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European Committee for Standardization 20 12 ANNUAL REPORT
European Committee for Standardization
2012ANNUAL REPORT
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TABLE OF CONTENTS
This report presents the main outcomes of activities carried out by CEN in 2012.Please note that the outcomes of joint activities carried out by CEN in cooperation with CENELEC are presented in a separate report on CEN-CENELEC activities in 2012.
Letter from the President . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
CEN and its community . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Core business highlights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Facts and figures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Annual accounts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
CEN Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
It is with pleasure and satisfaction that I present to you this report on the outcomes of our activities in 2012, which was the first year of my term as CEN President.
2012 was another productive year for CEN, as we published a total of 1148 deliverables, and our portfolio contained a total of 14 859 documents at the end of the year. I would like to thank the many thousands of individuals who contributed to the development of our standards and other deliverables by participating in our technical work. The continued success of our system depends on your expertise and engagement!
European experts are also helping to drive and influence the standards development process at international level. Nearly one third (30%) of CEN standards are identical to international standards published by ISO, and in certain sectors more than 80% of standards are the same. By aligning European Standards with international standards, we can help remove technical barriers to trade and reduce costs for European companies that want to sell their products and services all around the world.
The membership of CEN has continued to grow at a steady pace. In 2012 we added two new full members: TSE, the Turkish Standards Institution (in January); and ISRM, the National Standards Body of the former Yugoslav Republic of Macedonia (in July). This means that the CEN system
now covers 33 countries, representing 21% of global economic output, with a total population of some 600 million people. By developing state-of-the-art standards, which are accepted and used in all of these countries, we are helping to strengthen the Single Market, thereby supporting economic recovery and sustainable growth.
We continue to develop our cooperation with our Affiliates in 17 neighbouring countries, some of which are likely to become CEN Members in the coming years. When we add up all of our Members and Affiliates – we can say that there are 50 National Standards Bodies taking part in the European Standardization System. Meanwhile, we also maintain relationships with standards organisations in other parts of the world, and especially with our Partner Standardization Bodies (PSBs) in Australia (SA), Mongolia (MASM) and – since July 2012 – also in Kyrgyzstan (CSM).
We are continuing to develop our close cooperation with the American National Standards Institute (ANSI), focusing on areas of common interest such as Electric Vehicles and Smart Grids. We are also engaged in an ongoing dialogue with Russia’s Federal Agency on Technical Regulation and Metrology (Rosstandart). We trust that these discussions will provide us with a solid basis to strengthen our cooperation in the coming years in support of the regulatory trade dialogues,
and we are confident that the results of these negotiations will facilitate trade and enable market harmonisation in sectors of major interest.
In order to have a complete overview of all CEN activities, it is necessary to read both the CEN Annual Report and also the joint CEN-CENELEC Annual Report, which describes our joint activities during 2012. Our collaboration with CENELEC is becoming more important each year, and we are cooperating in an ever-expanding range of fields and sectors. This is shown by the growing number of Joint Technical Committees and Working Groups dealing with topics such as energy, design for all, accessibility in the built environment, medical devices, etc.
I would like to mention in particular CEN and CENELEC’s joint efforts aimed at encouraging small and medium-sized enterprises (SMEs) to make use of standards and participate in standardization activities. In 2012, we launched the ‘SME Toolbox of Solutions’ on the CEN-CENELEC website, and we also supported our members to develop their own activities at national level, notably in the framework of the SMEST2 project.
Along the same lines, we have also started work on aligning the concept of partnership between CEN and CENELEC, in order to ensure a more coherent approach and foster further effective participation in
Letter from the President
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European standardization. This objective will be pursued in full consultation with our existing partners – our associate members and technical liaison organisations – with the aim of producing a final proposal in 2013.
Many of our activities in 2012 were based on cooperation: with the R&D (research and development) community – in order to close the gap between research, innovation and standardization; with European regulators – to shape the new regulatory framework for European standardization; and with our friends in ETSI (European Telecommunications Standards Institute) – to address the need for technological convergence and develop a system approach to standardization.
A major highlight of the year was the First European Standardization Summit, organised by CEN and CENELEC and hosted by the Bulgarian Institute for Standardization (BDS) in Albena on 7 June. This high-level event provided a valuable opportunity to discuss with all our members and stakeholders the role of standardization in support of a sustainable
economy. As I said in the closing session of the Summit, I am convinced that the shift to a more sustainable economy represents a tremendous opportunity – both for businesses that are willing to innovate, and for the European Standardization Organisations.
Last year also saw the start of a process that we hope will lead to the adoption, in 2013, of a European Standardization System Strategy for the years leading up to 2020. For this, CEN and CENELEC have worked together with our European partners and with policy makers to prepare a series of strategic objectives. It is our intention that the proposed strategy should provide a framework for developing and strengthening the European Standardization System as a whole. CEN and CENELEC have decided to define common ambitions linked to these objectives, and both organisations will also develop their own implementation plans in 2013. Meanwhile, the ongoing revision and simplification of our governance structures should ensure that our decision-making procedures will enable us to achieve our objectives.
Our joint strategy will take account of the current legal and political framework, following the entry into force of the new EU Regulation on European Standardization (on 1 January 2013). It will also take account of the evolving needs of all our stakeholders, as well as emerging economic, environmental, societal and technological trends. We are convinced that this new strategy will enable us to make a significant contribution to the goals of the European Union, in terms of promoting smart, sustainable growth and creating quality jobs.
The success of all our activities depends on the active engagement of our Members in 33 countries and the support of the whole CEN community. Therefore, on behalf of the CEN Administrative Board, I would like to express our appreciation and gratitude to our Members, as well as our Associates and Affiliates, and all of the individuals who have contributed to the work of our Technical Committees and Working Groups during the year. Thank you all for your participation in 2012 – and for your continuing involvement in 2013 and beyond!
