Market Surveillance The UK Experience

1. Market Surveillance The UK Experience Steve Shaw UK Health and Safety Executive

2. Why do Market Surveillance? • Protecting the Public and workers by: • Correct implementation of the Directive • Remove or modifying unsafe Equipment on/from the Market • Ensure Level playing field • Increase the levels of Safety • Ensure correct use of CE mark • Inform Member states of Issues and actions taken • Check appropriateness of standards

3. Market Surveillance Authorities • Member States must nominate or establish authorities to carry out market surveillance • Market Surveillance authorities must: • Have the necessary resources and powers • Ensure technical competence • Ensure professional integrity of their personnel • Act in an independent and non-discriminatory way with regard to the principle of proportionality 3

4. Market Surveillance • Article 2 of the Pressure Equipment Directive requires member states to take all appropriate measures to ensure that pressure equipment and assemblies are not placed on the market and put into service unless they are safe Market Surveillance Authorities in UK: • Health and Safety Executive (HSE)- work equipment except in Northern Ireland • Local Government (Trading Standards)- consumer equipment 4

5. How do Trading Standards do it? • Deal with Consumer product Safety • Intelligence from accidents and complaints • Targeting products based on risk and history of problems • Sampling and testing of product types identified by above • E.g. Mass imports of low quality/cheap high risk goods from outside EA

6. How does the HSE do it? • Mainly Non Consumer Equipment • Risk based approach • Interventions based on:- • Accident/incident History • Complaints • Member states (via ICSMS) • Proactive visits to Manufacturers • Novel High risk designs • Information form outside EEA 6

7. How does the HSE do it? • Reactive - market surveillance issues identified by: • General inspectors: • Preventative inspection • Complaints • Accident investigation • Product Safety Teams: • Investigate issue • Take action in UK • If supplied in EU inform raise Safeguard pass to Safety Unit 7

8. Market Surveillance of industrial products • In UKIntegrated with use and user inspection • see lots of equipment in use, incl new • quick check to see if safe and CE marked, speak to workforce • defects can be hard to spot until assembled • if problems found full investigation made by Product Safety Team • often instructions/information defects are a cause of problems • If this is done by a separate market surveillance inspectorate then a good communication between the inspectorates is required 8

9. Who else is involved? • Safety unit responsible for: • overall operational policy • safeguard notifications and ICSMS database • liaison with DTI, Member States, Commission • Specialist inspectors support and expert advice on: • technical matters and Standards • also HSL’s research and testing expertise 9

10. Independence, Impartiality & Confidentiality • HSE employ a range of experts, but when we need outside help or a second opinion, it must be impartial and independent of decisions to enforce supply legislation • Testing/examination undertaken by our Health and Safety Laboratory (HSL) or a private test laboratory/consultancy • Critical they carry authority in court – we require an accredited Quality System • The United Kingdom Accreditation Service (UKAS) is the sole national accreditation body and uses internationally agreed standards – eg • ISO 9001:2000 (management systems) • ISO/IEC 17025 (test laboratories) 10

11. Market Surveillance Three stage approach to examination by general inspectors of new equipment found in workplace: • Check: documentation & obvious defects • Investigate: matters of evident concern • Enforcement: proportionate to risk 11

12. Market Surveillance • We Investigate matters of evident concern by: • getting basic information - product ID; supplier in EU; manufacturer; date of mf etc • check if known problem: ICSMS database, • if not – detailed examination by specialist engineer • pass to local office for action with supplier/manufacturer • manufacture contacted for relevant technical information • HSE rarely ask for all technical information for complex equipment: • not proportionate • unacceptable burden on business, inspector and HSE • remember if it may be in any of the EU official languages

13. Market Surveillance Policy • Where there is a breach- try to agree solution before formal enforcement action considered • Except- where persons at immediate risk • then quick action to prohibit product/use • Can appeal, but product stays withdrawn unless the court releases • Notification to EU/member states • possible challenge from them but also so they can take action to protect their populations 13

14. For non UK manufacture If from outside the UK, HSE will take action via the importer or distributor with the Manufacturer keeping the appropriate market surveillance authority informed and may ask for help if needed The member state where the problem was found should pursue the manufacture wherever they are, provided an offence has occurred in their country 14

15. RAPEX • Rapid Information Exchange • Applies to Consumer Products with a serious and immediate danger • Does not require the completion of an investigation to be reported • Must be sent in by a nominated person in the Member State to DG SANCO where if they validate the report it is then placed on the RAPEX system – but has restricted access • RAPEX system is to be interfaced with ICSMS so the information needs only to be entered once.

