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Independent Review of the

European Standardisation
System

Final Report – Annexes

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
EUROPEAN COMMISSION

Independent Review of the


European Standardisation
System

Final Report – Annexes


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Table of contents
1. INTERVIEWS ............................................................................................ 6
1.1 Interviewees .................................................................................... 6
1.2 Meetings or events ........................................................................... 6
2. DESK RESEARCH ...................................................................................... 7
2.1 General sources ............................................................................... 7
2.2 Main Websites ................................................................................. 11
2.3 Additional sources for case studies ..................................................... 12
3. ONLINE SURVEY ...................................................................................... 17
3.1 The online survey ............................................................................ 17
3.2 Analysis of the results ...................................................................... 20
4. QUESTIONNAIRE TEMPLATE ...................................................................... 56
5. CASE STUDIES ........................................................................................ 68
5.1 Speed - Responsiveness of the ESS in addressing EC needs .................. 68
5.2 Innovation and Research - Anticipation of standardisation needs
in additive manufacturing ................................................................. 76
5.3 IPR - IPR coverage by ESOs guidelines ............................................... 85
5.4 Stakeholders - Inclusiveness: principles and practical
implementation ............................................................................. 101
5.5 The eInvoicing standardisation request............................................. 116
5.6 Cooperation mechanisms extra-ESS in ITS ....................................... 128
5.7 Compliance checks, harmonized standards in gas appliances .............. 140
5.8 The primacy of international standardisation ..................................... 153
5.9 ICT rolling plan.............................................................................. 177
5.10 Standardisation in aerospace .......................................................... 187

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1. INTERVIEWS

1.1 Interviewees

Category (aggregated) Number of


interviewees/contributors
AIII 7
EC 33
EFTA 1
ESO 17
Industry 28
ISB 4
MS 5
NSB 14
Others 8
SDO 2
Societal stakeholder 2

1.2 Meetings or events

In addition, a total of 16 larger scale meetings/events have been attended, either


for presenting the Independent Review or for collecting information.

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2. DESK RESEARCH

2.1 General sources

Acemoglu, D.; Gancia, G. & Zilibotti, F. (2009). Innovation versus Standardisation.

AFNOR. Les étapes d'élaboration d'une norme européenne. Seen at


http://www.afnor.org/metiers/normalisation/la-vie-des-normes/les-etapes-d-
elaboration-d-une-norme-europeenne

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)

BSI Group (2013). Structuring Knowledge: Standards Development Briefing.

CEN. CEN Tools & Applications. Seen at


https://www.cen.eu/WorkArea/tools/Pages/default.aspx

CEN. Adoption of a new work item in a CEN Technical Committee. Seen at


http://boss.cen.eu/reference%20material/Guidancedoc/Pages/TCNewWI.aspx

CEN. Developing a European Standard - The Process .Seen at


https://www.cen.eu/work/ENdev/how/Pages/default.aspx

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.

CEN (2013). Annual Report 2013.

CEN (2015). BT Actions to speed up the development of European standards &


other CEN deliverables.

CEN-CENELC-ETSI (2010). Masterplan on Education about Standardisation.

CEN-CENELC-ETSI (2013). Strategic objectives for the European standardisation


system to 2020.

CEN-CENELEC. How is a standard made. Seen at


http://www.cenelec.eu/aboutcenelec/whatwedo/standardsmakingprocess/index.ht
ml

CEN-CENELEC (2003). CEN-CENELEC Guide 4: General guidelines for the


cooperation between CEN, CENELEC and ETSI, and the European Commission and
the European Free Trade Association.

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CEN-CENELEC (2008). Internal Regulations: Part 2: Common rules for
standardisation work.

CEN-CENELEC (2010). CEN-CENELEC Guide 17: Guidance for writing standards


taking into account micro, small and medium-sized enterprises (SMEs) needs.

CEN-CENELEC (2010). CEN-CENELEC Guide 19: Guidelines for the administration of


Specific Agreements by National Members including principles for subcontracting.

CEN-CENELEC (2013). Quarterly Statistical Pack 2013.

CEN-CENELEC (2014). Quality versus Speed for European Standards.

CEN-CENELEC (2014). Quarterly Statistical Pack 2014 Q1 : All CEN-CENELEC


secretariats of Technical Bodies producing standards or other deliverables, per
Country.

CEN-CENELEC (2014). Quarterly Statistical Pack 2014 Q4. p 6.

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.

DIN German Institute. How are Din standards developed? Seen at


http://www.din.de/cmd%3Fmenuid%3D47560%26menusubrubid%3D59377%26c
msareaid%3D47560%26menurubricid%3D59362%26level%3Dtpl-
unterrubrik%26cmsrubid%3D59362%26cmssubrubid%3D59377%26languageid%3
Den&sa=U&ei=4u89T_7xOYm3-
waqvNTPBQ&ved=0CCEQFjAE&usg=AFQjCNEi_zSIAl9SgNTHJ5FVyxNtUPND-Q

DIN German Institute (2011). The economic benefits of standardisation – an update


of the study carried out by DIN in 2000.

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.

EDF (2012). EDF Position on the Proposal for a Regulation on European


Standardisation .

ETSI. Electronic Working Tools; Roadmap including recommendations for the


deployment and usage of electronic working tools in the ETSI standardisation
process. Seen at
http://www.etsi.org/deliver/etsi_sr/002900_002999/002959/01.01.01_60/sr_0029
59v010101p.pdf"

ETSI. National Standards Organisations. Seen at http://www.etsi.org/about/our-


role-in-europe/national-standards-organisations

ETSI (2013). ETSI Guide on Intellectual Property Rights (IPRs).

European Commission - DG Joint Research Center (2014). How will standards


facilitate new production systems in the context of EU innovation and
competitiveness in 2025?.

European Commission (2005). Action plan for European Standardisation (2005 -


2012).

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European Commission (2008). Towards an increased contribution from
standardisation to innovation in Europe. (Publication nr COM 133 final)

European Commission (2009). Framework partnership agreement (Framework


Agreement Number FPA/CEN/ENTR/2009/C(2008)8758)."

European Commission (2010). Europe 2020: A strategy for smart, sustainable and
inclusive growth. (Publication nr COM 2020)

European Commission (2010). Public consultation on standardisation packages :


Overview of the responses.

European Commission (2011). COMMISSION DECISION of 28 November 2011


setting up the European multi-stakeholder platform on ICT standardisation.
(Publication nr 2011/C 349/04)

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 (2011). A strategic vision for European Standards: Moving


forward to enhance and accelerate the sustainable growth of the European
economy by 2020. (Publication nr COM 311 final)

European Commission (2011). Executive summary of the Impact Assessment.


(Publication nr SEC(2011) 1355/2)

European Commission (2011). Impact assessment. (Publication nr SEC 671 final)

European Commission (2011). Official Journal of the European Union, C 349.


(Publication nr OJ C 349)

European Commission (2011). Regulation (EU) No 182/2011 of the European


Parliament and of the Council of 16 February 2011 .

European Commission (2012). Regulation (EU) No 1025/2012 of the European


Parliament and of the Council of 25 October 2012.

European Commission (2012). Annual European standardisation work programme


2012. (Publication nr SWD(2012) 42 final)

European Commission (2012). Draft Vademecum on European Standardisation,


PART II : Preparation and adoption of the Commission’s standardisation requests to
the European standardisation organisations.

European Commission (2012). How to support SME Policy : from Structural


Funds.Using standards to support growth, competitiveness and innovation.

European Commission (2012). Using standards to support growth, competitiveness


and innovation.

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 (2013). Communication from the commission to the council,


the European Parliament and the European Economic and Social Committee, The
annual Union work programme for European standardisation. (Publication nr COM
2013/561)

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European Commission (2013). European Competitiveness Report : Towards
Knowledge Driven Reindustrialisation. (Publication nr SWD 347)

European Commission (2014). Committee Communication from the Commission of


the European Social Committee : The annual Union work programme for European
standardisation for 2015.

European Commission (2014). Rolling plan for ICT standardisation 2013.

European Commission (2014). Vademecum on European Standardisation (old and


draft update of 3.6.2014).

European Commission (2015). The 2015 Rolling plan for ICT standardisation.

European Multi-Stakeholder Platform on ICT Standardisation. (2013). Identification


process- ICT Technical Specifications.

Farell, J. & Saloner, G. (1985). Standardisation, Compatibility, and Innovation. The


RAND Journal of Economics, Vol. 16(1) p 70-83

Farrell, J. & Solaner, G. (1986). Competition, compatibility and standards: the


economics of horses, penguins and lemmings. Working paper 8610

Hesser W. and de Vries H. J. (2011). White Paper, Academic Standardisation


Education in Europe

IFAN (2014). Education and Training about Standardization – Different needs for
different roles, Guide 4.

IMCO (2010). European Standardisation: current challenges-future actions.

IPR Helpdesk (2012). How to reap the benefit of standardisation in R&D.

ISO (2004). Standardisation and related activities -- General vocabulary.

ISO (2014). ISO TC 20 Business Plan : Aircraft and space vehicles.

ITU (2012) ITU and ETSI renew Memorandum of Understanding. Seen at


http://www.itu.int/ITU-
T/newslog/ITU+And+ETSI+Renew+Memorandum+Of+Understanding.aspx

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?

Lemley, M. (2002). Intellectual Property Rights and Standard-Setting


Organisations. California Law Review, 90(6)

Miotti, H. (2009) The economic impact of standardisation: technological change,


standards growth in France.Seen at
http://www.sis.se/pdf/economic_impact_of_standardisation_france.pdf

Neyer, J. (1999). Justifying Comitology: The Promise of Deliberation.

Orgalime (2009). Draft Orgalime comments on EP IMCO report on the Future of


European Standardisation.

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Orgalime (2011). European standards: a useful tool for both the EU and companies,
which deserves support with less bureaucracy.

Orgalime (2013). Orgalime comments on CEN-CENELEC “European Standardisation


Strategy 2020”.

Pelkmans, J.(1987). The New Approach to Technical Harmonization and


Standardisation. Journal of Common Market Studies, XXV(3)

Standards Australia. Research Paper: The Economic Benefits of Standardisation.


Seen at
http://www.standards.org.au/OurOrganisation/News/Documents/Economic%20Ben
efits%20of%20Standardisation.pdf "

Stroyan, J. & Brown, N. (2012). Study on the implementation of service standards


and their impact on service providers and users. Technopolis Group.

Stroyan, J. & Brown, N. (2013). Study on the contribution of standardisation to


innovation in European-funded research projects. Technopolis Group.

Swann, G.M.P. (2000) The economics of standardisation : Standards and Technical


Regulations Directorate Department of Trade and Industry. Seen at
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/16
506/The_Economics_of_Standardisation_-_in_English.pdf "

Tassey, G. (1999). Standardisation in Technology-Based Markets. Forthcoming in


Research Policy

Technopolis Group for Nordic Innovation (2012). A study on services certification


linked to service standards at national level in Europe.

Technopolis Group (2010). Mapping services standardisation in Europe : Final


Report to the Danish Enterprise and Construction Authority.

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”

Verlag, B. Economic benefits of standardisation Summary of results. Seen at


http://www.din.de/sixcms_upload/media/2896/economic_benefits_standardisation.
pdf "

World Trade Organisation (2012). Trade and public policies: A closer look at non-
tariff measures in the 21st century. p 211.

2.2 Main Websites

European Commission: Standardisation Policy

http://ec.europa.eu/growth/single-market/european-standards/index_en.htm

EC-EUROPA. Comitology register


http://ec.europa.eu/transparency/regcomitology/index.cfm?CLX=en

EC-EUROPA. Standardisation request - mandates


http://ec.europa.eu/enterprise/policies/european-standards/standardisation-
requests/index_en.htm

CEN CENELEC: http://www.cencenelec.eu/Pages/default.aspx

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ETSI: http://www.etsi.org/

2.3 Additional sources for case studies

Speed - Responsiveness of the ESS in addressing EC needs

Dataset provided by the ESO in relation to the following mandates:

 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

Anticipation of standardisation needs in additive manufacturing

Allen, R. H., and Sriram, R.D. (2000). “The role of Standards in Innovation”,
Technological Forecasting and Social Change, 64.

Blind, K. (2013). “The Impact of Standardisation and Standards on Innovation -


Compendium of Evidence on the Effectiveness of Innovation Policy Intervention”,
Manchester Institute of Innovation Research, Manchester Business School,
University of Manchester.

BRIDGIT Research Study (2014). “Benefits of linking innovation and


standardization”. Seen at
ftp://ftp.cencenelec.eu/EN/ResearchInnovation/SuccessStories/ExecutiveSummary-
BRIDGIT-ResearchProject.pdf

European Commission (2014). “Additive Manufacturing in FP7 and Horizon 2020 -


Report from the EC Workshop on Additive Manufacturing held on 18 June 2014”.

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.

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.

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IPR coverage by ESOs guidelines

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)”.

European Commission (2014). “Standard-essential patents”, Competition policy


brief, nr. 8.

European Commission (2014). “Patents and Standards, A modern framework for


IPR-based standardisation”.

ETSI (2010). “Activities/Developments related to the ETSI IPR Policy - GS15”.

ETSI (2013). ETSI Guide on Intellectual Property Rights (IPRs) (19/09/2013).

ETSI (2014). ETSI Intellectual Property Rights Policy (19/03/2014).

Stakeholders - Inclusiveness: principles and practical implementation

World Trade Report (2012). “Trade and public policies: A closer look at non-tariff
measures in the 21st century”, p. 211.

ERFO (n.d.). “Information Document on EN15359 "Solid Recovered Fuels -


Specifications and Classes"”.

European Commission (2014). “Call for tender for “Representation of environmental


interests, consumer interests and social interests in European standardisation”” on
16/09/2014.

Vienna Agreement Guidelines, 6th edition (2014).

The eInvoicing standardisation request

Council of the European Union (2011). Factsheet – Entry into force of new
comitology rules.

Directive 2014/55/EU of the European Parliament and of the Council of 16 April


2014 on electronic invoicing in public procurement.

European Commission (2013). “Doc.: 05/2013 EN – Adaptation of the mandating


process to the Regulation (EU) 1025/2012”.

European Commission (2014). “Draft Vademecum on European standardisation –


Parts I to III” [slides version of 20.6.2014].

European Commission (n.d.). “[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”.

European Policy Centre (2011). Implementing Lisbon: what’s new in comitology?

Cooperation mechanisms extra-ESS and ITS

Castrillejo, E. (2013). Presentation at the 5th ETSI ITS Workshop (Vienna


5/02/2013).

CEN and ETSI (2010). “Joint CEN and ETSI Response to Mandate M/453”.

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CEN and ETSI (2013). “Final joint CEN/ETSI-Progress Report to the European
Commission on Mandate M/453”.

European Commission (n.d.). Action Plan for the Deployment of Intelligent


Transport Systems in Europe.

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.

Evensen, K. and Csepinkszky, A. (2013). iMobility Support - D3.5a -


Standardisation handbook.

Compliance Check, harmonized standards in gas appliances

Harmonised standards under the GAD, list available at:

http://ec.europa.eu/enterprise/policies/european-standards/harmonised-
standards/appliances-burning-gaseous-fuels/index_en.htm

European Commission (2014). Blue Guide on the implementation of EU product


rules.

CEN/CENELEC, “How to draft European Standards for citation in the Official


Journal”,
http://boss.cen.eu/reference%20material/guidancedoc/pages/oj.aspxGuide 51 of
ISO/IEC, Safety aspects - Guidelines for their inclusion in standards

The primacy of international standardisation

Agreement on Technical Co-operation between ISO And CEN (Vienna Agreement):


VA codified – Version 3.3 2001-09-20

CEN and CENELEC (2013). Joint ISO-CEN Coordinating Group of the Technical
(Management) Boards. Seen at
http://boss.cen.eu/TechnicalStructures/Pages/JointISOCENCoordGrBTs.aspx.

CEN/TC 264/WG 33 "Greenhouse gas emissions in energy-intensive industries", 2nd


Interim Report, May 2014

CEN (2014). CEN/TC 275 Business Plan, Date: 2014-09-16

CEN (2014). CEN/TC 261, Collection of standards, 2014

CENELEC (2001). CENELEC Guide 13 - IEC - CENELEC Agreement on Common


planning of new work and parallel voting Edition 1, 2001-01 (Dresden Agreement)

EUCOMED (2014). EUCOMED Position paper - The Revision of the EU Medical


Devices Directives (1st April 2014)

European Commission (2001). Commission Staff Working Paper SEC(2001) 1296 -


European Policy Principles on International Standardisation.

Guidelines for the implementation of the Agreement on Technical Cooperation


between ISO and CEN (the Vienna Agreement), 6th Edition, January 2014

Letter from ISO Vice-President (Technical Management) to CEN Vice-President


Technical (2014-10-06)

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Letter from Head of Unit, DG SANCO B.2, European Commission to CEN Director of
Standards (2014-11-07)

Letter from CEN Director of Standards to Head of Unit, DG SANCO B.2, European
Commission (2014-11-13)

Letter from CEN Vice-President Technical to Deputy Director-General Directorates


B, C, E and F DG ENTR European Commission (2014-11-26)

ISO Council resolution 11/1987 and CEN General Assembly resolution 3/1990.

ISO Council resolution 35/2001 and CEN Administrative Board resolution 2/2001.

ISO Technical Management Board Resolution 105/2014 - Delays in developing


standards in the medical devices sector under the Vienna Agreement. Adopted 9-10
September 2014

Memorandum of understanding between ETSI and ITU (2012)

Standardisation mandate to CEN, CENELEC and ETSI for the development of EU


technical standards in the field of greenhouse gas emissions, December 2010

The Vienna Agreement - Day to day management between ISO/CS and CCMC –
May 2014

ICT rolling plan

European Commission (2012). 2010-2013 ICT Standardisation Work Programme for


industrial innovation 2nd update.

European Commission (2014). ICT Rolling Plan 2014

European Commission (2015). ICT Rolling Plan 2015.

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

COM(2014) 910 final

European Commission (2013). Communication from the Commission COM(2013)


408 final, 2013

Ibac (2009). IS-BAO Receives European Standards Recognition? Seen at:


http://checkforaviation.net/japanese/IBAC%20IS-
BAO%20Press%20Release%20August%2025.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

Regulation (EU) No 216/2008

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Regulation (EC) No 1592/2002 of 15 July 2002

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.

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;eurocae,dc;net

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3. ONLINE SURVEY

3.1 The online survey

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

Consultation Validation of findings


via
online survey
Industry NSBs Strategic objectives

Forward looking

Societal Fora and


stakeholders consortia

Members (through representatives)

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.

Major part of the answers was submitted by companies/industry. This strong


participation of the businesses in the survey (48% of answers comes from the
industry) is in line with the context of the Independent Review, where industry
holds the main role. The latter being the main users of the system,
company/industry perspective needed to be correctly reflected in this survey. The
chart below shows the breakdown of respondents by category. The category
denoted by ‘other’ consists of participants from ‘other standardisation bodies’
together with all participants that could not be classified in one of the other defined
categories.

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Respondent share by category
250 214
200
150
100 75
33 41
50 19 13 25 17
10
0
Company/Industry

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).

23/04/2015 Page 18 of 199


Respondent share by activity
200
152
150
100 71 76
44 39 41
50 27 19 17 27 13
8 7 4 3 1 3 1 2 0 5
0

VEHICLES AND MOTORCYCLES

O - PUBLIC ADMINISTRATION AND

P - EDUCATION
B - MINING AND QUARRYING

C - MANUFACTURING

E - WATER SUPPLY; SEWERAGE,

F - CONSTRUCTION

H - TRANSPORTATION AND

J - INFORMATION AND

L - REAL ESTATE ACTIVITIES

Q - HUMAN HEALTH AND SOCIAL

S - OTHER SERVICE ACTIVITIES


A - AGRICULTURE, FORESTRY AND

D - ELECTRICITY, GAS, STEAM AND

I - ACCOMMODATION AND FOOD

K - FINANCIAL AND INSURANCE

M - PROFESSIONAL, SCIENTIFIC

SUPPORT SERVICE ACTIVITIES

T - ACTIVITIES OF HOUSEHOLDS

ORGANISATIONS AND BODIES


DEFENCE; COMPULSORY SOCIAL

R - ARTS, ENTERTAINMENT AND


G - WHOLESALE AND RETAIL

AND TECHNICAL ACTIVITIES

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.

From a geographical perspective, in total, 447 stakeholders coming from 32


different geographic areas (30 EU/EFTA countries + international scale + Non-
EU/EFTA) completed the survey. 62 respondents indicates their organisation to
have an international scale and 4 respondents responded for a non EU/EFTA
country. The majority of comments comes from Germany. The high share of
German answers corresponds to the high involvement of German stakeholders in
standardisation. The next highly represented stakeholders are: organisations with
international scale3, United Kingdom and Sweden.

Respondent share by country

Germany
25%
32% International scale
United Kingdom
Sweden
5%
Belgium
6% France
7% 14% Others
11%

The major part (85%) of respondents declares to participate in standardisation


activities. Around one quarter of respondents indicates they do participate in
standardisation activities, buy standards for direct use and inform others about
standards. A small share of respondents declares to use standards without

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.

23/04/2015 Page 19 of 199


participating in standardisation development (5.6% of respondents); the limited
incidence of this last category might come from the initial selection of potential
respondents, might be due to the detailed information requested by the
questionnaire, or the lack of interest in a questionnaire focused on standardisation
activities.

How is your organisation involved in the ESS ?


400 380
350
300
250 218
203
200
150
98
100
50
0
Participates in activities Buys standards for direct Informs others about Other
use standards

Note: Multiple responses were allowed.

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.

Self-assessment of knowledge about the ESS and standardisation practices


4% 1%

31% Very high


23%
High
Moderate
Low
Very low

41%

In short, we notice that the main characteristics of the respondents are:

 Representing company/industry perspective;

 Reflecting manufacturing/construction sectors;

 Expressing large companies opinion;

 Based in Germany;

 Participating in standardisation activities.

In order to grant a good representation of the different categories, the profiles of


the respondents will be taken into account in the analysis of the survey results.

3.2 Analysis of the results

23/04/2015 Page 20 of 199


This analysis focuses on the quantitative and qualitative assessment of the
achievement of the five strategic objectives, the assessment of the governance,
and final recommendations submitted by the respondents. All the values below
represent the percentage of respondents by response choice.

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.

Moreover, a quite fragmented picture emerges from the assessment of the


“governance” of the ESS, intended as the systems of management and control of
the ESS and the communication flows among the actors.

In the following paragraphs, the results are presented per each question. Split by
categories of respondents, sectors and company size are also presented.

Moreover, a statistical analysis has been performed, applying a multinomial log-


linear model. With this analysis (hereafter referred to as “statistical analysis”), we
obtain an estimate of the relative chance of an answer and its statistical
significance, e.g. the chance to obtain “High” as an answer to that specific question
is statistically higher than the chance to obtain “Moderate” as answer. Therefore all
conclusion are comparisons between the different possible answer. The same apply
to the influence that specific variables can play on the subjects’ answers. We tested
our hypothesis at a level of statistical significance of 5% 4.

When significant differences in the answers depending on sector, company size or


category of respondents are highlighted, we report in the footnote the results of the
statistical analysis, in order to show if the differences observed are statistically
significant or not.

3.2.1 Speed and timeliness

The objective “Speed and timeliness” is intended as the speed of the


standardisation process and the time needed for standards to become available.
This objective is considered to be achieved if standards are available in a “timely”
manner (i.e. if the standard is available at the time it is needed).

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.

Speed and timeliness of the standardisation deliverables

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.

23/04/2015 Page 21 of 199


Do you consider that standardisation deliverables within the ESS are available in a timely
manner?
2%

16%
Yes
No
52% No opinion/cannot answer
30% (blank)

When disaggregating the answers by category of respondent, it appears that the


assessment of this objective differs depending on the respondent profile. The most
critical respondent categories are the “EC/EFTA and other European institutions or
agencies", the Conformity assessment/testing bodies5. This finding has to be put in
perspective with the strong belief of national standardisation bodies and ESOs that
standardisation deliverables within the ESS are available in a timely manner. The
industry has an ambivalent opinion.

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:

 High administrative burden and very bureaucratic process;

 Emerging of country-specific interests and diverging views influencing the


process and interference;

 Requirements from the EC often unclear and poorly defined;

 Lack of resources, leading to the involvement of volunteers, not working


full-time on standardisation activities, factors that make the progress of
work depending on the availability and commitment of the experts;

 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);

 Requirements related to the translation in different languages.

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”.

23/04/2015 Page 22 of 199


At the same time, about half of the companies/industries considers that the process
is timely. These companies acknowledge that the current speed is acceptable,
since:

 Quality is important and should be given priority over time;

 Time is needed to achieve consensus;

 The process is highly complex.

Comparing companies based on their size, no strong divergence of opinion is


observed about the perception of this strategic objective6.

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

0% 20% 40% 60% 80% 100%

Achievement of the goals related to “Speed”

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?

Quick publication of available standards in the OJEU


(for harmonised standards only)

Overall Speed of the standards development process Very high


High
Prompt involvement of the stakeholders Moderate
Low
Timely start of standardisation activities Very low
Early indication of forthcoming Union policy needs (EC (blank)
needs only), through the Union Work Programme

0% 20% 40% 60% 80% 100%

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’.

23/04/2015 Page 23 of 199


According to your experience, to what extent has the ESS achieved the goal "Overall Speed of
the standards development process)" ?

Service providers Very high


High
Moderate
Low
Goods manufacturers Very low
(blank)

0% 20% 40% 60% 80% 100%

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)

0% 20% 40% 60% 80% 100%

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.

Involvement of research institutes

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.

23/04/2015 Page 24 of 199


Should research institutes be further involved in standardisation activities, to ensure early start
of standardisation activities?
3%

19%
Yes
46% No
No opinion
(blank)
32%

Speed vs. quality of standards and inclusiveness

The perceived impact of the interest in speed on the quality of standards is


balanced, as shown by the distribution of the answers and the high rate of
abstention.

Has the interest in speed decreased the quality of the standard?

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.

23/04/2015 Page 25 of 199


Did improvement in speed impair the inclusiveness of the ESS?
2%

20% Very high


23% High
4% Moderate
Low
17% Very Low
34% (blank)

3.2.2 Competitiveness of European businesses, in the internal market

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.

Support to the competitiveness of European companies in the internal market

54% of respondents considers the objective of supporting “competitiveness of


European businesses, in the internal market” as achieved, against 24% of the
respondents thinking the contrary.

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:

23/04/2015 Page 26 of 199


 Barriers to trade are being reduced/eliminated, with positive effects on
cross border activities and the commercialisation of products in the internal
market;

 Cost is reduced as the same requirements are valid for several countries;

 Standards increase interaction amongst companies across the value chain;

 Harmonised and listed standards represent a huge benefit, facilitating the


EC marking and giving businesses an EU-wide market access;

 Standards solve technical problems and provide interoperability.

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:

 Cost is increased by additional requirements induced by the standards (e.g.


production costs increase due to requirements of safety standards);

 Additional efforts are required by companies (and especially SMEs) to


comply with the standards;

 Innovative technologies are always ahead of standards, so cannot increase


market penetration for these technologies.

No major differentiation appears between the different sectors 9.

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

0% 20% 40% 60% 80% 100%

Looking at the distinction between goods and services, on average, goods


manufacturers tend to support to a slightly greater extent the opinion that the ESS
provides enough support to the competitiveness of European companies, while
among the service providers a higher incidence of negative rating and “no
opinion/cannot answer” are recorded.

9
The observed trend is confirmed for Manufacturing Construction and Information and Communication
Technologies.

23/04/2015 Page 27 of 199


In your opinion, does the ESS provide enough support to the competitiveness of
European companies in the Internal market?

Service providers
Yes
No
No opinion/cannot answer
Goods manufacturers (blank)

0% 20% 40% 60% 80% 100%

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

0% 20% 40% 60% 80% 100%

Failure of the ESS to support competitiveness in the single market

A quarter of the respondents observes failure(s) of the ESS to support


competitiveness in the single market.

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:

 Standards sometimes mirror achievements of some monopolistic industry


stakeholders, or tend to adapt US standards into European standards,
harming SMEs competitiveness;

10
The statistical analysis confirms the significance of the effect: the larger is the company, the is higher
the chance for a ‘Yes’.

23/04/2015 Page 28 of 199


 Standards lead to such an extent of interoperability, that these does not
support any more innovation and quality;

 No action is undertaken when a NSB maintains a conflicting standard.

