provided. 
• There is no clear c onsensus as to whether MSAs ar e supportive of this provision. 
In some cases it is felt to be unn ecessary because MSGs can already access 
standardisation committees for free and / or direct support for participation is 
already provided. In other cases there appears to be some support for the idea but 
there is not enough information to enable  NSBs and MSAs to identify costs and 
implications. 
• A small number of MSAs indicated that awareness and interest in participation 
remains a significant barrier to MSG par ticipation and this should be tackled 
before any direct support for participati on, while others do not support the idea of 
‘positive discrimination’ as it runs counter  to standardisation principles and may 
lead to distortion in the behaviour  of MSGs within the process. 
The ESOs  did not identify any implications / costs to them as a result of this 
provision 
Question 3.4: Member States to report to  the Commission on actions in place to 
support participation of SMEs, NGOs, consumers and trade unions. 
The Commission wished to understand the cost s to the MSAs of installing a system 
of annual reporting on the actions in place at  national level to en sure representation 
by MSGs, as well as the costs to the Co mmission in reviewing and assessing those 
reports. The Commission also wished to understand any other costs or practical 
implications of the provision. 
Replies by the MSAs:  
• Most MSAs were not able to provide an  account of the necessary procedures or 
the costs associated with a system of reporting on actions in place at national level to ensure the participation of MSGs in standardisation. 
 
EN 100   EN • 13 MSAs provided cost estimates but the procedures envisaged varied 
considerably resulting in very different estimates, ranging from a low of just €129 
to a high of just over €190k. 
• Some MSAs suggested that the provi sion would place an additional and 
unnecessary burden on already scarce resour ces while a similar number stated that 
the provision could be accommodated relatively easily and at little cost. 
• A small number of MSAs stated that they did not see the value in such a reporting 
system and that the administrative costs w ould outweigh the benef its realised. It is 
clear that MSAs support their respective NSBs and MSGs in different ways and 
that making comparisons may lead to wrong conclusions. 
• It was suggested that discussions / pr esentations through SOGS may be a more 
cost-effective way to share good pract ice and drive improvements in MSG 
participation at national level. 
The ESOs  did not identify any implications / costs to them as a result of this 
provision 
Replies by the NSBs : 
• Most NSBs did not comment, as the provision would affect the MSAs rather than 
themselves. However, some felt that the reporting system would place an 
additional burden on them as it is envi saged that NSBs may need to provide 
information and data on MSG involvement in standardisation committees, along with other actions in place at NSB leve l to support MSG participation. In some 
cases NSBs felt that the additional cost s would outweigh the benefits realised. 
• A small number of NSBs reiterated that many actions have been put in place at 
EU and national levels to support MSG i nvolvement in standardisation and that 
these efforts have not been recognised within the current exercise. The implication behind this set of provisions is that not enough is being done and that there is a 
need for corrective action, which many NSBs feel is not the case. 
9.1.6.4. Objective 4 – Improving Member State i nvolvement in the EU standardisation 
process 
Question 4.1: Member States to  be obliged to send official  experts to take part in 
all national mirror committees mirrorin g European TCs dealing with mandated 
standards under Directive 98/34/EC. 
The Commission wished to understand the num ber of mandated standards developed 
under 98/34 in the last five years, the numb er of formal objections raised in relation 
to these standards, and the number of cas es where formal objections are likely to 
have been avoided had MSA officials been  present in all relevant national mirror 
committees. It also wished to understand th e number of ESO TCs currently preparing 
mandated standards under 98/34, and the leve l of MSA official representation on 
these committees. Finally, the Commission wi shed to understand the number of days 
that would need to be devoted by an MSA expert in each relevant national mirror 
 
EN 101   EN committee in order to contribute to th e development of a mandated European 
standard and what the average co sts of MSA experts per day is.  
Replies by the ESOs : 
• ETSI reported that there are currently 18 technical bodies (TBs) dealing with 34 
‘active’ mandates and that 10 of these technical bodies (as a minimum) would 
require MSA expert involvement. B ecause ETSI operates under direct 
participation principles and because a ll MS public administrations are members 
they are able to attend and participate in all ETSI meetings.  
• While it could be argued that all TBs should have MSA expert involvement, 
standardisation is a voluntary activity and participation is a decision taken by each 
public administration on a case-by-case basis. 
• CEN/CLC reported that there are 347 activ e TCs that are developing or have 
developed harmonised standards. In prin cipal MSA experts should be present in 
all of these TCs, given that they ar e stakeholders within the context of 
Harmonised Standards. 
Replies by the NSBs : 
• NSBs could not report on the current le vel of MSA representation on national 
committees mirroring the development of mandated European standards because 
their information systems cannot link MSA participation to sp ecific (mandated) 
work items.r 
• However, 14 NSBs were able to provide  data on the number of active national 
mirror committees and the level of MSA representation on these. The results 
showed that these NSBs collectively operate just over 2,000 mirror committees 
and there is MSA representation on 66% of these. In some cases where there is no MSA involvement the committee will not be involved in mirroring mandated European standards, but the number of such cases cannot be determined. It is 
expected that the true level of MSA representation on such committees would be higher than 66%. 
• NSBs pointed out that all of their committees are ope n to MSA involvement and 
participation or not is a decision for th e relevant MSA based on their level of 
interest in the work of each committee. All new work items are notified to MSAs 
so there are no apparent barriers to partic ipation by MSAs where they feel that it 
is appropriate and where they have the necessary resources. 
• NSBs estimated that ~10 person days input would be required on average each 
year by an MSA expert participati ng on a national committee mirroring the 
development of a mandated harmonised standard. However, depending on the 
nature of their invol vement the actual level of input  could be slightly less or 
considerably more. 
• NSBs pointed out that MSA involvement in national mirror committees is 
encouraged, but warned against any kind of ‘compulsory’ part icipation as MSAs 
 
EN 102   EN do not always have an inte rest or may not always be  able to add value through 
their involvement. Particip ation is and should be volunt ary and based on the needs 
and interests of stakeholders, a nd should not be enforced top-down. 
Replies by the MSAs:  
• Data provided by 19 MSAs indicated that the costs in EUR per day for an MSA 
official participating in standardisation work averages just less than €500 per day. 
The range of costs varied substantiall y, from a low of €35 to a high of €1,200. 
However, in some cases only the ‘expens es’ were included while in other cases 
salary costs plus travel a nd other incidentals were incl uded. As such it is not 
possible to rely on these figures. 
• A small number of MSAs stated that they would not support any proposal to 
impose an obligation on their participati on in national mirror committees working 
on the development of mandated European standards. 
• Several MSAs stated that there is no evidence that the current voluntary system of 
participation presents any problems or th at formal objections would be avoided 
through increased levels of involvement. 
• Several MSAs pointed to the additional co sts and practical implications of the 
provision, in particular a lack of nece ssary human and financial resources. 
• A small number of MSAs felt that greater levels of involvement may be desirable 
as a means to enhance MSA competen cies and interest in relation to 
standardisation and to assi st other particip ants in understandi ng the legislative 
requirements. 
Question 4.2: European Commission to be  able to finance mirror committees in 
all EU Member States. 
The Commission wished to understand (i) how many of the current ESO Technical 
Committees developing European standards have mirror committees at national level 
and how many do not; (ii) what are the current  costs of NSB secretariat activities for 
mirror committees; and (iii) what are the cu rrent costs of NSB s ecretariat activities 
for running national enquiries  and national implementati ons. It also wishes to 
understand any other costs or practical  implications of this provision. 
Replies by the NSBs:  
• Based on the information provided by NSBs we can estimate that just less than 
half of the NSBs are mirroring all ESO TC s, just over a third are mirroring most 
and roughly one in five are mirroring less than half of the ESO TCs. A definitive 
number of cases where ESO TCs are not  being mirrored cannot  be determined 
based on the data provided, but  we can estimate that there is a shortfall of at least 
1,500 committees across the 15 NSBs where it  is clear that not  all ESO TCs are 
being mirrored. 
 
EN 103   EN • Most NSBs could not provide  a clear estimate of the costs of the secretariat 
functions they perform in relation to the running of national mirror committees, 
but an average cost of €22,000 was identified based on data supplied by 12 NSBs. The majority of the estimates prov ided were in the range €10k - €20k per 
committee per annum. 
• Most NSBs could not provide  a clear estimate of the costs of the secretariat 
functions they perform in relation to th e running of national enquiries and national 
implementations, but an average cost pe r standard of €1,600 was identified based 
on data supplied by nine NSBs. The basi s of calculation of the estimates was 
highly variable and so a more precise de finition of what costs should and should 
not be included would be needed befo re a more reliable estimate could be 
established. 
• Most NSBs would welcome additional fina ncial support for standardisation at 
national level but questioned whether the focus of this provision was appropriate. 
NSBs suggested that the mone y could be better spent on: 
– Measures to support the involvement of MSGs in national 
standardisation, particularly for sm aller countries where other sources 
of income are more limited and curta il the range of s upport that can be 
provided by NSBs to these groups 
– Translation of European standards into national languages. While the 
Commission does provide some support for this the NSBs still carry the majority of the costs and the financial arrangements are excessively bureaucratic, diminishing the tr ue level of support provided 
• Several NSBs pointed out that  it is not appropriate or  necessary to run national 
mirror committees in all cases where Eur opean standards are being developed, as 
in some cases the standards have no relevance to the national context. In these cases supporting the secretariat function w ould be meaningless in the absence of 
any stakeholder demand for participation. 
CEN/CLC
 reported a small number of concer ns in relation to this provision, 
specifically (i) the long-term su stainability of such an ac tion and the significant level 
of financing required; (ii) the risks of discriminating between EU NSBs and those 
from EFTA countries or accession states, and (iii) the lack of  clarity surrounding 
whether only the secretariat functions would be supported and not the participation 
of industry and other stakeholders. 
Replies by the MSAs:  
• MSAs also reported a number of concer ns, although the majority of those that 
responded stated that they would we lcome the provision. Potential positive 
benefits identified as a resu lt of the support were (i) grea ter levels of participation 
by stakeholders (ii) increas ed activity in areas where secretariat functions cannot 
be supported through the sale of standards, (iii) increased sustai nability of NSBs 
in certain (small) Member States, and (iv) improvement of standard production 
quality. 
 
EN 104   EN • Concerns reported by MSAs revolved ar ound the scale of the funding required 
and the potential for considerable added bureaucracy and administrative costs. It 
would also not be possible to focus th e funding only on European activities, as 
mirror committees would be involved in national and international work as well. It may also prove difficult to find par ticipants in some areas even though the 
secretariat functions are supported. 
9.1.6.5. Objective 5 – Accelerate the standards development process 
Question 5.1: ESOs to systematically use IT harmonised tools to support the 
participation of stakeholders in th e European standardisation process. 
The Commission wanted to understand (i) the extent to which existing IT tools are 
available to and used by existing ESO TCs and NSB MCs in the development of EU 
standards, (ii) what IT systems are ‘missi ng’ at ESO and NSB le vel that would need 
to be put in place in order to ensure that  all NSB MCs can make use of the available 
IT tools, and (iii) what the costs of imple menting these additional IT solutions would 
be. 
Replies by the ESOs:  
• The ESOs have undertaken considerable investment into modern technology in 
recent years, and all three ESOs provide d extensive details about the various 
existing IT tools available. 
• IT systems are now available to and used by ESO and NSB committees 
throughout the standards development proces s, helping to reduce delivery times 
and increase transparency. 
• CEN/CLC noted that different tools are available according to sector and / or 
which national member holds the secretar iat, but that all European TCs can 
benefit from similar facilities. 
• The three ESOs reported that there were no significant requirements for additional 
IT tools or developments (and therefor e no additional costs implied), beyond fine-
tuning and maintenance. 
• CEN/CLC did however identify a small number of areas where enhancements 
could be made to (i) the current NMC services (a common CEN/CLC NMC 
interface and centralised NMC platforms fo r purely national work) and (ii) the 
tools available to support CEN/CLC t echnical bodies (web-t ools to support the 
drafting process and central meeting manage ment facilities), and there are planned 
and ongoing projects within the ESOs in these areas aimed at further increasing 
the level of automation available (e.g. vi rtual meeting facilities for TCs in 2010). 
Replies by the NSBs:  
• The NSBs confirmed the comprehensive a nd detailed ESO account of the existing 
IT systems that are available to support national MC participation in European 
standardisation 
 
EN 105   EN • The vast majority of NSBs stated that all of these tools are available, in use and 
functioning well at the national level and th at all of the national MCs are able to 
make use of these IT tools. 
• They also complemented the ESOs on the considerable advances that had been 
introduced and believe that these IT solutio ns have contributed to a more effective 
and efficient process. 
• The majority of NSBs reporte d that there are no ‘missing’  IT tools at ESO or NSB 
levels that would need to be put in place. 
• Nevertheless, many other NSBs stated  that the proposed common CEN/CLC 
NMC interface and platforms, improved ‘virtual meeting’ facilities and new 
meeting management applications / tools are all welcome developments that will 
provide efficiency gain s at national level. 
• A small number of NSBs suggested that ta ke-up of the available tools is lower 
than desirable and that additional actions  might be useful. However, the main 
barriers identified to greater use are a lack of awarene ss, willingness and training, 
rather than availability or functionality. 
• A small number of cost estimates we re provided for specific desirable 
improvements. 
Question 5.2: Make it an obligation fo r European Standards Organisations to 
answer any standardisation requests fr om the Commission within 2 months. 
The Commission wanted to understand the num ber of mandates issued by the EC to 
the ESOs, the time taken to respond to each of these, and the current ESO/NSB 
procedures and timeframes for consulting on and responding to these mandates. The 
Commission also wished to understand whether a two-month timeframe for 
responding to mandates would be achievable (or what would be achievable), whether 
additional changes would be necessary and th e other costs and implications incurred 
by ESOs/NSBs in meeting a requirement to respond within this timeframe. 
Replies by the ESOs:  
• ETSI reported 17 mandates being issued ove r 3-years, with a 3-month average 
acceptance time. 
• CEN/CLC reported a total of 64 mandates issued over the past 3 years, with 
average response times each year varying between 10.4 and 13.6 months per year. 
• All three ESOs provided details of their procedures and average timeframes for 
consulting on and responding to mandates. 
• CEN/CLC reported a 2-month timeframe was achievable, while ETSI reported 
that 3-months would be the minimum tim eframe possible due to the need to 
coordinate and consult before acceptan ce. These targets would be achievable 
without any significant add itional financial costs. 
 
EN 106   EN • The ESOs reported that current delays ar e often due to fact ors outside of the 
control of the ESOs, and instead reside with the EC. Achieving shorter response 
times would require stronger and earlier consultation on mandate definition and 
drafting, improvements to the presentati on and clarity of drafts, simplified 
contractual processes an d for the EC to stick to a defined timeframe. 
Replies by the NSBs:  A small number of NSBs added that the time taken to respond 
to mandates is dictated by the time taken to consult national committees and other 
stakeholders, reach a position and prepare a response, all of which cannot always be undertaken as quickly as the Commission might wish. 
Question 5.3: ESOs to be  obliged to develop European standards requested by 
the EC in TCs managed directly by the Central Secretariats and not by the 
NSBs. 
The Commission wanted to understand (i ) the number of ESO TCs currently 
developing European standards under manda tes, (ii) the changes to processes and 
procedures that would be required if TC s developing mandated European standards 
were to be managed by the ESOs under Eur opean-level representation principles, and 
(iii) what the costs and implications of th is for ESOs, NSBs and stakeholders would 
be.  
The Commission also wished to understa nd (i) whether there might be any 
implications at the international level (on the Vienna and Dresden Agreements and on national participation and voting rights)  were the European Standardisation 
System to move away from the national de legation principle, a nd (ii) the number of 
cases in the last 2 years where European  interests would have  been outvoted in 
ISO/IEC if the EU NSBs had only on e collective vote, rather than 27. 
Replies by the ESOs:
 
• The ESOs reported that there are 352 TCs currently developing European 
standards under mandates issued by the EC (334 CEN/CLC and 18 ETSI). 
• ETSI and its stakeholders are alr eady operating under European-level 
representation principles and so no change  would be necessary for this provision. 
However, if more TBs were required in response to specific mandates, there may 
be a need to increase the si ze of the secretariat support. 
• CEN/CLC, by comparison, are currently c oherent with the national delegation 
principle and believe a move to Eu ropean-representation would require 
modification of all internal regulations and dramatically change the way the ESO works. There would be fundamental issues  to be solved arou nd new processes and 
procedures and such a radical ch ange would incur heavy costs. 
• CEN/CLC also noted that the provision ma y have implications for balanced TC 
representation and may encourage memb ers to look more to International 
Standards processes where possible. 
 
EN 107   EN • ETSI does not participate in ISO/IEC, but  CEN/CLC reported that a move away 
from the national-delegation principl e might undermine the weight of the 
European NSBs in the approval processe s and result in a loss of influence. 
• None of the ESOs were able to give  a figure for the number of cases where 
European interests would have been outvoted  at ISO/IEC in the last two years if 
EU NSBs had only one vote. 
• However, CEN/CLC noted that while the possibility of being outvoted is a serious 
issue, the biggest impact would be the lo ss of influence (e.g. seats at the Council, 
Board, TMB/SMB, etc.). 
Replies by the NSBs:  
• The information provided by the NSBs in  relation to the required changes to 
processes and procedures re quired for ESO-managed TC s largely mirrored that 
provided by CEN/CLC (above). 
• The NSBs are confused as to why th e Commission would consider such a 
proposal since it clearly jeopa rdises European interests (especially voting) and do 
not see any benefits to the provision. 
• Their main concerns in relation to th e Vienna and Dresden agreements are 
covered by the implications identified by ISO/IEC below. 
• None of the NSBs were able to provi de data on the number of cases where 
European interests would ha ve been outvoted in the la st two years with only one 
collective vote at ISO/IEC, although several ventured th at there would have been 
‘many’ cases. 
Replies by ISO/IEC:  
• ISO/IEC reported that moving away from the national delegation principle would 
have substantial impacts a nd would place the future of  the Vienna and Dresden 
Agreements in doubt. 
• The four main concerns set out by ISO/ IEC were (i) that the quality of the 
secretariat work of committ ees (expertise, resources a nd support) would need to 
be assured, (ii) that the representativene ss of national votes would be brought into 
question, (iii) that the national connection to stakeholders would be jeopardised, 
and (iv) that it is uncertain whether indi vidual European partic ipation in ISO/IEC 
would need to be revised to reflect the new single consolidated European 
representation and standards development process. 
• Based on the changes proposed, ISO/IEC woul d thus insist that their respective 
agreements with the ESOs be critically reviewed (with input from other parts of 
the world) to ensure that the commitment and appropriate mechanisms remain in place to continue to recognise the prim acy of international standards, whilst 
recognising the particular needs of Europe. 
 
EN 108   EN 9.1.6.6. Objective 6 – Improve the effectiv eness of European standardisation 
Question 6.1: Introduce the WTO/TBT principles of  standardisation as a 
requirement for European Standards Organisations to be included in directive 
98/34/EC and receive standardisation mandates to develop harmonised 
standards in the EU. 
The Commission wanted to know whether individual NSBs had already signed the 
WTO/TBT code of practice,  and to understand: (i) [ For those that have signed ] what 
the implications have been in terms of new or amended procedures actually 
implemented and the additional costs associ ated with these procedures, and (ii) [ For 
those that have not yet signed ] what the reasons are for this, whether the NSB has 
plans to do so in the near future, and if s o, what stage the discussions are at and what 
the likely outcome of those deliberations  will be. The Commission also wanted to 
understand whether there would be any other practical implications  or costs to the 
ESOs and NSBs of the provision. 
Replies by the NSBs:  
• Based on the replies, 37 of  the 40 NSBs have signed  the WTO/TBT code. 
• The vast majority of these NSBs stated th at there were no implications (or costs) 
in terms of new or amended procedures to  be implemented, as they were already 
compliant before signing. 
• Four NSBs provided brief details about  additional actions that were taken 
(including changes to notification procedur es, IT tools and access to information) 
and in one case the cost (€30,000). 
• Two of the NSBs that have not signed  reported that they do intend to sign up to 
the code of practice. One of these NSBs  explained further that they had not 
previously been requested to sign, but we re now in early st age discussions and 
expected a positive outcome in the near future. 
• No other substantive comments were receiv ed in relation to this provision from 
the NSBs. 
Replies by the ESOs : All three ESOs reported that th ere would not be any practical 
implications or costs to them of this pr ovision as ETSI is already signed up to the 
code and CEN/CLC and their members are already formally committed to 
WTO/TBT principles. 
Question 6.2: ESOs to op en the possibility to appr ove documents developed by 
forums and consortiums as European Standards following a simplified 
procedure, provided those F&C have deve loped the documents according to the 
WTO/TBT standardisation principles. 
The Commission wanted to understand (i) th e likely number (and names) of SDOs 
that may have to be approved by the ESOs and the likely number of documents to be transposed each year, (ii) whether other SDOs would cooperate with such a system 
 
EN 109   EN and be prepared to sign up to and abide by the WTO/TBT code of conduct, and what 
charges / other requirements (if any) these SDOs would impose, were their 
standardisation documents to be transposed  into European standards, (iii) what 
procedures the ESOs would have to put in place in order to develop a ‘fast track’ 
approval procedure for documents created by other SDOs and the estimated ‘unit’ 
cost (i.e. per SDO, per document), plus (iv)  any other practical implications or costs 
of the provision. 
Replies by the SDOs (F&C):  
• All of the responding F&C reported that they already adhered to and operated 
according to the WTO/TBT principles and / or would be prepared to sign up to 
and abide by the code of conduct. 
• They also all reported that they would  in principle coopera te with the proposed 
system, although most indicated some con cerns, potential challenges and issues 
that would need addressing, namely: 
– The possible confusion caused (and costs incurred) by two different 
documents (ESO and F&C version) being available and implemented 
separately and referenced in different ways; 
– The additional burden of keeping track of modifications, extensions and 
updates made by either party and an y confusion caused by one version 
lagging behind the other; 
– Issues of maintenance and change control, and whether either party 
could create derivative works and diverging subse quent versions of the 
specification; 
– Issues related to transposition into another IPR regime, with a need to 
assess the terms and conditions under which a standard can be used, implemented and accessed; 
– Questions regarding who would receive recognition/payment for 
transposed specifications; 
– Other issues relating to patent polic y, disclosure obliga tions and royalty 
charges. 
• Two F&C in particular had major reserv ations and would prefer to explore 
alternatives first, such as the possibility of directly referencing F&C 
standardisation documents. 
• Further investigation, thought and discussion around these issues would be needed 
before F&C would be able to agree on a ny charges and other requirements that 
might be imposed. 
Replies by the ESOs:
 
 
EN 110   EN • All three ESOs reported that they alrea dy have procedures in place to adopt 
specifications from other SDOs, however these are not currently used for this 
purpose at all (ETSI) or to any great extent (CEN/CLC) and there are likely to be 
cost implications to increased approval activity. 
• ETSI estimated the process would cost  €18,000 per SDO document (although this 
would vary). 
• All three ESOs also highlighted that ther e may be issues with ownership and IPR 
to be overcome. 
Replies by the NSBs : The main point raised by NSBs was that it is already possible 
to use the CEN/UAP and PQ procedures fo r the specifications drafted by SDOs and 
to adopt them as ENs, and it is unclear why another procedure would be necessary. 
Question 6.3: Extend the list of rec ognised ESOs beyond CEN, CENELEC and 
ETSI and make it possible to allocate standardisation requests (mandates) to 
these other organisations 
The Commission wanted to understand (i) th e likely number (and names) of SDOs 
that would be expected to be  ‘approved’ as formally recognised ESOs and the likely 
number of mandates and volume of co-financi ng that might be transferred to these 
SDOs each year, (ii) whether other SDOs  would be prepared to accept these 
standardisation mandates from the EC, (iii) the likely impact on ESOs and NSBs if 
some proportion of the mandates were tr ansferred, (iv) the likely impact on 
stakeholder participation in EU standards development if the number of ‘recognised’ 
ESOs developing EU standards were to incr ease, and (v) other pr actical implications 
or costs. 
Replies by the SDOs (F&C) : All of the responding F&C repo rted that they would, at 
least in principle, be prepared to accep t EC standardisation mandates, although 
further discussion and a closer review of the possible contractual relationships and 
practical details would be needed before this could be taken further. 
Replies by the ESOs:  
• All three ESOs reported that the impact of transferring mandates to other SDOs 
would be significant for these organisati ons, though for slightly different reasons. 
• ETSI expect the provision to lead to a reduction in membership and membership 
fee income, as industry invests in altern ative forums, damaging the infrastructure 
and financial stability of ETSI. It would be faced with either increasing fees to 
maintain budget, or reducing support to ce rtain issues and losi ng staff. A reduced 
budget may also reduce the EC/EFTA Operating Grant. 
• One-third of standards currently elaborated by CEN/CLC are mandated 
harmonised standards, so a reduction in mandates would result in less work for 
CCMC and reduced staff. 
 
EN 111   EN • The ESOs also raised wider concerns about potential damage to the ESS through 
increased competition, fragmentation, loss of coherence and clarity and reduced 
visibility internationally. 
• They would expect to see all SDOs appl ying the same rule s and guarantees as 
currently provided and clearl y defined responsibilities  and obligations (e.g. for 
maintaining/updating standards). 
Replies by the NSBs:  
• The NSBs indicated that the provision would not necessarily have a significant 
impact on them in terms of loss of work  or revenues, but w ould have significant 
negative implications for the cohe rence of the ESS more generally. 
• The extent of impact would depend on th e number of SDOs involved, the number 
of mandates given to other bodies, and also the extent to which other SDOs follow 
WTO/ESS principles. 
• The provision may go against the principl e of national delegation, cause exclusion 
of certain national stakehol ders, and make it more costly and difficult to track 
developments or participate. 
• The provision would require increased coordination and co mmunication activity 
in order to guard against fragmentati on and conflicting standards, adding 
complexity and cost to the system. 
• Responsibilities and obligations (e.g. for maintaining/updating/withdrawing 
standards and ensuring quality) will be difficult to define and maintain with increased numbers of SDOs. 
Replies by Stakeholders:
 
• A few Stakeholder Organisations sugge sted the provision would bring positive 
benefits in terms of increasing pressure on ESOs to improve services and become 
more efficient, effective and responsive, as well as creating greater flexibility and 
choice as to where to pursue standardisation. 
• However, the majority foresaw various negative consequences that would have 
negative implications (directly or indi rectly) for stakeholders and their 
participation. 
• In particular they highlighted that furthe r fragmentation of th e European standards 
landscape would place a greater time, co st and effort burden on stakeholders 
(especially weaker ones) to be able to monitor, follow and / or participate in relevant standards development activities,  which would lead to more scattered, 
less effective stakeholder participation and ultimately more situations where standards are developed without re levant stakeholder involvement. 
• There were also concerns about the ope rational implications  of an expanded 
system and the ability of other F&C to s upport the continuing success of the ESS. 
 
EN 112   EN In particular, Stakeholder Organisations ra ised their concerns about (i) barriers to 
accessing other F&C (higher fees, less a ppropriate tools/processes), (ii) the 
strength of certain interest groups in  other F&C and opportunities for private 
parties to manipulate standardisation outco mes for their own interests, (iii) the 
increasing difficulty in deliv ering a single coherent sta ndardisation response to a 
market need, risk of conflicting standards / requirements and greater difficulties in 
complying with them, and (iv) decreased legitimacy, respect for and trust in the formal standardisation process. 
Question 6.4: Commission to be able to request development of standards to any 
organisation via call for tenders to a ll Standards Developing Organisations 
meeting the WTO/TBT requirements 
The Commission wanted to understand (i) wh ether F&C would be likely to respond 
to calls for tender issued by the EC for the development of European standards, (ii) 
what the impact of the provision would be  on the Commission’s own procedures and 
workload, and (iii) what the implications or costs would be for the ESOs and NSBs 
and in particular th eir business robustness 
Replies by the F&C : Most F&C reported that they would, at least in principle, 
respond to calls for tender from the EC where these were felt to be relevant, although greater clarity over the pract icalities of such a provision would need to be 
investigated further before such a system could be agreed 
Replies by the ESOs:
 
• All three ESOs expected the provision to lead to a fragmentation of the ESS and a 
reduction in the ESO operating grants, wh ich in turn would either lead to 
increased fees or reductions in staff and secretariat support services provided to 
the EC and stakeholders. 
• CEN/CLC also expect the reduced income  to cause a certain ‘refocusing’ of 
standards development work, reducing sta ndards development in areas with high 
added value in social, public or regul atory terms, but with low expected 
commercial return. 
• CEN/CLC also felt that the increased co mmercial pressure on income may result 
in NSBs reconsidering the amount of year ly financing of ESO activities and to 
limit activities to core business and more  lucrative standardisation documents. 
Replies by the NSBs:  
• Most of the comments provided by NSBs did not relate directly to the impact of 
the provision on their bus iness robustness, but fo cused on possible wider 
consequences of the proposed change. 
• In particular, most NSBs suggested th at the negative impacts would include 
undermining the current basis of European  standardisation and many of its most 
important principles, leading to a lo ss of coherence and transparency, and 
weakening consensus as fewer actors and count ries would be able to participate in 
 
EN 113   EN the development process. Some NSBs went so far as to state that they would be 
unable to guarantee the implementation of European standards at national level if 
they were developed outside of th e scope of the established ESS. 
• In addition, expected income from selling standards may become a more 
significant driver for ESO and NSB busin ess decisions, as th e balance between 
best sellers and “niche” standard s cannot be ensured any longer. 
• NSBs also highlighted that although F& C may work faster and cheaper than 
NSBs due to their simpler structures and less restrictive (and lower quality) 
procedures, the outputs achieved may be of  far lower utility because the same 
level of input and consensus has not been achieved. 
• A number of questions were also rais ed by NSBs relating to the practical 
implementation of the provision (e.g. con cerning eligibility criteria, assessment 
criteria, tender evaluati on processes and procedures  and methods for ensuring 
compliance with WTO/TBT principles). 
Question 6.5: Commission and ESO to establish an accreditation system of 
Standards developing organisations in the EU 
The Commission wanted to understand the likely roles and procedures and the 
necessary infrastructure/ope rating costs of an EU-level  accreditation system for 
SDOs. To this end, it also wished to understand various aspects of an existing 
comparable system, namely the accred itation elements of ANSI’s operations 
(including the procedures and process in place to carry out accreditation, the criteria 
used to accredit SDOs, processes for ensuring procedures and practices are followed, and the costs and fees involved). The Comm ission also wanted to understand any 
costs and implications of th e provision on ESOs and NSBs. 
Replies by the ESOs
: The ESOs also felt unable to provide information on the ‘look’ 
of a new accreditation system. 
Replies by the NSBs:  
• The NSBs also felt unable to provide in formation on the roles, procedures and 
costs of a new agency, based on the in formation provided at this stage. 
• Indeed, most responding NSBs questioned why such a proposal was being 
considered when the existing system is effective, well-functioning and the 
preferred model for the majority of st akeholders. The need for, purpose and 
benefits of a new accreditation agency were unclear. 
• Based on the information available, there were concerns that the provision would 
lead to two parallel systems (unworkabl e, duplicative, costly and complex, with 
little added value), that it woul d increase bureaucracy, reduce 
transparency/coherence and ultimately be a regressive step. 
 
