A new philosophy for completing the internal market for products

1
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
2
Outline of presentation

• 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

3
Political Influence
DI - The Voice of Danish Industry
DI is a private organisation funded entirely by
its 6,400 member companies. We are more than 400
employees.
"DI was the first organisation in Denmark to
fully adapt to the vital nature of specialist
knowledge."   Ove Kaj Petersen, Professor of
Political Science, University of Copenhagen
DI promotes the views of industry - locally,
nationally and internationally.
DI aims at providing the best possible working
conditions for Danish industries.
Source Berlingske Tidendes Nyhedsmagasin,
December 2002
4
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

5
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

6
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

7
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)

8
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
• 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

9
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)

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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

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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

14
Revision of the New Approach

• 20 years' practice has shown a need for improving
  the system
• 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?

15
Thank you for your attention!