Friedrich SmaxwilCEN President
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CEN and its community
The Administrative Board (CEN/CA) acts as the representative of the General Assembly. It directs work and coordinates the actions taken by all CEN bodies and takes, in the name of the organisation, all the steps it deems essential for the achievement of the CEN corporate goals.
The President, Mr Friedrich Smaxwil, leads its activities. The Administrative Board comprises the President, Vice-Presidents (Finance, Policy and Technical), and the General Assembly’s authorised representatives.
CEN ADMINISTRATIVE BOARD 2013
From left to right: Jorge Marques dos Santos, Vice-President Finance; Elena Santiago Cid, Director General of CEN and CENELEC; Friedrich Smaxwil, President; Guðrún Rögnvaldardóttir, Vice-President Technical; Scott Steedman, Vice-President Policy.
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CEN and its community
President Friedrich Smaxwil
Dipl. Ing. Friedrich Smaxwil was elected as CEN President for a three year term starting January 2012. Mr Smaxwil has been a Board Member of the Transportations Systems Group with Siemens AG, where he was Senior Vice-President of the Mobility Division, responsible for managing the Corporate Account of Deutsche Bahn AG and Industry Relations. He has also been an Executive Board Member of the Association of the German Railway Industry (VDB), where he was President from 2004 until 2009.
Vice-President Policy Scott Steedman
Dr Scott Steedman is Director of Standards at BSI, the National Standards Body of the United Kingdom. Formerly an academic at Cambridge University, Dr Steedman spent twenty years in industry working for major consulting and contracting companies in the construction sector. Dr Steedman is an Executive Director on the Group Board of BSI and a non-executive director of the Port of London Authority. He was elected President of the European Council for Construction Research, Development and Innovation in 1997, holding this position for 11 years. Dr Steedman has been a Vice-President of both the Institution of Civil Engineers and the Royal Academy of Engineering and continues to act as Editor-in-Chief of the Royal Academy’s flagship magazine, Ingenia. Under the UK honours system, Dr Steedman was awarded a CBE in 2010 for his services to engineering.
Vice-President Technical Guðrún Rögnvaldardóttir
Dipl. Ing. Guðrún Rögnvaldardóttir studied electrical engineering in Iceland and Germany, graduating from the Technical University of Karlsruhe in 1986. After a few years as Associate Professor at the University of Iceland, she started working in standardization in 1991. She has been with Icelandic Standards since then, with the exception of one year (1995-1996) when she worked at the CEN Central Secretariat in Brussels. Since 1998, Mrs Rögnvaldardóttir has been the Managing Director of Icelandic Standards. She was a member of the CEN Technical Board (1991-2001), the CENELEC Technical Board (1996-1999), the CEN Administrative Board (since 1998), the ISO Council (2005-2006 and 2011-2012), and Vice-President and Administrative Board member of CENELEC (2007-2010). She studied Public Administration at the University of Iceland and graduated with a Masters degree (MPA) in 2006.
PRESIDENT AND VICE-PRESIDENTS 2013
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Vice-President Finance Jorge Marques dos Santos
Mr Jorge Marques dos Santos has been the President of the Portuguese National Standards Body (IPQ), since May 2004. He holds a degree in Chemical Engineering. He has assumed various management functions in industry since 1974, firstly at the Companhia Portuguesa de Amidos (COPAM), a maize starch and glucose factory and afterwards in business areas such as agro industry, tourism, logistics and retailing in SONAE, the biggest Portuguese conglomerate. Furthermore, Mr Marques dos Santos taught mathematics during 10 years at the Lisbon Economic University.
PRESIDENTS AND VICE-PRESIDENTS ELECTED FOR 2012
President: Mr Friedrich Smaxwil
Vice-President Policy: Mr Mike Low
Vice-President Technical: Mr Ernst-Peter Ziethen
Vice-President Finance: Mr Jorge Marques dos Santos
MEMBERS OF THE ADMINISTRATIVE BOARD 2012 (JULY)
AENOR – Mr Avelino BRITO MARQUINAAFNOR – Mr Olivier PEYRATASI – DDr Elisabeth STAMPFL-BLAHAASRO – Mr Gheorghe TUCUBDS – Mrs Iren DABIJEVABSI – Mr Mike LOWCYS – Dr Ioannis KARISDIN – Mr Ernst-Peter ZIETHENDS – Mr Jesper JERLANGELOT- Mr Nickolas VITANTZAKISEVS – Mr Priit KIKASHZN – Mr Mirko VUKOVICILNAS – Mr Jean-Marie REIFFIPQ – Mr Jorge MARQUES DOS SANTOSISRM – Mr Ljupco DAVCEVIST – Mrs Guðrún RÖGNVALDARDÓTTIRLST – Mr Brunonas ŠI KUSLVS – Mr Ingars PILMANISMCCAA – Mr Francis E. FARRUGIAMSZT – Mr Dominik KRANTZNBN – Mr Johan HAELTERMANNEN – Mr Jan WESSELDIJKNSAI – Mr Martin WHELANPKN – Dr Tomasz SCHWEITZERSFS – Mr Pekka JÄRVINENSIS – Mr Lars-Gunnar LUNDH SIST – Mr Bogdan TOPISN – Mrs Trine TVETERSNV – Mr Oscar ZOSSOSUTN – Mr Dan LÁDEKTSE – Mr Hulusi ENTÜRK UNI – Mr Alessandro SANTOROÚNMZ – Mr Milan HOLE EK
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national standards. CEN currently counts 17 Affiliates in the following countries: Albania, Armenia, Azerbaijan, Belarus, Bosnia and Herzegovina, Egypt, Georgia, Israel, Jordan, Lebanon, Libya, the Republic of Moldova, Montenegro, Morocco, Serbia, Tunisia and Ukraine.