The categories of respondents that declared encountering situations in which the


ESS failed to support competitiveness are “others” (28%) (this category mainly
includes consultant/advisors in areas such as public affairs, standardisation, law,
etc., as well as national federations and associations), and the universities/research
institutes (29%).
Have you experienced any situation in which, in your opinion, the ESS failed to support
competitiveness in the single market?
100%
80%
60%
40% (blank)
20% No opinion
0%
No

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

0% 20% 40% 60% 80% 100%

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)

0% 20% 40% 60% 80% 100%

23/04/2015 Page 29 of 199


Achievement of the goals related to “Competitiveness of European businesses, in
the internal market”

Finally, when looking at the detailed goals about “competitiveness of European


businesses in the internal market”, the goals with the lowest achievement are
“enhancing companies’ growth and competitiveness”, the “reduction of production
costs for companies” and the “facilitation of the innovative technologies market
penetration”. Nevertheless, a majority of respondents agrees on the fact that the
ESS does facilitate cross-border activities and trade in the internal market.
Compared to large companies and professional associations, SMEs have a lower
perception of the achievements related to the four first objectives. The
disaggregation by company size does not provide such trend for the other three
goals11.

According to your experience, to what extent has the ESS achieved the following goals?

Enhancing companies’ growth and competitiveness

Facilitate access to EU market for EU SMEs


Very high
Developing standard deliverables being market relevant
High
Increasing interoperability of products Moderate
Low
Reducing the production costs for companies
Very low
Facilitating the market penetration of innovative technologies (blank)
Facilitating cross-border activities and trade in the Internal
market

0% 20% 40% 60% 80% 100%

3.2.3 Support to EU policy and legislation

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.

Effective support from the ESS to EU legislation and policies

62% of respondents affirms that the objective is achieved, against 13% of


respondents being of the opposite opinion.

Does the ESS act as an effective support to EU legislation and policies?


4%

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’.

23/04/2015 Page 30 of 199


Does the ESS act as an effective support to EU legislation and policies?
100%
80%
60%
40%
(blank)
20%
No opinion/cannot answer
0%
No
Company/Industry

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.

Does the ESS act as an effective support to 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)

S - OTHER SERVICE ACTIVITIES

0% 20% 40% 60% 80% 100%

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.

Does the ESS act as an effective support to EU legislation and policies?

Professional associations

Large
Yes
Medium No
No opinion/cannot answer
Small (blank)

Micro

0% 20% 40% 60% 80% 100%

Achievement of the goals related to “Support to EU policy and legislation”

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.

23/04/2015 Page 31 of 199


depend on the respondent’s definition of “early”). The goal with the highest
achievement is the improved safety of products, which is also further reflected at a
later stage of the analysis.

According to your experience, to what extent has the ESS achieved the following goals?

Use standards for facilitating compliance with


directives and regulations
Very high
High
Improved safety of product Moderate
Low
Very low
Early identification of standardisation needs (blank)
supporting policies and legislation

0% 20% 40% 60% 80% 100%

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)

0% 20% 40% 60% 80% 100%

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)

0% 20% 40% 60% 80% 100%

13
For all the sub-questions, the higher the number of Employees the higher the chance of ‘High’ as
answer.

23/04/2015 Page 32 of 199


According to your experience, to what extent has the ESS achieved the goal "Early
identification of standardisation needs supporting policies and legislation" ?

Professional associations
Very high
Large
High
Medium Moderate
Low
Small
Very low
Micro (blank)

0% 20% 40% 60% 80% 100%

Response to increased demand for standards to support EU legislation and policies

The system ability to respond to an increased demand for standards to support EU


legislation and policies is rather mitigated, with 32% of respondents that consider it
as high or very high, 28% as moderate and 16% as low or very low.

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%

3.2.4 Inclusiveness of the ESS

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).

23/04/2015 Page 33 of 199


Assessment of the inclusiveness of the ESS

54% of respondents considers the objective “inclusiveness of the ESS” to be


achieved, against 26% of the respondents who thinks the contrary.

Do you consider the ESS to be inclusive?


3%

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.

Do you consider the ESS to be inclusive?

C - MANUFACTURING

F - CONSTRUCTION
Yes
J - INFORMATION AND COMMUNICATION No
No opinion
M - PROFESSIONAL, SCIENTIFIC AND
TECHNICAL ACTIVITIES (blank)

S - OTHER SERVICE ACTIVITIES

0% 20% 40% 60% 80% 100%

14
Statistically, the observed difference in the trend is not significant.

23/04/2015 Page 34 of 199


As for the previous goals, a link between the company size and the judgment on
the achievement of the objective can be observed. Smaller companies consider the
ESS to be inclusive to a lower extend than large companies and professional
associations. The medium-sized companies have a positive answer rate ,very close
to the micro companies but a lower negative answer rate 15.

Do you consider the ESS to be inclusive?

Professional associations

Large
Yes
Medium No
No opinion
Small (blank)

Micro

0% 20% 40% 60% 80% 100%

Achievement of the goals related to “Inclusiveness of the ESS”

No significant difference is identified in the achievement of the goals included in the


objective “Inclusiveness”. The perception on the overall achievement is balanced,
as “moderate” was the most selected option and the shares of “high” and “low” are
similar.

According to your experience, to what extent has the ESS achieved the following goals?

Participation of Member States' public authorities


5% 20% 29% 18% 11% 17%
in the ESS
Very high
Participation of research community in the ESS 2% 25% 33% 19% 6% 16% High
Moderate
Representation of societal stakeholders Low
3% 24% 32% 18% 8% 15%
perspective in the ESS
Very low
Representation of SMEs views in the ESS 4% 26% 29% 18% 7% 15% (blank)

0% 20% 40% 60% 80% 100%

As these goals concern very specific categories of respondents, the analysis of the
concerned groups’ replies appears to be more insightful:

 The participation of Member States’ public authorities in the ESS is


considered low (the “low” and “very low” answers rate is higher than the
one of “high” and “very high”). This statement is reinforced when only
looking at public authorities answers. Indeed, they consider themselves as
even less involved in the ESS. The interpretation of this result has to be
considered carefully as around a fifth of public authorities representatives
did not express their opinion for this question.

 The average of respondents (representing mainly the industry opinion) and


the research community have a very different opinion on the achievement
level of the participation of the research institutions in the ESS. Indeed,
while on average, one quarter of respondents believes the research
community participation in the ESS to be low or very low, a majority of
respondents from the concerned group consider themselves as not enough
involved.

15
Statistically, the effect of the Number of Employees is not confirmed.

23/04/2015 Page 35 of 199


 The opinion on the participation of societal stakeholders in the process is
quite polarised: the share of respondents that believe the ESS achievement
of participation of societal stakeholders to be low and very low is similar to
the share of those answering high and very high. However, in this case, the
opinion of societal stakeholders about their participation in the ESS is close
to the average thinking.

 A significant difference between the average and SMEs opinions is observed


for what concerns the representation of small and medium-sized companies
in the ESS. Indeed, while 25% of all respondents believes the SMEs
representation goal is not achieved (“low” and “very low” ratings), this ratio
reaches to 42% when only SMEs answers are considered.

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%

Range of participants involved in the ESS standard setting processes

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.

In particular, public authorities, stakeholder organisations or NGOs, the


universities/research institutes as well as micro companies are not fully positive on
the achievement of this objective16.

16
In particular, the statistical analysis confirms the positive effect of Number of Employees on ‘Yes’ as
answer.

23/04/2015 Page 36 of 199


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% Yes
0%
No opinion

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

0% 20% 40% 60% 80% 100%

3.2.5 Support to the competitiveness of European companies at global


level

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.

23/04/2015 Page 37 of 199


Does the ESS supports the competitiveness of EU companies in the global arena?

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

Again, this objective is considered to be less achieved by small companies than by


large ones and professional associations18.

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

0% 20% 40% 60% 80% 100%

Achievement of the goals related to “Competitiveness of European businesses, at a


global level”

The recognition of international standards at the European level is slightly better


achieved than the recognition of European standards at international level. The two
other goals are not yet considered as completed.

According to your experience, to what extent has the ESS achieved the following goals?

Recognition of international standards at


European level
Very high
Recognition of European standards at
international level High
Moderate
Facilitating the establishment of business Low
partnerships around the globe
Very low
Facilitating market access outside EU/EEA (blank)

0% 20% 40% 60% 80% 100%

While the recognition of international standards at European level is perceived as an


achieved goal, a smaller share of respondent considers European standards to be
recognised at international level. “Facilitating the establishment of business
partnership around the globe” is not considered as a core objective of the ESS (as
the open comments suggest and the low rating assigned).

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.

23/04/2015 Page 38 of 199


Finally, the ESS appears to only partly achieve the goal of facilitating market access
outside EU/EEA; the cooperation for the definition of international standards is
considered highly important, but this process can be blocked by the need to take
into account the EU legislative requirements and deviate from the joint work at
international level. Interestingly, the most critical categories of respondents are the
“EC/EFTA, other European institutions and agencies”, which tend to assign a
negative rating to all the goals identified (please see the disaggregated results
shown in the charts below).

Among companies, the perception is generally positive, although a correlation


between the size of the company and the rating assigned is observed (smaller is
the company, lower is the perception on the achievement of this goal).

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

0% 20% 40% 60% 80% 100%

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

0% 20% 40% 60% 80% 100%

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

0% 20% 40% 60% 80% 100%

23/04/2015 Page 39 of 199


According to your experience, to what extent has the ESS achieved the goal "Facilitating market
access outside EU/EEA" ?

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

0% 20% 40% 60% 80% 100%

3.2.6 Services vs. Products and Mandated Standards vs. industry-led


standards

In the context of each strategic objective, the online survey asked whether:

 the achievement of the ESS objectives was different in relation to standards


for services, compared to standards for products;

 the achievement of the ESS objectives was different in relation to standards


triggered by EC standardisation requests, compared to standards triggered
by industry.

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

0% 20% 40% 60% 80% 100%

When considering the difference between the standards triggered by EC


standardisation requests and the standards triggered by the industry, around 40%
of the respondents thinks there is no difference (for all objectives). When
differences are pointed out, these are particularly noticed in the objective “speed
and timeliness objective”, with 38% of respondents thinking that there is a
difference.

The different processes (mandated vs. industry-triggered) seem to have a small


impact on the inclusiveness of the system, with only 21% of the respondents
pointing out differences.

23/04/2015 Page 40 of 199


From your perspective, is the achievement of the ESS objectives different in the situation of
standards triggered by mandate, compared to standards triggered by industry ?

Global market

Inclusiveness Yes
No
Competitiveness No opinion
(blank)
Speed and timeliness

0% 20% 40% 60% 80% 100%

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.

Governance of the ESS

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.

Do you consider the ESS to be well-governed ?


5%

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.

Do you consider the ESS to be well-governed?

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’.

23/04/2015 Page 41 of 199


Only small-companies have a majority of representatives that considers the ESS to
be well governed. For all other categories, except micro-sized ones, the share of
respondents that consider the ESS to be well governed is around 50% 20.

Do you consider the ESS to be well-governed?

Professional associations

Large
Yes
Medium No
No opinion
Small (blank)

Micro

0% 20% 40% 60% 80% 100%

The following split shows very small variance among sectors, since around 40% of
respondents from all sectors considers the ESS well governed21.

Do you consider the ESS to be well-governed?

C - MANUFACTURING

F - CONSTRUCTION
Yes
J - INFORMATION AND COMMUNICATION No
M - PROFESSIONAL, SCIENTIFIC AND No opinion
TECHNICAL ACTIVITIES (blank)
S - OTHER SERVICE ACTIVITIES

0% 20% 40% 60% 80% 100%

Communication within the ESS

Interaction and communication flows between actors


With regards to the communication within the ESS, the results seem to indicate
contradictory opinions. Only 39% of the respondents thinks that the interaction and
communication flows among actors are satisfactory, while about the same share of
the respondents is of the opposite opinion.

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%

The chart below shows the split by category of respondents 22.

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.

23/04/2015 Page 42 of 199


Are the interaction and the communication flows among actors (EC, the ESOs, Member States, NSBs
and other stakeholders) satisfactory?
100%
80%
60%
40% (blank)
20% No opinion
0% No

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:

 Many actors are involved in standardisation, and are not necessarily


working under a common approach. This seems to be related to low
communication/coordination between EC and ESOs, and between the
different TCs within the ESOs;

 Communication is mainly based on information going bottom-up, and the


information going top-down is limited. The lack of information about what
occurs in the mandating process (i.e. during the preparation of the
mandate) is highlighted;

 The information is not available in a centralised way, especially for TC-level


information which is not made available in a uniform way between the
different TCs;

 The communication flows are also considered as hampered by bureaucracy


and are perceived as too slow;

 Consultation of stakeholders within the ESS.

The majority of respondents feels sufficiently consulted. Only two categories of


organisations have less than half of their respondents that feels sufficiently
consulted: universities/research institutes and the category “others.

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’.

23/04/2015 Page 43 of 199


Considering your position within the ESS, do you feel sufficiently consulted?

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

Professional associations, large and small-size companies appear sufficiently


consulted while micro and medium-sized companies are not23.

Considering your position within the ESS, do you feel sufficiently consulted?

Professional associations

Large
Yes
Medium No
No opinion
Small (blank)

Micro

0% 20% 40% 60% 80% 100%

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.

23/04/2015 Page 44 of 199


Considering your position within the ESS, do you receive enough information?

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

Professional associations, large and small-size companies stated receiving enough


information while micro and medium have a more negative perception24.

Considering your position within the ESS, do you receive enough information?

Professional associations

Large
Yes
Medium No
No opinion
Small (blank)

Micro

0% 20% 40% 60% 80% 100%

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.

Participation of the stakeholders in the process


The current ESS governance system does not yet appear to ensure a full
participation and representation of all stakeholders.

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;

 (More) funding should be provided to stakeholders (especially smaller


companies) to improve their participation;

 Participation should be open to all types of interested parties, while the


influence from some participants (e.g. big multinationals) should be limited;

24
The dimension of a Company influences positively the chance for a ‘Yes’ as answer.

23/04/2015 Page 45 of 199


 Decision should be based on consensus, with a good representation of all
parties.

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

On average, the assessment of the different kinds of public consultation remains


positive. The availability of information to analyse and prepare the participation is
the best-graded goal (64% agree or strongly agree).

Assessment of public consultations (level of agreement on given statements)

You receive sufficient feedback/status about


comment
Strongly agree
Your input is sufficiently taken into account Agree
Undecided
You have enough information to analyse and Disagree
prepare your participation
Strongly disagree
You have enough time to analyse and (blank)
prepare your participation in European
standardisation
0% 20% 40% 60% 80% 100%

Administrative burden

With regards to potential avoidable burden(s), 28% of respondents declares to


have experienced administrative burden associated with their role in the ESS. In
general terms, the ESS is governed by a high number of rules, which (1) make the
participants reluctant to follow them and (2) do not always support the work of the
standardisation committees. The foreseen revision of Vademecum by the dedicated
task force is also expected –by some stakeholders- to result in unnecessary
administrative burdens.

The following bottlenecks are the most mentioned:

 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.

 Structure: the overlap and lack of harmonised processes between CEN,


CENELEC and ETSI are mentioned as a burden, along with the overload of
Committees.
23/04/2015 Page 46 of 199
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?
6%

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.

Is the Comitology procedure , introduced by Art. 10 of the Regulation(EU) No1025/2012, an


effective system to ensure the timeliness, transparency and inclusiveness of the ESS during
the mandating process?
100%
80%
(blank)
60%
No opinion
40% No
20% Yes
0%
Timeliness Transparency Inclusiveness

National implementation of European standards

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%

23/04/2015 Page 47 of 199


Appeal procedure

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.

Are you aware of the existence of an appeal procedure?


Are you aware of the existence of an appeal procedure?
Are you aware of the existence of an appeal procedure?
4%
4% Professional associations

9%
9%
Large
Yes
Medium
Yes YesNo
No No No opinion
32% 55% Small No opinion
32% 55% No (blank)
opinion
(blank)
Micro (blank)

0% 20% 40% 60% 80% 100%

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.

If you already used the appeal procedure, did it appear to be effective?


If you already used the appeal procedure, did it appear to be effective?
If you already used the appeal procedure, did it appear to be effective?

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%

3.2.8 Final comments

Definition of a good quality standard

According to the stakeholders, a good quality standard should be clear,


unambiguous and understandable by all. By doing so, the standard should
therefore leave no room for interpretation and be easily implementable.
Moreover, it should fulfil stakeholders needs, ensure safety and be market

23/04/2015 Page 48 of 199


relevant. Considering the rapidly changing environment, it should represent the
state of the art, available in a timely manner and long lasting. Good quality
standards are ones that are based on a high consensus between stakeholders and
that are accepted, recognized and adopted at a European level. Finally, good
quality standards should encourage technical innovation and European
competitiveness.

Quality level of standard deliverables

Based on the above-mentioned definition of a good quality standard, it appears that


almost half of the respondents believes European standard deliverables to fulfil
their needs, while 8% are of the opposite opinion.

To what extent does the quality level of European standard deliverables respond to your
needs?
5%

10% Very High


2% 8% High
Moderate
6%
40% Low
Very Low
No opinion/cannot answer
29%
(blank)

According to professional associations, the quality of European standard


deliverables answers to industry needs. Large, medium and small-sized companies
appear satisfied with the quality, while micro are of a more moderate opinion25.

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)

0% 20% 40% 60% 80% 100%

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.

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To what extent does the quality level of European standard deliverables respond to your
needs?

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)

0% 20% 40% 60% 80% 100%

In general, reasons advanced for low and very low ratings are mainly related to:

 Content: standards lack clarity, as they either provide minimum


requirements or are too complicated, making it difficult to understand and
leaving room for interpretation by the implementing parties. In addition, it
is estimated that standards are defined for large enterprises (industry
dominance in some TC), and are therefore not taking into account all
stakeholders needs.

 Stakeholders: a low participation from some stakeholders in the


standardisation process often leads to a lack of consensus.

 Process: the decision process is not transparent and has insufficient


financial support. Moreover, standards either take too long to be developed
or, if prepared in short timeframes, the quality is likely to be low due to the
reduced time spent by the experts involved.

Barriers in the current system and practices

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.);

 Process: high administrative burden, lack of transparency, insufficient


information during the drafting of EU-standards, complicated process and
not efficient communication flow;

 Stakeholders: stakeholders involvement is limited, SMEs are not well


represented, diverging national interests, influence of personal, industry
and political interests, and lack of fair consensus process;

 Standards: some standards can slow down innovation, national deviations


from the European standards become barriers to the free movement, and
issues with translations;

 Structure: overlap of competences and differences in working procedures


between the ESOs.

Areas of action to improve the system

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

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one for which only 42% of respondents replied with “very high” or “high” (however,
it has to be balanced with the fact only 7% voted “very low” or “low”).

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

0% 20% 40% 60% 80% 100%

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”.

Based on quantitative answers, it is possible to rank the areas of actions. By giving


a weight of “+2” to the number of “very high” answers, a weight of “+1” to “high”
answers, “0” to moderate answers, “-1” to “low” answers and “-2” to “very low”
answers, the following ranking is obtained, from the most crucial to the less
relevant:

1. Promote cooperation at global and European level, between European and


international standardisation organisations including other professional
standards setting bodies;
2. Promote the involvement of stakeholders and the development of inclusive
processes, as means to grant the alignment of standards to
market/consumer needs;
3. Strengthen the cooperation, coordination and communication flows among
standardisation bodies;
4. Promote awareness on the benefit of standardisation processes for
competitiveness and innovation;
5. Anticipate the identification of standardisation needs and accelerate the start
of the standard development process, in order to promote innovation and
prevent other countries/regions to develop competitive advantage;
6. Consider organisational and procedural adaptations in the ESO/NSB network
to update it with the future needs (with focus on technology convergence).
Respondents suggested additional areas of actions to ensure the relevance of the
ESS against future needs, its effectiveness, efficiency and coverage:

 Provide more funding for standardisation, in particular for smaller actors


(e.g. SMEs);

 Ensure involvement of all relevant stakeholders to develop quality


standards;

 Improve speed of the process, although speed must not prevail over
quality;

 Move away from paper system to the use of online interactive


resources;

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 Strengthen cooperation between actors;

 Keep European standardisation as simple as possible.

New technical domains to be covered by the standards

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:

 Internet of things: smart meters, smart grids, smart water, smart


objects, smart cities, smart factories/industry 4.0, e-mobility/e-cars,
interoperability, etc.

 Energy: climate change adaptation, sustainability, energy efficiency,


energy production, energy storage, energy distribution systems, etc.

 Health: health, hygienic requirements, standards for health professionals,


etc.

 IT: IT-security, IT-Privacy, remote access, database, secured data


transaction for end-users, software, software engineering, safety of
software, liability from software faults, etc.

 Transport sector: in general, non-road mobile machinery type approval,


hybrid power trains on non-road mobile machinery, hybrid non-road mobile
machinery type approval

 Safety/Security: automation security, ATEX safety for PPE, PPE against


hot vapour, technical security (resilience to cyber-attacks) of public/critical
infrastructures, railings or balustrades on apartment buildings, work safety,
etc.

 Others: market surveillance, LED lighting, fire classification, valuation of IP


assets, finance and banking, food industry, concrete and ventilation
products, glass structures, accessibility, crafts, etc.

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:

1. Lack of financial resources to run new ESO technical committees


2. Lack of interest of industry or other stakeholders to provide experts
3. Lack of experts to run new ESO technical committees
4. Lack of consensus between the different actors of the ESS
5. National interests to keep national standards
6. Primacy of international standards
7. Lack of cooperation with other specialised standards setting bodies
8. Existence of other bodies developing standards

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What are, in your opinion, the reasons that prevent the ESS to expand its scope to these new
technical domains?
Existence of other bodies developing standards

Primacy of international standards


Very high
National interests to keep national standards
High
Lack of consensus between the different actors of the ESS
Moderate
Lack of cooperation with other specialised standards setting…
Low
Lack of interest of industry or other stakeholders to provide…
Very low
Lack of financial resources to run new ESO technical committees
(blank)
Lack of experts to run new ESO technical committees

0% 20% 40% 60% 80% 100%

Overall assessment of the five ESS objectives

Comparing transversally the five ESS objectives per organisation category


highlights following facts:

 Positive achievements: The European standardisation organisation


(ESOs) and National standardisation bodies (NSBs) representatives appear
the most optimistic as they do fully consider the ESS five objectives to be
completed.

 Objectives reasonably achieved: The industry, the conformity


assessment/testing bodies, the public authorities, the stakeholders
organisations or NGO as well as the “other” category do believe the five
ESS objectives to be reasonably reached.

 Moderate opinion: The other standardisation bodies are not convinced of


the objectives achievement as they indicated for 4 out 5 objective a
moderate level of success. The only objective that they consider as
reasonably attained is the one related to inclusiveness.

 Mainly negative opinion: The “EC/EFTA, and the other European


instititions or agencies” and the Universities/Research institutes show very
different opinions depending on the objectives, and mostly negative.

Achievements of the ESS

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.

Recommendations for the overall improvement of the ESS

The main suggestions mentioned by respondents are summarized below, according


to the main areas of intervention:

Table 1: suggestions for improvement

Resources Process

 Provide better (financial) support to  Reduce administrative burdens and


participants (experts, industry bureaucracy
practitioners, Annex III organisations,  Make the process faster and more
etc.) efficient
 Better staffing and more experts in the  Simplify the process: the ESS should be
new fields of technology made more flexible, the process less

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 Train standard developers about EU complicated and less focused on
legislation and increase the knowledge of procedural issues
the SMEs and other stakeholders  Greater transparency regarding
participants, responsibilities, rules and
results of standardisation process
 Innovate the process: moving from
paper-based business models to ICT
enabled processes
 Stabilize provisions for the drafting of
standards and give a longer life to
templates
 Use one working language (English)
 Improve the efficiency of the European
Mirror bodies in converting an ISO
Standard in EN ISO standard, skipping
bureaucratic delay

Stakeholders (involvement) Actors (cooperation)

 Promotion of standards based on a broad  Strengthen the cooperation and


consensus, both national and European consultation between all interested
 Increased stakeholder participation: make parties within the ESS, mainly amongst
sure that there is a continuous EC, national governments and ESOs
participation of technical experts from  Strengthen the NSBs in the smaller
industry, including the EU member state, member states, to improve attractiveness
SMEs, citizens, consumers, academia, for SMEs and other underrepresented
NGO's, etc. in the process stakeholders to contribute with their
 Less political steering, more recognition of technical expertise into the
the abilities of the market to find the right standardisation process
priorities  Improved coordination of ISO/ESS
 Standards should represent the needs of activities and consequent approval of
smaller businesses and the public these standards on a global level
authorities  Greater interest in cooperation with other
 More involvement of external fora and consortia
stakeholders through public consultations  Improved relationships with research to
 Increase the involvement of EU and enable the easier commercialization of
National Authorities in the drafting of the innovations
standards and increase the participation
and contribution of the CEN consultants
(NAC) since the early steps of the
standardisation process

Structure Role of the ESS

 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

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 Revision of access to standardisation and environment
“free” availability of standards
Communication
 Improve the quality of translations to
avoid technical mistakes  Better awareness and promotion of the
importance and potential benefits of
 Control the number of new standards and
European standards
reduce the multiple amendments
 Improve education about standardisation,
at all levels in companies, in policy and
decision makers - its coherent use and
trust in the expertise of the ESOs

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4. QUESTIONNAIRE TEMPLATE

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.

2. Information about the questionnaire

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).

In the questionnaire, the following key abbreviations are used:


• EC: European Commission
• ESS: European standardisation system
• ESO: European standardisation organisation (CEN, CENELEC and ETSI)
• NSB: National standardisation body

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Depending on the question, the input method will vary:

- “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.

This questionnaire is hosted on an independent platform guaranteeing safety of data. The


answers collected through this questionnaire will be treated in a confidential way and
individual results will not be communicated to any third party. Aggregated results by
category will however be used within the remit of the Independent Review.

3. General information on the


Institution/Organisation/Company

1. Please identify yourself


(The information provided will only be used for identification purposes and will not be
disclosed)

What is the name of your Click here to enter text.


Institution/Organisation/Company ?
What is your name (first name + last name) ? Click here to enter text.
What is your email address ? Click here to enter text.

2. For which country are you responding ?


(Please select international in case of international scale )

Please select a country


Responding for Click here to enter text.
the country

3. If relevant, please select the NACE code corresponding to your activity, or the activity you
represent:

☐ A - AGRICULTURE, FORESTRY AND ☐ L - REAL ESTATE ACTIVITIES


FISHING ☐ M - PROFESSIONAL, SCIENTIFIC AND
☐ B - MINING AND QUARRYING TECHNICAL ACTIVITIES
☐ C - MANUFACTURING ☐ N - ADMINISTRATIVE AND SUPPORT
☐ D - ELECTRICITY, GAS, STEAM AND AIR SERVICE ACTIVITIES
CONDITIONING SUPPLY ☐ O - PUBLIC ADMINISTRATION AND
☐ E - WATER SUPPLY; SEWERAGE, WASTE DEFENCE; COMPULSORY SOCIAL SECURITY
MANAGEMENT AND REMEDIATION ACTIVITIES ☐ P - EDUCATION
☐ F - CONSTRUCTION ☐ Q - HUMAN HEALTH AND SOCIAL WORK
☐ G - WHOLESALE AND RETAIL TRADE; ACTIVITIES
REPAIR OF MOTOR VEHICLES AND ☐ R - ARTS, ENTERTAINMENT AND
MOTORCYCLES RECREATION
☐ H - TRANSPORTATION AND STORAGE ☐ S - OTHER SERVICE ACTIVITIES
☐ I - ACCOMMODATION AND FOOD SERVICE ☐ T - ACTIVITIES OF HOUSEHOLDS AS

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ACTIVITIES EMPLOYERS; UNDIFFERENTIATED GOODS-
☐ J - INFORMATION AND COMMUNICATION AND SERVICES-PRODUCING ACTIVITIES OF
☐ K - FINANCIAL AND INSURANCE HOUSEHOLDS FOR OWN USE
ACTIVITIES ☐ U - ACTIVITIES OF EXTRATERRITORIAL
ORGANISATIONS AND BODIES

4. To what category does your Institution/Organisation/Company belong to ?

Please select one


To what category does your Click here to enter text.
Institution/Organisation/Company
belong to ?
For companies, please indicate the number of employees if it is a SME /For EC/EFTA, please
indicate the service / For Other European institutions or agencies, please indicate the
institution or agency/ For ESOs, please indicate what ESO/ For the NSBs, please indicate the
field of activity/ For other standardisation bodies, please indicate the name/ For Stakeholder
organisations or NGOs, please indicate whether it is national or international and the
stakeholder group represented/ For others, please specify the involvement within the ESS

Click here to enter text.