EN 114   EN 9.1.6.7. Objective 7 – Simplify the interf ace between the EC and the SDOs 
Question 7: The Commission to create an  agency or a similar organisation to 
manage the operational relations wi th standards development bodies 
The Commission wanted to understand (i) the consequences for the Commission of 
the creation of a new agency to manage cal ls for standardisation work in, and (ii) 
whether there would be any practical implic ations or costs to the ESOs of this 
provision. 
Replies by the ESOs:  
• All three ESOs expect that the creation of a new agency will make the ESS more 
complex. They reported that a new organi sation would result in more meetings, 
additional costs, a lack of  clarity over the boundaries between the EC and the new 
agency and more difficult coordination am ongst stakeholders at different levels. 
• ETSI reported that it could see no be nefits to the proposed approach. 
• CEN/CLC added that a lack of clarity  about the objectives of the proposed 
organisation mean that a thorough assessmen t of the practical implications and 
costs cannot be made. 
 
EN 115   EN 9.2. ANNEX 2 – ECONOMIC ASPECTS OF STANDARDS IN THE EU 
9.2.1. Benefits of standards 
Academic research and studies carried out in  different EU countries (and also outside 
the EU) agree on the beneficial overall effects of standards both for companies and sectors as well as the economy as a whole. 
9.2.2. Microeconomic benefits  
Various economic studies spell out the benef its that companies and industries in the 
European Union derive from the standardisation process.  
These benefits can be seen in several areas:  
(a) Cost reduction or cost savings
 derived mainly from economies of 
scale, the possibility to antici pate technical requirements, the 
reduction of transaction costs and the possibility to access 
standardised components. A ccording to the World Bank82, one of the 
most important economic benefits of standards is that they increase 
productive and innovative efficiency . They allow suppliers to 
achieve lower per-unit costs by  producing large homogeneous 
batches. In addition, producers gain skills and experience by focusing 
on fewer product variations. By allo wing producers to concentrate on 
a manageable number of product opti ons instead of fragmenting their 
R&D efforts, variety-reducing st andards also in crease innovative 
efficiency. Surveyed companies agreed that they would incur additional costs without standardis ation bodies because their in-house 
standardisers would have to work alone. 
(b) Improved market access as a result of increased competitiveness due 
to increased efficiency, reduced trad ing costs, simplified contractual 
agreements (because the characteri stics and functionalities of the 
product are clear as a re sult of the standards) and increased quality.  
(c) Better relations with suppliers and clients derived from increased 
safety for consumers, increased trus t, reduced liability risk and wider 
choice of suppliers for the same reasons mentioned above. Minimum safety standards are the most stra ightforward example of standards 
used to solve imperfect information problems . By conveying 
information about the harmful e ffects of products, they allow 
customers to avoid products that might negatively affect them, the 
general public, or the environment,  and they allow regulators to 
exclude unsafe products from the market. These standards allow 
buyers to confirm that products and processes have the characteristics 
they want without the additional transaction costs of independent 
                                                
 
82 Quality Systems and Standards for a Competitive Edge (drafted by J. Luis Guasch, Jean-Louis Racine, 
Isabel Sánchez and Makhtar Diop), The International Bank for Reconstruction and Development/The 
World Bank, 2007. 
 
EN 116   EN testing. By codifying market prefer ences, standards also save sellers 
the additional costs of defining co nsumer preferences. By reducing 
information asymmetries, standards can help mitigate adverse selection problems
83. 
(d) Standards spur innovation  and technological transfers. They 
increase the efficiency of R&D i nvestment and reduce the costs of 
research due to shared developm ent efforts and knowledge sharing 
between different actors. Othe rwise one company or group of 
companies would have to meet all the cost of providing information 
on the state of the art of a partic ular technology. When information on 
innovations is codified in standa rds and this information is non-
proprietary, it is accessibl e to everybody, at least in principle. Firms, 
universities, and research orga nizations can us e the knowledge 
embodied in standards to adopt in novations or generate new ideas. 
Standards play a particularly usef ul role in disseminating knowledge 
in industries where products and processes supplied by various providers must interact with one another. They ensure that information on innovations in one part of the sect or will be diffused to other parts 
of the sector.  
Optimized returns on investment 
resulting from the possibility to confront competing 
possible options for the development of a certain product or tec hnology early in the 
process and to avoid investments in those that will not be widespread. 
Compatibility and interface standards add economic value to goods with network 
externalities and facilitate the developmen t of networks. Compatibility standards can 
increase direct network externalities  by allowing products to work as part of a 
system or network. They allow each individua l participant in the network to derive 
benefits from interacting with ot her participants in the network. 
There are no quantitative data available on the impact of standards on companies’ 
results. Some studies (Collaz 1979) estim ated it at around 1% of turnover, although 
later studies (Blind 2004 ) concluded that this figure  should be revised downwards. 
Specific effects of standardisation for sp ecific sectors of the economy vary according 
to their characteristics. Studies and surveys carried out in companies indicate that the 
sectors that benefit the most  from standards are those more innovative, with bigger 
R&D and patents, bigger market concentra tion and more exports oriented. The size 
of the companies and the concentration of th e market might also play a role. Benefits 
are also higher in the case of long lifespan products because the cycle of creation of a 
standard is long. The greater role in r ecent years of ¨de facto standards¨, more 
flexible, might therefore be explained because  the life of products is getting shorter.  
Studies point out to sectors such  as aeronautics and aerospace and 
telecommunication as benefitting the most from the impact of standards.  
                                                 
83 Quality Systems and Standards for a Competitive Edge (drafted by J. Luis Guasch, Jean-Louis Racine, 
Isabel Sánchez and Makhtar Diop), The International Bank for Reconstruction and Development/The 
World Bank, 2007. 
 
EN 117   EN Surveys also point out that sectors such  as transport, communications services, 
business related services and highly regulat ed sectors benefit more from standards . 
The biggest needs for standards can be f ound in more fragmented markets, business 
services (that benefit more than consumer services), companies operating at international level, labour intensiv e services, and innovative companies . 
9.2.3. Macroeconomic benefits 
Econometric studies (DIN 2000, Blind 2004, DTI 2005, AFNOR 2009 ) in several 
EU countries (France, Germany, Un ited Kingdom) have established a positive 
influence of standards on innovation (sp ecially on disseminati on of innovation), 
on technological change, on productivity and on trade . This reflects a connection 
between standards and economic growth. St andards are a fundamental element of a 
country’s technical and economic infras tructure and influence technological 
development, which undoubtedly in fluences economic performance. 
The existence of standards is trade-enhancing because of their positive cost-
decreasing effect and the reduction of information asymmetries between the supply 
and the demand side, especially in the case of cross-border transactions
84.  
Studies also point out to the relation between the increase in the stock/portfolio of 
standards and the increase in  productivity and GDP growth . An increase of the 
national stock of standards of 1 % woul d contribute to around 0.12% of productivity 
growth and between 0,02%-0.1%  of output growth. This would result in an overall 
impact on the economic growth of existing standards that has been estimated (DIN 
2000) in 1% of German GDP per year. Si milar figures have been estimated for 
France (0,8%) and other technol ogical leading economies a nd slightly lower figures 
appear for the United Kingdom. With all pre cautions (the impact could be different 
for EU countries with a lower technologica l base) and lacking similar data at EU 
aggregated level, we can estimate that  the impact of standards on annual GDP 
growth could rage from 0,3 to 1%. This, in  terms of EU GPD value would give the 
figure between 35,000.37 and 120,000, million euro in 2009 (EU GDP 2009: 11,785,474.9 million euro according to Eurostat). 
9.2.4. Possible negative effects of standards 
Standards can have anticompetitive effects if only one or a few companies are able to 
internalize their benefits or cont rol their content. In this case, standards can be used 
as strategic instruments to expand market power . This occurs when the content of 
the standards covers technological areas in  which a limited number of firms have 
property rights, exclusive know ledge, or the exclusive re sources needed  to use a 
technology. Distortion of standardisati on, e.g. in the form of vendor specific 
extension or technologies, will subseque ntly distort the market built upon that 
standard, translating standard-bias into market-bias, resulting in failure of competition, and increasing the risk of monopo lization. This effect is amplified by an 
                                                
 
84 Blind K , « The role of standards for trade in services : hypotheses and first insights” in “The handbook 
of innovation and services : a multi-disciplinary pe rspective”, edited Gallouj F. and Djellal F, Edward 
Elgar Ltd., 2010; Den Butter F., Groot S., Lazrak F. “The Transaction Costs Perspective on Standards 
as a Source of Trade and Productivity Growth”, Tinbergen Institute Discussion Paper, 2007. 
 
EN 118   EN inherent bias for very large corporations  in standardisation, whereas innovation is 
often driven by small and me dium enterprises (SMEs). As  a result, standardisation 
has the potential to be abus ed by large players to create market bias and capture 
markets from the innovators85. 
The realisation of the innovative and compe titive benefits of standards depends upon 
the availability of standards to a ll potential innovators and competitors. Exclusive 
rights on a standard, for example through intellectual property rights , 
undermine the utility of standa rds. Participants in the st andardisation process attempt 
to mitigate the risk of patent hold-ups on standards86. Nevertheless, th ere is still a 
substantial risk of third party claims which cannot be addressed. Furthermore, the 
assurances provided are usually non-bi nding and do not constitute ex-ante 
permission to implement, leaving the possibi lity for future market capture by patent 
holders or exclusion of specific groups of competitors, e.g. user-driven and 
collaborative innovation models87. 
9.2.5. Types of standards by their economic effects 
Generally speaking, economic litera ture distinguishes different types of standards 
by their economic effects . For the purpose of this impact assessment, the following 
classification88 will be used: 
• Standards for interoperability (or compatibility ) define physical or virtual 
relationships between independent entities for the purpose of interoperability or 
communication. Most of a country’s infrastr ucture uses compatib ility standards to 
connect a number of disparate private and public entities, for example railway 
standards and network industries. 
• Minimum quality and safety standards  allow consumers to assess the quality or 
safety of a product before purchasing it. These standards are developed to specify 
acceptable product or service performance al ong one or more dimensions such as 
functional levels, performance variation, se rvice lifetime, efficiency, safety, and 
environmental impact. A standard that sp ecifies a minimum level of performance 
often provides the point of departur e for competition in an industry89. 
• Variety-reducing (or inter-changeability) standards  define the common 
characteristics of two or more entitie s. In this way they provide inter-
                                                 
85 Quality Systems and Standards for a Competitive Edge (drafted by J. Luis Guasch, Jean-Louis Racine, 
Isabel Sánchez and Makhtar Diop), The International Bank for Reconstruction and Development/The 
World Bank, 2007. 
86 See, for example, Geradin D. and Rato M., “Frand Commitments and EC Competition Law: a Reply to 
Philippe Chappatte”, in European Competition Jo urnal, 2010, p. 129; Chappatte P, “Frand 
Commitments – The Case for Antitrust Intervention”, European Competition Journal, 2009, p. 319. 
87 Greve, G.C.F., “Inside Views:  Innovation Policy: The Balance Between Standards and Patent 
Regulation”, Intellectual Property Watch, 26 February 2009. 
88 See Blind K., “The Economics of Standards: Theory, Evidence, Policy”, Edward Elgar Publishing Ltd, 
2004; Quality Systems and Standards for a Competit ive Edge (drafted by J. Luis Guasch, Jean-Louis 
Racine, Isabel Sánchez and Makhtar Diop), The International Bank for Reconstruction and 
Development/The World Bank, 2007. 
89 Tassey G., “Standardization in technology-based markets”, Research Policy, 2000, vol. 29, issue 4-5, 
pages 587-602.  
 
EN 119   EN changeability and generate economies of  scale and economies of learning in 
production. The majority of standard s fall into this category. A well-known 
standard of this type is  the international paper st andard, ISO 216, which defines 
the A4 format used in most of the world except for North America. The widespread use of A4 paper has many a dvantages other than economies of scale 
in paper production itself. It avoids the n eed to rework documents to fit different 
formats and allows consumers to choose between competing paper brands, calculate shipping weights from the numb er of pages (most A4 sheets have the 
same weight), and fit papers from differe nt sources into the same envelopes and 
binders, among many other advantages. 
• Information and measurement standards
 establish a common technical language in 
which to compare physical attributes  and convey descri ptive technical 
information. They include unit standards, such as the number system and weights 
and measures. 
 
EN 120   EN 9.3. ANNEX 3 – EUROPEAN STAND ARDISATION ORGANISATIONS 
9.3.1. Definitions – International context 
There is a wide variety of definitions  with respect to standards90. For the purpose of 
this impact assessment, the following definitions are used: 
(1) A “Standard ” means a technical specification approved by a recognised 
standardisation body or agreed u pon between economic operators, for 
repeated or continuous applicatio n and with which compliance is not 
compulsory . It can be an international, European, national or Fora and 
Consortia standard 
(2) An “International Standard ” means a standard adopted  by an international 
standardisation organisation91 and made available to the public; 
(3) A “European Standard ” means a standard adopted by a European 
standardisation body and made available to the public; 
(4) A “National Standard ” means a standard adopted by a national 
standardisation body and made available to the public; 
(5) A “European Standardisation Organisation ” or “ESO ” means a body referred 
to in Annex II to Directive 98/34/EC, i.e. CEN, CENELEC and ETSI. Annex 
3 of this impact assessment contains a detailed description of these bodies; 
(6) A “National Standardisation Body ” or “NSB ” means a body referred to in 
Annex II to Directive 98/34/EC; 
(7) A “Fora and Consortia Standard ” or “FCS ” means a technical specification, 
convention or system developed by fora and consortia92 compliant with WTO 
criteria in the development of new st andards but which has not been defined 
                                                 
90 The ISO/IEC Guide 2: 2004, defines a standard as a document, established by consensus and approved 
by a recognized body, that provides, for common and repeated use, rules, guid elines or characteristics 
for activities or their results, aimed at the achievement of the optimum degree of order in a given 
context. The terms as defined in ISO/IEC Guide 2 cover products, processes and services. The TBT 
Agreement, however, deals only with technical regulations, standards and conformity assessment 
procedures related to products or processes and production methods. Consequently, the corresponding definition of a standard is also limited to products or processes and production methods. Furthermore, 
standards as defined by ISO/IEC Guide 2 may be mandatory or voluntary. For the purpose of the TBT 
Agreement, standards are defined as voluntary an d technical regulations as mandatory documents. 
Standards prepared by the international standardization EU are based on consensus. The TBT 
Agreement covers also documents th at are not based on consensus. 
91 For example, ISO (International Organisation for Standardisation), IEC (International Electrotechnical 
Commission), ITU (International Telecommunications Union), UNECE (United Nations Economic 
Commission for Europe), OECD (Organisation for Economic Co-operation and Development), OIML 
(Organisation Internationale de la Métrologie Léga le), Codex Alimentarius (a unit of the FAO), OIE 
(Office International des Epizoöties) , IPPC (International Plant Protection Convention - also a unit of 
the FAO), International Pharmacopoeia (World Health Organisation ), ICH (International Conference 
on Harmonisation), IMO (International Maritime Organisation), ICAO, Central Office for International Carriage by Rail. 
92 See Annex 7. 
 
EN 121   EN or endorsed as a formal standard by an international standardisation 
organisation, a European Standardisa tion Organisation (ESO) or a National 
Standardisation Body (NSB).  
Basic reference for the principles of standardisation is the “Code of  good practice 
for the preparation, adoption and applicati on of standards” (hereinafter “Code of 
good practice”), which constitutes, as its Anne x 3, an integral part of Agreement on 
technical barriers to trade (h ereinafter “TBT Agreement”)93.  
The Code of good practice is open to accep tance by any standardising body within 
the territory of a Member of WTO94. The three ESO have accepted the Code of good 
practice. Nevertheless, unde r Article 4.1 of the TBT Agr eement, the obligations of 
WTO Members (including the European Union and its Member States) with respect to compliance of standardising bodies with the provisions of the Code of good 
practice continue to apply irrespective of whether or  not a standardising body has 
accepted the Code of good practice.  
9.3.2. General overview of the Eur opean Standardisation Organisations 
The European Standardisation Organisations for the purposes of this impact 
assessment are the European Standardisatio n Bodies as referred to in Annex I of 
Directive 98/34/EC
95, namely: 
– CEN (European Committee for Standardisation),  
– CENELEC (European Committee for El ectrotechnical Standards) and  
– ETSI (European Telecommunica tion Standards Institute). 
CEN and CENELEC are not-for-p rofit international associ ations under Belgian law, 
gathering exclusively the Na tional Standards Bodies (NSB s) of the EU and EFTA 
countries and of Croatia. CEN and CEN ELEC decision making pr ocesses are based 
on consensus.  
Preparatory documents and draft European  standards are deve loped in Technical 
Committees to which every NSB can send a de legation, whilst the Secretariat of the 
Committee is managed by one of them (the d ecision of allocation of the secretariat is 
also made by consensus). National Delegati ons generally include 1 to 5 delegates, 
appointed by the national mirror committees where all national stakeholders can be represented. Each national delegation presents a consen sual national position within 
the European Technical Committee. Once a st able draft European standard has been 
developed by the Technical Committee, it is approved by weighted votes of the 
NSBs. 
                                                
 
93 http://www.wto.org/english/docs_e /legal_e/17-tbt_e.htm#annexIII .  
94 For a detailed list, please consult 
http://www.standardsinfo.net/info/liv elink/fetch/2000/148478/6301438/docs_wto/TbtList_13.09.2010.p
df.  
95 Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a 
procedure for the provision of information in the field of technical standards and regulations and of 
rules on Information Society services (OJ L 204 of 21 July 1998) as amended. 
 
EN 122   EN All approved European Standards must be implemented as national standards by all 
CEN and CENELEC Members, and conflic ting national standards must be 
withdrawn, thus allowing th e creation of a coherent system of standards throughout 
the EU. 
ETSI’s governance is based on direct member ship of companies and organisations, 
including NSBs. ETSI develops European standards (EN) according to the same 
procedure as CEN and CENELEC. However, its main task is the publication of technical specifications, developed directly by expert committees and made available 
on ETSI’s web site. 
9.3.3. Main Deliverables of the ESOs 
9.3.3.1. CEN/CENELEC 
CEN/CENELEC deliverables differ in the le vels of transparency, consensus and 
approval required before issu e. These deliverables are: 
(1) the European Standard (EN), leading to full implementation as a national 
standard Europe-wide, which also serves  the European regulatory purposes of 
the New Approach;  
(2) the Technical Specification (TS), that serves as normative document in areas 
where the actual state of the art is not  yet sufficiently stable for a European 
Standard;  
(3) the Technical Report (TR) for informa tion and the transfer of knowledge;  
(4) the Workshop Agreement (CWA), which aims at bringing about consensual 
agreements based on deliberations of  open Workshops with unrestricted 
direct representation of interested parties;  
(5) the Guide (CEN or CENELEC Guide) , which gives information about 
standardisation principles and policie s and guidance to standards writers. 
Apart from the CWA, which has direct i ndustry representation in Workshops, these 
products are worked out among CEN/CENELEC members, who in turn consult their 
interested parties, usually by means of na tional mirror committees. 
9.3.3.2. European Standard (EN)  
The European Standard is a normative document made available by CEN/CENELEC 
in three official languages. The developm ent of a European Standard includes a 
public enquiry, followed by an approval by weighted vote of national members and final ratification. The European Standard is  announced at national level, published or 
endorsed as an identical nati onal standard and every conf licting national standard is 
withdrawn. 
The content of a European Standard  does not conflict with any other 
CEN/CENELEC Standard. 
 
EN 123   EN A European Standard is periodically re viewed. During the elaboration and whole 
lifetime of the European St andard, standstill applies. 
The EN is the appropriate deliverable where there is a need for national 
implementation and withdrawal of conflicting national standa rds. The values that the 
EN derives from the characteristics of its development process are: 
– Consensus : General agreement, characteri zed by the absence of sustained 
opposition to substantial issues by any impor tant interest parties concerned and by 
a process that involves seeking to take  into account the view of all parties 
concerned and to reconcile any conflic ting argument. Consensus does not imply 
unanimity. It makes sure that the standard  is wanted by the pa rties concerned and 
prepared with voluntary commitment to their use. 
– Openness  (open to all stakeholders): all in terested parties have the right to 
participate in (via national delegations) a nd contribute to the development of an 
EN. 
– Transparency : At the initiation phase, the project is made public (via 
announcement in standards bulletins, et c.). If it may have an impact on 
international trade it is also notified to a defined body (Code of Good Practice for 
Standardization of the WTO TBT agreem ent). The CEN programme of work is 
available as public information and ev erybody may react during the obligatory 
public comment phase (the CEN enquiry).  
– National Commitment : the formal adoption of EN is decided by a weighted 
majority vote of all CEN National Members and is binding on all of them (Formal 
vote). The standstill principle applies,  i.e. National Members agree that no 
national individual action, duri ng the preparation or afte r the approval of an EN, 
that would prejudice the European wor k, is taken and that no publication or 
revision of national standard, not in line with an existing EN, shall take place. 
Moreover, National Members must implement the European Standard which includes the withdrawal of any conflicting national standards. 
– Technical Coherence
: the European standards fo rm a collection which should 
ensure continuity and consistency of tec hnical content for the benefit of users, 
both at European and national levels. 
An EN is reviewed at least within five years from its publication or earlier when 
requested. 
9.3.3.3. Technical Specification (TS)  
A Technical Specification is a normative document made available by 
CEN/CENELEC in at least one of  the three official languages. 
A Technical Specification is established and a pproved by a technical body 
(Technical Committee or BTTF) by a wei ghted vote of National Members. The 
Technical Specification is announced and ma de available at national level, but 
conflicting national standards may continue to exist. 
 
EN 124   EN A Technical Specification may compete agai nst another Technical Specification with 
the same scope, but a Technical Specifica tion may not conflict with a European 
Standard. This means that an  existing Technical Specificat ion should be withdrawn if 
the publication of a subsequent EN brings  the Technical Specification into conflict 
with that EN. 
During the preparation of a Technical Sp ecification, or after its approval, no 
standstill obligation exists except if the Technical Board has specifically so decided. 
The maximum lifetime of a Technical Specif ication is 6 years (i.e. one three-year 
period and one confirmation). 
CEN/CENELEC introduced the Technical Sp ecification to provi de an appropriate 
consensus/transparency solution to a market  need where there is no immediate need 
for national implementation and withdraw al of conflicting national standards. 
A Technical Specification can be transformed into a European Standard (EN) and so 
it also serves as a 'pre-standard'. This pre-standardisation role is further acknowledged through the possibility of allowing 'competing' Technical 
Specifications which permits CEN to test two (or more) solutions to a specific 
market need: with experience, the preferred solution could then be transformed into a 
European Standard. The Technical Specificatio n can act as a pre-standard but it can 
also be accepted that the 'appropriate consensus' represented by the Technical 
Specification could continue to meet a mark et need without eventual conversion into 
an EN. 
A Technical Specification may be established with a view to serving for instance the 
purpose of: 
– publishing aspects of a subject which may support the development and progress 
of the European market but where a Europ ean standard is not feasible or not yet 
feasible;  
– giving guidance to the market on or by sp ecifications and related test methods;  
– providing specifications in experiment al circumstances and/or evolving 
technologies. 
Furthermore, a CEN Technical Committee ma y decide to publish an EN work item 
as a Technical Specification where: 
– there had been insufficient support at th e CEN Enquiry for the work item to 
progress to an EN;  
– no consensus can be reached on the submission of the work item to Formal Vote 
within the given target date. 
It may also be preferable to publish two or more Technical Specifications if, for 
instance, the draft EN had d ealt with more than one class of product, or included 
alternative methods of test . Technical Specifications may, therefore, compete with 
each other. 
 
EN 125   EN 9.3.3.4. Technical Report (TR)  
A Technical Report is an informative document made available by CEN in at least 
one of the official languages. 
A Technical Report is established and approved by a techni cal body (Technical 
Committee, Technical Board or BTTF) by a simple majority vote of national 
members. 
During the preparation of the Technical Report or after its adoption, there is no 
standstill obligation. The obligation at na tional level is limited to announcement of 
the existence of the TR and conflicting na tional standards may continue. Adoption as 
a national deliverable is optional. 
A Technical Report gives information on th e technical content of standardisation 
work. 
A Technical Report may be established as an  informative document in cases where it 
is considered urgent or advi sable to provide information to the national members, the 
European Commission, the EFTA Secretaria t or other governmental agencies or 
outside bodies, on the basis of collected data  of a different kind from that which is 
normally published as an EN. 
A Technical Report may include, for example, data obtained from a survey carried 
out among the national members, data on work  in other organizations, or data on the 
"state-of-the-art" in relation to nationa l standards on a particular subject. 
No time limit is specified for the lifet ime of Technical Reports, but it is 
recommended that Technical Reports be regularly reviewed by the responsible 
technical body to ensure that they remain valid. 
9.3.3.5. Workshop Agreement (CWA)  
A Workshop Agreement is a document made  available by CEN/CENELEC in at 
least one of the official languages. 
A Workshop Agreement is a technical agreem ent developed in an open structure, the 
CEN or CENELEC Workshop (WS), a nd not in a Technical Committee. 
A Workshop Agreement is adopted thr ough consensus, which is reached by the 
Workshop participants who ar e responsible for its conten ts. The main activity of a 
Workshop is the development and publication of a Workshop Agreement. In addition to this main activity, a Workshop may be us ed as a forum to organise other project 
activities within CEN/CENELEC, such as th e exchange of experiences with regard 
to implementing a specification, exchange of  views with regard to new technologies 
and their business opportuni ties (conferences and semina rs), creation of common 
web-sites, etc. For all Workshops, an appr oved business plan i ndicating the voluntary 
contributions of the participants to support these activities  is essential. 
During the preparation of a Workshop Agreem ent or after its adop tion, there is no 
standstill obligation. 
 
EN 126   EN The Workshop Agreement is announced and possibly made available at national 
level, and conflicting national normativ e documents may continue to exist. 
A Workshop Agreement may not conflict with any European normative document, 
but may compete with any European normative document. This means that an existing CWA must be withdrawn if the pub lication of a subseque nt EN brings the 
CWA into conflict with that EN. 
A Workshop Agreement should be valid for a limited duration of 3 years or until its 
transformation into another deliverable. When 3 years have passed, the CMC should 
consult the former Workshop participants to  see whether a renewa l of the publication 
for a further 3 years is appropriate; if not, the CWA should be withdrawn. 
9.3.4. ETSI 
9.3.4.1. European Standards 
ETSI adopts and publishes European Standa rds (ENs) in the telecommunications 
series. 
Before a draft EN (telecommunications series) is submitted for ETSI approval, a 
Public Enquiry should have been carri ed out for the draf t by the NSOs. Any 
comments received during the time set sha ll be given due consideration by ETSI. 
A draft EN (telecommunications series) is  approved by the weighted national voting 
procedure. 
The NSOs shall ensure the visibility of EN (telecommunications series) at national 
level, either by publication of an identical text, or by endorsement (that is, by 
publication of an endorsement  sheet or by announcement in an official journal) 
within a short time of thei r adoption. ENs (tel ecommunications seri es) thus published 
or endorsed have the status of national st andards. When an EN  (telecommunications 
series) has been approved and adopted on a specific matter, the NSOs must ensure 
that all conflicting national standard s on that specific matter are withdrawn. 
9.3.4.2. ETSI Standards and ETSI Guides 
ETSI also publishes ETSI Standards (ESs) and ETSI Guides (EGs). These 
documents are drawn up by Technical Committees, ETSI Projects or ETSI Partnership Projects, or be received from  other sources, and are, following approval 
at that level, submitted to the membership approval process. 
All full members and all associate members have the right to vote for adoption of 
ETSI Guides (EGs) and ETSI Standards (ESs). If the deliverable is not adopted as a result of the vote, an an alysis of the distribution of the votes among associate 
members and full members shall be conducte d. The deliverable shall be adopted for 
use within Europe if at least 71 % of th e weighted votes cast by full members are 
positive. 
 
EN 127   EN 9.3.5. The Mandates to the ESOs 
Through a mandate, the public authorities ask the ESOs to draw up technical 
specifications of a normative nature  that meet "their" requirements96. The concept of 
a mandate is based on the principle of part nership, cooperation a nd the clear division 
of tasks between the public  authorities and the ESOs. 
9.3.5.1. The process 
The mandate is normally drawn up on the initiative of a Commission department. 
However, Article 6(3) of Directive 98/ 34 stipulates that the 98/34/EC Committee 
may ask the Commission to invite the ESOs to draw up a European standard. The 
initiative for a mandate stems from the publ ic authorities. This does not prevent the 
various players on the market, such as cons umers, from contacting these authorities 
to demonstrate the value of having a mandate, and so of having European standards, 
in a particular area. 
The draft mandate, after informal consulta tion of various intere sted parties, is 
submitted to Committee 98/34/EC for formal consultation, as stip ulated in Article 
6(4)(d) of Directive 98/34/EC. This cons ultation is required for mandates under the 
New Approach directives, but also for any other request for standardisation to the 
ESOs. 
When the mandate has received a favour able opinion by Committee 98/34/EC, the 
Commission forward the final version of th e mandate in English, French and German 
to the ESOs by official letter. The manda tes can be addressed to any one of the 
ESOs, or any combination of them, as the work envisaged requires.  
Mandates are accepted or refused by the ESOs  according to their own internal rules, 
through the CEN and CENELEC Techni cal Boards and the ETSI Board.  
The acceptance of the standardisation manda te begins the standstill period, as 
specified in Article 7.1 of Directive 98/34/EC. From this moment the national 
standardisation bodies do not take "a ny action which c ould prejudice the 
harmonisation intended". 
In the event of refusal, it w ill, in the first instance, be for the Commission's services, 
together with the European standardisati on body concerned, to analyse the situation 
and find a solution. In a second step, th e 98/34/EC-Committee should be consulted. 
The withdrawal of a mandate by the Commi ssion must be subject to a consultation 
with the 98/34/EC-Committee.  
A mandate also specifies the dates of adop tion of the standards and if possible the 
dates on which these documents must be ready for public survey. 
                                                 
96 Vademecum on European Standardisation of 21 November 2008 see: 
http://ec.europa.eu/enterprise/policies/european-standards/documents/vademecum/index_en.htm. 
 
