1. Market Surveillance: The implementation of Regulation 765/2008 in the EU Bratislava, 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 REGULATION 765/2008  Accreditation  Market Surveillance Internal Imported products  General principles  Financing elements Applicable 1 Jan 2010 DECISION 768/2008  Definitions  Obligations for economic operators  Conformity Assessment Procedures  marking  Notified bodies  Safeguard mechanisms Basis for future legislation

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 processComplex process Many parties involved: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)Obligation to communicate information on MSA (art. 17 NLF Regulation) State of play: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 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)Obligation to establish NMSP (art 18(5) NLF Regulation) PurposePurpose State of play: all MS submitted NMSP in 2010-2011.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-2011http://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_SURVEIL LANCE_PROGRAMME_2010.pdfhttp://www.uvzsr.sk/en/docs/info/SK_NATIONAL_MARKET_SURVEIL LANCE_PROGRAMME_2010.pdfhttp://www.uvzsr.sk/en/docs/info/SK_NATIONAL_MARKET_SURVEIL LANCE_PROGRAMME_2010.pdfhttp://www.uvzsr.sk/en/docs/info/SK_NATIONAL_MARKET_SURVEIL LANCE_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 -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. - - 27 MS of the EU - - 3 EFTA/EEA Members

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. Exchange of information tools: RAPEX ‘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)

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/blankAboutIcs ms.jsp?threadId=21948&callId=14&winId=1 https://www.icsms.org/icsms/App/blankAboutIcs ms.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