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René NielsenHead of International Affairs

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Standardization Organizationsglobally and European

Europe Globally Scope

CEN ISO Civil engineering, mechanics, quality, managementAll electrical, electronic and related technologies

Telecommunication

CENELEC IEC

ETSI ITU

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Globally: WTO - TBT-agreementTBT-agreement (Technical Barriers to Trade) focus on:

• The use of international standards

• Recognition of the organisations: ISO, IEC and ITU

• Impartial, openness, transparent

• Efficient development

• Mutual recognition of testing

• www.wto.org/english/tratop_e/tbt_e/tbt_e.htm

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Europe• The internal market: Free movement of products,

labour, services and capital

• Legislation: Directives

• Official recognition of CEN, CENELEC and ETSI as competent organizations for the production of European standards according to the Commission Directive 98/34

• www.newapproach.org

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CENELEC Organization

30 CENELEC members

General Assembly (AG)

Administrative Board(CA)

CENELECCentral Secretariat

Technical Board(BT)

CENELEC ConformityAssessment Forum

(CCAF)

Technical Committees(TC's)

Technical BoardWorking Groups

(BTWG’s)

Technical BoardTask Forces

(BTTF’s)

Mutual RecognitionAgreement

(MRA)

Mutual RecognitionAgreement

(MRA)

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Technical Board Work• 3 meetings a year

• Ratification

• Survey of technical work

• Villamoura – Guide 8

• Cooperation with other organizations

• Operation of Dresden Agreement

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Technical work in CENELEC

• Technical committee's (TC)

• Subcommittee's (SC)

• Working Group in TC’s or SC’s

• BT Working Groups (BTWG)

• BT Task Force (BTTF)

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CENELEC products and their source

• European Standard, EN

• Technical Specification, TS

• Technical Report, TR

• CENELEC Workshop Agreement, CWA

• CENELEC Guides, G

• Harmonisation Document, HD

• Amendment, A

• Corrigendum, Corr

TC, BTTF, BTWG

TC, BTTF, BTWG

TC, BTTF, BTWG

Workshop of interested stakeholders

AG, BT, TC, BTTF, BTWG

TC

TC, BTTF, BTWG

BT, TC, BTTF, BTWG

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The Vilamoura Procedure

• CENELEC has set a notification procedure all members have to follow: the Vilamoura Procedure.

• In essence, this agreement obliges all CENELEC members to notify any national standardization project to all other members should there be an interest for a common standard at European level. If there is no reaction in a maximum period of 3 months, then the country in question may continue developing this internal project

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IEC Organisation

IEC COUNCILNational Committees

MANAGEMENTADVISORY

COMMITTEES

COUNCIL BOARD

CONFORMITY ASSESSMENT

BOARDManagement of Certification

TECHNICALCOMMITTEES

IECEE

SECTOR BOARDS

IECQIECEx

TECHNICALADVISORY

COMMITTEES

Standardization Management BoardManagement ofstandards work

CENTRALOFFICEEXECUTIVE COMMITTEE

Officers

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Standardization Management Board

• Responsible for the management of the IEC’s standards work including the creation, dissolution and scopes of the IEC Technical Committees

• Timeliness of standards production and liaisons with other international organizations. The SMB is a decision-making body and comprises a chairman, the IEC General Secretary and 15 members (and alternates) elected by Council.

• It reports all its decisions to the Council Board and to all National Committees.

• The SMB is also responsible for the appointment of secretariats and chairmen of TC’s

• Ensures that priorities for the technical work are set according to the recommendations of the IEC Sector Boards, technical advisory committees and technical committees. The SMB normally meets at least three times a year.

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Who produces the standards?• Each National Committee of the IEC handles the participation

of experts from its country.

• Some 179 technical committees (TC's) and subcommittees (SC's), and about 700 project teams / maintenance teamscarry out the standards work of the IEC. These working groups are composed of people from all around the world who are expert in electro technology. The great majority of them come from industry, while others from commerce, government, test laboratories, research laboratories, academia and consumer groups also contribute to the work.

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Who produces the standards?• The technical committees prepare technical documents

on specific subjects within their respective scopes, which are then submitted to the full member National Committees for voting with a view to their approval as international standards.

• In all, some 10 000 experts worldwide participate in the technical work of the IEC. Distribution of documents for standards production is 100% electronic, thus improving efficiency and reducing costs.

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Products of IEC

• International Standard (IS)

• Technical Report (TR)

• Technical Specification (TS)

• Guide (G)

• Public Available Specification (PAS)

• Industrial Technical Agreement (ITA)

• Interpretation Sheet (ISH)

• Technology Trend Assessment (TTA)

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Participation in standardization is a strategic choice for your enterprise

• During the last 50 years Acme developed and produced products to the process industry. Today Acme is among the worlds leading companies in this area.

• It is our goal to supply up-to-date solutions of high quality and by that increase our customers productivity and profitability.

Participation in standardization

supports these visions.

16Parallel Procedures

Common Planning of workCENELEC Guide 13

CENELEC / IEC CooperationDresden Agreement

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Numbering of standards in CENELEC

• Home-grown CENELEC:prEN 50170 => EN 50170

• IEC-candidate:IEC 61158 => EN 61158 (IEC 1158 => EN 61158)

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Portfolio of CENELEC standards

• Home-grown CENELEC: 25%

• IEC modified: 8%

• IEC identical: 67%

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Who initiates the work?

• EU (The EU Commission)

• Member countries of IEC and CENELEC

• The Danish Society

– Authorities– Labor unions– Associations– Enterprises– Individuals

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EN – the European Standard• European Standards (EN) are documents that have been ratified by one of

the 3 European Standards Organizations, CEN, CENELEC or ETSI. They are designed and created by all interested parties through a transparent, consensual process.

