Professional Documents
Culture Documents
European Standardisation
System
Written by EY
March – 2015
EUROPEAN COMMISSION
Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs
Unit J.4 Standards for Boosting Competitiveness
European Commission
B-1049 Brussels
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This document has been prepared for the European Commission however it reflects the views only of the
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information contained therein.
ISBN [number]
doi:[number]
1.1 Interviewees
ANEC. (2014). Preliminary draft of the Annual Union Work Programme for European
Standardisation 2014.
Ballmann, A.; Epstein, D. & O’Halloran, S. (2002). Delegation, Comitology, and the
Separation of Powers in the European Union.
Bekkers, R.; Verspagen, B. & Smits, J. (2002). Intellectual property rights and
standardisation: the case of GSM. Telecommunication Policy 26 171-188
Besen, S. & Farrell, J. (1994). Choosing How to Compete: Strategies and Tactics in
Standardisation. The Journal of Economic Perspectives, vol. 8(2)
CEN. Good practices to save time in the drafting of CEN standards. Seen at
http://boss.cen.eu/reference%20material/Guidancedoc/Pages/GoodPract.aspx
CEN (2009). The three year timeframe for the development of European Standards:
Rules and implementation system.
De Vries,H.; Blind, K.; Mangelsdorf, A.; Verheul, H. & van der Zwan, J. (2009). SME
Access to European standardisation : Enabling small and medium-sized enterprises
to achieve greater benefit from standards and from involvement in standardisation.
ECORYS & TU/e (2014). Patents and Standards, A modern framework for IPR-based
standardisation.
ECOS (2014). Preliminary draft of the annual Union work programme on European
standardisation for 2015.
European Commission (2010). Europe 2020: A strategy for smart, sustainable and
inclusive growth. (Publication nr COM 2020)
European Commission (2010). Report of the Expert Panel for the review of the
European Standardisation System : Standardisation for a competitive and
innovative Europe: a vision for 2020. (Publication nr EXP 384 final)
European Commission (2013). Notices from Member States: Publication of the list
of national standardisation bodies pursuant to Article 27 of Regulation (EU) No
1025/2012 of the European Parliament and of the Council on European
Standardisation.
European Commission (2015). The 2015 Rolling plan for ICT standardisation.
IFAN (2014). Education and Training about Standardization – Different needs for
different roles, Guide 4.
Joerges, C.; Schepel, H. & Vos, E. (1999). The Law’s Problems with the
Involvement of Non-Governmental Actors in Europe’s Legislative Processes: The
Case of Standardisation under the ‘New Approach. EUI Working Paper LAW No.
99/9.
Joint Research Center (JRC) (2013). How will standards facilitate new production
systems in the context of EU innovation and competitiveness in 2025?
Van Rossem, C.; Dalhammar, C.: Remmen, A. & Andersen, R.(2010). Energy-
related products directive and the role of standardisation in driving innovation.
Workshop “Ecodesign and resource efficiency”
World Trade Organisation (2012). Trade and public policies: A closer look at non-
tariff measures in the 21st century. p 211.
http://ec.europa.eu/growth/single-market/european-standards/index_en.htm
M/397 of 21/12/2006
M/417 of 7/12/2007
M/420 of 9/01/2008
M/453 of 13/10/2009
M/476 of 2/12/2010
M/478 of 16/12/2010
M/480 of 16/12/2010
M/513 of 13/12/2012
M/520 of 13/03/2013
M/522 of 13/03/2013
Allen, R. H., and Sriram, R.D. (2000). “The role of Standards in Innovation”,
Technological Forecasting and Social Change, 64.
European Commission (2014). “Final Report of the Foresight Study On: How will
standards facilitate new production systems in the context of EU innovation and
competitiveness in 2025?”, Brussels.
Blind, K., Bekkers, R., Dietrich, Y., Iversen, E., Köhler, F., Müller, B., Pohlmann, T.,
Smeets, S. and Verweijen, J. (2011). “Study on the Interplay between Standards
and Intellectual Property Rights (IPRs)”.
World Trade Report (2012). “Trade and public policies: A closer look at non-tariff
measures in the 21st century”, p. 211.
Council of the European Union (2011). Factsheet – Entry into force of new
comitology rules.
CEN and ETSI (2010). “Joint CEN and ETSI Response to Mandate M/453”.
http://ec.europa.eu/enterprise/policies/european-standards/harmonised-
standards/appliances-burning-gaseous-fuels/index_en.htm
CEN and CENELEC (2013). Joint ISO-CEN Coordinating Group of the Technical
(Management) Boards. Seen at
http://boss.cen.eu/TechnicalStructures/Pages/JointISOCENCoordGrBTs.aspx.
Letter from CEN Director of Standards to Head of Unit, DG SANCO B.2, European
Commission (2014-11-13)
ISO Council resolution 11/1987 and CEN General Assembly resolution 3/1990.
ISO Council resolution 35/2001 and CEN Administrative Board resolution 2/2001.
The Vienna Agreement - Day to day management between ISO/CS and CCMC –
May 2014
Standardisation in aerospace
Bagshaw, M. (n.d.). “Aircraft Cabin Air Quality: What has happened to the CEN &
SAE Standards?”. Seen at http://aerotoxic.org/wp-
content/uploads/2014/11/Aviation-Health-Bagshaw.pdf
CEN (2014). DRAFT Business Plan for the CEN Workshop on “Modules for Electro-
Mechanical Actuators in Aircraft” (to be approved during the Kick-off meeting on
2015-01-28). Seen at: ftp://ftp.cencenelec.eu/CEN/Sectors/List/Air/2014-11-
25_CEN_WS_BP_Modules_for_EMAs_v1_4.pdf
ISO (2014). BUSINESS PLAN - ISO/TC 20 - Aircraft and space vehicles. Seen at:
http://isotc.iso.org/livelink/livelink/fetch/2000/2122/687806/ISO_TC_020__Aircraft
_and_space_vehicles_.pdf?nodeid=1195698&vernum=-2
An online survey was launched for assessing in a quantitative way the perception of
multiple stakeholders regarding the suitability of the ESS for the future, the
perception on the fulfilment of the strategic objectives, the efficiency of the
processes and the governance model.
Commission
Online survey
COS
ESOs
Context
Forward looking
The circulation of the survey was based on a manifold approach: the link to the
survey was first diffused through direct mailing to a predefined list of contacts (528
email addresses); the stakeholders included in this list of contacts were invited to
disseminate the link to the consultation among additional relevant interested
parties in their own network. Moreover, the link to the survey was published on the
website of the European Commission, in the section related to standardisation
policy.
The consultation was initiated on October 20 th, with a deadline set on November
16th. Based on requests from various stakeholders, the deadline for submission of
answers to the online survey was extended to November 28 th.
The survey collected a total of almost 800 responses (447 complete answers, in
addition to 348 incomplete answers). The analysis below is based on the total of
447 complete answers received. The incomplete answers are not included in the
quantitative analysis of the survey results, but these are taken into account for the
analysis of open comments/qualitative considerations.
Other
EC/EFTA, Other EU
University/Research
standardisation
Public Authority
organisation or
assessment/testing
organisation (ESO)
Stakeholder
body (NSB)
standardisation
National
Conformity
European
NGO
institute
body
inst.
Regarding the “company/industry” category, the company size has been taken into
account in the analysis of the survey results. 42% of the companies did not provide
any information about their size. Based on the company name, EY searched for the
missing employees numbers based on publicly available data (e.g. company
website or national databases) and could reduce the “unknown” share from 42% to
2%. Taking into account the completion of missing values, 23% of the respondents
are SMEs while 62% are large companies1. The remaining 13% making part of the
“industry” category are associations and federations (therefore, their size –in terms
of employees- is not representative of their scope).
Size of companies
2%
5%
7%
13%
Micro
11% Small
Medium
Large
Professional associations
unknown
62%
It was noticed that major part of the answers was submitted by actors active in
“manufacturing”, “construction”, as well as “professional, scientific and technical
activities” sectors (based on NACE rev 2 classification). Some sectors (such as the
“activities of households as employees”, the Horeca sector, the “real estate” and
the “arts and entertainment activities”) are not –or very poorly- covered by the
study. Manufacturing, Construction, “Information and Communication
Technologies”, “Professional, Scientific and Technical activities” and “Other service
activities” are the five most represented sectors. In the next paragraphs,
disaggregated answers by sector of activity are presented only with reference to
these 5 sectors.
1
This consideration is based on the number of employees only, and relies on the headcount thresholds
defined by the European Commission (<10 FTEs for Micro-, <50 for Small- and <250 for Medium-sized).
P - EDUCATION
B - MINING AND QUARRYING
C - MANUFACTURING
F - CONSTRUCTION
H - TRANSPORTATION AND
J - INFORMATION AND
M - PROFESSIONAL, SCIENTIFIC
T - ACTIVITIES OF HOUSEHOLDS
UNDIFFERENTIATED GOODS
TRADE; REPAIR OF MOTOR
COMMUNICATION
WASTE MANAGEMENT AND
N - ADMINISTRATIVE AND
REMEDIATION ACTIVITIES
AIR CONDITIONING SUPPLY
EXTRATERRITORIAL
SERVICE ACTIVITIES
U - ACTIVITIES OF
WORK ACTIVITIES
AS EMPLOYERS;
STORAGE
RECREATION
ACTIVITIES
SECURITY
FISHING
Finally, the analysis sought to distinguishing the companies based on the type of
output their organisation produce – goods or services. An approximation is possible,
on the basis of the sector of activity of the respondent companies. To this end, we
assume that agriculture, mining, manufacturing, water supply and construction are
sectors producing goods, while we consider all other sectors as service providers.
As a result, we can estimate that 57% of respondents represents companies
providing service, while 43% represents goods producers 2.
Germany
25%
32% International scale
United Kingdom
Sweden
5%
Belgium
6% France
7% 14% Others
11%
2
The companies having answered to the survey provided the NACE code. Since several sectors include
both manufacturing and services sub-sectors (e.g. ICT), it is not possible to separate companies
producing goods and providing sectors. The distinction made above and presented in this survey is
based on an assumption and it is therefore aimed at providing an approximation, whereas it does not
represent an exact statistical analysis.
3
Respondents which selected “international scale” are mainly companies or stakeholders organisations.
ESOs and European Institutions replies are also included.
It can be observed that people who participated in the survey estimate having a
good knowledge of the European Standardisation System and standardisation
practices. Indeed, 31% of respondents indicates their knowledge as “very high” and
41% as “high”. Only 5% of the respondents votes for “low” or “very low”. This
statement suggests a good understanding of the questions and knowledgeable
contributions to the survey.
41%
Based in Germany;
In general terms, the results of the analysis show an overall positive assessment of
the ESS. The ESS is perceived by most respondents as a system which has
achieved, or is suited to achieve, the five strategic objectives defined by the new
standardisation package. Room for improvements has however been identified, with
reference to the different strategic objectives, and with reference to the ESS as a
whole.
In the following paragraphs, the results are presented per each question. Split by
categories of respondents, sectors and company size are also presented.
The timeframe considered for speed and timeliness –in the scope of the online
survey- is the time lapse between the identification of the standardisation need
(informally by industry, or formally through an EC standardisation request) and the
availability of the standard. In the case of harmonized European standards, the
time needed for publishing the reference of a standard in the Official Journal of the
European Union (OJEU) also needs to be taken into account.
52% of the respondents considers this objective to be achieved, against 30% who
considered it not to be achieved. As compared to the assessment of the other four
strategic objectives, the speed is the objective which received the lowest positive
assessment.
4
The analysis was run on R http://cran.r-project.org/ using the “multinom” function of the package
“nnet” http://cran.r-project.org/web/packages/nnet/index.html.
16%
Yes
No
52% No opinion/cannot answer
30% (blank)
Do you consider that standardisation deliverables within the ESS are available in a timely
manner?
100%
80%
60%
40% (blank)
20%
No opinion
0%
No
standardisation
Company/Industry
Other
assessment/testin
EC/EFTA, Other
University/Researc
Public Authority
organisation or
organisation (ESO)
Stakeholder
body (NSB)
standardisation
National
Conformity
Yes
EU inst.
h institute
European
NGO
g body
For the companies/industries that respond negatively, the following issues have
been identified (in the open comments to the relevant survey questions) as
elements slowing down the process:
The limitation of the meetings of the Working Groups (WGs) along the year
(e.g. speed would be improved if WGs use intermediate conference calls);
5
The conformity assessment/testing bodies have been considered as a separate category of
respondents. However, it should be noted that these bodies are service companies. Their answers,
therefore, should be seen in parallel with the answers provided by the category “Company/Industry”.
Do you consider that standardisation deliverables within the ESS are available in a timely
manner?
Professional associations
Large
Yes
Medium No
No opinion/cannot answer
Small
(blank)
Micro
With regard to the achievement of the suggested goals underlying the “Speed and
timeliness” objective, there is no significant difference in the achievement of the
five identified goals. Almost twice more people are satisfied (voted “very high” or
“high”) than dissatisfied (voted “very low” or “low”). “Moderate” accounts for
around one third of the answers7.
According to your experience, to what extent has the ESS achieved the following goals?
For all goals, the observed scores are very similar for product and services,
excepted for the: “Overall Speed of the standards development process”.
Companies which represent service providers give a positive rating to the
achievement of this objective, to greater extent than goods producers.
6
The statistical analysis shows a small effect of the number of Employees on Positive answers. The
larger the company the higher the chance of a ‘Yes’.
7
Based on the statistical analysis, the response ‘High’ has the most chance to be picked, except for
‘Early indication’ that show a preference for ‘Moderate’.
The construction sector appears particularly critical, with only 14% of respondents
that considers the goal as achieved (very high and high), compared to 45% with
the opposite opinion (low and very low) and an average achievement rate (all
sectors included) of 31%8.
According to your experience, to what extent has the ESS achieved the goal "Overall Speed of
the standards development process)" ?
C - MANUFACTURING
Very high
F - CONSTRUCTION
High
J - INFORMATION AND COMMUNICATION Moderate
M - PROFESSIONAL, SCIENTIFIC AND Low
TECHNICAL ACTIVITIES Very low
S - OTHER SERVICE ACTIVITIES (blank)
The main reasons advanced by the construction sector are similar to the ones
mentioned above for companies/industries. Additionally, it is highlighted that the
process is very slow and complex for the construction sector, due to the changing
legal framework and to differences in technological developments and regional
habits, all factors slowing down the standardisation process in their sector.
Almost half of the respondents considers that the early involvement of research
institutes might contribute to the early start of standardisation activities, while
around one third of respondents are of the opposite opinion. Universities and
research institutes seem open to it, as 15 out of their 17 representatives believe
that their organisation should be further involved in standardisation activities.
8
No clear pattern is highlighted by the analysis.
19%
Yes
46% No
No opinion
(blank)
32%
5%
15%
3% Very high
22% High
Moderate
18% Low
Very low
(blank)
37%
On the one hand, many respondents highlight that the interest in speed has a (high
or moderate) negative impact on quality and will cause poor standards. It is also
emphasized that further reduction of the development time would induce high risks
in the process, with consequences on the quality, technical correctness (less time
for research and testing) and level of consensus.
On the other hand, a few respondents highlight that speed would impact positively
standards, as standards are too static today and an increase in speed would
produce better quality standards, with a better response to market needs.
Regarding those who answered that the interest in speed has a low or very low
impact on the quality, they either (1) do not see any impact on the quality from the
increased interest in speed or (2) have not noticed any increase in speed, which
makes it difficult to judge the impact.
Overall, there is a general agreement that quality is more important than speed,
although it can depend on other aspects, such as the sector (e.g. sectors like ICT
need specifications to be ready quickly to cope with technological developments).
Finally, improvements in speed are considered to impair -to a certain extend- the
inclusiveness of the ESS, as 34% of the respondents answers “moderate” to the
question, 23% “high” and 17% “low”. One fifth of the respondents did not answer
the question.
Standardisation is a tool driven by the industry and its main purpose is to support
companies, i.e. enhancing competitiveness of European businesses. This objective
is key –together with the strategic objective of supporting competitiveness in the
global market-, as it drives the interest of companies in standardisation and
ensures the functioning of the system.
In your opinion, does the ESS provide enough support to the competitiveness of European
companies in the Internal market?
3%
19%
Yes
No
54% No opinion/cannot answer
24% (blank)
The most enthusiastic categories about the completion of this objective are the
national standardisation bodies and ESOs. Just above half of the companies think
their competitiveness in the internal market is sufficiently supported by the ESS,
while 30% is of the opposite opinion.
In your opinion, does the ESS provide enough support to the competitiveness of European companies in the Internal
market?
100%
80%
60%
13
40% 26
114 11 22 42 (blank)
20% 4
5
5 No opinion
0%
No
standardisation
Other
Public Authority
organisation or
Company/Industry
assessment/testing
EC/EFTA, Other
organisation (ESO)
University/Researc
Stakeholder
body (NSB)
standardisation
National
Yes
Conformity
EU inst.
h institute
European
NGO
body
For the companies that have a positive opinion of the support provided by the ESS
to their competitiveness, the following arguments are advanced:
Cost is reduced as the same requirements are valid for several countries;
However, around 30% of the companies is of the opposite opinion, mentioning the
following elements as reasons why the ESS is not supporting their
competitiveness:
In your opinion, does the ESS provide enough support to the competitiveness of
European companies in the Internal market?
C - MANUFACTURING
F - CONSTRUCTION
Yes
J - INFORMATION AND
No
COMMUNICATION
M - PROFESSIONAL, SCIENTIFIC AND No opinion/cannot answer
TECHNICAL ACTIVITIES (blank)
S - OTHER SERVICE ACTIVITIES
9
The observed trend is confirmed for Manufacturing Construction and Information and Communication
Technologies.
Service providers
Yes
No
No opinion/cannot answer
Goods manufacturers (blank)
The size of the company appears as inversely proportional to the perception that
the objective has been achieved. Less than 20% of micro-companies believes the
objective to be completed, while 60% of large companies and professional
associations considers the objective reached10.
In your opinion, does the ESS provide enough support to the competitiveness of European
companies in the Internal market?
Professional associations
Large
Yes
Medium No
No opinion/cannot answer
Small
(blank)
Micro
Have you experienced any situation in which, in your opinion, the ESS failed to support
competitiveness in the single market?
4%
24%
Yes
34% No
No opinion/cannot answer
(blank)
38%
The examples advanced by respondents who answered “Yes” are the following:
10
The statistical analysis confirms the significance of the effect: the larger is the company, the is higher
the chance for a ‘Yes’.
Public Authority
assessment/testi
standardisation
standardisation
Other
organisation or
University/Resea
Company/Industr
EC/EFTA, Other
Stakeholder
organisation
body (NSB)
European
rch institute
Conformity
Yes
National
EU inst.
ng body
(ESO)
NGO
y
The company categories that experienced most situations in which the ESS failed to
support competitiveness in the single market are the smallest ones. 34% of goods
manufacturers witnessed such situations, while only 24% of the service providers
did.
Have you experienced any situation in which, in your opinion, the ESS failed to support
competitiveness in the single market?
Professional associations
Large
Yes
Medium No
No opinion/cannot answer
Small
(blank)
Micro
Have you experienced any situation in which, in your opinion, the ESS failed to support
competitiveness in the single market?
Service providers
Yes
No
No opinion/cannot answer
Goods manufacturers (blank)
According to your experience, to what extent has the ESS achieved the following goals?
The Commission has the possibility to request the ESOs to develop standards for
supporting EU policies and legislation. This “Support to EU policy and legislation” is
perceived as the strategic objective with the highest achievement.
21% Yes
No
No opinion
13% 62% (blank)
The national standardisation bodies and ESOs are the categories that are the most
convinced of the objective achievement, followed by the group “EC/EFTA, other EU
institution or agency”, as well as stakeholder organisations.
11
Based on the statistical analysis, ‘High’ is the preferred answer except for ‘Facilitating the market
penetration’, where the preferred answer is ‘Moderate’.
EC/EFTA, Other EU
Other
University/Research
standardisation body
Public Authority
assessment/testing
organisation (ESO)
organisation or NGO
standardisation
Conformity Yes
Stakeholder
European
institute
National
body
(NSB)
inst.
The five sectors ratings are quite close to the average of 62% of respondents that
believes the ESS to effectively support EU legislation and policies.
C - MANUFACTURING
F - CONSTRUCTION
Yes
J - INFORMATION AND
No
COMMUNICATION
No opinion/cannot answer
M - PROFESSIONAL, SCIENTIFIC AND
TECHNICAL ACTIVITIES (blank)
The split by type of output shows that services providers are slightly below the
average, with 58% of respondents that indicates the ESS to be an effective support
to EU legislation, against 64% for goods manufacturers.
Again, the size of the company appears to have an important impact on the
perception of the ESS support to EU legislation and policies. The smaller the
company, the less effective the ESS support is perceived. Professional associations
strongly believe the ESS to provide an effective support to EU legislation and
policies12.
Professional associations
Large
Yes
Medium No
No opinion/cannot answer
Small (blank)
Micro
The two first goals are perceived as being fulfilled, while the completion of the early
identification of standardisation needs appears to be lagging behind (and might
12
However, the statistical analysis shows that the effect of the Employee Number is not significant.
According to your experience, to what extent has the ESS achieved the following goals?
When looking at the industry replies by company size, it can be noticed that, for the
three goals, professional associations and large companies are (among) the most
satisfied, while micro-companies assess the goals to be achieved to a lower level 13.
According to your experience, to what extent has the ESS achieved the goal "Use standards
for facilitating compliance with directives and regulations" ?
Professional associations
Very high
Large
High
Medium Moderate
Low
Small
Very low
Micro (blank)
According to your experience, to what extent has the ESS achieved the goal "Improved safety
of product" ?
Professional associations
Very high
Large
High
Medium Moderate
Low
Small
Very low
Micro (blank)
13
For all the sub-questions, the higher the number of Employees the higher the chance of ‘High’ as
answer.
Professional associations
Very high
Large
High
Medium Moderate
Low
Small
Very low
Micro (blank)
What is the system’s ability to respond to an increased demand for standards to support EU
legislation and policies ?
7% 3%
Very High
High
18% 29% Moderate
Low
4%
Very Low
11%
No opinion/cannot answer
28% (blank)
A split by category shows a big gap between (1) the NSBs and ESOs (high + very
high scores above 50%), and (2) companies (high + very high scores below 40%).
Universities and Research institutes do not appear confident in the system ability to
respond to an increased demand.
What's the systems's ability to respond to an increased demand for standards to support EU
legislation policies?
University/Research institute
Stakeholder organisation or NGO
Very High
Public Authority
High
Other
Moderate
National standardisation body (NSB)
Low
European standardisation organisation (ESO)
Very Low
EC/EFTA, Other EU inst.
No opinion/cannot answer
Conformity assessment/testing body
(blank)
Company/Industry
0% 20% 40% 60% 80% 100%
The objective “Inclusiveness of the ESS” is intended as the ability of the processes
in the ESS to involve a wide range of participants (representative of businesses of
all sizes, consumers, other societal stakeholders such as trade unions,
environmental NGOs, representatives of elderly and disabled people) and to
develop close cooperation among partners (ESOs, NSBs, public authorities at EU
and national level).
17%
Yes
No
54% No opinion/cannot answer
26% (blank)
The breakdown of the answers into the categories of organisations shows again
high positive answers from the ESOs and national standardisation bodies.
Stakeholder organisations and NGOs are less convinced of the inclusiveness of the
ESS with around half of the respondents that replies “no” to the question. The
critical position of the stakeholder organisations and other stakeholders deserves
attention, and the main causes behind the dissatisfaction will be addressed in the
context of the overall review.
Is the range of participants involved in the ESS standard setting processes (from the need
definition until the availability of the standard) wide enough?
100%
80%
60%
40% (blank)
20% No opinion
0%
No
University/Resear
organisation or
Other
Company/Industry
assessment/testin
EC/EFTA, Other
standardisation
standardisation
Public Authority
Stakeholder
organisation
body (NSB)
European
ch institute
National
Conformity
Yes
EU inst.