CEN Associates are umbrella organisations representing particular interests at European level. They include: the European Association for the Co-ordination of Consumer Representation in Standardisation (ANEC); AQUA EUROPA – which represents the water and wastewater supply chain; the Council of European Producers of Materials for Construction (CEPMC); the European Environmental Citizens Organisation for Standardisation (ECOS); the European Trade Union Institute (ETUI); the European Medical Technology Industry Association (EUCOMED); the European Construction Industry Federation (FIEC); and the European Office of Craft/Trades and Small and Medium-sized Enterprises for Standardisation (NORMAPME).
Partner Standardization Bodies (PSBs) are National Standards Bodies that are members of ISO, but are unlikely to become CEN Members or Affiliates for political or geographical reasons. The Centre for Standardization and Metrology (CSM) of Kyrgyzstan officially became a PSB on 1 July 2012, after its application was accepted by the CEN General Assembly in Albena on 7 June. The other two PSBs are Standards Australia (SA) and the Mongolian Agency for Standardization and Metrology (MASM).
GENERAL ASSEMBLY
The General Assembly (CEN/AG) is the supreme decision-making body of CEN, and brings together all of the National Members and Associates.
The 38th CEN General Assembly was held in Albena (Bulgaria) on 7 June 2012, hosted by the Bulgarian Institute for Standardization (BDS). As in previous years, an Extraordinary General Assembly was also held in Brussels on 21 November 2012.
The CEN/AG decided to initiate a process of modernisation of the CEN governance structure and practices, with the objective of increasing the efficiency of the decision-making process.
The General Assembly also agreed to launch an exercise, in coordination with CENELEC, aimed at harmonising and simplifying the rules regarding partnership with the European stakeholders of CEN (and CENELEC), in order to create a coherent framework for developing partnerships with such stakeholders.
The CEN/AG elected Mr Scott Steedman as CEN Vice-President Policy and Mrs Guðrún Rögnvaldardóttir as CEN Vice-President Technical (as from 1 January 2013).
THE CEN COMMUNITY
CEN offers an inclusive platform that is accessible to all: large companies and SMEs; public, societal and environmental groups; academia and research. More than 60 000 technical experts from industry, associations, public administrations, academia and societal organisations are involved in the CEN network.
The various stakeholders are represented in the decision-making structures of CEN through the 33 National Members in accordance with the national delegation principle. The 33 National Members include the National Standards Bodies of 27 European Union Member States and 3 acceding/candidate countries, as well as 3 European Free Trade Association (EFTA) countries.
ISRM, the National Standards Body of the former Yugoslav Republic of Macedonia, was admitted as a full member of CEN on 1 July 2012. The application of ISRM to become a full member of CEN and CENELEC was formally accepted by the General Assemblies of both organisations, which were held in Albena (Bulgaria) on 6 and 7 June 2012.
CEN Affiliates are National Standards Bodies (NSBs) in countries that participate in the European Neighbourhood Policy of the European Union. Affiliates may choose to participate in any CEN Technical Committee (TC) with observer status, on condition that they implement any European Standards (ENs) that are developed by the TC as national standards and withdraw any conflicting
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Core business highlights
The core business of CEN is to develop and publish European Standards and technical specifications that meet the constantly evolving needs of European businesses and other organisations. This important work brings concrete benefits, such as: improving the safety, quality and reliability of products and services; reinforcing the Single Market and underpinning economic growth; and supporting the spread of new technologies and innovation.
In order to prepare and produce state-of-the-art standards, CEN relies on the knowledge of some 60 000 experts who participate in various technical activities through a network of 50 National Standards Bodies (33 National Members plus 17 Affiliates) and continuous cooperation with organisations representing different stakeholders (including consumers, employees, environmental interests and SMEs).
CEN TECHNICAL BOARD
The CEN Technical Board (CEN/BT) is responsible for co-ordinating and managing the standards development work that is being carried out in more than 300 Technical Committees. In addition to overseeing these activities, as well as their related processes, the CEN Technical Board is also responsible for evaluating and addressing requests for standardization on new subjects.
Following requests from national members, 2012 saw the creation of 5 new Project Committees as well as the approval of 6 work programmes of Project Committees created in 2011, all of which are tasked with the development
of European Standards in specific areas (such as forensic science services, combustible air freshener emissions, or sustainable and traceable cocoa).
Within the framework of the CEN Strategy 2011-2013, the CEN Technical Board has also continued to work on the implementation of its related ‘Action Plan’ during 2012.
This includes the establishment of a centrally managed review system, with the aim of maintaining a high quality of published standards. The new system will ensure that CEN deliverables are systematically reviewed within the required timeframe, and will also reduce the administrative burden on Technical Committee secretariats, thereby allowing them to focus more on managing the results of the review process, rather than on the process itself.
Other measures endorsed by the Technical Board include the mandatory implementation of corrigenda at national level and the use of ‘project leaders’ in the standards development process. Both of these measures should contribute to enhancing the quality and efficiency of the CEN system.
COOPERATION WITH ISO
The ‘Vienna Agreement’ provides a framework for technical cooperation between CEN and the International Organization for Standardization (ISO). It includes provisions relating to the exchange of information between ISO and CEN, mutual representation at meetings, and parallel approval of standards.
As a result of this collaboration, one third (33%) of the CEN publications issued in 2012 were identical to ISO publications. If one looks at all the published standards in the CEN portfolio, one finds that some 30% of them are identical to ISO publications. The alignment of European and international standards is especially advanced in sectors such as: building and civil engineering, chemicals, environment, food, health and safety, healthcare, information and communication technologies (ICT), materials, mechanical engineering, measurement and quality, etc.
