1. General principles of the New Approach legislation
Workshop on the Pressure Equipment Directive, Riga
GORAN LINDHOLM, Principal Administrator
Directorate General for Enterprise
European Commission
General Principles of the New Approach legislation, Riga Göran Lindholm

2. FREE MOVEMENT OF GOODS IN THE EU
Contents
Background
The Old Approach
The New and the Global Approaches
The Voluntary sector
Details about the New and the Global approaches
Conclusions
General Principles of the New Approach legislation, Riga Göran Lindholm

3. 1 THE EU APPROACHES
General Principles of the New Approach legislation, Riga Göran Lindholm

4. THE SINGLE GOAL OF THE EU APPROACH IS
An Internal Market with free movement of goods ….. the resulting structures are a consequence of this effort.
General Principles of the New Approach legislation, Riga Göran Lindholm

5. FREE MOVEMENT OF GOODS GOAL INSTRUMENTS
Remove technical barriers to internal EU trade, deriving from national technical regulations, standards and test and certification procedures
INSTRUMENTS
MUTUAL RECOGNITION
TECHNICAL HARMONIZATION
General Principles of the New Approach legislation, Riga Göran Lindholm

6. MUTUAL RECOGNITION
Treaty of Rome Art /EC: take appropriate measures to ensure Internal market
Treaty of Rome: Art. 30/EC: avoid unjustified measures restricting the circulation of goods
General Principles of the New Approach legislation, Riga Göran Lindholm

7. TECHNICAL HARMONIZATION
1983: Directive 98/34/EC on information procedure for technical standards and regulations.
Council Resolution of 7 May 1985 on “New Approach”
Council Resolution of 21 Dec 1989 on “Global Approach”
Council Decision 93/465/EEC on the “modules” for conformity assessment
General Principles of the New Approach legislation, Riga Göran Lindholm

8. THE EU APPROACHES The Old “Approach” The New and the Global Approaches
The Voluntary sector
General Principles of the New Approach legislation, Riga Göran Lindholm

9. 2 THE OLD “APPROACH”
General Principles of the New Approach legislation, Riga Göran Lindholm

10. THE OLD “APPROACH”
Products covered by EU legislation with mandatory detailed technical specifications
The legislation may refer to mandatory use of European standards (that are nationally adopted)
The legislation usually needs frequent update to adapt to technical progress
Usually control by public authorities prior to placing products on the market
Voluntary markings may be used
General Principles of the New Approach legislation, Riga Göran Lindholm

11. 3. THE NEW AND THE GLOBAL APPROACHES
General Principles of the New Approach legislation, Riga Göran Lindholm

12. THE TWO PARTS OF THE NEW AND THE GLOBAL APPROACHES
PRE-MARKET ASSESSMENT
Products placed on the market must fulfil essential requirements. The manufacturer assures this by affixing the CE marking on the product
POST-MARKET CONTROL
Member States must control that the products on their market are in compliance with the essential requirements. This is done by national authorities using market surveillance
General Principles of the New Approach legislation, Riga Göran Lindholm

13. THE NEW AND GLOBAL APPROACHES’ BASIC FEATURES
Complementary instruments designed to:
cover wide fields of product or risk in one piece of legislation
impose generic essential requirements which do not get out of date
limit Government intervention to what is essential
General Principles of the New Approach legislation, Riga Göran Lindholm

14. 4. THE VOLUNTARY FIELD
General Principles of the New Approach legislation, Riga Göran Lindholm

15. THE VOLUNTARY FIELD No EU legislation, regulated nationally
European standards may voluntarily be developed within the European standards bodies.
National standards are allowed, but if European standards exist, competing national standards are not allowed
If products fulfil the national regulations they may usually move freely in the internal market
Voluntary marks may be used
General Principles of the New Approach legislation, Riga Göran Lindholm

16. 5. DETAILS ABOUT THE NEW AND THE GLOBAL APPROACHES - pre market assessment
General Principles of the New Approach legislation, Riga Göran Lindholm

17. ELEMENTS OF THE NEW APPROACH
Essential requirements in directives (presently 22 New Approach directives)
Harmonised standards
Conformity assessment
CE marking
General Principles of the New Approach legislation, Riga Göran Lindholm

18. Standards are voluntary….
Harmonised European standards => mandated by the Commission and giving presumption of conformity with essential requirements
… but remain voluntary!
CEN / CENELEC / ETSI elaborate European Standards
General Principles of the New Approach legislation, Riga Göran Lindholm

19. …and standardisation is independent
Standards are not defined by public authorities
Standards are adopted by a transparent consensus procedure
The standardisation bodies cover a very broad range of interests including the industry’s
… and are therefore widely recognised
General Principles of the New Approach legislation, Riga Göran Lindholm

20. GLOBAL APPROACH TO CONFORMITY ASSESSMENT
Manufacturer (or his authorised representative) is responsible for conformity
Shall use defined procedures (“modules”)
Must in many modules be aided by Notified bodies
Is free to choose any suitable Notified body
General Principles of the New Approach legislation, Riga Göran Lindholm

21. CONFORMITY ASSESSMENT - KEY ELEMENTS
Modules
Notified bodies
Quality assurance
Technical file
EC declaration of conformity
CE marking
=> free movement of goods in Single Market
General Principles of the New Approach legislation, Riga Göran Lindholm