5. Experience in standardisation: How is your organisation involved in the ESS ?

☐ 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.

7. Self-assessment of knowledge about the ESS and standardisation practices in general

Self-assessment Choose an item.

4. Objective "Speed and timeliness"

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?

☐ Yes ☐ No ☐ No opinion/cannot answer

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

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possible. If you see any other achievement, please specify.

Achievements to date Expected


(rating) achievement (rating)
Early indication of forthcoming Union policy Choose an item. Choose an item.
needs (EC needs only), through the Union
Work Programme
Timely start of standardisation activities Choose an item. Choose an item.
Prompt involvement of the stakeholders Choose an item. Choose an item.
Overall Speed of the standards development Choose an item. Choose an item.
process
Quick publication of available standards in Choose an item. Choose an item.
the OJEU (for harmonised standards only)
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

Click here to enter text.

10. Has the interest in speed decreased the quality of the standard? Also, what is the
expected impact?

Impact to date Expected impact


Impact of the improved interest in speed on quality of Choose an item. Choose an item.
standards
Additional comments
Click here to enter text.

11. Should research institutes be further involved in standardisation activities, to ensure


early start of standardisation activities? Please explain the expected impact/outcomes.

☐ Yes ☐ No ☐ No opinion/cannot answer


Additional comments
Click here to enter text.

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.

5. Objective "Competitiveness of European businesses, in the


internal market"

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14. In your opinion, does the ESS provide enough support to the competitiveness of
European companies in the Internal market (by removing conflicting national standards,
facilitating free movement of goods and providing state of art specification in wide range of
technical domains)?

☐ Yes ☐ No ☐ No opinion/cannot answer

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

Click here to enter text.

16. Have you experience any situation in which, in your opinion, the ESS failed to support
competitiveness in the single market?

☐ Yes ☐ No ☐ No opinion/cannot answer


Additional comments
Click here to enter text.

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.

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6. Objective “Support to EU policy and legislation”

19. Does the ESS act as an effective support to EU legislation and policies?

☐ Yes ☐ No ☐ No opinion/cannot answer

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.

Achievements to date Expected


(rating) achievement (rating)
Early identification of standardisation needs Choose an item. Choose an item.
supporting policies and legislation
Improved safety of products Choose an item. Choose an item.
Use standards for facilitating compliance with Choose an item. Choose an item.
directives and regulations
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

Click here to enter text.

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.

☐ Very High ☐ High ☐ Moderate ☐ Low ☐ Very Low ☐ No


opinion/cannot
answer
Additional comments
Click here to enter text.

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.

7. Objective “Inclusiveness of the ESS”

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

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elderly and disabled people) and develop close cooperation among partners (ESOs, NSBs,
public authorities at EU and national level)

24. Do you consider the ESS to be inclusive?

☐ Yes ☐ No ☐ No opinion/cannot answer

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.

Achievements to date Expected


(rating) achievement (rating)
Representation of SMEs views in the ESS Choose an item. Choose an item.
Representation of societal stakeholders Choose an item. Choose an item.
perspective in the ESS
Participation of research community in the Choose an item. Choose an item.
ESS
Participation of Member States' public Choose an item. Choose an item.
authorities in the ESS
Please specify other achievements you would have identified

Click here to enter text.

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.

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Click here to enter text.

8. Objective "Competitiveness of European businesses at a


global level"

Objective "Competitiveness of European businesses at a global level", intended as support in


reaching foreign market and establishing industry partnerships around the globe

30. Does the ESS supports the competitiveness of EU companies in the global arena?

☐ Yes ☐ No ☐ No opinion/cannot answer

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.

Achievements to date Expected


(rating) achievement (rating)
Facilitating market access outside EU/EEA Choose an item. Choose an item.
Facilitating the establishment of business Choose an item. Choose an item.
partnerships around the globe
Recognition of European standards at Choose an item. Choose an item.
international level
Recognition of international standards at Choose an item. Choose an item.
European level
Please specify any other achievements

Click here to enter text.

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.

9. Governance of the ESS

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”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 speed, efficiency of the communication and quality of the ESS

34. Do you consider the ESS to be well-governed?

☐ 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/cannot answer


If you do, which are the bottlenecks in the process and which corrective actions would you
suggest ?
Click here to enter text.

37. Is the Comitology procedure , introduced by Art. 10 of the Regulation(EU) No1025/2012,


an effective system to ensure the timeliness, transparency and inclusiveness of the ESS
during the mandating process?

Yes No No opinion
Timeliness ☐ ☐ ☐

Transparency ☐ ☐ ☐

Inclusiveness ☐ ☐ ☐

If the answer to one of the previous questions is “no", which improvements could be made?

Click here to enter text.

38. Have you identified issues in the delay for national implementation of European
standards?

☐ Yes ☐ No ☐ No opinion/cannot answer


Additional comments
Click here to enter text.

10. Governance of the ESS

Active participation of all the stakeholders

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

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If not, which improvements could be made?
Click here to enter text.

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?

Click here to enter text.

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.

45. Are you aware of the existence of an appeal procedure?

☐ 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?

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☐ Yes ☐ No ☐ No opinion
Other (please specify)
Click here to enter text.

11. Final comments and recommendations

Is the ESS fit for future challenges?

48. What is, in your opinion, the definition of a good quality standard?
Click here to enter text.

49. Based on your previous answer, to what extent does the quality level of European
standard deliverables respond to your needs?

☐ Very High ☐ High ☐ Moderate ☐ Low ☐ Very Low ☐ No


opinion/cannot
answer
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.Click here
to enter text.

50. Are there any new technical domains which you consider insufficiently covered by
European standards (i.e. where European standards are missing/urgently needed?)
Click here to enter text.

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
Click here to enter text.

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

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Anticipate the identification of standardisation needs and Choose an item.
accelerate the start of the standard development process, in
order to promote innovation and prevent other
countries/regions to develop competitive advantages
Promote the involvement of stakeholders and the development Choose an item.
of inclusive processes, as means to grant the alignment of
standards to market/consumer needs
Promote cooperation at global and European level, between Choose an item.
European and international standardisation organisations
including other professional standards setting bodies
Strengthen the cooperation, coordination and communication Choose an item.
flows among standardisation bodies
Promote awareness on the benefit of standardisation processes Choose an item.
for competitiveness and innovation
Consider organisational and procedural adaptations in the Choose an item.
ESO/NSB network to update it with the future needs (with focus
on technology convergence)
Please specify any other

Click here to enter text.

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?
Click here to enter text.

54. What do you consider to be the greatest achievements of the ESS?


Click here to enter text.

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.

12. Contact for follow-up

57. I accept to be contacted for further discussion about the ESS.

☐ Yes ☐ No

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5. CASE STUDIES
In the following paragraphs, the complete case studies are reported. The related
information and findings have been also used in the Final Report, to substantiate its
overall findings. Moreover, per each case study a number of “Opportunities for
improvements” are identified; these have formed the basis for the definition of the
general recommendations listed in the Final Report. Finally, the case studies
highlighted some areas to be further investigated, when the available evidence did
not allow to formulate conclusive suggestions for improvements.

5.1 Speed - Responsiveness of the ESS in addressing EC needs

5.1.1 Identified issue of the case study

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.

Scope of the case study

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.

The problem statement is the following:

“How fast is the standard development initiated, following the submission of a


mandate to the ESOs?”

Context

 Standardisation requests from the Commission: the Commission may


request European standardisation organisations to develop standards or
other deliverables, dedicated to support Union legislation and policies. These
documents, developed on the basis of a Commission mandate, concern less
than 20% of the standards developed within the European Standardisation
System.
This process is initiated where there is:

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- A need for standards supporting Union harmonisation legislation: the
standards delivered will be “harmonised standards” (as defined in
Art. 1(1)c of Regulation (EU) No 1025/2012).
- A need for standards or other deliverables supporting Union policies.

 Standardisation process: upon receipt of a standardisation request from


the Commission, two consecutives phases are undertaken by the ESOs.
First, a preparatory stage is performed. This preparatory stage includes
activities not considered (by the ESOs) as part of the standard development
process:
- Acceptance of the mandate – Confirmation of the acceptance of the
mandate by the relevant(s) ESOs and related analysis;
- Preparation work – All project management activities that need to be
performed by the ESOs prior to standard development;
- Pre-normative research (optional) – Development of knowledge and
expertise required for future standard development but not yet
available (e.g. in the case no expert is available for developing a
standard related to a highly technical matter, or/and when testing in
laboratories is required), or literature study on the basis of existing
available standards.

The speed of these individual stages is however difficult to monitor, as some


work might be initiated from an informal perspective, without being recorded
(excepted that for mandate acceptance, which should now occur within 1
month of notification of the mandate).
Second, the standards are developed26 as such. Standards therefore go
through:
- Drafting;
- Public consultations: time needed for this second phase can be
analysed based on ESOs data. For the European standards made
available between 2009 and 2013, being home-grown 1st edition
standards27, the average time for development decreases for all
ESOs.

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).

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Development time for home-grown 1st edition standards (extremes excluded (5%))
3000

2500

2000

1500

1000

500

0
2009 2010 2011 2012 2013
CEN CENELEC ETSI

Source: ESO Data. EY Computation.

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

Source: ESO Data. EY Computation.

 Defining speed and corresponding needs: speed is defined by the


Commission as one of the strategic objectives of the Communication
COM(2011) 311. This implies that:
- European standards (in general) need to be quickly available to
keep pace with quick changes occurring in modern markets.
Considering the fast-changing environment, the shorter life-cycles
and the reduced technologies time-to-market, standards need to be
available faster than ever.
- In case of harmonised standards, the Union partly relies on the
availability of technical specifications given in European standards,
and timely availability of such standards is usually crucial in order to
enable smooth functioning of the markets and appropriate
implementation of the relevant legislation.

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.

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Case selected

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.

Mandate Notification date CEN CENELEC ETSI


M/397 21/12/2006 
M/417 7/12/2007 
M/420 9/01/2008 
M/453 13/10/2009 
M/476 2/12/2010 
M/478 16/12/2010   
M/480 16/12/2010  
M/513 13/12/2012 
M/520 13/03/2013 
M/522 13/03/2013 

5.1.2 Analysis and findings

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.

Comments on area of focus

 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.

Volume of WI initiated in the given timeframe after transmission of a mandate/standardisation request


80
70
60
50
40
30 ETSI
20
CCLC
10
0

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).

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Second, major part of work items are initiated within 3 or 4 years after the
notification of the mandate to the ESOs. This implies that, in addition to the
time needed for developing a standard, 3 or 4 years need to be added as the
work is not initiated immediately upon receipt of the mandate.
Third, work has not yet been started for mandates M/420 and M/513.

 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.

 Close-up on M/453: the mandate was notified to the ESOs on 13/10/2009,


and a wide range of deliverables have been developed since by CEN and
ETSI. The graph below represents each work-item initiated by an ESO in the
scope of the Mandate M/453. It appears that major part of deliverables were
initiated within a timeframe of 3 years after the notification of the mandate
to the ESOs, and that most of work items were developed in less than one
year.

Progress on M/453 - Work item for 1st ed document start/end - CEN-ETSI


12/10/2015

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)

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In the end, despite having a very short development timeframe, it can be
observed that the late start of standardisation activities has a strong impact
on the timely availability of standards.

 Timeframe for starting and finishing the work: from a qualitative


perspective, it has been noted that the new mandates were acting in favour
of timely start of standardisation activities: considering the fact that the new
mandates are supposed to have a pre-defined scope and deadlines -which
are made compulsory through the binding nature of the mandate and
enforced through penalties in FPAs-, and the fact that ESOs should notify
their acceptance within one month upon receipt of the request.

Moreover, the more formalised involvement of European standardisation


organisations in the drafting of the work should ensure that the final
mandate is acceptable, and standardisation work is therefore expected to be
“more timely”29. For these reasons the risks encountered in the past (i.e.
mandates accepted and let “on hold” or only partly accepted) are also
expected to be overcome.

 Interest in speed: this case study is focused on the analysis of the


responsiveness of the ESS in addressing Union needs expressed in EC
mandates. This case therefore focuses on how timely the ESOs are in
answering EC requests. The concept of speed is however a very
controversial aspect, as all actors pursue very different objectives within
standardisation. This is however further elaborated in the main report (Final
Report).

 Other elements impacting speed: the “speed” analysis performed in this


case study only focussed on a single part of the process leading to the
publication of standards (or to publication of their references in the OJEU,
for harmonised standards). When looking at the speed of the process, it
should be highlighted that many parts of the process have an influence of
this overall timeframe, and that many parts of the process are inherent to
the standardisation work and can therefore not be reduced.

 Transparency of information: based on the difficulty for accessing data


about this case study, and on the basis of the difficulties encountered in
interpreting the data from the various databases, it cannot easily be used for
monitoring purposes.

5.1.3 Conclusions and recommendations

Conclusions

From a qualitative perspective, it appears that the implementation of the new


regulation has induced major changes in the way mandates are designed (the
scope of mandates is –theoretically- more accurate, as well as the deadlines for
publication), and therefore in the way mandates are accepted by the ESOs.

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.

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The fact that a one of the new mandates was rejected by the ESOs could be an
indication that the ESOs take into account their delivery capability assess the
market relevance of the mandate before its acceptance.

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.

Opportunity for improvement 1: Defining EC objectives and agree on


monitoring

The concept of “speed” needs to be better defined in particular for standards


requested by the Commission, together with criteria for the measurement of this
“speed”. Currently, ESOs monitor the “speed” of the standard setting process as
the time elapsed between “the decision on WI/start of drafting” (for CEN-CENELEC)
or “first draft available” (for ETSI), and “the date of availability of the standard” (for
CEN-CENELEC) or “publication of the standard” (within ETSI). Other critical
activities are undertaken outside of this timeframe, and we therefore understand
that the milestones selected for “speed” measurement should be refined: “the start
of the development” as usually selected by the ESOs is rather a date after which
the development process is officially opened to all stakeholders while preparatory
work may start even many years before.

Opportunity for improvement 2: Improved information exchange

In order to have a timely start of standardisation activities, ESOs should be


involved soon enough in the process and have accurate information about the
status of development of the mandates. Moreover, they should be continuously
informed about changes in the mandate. This aspect is further elaborated in the
case study dedicated to the functioning of the mandating process (the eInvoicing
standardisation request).

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).

Suggestion to be further studied: Comparing speed and benefits achieved

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.

Even though an improvement in the speed would be appreciated, such interest in


speed should not harm the benefits brought by the system.

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5.1.4 Appendix

Data collection

Information about the following milestones were communicated from CEN,


CENELEC and ETSI

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

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5.2 Innovation and Research - Anticipation of standardisation needs in
additive manufacturing

5.2.1 Identified issue of the case study

Legal basis – framework

The Communication COM(2011)311 Final highlights that European competitiveness


is highly depending on the ability to foster innovation. Innovation is a key
component of the Europe 2020 and of the Commission flagship initiatives on
“Industrial Policy” and “Innovation Union”30.

European standards can support innovation as they can 31:

 Codify the state of the art of existing technologies;


 Facilitate the introduction of innovative products;
 Facilitate market acceptance of innovations;
 Underpin a technological platform on which other innovation can take place;
 Help to bridge the gap between research and marketable products/services.

Scope of the case study

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.

The problem statement is the following:

“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:

 Timely start of standardisation activities: Many activities need to be


performed before the actual start of “standard development” activities (e.g.
pre-normative, peri-normative and co-normative research). These activities
should be started soon enough to ensure that standards are available when
they are actually needed.
 Cross-disciplinary aspects: Standardisation issues are becoming more
complex. To that extent, standardisation work now overlaps multiple fields
of expertise.

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.

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Context

Standards have been identified as a critical aspect of the smooth introduction


of innovative technologies in the market. In the telecommunications sector,
one major reason for the success of the GSM industry is the fact that standards (in
the newly-developed ETSI), innovation and research, and regulation went hand-in-
hand. Although the ICT sector recognised this synergy some decades ago, other
research communities saw standardisation in negative terms (as outlined below).

It is only relatively recently that a concentrated effort has been made to


systematise linkages between standardisation and innovation. Following a 2008
Commission Communication on the subject32, CEN and CENELEC formed a policy
group STAIR ("Standards, Innovation and Research"), including national standards
bodies, some partner organisations, and representatives of the Commission 33. This
STAIR group gives strategic advice to the two Technical Boards (of CEN and
CENELEC) in order to reach an integrated approach and to develop the links
between research, innovation and standardisation. STAIR advocated this
“Integrated Approach”, with the need for associated standards being systematically
considered as a part of research project planning, thus encouraging earlier
standardisation.

In 2013, CEN and CENELEC published a “Study on the contribution of


standardisation to innovation in European-funded research projects”, while some of
their members have been running a project BRIDGIT (“Bridging the Gap between
Research and Standardisation”34) –which held a conference in autumn 2014 on the
overall topic- and engaged a further study carried out by Technopolis on the overall
benefits of linking innovation and standardisation 35.

 Standards as enhancing or hampering innovation: as summarised in


the first paragraphs of this case, it is recognised that standardisation has a
huge impact on innovation. Indeed, standardisation can be considered as an
innovation catalyst, by:

- Supporting innovation: Standards support the conversion of


research in innovation, by helping bringing products to the market
and promoting technology diffusion36.
- Creating room for innovation: Standards make ground for future
innovation, by ensuring a common research infrastructure (e.g. this
was the case with the GSM industry)37. In that case, standardisation

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.

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designs the framework that will support future innovation38 39. In the
same logic, standards allow companies to work in a stable framework
and therefore to make investments with a reduced risk;
- Innovating through standards: The standard development
process is based on consensus building. Standards can therefore be
considered as the result of a cooperative innovative process, putting
together the knowledge and experience collected by different experts,
with different backgrounds.

It however appears that standardisation can also be perceived as


hampering innovation, through the early market harmonisation based
sub-optimal technologies. The QWERTY keyboard –as an example- is
currently not the most adequate layout for modern keyboards but benefits
from a widespread diffusion.

 Identified needs for the future: early identification of new standards


topics is paramount, and depends on a good process at research level. The
European Commission's Joint Research Centre (JRC) has been instrumental
in developing “foresight” of longer-term needs, and JRC has taken care to
develop greatly-improved links with standardisation: it now collaborates
closely with the ESOs on standards for innovation. The Joint Research
Centre performed a foresight study entitled “How will standards facilitate
new production systems in the context of EU innovation and competitiveness
in 2025?”. This study defines the future industrial landscape, identifies areas
requiring standard development and defines several required ESS
improvements to fulfil future needs.

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.

As a pilot, STAIR therefore decided to create a “Platform on Additive


Manufacturing” (STAIR-AM), as an informal working group aimed at improving
dialogue between the relevant research and standardisation communities
on an appropriate new subject. It was felt that such an informal group would be
able to deliver better and faster results than a more traditional approach, of first
setting up a new Technical Committee. Similarly to its mother platform, STAIR-AM
is not a funded activity and relies on the interest of stakeholders in participating in
the platform.

The current case study therefore focusses on the STAIR-AM perspective –and
additive manufacturing- for illustrating the link between research and innovation,
and standardisation.

Additive manufacturing is a game changer in manufacturing. Traditional


manufacturing has been mostly based on matter removal: cutting, milling, drilling,
for obtaining the desired physical object. With additive manufacturing, the concept

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.

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is fundamentally different: matter is progressively added, instead of removed. The
main advantage induced by additive manufacturing is flexibility: additive
manufacturing allows easy/fast prototyping, a facilitated idea-to-product process,
the production of a wide variety of physical objects on a single equipment, and
therefore an easy reaction to consumer/market/environment change, where small
batches of production are sufficient. This facilitated idea-to-product process could
also induce a radical change in the global value chain organisations, as they would
facilitate tailored local production at acceptable costs40. Moreover, based on the
logic of “adding matter”, only the needed amount of resources is used (against
traditional manufacturing, where unnecessary matter is removed and then thrown
away). However, a generally expressed drawback of additive manufacturing is that
improvements are still needed in end-product quality.

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”.

STAIR-AM, with a secretariat provided by the German standardisation body, DIN,


kicked off its activities in March 2013. The platform involved CEN Members, the
European Commission's Joint Research Centre research project participants, and
representatives of standards organisations such as ASTM or ISO. STAIR-AM's stated
mission was “to drive the growth of AM to efficient and sustainable industrial
processes by integrating and coordinating standardisation activities for Europe”,
and therefore STAIR-AM could take a view from the standardisers' perspective on
SASAM's emerging 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.

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5.2.2 Analysis and findings

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.

Comments on area of focus

 Timing: additive manufacturing is a concept which was developed a few


decades ago, but only the latest development in material science triggered
the actual uptake of this technology. However, additive manufacturing has
already a diverse range of applications in different “traditional” manufacturing
sectors, ranging from aerospace to plastics, and reaching into service sectors
such as dentistry.

In the field of additive manufacturing, it appears that some NSBs started


considering standardisation work some years ago. The Business Plan of ISO
TC26144 (itself created in 2011) –dedicated to additive manufacturing- states
that several initiatives had already been undertaken some years before (in
Germany, Spain, France and the US-based SDO ASTM45)46. In 2011, the
primary AM market was already estimated as being worth 1.7bn$ (report
cited in the ISO TC Business Plan). These initial activities are most likely to be
driven by industry seeking the added-value of early standardisation and
pushing for the creation of appropriate activities.

It is therefore surprising that, given the existence of the Commission-led AM


Platform since 2007, an earlier start was not made to the consideration of the
standards requirements for this subject at European level. Outside Europe,
ASTM was certainly active very early in this domain, and its Technical
Committee F.42 on AM (formed in 2009) now claims over 200 participants.

It is possible that the work in ISO TC261 was driven by European-based


industry as a reaction to the activities in ASTM, certainly DIN provides the
Secretariat to the TC and any working group activity. This said, the ISO TC is
now working closely with ASTM's, and a first agreement between the two was
set-up in 2011. Moreover, a fast-track process allow both organisations to
publish each-others standards, in order to avoid duplication of work.

It remains that, as late as February 2014, the AM-Platform Strategic Research


Agenda (SRA) references ASTM on standardisation issues, and not ISO, nor
SASAM, nor STAIR-AM. Subsequently, although the SASAM Project closed in
March 2014, at the time of writing there seems to be no further progress on
AM standards issues.

 Cross-disciplinary aspects: as noted above, additive manufacturing is a


technology that is of interest for quite a range of industry sectors. Moreover,
additive manufacturing is based on a wide range of technologies which enable
additive manufacturing (e.g. advanced materials, sensors, etc.). The February

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.

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2014 SASAM standardisation roadmap cited five TCs in ISO and two in CEN
that were already involved in additive manufacturing standardisation.
Industry sectors with an interest in AM standardisation clearly needed to take
appropriate action to ensure standardisation work to be performed as
smoothly and quickly as possible.

As a co-ordination activity, STAIR-AM could ensure collaboration and


alignment between the relevant Technical Committees– though it is not clear
whether this has really happened or was even needed as there were only two
TCs in Europe related to AM standardisation. Coordination between TCs
ensures that there is dialogue between the individual disciplines on matters of
common interest, and avoids having experts working in silos. A coordinating
aspect is therefore important for means of developing the horizontal aspects
of standardisation, needed for ensuring a consistent standardisation approach
between the different sectors. The “terminology”, “general process issues”
and “general test methods” are example of horizontal aspects, which require
coordinated standardisation. These horizontal standards are required as early
as possible, as they define the framework for future innovation and act as
“market enablers”. For AM, these horizontal standards have been produced,
or are under development- in ISO TC261, and any standardisation activity
carried out in individual CEN TCs should be compatible with ISO’s horizontal
standards.

 European versus international aspects: the SASAM project was a very


strong advocate of the concept of “Primacy of international standardisation”.
The SASAM Standardisation Roadmap notes an agreement between ISO and
ASTM to create a global framework, and the SASAM consortium “very much”
recommended that “Europe supports a common development of AM standards
via ISO-ASTM with an appropriate involvement of European experts 47”, rather
than seeking to develop the required standards only within Europe 48. To
ensure European adoption of the standards, the Vienna Agreement between
ISO and CEN was mentioned (this arrangement is covered in a separate case
study).

The documentation from the European AM Platform also supports this


approach, although in discussions at a Commission AM workshop (held in
June 201449), participants noted “a lack of standardisation efforts in the
coordination and alignment with existing EU and US efforts” (sic) and that
“there is a limited development of standards. Many research programmes
could have procedures on deliverables which could be transferred to
standardisation to help the development of AM”.

 Standards and research: SASAM made contact with 24 FP7 projects


concerned with AM, to ascertain their standards requirements, though it is not
clear how many actually responded. In general, ISO Technical Committees
will not be able to engage in links with specific European research projects,
but such synergies are possible at European level. When – as in this case –
there is a strong stakeholder wish to act globally in core standardisation

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.

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activities, there may well still be a strong justification for a European platform
for consensus-building, provided it is as fully aligned as possible with the
global work and can ensure contribution to it. If this does not happen, then
the European research results may not be fully reflected in the emerging
standards, with the resulting risk of fragmentation.

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.

5.2.3 Conclusions and recommendations

Conclusions

We conclude that STAIR-AM may well have contributed to a better understanding of


additive manufacturing issues within the standards community. As an informal
place for stakeholder discussions, this platform facilitated the linkage between
research communities and standardisers.

However, the assessment of the actual European standardisation requirements in


this domain was carried out by the SASAM project, whose establishment preceded
–and maybe and an influence on- that of STAIR-AM. To the extent necessary, the
cross-disciplinary aspects were covered through the involvement of the
representatives of the relevant standards activities (in ASTM and ISO as well as
CEN).

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.

However, the STAIR-AM platform is maybe not a representative example, as it was


the pilot of STAIR. Another initiative has now been launched in the scope of STAIR:
STAIR-EMPIR, which is in the scope of the third phase of the European Metrology
Research Programme.

It should also be noted that EU research projects generate “standards excitement”,


e.g. statements that more standardisation is needed and essential. Indeed, SASAM
was explicitly dealing with standards. Research projects cannot interface with
ISO in isolation. At the very least, the ESS owes it to Europe to consider what
might be needed in new standardisation areas.

Opportunity for improvement 1: Timely first action

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.

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Links should be established between research platforms and the standards
community at an as early stage as possible. It needs to be discovered within
Europe whether or not there is an interest in standardisation, and if so, at which
level (European or international, see comment below) that should take place. From
the time an interest is identified (and even in the “need identification” stage), pro-
active action should be undertaken, as involving the research and standard
community at an early stage will improve the speed of standardisation. This would
therefore foster innovation at EU level and promote EU competitiveness. With
STAIR-AM, the platform was triggered after/by SASAM, while it can be understood
that STAIR-AM might have been initiated before that.

Opportunity for improvement 2: Support from the Commission

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.

Opportunity for improvement 3: Synergies with research activities

Care needs to be taken to develop appropriate synergies with specific EU projects


related to standardisation (such as SESAM in this case), or technology platforms
and the like. Too many interfaces (liaison meetings and the like) and duplication of
efforts must be avoided. Even if a CEN national member body is participating in a
“standards-related” project, it might be preferable to ensure dialogue with the ESOs
as a whole about these synergies at the time such projects are being adopted.

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.

Opportunity for improvement 4: Identify areas where European work is


needed

Whether standardisation should take place at the European or the international


level will of course depend on the specific circumstances, but the choice should
always be guided by the views of the standards participants, i.e. industry and other
stakeholders and not by any formal blanket policy.

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.

However, the existence of an international standards committee should not prevent


the creation of European activities where these are needed. There does not always
need to be a Technical Committee, but it can be a less formal group such as a CEN
or CENELEC Workshop (these are often appropriately linked to research projects),

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or simply the continuation of an informal stakeholder consensus in a platform such
as STAIR-AM.

This choice for EU or international standard development, in innovation related


aspect, should not be based on single initiatives, and should be part of a bigger
picture. At an EU-level, focus should therefore be set on concrete themes which
should be further developed at European level, while others are primarily of
international interest and whose development should be left at international level.

Please note that the concept of “Primacy of International Standardisation” is not


further elaborated here as it is analysed in another case study.

Suggestions to be further investigated: Cross-discipline aspects

Where several activities related to a single technology are performed in different


domains, the early creation of a new group to consider new aspects should avoid
individual bodies to develop independent work. When it relates to cross-sectorial
aspects, the technological consistency should be ensured by the establishment of a
common standardisation logic between different bodies involved/competent in the
different areas. In the case of STAIR, this has not been fully reflected –due to the
late start of the platform. However, there is potential for the research community to
contribute to the development of a standardisation strategy for various technologies
(e.g. current developments in “Opportunities for Power to Hydrogen and HCNG”).

