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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. Outline. Market surveillance: Brief recall of the NLF legal provisions General aim
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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
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
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
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
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…
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
NLF Regulation: Implementation phase • Complex process • Many parties involved: • Commission (DGs ENTR,SANCO, TAXUD) • Member States (both sectoral and coordination levels – customs authorities)
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
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
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
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)
Members • - 27 MS of the EU • - 3 EFTA/EEA
Exchange of information tools: RAPEX • Notification criteria • Industrial products for consumers and professionals • Serious risk • Restrictive measures adopted by MS or economic operator concerned
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
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
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
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, …
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,…
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, …
‘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
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, …
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
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
Control of imported products Implementation: • General Guidelines elaborated • Support to customs and MSA • Examples of practical guidance • WG, events, further developments,..
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