1. Date: in 12 pts MARKET SURVEILLANCE IN THE EU ROLE IN THE NLF - EU ACTIONS and DEVELOPMENTS Rita L'Abbate European Commission DG ENTERPRISE AND INDUSTRY Unit C1: Regulatory approach for the free movement of goods and market surveillance

2. Outline ●The existing situation : pre and post market organisation ● The NLF – objectives and mains elements ●The « Market Surveillance » in the EU and its role ●Implementing activities - developments

3. The NLF - Pre-market Manufacture conditions

4. The New Legislative Framewok-NLF ● ● Regulation (EC) 765/2008 – for accreditation and market surveillance (OJEU L218/30 of 13/08/2008) ● Decision (EC) 768/2008 on common framework for the marketing of products (OJEU L218/82 of 13/08/2008) ● Regulation (EC) 764/2008 - procedures for application of certain national technical rules to products marketed in another Member State (OJEU L218/21 of 13/08/2008)

5. The NLF REGULATION 765/2008REGULATION 765/2008 AccreditationAccreditation Market surveillanceMarket surveillance - internal- internal - imported products- imported products general principles general principles Financing elementsFinancing elements Applicable from 1 Jan 2010Applicable from 1 Jan 2010 Lex SpecialisLex Specialis sectorals/GPSDsectorals/GPSD DECISION 768/2008 DECISION 768/2008 Definitions / obligations Definitions / obligations Notification (criteria / process / accreditation) Notification (criteria / process / accreditation) Conformity assessment procedures Conformity assessment procedures Safeguard mechanisms (& market surveillance) Safeguard mechanisms (& market surveillance) marking marking Basis for future legislation Basis for future legislation

6. In addition …. Horizontal legislation governing the placing of products on the EU market are: Directive concerning liability for defective products (85/374/EEC) General Product Safety Directive (2001/95/EC) Regulation for standardisation (under adoption) Etc.

7. Sectoral EU legislation Hazard and risks in products are being regulated in relevant sector-specific legislation (i.e.Directives) relating e.g. on: Electrical equipments Medical devices, Machinery, Toys, Pressure equipments ….

8. The NLF General Objectives ▪Appropriate and efficient regulatory model ▪Based on confidence ▪ Allows : ▫technological innovation ▫competitiveness

9. The NLF Specific Objectives Clear Framework for: ▫Conformity assessment ▫Accreditation ▫Market Surveillance

10. The NLF – consequences LEVEL OF SAFETY +QUALITY OF PRODUCTS +QUALITY OF OPERATORS + QUALITY OF CA PROCEDURES +QUALITY OF 3RD PARTIES +QUALITY OF ACCREDITATION +QUALITY OF MARKET SURVEILLANCE +QUALITY OF CONTROLS OF 3RD COUNTRIES -------------------------------------------------------------------- == SAFE PRODUCTS ----------------------------------------------------------------- --- (CE MARKING)

11. The NLF – post-market Market surveillaince

12. EU market surveillance framework Based on shared responsibilities between: ●Member States ●Economic operators ●The Commission

13. EU market Surveillance Framework Member States (1) In general ▪ Organise and carry out surveillance ▪Take measures ▪Organise coordination and cooperation

14. EU market Surveillance Framework Member States (2) ▪Obligation to perform controls ▪Obligation to withdraw dangerous products ▪Obligation to have the powers, authority & means (even to destroy) & Sanctions ▪Obligation to inform ▪Obligation to inform on national authorities ▪Obligation to organise cooperation between authorities ▪National market surveillance programmes ▪Role of customs/control of products from 3rd countries ▪…..

15. EU market surveillance framework Economic Operators ● Place or import on the EU market only safe and compliant products ●Take corrective measures or withdraw or recall products ●Cooperate with national authorities However ●Have the right to be informed (results of controls, remedies, ….)

16. EU market surveillance framework The Commission Ensure enforcement and implementation ● uniform enforcement (guidelines, WP, …) ●share ressources ●risk assessment methodologies ●Exchange of information: RAPEX and ICSMS ●International cooperation ●...

17. EU Market surveillance NLF Reg. 765/2008 + Sectoral legislation GPSD Harmonised areas Non-harmonised areas Non-consumer products

18. Why a single market surveillance framework?  Same control organisation for harmonised and non-harmonised products  Avoid gaps and legal uncertainties  Ensure efficient use of scarce resources  Ensure better organisation, effectiveness and consistency  …… Proposal for a EU Regulation

19. EU market surveillance framework Main Implementing activities (1) National Market Surveillance Programmes (NMSPs) Public part of NMSPs National Market Surveillance Authorities (NMSAs) List of NMSAs at http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory- policies-common-rules-for-products/index_en.htm

20. EU market surveillance framework Main Implementing activities (2) ● Information and communication IT systems (RAPEX, ICSMS, etc.) ● Risk Assessment – Available main elements for the review and update of the existing RAPEX methodology

21. EU market surveillance framework Main Implementing activities (3) ● Safety controls of imported products ( Articles 27-29) ▪ Guidelines for customs cooperation An initiative at providing practical tools to EU enforcement authorities for controls of products entering the EU market http://ec.europa.eu/taxation_customs/common/publications/info_docs/customs/inde x_en.htm ▪ Follow-up to the 2011 Strategic Workshop in Austria – Main activities in a Roadmap

22. Thank you for your attention More information at: New Legal Framework: http://ec.europa.eu/enterprise/policies/single-market- goods/regulatory-policies-common-rules-for-products/index_en.htmGPSD: http://ec.europa.eu/consumers/safety/prod_legis/index_en.htmRAPEX: http://ec.europa.eu/consumers/safety/rapex/index_en.htm