EN 128   EN It is common for the ESOs to request co-funding for the mandated work following 
acceptance – by means of action grants – al though the issuance of the mandate itself 
does not mean funding will necessarily be av ailable and the request for funding must 
undergo a thorough evaluation proce ss by the Commission services.  
A mandate can be issued on the basis of: 
• Either legislation (e.g. a New Approach directive), 
• Or policy (e.g. to support the creation of lead mark ets or to promote policy 
objectives such as accessibility). 
It can also be a combination of these two elements. 
Types of EC mandated EN Cen/Cenelec
end of the year excluding corrigenda 
01.0002.0003.0004.0005.0006.0007.000
1990
1992
1994 1996
1998
2000
2002
2004
2006 2008
NumberYearNon harmonised
Harmonised EN
Source: CEN/CENELEC
 
 
EN 129   EN During the period 2006-2009, for example, a to tal of 86 mandates were issued to the 
ESOs. The number of mandates concerni ng New Approach Directives has fallen 
compared to previous years.  
Mandates 2006-2009 – total 
Type 2006 2007 2008 2009 2010 Total 
After formal objection (New 
Approach) 4 2 0 0 0 6 
Amendments (New Approach) 4 0 1 4 0 9 
New Approach mandates 5 7 2 7 4 25 
Mandates under other legislation 7 5 9 8 10 39 
Mandates under EU policy 4 6 6 2 6 24 
Total 24 20 18 21 20 103 
9.3.5.2. Areas in which mandates can be used 
Mandates specify the public authorities’  expectations towards the European 
Standardisation Organisations. They indicate the general context of the 
standardisation work, as re gards a given European polic y and/or the legislation 
concerned. It is a unilateral act inviting the ESOs to draw  up standards, responding to 
certain conditions - such as the risks to be covered - and assuming certain tasks. Mandates must be regarded as the framework which refers to the public interest requirements and which enables the standard s bodies to devel op quality standards 
that meet these requirements. 
In principle, there are three types of  mandates: study mandates, programming 
mandates and standardisation mandates. 
(1) The study mandate  aims to determine if European standardisation is relevant 
and feasible in a specific field or for a certain subject. This type of mandate is 
most common in non-regulatory fields or for new sectors. 
(2) The programming mandate  asks the European Standardisation Organisations 
to draw up a standardisat ion programme in a given time. This programme has 
to contain inter alia the subjects to be standardised, the relevant technical organisations as well as the completion dates laid down. It can also include an inventory of the existing standards to be revised in order to meet the set 
requirements. 
(3) A standardisation mandate  calls on those drawing up standards or other 
alternative standardisati on deliverables to prepare and adopt within a given 
time European standards in a specific fi eld, possibly on specific subjects. It 
can also include the verification, and, if necessary, the revision of existing 
standards. 
Apart from these three types of mandates, there are also so-called "combined" 
mandates . This involves mandates asking the ES Os to prepare in a first phase a 
 
EN 130   EN work programme and in a s econd phase the implementati on of this programme. This 
normally happens in the case of major standardisation work where several families of products and/or several issu es (safety, for instance) n eed to be dealt with.  
In principle, any type of publication by the ESOs may be the subject of a 
standardisation mandate. Ho wever, in practice, and a fortiori  for the directives under 
the New Approach, it is mostly limited to EN standards in order to ensure that the various principles of European standardis ation (such as identical transposition at 
national level) are applied. 
Mandates 2006-2010 by subject area 
Subject 2006 2007 2008 2009 2010 Total 
Services 1 0 0 0 0 1 
ICT 0 1 1 3 0 5 
Energy 2 1 1 3 7 14 
Transport 3 1 1 1 1 7 
Environment 2 2 3 2 2 11 
Consumer protection 4 0 4 1 4 13 
Other 0 6 5 0 2 13 
New Approach 12 9 3 11 4 39 
Total 24 20 18 21 20 103 
9.3.6. EC financial support to ESOs 
The financing decision 1673/2006/EC establ ishes rules concerning the Commission's 
contribution to the financing of European  standardisation in order to support the 
implementation of specific policies, measures, actions and legislation. 
The Commission provides financia l support to the Central Se cretariats of European 
standardisation bodies with the aim of improving the qual ity of harmonised standards 
and promoting European standardisation at international level. The European 
Commission and EFTA establish Framework Partnership Agreements (FPAs) with 
each ESO, under which proposals for financ ing can be addressed to the Commission. 
The FPAs fix the administrative and fina ncial rules concerning the financing of 
standardisation activities and set out the general context and terms under which 
financial support can be allocated. The cu rrent FPA entered into force on the 1st of 
January 2009 and was concluded for a peri od of 3 years with the possibilty of 
renewal for the maximum of 2 years. 
The table below shows the number of speci fic grant agreements signed between the 
ESOs and the Commission between 2004 and 2009: 
 
EN 131   EN  
Numbers of standardisation grant agreements – (2004-2010) 
Year CEN CENELEC ETSI Total
2004 27 6 12 45
2005 9 5 13 27
2006 20 2 7 29
2007 10 2 6 18
2008 15 2 11 28
2009 11 2 10 23
2010 18 1 11 30
Total 110 20 70 200
There are six main areas or forms of activ ity that can receive financial support from 
EC/EFTA under the FPAs, as follows: 
• Operating Grants  (OGs), previously Annual Perf ormance Contracts (APCs) – to 
support the existence and functioning of th e Central Secretaria ts (or Management 
Centres) of the three ESOs 
• Standardisation Work  – financing provided to support the production and 
revision of standards and other standard isation products in support of European 
legislation and policies 
• Visibility Actions  - programmes of technical a ssistance, cooperation with third 
countries and the promotion and enhancem ent of the European standardisation 
system 
• Preliminary studies – the performance of work in  connection with European 
standardisation (studies, programmes, evaluations, comparative analysis, and 
other supporting actions) 
• Translation  - of European standards or ot her standardisation products into 
community languages other than the official languages of the ESOs 
• Quality Assessment  - the verification of the quality  and conformity of European 
standards, or any other standardisation products, to  the correspondi ng Community 
legislation, carried out by New Approach Consultants. 
The table below shows the EC contributi on to the European standadisation by the 
categories of activity supported. 
 
EN 132   EN Commission Financial Support to Standardisation 
  Support to Central 
Secretariats of ESO / 
Operating Grants  New Approach 
Consultants Translation IT 
Standardisation  Non-IT 
Standardisation  Visibility of 
European 
Standard System Other  Total 
Year M€ % M€ % M€ % M€ % M€ % M€ % M€ % M€ 
2000 4,96 29,7 2,01 12,0 1,54 9,2 5,07 30,3 3,03 18,1 0,04 0,2 0,06 0,4 16,71 
2001 5,80 35,9 1,47 9,1 1,81 11,2 4,25 26,3 2,55 15,8 0,00 0,0 0,26 1,6 16,14 
2002 6,32 39,6 2,11 13,2 1,72 10,8 2,79 17,5 2,96 18,6 0,04 0,3 0,00 0,0 15,94 
2003 7,83 52,9 1,73 11,7 1,05 7,1 2,26 15,3 1,53 10,3 0,31 2,1 0,10 0,7 14,81 
2004 6,37 42,2 1,72 11,4 1,49 9,9 3,05 20,2 2,24 14,8 0,22 1,5 0,01 0,1 15,10 
2005 6,30 63,3 1,80 18,1 0,00 0,0 1,04 10,4 0,07 0,7 0,59 6,0 0,16 1,6 9,96 
2006 6,73 38,5 1,19 6,8 2,88 16,5 6,51 37,3 0,08 0,5 0,08 0,5 17,47 
2007 9,85 56,7 0,00 0,0 4,91 28,3 1,58 9,1 0,20 1,2 0,82 4,7 17,36 
2008 10,40 57,8 0,00 0,0 4,00 22,2 3,30 18,4 0,08 0,4 0,20 1,1 17,98 
2009 10,40 49,1 1,20 5,7 2,50 11,8 5,20 24,5 1,55 7,4 0,35 1,7 21,20 
2010 10,17 42,5 1,20 5,0 4,47 18,7 7,86 32,8 0,20 0,8 0,05 0,2 23,94 
% of total budget            
 
EN 133   EN 9.3.7. Costs and financing of the Eu ropean Standardisation system 
Data provided by the European Standardis ation Organisations, and a study carried 
out by Roland Berger (200097) and own estimations ( methodology below ) indicate an 
estimated cost of the creation of standards of the European Standa rdisation System of 
around €3 000 million in 2009 . According to th e study, this cost results mainly from 
the expense of industry experts’ particip ation in the system (around 82%), followed 
by the costs of National Standardisation B odies and other national institutions (16%) 
and the costs of the management centres of  European Standardis ation bodies (around 
2%).On the basis of the relate d costs of experts, organisatio n of meetings, travel etc, 
we estimate an approximate cost for creation of a standard of around €1m.  
The study argues that the system is fi nanced primarily by industry [93-95%], 
followed by national governments [around 3-5%] and European Commission/EFTA 
contributions [around 2%]. The fact that i ndustry bears the bulk of the cost of the 
system, together with the voluntary character of standards, seem to indicate that, for 
industry, the benefit outweighs  the cost. Therefore, any in itiative taken to reform the 
system should not discourage industry participation. 
Sources and methodology  
a) Costs  The report “Future financing of the CEN system” prepared by Roland Berger for 
CEN in December 2000 estimated the cost of th e CEN system at that point in time. It 
was concluded that the total cost of th e system amounted to 704 million euro with 
three main expenditure components: Nati onal Standardisation Bodies and other 
national organisations, Common Manageme nt Centre and industry experts’ 
participation. On the basis of this figures, estimation was made for the three European Standardisation Organisati ons, CEN, CENELEC and ETSI updated to 
2009.  
From the CEN data we extrapolated th e costs for CENELEC and ETSI for 2000 and 
projected them for 2009. The cost for th e management centres of the CEN, 
CENELEC and ETSI was based on the figures  contained in the annual reports of 
these institutions. The costs for experts participation was estimated in relation to the evolution of the annual deliverables  of each organisation. The costs for National 
Standardisation Bodies were  estimated on the basis of figures related to income 
provided by NSB to the Commission in  a survey carried out in 2008.  
Figures were also compared with results obtained from EC financial data in relation 
to number of meetings carried  out within the standardisation process and the related 
costs of experts. 
Data from 2000 were adjusted to  inflation (data Eurostat).  
b) Financing 
                                                
 
97 The future financing of the CEN sy stem (Roland Berger, December 2000) 
 
EN 134   EN 2009 data on financing from industry and Me mber States were extrapolated on the 
basis of the Roland Berger report  (2000) and data from ESOs. 
 
EN 135   EN  
Estimated cost of European 
Standardisation system (euros)                     
2000 CEN CENELEC ETSI Total  2009 CEN  CENELEC ETSI Total  
National Standardisation Bodies and other 
national organisations ( Roland Berger 2000 
and Commission survey on revenues of 
NSB 2008 ) 183.000.000   367.816.868      446.875.123 
European Standardisation Organisations 
Management Centers ( annual reports )  11.000.000 3.253.000 20. 213.000 34.466.000   15.57 4.000 4.981.000 24.107.000 44.662.000 
Experts participation ( estimated in relation to 
annual standards and adjusted to inflation )  510.000.000 172.8 50.299 1.053.592.814 1.736.443.114   307.212.285 129.8 60.265 1.840.305.476 2.277.378.026 
Total     2.138.725.982      2.768.915.150 
             
             
Deliverables             
All deliverables portfolio ( Cen/Cenelec/ETSI ) 6.389 4.145 6.132 16.666   13.744 6.170 23.822 43.736 
Annual production all deliverables 
(Cen/Cenelec/ETSI ) 835 283 1.725 2.843   414 175 2.480 3.069 
EU inflation (Eurostat) 2001 2002 2003 2004 2005 2006 2007 2008 2.009Accumulated 
inflation 2001-
2009 
  0,02 0,02 0,02 0,02 0,022 0,022 0, 023 0,037 0,01   
  1,02 1,02 1,02 1,02 1,02 1,02 1,02 1,04 1,01 1,21 
             
             
Revenue NSBs 2000 ( data 2008 adjusted to 
inflation ) 367.816.868           
Revenues NSBs 2008 ( Commission survey ) 442.450.617                   
 
 
EN 136   EN 9.3.8. Other Statistics 
9.3.8.1. Breakdown of new national sta ndardisation activities from 
notifications (CEN and CENELEC) 2006-2009 by state 
Country 2006 2007 2008 2009 Total 
AT 357 219 219 196 991 
BE 6 50 50 30 136 
BG na 25 25 12 50 
CH 27 34 14 38 113 
CY na 0 0 2 0 
CZ 23 55 56 70 204 
DE 503 450 448 424 1825 
DK 8 9 9 8 34 
EE 16 10 10 9 45 
ES 190 131 129 208 658 
FI 10 11 11 3 35 
FR 238 243 242 277 1000 
GR 3 2 0 0 5 
HU 11 11 11 7 40 
IE 3 1 1 4 9 
IS 0 0 0 0 0 
IT 107 132 133 123 495 
LU 0 0 0 0 0 
LT 19 18 18 3 58 
LV  14 18 18 33 83 
MT 1 0 0 0 1 
NL 64 56 56 59 235 
NO 20 19 19 17 75 
PL 69 65 65 14 213 
PT 13 1 1 0 15 
RO 32 150 150 45 377 
SE 9 14 14 21 58 
SI 6 28 28 11 73 
SK 45 19 19 29 112 
UK  127 153 145 159 584 
      
CEN 1905 1904 1835 1769 5644 
CENELEC 16 20 56 99 191 
From EU-
15 1638 1472 1458 1512 4568 
From EU-
12 236 399 400 235 1035 
From 
EFTA 47 53 33 55 133 
TOTAL 1921 1924 1891 1802 5736 
 
EN 137   EN 9.3.8.2. New national standardisation activities from notifications (CEN and CENELEC) 
2006-2009  
 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 
EU-15 1305 1383 1511 1380 1168 1227 1512 1638 1472 1458 1512 
EU-10 
 28 62 55 135 287 261 204 224 225 178 
EU-2               32 175 175 57
 
0200400600800100012001400160018002000
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009From EU-2
From EU-10
From EU-15
 
 
EN 138   EN 9.3.8.3. Breakdown of new national standardisation activities from notifications (CEN and 
CENELEC) 1999-2008 by group of countries 
National Notifications
0500100015002000
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
EU-15 EU-10 EU-2
 
 
EN 139   EN 9.3.8.4. Evolution of number and t ype of standards over time 
Data provided by the ESOs, indicate that the portfolio of total deliverables (European 
standards and other deliverab les) from CEN and CENELEC together have increased 
significantly since the beginning of th e 1990s from 1,735 in 1990 to 19,914 in 2009. 
Annual production of all deliverables s hows an increasing trend until 2001 and a 
decreasing one since then.  
Most of the deliverables produced by CE N and CENELEC are European standards 
(EN) (92% in 2009). Therefore, their tre nd is similar to that described for the 
portfolio of all deliverables. The portfolio of European standards (EN) developed by 
CEN/CENELEC has increased  significantly from 1,280 in 1990 to 18,286 in 2009. 
This shows the increasing role of sta ndards in the European economy. Annual 
production of EN shows an increasing trend until 2001 with a decrease since then.  
 
Portfolio  E uropean standards (EN )  
en d  of the yea r e xcluding co rrigenda
02.0004.0006.0008.00010.00012.00014.00016.00018.00020.000
1990
19911992
1993
199419951996
1997
19981999
2000
20012002
2003
200420052006
2007
20082009Year NumnberCe n
Cenelec
To ta l 
So urce: CEN/ CENELEC
 
The ETSI portfolio of total deliverables s hows a sharp increase from 18 in 1990 to 
23,822 in 2009. In 2009, European Standards represented around 18% of the total 
ETSI portfolio; the biggest percentage , around 70%, corresponds to technical 
specifications. Annual deliverables from ETS I have shown a significant constant 
increase until 2002, with an uneven evolutio n since then and an all-time high in 
2009.  
 
EN 140   EN  
Portfolio all  deliverables ETSI
end of the year 
05.00010.00015.00020.00025.000
1990
1991199219931994199519961997199819992000
2001
20022003200420052006200720082009Year Number
Source: E TSI
 
 
Anual deliverables ETSI
05001.0001.5002.0002.5003.000
1990199119921993
19941995
1996 1997
1998 1999200020012002 20032004
2005 2006
2007 2008
2009
Ye arNumber
Source: ETSI
 
The percentage of the European standa rds portfolio mandated by the European 
Commission has increased in the last tw o decades from 18% in 1999 to 34% in 2009. 
Despite this increase, the large majority of  EN remains industry–i nitiated, indicating 
that these instruments mainly respond to the needs of the industry and are mainly privately driven. 
Some European standards dire ctly support EU dir ectives and confer a presumption of 
conformity with EU law. The percentage of European standard s that are harmonised 
standards has increased in the last two decade from 3.55% to 20% in 2009. This shows the increasing importance of standards as an instrument to accompany EU 
 
EN 141   EN legislation.
Harmonised EN
end of the year excluding corrigenda
02.0004.0006.0008.00010.00012.00014.00016.00018.00020.000
1990 1992 19941996 1998 2000 2002 2004 2006 2008
Year NumberTotal EN
Harmonised
 
9.3.8.5. Evolution and number of existing standards by sector  
If we analyse European standards from the sectoral perspective, we find a significant 
concentration in a few areas. Around 70% of European standards and other deliverables produced by CEN/CENELEC focus on the areas of transport, 
mechanical engineering, building and civil engineering, ICT, mate rials, electrical 
engineering, household goods, and electronics. This shows that even where standards 
do not derive from EC mandates and/or harm onised legislation the primary focus of 
industry seems to be in those sectors.  
The areas in which we find the biggest pe rcentage of harmonised standards are: 
health and safety (52%), household, leisur e and sports (51%), healthcare (46%), 
heating, ventilation and air conditioning (43%) and electr ical engineering (35%). 
 
EN 142   EN 

 
EN 143   EN 9.4. ANNEX 4 – SECONDARY EU LA W USING EUROPEAN STANDARDS 
9.4.1. New Approach directives 
The New Approach is a legislative technique  used in the area of  free movement of 
goods, particularly for industrial products. It moved away from the “Old Approach” of prescriptive detailed technical requiremen ts written into the legislation, to specify 
only the essential public inte rest requirements with wh ich products must comply. 
The result is a technology-neutral legal framework. A manufacturer therefore has 
flexibility as to how to comply with  the requirements and demonstrate such 
compliance. The final step is the applica tion of the CE marking by the manufacturer 
to signify that the product complies with the law. 
The New Approach was designed to be fully complementary to the old way of 
legislating and as such ma ny common elements are covere d but in a different way. 
Common elements include:  
– Clear identification of scope;  
– Use of common expressions, such as “pla cing on the market” or “manufacturer”; 
– Requirements which products must comply w ith in order to achieve the objectives 
of the legislation, expressed in terms of  essential requirements or in detailed 
technical specifications incl uded in the legislation; 
– Determination of the technical mean s and procedures for demonstrating 
conformity with these requirements; 
– Specific requirements for the labe lling or marking of products;  
– A “free movement clause”, prohibiting a ny national measure from restricting the 
free movement of products which comply w ith the legislation, to ensure the free 
circulation of products throughout the EU; 
– Very general market surveillance/enforcement requirements. Member States must 
take appropriate measures to ensure that  only compliant products circulate on the 
market;  
– A safeguard mechanism setting out the EU procedure where a national measure 
restricts circulation.  
Instead of setting out de tailed technical requirement s in the legislation, New 
Approach directives limit themselves to defi ning essential requirements in relation to 
issues such as health, safety, consumer protection and the protection of the environment. The legislation fixes the leve l of safety which products must meet but 
does not pre-determine the technical solutions used to achieve this level of safety. The choice of various solutions leading to  the same result is therefore left to 
manufacturers. 
Technical specifications, in the form of European “harmonised” standards, coming 
under the framework of the New Approach directives, allow pr oducts to meet the 
 
EN 144   EN essential requirements and may be consid ered as an ‘easy’ way to achieve 
compliance with the legislation (presumpti on of conformity). The use of harmonised 
standards guarantees the require d level of safety of products , but this is voluntary and 
a manufacturer may use any other technica l solution which demonstrates that his 
product meets the essential requirements.  
The directives also set out requirements fo r conformity assessment which, depending 
on the product, must be done either by third party testing, an inspection or 
certification body or the manufacturer hims elf. Certain directives require the 
intervention of third party conformity assessment bodies, known as notified bodies. 
These bodies are chosen (“designated”) by Member States on the basis of certain 
minimum criteria (competence, impartiality, integrity, etc) which are set out in the 
directives. They are then “notified” to the Commission, after which they are 
authorised to carry out conformity assessm ent activities according to the procedures 
set out in the directives. 
The New Approach also introduced a co mmon marking of conformity, which has 
become its most visible and well known element. The CE marking is in effect a declaration by the manufacturer that the product conforms to all the essential 
requirements of the relevant legislation and that it has been subject to the applicable 
conformity assessment procedures. Sin ce products bearing the CE marking are 
presumed to be in compliance with all appl icable directives a nd hence benefit from 
free circulation, the CE marking operates as  a “passport” to the whole EU market. 
9.4.2. New Approach Directives 
• Simple Pressure Vessels Directive:  Directive 2009/105/EC of the European 
Parliament and of the Council of 16 Sept ember 2009 relating to simple pressure 
vessels ;  
• Toys Safety Directive:  Directive 2009/48/EC of the European Parliament and of 
the Council of 18 June 2009 on the safety of toys ;  
• Construction Products Directive:  Council Directive 89/106/EEC on the 
approximation of laws, regulations and ad ministrative provisions of the Member 
States relating to c onstruction products; 
• Electromagnetic Compatibility Directive : Directive 2004/ 108/EC of the 
European Parliament and of th e Council of 15 December 2004 on the 
approximation of the laws of the Member  States relating to electromagnetic 
compatibility and repealing Directive 89/336/EEC ;  
• Personal Protective Equipment Directive:  Council Directiv e 89/686/EEC on 
the approximation of the laws of the Memb er States relating to personal protective 
equipment;  
• Non-automatic Weighing Instruments Directive:  Directive 2009/23/EC of the 
European Parliament and of the Council of 23 April 2009 on non-automatic 
weighing instruments; 
 
EN 145   EN • Active Implantable Medical Devices Directive : Council Directive 90/385/EEC 
on the approximation of the laws of the Member States relating to active 
implantable medical devices; 
• Gas Appliances Directive:  Council Directive 90/396/ EEC on the approximation 
of the laws of the Member States relati ng to appliances burning gaseous fuels;  
• Hot Water Boilers Directive : Council Directive 92/42/EEC on efficiency 
requirements for new hot-water boilers fired with liquid or gaseous fuels; 
• Civil Explosives Directive : Council Directive 93/15/ EEC on the harmonisation 
of the provisions relating to the placi ng on the market and supervision of 
explosives for civil uses;  
• Medical Devices Directive:  Council Directive 93/42/EEC concerning medical 
devices; 
• ATEX Directive:  Directive 94/9/EC of the European Parliament and the Council 
on the approximation of the laws of the Member States concerning equipment and 
protective systems intended for use in  potentially explosive atmospheres; 
• Recreational Craft Directive:  Directive 94/25/EC of th e European Parliament 
and of the Council on the approximation of the laws, regulations and 
administrative provisions of the Member States relating to recreational craft;  
• Lifts Directive : European Parliament and Co uncil Directive 95/16/EC on the 
approximation of the laws of the Member States relating to lifts; 
• Pressure Equipment Directive:  Directive 97/23/EC of the European Parliament 
and of the Council on the approximation of the laws of the Member States 
concerning pressure equipment;  
• Machinery Directive : Directive 2006/42/EC of the European Parliament and of 
the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast) ; 
• In-vitro Diagnostic Medical Devices Directive : Directive 98/79/EC of the 
European Parliament and of the Council on in vitro diagnostic medical devices; 
• R&TTE Directive:  Directive 1999/5/EC of the Eur opean Parliament and of the 
Council on radio equipment and telecommuni cations terminal equipment and the 
mutual recognition of their conformity; 
• Cableway Directive : Directive 2000/9/EC of the Eu ropean Parliament and of the 
Council relating to cablewa y installations designed  to carry persons;  
• Measuring Instruments Directive : Directive 2004/22/EC of the European 
Parliament and of the Counc il on measuring instruments; 
 
EN 146   EN • EUP Directive : Directive 2005/32/EC of the Europ ean Parliament and of and of 
the Council establishing a framework fo r the setting of eco-design requirements 
for energy using products. 
9.4.3. List of directives which are based on certain elements of the New Approach 
• Low Voltage Directive : Directive 2006/95/EC of the European Parliament and of 
the Council of 12 December 2006 on the harm onisation of the laws of Member 
States relating to electrical equipment designed for use within certain voltage 
limits;  
• Packaging and Packaging Waste Directive : European Parliament and Council 
Directive 94/62/EC on packag ing and packaging waste;  
• Interoperability of Trans-European High-speed Rail System Directive : 
Council Directive 96/48/EC on the interoperability of the trans-European high-
speed rail system;  
• Marine Equipment Directive : Council Directive 96 /98/EC on marine 
equipment;  
• Interoperability of the Trans-European  Conventional Rail System Directive : 
Directive 2001/16/EC of the European Parliament and of the Council on the 
interoperability of the trans-Eu ropean conventional rail system;  
• Energy Efficiency Requirements for Household Electric Refrigerators 
Directive : Directive 1996/57/EC of the Europe an Parliament and of the Council 
on energy efficiency requirements for house hold electric refrig erators, freezers 
and combinations thereof;  
• Transportable Pressure Equipment  Directive : Council Directive 1999/36/EC 
on transportable pressure equipment;  
• Noise Emission  Directive : Directive 2000/14/EC of the European Parliament and 
of the Council on the approxi mation of the laws of the Member States relating to 
the noise emission in the environm ent by equipment for use outdoors 
• Energy Efficiency Requirements for Ballasts for Fluorescent Lighting 
Directive: Directive 2000/55/EC of the Europe an Parliament and of the Council 
of 18 September 2000 on energy effici ency requirements for ballasts for 
fluorescent lighting . 
 
EN 147   EN  
9.4.4. Other standards-rec eptive directives 
• Airborne noise emitted by household appliances : Council Directive 
86/594/EEC of 1 December 1986 on air borne noise emitted by household 
appliances; 
• General product safety : Directive 2001/95/EC of the European Parliament and 
of the Council of 3 December  2001 on general product safety; 
• Postal services : Directive 97/67/EC of the Eu ropean Parliament and of the 
Council of 15 December 1997 on common rules for the development of the internal market of Community postal serv ices and the improvement of quality of 
service; 
• Restrictions on the marketing and use of certain dangerous substances and 
preparations : Council Directive 76/769/EEC of 27 July 1976 on the 
approximation of the laws, regulations and administrative provisions of the 
Member States relating to restricti ons on the marketing and use of certain 
dangerous substances  and preparations; 
• Energy labelling of household appliances : Council Directive 92/75/EEC of 22 
September 1992 on the indication by label ling and standard product information 
of the consumption of energy and ot her resources by household appliances; 
• Waste electrical and electronic equipment : Directive 2002/96/EC of the 
European Parliament and of the Council  of 27 January 2003 on waste electrical 
and electronic equipment (WEEE). 
• Electronic communications networks and services : Directive 2002/21/EC of 
the European Parliament and of the Council of 7 March 2002 on a common regulatory framework for electronic co mmunications networks and services 
(Framework Directive). 
9.4.5. Other standards-receptive EU legislation 
• Regulation (EC) No 765/2008 of the European  Parliament and of the Council of 9 
July 2008 setting out requirements for accreditatio n and market surveillance  
relating to the marketing of products and repealing Regulation (EEC) No 339/93.  
9.4.6. Formal objections 
The “New Approach directives” contain safeguards in cases where a harmonised 
standard cannot enable products to meet th e essential requirements of the directives 
concerned. When such cases occur, th e Member States or the Commission may 
introduce a formal objection to the standa rd in question on which the Committee is 
consulted. 
 
EN 148   EN The procedure begins with a formal objec tion, either receive d by the Commission 
through the Permanent Representation or launched by the Commission itself. The 
documents are then circulated to the Committee, and normally a Member State 
expert group is also consulted. Once a draft Commission Deci sion is ready, the 
Committee is consulted on it. On receipt of a positive opinion, the Decision proceeds to the next stage. 
The number of objections is fairly low but nevertheless on the rise  (sees point 7 of 
this annex) with most occurring in relati on to the directives on machinery, toys and 
pressure equipment. 
D
IRECTIVE  P ROCEDURE FOR OBJECTIONS TO A HARMONISED STANDARD  
Council Directive 
86/594/EEC of 1 
December 1986 on 
airborne noise 
emitted by household appliances 
 Article 9 
 
1 Where a Member State or the Commission considers that the 
harmonised standards referred to in  Article 8 (1) (a) do not fully 
satisfy the requirements of Article 6, that Member State or the Commission shall bring the matter before the Standing Committee set up by Directive 83/189/EEC, hereinafter referred to as the 'Committee', setting out its reasons for doing so. The Committee shall deliver an opinion as a matter of urgency.  
 In the light of the Committee's opinion, the Commission shall notify 
the Member States as to whether or not the standards concerned should be withdrawn from the publica tions referred to in Article 8 
(1)(a).  
Council Directive 89/106/EEC of 21 December 1988 on 
the approximation of 
laws, regulations and administrative provisions of the Member States 
relating to 
construction 
products   
 Article 5
 
1 Where a Member State or the Comm ission is of the opinion that the 
harmonised standards or European t echnical approvals referred to in 
Article 4 (2), points (a) and (b), or the mandates referred to in 
Chapter II, do not satisfy the provisions of Articles 2 and 3, that Member State or the Commission shall notify the committee referred to in Article 19, setting out its reasons. The committee shall 
deliver an urgent opinion. In the light of the opinion of the 
committee, and after consultation with the committee set up under 
Directive 83/189/EEC where it concerns harmonised standards, the Commission shall inform Member States if the standards or approvals concerned should be withdrawn in the publications 
referred to in Article 7 (3). 
2 On reception of the communication referred to in Article 4 (3), the 
Commission shall consult the committe e referred to in Article 19. In 
the light of the opinion of the committee, the Commission shall notify Member States whether the t echnical specification in question 
should benefit from the presumption of conformity and, if so, publish a reference to it in the Official Journal of the European 
Communities. If the Commission or a Member State believes that a 
technical specification no longer fulfils the conditions necessary for presumption of conformity with the provisions of Articles 2 and 3, the Commission shall consult the committee referred to in Article 
 
EN 149   EN 19. In the light of the opinion of the said committee, the 
Commission shall notify the Member States whether the national 
technical specification in question should continue to benefit from 
presumption of conformity, and, if not, whether the reference to it referred to in Article 4 (3) should be withdrawn. 
Council Directive 89/686/EEC of 21 December 1989 on the approximation of 
the laws of the 
Member States relating to personal 
protective 
equipment  
(89/686/EEC) 
 Article 6
 
1 Should a Member State or the Commission consider that the 
harmonised standards referred to in Article 5 do not completely 
satisfy the relevant basic requireme nts referred to in Article 3, the 
Commission or the Member State concerned shall refer the matter to 
the committee created pursuant to Directive 83/189/EEC (1), setting out its reasons. The committee sha ll deliver an opinion without 
delay.  
 In the light of the committee's opinion, the Commission shall notify 
Member States of whether or not it is necessary to withdraw the 
standards concerned from publications  made pursuant to Article 5. 
Council Directive 
90/385/EEC of 20 June 1990 on the approximation of the laws of the Member 
States relating to 
active implantable 
medical Devices  
 Article 6
 
1 Where a Member State or the Commission considers that the 
harmonised standards referred to in Article 5 do not entirely meet the essential requirements referred to  in Article 3, the Commission 
or the Member State concerned shall bring the matter before the 
Standing Committee set up under Directive 83/189/EEC, giving the 
reasons therefor. The Committee shall deliver an opinion without delay. 
 In the light of the opinion of the Committee, the Commission shall 
inform Member States of the measures to be taken with regard to the 
standards and the publication referred to in Article 5. 
Council Directive 
92/42/EEC of 21 
May 1992 on 
efficiency 
requirements for new hot-water boilers fired with 
liquid or gaseous 
fuels  [No procedure for objections] 
Council Directive 
93/15/EEC of 5 April 1993 on the harmonization of the provisions relating to 
the placing on the 
market and supervision of 
explosives for civil 
uses Article 5 
 
Where a Member State or the Commission considers that the harmonised 
standards referred to in Article 4 do not  fully satisfy the essential requirements 
referred to in Article 3, the Commission or the Member State concerned shall bring the matter before the Standing Committee set up by Directive 
83/189/EEC, giving its reasons. The Committee shall deliver its opinion 
without delay.  
In the light of the Committee's opinion the Commission shall inform the 
 
EN 150   EN Member States of the measures to be taken regarding the standards and the 
publication referred to in Article 4.  
Council Directive 93/42/EEC of 14 
June 1993 concerning medical 
devices  Article 5
 
1 If a Member State or the Commission considers that the harmonised 
standards do not entirely meet the es sential requirements referred to 
in Article 3, the measures to be taken by the Member States with regard to these standards and the pu blication referred to in paragraph 
1 of this Article shall be adopted by the procedure defined in Article 
6 (2). 
Article 6
 