5.2.4 Appendix

Interviewees

Category Number of
interviewees/contributors
European Commission 3
European standardisation organisations 2
NSBs 2

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5.3 IPR - IPR coverage by ESOs guidelines

5.3.1 Identified issue of the case study

Legal basis for the case study

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.

Scope of the case study

IPR and standardisation are closely interrelated, although being


fundamentally different. In most cases, IPR in standardisation is materialised
through patents. This case therefore focusses on the interconnection between
standardisation and patents, and potential issues resulting from this cohabitation.

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.

In addition to the need for having a good licensing framework, transparency


about patents is key, as50:

 When developing standards, standardisers should have appropriate IPR


information when selecting the technologies to be included in the standard;

 Once the standard is developed, potential users should have the


appropriate IPR data when selecting the standard they are interested in
using.

This transparency can be enabled through an appropriate patent declaration system


and processes. On that basis, the central research question in this case study is the
following.

“Does the ETSI patent declaration system lead to sufficient transparency?”

In more details, this case study focusses on:

 The concept of general declarations and specific declarations; and

 The timeframe for IPR declaration.

50
European Commission Directorate-General for Enterprise and Industry, “Patents and Standards, A
modern framework for IPR-based standardisation,” 2014.

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Context

 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.

Research and development (R&D) expenditures in businesses are usually


driven by a cost/benefit logic. Companies that invest in R&D expect to
perceive return on their investments and therefore try to get benefit from
their inventions through:

- Own exploitation of the invention/technology and generation of


profit through sales;
- Third party use of the invention/technology by profit generation
through licensing fees paid by the licensee.

 Standardisation and patents: where compatibility and interoperability with


other products or systems is essential, standardisation of technology is
regarded to boost the free movement of goods and services, means of
communication, technological development and innovation51. As standards
define a “common way of doing something”, they should include the best-
in-class practices/technologies. In some cases, these
practices/technologies might be protected by a patent.

Such a patent, that protects technology which is essential to a standard, is


called a standard-essential-patent (SEP). Complying with that standard is
then only possible under the condition of requesting and obtaining a license
from the rights holder. The most common licensing framework to do so is
based on “fair, reasonable and non-discriminatory” (FRAND) licensing
terms. ESOs, and therefore ETSI, promote and encourage this licensing
framework.

 Patent declaration process (ETSI): ETSI holds a database in which SEPs


are declared by rights holders. In the patent declaration process, prior
thereto, ETSI and the rights holder negotiate on the terms under which a
license can be contracted. ETSI has drafted a policy52 and a guide53
concerning the patent declaration. From a legal perspective, it is important to
note that the policy and the guide are not binding for the rights
holders. In a specific case, a rights holder can choose to declare its patent
different from the policy and the guide or draw different conditions concerning
the licensing. However, the policy and the guide can be used to give an
indication about the patent declaration.

 Objectives pursued through patent declaration: the ETSI Intellectual


Property Rights Policy is dedicated at reducing the tension induced by the
proprietary nature of patents (and other IPRs) against the broad-

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)

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diffusion of standards54. The goal of ETSI’s IPR policy is therefore
articulated on the three following aspects:

- The standardisation work should be performed without being


hampered by potential existing IPRs55, and the technical effort
provided in the standard development should not be wasted because
of IPRs;
- The IPR owners should get a fair reward based on the use of their
rights56;
- The standards should be available to interested parties, and the
related SEPs should therefore be made easily available to interested
users57.

 Summary of the relevant rules:

- The declaration of SEPs should be performed spontaneously by


members, once they are aware of the essential character of their
patents (SEPs)58, especially in the case of a member submitting a
standard59. Moreover, members should inform ETSI about the
existence of other entities’ SEPs.
- The IPR owner should provide licenses for their SEP under FRAND
terms and conditions60. In the case an SEP owner would not be
willing to license its IPRs under FRAND terms, ETSI would try to find
an alternative solution61.
- The declaration should be made using the “ETSI IPR Licensing
Declaration form” (provided in Annex to the current document). This
declaration form includes the “IPR information statement and
licensing declaration” and the “General IPR licensing declaration
form”, respectively being SEP specific and general (covering all
potential SEPs in a given scope, also called blanket declarations). The
latest declaration is encouraged, even though it should be completed
by detailed information about the individual SEPs in scope.

 In order to support the declaration of SEPs, the Technical Body Chairmen


should perform a “Call for IPRs” at the beginning of each meeting62 (an
example of “Call for IPRs” is available in annex). The declared SEPs should be
recorded by the Chairman, which should inform ETSI’s Secretariat 63. In case

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.

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of assumption of existence of non-declared IPR (based on the participants’
contribution to the technical work), the Chairman should inform the Legal
Advisor of the ETSI Secretariat.

 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.

 The lack of transparency has an impact on the decision taken by


standardisers and manufacturers. In more details, lack of transparency has
the following negative impacts65:

- Increase of transaction costs;


- Increase of time-to-market;
- Excess royalty rates or skewed cross-licensing agreements due to
asymmetric information;
- Increase of the risk to ambushes and/or hold-ups.

 Availability of IPR data: ETSI is making IPR declaration data available on a


dedicated portal (http://ipr.etsi.org/)66. ETSI’s secretariat is responsible for
the maintenance of this online database. IPRs declaration received are also
made available through the “ETSI Special Report (SR) 000 314”. Moreover,
relevant SEP information should be included in the relevant standards 67.

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.

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SEP and litigated SEP by technology area

Telecommunications via public networks

Information technology and internet

LAN/PAN(BAN networks, wired and wireless)


Audio/video systems, coding and compression, broadcasting,
home systems, home entertainment
Security, identification, cryptography, biometrics

Industrial equipment, manufacturing, production

Measurement, testing, safety standards, language standards


Energy generation and distribution and storage, fuels cells,
power electronics
Transport, logicistcs, aerospace, intelligent transport systems

0 500 1000 1500 2000 2500 3000 3500 4000 4500


Litigated SEPs SEPs

This extreme volume of litigations in the telecommunication field (in comparison


with other sectors) comes from a high industry reliance on standardisation, and the
fact that a large share of R&D intensive innovations are protected by patents 70.

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.

5.3.2 Analysis and findings

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

 General and specific declarations: within the selected project, a total of


303 declarations of IPR were performed by ETSI members. Out of these
declarations, less than 5% were general declarations73.

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%).

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Ratio between GD and SD in "Rel-8 LTE – 3G Long Term Evolution - Evolved Packet System RAN part"

14

General declaration (GD)


Specific declaration (SD)

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

In total, 60 different companies submitted IPR declarations in the


scope of this project. However, a mere 13,3% of companies performed a
general declaration.
Ratio of companies which performed -or not- a GD in the field of
"Rel-8 LTE – 3G Long Term Evolution - Evolved Packet System RAN part"

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;

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- Four companies performed one or several GDs, and submitted
simultaneously74 one or several SDs;
- Three companies performed a GD, followed by one or several SDs.

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).

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SDs related to TS136.213 (v8.x.x), by quarter
6

Publication of TS 136.213 v8.8.0

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.

Conceptual representation of ideal declaration process, GD and SD perspectives

Start of drafting DAV

Standardisation work
Volume

GD SD
Time

Such a functioning should guarantee transparency at two key parts of the


process:
- For standardisers, during the selection of the technology, where
standardisers should rely on technologies available under FRAND
terms;
- For manufacturers, during the selection of the standard, where
manufacturer should be aware of existing IPRs and should have
certainty about their FRAND licensing.

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.

 Late declaration: based on the initial representation of timing, although no


accurate conclusion can be made, it appears that the timing for the
submission of the request occurs at a late stage of the standardisation
work.
When looking in details at the case of the TS 136.213, it appears that the
last declarations (for v8.x.x) were actually submitted a long-time
after the last version of the standard was made available.

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Furthermore, it is even surprising to have declarations in 2014 that relate to
work performed 4 years before77.
However, it can be assumed that these late declarations have a negative
impact on the transparency, as:
- Standardisers are assumed not to take these patents into account
when preparing the standard and selecting the best technologies
available;
- Manufacturers who used these standards were assumed not to know
the existence of additional IPRs on the technology.

 Over-declaration: although this has not been analysed through statistics,


it should also be noted that the ETSI’s IPR policy is assumed to lead to over-
declaration. ETSI’s IPR Policy is based on the logic of ensuring future
applicability of the standard, and therefore puts emphasis of declaring
anything that might be covered by a patent, with low care for its
essentiality: the only objective is to ensure that technology that is included
in a standard will be licensed –if needed- under FRAND terms.

This is for instance noticed in the following paragraphs (a larger extract is


available in annex):
- “Members are encouraged to make general IPR
undertakings/declarations that they will make licenses available for
all their IPRs” (from example of formal call for IPRs);
- “to the extent that the IPR(s) are or become, and remain
ESSENTIAL” (from a general declaration);
- “it believes that the IPRs may be considered ESSENTIAL to the
Standards listed above” (from a specific declaration).

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.

 Different business models: as an underlying aspect of the previous


issues, it has to be highlighted that the various businesses taking part in
standardisation have different business models, and therefore a different
perspective towards IPRs and patent declaration: strategy with regard to
innovative aspects and management of intellectual property.
Independently from the players who can be considered as having a well-
established IPR strategy and work on the basis of complete and accurate
information about their existing IPRs, it is assumed that many other player
do not follow in an accurate way their patent portfolio and are therefore not
able to provide information in an accurate way.

The declarations of IPR performed by different companies therefore result


from different logics, and the management of the declarations is therefore
different –leading to difficulties in interpreting a complete set of data and to
lower transparency.

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.

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Other comments

 DARE project: the DARE project (database restructuring project) was


initiated a few years ago. The objective of this project was to improve the
transparency of IPR within the ETSI IPR database. This led to the
implementation of a range of key features, such as data normalisation,
integration of the concept of patent family, the history of modification, the
possibility for IPR owners to indicate the essentiality of their IPR,
consistency checks, the possibility to perform dynamic reporting and generic
query access78.

 Functioning on IPR dynamic report: when performing our analysis, we


noticed that additional functionalities might be added to the ETSI Dynamic
reporting tool, which would facilitate access to some information:
- Dynamic reporting based on declarations: is currently impossible to
perform. The only means to go through a declaration is to use the
“search declaration” module, which does not facilitate excel exporting
(or to export bigger datasets and extract interesting aspects);
- Dynamic reporting for general declarations: is not foreseen. However,
when reporting on a standard or project, it would be helpful to have
direct access to GDs, in addition to SDs.
- Versions of standards: the way declaration are performed is not
similar, and we can therefore have the same version of a standard
referenced as “[…] v8.8.0” or “[…] (8.8.0)”, which does not facilitate
data analysis.

5.3.3 Conclusions and recommendations

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.

23/04/2015 Page 94 of 199


should not be endangered. Changing the characteristics of the IPR standardisation
framework could have a strong impact on companies, and a local improvement (in
the field of standardisation) should not go against overall improvement and
optimisation of the complete ESS80.

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.

Opportunity for improvement 1: General declaration or default acceptance


of FRAND

As –based on the case- we do not perceive GDs as an effective indicator of future


SDs, GDs do not increase significantly the transparency of the system. Should the
results of further studies confirm this statement, the GD concept as such could be
further improved.

Opportunity for improvement 2: Solving non-essentiality

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.

For that reason, implementing an essentiality check of IPR on standards would be


of interest. However, such a change would need to be carefully studied. The
potential implementation would anyway need to be incremental and should first
focus on the new and revised IPR, prior to evaluating the possibility of performing a
review of existing ones (in order to decrease the effort for implementation).

Opportunity for improvement 3: Patent exposure

Currently, the functioning of ETSI’s IPR database is based on an informative logic,


in order to facilitate standardisation work and avoid hurdles related to ignorance
about existing IPRs.

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”.

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Such a suggestion needs to be balanced, as the cost of the update of the current
database, and further costs required for maintaining and updating the database,
would finally be imputed to the final consumer. The benefits generated by such
increased transparency should therefore be compared with the cost for
implementation of the solution.

Suggestions to be further investigated

 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.

However, this should be nuanced, as:


- In case standards –with SEPs- are developed at ISO or IEC lead,
these patents are not recorded by CEN or CENELEC;
- In the future, with the ongoing digitalisation trends, it could be
expected that ICT becomes a predominant aspect in many domains,
inducing an additional IPR activity within CEN and CENELEC.

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

ETSI IPR Database disclaimer

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.

Example of a formal call for IPRs (from ETSI Guide on IPRs)

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.

The members take note that they are hereby invited:

• 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

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they can obtain from the ETSI Technical Officer or
http://www.etsi.org/WebSite/document/Legal/IPRforms.doc.

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.

Notes from ETSI IPR declaration “GD-200904-001”

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.

Notes from ETSI IPR declaration “ISLD-200904-002”

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.

IPR declaration profiles

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

23/04/2015 Page 97 of 199


0
1
2
3
4

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

Profile 3 – GD followed by SDs


2012-Q1 2012-Q1 2012-Q1 2012-Q1 2012-Q1 2012-Q1
2012-Q2 2012-Q2 2012-Q2 2012-Q2 2012-Q2 2012-Q2
2012-Q3 2012-Q3 2012-Q3 2012-Q3 2012-Q3 2012-Q3
2012-Q4 2012-Q4 2012-Q4 2012-Q4 2012-Q4 2012-Q4
Profile 2 – Simultaneous submission of GD and SD

2013-Q1 2013-Q1 2013-Q1 2013-Q1 2013-Q1 2013-Q1


2013-Q2 2013-Q2 2013-Q2 2013-Q2 2013-Q2 2013-Q2
2013-Q3 2013-Q3 2013-Q3 2013-Q3 2013-Q3 2013-Q3
2013-Q4 2013-Q4 2013-Q4 2013-Q4 2013-Q4 2013-Q4
2014-Q1 2014-Q1 2014-Q1 2014-Q1 2014-Q1 2014-Q1

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

Milestones used for TS 136.213

 3GPP LTE work programme Release 8


Name Release Start Finish TS_TR
Rel-8 LTE – 3G Long Term Evolution - Evolved Packet System RAN part Rel-8 25/09/2006 12/03/2009 LTE 36.300, 36.938
LTE – Physical Layer Rel-8 25/09/2006 07/03/2008 36.201, 36.211, 36.212, 36.213, 36.214, 25.215, 25.225
LTE – Radio Interface Layer 2 and 3 Protocol Aspect Rel-8 25/09/2006 05/12/2008 36.302, 36.304, 36.306, 36.314, 36.321, 36.322, 36.323, 36.331, 25.302, 25.304, 25.331
LTE – eUTRAN Interfaces Rel-8 25/09/2006 05/12/2008 36.401, 36.410, 36.411, 36.412, 36.413, 36.414, 36.420, 36.421, 36.422, 36.423, 36.424, 25.413
LTE – Evolved UTRA and UTRAN RF Radio Transmission/Reception, System
Rel-8Performance
25/09/2006
Requirements
05/12/2008
and36.101,
Conformance
36.104, Testing
36.113, 36.124, 36.133, 36.141, 36.942, 25.123, 25.133
LTE – FDD repeaters Rel-8 14/09/2007 06/03/2009 36.106, 36.143, 25.113
E-UTRAN Data Definitions Rel-8 17/09/2007 12/03/2009 -
Subscriber and Equipment Trace for E-UTRAN and EPC Rel-8 17/09/2007 12/03/2009 32.421, 2.422, 32.423, 2.441, 32.442, 32.443, 32.445
E-UTRAN Network Resource Model (NRM) Integration Reference Point Rel-8
(IRP) 07/01/2008 12/03/2009 new (32.761, 32.762, 32.763, 32.765)
Performance measurements for E-UTRAN Rel-8 22/02/2008 12/03/2009 new 32.425
Key Performance Indicators (KPIs) for E-UTRAN Rel-8 22/02/2008 12/03/2009 new (32.450, 32.451)
Self-Organizing Networks (SON) Rel-8 22/02/2008 11/12/2008 -
SON Concepts and requirements Rel-8 22/02/2008 11/12/2008 new 32.500
Self-Establishment of eNBs, including automated Software Management
Rel-8 22/02/2008 11/12/2008 new (32.501, 32.502, 32.503, 32.531, 32.532, 32.533)
SON Automatic Neighbour Relations (ANR) List Management Rel-8 22/02/2008 11/12/2008 32.761, 32.762, 32.763, 32.765, new 32.511

 ETSI details on TS 136.213 v8.8.0 publication

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List of interviewees

Category Number of
interviewees/contributors
European Commission 4
European standardisation organisations 2
Industry or industry representatives 4
European Patent Office 1

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5.4 Stakeholders - Inclusiveness: principles and practical
implementation

5.4.1 Identified issue of the case study

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 proposal and acceptance of new work items;

 The technical discussion on proposals;

 The submission of comments on drafts;

 The revision of existing European standards (ENs) or European


standardisation deliverables;

 The dissemination of information and awareness building about ENs or


European standardisation deliverables.

The Annex III of the same Regulation identifies four specific categories of
stakeholder interests that should be included:

 Interest of SMEs – specifically highlighted by Art. 6 which requires a proactive


approach from NSBs and draws suggestions related to access of SMEs to
standards and to the standard development process;

 Interests of Consumers;

 Environmental interests;

 Social interests.

Scope of the case study

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”.

The problem statement for this case study is the following:

“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:

 ESO membership of the Annex III organisations;


 Awareness on the role of Annex III organisations;
 Alignment of working methods and governing rules;
 Higher level of democracy and transparency in the management/functioning
of TCs.

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The scope of this case study does not include an assessment of the legislation, nor
the reporting and financing perspectives, which have been defined as out of the
scope of this case by the Commission.

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.

Independently from the above-mentioned evolution of the standardisation


ecosystem, industry remains the core element of the European standardisation
system, being the main standards user and, at the same time, leading the
contribution to technical standardisation work. However, the fact that European
standards are used as “support to legislation” (and are often used to address
safety, environmental and social aspects) stresses the need to ensure under-
represented stakeholders at national level are also represented in the European
standards development process.

Moreover, standards –in spite of being considered as of voluntary nature- may


become a requirement for accessing the market 81 and can therefore broadly impact
the society as a whole, workers and/or the environment. Big companies can more
easily participate in standardisation –as they have the needed resources and
expertise- and to collect direct benefit from it, while other actors (being however
directly impacted by standards) have less direct impact on standardisation:

 Societal stakeholders (here understood as consumers, environmental interest


and trade unions) have no financial interest in participating in standardisation
and their representation is therefore not ensured through cost-benefit logic.
However, their interests can be highly influenced by standardisation work, for
instance in the case of standards related to health, safety and environmental
protection;

 SMEs –although representing 99,8% of the industry- appear to have


individually very limited resources to invest in standardisation (even based on
cost-benefit logic) –and therefore experience difficulties in participating-,
while their business can be highly impacted by standardisation work. In
comparison with bigger businesses, it is assumed that SME participation is –in
relative terms- more expensive than for bigger businesses, and SMEs –
although being able to directly benefit from standardisation- are therefore
considered as “weaker stakeholders”.

81
World Trade Report 2012. Trade and public policies: A closer look at non-tariff measures in the 21st
century, p. 211.

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As the EXPRESS Report noted, “participation of these stakeholders at national level
is weak in many countries for several reasons. In order to address this weakness –
and so guarantee the relevance of the European standards process built on national
delegations- it has been recognised since 1990s that it is essential to ensure
participation of these stakeholders directly at European level” 82.

This weak national representation can be related to a lack of resources (especially


in expertise of the product or service being standardised), of time, of awareness or
of procedural knowledge.

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.

These under-represented stakeholders are supported by representative bodies


participating in standardisation at a European level, hereinafter called “Annex III
organisations”, and the inclusiveness of the ESS –including through the Annex III
organisations- increases the quality of related deliverables and brings added value
to the ESS.

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:

 The interests of the SMEs are currently represented by SBS;

 The interests of consumers are currently represented by ANEC;

 Environmental interests are currently represented by ECOS;

 Social interests are currently represented by ETUC84.

Independently from representing ”huge minorities” 85, Annex III organisations


contribute to the quality of standards and standardisation deliverables, in
particular by providing additional expertise in the technical work (specifically related
to the interest their represent), and contribute to bringing additional legitimacy
to the European Standardisation System by ensuring that all interested parties are
represented. The delivery of such contributions is however subordinated to the
effective participation and influence of the Annex III organisations in the ESS.

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.

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The participation of Annex III organisations is cited in the “CEN-CENELEC Guide
25”, which focusses on the concept of Partnership with European Organisations and
other stakeholders.

As explained in this guide, Annex III organisations are “Partner Organisations” of


CEN and CENELEC. This status grants them –from a theoretical point of view- a
facilitated access to the level of governing bodies and their working or advisory
groups, and the right to participate in technical work in Technical Bodies (no voting
rights are granted to the Annex III organisations, but the possibility to participate
to any technical body and to have access to working documents).

In addition to these guidelines, the importance of underrepresented stakeholders


was already highlighted before the formalisation of the “Annex III organisations”, in
the following guides:

 CEN-CENELEC Guide 2 – Consumer interests and the preparation of


European Standards (2001);
 CEN-CENELEC Guide 5 – Trade Unions and the preparation of European
Standards (2001);
 CEN-CENELEC Guide 17 – Guidance for writing standards taking into account
micro, small and medium-sized enterprises (SMEs) needs (2010).

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.

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In order to participate in the standardisation activities performed at international
level, Annex III organisations need to request a “Category A Liaison”, granted
individually for a TC or sub-committee. The procedure for establishing this liaison
and the corresponding conditions are defined in clause 1.17 of ISO/IEC Directives
part A (version of May 2014).

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.

After application, a “Category A Liaison” is granted based on the vote of the


relevant TC (for which a “Category A Liaison” is requested).

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.

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Operating Grants (OG) to provide Annex III organisations with the needed financial
support for the fulfilment of their work programme.

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.

5.4.2 Analysis and findings

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.

Comments on area of focus

As mentioned earlier, the focus is on four aspects, related to the participation of


Annex III organisations, the awareness of TCs about the role of the Annex III
organisations, TCs working practices and TCs transparency.

 Participation of the Annex III organisations in the ESOs: within CEN-


CENELEC, the national delegation principle applies and Annex III
organisations are recognised, among other actors, as “Partners
Organisations”. From a practical perspective, it appears that not all TCs are
aware of this role nor recognise this specific partnership or respect the
related rights (see below). Moreover, the current rights granted to Annex III
organisations and their lack of voting rights do not facilitate their
participation and limit their influence in the technical work during the
consensus building phase, and through the appeal mechanism (not allowed
for standards for which they did not participate in the development, as
defined in CEN CENELEC Guide 25).
Within ETSI, Annex III organisations can be direct members. Their vote is
valued in a similar way as for other members, based on their size/fees paid
(from one vote to a maximum of 45 votes). This implies that the European
stakeholder representatives are offered the same rights as other members
but the very small size of Annex III organisations –from an accounting
perspective- means the votes they are awarded do not reflect the range of
stakeholders they represent.

 Awareness on the role of Annex III organisations: European


standardisation work is performed according to a decentralised structure,
and –according to one of the points outlined in the coordination meetings
mentioned above- there is a lack of awareness or recognition among the
Technical Committees (TCs) and Working Groups (WGs) about the
importance, the role and the rights of Annex III organisations. Moreover,
Annex III organisations reported that –independently from the non-
awareness- there is sometimes a lack of willingness to respect these rights.
Due to this decentralised functioning, and as the TCs are managed by
various NSBs, the recognition of the importance of the value of the Annex III
organisations is not the same within all TCs, and access to standardisation
activities is reported by Annex III organisations as difficult.

EN 15359 “Solid recovered fuels — Specifications and classes”

One of the key principles of waste management is the waste hierarchy: generation
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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.

CEN/TC 343 developed the EN15359 to provide a system of specification and


classification of SRF.

During the development of the standard (7 years of work), ECOS’s experts


highlighted that the definition of the “solid recovered fuels” could not be accepted,
as the thresholds selected were far from guaranteeing good practices of waste
management (e.g. heavy metals and mercury concentration). Moreover, it was
understood that the lowest classes of SRF did not generate a calorific gain through
their combustion. Based on the prEN, waste could therefore be classified as SRF,
although it did not had a positive environmental impact.

After no-consideration of ECOS comments and a positive vote on the standard,


ECOS made use of the appeal mechanism. The publication of the standard was
interrupted and CEN’s Technical Board advised the Technical Committee to further
consider the recommendations of ECOS.

However, after extended discussions, the standard was published without


amendment. Main reasons for this publication was that the objective of the
standard was to provide a scale for ranking of waste/fuel, but that the identification
of “good” SRF and “lower grade fuels” was not the responsibility of the
standardisers.

Key messages out of this case needs to be reminded:

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.

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 Alignment of working methods and governing rules: as mentioned
earlier, management of technical committees is not uniform and the NSB
responsible for managing a TC and related WGs often follows its own
practices and procedures. This inconsistent way of working harms
participation of Annex III organisations: stakeholder representatives are
usually active in many different sectors and therefore need to comply with
multiple different procedures. This creates, in addition to the awareness
issue mentioned above, administrative burdens and decreases the efficiency
of the participation of European stakeholder representatives in the
standardisation process.
Moreover, it appears that the internal procedures have changed several
times in the last years, forcing the Annex III organisations to adapt to the
evolving procedures. A change recently recorded is the modification of the
conditions for CEN and CENELEC partner organisations to make use of their
right of appeal.

In addition to differences between TCs’ working practices, rules are not


always the same within CEN and CENELEC (e.g. the criteria to be fulfilled to
omit the Formal Vote). In case of joint working groups among all three
ESOs, these differences are exacerbated and lead to further difficulties in the
participation and influence of Annex III organisations.

 Higher level of democracy and transparency in the management


functioning of TCs: CEN and CENELEC Technical Committees are based on
the National Delegation Principle and hence their members are the national
delegations nominated by the CEN-CENELEC members. Other organisations
may participate as observers, including CEN-CENELEC Partner Organisations
and Liaison Organisations. Working Groups under the Technical Committees
are meant to be composed of individual experts 92, nominated by CEN or
CENELEC members and partners. The ESO guidelines do not guarantee that
the composition of the technical bodies includes mixed representation of
interests, as multiple representatives/experts, although being selected in
diverse countries, might be coming from a single international company or
might represent very close interests. Moreover, it was reported that not all
experts are recognised equally, and experts sent by Partner Organisations
are said to be often devalued.
Although no specific example has been analysed in this case study, it is
assumed that a potential unbalanced representation of interests
encountered in some technical bodies might lead to a unilateral positioning
of the Technical Committee and an increased difficulty for representing
effectively the interests of underrepresented stakeholders.

Other comments

 Vienna and Dresden agreements: based on the Vienna and Dresden


agreements, the technical work for standard development can be performed
at international level (see case on “Primacy of international standardisation”)
instead of European level, including standardisation work mandated by the
European Commission to support laws and legislation. Moreover, based on
the latest developments, it appears that an increasing amount of work is
performed at international level. CEN and ISO agreed to revise ENs identical
to ISO standards under ISO leadership, even if the current version was
developed in CEN93.

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.

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For participating in standardisation work in ISO and IEC –and as explained
earlier-, Annex III organisations need to rely on the concept of “Liaison A”,
which allows organisations fulfilling required criteria to contribute to the
work performed in a Technical Committee –or subcommittee- directly or via
an appointed expert. The request for “Liaison A” applies to individual
Technical Committees, and therefore needs to be submitted specifically for
TCs where an Annex III organisation has an interest.
From a practical perspective, this is an issue for Annex III organisations,
since they are not recognised in a similar way within ISO and IEC as they
are by CEN and CENELEC, and neither do they usually have sufficient
funding to ensure their physical participation at international level.

Moreover, although there are “parallel votes”, it is difficult for represented


stakeholders to influence the EN if multinational industry has already
reached agreement at the international level. Finally, Annex III
organisations do not receive the documents for parallel vote unless they
have liaison status in the corresponding ISO or IEC technical bodies.

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).

