EUROPEAN Standards

Andy Henson

December 2003

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

The main elements of the New Approach

The main elements of the New Approach

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.

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

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

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- The European Standards must be transposed into national standards and conflicting standards withdrawn.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

The European standardization system and its partners

CENCENELEC

ETSI

National Members as integral part of the

European standardization

system

ISO/IEC/ITU

Associates

EU and EFTA (Counsellors)WTO

Organizationsin liaison

Affiliates

Corresponding Organizations

CEN Principles

Voluntary

Public and open to everybody

Consensus

Coherence

Current state of technology

Primacy of international standardization

CEN System Members and Affiliates

22 National MembersNational standards organizations of the 18 EU and EFTA countries, Malta, the Czech Republic, Hungary and Slovakia

6 AssociatesEuropean sector organizations: ANEC, CECIMO, CEFIC, FIEC, TUTB, EUCOMED (NORMAPME)

11 AffiliatesAlbania, Bulgaria, Croatia, Cyprus, Estonia, Latvia, Lithuania, Poland, Slovenia, Romania, Turkey

CEN National Members, Affiliatesand 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

HOW IT WORKS1 – European Standards etc:

REQUEST

DECISION - TECHNICAL BOARD

INDUSTRIAL AND SOCIAL NEEDS

WORK WITH ISO(Vienna Agree.)

USE EXISTING

DOCUMENT(e.g. ISO)

SET UP NEWTECHNICAL COMMITTEE

(Businessplanning)

PUBLIC ENQUIRY

FORMAL VOTE

NATIONAL IMPLEMENTATION

OR OR

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

What do I want ?

I 'll put it on paper

Any comments ?

Make it available

Can I do it ?

Does it suit everybody ?

Does everybody accept ?

Is it still valid ?

CEN ProcessShort reminder

Proposal

Planning

Drafting

Consensus

CEN enquiry

Formal vote

Adoption

Review

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

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

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.

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

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.

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