1. The New Legislative and Market Surveillance Framework Rita L’Abbate WELMEC Market Surveillance Conference Malta, 24 October 2008

2. Overview  The New Legislative Framework (NLF)  The New Market Surveillance Framework  Implementation phase…

3. Why did we propose the review ?  Enhance and complete the existing NA system  More than a NA review  Legal framework for the marketing of goods

4. The Revision of the New Approach Some 700 Old Approach Directives 27 New Approach Directives Missing Chapters Incoherence / Confusion Mutual recognition not working as it should The New Legislative Framework

5. New Approach concept Conformit y Assessmen t Harmonised standards / Direct compliance Essential Requirements

6. New Legislative Framework - Texts OJEU L 218 - 13.08.08 :  Regulation 764/2008 – procedures relating to the application of certain national technical rules to products lawfully marketed in another MS (Mutual Recognition)  Regulation 765/2008 - requirements for accreditation and market surveillance relating to the marketing of products  Decision 768/2008/EC - a common framework for the marketing of products

7. Timeframe/Process  Adoption : 19 July 2008  Publication in OJEU – 13 August 2008  Entry into force 20 days after publication  Date of application of Regulation 765/2008 is 1 Jan 2010  Decision ‘sui generis’ = by issue/by sector

8. New Legislative Framework concept Member State A National Authorities Political trust ‘ v ’ Dispute Member State B National Authorities Technical trust Accreditation Marking Notified Bodies Conformity Assessment Procedures Manufacturers Market – Product – Consumers Market Surveillance

9. Interdependent relationships Manufacturer Market surveillance Notified Bodies Member States

10. Complementary legislative tools REGULATION  Accreditation  Market Surveillance Internal Imported products  General principles  Financing elements Applicable 1 Jan 2010 DECISION  Definitions / Obligations  Notification (criteria / process / accreditation)  Conformity Assessment Procedures  Safeguard mechanisms (& market surveillance)  marking Basis for future legislation

11. ACCREDITATION  Objective is to create confidence in accredited certificates thus establishing trust in the market place  Objective is to ensure ONE accreditation certificate for whole territory of EU  Need to introduce a horizontal framework for accreditation and to lay down principles for its operation and organisation at Community level to ensure uniform application

12. Conformity Assessment Modules give flexibility of Approach Manufacturer chooses Remains responsible for products placed on the market All procedures lead to marking Choice product / QA certification

13. Notified Bodies Where the Directives delegate conformity assessment to third parties, these are undertaken by ‘Notified Bodies’ Notified Bodies are officially ‘notified’ on the basis of set criteria (EN 45000..) National authorities justify conformity via accreditation or other evidence

14. Market Surveillance - An essential tool Market surveillance guarantees: Uniform application of Community law Equal protection for all citizens Maintenance of a level playing field for enterprises Market surveillance: Monitors products and checks conformity Takes action, as necessary, to establish conformity

15. Why strengthen Market Surveillance? Levels and rigour of market surveillance differ widely throught the EU → Stop unsafe products on the market → Stop fraud / counterfeit → Stop distortion of competion

16. Market Surveillance – Overall framework REGULATION & DECISION  Scope  Organisation / Surveillance measures  Restrictive measures  Rapid information  Communication and Co-ordination  Control of products entering the Community (ex Regulation 339/93)  CE marking  Definitions, economic operators obligations, safeguards into the Decision, …

17. Market Surveillance – scope (1) REGULATION PART I (controls on the EU market) General – applies to “industrial products” covered by Community harmonisation legislation

18. Market Surveillance – scope (2)  EXCLUSIONS : 1. via the product definition (Article 15): food - feed, living plants, animals, human tissues, … 2. Lex specialis : ▪ Pharmaceuticals, aviation, drug precursors, medical devices and motor vehicles - given as examples in recitals Authorities may take more specific measures as provided for in GPSD (Consumer products)

19. Market Surveillance – Requirements (1)  Organisation  Organise and carry out market surveillance activities  Inform on the responsible national authorities  Establish adequate procedure to manage non- compliances  Have the necessary powers and resources  Establish programmes (general or sectoral)  ….