 Danger of speeding up the process: ”speed” is currently a “hot topic” in


standardisation, and many actors within the system are incentivised to
decrease the development time.
However, societal representatives stress that improving the speed of
standards development should not be pursued at all costs, and reducing the
development time should only be performed when considered necessary.
Speeding-up the process can be a necessary improvement for some sectors,
especially related to innovative aspects or in the ICT field. However, bearing
in mind the need for certain standards to support policy or legislation, it is
important to attain a robust consensus and the participation of all relevant
parties94. Standardisation –and especially the consensus building process-
requires time and Annex III organisations could have difficulties in defending
–with limited time and resources- the interests of the stakeholders they
represent. Moreover, the participation of Annex III organisations is limited to
given steps, which should not be shortened/removed.
Speed of the process is not necessary considered by SMEs as a challenge,
but modification in the standards development process might harm their
participation: the reduction of development time should not be achieved
through cancellation of steps which ensure inclusiveness of the system.

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.

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As an example, and as consequence of decisions of CEN and CENELEC to
mirror the rule of ISO and IEC on the public comment phase, the consensus
needs to be formed at an earlier stage in the standards development. This
modification induces that comments submitted during the enquiry phase are
not considered in the case of a positive vote by CEN and CENELEC members.
As the enquiry phase is the only phase where Annex III organisations could
effectively contribute by submitting comments, those would simply be
ignored if the NSBs vote in favour of the standard.

5.4.3 Conclusions and recommendations

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:

 Participation in standardisation activities,


 Access to standardisation information.

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.

Opportunity for improvement 1: Specific support to the participation of


Annex III in standardisation

 Specific category of partnership: a specific category should be dedicated


to the Annex III organisations, in order to highlight the specific role they
have, the importance of their effective participation and their rights.
Independently from the rights associated to this specific category, the fact of
having a separate category for Annex III organisations would
highlight their specific role and rights, and would go hand-in-hand with
the formal recognition of these actors by the new Regulation.
Although a special status is granted to Annex III organisations by CEN and
CENELEC (which consider Annex III organisations as “Partners
Organisations”), it should be noted that the specific character of the Annex
IIII organisations is not reflected through the category, and the fact that
other stakeholders are included in the “Partner Organisations” members
reduces the special character of this category.
Currently, ETSI does not grant specific rights to Annex III organisations,
which –being established in Belgium- are considered as part of Belgian
delegation to ETSI (within ETSI, only ANEC and SBS are recognised as

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“users”95). A similar comment (as the one for CEN and CENELEC) can
therefore be made for ETSI.
The concept of Partner Organisations is defined within CEN-CENELEC
Internal Regulations Part 2, in clause 4.2.4. The membership of ETSI is
defined in ETSI’s Rules of Procedure, Article 1.

 Right of appeal in CEN-CENELEC: We suggest reverting to the unlimited


right of appeal, and giving back to Annex III organisations the right to use
the appeal mechanisms for all standards.
Considering the underrepresented character of Annex III
organisations/stakeholders, and their limited participation in the
standardisation work, it is of importance for Annex III organisations to be
able to contribute to the standards development process until the end of the
process, even if they have not been involved along the process. Annex III
organisation do not always have the capability and resources to be involved
in the process for every standards they might have an interest for. If they
become of a critical issue only at a late stage of development, it is important
to give them the opportunity to express their views and share their
expertise, avoiding the adoption of a standard that can e.g. have negative
impacts on the society or the environment.
Moreover, considering the limitation of the appeal mechanisms, and the fact
that the current mechanism for solving an appeal procedure is based on the
Technical Board decision, we highlight the importance of independent
Technical Experts to provide advice to the Technical Board. The Technical
Board does not necessarily have in depth expertise about the issue at stake,
and should make a decision based on views other than those of the directly
interested parties (the involvement of independent experts through a
“conciliation panel” is already defined in CEN-CENELEC Internal Regulations
7.5).
Finally, it appears that the right to appeal has been used in a very modest
way by Annex III organisations, which have –by definition- no interest in
harming the European standardisation system and which have therefore no
interest in blocking the publication of standards without fundamental reason.
Granting them the right of appeal is therefore not expected to harm the
speed of the process.
The limitation of the appeal procedure is referred to in Guide 25. However, it
has to be noted that CEN-CENELEC Internal Regulations Part 2, clause 7,
indicates that “[a] partner organisation may appeal against any action, or
inaction, on the part of a Technical Committee [... in case it is not in
accordance with] public concerns as safety, health or the environment”. This
limitation in the guide however did not exist before and entered into force
with the revision of Guide 25 in 2014.

 Support participation in international standardisation: based on the


practical issues encountered for participating in international
standardisation, actions should be undertaken to ensure that European
standards are developed with the same level of inclusiveness and legitimacy,
independently from being developed by CEN/CENELEC or ISO/IEC.
For standards to be implemented at European level, mechanisms should be
identified for ensuring representation of the interests of underrepresented
stakeholders at international level. As parallel work is performed based on
the Vienna and Dresden agreements, CEN and CENELEC could support in the

95
From: http://www.etsi.org/membership/current-members

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identification of the appropriate measure for ensuring this representation at
international level.
Participation at an international level through the Annex III organisations
counterpart –if existing- could also be envisaged, although it appears that
these international representatives are not granted additional rights within
international standardisation organisations. Moreover, it could be expected
that these international organisations may be required to present a position
that is different from an exclusively European view.
Opportunity for improvement 2: Uniformising of TC working rules

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.

The development of more accurate and consistent guidelines for TC and WG


management and working process would facilitate the participation of Annex III
organisations –and other stakeholders- in the standard development process
(including smaller NSBs).

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.

In addition to uniformising the way of working, it should be noted that the


information logic of all TCs might benefit from being harmonised (see details in the
following recommendation).

This recommendation falls into the scope of Art. 6 of Regulation (EU) No


1025/2012, which states that NSBs shall encourage and facilitate the access of
SMEs to standards development process.

Opportunity for improvement 3: Revision of the information platforms

Currently, the access to technical documents of a Technical Committee is limited to


the actors involved in the technical work of the Technical Committee. For actors
involved in multiple fields of activity –which include Annex III organisations-,
obtaining accurate information about the state of play of standard development
activities can be difficult, as documentation requests require direct contact with the
relevant TC.

In alignment with a similar suggestion performed in the scope of another case


study, the implementation of the appropriate tools –which would ensure the
availability of good and consistent information for non-participants (e.g. NWIP)-
would support the ESS. The ideal improvement would be the creation of a
centralised platform for information, which would facilitate the access to the right
information and would therefore empower the inclusiveness of the system. This
recommendation is also aligned with the uniformisation of TC working rules, in the
previous recommendation. However, this is based on the expected positive impact,
and should be balanced by the cost and effort needed for the implementation of
such tools.

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Suggestions to be further investigated 1: Involvement in standard related
activities

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.

The involvement of Annex III should be considered especially in cases where


standards relate to societal and social needs. This would help building awareness
about the role, mission and rights of Annex III organisations, as well as facilitate
further involvement at a later stage of the standardisation work. This is however
currently out of scope of the Regulation and does not necessarily fit with the
current strategy and roadmap of Annex III organisations but we still want to open
the discussion about this topic.

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.

Suggestions to be further investigated 2: Further participation during the


formal vote

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:

“Annex III organisations should be granted a non-weighted “right of vote” or “right


of opinion” with the following effects”:

 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;

 if an Annex III organisation submits a negative vote/opinion, and the


standard has passed the weighted vote of members, this negative vote and
comments would be sent to the responsible TC and the TC would be required
to report fully on whether and why it agrees with or rejects the position of the
Annex III organisation. If it agrees, an immediate revision of the standard
would start. Meanwhile, implementation of the EN as adopted by the national
members would proceed (as only an appeal can stop implementation).”

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.

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5.4.4 Appendix

List of interviewees

Category Number of
interviewees/contributors
Annex III organisations 6
European Commission 1
ESOs 2
NSBs 2

Extracts from Regulation EU 1025/2012

Regulation (EU) No 1025/2012 – Article 5(1)

European standardisation organisations shall encourage and facilitate an appropriate


representation and effective participation of all relevant stakeholders, including SMEs, consumer
organisations and environmental and social stakeholders in their standardisation activities. They shall in
particular encourage and facilitate such representation and participation through the European
stakeholder organisations receiving Union financing in accordance with this Regulation at the
policy development level and at the following stages of the development of European standards or
European standardisation deliverables:

(a) the proposal and acceptance of new work items;


(b) the technical discussion on proposals;
(c) the submission of comments on drafts;
(d) the revision of existing European standards or European standardisation deliverables;
(e) the dissemination of information of, and awareness-building about, adopted European
standards or European standardisation deliverables.

Regulation (EU) No 1025/2012 – ANNEX III

European stakeholder organisations eligible for Union financing

1. A European organisation representing SMEs in European standardisation activities which:


(a) is non-governmental and non-profit-making;
(b) has as its statutory objectives and activities to represent the interests of SMEs in the
standardisation process at European level, to raise their awareness for standardisation and
to motivate them to become involved in the standardisation process;
(c) has been mandated by non-profit organisations representing SMEs in at least two thirds of
the Member States, to represent the interests of SMEs in the standardisation process at
European level.
2. A European organisation representing consumers in European standardisation activities which:
(a) is non-governmental, non-profit-making, and independent of industry, commercial and
business or other conflicting interests;
(b) has as its statutory objectives and activities to represent consumer interests in the
standardisation process at European level;
(c) has been mandated by national non-profit consumer organisations in at least two thirds of
the Member States, to represent the interests of consumers in the standardisation process
at European level.
3. A European organisation representing environmental interests in European standardisation
activities which:
(a) is non-governmental, non-profit-making, and independent of industry, commercial and
business or other conflicting interests;
(b) has as its statutory objectives and activities to represent environmental interests in the
standardisation process at European level;
(c) has been mandated by national non-profit environmental organisations in at least two thirds
of the Member States, to represent environmental interests in the standardisation process at
European level.
4. A European organisation representing social interests in European standardisation activities which:
(a) is non-governmental, non-profit-making, and independent of industry, commercial and
business or other conflicting interests;
(b) has as its statutory objectives and activities to represent social interests in the

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standardisation process at European level;
(c) has been mandated by national non-profit social organisations in at least two thirds of the
Member States, to represent social interests in the standardisation process at European
level.

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5.5 The eInvoicing standardisation request

5.5.1 Identified issue of the case study

Legal basis for the case study

This case study is performed in response to Art. 25 of Regulation (EU) No


1025/2012, which requires the Commission to evaluate the impact of the procedure
established by Art. 10 of the same Regulation on the timeframe for issuing
standardisation requests.

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.

Scope of the case study

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.

The problem statement is the following:

“How effective is the new mandating process?”

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?”;

 Formalisation – “Is the process formal enough and supported by appropriate


documentation, ensuring that the elaboration of the request is performed in a
consistent way? Also, are requests formalised?”;

 Transparency – “Are the information related to the process of request


elaboration –and the information related to draft requests- available and
easily accessible?”;

 Market relevance – “Do the standards, developed upon request from the
Commission, respond to market needs?”.

Context

 Standardisation requests from the Commission: as explained earlier, it


is understood that the Commission may request European standardisation
organisations to develop standards or other deliverables, dedicated to support
Union legislation and policies. These documents, developed based on a
Commission request, concern less than 20% of the standards developed
within the European Standardisation System.

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The logic behind these Commission requests comes from one of the
following:
- Need for standards supporting Union harmonisation legislation: in
that case, these standards will be called harmonised standards (as
defined in Art. 1(1)c of Regulation (EU) No 1025/2012). These
harmonised standards will then confer (to their user, after their
referencing in the Official Journal of the EU) a presumption of
conformity with the essential or other requirements of the
directive/regulation covered by such harmonised standards.
- Need for standards or other deliverables supporting Union policies.

 Elaboration of the request: the mandating process is composed of various


steps, as represented in the figure below:

Figure 1 - The elaboration of the standardisation request,


under Regulation (EU) No 1025/2012

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.

 Comitology background: given the average time needed to prepare a


request, and the fact that the new Regulation entered into force as of January
1st, 2013, only a small number of requests have been prepared under the new
procedure. These rules define how Member States control the implementing
powers of the European Commission. These powers can be conferred to the

98
Doc.: 05/2013 EN – Adaptation of the mandating process to the Regulation (EU) 1025/2012.

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Commission through Union legislation about specific areas, as foreseen by
Article 291 of the Treaty of the Functioning of the European Union (TFEU) 99.

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.

The two key principles of this directive appear to be the following:

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.

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 First, the directive foresees the development of a European standard for a
semantic data model of the core elements of an eInvoice, dedicated to B2G
transactions (and that might have a spill-over effect on B2B relationships);

 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.

5.5.2 Analysis and findings

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”.

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Figure 2 - Key milestones related to the eInvoicing directive, mandate and
standardisation work

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 assume that this increase in timeframe might come from:

 Parallel work on the directive, whose revisions induced amendments in the


draft request (thanks to the feed-back coming from the debate in the
European Parliament and the Council). However, the draft request could only
be finalised after the adoption of the Directive, since consistency between the
requested standards and the legal needed to be ensured. This requirement
led to dependency from the legislative process, which extended the duration
of the preparatory phase;

 Increased timeframe due to formal steps, such as Commission’s internal


Inter-Service Consultation or the consultation of the Comitology Committee
and other Commission’s formal controls and procedures which are common to
all legislative proposals.

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.

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Time in days elapsed between first contact with B5 and notification to the ESOs

GPSD - Certain seats for children

Electronic invoicing in public procurement

Deployment of alternative fuels infrastructure*

Methods for quantitate analysis of certain binary textile fibre


mixtures *

Ecodesign - water heaters*

Ecodesign - Space heaters*

Ecodesign - Material efficiency*

GPSD - Laser pointers*

Privacy management of security technologies*

0 100 200 300 400 500 600 700 800

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.

In general terms, interviewees informed that the timeframe for elaboration of


standardisation requests varies a lot depending on the Commission Directorate
responsible for the drafting. We however noticed that, even though the time
needed for developing requests seems to have increased, the variance of this
timeframe has decreased. Still, some interviewees perceive that the process is “too
bureaucratic” and that some steps of the elaboration of the requests could be
avoided. Also, the fact that all the steps of the new process need to be carried out
according to a given sequence implies that a mistake or adverse event in an activity
automatically delays the overall process.

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.

 Formalisation of the process: the new legislation package re-defines, in


Art. 10, the concept of the standardisation requests. The “old” version of the
Vademecum108 is therefore not tailored for the new Regulation, as it does
not give guidance on how to draft requests under the form of “Implementing
Acts”. Therefore, there is –at the moment- no up-to-date reference
document explaining and uniformising the Commission procedures.

This has an impact on:


- First, the way the work is performed within the Commission:
discrepancies in the mandating process were notified, depending on
the Directorate General developing the request (for requests under
previous regulation);
- Second, stakeholders outside of the Commission have no information
about detailed Commission procedures (cf. “transparency” below).
Even though such a requirement is not explicitly mentioned in the
Regulation, it is mentioned –on the vademecum page- that its

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 .

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objective is to support all stakeholders in understanding the EC
mechanisms (and therefore increasing transparency and ease of
participation).


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:

 Consultation of sectorial committees for the preparation of the Union


work program and publication of the future standardisation needs in the
Union work program – This annual Communication provides insight about the
future standardisation needs that will be requested by the Commission.
However, it appears that the UWP, in its current state, cannot be used as an
efficient planning tool as the mandating timeframe is not necessarily known.
It is also understood that the anticipation capability of the Commission –in
building the UWP- depends on the legislator.
Taking the example of the standardisation request on eInvoicing: the UWP of
for 2014 and for 2015, as well as to the Annual European standardisation
work programme published in 2012 all refer to areas closely related to the
eInvoicing field. The directive proposal however occurred in July 2013 and the
actual reference in the UWP to a potential request is made for year 2014.

 Consultation with sectorial Committees or Commission’s expert


groups.

 Informal consultation with ESOs and Annex III organisations (as


mentioned in Art. 10(2) of Regulation 1025/2012) – It has been commented
that the extent of the consultation, and the integration of collected
comments, depends on the Commission Directorate responsible for the
drafting of the request109;

 Publication of the draft request on the notification system110: such a


tool can highly support the transparency of the process. However, it was
noticed that the notification system –in its current state- does not provide the
possibility to browse previous notifications (e.g. no notification about the
eInvoicing request was found). The interest of the notification system is also
limited to the transparency perspective, for information purpose, but this
stage does not allow effective reaction from interested stakeholders (as the
simultaneous inter-service consultation should use the last version of the
file).

 Inter-service consultation (occurring at the same time than the publication


of the mandate on the notification system);

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.

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 Publication of draft standardisation requests on the Comitology register;

 Vote through the Committee on Standards;

 Publication of the request on DG GROW website.

Independently from the above-mentioned notifications, it was noticed that


information about standardisation requests is not easily available to interested
parties. First, the information is not centralised and is disseminated on among
different platforms/websites; second, some basic useful information is not
necessarily available (e.g. timeframe for the elaboration of the request, as
presented in Figure 2, or the current development state of the draft requests).

Moreover, as mentioned above in the part dedicated to “formalisation”, various


stakeholders active in standardisation are not aware of the mechanism for
elaboration of requests (performed within the EC). Also, at the current state, and as
noticed during the Vademecum meeting on 14.10.2014, it appears that the role of
the Commission within the European standardisation system and the objectives
pursued are not clear for all stakeholders.

Comments on market relevance

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.

Considering the nature of these comments, it can be assumed that the


understanding and interpretation of the new standardisation package provisions is
not the same for all actors involved within the system.

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.

Comments on the standardisation request logic:

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

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Commission might however trigger, using other mechanisms than standardisation
requests, the preparation of studies for identifying standardisation needs being
related to policies.

5.5.3 Conclusions and recommendations

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;

 The formalisation of the requests and the underlying process is improved


through the new regulation, even though there is a need for having a
common guidance document;

 The transparency of the process might be improved, as is based on using


ESOs as a relay: information goes to ESOs which inform their members,
which then come back to the ESOs and finally to the Commission. Providing a
better access of information to ESO members might facilitate the
stakeholders consultation.

 The market relevance should be ensured by the above-mentioned


transparency. We however note the case of the standardisation request on
eco-design which went through the whole process and was finally refused by
the ESOs.

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.

Opportunity for improvement 1: Definition of the role of the Commission,


of internal guidelines, and of a unified understanding of the new
standardisation package

The European Standardisation System (ESS) is based on voluntary cooperation of


all standardisation actors. European standardisation organisations, the most
important part of the ESS, have been created from the needs of industry. Since late
1980s, the ESOs have, amongst others, supported EU legislation and policies
(support to legislation and policies) with deliverables responding to the Commission
mandates.

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.

Then, the Commission should develop further, and communicate, internal


guidelines about the process for elaboration of standardisation requests

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(from the planning to final adoption). This would ensure a coherent process,
independent of the Directorate responsible for the drafting of the request. These
guidelines will therefore facilitate the process on the European side (speed and
internal procedures effectiveness).

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).

In addition to that, there is a need to develop a unified understanding of the


Regulation, developed in agreement and collaboration between the various
stakeholders, and that would ensure that all actors are working based on a similar
understanding of the new standardisation package.

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.

Opportunity for improvement 2: Information system

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.

In alignment with the previous suggestion, we suggest the development of a


unified platform, facilitating access to information about requests, from a
centralised module. Informing stakeholders (mainly ESOs, Annex III organisations,
and even other interested stakeholders) about the status of activities undertaken
by the Commission might help these stakeholders have the appropriate actions for
preparing and participating efficiently during the consultation of the ESOs. This
would also increase the speed of the process, by allowing stakeholders to anticipate
and prepare comment based on this data; and would allow stakeholders to react on
the requests which they are interested in, without waiting for a specific suggestion
from the ESOs to contribute in the mandate.

Suggestions to be further investigated:

 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.

 Further use of parallel legal and mandating work: the standardisation


request on eInvoicing is an interesting example for quick start of elaboration
of the request (and of standardisation activities). This parallel work needs
however to be carefully envisaged, as initiating work prior to having a
“stable” regulation might lead to excessive correction work within the
standardisation request. Further analysis should therefore be made about the
possibility of linking the legal activities and elaboration of mandates,

111
European Commission (2014). “Draft Vademecum on European standardisation – Parts I to III”
[slides version of 20.6.2014].

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especially in the case of directives explicitly making the use of the standards
compulsory.

5.5.4 Appendix

Extracts UWP and Annual European standardisation work programme

Annual European standardisation work programme published in 2012 p. 13

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.

Annual Union Work Programme 2014 (p. 15-16)

2.4.4 eProcurement/eCatalogues

The Commission aims to make eProcurement straightforward by facilitating the emergence of an


interoperable European framework, building where possible on European standards. Standardisation
work already under way may need to be reinforced or completed. Standards should help to make
eProcurement more efficient by taking account of the results of EU projects such as the Pan-European
Public Procurement Online (PEPPOL) project and the work undertaken by CEN.

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.

2.4.5. Electronic invoicing (eInvoicing)

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.

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The Commission may issue a mandate covering the definition of a semantic interoperability model and of
a European eInvoice data model.

Annual Union Work Programme 2015 (p. 14)

3.3.10. eProcurement /eCatalogues

e-Procurement technology interoperability and standardisation is a key strategy to remove technical


barriers or extra costs when suppliers bid on a plurality of systems. In order to achieve a true single
market, bidders including SMEs ideally should be able to communicate and participate, in multiple
markets across various systems, through their favourite or a common system. The need for
standardisation in the e-Procurement domain was strongly reaffirmed by the e-Tendering Expert (eTEG)
group in a report issued in February 2013, which included a number of standardisation actions to be
undertaken as soon as possible.

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

List of milestones related to the eInvoicing case

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.

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5.6 Cooperation mechanisms extra-ESS in ITS

5.6.1 Identified issue of the case study

Legal basis

This case study is performed in alignment with the Communication COM(2011)311


final, which highlights the need for increased cooperation between the different
actors of the ESS:

“The continuous improvement of standardisation structures and governance will


also require effective and closer collaboration between all partners, above all
between the European standardisation bodies and between national standardisation
bodies on the one hand, and the public authorities and legislators on the other.”

Scope of the case study

The above-mentioned communication defines, in a broad perspective, the scope of


this case study. From a more detailed perspective, this case study will assess the
coordination mechanisms between the ESS and other entities acting in the
standardisation ecosystem, and the impacts on aspects such as the speed of
standards development.

The problem statement is the following:

“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

 ESO functioning: European standardisation is based on EU-wide


involvement of industry experts:
- European standardisation work is managed by the responsible
European standardisation organisation (ESO), based on the
standardisation branch (CENELEC for electro technical matters, ETSI
for telecommunication matters and CEN – in principle -for all other
matters113);
- In each ESO, standardisation work is managed by different technical
committees (TCs), each of them being dedicated to a specific field of
expertise; and
- The TCs are composed of various working-groups (and even sub
working groups) which are responsible for a specific parcel of
standardisation, and which actually perform the standardisation
work.

 Evolving standardisation needs: this separation among standardisation


organisations does not always comply with the reality of standardisation to
be performed: products and services are getting more complex and often

113
It should be noted that CEN also develops ICT standards, depending on the area of competence.

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rely on several technologies, cross-cutting various fields of expertise,
and even standardisation branches.
Moreover, standardisation work is not solely performed by the ESOs, and
standardisation activities, previously performed or being undertaken
in other SSOs, should be considered when developing new standards.
Based on these two reasons, coordination mechanisms are needed, to
ensure efficient standardisation work and avoid duplication of
standards.

Overview of the case

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.

The concept of “Intelligent Transportation Systems” corresponds to the ICT


enablement of the transport sector. It consists in information collection,
storage, analysis and transmission, in order to create benefits for efficiency,
sustainability, safety and security 114,115,116.

The concept of “Intelligent Transportation” is a response to the increasing


challenges met in current networks: road congestion is increasing, road transport
accounts for a high percentage of CO2 emissions and road fatalities should be
reduced as much as possible117.

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.

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 Vehicle to vehicle (V2V);

 Vehicle to infrastructure, or infrastructure to vehicle (V2I or I2V);

 Infrastructure to infrastructure (I2I).

The information is shared through access technologies (e.g. mobile communication


systems, WLAN or infrared based systems) and is used for generating advice
and/or facilitating actions. This increased availability of information for stations is
aimed at improving the safety (e.g. an infrastructure informs a vehicle of hazardous
conditions), sustainability (e.g. adaptation of the speed for avoiding stops, reducing
useless start-stops of the car and congestion of the network), efficiency (e.g.
reorganisation of transport flows for avoiding congestion) and comfort of network
users (e.g. self-driving cars)118.

This co-operative logic is, normally, based on relatively short range


communication (300-800 meters) of safety critical information, exchanged
between vehicles and road infrastructures 119, while non-critical information could
use longer range communications. The messages exchanged can fall in three
different categories:

 Co-operative awareness message (CAM): This is a message sent at


periodically (every 100ms), that communicates the station characteristics
(vehicle type, status), location and the activity it is performing (trajectory,
velocity).

 Decentralised environmental notification (DENM): Special event messages,


triggered by the occurrence of a specific event (hazard detected, weather
conditions, etc.). It provides information about an event occurring on a road
network (location, type of event, cause, status).

 Service announcement, based on road infrastructure.

Considering the advantages that can be generated by the implementation of C-ITS


at a European (or worldwide) level, the Commission highlighted the need for a
coherent EU (or worldwide) framework for interconnecting road
infrastructures and vehicles120. The development of a harmonised framework –
covering Europe and beyond- should ensure geographical continuity and
interoperability of services and systems. Support road infrastructures have been
deployed in Europe for a long time (light signals, automatic speed control systems,
camera surveillance, etc.) but these systems are not developed under a common
framework and based on (international) standards 121, and do not yet benefit from
the potentialities of advanced interconnections. Also, vehicles currently rely on
sensors systems which support the driver, but these rely on a stand-alone
understanding environment and could not reach the same potentialities of co-
operative systems122,123. Finally, interoperability and harmonized standards would

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

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also facilitate the creation of global platforms for OEMs, and multiply the efficiency
of the service by enabling a better transfer of the messages.

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 development of these set of standards would 125:

 Ensure interoperability of systems (through reducing fear and


uncertainty for system manufacturers and users, and facilitating reaching
critical mass);

 Ensure that ITS reaches the above-mentioned goals (efficiency,


sustainability, safety and security);

 Provide an architecture facilitating innovation, and to facilitate the


production of world-class vehicles and road infrastructures;

 Make Europe a better place, more attractive for investments.

The standardisation activities are targeted at covering the whole C-ITS architecture,
and therefore induce standardisation work in the following categories 126:

 Standardisation of architectures for ITS services,

 Radio communications systems,

 Formats and structure of message systems and transport,

 Security and privacy technologies and system aspects,

 Interfaces and reference points, and

 Database technologies and data file structures.

Case complexity

The complexity of standard development in the field of Cooperative ITS mainly


comes from two different perspectives127:

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.

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 First, Cooperative ITS is a multi-disciplinary concept which crosses
multiple fields of expertise and industries. For that reason,
standardisation work in C-ITS requires strong cooperation between
multiple entities.

 Second, the standardisation work in C-ITS should not be started from


scratch: a lot of work has already been performed in the field of ITS,
and many different entities are already involved in collaborative research
and C-ITS standardisation development. For that reason, standard
development in C-ITS needs to take into account what has already been
developed in the past and should involve the right entities in
standardisation development, to benefit from the best knowledge available
and to avoid re-inventing the wheel (and duplication of standards).

 A third aspect has been highlighted by the Standardisation Handbook from


the iMobility Support project128: car makers have a strong interest in
ITS and have the political and financial capability to drive ITS
standardisation in a way that suits them, focussing on their part of the
equation (vehicles only).

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:

 Within CEN: CEN/TC 278 European ITS committee, previously “Road


Transport and Traffic Telematics” (RTTT);

 Within ETSI: ETSI TC ITS.

As mentioned previously, C-ITS covers multiple fields of expertise and


standardisation work has already been undertaken by various
standardisation organisations. The standardisation work initiated at European
level therefore needed to take into account the work performed by other
standardisation organisations:

 ISO

 ISO TC 204 Intelligent Transport Systems, previously Transport Information


Control Systems (TICS)

 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.

23/04/2015 Page 132 of 199


 IETF (production of internet standards with relevance to ITS, in particular
the MEXT group)

 IEEE (essential base standards for 5.9Ghz communications)

 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:

 Organisations representing consumers’ interests, environmental protection,


workers and SMEs, now being known as Annex III organisations

 Industrial and multi-stakeholders organisations active in ITS


- Car2Car
- TISA
- iMobility forum
- ERTICO
- EUCAR – European Council for Automotive R&D
- ACEA – European Automotive Manufacturers’ Association
- CLEPA – European Association of Automotive Suppliers

 Toll providers organisations

 Road infrastructure operators and authorities


- CEDR – Conférence Européenne des Directeurs des Routes
- ASECAP – European Association with tolled motorways, bridges and
tunnels concessionaires)

In addition, the EU-US-Japan cooperation on joint standardisation of C-ITS, the


Memorandum of Cooperation agreed between ETSI and U.S. DoT RITA, as well as
the previous R&I projects (EU and national funded) needed to be taken into
account, as means that supported the validation and fine-tuning through field and
operational tests 129.