16. Local MS Authority National Focal Point (NFP) Local MS Authority Local MS Authority RAPEX Translation RAPEX Validation Entry Case No Validation

17. Local MS Authority National Focal Point (NFP) Local MS Authority Local MS Authority ICSMS RAPEX + ICSMS Validation Translation RAPEX Interface Entry Case No Validation

18. Why use ICSMS? This database shall serve the following purposes: • Exchange of general information on market surveillance activities, including detected non conformities; • Statistics, information by sector, by product, etc. • Making available information on risk analysis methodologies and results; • Notification of non conformities not covered by RAPEX system • Safeguard procedures, withdrawls, prohibitions or marketing limitations for products covered by directives and which present a potential danger or any other serious risk; voluntary measures • Analysis of accidents by the publication of comparative data; • Information on counterfeits that could have an impact on health, safety or other issues of public interest.

19. ICSMS: initiated by the EU, Belgium, Sweden and Germany in 2000. Austria and Luxemburg joined the system during the development phase. Estonia started with the system in September 2003. Slovenia started a trial in 2003 and started in spring 2006 with the system. United Kingdom started the trial in June 2004 and continues. Switzerland started with the system in September 2004. The Netherlands started with the system end of 2005. Malta started with the system in 2006. European Market and ICSMS

20. Which DIRECTIVES are covered today 98/37/EC – Machinery Directive  73/23/EEC – Low Voltage Directive 88/378/EEC – Toy Safety Directive 97/23/EC – Pressure Equipment Directive 89/686/EEC – Personal Protective Equipment Directive 95/16/EC – Lift Directive 87/404/EEC – Simple Pressure Vessels Directive 94/25/EC – Recreational Craft Directive 2001/95/EC – General Product Safety Directive 1999/45/EC Dangerous Preparations 98/8/EC Biocidal Products 89/336/EEC – Electromagnetic compatibility (EMC) 1999/5/EC R&TTE – Radio equipment and telecommunications terminal equipment 90/396/EEC – Appliances Burning Gaseous Fuels 94/9/EC – Potentially explosive atmospheres (ATEX) 2001/14/EC – Noise Emission (Outdoor Directive) 89/106/EEC – Construction products 75/324/EEC Aerosol dispensers 2000/9/EC Cableways Directive 1999/36/EC Transportable Pressure Equipment 67/548/EEC Dangerous Products

21. Safeguard or RAPEX Notification

22. Safeguard or RAPEX Notification • Creating of Safeguard Clause or RAPEX Notifications • Data input of a non-compliant product • Selecting the relevant template, MD-, LVD-, … Safeguard Clause Notification form or RAPEX Notification form • ICSMS provides automatically the notification document • Advantage: Avoiding of redundant work, information need to be written only once

23. New Approach SOGS N 529 EN (issued: 23.02.2006, Version 0.2) b) Exchange of information and communication between national authorities:ii. Wider information concerning the overall cooperation activities will be stored in a single database. It is suggested to use the existing ICSMS database. This database will be made available, at different levels, to all stakeholders (national authorities, private organisations, industries, consumers, etc.)

24. When to use RAPEX and Safeguard • RAPEX – for Consumer products and where there is a serious or immediate danger to the general public under PED these could be Pressure cookers small compressors • Safeguard – • Formal- all products (including consumer items) where a MS decides to prohibit supply • Informal- where a ban is not required but information needs to be exchanged

25. Other ways to inform MS • Individually using contacts from ADCO where only a few MS have the same products • At EU meetings – ADCO

26. Why do we need Safeguard Actions • Market surveillance, includes notification of 'barriers to trade', (article 8) • Common approach and action across the EEA • Increase safety of pressure equipment by following up on poor design with manufacturers and suppliers, not just resolving the matter in member state • Ensure member states are kept informed or non compliant equipment and action taken e.g. modifications

27. What information is required when informing MS? • Manufactures or importers details • Number of items supplied in each MS • Location of Items (this is may not possible for small items of pressure equipment) • Details of the problem/risk and ESRs • Proposed modification or rectification • Action taken by Manufacturer or Supplier • Action required by Member states

28. What is the Safeguard Procedure

29. Safeguard forms • Can be made available direct from ICSMS as a form (yet to be agreed at PED ADCO) • Should contain sufficient information for Commission to give an opinion • Can be used for informal and formal notifications • Common to all member states • Can be attached as word document to CIRCA

31. Thank You Any Questions?