1 The Commission shall be assisted by the Committee set up by 
Article 5 of Directive 83/189/EEC, hereinafter referred to as ‘the 
Committee’. 
2 Where reference is made to this Article, Articles 3 and 7 of Decision 
1999/468/EC (1) shall apply, having regard to the provisions of 
Article 8 thereof. 
3 The Committee shall adopt its rules of procedure.  
Directive 94/9/EC of 
the European Parliament and the Council of 23 March 
1994 on the 
approximation of the laws of the Member States concerning 
equipment and 
protective systems 
intended for use in 
potentially explosive atmospheres  Article 6
 
1 Where a Member State or the Commission considers that the 
harmonised standards referred to in Article 5 (2) do not entirely satisfy the relevant essential health and safety requirements referred 
to in Article 3, the Commission or the Member State concerned shall 
bring the matter before the Committee set up under Directive 83/189/EEC, hereinafter referred to as 'the Committee', giving 
reasons therefor. The Committee shall deliver an opinion without delay. 
 Upon receipt of the Committee's opinion, the Commission shall 
inform the Member States whether or not it is necessary to withdraw 
those standards from the published in formation referred to in Article 
5 (2). 
Directive 94/25 of the European Parliament and the Council of 16 June 
1994 on the 
approximation of the laws, regulations and administrative provisions of the 
Member States 
relating to 
recreational craft  Article 6
 
1 Where a Member State or the Comm ission is of the opinion that the 
harmonised standards referred to in Article 5 do not fully meet the essential requirements referred to in Article 3, the Commission or 
the Member State shall notify the committee set up under Directive 
83/189/EEC 
 In the light of the opinion of the committee, the Commission shall 
inform Member States if the standards concerned should be withdrawn from the publications referred to in Article 5. 
European Parliament Article 6  
 
EN 151   EN and Council 
Directive 95/16/EC 
of 29 June 1995 on the approximation of the laws of the Member States relating to lifts 1 Where a Member State or the Commission considers that the 
harmonised standards referred to in Article 5 (2) do not entirely 
satisfy the essential requirements referred to in Article 3, the Commission or the Member State concerned shall bring the matter before the Committee set up under Di rective 83/189/EEC, giving the 
reasons therefor. The Committee shall deliver an opinion without delay. 
 Upon receipt of the Committee's opinion, the Commission shall 
inform the Member States whether or not it is necessary to withdraw those standards from the published in formation referred to in Article 
5 (2). 
Council Directive 96/48/EC of 23 July 1996 on the interoperability of the trans-European high-speed rail system  
 Article 11
 
Where it appears to a Member State or the Commission that European 
specifications used directly or indirect ly for the purposes of this Directive do 
not meet the essential requirements, partial or total withdrawal of the 
specifications concerned from the publi cations containing them, or their 
amendment, may be decided upon in accord ance with the procedure set out in 
Article 21(2) after consultation of  the Committee set up under Directive 
98/34/EC of the European Parliament and of the Council of 22 June 1998 
laying down a procedure for the provision of information in the field of 
technical standards and regulations and of rules on information society services. 
Council Directive 96/98/EC of 20 December 1996 on 
marine equipment   
 [No procedure for objections] 
Directive 97/23/EC 
of the European 
Parliament and of 
the Council of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment Article 6
 
Where a Member State or the Commission considers that the standards 
referred to in Article 5 (2) do not en tirely meet the essential requirements 
referred to in Article 3, the Member State concerned or the Commission shall inform the Standing Committee set up by Article 5 of Directive 83/189/EEC giving the reasons therefor. The Comm ittee shall issue an opinion as a matter 
of urgency. 
Taking into account the Committee's opinion, the Commission shall notify the 
Member States as to whether or not those standards should be withdrawn from 
the publications referred to in Article 5 (2). 
Directive 97/67/EC of the European Parliament and of the Council of 15 December 1997 on 
common rules for 
the development of the internal market of Community postal services  and Article 20
 
The harmonisation of technical standard s shall be continued, taking into 
account in particular the interests of users. 
The European Committee for Standardisa tion shall be entrusted with drawing 
up technical standards applicable in the postal sector on the basis of remits to 
it pursuant to the principles set out in Council Directive 83/189/EEC of 28 
March1983 laying down a procedure for the provision of information in the 
 
EN 152   EN the improvement of 
quality of service 
 field of technical standards and regulations.  
This work shall take account of th e harmonisation measures adopted at 
international level and in particular those decided upon within the Universal 
Postal Union. 
The standards applicable shall be publis hed in the Official Journal of the 
European Communities once a year. 
Directive 98/79/EC of the European Parliament and of 
the Council of 27 
October 1998 on in 
vitro diagnostic 
medical devices  
 Article 5
 
2 If a Member State or the Commission considers that the harmonised 
standards do not entirely meet the es sential requirements referred to 
in Article 3, the measures to be taken by the Member States with 
regard to these standards and the pu blication referred to in paragraph 
1 of this Article shall be adopted by the procedure defined in Article 
6(2). 
Article 6  
1 The Commission shall be assist ed by the committee set up by 
Article 5 of Directive 98/34/EC. 
2 The representative of the Commission shall submit to the committee 
a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay 
down according to the urgency of the matter, if necessary by taking 
a vote. 
 The opinion shall be recorded in the minutes; in addition, each 
Member State shall have the right to ask to have its position recorded in the minutes. 
 The Commission shall take the utmost account of the opinion 
delivered by the committee. It shall inform the committee of the 
manner in which its opinion has been taken into account. 
Directive 1999/5/EC 
of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment  
and the mutual 
recognition of their 
conformity 
 Article 5
 
2. Where a Member State or the Commission considers that conformity 
with a harmonised standard does not ensure compliance with the 
essential requirements referred to in Article 3 which the said standard is intended to cover, the Commission or the Member State 
concerned shall bring the matter before the committee. 
3 In the case of shortcomings of harmonised standards with respect to 
the essential requirements, the Commission may, after consulting the committee and in accordance with the procedure laid down in 
Article 14, publish in the Official Journal of the European Communities guidelines on the in terpretation of harmonised 
standards or the conditions under which compliance with that 
standard raises a presumption of conformity. After consultation of 
the committee and in accordance with  the procedure laid down in 
Article 14, the Commission may withdraw harmonised standards by publication of a notice in the Official Journal of the European 
 
EN 153   EN Communities. 
Directive 2000/9/EC 
of the European 
Parliament and of 
the Council of 20 March 2000 relating to cableway 
installations 
designed to carry 
persons 
 Article 2
 
2. "European specification" shall mean a common technical 
specification, a European technical approval or a national standard 
transposing a European standard. 
3 The references of European specifications, which may be common 
technical specifications, European technical approvals within the meaning of Directive 93/38/EEC or national standards used to transpose harmonised European sta ndards, shall be published in the 
Official Journal of the European Communities. 
4 Member States shall publish the references of national standards 
used to transpose harmonised  European standards.  
7 Where a Member State or the Commission considers that a 
European specification as referred to in paragraph 2 does not 
entirely satisfy the essential requirements referred to in Article 3(1), 
the Commission or the Member State concerned shall bring the matter before the committee referred to in Article 17 giving the reasons therefor. The committee shall deliver an opinion without delay. 
 In the light of the committee's opinion and following consultations 
with the committee set up pursuant to Directive 98/34/EC in the case of harmonised European standards, the Commission shall inform the Member States whether or not it is necessary to withdraw the European specifications in ques tion from the published information 
referred to in paragraph 3. 
Directive 2001/16/EC of the 
European Parliament 
and of the Council of 19 March 2001 on the interoperability 
of the conventional 
rail system Article 11
 
Where it appears to a Member State or the Commission that European 
specifications used directly or indir ectly to achieve the objectives of this 
Directive do not meet the essential requirements, partial or total withdrawal of the specifications concerned from the pub lications containing them, or their 
amendment, may be decided upon in accord ance with the procedure set out in 
Article 21(2) after consultation of the committee set up under Directive 
98/34/EC. 
Directive 2001/95/EC of the 
European Parliament and of the Council of 3 December 2001 on 
general product 
safety 
 Article 4
 
2. The Commission shall publish in the Official Journal of the 
European Communities the referen ces of the European standards 
adopted in this way and drawn up in accordance with the requirements referred to in paragraph 1. 
 If a standard adopted by the European standardisation bodies before 
the entry into force of this Dir ective ensures compliance with the 
general safety requirement, the Commission shall decide to publish 
its references in the Official Journal of the European Communities. 
 
EN 154   EN  If a standard does not ensure compliance with the general safety 
requirement, the Commission shall withdraw reference to the 
standard from publication in whole or in part. 
 In the cases referred to in the second and third subparagraphs, the 
Commission shall, on its own initiative or at the request of a Member State, decide in accordan ce with the procedure laid down in 
Article 15(2) whether the standard  in question meets the general 
safety requirement. The Commission shall decide to publish or 
withdraw after consulting the Committee established by Article 5 of Directive 98/34/EC. The Commission shall notify the Member States of its decision. 
Directive 2004/22/EC of the European Parliament 
and of the Council of 
31 March 2004 on 
measuring 
instruments 
 Article 14
 
Where a Member State or the Commission considers that a European 
harmonised standard as referred to in Article 13(1) does not fully meet the 
essential requirements referred to in Anne x I and in the relevant instrument-
specific Annexes, the Member State or  the Commission shall bring the matter 
before the Standing Committee set up unde r Article 5 of Directive 98/34/EC, 
giving its reasons for doing so. The Committee shall deliver an opinion without delay. 
In the light of the Committee's opinion, the Commission shall inform the 
Member States whether or not it is necessary to withdraw the references to the national standards from the publication refe rred to in the third subparagraph of 
Article 13(1). 
Directive 2004/108/EC of the European Parliament and of the Council of 
15 December 2004 
on the approximation of the laws of the Member States relating to electromagnetic 
compatibility  and 
repealing Directive 89/336/EEC  Article 6
 
1 "Harmonised standard" means a t echnical specification adopted by a 
recognised European standardisation body under a mandate from the Commission in conformity with the procedures laid down in 
Directive 98/34/EC for the purpose of establishing a European 
requirement. Compliance with a "harmonised standard" is not compulsory. 
2 The compliance of equipment with the relevant harmonised 
standards whose references have been published in the Official 
Journal of the European Union shall raise a presumption, on the part 
of the Member States, of conformity with the essential requirements referred to in Annex I to whic h such standards relate. This 
presumption of conformity is limite d to the scope of the harmonised 
standard(s) applied and the releva nt essential requirements covered 
by such harmonised standard(s). 
3 Where a Member State or the Commission considers that a 
harmonised standard does not entirely satisfy the essential requirements referred to in Annex I,  it shall bring the matter before 
the Standing Committee set up by Directive 98/34/EC (hereinafter "the Committee"), stating its reasons. The Committee shall deliver 
an opinion without delay. 
4 Upon receipt of the Committee's opinion, the Commission shall take 
 
EN 155   EN one of the following decisions with regard to the references to the 
harmonised standard concerned: 
(a) not to publish; (b) to publish with restrictions; (c) to maintain the reference in th e Official Journal of the European 
Union; 
(d) to withdraw the reference from the Official Journal of the 
European Union. 
The Commission shall inform the Member States of its decision 
without delay 
Directive 2006/42/EC of the European Parliament and of the Council of 
17 May 2006 on 
machinery , and 
amending Directive 95/16/EC  
 Article 10
 
Where a Member State or the Commission considers that a harmonised 
standard does not entirely satisfy the essential health and safety requirements which it covers and which are set out in Annex I, the Commission or the 
Member State shall bring the matter before the committee set up by Directive 
98/34/EC, setting out the reasons therefor. The committee shall deliver an opinion without delay. In the light of the committee's opinion, the Commission shall decide to publish, not to publish, to publish with restriction, to maintain, to maintain with restricti on or to withdraw the references to the 
harmonised standard concerned in the Official Journal of the European Union. 
Directive 2006/95/EC of the 
European Parliament and of the Council of 12 December 2006 on the harmonisation of the laws of 
Member States 
relating to electrical 
equipment 
designed for use within certain 
voltage limits  
(codified version)  
 [No procedure for objections] 
Directive 
2007/23/EC of the European Parliament and of the Council of 23 May 2007 on the 
placing on the 
market of 
pyrotechnic articles   Article 8
 
4. Where a Member State or the Commission considers that the harmonised 
standards referred to in paragraph 2 of this Article do not fully satisfy the 
essential safety requirements set out in Annex I, the Commission or the Member State concerned shall refer th e matter to the Standing Committee set 
up by Directive 98/34/EC, giving its reasons. The Standing Committee shall 
deliver its opinion within six months of such referral. In the light of the Standing Committee's opinion the Commission shall inform the Member States of the measures to be taken rega rding the harmonised standards and the 
publication referred to in paragraph 2. 
 
EN 156   EN Directive 
2009/23/EC of the 
European Parliament and of the Council of 23 April 2009 on 
non-automatic 
weighing 
instruments 
 Article 7
 
Where a Member State or the Commission considers that the harmonised 
standards referred to in Article 6(1) do not fully meet the essential requirements set out in Annex I, the Commission or the Member State concerned shall bring the matter befo re the Standing Committee set up under 
Article 5 of Directive 98/34/EC, hereinafter referred to as "the Committee", giving its reasons for doing so. 
The Committee shall deliver an opinion without delay. 
In the light of the Committee’s opinion, the Commission shall inform the 
Member States whether or not it is necessary to withdraw those standards from the publications referred to in Article 6(2). 
Directive 2009/48/EC of the European Parliament 
and of the Council of 
18 June 2009 on the safety of toys 
 Article 14
 
1 When a Member State or the Commission considers that a 
harmonised standard does not entirely satisfy the requirements 
which it covers and which are set out  in Article 10 and Annex II, the 
Commission or the Member State concerned shall bring the matter before the Committee set up by Article 5 of Directive 98/34/EC, giving its arguments. The Committee shall, having consulted the relevant European standardisation bodies, deliver its opinion without 
delay. 
2 In the light of the Committee's opinion, the Commission shall decide 
to publish, not to publis h, to publish with restriction, to maintain, to 
maintain with restriction or to withdraw the references to the 
harmonised standard concerned in or  from the Official Journal of the 
European Union. 
3 The Commission shall inform the European standardisation body 
concerned and, if necessary, request the revision of the harmonised standards concerned. 
Directive 2009/105/EC of the European Parliament and of the Council of 
16 September 2009 
relating to simple 
pressure vessels 
 Article 6
 
Where a Member State or the Commission considers that the harmonised 
standards referred to in Article 5(1) do not entirely meet the essential safety requirements set out in Annex I, the Commission or the Member State 
concerned shall bring the matter before  the standing committee set up under 
Article 5 of Directive 98/34/EC, hereinafter referred to as "the committee", giving the reasons therefor. 
The committee shall deliver an opinion without delay. In the light of the committee’s opini on, the Commission shall inform the 
Member States whether it is necessary to withdraw those standards from the 
publications referred to in Article 5(1). 
Directive 
2009/142/EC of the European Parliament Article 6
 
1. Where a Member State or the Commission considers that 
the standards referred to in Article 5(1) do not entirely meet 
 
EN 157   EN and of the Council of 
30 November 2009 
relating to 
appliances burning 
gaseous fuels   the essential requirements set out in Annex I, the 
Commission or the Member State concerned shall bring the 
matter before the standing committee established under Article 5 of Directive 98/34/EC, hereinafter referred to as "the committee", giving the reasons therefor. 
 The committee shall deliver an opinion without delay. 
 In the light of the comm ittee’s opinion, the Commission 
shall inform the Member States whether or not it is 
necessary to withdraw those standards from the publications referred to in the first subparagraph of Article 5(2). 
2. After receipt of the communication referred to in the second 
subparagraph of Article 5(2) , the Commission shall consult 
the committee. 
 Upon receipt of the committee’s opinion, the Commission 
shall, within one month, inform the Member States whether 
the national standard(s) in question are to enjoy the presumption of conformity. If they are, the Member States shall publish the reference numbers of those standards. 
 The Commission shall also publish them in the Official 
Journal of the European Union. 
 
EN 158   EN  
FORMAL OBJECTIONS (2002-2010) 
  Standard Directive  Decision Date Decision 
number O.J. Reference 
1 EN 848-3 "Safety of woodworking machines — 
One-side moulding machines with rotating tool — Part 3: Numerical control boring machines and 
routing machines 98/37/EC 
machinery Presumption of conformity 
not withdrawn 17/12/2002 2002/1002/EC
  L 349/103 
24/12/2002  
EN 613:2000 ‘Independent  gas-fired convection 2 
heaters’ 90/396/EEC 
appliances burning 
gaseous fuels Presumption of conformity 
not withdrawn 18/03/2003 2003/189/EC   L 74/26 
20/03/2003  
EN 521:1998 ‘Specifications for dedicated 
liquefied 3 
petroleum gas appliances — Portable vapour 
pressure liquefied petroleum gas appliances’, 90/396/EEC 
appliances burning 
gaseous fuels Presumption of conformity 
not withdrawn 18/03/2003 2003/190/EC   L 74/28 
20/03/2003 
EN 1495:1997 ‘Lifting platforms — mast climbing 4 
work platforms’ 98/37/EC 
machinery Partial withdrawal of 
presumption of conformity21/03/2003 2003/224/EC L 83/70 
01/04/2003  
30 standards relating to thermal insulation products, geotextiles,  5 
fixed fire-fighting equipment and gypsum blocks  89/106/EEC 
construction 
products Presumption of conformity 
not withdrawn 9/04/2003 2003/312/EC   L 114/50 
08/05/2003  
EN 1970:2000 ‘Adjustable beds for disabled 6 
persons — Requirements and test methods’ 93/42/EEC medical 
devices Presumption of conformity 
not withdrawn 20/04/2004 2004/376/EC   L 118/76 
23/04/2004  
EN 12180:2000 ‘Non-active surgical implants — 7 
Body contouring implants — Specific 
requirements for mammary implants’ 93/42/EEC medical 
devices Presumption of conformity 
withdrawn 20/04/2004 2004/389/EC   L 120/48 
24/4/2004  
8 EN 71-1:1998 “Safety of Toys – Part 1: 
mechanical and physical properties 88/378/EEC toys Partial withdrawal of 
presumption of conformity 9/03/2005 2005/195/EC L 63/27 
10/03/2005 
 
EN 159   EN 9 EN 143:2000 -“Respiratory protective device – 
Particle filters - Requirements, testing, marking” 89/686/EEC 
Personal 
Protective Equipment  Presumption of conformity 
partially withdrawn 16.03.2006 2006/216/EC L 080/76 
17.03.2006 
10 EN 13000 - Cranes 98/37/CE 
Machinery Presumption of conformity 
partialy withdrawn 24.11.2005 2006/731/EC L 299/26 
28.10.2006 
11 EN 13683 :2003 - Garden equipment - Integrally 
powered shredders/chippers 98/37/CE 
Machinery Non publication of the 
reference on the OJ 24.11.2005 2006/732/EC L 299/29 
28.10.2006 
12 EN ISO 14122-4 - Safety of machinery - 
Permanent means of access to machinery - Part 4: Fixed ladders (ISO 14122-4:2004) 98/37/CE 
Machinery Non publication of the 
reference on the OJ 24.11.2005 2006/733/EC L 299/30 
28.10.2006 
13 EN 848-3 - Safety of woodworking machines - 
One side moulding machines with rotating tool - Part 3 : numerical control boring machines and routing machines 98/37/CE 
Machinery Presumption of conformity 
partially withdrawn 02.03.2006 2006/704/EC L 343/102 
08.12.2006 
14 EN 10080:2005 – Steel for the reinforcement of 
concrete 89/106 
Construction Products Presumption of conformity 
withdrawn 15.09.2006 2006/893/EC L 291/35 
21.10.2007 
15 EN 71-1:2005 - Hemispheric toys - 5.12 first 
indent (former A 10) 88/378/EEC Toys Presumption of conformity 
partially withdrawn 25.09.2006 2007/184/EC L 85/7 
27.03.2007 
16 EN 71-1:2005 - Suction cups - 8.4.2.3 (former A 
11) 88/378/EEC Toys Presumption of conformity 
partially withdrawn 25.09.2006 2007/224/EC L 96/18 
11.04.2007 
 
EN 160   EN 17 EN 12929-2:2004 - Safety requirements for 
cableway installations de signed to carry persons 
— General requirements — Part 2: Additional requirements for reversible bicable aerial ropeways without carrier truck brakes 2000/9/EC 
cableway 
installations designed to carry persons Presumption of conformity 
non withdrawn 26.11.2008 Decision in the 
communication 
C(2008)7289  Not published 
18 EN 3-8:2006 - Portable fire extinguishers - Part 
8: Additional requirements to EN 3-7 for the 
construction; resistance to pressure and 
mechanical tests for extinguishers with a maximum allowable pressure equal to or lower than 30 bar 97/23/EC Pressure 
Equipment Publication of the 
reference on the OJ 13.11.2008 2009/111/EC L 48/13 
19.02.2009 
19 EN 3-9:2006 - Portable fire extinguishers — Part 
9: Additional requirements to EN 3-7 for pressure resistance of CO2 extinguishers 97/23/EC Pressure 
Equipment Non publication of the 
reference on the OJ 13.11.2009 2009/140/EC L 40/33 
11.02.2010 
 
EN 161   EN 9.5. ANNEX 5 – DISCARDED OPTIONS 
During the public consultation, stakeholders  commented on severa l possible options 
which, mainly on the basis of the comments made by stakeholders, were not retained 
for further analysis in this impact assessm ent report for the reasons set out below.  
9.5.1. Fundamental changes to the EU fi nancing of European standardisation 
An external evaluation of the financial support allocated to the ESOs by EC/EFTA 
through operating and action grants si gned between 1 January 2004 and 31 
December 200798 shows, inter alia, that the financ ing of European st andardisation by 
EC/EFTA is both appropriate and nece ssary, and widely supported by all 
stakeholders. The evaluation indicates that this financing is very useful to the 
European standardisation system, provi ding additional management capacity and 
expertise and helping to offset the costs to  industry of standa rd development. The 
evaluation suggests that, under improved conditions, there would be a strong case for an increased budgetary alloca tion due to the significant benefit the support delivers. 
While the Commission has a strong policy interest in ensuring that standardisation 
work goes ahead, EU/EFTA financing is not so high as to motivate stakeholders, in 
particular businesses, to carry out unneces sary standard development work that 
ultimately will not be taken up. As a result, business input into the process is not financed by the EU. Instead, the financing is concentrated on the infrastructure that coordinates and administrates the work, a nd then only to share the cost of this 
activity. The financing does not support th e national mirror committees or national 
delegations through which most industry and other stakeholder input is provided. As 
such, the financing of standardisation does not follow a traditional ‘market failure’ 
logic wherein public money is used to s upport economically or socially useful 
activity that industry will not finance itself (except as re gards the participation of 
SMEs and societal stakeholders). In fact , if businesses are not willing to put their 
own resources into standardisation work, then nor should the Commission or EFTA, 
as this would foster the development of redundant standards. Instead, the financing 
follows more of a cost-sharing model, wher e it is recognised that common interests 
are being pursued and that it is therefore appropriate that some level of support is 
provided through public financing. 
9.5.2. Making European standards available free of charge 
CEN and CENELEC adopt European standard s which are transposed into national 
standards which are then sold by NSBs. Some stakeholders argue that if the 
Commission pays a financial contribution to the development of European standards, 
those standards should be made freely availabl e, rather than being sold by the NSBs. 
This is considered particularly important for SMEs who may struggle to afford the purchase price of the standa rds they need to use.  
                                                
 
98 Evaluation of the Contribution of Community Financing of Standardisation to the Fulfilment of Policy 
Objectives of the Commission, submitted by GHK/Technopolis on 30 June 2009. 
http://ec.europa.eu/enterprise/dg/files/evaluation/2009-06-30__final_report_and_appendices_en.pdf .  
 
EN 162   EN At first glance, the idea of making all Eur opean standards freely available seems an 
attractive concept. However,  there are also strong ar guments against making all 
European standards freely available: 
(1) The Commission does not pay the entire cost of development of European 
standards. The vast majority of the costs are borne by i ndustry. The financial 
contribution of the EU relates only to a share of certain specific elements of 
the overall input.  
(2) There would be very significant financial implications to the adoption of this 
option, with losses at NSB level runni ng into many tens and possibly more 
than a hundred million euros annually (acr oss all European NSBs). The total 
operating budget in 2008 for the 32 NSBs wa s €437m, an average of just over 
€13.6m each. The budgets ranged between  less than €200k and over €70m, 
but were skewed towards the lower end of this range. Near ly half (47%) of 
the NSBs had an operating budget in 2008 of less than €2.5m, while less than a third (29%) had a budget of more than €10m. The total revenue from the 
sale of standards for the 32 NSBs wa s €113m, an average of just over €3.5m 
each. As with overall budgets, the revenue from the sale of standards varied 
considerably between NSBs, ranging from €25k to €25m. Over one third 
(34%) of NSBs received less than €500k in sales, while another third (34%) 
received more than €3m. Based on the figures provided for the 32 NSBs, just 
over one quarter (26%) of  the operating budgets of these NSBs in 2008 (in 
total) was made up from the sale of standards. For the individual NSBs, this proportion varied between 2% and 62% , with a reasonably even spread 
between the two extremes. There is no obvious correlation between the 
overall size of an NSB’s operating budge t and the proportion of  sales that are 
accounted for by the sale of standards. 
(3) Purchasing a standard is a legitimate business cost or investment. There are 
many things that businesses need to buy in order to operate effectively, and 
within the overall scheme of things the purchase price of standards is a 
relatively modest element.  
(4) Making standards freely available implies that large sections  of industry that 
have made no contribution to their de velopment would gain the same rights 
of free access as those that have contributed significantly to their development.  
(5) The public sector would have to take  over a substantial element of the 
financing of the NSBs and may also have  to increase the extent to which it 
supports the wider costs of development of standards, reduc ing the extent to 
which standard development is indust ry-driven as opposed to publicly-driven. 
The principles of the New Approach  strongly suggest that standard 
development should be left to the mark et, and this principle arguably extends 
to questions about how development co sts are financed/recouped. The danger 
is that a push for free standards would involve a shift towards a model where 
the public sector pays a much higher sh are of development costs, potentially 
leading to a situation where the public sector exercises greater control over how and where standards are developed, who participates, etc. This would 
 
EN 163   EN inevitably mark a shift away from the principles of the New Approach, with 
unclear and possibly unwelcome consequences for the functioning of the system as a whole.  
Consequently, this option wa s not further analysed.  
9.5.3. Making harmonised standards available free of charge 
The vast majority of NSBs were unable to  provide an estimate of the income from 
the sale of European Harmonised Standa rds separately from the sales of all 
standards. Many NSBs also provided suppor ting arguments (see below) as to why 
such an estimate is in any case not a sound basis for estimating the losses to the 
NSBs and the system more widely. 
Four of the NSBs did provide an estimate of the income from sales of Harmonised 
standards, but in one case only one year’s data could be provided and in another the 
figures did not include sales of harmonised standards that are based on ISO or IEC 
standards. The income data for the sale of European harmonised standards provided 
by the four NSBs totalled €1.46 million acro ss the five year period, an average of 
€365.4k for each NSB across the five year period. This equates to an average annual loss per NSB of €73k each. It should be noted, however, that where an NSB could not provide estimates for each of the last fi ve years an ‘average  amount per year’ has 
been calculated from the data provided in orde r to give a full five year total. It should 
also be noted that in one case the sales of European HS based on ISO/IEC data has not been included in the figures. Because da ta only covers four out of 40 NSBs it is 
not possible to gross these figures up to identify total income from sale of European HS in any reliable way.  
Most NSBs stated that it wa s not possible to provide income data for European HS 
separately from other European standards and / or sales of other publications such as 
national standards because their informati on systems do not record separate figures 
for these different revenue streams. Some of  these NSBs pointed out that due to the 
various access models and charging arrange ments, often linked to membership and 
other products developed for customers,  it would be a very complex and time-
consuming (in some cases impossible) task to provide a realisti c estimate. Several 
NSBs rejected the idea that the purchase pri ce of European HS is a significant barrier 
to their use by SMEs. Some pointed to information contained in ‘SME access’ studies carried out e ither by the Commission or by CEN /C LC that shows that lack of 
awareness of the benefits of standards, l ack of understanding of  which standards to 
use, lack of information on standards a nd the costs of implem enting standards are 
more significant barriers. Several NSBs also  pointed out that they are constantly 
striving to improve access to standards in  general and harmonised standards in 
particular, and that they ar e providing more information about standards and more 
competitive (i.e. lower priced) products, ofte n tailored to SMEs, in order to improve 
access and take-up. 
During the consultation of January-Febru ary 2010, only 10 provided a quantitative 
estimate of the losses average annual losse s, in EUR, to the NSB if harmonised 
standards would be made freely available. The other 30 NSBs reaffirmed their earlier 
comments, stating that it is not possible to  provide an estimate of the annual loss of 
 
EN 164   EN revenue as the sale of European ha rmonised standards ca nnot be identified 
separately. Of the ten NSBs providing qua ntitative informati on, eight provided an 
estimate of the annual losses ar ising were European HS to be made freely available. 
Among these eight NSBs the estimated total annual losses would be €11.37 million, equivalent to just over €1.42 million per NSB.  This is close to (~95% of) the total 
income from sales of all products cont aining standards for these eight NSBs, 
although the ratios varied significantly, from a low of ~20% of all income from sales 
of standards to ~120% of the income from  sales of standards. The reasons for the 
variations and the high overall estimate of  losses as a proportion of sales of (all) 
standards can be explained by  the fact that different NSBs have used different 
methods for calculating potential losses. Three NSBs that did not provide a € 
estimate of the losses nonetheless stated th at they would lose between 20% and 30% 
of their total revenues if the ability to se ll European HS would be withdrawn. If these 
estimates of the share of total income lost are correct then the total losses to all European NSBs would be in the orde r of between €100-150 m illion per annum. 
Due to the lack of accurate data on NSB income from sales from European HS and 
due to uncertainties surrounding the ‘knock-on’ effects to ot her revenue streams it is 
not possible to provide a robust estimate of th e financial impact of  this provision on 
NSBs. However, a ‘lower’ estimate might be that NSBs would lose 40% of their total 
income from sales of standards, equivalent  to ~10% of their total operating budgets. 
This would equate to roughly €50 million pe r annum across all European NSBs. An 
‘upper’ estimate might be that NSBs would lose 20% of their total operating costs, 
equivalent to around €100 million per annum in total across all European NSBs.  
In any event, there would be very significan t practical implications to the adoption of 
this option, including disruption to the estab lished business models of standardisation 
at national, European and International leve ls, and contravention of legal agreements 
and frameworks outside the scope of Di rective 98/34/EC. More over, the specific 
consultation of January-February 2010 s hows significant opposition to the adoption 
of this option at ESO, NSB and MSA le vels, although it has some backing ‘in 
principle’ by some MSAs. 
9.5.4. Member States to compensate losses generated for the budget of NSBs due to free 
access to Harmonised Standards 
83% of MSAs responding to the specific consultation of January-February 2010 
stated that they would not be willing and / or able to compensate for losses. They 
pointed to issues of funding (the scale of losses to NSBs  and the inability of public 
funds to compensate) and the potential lack of  benefits as reasons for this response. 
Four MSAs highlighted the potential scale of the compensation package necessary, quoting figures of between €180,000 and €6 mill ion as estimates of the potential 
losses to NSBs. They reported that a la rge proportion of nati onal standardisation 
activities are already being funded by the st ate, and that the real scale of any 
potential financing need may be equivale nt to a significant proportion of these 
existing levels of financing. Two MSAs also raised thei r concerns as to how the 
compensation system would work and whethe r the financing package would increase 
with the number of standard s distributed. They suggested that free access to HS may 
increase demand and therefore the nece ssary compensation costs further.  
 