20. Market Surveillance – Requirements (2)  Surveillance measures  Perform appropriate checks on an adequate scale  Enter the premises of economic operators, and destroy unsafe products, if necessary  co-operation with economic operators (require documentation, reduce the risks, etc.)  Alert the users, where appropriate  Observe independence, confidentiality, professional secrecy

21. Market Surveillance – Requirements (3) Restrictive measures  Ensure recall/withdrawal of products posing a serious risk  Inform the economic operators of remedies taken → Hear operator (10 days, except urgency) →Measures : Proportionate well founded appeal possible

22. Market Surveillance – Requirements (4)  Rapid information  Rapid intervention in case of serious risks also if the effects are not immediate  Inform rapidly on products presenting a serious risk by using a rapid exchange information system like RAPEX  Develop a general IT tool for the exchange of information

23. Market Surveillance – Requirements (5)  Communication and Co- ordination  Ensure efficient co-operation at EU and national levels  Provide assistance and information to other Member States  Share expertise and best practices, improve the overall system, develop and organise trainings, exchange of officials, common projects, joint visit programmes, etc.

24. Market surveillance – Border Controls (1) PART II Controls by customs authorities (ex Regulation 339/93) Scope:  General – applies to “all products” covered by Community legislation  Exclusions: Lex specialis - Specific provisions relating to the organisation of border controls prevail

25. Market Surveillance – Border Controls (2)  Requirements  Perform checks on adequate scale  Suspend the release for free circulation if there are grounds to believe that the product presents a serious risk  Destroy the products, if necessary

26. Market Surveillance – Border Controls (3)  Requirements  Restore the release if no action  Prohibit the placing on the market by stamping on the official document : dangerous product or non- conforming product

27. Market Surveillance – CE marking marking – General principles  Clarification on use  Clarification on meaning  Clarification of role ‘ v ’ other marks  The ONLY conformity mark  Rules and conditions for its affixing  Community collective trade mark  MS to ensure correct implementation

28. Market Surveillance – Decision (1)  …  Definitions (for ex. manufacturer,..)  Obligations of economic operators  Safeguard procedures  CE marking

29. Market surveillance – Decision (2) OBLIGATIONS Economic operators are responsible for the compliance of the product in relation to their role in the supply and distribution chain OBLIGATIONS of MANUFACTURER  Only manufacturer has detailed knowledge of design and production process -> Distinguish between manufacturer and operators further down the chain: conformity assessment is responsibility of manufacturer alone

30. Market Surveillance – Decision (3) OBLIGATIONS of IMPORTER  Need to ensure compliance of third country products -> IMPORTER shall ensure that -manufacturer has carried out conformity assessment -manufacturer has drawn up the technical documentation -product bears conformity mark(s) -> Indication of importer ’ s name and address

31. Market Surveillance – Decision (4) OBLIGATIONS of DISTRIBUTOR  Act with due care  Ensure presence of conformity marking and required documents

32. Market Surveillance – Decision (5) TRACEABILITY  Each operator shall be able to identify to market surveillance authorities : →Any operator who has supplied them with a product →Any operator to whom they have supplied a product

33. Market Surveillance – Decision (6) SAFEGUARD MECHANISMS Two phases:  MS informs MS and COM about specific measure taken  ▪ If all MS agree: all MS to take measure; measure is deemed to be justified ▪ If objections are raised: COM to decide whether measure is justified; depending on the decision: -measure to be withdrawn or -other MS have to ensure that product is withdrawn

34. Implementation phase…(1) REGULATION Work plan to ensure consistent application Wider consultation  with MS and Stakeholders  Internal to the Commission

35. Implementation phase …(2) REGULATION Agreement on scope (Art. 15 – sectoral legislation and GPSD) Extension of RAPEX General IT tool, possible use of ICSMS Co-ordination infrastructure Customs co-operation (e.g. RIF review) Budget, etc….

36. Implementation phase … (3) REGULATION – CE Marking In-depth study on the feasibility of a consumer safety mark – Commission information to EP and Council Finalise registration of marking as a collective mark Feed into National legislation concerning sanction of misuse and abuse

37. Implementation phase …(4) DECISION: By issue / by sector Practical issues -NANDO -Validity of existing notifications – “clean-up” -Information mechanisms – safeguard mechanism application

38. Implementation phase … (5) In other words create a comprehensive environment to strengthen the market surveillance and reinforce safety

39. Web site addresses New internal market package: http://ec.europa.eu/enterprise/regulation/internal _market_package/index_en.htm Questions: Entr-reg-approach-for-free-circ@ec.europa.eu

40. Thank you for your attention