In 2012, the CEN Technical Board (CEN/BT), together with the ISO Technical Management Board (ISO/TMB), decided to establish a Joint CEN/BT - ISO/TMB Editing Task Force, which will review the contents of the Vienna Agreement and associated guidelines for implementation.
In line with ongoing efforts to shorten the amount of time needed to approve and publish international standards, CEN/BT decided to implement a pilot project in 2013. A limited number of draft standards developed in the framework of cooperation between CEN and ISO will be subject to an enquiry period of 3 months associated with a vote, thereby speeding-up the approval process. The experience gained from this pilot project will allow CEN/BT to assess the possibility of shortening the approval process for all European Standards (including so-called “homegrown“ standards).
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STANDARDS PUBLICATIONS
The CCMC Standards Publications Unit is responsible for the processing and editing of texts of all CEN deliverables in accordance with the Internal Regulations. The careful editing of documents, according to a consistent set of rules, ensures that high quality publications are delivered to CEN members and their customers.
In 2012, CEN published 608 Drafts, 1210 Final Drafts and 1148 publications. These publications included: 1014 European Standards, 66 Technical Specifications, 46 Technical Reports, 17 Workshop Agreements and 5 Guides. At the end of the year, the total number of valid (or ‘living’) CEN documents was 14 885, which represents a growth in the CEN portfolio of 387 (or 2.7%) since the end of 2011.
In 2012, the introduction of a new publication management tool (the ‘CCMC internal monitoring dashboard’) has contributed to improving the efficiency of the publication process and allowed for a more effective allocation of work within the Standards Publications Unit. Meanwhile, steps were also taken to plan the integration of XML (Extensible Markup Language) into the production line, so that European Standards and other CEN deliverables will also be available in this format in the future.
Standardization activities in 2012CEN provides a European platform for the standardization of products, services, processes and systems across a wide range of sectors. These include: Air and Space, Bio-based products, Chemistry, Construction, Consumer products, Energy and Utilities, Environment, Food, Health and Safety, Healthcare, Heating, Ventilation and Air Conditioning (HVAC), Information and Communication Technologies (ICT), Innovation and Research, Machinery safety, Materials, Measurement, Nanotechnologies, Pressure equipment,
Security and Defence, Services, Transport and Packaging.
A growing number of sectors are being addressed by both CEN and CENELEC in the framework of their joint activities. These include: Accessibility, Defence procurement, Electric vehicles (e-mobility), Energy, Nuclear energy, Security, Smart Grids, Smart Metering, Space, Information and Communication Technologies (ICTs), Medical equipment, Machinery safety, and Railways.
Please note that the outcomes of joint activities carried out by CEN in cooperation with CENELEC are presented in a separate report on CEN-CENELEC activities in 2012.
Here we present a selection of the main outcomes of standardization activities that were carried under the CEN umbrella during 2012.
CONSTRUCTION
The building and construction sector remains one of the most important areas of standardization activity for CEN, with some 77 Technical Committees established at European level.
One of the most important tasks undertaken in 2012 was the approval of Annex ZA that takes in consideration all the provisions of the European Union’s new Construction Products Regulation (CPR) (305/2011/EU), which will enter into force on 1 July 2013, replacing the Construction Products Directive (89/106/EEC). All new harmonised standards will have to include this new Annex ZA, and existing standards will also have to be amended accordingly when they are next due for revision.
Eurocodes are a set of harmonized standards developed by CEN for the structural design of construction works, which provide a presumption of conformity with the essential requirements of the Construction Products Directive/
Regulation. In December 2012, CEN received a request from the European Commission (Mandate M/515) to amend existing Eurocodes and extend the scope of structural Eurocodes. During 2013, CEN/TC 250 ‘Structural Eurocodes’ will prepare a work programme responding to this mandate, begin the revision of the existing Eurocodes (58 parts) and start to prepare a new Eurocode on glass.
In order to support the implementation of the Energy Performance of Buildings Directive (2010/31 EU), which aims to promote greater energy efficiency, the European Commission has identified the need for a standardized methodology to calculate the integrated energy performance of buildings. Mandate M/480 was accepted by CEN and CENELEC in February 2011, and this work is being coordinated by the CEN Project Committee on Energy Performance of Buildings (CEN/TC 371), in liaison with other relevant technical bodies, including the CEN-CENELEC Ecodesign Coordination Group (Eco-CG).
CONSUMER PRODUCTS
The development of European Standards in relation to various types of consumer products is among the core activities of CEN and CENELEC. Standardization work is carried out in the framework of the relevant EU legislation: the General Product Safety Directive (2001/95/EC) and the Toy Safety Directive (2009/48/EC).
In 2012, CEN completed the work under mandate M/465 - safety of consumer-fitted child-resistant locking devices for windows and balcony doors. Meanwhile, work has continued to execute a number of other mandates which also relate to the safety of children, notably: M/427 - child-resistant cigarette lighters; M/445 - toy safety; M/464 - safety of bath-related products; and M/497 - risks in the sleeping environment (mattresses, duvets, sleeping bags, etc.).
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CEN accepted four new standardization mandates from the European Commission in the area of consumer products, namely: M/505 - risks posed to children by internal window blinds; M/506 - stationary training equipment; M/507 - gymnastic equipment; and M/508 - bicycles, bicycles for young children and luggage carriers for bicycles.