EN 165   EN The most commonly reported reason give n by MSAs was that the necessary budget 
would not be available to compensate the NSBs for loss of income (mentioned by eleven MSAs). It was reported that the provi sion would require a substantial increase 
in the demands on state budgets, and that this was unlikely to be acceptable, 
particularly in the current financial clim ate when public spending is being tightened. 
Other individual MSAs highlighted relate d concerns, namely (i) the risk of 
inconsistency in the annual approval of stat e funding in the future, (ii) the need to 
consider not only the loss of income, but al so the cost to the whole HS development 
process and the costs arising from changing the financing mo del, and (iii) the lack of 
a suitable mechanism to allow such a compensation package to be provided. Other 
MSAs (six in total) reported that they are not convinced that there is sufficient 
justification for the provision and for the additional state financial support. 
Specifically, they reported that (i) it is not  clear that the pri ce of standards is a 
significant barrier to access, or that free access would substantially increase uptake, 
and that (ii) an important as pect of the ESS is that it ensures orientation to market 
needs and avoids misuse of funds, wh ich may be damaged by the provision. 
CEN/CLC reported that as it does not sell standards itself, any compensation package 
should be directed to the NSBs and NC  members of CEN/CLC. However, the 
majority of these NSBs/NCs are (semi) private independent organisations, whose 
legal status is recognised as important by i ndustry and the majority of stakeholders in 
order to preserve independence in the sta ndardisation process. CEN/CLC believe that 
if these organisations were to accept receipt of EC/MSA financial support to 
compensate their financial loss, it would result in an increased dependency on these 
bodies, which may in turn have repercussions on the attitude of other actors. Such an 
approach also raises concerns for CEN/ CLC as to the long-term sustainability 
commitment of all Member States and the n eed for a wide coordina tion to ensure that 
the same activities are supported similarly a nd fairly in all countries. CEN/CLC also 
highlighted that, given that no more than 2%  of standardisation work is co-financed 
and the fact that NSBs are not keen to pa rticipate in co-financed mandated work (due 
to the heavy administrative workload), it may be unrealistic to believe that any loss of income could be compensated through use of additional co-financed mandates. 
There does not at present appear to be a ny clear basis for compensating NSBs for the 
losses that would be incurred from maki ng harmonised European standards freely 
available, with the majority of MSAs cu rrently unable or unwilling to be able to 
confirm that they would be in a position to  provide a compensation package. There is 
little consensus as to how any compensati on package should be organised, largely 
due to widespread rejection of the relate d option that gives rise to the need for 
compensation measures. However, it appears most likely that the package would have to be based on the full costs incurred by NSBs in supporting the development, 
implementation, dissemination and distribution of European HS. 
Even if an appropriate compensation p ackage could be implemented, fundamental 
issues relating in particular to the use of ISO/IEC standards as the basis for European 
standards would still have to be overcome. 
 
EN 166   EN 9.5.5. NSBs to provide free access to national  committees for SMEs, NGOs, consumer 
organisations and trade unions  
During the consultation of January-Februar y 2010, 21 NSBs (57%) stated that they 
do not levy any charges for participati on in standardisation committees, although 
several pointed out that this position is only possible due to the income generated from the sale of standards. There were a small number of caveats to this general 
position. In two cases participation is only granted to members, for which an annual 
fee is charged (€1,500 in one case, €500 in th e other). One other NSB noted that it is 
considering moving to a compulsory memb ership model in future (but doesn’t 
operate one presently). One other NSB stated that it expects to begin charging a fixed 
rate for committee membership (€500 per committee per year). It should be noted that in some cases it is not clear whether the ‘free access’ to committees is only available for members. One NSB operates a system with different charging mechanisms in different sectors. Detail ed information could therefore not be 
provided. One NSB operates a system wher e the members of each committee decide 
who will contribute and in what proportion. Two NSBs operate a form of ‘fixed rate’ 
charging. In one of these cases the rate is  fixed at €50 for all types of participant 
apart from public authorities where no charge is made. In the other case the rate is 
fixed at between €200 and €700 depending on th e project workload in the relevant 
EU or International committees. Two NSBs charge a one-off ‘entry’ fee (€420 in one 
case, €360 in the other) for each expert, i rrespective of how many committees they 
participate in or for how long. The entry fee includes a one day training course in 
standardisation. Ten NSBs operate some kind of tiered system of charges (different 
levels of fees to different types of participant). 
Across the ten NSBs that provided data, the average number of organisations paying 
fees for participation in standardisa tion committees each year from 2005-9 was 
10,045. This equates to an av erage of just over 1,000 orga nisations paying fees per 
NSB per year. Due to differences in the extent to which certain groups are or are not charged, and the numbers of committees opera ting at national level, there was a very 
broad range in the numbers of  organisations paying fees, from a low of 34 to a high 
of almost 6,000.  
For the six NSBs providing financial data on revenues generated, the total volume of 
fees generated between them per year was calculated to be just over €3.5 million. 
This equates to an averag e revenue of just over €580k pe r NSB per year. Once again 
there was a broad range in the data, with one NSB generating only €44k in fees each 
year on average, while at the other end of  the spectrum one NSB generated just over 
€1.4 million in fees. In some cases these reve nues relate to membership fees rather 
than revenues specifically rela ting to participation in committees. In all cases the data 
provided did not allow us to assess the revenues generated by different types of 
organisation. 
The three NSBs that provided data on th e share of revenues derived from each 
category of organisation paying contribu tions for participation in committees 
employed different categories so it was not possible to combine these two data sets into an overall result. However, broadly speaking public authorit ies and state bodies 
accounted for between 12% and 36%; enterp rises and professional bodies between 
50% and 80%; research organisations betw een 7% and 9%, and ‘others’ around 10%.  
 
EN 167   EN Because the charging models are very di fferent it is not possible to provide a 
breakdown by type of committee or types of organisation. In most cases the charging 
models are not based around the type of committee and in only around half of the 
cases are different levels of fees charge d to different types of organisation. The 
categories used to organise different types of participan t are different in each case, 
making any kind of aggregation of the data by organisation type impossible. 
Most NSBs would not be affected by the option as they do not currently charge for 
access to national committees. A small number of NSBs and MSAs clearly do not support this option, others appear to support the idea of free access in principle but 
most have not provided an  indication either way. 
Nevertheless, it is uncertain that there w ould be a legal basis fo r pursuing this option 
and that it would meet the subsidiarity test . A more detailed investigation would be 
necessary, including of the costs associat ed with providing free access to certain 
groups in those countries where such char ges are applied app ears warranted as a 
basis for further understanding the costs and implications of this option. 
9.5.6. Member States to ensure that minority stakeholders are represented in all national 
standardisation committees, including by providing financial support for representative groups at national level 
Support to enable MSG participation in sta ndardisation at nationa l level appears to 
be in place in around a third of the countries covered by the consultation. The nature of support provided varies, as does its scale,  the groups it is di rected to, how it is 
administered and so on. Most of the NSBs  stated that the pr inciple of open and 
equitable access applies, meaning that a ll groups have equal rights as regards access 
to standardisation committees and there is no ‘positive’ or ‘negative’ discrimination. 
In most of these cases participation in sta ndardisation is free to  all groups, and in the 
remaining cases the same fee is charged regardless of the type of participating organisation. Therefore, in these countries the principle followed is that all groups 
are treated equally and all ha ve equal access. In a small number of cases funding for 
MSGs enables free or reduced cost access to standardisation committees. Regardless of the financing situation, many NSBs indi cated that they relay information on new 
work items and new committees to MSGs to ensure  that they are ke pt informed about 
new opportunities to participate. Some also proactively target information on specific 
opportunities to specific groups. In several cases the NSBs operate dedicated committees to facilitate coordination of MSG involvement in standardisation at 
national level. One NSB stated that IT tool s have been developed that enable MSGs 
to participate remotely via tele- or video-conferencing. 
NSBs and MSAs were asked to estimate the cost to install and maintain a system of 
support for MSGs at national level (cos t per stakeholder gr oup per country per 
annum). 29 of the 40 NSBs (73%) provided a response to this question, but only 6 
felt able to provide an estimate of costs. The six NSBs providing an estimate of costs 
each came up with very different estimates, varying from €2,400 per annum (based on two person days support per month), €10,32 0 per annum (based on 10 participants 
in an average of 8 committees for 1 day per year), €44,345 per annum (costs not explained), €55,000 per annum (based on curre nt support to three MSGs, totalling 
€165,000 per annum), €83,600 per annum (cost basis not clear) to €600,000 (costs 
 
EN 168   EN not explained). Only one NSB provided an es timate of the ‘insta llation costs’ (€217, 
360, basis unclear).  
Several NSBs indicated that ‘free access’ to standardisation committees is not 
sufficient to ensure stakeholder participa tion, as many of the MSGs lack the human 
resources and expertise to become invol ved. Several mentioned that MSGs would 
need (or indeed would ‘expect’) to be paid to  participate, and installing such a system 
of financial support may prove to be rath er costly, and not something the MSAs 
would necessarily be able to afford. Ev en if such a funding system could be 
established, some of the MSGs  would still have difficulty in finding people with the 
necessary expertise to part icipate, although the assuranc e of a fee would certainly 
help boost participation rates.  
However, some other NSBs do not agree that  a system of financial support along the 
lines envisaged would be appropriate. On e of the core principles is that 
standardisation should be ope n and transparent and that  it should provide equal 
access to all interested stake holders. There is a danger that  the introduction of strong 
financial incentives for participation by certain groups would run counter to these 
principles. In addition, stakeholder partic ipation should be based around awareness 
of the benefits that particip ation will bring, rather than  as a means to obtain funding. 
There is accordingly a risk that participat ion by MSGs will not be effective as it 
could be because the wrong drivers are in place. 
One final issue that was mentioned is that some of the groups lack the necessary 
human resources and networks to cons ult their members effectively, and so 
providing funding for participation on st andardisation committees would only 
address part of the problem. If the MSGs are not equipped with sufficient levels of 
human resources and expertise to understa nd developments in standardisation, 
consult on those developments, and reach agreed  positions it is unclear what role the 
MSG ‘experts’ would be able to play in the standardisation meetings.  
The 12 MSAs (44% of those responding) providing quantitative figures estimated a 
cost of €200,000 per stakeholder per annum  on average. However, individual 
estimates varied greatly (between €2,400 and €1.1 million), as did the systems envisaged and the tasks required. Each  of the estimates provided and any 
supplementary information on the methodol ogy used to calculate these costs are 
summarised in the table below. 
 
EN 169   EN Estimated cost Comments 
€ 2,400 Based on 2 person-days per month 
€ 2,500 (No further explanation) 
€ 5,000 (No further explanation) 
€ 10,320 Based on 10 stakeholders in 8 TC s each, requiring one person-day of 
support per year 
€ 25,000 Development of a new structural unit, with 5 employees 
€ 75,000 Average - costs will vary per group 
€ 100,000 Includes the costs of personnel dedicated to the administration and 
operation of MSGs as well as the participation of up to ten 
representatives from those MSGs 
€ 100,000 Based on current Government support for consumer travel/expenses 
€ 190,000 Based on the costs of translation/in terpretation of En glish documents, 
covering mandated standards (1 employee), all other European standards of interest to MSG (2 employees), and all other relevant 
normative documents (2 employees) at ~€40,000 per employee 
€ 210,000 Based on current experience of funding trade unions, covering 
participation in ~50 national TCs (particularly those relating to Ergonomic and Social responsibility) 
€ 577,000 (No further explanation) 
€ 1,100,000 Based on experience of co-financing SME participation. Covers (i) 
the co-financed costs of SME-commissioned experts representing them in European/international sta ndardisation work (€1 million), and 
(ii) the management of the MSG group, involving identifying the 
professions concerned, highlighting the standardisation issues they face, selecting the most interesting projects and monitoring work in progress (1 FTE at €100k per year) 
One MSA reported that the possibility of developing a national system for supporting 
the representation of MSG interests in national TCs using public funds could be 
considered in cases where there was real interest from the MSG in an activity and 
where the support materialised in particip ation in relevant committees. However, 
they reported that actions aimed at impr oving MSG awareness of the importance of 
participation in standardisa tion activities and the implem entation of standards should 
be increased and diversified first. Another MSA stated that they would not support 
this provision as financial support to MS Gs might lead to a distortion of the 
behaviour of those parties in the standardisation process. 
In order to obtain a more reliable understanding of the costs and implications of this 
option one would need to make  clear whether the objectives are to ensure that MSGs 
have free access to standardisation comm ittees only or whether the costs of 
participation are also to be covered (fees , travel, subsistence) . It would also be 
necessary to specify what level of involveme nt is envisaged (i.e. participation in all 
committees or only some) and whether othe r activities of the MSG/NSB to support 
MSG participation are envisaged. Neverthe less, the legal basis for pursuing this 
option is uncertain and more information is needed to perform the subsidiarity test.  
 
EN 170   EN 9.5.7. Member States to be obliged to send of ficial experts to ta ke part in all national 
mirror committees mirroring European TCs dealing with mandated standards under Directive 98/34/EC 
No information has been provided to support a link between MSA official 
involvement in mandated European standard s development and the raising of formal 
objections. MSA officials are involved in  at least 66% of the national mirror 
committees and their involvement in comm ittees dealing with mandated standards 
under 98/34/EC may be much higher. The av erage costs of MSA involvement cannot 
be reliably established based on the data prov ided as it is not clear what costs should 
be included or what role they  would be expected to play. 
The specific consultation of January-February 2010 indicates that there appears to be 
little support for the placing of an obligati on on all MSAs to pl ace an expert in all 
national committees mirroring mand ated standards under 98/34/EC. 
The principle of voluntary participati on as and where appropriate and where 
resources allow would appear to hold in th e absence of any firm evidence that the 
current level of participation weakens the resulting standards or leads to formal objections. 
Therefore, this option was not examined in detail. 
9.5.8. European Commission to be able to finan ce mirror committees in all EU Member 
States 
Most NSBs currently have a full or n early full complement of national mirror 
committees in place. Even so, the number of ‘missing’ national mirror committees is estimated to be >1,500 across the countries in volved in the specific consultation of 
January-February 2010. Costs of secretaria t functions to support national mirror 
committees, national enquiries and nationa l implementations cannot be reliably 
determined but based on the estimates pr ovided it would cost  in excess of €20 
million per annum to fill all of the identif ied gaps, implying the need for any support 
to be targeted in specific areas or countries. 
It does not appear appropriate  or necessary for national mirror committees to be in 
place in all areas in all countries, as so me ESO TCs are developing standards that 
have little or no relevance at national level and there would not be sufficient 
participation by stakeholders to justify the costs. While NSBs and MSAs would 
welcome additional financial support from the Commission at national level, stakeholders argue that it may be more appropriate to allocate any additional 
financing to (i) measures to improve the involvement of MSGs in national 
standardisation, and /or (ii) m easures to improve the level of translation of European 
standards into national languages. 
Consequently, this option was not  examined in further detail. 
 
EN 171   EN 9.5.9. ESOs to systematically use IT harmonised tools to support the participation of 
stakeholders in the Euro pean standardisation process 
During the specific consultation of January -February 2010, ETSI reported that it is 
recognised as a worldwide leader in the use of IT tools to support its members 
activities in standardisation. Although the i ssue of mirror committees is not relevant 
to ETSI, its NSOs work electronically with  ETSI and use the ETSI platform in their 
daily collaboration with the ESO. 
Similarly, CEN/CLC report that they have  developed tools a nd applications to 
support the whole standards development process electronically, from inception 
through to national implemen tation, monitoring and decision-making. They report 
that many sub-processes are already fu lly electronic and that planned/ongoing 
projects aim to further increase the leve l of automation availa ble. In addition, 
CEN/CLC note that the high investment s made by CEN and CENELEC in modern 
technologies have contributed considerab ly to reducing the delivery time of 
standards over the last year s and increasing transparency. 
CEN/CLC provided further details about the various IT tools available to and used 
by existing ESO TCs and NSB MCs involved in developing EU standards. These 
points are summarised below: 
• The work of CEN/CLC TCs is supporte d by electronic collaborative platforms. 
Different tools are available according to  sector and/or which national member 
holds the secretariat, but all European TC s can benefit from similar facilities and 
their participants can access their worki ng documents at any time, from anywhere 
in the world. 
• CEN/CLC provides electronic templates to TC  secretaries to gui de the drafting of 
standards, and all standards documents are exchanged electronically between the 
parties involved. 
• CEN has set up an exchange platform to support the standards preparation process 
between TC secretaries, translators and CCMC. 
• The CEN and CENELEC Work Progra mmes are available on-line (CEN 
PROJEX-ONLINE and password-protected  access on the CENELEC web site) to 
the players directly involve d in the standardisation process, providing high 
transparency on all the CEN and CENELE C projects and sta ndards’ details, 
planning, interactions and legislative aspects as well as monitoring tools. 
• For a wider audience, the CEN and CE NELEC Work Programmes are available 
on the CEN and CENELEC Web Sites re spectively with powerful search 
facilities. 
• CEN/CLC Technical Body documents can al so be made available automatically 
to national MCs, with or without human intervention: 
– CEN provides an NMC environment and web services that can be used 
by national members to provide access to CEN documents to their 
 
EN 172   EN NMCs, in a similar way to ISO. It  does not, however, currently provide 
a centralised environment to  support purely national work; 
– CLC provides access to CENELEC/TC documents via a joint IEC/CLC 
platform. The IEC/CLC Collaboration Tool also provides platforms to 
support purely national work to in terested national members. 
• CEN and CENELEC electronic platforms and distribution channels are also 
available to make draft standards a nd standards available to Members and 
Affiliates (specific CEN and CENELEC systems). The documents are available in a few seconds and only to authorised users 
• A significant data flow between CCMC a nd National Members is also supported 
electronically:  
– From CCMC to National Members, Affiliates and other authorised 
partners: A similar file de livery service (with identical data structure) is 
ensured by CEN and CENELEC, allowing the National Committees to feed their local Information systems with project data and start national 
workflows (CEN PROJEXDATA & CENELEC PROJEXDATA) 
– From National Members and Affiliates to CCMC: On the CEN side 
bulk data update of the CCMC da tabase by CEN Members’ and 
Affiliates’ data, such as National Implementations and titles, data delivered in the framework of Dir ective 98/34 is fully electronic (i-
Projex). CENELEC supports automa tic or semi-automatic electronic 
delivery according to the type of information 
• The standards acceptance process is ma naged electronically via the CEN and 
CENELEC electronic voting systems. Nati onal votes are registered on-line and 
balloting results are available immediately at  closure. In CEN, eBalloting facilities 
are also available to support th e Governance Bodies’ decisions. 
• The access to the collaborative platfo rms and electronic voting systems is 
managed via the centralised repository of users and roles, allowing a decentralised management by responsible National Members (CEN/Global Directory and 
CENELEC Expert Management System). 
• The electronic working platforms (includi ng NMC), electronic voting applications 
and users directories are collaborative projects with ISO and IEC respectively. 
Further details on planned/ongoing projects within CEN/CLC to further increase the 
level of automation available were provided, as follows: 
• Virtual meeting facilities (tele- and web- conferencing) will be available as of 
2010 to CEN and CENELEC technical comm ittees (ensured by CCMC) and will 
allow the organisation of more and faster working meetings, participation of team 
members who cannot attend physically, reducing travelling time and costs 
• A common CEN/CLC bulk data delivery  interface is unde r consideration 
 
EN 173   EN • On the CEN side, mutual visibility on re sults of parallel ballots to CEN and ISO 
technical committees involved via the eBa lloting application is currently under 
development 
During this consultation, stakeholders sa id that there has been considerable 
investment into modern technology and IT sy stems are now available to and used by 
ESO and NSB committees throughout the st andards development process that are 
considered to be functioning well in the va st majority of cases. Most organisations 
report that there are no ‘missi ng’ IT tools at ESO or NSB levels that would need to 
be put in place and there are no significant requirements for any additional 
developments. 
While IT tools have undoubtedly helped to improve the speed and efficiency of 
European standardisation over recent years, th ese tools (or a lack of them) are not the 
main driver of the time that it takes to develop standards. 
Therefore, this option was discarded for further analysis. 
9.5.10. ESOs to be obliged to develop European standards requested by the EC in TCs 
managed directly by the Central Se cretariats and not by the NSBs 
The ESOs reported in the consultation of  January-February 2010 that there are 352 
TCs currently developing European standards under mandates issued by the EC (334 CEN/CLC and 18 ETSI). ETSI and its stak eholders are already operating under 
European-level representation principles and so no change would be necessary for 
this option. However, if more TBs were re quired in response to specific mandates, 
there may be a need to increase the si ze of the secretariat support. CEN/CLC, by 
comparison, are currently cohe rent with the national dele gation principle and believe 
a move to European-representation woul d require modificati on of all internal 
regulations and dramatically change th e way the ESO works. There would be 
fundamental issues to be solved around new processes and procedures and such a radical change would incur heavy costs.  
CEN/CLC also noted that the option may have implications for balanced TC 
representation and may encourage members to  look more to Inte rnational Standards 
processes where possible. ETSI does not participate in ISO/IEC, but CEN/CLC 
reported that a move away from the na tional-delegation principle might undermine 
the weight of the European NSBs in the ap proval processes and result in a loss of 
influence. None of the ESOs were able to give a figure for the nu mber of cases where 
European interests would have been outvoted at ISO/IEC in the last two years if EU 
NSBs had only one vote. However, CEN/CLC noted that while the option of being outvoted is a serious issue, the biggest im pact would be the lo ss of influence (e.g. 
seats at the Council, Board, TMB/SMB, et c.). During the specific consultation of 
January-February 2010, ISO/IEC reported that moving away from the national 
delegation principle would have substantial impacts and would plac e the future of the 
Vienna and Dresden Agreements in doubt. The four main concerns set out by ISO/IEC were (i) that the quality of the secretariat work of committees (expertise, resources and support) would n eed to be assured, (ii) that the repr esentativeness of 
national votes would be brought into questi on, (iii) that the national connection to 
stakeholders would be jeopardised, and (iv)  that it is uncertain whether individual 
 
EN 174   EN European participation in ISO/IEC would need  to be revised to reflect the new single 
consolidated European representation  and standards development process. 
Therefore, it is not clear to any of those consulted what the benefits, if any, of this 
option would be. There is no evidence that the option would accelerate the standards 
development process or improve the bala nce of representation of stakeholders 
(indeed the opposite may be true). Stakehol ders argue that there would be a very 
significant cost and disruption associated with  the change in procedures necessary in 
Europe, with many negative implications a nd few if any benefits. They also claim 
that this option would negativ ely impact on the influence of European countries in 
international standardisation, with negativ e consequences for European industry in 
the global markets. According to the results  of the specific consultation of January-
February 2010, this option would place the fu ture of the Vienna/Dresden Agreements 
in doubt, might seriously undermine European  involvement in ISO/IEC, jeopardise 
its interests, increase the number of cases  where European interests are outvoted and 
cause a significant loss of influence. 
Consequently, this option was not analysed any further. 
9.5.11. ESOs to open the option to approve docu ments developed by forums and consortiums 
as European Standards following a simplifie d procedure, provided those F&C have 
developed the documents according to the WTO/TBT standardisation principles 
During the specific consultation of Janua ry-February 2010, all of the responding 
F&C reported that they already adhered to and operated according to the WTO/TBT 
principles and / or would be prepared to sign up to and abide by the code of conduct. 
They also all reported that they would  in principle cooperate with the proposed 
system, although most indicated some concerns , potential challenges and issues that 
would need addressing, namely the possible confusion caused (and costs incurred) by 
two different documents (ESO and F&C ve rsion) being available and implemented 
separately and referenced in different ways, the additional burden of keeping track of modifications, extensions and updates made by either party and any confusion caused by one version lagging behind the othe r, issues of maintenance and change 
control, and whether either party coul d create derivative works and diverging 
subsequent versions of the sp ecification, issues related to transposition into another 
IPR regime, with a need to assess the terms and conditions unde r which a standard 
can be used, implemented and accessed, que stions regarding who would receive 
recognition/payment for transposed specificatio ns and other issues relating to patent 
policy, disclosure obligati ons and royalty charges. 
All three ESOs reported that they alrea dy have procedures in place to adopt 
specifications from other SDOs, however these are not currently used for this 
purpose at all (ETSI) or to any great exte nt (CEN/CLC) and there are likely to be 
cost implications to increased approval  activity. ETSI estimated the process would 
cost €18,000 per SDO document (although this would vary). All three ESOs also 
highlighted that there may be issues with  ownership and IPR to be overcome. The 
main point raised by NSBs in the specifi c consultation of January-February 2010 was 
that it is already possible to use th e CEN/UAP and PQ procedures for the 
specifications drafted by SDOs and to a dopt them as ENs, a nd it is unclear why 
another procedure would be necessary. 
 
EN 175   EN There is evidently some interest and willingness from both the ESOs and F&C to 
build on existing cooperative activity a nd to have a formalised process for 
referencing other SDO specifications. Howe ver, there are a number of important 
concerns and questions about the practicalities of the opti on and there is likely to be 
considerable resistance to any requiremen t to transfer ownership or control of 
specifications to the ESOs. Consequently, this  option was discarded at an early stage. 
9.5.12. Extend the list of recognised ESOs beyond CEN, CENELEC and ETSI and make it 
possible to allocate  standardisation requests (mandates ) to these other organisations 
The F&C consulted in January-February 2010 a ppear to be interested in the option 
and generally willing to explore further the possibilities of recognition for their 
organisations and receiving EC mandates.  
Other respondents appear to be considerably le ss supportive of the idea. There is 
some evident interest in being able to recognise and reference certain activities 
already undertaken by other SDOs, but expans ion of the ESS to include these other 
organisations as more integral players in that system raises numerous concerns and 
fundamental objections from most responde nts, who suggest that the negative 
implications may far outweigh, or even count eract, any benefits sought. The option is 
widely expected to damage the infrastructure and financial stability of the current ESOs, lead to greater fragmentation of the ESS and a consequent loss of coherence 
and clarity in the development of standard s in response to mark et needs. The option 
is expected to lead to more scattered, less effective stakeholder participation and 
result in standards being developed wit hout sufficient involvem ent or input from 
relevant stakeholders and th erefore less legitimacy within  the market. The scale of 
the negative implications would depend on the likely number of SDOs involved, the 
number of mandates envisaged and the speci fic cases that might require such an 
approach.  
Nevertheless, the option woul d appear, on a fundamental level (and regardless of 
scale) to go against New Approach a nd national delegation principles and run 
counter to ongoing efforts to improve the current ESS, with a move away from 
further integration of standardisation pro cesses and activities, reduced coherence and 
increased risks of duplication of effort, ba rriers to trade and confusion within the 
market, and consequently risks reducing the cr edibility of the ESS. It is clear that 
most would expect any newly recognise d SDOs to have the same rules, 
responsibilities and obligations placed on th em as with the current ESOs and that 
they would match the principles, processes a nd procedures that are currently in use. 
Greater alignment between new and old ES Os would allay some of the concerns 
raised, but achieving this may be comp lex, time consuming and costly, and may 
ultimately reduce any benefits (e.g. speed of standards development) that might have 
led to option being suggested in the firs t place. Therefore, this option was not 
examined in greater detail. 
 
EN 176   EN 9.5.13. Commission to be able to request developm ent of standards to any organisation via 
call for tenders to all Standards Devel oping Organisations meeting the WTO/TBT 
requirements 
The specific consultation of January-Februar y 2010 shows that there is little or no 
support for this option. Similar arguments are made as in previous options regarding 
the expected fragmentation of the ESS, loss of coherence and transparency and issues 
of weaker consensus being achieved as a result of the opti on. Some NSBs also 
suggest that there may be potential issues  with national implementation of standards 
developed by other bodies. 
ESOs and NSBs expect the option to lead  to a reduction in the operating budgets of 
the ESOs and a consequent reduction and refocusing of activiti es undertaken by the 
ESOs and their members. There would also be less interest and ability to work in 
areas of high social, public or regulatory be nefit (but low commercial return) than is 
currently the case. 
It is not clear that the be nefits of F&C (speed, pric e and simplicity) outweigh the 
drawbacks (lower quality and utility). It would be necessary for other SDOs to comply and adhere to various principles and processes associated with the current 
ESS if the option is to gain additional support amongst the various  stakeholders, but 
achieving these standards will remove much of the benefit offered by the use of F&C. 
Consequently, this option was not examined any further. 
9.5.14. Commission and ESO to establish an accred itation system of Standards developing 
organisations in the EU 
This option was developed in the light of  the system established by ANSI, the body 
facilitating the development of American National Sta ndards (ANS) by accrediting 
the procedures of SDOs, who work coope ratively to develop voluntary national 
consensus standards. Accredited SDOs mu st have procedures compliant with ANSI 
essential requirements for due process, whic h are ten principles related to developing 
ANS (openness, lack of dominance, balance, coordination/harmonisation, 
notification, considerat ion of views / objections, consen sus voting, appeals processes, 
written procedures and compliance with  other policies). Those SDOs seeking 
accreditation must apply with satisfactor y evidence of comp liance with these 
essential requirements and criteria. They  must continue to adhere to updated 
requirements and are audited by ANSI at se lected intervals to confirm adherence. 
Total annual expenditure by ANSI on its acc reditation services was €3 million in 
2009. However, this figure covers various ac tivities and organisati on types (not just 
standards development) and includes th e ongoing accreditation of over 220 SDOs. 
An EU-level accreditation system would be unlikely to operate at the same scale. 
ANSI operates on a cost-recovery basis, with accredited SDOs paying fees and 
charges approximately equivalent to the costs of the system. They each contribute 
between €2,400 and €46,000 per annum de pending on circumstances (including 
accreditation maintenance fees and fees base d on scale of standards development and 
national/international participation activity). 
 
EN 177   EN Indeed, most NSBs responding during the specific consultation of January-February 
2010 questioned why such a proposal was bei ng considered when the existing system 
is effective, well-functioning and the preferred model for the majority of stakeholders. The need for, purpose and bene fits of a new accreditation agency were 
unclear to them. Based on the information available, there were concerns that the option would lead to two parallel system s (unworkable, duplicative, costly and 
complex, with little added value), that it would increase bureaucracy, reduce 
transparency/coherence and ultimately be a regressive step. 
The basic idea of an accreditation system as set out in the option has already raised 
concerns about duplication and complexity and led to several respondents of the 
specific consultation of January-Februar y 2010 questioning the justification and 
potential benefits of such a system. It is clear from this information that the 
requirements on SDOs within the ANSI system  are similar to those already required 
of actors within the existing ESS and th at similar processes for maintaining 
adherence to principles exist. The annual costs of an ANSI-style accreditation system 
in Europe are likely to be below €3 m illion in the longer term, although the set-up 
costs may be considerable. Therefore, there were not sufficient arguments to examine this option in greater detail. 
9.5.15. Request Member States to monitor and report on the balance of representation of 
stakeholders in NSB mirror committees 
For the 20 NSBs providing estimated cost data during the consultation of January-
February 2010, the total costs for the set up of the monitoring and reporting system is 
estimated to be €2.24 million, or an aver age cost of €112k per NSB. The range of 
estimated set up costs run from €0 to  €500k per NSB. The ongoing implementation 
costs for the 20 NSBs are estimated to total €1.49 million per year, or €75k per NSB per year. The lowest estimate provided by a single NSB was €2,000 per annum and the highest was €650,000. Roughly a third of the NSBs provided an explanation / 
justification for their cost ca lculations in order to show how the estimates have been 
arrived at. For example, set up costs of 200 NMCs x 3 days per committee + IT tool 
and database development x 50 days = 650 days @ €770 per day = €500k. (Note this 
is not a real example). However, a similar number explained that their cost estimates 
were very rough or subject to a high degr ee of uncertainty because the monitoring 
and reporting system has not yet been defined. 
Comments received from NSBs in relation to the cost estimates mainly revolved 
around the difficulties in working out the cost s accurately (or even estimating them) 
in the absence of any detailed ‘specifi cation’. These comments were made both by 
NSBs that did provide cost estimates and also  by those that could not. NSBs seem to 
be in agreement that the specification fo r the monitoring would have to be defined 
and agreed at European level before bei ng implemented at national level. A small 
number of NSBs pointed out that the costs could be relatively low if the agreed 
system is close to the one already implemented at national level. However, most 
NSBs expect the costs to be significan t, either because no monitoring system 
currently exists or because it is envisa ged that the new system would require a 
complete overhaul of the existing monitoring activity. 
 