The picture below provides a representation of the complex ecosystem involved in


the C-ITS standardisation activities.

129
COMeSafety, COMeSafety2, COOPERS, CVIS, Drive C2X, iCar Support, iMobility Suport, SAFESPOT,
Safety Pilot, SmartFreight, etc.

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Figure 3: C-ITS Standardisation ecosystem

5.6.2 Analysis and findings

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.

Comments: general description and constraints of the request

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”.

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timeframe. The Release 1 provided the “minimum set of standards” for
interoperability in accordance with M/453, for the initial deployment of C-ITS:
ETSI focused on the communication protocols for road-safety applications, whilst
CEN TC278 (WG16) - CEN TC278 develops standards jointly with ISO TC204 -
covering the full scope of C-ITS and ITS in general132.

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.

Comments on coordination mechanisms

A strong cooperation framework was implemented for ITS standardisation,


addressing the need for cooperation among ESOs, the involvement of all the
stakeholders (Car2Car, Toll providers organisations, road infrastructure operators
and authorities, suppliers, etc.), the cooperation with different standardisation
organisations and international actors.

 Coordination between ESOs and the Commission: the ITS Coordination


Group (ITS CG): the Mandate requirements included strong coordination
between CEN and ETSI in the development of the standards. This
requirement was already taken into account in the split of responsibilities for
standards development agreed between CEN and ETSI in the Response to
the Mandate in April 2010. To this end, CEN/TC278 and ETSI TC ITS work on
basis of informal coordination activities, with cross participation of
standardisation experts, and on-going contacts between chairmen/conveners
of the two ESOs.
The ITS Coordination group (ITS-CG) established by the European
Commission and the ESOs134 further strengthened the coordination between
CEN/TC 278 and ETSI TC ITS, and facilitated the active participation of the
relevant European Commission Services (e.g. DG Enterprise and Industry,
DG Connect, DG MOVE).

 Involvement of stakeholders: the involvement of stakeholders


organisations has been another key element of the development of ITS
standards. An extensive list of stakeholders to be involved in the
project was presented in the Response to Mandate M/453 and further
expanded during the period of implementation of the Mandate.
The stakeholders involved included relevant forum and partnerships working
on ITS (such as Car-2-Car CC - Car to Car Communication Consortium, TISA
- Traveller Information Services Association, ERTICO – ITS Europe), the
automotive industry and equipment suppliers (such as EUCAR - European
Council for Automotive R&D, ACEA -European Automotive Manufacturers’
Association, CLEPA - European Association of Automotive Suppliers), public
mobile operators and mobile industry (the GSM-A organisation, the iMobility
Forum), road infrastructure and toll providers’ organisations (CEDR -

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”.

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Conférence Européenne des Directeurs des Routes, ASECAP - European
Association with tolled motorways, bridges and tunnels concessionaires), as
well as the relevant European stakeholders in the standardisation domain
(such as ANEC, ECOS, NORMAPME).
Finally, means for the dissemination of information about the
standardisation work have been set up through two dedicated websites
(www.etsi.org/m453 and www.itsstandards.eu and www.tc278.eu), and a
newsletter was regularly sent to 800 stakeholders. In addition the
Commission funded support actions, such as the iMobilitySupport, which
contributed to create awareness about C-ITS, and the standardisation
progress.

 Coordination between research projects and ESOs: the cooperation has


been extended to European research and development projects as well as
on-going Field Operational Tests (FOTs), through on one side the obligation
of the EU funded projects to take into account the existing standardisation
activities and to contribute to them through their projects’ results, and on
the other hand through the cross participation of CEN and ETSI TC ITS
members in the relevant R&D projects concerning C-ITS Systems.
The EU funded Integrated Projects with representative partners of the
different stakeholders able to leverage consensus on building blocks,
complemented with focused research projects for concrete issues, and later
with Field Operational Tests to test preliminary standards and provide
feedback to standardisation organisations. Projects were requested to
cooperate among them and feed with their results the standardisation
activities.
This included also funding of cooperative support actions especially
dedicated to support C-ITS standardisation and to federate projects results
to provide valuable input to the ESOs. Paradigm of this cooperation was the
development of the European C-ITS Architecture, deliverable produced by
several projects under coordination of COMeSafety, which was the basis for
the ETSI standard.135

 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

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- ETSI – IEEE and - SAE: ETSI also established a close cooperation
with IEEE, on the basis of an existing formal agreement, and with
SAE through a Letter of Intent and a Memorandum of Understanding.
- CEN-ISO: CEN/TC278 and ISO/TC204 Working Groups operated in a
wholly joint manner under the Vienna Agreement.

Finally, a EU-US-Japan cooperation on joint standardisation of C-ITS was


established in order to strengthen the harmonisation of standards for ITS,
achieve global interoperability and harmonise safety.
More specifically, the cooperation was established between the US Research
and Innovative Technology Administration (RITA), the European
Commission, Directorate General for Information Society and Media (DG
INFSO) and the Road Bureau of the Ministry of Land, Infrastructure,
Transport and Tourism (MLIT) of Japan. In addition, a Memorandum of
Cooperation (MoC) was agreed between ETSI and the U.S. DoT RITA in
2011.
In this framework, a Joint ITS Technical Task Force as well as Working
Groups, co-led and staffed by representatives of the U.S. Department of
Transportation’s (USDOT) and the EU, were establish to conduct the work
for this collaboration.
Among these, the Harmonization Task Groups HTG1 and 3 were convened to
develop recommendations for harmonizing the standards for
communications and security for connected vehicle technologies, which have
been developed separately in the EU and US, and then brought these
recommendations to the various SDOs with which the experts work.
This was one of the first substantive standards harmonization activities
under the EU-US ITS Cooperation agreement, and as such served as a
laboratory for learning how the European and American SDOs and
government stakeholders can work together more effectively on ITS issues.
Finally, the cooperation at international level and the stakeholders’
involvement were fostered through large scale events, organised within
the European Commission support Action COMeSafety2. COMeSafety2
organised several webinars in the course of the mandate and, after its
completion, 9 international workshops on Inter-Vehicle Safety
Communications. Bringing together experts from all the regions, from the
public administration, research, industry and standardisation domain, these
workshops have been the occasion to inform about the status of the
cooperation between Europe, the US and Japan, the main building blocks
and outstanding issues for harmonisation, validation and testing,
deployment of C-ITS.

 Funding of standardisation activities: the activities for the development


of the C-ITS minimum set of standards were supported by leveraging on a
range of different instruments. It should be noted that the EC Funding to
direct grants on C-ITS standardisation was relevant (and around 1,8 million
euros), but most of the contributions were provided by the stakeholders
(with an amount estimated three times as important as the EC funding) 136,
and namely by the industry.
Finally, contributions from EU and national funded research projects on C-
ITS (e.g. Coopers, CVIS, Safespot, COMeSafety, SCORE@F, SIM-TD,
EuroFOT and Drive C2X) all contributed to the development and the success
of the work on the C-ITS.

136
Castrillejo, E. (2013). Presentation at the 5th ETSI ITS Workshop (Vienna 5/02/2013).

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5.6.3 Conclusions and recommendations

Conclusions

 Effectiveness of the coordination systems implemented and


difficulties encountered: in general terms, based on the information
available, the work carried out met the ambitious objectives fixed by the
M/453: to prepare a coherent set of standards, specifications and guidelines
to support European Community wide implementation and deployment of
cooperative ITS. The Release 1 represented an important milestone, while
the Release 2 is expected to include the additional features needed to
support the deployment of complex cooperative systems.
Positive feedback from industry stakeholders is also perceived, and usage
and access to more information can be achieved following the further
deployment of C-ITS standards, and their uptake.
However, one of the most relevant achievements for this case study is the
collaborative ecosystem created at international level, including actors from
inside and outside the ESS, as well as the achievements in terms of
transparency and stakeholders’ involvement.
A large international cooperation was implemented, relying on formal
agreements (the Memorandum of Cooperation, the EU-US Task force, etc.),
but also on the various liaison tools, joint working groups, and the cross-
participation of TC members in different ESOs/SDOs.
Continuous political support and involvement from the administrations of the
different regions (e.g., US DoT, EU Commission, Japanese MLIT) also
contributed to foster the progress and cooperation.
Another important component was represented by the synergies created
with EU-funded research projects, which integrate the standardisation
activities with tool to strengthen cooperation at international level, to
support the deployment of C-ITS standards, or awareness rising. Some
examples of different but complementary projects are: COMeSafety
(supporting the implementation of the EU-US cooperation, and deployment
preparation), iCarSupport (addressed to the public at large to raise
awareness on ITS technologies and applications), eCoMove (linking
cooperative mobility systems and services with energy efficiency).
Finally, stakeholders where involved through workshops and had increased
access to information through dedicated portals, during the overall duration
of the Mandate period, and beyond 137.

 Adaptability to other fields: this case study was selected as an example


of cooperation mechanisms implemented for the development of standards
relevant to different “levels” (in particular at European and international
level), and different categories of stakeholders.
As such, the mechanisms identified in the case of the C-ITS, and considered
as successful, are expected to be transferable to several areas of European
policy and legislation, in the fields where the coordination with the
international level assumes a key importance, as well as the cooperation
needs to be expanded across sectors (e.g. in the ITS case, between toll
providers, automotive, telecoms).

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.

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This is for example the case of ICT standardisation, in general,
characterised by a fast changing environment, and the multiplicity of parallel
actions carried out by Fora and Consortia, and other standards-setting
organisations acting at international and regional level. Based on that, the
Rolling Plan recently being introduced as a tool to identify the
standardisation needs at European level, but also to provide an overview of
the activities underway, carried out by SDOs or by global industry-driven
ICT fora and consortia.

Opportunity for improvement 1: Collaboration and coordination with


externals

As mentioned earlier, in some fields, standardisation work cannot be limited to the


European area: in C-ITS, the innovative logic is of worldwide interest, and full
benefits of C-ITS can only be reaped through the involvement of a global
community, ensuring the co-operative character of the system.

In addition to the improvement of the strategic alignment between the various EU


stakeholders, a strategy for international standardisation should be developed. The
development of such a long-term common vision should be ensured through the
involvement of European and international actors, in order to avoid double work
and to ensure worldwide applicability of the standardisation work performed.

Opportunity for improvement 2: Open platform and interaction with the


stakeholders

One important aspect in ensuring this effective cooperation is the development of a


unified information platform. In addition to the differences in information logics
between the technical committees (at EU level), worldwide standardisation needs to
deal with a broader range of stakeholders, included in a complex ecosystem. The
European practices are therefore confronted with different international information
logics. The information framework should therefore be adapted –since the very
start of the work- in order to ensure availability of information (centralisation and
access), and effective contribution of the various stakeholders138.

138
CEN and ETSI (2010). “Joint CEN and ETSI Response to Mandate M/453”.

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5.7 Compliance checks, harmonized standards in gas appliances

5.7.1 Identified issue of the case study

Legal basis for the case study

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.

“[…] The Commission together with the European standardisation organisations


shall assess the compliance of the documents drafted by the European
standardisation organisations with its initial request.” (Art. 10.5 of Regulation (EU)
No 1025/2012)

“Where a harmonised standard satisfies the requirements which it aims to cover


and which are set out in the corresponding Union harmonisation legislation, the
Commission shall publish a reference of such harmonised standard without delay in
the Official Journal of the European Union or by other means in accordance with the
conditions laid down in the corresponding act of Union harmonisation legislation.”
(Art. 10.6 of Regulation (EU) No 1025/2012)

Scope of the case study

Based on the above-mentioned legal aspects, and considering the work we


performed during the first phase of the Independent Review, it is important to
carefully consider the mechanisms ensuring that the documents developed
actually correspond to the needs expressed by the Commission.

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?”

Two areas are key within this case study:

 The indication of the relationship with legal requirements in harmonised


standards (materialised through “Annex Z”): the way it is developed and
presented;

 The experts independent from the standardisation process (i.e. New


Approach consultants): their role/position and link with the different
stakeholders in the ESS (with a focus on potential conflicts of interest).

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Although the “compliance check” applies to all mandated standards (i.e. also
standards supporting EU policies), this case study focuses on harmonised standards
only

Context

 EC requests for harmonised standards: the Commission may request


the ESOs to develop standards responding to regulatory needs -or policy
needs- by submitting standardisation requests 139 (Art. 10.1). In case ESOs
accept the request, they have to develop a standard (or set of standards)
respecting the mandates concerned as well as their internal guidelines and
the requirements defined –or referenced to- in the mandate.
Once the requested standard is developed, the Commission should
assess the standard’s compliance with the standardisation request
(Art. 10.5) together with the ESOs. Where a harmonised standard satisfies
the requirements it aims to cover and which are set out in the corresponding
Union harmonisation legislation, the Commission shall publish its references
in the Official Journal of the European Union (OJEU) 140 (Art 10.6). In general
–as it is the case with NLF legislation for products-, the publication of the
references of a harmonised standard in the OJEU confers a presumption of
conformity to the essential requirements (of the directive/regulation) it aims
to cover. This “presumption of conformity” or other legal effect is defined
and set in the relevant sectorial directive or regulation.
“Compliance checks” thus help in assessing whether conditions for the
publication in the OJEU are fulfilled.

 Concept of “presumption of conformity” in Union harmonisation


legislation for products: as a consequence of OJEU publication, using the
harmonised standard provides the legal effect specified in the relevant Union
legislation. In general, this means that a product or a service which is
compliant with the harmonised standard is presumed to comply with the
corresponding legal requirements of the Union harmonisation legislation
covered by the harmonised standard.

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.

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manufacturer is the only responsible for assessing the risk of its
products and to identify the requirements he needs to fulfil. The
major advantage of the presumption of conformity is therefore that it
reflects a positive “opinion/image” about the goods being designed and
manufactured, and therefore facilitates discussion with potential business
partners about the safety and compliance of the goods to the directive143.
As an example: out of a Union directive, a manufacturer identifies he needs
to comply with 3 essential requirements (ESR): 1, 3 and 7. The ESRs 1 and
3 are covered by a harmonized standard, and presumption of conformity can
apply: the manufacturer is assumed to comply with ESR 1 and ESR 3 if he
respects the corresponding clauses in the harmonized standard. However,
the ESR 7 cannot be complied with through harmonized standards and the
manufacturer needs to prove compliance through other means.
Applicable ESR to be Specifications to comply with
All ESR (legally binding, complied with (identified appilcable ESRs (selected by
given in legislation) by a manufacturer) a manufacturer)

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

Source: Blue Guide 2014.

Although essential requirements can be complied with through the use of


harmonised standards, it has to be reminded that the use of these
harmonised standards remains voluntary (in most cases) and that
manufacturers are free to use any other means for complying with the
relevant Union legislation –in general. In that case, the manufacturer is
responsible for proving through other ways (e.g. applying other standards or
his own specifications where no “presumption of conformity” is granted) that
his products comply with the essential requirements not covered by
harmonised standards. In the above-mentioned example, it means that the
manufacturer could have selected other means for complying with the ESR 1
and 3, and would then have needed to prove compliance as he has to do for
ESR 7.

 Indication of the relationship with legal requirements in harmonised


standards (Annex Z): as mentioned earlier, the link between essential
requirements and technical content of the standard is usually given in a
dedicated Annex Z of the standard. In other words, this annex indicates
which legal requirements are adequately covered by the normative clauses
of a harmonized standard to provide presumption of conformity (after their
citation in the OJEU).
The Annex Z should be drafted according to ESOs’ internal rules 144. Note
that the Annex Z should not refer to clauses not related to essential
requirements.

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”

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Source: CEN-CENELEC Boss.

This supports the manufacturer in identifying what requirements are


possibly required by law. However, the manufacturer should perform his
own risk assessment to find out which essential requirements are applicable
to his product. On the basis of this assessment and Annex Z, the
manufacturer may then apply the harmonised standards –or parts of- to
confer presumption of conformity with relevant essential requirements. The
Annex Z therefore helps the manufacturer in the steps for having his product
compliant and marketable at EU level.

 Compliance check process: to assess whether a harmonised standard (or


a draft harmonised standard) “satisfies the requirements it aims to cover
and which are set out in the corresponding Union harmonization legislation”
(Art 10.6) and to allow publication in the OJEU by the EC, a “compliance
check” needs to be performed by the Commission. This compliance
checks includes the following:
- Assess whether the standard responds to the relevant
Commission standardisation request; “responding to the request”
means respecting its requirements and covering one or more of those
legal requirements given in corresponding Union harmonization
legislation (and referenced in the relevant mandate);
- Assess whether the covered legal requirements by the standard
are correctly or sufficiently addressed;
- Check that this claimed coverage of the legal requirements is
appropriately and correctly indicated in the standard (typically
in “Annex Z” to a harmonised standard).

As an example: the harmonised standard represented below includes 4


different specifications (a, b, c and d), while the directive includes 4 different
legal requirements (, ,  and ).

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.

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It must however be mentioned that in this case: first, specifications [a] and
[d] of the standard are not aiming to support any legal requirements and
they are not linked to legal requirements (and there is no need for the
manufacturer to be compliant with [a] and [d] to benefit from the
presumption of conformity); second, complying with this harmonised
standard does not provide presumption of conformity for all legal
requirements of the directive ( and  not being covered).

The controls to be performed are, in this case, that:


- The harmonised standard responds to mandate requirements
meaning that at least one legal requirement within the context of
the Directive is covered and the legal requirements aimed to be
covered are known [legal requirements  and  are supported];
- Specifications supporting the legal requirements are known (the
whole standard or some clauses of it) and they address correctly
or sufficiently those legal requirements they aim to support
[specifications b and c are assessed in terms of their support to
legal requirements  and  considering also the generally
acknowledged state of the art]; in addition there may be a need
to review that the rest of the standard [specifications a and c ] do
not conflict with law;
- The relationship between the covered legal requirements and the
specifications supporting those requirements is addressed
accurately in the (draft) standard (typically in “Annex Z”);

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.

There is also an expectation that harmonised standards are always drafted


following the rules for drafting and presentation of international standards to
ensure their appropriate quality. The assessment should also identify
deviations from those principles.

 “Compliance checks” as intended above are performed by the Commission


prior to publication of the standards in the OJEU. However, other controls
are performed by experts independent from the standardisation
process (i.e. New Approach consultants) prior to the submission of the draft
standard to the formal vote. New Approach Consultants: as mentioned
earlier, the ESOs are requested to verify the compliance of the published
standards with the requirements of the mandate and legislation.
Independent consultants can be appointed by the ESOs for performing this
assessment, i.e. the New Approach Consultants (NACs).
The New Approach Consultants are independent consultants whose
activity is funded by the Commission through ESOs on their request, while
their work is managed by CEN and CENELEC.
Their role is extensively defined in the CEN-CENELEC Guide 15, dedicated to
the “Tasks and responsibilities of the New Approach Consultants” (May
2014): in short, the NACs should be involved at the earliest stage of
standard preparation, in order to provide comments and guidance from
the beginning; and then to assess the document prior to the formal vote
(they participate as an “advisor” in the development of the standard).

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)

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The New Approach Consultants should also provide a formal assessment
of the coverage of essential requirements, and check the quality of the
Annex Z.
In case New Approach Consultants have been involved in the development
of a standard, their assessment of the standard may be used by the
Commission as a basis for compliance checks above-mentioned. However,
based on Art. 10(5), it appears that the controls performed by the New
Approach Consultants do not replace the Compliance Checks
performed by the Commission. Despite performing an assessment which
is closely related to the compliance checks performed by the Commission,
the New Approach Consultants are not formally representing the
Commission nor are delegated the tasks of the Commission.
It should be noted that in 2014, no New Approach Consultants were
appointed before mid-2014, due to the lack of FPA between the ESOs and
the EC.

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

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should be met and harmonised standards were needed to support this
directive149. These standards are developed in the scope of the mandate
M/BC/CEN/89/6, which was submitted in 1989 to European standardisation
organisations for the standardisation of appliances burning gaseous fuels.
These harmonised standards provide presumption of conformity to the
manufacturers respecting the standards (as explained in Art. 5 of the
Directive 2009/142/EC), facilitating compliance with the GAD.
The compliance with these standards cannot however be based on
self-assessment (Module A), but relies on a positive assessment from
a notified body (by opposition to other approaches such as the Low
Voltage Directive150).
The standardisation work related to GAD is in CEN’s field of work “Sector
Heating, Ventilation and Air Conditioning” (HVAC), and the following
technical bodies are involved in standardisation for “Appliances burning
gaseous fuels”:
Technical Bodies
CEN/TC 48 Domestic gas-fired water heaters
CEN/TC 49 Gas cooking appliances
CEN/TC 58 Safety and control devices for gas-burners and gas-burning
appliances
CEN/TC 62 Independent gas-fired space heaters
CEN/TC 106 Large kitchen appliances using gaseous fuels
CEN/TC 109 Central heating boilers using gaseous fuels
CEN/TC 131 Gas burners using fans
CEN/TC 180 Non-domestic gas-fired overhead radiant heaters
CEN/TC 181 Dedicated liquefied petroleum gas appliances
CEN/TC 238 Test gases, test pressures and categories of appliances
CEN/TC 299 Gas-fired sorption appliances and domestic gas-fired washing
and drying appliances
CEN/CLC/JWG/FCGA CEN/CENELEC Joint Working Group on FCGA (Fuel cell gas
appliances)

CEN/SS H99 Products for household and leisure use - Undetermined

5.7.2 Analysis and findings

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.

General issues identified

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.

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publication of references of harmonised standards under the GAD occurred in
December 2010. Since then, the publication of references of GAD harmonized
standards in the OJEU was set “on hold” by the Commission, mainly due to
the lack of a clear distinction between the product specifications dedicated to
supporting essential requirements, and specifications not supporting the application
of the GAD (in Annex Z)151. This lack of accuracy in the Annex Z was against the
CEN-CENELEC internal drafting rules and the mandate M/BC/CEN/89/6, which
require having a clear separation between specifications related to essential
requirements from the others. Other elements were highlighted about the non-
compliance of the Annex Z with common drafting principles, but will not be further
developed in this case.

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.

Issues on annex Z quality

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.

The interviews performed show a divergent perception of the Commission and


industry about this issue.

 Commission’s views: the main issue encountered by the Commission is a


lack of clear distinction (in Annex Z) between product specifications
corresponding to essential requirements of the GAD, and product
specifications not related to essential requirements.
From the legislator perspective, this has a negative impact on the
functioning of the internal market as non-harmonised specifications
incorrectly linked to the essential requirements of the GAD would introduce
stricter requirements that what is asked by the directive, and could

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.

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therefore hamper market access and therefore have an adverse effect
on competition between manufacturers.
The drafting of harmonised standards should be based on the related
directive(s)155, and the development of the Annex Z should be closely
interrelated with drafting activities156. However, issues can still occur. In the
GAD case, standards were deemed to fail in correctly identifying the product
specifications related to essential requirements and, these standards were
not considered as compliant with the GAD mandate.

 Industry’s views: while the Commission focusses on the concept of “free


trade” and avoiding locking the market, other aspects should be taken into
account.
First of all, standardisation work on gas appliances was already ongoing
before the GAD and the submission of the mandate to the ESOs. In order to
avoid reinventing the wheel, the mandate (and as described in the blue
guide) foresees that existing standard should be reviewed –to ensure
coverage of essential requirements- and would then be usable for
presumption of conformity.
However, from the time standards already exist, the industry has no-
incentive in re-initiating work on existing standards, especially in the
case the product specifications should be lowered. This is perceived as
against the will of the industry, as standards should illustrate the state of
the art of the technology and related best practices.
Second, presumption of conformity –although being an important aspect
of the internal market- does not have a legal value in front of courts:
when ensuring safety of products, technological advancement, best
practice and state of the art technology should be used, in order to
ensure risk to be mitigated in an efficient way 157. It therefore implies
that, from the time state of the art of the technology changes (in terms of
safety), manufacturers should integrate these changes. From a practical
perspective, there is a need to respect requirements which are higher than
the essential requirements referred to in the directive. In the same logic, the
mandate foresees that pursuit for safety should not be limited to the
directive: “In conformity with paragraph 3 of Art. 100A of the EEC Treaty,
the joint position adopted by the Council related to the appliances on
burning gaseous fuels is conceived on the basis of a high level of protection.
To this end scientific findings and available medical information in the field
will be take into account where appropriate”.
Third, the concept of essentiality cannot be looked at from a “black or
white” perspective. The New Approach relies on standardisers for
translating essential requirements in product specifications, and the frontier
between something “essential” and not essential cannot always be easily

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.

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done (e.g. in the case of numerical thresholds, when fixing a threshold
temperature).
Furthermore, the case of the GAD is very specific, in the sense that
currently applied standards are based on existing national
standards, developed by gas industry, and which therefore refer to the
specification of their national gas network. Although the GAD identifies a
common framework for safety, it appears that the requirements for gas
appliances cannot be the same in all countries, as the characteristics of the
gas from the network is not the same (e.g. pressure). The standard refused
for publication therefore included elements related to these national
differences, while not being in the harmonisation legislation. The issue
encountered in GAD are therefore related to the additional complexity
induced by the harmonisation of standards, which are based on non-
harmonised input.

 Other Annex Z issues: moreover, despite the drafting guidelines applied


within the ESOs, other issues have been noted by interviewees, such as:
- Annex Z not referencing separately the different relevant directives
(i.e. a harmonized standard can cover the essential requirements of
different directives);
- Insufficient coverage of the essential requirements;
- Cascading references between standards, sometimes referring to
obsolete versions of standards.

Role of New Approach Consultants

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.

As explained earlier, these New Approach Consultants should assist experts in


preparing harmonised standards and provide the recommendation on how to
prepare the harmonised standard.

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.

In addition to this difficult task encountered by New Approach Consultants, it


appears that their opinion is not necessarily shared by the Commission: for
instance, in the case of the GAD, the consultant made a positive assessment of this
standard and the Commission refused to publish the standard. It appears that this
difference of assessment is based on different rules for assessing whether the
standard intended for publication should actually be published, and a difference in
the proximity with the standardisers.

Based on our perception of the controls performed by the Commission, it also


appears that the depth, extent and scope of the compliance checks vary
based on the responsible DG.

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Issues on timeliness

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.

Based on the issue encountered, several meetings (involving standardisers and


legislators) were organised. In these meetings, the issue encountered were
discussed and corrective actions to be undertaken by CEN were agreed to rectify
the issue encountered in the field of GAD.

5.7.3 Conclusions and recommendations

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.

This non-publication of harmonised standards in the OJEU is perceived as induced


by the lack of alignment between the European Commission and the
industry participating in standardisation: on one hand, the European Commission
considers that only essential requirements should be covered, to ensure free trade;
on the other hand, the industry logic is based on the fact that standards already
exist, that security relies on higher concepts than the directive only and that
existing standards can be used to respond to legislation.

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.

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Opportunity for improvement 1: Identification of roles and responsibilities
in the process

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.

Solving this misunderstanding and reaching an agreement on the common needs of


the ESS in terms of harmonised standards, and what are the key quality criteria
which should be respected (as well as the corresponding controls).

In particular, alignment should be reached on the process to follow in the case of


harmonised standards being based on existing standards, and not being developed
in response to the mandate.

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.

Opportunity for improvement 2: Development of guidelines for drafting


standards supporting legislation

The above-mentioned suggestion should be supported by the development of


guidelines related to New Approach Directives and harmonised standards.
This could therefore include:

 The expectations of the EC through New Approach Directives;

 The key criteria that ensure the expectations to be reached;

 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).

Opportunity for improvement 3: Continuous support in the preparation of


Annex Z

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.).

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5.7.4 Appendix

Extracts from relevant documents

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

Category Number of interviewees/contributors


European Commission 2
European standardisation organisations 1
Industry or industry representatives 3
National standardisation body 1
New approach consultant 1
Notified body 1

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5.8 The primacy of international standardisation

5.8.1 Identified issue of the case study

Legal basis

This case study is performed in relation to:

Regulation (EU) No 1025/2012, which states the following:

 European standardisation plays an increasingly important role in


international trade and the opening-up of markets. The Union should seek to
promote cooperation between European standardisation organisations and
international standardisation bodies

 European standardisation reinforces the global competitiveness of European


industry especially when established in coordination with the international
standardisation bodies, namely the International Organisation for
Standardisation (ISO), the International Electrotechnical Commission (IEC)
and the International Telecommunication Union (ITU)

Art 2 of Regulation (EU) No 1025/2012 (Definitions) states that ‘international


standard’ means ‘a standard adopted by an international standardisation body’ and
states that ‘international standardisation body’ means ‘the International
Organisation for Standardisation (ISO), the International Electrotechnical
Commission (IEC) and the International Telecommunication Union (ITU)’.