Two new technical bodies were created in 2012. CEN/TC 416 ‘Project Committee – Health Risks of Chemicals’ is working to develop a new standard defining the requirements of training programmes to train risk assessors. CEN/TC 421 ‘Project Committee – Emissions safety of Combustible Air Fresheners’ will prepare standards in relation to test methods and the assessment of test results, as well as information for consumers.
ENERGY (FUELS)
European Standards relating to fuels and biofuels can contribute to reaching Europe’s environmental goals regarding the promotion of renewable energy sources and the reduction of CO2 emissions. In 2012, CEN and CENELEC together with the European Commission (DG Energy) organised two meetings with stakeholders in order to explore standardization needs and discuss the elaboration of mandates in relation to pyrolysis oil and algae. CEN also contributed to a stakeholders conference on fuel labelling and transport fuels organised by the Commission (on 27 April 2012), with a presentation on European Standards relating to gaseous and liquid fuels (as developed by the Technical Committee CEN/TC 19).
FOOD
CEN’s activities in relation to food safety are in line with the European Union’s objective to achieve the highest possible level of health protection for consumers. CEN also responds to market demands, for example regarding standards relating to the sustainability of certain foods.
During 2012, CEN continued to work on a number of standards requested by the European Commission (under various mandates), notably in relation to Food Contaminates and Food Hygiene. CEN also submitted responses to consultations on draft mandates for standards relating to Mycotoxins and Phytotoxins.
The CEN Project Committee on ‘Traceable and sustainable cocoa’ (CEN/TC 415) worked during 2012 on the development of a European Standard in two parts to specify requirements and verification criteria for determining the traceability and sustainability of cocoa – taking environmental, social and economic issues into account. In view of the fact that the majority of producers are outside Europe, CEN has invited ISO to contribute to this ongoing work, with the aim of developing standards that will complement existing certification schemes and labelling initiatives by providing a common framework.
INFORMATION AND COMMUNICATION TECHNOLOGIES (ICT)
e-Health (also known as ‘Health informatics’) refers to the application of electronic information and communication technologies (ICT) in relation to the provision of healthcare services. The CEN Technical Committee on ‘Health informatics’ (CEN/TC 251) has continued to work on e-Health standards, in co-operation with its international counterpart (ISO/TC 215) in the framework of the Vienna Agreement.
Interoperability in this field is of paramount importance, especially for the safety of patients. European experts have been contributing to international standardization activities, in order to produce documents that can also be adopted as European Standards. The EN 13606 series of European Standards for ‘Electronic health record communication’, which were originally developed within CEN/TC 251, are being revised and
harmonised with the corresponding international standards. This work is being undertaken in co-operation with stakeholders, including the members of the EN 13606 Association.
ICT Skills are more important than ever before, as companies and organisations have become increasingly dependent on the knowledge of their employees and ICT support staff. The CEN Workshop on ICT Skills is a network of experts representing the ICT industry, academic institutions, vocational training organisations, ICT professional associations, social partners and research institutions. This workshop aims to promote excellence in the ICT sector and strengthen the ICT profession through the creation of relevant supporting standards that can be applied throughout Europe and around the world.
In 2012, the workshop finalised the European ICT Professional Profiles (CWA 16458), consisting of 26 profiles that refer to the competences set out in the European e-Competence Framework for ICT Professionals (CWA 16234). This CEN Workshop Agreement includes practical guidance on how to adapt the ICT Professional Profiles to different needs. It is available in English, French, German and Italian versions.
NANOTECHNOLOGIES
Nanotechnologies relate to the production and application of materials, devices, structures and systems that depend on the manipulation of individual atoms and molecules. As ‘Key Enabling Technologies’, nanotechnologies and nanomaterials will bring advances in areas such as: consumer products, health-related and environmental applications, manufacturing and knowledge-based technologies.
Recognising the need for standards in this area, the European Commission has asked the European Standardization Organisations to develop standards for
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nanotechnologies and nanomaterials. Some 14 Technical Committees at European and international levels are involved in standardization activities in the framework of mandate M/461 (accepted in 2010), which covers: methodologies for nanomaterial characterization; sampling and measurement of exposure to nanomaterials; methods to simulate exposures to nanomaterials; HS&E (health, safety and the environment).
CEN has continued to proceed with work to develop a series of 10 European Standards and 6 Technical Specifications. This work is being coordinated by CEN’s Technical Committee on ‘Nanotechnologies’ (CEN/TC 352), with the participation of the Technical Committees on ‘Air filters for general air cleaning’ (CEN/TC 195) and ‘Assessment of workplace exposure to chemical and biological agents’ (CEN/TC 137). CEN is cooperating closely with the responsible Technical Committee at international level (ISO/TC 229) and with the European Commission’s Joint Research Centre.
SERVICES
The new EU Regulation on European Standardization (1025/2012), which entered into force on 1 January 2013, makes clear that the European Commission may issue requests (‘mandates’) for the development of European Standards in relation to services, just the same as it does for products, in cases where such standards could help to support the successful implementation of EU legislation and/or policies. CEN and CENELEC are convinced that the elaboration and publication of more European Standards (and other types of deliverables) will help to open-up the European Single Market and create a level playing field for service providers, which will also benefit consumers.
The CEN Strategic Advisory Group on Services (SAGS) was created in 2011. The first meeting of the group took place in February 2012. The activities of SAGS in 2012 concentrated on three main areas:
■ the development of actions to raise awareness among stakeholders about the benefits of service standardization;
■ the realisation of a mapping exercise to compile information on existing service standards at national level, in order to identify areas in which new European Standards might be required;
■ discussions with the European Commission regarding the development of a mandate for the elaboration of horizontal service standards.