EN 178   EN 93% of the 30 MSAs that contributed to  the consultation of January-February 2010 
provided some kind of response to this questi on. However, the vast majority of these 
MSAs stated that they were unable to provi de an actual estimate of the costs to the 
MSA of a system to monitor and report on th e balance of representation in national 
mirror committees. Instead, many MSAs provi ded other comments (see ‘comments’ 
below) concerning the provisi on more broadly. The estimates provided by ten MSAs 
for the cost of the set-up of a monitori ng and reporting system total €1.5 million, an 
average of €149.9k each. However, it should be  noted that the individual estimates 
varied considerably, between €0 and €1 million, with the highest estimate being 
considerably above the next highest estimate of €250k. Removing this ‘outlier’ 
would reduce the average estimated set- up cost considerably, to €55.5k per MSA. 
The estimates provided by ten MSAs for the cost of the annual implementation of a 
monitoring and reporting system tota l €396.3k, an average of €39.6k each. However, 
again it should be noted that the individual estimates varied considerably, from €0 to 
€200k, with the highest estimate being consid erably above the next highest of €100k. 
Removing this ‘outlier’ would reduce the average estimated annual implementation 
cost considerably, to €21.8k per MSA. Only  four MSAs provided further details to 
explain the methodology behind the estimates they provided. These are summarised 
in the table below and show the variety of systems and n ecessary costs envisaged by 
the different MSAs when responding to this question. 
Set-up Implementation Notes on estimates 
€2k €1.5k Set-up covers launch of  web-application and 
registration of chairmen. 
Implementation covers annual extraction of 
information from the database and finalisation of 
a report. 
€18.1k €2.6k Set-up costs cover 140 person days (at €129) for 
10 mirror committees.  
Implementation costs cover 20 person-days. 
€25k €17k Costs cover extra staff members 
€250k €100k Set-up covers: (i) European definition and 
mapping of stakeholder types, (ii) classification 
of existing MC members, (iii) set up of ICT systems to monitor/report, and (iv) completion of initial databases. 
Implementation covers updating the classification 
system and list of participants to include changes 
to MC formation and changes in member 
classifications (e.g. company growth), plus reporting. 
There was general agreement between th e 15 MSAs that provided additional 
qualitative information that: (i) Member Stat es should be vigilant with regards to the 
balance of participation within standardis ation committees, (ii) that it is in each 
Member State’s interest to organise itself to best promote balanced representation at 
a national level, and that (iii) NSBs shoul d be transparent and provide information 
publicly to demonstrate their openness to all participants. Indeed, three MSAs 
specifically reported that balanced represen tation within their national TCs is a key 
issue stipulated in existing MoUs, standard s, agreements and other documents, and a 
 
EN 179   EN further two MSAs reported th at their national standardis ation systems were already 
open to participation by all stakeholders. 
The general conclusion of this part of the consultation is that there would be very 
substantial costs associated with the se t-up and ongoing implementation of a national 
monitoring and reporting sy stem concerning the balanc e of representation of a 
defined set of stakeholder groups in na tional mirror committees. Such a system 
would have to be defined centrally and in  significant detail in order to ensure a 
consistency of approach across the NSBs  / MSAs in different countries. The 
difference between, on the one hand, open access systems that allow all stakeholders 
to participate and on the other, ‘controll ed’ systems that enforce a pre-defined 
idealised balance are particularly salient he re. The former is currently in place and 
the latter cannot be put into place, because  what is an appropriate (and hence ideal) 
balance will vary from committee to co mmittee and from country to country and 
cannot always be ensured. 
The specific consultation of January-Febru ary 2010 did not reveal  any significant 
objections to the option, a lthough some respondents beli eve that the resulting 
information would be of limited practical utility and that therefore the resources 
could be better spent on more  direct support to under-rep resented stakeholder groups. 
Balanced representation (however defined) may be less achievable in smaller countries where expertise and resources are limited. 
 
EN 180   EN 9.6. ANNEX 6 – EXISTING STUDIES ON  PROBLEMS OF SMEs IN EUROPEAN 
STANDARDISATION 
The quotations, data and other information shown below have been extracted from 
the following documentation that reports on the problems faced by SMEs. The findings are presented under each of the ma in identified issues, and the numbers in 
parenthesis refer to the list of source documents. 
Documents / sources
 
– I ‘SMEs and Standardisation in Europe  – 23 good practices to promote the 
participation of craft and SME enterpri ses in standardisa tion and the use of 
standards’ (2006, EIM Business and Polic y Research, for DG Enterprise and 
Industry).  
– II ‘Efficiency and accountability in Eu ropean standardisation under the new 
approach’ (1998, Report by the Commi ssion to the Council and European 
Parliament COM (1998) 291 Final).  
– III. ‘Action plan: the European agenda  for entrepreneurship policy’ (2004, 
Commission Communication COM (2004) 70 Final).  
– IV ‘Information on occupational health a nd safety and standardisation for small 
and medium-sized enterprises – re quirements and availability’ (2001, 
Commission for Occupational Health and Safety and Standardisation – KAN).  
– V ‘Observatory of European SMEs’ ( 2002, EIM in cooper ation with ENSR 
partners). A survey of circa 8,000 SMEs, wh ich paid attention to standardisation 
among some of the questions put to organisations. 
– VI ‘Observatory of European SMEs  – analytical report’ (2007, Gallup 
Organisation Hungary, for DG Enterprise and Industry).  
– VII ‘Study to evaluate the internal mark et and competitiveness effects of council 
directive 89/106/EEC construction products directive’ (2007, PRC). 
– VIII ‘Towards an increased contribution from standardisation to innovation in 
Europe – discussion paper’ (2007, DG En terprise and Industry, Unit I.3).  
– IX ‘Towards and increased contribution from standardisation to innovation in 
Europe – Commission communication’ (2008, Commission communication COM 
(2008) 133 Final).  
Lack of understanding of the benefits of standardisation  
• Only 60% of SMEs consider standards im portant issues to th eir business and the 
figure was lower for micro enterprises than for medium-sized enterprises (v); 
• When managers were asked about the rela tive importance of the major features of 
the internal market, 38% regarded 's ingle market legislation, including 
harmonised technical standards', as important or very important. (vi); 
 
EN 181   EN • 52% of SMEs reported that they do not see any benefits in EU standards replacing 
national regulations'. By comparison 29% cl aimed that the process was beneficial 
for them (vi); 
• The results of the EUROMANAGEMENT p ilot action (1994) showed that there 
was a lack of information among SMEs on the basic mechanisms of the Single 
Market and the benefits to be gain ed from harmonised standards (x); 
Lack of understanding of which standards can or should be applied  
• SMEs and craft enterprises feel, to a larg e extent, that standards are something for 
the large corporate sector and think th ey are not involved. Consequently the 
participation of such enterprises in standardisation is rather low in terms of accessing relevant information and actually using standards in their own enterprises (ix); 
• To improve awareness: It is necessary to  bring standardisation and standards to 
the attention of market particip ants, in particular SMEs (ii); 
• SMEs frequently lack an inexpensive and easily accessible source for information 
on standards (iv); 
• Practically all SMEs expect a service cen tre that helps them procure information 
on standards to provide up-to-date and precise information on applicable 
standards; more than 90 % would like to be able to make an almost unlimited 
number of follow-up inquiries and low cost s; and almost the same number would 
like the information to be converted more to their needs. They would also like 
better search possibilities regarding the ac tual contents of standards, information 
about standards that have been withdr awn, and information on the interpretation 
of product-related standards fo r specific industries (iv); 
• 55% of SMEs said they did not receive  relevant information on standards and 
standardisation (v); 
• In response to the question 'which probl ems do you face regarding standards and 
standardisation?’ 23% said 'lack of info rmation on which standards have to be 
met’ and 26% said 'lack of information on new standards' (v); 
• Potential users of standards, in particul ar SMEs, may have difficulty identifying 
the standards relevant to them. The reas ons for this include the existence of 
several standards, possibly with different  status, addressing similar needs (viii); 
• Regarding access to standards,  other issues relate to the difficulty in identifying 
the group of standards relevant for a product or process (ix). 
The cost of purchasing standards
 
• The cost of obtaining relevant standard s may be relatively high for SMEs and 
other users, especially if the standard s contain many cross-references to other 
standards (viii); 
 
EN 182   EN • Regarding access to standards, the cost of purchasing standard s is increasingly 
cited as a problem by SMEs and other stakeholders (ix); 
Complexity of standards / cost of implementation  
• The technical aspects of standards are very  similar for SMEs, craft enterprises and 
large enterprises, but more  attention should be paid to simplicity of form and 
wording. Presently parties feel the need to  ‘downsize’ existing standards in order 
to make them more easy to digest for smaller enterprises (ix); 
• SMEs would advise that standards s hould: be comprehensible and clearly 
arranged; contain instructi ons for their implementation and concrete technical 
solutions (instead of general concepts);  repeat excerpts from other standards 
instead of merely referring to them (iv); 
• The contents of the standards used frequently meet the requirements of 
companies. 88% rated the comprehensibilit y and arrangement of the standards as 
good or very good (iv); 
• To the question 'which problems do you face regarding standards and 
standardisation?’ 21% said 'difficulties in applying standards correctly' (v); 
• Potential users of standards, in particul ar SMEs, may have difficulty identifying 
the standards relevant to them. The reasons for this include the complexity of the 
technical specifications. Even if the righ t standards have been identified and are 
available, implementing and using them  may still be very complex without 
adapted support (viii); 
• Standardisation is a powerful tool for the dissemination of the st ate of the art to 
SMEs and facilitates the uptake of i nnovation by the market. However, this 
potential is often not realised because of  barriers such as the complexity of the 
language of standards and the cost of de liverables. Other issues relate to the 
excessive number of cross-refe rences between standards (ix). 
Lack of understanding / cost of c onformity testing and certification  
• The majority of companies indicate that  they find it expens ive or difficult to 
evaluate the applicability of standards and to conduct external tests determining 
conformity. 75% of companies would like to verify whether they actually fulfil all 
the standards relevant to th eir manufacturing process (iv); 
• To the question 'which problems do you face regarding standards and 
standardisation?’ 16% said 'difficulties in obtaining certification of compliance 
with standards’ (v); 
• The report considers the cost and burden of CE-Marking for SM Es. It notes that 
the perceived problem is that, whereas CE-marking should brin g savings in the 
overall testing and certifica tion process for larger firm s or firms close to state 
borders which sell in more than one Member State, many small firms will suffer 
either (ix) because they are in Member  States where no 3rd party certification 
 
EN 183   EN requirement existed previously, so they have  to do something for the first time, or 
(ii) because the product evaluation or conformity procedures are now more 
difficult, because of harmonisation. Howe ver, the report finds that whilst SME 
concerns need to be taken very seriousl y, there is reason to believe that the 
problem is not as serious as previously thought. Also, the dominant industry view 
of CE-marking seems to have shifted from  concern that it is  a burden and would 
drive some SMEs out of business, to acceptance that it is a good protective measure against low-quality non-EEA imports (w ith the caveat that it is not strict 
enough and not adequately enforced). A larg e number of companies and nearly all 
SMEs do not carry more than one nationa l mark. The yearly cost of CE-marking 
will be less than the cost of previous national conformity marks for these companies (vii). 
Lack of participation / re presentation in the standards development process
 
• SME and craft enterprises feel, to a large extent, that standards are something for 
the large corporate sector and think th ey are not involved. Consequently the 
participation of such enterprises in standardisation is rather low in terms of participation in Technical Committees where standards are actually developed (ix); 
• The majority of measures found [by the study] at national level are aimed at 
raising awareness and providing informati on. Relatively little is done to support 
the participation of SME and craft enterprises in standard isation, or to defend their 
interests (ix); 
• Specific constraints of SMEs in terms of  human resources and finance, lead to 
relatively low active participation of SMEs in the standardisation process (ix); 
• The Internal Market has made the lives of businesses, particularly SMEs, much 
easier. But the Internal Market is not complete. There are still obstacles. The 
Commission will also continue to pr omote the involvement of SMEs in 
standardisation (iii); 
• 40% of the companies surveyed would be interested in participating in 
standardisation work; however, at pr esent, only 12 % are actively involved. 
Considerable obstacles prevent SMEs from exerting a greater influence on 
standardization, especially the lack of free resources (iv); 
• To the question 'which problems do you face regarding standards and 
standardisation?’ 16% said 'lack of possibi lity of participation in development of 
new standards’ (v); 
• SMEs and other economic operators have great difficulty participating in the 
standard-making process as it is current ly established: SMEs have problems 
allocating their limited human and financial assets to the resource-heavy and time-consuming process of standardisation, wh ich includes many face-to-face meetings 
and often demands a membership fee. Th is is especially critical for micro-
enterprises; it is necessary to address the concerns of SME representatives that standardisation processes ar e often dominated by large industry and do not take 
 
EN 184   EN SMEs’ interests sufficiently into account . The need to attend standardisation 
meetings physically is probably the most significant barrier to SME participation. 
(viii); 
• Standardisation is a powerful tool for the dissemination of the st ate of the art to 
SMEs and to facilitate the uptake of innovation by the market. However, this 
potential is often not  realised because of barriers such as the time required to 
participate in standard-making (ix). 
Lack of availability of standards in native language  
• The technical aspects of standards are very  similar for SMEs, craft enterprises and 
large enterprises, but more  attention should be paid to simplicity of form and 
wording. Presently parties feel the need to ‘translate’ existing st andards in order to 
make them easier to digest for smaller enterprises (ix); 
• Potential users of standards, in particul ar SMEs, may have difficulty identifying 
the standards relevant to them. The reasons  for this include the lack of standards 
in their own language (viii); 
• Regarding access to standards, other issues  relate to the lack of standards in 
national languages (ix). 
 
EN 185   EN 9.7. ANNEX 7 – GLOBAL FORA AND CO NSORTIA IN THE FIELD OF ICT 
9.7.1. Introduction 
The technological foundations of the Third Industrial Revolution are innovations in 
computing and electronics, including the inve ntion of transistors, integrated circuits, 
digital computers and networks, and wirele ss technologies. These innovations can be 
described as modular innovations whereby system coordination became embedded in 
standardised interfaces, so that a varie ty of products could work within the 
same system architecture . Once multiple firms contributed components to the 
system, new strategies beyond horizontal and vertical integration became necessary 
to coordinate the system architecture and to  make sure it func tioned properly. This 
shift towards greater modularity was due in  part to the increasing complexity of 
technology: in many cases, a single firm  did not have th e technological or 
organizational capabilities to produce all of the components necessary for an entire system. The most striking example of a ne twork industry that needs standardised 
interfaces is the ICT sector in which standards play an essential role in ensuring 
compatibility . Such standards can serve to increas e network effects and that in turn 
supports innovation
99. In a digitally driven society, ICT solutions are used in any 
economic sector as well as in our daily liv es. To fully exploit the potential provided 
by the digital society, ICT solutions, applica tions and services ha ve to be able to 
communicate with each other; they should be interoperable. Interoperability requires 
standards and specifications.  
The regulatory framework and the underl ying ESO governance mechanisms that 
have proven very successful in tackling th e harmonisation of national standards for 
internal market purposes have not proved as adequate to cope with the interoperability requirements of ICT policy. The issue is related to the proliferation 
of relevant ICT standards more or less informally created by global fora and 
consortia. Nowadays it can be roughly es timated that some 80% of the global ICT 
standardisation work of interest to the Eur opean ICT market is car ried out outside the 
formal European standardisation system. 
The phenomenon affects the IT and telecom industries differently, because formal 
standardisation in the latter is more protect ed by the need to have interoperability 
ensured over a relatively longer period of ti me (infrastructural investments have a 
pay-off period of decades) and by a str onger regulatory framework for standard 
referencing. But evolution in the IT i ndustry and software and internet-related 
applications has been very fast and the di sintermediation of the formal process much 
more advanced. 
9.7.2. Global fora and consortia 
The ICT standardisation landscape has dramatically changed over the last decade. 
Alongside the traditional standard stetti ng organisations, specialised and mostly 
global fora and consortia have become mo re active and several have emerged as 
                                                
 
99 Swann G.M.P., “The Economics of Standardization: An Update’, Report for the UK Department of 
Business, Innovation and Skills (BIS), 2010. 
 
EN 186   EN world-leading ICT standards development bodies, such as those responsible for the 
standards covering th e internet and the world wide web. 
These fora and consortia include, for example, the following bodies: 
(1) The Internet Engineering Task Force (IETF)  is a large open international 
community of network designers, ope rators, vendors, and researchers 
concerned with the evolution of in ternet architecture and the smooth 
operation of the internet. It is open to  any interested individual. The actual 
technical work of the IETF is done in its working groups, which are organized by topic into several areas (e .g., routing, transport, security, etc.). 
Much of the work is handled via mailing lists. The IETF holds meetings three 
times per year. The IETF's official products are documents, published free of 
charge as Requests for Comments (RFC s) which are frequently updated. As 
well as producing RFCs, the IETF is a forum where network operators, hardware and software implementers and researchers discuss future protocols, 
standards and products. It is also the forum where the basic technical 
standards for internet protocols are set and maintained. The IETF does not 
standardise transmission hardware nor sp ecialized applicati on layer protocols. 
However, the IETF standardises all the protocol layers in between.  
(2) The World Wide Web Consortium (W3C)
 is an international community 
where Member organisations, a full-time staff, and the public work together to develop Web standards. Its membership is open to all types of organisations (including commercial, educational and governmental entities) 
and individuals. Any entity that can sign the Membership Agreement can become a Member. Members may be e ither for-profit or not-for-profit 
organizations. Most Members are specia lised in web technologies and/or are 
developing web-based products, using web technologies as an enabling 
medium, conducting research on the Web, or developing specifications based 
on W3C work. W3C develops technical specifications and guidelines through 
a process designed to obtain consensus a bout the content of a technical report, 
to ensure appropriate tec hnical and editorial quality, and to earn endorsement 
by W3C and the broader community. Th ese specifications  and guidelines 
cover, inter alia, web design and app lications (i.e. the specifications for 
building and rendering Web pages, incl uding HTML5, CSS, SVG, Ajax, and 
other technologies for Web Applica tions, the so-called “WebApps”), Web 
architecture (i.e. focusing on the f oundation technologies and principles 
which sustain the Web, including URIs and HTTP), XML Technologies including XML, XQuery, XML Schema , XSLT, XSL-FO, Efficient XML 
Interchange (EXI), technologies to enable Web access anywhere, anytime, 
and using any device, browse rs and authoring tools. 
(3) OASIS (Organization for the Advan cement of Structured Information 
Standards ) is a not-for-profit consortium that drives the development, 
convergence and adoption of open standards for the global information society. It was founded in 1993 under the name SGML Open as a consortium 
of vendors and users devoted to devel oping guidelines for interoperability 
among products that suppor t the Standard Generalized Markup Language 
(SGML). The name changed in 1998 to  reflect an expanded scope of 
 
EN 187   EN technical work, including the Extens ible Markup Language (XML) and other 
related standards. Companies, governme nt agencies, non-profit associations, 
and academic and research institutions may become members. The Consortium hosts two of the widely known information portals on XML and 
Web services standards, namely Cover Pages and XML.org.  
(4) IEEE (Institute of Electrical and Electronics Engineers
) is a large technical 
professional society. It is designed to  help professionals involved in all 
aspects of the electrical, electronic a nd computing fields and related areas of 
science and technology. There are more  than 395,000 IEEE members in over 
160 countries around the world. IEEE member s are engineers, scientists and 
allied professionals whose technical in terests are rooted in electrical and 
computer sciences, engineering and related disciplines. The IEEE-SA 
standards program produces standards for a broad range of technologies and 
industries. It has an active portfolio  of nearly 1,300 standards with many 
more projects currently  under development. 
Overall, there are uncertainties as to the total number of standardisation consortia, 
especially in the field of ICT. CEN makes a periodical survey of these entities in the 
area of ICT and currently counts some 238, but makes a subjective screening not to 
include what they consider the most pate ntly commercially-motivated ones. Other 
private sources that do not do any such screening list a total of 534100. The Japanese 
Government routinely monitors for its ow n ICT strategic development purposes the 
activities of some 120-130. Many fora and co nsortia work at different levels in 
numerous overlapping technol ogy areas relevant to ICT and networks. Over 500 are 
listed in web-based catalogues of fora a nd consortia and, at one time (before the 
collapse of the dot com bubble), new fora a nd consortia were being created at the 
rate of at least one a week. It is impossible for service pr oviders to keep track of all 
of these, and it is not clear to a service provider (or even to an equipment vendor) 
which group to work with for the standards they need. Vendors often create new fora to obtain a significant influence in the mark etplace and to ensure that any resulting 
technical standards are based on their own pr oduct specifications. During the internet 
boom, consortia emerged at a very high rate a nd, contrary to  expectations, in the last 
few years they have proved quite resilient to the end of that boom and have survived 
the consequent decline in their membership  base and any possible reduction in total 
private investment in standardisation. It is not uncommon for European ICT 
multinationals anecdotally to report attendance at works of over 150 different standardisation entities.  
                                                
 
100 www.consortiuminfo.org/links  
 
EN 188   EN 9.7.3. Comparison of C&F Management Feat ures with those of ESO and JTC1 
 OASIS OMG W3C ETSI JTC1 
IPR policy RF  
FRAND  
RF Open Source RF RF FRAND FRAND 
Liaisons Numerous 
(including e.g. ISO, JTC1, ISSS, 
W3C) Crossmembersh
ip (OASIS, W3C, 
NIST Numerous 
(including e.g. ETSI, IETF, 
ITU, 
JTC1 Numerous 
(including e.g. ISO, JTC1, ITU, 
national/regional 
SDO many 
consortia) Over 16 liasons 
Overall # of 
members Ca. 400 
organizations Ca. 200 
individuals Ca. 800 Over 400 700+  67 (member 
states at JTC1 level) 
Membership levels 4: 
Foundational sponsors 
Sponsors, 
Contributors, Individual (may 
not vote 5 (three main): 
Contributing Domain 
Platform 
Influencing Residual: Test 
and Analyst 2: 
Full, Affiliate 
(both have same 
rights) 4: 
Full, Associate, (may vote) 
Observer, 
Counsellor 2: 
(P)articipating (may vote) 
(O)bserving 
Membership 
Fees Foundational 
sponsors: from 50,000 to 44,000 
USD according to 
the type of organization and 
the number of 
employees; Sponsors: from 
16,000 to 9,500 
USD according to 
the type of 
organization and the number of 
people employed; 
Contributors: from 8,000 to 
1,100 USD 
according to the type of 
organization and 
the number of people employed; 
Individuals: 
US$300 Membership 
fees according to the annual 
gross revenue;  
only contributing 
members have 
full voting capacity. 
Fees range from 
75,000 USD for 
contributing 
members to 550 USD for 
university 
members.  Depends on the 
country and on the annual 
revenue; the fee 
can be calculated via 
the website and 
may vary from 68,500 to 953 
USD. Based on 
turnover; from 2000 EUR 
(Universities, 
Non-profit organizations 
etc.) to 154,720 
EUR.  Based on GNP 
Individuals’ 
capacity member 
representative 
(but individual 
vote at TC level) member 
representative WG: member 
representative; 
AB: individual (member) 
representative individual 
To establish 
new activity 3 ‘eligible 
persons; 
business plan; decision after 15 
days, BoD may 
veto RFP: initiated in 
TC (also SIG), 
TF elaborate RFP, 
approved by 
AB. Initiated by 
W3C 
staff, general review at least 4 
weeks; decided 
upon by 4 supporting 
Members 
prepared to contribute; 
decision after one 
month No time frame 
specified 
 
EN 189   EN Accepted by TC 
(vote). 
RFC: bypasses RFP 
 Director 
Average time 
until finalisation 16 – 24 months 12-15 months 
from RFP: shorter for RFC Typically 
around 24 months Around 4 years 
for a European Standard Up to 48 months; 
ca. 12 months for PAS process 
Openness 
technical 
activities Every ‘eligible 
person’ may 
participate Eligible 
members 
may submit 
proposed 
solutions Information 
(RFI) 
may be invited from outside 
 Open to all 
members Open to Full and 
Assoc. ETSI 
members; 
external experts 
for STF62 Individual WG 
members must 
be authorised by 
national SDO 
Transparency description of 
process and voting procedure 
publicly available Ability to track 
the adoption 
process. 
Finalized documents are 
publicly 
available info on process 
and outcome publicly 
available; 
public may comment; TRs 
undergo public 
review Limited (largely 
to members) 
transparency Limited (largely 
to members) transparency 
Required level of consensus Balloting 
mechanism at TC 
and OASIS level; 
BoD may keep proposal from 
balloting 2/3 majority of 
eligible voters 
on 
finalized submission. 
Submitted to 
BoD 
for final 
decision Consensus 
based, at both 
technical and 
W3C level, but W3C director’s 
approval is 
always required At TB level: 
consensus/voting 
At ETSI level: 
consensus/weigh ted individual 
voting by 
members Balloting should 
only take place 
once consensus 
has been achieved; Pmembers 
cast 
votes 
Implementations required? Yes (three 
interoperable 
implementations A precondition. 
Non-
implemented 
can be ‘retired’ Yes (one 
implementation) No No 
Types of 
‘products’ Committee Drafts 
Standards OMG 
specification 
(‘adopted 
technology’) Working Notes 
Recommendatio
ns ETSI Standard, 
ES 
European 
Standard, EN ETSI Technical 
Specification 
ETSI Technical Report, TR 
ETSI Guide, EG 
Special Report, SR ISO Standard 
ISO/PAS 
ISO/TS Technical 
Specification ISO/TR Technical 
Report 
International Workshop 
Agreement (IWA) 
Output 17 Committee 
Drafts 
(excluding 
ebXML 
specifications prior to 2002) 
71 standards from 
2003 to 2009 130+ in total 
http://www.omg
.o 
rg/technology/d
oc uments/spec_cat 
alog.htm 
since 2002: 114  55 
Recommendatio
ns (2005-2009) ES ETSI: 381 
standards from 
January 2004 to 
August 2009, 
Total standards from January 
2009: 567; 
EN –ES TelecommunicatiCA 420 technical 
standards modified 
between 2007-2009 
11 Technical 
Standards published from 2003 - 2006 
 
EN 190   EN ons: 414 from 
January 2004 to 
August 2009; 1744 from 1999 
to 2009; 
EG Guide: 66 from January 
2004 to August 
2009 167 from 1999 to 
2009 
Specs for free Yes Yes Yes Yes No 
Standards 
maintenance No official 
mechanism, but 
new versions are 
produced relatively 
frequently Codified 
revision 
process, 
including bug page. Error tracking is 
part of the 
process; 
dedicated ‘errata page’; approval 
of new version 
follows same procedures as 
for 
new TR No official 
procedure for 
most 
deliverables; reaction to 
comments; 
approval of new version follows 
same procedures 
as new deliverables Regular reviews 
every 5 years (3 
years for PAS 
submissions); Amendments are 
also used 
 
 
EN 191   EN 9.8. ANNEX 8 – SME TEST 
(1) Consultation with 
SMEs representatives One of the objectives of the Small Business Act (SBA) is 
to help SMEs to benefit more from the opportunities 
offered by the Single Market and third-country markets. 
For that purpose, the SBA stated that it would increasing “EU financial support (to €1 million in 2008 and € 2.1 million from 2009) to promote SMEs’ participation and defence of their interests in standardisation and to improve SMEs’ information on, and use of, European 
standards". In its report adopted on 21 October 2010 (see 
section 2.1), the European Parliament  stresses that the 
SMEs are not adequately invol ved in the standardisation 
system. It believes that it is essential to increase their representation and participation in the system. Consequently, SMEs representatives have been widely consulted during the preparat ory process (see point 9.1.3 
of Annex 1). Questions 6 and 13 of the general consultation related specifical ly to problems encountered 
by SMEs. In parallel, specif ic studies were made to 
examine the problems of SMEs in standardisation. These studies are set out in more detail in Annex 6. 
(2) Preliminary 
assessment of businesses likely to be affected The studies showed that SMEs encounter a series of 
problems with respect to standards and standardisation. The main problems and barriers are the lack of understanding of the benefits of  standardisation, the lack 
of understanding of which st andards can or should be 
applied, the cost of purchasi ng standards, the complexity 
of standards/cost of implementation, the lack of understanding/cost of conformity testing and certification, the lack of pa rticipation/representation in 
the standards development process and the lacking availability of standards in the language used by the 
SME. 
The overall conclusion of these studies is that SMEs are 
enterprises which need to  apply standards in the 
production of goods and services, like larger enterprises. 
However, due to their size and limited resources, SMEs have more difficulties in choosing the right standard, in understanding it and it implementing it. Standards may be drafted in an unnecessa ry complex way, with too 
many cross references to other standards, making it more difficult to understand and to implement them. The more SMEs participate in the t echnical committees, the more 
standards will be SME-friendly and the more SMEs will use and implement them. 
 
EN 192   EN Although SMEs face similar problems as societal 
stakeholders, the concerns of SMEs differ since standards have to be suitable for SMEs in terms of their use and application while the broader societal interest lies in the results of the use of standards. 
(3) Measurement of the impact on SMEs One of the specific objectives of the initiative is to ensure 
that SMEs are adequately represented in the standardisation process (poi nt 4.2). The impacts on SMEs 
are measured specifically in all options. The involvement of SMEs in the standardisat ion process is one the three 
main problems examined in this impact assessment. 
(4) Assess alternative options and mitigating measures At the end of the impact assessment, there was no 
indication that the selected options might result in a disproportionate burden for SM Es. Consequently, there is 
no element showing the need for SME specific measures 
in order to ensure compliance with the proportionality principle.  
 
