General introduction to the New Approach
and CE marking
Contribution to workshop
in Sofia, Bulgaria
on
19 and 20 april 2006
by
Annette Dragsdahl,
Senior Adviser,
Confederation of Danish
Industries
Outline of presentation
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Brief introduction to DI and own background
Creating a single market
New Approach directives, in general
CE-marking and the conformity assessment procedure
Revision of the New Approach
Political
Influence
DI - The Voice of Danish Industry
"DI was the first organisation in
Denmark to fully adapt to the
vital nature of specialist
knowledge."
DI is a private organisation funded
entirely by its 6,400 member
companies. We are more than 400
employees.
Ove Kaj Petersen, Professor of Political Science,
University of Copenhagen
DI promotes the views of industry locally, nationally and internationally.
Source: Berlingske Tidendes Nyhedsmagasin,
December 2002
DI aims at providing the best possible
working conditions for Danish
industries.
DI in Brussels
• Own office in Brussels (5 persons)
• All issue managers active also in
Brussels
DI is a member of:
• UNICE (horisontal)
• Orgalime (mechanical, electrical and
electronical industries)
• European sector federations, e.g.
ITC, food and construction
Own background
Work in the European Affairs unit of DI
• Horisontal, Internal Market policy
• Directives under the New Approach (technical safety)
• Standardisation
• Certification
• Accreditation policies
• Metrology
• Barriers to Trade (IM and global)
All areas include informative, advisory and political work
Creating a single market
• Free movement of goods is a cornerstone of the Single Market
• Abolishing customs duties not enough
• National technical regulations were increasing in the 70'ies and
became technical barriers to trade
• Technical harmonisation on Community level is needed to avoid
barriers
• Detailed legislation takes time…
• A new philosophy was born…
Rules and regulations for products in
the Single Market
• Mutual recognition
– Acceptance in each Member State of products lawfully
manufactured in the rest of the Community
– Applies to:
• test results and certificates
• legislation
• Harmonisation
– Old Approach
– New Approach combined with the Global Approach for conformity
assessment
• Monitoring national regulations
– A preventive procedure including notifications (directive 98/34)
The New Approach:
A new regulatory technique
• Stimulates industrial development
– Flexibility
– Invites for innovations and modifications
• Based on confidence
• Pre-market procedures to be balanced by efficient market
surveillance by national authorities
• Comprises a whole system:
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Risk assessment and conformity assessment by the manufacturer
Notified bodies, if required
National authorities to ensure market surveillance
European co-operation to ensure level playing field
NB: Guide to implementation of directives
– Specifies the principles and tasks of the different actors
New Approach directives
• Deal with important economic sectors/product areas
• Define the essential requirements for the product (covering
health, safety and the environment, in particular)
• Technical details to be fixed in European standards
• Voluntary use of standards (in principle)
• Specify the requirements for conformity assessment
– Different modules depending on the type of products and the risks
involved, cf. the Global Approach
– Main principle: Module A - Internal design control
– European standards give presumption of conformity
– For certification, if required: Reference to Notified Bodies
• CE-marking (21 out of 25 directives)
What is CE-marking?
• The CE-marking symbolises the conformity of the product with
the applicable Community requirements
• Originally addressed to authorities
• When affixed to products = declaration by the manufacturer that
the product conforms to all applicable provisions
• For the buyer/consumer:
= a signal that EU regulation exists and that the manufacturer
has done what he can to ensure that the product meets the
requirements
CE-marking procedure
• Specify appropriate directives
(download text from europa.eu.int/eur-lex)
• Define appropriate standards (harmonised, if any)
• Determine applicable essential requirements
• Carry out risk assessment (eliminate or reduce risks, or…); for
machinery see EN 1050
• Fulfil conformity assessment procedure
• Establish technical file
• Instructions for use, handling, maintenance etc.
• Declaration of conformity
• CE-marking
Revision of the New Approach
• 20 years' practice has shown a need for improving the system:
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Efficient market surveillance
Common definitions
Coherent requirements
Uniform requirements for Notified Bodies
Clarification of the role of the different economic operators
• Possible extension to other areas in line with the "Better
Regulation" initiative
• Regulation in stead of directives?
Thank you for your attention!