During 2012, CEN also published a new European Standard on healthcare provision by chiropractors (EN 16224). European standardization in the healthcare sector has traditionally focused on medical devices and health informatics (e-Health). Nevertheless, in recent years there has been an increasing level of demand from stakeholders in relation to the standardization of healthcare services. Other types of healthcare services for which CEN is developing standards include aesthetic surgery and osteopathy.
On the operational side, CEN finalised and published a new ‘Guidance document for the development of service standards’ (CEN Guide 15). This publication provides guidance to standardizers and other stakeholders interested in developing standards for different kinds of services, whether business-to-business (B2B) or business-to-consumer (B2C). The Guide covers a wide range of aspects such as the structure of a service standard document, how to measure customer satisfaction, and how to ensure compatibility with management system standards and/or relevant legislation.
SECURITY–RELATED SERVICES
In 2012, CEN has embarked on standarization activities in relation to two types of security-related services, namely forensic science services and port security services.
The CEN Project Committee on ‘Forensic science services’ (CEN/TC 419) was established with the aim of developing a set of standards that define procedures for forensic science processes, starting at the scene of crime – through the recognition, recording, recovery, transportation and storage of material – followed by the examination and analysis of material, the interpretation of results, reporting and data exchange.
European Standards will help to build a common language and establish identical service requirements among forensic science service providers across Europe. This should contribute to improving the effectiveness of criminal investigations, and more efficient cooperation among service providers, law enforcement and judicial authorities.
Meanwhile, a CEN Project Committee on ‘Maritime and port security services’ (CEN/TC 417) has been set up on the basis on an initiative taken by COESS (Confederation of European Security Services). The aim is to develop a standard describing the tasks and responsibilities of private security providers, which play an essential role in ensuring the security of ports and the maritime environment.
Core business highlights
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Conformity assessment and KeymarkIn 2012, the work of the CEN Certification Board (CEN/CB) has been mainly dedicated to a strategic review of the CEN policy in relation to conformity assessment and the Keymark. Recognising the valuable concept of the Keymark, but also noting its fairly limited success during the last ten years, CEN/CB decided to establish a Task Force to conduct an in-depth study of the possible consequences of different future scenarios. This exercise should be completed in 2013.
International cooperation activitiesTechnical assistance projects complement the ongoing efforts of CEN and CENELEC to cooperate with their international partners in certain strategically-important countries and regions, and contributes to raising awareness and understanding of the European Standardization System around the world.
CEN is part of the consortium responsible for managing the EU-China Trade Project (EUCTP II), which is the third major EU-China trade-related technical assistance project since 2000 and provides support to China’s Sustainable Trade and Investment System. Within the framework of the ongoing economic and trade dialogues between the EU and China, the EUCTP II project aims to promote fair competition, to improve food safety and quality, to enhance product safety and facilitate harmonisation with international standards. It also contributes towards greater transparency, good governance and sustainable development.
CEN is involved in the elements of the project that focus on Quality Infrastructure and Technical Barriers to Trade (TBT). In 2012, a number of experts from the European Standardization community participated in working visits to China where they helped to build capacity among local stakeholders in a variety of fields, including (among others): metrology, information security, and ICT-related goods and services.
CEN is also involved in a regional project supporting Quality Infrastructure in the Western Balkans and Turkey. This project covers Albania, Bosnia & Herzegovina, Croatia, Kosovo, the former Yugoslav Republic of Macedonia, Montenegro, Serbia and Turkey. The main aim of the project is to improve the capabilities of the responsible (national) public authorities and quality infrastructure bodies, all of which have been implementing strategies to comply with EU legislation and enable the integration of their economies into the European Single Market. In 2012, the project provided a series of 8 Training Seminars and launched proficiency testing exercises involving 55 conformity assessment bodies in 11 product areas.
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DELIVERABLES* 2010 2011 2012
European Standards (EN)** 983 999 1014
Workshop Agreements (CWA) 32 69 17
Technical Specifications (TS) 38 50 66
Technical Reports (TR) 33 30 46
Guides (CG) 4 2 5
TOTAL 1090 1150 1148
DELIVERABLES* 2010 2011 2012
Standards (ENs)** 12.432 12.797 13.131
Amendments 499 492 456
Workshop Agreements (CWA) 356 375 387
Technical Specifications (TS) 402 378 412
Technical Reports (TR) 249 275 317
Guides (CG) 10 12 26
Pre-Standards (ENV) 85 70 58
Reports (CR) 102 99 98
TOTAL deliverables published 14.135 14.498 14.885
TECHNICAL BODIES 2010 2011 2012
Active CEN Technical Committees (CEN/TC) 299 307 307
CEN TC/Sub-Committees (CEN/TC/SC) 57 56 52
CEN TC/SC Working Groups 1411 1430 1434
Active Workshops 26 23 27
TOTAL number of Technical Bodies 1793 1816 1820
CEN and CENELEC Joint Technical bodies 15 17 20
*Including deliverables of CEN and joint work of CEN-CENELEC and CEN-CENELEC-ETSI
**excluding corrigenda
*Including deliverables of CEN and joint work of CEN-CENELEC and CEN-CENELEC-ETSI
**Excluding corrigenda
European Standards (EN)
CEN Workshop Agreements (CWA)
Technical Specifications (TS)
Technical Reports (TR)
CEN Guides (CG)
1014
54666
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CEN OVERALL AT THE END OF 2012
CEN IN 2012
Facts and figures
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INTERNATIONAL RELATIONS
CEN portfolio: % of deliverables per business domain identical to ISO publications
Hea
lthca
re
Gen
eral
Sta
ndar
ds (Q
uality
, etc
.)
