Transcript No Slide Title

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
What
Essential requirements
Published in the OJ
“Technical file”
How
Enables innovative solutionsCareful, it does vary by Directive
to be brought to market
More costly:
- Technical file
- Notified body
“Modules” approach to
CA and CE marking
Harmonised Standards
Works well for “standard
solutions”
Cheaper and easier – if there
is a standard
http://europa.eu.int/comm/enterprise/newapproach/legislation/guide/legislation.htm
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conflicting standards withdrawn.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
ISO/IEC/ITU
WTO
Corresponding
Organizations
Affiliates
CEN
CENELEC
ETSI
EU and EFTA
(Counsellors)
Associates
National Members as
Organizations
integral part of the
in liaison
European
standardization system
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 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
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
HOW IT WORKS
1 – European Standards etc:
INDUSTRIAL AND
SOCIAL NEEDS
REQUEST
DECISION - TECHNICAL BOARD
WORK WITH ISO
(Vienna Agree.)
USE EXISTING
DOCUMENT
(e.g. ISO)
OR
SET UP NEW
TECHNICAL
COMMITTEE
(Business
planning)
OR
PUBLIC ENQUIRY
FORMAL VOTE
NATIONAL IMPLEMENTATION
CEN - Principles applied through
 Consensus
 Drafting EN
 Openness and
transparency
 National commitment
 CEN Enquiry
 Formal vote/standstill
 Technical coherence at
national and European
level
 Correct integration with
other international work
 Implementation
 CEN/ISO technical
cooperation
CEN Process
Short reminder
What do I want ?
Proposal
Can I do it ?
Planning
I'll put it on paper
Drafting
Does it suit
everybody ?
Consensus
Any comments ?
CEN enquiry
Does everybody
accept ?
Formal vote
Make it available
Adoption
Is it still valid ?
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:
 Active technical committees:
 Documents being prepared
9110
276
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.
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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