(ESO)
NGO
g body
The split by sector shows homogenous positive answers close to the average of
54%. Again, the construction sector is slightly less positive than the other sectors
while the “other service activities sector” is slightly more positive14.
C - MANUFACTURING
F - CONSTRUCTION
Yes
J - INFORMATION AND COMMUNICATION No
No opinion
M - PROFESSIONAL, SCIENTIFIC AND
TECHNICAL ACTIVITIES (blank)
14
Statistically, the observed difference in the trend is not significant.
Professional associations
Large
Yes
Medium No
No opinion
Small (blank)
Micro
According to your experience, to what extent has the ESS achieved the following goals?
As these goals concern very specific categories of respondents, the analysis of the
concerned groups’ replies appears to be more insightful:
15
Statistically, the effect of the Number of Employees is not confirmed.
Public authorities perspective on the ESS Research community view on the ESS
achievement of their participation in the ESS achievement of their participation in the ESS
2% 6%
6%
15% 18%
22%
15% 23%
29%
47%
17%
Societal stakeholders perspective on the ESS SME view on the ESS achievement of their
achievement of their representation in the ESS representation in the ESS
2%
5%
15% 14%
22%
9% 24%
18%
23% 20%
24% 24%
In relation to the previous question, it was asked whether the range of participants
involved in the ESS standard setting processes (from the need definition until the
availability of the standard) is wide enough.
16
In particular, the statistical analysis confirms the positive effect of Number of Employees on ‘Yes’ as
answer.
University/Resear
organisation or
Other
Company/Industry
assessment/testin
EC/EFTA, Other
standardisation
standardisation
Public Authority
Stakeholder
organisation
body (NSB)
European
ch institute
National
Conformity
No
EU inst.
(ESO)
NGO
g body
Is the range of participants involved in the ESS standard setting processes (from the need
definition until the availability of the standard) wide enough?
Professional associations
Large
Yes
Medium No
No opinion
Small (blank)
Micro
The assessment of the achievement of this strategic objective is positive, with 56%
of the respondents considering this objective to be achieved, against 18%
considering this objective not to be achieved.
Does the ESS supports the competitiveness of EU companies in the global arena?
5%
21% Yes
No
56% No opinion/cannot answer
18% (blank)
The perception differs depending on the respondent category. The standard setting
organisations consider this objective to be achieved with scores above 80%, while
“EC/EFTA, other European institutions and agencies” consider this objective as not
yet fully achieved17.
17
Statistically, National Standardization bodies have a higher chance for positive answer.
100%
80%
60%
(blank)
40%
No opinion
20%
0% No
organisation or
University/Resear
Other
Company/Industry
assessment/testin
EC/EFTA, Other
standardisation
standardisation
Public Authority
Yes
Stakeholder
organisation
body (NSB)
European
ch institute
National
Conformity
EU inst.
(ESO)
NGO
g body
Does the ESS supports the competitiveness of EU companies in the global arena?
Professional associations
Large
Yes
Medium No
No opinion/cannot answer
Small (blank)
Micro
According to your experience, to what extent has the ESS achieved the following goals?
18
The relation between the size of the company and the chance of positive answer is statistically
significant: larger the Company the higher the chance for a positive answer.
According to your experience, to what extent has the ESS achieved the goal "Recognition of
international standards at European level" ?
Company/Industry
Conformity assessment/testing body
European standardisation organisation (ESO) Very high
National standardisation body (NSB) High
EC/EFTA, Other EU inst. Moderate
Other Low
Public Authority Very Low
Stakeholder organisation or NGO (blank)
University/Research institute
According to your experience, to what extent has the ESS achieved the goal "Recognition of
European standards at international level" ?
Company/Industry
Conformity assessment/testing body
European standardisation organisation (ESO) Very high
National standardisation body (NSB) High
EC/EFTA, Other EU inst. Moderate
Other Low
Public Authority Very Low
Stakeholder organisation or NGO (blank)
University/Research institute
According to your experience, to what extent has the ESS achieved the goal "Facilitating the
establishment of business partnerships around the globe" ?
Company/Industry
Conformity assessment/testing body
European standardisation organisation (ESO) Very high
National standardisation body (NSB) High
EC/EFTA, Other EU inst. Moderate
Other Low
Public Authority Very Low
Stakeholder organisation or NGO (blank)
University/Research institute
Company/Industry
Conformity assessment/testing body
European standardisation organisation (ESO) Very high
National standardisation body (NSB) High
EC/EFTA, Other EU inst. Moderate
Other Low
Public Authority Very Low
Stakeholder organisation or NGO (blank)
University/Research institute
In the context of each strategic objective, the online survey asked whether:
On average, around 40% of the respondents believes that the ESS performance is
similar in the two situations (standards for services vs. products), while around
20% observes a difference (and about the 40% of respondents has no opinion on
the subject).
From your perspective, is the achievement of the ESS objectives different in the situation of
standards for services, compared to standards for products?
Global market
Inclusiveness
Yes
Policies and legislation No
No opinion
Competitiveness
(blank)
Speed and timeliness
Global market
Inclusiveness Yes
No
Competitiveness No opinion
(blank)
Speed and timeliness
3.2.7 Governance
“The governance of the ESS” is defined as: the systems of management and control
of the ESS, its rules and operating procedures, and the bodies (boards,
committees, directors) that govern it.
Overall, 44% of respondents believes the ESS is well-governed, while 21% is of the
opposite opinion. However, we notice that an important share of stakeholders does
not express any opinion on this aspect.
Yes
30% 44% No
No opinion
(blank)
21%
The perception of the achievement of this objective differs again depending on the
respondent category. The ESOs and national standardisation bodies consider the
ESS to be better governed than the other categories of respondents. The most
critical parties are universities/research institutes as well as the stakeholder
organisations and NGO. Very high “no opinion” rates can be observed for some
categories19.
100%
80%
60% (blank)
40%
No opinion
20%
0% No
EC/EFTA, Other
Other
University/Resear
assessment/testin
standardisation
standardisation
Company/Industr
Public Authority
organisation or
Yes
Stakeholder
organisation
body (NSB)
European
National
ch institute
Conformity
EU inst.
(ESO)
NGO
g body
y
19
The statistical analysis shows that NSBs, ESOs and other EU institutions have a higher chance for
‘Yes’, Universities have a higher chance for ‘No’.
Professional associations
Large
Yes
Medium No
No opinion
Small (blank)
Micro
The following split shows very small variance among sectors, since around 40% of
respondents from all sectors considers the ESS well governed21.
C - MANUFACTURING
F - CONSTRUCTION
Yes
J - INFORMATION AND COMMUNICATION No
M - PROFESSIONAL, SCIENTIFIC AND No opinion
TECHNICAL ACTIVITIES (blank)
S - OTHER SERVICE ACTIVITIES
Are the interaction and the communication flows among actors (EC, the ESOs, Member States,
NSBs and other stakeholders) satisfactory?
4%
21% Yes
39%
No
No opinion
(blank)
36%
20
The relation between the size of the company and the chance of positive answer is statistically
significant.
21
The statistical analysis does not show any significant effect.
assessment/testing
Company/Industry
Other
EC/EFTA, Other
standardisation
University/Researc
organisation (ESO)
Public Authority
organisation or
Stakeholder
body (NSB)
standardisation
Yes
National
Conformity
EU inst.
h institute
European
NGO
body
For the respondents who estimate that the interaction and communication flows
among actors are not satisfactory, the following answers stood out:
Considering your position within the ESS, do you feel sufficiently consulted?
5%
16%
Yes
No
No opinion
21% 58% (blank)
22
The statistical analysis shows that NSBs have a higher chance for ‘Yes’, other EU institutions a higher
chance for ‘No’.
100%
80%
60%
40% (blank)
No opinion
20%
No
0%
Yes
Company/Industry
Other
University/Researc
EC/EFTA, Other
standardisation
organisation or
assessment/testing
organisation (ESO)
Public Authority
Stakeholder
body (NSB)
standardisation
National
Conformity
EU inst.
h institute
European
NGO
body
Considering your position within the ESS, do you feel sufficiently consulted?
Professional associations
Large
Yes
Medium No
No opinion
Small (blank)
Micro
Communication of information
The majority of respondents considers receiving enough information within the ESS.
Considering your position within the ESS, do you receive enough information?
6%
13%
Yes
No
No opinion
21%
60% (blank)
23
Statistically, the dimension of a Company influences positively the chance for a ‘Yes’ as answer.
100%
80%
60%
(blank)
40%
No opinion
20%
0% No
Company/Industry
Other
EC/EFTA, Other
University/Researc
standardisation
Public Authority
organisation or
assessment/testing
organisation (ESO)
Yes
Stakeholder
body (NSB)
standardisation
National
Conformity
EU inst.
h institute
European
NGO
body
Considering your position within the ESS, do you receive enough information?
Professional associations
Large
Yes
Medium No
No opinion
Small (blank)
Micro
In conclusion, communication and interactions flows are not satisfactory for some
categories: they do not feel sufficiently consulted and do not receive enough
information from their point of view. A relevant level of dissatisfaction is also
present among the other categories (and more particularly among
stakeholders/NGO and universities/research institutions). Micro and medium-sized
companies seem to be less involved in the communication processes than other
company sizes.
In particular, two times more respondents believe that the current voting system
enables the creation of a balanced consensus. From those who are not satisfied
with the current system, the following improvements are suggested:
The voting process should be more transparent, and the weighted voting
system should be reconsidered, as it gives advantage to larger countries,
with no regards to their involvement in the development;
24
The dimension of a Company influences positively the chance for a ‘Yes’ as answer.
Does the current governance ensure the Does the current ESS governance and Do you think that current voting rights
actual and active participation of all the ESO guidelines offer the guarantee for
allow for balanced consensus making?
stakeholders involved in the process ? effective representation of stakeholders
within the process? 5%
4%
4%
Do you think that current voting rights allow for balanced consensus making?
24% 28%
40% 28% 45%
5% 40%
Yes
28%
32% 45% No 22%
28%
No opinion
(blank)
22%
Public consultations
Administrative burden
Process: the process is considered as lengthy and heavy, due to: too much
paperwork, unnecessary translations, extensive reporting requirements,
change requests that are not prioritized, enquiry validation process being
time consuming, process too elaborated and formal, and difficult
communication between the WGs and the EC.
Tools: the system (e.g. CEN Livelink) is considered as complicated and the
tools too paper-based. Problems with the standard templates are also
highlighted.
28% Yes
30% No
No opinion
(blank)
36%
Comitology procedure
It is observed that a large part of respondents does not have any opinion with
regard to the Comitology procedure. Respondents who have “no opinion” on this
question pointed out that they either do not know the Comitology procedure (due
to the fact it has been recently be implemented, a lack of time to understand it, a
lack of information, etc.), or they do not have experience with it.
Half of the respondents does not observe any issue in the delay for national
implementation of European standards, while one fifth did observe one or more
issues. The main issue identified is that the translation into national languages
delays the implementation. Additional reasons mentioned are: conflict of interests
at national level (standards conflicting with national regulations), lack of quality of
the original documents issued by the ESOs leading to interpretation difficulties,
different implementation approaches depending on the country, and bad channels
of communication.
Have you identified issues in the delay for national implementation of European standards?
7%
21%
Yes
23%
No
No opinion/cannot answer
(blank)
49%
Three questions were related to the ESS appeal procedure, in order to investigate
its popularity, its use and its effectiveness. The results show that slightly more than
half of the respondents are aware of the existence of the appeal procedure. The
professional associations appear more aware of the appeal procedure than
individual companies of all sizes.
9%
9%
Large
Yes
Medium
Yes YesNo
No No No opinion
32% 55% Small No opinion
32% 55% No (blank)
opinion
(blank)
Micro (blank)
Among the respondents who are aware of the appeal procedure, slightly less than
one fifth (17.5%) already triggered it. Companies that indicate having already
triggered the appeal procedure are the medium and large-sized companies, as well
as the professional associations.
If you are aware of the existence of an appeal procedure, have you already used this
If you are aware of the existence of an appeal procedure, have you already used this
procedure? procedure?
If you are aware of the existence of an appeal procedure, have you already used this
procedure?
Professional associations
13% 11% Professional associations
Large
Large Yes YesYes
No
24% Medium Medium No No
No opinion
No No opinion
opinion
Small (blank)
52% Small (blank)
(blank)
Micro
Micro
0% 20% 40% 60% 80% 100%
0% 20% 40% 60% 80% 100%
Among the respondents who used or triggered the appeal procedure, 57%
considers it to be effective, meaning 8% of the total respondents.
Professional associations
8%
8%
6% Large
6%
25% 25%
YesYes
Yes
Medium No
No No
No opinion
Small
No opinion No(blank)
opinion
(blank)
(blank)
61% Micro
61%
0% 20% 40% 60% 80% 100%
To what extent does the quality level of European standard deliverables respond to your
needs?
5%
To what extent does the quality level of European standard deliverables respond to your
needs?
Professional associations
Very High
Large
High
Medium Moderate
Low
Small
Very Low
Micro (blank)
The different sectors answers are balanced between “high” and “moderate”. The
construction sector is again the most critical with the lowest level of “high” answers
and the highest level of “low” answers.
25
Statistical analysis shows that the chance of Yes is highly correlated with the company size.
C - MANUFACTURING
Very High
F - CONSTRUCTION
High
J - INFORMATION AND COMMUNICATION Moderate
M - PROFESSIONAL, SCIENTIFIC AND Low
TECHNICAL ACTIVITIES Very Low
S - OTHER SERVICE ACTIVITIES (blank)
In general, reasons advanced for low and very low ratings are mainly related to:
Stakeholders were asked about the barriers or blocking factors in the current
system and practices, which prevent the full effectiveness and efficiency of the ESS.
Respondents highlight the following:
Resources: lack of funding and time to participate, high costs for the
implementation of standards and lack of specific knowledge by some actors
(NSBs, national authorities, experts in the EC, etc.);
In terms of potential improvements within the system, we note that all the
suggested actions were considered as relevant by the respondents, except the first
In order to ensure the relevance of the ESS against the future needs, its effectiveness,
efficiency and coverage, which areas of action do you deem as crucial?
Consider organisational and procedural adaptations in the
ESO/NSB network to update it with the future needs
Promote awareness on the benefit of standardisation processes
for competitiveness and innovation Very high
Strengthen the cooperation, coordination and communication High
flows among standardisation bodies
Moderate
Promote cooperation at global and European level
Low
Promote the involvement of stakeholders and the development of
inclusive processes
Very low
Anticipate the identification of standardisation needs and (blank)
accelerate the start of the standard development process
The six areas of action are globally all considered of high importance for ensuring
the ESS against the future needs. The different categories of repondents expressed
similar opinions, althought the highest supporters of the actions suggested in the
questionnaire are the NSBs, “EC/EFTA, and the other European instititions or
agencies”.
Improve speed of the process, although speed must not prevail over
quality;
Respondents were asked to indicate the technical domains which are currently
insufficiently covered by the ESS and should be covered in the future. The main
new technical domains identified are the following:
Reasons that prevent the ESS to expand its scope to these new technical domains
were investigated as well. By applying the same method of weighting the answers
as above, the following ranking is obtained, from the reasons preventing the most
the ESS to expand its scope, to the least:
When asked about “greatest achievements of the ESS”, the respondents highlighted
as successes factors: the harmonization of EU standardisation and the
reduction of trade barriers. The facts that the ESS deliverables have a “good”
recognition at an international level and that the ESS highly supports the “safety”
within the single market are also emphasized. It is also mentioned, at a lower
extent, that the ESS facilitated technology transfer and ensured interoperability.
Resources Process
Alignment of the working methods and The ESS should have a wider and more
governing rules of the three ESOs (voting direct influence at national level, taking
procedures, methods of standardisation some of the role and responsibilities of
work) NCs
Improvements in the ESOs structure to The ESS should be bolder in identifying
facilitate the development of European new stakeholders and their
standards in all fields responding to standardisation needs, to demand
technological convergence support for actions that enhance
Reduction of horizontal European competitiveness and
committees/multiple layers of bodies (for increasingly look beyond the short term
instance at national level) that do not add
value to standardisation
Standards Regulation
Focus more and more on the global Provide periods of stability without any
harmonisation of standards changes of the framework conditions at
Improve market relevance of new and legislative and standardisation level
existing standards and keep them as Reduce the red tape
simple as possible Simplification of the regulatory
1. Background
The Commission (EC) strategic communication “A strategic vision for European Standards”
(COM(2011)311 final) and the Regulation (EU) No 1025/2012 on European Standardisation
form the so called Standardisation Package, established with the aim to “increase the
contribution of European standards and other European standardisation deliverables to a
better functioning internal market, stimulating growth and innovation, and fostering the
competitiveness of EU enterprises, especially SMEs”.
In response to Action 29 of the Communication, EY (Ernst & Young) is carrying out on behalf
of ”Directorate General for Enterprise and Industry” an Independent Review of the European
Standardisation System (ESS). This survey is to collect the opinion of a broad range of
stakeholders in order to assess:
- Progress against the strategic objectives, defined by COM(2011)311: speed of the standard
setting process, support to competitiveness for European businesses, support to legislation,
inclusiveness and support to competitiveness worldwide;
- The impact of the current governance on the performance of the European Standardisation
System;
- The overall performance of the ESS and areas where improvements are required.
The European standardisation system (ESS) is understood as a network –and its related
processes- of stakeholders active in European standardisation. This includes, in alphabetical
order: the European Commission (EC), the industry (and companies in general), Member
States, stakeholders representatives and standard setting organisations (European
standardisation organisations (ESO) and National standardisation bodies (NSB)).
The processes that are in scope of this questionnaire are: the mandating process
(identification of need for standard development, standards developed upon Commission
request), the standardisation work performed by ESOs (reception of the request until
availability of the standard) and referencing in the OJEU (for mandated standards supporting
legislation needs).
All European standard deliverables are in scope of this study, including harmonised
standards, with the meaning defined by Art. 2(1c) of Regulation (EU)1025/2012, or “adopted
on the basis of a request made by the Commission for the application of Union harmonisation
legislation”.
This is your opportunity to make your voice heard and to express your views about progress
made within the ESS.
When completing this questionnaire, please answer about your own sector, experience, and
practical experience about the European Standardisation System. Please base your answers
on facts that you have already observed.
The survey is open as of October 20th, 2014, and filled questionnaires needs to be submitted
before November 16th, 2014 COB. Filling the survey takes on average 30 minutes. When
answering the questionnaire, you have the possibility to come back to previous questions to
edit your answers. It is also possible to complete a part of the questionnaire and to finalise it
later (note that the same computer and browser must be used, and the cookie must not
have been deleted).
- “Yes or No” – This statement is the best way for having strong categorisation between
stakeholders and is either used for very broad statements or for very accurate questions.
Answers to these questions will serve as preliminary statistics and will not be used without
deep analysis of other answers (see description below);
- “5-ranked evaluation” – For the assessment of specific goals or targets, the survey
identifies 5 levels of appreciation, such as “very low” to “very high”; “never” to “always” (for
frequency only); “very good” to “very bad”.
- “Open comments” – For more complex questions, an open comment is requested, offering
more flexibility to respondents.
In case you cannot answer a question, or if a question is irrelevant for you, please skip the
question.
3. If relevant, please select the NACE code corresponding to your activity, or the activity you
represent:
☐ Participates in activities
☐ Buys standards for direct use
☐ Informs others about standards
☐ Other (please specify)
Click here to enter text.
6. What is the estimated FTEs (full time equivalent) participating in standardisation activities,
within your organisation ?
Click here to enter text.
Objective “Speed and timeliness”, intended as speed of the standardisation process and the
time needed for standards to become available. It is understood that this objective is
achieved if standards are available in a timely matter (when needed).
The timeframe considered for speed and timeliness is the time lapse between the
identification of the standardisation need (informally by industry or formally through a EC
mandate) and the availability of the standard. In the case of harmonised European
standards, we understand that the time needed for publishing the reference of a standard in
the Official Journal of the European Union (OJEU) also needs to be taken into account.
8. Do you consider that standardisation deliverables within the ESS are available in a timely
manner?
9. According to your experience, to what extent has the ESS achieved the following goals?
Also, how do you expect the ESS to achieve those goals?
Please give a rating from “very high” to “very low” to achievements under each heading.
Please also explain the reasons of your rating and the issues identified (in the case of
“moderate”, “low”, “very low” rating). Please provide examples and concrete cases if
10. Has the interest in speed decreased the quality of the standard? Also, what is the
expected impact?
12. From your perspective, is the achievement of the objective “Speed and timeliness”
different in the following situations?
Yes No No opinion
Standards for services, compared to ☐ ☐ ☐
standards for products
Standards triggered by mandate, compared to ☐ ☐ ☐
standards triggered by industry
Additional comments
Click here to enter text.
13. Please describe any bottlenecks to the “timely availability” of standards, that you have
experienced. If any, please explain how to overcome these bottlenecks.
Click here to enter text.
15. According to your experience, to what extent has the ESS achieved the following goals?
Also, how do you expect the ESS to achieve those goals?
Please give a rating from “very high” to “very low” to achievements under each heading.
Please also explain the reasons of your rating and the issues identified (in the case of
“moderate”, “low”, “very low” rating). Please provide examples and concrete cases if
possible.
Expected
Achievements to
achievement
date (rating)
(rating)
Facilitating cross-border activities and trade in the Choose an item. Choose an item.
Internal market
Facilitating the market penetration of innovative Choose an item. Choose an item.
technologies
Reducing the production costs for companies Choose an item. Choose an item.
Increasing interoperability of products Choose an item. Choose an item.
Developing standard deliverables being market Choose an item. Choose an item.
relevant
Facilitate access to EU market for EU SMEs Choose an item. Choose an item.
Enhancing companies’ growth (e.g. market share) and Choose an item. Choose an item.
competitiveness
Please explain the reasons of your rating and the issues identified (in the case of “moderate”,
“low”, “very low” rating). Please provide examples and concrete cases if possible. Please also
specify any other achievements
16. Have you experience any situation in which, in your opinion, the ESS failed to support
competitiveness in the single market?
17. From your perspective, is the achievement of the objective “Competitiveness of European
business in the internal market” different in the following situations?
Yes No No opinion
Standards for services, compared to ☐ ☐ ☐
standards for products
Standards triggered by mandate, compared to ☐ ☐ ☐
standards triggered by industry
Additional comments
Click here to enter text.
18. Based on your experience, what changes (if any) do you recommend to be made to
increase the contribution of the ESS to the competitiveness of European companies in the
single market?
Click here to enter text.
19. Does the ESS act as an effective support to EU legislation and policies?
20. According to your experience, to what extent has the ESS achieved the following goals?
Also, how do you expect the ESS to achieve those goals?
Please give a rating from “very high” to “very low” to achievements under each heading.
Please also explain the reasons of your rating and the issues identified (in the case of
“moderate”, “low”, “very low” rating). Please provide examples and concrete cases if
possible. If you see any other achievement, please specify.
21. What is the system’s ability to respond to an increased demand for standards to support
EU legislation and policies (e.g. increased standardisation requests from the Commission to
the ESOs)? What, if any, steps need to be taken now to ensure the readiness of the system?
Please also explain the reasons of your rating and the issues identified (in the case of
“moderate”, “low”, “very low” rating). Please provide examples and concrete cases if
possible.
22. From your perspective, is the achievement of the objective “Support to EU legislation and
policies” different in the following situations?
Yes No No opinion
Standards for services, compared to ☐ ☐ ☐
standards for products
Additional comments
Click here to enter text.
23. Based on your experience, what (if any) changes do you recommend to be made to
increase the contribution of the ESS as support to EC legislation and policies?
Click here to enter text.
Objective “Inclusiveness of the ESS”, intended as the ability of the processes in the ESS to
involve a wide range of participants (representative of businesses of all sizes, consumers,
other societal stakeholders such as trade unions, environmental NGOs, representatives of
25. Did improvement in speed impair the inclusiveness of the ESS? Also, what is the
expected impact?