Food
Envir
onm
ent
Mat
eria
lsM
echa
nica
l eng
inee
ring
Che
mist
ryPa
ckag
ing
ICT
Hea
lth a
nd s
afet
y
Build
ing
and
civil
eng
inee
ring
Hou
seho
ld g
oods
, spo
rts a
nd le
isure
Utili
ties
and
ener
gy
HVA
C
Tran
spor
t
Serv
ices
76%71%
54%49% 49%
44% 43%
31%25%
22%
11% 11% 11%7% 4% 2%
*Excluding Corrigenda and Guides
CEN portfolio – Relation to ISO – at the end of 2012
Facts and figures
DELIVERABLES* Number Percentage
Identical to ISO 4.494 30,24%
Based on ISO 21 0,14%
Homegrown 10.344 69,61%
TOTAL 14.859 100,00%
Healthcare: 76%
General Standards (Quality, etc.): 71%
Food: 54%
Environment: 49%
Materials: 49%
Mechanical engineering: 44%
Chemistry: 43%
Packaging: 31%
ICT: 25%
Health and safety: 22%
Building and civil engineering: 11%
Household goods, sports and leisure: 11%
Utilities and energy: 11%
HVAC: 7%
Transport: 4%
Services: 2%
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Total number of harmonised standards and other deliverables cited or intended for citation in the Official Journal of the European Union (OJEU) (including Amendments)
DIRECTIVE/REGULATION REFERENCE
TITLE End 2012 in 2012
2006/42/EC Machinery 662 57
89/106/EEC Construction Products 488 45
89/686/EEC Personal protective equipment 301 29
97/23/EC Pressure equipment 217 26
93/42/EEC Medical Devices 186 18
2009/142/EC Gas appliances 112 8
2008/57/EC Railways 88 11
94/25/EC Recreational craft 70 6
2001/95/EC General Product Safety 64 4
94/9/EC Explosive atmospheres 60 7
93/15/EEC Explosives for civil use 57
90/385/EEC Active implantable medical devices 39 5
98/79/EC In vitro diagnostic medical devices 34 4
765/2008 Accreditation and Market Surveillance 27 3
2003/2003 Fertilisers 25 2
2000/9/EC Cableways 23
2004/22/EC Measuring instruments 15
95/16/EC Lifts 15 1
2007/23/EC Pyrotechnic articles 13 8
2004/108/EC Electromagnetic compatibility 12
2009/105/EC Simple pressure vessels 12 1
97/67/EC Postal Services 8
94/62/EC Packaging 6
1907/2006 REACH 5 2
2009/48/EC Safety of Toys 3
641/2009 Eco-design of energy using products 3 3
1223/2009 Cosmetic Products 1
2009/23/EC Non-automatic weighing instruments 1
GRAND TOTAL 2.547 240 Note: a deliverable may be counted more than once if cited or intended for citation under more than one Directive
RELATION TO EUROPEAN UNION LEGISLATION
20
Portfolio of harmonised deliverables at the end of 2012
*All deliverables (excluding Corrigenda and Guides)
% of harmonised deliverables identical to ISO (per business domain)
Envir
onm
ent
Gen
eral
Sta
ndar
ds (Q
uality
, etc
.)H
ealth
care
Tran
spor
t
Mec
hani
cal e
ngin
eerin
gH
ealth
and
saf
ety
Che
mist
ry
Hou
seho
ld g
oods
, spo
rts a
nd le
isure
100%
73% 68%
33%
20%14%
2% 2%
Facts and figuresRELATION TO EUROPEAN UNION LEGISLATION
DELIVERABLES* Number Percentage
Identical to ISO 494 20,24%
Based on ISO 3 0,12%
Homegrown 1.944 79,64%
TOTAL 2.441 100,00%
Environment: 100%
General Standards (Quality, etc.): 73%
Healthcare: 68%
Transport: 33%
Mechanical engineering: 20%
Health and safety: 14%
Chemistry: 2%
Household goods, sports and leisure: 2%
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Annual accounts
* Figures are given in thousands of euro.
EXPENDITURE (€ X 1000)* 2012 2011 2010
Staff costs 6 839 6 741 6 912
Other operating costs 2 422 2 304 2 235
Contractual payments 7 485 8 267 11 704
Difference between income and expenses - - -
TOTAL 16 746 17 312 20 851
INCOME (€ X 1000)* 2012 2011 2010
Contributions 5 462 5 101 5 084
Interest 70 49 16
Contractual income 11 007 11 953 15 566
Miscellaneous 207 209 185
TOTAL 16 746 17 312 20 851
FINANCING OF THE CEN-CENELEC MANAGEMENT CENTRE (CEN PART)
2012 2011 2010
Membership fees 59% 56% 56%
EU/EFTA support to standardization 38% 41% 42%
Other support 3% 3% 2%
TOTAL 100% 100% 100%
ASSETS (€ X 1000)* 2012 2011 2010
Fixed assets 509 381 422
Current assets 4 072 5 192 8 282
Liquid assets 6 338 6 600 7 487
Prepaid expenses and accrued income 247 238 178
TOTAL 11 166 12 411 16 370
LIABILITIES (€ X 1000)* 2012 2011 2010
Reserves 1 962 1 882 1 802
Provisions for liabilities and charges 1 852 2 171 1 952
Payables 6 415 7 447 11 747
Accrued expenses & deferred 937 911 869
TOTAL 11 166 12 411 16 370
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National MembersAustria
ASI - Austrian Standards Institute [email protected]
AS+ - Austrian Standards Pluswww.as-plus.at
Belgium
NBN - Bureau de Normalisation/Bureau voor [email protected]
Bulgaria
BDS - Bulgarian Institute for [email protected]
Croatia
HZN – Croatian Standards [email protected]
Cyprus
CYS – Cyprus Organisation for [email protected]
Czech Republic
UNMZ - Czech Office for Standards, Metrology and [email protected]
Denmark
DS – Danish [email protected]
Estonia
EVS – Estonian Centre for [email protected]
Finland
SFS – Finnish Standards [email protected]
France
AFNOR - Association Française de [email protected]
Germany
DIN - Deutsches Institut für Normung [email protected]
Greece
ELOT – Hellenic Organization for [email protected]
Hungary
MSZT – Hungarian Standards [email protected]
Iceland
IST – Icelandic [email protected]
Ireland
NSAI - National Standards Authority of [email protected]
Italy
UNI - Ente Nazionale Italiano di [email protected]
Latvia
LVS – Latvian [email protected]://www.lvs.lv
Lithuania
LST – Lithuanian Standards [email protected]
Luxembourg
