The New Legislative Framework and Market Surveillance: UNECE "MARS" Group Meeting

1. The New Legislative Framework - Market SurveillanceUNECE “MARS” Group meetingBratislava, 10-13 October 2007 Rita L’Abbate Unit C1: Regulatory approach for the free circulation of goods

2. Main elements covered by the Review • Market surveillance • Notified Bodies • Role and significance of CE marking • Improved coherence (terminology, procedures,..) Strengthen system through review of the main features

3. Complementary legislative tools REGULATION • Accreditation • Market surveillance - internal - border controls • Financing Immediately applicable DECISION • Definitions • Obligations • Notified Bodies (criteria/ notification process ) • Conformity assessment procedures • Safeguard mechanisms • marking Basis for future legislation

4. Regulation – Overall framework (1) • Accreditation • Scope • Single accreditation body • Public authority activity • Requirements for accreditation bodies • Cross frontier accreditation • Peer evaluation • Coordination - EA

5. Regulation – Overall framework (2) • Strengthening of Market surveillance • Scope • Organisation / Surveillance measures • Restrictive measures – rapid information • Communication and Co-ordination • Control of products entering the Community(ex Regulation 339/93)

6. Regulation – market surveillance (1) • Definition • “market surveillance” means the activities carried out and measures taken by public authorities to ensure that products made available on the market are in compliance with the legal requirements or do not endanger health and safety or other issues of public interest protection set out in the relevant Community harmonisation legislation

7. Regulation – market surveillance (2) • Scope • General – applies to “industrial products” covered by Community harmonisation legislation • Exemptions: • List of sectoral directives (medical devices, motor vehicles, food and feed, tobacco, etc.) – Art. 1(2), Art. 13(3) • Products in so far as health and safety of consumers are concerned – Art. 13(2)

8. Regulation – market surveillance (3) • Organisation • Organise and perform market surveillance activities • Inform on the responsible national authorities • Establish adequate procedure to manage non-compliances • Have the necessary powers and resources • Establish programmes • ….

9. Regulation – market surveillance (4) • Surveillance measures • Perform appropriate checks on an adequate scale • Enter the premises of economic operators, if necessary • co-operation with economic operators (require documentation, reduce the risks, etc.) • Alert the users, where appropriate • Observe independence, confidentiality, professional secrecy

10. Regulation – market surveillance (5) • Restrictive measures – rapid information • Rapid intervention in case of serious risks also if the effects are not immediate • Inform the economic operators of remedies taken • Inform rapidly via the existing RAPEX system • Develop a general IT tool

11. Regulation – market surveillance (6) • Communication and Co-ordination • Ensure efficient co-operation at EU and national levels • Provide assistance and information to other Member States • Share, as far as possible, expertise and best practices, improve the overall system, develop and organise trainings, etc.

12. Regulation – market surveillance (7) • Control of products entering the Community by customs authorities (ex Regulation 339/93) • Scope

13. Regulation – market surveillance (8) • Measures • Perform checks on adequate scale • Suspend the release for free circulation if there are grounds to believe that the product presents a serious risk • Restore the release if no action • Prohibit the placing on the market by stamping on the official document : dangerous product or non- conforming product

14. Decision - Toolbox for future legislation (1) • Definitions • Placing on the market, making available on the market, manufacturer, distributor, importer, etc • Obligations for economic operators • Manufacturers, importers, distributors • Traceability

15. Decision - Toolbox for future legislation (2) • Notification • Requirements for notifying authorities • Requirements / obligations for NBs • Subsidiaries and sub-contracting • Link to accreditation • Procedure – electronic notification • Denotification, role of Commission • Co-ordination

16. Decision - Toolbox for future legislation (3) • Conformity of the product • Assessment procedures, EC Declaration of conformity • Market surveillance • Safeguard procedures • marking • The only conformity mark • Rules and conditions for affixing the marking … Community trade mark

17. Timeframe / Process • Proposal was adopted by the Commission on 14 February 2007 • Council working group • European Parliament Committees • Adoption by Council / EP in 2008?

18. Enterprise and Industry DG European Commission • European Commission: • Jacques.McMillan@ec.europa.eu • Rita.L’Abbate@ec.europa.eu • DG ENTR website THANK YOU Contacts