In addition, and as part of its 2012 ‘standardisation package’, the Commission


Communication COM (2011) 311158 states that “The European standardisation
system … recognises the primacy of international standards” and goes on to state
that “European standards should, wherever possible, be based upon the
internationally accepted standards of ISO, IEC and ITU.” It is accepted that
separate European standards are necessary “where international standards are not
available or where they do not adequately serve legitimate regulatory and policy
objectives” but stipulates that “Where European standards deviate from existing
international standards, an outline of the reasons for the deviation should be
provided”.

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.

Scope of the case study

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

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agreements between the European and International levels, assess their
operational implementation (practical use), identify any material differences
between the ESOs in terms of how their work is coordinated with the international
level, and provide conclusions and recommendations.

The problem statement is the following:

“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?

 How is the principle of the primacy of international standardisation reflected


in the agreements? How and why do they differ from each other in this
respect?

 What proportion of European standards is aligned to international standards?


What are the differences between the ESOs in the degree of alignment? What
are the differences between different industrial sectors? What are the reasons
for these differences?

 What problems have been identified in the operational implementation of the


agreements, and what measures have been taken to address those problems?
What problems remain?

Based on the findings, recommendations for improvements are formulated.

Context

Europe is an innovator in developing new types of tradable goods, services and


technologies, for example in areas such as electric vehicles, security, energy
efficiency and smart grids. By driving the development of European or international
standards in these areas Europe can maximise first mover advantage and increase
the competitiveness of European industry. Standardisation bodies based in the EU
should therefore continue to put forward proposals for international standards in
those areas where Europe is a global leader to maximise European competitive
advantage.

International standards, in particular, contribute to the removal of trade barriers


resulting from differences in standards of various countries, and are a powerful tool
for promoting regulatory convergence. Effective action requires co-operation
between the ESOs and their international counterparts during the definition of the
work items.

5.8.2 Analysis and findings

Data collection

The information used in this case study is based on a review of relevant


documentation and data, supplemented by a series of targeted interviews.

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
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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.

ESO-ISB cooperation agreements overview: CEN-ISO

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.).

The objective of the VA is to generate benefits in terms of (i) increased


transparency of work ongoing in CEN to ISO members and vice versa, (ii)
avoidance of duplication of work and structures, allowing expertise to be focused
and used in an efficient way to the benefit of international standardisation, and (iii)
increasing the speed of elaboration, availability and maintenance of standards
through a need to establish consensus only once.

These benefits are generated through five modes of cooperation, as follows:

 Regular exchange of information between ISO Central Secretariat (ISO/CS)


and the CEN Management Centre (CMC)

 Cooperation by correspondence

 Cooperation through mutual representation at meetings of technical entities

 Adoption by one organisation of available publications from the other


organisation

 Cooperation by submission of relevant and approved work items within the


same scope to parallel procedures, with agreement on leadership (CEN lead
or ISO lead).

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

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which a need has not been recognized at the international level’ and (ii) ‘the
prioritization of ISO work is also such that in some instances CEN needs to
undertake work which is urgent in the European context but less so in the
international one’. The basic principles of the agreement also indicate that the
transfer of work from CEN to ISO (i.e. ISO lead) is the preferred route but is not
automatic, and stipulate that the processes of consensus confirmation and approval
are synchronised wherever possible to achieve the objective of simultaneous
publication. The CEN lead is only possible if this is supported by a simple majority
of the members of the respective ISO committee that are not CEN national
members.

A Joint Coordinating Group (JCG161) of the ISO Technical Management Board


(ISO/TMB) and the CEN Technical Board (CEN/BT) has been responsible for
overseeing the application of the VA. Comprised of four members each from ISO
and CEN, the JCG has monitored the general implementation of the VA, and has
reviewed and proposed improvements to existing procedures and mechanisms. It
reports to ISO/TMB and CEN/BT and acts in an advisory capacity only.

ESO-ISB cooperation agreements overview: CENELEC-IEC

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 expedite the publication and common adoption of International (IEC)


standards

 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

 To accelerate the standards preparation process on response to market


demands

The DA sets out the detailed implementation procedures to be followed in regard


to:

 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

 Parallel voting on draft international standards - IEC drafts submitted to


enquiry or vote are automatically submitted for parallel enquiry and vote
within CENELEC, with the exception of (i) standards emanating from IEC TCs
that have been nominated by the CENELEC Technical Board (CLC/BT) as
outside CENELEC’s requirements, or (ii) draft amendments to IEC standards
that have not been harmonized by CENELEC as European standards (EN) or
harmonization documents (HD)

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.

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 Conversion of European standards and drafts into international standards –
setting out the procedure for IEC votes on already published EN and HD, and
in the case of new standards of European origin

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.

ESO-ISB cooperation agreements overview: ETSI-ITU

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.

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satisfactorily resolved are referred for discussion at the level of Director-General
(ETSI) and Secretary General (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.

ESO-ISB cooperation agreements overview: Differences/analysis

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.

Table 2: Modes of cooperation in ESO-ISB agreements


Mode of cooperation CEN-ISO CENELEC- ETSI-ITU
IEC
Regular exchange of information between central ✔ ✔ ✔
secretariats
Regular exchange of information between ✔ ✔ ✔
technical bodies (TC/WG)
Process for participation in technical (TC/WG) ✔ ✔
meetings
Process for adoption by one party of standards ✔ ✔ ✔
published by other party
Preference given to ISB to lead development of ✔ ✔
new work items
Process for parallel development / approval of ✔ ✔ ✔
standards
Process for monitoring the implementation of the ✔
agreement

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

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business domains (as does ISO) while CENELEC focuses on the
electrotechnical field (as does IEC). Because CENELEC and IEC cover
only one sector their cooperation agreement and associated
processes can and have been optimised to the needs of that
particular sector, which is inherently international in terms of its
actors and requirements, and where there are relatively few needs or
requirements that are unique to Europe. Because of this,
electrotechnical standards developments are most commonly
driven at the international rather than European level, and the
Dresden Agreement reflects this through a ‘default’ expectation that
most standardisation work will be carried out by IEC, and a process
to ensure that all new work items generated in CENELEC will be
offered to IEC rather than pursued at the European level. This
arrangement obviates the need for a process for (non-EU) members
of IEC to participate in CENELEC TC meetings, since CENELEC only
leads on work where non-EU members of IEC express no interest
developing the standard themselves.
By contrast, CEN (and ISO) cover multiple sectors. In some
cases the cooperation will happen in an almost identical way to that
of CENELEC-IEC but in other sectors the markets, actors and
requirements are more national or regional than international. This
greater plurality in the sectors covered by CEN and ISO means that
the Vienna Agreement allows for the possibility of greater divergence
between European stakeholders’ requirements and those of the
international community. In particular there is the possibility that in
some sectors European actors may be driving standards development
in areas that are not seen as relevant (or not yet relevant) by
ISO’s (non-EU) members. In other areas, CEN may be developing
standards to address specific regulatory requirements in the
EU, which do not apply at the International level. As such, there is
greater scope for work to be carried out exclusively by CEN (to
address specific European requirements) and for CEN rather than ISO
to lead when the main interest is coming from European members.
- Notification of work items: one additional very notable difference
is that under the Vienna Agreement is up to the individual CEN
TCs to decide whether (or not) to refer new work items to ISO
under the Vienna Agreement, whereas this happens automatically
under the Dresden agreement through exchange of information
between CENELEC and IEC. CCMC manages the exchange of
information with ISO/CS under the VA but does not automatically
refer new CEN work items to ISO/CS for consideration at the
international level (this is left to the single TCs). The one exception is
in the case of revisions or amendments to standards that are already
published under the VA or adopted by ISO – here the work item is
automatically processed under the VA with ISO lead. Otherwise,
however, it is left to individual TCs to notify new work items, or not.
As a result, the CEN/ISO monitoring and reporting focuses only
on the work items that are registered or notified under the VA,
rather than on the portfolio of new work items as a whole.
CCMC explains that the notification system in CEN operates in a self-
regulatory way because the TCs themselves are best placed to
manage the linkages and notifications. The NSB members of CEN are
also NSB members of ISO, and so the relationships between the two
organisations’ respective committee structures and work programmes
are best managed at the technical (e.g. TC) rather than
administrative (central secretariat) level. In fact there are many
European standardisation activities (and TCs) with no equivalent in
ISO, so many CEN TCs do not have an ISO TC to refer new work

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items to, making automatic notification in some areas redundant.
Overall, CCMC and ISO/CS consider that the international committees
are well-informed as to what is going on at the European level - there
is a high degree of overlap between CEN and ISO TC membership,
and the same experts often also often work in both committees – so
a universal notification system is not required or efficient.
- Efforts to align the procedures: efforts to continue to further align
the two systems do however continue. For example, in the case of
creation of a new TCs, the default position is to have an ISO
committee only, with no need for a CEN committee. In cases where
such specific EU need exists, then the CEN TC is only charged with
addressing EU-specific requirements; everything else is managed by
the ISO TC. This default position reasserts the primacy of
international standardisation and the desire for European standards
to, wherever possible, be based on International ones.

 ETSI: ETSI and ITU cooperate on standardisation matters and share


information for the benefit of their respective members and to avoid
contradictions and duplication of effort 164. The aim of the 2012 MoU was to
clarify the relationships and procedures, make the interactions between the
two organisations explicit, and to improve coordination and synergy.
ETSI and ITU operate to a different membership structure than the other
ESOs and ISBs, and are open to any interested organisation whether it is a
company, NGO, public institution, sectoral body or NSB. In ETSI, standards
development is organised by technical bodies that comprise interested
members, and the members of the technical body vote on and approve
standardisation deliverables, based on simple consensus or weighted vote.
This contrasts with the national (NSB) membership structures and voting
systems of CEN and CENELEC and their international counterparts.
The modes of cooperation between ETSI and MoU are threefold:
- ETSI is a sector member of ITU165 and is entitled to participate in
its technical meetings (study groups) and make contributions.
However, its main role as sector member of ITU is to share
knowledge and provide inputs on behalf of its members.
- The MoU between ETSI and ITU aims at further strengthening
information exchange. An Annex to the MoU maps the connections
between ETSI and ITU technical bodies and provides the relevant
points of contact. Not all areas have activity but all ongoing
connections are made explicit. The mapping is available to all
members and is updated and redistributed annually. In addition the
MoU provides the basis for joint work and joint meetings, mainly to
try to ensure compatibility or harmonisation at the interfaces
between ETSI and ITU standards. The MoU also provides the basis for
other levels of cooperation, such as exchange of information on work
programmes, events, and attendance at each other’s’ events (e.g.
general assemblies, IPR committees, and other major meetings).

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.

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- The third mode of cooperation relates to the promotion or
submission of ETSI positions to ITU. This aspect is governed by
ETSI’s internal directive on rules and procedures, which stipulates
that ETSI members must agree a position on a subject before a
statement / document can be submitted. This is to avoid a situation
where more than one (non-aligned) position is being presented in ITU
under ETSI’s name, and hence seeks to avoid the potential for
confusion or contradictions.
ETSI explained that there is no explicit aim or scope to publish identical
standards or to get either party to recognise or adopt the standards of the
other. There is also no explicit recognition of the ‘primacy’ of international
standards. Rather the aim is to avoid duplication of effort, and to ensure
compatibility, reduce overlaps and confusion, and thereby increase efficiency
and speed. ETSI may reference ITU documents and vice-versa, and the two
organisations may seek to harmonise elements of their standards where
they interface with each other and need to be interoperable.

Data on the use of the cooperation agreements: Vienna agreement - CEN-


ISO

Frequency of use of the Vienna agreement: data on annual Work Items

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.

Table 3: – CEN work items 2006-2013


VA Work item
2006 2007 2008 2009 2010 2011 2012 2013 Total Share
type
No Home grown
European 603 1075 826 855 758 847 785 755 6504 65%
standards
Yes Endorsed from
55 146 159 129 98 87 68 64 806 8%
ISO – Identical
Yes Endorsed from
0 0 2 0 3 2 10 3 20 0%
ISO – Modified
Yes Parallel
procedures – 25 38 53 74 42 47 44 36 359 4%
CEN lead
Yes Parallel
procedures – 178 326 317 252 259 290 313 360 2295 23%
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.

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VA Work item
2006 2007 2008 2009 2010 2011 2012 2013 Total Share
type
Grand total 861 1585 1357 1310 1160 1273 1220 1218 9984 100%

Degree of alignment between CEN and ISO standards: data on


standardisation deliverables

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)

CEN - Portfolio - Relation to ISO by Business Domain


Identical to ISO publications Based on ISO publications No relation to ISO publications

Healthcare 478 2 138


General (Quality, measurement,…) 430 1 169
Food 256 1 203
Environment 228 1 220
Materials 921 2 904
Mechanical engineering 1097 14 1252
Chemistry 456 3 625
Packaging 83 205
ICT 181 1 540
Health and safety 154 525
Household goods, sports & leisure 70 439
Utilities and energy 59 442
Building and civil engineering 264 2 2063
HVAC 29 320
Services 7 93
Transport 126 2577

0% 20% 40% 60% 80% 100%


Percentage of documents

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.

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CCMC and ISO/CS have explained that the variation in alignment of CEN and ISO
standards across the various business domains reflects natural differences between
the sectors in terms of the following aspects:

 Different market contexts, some of which are global / multinational in


character with mainly international players, while others are more regional,
national or local in character (in some sectors, such as services, standards
developments have followed a pattern more based on national needs; in other
sectors the need for international/global standards clear prevails, such as in
the sector of medical devices – see the case in the paragraphs below, or in
the aerospace sector – subject of another case study within the Independent
Review). The extent of internationalization of the sector and its industry is the
main driver for a high or low level of alignment between European and
International standards. For example, in the medical devices (healthcare)
sector most of the operators are (US-based) multinationals that operate in a
global market. Standards development is therefore driven at an international
level and there is good scope for EU standards to be aligned to the
international ones. By contrast, in the construction sector there are relatively
few international standards because construction markets and operators are
mainly national or regional in character rather than international, and
because local climates, materials and traditions mean that global standards
are rarely possible169.

 Another main driver of sectoral differences concerns legislation, and specific


cases where EU legislation sets specific requirements 170 that are not relevant
to the global (ISO) actors outside Europe. In some sectors where standards
are used to meet legislative requirements that are specific to Europe there is
a non-alignment between the international needs and the European needs,
leading to divergence in standards at the two levels. Put simply, the
international standard is not sufficient for the European legislative purposes,
thereby creating the requirement for the creation of a EU-specific standard. In
this sense, one of the main drivers for European standards being non-aligned
to international ones is the legislative requirements of the Commission.

 Another factor that can cause a divergence in EU and International standards


is the issue of time and speed of development and publication, which
can hamper alignment in two ways. The first is that a higher priority is
(increasingly) given to speed within the EU, meaning that CEN stakeholders
may wish or need to develop standards before ISO stakeholders are ready, or
in timescales that ISO members cannot meet 171. This can lead to a situation
where Europe proceeds with development of standards before equivalent
development takes place at international level. The second issue with speed is
that in some cases delays to publication of approved EN-ISO (identical)
standards can occur if EU regulators are not satisfied that the standard fully
meets the necessary EU regulatory requirements. In such cases a desire by
the international community to publish the approved standard quickly may
lead to a situation where CEN has no choice but to proceed to develop EU

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).

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standards that diverge from the ISO standards that are already published and
in use.

 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.

Data on the use of the cooperation agreements: Dresden Agreement -


CENELEC-IEC

Data on the frequency of use of the Dresden agreement:

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.

Table 3 – CENELEC work items 2006-2013


DA Work item type 2006 2007 2008 2009 2010 2011 2012 2013 Total Share
No Home grown
European 106 75 99 112 108 127 116 94 837
standards 23%
Yes Endorsed from IEC
4 5 10 17 6 7 3 6 58
– Identical 2%
Yes Endorsed from IEC
16 12 30 20 12 10 9 8 117
– Modified 3%
Yes Parallel procedures
298 401 282 399 322 332 311 336 2681
– IEC lead 73%
Grand total 424 493 421 548 448 476 439 444 3693 100%

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Data on the degree of alignment between CENELEC and IEC standards:

CCMC data on the alignment between CENELEC standardisation deliverables 172


(SDs) and IEC publications indicates that of its current portfolio of 6,811 SDs, some
4,830 (70.9%) are identical to IEC publications and a further 402 (5.9%) are
based on IEC publications. The remainder – 1,579 SDs (23.2%) – have no relation
to IEC publications.

Looking only at CENELEC’s portfolio of (1,762) harmonized European standards at


the end of 2013; the proportion that is identical to IEC standards is slightly lower at
59.9% and a greater proportion is based on (but not identical to) IEC standards
(13.8%). The proportion of ‘home grown’ harmonized CENELEC standards is
26.3%.

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)

CENELEC - Portfolio - Relation to IEC by Business Domain


Identical to IEC publications Based on IEC publications No relation to IEC publications

General (Quality, measurement,…) 506 13 55


Electronics 808 4 136
Electrical engineering 965 95 137
Healthcare 140 2 32
ICT 1293 17 419
Household goods, sports & leisure 532 112 88
Environment 10 6
Utilities and energy 365 37 281
Health and safety 119 119 117
Transport 85 3 215
Services 7 93

0% 20% 40% 60% 80% 100%


Percentage of documents

Data on the use of the cooperation agreements: MoU - ETSI-ITU

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

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ETSI points out that it is not possible to closely monitor and count the many formal
and informal interactions between ETSI and ITU that take place all over the world
every day. There are many types of interactions and many delegates in both
camps, and the joint members lead on information exchange. This is the most
efficient way. ETSI does not consider that the costs of tracking and reporting on the
interactions would be affordable, nor would the information gained be of particular
value or strategic importance. The existing monitoring system correctly focuses on
making the points of interaction and exchange explicit, and on keeping these visible
and up to date, rather than on counting the number of interactions taking place.

5.8.3 Issues in the implementation of cooperation agreements

CEN and ISO

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).

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CENELEC and IEC

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 and ITU

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:

 On the Radio-communications (ITU-R) side the two organisations cooperate


well, both bilaterally and with other national and regional standards
development organisations. The relationships in this sector are fruitful and
work well.

 On the telecommunication side (ITU-T), while cases of very good cooperation


in standardisation activities are reported, ITU believes that the competitive
aspects prevail. Even though ETSI is a regional organisation by name and
mandate, ETSI’s aspirations are global. In general ETSI does not include ITU-
T at the outset of new standardisation activities, involving ITU-T only after
certain critical decisions have been made. For instance, ITU-T feels that it was
excluded in the early discussions of the formation of oneM2M. ETSI also led
the discussions to change the bylaws of the Global Standards Collaboration
(http://www.itu.int/en/ITU-T/gsc/Pages/default.aspx), a voluntary
organisation dedicated to enhancing global cooperation and collaboration
regarding communications standards and the related standards development
environment, which puts ITU at the same level as national and regional
organisations.

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.

Failures of the system in the adoption of international standards at EU


level/the continuation of parallel work at international level

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).

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Example 1: Adoption of international standards – medical devices case example

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.

In cases where European standards are to be harmonised and provide presumption of


conformity to specific ER, they must contain (one or more) Annex ZA, with a table showing
the correspondence between (a) the text of the standard and (b) the essential requirements
or parts of essential requirements addressed by the standard. During the drafting process,
New Approach consultants employed by the ESOs assist Technical Committees in preparing
the Annex ZA, and once a candidate hEN has been developed and approved it is submitted to
the European Commission for publication in the Official Journal. However, publication of the
hEN is not ‘automatic’, and the Commission and Member State Authorities have the right to
formally object to publication of any hEN.

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

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agree that the European process should not be allowed to hold up the International one
indefinitely, and so ISO / IEC may be justified in decoupling themselves from the process
(i.e. withdraw the standard from VA/DA procedures) and publish first, with Europe publishing
the standard later, if and when it is ready.

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.

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The situation also acts against many of the strategic objectives of the ESS defined by the
Commission. First and most obviously, it leads to delays in the publication of standards,
which means that they are not made available to the market in a timely manner. Second, it
increases the likelihood of divergence between EU and International standards, harming the
competiveness of European industry both within the internal market and in international
markets.

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.

Example 2: Coordination of the work at international level – Greenhouse gas


emissions (GHG) example

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.

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(WG33).

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:

 In the field of packaging (materials used, manufacturing technologies and


contents), the CEN/TC 261 does not report specific issues in the application
of the VA, whereas a close cooperation and alignment with the relevant ISO
TCs has been established since the beginning. As a result of this alignment,
out of a total collection of 233 published standards, around 28% are EN ISO
standards (consistently with the average).

 In the field of food security, the availability of standards is of utmost


importance to fulfil the requirements of a free movement of goods in the
common market and international level. The CEN/TC 275 works in close

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.

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collaboration with ISO/TC 34, with a number of common standards
developed under the Vienna agreement, with either an ISO or a CEN lead,
thus seeking to ensure common international requirements. In particular,
the working groups dealing with the areas of microbiological contaminants
(WG 6) and genetically modified foodstuffs (WG 11), the documents
(standards or technical specifications, etc.) were and are elaborated under
the Vienna agreement, both under ISO-lead as well as under CEN-lead180.

Other issues on the alignment of EU and International standards:


Participation of Annex III organisations in international standardisation

European stakeholder organisations face particular challenges as a result of the


preference for European standards to be aligned with international ones, and for
work to be carried out at the international level wherever possible. The four ‘Annex
III’ organisations representing SMEs (SBS-SME), consumers (ANEC), environment
(ECOS) and ETUI (workers) have been afforded specific rights under Regulation
(EU) No 1025/2012, aimed at strengthening their role within the ESS. However,
they do not have the same rights at the International level, where European
standards will increasingly be set.

There are three main implications for Annex III organisations:

 They will face more difficulties in influencing changes in standards.


Although there are European votes on standards developed in parallel with
ISO & IEC, in practice it is difficult for European public interest and social
interest stakeholders to influence the fundamental characteristics of a draft
standard on which multinational industry has already reached agreement at
the international level.

 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.

 ISO/TCs are encouraged to meet around the world, which adds to


the costs faced by Annex III organisation when seeking to deploy experts
to those committees.

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.

In this perspective, the European Standardisation System must be proactive in


ensuring that standards (regardless of their origin) are fit to meet European
regulatory and political needs. This means ensuring the European system is
effective in facilitating the participation of all interested stakeholders at the
European level, coupled to a real means in CEN-CENELEC to influence standards
being developed in ISO and IEC. This may entail new mechanisms for ensuring a
strong input from Annex III organisations into CEN and CENELEC and ensuring that
those inputs are clearly stated at ISO and IEC levels. It may also entail the
provision of funding to ensure that the Annex III organisations can have an
effective input at the international level, particularly in cases where societal
representation at the international level is most needed but least evident.

180
CEN/TC 275 Business Plan, 2014.

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5.8.4 Conclusions and recommendations

Conclusions

Overall functioning of the cooperation agreements: the available evidence


indicates that the cooperation agreements signed between CEN, CENELEC and their
international counterparts (ISO and IEC) are effective and efficient mechanisms for
ensuring strong coordination of European and international activities, in line with
the principle of the primacy of international standardisation. ETSI and ITU
cooperate through different arrangements, which are not comparable with the
activities for parallel work at international level set up for CEN/ISO and
CENELEC/IEC. While CEN and CENELEC are largely the European equivalents of ISO
and IEC, providing the possibility for large numbers of common standards
applicable at both levels, ETSI occupies a different space to ITU, serving the needs
of its European members in areas where ITU is not active. In the case of ETSI and
ITU, the cooperation is necessarily weaker, and no full alignment of European and
international standardisation is granted. Better/more cooperation between the two
organisations would be beneficial; however the different interests and the structure
of the two organisations should be taken into account.

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.

Use and monitoring of the cooperation agreements: the mechanisms for


cooperation and coordination between the ESOs and ISBs are actively used (a high
share of work items are placed under the VA or DA). Ongoing regular monitoring of
the implementation of the agreements has led to revisions, simplification and in the
case of the VA the development of detailed operational guidelines.

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:

 In the medical devices sector, the European legislation establishes


requirements to grant a high level of protection of the human health. It is
outside the scope of this case study to establish whether the standards
developed at the international level grant the high level of safety promoted by
the European legislation. Focusing on the processes of the ESS, and based on
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the interviews carried out, the issues encountered relate to the part of the
process operating at the European level, wherein TCs and New Approach
consultants have found themselves unable to meet the expectations from the
Commission on an acceptably detailed and precise Annex ZA. Failure to
resolve the situation is damaging and expensive for European industry and
harms the reputation of the ESS internationally.

 In the case of GHG, issues emerged in relation to a more general difficulty to


balance the European interests (i.e. developing the mandated standards
within the established time, and maintaining the lead), and the need for
alignment with the requests and procedures at the international level.

 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.

Opportunity for improvement 1: Monitoring systems

We recommend that CCMC investigate the possibility of developing and publishing a


mapping of the relationships between CEN <-> ISO and CENELEC <-> IEC TCs, in
order to aid transparency of the areas of close cooperation and joint work between
the European and international levels. A better collection of data and monitoring of
the agreements would also provide enhanced possibilities to develop a strategic
planning of the work to be aligned at international level.

Opportunity for improvement 2: Prevention of the issues related to the


compliance with EC legislation

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).

Another option to facilitate the compliance between international standards and EU


requirements is the possibility for defining the Annex Z to standards (a document
matching each standard with regulatory essential requirements) before starting
standardisation work at international level, in order to facilitate the process of
matching standards to essential requirements in a coherent and mutually
acceptable way.

Opportunity for improvement 3: Strategic planning

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
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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.

Opportunity for improvement 4: Annex III Organisations

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).

Other suggestions specific to the case study: Resolution of issues in


sectors covered by the New Legislative Framework

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.

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5.8.5 Appendices

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

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5.9 ICT rolling plan

5.9.1 Identified issue of the case study

Legal basis

This case study is based on the standardisation package and on Commission


Decision of 28.11.2011 to set up the European Multi Stakeholder Platform on ICT
standardisation.

The Communication COM (2011)311 gives a special emphasis to standardisation in


the ICT field, and highlights the strong need to ensure interoperability of networks
and the development of a successful digital society.

Scope of the case study

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:

“What is the impact of the Rolling Plan on ICT standardisation, in terms of


effectiveness, transparency and speed?” Which are the lessons learnt so far which
can be applied to the ESS as a whole?

Context

 ICT Standardisation: being a fast changing and competitive environment,


the ICT sector requires standards to be developed in an efficient and timely
way, in order to keep up with the fast developing new technologies.
Moreover apart from the three ESOs, global industry-driven ICT fora and
consortia are very active in ICT standardisation. In addition to the
standardisation activities performed by these SDOs, a wide range of
proprietary “standards” are developed and promoted by individual
companies (or groups of them).
In this context, the Digital Agenda for Europe -one of the leading initiatives
of the Europe 2020 strategy- focuses on improving the framework conditions
for interoperability between ICT products and services in order for Europe to
develop the single market. Standards are one of the tools to promote
efficiency, interoperability, and innovation in the ICT sector. ICT standards
and technical specifications help vendors develop products and services that
work together better for users, and ensure interoperability among different
technologies and processes. Standardisation also helps preventing
technology lock-in (i.e. need to use proprietary standards, dominant on the
market, in order achieve interoperability). Therefore, standardisation plays
an important role in the current ICT sector, and is expected to have an even
more prominent role in the future of the sector.

 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

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policy interest. In ICT, this RP can be considered as complementary to the
annual Union work programme181.
The objectives of the ICT RP can be summarised as follows:
- Identify the needs in standardisation, i.e. the most relevant actions
which will produce the greatest effects to support the EU policies.
This is achieved via inclusiveness –e.g.: consulting a wide variety of
actors.
- Bridge the EU policy and the standardisation world. This is
achieved by documenting EU policies and relating them to ongoing
work, including global standardisation, actions undertaken by
industry consortia, technology platforms, ICT R&I projects, etc.
- Provide transparent view on the EU policy actions under way or
foreseen;
- Enhance the steering of standardisation activities, by elaborating a
more detailed program of standardisation, accompanied with a
standard tool to track progress;
- Indirectly, we can also expect the ICT RP to create awareness of the
importance of standards.
The ICT RP is a living document and it does not claim completeness. It aims
at covering as much as possible the broad range of standardisation
activities, technical specifications and standards relevant for the respective
policy objectives and topic areas.