Expected
Positive/negative
positive/negative
impact to date
impact
Impact that the interest in speed has on Choose an item. Choose an item.
inclusiveness
26. According to your experience, to what extent has the ESS achieved the following goals?
Also, how do you expect the ESS to achieve those goals?
Please give a rating from “very high” to “very low” to achievements under each heading.
Please also explain the reasons of your rating and the issues identified (in the case of
“moderate”, “low”, “very low” rating). Please provide examples and concrete cases if
possible. If you see any other achievement, please specify.
27. Is the range of participants involved in the ESS standard setting processes (from the
need definition until the availability of the standard) wide enough?
☐ Yes ☐ No ☐ No opinion
If not, please identify any relevant groups that are not sufficiently included and indicate how
they could be better involved
Click here to enter text.
28. From your perspective, is the achievement of the objective “Inclusiveness” different in
the following situations?
Yes No No opinion
Standards for services, compared to ☐ ☐ ☐
standards for products
Standards triggered by mandate, compared to ☐ ☐ ☐
standards triggered by industry
Additional comments
Click here to enter text.
29. Please describe any bottlenecks to the inclusiveness of the ESS that you have
experienced. If any, please explain how these bottlenecks could be overcome in your
opinion.
30. Does the ESS supports the competitiveness of EU companies in the global arena?
31. According to your experience, to what extent has the ESS achieved the following goals?
Also, how do you expect the ESS to achieve those goals?
Please give a rating from “very high” to “very low” to achievements under each heading.
Please also explain the reasons of your rating and the issues identified (in the case of
“moderate”, “low”, “very low” rating). Please provide examples and concrete cases if
possible.
32. From your perspective, is the achievement of the objective “Competitiveness of European
business at global level” different in the following situations?
Yes No No opinion
Standards for services, compared to ☐ ☐ ☐
standards for products
Standards triggered by mandate, compared to ☐ ☐ ☐
standards triggered by industry
Additional comments
Click here to enter text.
33. Based on your experience, what changes (if any) do you recommend to be made to
increase the contribution of the ESS to the competitiveness of European companies at global
market?
Click here to enter text.
☐ Yes ☐ No ☐ No opinion
If not, which elements are not well-governed and which corrective actions would you suggest
?
Click here to enter text.
35. Are the interaction and the communication flows among actors (EC, the ESOs, Member
States, NSBs and other stakeholders) satisfactory?
☐ Yes ☐ No ☐ No opinion
If not, please describe which improvements could be made and between what actors
Click here to enter text.
36. Do you experience any avoidable administrative burden associated with your role in the
ESS, or at specific parts of the process in which you are involved?
Yes No No opinion
Timeliness ☐ ☐ ☐
Transparency ☐ ☐ ☐
Inclusiveness ☐ ☐ ☐
If the answer to one of the previous questions is “no", which improvements could be made?
38. Have you identified issues in the delay for national implementation of European
standards?
39. Does the current governance ensure the actual and active participation of all the
stakeholders involved in the process (in particular the ones referred to in Annex 3, being
SMEs, consumers, stakeholders representing environmental interests and social interests)?
☐ Yes ☐ No ☐ No opinion
40. Does the current ESS governance and ESO guidelines offer the guarantee for effective
representation of stakeholders within the process?
Yes No No opinion
Does the current ESS governance
and ESO guidelines offer the
guarantee for effective ☐ ☐ ☐
representation of stakeholders
within the process?
In particular, do you think that
current voting rights allow for ☐ ☐ ☐
balanced consensus making?
If the answer to one of the previous questions is “no”, what improvements could be made?
41. In your opinion, to what extent can the participation level be related to the level of
knowledge and awareness on the importance of standards?
Click here to enter text.
42. Considering your position within the ESS, do you feel sufficiently consulted?
☐ Yes ☐ No ☐ No opinion
If not, please explain the main gaps in the consultative processes and which corrective
actions you would suggest
Click here to enter text.
43. Considering your position within the ESS, do you receive enough information?
☐ Yes ☐ No ☐ No opinion
If not, please explain the main gaps in information provision and which corrective actions
you would suggest
Click here to enter text.
44. In the scope of public consultations about draft standards, during the commenting phase
(public enquiry):
Agreement
You have enough time to analyse and prepare your participationChoose an item.
in European standardisation
You have enough information to analyse and prepare your Choose an item.
participation
Your input is sufficiently taken into account Choose an item.
You receive sufficient feedback/status about comment Choose an item.
☐ Yes ☐ No ☐ No opinion
46. If you are aware of the existence of an appeal procedure, have you already used this
procedure?
☐ Yes ☐ No ☐ No opinion
47. If you already used the appeal procedure, did it appear to be effective?
48. What is, in your opinion, the definition of a good quality standard?
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49. Based on your previous answer, to what extent does the quality level of European
standard deliverables respond to your needs?
50. Are there any new technical domains which you consider insufficiently covered by
European standards (i.e. where European standards are missing/urgently needed?)
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51. What are, in your opinion, the reasons that prevent the ESS to expand its scope to these
new technical domains?
Please explain the reasons of your rating and the issues identified (in the case of “moderate”,
“low”, “very low” rating). Please provide examples and concrete cases if possible.
Agreement
Lack of experts to run new ESO technical committees Choose an item.
Lack of financial resources to run new ESO technical Choose an item.
committees
Lack of interest of industry or other stakeholders to Choose an item.
provide experts
Lack of cooperation with other specialised standards Choose an item.
setting bodies
Lack of consensus between the different actors of the Choose an item.
ESS
National interests to keep national standards Choose an item.
Primacy of international standards Choose an item.
Existence of other bodies developing standards (e.g. Choose an item.
Fora and Consortia)
Please specify any other reasons
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52. In a long term perspective (by 2020), the ESS should be able to adapt to a quickly
evolving environment and to contribute to the Union’s strategic objectives, in the field of
industrial policy, innovation and technological development. In order to ensure the relevance
of the ESS against the future needs, its effectiveness, efficiency and coverage, which areas
of action do you deem as crucial?
Please rate the importance of each area of action from “very high” to “very low”.
Long-term interest
53. Can you identify any barriers or “blocking factors” in the current system and practices,
which prevent the full effectiveness and efficiency of the ESS?
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55. Which are your recommendations for the overall improvement of the ESS?
Click here to enter text.
56. In addition to the answers and comments provided earlier in this questionnaire, please
use the following textbox to provide additional comments you might have.
Click here to enter text.
☐ Yes ☐ No
Legal basis
The need for “speed” and timeliness in European standardisation is defined as one
of the strategic objectives of COM(2011)311 final, and is aligned with the Europe
2020 Strategy for smart, sustainable and inclusive growth. As mentioned in the
Communication:
“Standards need to be quickly available – especially but not only – to assure the
interoperability between services and applications in the field of information and
communication technologies so that Europe can reap the full benefits of ICT. […]
Standards must keep pace with ever faster product development cycles.”
The need for “speed” is also highlighted in the Framework Partnership Agreements
between the European Commission and the European standardisation
organisations.
Within the topic “speed of standardisation”, the case targets mandated standards,
and therefore aims at analysing the responsiveness of the ESS in addressing EC
needs. In more details, this case study analyses the possible delay between the
submission of a mandate to ESOs and the actual start of the work. The
concept of “speed” in this case study will therefore be understood as time needed
for starting the standard development.
Context
26
To the purposes of this case study, the notion of start of development corresponds to the start of the
drafting. This corresponds to milestones ”20.20.000 Start of Drafting” in CEN and CENELEC (date is
sometimes based on code “10.99.000 – Decision on WI Proposal”, as –when both codes are provided-
they are equal in 99,4% of the cases), but is not recorded within ETSI. In ETSI, status code 4 is
therefore used (“first stable draft available”). The end of the development is considered as the time of
publication of the standard. Within CEN and CENELEC, this corresponds to the milestone ”60.60.0000 –
DAV/Definitive text available”; while ETSI records it as Status 12.
27
“Home-grown 1st edition standards” are understood as first version standards (as opposed to
updates/amendments) whose development is led at European level (by opposition to international lead).
2500
2000
1500
1000
500
0
2009 2010 2011 2012 2013
CEN CENELEC ETSI
Moreover, two out of three of the standards have a development time which
is lower than three years, and the development of some standards recently
made available started a long time ago.
Home-grown 1st edition standards made available between 2009 and 2013, by date of decision on WI
300
250
200
150
100
50
0
1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
In this case, focusing on the time needed for ESOs to start working upon
mandated request, two different aspects are considered as “indicators” of
speed:
1) The timeframe between submission of the mandate by the EC to the
ESOs, and the official start of standardisation (start of drafting) on the
ESO side;
2) The volume of mandates for which no work programme has been
developed nor standardisation work has already been formally initiated.
The case study focuses on a sample of mandates under the old regulation. For that
purpose, a sample of 10 “old” mandates has been selected. The initial population is
a “list of recent mandates”, which exclude requests for studies and mandates
amendments, that was provided by the Commission. The mandates were selected
through a random selection procedure.
Data collection
The information used in this case study comes from the Commission and ESOs
databases. Qualitative comments and detailed information about specific mandates
(or related standards) have however been collected. In addition to these interviews,
information collected during the first phase of the project has been used.
Mandate status: for all the 10 mandates analysed, the ESOs provided
statistics about the development timeframe of related standards. The graph
below represents, for the mandates analysed, the time elapsed between the
notification of the mandate by the EC to the ESOs and the first milestone
recorded in the ESO database28. This is assumed to proxy the length of the
“preparatory stage” that occurs after the notification of the mandate and
prior to start of standardisation activities.
First of all, it appears that a series of work items were initiated a long time
before the mandates were notified to the ESOs, and were then related
afterwards to their respective-mandate (in total, 11% of the work items in
the sample were recorded prior to the formal notification of the mandate).
28
Distinction is made between CEN-CENELEC and ETSI, as the first milestone recorded is not the same
(tables at the end of the case study define what milestones were used for the various ESOs, and to what
standardisation “event” they do correspond).
Practical reasons for delay: some reasons for the delay in these
mandates were explained by CCMC. First of all, six of these mandates were
associated to financial contracts which foresee a longer timeframe than
usual, and some of them include a pre-normative research phase. Secondly,
the FPA between the EC and the ESOs induced some changes to be
performed for some mandates, which were set on-hold (the case of
mandates M/420 and M/513). Finally, one of these mandates required the
development of a feasibility study prior to the actual start of technical
standardisation work.
12/10/2014
Date of publication (or last milestone registered)
12/10/2013
12/10/2012
13/10/2011
13/10/2010
CEN WI led to pub.
CEN WI not led to pub.
ETSI WI led to pub.
ETSI WI not led to pub.
13/10/2009
13/10/2009 13/10/2010 13/10/2011 12/10/2012 12/10/2013 12/10/2014 12/10/2015
Start of work (or first milestone registered)
Conclusions
Based on these new requirements (and the underlying financial aspects), the ESOs
now accept the mandates based on a more detailed assessment of the mandate
and its underlying requirements.
29
It has to be noted that this was not the case for the mandate on eco-design, which was refused after
having been approved by the Committee on Standards. This issue is however out of scope for this case
study.
Independently from this impact on the speed, it has however to be noted that the
information for monitoring the activities performed by the ESOs as a response to a
mandate is a difficult exercise, and a continuous monitoring of the responsiveness
of the ESOs is a difficult task –in the current situation.
Similarly, once the ESOs accepted the mandate, the information about the
development of the standards requested should be made easily available to the
Commission and to other stakeholders.
Moreover, the current data does not allow for efficient monitoring of the speed of
the process, based on the different structuring of the DB, the non-reliability on all
milestones and the reliability of the data for identifying actual standardisation
events. It has to be noted that, within CEN and CENELEC, best practices are
identified in order to ensure that standard development is below 3 years. This also
includes procedures to perform work outside of the formal codes for standard
development, and ensuring the closure of existing work items after three years
(which can be followed by further work on the same standard in another work
item).
Even though the concept of speed is an aspect which generates discussion within
the ESS, it also has to be reminded that the ESS is a tool which speeds up the
economy: when considering the time which would be needed for reaching
interoperability, safety, etc. without the ESS, it can be considered that the time
needed for developing standards is short.
Data collection
CEN-CENELEC
Stage code Usage
10.99.000 – Decision on WI Proposal First milestone available, and therefore generally used for
computing the start of activities within CENELEC.
20.20.000 – Start of Drafting Second milestone available. For many standards, is equal to
10.99.000. When standards lack 10.99.0000, 20.20.0000 is
therefore used
60.60.0000 – DAV/Definitive text Last milestone available, and therefore generally used for
available computing the end of activities within CEN-CENELEC.
ETSI
Stage code Usage
4 - Stable draft First milestone available, and therefore generally used for
computing the start of activities within ETSI.
12 - Publication Last milestone available, and therefore generally used for
computing the end of activities within ETSI.
Interviewees
Category Number of
interviewees/contributors
Annex III organisations 1
European Commission (or agency) 2
European standardisation organisations 3
Industry or industry representatives 1
This case focuses on the linkages between standards, and research and innovation.
This case therefore analyses the mechanisms in place for ensuring the
appropriate start of standardisation activities and the mechanisms in place
for tackling standardisation needs involving various technologies.
“To what extent is the ESS prepared to take on challenges of the future?
Focus on timely start of standardisation and cross-disciplinary aspects.”
As agreed with the Commission, and in more details, the case focuses on two
perspectives, being the following:
The concepts of “Research and Innovation” are also relevant to other case study
topics. Where there are overlapping aspects, cross-reference will be made to the
appropriate case study.
30
European Commission, COM(2011) 311 Final - A strategic vision for European standards: Moving
forward to enhance and accelerate the sustainable growth of the European economy by 2020, Brussels,
2011.
31
See footnote above.
32
COM(2008) 133 final of 11.03.2008.
33
Like most similar groups of CEN and CENELEC members, STAIR is purely an unfunded voluntary
activity, with CCMC providing the Secretariat.
34
http://www.cencenelec.eu/research/BRIDGIT/Pages/default.aspx
35
Preliminary conclusions available at:
ftp://ftp.cencenelec.eu/EN/ResearchInnovation/SuccessStories/ExecutiveSummary-BRIDGIT-
ResearchProject.pdf
36
Allen, R. H., and Sriram, R.D. (2000). The role of Standards in Innovation, Technological Forecasting
and Social Change, 64, p. 171-181.
37
Allen, R. H., and Sriram, R.D. (2000). The role of Standards in Innovation, Technological Forecasting
and Social Change, 64, p. 171-181.
Case selected
In its initial phase, the policy group STAIR considered how to accelerate the start of
standardisation on technology issues that either are related to new science areas,
or science areas where rapid technological evolution is expected to radically change
market conditions.
The current case study therefore focusses on the STAIR-AM perspective –and
additive manufacturing- for illustrating the link between research and innovation,
and standardisation.
38
Friedrich, J. (2014). Facilitating Innovation: The Role Of Standards And Openness In The Broader
Innovation Ecosystem,in Research On Open Innovation - A collection of papers on Open Innovation from
leading researchers in the field, OpenForum Europe LTD, p. 32-52.
39
Blind, K. (2013). The Impact of Standardisation and Standards on Innovation - Compentidum of
Evidence on the Effectiveness of Innovation Policy Intervention, Manchester Institute of Innovation
Research, Manchester Business School, University of Manchester.
Prior to STAIR-AM, CEN had not addressed standardisation in the field of additive
manufacturing. However, an EU FP7 project was established in September 2012:
SASAM (Standardisation in Additive Manufacturing”41) involved significant industry
partners, as well as NEN, the Dutch standards body. SASAM's main objective was to
produce a “Standardisation Roadmap”.
The SASAM project completed its work in March 2014. STAIR-AM subsequently
continued some activity in conjunction with the Commission-led “AM Platform42” - a
sub-platform of the ETP on manufacturing (“Manufutures”). One recommendation of
the SASAM Roadmap was that a European-level CEN Technical Committee on
additive manufacturing as such should be considered 43. Such a Committee would be
expected to replace the STAIR-AM Platform, as the focal point for European
standardisation issues in the domain. This Technical Committee could also produce
any actual standardisation deliverables that were required at European level, in so
far as they were not within the remit of those TCs dealing with AM as part of their
standards work relating to specific industries (see section 2.2.2 below). This
suggestion of creating a dedicated TC is under discussion within CEN.
However, the main conclusion of SASAM was not based on European primacy, as
industry expressed a clear preference for an international standard - “European
participants are definitely more inclined to the ISO than to the ASTM or any other
(VDI, CEN) standard”. The project therefore resulted to the conclusion that any
future European standards activity should be complementary to the international
work, and that specific European standards should only be developed when
necessary.
40
European Commission, „Final Report of the Foresight Study On: How will standards facilitate new
production systems in the context of EU innovation and competitiveness in 2025?,” Brussels, 2014.
41
www.sasam.eu
42
www.rm-platform.com
43
Two CEN TCs (TC 121 and TC 138) are cited in SASAM’s roadmap as being interested in aspects of
Additive Manufacturing. However, their business plan currently shows no specific development related to
Additive Manufacturing.
Data collection
The information used in this case study has been collected through desk research
on documents available on the Internet, and discussions with stakeholders within
the ESS.
44
The ISO work is not be funded directly using public or research funds, but is based on indirect funding
through involvement of the participants. The cost of running Technical Committees as such is small
compared with the overall effort required for industry to participate in the standardisation processes.
45
www.ASTM.org
46
ISO/TC 261, „Business Plan - ISO/TC261 - Additive manufacturing,” 2012.
47
SASAM, „Additive Manufacturing - SASAM Standardisation Roadmap,” 2014.
48
This interest in international standardisation was explained through different means by various actors:
some of them advocated the importance of additive manufacturing activity in the US, while other
supported the fact that the innovative character of such an innovation required international
development. Moreover, it has been highlighted that ISO does not imply compulsory national
transposition of the standard, and consensus might therefore be easier to reach on innovative aspects.
49
European Commission (2014). Additive Manufacturing in FP7 and Horizon 2020 - Report from the EC
Workshop on Additive Manufacturing held on 18 June 2014.
Other comments
A very limited quantity of information about the STAIR-AM platform and related
activities is available online. Considering the innovative aspect on the platform and
its collaborative logic, having modern ICT tools for facilitating access to information
and contribution to the platform would be considered as necessary.
Conclusions
On one hand, the approach of an informal working group to consider initially the
standards needs in an innovative area is a useful one. On the other hand, the
creation of STAIR-AM, and indeed of the SASAM project, seem to have taken place
rather late, given the advancement of ASTM’s and ISO’s standardisation activities
(the latter driven by a European NSB) in additive manufacturing and the start of
activities in some NSBs. It could also be assumed that the creation of the STAIR-AM
platform –and the start of SASAM- were performed in response to standardisation
in ISO, in order to ensure that standardisation activities are also performed at
European level. At the very least, the investigation of what – if anything – was
required at European level could have begun earlier with consequent advantages
for overall stakeholder awareness.
The Commission and the ESOs need to consider how to act earlier for new topics.
Careful and close attention needs to be paid to possible future standardisation
requirements in areas where European-level innovation and research are strongly
active, and where there is a strong European strategic interest in taking the lead.
Where it provides the funding, the European Commission has to ensure the
appropriate engagement of the research communities with standardisation.
One way to help overall awareness in Member States and the research community
would be for the Commission to consider the establishment of specific proposals to
the ESOs to carry out preliminary actions in new areas for standards.
Previously, especially in ICT, the Commission issued mandates for such first
assessments to take place. However, the new Regulation does not foresee the
development of such mandates, and the Commission cannot use Art. 6 for
requesting pre-standardisation work. Even though such requests could be
developed under other form, the legislation nor the current version of the
Vademecum provide guidance about this.
However, it needs to be ensured that all “ordinary” research projects in the domain
are made aware of where it is that standards issues are being addressed.
Where international activities in new areas are being promoted, CEN and CENELEC
members should inform their counterparts at European level of this fact. Any
subsequent European-level standards activities should certainly be linked as
appropriate with the international work in accordance with the Vienna or Dresden
Agreements. If Europe wishes to establish and maintain technology leadership,
standardisation primacy is a major factor. If it does not, then stakeholders need to
know who to address at the global level and how.
5.2.4 Appendix
Interviewees
Category Number of
interviewees/contributors
European Commission 3
European standardisation organisations 2
NSBs 2
This case study is performed upon the Commission’s request for further studying
the link between standardisation and intellectual property rights (IPRs). Considering
the extensive ongoing and past research about IPR, this case study focuses on a
single aspect of intellectual property rights in standardisation and provides ground
for further analysis of the attention points being raised.
More specifically, this case will consider the telecommunication field. The reason for
this is that there is a high industry reliance on standardisation in the
telecommunication field and that a large share of innovations is protected by
patents (see details of the case below). In this field, ETSI produces globally-
applicable standards. As an ESO, ETSI promotes and encourages a licensing
framework for standard-essential-patents that are declared in its database.
Potential licensees can then use the patented technology under the specific terms
of the license.
50
European Commission Directorate-General for Enterprise and Industry, “Patents and Standards, A
modern framework for IPR-based standardisation,” 2014.
Innovation and patents: of all IPRs, a patent is the right that relates to
innovative technology. It is basically a set of exclusive rights with territorial
effect, which are granted to an inventor. After registration of the patent, the
rights holder has the exclusive right to exploit the invention/technology by,
for example making, using and selling it. The rights holder can forbid others
to perform these actions regarding the patent. The rationale behind granting
these right is based on protecting return on investment for innovators,
and therefore to stimulate innovation.
51
Regulation(EU) No 1025/2012
52
“ETSI Intellectual Property Rights Policy” (19/03/2014)
53
“ETSI Guide on Intellectual Property Rights (IPRs)” (19/09/2013)
54
See details in “ETSI Guide on Intellectual Property Rights (IPRs)” (19/09/2013), page 50.
55
See details in “ETSI Intellectual Property Rights Policy” (19/03/2014), paragraph 3.1.
56
See details in “ETSI Intellectual Property Rights Policy” (19/03/2014), paragraph 3.2.
57
See details in “ETSI Intellectual Property Rights Policy” (19/03/2014), paragraph 3.3.
58
The following rules are based on the ETSI guide and policy IPR.
59
See details in “ETSI Intellectual Property Rights Policy” (19/03/2014), paragraph 4.1.
60
See details in “ETSI Intellectual Property Rights Policy” (19/03/2014), paragraph 6.1.
61
See details in “ETSI Intellectual Property Rights Policy” (19/03/2014), section 8.
62
See details in “ETSI Guide on Intellectual Property Rights (IPRs)” (19/09/2013), page 54.
63
See details in “ETSI Guide on Intellectual Property Rights (IPRs)” (19/09/2013), page 56.
The declaration can also be performed upon ETSI request: in case a non-
declared SEP is identified, ETSI will request the IPR owner to declare its SEP
and accept licensing under FRAND conditions64. In case this request is not
accepted, alternatives will be selected.
Case selected
The “telecommunications via public networks” have been identified as being the
technology area with the highest amount of patents and amount of litigations, as
represented below68 69. It however needs to be highlighted that an SEP can be
subject to over or multi-declaration, and that the actual number of unique SEP is
not known.
64
See details in “ETSI Intellectual Property Rights Policy” (19/03/2014), paragraph 6.1.
65
European Commission Directorate-General for Enterprise and Industry, “Patents and Standards, A
modern framework for IPR-based standardisation,” 2014.
66
In accordance with “ETSI Intellectual Property Rights Policy” (19/03/2014), paragraph 7.2.
67
See details in “ETSI Intellectual Property Rights Policy” (19/03/2014), paragraph 7.1.
68
Blind, K., Bekkers, R., Dietrich, Y., Iversen, E., Köhler, F., Müller, B., Pohlmann, T., Smeets, S. and
Verweijen, J. (2011). “Study on the Interplay between Standards and Intellectual Property Rights
(IPRs)”.