 
EN 193   EN 9.9. ANNEX 9 – CONCLUSIONS AND RECOMMENDATIONS OF THE 
EXTERNAL EVALUATION OF THE CO NTRIBUTION OF EU FINANCING 
OF STANDARDISATION TO THE FULFILMENT OF POLICY OBJECTIVES OF THE COMMISSION 
A study produced by the Enterprise Ev aluation Consortium GHK / Technopolis
101 
draws the following conclusions and makes the following recommendations. The views expressed are those of the authors a nd do not necessarily reflect those of the 
Commission.  
The focus of the evaluation was the fina ncial support allocated  to the ESOs by 
EC/EFTA through operating and action grants  signed in the period 1st Jan 04 – 31st 
Dec 07. The overall aim of the study was to evaluate the extent to which EC/EFTA financing of European standardisation contributes to the implementation and 
achievement of the policy objectives of the Commission as laid out in relevant 
documentation. In addition, the evaluation has assessed the relevance, effectiveness, 
efficiency and utility of the system of financing, including the associated 
management and administrative procedures . Finally, the evaluation has considered 
whether the system of financing is opt imised and makes recommendations for 
improvements where appropriate. The assessments are based on a review of all relevant documentation and data relating to the financing, plus extensive consultation 
with the European Commission, EFTA, th e European and National Standards 
Bodies, industry and other stakeholders. Over 160 people were consulted during the 
course of the study. 
1. O
VERALL CONCLUSIONS  
The overarching objective of the evaluati on was to “assess to what extent the 
financing of European standardisation by the European Commission contributes to 
the achievement of the objectives of its polic y”. It also aimed to determine “whether 
the current financing scheme and the cos t/benefit ratio are optimised to reach the 
objectives of the actions”. 
Our overall conclusions  are as follows: 
• The financing of European standardis ation by EC/EFTA is  both appropriate 
and necessary, and attracts strong suppor t inside the Commission, from the 
standardisation bodies at EU and nationa l levels, and from industry and other 
stakeholders 
• The financing granted from 2004-7 has s upported activities th at are of clear 
and high relevance to the po licy objectives of the Comm ission, as set out in the 
financing agreements and in vari ous communications issued by the 
Commission 
                                                 
101 Evaluation of the Contribution of Community Financing of Standardisation to the Fulfilment of Policy 
Objectives of the Commission, submitted by GHK/Technopolis on 30 June 2009. 
http://ec.europa.eu/enterprise/dg/files/evaluation/2009-06-30__final_report_and_appendices_en.pdf .  
 
EN 194   EN • The six main areas of activity that have attracted EC/EFTA financing each 
contribute significantly to the achievement of multiple Commission policy 
objectives, but to different  extents and in different  but mutually supporting 
ways 
• The main role of the financing is to support and strengthen the ESO platform 
and to facilitate and support standard s development work in areas closely 
linked to Commission policy and legislation 
• The system of financing is effective and has delivered a high level of positive 
benefits in its intended areas of influen ce, but its efficiency has been severely 
hampered by administrative burdens wh ich detract from the overall added 
value of the support 
• The financing is of significant utility to the European standardisation system, 
providing additional management capacity and expertise and helping to offset 
the costs to industry of standards deve lopment in areas closely linked to 
Commission policy 
• The overall financial allocation by EC/EFT A is modest in the context of the 
total costs of EU standardisation and in relation to the benefits that the 
financing delivers, but only appears to be under a moderate amount of pressure 
under the current arrangements. The pressu re has been alleviated significantly 
by the withdrawal of some ESOs and NSBs  from certain lines  of support due to 
problems with the detailed, complex and unstable financial rules and the high administrative burden 
• Under improved conditions there would be a strong case for an increased 
budgetary allocation due to the significant benefits that the support can deliver 
The following sections present more de tailed conclusions and recommendations, 
organised around the issues that the ev aluation was asked to address and the 
questions that it was designe d to answer. The main body of  this report sets out the 
information and data that have been used to arrive at these conclusions and recommendations, and contains further, more  detailed information that may be useful 
for strengthening the system of financing in future.  
2. R
ELEVANCE  
2.1. Commission policy objectives regarding standardisation 
The terms of reference for the study asked th e evaluators to identify and describe the 
policy objectives of the Commission regard ing standardisation. A review of the 
supplied documentation has identified the following objectives of the Commission 
that are all intended, in some way, to  be supported through the financing of 
standardisation: 
Objectives relating prim arily to industrial policy  Objectives relating primarily to public policy / 
societal needs  
• To enhance the competitiveness  of • To provide a high level of protection 
 
EN 195   EN European Industry 
• To assist in the completion (and 
improve the functioning) of the single 
market  
• To assist European  industry to access 
world markets  
• To facilitate innovation  
• To facilitate and ensure 
interoperability  
• To increase the market relevance  of 
standards development 
• To facilitate the take-up  of European 
standards 
• To ensure effective use of standards 
by SMEs  of health and safety  
• To contribute to environmental 
protection  and sustainable 
development 
• To use standardisation as a tool for 
ensuring accessibility  for all  
• To support the public interest  
dimension of standards  
Objectives relating primar ily to the existence of a 
strong EU standardisation system  Objectives relating prim arily to the extension  of 
the EU standardisation system and the inclusion  
of relevant actors  
• To provide a flexible and transparent 
platform for consensus building  
• To strengthen the institutional 
framework and structures  of 
European standardisation 
• To ensure the financial viability  of 
European standardisation 
• To increase the efficiency  of 
European standardisation 
• To improve the synergies  between the 
European Standardisation 
Organisations 
• To improve the timeliness  of 
standards development 
• To improve the coherence  of 
European standardisation and of its 
institutional framework 
• To improve the effectiveness  of 
European standardisation 
• To improve and extend the European 
key mark  system  • To promote and increase the  
visibility  of the European 
standardisation system 
• To assist with the integration of 
candidate countries 
• To ensure effective participation  by 
all relevant actors  
• To increase the role of standards in 
support of European policies and 
legislation  
• To increase the role of standards in 
the area of security  
• To increase the role of standards in 
the area of services  
• To strengthen the link between 
research  and standards 
• To promote the development and use 
of international  standards  
 
These objectives relate to both the positive benefits  that standardis ation brings to 
society and the economy, which help to explain why the Commission provides 
financial support to European standardisa tion, and to more purposeful objectives 
relating to desired improvements  in the overall structure a nd performance of the EU 
standardisation system.  
 
EN 196   EN 2.2. The relevance of the financial support to  the achievement of  these objectives 
The study was asked to assess whether the allocation of fi nancial support is relevant 
to the achievement of these objectives . We have found that the financing of 
standardisation by EC/EFTA is considered  by all stakeholder groups to be highly 
appropriate and necessary and that the specific activities attracting financing in the 
period 2004-7 are very str ongly linked to and are of  clear relevance to the 
achievement of Commission policy objectives.  
The different elements of the financing and the different act ivities supported are 
relevant to different groups  of objectives as follows:  
• The financial support provide d to the central secretar iats of the ESOs through 
Operating Grants  can be seen to be of clear relevance to the achievement of 
all of the identified policy objectives. The financing enables the central secretariats to strengthen the EU sta ndardisation system and platform, and 
provides additional capacity to enable a timely and effective response to Commission requests for standards devel opment work and related activities in 
support of its policy and legislation. Th is includes standardisation activities 
designed to support industrial policy objectives (e.g. innovation, competitiveness, interoperability, single market), public policy objectives (e.g. health and safety, environmental protecti on, accessibility for all) and objectives 
relating to the extension of the EU sta ndardisation system (e.g. into new areas 
of policy and legislation such as servi ces) and the inclusion of relevant actors 
(e.g. SMEs, NGOs, etc.) 
• The financing provided to support specific standards development  projects 
(actions) is relevant to the achievement  of industrial polic y objectives, as the 
majority of the actions are intended in some way to improve interoperability, 
assist with the completion of the inte rnal market, promot e innovation and the 
take-up of innovative solutions, and th ereby enhance the competitiveness of 
industry. The majority of the financed standards development projects are also 
of clear relevance to public  policy objectives, given that they are often aimed at 
providing a high level of protection of health and safety, contribute to 
environmental protection or otherwise s upport the public interest dimension of 
standards. The standards development work is also of relevance to the 
extension of the European standardisa tion system, in particular by increasing 
the role of standards in suppor t of EU policy and legislation 
• The financing provided to support visibility  projects is of most clear relevance 
to the policy relating to the extension of the system and the inclusion of 
relevant actors. The activities that ha ve attracted EC/EFTA financing have 
been aimed at increasing the visibility of the European standardisation system 
both inside the EU but particularly inte rnationally, and are of  relevance to the 
objectives of helping to integrate candida te countries and ensuring the effective 
participation by all relevant actors. The fi nancing of visibility projects is also 
of clear relevance to the industrial pol icy objectives of a ssisting European 
industry to access world markets, assisti ng in the completion of the internal 
market, and facilitating the take-up of standards (through, for example, an 
 
EN 197   EN increased awareness of European standa rdisation and increased participation 
within it) 
• The financing for preliminary work / supporting activities  has also been 
found to be of clear relevance to seve ral of the identified policy objectives, 
including in particular by helping to increase the market relevance of standards 
development, facilitating th e take-up of standards, a nd increasing the role of 
standards in support of EU  policy and legislation 
• The financing for translation  of European standards is also judged to be of 
high relevance to Commission policy objec tives, particularly those relating to 
industrial policy, by fo r example, helping facilitate the take-up of standards and 
ensuring their effective use by SMEs, and thereby helping to facilitate 
interoperability and assist with the completion of the internal market. The 
financing of translation is also of clear relevance to  the objectives of extending 
the EU standardisation system and inclus ion of relevant actors, by for example, 
helping to increase the visibility and us e of European standards in specific 
countries and by assisting with the inte gration of candidate countries to the 
Community market 
• The financing of quality assessment work carried out by New Approach 
consultants is of relevan ce to a range of policy objec tives, in particular by 
increasing the role of standards in suppor t of European legislation and helping 
to ensure a high level of protection of health and safety and in some cases 
environmental protection, thereby assisti ng in the completion of the internal 
market. This line of financing is also  of relevance to the objectives of 
improving the efficiency and effectiven ess of European st andardisation and 
improving the timeliness of standards development 
As indicated above, most of the financed act ivities have the potenti al to contribute to 
multiple different policy objectives of  the Commission, though there are clear 
differences between the lines of support, w ith some contributing in general terms to 
large numbers of objectives while others are of more specific and direct relevance to 
a more limited set of objectives. 
It is therefore concluded that there ar e clear links between the Commission policy 
objectives (industrial, e nvironmental, market, regulatory) and European 
standardisation, particularly  in those areas that have attracted EC/EFTA financing.  
2.3. Mechanisms to ensure the relevan ce of the financial support 
The study terms of reference asked us to assess how the Commission evaluates the 
relevance of the financial support requested by the ESOs with respect to their achievement of its policy objectives.  
In the case of the Operating Grant, the link between the policy objectives and the 
financed activity is in large measure given or assured through the type of financing 
provided (this holds to some extent for the other areas of support also). The activities 
of the Central Secretariats are known to  support many of the objectives of the 
Commission, and the provision of the Oper ating Grant is provided specifically 
 
EN 198   EN because of this contribution, and in order to  provide additional capacity to deliver on 
those objectives. However, in addition, th e ESO grant applications, submitted each 
year and based around the central secretaria ts’ annual business pl ans make clear the 
ways in which the activities will cont ribute to Commission policy objectives, 
particularly by strengthening the ESO plat forms and activities, and also by ensuring 
an effective and efficient management of  requests issued by the Commission for 
standardisation work throughout the course of the year.  
The OG proposals submitted by the ESOs ar e evaluated by the Commission with 
regard to their relevance to Commission policy objectives. However, it should be 
noted that the Operating Gran ts are intended as a subsidy or subvention to the day-to-
day activities of the central secretariats because of the important role they play in 
supporting the achievement of Commission pol icy. The intention of  the evaluation is 
therefore to confirm  that relevance rather than as a mechanism to identify ways in 
which the ESOs could better  support Commission policy.  
However, a range of other mechanisms ar e used to convey the Commission’s policy 
objectives to the ESOs, and the ESOs can cl early be seen to respond to those signals 
through revisions to their processes a nd improvements to their functioning. One 
obvious example is efforts undertaken  by CEN to speed up the standards 
development process in response to signa ls from the Commission that this was a 
priority objective. Another example is efforts undertaken by all of the ESOs in recent years to better integrate environmental as pects into standardisation, which were 
carried out in response to a 2004 Commission communication on this specific topic. 
In the years following publication of this communication the ESOs, with the assistance of the Operating Grant, implemented a number of process improvements and developed specific tools to enhance th e ways in which their technical bodies 
integrate environmental considerations into their work. 
In the case of the more specific action grants  issued to the ESOs to support standards 
development work, preliminary studies, vi sibility actions, etc.  a formal proposal 
evaluation process is implemented in order to assess and ensure the relevance of the 
proposed work to the achievement of Commission policy. While the policy objectives themselves are not made explic it in the assessment process, Commission 
officials with responsibility for standard isation policy and those responsible for 
policy in specific sectors (e.g. railways, eH ealth, chemicals, etc. ) participate in the 
evaluation of the proposals and assess their relevance to Commission policy. Based 
on the information available there have b een few if any problems relating to this 
aspect of the process, largely because the mandates or work programmes issued to the ESOs and against which the proposals are submitted, reveal the objectives of the Commission and serve to ensure that both the proposed actions and the financing are 
closely targeted in po licy-relevant areas.  
We have not encountered any cases where work supported from 2004-7 was of 
limited or unclear relevance to Commission po licy, and most actions are relevant to 
the achievement of multiple objectives. With in the current system most of the ESO 
grant applications are evaluated largely on  a case by case basis, on their own merits, 
rather than in competition with each other.  It is not clear how the Commission might 
use the relevance criteri on to choose between competing  proposals for financing, 
although the work supported under the annual IC T standardisation action plans offers 
 
EN 199   EN perhaps the closest approximation to a co mpetitive environment, with the number 
and value of proposals submitted exceeding the notional budget available for ICT 
standards development. Within that system , work intended to support directly the 
implementation of EU legislation is affo rded the highest priority, so could be 
considered most relevant to the achiev ement of policy objectives. Work that is 
closely aligned and supports the implementation of ‘flagship’ or newly announced initiatives of the Commission is  judged to be the next most  relevant category of work 
to support. As such, there is something of  a gradation in the adjudged relevance of 
the proposals, based not on the number  of objectives addre ssed but rather on the 
adjudged ‘importance’ or ‘pri ority’ of the policy areas to which they contribute. 
In addition to the evaluation process th at is implemented by the Commission to 
ensure the relevance of the proposed work prior  to the financing being granted, the 
work is also monitored during its execution and assessed at the end, and there is the 
potential at these points to identify problems with the relevance of the work to the achievement of Commission policy. However,  the major effort at these stages is 
devoted to monitoring and assessment from a contractual and financial perspective, 
ensuring that workplans and timetables ar e being followed and th at financial rules 
have been observed when submitting claims fo r payments. There is little or no desire 
on the part of the Commission to actively ‘steer’ the work to ensure or maximise its 
relevance to or fit with Commission policy obj ectives, other than in isolated cases for 
specific reasons. This seems largely appropr iate, as the objective of the Commission 
is not to get involved or ‘interfere’ in the work at a technical level, but to use its 
financing to support and to some extent to encourage and accelerat e the flow of work 
that is relevant to its policy objectives. The relevance test is  therefore applied, 
correctly, prior to the initiation of the work.  
Care is also taken not to ‘distort’ the market by pushing too strongly for standards 
development work in policy areas, or by sp ecifying too precisely what is needed and 
how that work should be carried out. It is  considered important by the Commission 
(and other actors) that its role should not ex tend too far into the technical level, and 
that it should instead act as an amplifier of European policy objectives  and as an 
enabler and supporter of actions that fit with those priorities but which, crucially, 
have a sufficient level of industry support. The additional resources, in the form of 
financing, are offered in order to strengthen th e activities rather than to cause them to 
go ahead, and the level of support offered is not sufficient to drive the work forward 
if there is no industry demand to carry it ou t. Again, this is an appropriate level of 
intervention under the principles of the New Approach, which sees standardisation as 
an industry-driven activity and not something that the public sector should be 
controlling or dr iving directly. 
2.4. Alternative ways to support standard isation and the achievement of its 
objectives 
The study was asked to assess whether there are alternative ways for the Commission 
to support standardisation to contribute to its objectives. Based on our consultation 
with all of the main groups of actors involve d in the financing and the work, there are 
no obvious alternative ways for the Commi ssion to support standardisation, although 
as we will go on to explain progression to a more stable and less complex financial support system appears warranted. 
 
EN 200   EN It should be noted that the support to standardisation come s not just through financial 
means, but by the development of Europ ean legislation and policies that have 
provided much of the basis for European st andardisation over the past 20-30 years. 
Previously standardisation was carried out  mainly at a national level, and the 
Commission has played a central role in en couraging the creation of a single market 
within Europe and the remova l of national barriers to trade. This effort has been 
underpinned by a strong industry policy logic, with advancement of the 
competitiveness of EU industry at its hear t. A significant number of commentators 
have highlighted the importa nt role played by the Co mmission in promoting this 
‘single vision’ and in ar guing strongly and supporting  actively a centralised 
European system of standardis ation, albeit one that reli es heavily on national-level 
activities and inputs. Referen ce is often made to the ‘inferior’ US approach to 
standardisation, which is described as highly fragmented a nd less efficient and 
effective as a result. Therefore the Co mmission supports standardisation not just 
through its financing but through  its strong lead In promoti ng the concepts of a single 
Europe, a single market for products and se rvices, and an EU-level standardisation 
system based on the principles of the New Approach. These are also seen to be key mechanisms through which the Commission has helped to suppor t the achievement 
of its own policy objectives.  
The study was also asked to assess whether there are areas or actions where means 
other than financing could better contribute  to the achievement of the objectives. We 
did not identify any such area  or actions, or indeed an y other means by which the 
Commission could support the achievement of its objectives. Therefore we have 
concluded that there are no alternative system s or mechanisms that could better serve 
the defined needs than the current one. Ho wever, suggestions for improving the basis 
of the financial support were  readily identified, and ther efore form the bulk of the 
concrete recommendations that we make in this report.  
2.5. Ways to increase the relevance of the financing to the achievement of 
Commission policy 
As indicated above, all of th e activities that have attract ed financing from EC/EFTA 
from 2004-7 were found to be of clear a nd high relevance to the achievement of 
Commission policy objectives, and we ther efore have no specific recommendations 
for improving the relevance of the support.  
3. E
FFECTIVENESS  
3.1. Communication of policy objectives to the ESOs 
In order to ensure the relevance of the financed activities to the achievement of 
Commission policy objectives it is important  that those objectives are communicated 
clearly to the standardisation bodies. This is done in a variety of ways and at a 
variety of different levels.  
The objectives that we have used to gui de the study were identified from within 
communications, policy papers and othe r documents relating to European 
standardisation and in some cases rela ting specifically to the financing of 
standardisation by EC/EFTA. These documen ts all, in various ways, set out in 
 
EN 201   EN general terms the objectives of the Comm ission’s standardisati on policy, explaining 
both why the Commission wishes to support  standardisation and the kinds of 
improvements it feels are necessary in order to improve the performance of the system as a whole.  
Some of the most important documents among these include: 
• General guidelines for the cooperati on between CEN, CENELEC and ETSI 
and the European Commission and the European Free Trade Association 
(2003/C 91/04) 
• Decision No 1673/2006/EC of the Europ ean Parliament and of the Council - 
On the financing of European standardisation 
• Communication from the Commission to  the Council and the European 
Parliament - on the role of European Standardisation in the framework of 
European Policies and legi slation (COM (2004) 674) 
The documents are communicated to the ESOs, and there is good evidence that they 
provide an effective means for conveying the Commission’s standa rdisation policy to 
the ESOs in general terms. The ESOs are aware of the texts and have considered them all carefully and make use of them on an ongoing basis. This, therefore, is the 
first level at which the objectiv es are communicated to the ESOs. 
The second level of communication of polic y objectives is through the mandates and 
work programmes addressed to  the ESOs and which prov ide specific requests for 
standardisation work. The documents often set out the ‘policy context’ behind the 
request for the work and convey in more de tailed terms what the objectives of the 
Commission are in one or mo re specific policy areas and how the ESOs are being 
asked to contribute. These documents vary co nsiderably in terms of how they set out 
to explain or convey the policy objectives th at lay behind the reque sts, and naturally 
tend to focus more on what is required or where it is required rather than why its is required. 
Again there is good evidence that the mandates and work programmes offer an 
effective means by which to  convey further informa tion about the Commission’s 
policy objectives, intentions, needs and so on. There is evidence to suggest that some 
of these communications can also prove confusing to th e ESOs but this tends to 
relate to uncertainties about  what specifically is require d rather than the general 
policy objectives that underpin the requests. 
The third and perhaps most importan t way in which the Commission’s policy 
objectives are communicated to the ESOs  is through the many forms of dialogue, 
meetings, day to day communications and inte ractions that guide the relationship on 
an ongoing basis. This helps to ‘fine tune ’ the communication of objectives at the 
level of specific actions and also helps to  reinforce the importa nce of certain higher 
level objectives contained in the general policy documents used to guide this study.  
Again, while this third level of communica tion is an effective means by which to 
convey policy objectives to the ESOs, it is  clear that too much of the dialogue 
 
EN 202   EN between the two parties is taken up with  discussions about financial rules and 
detailed administrative issues, detracting from the amount of time that can be 
devoted to explaining the ‘bi gger picture’. However, this third layer also supports to 
some extent an improved understanding of the Commission’s policy objectives. 
Overall, then, a largely effective set of mechanisms is in place that allows the ESOs 
to fully understand Commission policy at a suffi cient level of detail to ensure that 
their activities fit wi th and support those objectives. Ha ving said this, there is no 
single source or reference for the ESOs to re fer to, and the flow of documents that in 
some way convey the Commission’s polic y objectives are many and various. In 
addition, while there are many documents that  can be said to contain Commission 
policy objectives, there is no way to clear ly discern their relative importance or 
priority vis-à-vis each other and how this mi ght be changing over time. It is clear to 
us that the 29 policy objectives that we iden tified and have used in the course of our 
work are not all equally important, and indeed many are inter-related and mutually supportive while others ‘stand alone’. As such, while all of the objectives are clear, 
their relative importance or priority at any given point in the polic y cycle is far from 
clear. As such, they provide only a general indication of the kinds of benefits that 
standardisation is expected to deliver a nd the kinds of improvements that the ESOs 
are being asked to make.  
As such there is a case for a more orga nised regular annual  process by which the 
Commission could convey its policy objectiv es to the ESOs, and which may help 
them to better respond to new and ongoing priorities. There is also a case for 
describing the objectives in more purposef ul terms, making them a little more 
specific and a little more actionable on the part of the ESOs.  
We recommend that the Commission seeks to  develop a clearer statement of its 
main policy objectives in the area of standardisation, and refreshes this list on 
an annual or multi-annual basis. The object ives should be cast in the form of 
specific, purposeful statements as to th e kinds of benefits, impacts or changes 
that it wishes to make 
3.2. Establishing the link between the ob jectives and the financial support 
The policy objectives of the Commission a nd the financing are linked in a number of 
ways, both in official documents that provi de the formal basis for the financing and 
through the processes and procedures of  the Commission a nd the ESOs when 
deciding on specific actions.  
At the first of these two levels the various documents that relate to the financing, 
including the Council Decision, the guideli nes for cooperation, and the Framework 
Partnership Agreements all establish a ge neral link between the financing and the 
objectives. This does not, how ever, go beyond general statemen ts to the effect that 
the financing is provided because of the role played by the ESOs in helping the Commission to meet those objectives. 
The more meaningful link is provided through the work programmes and mandates 
that constitute requests for standardisa tion work and through the proposals submitted 
by the ESOs in response. At this level th e Commission’s needs in very specific or 
 
EN 203   EN more general policy areas are set out and th e ESOs are invited to propose work to 
address those needs. The grant applications that are then prepared by the ESOs, with 
inputs from their members and technical bod ies, further establis h the links between 
the actions to be financed and the polic y objectives of the Commission. However, 
this is done within a reasonably open fo rmat, and there is no specific requirement 
(although a general convention) to provide  an explanation of how the two fit 
together. 
Based on our analyses the li nk between the financial suppor t and the objectives are in 
some respects not as clear as they could be. In particular, the extent to which the 
financing is (or should be) being depl oyed purposefully in pursuit of specific 
objectives is unclear. It can be seen that  there are ‘spikes’ in financial support 
directed to specific areas of policy (e.g. the environment) following the publication 
of a new communication, strategy or initiativ e in a particular policy area, but the 
duration of those spikes and how and when  it is decided that enough attention and 
financing has been given is rather  more difficult to determine.  
At the same time we can identify certain trends, such as the fall off in the number of 
visibility actions from 2004-7, but have no way to account for these trends, other 
than to guess that this objective was more of a policy priority in  2004 than it was in 
2007. There is little to indicate that any kind of assessmen t is being made to establish 
how much of the financing is being devoted towards each objective or policy area, or 
that any judgements are being made as to wh ether this is sufficient or not. As such 
we believe that the connections between the financial support and the objectives 
being addressed could be more e ffectively monitored and assessed.  
We recommend that the Commission establ ishes a mechanism to assess, on a 
regular basis, the extent to which its fi nancing is being depl oyed in pursuit of 
each of its main policy obj ectives, in order to more clea rly establish the extent to 
which each ‘area’ is receiving sufficient support 
3.3. The extent to which the financing has contributed to the Commission’s policy 
objectives 
The study was asked to evaluate the extent to which the financi ng of standardisation 
activities has contributed to the Commission’s objectives of its standardisation policy, especially towards SMEs. We were also asked to assess the effect of the 
actions financed by the Commission, in view of the implementation of the EU standardisation policy. 
At an overall level we can state that th e financing of standardisation by EC/EFTA 
has made a significant positive contribu tion to the achievement of Commission 
policy objectives: 
• Most of the financed actions are considered to have contributed to the 
achievement of (multiple) Commission policy objectives, or are expected to do 
so in the fullness of time 
 
EN 204   EN • The financial support has encouraged sta ndardisation activities to become more 
aligned with Commission policy object ives and has provided impetus to 
activities in specific ‘priority’ areas  
• The existence of expressed Commission policy need and the availability of 
financing in combination provide c onfidence and encourage commitment on 
the part of other actors, acceler ating the work in those areas  
• The financing allocated by EC/EFTA st rengthens the activities by expanding 
the level of management and coordina tion support availabl e, the level of 
expertise involved in the work, and its overall size and scale  
• The financial support has been effectiv e in enabling significant improvements 
in the operations of the Centra l Secretariats of the ESOs 
• There is little overt focus on suppor ting SMEs through the financing, though 
there are some specific examples where actions have been financed that are 
directly targeted on SME needs  
• The principle that standard isation activity should be an  industry-driven venture 
is broadly observed, and th e financing is not used to  proactively ‘direct’ the 
standardisation work (which seems appr opriate). However significant influence 
is exerted over time through a range of relatively subtle mechanisms 
While the financing clearly supports the achi evement of the policy objectives of the 
Commission there are unfortunately no reliable means available to determine the scale of the impacts or the economic return on investment. The policy objectives are stated in terms that are too open (non-specifi c) to gauge the extent to which they are 
being achieved, and insufficient data and evid ence exists to quantify the scale of the 
benefits achieved through the fi nanced activities, either se parately or in aggregate. 
Having said this, our evaluati on has enabled us to build up something of a profile of 
the extent to which the different actors involved believe that the different policy 
objectives have been supported by the financ ing in the period 2004-7, and the results 
of these analyses are presented in the main  body of the report, organised against each 
element of the financing. This is a fair ly crude analysis, ba sed on discussions and 
ratings assigned by interviewees as to th e contribution or expected contribution of 
the supported actions to th e achievement of Commission policy. This has confirmed 
that most of the policy objectives have been supported by multiple actions and that 
most are addressed by more than one of the forms of activity attracting support. This 
analysis has also demonstrated that so me policy objectives have received little 
attention and there is little to indicate that the financing will have contributed 
significantly to their achievement, at l east in comparison to other objectives.  
To summarise this analysis we can say th at the financing has had the strongest and 
most positive impact on the following objectives: 
Industrial policy –  Facilitating interoperability  
– Assisting completion of the internal market  
 
EN 205   EN – Supporting technological innova tion within EU industry 
– Advancing the competitiveness of European industry 
Public policy –  Providing a high level of prot ection of health and safety 
– Supporting the public interest dimension of standards 
Strengthening European 
standardisation  – Providing a mechanism for consensus building on identified issues 
– Improving the effectiveness of European standardisation  
– Improving the timeliness of  standards development  
Extending the system and 
increasing 
inclusion – Increasing the role of standards in  support of EU policy / legislation 
– Increasing the visibility of the European standardisation system 
– Assisting the integration of candidate countries  
– Ensuring effective participation by all relevant actors  
 
The study was specifically asked to asse ss how the Commission’s financing policy 
and practices have contributed to the integration of new Member States. Our 
conclusion is that the financing of st andardisation by EC/EFTA has effectively 
contributed to this objectiv e both through support for a sm all number of specific 
actions targeted in this direction (visib ility actions, training programmes, etc.) and 
through more general improvements (simplif ication, information) effected through 
the provision of Operati ng Grants to the ESOs.  
This question and answer provides an opport unity to consider how the Commission 
actually uses its financing to address specifi c objectives of its st andardisation policy, 
and whether there is a case for a more organised and concerted effort in specific areas. What this means is that when the Commission decides that one of the objectives of its standardisation policy is to assist with the integration of new member states, should there be an explanati on as to how it intends to do this and an 
indication of the level of resource it feel s is appropriate to devote towards that 
objective? This would certainl y help to ensure that spec ific objectives are given a 
certain status through clear statements  about what the Co mmission is hoping to 
achieve, which in turn would help to enc ourage proposals from the ESOs as to how 
EU standardisation could help to meet those objectives. In  this way there could be a 
clearer communication of specific objectives , better targeting of  resources on those 
objectives, and the basis for a clearer asse ssment (subsequently) as to the impacts 
that the financing and the supported actions  have had on the achievement of those 
objectives.  
Some of the more specific (or targeted) polic y objectives where the intentions of the 
Commission remain somewhat unclear include, for example, improving and extending the European Keymark system, increa sing the role of sta ndards in security, 
and ensuring the effective take-up of standards by SMEs. 
 
