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MARKET SURVEILLANCE IN THE EU ROLE IN THE NLF - EU ACTIONS and DEVELOPMENTS

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. Outline.

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MARKET SURVEILLANCE IN THE EU ROLE IN THE NLF - EU ACTIONS and DEVELOPMENTS

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  1. MARKET SURVEILLANCE IN THE EU ROLE IN THE NLF - EU ACTIONS and DEVELOPMENTS Rita L'Abbate European CommissionDG ENTERPRISE AND INDUSTRYUnit 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. REGULATION 765/2008 Accreditation Market surveillance - internal - imported products general principles Financing elements Applicable from 1 Jan 2010 Lex Specialis sectorals/GPSD DECISION 768/2008 Definitions / obligations Notification (criteria / process / accreditation) Conformity assessment procedures Safeguard mechanisms (& market surveillance) marking Basis for future legislation The NLF

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

  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/index_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.htm GPSD: http://ec.europa.eu/consumers/safety/prod_legis/index_en.htm RAPEX: http://ec.europa.eu/consumers/safety/rapex/index_en.htm

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