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The New EU Market Surveillance Framework

The New EU Market Surveillance Framework. Rita L’Abbate. 6th MARS Group meeting Bratislava, 2 October 2008. Overview. The New Legislative Framework (NLF) The New Market Surveillance Framework Implementation phase…. Why did we propose the review ?.

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The New EU Market Surveillance Framework

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  1. The New EU Market Surveillance Framework Rita L’Abbate 6th MARS Group meeting Bratislava, 2 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. Conformity Assessment Harmonised standards / Direct compliance Essential Requirements New Approach concept

  6. New Legislative Framework - Texts OJEU L 218 - 13.08.08 : • 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 • Regulation 764/2008 – procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State

  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 on accreditation and market surveillance is 1 Jan 2010 • Decision ‘sui generis’ = by issue/by sector

  8. New Legislative Framework concept

  9. The Regulation & the Decision DECISION • Also EU “law” • Sui Generis Decision • Applies to legislators themselves • Model Articles “toolbox” Applies ONLY when sectoral legislation is revised or to new legislation REGULATION • EU “law” • Becomes law in all Member States at same time • Directly Applicable • Member States need to be ready to apply Immediately enforceable

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

  11. Why 2 ? a Regulation & a Decision DECISION • Covers elements already included in legislation e.g. notification / safeguard clause mechanisms etc • BUT sectors will be able to deviate according to specificities of the sector REGULATION • Covers elements not already included in sectoral legislation e.g. accreditation / market surveillance etc • Common elements to facilitate the internal market

  12. 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

  13. Market Surveillance – Overall framework • 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, …

  14. Market Surveillance - Definition « market surveillance » means the activities carried out and measures taken by public authorities to ensure that products comply with the requirements set out in the relevant Community harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection

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

  16. Market Surveillance – scope (2) • EXCLUSIONS (Article 15) : • via the product definition: food - feed, living plants, animals, human tissues, … • 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)

  17. 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) • ….

  18. 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

  19. 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

  20. 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

  21. 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, etc.

  22. 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

  23. 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

  24. 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

  25. 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

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

  27. 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

  28. 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

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

  30. 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

  31. 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

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

  33. Implementation phase … (2) DECISION Alignment of sectoral Directives • By issue? • Separate Directives? • Groups of Directives? • Omnibus?  to be decided within the next months

  34. Implementation phase … (3) In other words create a comprehensive environment to strengthen market surveillance and reinforce safety

  35. 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

  36. NLF & Market Surveillance Framework Thank you for your attention

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