The European Standardization System. Diana Dus Programme Manager International Cooperation
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1 The European Standardization System Diana Dus Programme Manager International Cooperation
2 The European Standardization Organizations (ESOs) CEN... (European Committee for Standardization) CENELEC... (European Committee for Electrotechnical Standardization) ETSI... (European Telecommunications Standards Institute) CEN-CENELEC
3 Sectors European Committee For Standardization European Committee for Electrotechnical Standardization European Telecommunications Standards Institute CEN-CENELEC
4 What is a European Standard? A definition of common requirements An agreed basis of understanding which promotes efficiency and reliability simplifies life increases reliability and effectiveness of goods and services we use CEN-CENELEC
5 Some types of standard Test and measurement standards Measure content or parameter Product standard Specify product performance Management standards Models for managing activities CEN-CENELEC
6 Types of European Standard Prescriptive Specifications Methods Vocabularies Non-prescriptive Recommendations Codes of practice Guides Classifications CEN-CENELEC
7 What standards do enhance the safety of products allow economies of scale help manufacturers comply with European legislation promote the interoperability of products and services encourage greater competition facilitate trade by removing trade barriers promote ecological safety and sustainability help safeguard the environment aid the transfer of research promote common understanding CEN-CENELEC
8 What do we standardise? CEN-CENELEC
9 CEN-CENELEC
10 Main principles of European standardization Voluntary standards are voluntary in application Openness and transparency open to participation of all interested parties and broad consultation Consensus we build European consensus among all stakeholders National commitment to implement European standards as identical national standards and withdraw conflicting national standards Market relevance reflect market needs Correct integration with international work cooperation with ISO (Vienna agreement) and IEC (Dresden agreement) CEN-CENELEC
11 Trading within the European Union Four basic freedoms: Free movement of goods Free movement of persons Free movement of capital Freedom of establishment and free movement of services Barriers to trade: Traditional barriers such as tariffs or quotas Technical barriers such as differences in standards and conformity assessment CEN-CENELEC
12 Why European Standards? To build the Single Market Larger markets create wealth Free trade throughout the European Economic Area More than 500 million customers To help competitiveness and technical innovation State of the Art Transfer of European Research results To strengthen the regional influence in global economy Export European know-how To enable access to the Single European Market Accession of new Members to the EU To provide an alternative for better regulation Self regulation by the market and best practice benchmark A co-regulation approach in Europe since 1985 CEN-CENELEC
13 Before: Trade barriers hindered the European economy DIN CEN-CENELEC
14 A fact to remember 1 European standard Replaces 31 different national standards in Europe Creates access to a market of over 500 million CEN-CENELEC
15 Some examples EN 71 EN 115 EN 228 EN 1078 EN 1725 Safety of toys Escalators and moving walks Automotive fuels Unleaded petrol Helmets for pedal cyclists Domestic furniture (Beds and mattresses) EN Biotechnology (Laboratories for research etc.) EN Recreational diving services EN Postal services CEN-CENELEC
16 How to search the CEN catalogue? CEN-CENELEC
17 How to search the CENELEC catalogue? CEN-CENELEC
18 National Members All the National Members are members of all TCs Other members may join in an observer capacity Official languages are English, French and German Development through discussion leading to consensus Final decisions reached by weighted vote European standards must be adopted as National Standards even if the country voted against the draft CEN-CENELEC
19 Participation in the standardization process CEN and CENELEC Technical or Project Committee DELEGATION DELEGATION DELEGATION National Standardization Body National Standardization Body National Standardization Body Experts in a specific field representing: industry, trade associations, government, consumer, academia, customers, etc CEN-CENELEC
20 European standards can support EU policies and legislation They can help business to comply with requirements established by EU legislation (New approach) in important industrial sectors such as toys, pressure equipment, electromagnetic compatibility, machinery, lifts, construction products, medical equipment, packaging, ICT, etc. CEN-CENELEC
21 The legal framework: New Approach CEN and CENELEC prepare voluntary standards New Approach Directives and associated mandates link harmonized standards to the legal framework Products manufactured in accordance with harmonized standards, the reference numbers of which have been published in the Official Journal, are presumed to conform to Essential Requirements of the relevant Directive 21
22 New approach: Actors & basic principles Law (mandatory) Standard (voluntary) New Approach Directives (Essential Requirements) MANDATE European Standard National law National Standard 22
23 New approach: Actors & basic principles Mandates are issued by the European Commission expressing a political wish that standardization work should be performed in the framework of a directive 23
24 New approach: Actors & basic principles Directives address a broad product scope listing essential (health and safety) requirements that products have to meet, without specifying how to achieve the desired outcome 24
25 New approach: Actors & basic principles Standards provide technical details on how to conform to the essential requirements of a given directive shall state which (all, only certain identified, all except certain identified) essential requirements of the directive are covered. 25
26 New approach: Actors & basic principles Conformity assessment The references of harmonised standards are listed in the Official Journal of the European Union (OJEU) Manufacturers following these harmonised standards have presumption of conformity (CE marking) 26
27 New Approach Basic principles EC Directives define essential requirements (e.g. safety) indicate desired outcome WITHOUT specifying how it should be achieved Reference to standards Standards organizations develop or approve harmonized standards EN s set out technical specifications to meet directives essential requirements Conformity assessment (CA) policy Standards are voluntary Manufacturers do not have to follow EN IF they follow = presumption of conformity ( ) In many cases opens way for CA without 3rd party intervention CEN-CENELEC
28 The standards-based co-regulation in Europe Mandatory Voluntary Directive Essential requirements EC Mandate to CEN European Standard OJ citation Harmonized EN = presumption (proof) of conformity to mandatory essential requirements 28
29 CEN and CENELEC in Europe and beyond ISO Partner Standardization Bodies Affiliates CEN Associates Memoranda of Understanding with regional bodies EC/EFTA National Members Technical Assistance Programmes CENELEC Cooperating Partners Europe IEC Affiliates Beyond Europe CEN-CENELEC
30 Cooperation with ISO: Vienna Agreement In place between ISO and CEN since 1991 To adopt International Standards in Europe whenever possible No duplication of work Types of cooperation between ISO and CEN: Correspondence Mutual representation at meetings Adoption of same text as ISO and European standard: Adoption by CEN of an available ISO Standard and vice versa Elaboration of a standard in one organization, parallel ISO/CEN approval procedure CEN-CENELEC
31 Cooperation with IEC: Dresden Agreement Agreement on common planning of new work and parallel voting between IEC and CENELEC Signed in 1991 (Lugano Agreement) Current version dated 1996 Very similar to Vienna Agreement IEC created in 1906 (ISO created in 1947) Electrotechnical standardization started at international level In principle, IEC standards implemented as European and national standards CEN-CENELEC
32 Opening Up The European System CEN and CENELEC have harmonized their formal relations with third countries and regions Affiliate status for the Standardization Organizations of countries listed in the European Neighbourhood Policy Partner Standardization Bodies for all other Standardization Organizations (Guide 13) Memoranda of Understanding for regional level Moreover, CEN, CENELEC and ETSI are increasingly joining forces for international visibility actions. CEN-CENELEC Sarah Penny, EC Info Session
33 Relevant cooperation activities CEN MoUs with: CENELEC MoU with: SADCSTAN Licence agreements (for the adoption of ENs) with: BOBS GSB SABS CEN-CENELEC
34 Thank you for your attention! Any questions? CEN-CENELEC
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