• The Internal Regulations, Part 3, states that the EN (European Standard) “carries with it the obligation, in accordance with IR Part 2, to be implemented at national level, by being given the status of a national standard and by withdrawal of any conflicting national standards”.

• The implementation in all member countries guarantees that a manufacturer has easier access to the market of all these European countries when applying European Standards.

• Member countries must also withdraw any conflicting national standard: the EN prevails over any national standard.

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Dates related to standards

• The date of ratification (DOR): Date the CENELEC Technical Board notes the approval of an EN or HD, from which time the standard may be said to be adopted. For administrative reasons, the formal DOR date is taken as the first day of the month following the Technical Board decision

• Date of availability (DAV): Date when the definitive text in the official language versions of an approved EN or HD is distributed by the CENELEC Central Secretariat

• Date of announcement (DOA): Latest date by which the existence of an EN or HD has to be announced at national level by the CENELEC members

• Date of publication (DOP): Latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement

• Date of withdrawal (DOW): Latest date by which national standards conflicting with an EN or HD have to be withdrawn

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Special National Conditions and A-deviations

• A special national condition is a national characteristic or practice that cannot be changed even over a long period of time. These special conditions normally refer to weather and ground conditions that for obvious reasons cannot be altered. For the countries in which the special condition applies, these provisions are normative. For the others, they are simply informative.

A-deviation

• national deviation from an EN (and HD for CENELEC) due to regulations the alteration of which is for the time being outside the competence of the CEN/CENELEC national member

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Special National Conditions and A-deviations

• The strength of the CENELEC Standard is that all these special national conditions are listed in an annex to the standard. This way, they are available to all manufacturers and no one has an advantage over the others in terms of nationality, in an efficient way to building up a truly unified market.

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EU Commission - harmonisation

NEW APPROACH

EU Directive

Essential requirements

requirements

Testing

Standards

”OLD APPROACH”

All requirements

TestingEU Directive

Standard

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New ApproachDirectives (ER) Mandate

EuropeanStandard

NationalLegislation

Reference NationalStandard

Legislation(mandated)

Standard(Voluntary)

EUROPEEUROPE

CountryCountry

Connection between national legislationand European standards

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Standards and directives• Council of the European Union adopts the

directives

• Frame Directive => Standards via mandate

• All EU-countries are committed to implement the directives as national legislation

• Requirement of CE-marking is the visible evidence of compliance of all relevant requirement in the directives

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Standards and directives• Blue Guide is the bible

http://ec.europa.eu/enterprise/newapproach/legislation/guide/index.htm

• Also read Primer on Standards

Can be downloaded from CENELEC

www.cenelec.org selecting CENELEC in action in the menu

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The New Approach to EU Legislation

• The principal goal of the Single Market was to eliminate all barriers to trade existing between the Member States.

• In order to faster remove these barriers, a new legislative technique and strategy was established: The New Approach.

• It was created in order to "harmonize" the health, safety, and environmental requirements of Member States into one single European legislative package. The outcome was called New Approach Directives, which are broad regulatory requirements to which confronted products must conform.

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The New ApproachCE marking

• The CE marking is mandatory and must be affixed before any product subject to it is placed on the market and put into service, save where specific directives require otherwise.

• Where products are subject to several directives, which all provide for the affixing of the CE marking, the marking indicates that the products are presumed to conform to the provisions of all these directives.

• A product may not be CE marked, unless it is covered by a directive providing for its affixing.

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The New ApproachMarket Surveillance

• Market surveillance is an essential tool for the enforcement of New Approach directives.

• The purpose of market surveillance is to ensure that the provisions of applicable directives are complied with across the Community. Citizens are entitled to an equivalent level of protection throughout the single market, regardless of the origin of the product. Further, market surveillance is important for the interest of economic operators, because it helps to eliminate unfair competition.

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The New ApproachMarket Surveillance

• Member States must nominate or establish authorities to be responsible for market surveillance. These authorities need to have the necessary resources and powers for their surveillance activities, ensure technical competence and professional integrity of their personnel, and act in an independent and non-discriminatory way respecting the principle of proportionality.

• Notified bodies should, basically, be excluded from the responsibility of market surveillance activities. This is to avoid conflicts of interest.

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The New ApproachMarket Surveillance

RAPEX system

• http://ec.europa.eu/consumers/dyna/rapex/rapex_archives_en.cfm

• Coordination tool for authorities

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The New ApproachMarket Surveillance

E·MAR·S• Enhancing Market Surveillance through Best

Practice• www.emars.eu• Improving market surveillance• Improving European coordination

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The New ApproachRevision of directives

Low Voltage Directive 2006/95/EC

• Substitutes 73/23• Into force 20 days after publication in OJEC

(2007-12-27)• No major effect on standards

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The New ApproachRevision of directives

EMC Directive 2004/108/EC• Substitutes 89/336/EC• Into force 20 days after publication in OJEC

(2004-12-31)• Transition period until 2009-07-20• Existing standards is transferred for listing in

OJEC• Existing standards will be evaluated and

revised in accordance with the new directive

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The New ApproachRevision of directives

Machinery Directive 2006/42/EC• Substitutes former directive 98/37/EC• Into force 20 days after publication in OJEC

(2006-06-09)• Transition period until 2009-12-29• Existing standards is transferred for listing in

OJEC• Existing standards will be evaluated and

revised in accordance with the new directive

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Thank you very much

Questions?