 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.

Based on the Commission Decision, the MSP is composed of representatives


of national authorities of Member States and EFTA countries, stakeholder
organisations representing industry, small and medium-sized enterprises,
consumers and other societal stakeholders, as well as European and
international standardisation bodies and other non-profit making
organisations, which are professional societies, industry or trade
associations or other membership organisations active in Europe that within
their area of expertise develop standards in the field of ICT.
Regulation (EU) No 1025/2012 further defined that, before identifying ICT
technical specifications which may be eligible for referencing in public
procurement, the MSP should be used as a forum for consultation of
European and national stakeholders, European standardisation organisations
and Member States in order to ensure legitimacy of the process.
The European MSP, therefore, advises on matters related to the
implementation of ICT standardisation policies and more specifically on:

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.

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- potential future ICT standardisation needs in support to European
legislation, policies and public procurement;
- technical specifications for public procurements, developed by global
ICT standards-developing organisations;
- cooperation between ICT standards-setting organisations;
- the ICT RP, which provides a multi-annual overview of the needs for
preliminary or complementary ICT standardisation activities in
support to the EU policy activities.

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.

Moreover, we looked at a specific case of integration of stakeholders’ comments in


the ICT RP (i.e. needs/areas of intervention that were not identified by the EC, but
included upon the proposal of the stakeholders). On this matter, we took into
account the proposals formulated by Switzerland on the eHealth section of the ICT
RP.

5.9.2 Analysis and findings

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.

Comments on areas of focus

 The content of the Rolling Plan: the ICT RP is set up to define:


- The topics selected as policy priorities, i.e. fields where
standardisation plays a role in the implementation of the respective
policies;
- Standardisation needs, ongoing activities and progress, including the
standards development activities undertaken at both European and
international level;
- The recommendations, in terms of standards development and other
activities around standardisation.

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As compared to the previous ICT Standardisation Work Programmes 184, the
“new” ICT RP185 offers a more complete overview on actions underway and
on the international framework, in several policy clusters:
- Societal Challenges: eHealth, Accessibility of ICT products and
services, Web Accessibility, e-Skills and e-Learning, Emergency
communications, eCall, and advanced manufacturing;
- Innovation for the Digital Single Market: e-Procurement, e-
Invoicing, Card/Internet and Mobile payments, eXtensible Business
Reporting Language (XBRL), Online Dispute Resolution (ODR), and
preservation of digital cinema;
- Sustainable Growth: Smart grids and Smart metering, Smart
cities, ICT Environmental Impact, European Electronic Toll Service
(EETS), Intelligent Transport System (ITS);
- Key Enablers and security: Cloud computing, (Open) Data, e-
government, Electronic identification and trust services including e-
Signatures, Radio Frequency Identification (RFID), Internet of Things
(IoT), Network and Information Security (cyber-security), ePrivacy,
broadband infrastructures and computer-intensive research.

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:

(A.) Policy objectives

(B.) Legislation and policy documents

(B.1) At European level

(B.2) Others

(C.) Standardisation needs, ongoing activities and progress report

(C.1) Commission perspective and progress report

(C.2) Ongoing standards related developments

(C.3) MSP Members’ and Stakeholders’ remarks

(D.) Proposed new standardisation actions

(D.1) Standards developments

(D.2) Other activities around standardisation

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.

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- The European Commission, which triggers the process, by providing
information, input, indications on the identification of new policy
areas;
- The MSP, which collects input from its members, and provides new
input, information and feedback through the Task Force for the ICT
RP.

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.

Commission services New version


Feedback, New version
input of the RP
input, of the RP
endorsed by
comments endorsed and
New policy areas the MSP as
from all MSP published by
advice to the
members the EC
New information EC

Next to this established structure of MSP membership, some flexibility


ensures the involvement of the right people in the MSP: if needed, experts
can be invited to provide an opinion on a field where their expertise is
required. In particular, sectorial expert groups, set up by the EC as advisory
groups, are involved at the very beginning of the process. The experts
groups can support the EC in the identification of the policy needs and
proposals for standardisation actions. These experts may also be involved
throughout the process in order to give advice on the development of the
ICT RP (i.e. on comments received, new issues raised by the MSP, etc).
The publication of the ICT RP happens around 10 months after the start of
the process. The ICT RP is created once a year in stable version, while
amendments that arise during the year (due to changes in the landscape,
new needs, etc.) are collected in a separate document. These amendments
are integrated once a year in the main plan, through the drafting of the new
version.

 The integration of stakeholders comments: the integration of


stakeholders’ comments is a strong aspect of the ICT RP, and it ensures that
expertise from ICT specific fields is correctly reflected in the ICT RP. The
views collected during this case study confirm that stakeholders’ comments
are generally taken into account. The box below illustrates an example
related to the integration of actions in the field of eHealth as a result of a
stakeholders’ proposal, and the process behind that proposal.

Regarding the integration of stakeholders’ comments, there are sheets


prepared to summarize each comment and how it was taken into account,
and they are published on the website.

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

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standardisation needs by stakeholders: the eHealth area.

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:

 Targeted policy initiatives developed by the European Commission;

 High level of commitment to the eHealth policy agenda by the Member


States;

 Adoption in 2011 of the Directive on the Application of Patients’ Rights in


Cross Border Healthcare and its Article 14 establishing the eHealth Network.

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.

 The involvement of the stakeholders: the broader perspective: in


general terms, the MSP is a large forum, bringing together different
categories of stakeholders186. At the same time, the participants of the MSP
represent the interests of their own members, which must be informed and
consulted during the process to create the ICT RP.
Some organisations, such as CEN/CENELEC, have created a mirror group to
the MSP, which is open to all their own members and where the information
from the MSP is provided. It is also in this mirror group that the input to be
provided to the MSP on the RP is prepared.

186
As mentioned above, Member States and EFTA countries, ICT standardisation actors, industry, SMEs,
and society representatives.

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The involvement of the MSP ensures the achievement of a broad stakeholder
representation and the definition of a comprehensive and shared strategy
document.
However, it should be further explored whether mechanisms are in place to
ensure that all the relevant stakeholders actively contribute to the process.
In particular, some actors may not participate fully, notably the global
standards setting organisations (which might see this as a purely European
activity), standards consortia active in only one or two specific domains, or
SDOs without a European presence (not eligible to participate as members
of the MSP).

5.9.3 Conclusions and recommendations

Conclusions

 ICT RP as a collaborative tool: the main achievement of the ICT RP has


been to bring together the European Commission and the ICT
standardisation stakeholders – EU and global- by increasing their
coordination and cooperation.
Since the process has been broadly opened to external stakeholders (in
2011 through the setup of the MSP), the quality of the ICT RP is deemed to
have considerably improved. The last version of the ICT RP is a much richer
and concrete document as compared to the previous work programme,
representing the views of a wide variety of experts who have knowledge in
specific and different fields of ICT standardisation.

 Impact of the Rolling Plan on effectiveness, transparency and speed:


overall, the recent introduction of the ICT RP, based on the consensual
process described above, makes it difficult to assess its effectiveness in
promoting ICT standardisation, as well as its impact in terms of
transparency and speed in the definition of ICT standards.
However, it should be mentioned that the first version of the ICT RP, was
assessed by stakeholders as having no influence on ICT standardisation in
terms of effectiveness, transparency and speed. The new ICT RP is largely
welcome as a step forward in the definition of a comprehensive strategy for
ICT standardisation, and some general comments on its achievements are
formulated below.

 Impact on effectiveness of ICT standardisation: the Rolling plan


focuses on identifying the most relevant actions to support the EU policy. In
this sense, it ensures actions are addressed under the same strategy,
enabling readers of the Rolling plan to converge in the same direction, and
rejecting negative priorities. Indeed, when the ESOs ask for funding, it is
only considered by the Commission when addressed in the Rolling Plan (or in
exceptional cases duly justified).
It should be considered that the ICT RP does not pursue the objective of
prompting standardisation work, but is aimed at identifying the current and
future needs in terms of standardisation and, by collecting the activities
undertaken in these different fields, at avoiding duplication of work. The
concrete actions for the initiation of standardisation activities are left to the
willingness of standardisation organisations to take up work which can
contribute to the achievement of the defined policy priorities.
Overall, its suitability to encourage the start of standardisation work,
considered relevant for the EU, should be monitored and, if needed, further
strengthen as an indirect objective of the ICT RP. This should permit to
measure but also to strengthen the effectiveness of the ICT RP in terms of
standardisation activities promoted.

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An important step in this direction is the planned introduction of a
mechanism for the Commission and the Task Force to monitor
standardisation activities in scope of the RP, and the progress made.

 Impact on transparency: the RP has an impact on the transparency of ICT


standardisation in general, i.e. availability of information about
standardisation work, awareness raising among stakeholders, etc.
From a theoretical perspective, as it provides a complete overview, the RP
increases the transparency of the ICT standardisation process, by giving a
relevant list of activities and gathering the opinions and views of the
different stakeholders involved in each topic addressed. It improves the
visibility of who is developing what and, in this perspective, it contribute to
create a link between policy-makers, standardisers and other stakeholders
acting at different levels, research and innovation projects, etc.
However, from a practical perspective, it should be better assessed to what
extent the ICT RP is really widely known, and whether it is able to attract
the attention of standardisation committees (especially, but not only, at
international level).
 Impact on “speed”187: the RP can have an impact on speed in the
following terms:
- Ability to anticipate standardisation needs and to start the activities
in a timely manner;
- Coordination and agreements between the EC and the other
stakeholders at an early stage of the process.

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.

Opportunity for improvement: Lessons learned for the ESS

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:

 Alignment between stakeholders: promoting the involvement of


stakeholders and the development of shared inclusive processes is a key
objective of the ESS, as well as a condition to grant the alignment of
standards to market/consumer needs. In this perspective, the collaboration
logic implemented in the ICT RP, and bringing together the EC and the other
stakeholders, represents an element which can be taken into consideration in
other sectors/non-ICT standardisation fields. Of course, this would require the
implementation of formal and informal structures for the setting up of

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.”

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consensual ways of identifying policy needs and related standardisation
actions.

 Operational information layer: the Annual Union Work Programme


(AUWP) for standardisation provides insights -at a strategic level- on the
expectations and priorities of the Commission. This strategic layer could
however benefit from being supported by operational contents, such as those
included in the RP: in the ICT field, the RP provides -on a concrete basis-
explanation about the high-level needs identified in the UWP (not exclusively)
and relates it to potential standardisation action.

 Linkages with the stakeholders outside the ESS: finally, by identifying


the ongoing actions and the actors involved, the ICT RP can be a useful
instrument to further stimulate the cooperation between standardisers on the
hand, and R&D projects and other Standards-setting organisations or
industry-driven consortia active on standards development, on other hand.

Other suggestions specific to the case study: improvements of the Rolling


Plan

 Visibility of the Rolling Plan: Fostering visibility and raising awareness on


the ICT RP are crucial steps for ensuring the effectiveness of this instrument.
In a forward-looking perspective, major attention should be placed on the
dissemination of the relevant information among all the key stakeholders,
operating within and outside the ESS, and on incentivising the ESOs to use
the RP as an operational instrument to start standardisation work. This
objective can be achieved, for example, by: referencing the RP in the other
strategic plans and guidance documents issued by the EC (such as the Annual
Union work programme for European Standardisation or the Vademecum) and
the ESOs; ensuring that a consistent knowledge and use of the RP is built in
the different EC units, as well as across the TCs operating in the ESOs, at EU
and international level; disseminating the ICT RP among industries and
industry-driven consortia acting in the field of standardisation.

 Stakeholders participation: The process allows the inclusion of the full


range of stakeholders in the drafting of the ICT RP, making it a rich
representation of stakeholders’ views, going beyond the frontier of EU
standardisation. We consider that collecting additional information on the
actual stakeholders’ involvement and on the drivers of participation could
support the better understanding of the collaboration mechanism set up and,
in a forward-looking perspective, the implementation of actions for the
continuous improvement of the ICT RP. Therefore, it would be useful to gain
an in-depth overview of the participation of the different members of the MSP
in the definition and update of the ICT RP, in order to understand to what
extent the involvement varies across MSP members, which groups might be
less active and the reasons behind that (for example, MS could be less active
due to the a major interest in national policies rather than European policies;
small players could face more barriers due to the lack of resources for
participating in the ICT RP activities, or the lack of information and
involvement through their representatives in the MSP, etc.).

 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.

Another suggestion is dedicated to ensuring the relevance of the actions


proposed and the interest of the different groups. To this end, it could be
further assessed the possibility of “prioritising” the actions proposed in each
area, by indicating the relevance of the actions according to their ability to
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meet the overall policy objectives, their urgency and/or strategic value in
terms of European competitiveness and growth. Such a prioritization should
not be intended as a mere classification of the actions, but it should give an
overview of the positions of the different stakeholders involved and the
related interests. This can represent a burdensome and sensitive exercise
(since finding an agreement of the prioritization can be difficult), but it could
contribute to draw the attention on the prioritized actions.

Finally, an area of improvement relates to the continuous incorporation of


new topics and updates: currently the ICT RP is published once a year, while
the amendments and modifications are collected in a separate document to
be reintegrated in the following issue. Our suggestion would be to directly
integrate these changes in the main document, as to keep its main purpose
by being a continuous RP. Also in this case, the implementation of continuous
improvements would have significant impact on the required work and
additional costs, which should be analysed and compared to the benefits
gathered from such a continuous update.

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.

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5.10 Standardisation in aerospace

5.10.1 Identified issue of the case study

Legal basis – framework

Aviation safety is necessarily heavily regulated and multilayer. At European level,


responsibility for relevant legislation and its enforcement are shared between the
national (EU Member States) and European (the European Commission and the
European Aviation Safety Agency - EASA188) levels, as well as with other entities
such as the European Organisation for the Safety of Air Navigation
(EUROCONTROL189)- which is a separate intergovernmental organisation. Finally,
although it is part of a distinct UN system, the International Civil Aviation
Organisation (ICAO190) indirectly influences the functioning of the EU aviation
safety system by setting minimum “standards” –with the meaning of regulatory
requirements- at the global level, and by overseeing their implementation by EU
Member States and, in certain areas, by EASA. There are also a number of
specialized bodies or functions which contribute to the functioning of the EU
aviation safety system such as the SESAR Joint Undertaking191.

Representation of the EU aerospace regulatory functioning

European level International level (incomplete)

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.

To supplement the above “Basic Regulation”, there are “Implementing Rules”


adopted by the European Commission on the basis of technical proposals of EASA,

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

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and a number of other Regulations on accident investigation, “occurrence” reporting
and analysis, and banning of unsafe operators.

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.

Representation of the Regulatory Structure

Agency opinion
Decision from the EP and EC Basic
Regulation

Agency opinion
Decision from the EC Implementing Rules

Agency decision
Soft Law

Source: E. Sivel (2013). Slides: “EASA: An Authority Managing the Crisis”.

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.

DG MOVE, in a Roadmap document concerning possible revision of the 2008 EASA


Regulation196 , noted that the present regulations are often perceived by part of the
industry "as burdensome, costly and in certain cases hampering innovation", and
"the prescriptive safety rules [to be] too complex, detailed, and occasionally
redundant or inefficient with regard to the safety objective”. To an extent, the
complex institutional setup was felt to be leading to inefficiency.

The revision –suggested in the above-mentioned roadmap- of EASA Regulation


would be targeted at modernizing the regulatory system (similarly to what has
been done in other fields with the New Approach of 1985), by defining essential
requirements in the Regulation and defining the corresponding specifications
through standards.

Scope of the case study

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.

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The problem statement is the following:

“In the aerospace sector, what improvements should be made to the ESS to ensure
future suitability?”

This includes the following sub-questions:

 How to improve the ESS to suit the needs of aerospace companies?


 What improvements of the ESS are necessary to meet the expectation of the
future aviation safety legislation?
 How to ensure that the ESS activities remain significant and useful in the
aerospace sector?

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.

As aerospace standardisation is a broad field; we have chosen to concentrate our


case study on the perspective of standards requirements for the manufacturing of
aircraft and components, rather than that of air traffic management
standardisation, which poses somewhat different issues. Moreover, the case targets
“civil aviation” (and does not address “military aviation”).

Context

Standardisation in this sector –whether in terms of open consensus voluntary


standards or of quasi-regulatory documents- is being carried out by a complex set
of actors at European and international levels.

In addition to the international or European regulatory bodies ICAO, EASA, and


EUROCONTROL, activities are undertaken within the ESS (both in CEN and in ETSI),
and in ISO.

There are also industry-based standardisation activities, both at European and


international levels. These include two "private" standards bodies acting in Europe,
ASD-STAN and EUROCAE. They carry out most of the relevant work in the sector –
in Europe- that is not linked to legislation. In particular, ASD-STAN has a special
status with CEN, as a producer of draft European Standards that CEN then submits
to its own formal processes of enquiry and national voting to become ENs (further
explained below).

 Standards in Aerospace: based on the interviews carried out and the


information collected, it appears that standards are needed for two reasons.
Firstly, standards can be used from a legal perspective, and are therefore
used in order to ensure compliance with the regulatory framework in place.
Secondly, standards are used from a business perspective, in order to
decrease cost of production through volume effect or to ensure
performance. It should also be noted that the wording “standard” in
aerospace has different meanings, and a distinction needs to be clearly
made between: “Regulatory standards” within the meaning of EASA, and
Standards with the meaning of Regulation (EU) No 1025/2012.

 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

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understood by stakeholders as developing major part of “standards”, with
the meaning of Reg. 1025/2012.
However, this approach does not seem to be suited for the future, as
highlighted in the Article 62 panel evaluation, final report of 9/12/2013. In a
similar way than what happened earlier in standardisation in other fields
with the New Approach of 1985, EASA is willing to review its soft-law and to
transfer the “specification development work” (currently performed by EASA,
e.g. through its AMCs) to actual standardizers, offering more flexibility to the
industry.
The corresponding revision of the “Basic Regulation 216/2008” on Aviation
safety is referenced in the Commission Work Program 2015 (Initiative no.
11)197.
It should be noted that the a first step has already been made by EASA
about the certification of smaller airplanes, where 16 draft standards
developed by ASTM Committee F44 will be used as support to a simplified
soft-law (Certification Specification 23, or CS23)198.

 Actors: the main standard developers considered in this case study –and
being at the core of European aerospace standardisation- are the following:

o Standardisation organisations/bodies recognized by


Regulation(EU) No 1025/2012: The ESOs and NSBs;

o European-based association active in standardisation in


aerospace: ASD-STAN and EUROCAE;

o International standards body: ISO;

o Other standards associations: ASTM and SAE;

o Trade association: GAMA.

In more details, the role of each actor is presented below:

o ICAO is a UN specialised agency, based in Montreal. Its function is


to work "with the Convention’s 191 Member States and global
aviation organisations to develop international Standards and
Recommended Practices (SARPs) which States reference when
developing their legally-enforceable national civil aviation
regulations199". There are currently over 10000 SARPs.

ICAO standards are proposed by member countries or ICAO itself,


and the standards are drawn up either within groups of member
countries or by specialised working groups of technical experts.

o EASA broadly works at European level in a more detailed manner


to produce the draft rules at European level, obviously taking full
account of ICAO requirements (EASA has a Memorandum of Co-
operation with ICAO). The Agency works in close cooperation with
the Commission, and together with EU-Member States and

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

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National Competent Authorities (National Aviation Authorities,
National Surveillance Authorities), which form a so called "EASA
System"200. The rules are drafted in consultation with
stakeholders, including organisations and associations
representing industry, social partners and end-user groups.

o EUROCONTROL forms a platform for the implementation of the


Single European Sky. As well as the day-to-day operation of the
European ATM network, it provides the technical expertise for
building the Single European Sky, including the organisation of
civil-military collaboration. As (together with the Commission) the
public part of the SESAR Joint Undertaking, it is contributing to
the specifications for the ATM network.

o ASD-STAN is a European organisation responsible for the


technical aspects of standards defining products, materials, test
methods and procedures for the construction, maintenance and
use of aircraft and space vehicles including their propulsion units,
equipment and electric equipment (in other words, ASD-STAN
takes care of every aspect which is not covered by EUROCAE).

ASD-STAN's relationship with CEN goes as far back to 1973. In


1986 it became one of only two "Associated Standardisation
Bodies" of CEN, and is therefore assigned the standard drafting
process. CEN carries out the national enquiry and formal votes on
the ASD-STAN drafts and publishes the results as European
Standards; so far over 1600 ENs have been published in this way,
with the database currently showing a further 449 under
development201.

ASD-STAN's website only records seven members –various


national associations (industry including one CEN Member)- and
EASA, although industry experts across Europe carry out the
technical work. Note that the "associated body" standards
drafting process may not be aligned with the normal CEN rules
regarding transparency, as representatives of other organisations
may not be made aware of processes under way before the
national enquiry starts. In 2013, there was resulting controversy
concerning standards on cabin air quality, which consumers and
cabin crew associations felt took insufficient account of their
concerns202, resulting in action at CEN Board level.

In more details, in case of company’s interest in having a


standard, a “group of common interest” is created, and the
interested industry prepares a prEN, within ASD-STAN. This draft
standard is then sent to CEN for commenting. Finally, after
revision of the standard based on the comments received, ASD-
STAN gives the lead to CEN for the submission of the last version
of the prEN to formal vote, and is then treated as a standard
developed within CEN.

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

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o The European Organisation for Civil Aviation Equipment
(EUROCAE) is a not-for-profit standards organisation formed at
Lucerne, Switzerland, in 1963, as a European forum focusing on
electronic equipment for air transport, and deals exclusively with
aviation standardisation in this domain, for both airborne, and
ground systems and equipment.

EUROCAE has a broad membership of some 130 entities,


including equipment and airframe manufacturers (worldwide),
regulators, European and International civil aviation authorities,
air navigation service providers, and airports, and is also financed
through sales of standards. The standards developed within
EUROCAE are known as "EUROCAE Documents" (ED) and are
drawn up by Working Groups of member experts.

EUROCAE has published more than 120 EDs, several of them


developed jointly with US partners, and many being referenced by
EUROCONTROL or the US Federal Aviation Authority.

In November 2014, EUROCAE signed a Memorandum of Co-


operation203 with the US-based SDO ”the Radio Technical
Commission for Aeronautics” (RTCA) – half the work programme
of the two SDOs is now carried out in common. EUROCAE also
collaborates with another US SDO, SAE (see below).

o The General Aviation Manufacturers' Association204 (GAMA) is a


global association of some 80 companies active in the sector, with
a focus on general aviation. General aviation includes all civil
aviation operations other than scheduled air services and non-
scheduled air transport operations for remuneration or hire.
General aviation flights range from gliders and powered
parachutes to corporate jet flights.

GAMA is working with ASTM International on standards to


modernise the way smaller aeroplanes are certified, and in
September 2014 it hosted a meeting of ASTM's General Aviation
Standards Committee in Brussels, with the European Commission
and EASA participating205.

o SAE International is another US-based industry SDO with


aerospace activity. SAE claims no fewer than 1444 aerospace
standards under development, in an enormous number of fields
relating to aircraft206. It has a “Standards Europe Office”, based in
London. SAE is an engineering-based organisation, and also
issues technical papers and provides training.

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/

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o Apart from the work of the CEN-CENELEC performed as
“Associated Standardisation Body” of ASD-STAN (as outlined
above), there has not been a lot of activity dedicated to the
aircraft manufacturing sector performed by the ESOs themselves.
Standards related to the equipment are however developed by
the ESOs, for instance in ETSI for aeronautical radios.

Within CEN, two CWA have been developed in the field of


aerospace. In 2009, a CWA was published as an industry standard
for operators of business aircraft, based on inputs from The
International Business Aviation Council (IBAC) and the European
Business Aviation Association (EBAA)207.

More relevant to the current case, a new CEN activity in the


aircraft domain started on 28 January 2015, in the form of CEN
Workshop 77 "Modules for Electro-Mechanical Actuators in
Aircraft"208. EMA technology is targeting as a first priority the next
generation of short and medium range aircraft families,
successors of the A320/B737 families. The Workshop has been
proposed by an FP7 Research Project ACTUATION 2015, with
some 35 major European aerospace companies participating:
Workshops are often very useful for consensus based on research
projects, as they can be carried out very fast and within the
timescale of researchers209.

o ISO activity is concentrated in TC20 "Aircraft and space vehicles",


which dates back to 1947 - its scope comprises "standardisation
of materials, components and equipment for construction and
operation of aircraft and space vehicles as well as equipment used
in the servicing and maintenance of these vehicles".

TC20 has produced 86 standards and updates; it has currently


nine Working Groups, some of which currently have extensive
work programs. The TC liaises with 24 international or European
organisations including all those mentioned above, and CEN and
CENELEC, where the Vienna and Dresden Agreements apply.

Case selected

This case study focuses on the aerospace as a sector, the specificities of


standardisation activities and the performance of the ESS in this particular field of
action. The case also elaborates on the potential changes induced by the

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.

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modification of EASA soft-law and an increased role of standards in the aerospace
ecosystem.

5.10.2 Analysis and Findings

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.

European Commission/EFTA mandates in this whole sector seem to have been


confined to the area of Air Traffic Management, and, since EASA has been up-and-
running, have not been issued. It needs to be checked if EASA has assumed some
responsibilities that formerly were dealt with by ESOs in association with
EUROCONTROL.

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.

European versus international aspects

Two opposite trends are currently characterising the aerospace sector.

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.

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ISO has retained a significant amount of activity, with its very long-standing TC20
and with (still today) 66 work items excluding the purely space activities. However,
ISO is facing difficulties in maintaining a leading role. The current Business Plan for
TC20212 notes (inter alia) that:

 “For the foreseeable future, resources for aerospace standardisation work


could be lower than has been historically the case”;

 “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”;

 “Industry and regional standards-developing organisations each have their


own business interests in promoting/protecting the standards that they
develop”;

 “Due to lack of engagement in the international standards development


process, some manufacturers tend to be more comfortable with company
generated and controlled standards and to a lesser extent industry and
national/regional standards”.

From industry’s point of view, it appears that the different types of standards
should be differentiated:

 For standard supporting legislation, standardisation work should be


made at European level, due to the EU specificities of the regulatory
framework. However, it could also be envisaged to have standards from
outside to be amended to suit the EU regulatory framework.

 For standards supporting interoperability and performance, it is


important for manufacturers to have standards which have a geographical
applicability corresponding to the industry’s area of action, which often refers
to having globally applicable standards. However, standards are not
necessarily expected to be global as such, but to have sufficient equivalents
to be applicable at global level. In short, the main interest of the industry is
actually to have the “right” standard, independently from its origin.

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 role of private standardisation

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).

It seems therefore quite possible that some aerospace sector companies, as a


result, will be more inclined to join industry-based SDOs rather than taking the
CEN-ISO routes, which are not dedicated to the aerospace industry.

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

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From a practical perspective, some matters are relevant to industry only, without
necessarily taking care of other actors in the system and being limited by
procedural limitations of the system (e.g. representation of weaker stakeholders in
the ESS, or the use of national delegation principle).

Quality of European deliverables

Aerospace standardisation is related to an extreme level of criticality, and the level


of correctness and accuracy of standards related to aviation have much lower level
of tolerances than what is accepted in other fields. This may also be a factor
encouraging companies to work in dedicated committees that even form something
of closed circles compared with the ESS, i.e. where there are some fundamental
principles of openness to all interested parties.

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).

Speed of European standardisation

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.

5.10.3 Conclusions and recommendations

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 lack of responsiveness in the ESS – ASD-STAN seems to have very few


members, and (at least from the web presentation) not a very dynamic
approach);

 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.

However, there may be some European industry interest in ensuring consensus at


European level on innovative topics, as witnessed with the recent creation of CEN
Workshop 77.

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Moreover, the potential evolution of EASA’s soft law mentioned earlier might lead to
an increased role of standardisation in aerospace. This could therefore give more
emphasis to the work performed at European level.

Opportunity for improvement 1: Ensuring proper dialogue

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.

Opportunity for improvement 3: Ensuring synergies between innovation


and standardisation are promoted

Attention should be also placed on ensuring a welcoming environment for European


research and similar. The recently-started standards work on electro-mechanical
actuators (started in the CEN Workshop) is a good example. Care should be taken

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).

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to identify any similar cases and make sure that the necessary platforms are put in
place without undue complexities.

Other suggestion specific to the case study: Clarifying the terminology of


the European regulations and relevant policy documents

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

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[Catalogue
number]