69
European Commission (2014). “Standard-essential patents”, Competition policy brief, nr. 8.
For performing the analysis of this case, the focus as set on the “LTE” project within
ETSI (full name: “Rel-8 LTE – 3G Long Term Evolution - Evolved Packet System
RAN part”). The release 8 (standards v8.x.x) is the basis for the first wave of LTE
equipment.
A small amount of patents is declared within CEN and CENELEC. Even though CEN
and CENELEC standards based on ISO standards include a larger amount of
patents, it is noted that most of IPR related activity occurs within ETSI 71. This case
study therefore focuses on ETSI’s declaration process.
Data collection
The information used in this case study has been collected through different
interviews and conference calls. The list of interviewees is available in Annex 1. In
addition to these interviews, information collected during the first phase of the
project through preliminary interviews with different stakeholders was used.
Quantitative data has been collected through ETSI IPR database 72 and desk
research (see details of the desk research and bibliography in appendix).
Data summary
70
European Commission Directorate-General for Enterprise and Industry, “Patents and Standards, A
modern framework for IPR-based standardisation,” 2014.
71
It has to be noted that the trend of digital-enabling of products/services might lead to an increased
IPR activity in other fields than ICT.
72
The disclaimer about ETSI IPR database is available in Appendix.
73
When looking at the complete ETSI IPR database, it should be noted that a total of 1721 specific
declarations were submitted, against 154 general declarations (8,2%).
14
289
Based on the ETSI IPR policy, and considering the logical link between
general declarations and specific declarations, we would expect that general
declarations would anticipate on the declarations performed afterwards.
However, when looking at the graph below, we notice that this is not the
case. First of all, a specific declaration was performed in the scope of the
project in 2001. Then, a few general declarations were performed between
2007 and 2011. Major part of specific declarations was performed in
between 2008 and 2012. A second “batch” of declarations then started
between mid-2012 and end 2014.
GD and SD in "Rel-8 LTE – 3G Long Term Evolution - Evolved Packet System RAN part", by quarter
25
20
15
10 GD
SD
5
Performed a GD
Did not perform a GD
52
For the next stage of the analysis, we can therefore already differentiate
companies which performed a GD, and the ones which did not.
When focussing on the eight companies that performed a GD, we noticed
three different profiles:
- One of the company only performed a GD, which was not followed by
specific declarations;
On the other hand, major part of companies only performed specific declarations.
GD SD Profile Companies75
GD submitted No following SD Profile 1 1/60
Simultaneous SD Profile 2 4/60
Followed by SD Profile 3 3/60
No GD SD only Profile 4 52/60
The detailed timing of the patent declarations for the analysed companies is
shown in Annex (the three companies with the most IPR declarations were
selected for illustrating profile 4).
Timing: when looking back at the previous graph, the timing of IPR activity
is surprising: major part of IPR activity occurs between 2008 and
2014, while the LTE rel-8 was frozen in December 2008. As freezing a
Release assumes that the features to be included in the Release are well
defined, it can be understood that major part of IPRs should already have
been declared at that date. Moreover, when looking at the 3GPP programme
for LTE, we notice that all work items for the release are closed by the first
quarter of 2009.
When looking at the details of data declaration, it was noticed that the
extract performed based on the ETSI databases also includes revision of
these standards (i.e. releases 9, 10, 11 and 12), and that –from a global
perspective- the above-mentioned IPR activity cannot be compared to
standardisation activity for LTE rel-8.
In order to be able to focus on the timing between standardisation and IPR
declarations, one specific standard was randomly selected: TS 136.213,
being the translation at ETSI level of the 3GPP TS 36.213. In order to reduce
the scope, the analysis is focused on the version 8 of this specification,
being part of Rel. 8 of LTE. This specification is part –together with 6 other
specifications- of the framework for the LTE-Physical layer.
Activities in 3GPP for preparing the Rel8 physical layer were initiated on
25/09/2006 and ended on 7/03/2008. Last version of the standard in rel 8
(v8.8.0) was published 13/10/2009. However, when looking at the IPR
declaration performed in “Rel-8 LTE – 3G Long Term Evolution - Evolved
Packet System RAN part”, related to that standard, and to a version 8.x.x,
we notice that major part of IPR declarations occurred outside of
3GPP work, and after the last change in version 876.
74
The graph shows a level of accuracy up to quarters. For these cases, detailed data has been analysed
and submission of the GD and SD are exactly the same.
75
One of the companies performed three GD and SD simultaneously, and then submitted two SD. It has
been set as “profile 2”, also latest events might lead to “profile 3”.
76
For further detail, the last 5 declarations were carefully looked at, and it appears that v8.x.x is directly
referred to in these 5 declarations ISLD-201409-049 (disclosure 21), ISLD-201407-013 (disclosures 2
and 8), ISLD-201410-018 (disclosure 2), ISLD-201410-033 (disclosures 40, 49, 50, 51, 53, 60, 70, 71,
72, 73, 82, 83 and 114) and ISLD-201412-005 (disclosures 20 and 29).
Issues identified
Low reliance on the GD-SD scheme: the ideal logic of IPR declaration is
based on a twofold procedure: submission of a general declaration at an
early stage, for facilitating standardisers work; followed by the submission of
the actually needed specifications.
Standardisation work
Volume
GD SD
Time
However, as noticed in the case of the LTE project, the declaration practices
are not the same for all companies. First, major part of companies did
not make a general declaration; second, companies who submitted a GD
actually did not declare their IPRs in the same way.
This suggests that members are encouraged to declare any IPR, from a
cautious perspective, to ensure that all standards can be used under FRAND
terms. This therefore means that, although all essential IPRs are therefore
assumed to be made available under FRAND conditions, it is difficult for
standardisers and manufacturers to actually identify the patents (or
essential patents) that they should consider when developing the
standard/implementing the standard.
77
This can however not be interpreted without detailed analysis of the patents and discussion with the
relevant companies, which is out of scope for this case study. E.g. the patent application process should
also be looked at, and the analysis should integrate the full process.
Conclusions
In order to ensure transparency about existing IPRs, the overall IPR declaration
process should be based on a two-fold logic (specific declaration and general
declaration GD/SD), and that IPR declarations should be performed in a timely
manner (prior to actors making decisions based on existing –but not declared-
intellectual property).
Based on the case studied, it appears that these two pre-conditions are not fulfilled,
which lead standardisers and manufacturers to make decision based on incomplete
information.
First, based on the example analysed79, it appears that the GD/SD scheme is not
fully applied. From the time this GD/SD link is not reliable (which should be
validated through further analysis, in other projects and analysing other standards).
Second, ETSI Policy does not set any pre-defined timing for patents to be declared,
nor identifies “best practices” for the timely notification of IPRs. An intentional delay
in the declaration of patent consists in a breach of ETSI IPR Policy, but is however
very difficult to prove. However, delay cannot always be intentional and could be
related to lack of awareness or late granting of the patent.
Independently from the area of patent declaration, it should also be reminded that
IPRs are considered as crucial, and the functioning of the IPR in standardisation
78
ETSI, „Activities/Developments related to the ETSI IPR Policy - GS15,” 2010.
79
We consider that further conclusion would need in-depth analysis of the whole ETSI IPR database.
Finally, it should be noted that the patent declaration system of ETSI is based on
goodwill, and therefore relies on the fair participation of actors within the system.
IPR policy strongly recommends their members to provide information, but there is
no requirement for performing IPR searches (as mentioned in clause 4.2 of ETSI’s
IPR Policy). Similarly, the distinction between what is SEP and what is not SEP
relies on the fair identification of the company, and no one is responsible for
assessing the essentiality of a patent, excepted from the court. In the same logic,
updating the patent declaration is not considered as compulsory.
One of the issues highlighted in this document is the difficulty for accurate analysis
of the essentiality of the patent. In the current state, the only possibility for
determining the actual (or not) essentiality of the patent, is to refer to a court
decision.
However, some interviews highlighted that such a tool should also facilitate the
work of standards users, by allowing the identification –through the IPR database-
of the patent exposure related to given standards: in other words, the IPR database
could be further improved to identify what are the actual IPRs (and potential
estimated fees) related to the use of a given standard.
This would also facilitate monitoring aspects from the public authorities’
perspective.
This is however not suited to the IPR database practices, which currently “promote”
over-declaration –through the logic of ensuring FRAND on any potential IPRs-, and
does not ensure essentiality of patents registered in the database.
80
E.g. forcing declaration prior to the availability of a standard might lead to a increase of the time for
development of standards; and the environment should not be made less “innovation friendly”.
Further analysis of the late declarations: this case study noted that many
declarations were made about a standard published –sometimes- a long time
before. This should be studied in details, through analysis of the specific
declarations and underlying patent(s), as many different reasons could be
envisaged for these late declarations.
Extension of the case to CEN and CENELEC: this case study focuses on a
specific case within ETSI. As mentioned earlier in the case, IPR seems
generate less interest on CEN and CENELEC sides, who have registered a very
limited amount of patents on their standards.
The issues encountered –in terms of GD/SD and timing for the declaration-
should therefore be further anticipated in CEN and CENELEC, prior to a
potential increase of IPR activity.
5.3.4 Appendix
Extracts
No representations and/or warranties (whether express or implied) are made by the ETSI Secretariat
regarding any of the intellectual property rights contained in the present IPR online database, including
but not limited to the accuracy, completeness, validity, applicability or relevance of the information or
whether or not such rights are essential as per the definition of the ETSI IPR Policy.
The bibliographic data of the declared patents are based on the information received from declarants
and may also contain data imported from the patent database “Espacenet” of the European Patent
Office. For the avoidance of doubt, in case of discrepancy and/or inconsistency between the content of
any ETSI IPR licensing declaration form signed by the declarant*, and of the ETSI IPR online database,
the signed version of the ETSI IPR licensing declaration form shall prevail.
The attention of the members of this Technical Body is drawn to the fact that ETSI Members shall use
reasonable endeavours under Clause 4.1 of the ETSI IPR Policy, Annex 6 of the Rules of Procedure, to
inform ETSI of Essential IPRs in a timely fashion. This section covers the obligation to notify its own IPRs
but also other companies' IPRs.
• to investigate in their company whether their company does own IPRs which are, or are likely to
become Essential in respect of the work of the Technical Body,
• to notify to the Chairman or to the ETSI Director-General all potential IPRs that their company
may own, by means of the IPR Information Statement and the Licensing Declaration forms that
Members are encouraged to make general IPR undertakings/declarations that they will make licenses
available for all their IPRs under FRAND terms and conditions related to a specific standardisation area
and then, as soon as feasible, provide (or refine) detailed disclosures.
In accordance with Clause 4.1 of the ETSI IPR Policy the Declarant and/or its AFFILIATES hereby informs
ETSI that with reference to ETSI Project(s) 3GPP, GERAN, LTE, the Declarant hereby irrevocably declares
that it and its AFFILIATES are prepared to grant irrevocable licenses under its/their IPR(s) on
terms and conditions which are in accordance with Clause 6.1 of the ETSI IPR Policy, in respect
of the STANDARD(S), TECHNICAL SPECIFICATION(S), or the ETSI Project(s), as identified above, to the
extent that the IPR(s) are or become, and remain ESSENTIAL to practice that/those
STANDARD(S) or TECHNICAL SPECIFICATION(S) or, as applicable, any STANDARD or TECHNICAL
SPECIFICATION resulting from proposals or Work Items within the current scope of the above identified
ETSI Project(s), for the field of use of practice of such STANDARD or TECHNICAL SPECIFICATION.
The SIGNATORY has notified ETSI that it is the proprietor of the above listed IPRs and has informed ETSI
that it believes that the IPRs may be considered ESSENTIAL to the Standards listed above. The
SIGNATORY and/or its AFFILIATES hereby declare that they are prepared to grant irrevocable
licences under the IPRs on terms and conditions which are in accordance with Clause 6.1 of
the ETSI IPR Policy, in respect of the STANDARD, to the extent that the IPRs remain
ESSENTIAL.
The four profile previously identified represent the structure of the declaration for
companies. General declarations are represented in green, while specific
declarations are represented in orange. Note that the timeframe used for the
graphical representation starts in 2007, as none of the selected companies
submitted a SD or GD before that year.
Profile 1 – GD only
Company A
1,5
1
0,5
0
2008-Q4
2013-Q3
2007-Q1
2007-Q2
2007-Q3
2007-Q4
2008-Q1
2008-Q2
2008-Q3
2009-Q1
2009-Q2
2009-Q3
2009-Q4
2010-Q1
2010-Q2
2010-Q3
2010-Q4
2011-Q1
2011-Q2
2011-Q3
2011-Q4
2012-Q1
2012-Q2
2012-Q3
2012-Q4
2013-Q1
2013-Q2
2013-Q4
2014-Q1
2014-Q2
2014-Q3
2014-Q4
0
1
2
3
4
0,5
2,5
0,5
0,5
1,5
2,5
1,5
1,5
0
1
2
0
1
1,5
0
1
2
0,5
2,5
0
1
2
2007-Q1 2007-Q1
2007-Q1 2007-Q1 2007-Q1 2007-Q1
2007-Q2 2007-Q2
23/04/2015
2007-Q2 2007-Q2 2007-Q2 2007-Q2
2007-Q3 2007-Q3
2007-Q3 2007-Q3 2007-Q3 2007-Q3
2007-Q4 2007-Q4
2007-Q4 2007-Q4 2007-Q4 2007-Q4
2008-Q1 2008-Q1
2008-Q1 2008-Q1 2008-Q1 2008-Q1
2008-Q2 2008-Q2
2008-Q2 2008-Q2 2008-Q2 2008-Q2
2008-Q3 2008-Q3
2008-Q3 2008-Q3 2008-Q3 2008-Q3
2008-Q4 2008-Q4
2008-Q4 2008-Q4 2008-Q4 2008-Q4
2009-Q1 2009-Q1
2009-Q1 2009-Q1 2009-Q1 2009-Q1
2009-Q2 2009-Q2
2009-Q2 2009-Q2 2009-Q2 2009-Q2
2009-Q3 2009-Q3
2009-Q3 2009-Q3 2009-Q3 2009-Q3
2009-Q4 2009-Q4
2009-Q4 2009-Q4 2009-Q4 2009-Q4
2010-Q1 2010-Q1
2010-Q1 2010-Q1 2010-Q1 2010-Q1
2010-Q2 2010-Q2 2010-Q2 2010-Q2 2010-Q2 2010-Q2
2010-Q3 2010-Q3 2010-Q3 2010-Q3 2010-Q3 2010-Q3
2010-Q4 2010-Q4 2010-Q4 2010-Q4 2010-Q4 2010-Q4
2011-Q1 2011-Q1 2011-Q1 2011-Q1 2011-Q1 2011-Q1
Company F
Company E
Company C
Company B
Company D
Company G
2011-Q2 2011-Q2 2011-Q2 2011-Q2 2011-Q2 2011-Q2
2011-Q3 2011-Q3 2011-Q3 2011-Q3 2011-Q3 2011-Q3
2011-Q4 2011-Q4 2011-Q4 2011-Q4 2011-Q4 2011-Q4
Page 98 of 199
2014-Q2 2014-Q2 2014-Q2 2014-Q2 2014-Q2 2014-Q2
2014-Q3 2014-Q3 2014-Q3 2014-Q3 2014-Q3 2014-Q3
2014-Q4 2014-Q4 2014-Q4 2014-Q4 2014-Q4 2014-Q4
Company H
5
4
3
2
1
0
2007-Q1
2008-Q3
2010-Q1
2007-Q2
2007-Q3
2007-Q4
2008-Q1
2008-Q2
2008-Q4
2009-Q1
2009-Q2
2009-Q3
2009-Q4
2010-Q2
2010-Q3
2010-Q4
2011-Q1
2011-Q2
2011-Q3
2011-Q4
2012-Q1
2012-Q2
2012-Q3
2012-Q4
2013-Q1
2013-Q2
2013-Q3
2013-Q4
2014-Q1
2014-Q2
2014-Q3
2014-Q4
Profile 4 – No GD
Company I
10
8
6
4
2
0
2013-Q4
2007-Q1
2007-Q2
2007-Q3
2007-Q4
2008-Q1
2008-Q2
2008-Q3
2008-Q4
2009-Q1
2009-Q2
2009-Q3
2009-Q4
2010-Q1
2010-Q2
2010-Q3
2010-Q4
2011-Q1
2011-Q2
2011-Q3
2011-Q4
2012-Q1
2012-Q2
2012-Q3
2012-Q4
2013-Q1
2013-Q2
2013-Q3
2014-Q1
2014-Q2
2014-Q3
2014-Q4
Company J
5
4
3
2
1
0
2008-Q2
2009-Q4
2011-Q2
2007-Q1
2007-Q2
2007-Q3
2007-Q4
2008-Q1
2008-Q3
2008-Q4
2009-Q1
2009-Q2
2009-Q3
2010-Q1
2010-Q2
2010-Q3
2010-Q4
2011-Q1
2011-Q3
2011-Q4
2012-Q1
2012-Q2
2012-Q3
2012-Q4
2013-Q1
2013-Q2
2013-Q3
2013-Q4
2014-Q1
2014-Q2
2014-Q3
2014-Q4
Company K
4
3
2
1
0
2007-Q1
2008-Q3
2010-Q1
2007-Q2
2007-Q3
2007-Q4
2008-Q1
2008-Q2
2008-Q4
2009-Q1
2009-Q2
2009-Q3
2009-Q4
2010-Q2
2010-Q3
2010-Q4
2011-Q1
2011-Q2
2011-Q3
2011-Q4
2012-Q1
2012-Q2
2012-Q3
2012-Q4
2013-Q1
2013-Q2
2013-Q3
2013-Q4
2014-Q1
2014-Q2
2014-Q3
2014-Q4
Category Number of
interviewees/contributors
European Commission 4
European standardisation organisations 2
Industry or industry representatives 4
European Patent Office 1
Legal basis
This case study is based on Art. 5 of Regulation (EU) No 1025/2012. This article is
dedicated to defining “Stakeholder participation in European standardisation”. The
first part of the Article highlights the importance of appropriate representation and
effective participation of all relevant stakeholders’ and underlines the need for the
European standardisation organisations to support this participation in:
The Annex III of the same Regulation identifies four specific categories of
stakeholder interests that should be included:
Interests of Consumers;
Environmental interests;
Social interests.
This case study is dedicated to the stakeholders’ access to and participation in the
standardisation process, with focus on ESOs activities. This case is therefore mainly
related to the strategic objective “inclusiveness”.
“For stakeholders identified by Annex III of Regulation (EU) 1025/2012, what are
the issues encountered harming their participation in the standardisation
development process?”
As agreed with the Commission, the case will focus on the issues identified by
Annex III organisations, being the following:
Context
The need for “standards” (in a broad way) initially came from industry, as
standards are dedicated to ensuring a “common way of doing something” (e.g.
interoperability, performance) and therefore allow different economic actors to
collaborate, using a common reference.
The British Standards Institution (BSI) was the first national standards body in
1901. The International Electrotechnical Commission (IEC) followed in 1906 and the
International Organisation for Standardisation (ISO) in 1947. In the early 1960s,
CEN and CENELEC emerged, essentially to facilitate the application of international
(ISO or IEC) standards at the European level. ETSI was created in the late 1980s as
a dedicated European Standardisation Organisation in the field of telecoms (later
ICT).
With the New Approach of 1985, European standards started being used for
supporting legislation, by translating in technical terms the general concepts of the
New Approach Directives, and achieving a homogeneous standardisation at
European level.
81
World Trade Report 2012. Trade and public policies: A closer look at non-tariff measures in the 21st
century, p. 211.
SMEs have a particular position as they are producers and users of standards, and
have a predominant position in all sectors of the European economy. Their
insufficient participation is not necessarily referred to lack of expertise, but rather
to structural difficulties (resources, time) and their distorted weight in comparison
with big companies, already dominating the standardisation process.
Based on the new legislation, a call for proposals (according to the provisions of
Regulation 1025/2012) was issued 83 and four organisations selected for
representing, at a European level, the four categories of interests identified in the
Annex III of the Regulation (EU) 1025/2012:
82
Report of the Expert Panel for the Review of the European Standardisation System (EXPRESS):
Standardisation for a competitive and innovative Europe – a vision for 2020, p. 28.
83
European Commission (2014). “Call for tender for “Representation of environmental interests,
consumer interests and social interests in European standardisation”” on 16/09/2014.
Available:
http://ec.europa.eu/enterprise/newsroom/cf/itemdetail.cfm?item_id=7688&lang=fr&title=Representatio
n-of-environmental-interests%2C-consumer-interests-and-social-interests-in-European-standardisation.
84
It should be noted that, until the end of 2014, the ETUI has represented the “social interests” in the
ESS. The transition has been performed to ETUC in 2015.
85
Annex III organisations represent underrepresented actors in standardisation activities, but including
millions of consumers, workers and citizens with environmental concerns, as well as SMEs accounting for
99,8% of all businesses.
Within CEN and CENELEC, Annex III organisations may therefore participate in the
consultation stages of the standard development process. This includes
participation in drafting activities, and submission of comments during the enquiry
stage. Since 2013, the CEN-CENELEC Internal Regulations Part 2 have sought to
have the Partner Organisations –including Annex III organisations- as part of the
consensus underpinning the decisions of a Technical Committee at key stages in the
development of an EN. However, the votes are based on national delegation, and
Partner Organisations do not have a vote (or veto) in these decisions.
The rights of Partner Organisations include the right to appeal 86 on technical bodies
decisions. However, the internal regulations foresee that Partner Organisations can
appeal against standards only if they contributed to its development. In April and
May 2014, the CEN BT and the CENELEC BT respectively voted accordingly to limit
the right of appeal for partners. These decisions are operational from 1/01/2015 for
CEN and 1/05/2015 for CENELEC.
ETSI does not foresee specific guidelines for the participation of Annex III
organisations.
Based on the direct membership approach of ETSI, all Annex III organisations have
the possibility to participate as full members of ETSI, similarly to all other ETSI
members. Upon registration as full member –and payment of the related fees-,
Annex III organisations have full access to the meeting of ETSI’s technical bodies
and have a voting right (corresponding to their size and level of the financial
participation in ETSI).
In the current situation, ANEC and SBS are involved in ETSI work and are full
members of ETSI. Based on the evolution of standardisation needs, and the
increased digital-enabling of the economy, the involvement of the other Annex III
organisations might increase in the next years.
86
The appeal mechanism allows CEN/CENELEC members and partner organisations to react to an action
–or inaction- considered as inappropriate, and can e.g. lead –in case of successful appeal- to non-
publication of a document. The appeal policy is accurately defined in CEN-CENELEC Internal Regulations
Part 2, in clause 7.
According to the contents of the clause, Annex III organisations are eligible for
“Category A Liaison”, as they are:
Not-for-profit;
Legal entities;
Membership-based and open to members worldwide or over a broad region;
Competent in their field of expertise and can therefore contribute to
standards development;
Based on stakeholder engagement and consensus decision-making.
For the ISO-IEC TCs with which they have a “Category A Liaison”, Annex III
organisations are granted access to all documentation and are invited to TC
meetings. Annex III organisations may also nominate experts for participating in
working groups.
In the past, the four categories of interests were managed in different ways:
SMEs’ interests were managed by the SME unit within the Directorate-
General for Enterprise and Industry (ENTR);
Consumers’ interests were managed by the Directorate-General for Health
and Consumers (SANCO), initially directly and, more recently through an
agency;
Environmental interests were managed by the Directorate-General for
Environment (ENV);
Social interests were managed by the Directorate-General for Employment,
Social Affairs and Inclusion (EMPL).
The new Regulation foresees that the Commission may provide a financial support
to Annex III organisations, as described in Art. 16 and Art. 17 of the Regulation.
This is managed by DG Internal Market, Industry, Entrepreneurship and SMEs
(GROW).