ILNAS – Institut Luxembourgeois de la Normalisation, de l’Accréditation, de la Sécurité et qualité des produits et [email protected]
Former Yugoslav Republic of Macedonia
ISRM - Standardization Institute of the Republic of [email protected]
Malta
MCCAA – Malta Competition and Consumer Affairs [email protected]
The Netherlands
NEN – Nederlands [email protected]
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Norway
SN - Standards [email protected]
Poland
PKN – Polish Committee for [email protected]
Portugal
IPQ – Instituto Português da [email protected]
Romania
ASRO – Romanian Standards [email protected]
Slovakia
SUTN - Slovak Standards [email protected]
Slovenia
SIST – Slovenian Institute for [email protected]
Spain
AENOR – Asociación Espàñola de Normalización y Certificació[email protected]
Sweden
SIS - Swedish Standards [email protected]
Switzerland
SNV – Schweizerische [email protected]
Turkey
TSE – Turkish Standards [email protected]
United Kingdom
BSI – British Standards [email protected]
AffiliatesAlbania
DPS - General Directorate of [email protected]
Armenia
SARM - National Institute of [email protected]
Azerbaijan
SCSMP - State Committee for Standardization, Metrology and Patent of the Republic of [email protected]
Belarus
BELST - State Committee for Standardization of the Republic of [email protected]
Bosnia and Herzegovina
BAS - Institute for Standardisation of Bosnia and [email protected]
Egypt
EOS - Egyptian Organization for Standardization & [email protected]
Georgia
GEOSTM - Georgian National Agency for Standards, Technical Regulations and [email protected]
Israel
SII - Standards Institution of [email protected]
Jordan
JSMO - Jordan Standards and Metrology [email protected]
Lebanon
LIBNOR - Lebanese Standards [email protected]
CEN Network
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Libya
LNCSM – Libyan National Centre for Standardization and [email protected]
Republic of Moldova
INSM - National Institute of Standardization and [email protected]
Montenegro
ISME - Institute for Standardization of [email protected]
Morocco
IMANOR – Institut Marocain de [email protected]
Serbia
ISS - Institute for Standardization of [email protected]
Tunisia
INNORPI - National Institute for Standardization and Industrial Property [email protected]
Ukraine
DSSU - State Committee of Ukraine for Technical Regulation and Consumer [email protected]
Partner Standardization BodiesAustralia
SA - Standards Australia [email protected]
Kyrgyzstan
CSM - Centre for Standardization and Metrology (CSM) [email protected]
Mongolia
MASM - Mongolian Agency for Standardization and [email protected]
AssociatesANEC
European Association for the co-ordination of consumer representation in [email protected]
AQUA EUROPA
Confederation of Trade associations representing the interests of the water and wastewater supply [email protected]@aqua-europa.eu
CEPMC
Council of European Producers of Materials for [email protected]
ECOS
European Environmental Citizens Organisation for [email protected]
ETUI
European Trade Union Institute Health and Safety [email protected]
EUCOMED
European Medical Technology Industry [email protected]
FIEC
European Construction Industry [email protected]
NORMAPME
European Office of Craft/Trades and Small and Medium-sized Enterprises for [email protected]
CounsellorsEuropean Commission
http://ec.europa.eu
EFTA Secretariat
http://secretariat.efta.int/
CEN Network
CREATED & PRINTED BY:LOSFELD COMMUNICATION RUE DE LA COURONNE, 76B-7730 ESTAIMPUIS, BELGIUMWWW.LOSFELD.BE
RESPONSIBLE EDITOR: SARAH PENNYAVENUE MARNIX, 17B-1000 BRUSSELS, BELGIUM© CEN 2013ISBN 978-92-9097-268-6
PEFC-Recycled
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This brochure is fromrecycled and controlledsources.
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ABOUT CEN The European Committee for Standardization (CEN) is one of three officially recognised organisations responsible for developing and defining standards at European level (alongside CENELEC and ETSI). Through its services, CEN provides a platform for the development of European Standards and other technical specifications. CEN brings together the National Standards Bodies of 33 European countries, covering some 600 million consumers. These include all 27 countries of the European Union and three countries of the European Free Trade Association (Iceland, Norway and Switzerland) plus three EU acceding/candidate countries (Croatia, the former Yugoslav Republic of Macedonia and Turkey). The members of CEN work together to develop voluntary European Standards (ENs) in various sectors, to build a European single market for goods and services, and to strengthen Europe’s position in the global economy. Where possible, CEN cooperates with the International Organization for Standardization (ISO). By supporting research and helping disseminate innovation, standards are a powerful tool for economic growth. More than 60 000 technical experts, as well as business federations, consumer and environmental organisations, and other societal stakeholders are involved in the CEN network. CEN also collaborates with CENELEC and ETSI to promote standardization activities in areas of common interest, and to strengthen the European Standardization System for the benefit of businesses, consumers and society as a whole. For further information, please visit: www.cen.eu
Avenue Marnix, 17 – B-1000 Brussels – www.cen.eu