22. 1. Modules...
The Global Approach establishes eight basic modules to cover different situations
Each Directive specifies which modules can be used
There are modules for both the product’s design and production phase
Most modules require use of notified bodies
General Principles of the New Approach legislation, Riga Göran Lindholm

23. …the basic Modules Internal control of production (design&production)
EC type examination (design) (notified body)
Conformity to type (production)
Production quality assurance (prod.) (notified body)
Product quality assurance (production) (notified body)
Product verification (production) (notified body)
Unit verification (design&production) (notified body)
Full quality assurance (design&prod.) (notified body)
General Principles of the New Approach legislation, Riga Göran Lindholm

24. 2. Notified Bodies... 1100+ Independent third parties
Notified by Member States, who ensure their competence
Co-operation
…. and competition
General Principles of the New Approach legislation, Riga Göran Lindholm

25. ...Notified Bodies’ qualifications...
Supported by:
Accreditation
EN series of standards (usually identical to ISO guides / standards)
Sector criteria / technical competence
General Principles of the New Approach legislation, Riga Göran Lindholm

26. ...Notified Bodies’ responsibilities
Provide conformity assessment services on the conditions set out in Directives
Operate impartially, independent of clients
Provide relevant information to notifying authority, market surveillance authorities, other notified bodies
Ensure confidentiality of information as necessary
Take part or be represented in European standardisation
General Principles of the New Approach legislation, Riga Göran Lindholm

27. 3. Quality Assurance Three modules require quality assurance
ISO 9000 offers one solution, but is not mandatory!
General Principles of the New Approach legislation, Riga Göran Lindholm

28. 4. Technical File (technical documentation)
Prepared by manufacturer
Kept by him
Provides information on the design, manufacture and operation of the product
The detailed requirements are defined in each directive
Must be available to authorities and Notified bodies
General Principles of the New Approach legislation, Riga Göran Lindholm

29. 5. EC Declaration of Conformity
Drawn up and signed by manufacturer (or his authorised representative) on own responsibility
Contains all relevant information, as defined in each Directive
The information must include the product, the manufacturer, applicable directives and standards, assurance of conformity and the notified body, if used
General Principles of the New Approach legislation, Riga Göran Lindholm

30. 6. CE marking
Affixed by manufacturer (or his authorised representative) on own responsibility meaning that:
the product meets the legal requirements
it is presumed to be marketable
The CE mark is not a mark of origin – and not a quality mark!
General Principles of the New Approach legislation, Riga Göran Lindholm

31. THE MANUFACTURER’S RESPONSIBILITIES UNDER THE NEW AND GLOBAL APPROACH ARE TO...
Ensure compliance with essential requirements of Directive(s)
Use appropriate assessment modules
Choose appropriate notified body
Establish the technical file
Draw up the EU declaration of conformity
Affix the CE marking as the final sign of conformity
General Principles of the New Approach legislation, Riga Göran Lindholm

32. …AND HIS ADVANTAGES OF THESE APPROACHES ARE
Only one set of technical regulations and marking requirements that gives fast-track access to the whole EU market
Availability of a coherent set of European standards, which do not compete with each other
Same rules for importers and EU manufacturers
General Principles of the New Approach legislation, Riga Göran Lindholm

33. 5. DETAILS ABOUT THE NEW AND THE GLOBAL APPROACHES - post market control
General Principles of the New Approach legislation, Riga Göran Lindholm

34. MARKET SURVEILLANCE...
Market surveillance guarantees equal protection for citizens and a level playing field for enterprises
the goal is a uniformly high level of enforcement of Internal Market legislation
General Principles of the New Approach legislation, Riga Göran Lindholm

35. ...MARKET SURVEILLANCE...
Market surveillance is a national responsibility
It is carried out by government officials in the market place
Few explicit requirements in the Directives but implicit requirements in the Treaties
Rapex communication system between the Commission and Member States
General Principles of the New Approach legislation, Riga Göran Lindholm

36. ...MARKET SURVEILLANCE Different national structures
local authorities, state or autonomous region or national
Different national approaches
systematic sampling, annual campaigns, targeting purchasers
General Principles of the New Approach legislation, Riga Göran Lindholm

37. 6. CONCLUSIONS
General Principles of the New Approach legislation, Riga Göran Lindholm

38. Development…
The New and Global Approach is working properly and has proven to be successful
Improvements and expansions take place
General Principles of the New Approach legislation, Riga Göran Lindholm

39. …Development Example of activity areas:
Co-operation in market surveillance between Member States
Designation and notification of Notified bodies
Understanding of the CE marking
The use of the New and Global approach principles in other legislation
General Principles of the New Approach legislation, Riga Göran Lindholm

40. International extension of the New and Global Approach
European Economic Area
PECAs under the Europe Agreements
Mutual Recognition Agreements (MRAs)
Other recognition/cooperation forms (toolbox)
General Principles of the New Approach legislation, Riga Göran Lindholm

41. This approach completes the Single Market by
enhancing safety and performance of products
offering a flexible technology-neutral legal environment
offering alternatives and reducing undue burdens for enterprises
…the resulted successful structures and free movement of goods are a consequence of this effort
General Principles of the New Approach legislation, Riga Göran Lindholm

42. For more information
Guide to the implementation of directives based on the New Approach and the Global Approach (11 EU languages) on Internet (http//europa.eu.int/comm/enterprise/newapproach/index.htm)
New and Global Approach CD-ROM
General Principles of the New Approach legislation, Riga Göran Lindholm