The relationship between Annex III organisations and the European Commission is
based on Framework Partnership Agreements (FPAs), which were granted following
specific calls for proposal. These FPAs formalise the partnership between the
European Commission and the Annex III organisations by defining the common
objectives, the underlying actions, the procedure for grant allocation and the
general rights and obligations of each party. These FPAs are established for ANEC,
ECOS and ETUC for a duration of 4 years, with a possibility of extension of 2 years;
and for SBS for a duration of 3 years, with a possibility of extension of 1 year 87.
Based on the FPAs, and based on the annual work programmes and budgets
submitted by the Annex III organisations, the Commission may award annual
87
Differences in the timing of the FPAs might come from a non-simultaneous launch of call for proposals,
resulting in different FPA conditions.
In addition to the OGs, action grants might be awarded to the Annex III
organisations for the fulfilment of specific activities.
The new Regulation also foresees that the Annex III organisations should report on
a yearly basis to the Commission about the fulfilment of the activities highlighted in
Art. 16 of the Regulation, as foreseen in Art. 24(2) of the same Regulation.
The analysis presented in the next paragraphs takes into account the points
outlined in the coordination meetings between Annex III organisations and the
European Commission, which took place on March and June 2014, and the results
of a workshop organised by EY and involving representatives of the Annex III
organisations.
One of the key principles of waste management is the waste hierarchy: generation
23/04/2015 Page 106 of 199
of waste should be prevented, and then re-used, recycled, recovered or finally
disposed88. One of the options is to process the waste into Solid Recovered Fuel
(SRF), which can be used afterwards by providing calorific energy 89.
In 2002, the Commission mandated CEN for the development of standards (first
technical specifications, then standards) concerning the use of SRF.
1) ECOS’s views were not taken into account during the drafting of the
standard, which demonstrates a difficult position for Annex III when
participating in standard development. Moreover, independently from not
being taken into account, the comments from ECOS initially did not benefit
from awareness nor of a formal recognition;
2) The appeal procedure has not triggered any change in the standard. It has
to be noted that the process did not involve independent parties in the
process and left the responsibility back to the TC to decide how to treat the
issue90;
3) The appeal mechanism allowed ECOS to raise awareness about the case
and, even though no changes were made in the standard, it can be assumed
that additional effort has been put in the analysis of their recommendations;
4) This case is one of the rare cases where the appeal procedure was used, and
none of the appeals made by Annex III organisations succeeded 91.
88
ERFO, „Information Document on EN15359 "Solid Recovered Fuels - Specifications and Classes"”.
89
ERFO, „Information Document on EN15359 "Solid Recovered Fuels - Specifications and Classes"”.
90
It has to be noted that the functioning of the appeal mechanism has changed since.
91
Based on Annex III organisation data, it appears that, in the last 10 years, only 6 appeals were
initiated by the organisations currently recognised by the Annex III of the Regulation (EU) No
1025/2012.
Other comments
92
Within working groups, these experts can express their views in the same way and no vote is
performed in WGs.
93
Vienna Agreement Guidelines, 6th edition (2014), p. 9.
An example of this issue was highlighted with the IEC TC 34 about “Lamp and
related equipment”. ECOS was interested in participating in the activities performed
by the TC, as the IEC standards being developed were supposed to be brought to
Europe and were related to standardisation matters of interest for citizens,
industry, regulators and the environment. However, ECOS has not been considered
by the TC committee as relevant for participating in this standardisation work,
despite the experience and expertise of ECOS in energy efficiency matters and the
potential contribution ECOS could have therefore brought expertise to the standard.
The requested “Liaison A” was therefore not granted to ECOS on grounds that there
was a need to limit the number of delegations involved in one case, and on ground
that ECOS was not an international organisation in the other case (independently
from ECOS being open to international membership and having a broad geographic
coverage, as requested in IEC rules).
94
This position should however be balanced with the need for standards supporting legislation to be
quickly available, when standards are needed at the same time than the entry into force of the
legislation.
Conclusions
The legal basis for Annex III organisations introduced by the Regulation (EU) No
1025/2012 foresees that the interests of weaker stakeholders should be effectively
represented at European level, by specific representatives.
In order to ensure the right representation, these Annex III organisations should be
put in a position of effectively ensuring that the views of their members and the
interests they represent are expressed and taken into account in standardisation.
However, some obstacles have been identified as harming this representation in
European standardisation.
The comments above support the possibility to act in the following areas:
Due to the increased importance of standards including in the current policy context
and European economic system, and the impact they have on the whole society,
there is a strong need for European stakeholder representatives to have the right to
effectively participate in standardisation at European level and to efficiently express
and defend the rights they represent, even though these stakeholders should also
defend their rights at national level, where possible.
95
From: http://www.etsi.org/membership/current-members
The fact that the internal practices of the Technical Committees are based on their
secretariat NSBs’ national practices adds complexity to the way the system is
working, and does not facilitate the participation of stakeholders, especially
underrepresented ones.
These guidelines should also be developed for ensuring the facilitated participation
of Annex III organisations in TC/WG work, highlighting their role –as understood by
the new Regulation- and avoiding burdens generated by different national practices
(e.g. fees for participation in a TC, or limited size for participation in a TC/WG). This
should also be supported by further training of standardisers about standardisation
practices and the role and importance of having societal stakeholders and SMEs
being represented.
Based on the findings on the case study dedicated to “Research and Innovation”, it
appears that key decisions can be made during the stage occurring before the
formal start of standard development.
Finally, Annex III Organisations have also expressed their strong interest in
accreditation and certification processes, as these activities contribute to the
strength of European and international standards.
The current rights granted to Annex III organisations lead to restricted participation
during the formal vote (within CEN-CENELEC, as they have no voting right; in ETSI,
as they have a very limited weight). A possibility to be further studied would be to
grant them a separate “right of opinion”, which would trigger some mechanisms
within the ESOs. One of the possible materialisation of this “right of opinion”
would be that, in case a standard is published after a negative opinion from the
Annex III organisation, the foreword of the standard should be adapted to indicate
the negative opinion and reference the reason for this assessment 96.
In more details, the following elements could characterise the voting rights97:
each Annex III organisation would have the right to submit a vote/opinion
during the Enquiry (or Formal Vote if used) stating whether it accepts the
draft standard as an EN. This period for “voting” would be simultaneous with
the vote of the CEN-CENELEC national members (or the ETSI NSOs);
the votes/opinions of the Annex III organisations would appear in the same
voting report as that used for the result of the national weighted vote;
96
Such a method is already applied for CWA when a party does not agree with the final decision.
97
Based on suggestions of Annex III organizations. Being this a significant change in the current system,
the potential impacts of these voting rights should be further assessed.
List of interviewees
Category Number of
interviewees/contributors
Annex III organisations 6
European Commission 1
ESOs 2
NSBs 2
Art. 10.1 of the Regulation defines the provisions under which the Commission may
request European standardisation organisations to develop standards supporting
Union legislation and policies. The request submitted is referred to as
“standardisation request” in the Regulation and was previously called “mandate”.
Art. 10 then refers to Art. 22 of the same Regulation. This article foresees that the
Commission should be assisted by a Committee (called “Committee on Standards”
or “Comitology Committee”), as described in Regulation (EU) No 182/2011, which
should be consulted before adopting a standardisation request.
The above mentioned pieces of legislation define the scope of this case study, which
analyses the mandating process. This case integrates all the steps performed
during the elaboration of the standardisation request, from the identification of the
standardisation need, until the submission of the standardisation request to the
ESOs.
As agreed with the Commission, the case focuses on the following aspects:
Speed – “Is the elaboration of the standardisation request fast enough, and
are the requests submitted to the ESOs in a timely manner?”;
Market relevance – “Do the standards, developed upon request from the
Commission, respond to market needs?”.
Context
Informal
Examination
Union Work First draft of consultation Inter-service Adoption and Submission to
procedure
Programme the mandate of consultation signature the ESOs
(COS)
stakeholders
This new process98 has the following differences with the previous one:
- The Commission must inform on its plans to issue requests in the
annual Union Work programme (Art. 8 of Regulation (EU)
1025/2012).
- The Commission must informally consult the ESOs, Annex III
organisations and sectorial Committees and expert groups during
preparation of a request (Art. 10(2) or Regulation (EU) 1025/2012)
- The Art. 12.b of Regulation (EU) 1025/2012 foresees that the
Commission should inform all stakeholders about the requests before
it adopts them.
- A Committee on Standards is set up by Art. 22 of Regulation (EU)
1025/2012. It is a Comitology Committee, with the meaning of
Regulation (EU) 182/2011 and assisting the Commission. One of the
tasks of this Committee is to provide an opinion about draft requests
(cf. next bullet point).
- In parallel with the creation of this Committee on Standards, and as
the Comitology procedure only applies to Implementing Acts, the
legal form of a request was changed to an “Implementing Act” (a
“Commission Implementing Decision). The submission of requests to
the ESOs is therefore preceded by an examination procedure of the
Comitology Committee.
98
Doc.: 05/2013 EN – Adaptation of the mandating process to the Regulation (EU) 1025/2012.
The Art. 291 of the TFEU identifies that, “where uniform conditions for
implementing legally binding Union acts are needed, those acts shall confer
implementing powers on the Commission […]”.
The Comitology100 rules identifies two different procedures for controlling the
Commission’s use of its implementing power (as defined in the above-
mentioned Art. 291 of the TFEU): the examination procedure, explained
further; and the advisory procedure, out of scope for this study. The
examination procedure (used within the European standardisation system,
e.g. when preparing standardisation requests) “applies to measures of
general scope and specific measures with a potentially important impact
[…]”101. Through this examination procedure, a Committee of Member
States’ representatives provide a binding opinion on draft Commission
Implementing Acts.
More generally, the Comitology procedure is to be framed in the overall
context of the mechanisms for transparency and coordination established by
the Regulation 1025/2012, and providing for the broad involvement and
consultation of relevant stakeholders, including European standardisation
organisations and European stakeholder organisations, in the adoption of the
annual Union work programme, the adoption of requests, and other relevant
decisions102.
Case selected
Considering the fact that the new Regulation became applicable as of January 1st,
2013, and the average time needed to prepare a mandate, only a few mandates
went through the mandating process. As agreed with the Commission, this Case
Study will use as an example the draft request on eInvoicing. This mandate103 was
submitted to the ESOs on 11/12/2014.
Through this standardisation request, the Commission will –through the formal
submission of the mandate to the ESOs- request the ESOs to develop a European
standard on electronic invoicing and a set of ancillary standardisation deliverables,
in order to comply with the provisions of Directive 2014/55/EU 104 on electronic
invoicing in public procurement.
99
Article 290 of TFEU, dedicated to delegated acts, is out of scope for this study.
100
European Policy Centre (2011). Implementing Lisbon: what’s new in comitology?
101
Council of the European Union (2011). Factsheet – Entry into force of new comitology rules.
102
See the reference to the Comitology procedure in art. 8, 10 (2) and the notification system in art. 12.
103
[DRAFT] Commission Implementing Decision of XXX on a standardisation request to the European
standardisation organisations as regards a European standard on electronic invoicing and a set of
ancillary standardisation deliverables pursuant to Regulation (EU) No 1025/2012 of the European
Parliament and of the Council.
104
Directive 2014/55/EU of the European Parliament and of the Council of 16 April 2014 on electronic
invoicing in public procurement.
Second, the directive establishes the obligation for all public entities to
receive and process eInvoices which comply with the European standard and
that make use of any of the syntaxes that will be listed in a CEN Technical
Specification.
This directive and the development of the underlying standard are in line with the
logic to dematerialize invoicing flows, in the field of public procurement. First, this
aims at harmonising the semantic of eInvoicing data models and therefore at
removing market barriers and obstacle to trade caused by the existence of different
eInvoicing standards. Second, this promotes eInvoicing and therefore leads to cost
savings and reduction of related administrative burdens.
Data collection
The information used in this case study has been collected during different
interviews and conference calls. The purpose of these calls were to develop an
assessment of the process based on practical involvement, and to provide real life
examples of potential issues encountered. The people list of people interview is
available at the end of the case. In addition to these interviews, information
collected during the first phase of the project through preliminary interviews with
different stakeholders was used. Finally, our understanding of the process and
underlying issues have been confirmed during the Meeting on Vademecum on
European standardisation, on October 14th, 2014.
Comments on speed
The eInvoicing case is a very specific case with regard to speed: the negotiation of
the directive and the development of the related standard were performed in
parallel. This comes from the short timeframe between the development of the
directive and its entry into force.
The need for eInvoicing standardisation has been mentioned in the UWP for years
2014 and 2015, and in the Annual European standardisation work programme
published in 2012. However, actual reference to a potential standardisation request
is made in the UWP for year 2014, published on 31.07.2013.
The figure below represents some of the main milestones related to the eInvoicing
request: some of them are legislative milestones; some others are milestones of
the mandating process; and finally milestones related to the preparation for
standard development105.
105
The list of milestones collected is available in annex. Note that the milestones are represented
independently from the responsible stakeholder, and are only categorized depending on their role in the
“legislative work”, “mandating process” and “preparation for development”.
2013 2014
M J J A S O N D J F M A M J J A S O
Legislative work
Mandating process
Preparation for development
The average time for development of standardisation requests under the previous
regime –from the identification of the need, until the submission to the ESOs- is
364 days (with standard deviation of 180 days)106. The timeframe for this request is
a bit longer (as the standardisation need is assumed to be identified on 21.6.2013
and considering the fact that the final version of the request has been submitted on
11.12.2014 to the ESOs).
We consider below the 9 standardisation requests which have been developed after
the implementation of the new regulation107. These standardisation requests were
submitted to the ESOs after an average of 500 days after the first contact between
the standardisation unit and the interested unit (standard deviation of 78 days).
106
This data has been computed based Commission data. The values correspond to the timeframe
elapsed between the milestones “first contact with ENTR.B5” and “submission to ESOs”. The sample is
composed of 25 mandates, from M/501 to M/525, being the latest mandate developed prior to
implementation of the new Regulation.
107
Based on statistics received on 8/1/2015.
Note: the notification date for mandates mentioned with a (*) was note available . The notification date has therefore
been extrapolated, based on the date of the Committee of Standards (or deadline for the COS vote). In these cases,
the notification date is considered to be equal to the vote deadline (or Commitee date) + 21 days.
Comments on formalisation
As explained earlier, the formalisation can be considered in two different ways: the
formalisation of the process, and the formalisation of the requests.
108
The Vademecum on European standardisation is a guidance document supporting Commission official,
Member States and other stakeholders. It provides guidelines for the use of European standardisation as
a tool for supporting EU policies and legislation, and aims at ensuring a common understanding of EC
mechanisms and practices. Its different sections are available on the following webpage:
http://ec.europa.eu/enterprise/policies/european-standards/documents/vademecum/index_en.htm .
Formalisation of the mandates: the eInvoicing mandate is perceived as a
good example for a formalised mandate, as it clearly identifies what
standardisation needs are requested and in what timeframe (compliant with
Art. 10(1) of the Regulation). However, among the first standardisation
requests having gone through the process, an exception was noticed: i.e.
the standardisation request related to Climate Change.
Comments on transparency
Different consultation and information stages occur during the process. In addition
to ensuring a good quality request, the following events contribute to the
transparency of the process:
109
No quantitative information was gathered about this comment, and it is also understood that this
comment does not make a distinction between old and new mandates.
110
Doc.: 03/2013 EN – Notification system pursuant to Article 12 of the Regulation 1025/2012.
From a general perspective, it understood that the market should have an interest
in having harmonised standards. However, it seems that the market is against a
restriction of the scope of requests, as suggested by Art. 10(1), and the related
additional bureaucracy. The two major comments about this are the following:
First, some actors believe the process leading to the development and
publication in the OJEU of harmonised standards could have other triggers
than the Commission. In the past, stakeholders could trigger the
development –and then publication in the OJEU- of harmonised standards,
under the frame of an existing programming mandate.
Second, even though the need for speed is clearly identified in the
Communication COM(2011)311 final, the accurate definition of deadlines is
against the will of various actors, as the time required for reaching a
consensus in incompressible and the timeframe for development of each
standard is inherent to the standard in itself.
With a more detailed approach, defining the market relevance of the requests
submitted is a difficult exercise. A true indication of market relevance could only
come from information about the diffusion and use of the standards developed
upon Commission request, data not currently available.
However, it can be assumed that a mandate submitted to the ESOs after a very
transparent process would ensure its market relevance, as the different
stakeholders would have good possibilities to comment on the requested standards
and ensure their alignment with the market.
Some interviewees indicated that, in the case of a fully efficient system, after the
identification of policy related standardisation needs, the industry would
spontaneously trigger the standardisation process, without the need for a
standardisation request from the EC. For that reason, it was suggested that the
Commission should not develop and submit requests related to policy needs. The
Conclusions
Based on the qualitative and quantitative data used (mainly based on the
eInvoicing request, cf. 3.3.1 about potential extension of dataset), we conclude
that, despite the fact that the efficiency of the process seems to vary from a
standardisation request to another:
The speed of the new requests seems to be lower than for the mandates
developed under the old regulation. Independently from being related to the
internal adaptation to change, it also has to be noted that the practice of
parallel legal/request elaboration/standardisation work used for eInvoicing
process actually accelerates the start of the development;
Moreover, the new regulation induces many changes and there is a need to ensure
that the position of the Commission and the new standardisation packages are
understood in a similar way. In the same logic, the process for elaboration of
requests should be well-known by all, being internal Commission staff or external
stakeholders.
The new legislation induced many new changes in issuing standardisation requests
and it is understandable that some actors involved in the system –especially those
involved for a long time- do not see all changes reasonable. For that reason, it is of
crucial importance that the Commission explains its objectives, position and role
within the standardisation system, including the role of standardisation
requests under the new Regulation.
Moreover, having a coherent process for elaboration of the request and summarised
guidelines available to all stakeholders would increase the transparency of the
process. This would facilitate stakeholders’ contribution or participation in the
process (inclusiveness) and their anticipation of Commission activities (speed).
The Commission is currently performing these tasks 111 through the drafting of a
revised Vademecum on European standardisation, in cooperation with other
stakeholders. We highlight here the need for having support from stakeholders, as
the European standardisation is market driven.
We noticed that information regarding the process for elaboration of requests is not
easily available to interested parties, with regards to the procedures (cf. previous
recommendation) or to the (draft) requests.
Validation through other cases: this case study was performed on the
basis of the eInvoicing request and using general information available. This
document should therefore be confronted against other standardisation
requests, related to other sectors. Moreover, the conclusions and
recommendations presented are based on an analysis performed at a very
early stage of the existence of the new standardisation package and the
“running-in” period of this package is not over yet.
111
European Commission (2014). “Draft Vademecum on European standardisation – Parts I to III”
[slides version of 20.6.2014].
5.5.4 Appendix
4.5 eProcurement/eCatalogues
Electronic procurement offers considerable scope to achieve efficiency savings and faster procurement
procedures. The Commission aims to make online and crossborder eProcurement straightforward by
facilitating the emergence of an interoperable European framework, building where possible on common
European standards. Standardisation work already under way may need to be reinforced or completed
through specific actions.
eCatalogues are used by suppliers to offer for sale goods or services and by contracting authorities to
obtain product or pricing details, to source and purchase them. They are a component of both the
tendering (pre-award) and the purchasing (post-award) eProcurement processes.
The lack of a standard definition of eCatalogues across the EU is one of the obstacles that enterprises –
especially SMEs – face when trying to carry out cross-border public eProcurement transactions.
Standards should help, and make eProcurement more efficient by taking account of ongoing EU projects
such as PEPPOL17.
4.6. eInvoicing
Electronic invoicing, the process by which invoices are sent and stored by electronic means, brings
multiple benefits to enterprises. The Commission aims to make online and cross border transactions
straightforward, by ensuring the completion of the Single Euro Payments Area (SEPA) and by facilitating
the emergence of an interoperable European e-invoicing framework.
To achieve this, the Commission wants to encourage all market actors, private and public, to converge
on solutions that are compliant with the UN/CEFACT Cross-Industry Invoice (CII) v.2 semantic data
model. Moreover, at the Commission’s request, CEN is supporting the development of a Code of Practice,
to analyse addressing and routing needs, and to design implementation guidelines.
2.4.4 eProcurement/eCatalogues
The lack of a common definition of eCatalogue across the EU and multiple classification schemes for
products and services are among the obstacles that enterprises – especially SMEs – face when trying to
carry out eProcurement transactions. To ensure consistent and holistic solutions, elements of both the
preaward and post-award phases should be further addressed by CEN, including their interfaces to
eInvoicing and payment solutions.
The Commission aims to make online transactions straightforward, by ensuring the completion of the
Single Euro Payments Area (SEPA) and by facilitating the emergence of an interoperable European
eInvoicing framework. The European multistakeholder Forum on eInvoicing is advising on specific
standardisation needs.
The Commission and CEN will assess the inputs to ensure that appropriate European standards are
available. Standards in the area of eInvoicing need to assure a linkage with relevant standards in
eProcurement and SEPA. Moreover, European and international standardisation bodies should pursue the
fast development of complementary eBusiness messages to improve the ability to exchange products
and services effectively.
List of interviewees
Category Number of
interviewees/contributors
European Commission (or agency) 2
ESOs 4
Member States 3
Industry or industry representatives 1
NSB 3
Time Event
06.2013 Proposal of directive
21.06.2013 “First contact with B5 (as recorded in B5 database)
26.09.2013 First mandate meeting
12.2013 Launch of stakeholder consultation
04.2014 Directive 2014/55/EU available
06.05.2014 Creation of CEN project committee on electronic invoicing (PC 434)
06.05.2014 Directive 2014/55/EU published
27.05.2014 Draft mandate sent to ISC
13.06.2014 ISC acceptance
08.2014 Mandate available in the tree requested languages (EN, FR and DE)
09.2014 Launch of the written examination procedure of the COS
09.09.2014 First plenary meeting of PC 434112
10.12.2014 IA adoption
11.12.2014 Notification to the ESOs
112
CEN/PC 434 Electronig Invoicing N001 – Calling notice for the first plenary meeting of CEN/PC 434
Electronic Invoicing on 9 September 2014, at CEN-CENELEC Meeting Centre, Brussels.
Legal basis
“What are the mechanisms which ensure a smooth cooperation between the ESOs
and other entities involved in standardisation?”.
The case study is focused on the standards developed for Cooperative Intelligent
Transport System (C-ITS) and the analysis also considers the possibility to
transpose the coordination mechanisms implemented for the C-ITS to other
standardisation fields.
Context
113
It should be noted that CEN also develops ICT standards, depending on the area of competence.
The example selected for the analysis of this case study is “Intelligent
Transportation System (ITS), with a focus on “Cooperative ITS”, as defined in the
scope of the mandate M/453.
Source: ETSI.
Cooperative ITS (or C-ITS) is a subset of ITS which corresponds to the part of
ITS that communicates and shares information between ITS entities (also
called “stations”). Depending on the stations used for treating information, the
communication will fall in one of the following categories:
114
European Commission (2009). “Standardisation mandate addressed to CEN, CENELEC and ETSI in the
field of Information and Commmunication Technologies to support the interoperability of Co-operative
systems for Intelligent Transport in the European Community”, Brussels.
115
European Commission, Action Plan for the Deployment of Intelligent Transport Systems in Europe.
116
Evensen, K. and Csepinkszky, A. (2013). iMobility Support - D3.5a - Standardisation handbook.
117
European Commission, Action Plan for the Deployment of Intelligent Transport Systems in Europe.
118
CEN and ETSI (2010). “Joint CEN and ETSI Response to Mandate M/453”.
119
Evensen, K. and Csepinkszky, A. (2013). iMobility Support - D3.5a - Standardisation handbook.
120
European Commission, Action Plan for the Deployment of Intelligent Transport Systems in Europe.
121
Evensen, K. and Csepinkszky, A. (2013). iMobility Support - D3.5a - Standardisation handbook.
122
CEN and ETSI (2010). “Joint CEN and ETSI Response to Mandate M/453”.
