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Implementing Regulation 765/2008: Market Surveillance in the EU

This document provides an overview of the implementation of Regulation 765/2008 on market surveillance in the EU, including its aims, state of play, and exchange of information tools. It also outlines the New Legislative Framework and its two complementary instruments. The text language is English.

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Implementing Regulation 765/2008: Market Surveillance in the EU

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  1. Market Surveillance: The implementation of Regulation 765/2008 in the EUBratislava, 13 September 2011 Rita L’Abbate Unit C1: Regulatory approach for the free movement of goods and market surveillance

  2. Outline • Market surveillance: • Brief recall of the NLF legal provisions • General aim • State of play of implementation: • MSA and NMSP • Exchange of information tools • Custom cooperation

  3. New Legislative Framework • TWO complementary instruments • Regulation 765/2008/EC - on accreditation and market surveillance • Decision 768/2008/EC - a common framework for the marketing of products • Objective: Improve the functioning of the internal market in practice and protection of public interest

  4. 2 complementary legal texts DECISION 768/2008 • Definitions • Obligations for economic operators • Conformity Assessment Procedures • marking • Notified bodies • Safeguard mechanisms Basis for future legislation REGULATION 765/2008 • Accreditation • Market Surveillance • Internal • Imported products • General principles • Financing elements Applicable 1 Jan 2010

  5. Market surveillance: scope of Reg.765 FOR WHICH PRODUCTS? • All products covered by Community harmonisation legislation… • ‘Product’ means: substance, preparation or good produced through a manufacturing process • … unless specific provisions already exist (Lex specialis principle) • Excluded: food, feed, living plants and animals, products of human origin…

  6. Market surveillance: general aim GENERAL PRINCIPLES • General obligation to act against: • Products liable to compromise health and safety or • Which otherwise do not conform to EU harmonisation legislation • This means: • Duty to perform checks of products (documentary, physical, laboratory checks, as appropriate) on an adequate scale • Cooperation with economic operators • Adoption of measures restricting availability of products on the market (e.g. withdrawals or recalls of products) • Information of public, Commission and other MS

  7. NLF Regulation: Implementation phase • Complex process • Many parties involved: • Commission (DGs ENTR,SANCO, TAXUD) • Member States (both sectoral and coordination levels – customs authorities)

  8. National Market Surveillance Authorities • Obligation to communicate information on MSA (art. 17 NLF Regulation) • State of play: Commission has received communications from all Member States • Information can be found on Commission website http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-rules-for-products/index_en.htm

  9. National Market Surveillance Programmes • Obligation to establish NMSP (art 18(5) NLF Regulation) • Purpose • State of play: all MS submitted NMSP in 2010-2011. The majority have published them on the national WEB sites • Examples: • http://www.bis.gov.uk/assets/biscore/business-sectors/docs/n/10-p92-new-legislative-framework-general-national-market-surveillance-2011 • http://www.uvzsr.sk/en/docs/info/SK_NATIONAL_MARKET_SURVEILLANCE_PROGRAMME_2010.pdf

  10. National Market Surveillance Programmes • EU methodology for the establishment of NMSPs • Elements of a general and sector specific NMSP • Template • common indicators • What next : • ensure NMSP are comparable and comprehensive • homogeneity, translations, publication on the Commission WEB

  11. Exchange of information tools: RAPEX • RAPEX - Rapid Alert System for products presenting a serious risk • NLF Regulation (Article 22) extends RAPEX to: • Consumer and Professional goods • All risks including those others than health and safety • Restrictive Measures (obligatory, voluntary)

  12. Members • - 27 MS of the EU • - 3 EFTA/EEA

  13. Exchange of information tools: RAPEX • Notification criteria • Industrial products for consumers and professionals • Serious risk • Restrictive measures adopted by MS or economic operator concerned

  14. Exchange of information tools: RAPEX MAIN ELEMENTS: • RAPEX Guidelines • RAPEX Contact Points Network at the EU level • RAPEX networks at the MS level • RAPEX Contact Points Working Group • Online application ‘REIS’ • Commission RAPEX Team • RAPEX website (www.ec.europa.eu/RAPEX) • RAPEX paper and electronic publications • Seminars

  15. Exchange of information tools: RAPEX Current main activities: • Operation of RAPEX in relation to the Regulation needs • Adaptation of IT platform • Common basis for the assessment of risks for products • Task Force is working to review the RAPEX risk assessment method

  16. Exchange of information tools: RAPEX • RAPEX notifications in 2010 • Around 2000 notifications • Increase of 13% in relation to 2009 • Not only quantitative improvement, but notably qualitative

  17. Exchange of information tools: RAPEX • RAPEX notifications in 2010 • Main notifying Member States: Germany, Bulgaria, Hungary, Cyprus, Greece, … • Main product categories notified : clothing, toys, motor vehicles, electrical appliances, childcare articles, … • Main risk categories notified: injuries, chemical, strangulation choking, electrical shocks, …

  18. Exchange of information tools: RAPEX • RAPEX notifications • Member States must check all the notifications: • No reaction = acceptance of the notified national restrictive measure • Reaction = either disagreement or additional information or product not found on the market • Reactions in 2010 - main products: motor vehicles, toys, childcare, electrical appliances, clothing,…

  19. Exchange of information tools: RAPEX • RAPEX Notifications in 2010 • Business notifications • 133 of the 2010 notifications received had a business origin • All Member States have received business notifications • Main notifying countries: FR, NL, ES, DE, BE • Main product categories notified: electrical appliances, motor vehicles, toys, childcare, …

  20. ‘new’ types of notifications (2010-2011) • Goods for Professional use: Machineries for use in workplace, Equipment for use in potentially explosive atmospheres, Motor vehicles, Chemical products: fertilisers infringing Reg 2003/2003 • Risks others than health and safety (e.g. environmental risk):Plastic products and plastic packages of various consumer products containing cadmium (REACH Regulation), Fireworks infringing Reg 850/2004 (persistent organic pollutants) Exchange of information tools: RAPEX

  21. Exchange of information tools: RAPEX • INTERNATIONAL dimension • MED-RAS project - started in 2009 – establishment in the Mediterranean region of a rapid alert system similar to RAPEX (in operation in 2012) • RAPEX-China system – started in 2006 – informs Chinese on RAPEX notified products of Chinese origin – Reports on enforcement actions carried out • United States–cooperation with CPSC–strengthen exchange of information, formalise the ongoing dialogue • Japan, ICPSC, OECD, …

  22. Exchange of information tools: ICSMS • A general market surveillance database (Article 23 of NLF Regulation) • information on general issues relating to market surveillance • information on products presenting a risk, identification of risks, test results, provisional measures, contacts with economic operators • State of play • Discussions with ICSMS board • https://www.icsms.org/icsms/App/blankAboutIcsms.jsp?threadId=21948&callId=14&winId=1

  23. Control of imported products • Obligation of border controls on an adequate scale before release for free circulation (Articles 27 to 29 of NLF Regulation) • customs must suspend release for free circulation • they must inform Market Surveillance Authorities (MSA) • MSA can prohibit marketing if products dangerous • Apply to all products covered by EU legislation • Cooperation with customs is a key factor

  24. Control of imported products Implementation: • General Guidelines elaborated • Support to customs and MSA • Examples of practical guidance • WG, events, further developments,..

  25. Further information? New internal market package: http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-rules-for-products/index_en.htm Thank you for your attention

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