1. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 1 Product Conformity Assessment Requirements for Access to the European Market CASCO/DEVCO Pascale MIENVILLE AFNOR – French Member of CEN COPANT Workshop on Management System and Products Certification in Developing Countries

2. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 2 FREE MOVEMENT OF GOODS GOAL Remove technical barriers to internal EU trade, deriving from national technical regulations, standards and conformity assesment procedures INSTRUMENTS MUTUAL RECOGNITION TECHNICAL HARMONIZATION

3. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 3 MUTUAL RECOGNITION Treaty of Rome Art. 28-29/EC: take appropriate measures to ensure Internal market Treaty of Rome: Art. 30/EC: avoid unjustified measures restricting the circulation of goods

4. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 4 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

5. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 5 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

6. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 6 THE “ NEW” APPROACH Products covered by EU legislation with mandatory essential requirements The legislation may refer to voluntary use of European standards EN (that are nationally adopted) The legislation does not need frequent update to adapt to technical progress The CE marking is mandatory to declare the conformity to regulation Voluntary markings still may be used

7. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 7 THE “ GLOBAL” APPROACH The control of products covered by EU legislation is with mandatory essential requirements The legislation may refer to voluntary use of European standards (that are nationally adopted) The legislation does not need frequent update to adapt to technical progress Voluntary markings still may be used

8. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 8 THE TWO PARTS OF THE NEW AND THE GLOBAL APPROACHES PRE-MARKET ASSESSMENT Products placed on the market must fulfil essential requirements, under the responsabilty of the manufacturer, who 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

9. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 9 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 strictly necessary

10. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 10 ELEMENTS OF THE NEW APPROACH Essential requirements in directives (presently 22 New Approach directives) Harmonised standards Conformity assessment CE marking

11. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 11 22 “new approach” directives (ex.) Low voltage Safety of toys Machines Gaz devices Lifts Building products Medical devices, Packaging and packaging waste Etc. All the products covered by these Directives should be affixed with the CE marking to be allowed to circulate in the EU market

12. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 12 Principles of “new approach” directives Only products fulfilling the essential requirements may be placed on the EU market (and then circulate within the EU market) Products in conformity to EN standards benefit from a presumption of conformity with the essential requirements (but they remains voluntary) Manufacturers may choose between different conformity assesment procedures provided for in the applicable directive CE marking is mandatory

13. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 13 Standards are voluntary…. Harmonised European standards => mandated by the Commission and giving presumption of conformity with essential requirements … but remain voluntary! CEN, CENELEC and ETSI elaborate European Standards

14. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 14 …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

15. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 15 CEN : a tool for integration for free trade (1) 28 Members (25 E.U. + 3 EFTA) Members are obliged to adopt EN standards as national standards, and to cancel all national standards in contradiction, Standstill procedure Procedure of notification

16. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 16 CEN : a tool for integration for free trade (2) Adoption of standards by vote (qualified majority according to the treaty of Nice) Close relation between regulation and standardization (new approach) EN standards do not exist by themselves, only by the adoption by members (NF EN, NF BS, etc.)

17. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 17 Modalities of cooperation between ISO and CEN : General exchanges of informations Adoption of ISO standards as EN Cooperation by mail Representation in technical works Transfert of CEN work to ISO (ISO lead) Adoption of EN standards by ISO (CEN lead) VIENNA AGREEMENT (June 1991) 2080 EN ISO = 1/3 of EN 1000 work items in course for parallel approval Of which 30 % CEN lead

18. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 18 GLOBAL APPROACH TO CONFORMITY ASSESSMENT Manufacturer (or his authorised representative) is responsible for conformity: Shall use defined procedures (“modules”) In many modules must be aided by Notified bodies Is free to choose any suitable Notified body

19. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 19 CONFORMITY ASSESSMENT - KEY ELEMENTS 1Modules 2Notified bodies 3Quality assurance 4Technical file 5EC declaration of conformity 6CE marking => free movement of goods in Single Market

20. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 20 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

21. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 21 …the basic Modules A Internal control of production (design&production) B EC type examination (design) (notified body) C Conformity to type (production) D Production quality assurance (prod.) (notified body) E Product quality assurance (production) (notified body) F Product verification (production) (notified body) G Unit verification (design&production) (notified body) H Full quality assurance (design&prod.) (notified body)

22. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 22 2. Notified Bodies... 1100+ Independent third parties Notified by Member States, who ensure their competence (*) Co-operation …. and competition

23. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 23...Notified Bodies’ qualifications... Supported by: Accreditation EN 45000 series of standards (usually identical to ISO guides / standards) Sector criteria / technical competence

24. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 24...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

25. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 25 3. Quality Assurance Three modules require quality assurance ISO 9000 offers one solution, but is not mandatory!

26. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 26 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

27. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 27 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

28. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 28 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!

29. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 29 THE MANUFACTURER’S and IMPORTERS 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

30. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 30 … AND THE 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

31. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 31 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

32. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 32...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

33. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 33...MARKET SURVEILLANCE Different national structures local authorities, state or autonomous region or national Different national approaches systematic sampling, annual campaigns, targeting purchasers

34. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 34 Development… The New and Global Approach is working properly and has proven to be successful Enhancing the implementation of New Approach Directives will take place in 2004

35. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 35 …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

36. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 36 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

37. Conformity assessment in EU - 12 may 2004 - Pascale MIENVILLE 37 For more information Guide to the implementation of directives based on the New Approach and the Global Approach (all EU languages) on Internet ( http//europa.eu.int/comm/enterprise/newapproach/index.htm) New and Global Approach CD-ROM www.cenorm.be