123
As an example, some vehicles are currently enabled with “frontal collision warning” systems, which
warn the driver in case of potential collision with another vehicle. This functionality is currently based on
sensors which detects the existence of an obstacle in front of the car. The efficiency of this system is
Various actions and initiatives have been undertaken at EU level for promoting C-
ITS. One of these is a Commission request to the ESOs for the development
of a set of standards to support EU-wide implementation of Co-operative
ITS, i.e. the Mandate M/453124.This standardisation request is focused on the
development of standards ensuring the deployment and interoperability of co-
operative systems, in particular those operating in the 5Ghz frequency –and aligned
with the “Commission Decision of 5 August 2008 on the harmonised use of radio
spectrum […] for safety-related applications of [ITS]”.
The standardisation activities are targeted at covering the whole C-ITS architecture,
and therefore induce standardisation work in the following categories 126:
Case complexity
however limited, e.g. by the positioning of sensors. With co-operative system, vehicles would
communicate their positioning, speed and trajectory to their surroundings, and collisions could be
detected and prevented much more easily: the elements composing the road ecosystem communicate
information about themselves and the extrapolation of data is reduced.
124
European Commission (2009). “Standardisation mandate addressed to CEN, CENELEC and ETSI in the
field of Information and Commmunication Technologies to support the interoperability of Co-operative
systems for Intelligent Transport in the European Community”, Brussels.
125
European Commission (2009). “Standardisation mandate addressed to CEN, CENELEC and ETSI in the
field of Information and Commmunication Technologies to support the interoperability of Co-operative
systems for Intelligent Transport in the European Community”, Brussels.
126
Evensen, K. and Csepinkszky, A. (2013). iMobility Support - D3.5a - Standardisation handbook.
Case ecosystem
The mandate M/453 was addressed to all ESOs, and CEN and ETSI replied
positively to the mandate. The C-ITS standardisation work was affected to the
following Technical Committees, dedicated to ITS and responding to the Mandate
M/453:
ISO
ISO TC 211
ISO TC 22
ITU
ITU-T
ITU-R
127
CEN and ETSI (2010). “Joint CEN and ETSI Response to Mandate M/453”.
128
Evensen, K. and Csepinkszky, A. (2013). iMobility Support - D3.5a - Standardisation handbook.
SAE (mainly SAE J2735 is the standard US data set definition for ITS)
Finally, the right stakeholders, from different sectors, needed to be involved in the
standard development, which may be outside the usual participants in
standardisation activities:
129
COMeSafety, COMeSafety2, COOPERS, CVIS, Drive C2X, iCar Support, iMobility Suport, SAFESPOT,
Safety Pilot, SmartFreight, etc.
Data collection
The information used in this case study has been collected during different
interviews and conference calls. The list of people interviewed is available at the
end of this case study. In addition to these interviews, information collected during
the first phase of the project through preliminary interviews with different
stakeholders was used.
Following the EC Mandate M/453 issued in October 2009, CEN and ETSI provided
a joint response in April 2010, providing the work plan for the delivery of a
minimum set of standards on C-ITS, and the division of responsibilities among
ETSI and CEN.
The mandates placed the ESOs in front of two main issues: the development of a
significant number of ENs, technical specifications, guidelines and test specifications
in a short timeframe: the need for ensuring an extensive cooperation and liaison
with the European Industry, stakeholders from different sectors (from automotive
to road authorities), European and National R&D projects and international
cooperation130.
To speed up the process CEN and ETSI agreed on a procedural change aimed at
merging the public enquiry procedure with the voting procedure (i.e. the so-
called ENAP131). The Final report on the standardisation work for C-ITS was
submitted in July 2013, detailing the achievements during the Mandate period and
the plans for finalising the standards listed in the April 2010 response to the
Mandate. According to the report, a number of standards have been developed and
published as European Norms (EN) or Technical Specifications (TS) in the given
130
CEN and ETSI (2010). “Joint CEN and ETSI Response to Mandate M/453”.
131
CEN and ETSI (2013). “Final joint CEN/ETSI-Progress Report to the European Commission on
Mandate M/453”.
Focusing on the need for an extensive collaboration with existing entities and the
collaboration with all the stakeholders involved, several mechanisms were put in
place133. These are discussed in the next paragraphs.
132
However, a comparison between the requirements of the mandate and the deliverables of the Final
Report proves to be difficult, due to the complexity of the Mandate itself, and the changes occurred
during the development of the mandate. Therefore, quantifying to what extent the initial objectives of
the Mandate have been achieved is particularly challenging. This aspect is not considered to be focus of
the case study, more concerned with the cooperation mechanisms and the ecosystem created. In any
case, as consequence of the mandate, both ETSI and CEN have published the Release 1 of the standards
needed for the initial deployment of C-ITS.
133
CEN and ETSI (2010). “Joint CEN and ETSI Response to Mandate M/453”.
134
CEN and ETSI (2010). “Joint CEN and ETSI Response to Mandate M/453”.
Coordination at global level: coordination with SDOs, ISO and the EU-US
Task Force: as mentioned, in order to achieve ITS standards which are
applicable worldwide, it is important to take into account the standards
and technical specifications developed from other SDOs and to
establish a close cooperation during the development of European ITS
Standards.
To the purpose of standards development in the scope of the European
M/453, the cooperation was developed with several standardisation
organisations that produce standards relevant to ITS as part of their work:
IETF (Internet Engineering Task Force), IEEE (Institute of Electrical and
Electronics Engineers), SAE, and ISO/TC204 (Technical Committee on
Intelligent transport systems).
This cooperation included different forms and a complex system of relations:
- ETSI-ISO: ETSI leveraged on the close cooperation on standards
developments with ISO, including cross participation of ISO and ETSI
members in the relevant working groups (ISO working groups and
ETSI TC ITS), and the active exchange of information about
standardisation activities.
135
Such as COMeSafety and iMobilitySupports projects
136
Castrillejo, E. (2013). Presentation at the 5th ETSI ITS Workshop (Vienna 5/02/2013).
Conclusions
137
In particular, it was noted that the ETSI database on C-ITS offers the complete list of deliverables,
published and under draft. Deliverables (final or at the draft stage) are not made available by CEN.
However, this is strongly related to the different business and governance models adopted by the two
ESOs.
138
CEN and ETSI (2010). “Joint CEN and ETSI Response to Mandate M/453”.
The Art. 10.1 of the Regulation (EU) No 1025/2012 foresees that the Commission
may request European standardisation organisations to develop a
European standard or a European standardisation deliverable –or a set of
standards/deliverables- dedicated to support EU legislation or policies.
“The Commission may within the limitations of the competences laid down in the
Treaties, request one or several European standardisation organisations to draft a
European standard or European standardisation deliverable within a set deadline.
European standards and European standardisation deliverables shall be market-
driven, take into account the public interest as well as the policy objectives clearly
stated in the Commission’s request and based on consensus. The Commission shall
determine the requirements as to the content to be met by the requested document
and a deadline for its adoption.” (Art. 10.1 of Regulation(EU) No 1025/2012).
As described in Art. 10.5, the Commission shall assess, together with the ESOs,
the compliance of these documents with the initial request. For harmonised
standards, in case of compliance, the Commission should then publish the reference
of the standards in the Official Journal of the European Union.
On that basis, the central research question of this case study is the following.
“How compliance checks and related guidance can best contribute in developing
harmonised standards which correspond to legislative needs?”
Context
The standard must indicate –usually in an Annex- the essential or other legal
requirements it aims to cover141 (and when appropriate the ones it does not
cover) in order to allow a manufacturer to identify which essential
requirements of the directive he complies with (i.e. “presumption of
conformity” is conferred) when applying the harmonised standard.
It has to be noted that, although harmonised standards provide presumption
of conformity, they do not free the manufacturer from his liability but
reduce the likelihood of damage caused by incompliance of products. In
other words, harmonised standards do not replace the binding requirements
of legislation, but provide a technical solution for complying with it
(preferably reducing the cost of compliance with legislation, when internal
production control142 is applicable –see below). It also implies that the
139
The elaboration of the standardisation request is performed in another case study. It should also be
noted that “standardisation request” was called, prior to the implementation of Regulation (EU) No
1025/2012, a “mandate”.
140
Corresponding act of Union harmonisation legislation may also set other means to publish the
references. Those other means are excluded in this case study.
141
It should also differentiate the specifications of the standards which relate to essential requirements,
from the ones which are not related to essential requirements. This will be further detailed below.
142
“Module A” according to Decision No 786/2008/EC.
ESR 1 presumption
ESR 1 of conformity Harmonised standard (hEN) and
reference published in the OJEU
ESR 2
presumption ESR 1 covered
ESR 3 ESR 3 of conformity ESR 3 covered
Risk assessment
or equivalent
ESR 4
(by a
manufacturer)
ESR 5
ESR 6
Other specifications or direct
ESR 7 ESR 7
application
143
However, when it relates to court decisions, the presumption of conformity is not sufficient.
144
“How to draft European Standards for citation in the Official Journal / Annex Z – Examples”
This (draft) harmonised standard aims to cover the legal requirements and
. If this is the case and if a product/service is compliant with the
specifications [b] and [c] of the harmonised standards, it is assumed to
comply with legal requirements and of the directive after the references
of this harmonised standard are published in the OJEU.
It has to be noted that –in general- the Commission does not perform an
assessment of the technical content of the standard, as the Commission
does not take the responsibility for the technical content of the standard 145.
145
However, the Commission should pay attention to the quality of the submitted standards, and react in
the case inconsistencies, shortcomings or other issues. (see blue guide p. 36)
Case selected
This case study is based on the issues encountered in the gas appliances sector,
which were highlighted by various actors within the system.
Framework: the legislation for the gas appliance sector has been
harmonised at a European level, ensuring free movement and safety of
gas appliances (from simple portable cookers to boilers for big buildings).
The gas appliance sector is currently covered by the following directive:
Directive 2009/142/EC146 (called hereinafter GAD), being a codified version
of 90/336/EEC, and which has therefore been operational more than twenty
years147. This directive is mainly directed to consumer and not to gas
appliances direct to industrial usage.
The directive includes a set of requirements about the design and
performance of gas appliances; also identifies a series of administrative
requirements; and requires a series of tests to be performed (all
requirements being mentioned in Annex 1 of the Directive 2009/142/EC, and
as indicated by Art. 3 of the same Directive).
The objective of the GAD is 1) to ensure the free movement –placing on the
market and/or putting into service- of gas appliances through technical
harmonisation with regard to risks due to gas and the rational use of energy
(energy efficiency); and 2) to guarantee a high level of safety and protection
of public interests. The respect of the essential requirements of the
GAD relies on an assessment by notified body 148, and the need for
having this body involved both in the type-examination related and
production phase conformity assessment procedures of all appliances and
fittings.
Standards and GAD: as mentioned above, the directive is one of the early
New Approach Directives and therefore does not identify how the GAD ESRs
146
Note that the first directive was developed in 1990, and then modified in 1993 by the Directive
93/69/EC, prior to the introduction of Directive 2009/142/EC, being simplified and including the changes
induced by all previous amendments.
147
It should be noted that work has been undertaken for preparing a proposal for a “Regulation of the
European Parliament and of the Council on appliances burning gaseous fuels”.
148
The list of notified bodies for the GAD is available on the following web-page:
http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id
=9
Data collection
The information used in this case study has been collected through different
interviews and conference calls. In addition to these interviews, information
collected during the first phase of the project through preliminary interviews with
different stakeholders was used as background.
The first generation of standards under the GAD were developed and their
references were listed in the OJEU by the Commission. However, the last
149
The list of harmonised standards under the GAD is available on the following web-page:
http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/appliances-burning-
gaseous-fuels/index_en.htm.
150
In short, in the scope of the LVD, market access is based on self-assessment of compliance and on
providing a certificate of presumption of conformity together with the marketed goods.
In the case of the GAD, the issue of non-publication of references has little
effect, since “Module A” is not used, European Standards are adopted anyway as
national standards152, and a certification by a notified body is compulsory.
Compliance with the latest standards does not rely on OJEU publication and allows
market access, independently from the publication of the standards references in
the OJEU. The missing publication of references of harmonised standards may
however have a negative impact on gas appliance and fitting manufacturers, as
additional effort would be needed to identify what specifications are actually
essential. The missing publication of references of harmonised standards can have
a major impact in other sectors, where this would force companies to bear major
additional costs to prove the conformity of their products.
Issues encountered related to compliance checks -that are behind the non-
publication of standards- and the additional implications are described in the
following paragraphs.
Within the scope of the GAD, a list of inconsistencies and shortcomings (in
comparison with CEN-CENELEC internal drafting rules and the mandate
M/BC/CEN/89/6) has been identified by the Commission153. Major part of them
consisted in quality issues of the Annex Z of the GAD harmonised standards 154.
Based on the issues encountered, the publication of harmonised standards is on
hold and awaiting the CEN to carry out the necessary rectifying actions.
151
In March 2012, the GAD Consultant informed the respective TCs about Commission complaints.
152
After their publication by CEN, and independently from the opinion of the Commission.
153
These issues do not refer to the technical content of the standard, as ESOs are the only responsible
for it.
154
The full list of issues will not be discussed in this case, and a single issue is considered as the main
focus of the case.
155
As described in CEN-CENELEC Boss system, TCs are advised to use a checklist during drafting for
ensuring correct linkage between Essential Requirements and product specifications.
156
This is also highlighted in Guide 51 of ISO/IEC, which indicate that the knowledge of the legal
framework should be part of committee expertise, and that regulatory requirements should be
considered.
157
As the manufacturer “remains responsible for assessing the risk of his products to identify which
essential (or other) requirements are applicable” (Blue Guide 2014, p. 34). The legal application of good
practices is not directly included in the directive, but is based on the need for the manufacturer to
identify and mitigate risks in an appropriate manner.
It therefore assumes that the court could consider some specifications, which are not related to essential
requirements, to be needed for ensuring safety. In that case, specifications not related to the directive
could therefore be considered as informally compulsory.
The concept of the New Approach Directives generates –by definition, and as shown
above- a tension in the European Standardisation System, as it brings together two
different perspectives, being the legislator and the standardisers. In order to
facilitate the link between standardisers and the legislator, New Approach
Consultants have been included in the system.
However, from a practical perspective, when the mandate requires the publication
of existing standards, the New Approach Consultants take care of the preparation of
the Annex Z. This does not cope with the previously explained drafting logic: the
standard –although being related to New Approach Directive- has not been
designed according to the legislation (as being anterior to it), and establishing
the link between product specifications and essential requirements can be
considered as a tricky task.
The above-mentioned issues in the Annex Z have a negative effect on the speed
of the system, as the non-compliance with the CEN-CENELEC internal drafting
rules and the mandate (or other issues) takes time to be resolved. The time
required for compliance control is on average 115 days. However, the standard
deviation is 108, with some standards only taking a few days between their first
importation and publication, while a few of these are only published after a few
years.
The delay in publication can therefore occur in various cases, as the changes in
Annex Z can be caused by several events, being 1) the implementation of a new
legislation; 2) the update of an existing legislation; or 3) a formal objection on
existing standards.
Conclusions
In the case of the GAD, the current situation allows companies to refer to standards
listed –but outdated- as no recent standard (or update of “old” standards) has been
published in the OJEU. Presumption of conformity is therefore still granted based on
the old standards. However, market access relies on assessment by notified body,
and therefore relies on the latest standards –although not being published in the
OJEU.
Independently from the quality of the Annex Z, the case of GAD raises other
questions, as the standards put on hold by the Commission due to above
inconsistencies and shortcomings were approved by the New Approach Consultant
in charge. As explained earlier, this comes from different assessment
methodologies, and is also due to a different proximity with the standardisers.
There is therefore a need for a basic ground to be correctly set and guidelines to be
developed in order to avoid the issues previously encountered.
For the GAD, this issue has little, if any, financial impact on manufacturers since
Module A is not used under this Directive (excepted from additional practical burden
induced by the identification of actual requirements, as mentioned above). In that
case, the presumption of conformity is mainly used for the “image”, in order to
facilitate contacts with third party (e.g. market surveillance authorities) assessing
the safety of the product and conformity with other requirements. For market
access, certification by a notified body is needed.
However, such an issue occurring in another field (e.g. LVD) might have an
important impact on the market, as Module A is mainly used. Forcing companies
to find another solution for accessing the market (e.g. certification through notified
body) would induce additional costs for the manufacturing companies.
Before discussing about the way compliance checks are performed, and identifying
means for improving this, it should first be understood that the expectations and
incentives of the various actors of the system are not the same.
This was part of the previous Vademecum. However, the draft for the new
Vademecum currently lacks some aspects of compliance checks, which should be
included to avoid referring to the previous Vademecum.
The process which need to be followed for performing the compliance checks;
The process for NAC to perform an assessment which will be used by the
Commission;
Especially, in the case of refusal, we understand that the reasons for non-
publication should be highlighted.
The responsibilities of the actors involved (i.e. the EC, the industry and the
ESOs secretariats).
The New Approach Consultants were introduced in order to help in bridging the gap
between standardisers and the legislator perspective, by providing knowledge on
both aspects, it appears that this is not currently achieved (issues encountered in
the GAD, and diverging opinion between the consultants and the Commission
services).
It should be noted that the first recommendation of this case should help in
resolving this issue, by clearly identifying pursued objectives, conditions of success
and procedures to be followed. In the end, the Commission should be able to fully
rely on the consultant assessment, which would therefore result in reduction of
double work.
However, based on the issues encountered in GAD, the opinion of the NAC
should not be limited to a formal “yes” or a formal “no”, and should be
nuanced by various elements (e.g. ongoing actions, specific market conditions,
etc.).
Extract from “How to draft European Standards for citation in the Official Journal”
http://boss.cen.eu/reference%20material/guidancedoc/pages/oj.aspx
“Technical bodies drafting European Standards in support of New Approach Directives are strongly
advised to use a checklist during the drafting stage. That checklist documents the relationship between
the Essential Requirement(s) of the Directive(s) and the clauses of the draft.
The checklist can enable the technical body to have a clear view on the appropriate coverage of the
relevant Essential Requirement(s) because both the relevant Essential Requirement(s) and the technical
solution(s) offered in the draft are listed.”
Interviewees
Legal basis
The ambition for a high proportion of uniform standards at the international level is
in line with the WTO Agreement on Technical Barriers to Trade (WTO-TBT) on the
global market. The agreement tries to ensure that regulations, standards, testing
and certification procedures do not create unnecessary obstacles, and strongly
encourages the use of international standards. The agreement also recognizes
countries’ (and regions’) rights to adopt the standards they consider appropriate —
for example, for the protection human health and safety or for the protection of the
environment. However, a myriad of national regulations can prove costly for
manufacturers and exporters, and international trade is facilitated most effectively
when governments use international standards. The WTO-TBT agreement therefore
encourages governments to apply international standards wherever possible.
The pieces of legislation mentioned above define the scope of this case study, which
will analyse how the three ESOs (CEN, CENELEC, ETSI) cooperate with their
respective international standardisation bodies (ISO, IEC and ITU). The main aims
of the case study are to describe the formal cooperation mechanisms and
158
See Section 7 – Standards to increase EU competitiveness in the global market
“What are the mechanisms in place for aligning European and International
standards and are those mechanisms effective and sufficiently used?”
This case study analyses the cooperation agreements between the ESOs and
international standardisation bodies (ISBs) and their practical implementation. The
following aspects are explored:
Which modes of cooperation are covered by the agreements? How and why
do they differ from each other?
Context
Data collection
Information has been sought from the ESOs and their international counterparts,
and selected stakeholders including the European Commission. A list of the
interviews conducted for the case study is presented in Appendix. In addition, for
23/04/2015 Page 154 of 199
the purpose of investigating the specific case of medical devices, greenhouse gas
emissions, and other examples, interviews were sought with a range of relevant
stakeholders.
The documentation and data reviewed as part of the case study is listed in
Appendix, and includes the Commission’s regulatory and policy statements, the
ESO-ISB cooperation agreements and any associated implementation guidelines,
along with various data provided by the ESOs and ISBs. In addition,
correspondence between ISO and CEN and between CEN and the European
Commission in relation to the medical devices case example has been reviewed.
In 1990 the ISO Council and CEN General Assembly each approved 159 an
agreement on technical cooperation between the two organisations (the Vienna
Agreement), which was then published in June 1991. The following year a set of
operation guidelines for TC/SC chairpersons and secretariats was published, which
was revised in 1996 and again in 1998. In 2001 the need for the Vienna Agreement
(VA) was confirmed and a new simplified version was approved 160 and published
the same year, along with a new set of more detailed ‘Guidelines for
implementation of the Agreement on technical co-operation between ISO and CEN
(Vienna Agreement)’, which specified the operational and process specifications.
The latest version of the guidelines (6th edition) was published in 2014 and
embodies a number of amendments intended to help overcome difficulties in the
implementation of the VA (it relates to practical arrangements, such the
cooperation by correspondence, mutual representation in meetings, adoption by
one organisation of available publications from the other organisation, etc.).
Cooperation by correspondence
The VA recognises the primacy of international standards (as stipulated in the WTO
Code of Conduct), but also recognises that (i) ‘particular needs (of the Single
European market for example) might require the development of standards for
159
ISO Council resolution 11/1987 and CEN General Assembly resolution 3/1990
160
ISO Council resolution 35/2001 and CEN Administrative Board resolution 2/2001
The IEC and CENELEC first signed a cooperation agreement on common planning of
new work and parallel voting in 1991 (the Lugano agreement). In light of
experiences gained over the first years of its operation, the agreement was revised
and a new agreement - the Dresden agreement (DA) - was approved by IEC and
CENELEC in 1996. The objectives of the DA are:
To ensure rational use of resources, with a preference that the full technical
consideration of the content of standards takes place at the international
level
The common planning of new work (in the case of work of European origin,
common modifications to IEC standards, and revision of an IEC standard) -
including submission of information to IEC and how the work proceeds under
certain different circumstances. All new work items originating in CENELEC
are offered to IEC and if accepted the work is ‘promoted’ to the international
level. In cases where IEC rejects the CENELEC proposal or cannot meet its
timescale requirements then the work is carried out in CENELEC
161
CEN and CENELEC (2013). Joint ISO-CEN Coordinating Group of the Technical (Management) Boards.
Seen at http://boss.cen.eu/TechnicalStructures/Pages/JointISOCENCoordGrBTs.aspx.
The DA recognises the primacy of international standards through its objective that
full technical consideration of the content of standards should preferably take place
at the international level, and the ‘default’ position that new work items will be
taken up and led by IEC, unless specific circumstances - which should be logged -
prevent the ‘standard’ procedure from being followed. This is the most notable
difference between the cooperation CEN-ISO and CENELEC-IEC.
ETSI has collaborated since its foundation with ITU, a United Nation specialised
Agency for Information and Communication technologies, based on public-private
membership including countries and public or private entities162. ITU operates in
three sectors (Telecommunication, ITU-T; Radiocommunications, ITU-R; and
Telecommunication Development Sector, ITU-D), and it produces global
ICT/Telecommunication standards, known as “Recommendations”, in the field of
Telecommunications and Radiocommunications163.
In the past, ETSI has had separate agreements with each the ITU sector
(Telecommunications, Radiocommunications and Development). In 2012 a new
wide ranging Memorandum of Understanding (MoU) was signed between ETSI
and ITU, which provides a common framework for cooperation and provides a
mechanism for the exchange of documents and referencing of each other’s
technical specifications. The new MoU replaced the previous agreements between
ETSI and ITU-R (2002) and ETSI and ITU-T (2000). The MoU is related to three ITU
sectors mentioned above: Radiocommunication sector (ITU-R), Telecommunication
Standardisation sector (ITU-T), Telecommunication Development sector (ITU-D).
ETSI is a sector member in ITU-R, ITU-T and ITU-D.
The aims of the 2012 MoU are to strengthen dialogue, information exchange and
cooperation between ETSI and ITU on technical standardisation activities. The
agreement notes several factors driving the desire for closer cooperation, including
the parties’ interest in adopting a complementary approach in the domains of
mutual interest, and the need to engage all concerned stakeholders - including
regional SDOs (i.e. ETSI) in the development of international ICT standards.