EN 206   EN We recommend that the Commission seek s to explain more clearly how it 
intends to use its financing to pursue the achievement of specific policy 
objectives, and that it considers ea rmarking funding for those purposes 
3.4. How does the Commission measure the achievement of its objectives?  
The study was asked to assess how the Co mmission measures the contribution of 
standardisation to the achievement of its policy. Based on our work we have to say 
that it is not clear that the Commissi on seeks to measure (or even assess 
qualitatively) the contribution of standardisation to the achievement of its objectives on any kind of regular basis. Having said this , it is clear that due to the very general 
or ‘high-level’ nature of the objectives being pursued, the absence of performance 
indicators and data with which to gauge  their achievement, and the inevitable 
problems associated with attributing the sp ecific role that the financing plays in 
relation to all other inputs to those objectiv es, means that it is unlikely that any kind 
of robust quantitative assessment could be made.  
However, the recommendations already made  above concerning (i) the need for more 
purposeful statements of objectives and ( ii) clearer explanations as to how the 
financing is expected to c ontribute to these should, if implemented, provide a better 
basis for assessing retrospectively the cont ribution that the fina ncing has made to 
their achievement. 
3.5. Effective deployment of the financing 
The study terms of reference asked the ev aluators to identify whether there are 
actions of the ESOs, which, although not fi nanced by the EC, contribute to the 
achievement of its policy objectives, and whether the objectives would be better 
achieved with EC/EFTA financing support.  
Based on our findings we can say that ther e are many and various actions performed 
by the ESOs that contribute to the achievement of Commission policy but where no financial support is currentl y given. One of the most obvious examples is work 
carried out by CENELEC under New Approa ch Directives (RTT, LV and EMC), 
which supports directly the implementation of Community legislation, but for which 
CENELEC no longer seeks financial suppor t due to past ne gative experiences 
associated with many elements of the administration of th e financial support. 
CENELEC and its members have elected to no longer seek suppor t delivered through 
action grants due to the delays, high ad ministrative burden, and the complex and 
unstable financial rules that do not fit well with how the ESO systems operate, involving as they do significant elements  of subcontracting of tasks to experts 
appointed by TCs. However, given the open nature of th e Commission’s policy 
objectives it is clear that most of the activiti es the ESOs undertake can be seen to be 
of relevance to and support in some way Commission policy. However, a significant 
portion of that work does not currently attract financing. 
It is clear that, base d on the findings of this report , the financing brings significant 
benefits from the perspective of all actors, and in this sense a fi nancial allocation by 
EC/EFTA for this work would be benefici al. However, the current punitive financial 
rules and the high administrative burden associated with acce ssing the support are 
 
EN 207   EN limiting seriously the propensity of the ESOs and their members to take-up the 
available financial support. Unless a more stable and reasonable  basis for providing 
the support can be found there is a danger th at the real underlying extent of demand / 
need for the support will not be revealed, and that a lot of work that could be 
enhanced by EC/EFTA financing will have to make do without it.  
The study was also asked to identify whet her there are actions  carried out by the 
ESOs that could contribute to the achie vements of the policy objectives of the 
Commission but which are  not being performed, because of a lack of financing, and 
if so, would a Commission financial support help develop such actions. Based on our 
assessment it does not seem that there ar e any significant activities that are 
considered desirable / necessary that are not  being performed at a ll because of a lack 
of financing, but it is clear that certain activities are carried out less frequently or 
with less resource due to limitations in the financial support available.  
The first area identified where a majority of commentators felt that important work 
was going on at a lower level than is desirable and where the level of support might reasonably be increased is in the area of translation . Most commentators consider 
that making standards available in the natio nal languages of their intended users is 
absolutely vital if the standards are to be widely used and the pot ential benefits of 
standardisation are to be fully realised. The 2006 evalua tion of EC/EFTA support for 
translation identified a range of problems li miting the uptake of the available support, 
and we are pleased to report that a number of measures have now been put in place to overcome some of those problems. However, these changes have only recently been implemented and it is therefore important that the Commission monitors closely the 
extent to which these change s are having a material imp act on the uptake of the 
support over the next few years.  
We recommend that the Commission clos ely monitors the level of uptake of 
financing for translation over the coming 2-3 years to assess the effects of recent 
improvements to the financial arrangements , and that it takes corrective action 
as necessary if the changes are not h aving the intended (positive) effect  
We have also identified strong support fo r increasing the level of financing for 
visibility  actions, as this is widely seen as an area where EC/EFTA financing is both 
legitimate and most value adding in the sense that other act ors are unable or 
unwilling to finance the work. More specifi cally, there is no strong case for industry 
to support the wider promotion of the Eur opean standardisation system, but it is 
considered to be vital for helping EU indus try to access world market s, to assist with 
the integration of New Member States, and to support the take-up and use of 
European standards.  
Problems with the administrative complexities  of the financing as detailed elsewhere 
in this report have limited the willingne ss of some ESOs and their members to 
participate in these actions, but we have also identified a diminishing desire on the 
part of the Commission to encourage such ac tions in recent years, leading to a sharp 
fall in the extent of support for these activities. While much of the standardisation work is likely to proceed at some point  in the absence of EC/EFTA financing, 
visibility actions are unlikely to, and we therefore recommend that the Commission 
 
EN 208   EN restate its commitment to promoting the European standardisation system 
internationally, and ensure that resources  are made available for this purpose. 
We recommend that the Commission restates its support for visibility actions 
and ensure that sufficient resources are available to support these projects in 
future  
Over the period covered by the study EC/EFTA financing has successfully 
contributed to a number of preliminary scoping or feasibility studies that have investigated the potential for standards de velopment in new areas such as services 
and fuel cells. It has also financed other ‘s upporting’ activities such  as ‘helpdesks’ to 
assist with the implementation of large suites of standards (e.g. pressure equipment) 
and encourage their wider take-up.  
These actions are widely considered to be important areas for EC/EFTA financing 
for a number of reasons. The feasibility / sc oping studies hold the potential to either 
confirm the need to proceed with st andards development in new areas of 
Commission policy, and help to avoid the possibility that the Commission would 
encourage such work before the market is ready. The helpdesks have been shown to 
assist in the uptake of standards, there by supporting directly the implementation of 
New Approach legislation. There is also th e potential for other types of supporting or 
preparatory actions to be used in order to generate similar / additional benefits.  
There was relatively few of these types of actions supported from 2004-7 and we 
believe that there is the pot ential for them to be suppor ted more actively by the 
Commission, particularly as a means to in vestigate the role of standards in new 
policy areas and to support the dissemination and uptake of standards, thereby supporting both ends of the standards develo pment cycle, while leaving industry to 
drive the main body of standards development work itself. We therefore suggest that 
the Commission also restate its support for these types of actions and ensure that 
financing is availa ble to support them. 
We recommend that the Comm ission restates its supp ort for (i) preliminary 
studies that assess the potential for sta ndards in new areas and (ii) other forms 
of support action that contribute to the wider take-up and use of European 
standards  
As regards support for standards development work itself, there is clearly a strong 
case for EC/EFTA financing to continue to be used, as it clea rly helps to provide 
impetus for and strengthen work going on in  areas closely linked to EC policy and 
legislation. However, of all the forms of  support provided it was the area where 
many stakeholder groups were more ambivale nt about whether there was a real need 
and whether the financing might have negati ve effects as well as positive ones. We 
are reluctant to suggest that EC/EFTA shoul d withdraw from this line of support, or 
even curtail its expenditure due to the cl ear and positive impacts that the financing 
has in encouraging and strengthening work in areas related to public policy and where the public interest dimensi on of the standards is clear.  
We did, however, identify strong demand for increased support for a specific element 
of the standardisation work, namely round robin testing  to validate the test methods 
 
EN 209   EN that form an integral part of many sta ndards. The ESOs, NSBs and some industry 
stakeholders have indicated that certain areas of standards development work were 
effectively ‘stuck’ due to an inability to find financial resources  to carry out round 
robin tests. The bodies of st andards affected all support directly the implementation 
of Commission Directives or legislation a nd the accuracy and validity of the test 
methods is of vital importance in ensuring that compliance with the standards ensure 
the necessary level of protection of health  and safety or environmental protection, 
and as such there is a strong case for public support.  
We understand that the Commission’s reluctan ce to finance round robin tests relates 
partly to the high costs and partly to the f act that this element of the work involves 
little input from the ESOs and NSBs, and as  such the work may need to be tendered 
competitively. It is not clear whether this is actually the case as the programme of testing would have to be coordinated and directed in some way by the TCs 
responsible for developing the standards. Even  if it turns out that the work has to be 
competitively tendered then this route s hould be followed in order to allow the 
standards development work to be comple ted in a timely fashion. As regards the 
costs, the overall EC/EFTA budget for standa rdisation is relativel y modest given the 
scale of the benefits realised  and there is certainly a case for seeking to increase the 
budget in the face of increased need. We therefore recommend that the Commission seek to find ways to provide a greater level of support to round robin testing. 
We recommend that the Comm ission seeks ways to pr ovide a greater level of 
support to round robin testing in order to ensure that important bodies of 
standards can be completed and used  to support Community legislation 
One final area where there is a case for increased funding from EC/EFTA is for the 
revision of standards, particularly where the need to revise standards has been 
prompted by changes to EC Directives or other forms of legisl ation. Under these 
circumstances, changes required to bodies of standards to ensure that they can 
continue to be used to suppor t the implementation of the legi slation is as much in the 
interest of the Commission as it is industr y, and it therefore seems appropriate that 
EC/EFTA should help to support that  revision process where possible. 
We recommend that the Commission pr ovides support for the revision of 
European standards in cases where the need to revise has been prompted by 
changes to Directives or other legislation 
3.6. Strengthening the role of Units I3 and D4 [currently Units C5 and D3]  
DG ENTR Units I3 and D4 [currently Units C5 and D3  of the Enterprise and 
Industry DG of the Commission]  provide a valuable serv ice in facilitating other 
Commission services’ access to standardisation. This role is effective but based on 
the feedback received it c ould be further strengthened.  
One of the key roles played by these two units is to promote the wider use of 
standardisation across the Commission, helpin g other policy units to understand the 
benefits that standards can bring and pr oviding a route by which they can make use 
of standardisation in support of their own areas of policy and legislation. We spoke 
to a number of units that spoke very hi ghly of the ‘service’ provided by these units, 
 
EN 210   EN some of which indicated that they would have struggled to address requests to the 
ESOs and provide an impetus to standardis ation work without their help. Some of 
these units have indicated that more c ould be done to promote the benefits of 
standardisation within the Commission, and that standardisatio n could be given a 
higher profile. We are aware that resource c onstraints within units I3 and D4 limits 
the extent to which they can undertake su ch promotional wor k, although both have 
been effective in these role s in the past. We hope that in future more time can be 
given to continue this good work. 
We recommend the Commission seeks to more actively promote the benefits of 
standardisation within the Commissio n, helping to extend the range of 
Directorates and policy units that use it in support of their policy  
Many of the policy units manage their own links to the standard isation work being 
carried out in their policy areas. Most of these units  are responsible for New 
Approach Directives and have long-standi ng links to the ESOs, and in some cases 
the Technical Committees that are undert aking the work. These units usually 
communicate directly with the ESOs and some also access the ESO’s information 
systems directly in order to stay appraised of progress. In  addition, some of the units 
meet regularly with the ESOs, through standing committees and other bodies 
connected to the standardisation work, with a minority also attending relevant Technical Committee meetings.  
Some units, however, rely on unit I3 or D4 to keep them informed about the 
standardisation work that they have (or s hould have) a policy intere st in, but lines of 
communication in many cases are weak, a nd in some cases non-existent, meaning 
that these units are not being kept prope rly informed about the work. Indeed, we 
struggled ourselves to identify which units have an inte rest in some of the actions, 
and there seems to be no centralised syst em for documenting the links and ensuring 
that regular communication is maintained. Th e situation was most acute with respect 
to ICT standards work, which has suffered from changes in how the work has been organised and managed from a contractual pe rspective, and from the fact that the 
work is no longer (or only rarely) request ed through mandates de veloped by specific 
policy units. There are also clearly res ource constraints insi de many Commission 
units, and a lack of specific technical expertis e that might help the units to engage in 
the standardisation work directly, without relying on Units I3 and D4. These factors 
certainly go some way to explaining the problems.  
However, we believe that both unit I3 a nd D4 could and should develop clearer and 
stronger processes for connecting the actio ns for which they have contractual 
responsibility to the units whose policy area s the work is intended to contribute to, 
and for ensuring that the relevant units are kept regularly informed about the 
standardisation work. As such there is a need for the relevant policy contact or 
contacts to be named in the grant agreements and for some system to keep that information updated in the event of staff ch anges. In this way, units I3, D4 and the 
ESOs would always be aware of which indi viduals and units within the Commission 
have a policy interest in the work. 
A related concern raised by some of the policy units concerned the nature of the 
information they receive in relation to the work, which is often considered to be too 
 
EN 211   EN technical in nature and not sufficiently ta ilored to their needs. The best way to 
facilitate their interest and engagement in the work would be to provide regular 
information on the work, in laypersons terms, identifying any specific issues that the Commission might need to be aware of. Th e ESOs, via their TCs/TBs would be in 
the best position to provide such information, though there would be a cost to this that could reasonably be met by EC/EFTA as pa rt of the eligible costs of the actions.  
We recommend the Commission establish (i) a clear process for linking specific 
actions that have attracted EC/EFTA fi nancing to named officials within the 
relevant policy units, and (ii) an impr oved process for ensuring that those 
officials are provided with regular updates concerning the progress of the work 
and any issues arising. 
The policy units are also interested in the im pacts of the work and in particular would 
like to be kept informed about the extent of take-up of the sta ndards and whether the 
standards are proving useful in resolving, for example interoperability problems or 
improving compliance with Directives. Such information is not easy to obtain, and 
there are no processes currently in place to collect it. 
We believe that stronger engagement by the Commission in the work, facilitated by 
improved lines of communication with th e ESOs, would help to strengthen the 
relationship between the Commission and the ESOs, and would allow the 
relationship to be based more around comm on objectives, the progress of the work, 
and the benefits realised than about the administrative rules, payment delays, and time delays, which unfortunately often seem to be the most salient feature of the 
support system.  
4. E
FFICIENCY  
4.1. Proportionality of the financing allocated to the ESOs 
The study was asked to assess whether the financial support allocated by the 
Commission to the ESOs is proportionate to  their contribution to  the achievement of 
the policy objectives. Based on our evaluati on we conclude that the total volume of 
financial support provided by EC /EFTA for standardisation a ppears to be relatively 
modest, given the important ro le that standardisation plays in the implementation of 
EU legislation and policy. The Commission is able to make significant use of, and 
enjoys significant influence over, the standa rdisation system in relation to the scale 
of its financial contribution. In this sens e the financing delivers very good value for 
money, and there is a case for an increased  level of financing in specific areas in 
order to address identified needs. 
We believe that there is something of a contradiction between the statements made 
by the Commission about the importance of  standards to the economy and society 
and its very modest, some might say ungene rous, approach to financial support in 
this area. Despite the key role played  by the ESOs in implementing the New 
Approach and supporting Commission polic y and legislation, only €15 million per 
annum is currently spent and a significant por tion of that is consumed in meeting the 
administrative burden that has to be complie d with in order to receive that support. 
 
EN 212   EN Regrettably one of the ESOs, several NS Bs and a number of Technical Committees 
and Bodies have elected to no longer  apply for support de livered through action 
grants (other than the OGs) as a result of  the financial and administrative difficulties 
and the delays that are associated with the financial support, and this is testament to 
the fact that the political  ambition is not being met by corresponding levels of 
(useful) financial support. We might have expected that the st andardisation unit (I3) 
would be keen to expand its budget and to do more to help and assist with the effort 
in areas that contribute to Commission pol icy, but the approach is invariably to 
question or doubt the need, or to seek to  minimise the amount of support that is 
offered, despite the fact that the Comm ission’s input into the overall costs of 
standardisation is very modest.  
Under the current arrangements the budget only appears to be under a moderate 
amount of pressure. The pressure has been alleviated significantly by the withdrawal 
of some ESOs and NSBs from certain lin es of support due to problems with the 
detailed, complex and unstable financial ru les and the high administrative burden. 
Under improved conditions there would be a strong case for an increased budgetary 
allocation due to the significant benefits  that the support can deliver. Many policy 
units plan to make more use of standards in future, and we have identified a range of 
areas where an increased level of financing would be useful, but it is not clear that the ESOs and their members and technical bodies will make full use of that support 
unless the administrative and fi nancial problems can be significantly reduced. If this 
can be done, and we make a number of recommendations for doing so below, then there is significant potential for increasing the budget and using it to extend the range 
of ways and the number of areas in which the financing can support the implementation of Commissi on policy and legislation. 
We recommend that the Commission seek to increase its budget for 
standardisation in the medium term, in order to better reflect the considerable 
benefits that the support can bring a nd in order to provide support to an 
increased range of activities across a broad er range of policy areas. In order to 
ensure that the support is taken up and used effectively, an improved set of 
administrative arrangements should be put in place to ensure that the financing 
can be accessed easily and used for its in tended purposes / bene fits rather than 
being consumed in administrative costs. 
We have also looked at the question of whether the volume of financing allocated to 
each ESO is proportionate to their relative contribution to Commission policy. This 
is not easy to answer as there are no agreed indicators for making such an assessment. It is clear that the three ESO systems and their centr al secretariats are 
very different, and it is clea r that the range of sectors covered by each ESO impacts 
on the level of financing that each is alloca ted. However, a host of other factors also 
affect the volume of financing they receive , including conscious decisions on the part 
of some to limit their level of financia l reliance on the EC/E FTA support. It is 
therefore not possible to say whether the current balance is  correct, but we received 
no indications from any of those consulte d that the balance was obviously wrong or 
required adjustment. Having said this, if the Commission clarifies its policy objectives and provides more de tail on how it exp ects standardisation to contribute to 
those objectives, this may provide a better ba sis in future for arriving at a clearer 
perspective on how each of the ESOs is cont ributing to these. This could help to 
 
EN 213   EN determine the appropriate scale of the Op erating Grants and may provide the basis 
for deciding a suitable ‘allocation’ for standards development work within a more straightforward future system of financ ing, if one could be found. However, under 
the current arrangements we do not see any strong need to undertake such an 
exercise. 
4.2. The de-facto monopoly position of the ESOs 
The study was asked to assess whether the de-facto monopoly of the ESOs generates 
a loss of efficiency regarding the financia l support allocated by the Commission. It is 
our contention that the de-facto monopoly position of the ESOs does generate a loss 
of efficiency, but this is not because the ES Os abuse in any way the position that they 
hold, or seek to maximise their gains because they can access financing in a largely non-competitive environment. The loss of effi ciency is created by the financial and 
administrative rules that are applied by the Commission because of the monopoly 
position.  
Under normal circumstances the Commission issues open, competitive calls for 
tenders when wishing to support specific forms of activity undertaken by external 
organisations. However, the ESOs are form ally recognised as the three European 
standardisation bodies, and as a result they are uniquely qualified to undertake 
certain types of work, specifically those rela ting to the ‘core process’ of developing 
recognised European standards (ENs). As such, the Commission financing rules 
indicate that a full competitive tender is not necessary, and speci fic provision is made 
in the financing decision to allow the Co mmission to direct reque sts to the ESOs and 
provide financial support without running an open tendering process. This facility is intended to make the financing of the actions  more efficient, as it saves time and 
money associated with th e full tendering process.  
However, it seems that the de-facto monopoly status of th e ESOs brings into play a 
number of other financial ru les and creates a certain ner vousness on the part of the 
Commission, which together have led to a s ituation where the financial controls and 
administrative requirements have now become excessively demanding and bureaucratic and seem to go far beyond th e level applied to competitively tendered 
work. Many of those rules also appear to be a poor fit with the ESOs’ natural ways of working, which inevitably involve a certain  level of subcontracting, and there have 
been significant problems associated with  frequent changes to the rules and an 
inconsistent application of the rules by differe nt officials. This si tuation has created a 
significant loss of efficiency and has led to a situation where a significant element of 
the financing allocated to the ESOs is e xpended in administeri ng the grants rather 
than carrying out the work. The administ rative burden is no longer commensurate 
with the level of EC/EFTA contributi on to the real costs of the work. 
This situation has le d to a breakdown in relationsh ips between the Commission and 
the ESOs and their members, to the point wh ere the support is no longer viewed in as 
positive terms as it should be, and where little time or energy is left for positive, creative discussions about how to enhance the system  as a whole and how to 
maximise the value added by the support. The underlying trend now appears to be for the ESOs to avoid applying for action grants  wherever possible. This is clearly a 
regrettable situation and one that needs to  be addressed as a matter of urgency. It 
 
EN 214   EN should be noted, however, that significant e fforts have been made in recent years to 
reduce the administrative complexity and develop improved process in order to 
increase efficiency, with some positive effects. However, further more substantial improvements would be beneficial, and a mo re straightforward, stable system of 
financial support would bring significant be nefits. Our recommendations in this area 
are set out in Section 4.3 below. 
The terms of reference also asked the evaluators to determine whether the 
achievement of the policy objectives of th e Commission would be better supported if 
the Commission were to allocate grants or c ontracts to other orga nisations, especially 
as far as promotion actions are concerned. It is our conclusion that it is unlikely that 
the allocation of grants or contracts to ot her organisations for similar activities would 
better support the Commission’s policy obj ectives. The ESOs are all highly 
organised, professional orga nisations that have, by a l ong way, the best command of 
European standardisation and are in the be st position to carry out the full range of 
tasks that currently attr act EC/EFTA financing.  
4.3. How can the current method of fi nancing be further simplified and 
streamlined? 
The study terms of reference asked us to  assess how could the current method of 
financing be further simplif ied and streamlined, and how could project management 
be further simplified, bearing in mind the role of the Central Secretariats of the European Standards Organisations and th e role of National Standards Bodies. 
As indicated in the preceding section and as discussed extensively in the main body 
of this report, the current method of financing has become bogged down by a high 
level of administrative bur den, with unstable and complex financial rules, an 
atmosphere of mistrust, and significant dela ys in certain parts of the process that 
together significantly diminish the le vel of value added by the financing. 
Unfortunately, this has come to be the most salient feature of the system of financing 
implemented by the Commission and has come to dominate the basis of the relationship between the Co mmission and the ESOs. The problems have become so 
serious that take-up of  the support is in de cline, despite the c onsiderable positive 
benefits that it can and ofte n does bring to both parties. 
We are aware that the situation has been improved in the past couple of years and 
that the new Framework Partnership Agreem ents signed this year  (2009) offer the 
potential for smoother and less burdensome pr ocesses in relation to certain elements 
of the overall administration of the grants. However, while significant efforts have 
been made to improve the situation and address the significant backlog of actions 
where there has been a failure to agree on the final cost claims, significant problems 
remain and in many respects the damage has already been done.  
It is our contention that a shift to a radically simpler,  faster and more stable 
arrangement is necessary in order to incr ease the efficiency of  the financial support 
and in order to ensure that it is fully utilis ed and indeed extended in future. The ESOs 
have signalled that there ha ve been enough minor revisions to the rules and processes 
in recent years and that what is now needed is a period of stability and consistency in 
the application of the current rules and pr ocesses, and a serious attempt to find a 
 
EN 215   EN more suitable financial arrangement in the medium-term. In the short term we also 
believe that the Commission should appl y a more constructiv e and proportionate 
approach to the resolution of any points of confusi on or disagreement over the 
interpretation of the financial rules and administrative requirements, in order to 
facilitate improved uptake of the support as opposed to a further diminution of it.  
We recommend that the Commission seeks to identify a significantly simpler 
and less bureaucratic set of arrangements in the medium term, and that in the 
interim the administrative requirements and financial controls are defined as 
clearly as possible and are then applied fairly, proportionately and consistently 
across the various contracts. 
While the administrative problems surrounding  the interpretation and application of 
the financial rules have been the most se rious problem area, th ere are also notable 
problems concerning the (slow) speed of certa in processes. We have identified that 
one of the major benefits of the Commissi on’s financing support and policy lead can 
be to accelerate the onset of new standard isation work in areas closely linked to 
public policy, bringing confidence to stakeh olders and providing impetus for the 
work to move forward. However, having signalled its need or wish to support 
standardisation in a particular area, the pr ocess of agreeing the financing and drawing 
up the contracts can in many cases delay the start of the work, in some cases by more 
than a year. This causes frustration among  the standardisation bodies and industry, 
and in some cases has caused those involve d to not apply for th e support, electing to 
proceed instead with less re sources in order to avoid th e delays and administrative 
burden associated with EC/EFTA financing.  
The main cause of the delays appears to relate to the time taken to evaluate and 
assess ESO grant applications, and to agr ee and sign the contracts. These problems 
affect both the annual Operating Grants and the individual grants  for actions that 
support the standards developmen t work, feasibility studies, visibility actions, and so 
on. The reasons for the delays appear to relate mainly to the time that the Commission takes to organise  and undertake the evaluati on process, and the number 
of iterations that proposals have to go th rough before the contracts can be agreed. 
There also appear to be problems with the Commission’s own budgeting cycle, with 
signature of contracts sometimes being de layed pending a decision on the size of the 
budget for the coming year. There were also some suggestions that there have been 
specific shifts in policy pr iorities within the Commi ssion, which has meant that 
standardisation work in new areas orig inally prompted by the Commission has 
subsequently (following a grant applica tion) been de-prioritised, leading to 
uncertainties as to whether the work is st ill required. Such situations may also have 
delayed decisions on some occasions, but are perhaps not easy to always avoid within a policy environment.  
Given the simplicity of the evaluation proce ss used to assess the proposals it appears 
in many cases to take too long, and the process should be accelerated wherever 
possible in order to expedite  the start of the work. It would be helpful if the 
Commission could agree and observe a maximum period of  1-2 months to undertake 
the evaluation of proposals and to rende r a decision or request for further 
information, with requests for minor revi sions to otherwise acceptable proposals 
being agreed and made without the need for formal resubmission and reassessment 
 
EN 216   EN of grant applications. In cases where mo re substantial revisions to proposals are 
needed the ESOs should be given a furthe r month to respond, and the Commission a 
further month to review the changes and take its decision. The drawing up and signing of contracts should take no more  than a further month to achieve. 
The Commission has indicated th at one of the reasons why it takes so long to assess 
proposals and agree the contracts is the variable quality of the proposals submitted by the ESOs, which in many cases are adjudged to be insufficiently developed or containing mistakes that then need to be rectified. They suggest  that if the ESOs 
implemented an improved ‘quality control’  process before releasing proposals there 
would be a reduced need for the Commission to ask for revisions or further 
information before the contract can be agr eed. In response, the ESOs have indicated 
that the comments received are often very  minor, and that under-developed proposals 
tend to occur when the Commission’s request s are too open or unclear or when the 
time that their Committees have to respond to  the requests is too short to allow a full 
and considered response. It is contended that the time given to  prepare proposals is 
often less than the time that the Commission takes to read and assess them, and given the relative workloads involved, the evaluati on process should be able to be carried 
out much more quickly than the development of the proposals.  
We recommend that the Commission define s a clear process with agreed time 
limits for carrying out the evaluation of  ESO proposals and issuing decisions, 
and strictly observes those time limits. In addition, requests for minor revisions 
to proposals should be negotiated directly  and if complied with should obviate 
the need for a full re-evaluation of the proposals 
The ESOs have also indicated that a st andard template and guidelines for the 
development of proposals would be helpful, which go beyond those already developed and which provide a more functi onal specification concerning the types of 
information the Commission needs and the preferred length and format of the 
information. If such a template and associ ated guidelines can be agreed it should 
improve the extent to which the ESOs are able to get their proposals ‘right first time’. 
We recommend that the Commission de fine more clearly its requirements 
concerning the format and content of proposals, and that the ESOs observe 
these requirements in order to minimise the extent to which proposals have to 
go through multiple iterations before contract signature. 
5. UTILITY  
5.1. Is the financing vital to the ESOs? 
The study terms of reference asked us to determine whether the financial support 
delivered by EC/EFTA is vital to the ESOs , and whether the ESOs would contribute 
the same way to the achievements of the Commission policy objectives if the financial support were  not available.  
Our conclusion is that the fi nancial support is of significan t utility to the ESOs, NSBs 
and industry and in many cases is the critic al driver for the decision (by industry and 
 
EN 217   EN other stakeholders) to proceed with standa rdisation work in a given area. In other 
cases the financing affords additional prio rity to the work, and causes it to happen 
sooner rather than later. The ESOs would cer tainly not be able to contribute to the 
achievement of Commission policy objectives to the same extent  in the absence of 
the financing, though it is cl ear that they would contin ue to contribute to the 
achievement of Commission policy objectives , due to the high de gree of alignment 
between the Commission, the ESOs and indu stry stakeholders involved in the 
standardisation work. There are many points of common or shared interest and part 
of the rationale for EC/EFTA support is to contribute to the wi der body of activity 
that contributes to community objectives as part of a ‘fair deal ’ between the various 
stakeholders.  
The question of whether the work is vital to the ESOs is more difficult to answer. 
Certainly the Operating Grants are vital in enabling the central secretariats to 
continue their operations at the curren t levels, respond to Commission requests and 
requirements, and to continue to drive the same level of improvement within the standardisation system than they are curren tly able. It is not how ever vital to their 
ultimate survival, nor should it be. The other forms of financing are vital to certain 
actions being undertaken, in particular th e volume of visibility work, preliminary 
studies, supporting actions and a certain am ount of translation work. The support is 
less vital to the continuation of the standa rds development work, but certainly has a 
significant role to play in encouraging and strengthening that work in defined areas 
related to Commission policy and legislation.  
5.2. Industry perceptions of the financial support 
The study terms of reference asked us to assess whether industry (including SMEs) 
perceives the financial support allocated to the ESOs as a useful contribution to the 
European policy. Feedback from industry re presentatives and i ndustry participants 
consulted as part of this study strongly c onfirms that industry sees the financial 
support provided by EC/EFTA as of signifi cant utility, not only to European policy 
but to industry itself by helpi ng to co-finance at least some aspects of the system that 
industry might otherwise have to carry itself. It is clear that indus try players see their 
own inputs into the overall standardisation effo rt as the largest sh are (which it is) and 
many believe that EC/EFTA could and should do more to help to offset the costs of 
the activities, which are significant and which in some sectors have been very 
considerable, extending over many years. Ther e is a strong view from industry that 
the Commission should do more rather than less to support Europ ean standardisation 
from a financial perspective. Industry repr esentatives and NSBs have also noted the 
important and valuable non-financial  role played by the Commission in developing 
and promoting the New Approach principles  and in observing those principles by 
limiting the extent to which it seeks to direct  or control the standa rdisation process.  
5.3. The counterfactual 
The study terms of reference asked what w ould be the impacts if the Commission 
stopped its financing.  
Our conclusion, based on the study findings , is that if EC/EFTA withdrew its 
financing entirely there would be a very significant negative impact on the activities 
 
EN 218   EN of the ESOs and the work undertaken in support of Commission policy would be 
significantly reduced or weak ened. The various benefits that the financial support 
brings would be lost or si gnificantly diminished and the ability of the Commission to 
influence the system would be weakened. This  is not, therefore, a course of action we 
would recommend. 
A related question contained in the term s of reference asked whether there are 
alternative sources of financing for the ESOs for the same actions. One way to 
answer this question is to say yes, there ar e alternative sources of financing and these 
are already being used to finance the actions. All of the financing provided by 
EC/EFTA is co-financing the activities, cove ring only a share of the real full costs. 
As such, other contributors to the system, primarily industry, are already ‘alternative’ 
sources of financing.  
If we are asked whether there are al ternative sources of financing for those elements 
of the costs currently be ing carried by EC/EFTA , the answer in most cases is no. As 
indicated above, industry already finances the vast majori ty of the costs of European 
standardisation and public sector inputs are fairly low in real terms. It is unlikely that alternative sources of financ ing could be found to support  the additional capacity 
within the ESOs provided th rough the Operating Grants, a nd it is also unlikely that 
alternative sources of fina ncing could be found for the visibility actions and 
preliminary / supporting actions, or for the tr anslation of standard s. In some cases 
alternative sources of financ ing for standardisation work could be found, but in most 
cases the activities w ould simply be carried out late r, over a longer period of time, 
and with less management resource and expertise. 
5.4. Negative effects of the financing 
The study terms of reference asked whethe r there are any negative effects to the 
financing allocated to the ESOs.  
We received a small number of indications that on occasion the financing may have 
prompted standards development work to st art at EU level, undertaken by the ESOs, 
when there are already parall el developments underway either at international level 
(ISO) or within other fora that develop standards. However, in most cases such 
duplication of effort has been avoided and we believe that it is unlikely that ‘parallel’ 
efforts would be going on without each part y having some awareness of the activities 
of the other. It is therefore unlikely that  the financing has cr eated any significant 
level of duplication. 
The main negative effects that we have identified relate to the loss of goodwill and 
wasted effort associated with complex and unstable financial rules, which has created 
something of a rift between the Commission and the ESOs, at least with regard to the financial and administrative elements.  
The financing is given in light of the f act that EC/EFTA and the standardisation 
bodies have common objectives and shared inte rests, and the financ ing is intended to 
support  and enable  the activities of the ESOs wher e their activities and objectives 
align with those of the Commi ssion. It is therefore vital th at the financing is provided 
within an atmosphere of mutual trust and resp ect, and that all parties work together to 
 
EN 219   EN ensure that the financing is delivering th e maximum value and is used in the most 
effective ways possible, and with a minimum of administrative burde n. It is therefore 
necessary for the Commission officers involve d to see their primary role as to help 
and support the ESOs and to enable Commi ssion policy units to make greater use of 
the system. Financial administration and cont rol are or should be  secondary roles, 
and ones that should not in terrupt the core business of  expanding and strengthening 
the system. It would seem that these ‘pri nciples’ are regretta bly not always being 
observed, and we hope that this  report can signal the star t of a new phase of stronger 
cooperation between the Commission and the ESOs.