1. EUROPEAN Standards Andy Henson December 2003

2. European Directives  1985 Council Resolution on A New Approach to technical harmonisation and standards  The New Approach was devised to: - facilitate the achievement of the Internal Market - develop flexible and technology-neutral legislation by moving from detailed product specific technical requirements to defining the essential requirements for types of products  1989 - Council Resolution on a Global Approach to conformity assessment  > 20 NA/GA Directives - Euro 1500 billion

3. The main elements of the New Approach

4.  Definition of mandatory essential requirements to ensure a high level of protection of the public interest at issue, such as health, safety, consumer protection or the protection of the environment.  Manufacturers are free to choose any appropriate technical solution that meets the essential requirements. Products that comply with harmonised standards are presumed to meet the corresponding essential requirements. Harmonised standards are produced by the European standardisation bodies on the basis of mandates from the Commission.

5. The main elements of the New Approach Directives Essential requirements “Technical file”Harmonised Standards What How Published in the OJ Works well for “standard solutions” Cheaper and easier – if there is a standard Enables innovative solutions to be brought to market More costly: - Technical file - Notified body Careful, it does vary by Directive http://europa.eu.int/comm/enterprise/newapproach/legislation/guide/legislation.htm “Modules” approach to CA and CE marking

8. Standardisation in Europe  Note – Not all standards in Europe are related to Directives  In CEN about a quarter are Harmonized standards in the meaning of the Directives

9. The European Standardization bodies  CEN, the European Committee for Standardization  CENELEC is the European Committee for Electrotechnical Standardization  ETSI –European Telecommunications Standards Institute - Cooperation with European Commission and EFTA* outlined in “General Guidelines” - The European Standards must be transposed into national standards and conflicting standards withdrawn. *Iceland, Liechtenstein, Norway and Switzerland

10. The European standardization system and its partners CEN CENELEC ETSI National Members as integral part of the European standardization system ISO/IEC/ITU Associates EU and EFTA (Counsellors) WTO Organizations in liaison Affiliates Corresponding Organizations

11. CEN Principles  Voluntary  Public and open to everybody  Consensus  Coherence  Current state of technology  Primacy of international standardization

12. CEN System Members and Affiliates  22 National Members National standards organizations of the 18 EU and EFTA countries, Malta, the Czech Republic, Hungary and Slovakia  6 Associates European sector organizations: ANEC, CECIMO, CEFIC, FIEC, TUTB, EUCOMED (NORMAPME)  11 Affiliates Albania, Bulgaria, Croatia, Cyprus, Estonia, Latvia, Lithuania, Poland, Slovenia, Romania, Turkey

13. CEN National Members, Affiliates and Corresponding Organizations National Members Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland, United Kingdom Affiliates Albania, Cyprus, Croatia, Bulgaria, Estonia, Latvia, Lithuania, Poland, Romania, Slovenia, Turkey Corresponding Organizations Egypt, Serbia and Montenegro, South Africa, Ukraine

14. HOW IT WORKS 1 – European Standards etc: REQUEST DECISION - TECHNICAL BOARD INDUSTRIAL AND SOCIAL NEEDS

15. WORK WITH ISO (Vienna Agree.) USE EXISTING DOCUMENT (e.g. ISO) SET UP NEW TECHNICAL COMMITTEE (Business planning) PUBLIC ENQUIRY FORMAL VOTE NATIONAL IMPLEMENTATION OR

16. CEN - Principles applied through  Consensus  Openness and transparency  National commitment  Technical coherence at national and European level  Correct integration with other international work  Drafting EN  CEN Enquiry  Formal vote/standstill  Implementation  CEN/ISO technical cooperation

18. CEN - Formal Vote process  Period of vote: 2 months  Unconditional vote  Negative votes to be justified  Vote by electronic means  Weighted vote  Adoption: 71% of weighted vote cast are in favour  Voting report established by CMC

19. CEN  CEN, the European Committee for Standardization, was founded in 1961 by the national standards bodies in the European Economic Community and EFTA countries  European Standards & approved documents: 9110  Active technical committees: 276  Documents being prepared 6772  Budget approx 11 M Euro  Note no income from sales of standards (national members)  51 % membership fees, 41 % EC 2% EFTA + odds and ends

20. CENELEC  CENELEC is the European Committee for Electrotechnical Standardization.  1973 as a non-profit-making organization under Belgian Law.  Officially recognized as the European Standards Organization in its field by the European Commission in Directive 83/189/EEC.  National Electrotechnical Committees of 23 European countries. In addition, 12 National Committees from Central and Eastern Europe are participating in CENELEC work with an Affiliate status.  CENELEC works with 35,000 technical experts from 22 European countries to publish standards for the European market.

21. CENELEC  Enquiry  Draft is is submitted to the NCs for CENELEC enquiry, - 6 months.  Comments received are studied by the technical body working on the draft and incorporated into the document, where justified, before a final draft is sent out for vote.  Voting - The vote usually takes 3 months. - Weighted votes corresponding to the size of the country they represent - the larger countries like France, Germany, Italy and the UK have 10 votes each while the smaller ones have one or two weighted votes. - There are two requirements for a standard to be approved. The vote must yield: - a majority of NCs in favour of the document - at least 71% of the weighted votes cast are positive

22. CENELEC  Ways to start harmonizing a standard: - From the International Electrotechnical Commission (80% of cases). - A document of European origin arises in one of CENELEC's own technical bodies. - A first draft of a European document comes from one of CENELEC's Cooperating partners. - A fourth source is the National Committees themselves. Under the Vilamoura Procedure, the NCs have agreed to notify CENELEC when they are planning any new work. CENELEC can, if it wants, take on this work.  The main factor defining the work of CENELEC remains the close co-operation with the  International Electrotechnical Commission (IEC).  - In response to the ongoing globalization of technical standards, the national electrotechnical  committees, members of CENELEC, will continue to concentrate their activities and  contributions at the international level of IEC.  - Another consequence is that the resulting IEC international standards will be implemented in  Europe as far as possible unchanged.

23. Summary  Standards in Europe are voluntary (unless referenced in Regulation)  Standards are developed by consensus  Committee work is voluntary (and unpaid)  Member States must withdraw conflicting standards  Many standards support Directives  The majority are not connected with Directives