The MoU the goes on to detail procedures for (i) ITU participation in ETSI technical
body and other meetings, (ii) working methods, including the procedure for
adoption of materials (standardisation deliverables) from the other party and
harmonization of texts but recognising that ETSI and ITU may come to different
conclusions and publish different texts, and (iii) copyright and IPR policies relating
to the texts.
The MoU lasts for three years and may be renewed and amended in future by
mutual consent. Any difficulties or disputes in connection with the MoU should be
discussed between the two parties at the working level, and matters that cannot be
162
ITU has a membership of 193 countries and over 700 private-sector entities and academic
institutions. The ITU Europe Unit focuses on 43 Member States of ITU within the Region and a number of
Sector Members including private sectors, industries, scientific organizations and regional organizations.
163
The main product of ITU is represented by “recommendations” in the field of Telecommunications and
Radiocommunications, i.e.: Recommendations of ITU-T are “normative Recommendations” in the field of
telecommunication, intended as non-binding standards that define how telecommunication networks
operate and interwork; Recommendations of ITU-R are international technical standards developed by
the Radiocommunication Sector (formerly CCIR) of the ITU.
In general terms, the cooperation between ESTI and ITU is very different and
hardly comparable with the cooperation in place between CEN/CENELC and
ISO/IEC.
While CEN/CENELEC and ISO/IEC all operate in the same fields and according to
the same principles (i.e. the national delegation principle), ETSI and ITU each serve
their own members’ needs and, while they operate in similar domains, their
respective members expectations in terms of standards can be diverging. Where
there is overlap/need for cross-referencing, the MoU enables to organisation to rely
on that, e.g. in order to ensure interoperability. However, it can happen that ETSI
works on a standard that is competitor to one being developed by ITU, and
viceversa. As a consequence, the work is not always aligned and the principle of
primacy can be hardly applied.
Each of the three agreements focuses on processes and procedures for the
exchange of information and cooperation between the signatories, and covers a
number of specific modes or routes by which that cooperation will take place. The
three agreements cover many of the same elements, but with some variation as
shown in Table 2.
THE ESOs and ISBs report that the three agreements reflect certain differences
between the three ESOs (and between their three international counterparts),
which in turn influences the ways in which the three respective sets of
organisations cooperate.
CEN and CENELEC: CEN and CENELEC both have similar membership
structures and operate in a similar way, as do their international
counterparts – ISO and IEC. The organisations’ core members are national
standardisation bodies and their standardisation activities are organised
according to the national delegation principle, wherein standards are
developed under the guidance of and voted on / approved by technical
bodies comprised of national standardisation bodies. The Vienna and
Dresden agreements therefore provide for similar types of cooperation, with
only a few notable differences.
- Sectors covered: the main difference between CEN and CENELEC
(and between ISO and IEC) is that CEN covers multiple sectors or
164
There are many examples of areas where active relations exist between ETSI and ITU. In the
Telecommunication sector (ITU-T), some examples are: Network Technologies, Climate change,
Television and sound transmission, Cybersecurity, Optical transport networks and access network
infrastructures, Internet of Things; in the Radiocommunication sector (ITU-R): spectrum management,
radiowave propagation, satellite services, terrestrial services, maritime mobile services, etc.
165
ETSI is a sector member in the: Radiocommunication sector (ITU-R), Telecommunication
Standardisation sector (ITU-T), Telecommunication Development sector (ITU-D). For some examples on
areas of work where active connections exist, see footnote above.
CCMC has provided data on the number of new CEN work items each year (2006-
2013), the number of these that are developed under the VA (and hence are aimed
at alignment of EU-International standards), and the number of ‘home grown’
European standards, developed with no link to standards at the international level.
The data is presented in Table 3 below166.
It shows that over the past eight years some two-thirds (65%) of CEN work
items have related to ‘home grown’ standards (not registered for development
under the VA), while the remaining third (35%) relates to work items to be
developed under the VA. The ratio of European only work items to joint EU-
International work items (under the VA) has slightly decreased over the period
(from 2,3% in 2006, to 1,8% in 2013).
Of the work items developed under the VA, approximately three quarters are
developed under parallel procedures, and the remaining quarter are cases where
CEN adopts (endorses) an ISO standard. ISO has led the development of the
standards in 86% of cases under parallel procedures, reflecting the preference in
the VA for ISO lead.
166
This paragraph is related to the new work items registered each year, and developed by CEN alone or
under the VA in conjunction with ISO.
The data set presented in this paragraph focused on the standards actually
delivered and published, as CEN standardisation deliverables (SDs) or as SDs based
on or identical to ISO publications.
CCMC data on the degree of alignment between CEN SD167 and ISO publications
indicates that of its current portfolio of 15,581 SDs, some 4,839 (31.1%) are
identical to ISO publications and a further 27 (0.2%) are based on ISO
publications. The remainder – 10,715 SDs (68.8%) – have no relation to ISO
publications168.
CCMC data on the degree of alignment between CEN and ISO publications at the
level of individual business domains or sectors reveals a very high degree of
variability (see Chart 1 below). The percentage of CEN SDs that are identical to ISO
publications is highest in the Healthcare (77%), General standards (72%), Food
(56%), Environment (51%) and Materials (50%) business domains, and lowest in
the fields of Transport (5%), Services (7%), HVAC (8%), Building and civil
engineering (11%), and Utilities and energy (12%).
Chart 1– Relation of CEN portfolio to ISO by business domain (2013, last year
available)
167
All documents in the current CEN portfolio, excluding Corrigenda and Guides
168
This data is different from the one reported in Table 3: the data presented in this paragraph refers to
the standards published, while Table 3 refers to the “work items” initiated and developed. The two
datasets (on work items and standardization deliverables) are consistent.
169
Based on explanations provided by the standardisation bodies at European and International level.
170
Any legislation for which standards may be used as a route to demonstrate or support compliance.
171
However, it should be noted that there is no significant difference between the time for development
of standards at European level, and the time for development in parallel procedures at international
level. Based on estimates carried out during the Independent Review, in CEN and CENELEC, the time for
the development of home grown standards and the time for the development of standards led at
international level is similar, no signification differences are recorded (elaboration of EY, based on CEN
and CENELEC database).
Another key factor is that in some sectors there has been a natural evolution
in terms of national standards being developed first, which have then
been harmonized in some cases at European level, and which may then
subsequently be adopted as international standards. This is the case with, for
example, diving standards and removal standards (both services), where
individual EU member states first developed national standards, which
subsequently formed the basis for CEN standards and in turn ISO standards.
Services in general have a low alignment because there are relatively few
services that are traded internationally and hence few standards have ever
been set at this level. Service standards often address local / national needs,
and the sector is still in its infancy in terms of moving standards from national
to regional and then international levels. This is the natural order of
development.
To summarise, the main reasons why there are many European standards that are
not linked to international ones are (a) no international standard exists in an area
of European interest and the demand for a standard starts and stops at the EU level
(at least for now), and (b) an international standard exists but it is not suitable for
use in the European context due to specific regional (e.g. legislative) requirements.
CCMC has provided data on the number of new CENELEC work items each year
(2006-2013), the number of these that have been developed under the DA (and
hence are aimed at alignment of EU-International standards), and the number that
relate to ‘home grown’ European standards with no link to standards at the
international level. The data is presented in Table 3 below.
It shows that over the past eight years approximately one quarter (23%) of
CENELEC work items have related to ‘home grown’ standards not developed under
the DA, while the remaining three quarters (77%) have been developed under
the DA. The ratio of European only work items to joint EU-International work items
(under the DA) has varied from year to year with no clear trend evident. Of the
work items developed under the DA, approximately three quarters (73%) are
developed under parallel procedures, and the remaining quarter are cases where
CENELEC adopts (endorses) an IEC standard. As indicated above, IEC always leads
on joint (parallel procedures) work so there is no category for CENELEC lead.
While CLC operates in the electrotechnical sector, it is still possible to categorise its
standardisation deliverables according to business domain in which the
electrotechnical standards apply. CCMC data on the degree of alignment between
CLC and IEC publications at the level of individual business domains or sectors
again reveals a high degree of variability (see Chart 2 below). The percentage of
CLC SDs that are identical to IEC publications is highest in the General standards
(88%), Electronics (85%), Electrical engineering (81%) and Healthcare (80%)
business domains, and lowest in the fields of Services (7%), Transport (28%), and
Health and safety (34%).
Chart 2 – Relation of CENELEC portfolio to IEC by business domain (2013, last year
available)
The link ETSI – ITU cannot be compared to the cooperation between CEN/ISO and
CENELEC/IEC, and it is based on many types of different interactions. ETSI has
indicated that no data is available in relation to its MoU with ITU. However, it has
provided a copy of the mapping between ETSI Technical Bodies and those of ITU,
which shows the 81 active linkages between ETSI technical bodies and study
groups and those of ITU.
172
All documents in the current CEN portfolio, excluding Corrigenda and Guides
ISO/CS and CCMC have indicated that the VA works well, and they see no obvious
problems with the agreement itself or with the cooperation between CEN and ISO.
CEN and ISO technical boards (ISO/TMB and CEN/BT) have actively monitored the
implementation of the agreement, and have regularly discussed any problems or
issues arising173. ISO/TMB routinely discusses VA implementation and any issues
arising as part of the ‘regional issues’ element of its regular agenda 174. In addition,
the JCG met on at least an annual basis during the 2000s to review and report back
to the respective technical boards on the functioning of the agreements.
Over the years the monitoring has resulted in changes to the agreement itself
(simplification) and the development of more detailed guidelines for the
implementation of the agreement, guidance on day to day management between
ISO/CS and CCMC, and an evolving set of FAQs175.
However, apart from minor and practical issues, the ISO/TMB representative also
reported no substantive issues with the implementation of the VA at present. In the
early days of the VA the agreement and the relationship between ISO and CEN was
a sensitive issue, with the US and other international players expressing concern
that the agreement might give the EU an unfair advantage. However, this is no
longer an issue, the different countries seem to have a good level of trust, the
various ISO and CEN members are content and the VA works well.
It is both ISO and CEN policy to continue to strengthen the agreements and to
improve the interaction between CEN and ISO, in line with ISO TBT principles. ISO’s
new strategy will focus on closer working with regional actors (like CEN) and
ensuring good VA implementation, meaning international first. This is also an active
policy of CEN, led by VP policy, and will likely involve the development of action
plans for closer alignment in each sector, proposals for fewer European TCs, and
other options.
173
CCMC reports to be active in monitoring interactions, checking it all works well, addressing
complaints, and revising guidelines.
174
Based on the interview with ISO.
175
The latest implementation guidelines (6th edition, 2014) noted that previously “difficulties have arisen
in the implementation of the VA and in the training and education of National Standards Bodies (NSBs),
committee leaders, delegates, experts and Technical Programme Managers (TPMs) on the proper
implementation of the VA” and that as a result, “Resolution 107/2011 of the ISO/TMB established a Task
Force (VATF), which was requested to review the VA Guidelines and to come forward with proposals for
improvements.” Specific problems were noted around incorrect implementation of the guidelines and
difficulties in synchronization of work in ISO and CEN. ISO/TMB and CEN/BT approved the final report of
the VATF and its recommendations, leading to publication of the revised guidelines (6th Edition).
CCMC has reported that there are no noteworthy issues in the implementation of
the Dresden agreement, with both parties and their stakeholder communities
satisfied with the nature and functioning of the cooperation.
ETSI has reported that its cooperation with ITU works well and that there are no
problems or issues from ETSI’s perspective, or from the perspective of its
members. ITU has also reported that its cooperation with ETSI functions well
overall, although this is not the case in every area in which ITU operates:
ITU explains that in the ICT sector there is a lot of competition among a plethora of
SDOs and forums, and this is also the case for ETSI and ITU in certain areas. SDOs
and forums strive to maintain and where possible increase its market share, and as
such ETSI seeks to establish a foothold or stronghold in areas of standards
development that have global as well as European relevance. ETSI seeks to develop
and deliver globally applicable standards, based on the needs of its members, so
while cooperation is sought ETSI would not automatically assume or agree that
ITU-T should lead developments in areas where ITU-T and its members have an
interest. This can create problems for ITU, if, for example, its members from other
world regions (e.g. Asia, Africa, Arab and RCC) wish to be involved in standards
development but ETSI is seeking to, or has already, established itself as the lead
SDO in a particular area. This may lead to a duplication of effort among the work
done in the regions and in international SDOs. In this respect ITU indicates that its
cooperation with ETSI would be enhanced if ETSI focused more on their region and
respected other regions as well as international SDOs.
Issues related the application of the cooperation agreements and/or to the efficient
completion and availability of the needed standards might emerge. The examples
below represents two different kind of issues: application of the principles and
procedures of the New Approach legislative framework and delays in publication of
the standard at European level (medical devices); and conflicting EU and
international interests which comprise the continuation of parallel work (greenhouse
gas emissions).
Background
In the medical devices sector there are three New Approach Directives, which set European
legislative requirements in the form of essential requirements (ER) that have to be met by
manufacturers if they wish to place or use medical devices on the European market. These
are the Medical Device Directive (MDD), the Active Implantable Medical Devices Directive
(AIMDD) and the In-Vitro Diagnostic Devices Directive (IVDD).
Within New Approach sectors such as this, compliance with Harmonised European standards
(hEN) provides one possible route through which manufacturers can meet some or all of the
ER of the European Directives. hEN are seen to be one of the most efficient and effective way
to codify and promulgate the state of the art in terms of commonly agreed and understood
practices for achieving a high level of medical device safety and integrity.
Identified issues
For many years hEN developed in the medical devices sector were accepted and published by
the Commission without any noteworthy problems. However, in the past 3-4 years the
relevant Commission services (DG SANCO) have scrutinised the Annex ZA more closely and
identified a number of gaps, inconsistencies or deviations - problems that suggested that
medical device standards were not in all respects fulfilling the essential requirements they
claimed to. This led the Commission to object to (and hence delay) the publication of
candidate hEN pending improvements to the Annex ZA, such that the correspondence
between the text of the essential requirements and the text of the standard is more detailed,
explicit and correct. An aspect to be mentioned is that the Annex ZA is prepared by the CEN
committee, and specifically by the NAC (New Approach Consultant), who does not have
direct access to ISO TCs.
Stakeholders have in most cases acknowledged that the Commission was (and is) correct to
point out deviations and inconsistencies, and stakeholders also agree that it is important that
standards do not purport to cover essential requirements where they do not in fact do so. In
other words, whether developed at European or international level, harmonised standards
have to ensure the correspondence with the essential requirements of the related legislation,
as an important element, in this case, the highest safety and protection for human health.
Whether standards developed at international level do not ensure that the essential
requirements of regional legislation are covered, the WTO agreement also recognizes
countries’ (and regions’) rights to adopt the standards they consider appropriate and deviate
from international work.
However, since the inconsistencies were first identified by the Commission, an entirely new
(and so far largely unattainable) level of detail is now expected in the Annex Z. This in turn
has led to a situation where for the past few years the CEN and CENELEC TCs and the New
Approach consultants have struggled to meet the new (and evolving) level of detail and
precision required by the Commission, and a large number of new or revised standards
needed by the sector have not been able to be published as European harmonised standards.
The medical devices sector is characterised by global players and markets, and
standardisation in the sector has historically taken place at International level, with Europe
(CEN and CENELEC) adopting international (ISO and IEC) standards under VA/DA parallel
procedures. Most of the candidate hEN have therefore been developed in ISO, with the
objective of parallel approval and joint publication. This has meant that delays in publication
of the standard at European level has held up publication of the same standard at
International level, leading to frustrations within the international community. Stakeholders
Recently ISO/TMB adopted a resolution (105/2014) noting “concerns raised by ISO and its
stakeholders about the extensive delays caused by administrative and legal complications at
the European level (e.g. regulatory compliance assessments and the European Commission’s
approval) in the medical devices sector (e.g. in ISO/TC 121 and ISO/TC 194) for standards
developed under the Vienna Agreement.” The resolution expressed “deep concern about such
delays and the impact this has in the publication of standards that are needed in the sector”
and requested that “standards in the medical devices sector be published by both ISO and
CEN at the same time without further delay and without decoupling the development of the
standards from the Vienna Agreement”.
In response CEN/BT prepared a decision (BT 55/2014, adopted at its October 27/28
meeting), which noted the delays and the ISO/TMB Resolution, acknowledged the ISO/TMB
concern, and confirmed its commitment that every effort should be put into preserving the
good functioning of the VA. The decision also invited CEN’s VP Technical to raise awareness
with the Commission on the need to consider the international dimension while supporting
European legislation.
CEN’s VP Technical wrote (26 Nov 2014) to the Deputy Director-General ENTR Dir. B, C, E
and F, drawing attention to the issue. The letter explained the ambitions of the VA and that
“a large proportion of medical Harmonized Standards are actually drafted at international
level by ISO TCs in collaboration with corresponding CEN TCs”… which “means that most CEN
medical Harmonized Standards are officially recognised and used globally, thereby
strengthening the EU industry’s competitiveness by creating a level playing field”. However,
this situation is threatened by the “unnecessarily legalistic scrutiny” by DG SANCO and a
substantial increase in the “degree of details with which they examine the Annex ZA”, which
then causes them to not cite in the OJEU “dozens of standards whose content is, though, the
most state-of-the-art and constitutes an improvement (both technology- and safety-wise)
from the previous edition.” The letter goes on to note the significant delays created by efforts
to accommodate the concerns of DG SANCO, “with no impact whatsoever on the quality of
the standard or the quality of products produced in line therewith”. This is leading to the
interruption of the cooperation under the VA and the need for CEN to develop a standard
that is different to the international one. The letter seeks the support of the DDG’s services
to consider the “adverse implications of the current practices applied by DG SANCO and of
their spreading into the draft Vademecum”, which in turn could encourage the wider
application of such practices within the Commission, further threatening the good
relationship between CEN and ISO.
The New Approach consultants report that they have now reached a better understanding of
what the Commission expects and will accept in terms of the Annex ZA and so feel more able
to advise TCs accordingly. There have been various meetings between the Commission,
CCMC and the New Approach consultants to address the issues, and the Advisory Board on
Health Standards established a Special Task Force to look into the problems with the Annex
ZA, leading to development of new guidelines that are soon to be published. This should
mean that the kinds of delays seen over the past few years would be reduced in future.
Implications
Standards are written at a global level to meet global requirements; they are not written for
or tailored to meet EU legislative requirements and they cannot, under the current process,
act as perfect-fit ‘how to’ guides for meeting European regulatory requirements.
As the Annex ZAs become ever longer and more complex, the ability of the standards to act
as an efficient route to regulatory compliance is reduced. This can lead to increased costs of
compliance and approval regimes/systems, and may potentially lead to a situation where the
harmonised European Standard is no longer the preferred route to meeting ER, as there are
so many exclusions (parts of the ER not addressed) that the standards are no longer
effective tools in this regard. This is expected to hurt SMEs more than the larger players, as
the latter can invest in system-wide procedures to meet essential requirements while SMEs
tend to rely on using Harmonised Standards to demonstrate compliance.
Stakeholders rightly consider this to be a serious problem, which has been continuing for
several years and now desperately requires resolution. Significant time and money has been
expended on these specific issues within this specific sector, but with no clear end or
workable resolution in sight. The situation has caused some stakeholders to question
whether the benefits of the New Approach can continue to work under this ‘new regime’.
Stakeholders also consider that part of the problem is that the EC regulators are largely
absent from the standards development process, even in cases where they have mandated
the development of harmonised European standards to underpin their own legislation. The
need to reach consensus applies as much to the role that specific standards play in
supporting specific regulatory requirements as it does to the development of the standards
themselves. The two go hand in hand and as such it seems inappropriate and inefficient for
European regulators to not be involved in the development of the standards (and more
specifically the development of the Annex ZA) that will be used to underpin the regulations.
The current situation where regulators are not involved in the development of candidate hEN
and their Annex ZA and yet block those standards from publication at the end of the process
is not good practice.
Background
A first example relates to the EC Mandate M/478 to CEN, CENELEC and ETSI for the
development of EU technical standards in the field of greenhouse gas emissions (also
referred to as GHG). The mandate, issued in 2010176, was aimed at drawing up a
comprehensive standardisation work plan with a view to produce and adopt an EN standard,
in particular, containing harmonised methods for:
ensuring, testing and quantifying greenhouse gas (GHG) emissions from sector-
specific sources;
assessing the level of GHG emissions performance of production processes over time,
at production sites;
establishing and providing reliable, accurate and quality information for reporting and
verification purposes.
The mandate was accepted by CEN TC/264, which started the work based on a grant
agreement with the EC, signed in December 2011 and fixing the deadline for the completion
of the work at July 2016. The expected result is the delivery of 6 standards, which have been
already produced by CEN as draft documents177. The need for cooperation with ISO was
established in the Mandate. Therefore, ISO was involved from the beginning, through an
observer from Japan who participated in several meetings of the relevant working group
176
This followed the M/431.
177
The list is the following: prEN xxxxx, Stationary source emissions – Determination of greenhouse gas
(GHG) emissions in energy-intensive industries – Part 1: General Aspects; prEN xxxxx, Stationary
source emissions – Determination of greenhouse gas (GHG) emissions in energy-intensive industries –
Part 2: Iron and steel industry; prEN xxxxx, Stationary source emissions – Determination of greenhouse
gas (GHG) emissions in energy-intensive industries – Part 3: Cement industry; prEN xxxxx, Stationary
source emissions – Determination of greenhouse gas (GHG) emissions in energy-intensive industries –
Part 4: Aluminum industry; prEN xxxxx, Stationary source emissions – Determination of greenhouse gas
(GHG) emissions in energy-intensive industries – Part 5: Lime industry; prEN xxxxx, Stationary source
emissions – Determination of greenhouse gas (GHG) emissions in energy-intensive industries – Part 6:
Ferro-alloy industry.
Issues identified
The draft standards were transferred to ISO in order to be processed as prEN ISO standards
under the Vienna Agreement and to apply for the parallel approval procedure. The objective
was to initiate the parallel processing of the standards at CEN and ISO level. However,
several issues emerged:
The ISO members denied to accept the CEN lead in this standardisation process178.
This was based on the revised Vienna agreement which gives ISO the lead in all global
standardisation procedures in the future, unless that ISO members specifically vote for
a CEN lead. In this case, the vote for the CEN lead was negative, while the leadership
by CEN was one of the provisions of the contract agreement between the EC and CEN.
From ISO, a number of comments on the contents of the draft standards were
presented (mainly of the general aspect standard). Processing the comments would
have been brought the drafting of the standards at an early stage, with consequences
on the ability of CEN to meet the deadline.
Finally, the changes proposed by ISO would have not ensured the respect of the
original objectives of the Mandate.
As a consequence, in January 2014 the use of the Vienna Agreement failed. The standards
will be developed by CEN as ENs, and ISO will take them over at a later stage if deemed
appropriate179. CEN will any way take into account the comments made by ISO, as far as
possible and when relevant.
Implications
Differently from the case on Medical devices, in the case of GHG the use of the Vienna
Agreement did not lead to the expected results. This example raises some general questions,
which can be stimulate an overall reflection on the ESS: when the development of standards
under the Vienna Agreement implies longer development times, how to handle the trade-offs
between the quick development of standards and the need for ensuring the primacy of
international standardisation should be considered; to what extent, the strengthening of
coordination activities at international level and the early agreement on the drafts could have
avoided possible conflicts since the beginning; how CEN lead can be better enforced under
the Vienna Agreement.
Nevertheless, there are also positive examples, in several fields of action. Some
sectors were suggested as examples of good international cooperation:
178
According to the VA, CEN lead is accepted based on the vote of non-EU Members of the TC. In this
case, the vote on CEN lead was negative.
179
According to the information collected during the interviews, there is no formal commitment by ISO
to adopt the EC standards.
Annex III organisations have only an observer status in ISO, and ISO/TC
must agree to their participation. This is a weaker position than they occupy
in CEN, serving to limit their potential influence during the standards
drafting process.
As pointed out by stakeholders organisations, there are some “dangers” that should
be taken into account. In particular, international standardisation can have the
consequence to introduce standards that the European system would do differently.
In other words, there not mechanisms to make sure that international standards
are sufficiently good for European companies.
180
CEN/TC 275 Business Plan, 2014.
Conclusions
The ESOs and ISBs cooperate in many different ways, principally through the
exchange of information at central secretariat and technical body levels, attendance
at each other’s meetings, through adoption of standardisation deliverables, the
harmonisation of texts, and parallel development and joint publication of common
standards. Variations in the nature and the extent of cooperation across the three
ESOs reflect the different sectors they cover, as well as differences in their
respective markets, structures and operating procedures.
In the 3 ESOs, the monitoring systems do not seek to count the numbers of the
many different types of ‘exchanges’ that take place between the respective
organisations, since these take place at multiple points throughout the system
every day. The costs of collecting and reporting those data would be high, also as
compared to the real value this would offer. However, making the links explicit at
the level of technical bodies, as has been done by ETSI and ITU, does usefully help
to clarify where the principal connections are, and hence where most of the
important exchanges take place.
Efforts to align European standards to international ones under the Vienna and
Dresden agreements are effectively monitored by CCMC (and ISO & IEC), and data
is readily available on the numbers of work items implemented under the
agreements. These data shows that over the past eight years some two-thirds
(65%) of CEN work items have related to ‘home grown’ standards (not developed
under the VA), while the remaining third (35%) have been developed under the VA.
Regarding CENELEC, over the past eight years some two-thirds (65%) of CEN work
items have related to ‘home grown’ standards (not developed under the VA), while
the remaining third (35%) have been developed under the VA.
Issues highlighted:
Finally, the clear intention to align European (CEN and CENELEC) standards to
international ones and for the ISBs (ISO and IEC) to lead developments
wherever possible presents specific challenges for European stakeholder
organisations. The need for effective stakeholder input remains the same
whether the standards applicable in Europe are developed at the European or
international levels. However, the capacities of the Annex III organisations to
provide effective representation is clearly more limited at the international
level than at the European one. It is therefore important to assess how the
Annex III organisations can be supported by the Commission (in terms of
resources) and by the ESOs (in terms of clear access routes) to ensure that
the bodies representing European societal interests can have an appropriate
influence.
The Commission could consider the need to ensure that a regulatory official
participate in TCs where hEN are being developed under European Commission
mandates, so as to assist in the process of matching standards to essential
requirements in a coherent and mutually acceptable way. Also, the role and the
tasks of the New Approach Consultants, in parallel procedures, should be clarified
(notably, in relation to their task of providing advice to TCs and WGs during the
elaboration of standards).
The application of the VA, in particular, may conflict with the interest of European
stakeholders (e.g. to lead the standardisation activities, or to develop and publish
the standards in given deadlines). Similarly, the interest to set up standards at the
EU or international level can largely vary across sectors. Generalisations are difficult
to be made, whereas a clear and shared assessment of the objectives and the
priorities behind different standardisation works should be made, in order to guide
23/04/2015 Page 174 of 199
the decision on whether pursuing the work under the EU or international
framework, and implement that in the most efficient way.
To this end, the balance of European and international activities in different
sectors/standardisation areas should be understood and planned in advance. A
more strategic planning in this field would favour the definition of more
comprehensive strategies, identifying the relevance of international standardisation
in the different sectors, and planning in a structured way the portfolios of work
items for which international standardisation should be pursued as a priority. A
structured planning would allow to anticipate the needs of coordination at
international level and avoid, since the beginning, possible issues.
We recommend that the Commission and CCMC work with the Annex III
organisations to identify mechanisms for ensuring effective stakeholder
representation of societal stakeholders in cases where European standards are
being developed at the international level. Within this context we recommend that
Annex III organisations elaborate specific priority setting criteria for participation in
international standardisation, the Commission investigate the possibility of
providing additional funding to support Annex III participation in ISO/IEC work, and
for CCMC to investigate mechanisms to facilitate an effective representation of
European societal interests into work carried out in ISO and IEC (see details about
this in the case study dedicated to Annex III organisations).
We recommend that the Commission, ESOs, and relevant industry and other
stakeholder bodies convene to seek a solution to the problems identified in the
medical device sector. Problems such as these, if they become further entrenched
or spread to other sectors, could threaten the functioning of the New Approach and
have serious negative impacts on the competitiveness of European industry. As
such, an agreed, permanent and mutually satisfactory solution needs to be found
that is applicable to all of the New Approach sectors and is consistently understood,
accepted and applied.
List of interviewees
Category Number of
interviewees/contributors
Annex III organisations 3
European Commission 5
ESOs 4
Industry 4
ISBs 4
NAC 2
NSBs 1
TC chairs/secretary 7
Legal basis
The Rolling Plan on ICT Standardisation is a tool supporting the EU policy in the ICT
field, by identifying, in operational terms, the policy-related standardisation needs
for the upcoming years (3-5 years) and providing an overview of the relevant
activities already underway at a global level on individual ICT standardisation
subjects. This tool is developed by the European Commission, with the support of
the Multi Stakeholder Platform on ICT Standardisation.
The problem statement, also developed on the basis of the analysis carried out, for
this case study is the following:
Context
The ICT Rolling Plan: the Rolling Plan for ICT standardisation (hereafter
ICT RP or RP) is a document that identifies areas of activity where
standards, technical specifications, and standardisation in general can
provide support to the EU policy priorities. As such, the ICT RP reflects the
potential role of standardisation in (ICT) areas where the Commission has a
The MSP: the ICT RP is the result of a cooperation between the European
Commission and the Multi Stakeholder Platform in the field of ICT
standardisation (hereafter MSP), announced by the Communication
COM(2011)311182 and established by the Commission Decision of 28
November 2011183.
181
Annual Union Work Programme (AUWP) defines the strategic priorities for European standardisation
across all sectors. The AUWP primarily addresses the work where the Commission intends to issue
standardisation requests for European standards and other deliverables from the ESOs.
182
The Communication stated that in 2011 the Commission would create and chair a dedicated MSP to
advise the Commission on matters relating to the implementation of standardisation policy in the ICT
field, including the work programme for ICT standardisation, priority-setting in support of legislation and
policies and identification of specifications developed by Global ICT Fora and Consortia.
183
OJ C 349, 30.11.2011.
The Rules of Procedure of the MSP were drafted in accordance with the
views of its members, and the draft rules were presented to them during the
MSP meeting on 13 June 2013. The document contains 15 Articles defining
the rules, ethics, and customs governing meetings and other operations of
the MSP.
Finally, in 2013, the MSP also decided to set up a Task Force for the ICT RP
(also referred to as TFRP) to further work on the ICT RP proposals presented
by the Commission and participating in the drafting of the ICT RP. Any
member of the MSP can join the Task Force.
Case selected
In this case study, we looked at the ICT RP from 2 perspectives: at the objectives
and the contents of the Plan as such, and at the process that brings to its definition.
Data collection
The information used in this case study has been collected during different
interviews and meetings with the Members of the TF on the ICT RP. The list of
people interviewed is available at the end of this case. In addition to these
interviews, information collected during the first phase of the project was used.
Each policy area is presented according to the structure below, including the
rationale for proposing the topic as a policy priority and the details related to
standardisation and standards:
(B.2) Others
The ICT RP 2015 updates the first version, and consists of a document of
154 pages, detailing the policy areas of focus according to the structure
shown above.
The process for the development of the ICT Rolling Plan: the ICT RP is
drafted on the basis of an interactive exchange between:
184
2010-2013 ICT Standardisation Work Programme for industrial innovation.
185
ICT Rolling Plan 2014 and its updated version ICT Rolling Plan 2015.
The process starts on the European Commission side, notably with the
Mirror Group (created as an EC inter-service group), which formulates and
collects the first insights (new policy areas and new information) for the next
issue of the ICT RP. This first input is submitted to the MSP for feedback.
The MSP members consult their own member organisations for comments
and submit them to the Task Force for the ICT RP that compiles the
comments together with the Commission. A new version of the ICT RP is
therefore submitted to the MSP for further comments.
The ICT RP is endorsed by the MSP as advice for the Commission, and
endorsed and published by the Commission. The picture below is a
representation of the main steps of process.
The case selected focuses on one of the policy areas supported by the RP for ICT
standardisation and in which additions were made following the identification of
The healthcare sector is currently facing big challenges, with significant budget cuts
due to the economic crisis, an ageing population and a growing number of people
with chronic diseases. In this challenging environment, there is a huge opportunity
for improving patient care through ICT. Digital technologies can help prevent and
cure illness, as well as making healthcare systems more efficient, sustainable and
effective.
Several initiatives have been launched to push in the direction of eHealth adoption
throughout the EU and maximise social and economic benefits, such as:
However, opportunities deriving from ICT are not yet fully exploited. Issues still
exist around the quality and usability of data, due to the poor adoption of common
standards in eHealth systems and to a lack of interoperability between eHealth IT
systems, meaning that the systems are not interconnected and data cannot be
exchanged between hospitals and healthcare providers.
As the eHealth rapporteur, the Swiss representative of the MSP created a mirror
group on the topic of eHealth to support the drafting of recommendations in the ICT
RP in that field. The first priority when setting up that mirror group was to find
partners with specific experience in that field, such as research institutes,
standardisation bodies, independent and governmental offices for health, local
hospitals and authorities and the European Commission. The challenging but
essential aspect of this process was to find the appropriate experts to support the
development of proposals and amendments on the ICT RP. Several drafts were
produced as they evolved after discussions with the relevant parties. The resulting
amendments were, therefore, the outcome of a collaborative work between
different stakeholders, with a final coordination by the Commission.
The points raised by Switzerland on eHealth led to the proposal and adoption of
new standardisation actions in the RP, including: the launch a study for a general
architectural concept for the overall eHealth; methods to enhance acceptance of
eHealth in the society in general and particularly among health professionals.
186
As mentioned above, Member States and EFTA countries, ICT standardisation actors, industry, SMEs,
and society representatives.
Conclusions
The impact of the ICT RP on the speed of ICT standardisation is, therefore,
largely indirect. The ICT RP is seen as playing an enabler role to trigger the
work of standardisation organisations (although the main trigger remains the
industry). In this view, the ICT RP can favour “speed” at the embryonic
stage of the process of standardisation, but once the process has started,
the speed is not influenced by the RP anymore.
As mentioned in the introduction to the case, the analysis of the ICT RP, in terms of
objectives, contents and process, has been carried out in order to draw lessons
learned which can be applied to the ESS as a whole and can contribute to improve
its performance.
Based on the review presented above, the ICT RP represents a positive practice,
and some concepts behind it can be replicated in the ESS:
187
The concept of speed is based on the strategic objective defined by the Commission Communication
(2001) 311 final: “Standards need to be quickly available – especially but not only – to assure the
interoperability between services and applications in the field of information and communication
technologies so that Europe can reap the full benefits of ICT. […] Standards must keep pace with ever
faster product development cycles.”
Content of the ICT Rolling Plan: The increasing size of the document has
improved its accuracy but decreased the informative and “easy to read”
aspects. For example, a more complete executive summary would give the
reader an overview of what is included in the document.
5.9.4 Appendix
List of interviewees
Category Number of
interviewees/contributors
EC 5
Industry 3
MS 2
NSB 1
SDOs 2
The preparation of this case study also included the participation in a meeting of
the mirror group on the ICT Rolling Plan.
EU
(EC + EASA)
Others
(e.g. International
regulatory requirements ICAO
EUROCONTROL)
MS MS MS
The legal framework for the European civil aviation safety system is primarily based
on the so-called ‘EASA Basic Regulation’, which was originally adopted in 2002. 192
This Regulation was adopted by the European Parliament and the Council,
establishes the main functions of the system such as rulemaking, certification,
oversight, and international cooperation, and creates the EASA as a specialized EU
aviation safety body with legal personality. EASA's mandate was originally limited
to airworthiness and certification of environmental protection, but this initial scope
was subsequently extended in 2008 to flight operations and aircrew 193 and in 2009
to safety aspects of aerodromes, Air Traffic Management (ATM) and Air Navigation
Services (ANS)194.
188
www.easa.europa.eu
189
www.eurocontrol.int
190
www.icao.int
191
www.sesarju.eu
192
Regulation (EC) No 1592/2002 of 15 July 2002
193
Regulation (EU) No 216/2008
194
Regulation (EC) No 1108/2009
Finally, considering the complexity of aerospace and due to the need for greater
flexibility than the one provided by the regulatory system, the “Basic Regulation”
allows EASA to develop “soft law”. This “soft law” can be under the form of
Certification Specifications (CS), Acceptable Means of Compliance (AMC) and
Guidance Material. This soft-law is currently developed by EASA.
Agency opinion
Decision from the EP and EC Basic
Regulation
Agency opinion
Decision from the EC Implementing Rules
Agency decision
Soft Law
For air traffic management, in October 2001, the European Commission adopted
proposals for a Single European Sky (SES). The aim of SES is to create a Union
regulator for air traffic management within the EU (including Norway and
Switzerland). The safety technical aspects are now within EASA as noted above;
some additional work is under way in the SES II+ initiative which aims, amongst
other issues, to “eradicate the overlap between SES and EASA regulations” 195.
The case study focuses on the issues encountered in the aerospace sector and
investigates to what extent and why standardisation activities are performed
outside of the European Standardisation System. This is further completed by the
identification of the improvements needed in the European Standardisation System
to better suit aerospace needs.
195
Communication from the Commission COM(2013) 408 final, 2013
196
Roadmap for “Policy initiative on aviation safety and a possible revision of Regulation(EC) No
216/2008 on common rules in the field of civil aviation and establishing a European Aviation Safety
Agency, 26/03/2014.
“In the aerospace sector, what improvements should be made to the ESS to ensure
future suitability?”
The case study also considers to what extent potential issues encountered in the
aerospace sector could occur in other sectors, and how the identified
recommendations could be applied to them.
Context
Softer law: based on the current legislation, it appears that the soft law
developed by EASA is based on different levels of accuracy, with a soft-law
in some fields being very accurate (e.g. airplane manufacturing), and
defining in its reference documents (e.g. Acceptable Means of Compliance,
or AMC) the product specifications to be respected. In that logic, EASA is still
Actors: the main standard developers considered in this case study –and
being at the core of European aerospace standardisation- are the following:
197
http://ec.europa.eu/atwork/pdf/cwp_2015_new_initiatives_en.pdf
198
http://www.astmnewsroom.org/default.aspx?pageid=3562
199
http://www.icao.int/about-icao/Pages/default.aspx
200
Note that this system has been extended to neighbour countries.
201
http://standards.cen.eu/dyn/www/f?p=204:105:0 However, the database does not show target
deadlines for these deliverables.
202
Bagshaw, M. (n.d.). “Aircraft Cabin Air Quality: What has happened to the CEN & SAE Standards?”.
Seen at http://aerotoxic.org/wp-content/uploads/2014/11/Aviation-Health-Bagshaw.pdf
203
RTCA and Eurocae Formalize Commitment to Harmonize Industry Performance Standards (2014).
Seen at
https://www.eurocae.net/static/download/?download=documentIdentifier;Moc1114,dc;documents,dc;eu
rocae,dc;net
204
www.gama.aero
205
From: http://www.gama.aero/media-center/press-releases/content/gama-welcomes-strong-eu-
endorsement-forthcoming-new-means-certif
206
http://www.sae.org/aerospace/
Case selected
207
Ibac (2009). IS-BAO Receives European Standards Recognition? Seen at:
http://checkforaviation.net/japanese/IBAC%20IS-BAO%20Press%20Release%20August%2025.pdf
208
CEN (2014). DRAFT Business Plan for the CEN Workshop on “Modules for Electro-Mechanical
Actuators in Aircraft” (to be approved during the Kick-off meeting on 2015-01-28). Seen at:
ftp://ftp.cencenelec.eu/CEN/Sectors/List/Air/2014-11-25_CEN_WS_BP_Modules_for_EMAs_v1_4.pdf
209
For supporting the regulatory framework, several mandates were issued by the European
Commission, asking the ESOs to develop Community Specifications (CS) for the interoperability of the
European Air Traffic Management Network (EATMN). These mandates ask for European Standards that
satisfy the essential requirements and/or implementing rules of the interoperability regulation for
systems, together with the relevant procedures or constituents.
As a result, the ESOs established the Air Traffic Management Standards Coordination Group (ATMSG), to
ensure a co-ordinated approach. This group comprises CEN, CENELEC, ETSI, EUROCAE, EUROCONTROL,
EASA and EC/EFTA.
Data collection
The information used in this case study has been collected through desk research
on documents available on the Internet, and discussions with aerospace actors.
Role of the ESS in this area
From a general perspective, the ESS works closely with industry associations to
develop the standards needed by a particular sector. However, in the aircraft
domain, the actual standards drafting activity has been concentrated in ASD-STAN,
which is considered as Associated Standardisation Body210 by CEN, and which is
therefore responsible for drafting ENs in the field of aerospace.
Otherwise, apart from the specific field of Air Traffic Management, and
requirements for “new approach” standardisation in support to Regulation, then the
ESS in itself has had little additional activity – as the role of an Aerospace Technical
Committee has been taken by ASD-STAN. The very recent establishment of a
research project-related CEN Workshop on a specific aircraft technical issue, is an
interesting development, which is worth further analysis211.
However, although the formal role of the ESOs in aerospace was limited, based on
the revision of EASA’s soft law and a potential increased role of standards in the
aerospace ecosystem, it is understood that the role of the standardisation bodies –
and therefore maybe of the ESS (including ASD-STAN and EUROCAE)- might
increase in the following years. This can therefore be considered as an opportunity
for the European Standardisation System.
On the one hand, Europe retains a very important capability in the aerospace
sector, in terms of the manufacture of both complete aircraft and components. This
means there is a strong research agenda, whether company-driven or with public
support, and therefore an ongoing interest in standardisation at local level (noting
the recent establishment of CEN Workshop 77).
On the other hand, by definition, the aerospace industry - at least in terms of public
carriers - is global, and therefore the reach of standardisation must also be global.
210
The only other example of Associated Standardisation Body is ECISS, in the iron and steel sector.
211
The collaboration of the ESS with EUROCAE, which is preparing consensus specifications on electronic
equipment (covering both aircraft equipment as such and ATM-related electronics), has been less
intense, although EUROCAE does have a (2010) partnership agreement with ETSI, and it is also a
member of ASD-STAN's Co-ordination Committee. EUROCAE's website also refers to a MoU with CEN and
a Co-operation Agreement with CENELEC, in terms of contribution to CEN and CENELEC activities to
prepare “Community Specifications” (a Single European Sky activity). Neither the CEN nor the CENELEC
web sites refer to these agreements, and we assume they are no longer used/valid.
“There will be competition for these resources from the business needs of
individual companies as well as from industry, national, regional and
international standardisation efforts”;
From industry’s point of view, it appears that the different types of standards
should be differentiated:
Finally, it should also be noted that major part of aerospace standardisation work is
currently performed at international level. Independently from the intrinsic
characteristics of the different standardisation systems, it should be reminded that
the standardisation work has inertia, and that industry will naturally demonstrate a
reluctance to change.
The ISO Business Plan just quoted implies companies give “industry”
standardisation some priority (at least as much as they do to regional SDOs), and
the possibility that US-based “industry” SDOs seek to expand their area of influence
over topics traditionally standardised in CEN/ISO (non-aerospace).
212
ISO (2014). BUSINESS PLAN - ISO/TC 20 - Aircraft and space vehicles. Seen at:
http://isotc.iso.org/livelink/livelink/fetch/2000/2122/687806/ISO_TC_020__Aircraft_and_space_vehicles
_.pdf?nodeid=1195698&vernum=-2
The case of air cabin quality (already mentioned earlier) refers to a standard that
was developed by industry in a private SDO, without the involvement of other
stakeholders (as it should be in the case of an EN). When disclosed, the standard
was not accepted by the aerospace ecosystem as it focused on industry
requirements, and did not take into account the opinion of stakeholders impacted
by the standard (i.e. cabin crew and passengers).
Finally, the last aspect of focus is related to the speed of European standardisation:
it has been noted that the industry does not consider the speed of European
standardisation to reach the expected objectives, and does not fit with the rhythm
of the aerospace work.
Additionally, it should be noted that the interest of industry in having a softer law
and using standards is based on a need for speed and flexibility: considering the
procedures to be followed for amending EASA regulation, industry is interested in
going through standards for having a faster means for adapting to technology or
market changes. However, in case the standard development time does provide
this additional speed and flexibility, industry has no interest in a revision of EASA
regulation.
Conclusions
In this sector there seems to be less use of and interest in the ESS as such (and
the ISO TC Business Plan suggests the same is the case internationally). There may
be at least three reasons:
The creation of EASA, which may have taken on some safety-related activities
that the ESOs formerly might have carried out – although available evidence
suggests these were mainly in the Air Traffic Management domain;
A proactive approach from the private SDOs, cited in several examples above.
SAE International, GAMA, and ASTM (at least) are affirming themselves in
Europe as places where global standards activities can be carried out in the
sector.
It is noteworthy that the Associated Body status of ASD-STAN within CEN goes back
to 1986. It is time, in the light of the fundamental changes in industry since then,
for a review in order to assess whether the current arrangements are still fit for
purpose. Although it may not be welcome to spend time on assessment of
institutions, it needs to be examined whether the current system with ASD-STAN as
a drafting body and CEN as publishing house makes real sense today, against a
more flexible and fast operation to draft standards rapidly. The use of a “normal”
CEN Technical Committee (or more than one) in the domain seems however not to
be adapted, as the industry does not seem to be prepared to undergo the “normal”
standardisation process.
Internationally, whilst the basic principle of ISO as the European standards
interface for CEN should be retained, the ESOs might consider whether any MoU or
similar would be needed with SAE International or ASTM on subjects of common
interest, to collaborate –in some specific cases- over standards efforts. Moreover,
this is motivated by the strong interest for the industry in having interoperability
and performance standards usable at global level, potentially through the use of
equivalent standards. However, we recognise the sensitivity of this at European
level (and the TTIP-related aspects).
In addition, in order to ensure the success of such initiative, dialogue between the
ESOs, ASD-STAN, EUROCAE and the industry should be further established.
Opportunity for improvement 2: Identifying EU priorities
Clearly identifying the European priorities would also be very useful and timely for a
more in-depth examination of the real requirements at European level for
standardisation in aerospace. This should identify at least high level EU priorities for
aerospace standards topics, those which need support at EU level, and what can be
developed in other SDOs, at international/regional levels213.
This examination clearly needs to involve the European Commission, and the two
local regulatory actors EASA and EUROCONTROL, but predominantly needs to
involve industry and the European-based SDOs.
The specific positions of ISO and the US-based SDOs need to be taken into account.
More than that, and as mentioned above, the appropriate framework should be set-
up for avoiding duplication of the work and for increasing cooperation with other
SDOs outside of the ESS.
Finally, the strategy should be clearly established, with respective roles and
responsibilities for the various SDOs, ensuring the expert to spend time on the
appropriate subject matters: with the changes in the soft-law, and the increased
work generated by the REACH project (due to surface treatment of metallic parts),
time and expertise are expected to become very scarce resources.
213
This could refer to the logic implemented in C-ITS (see the related case) or in ICT in general with the
Rolling Plan on ICT Standardisation (see the related case).
Finally, as described in the introduction, the meaning of the term 'standard' varies
largely between the different stakeholders. A clear perspective is therefore needed
to ensure that there is a good understanding amongst all these actors - regulatory
authorities, industry and SDOs - of the respective scopes of activities in this
domain. Such an understanding will ensure that subjects requiring consensus are
correctly handled, with the right actors around the right tables.
5.10.4 Annexes
Interviews
Category Number of
interviewees/contributors
European Commission (or agency) 2
ESOs 2
Industry or industry representatives 7
NSB (or associated) 1