Workshop on the Implementation of the Pressure Equipment Directive Nicosia 3-5 October 2005

1. Workshop on the Implementation of the Pressure Equipment Directive Nicosia 3-5 October 2005 Effective Market Surveillance – making maximum use of limited resources Phil PapardProduct Safety Section, HSE Safety Unit, UK 1

2. History of pressure legislation in UK • 1680 safety valve Denys Papin FRS • 85+yrs - early steam engines had over pressure explosions • 1817 Select Committee considers“the means of preventing the mischief of explosion from happening on board steam boats, to the danger or destruction of His Majesty’s subjects on board such boats” • Found:High Pressure Engines can be used safely if used “well constructed boilers” and “properly adapted safety valves” 2

3. History of pressure legislation in UK 1974 Health & Safety at Work etc Act • Set up HSE with extensive powers • Legislation with goal setting approach • Allowed Regulations to be made by HSC backed by codes of practice and Guidance • eg The Pressure Systems and Transportable Gas Containers Regs – • Supply aspect of regulation now replaced by transpose EU Directives, with EN Standards acting in a similar way to the old Codes of Practice 3

4. Market Surveillance • An essential tool for the enforcement of New Approach Directives • Purpose is to ensure compliance with Directives across EC • Member States must nominate or establish authorities to carry out market surveillance • Must not be Notified Body, because of conflict of interest. 4

5. 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 5

6. 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 6

7. Health and Safety Executive Structure Made up of a number of operational parts: • Field Operations Directorate (factories, construction, health services etc) • Nuclear Safety Directorate • Hazardous Installations Directorate (chemical plants, mines, off-shore oil/gas etc) • Railway Inspectorate with support from • Local Authority Unit (support in liaison with LACORS to 300+ local authorities) • Safety Unit • Specialists and Engineering Groups 7

8. How do we do it? HSE operates on work plans over 3 years that reflect • Government targets – eg to reduce injury and ill-health • Statutory duties - incl market surveillance allocated to: • General inspectors for: • Preventative inspection • Complaints • Accident investigation • 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 they can call on HSL’s research and testing expertise 8

9. 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) 9

10. Work plan for 2005/2006 Resources are limited so we target products based on Risk • Priorities identified by industry group with good knowledge of poor companies or products types; • Time elapsed since the last contact; • Other information from: • Members of the Public • Complaints • Accidents • Local authorities, member states, EU Commission, etc • Suppliers/installers and manufacturers • Inspection Bodies • Adverse inspection report 10

11. Boiler being removed from house where it landed from a factory a few hundred meters away. Cause - faulty safety valve (yield pressure of boiler about 55bar) 11

12. Adverse insurance report • Statutory duty to report unsafe equipment to relevant enforcing authority for lifting equipment; power presses; pressure equipment • No requirement to report non-CE marked equipment unless it is dangerous, but we have agreed that: • All inspecting bodies to report non-CE marked equipment to Safety Unit • Distinction made between: • dangerous non-CE marked – these dealt with as a “complaint” by general inspectors with expert support • and safe non-CE marked equipment – these are dealt with by Safety Unit using an administrative procedure 12

13. Market Surveillance Policy in UK • HSE’s market surveillance of pressure equipment is: • Integrated 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 • often instructions/information defects are a cause of problems • Is not done by a separate market surveillance inspectorate for work products, but it is for consumer items like pressure cookers 13

14. Market Surveillance Policy • If 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 • Formal notification to EU/member states • possible challenge from them but also so they can take action to protect their populations 14

15. System to track problems • If defective products found - HSE office near supplier/importer alerted with information put on ICSMS • Inspector pursues the matter with the supplier in the UK • If from outside the UK, HSE will take action there 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 This may be a problem with internet sales 15

16. 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 16

17. Market Surveillance • getting basic information - product ID; supplier in EU; manufacturer; date of mf etc • check if known problem: ICSMS database, Sector • 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 We Investigate matters of evident concern by: 17

18. How can we all improve without more resources? • Intensified cross-border co-operation between market surveillance authorities • A relevant and well managed information system all can access • The need for special alertness and rapid action in relation to non-compliant products which impact seasonally on consumers. • Consistency of all aspects of administration both within and between different national systems 18

19. I C S M S IInformation and C Communication S System for M Market S Surveillance 19

20. Market surveillance needs TEAMWORK across EU ! POOR INFORMATION EXCHANGE ON MARKET SURVEILLANCE • Inspection bodies can lack efficient means to interact and exchange important information quickly • Current market inspection works on a REGIONAL/NATIONAL level – while the markets works INTERNATIONALLY and even GLOBALLY: • Current Notification procedures (RAPEX, Safeguard Clause) are not efficient enough to fulfill our and EU‘s future needs 20

21. ICSMS: initiated by the EU, Belgium, Sweden and Germany. Austria and Luxemburg joined the system during the development phase. Estonia started with the system in September 2003 Switzerland, Slovenia and the Netherlands started the trial in 2003. United Kingdom and Malta joined in 2005. European Market and ICSMS 21

22. Market Surveillance CUSTOMS INDUSTRY ? ICSMS.ORG CONFIDENTIALITY CONFIDENTIAL PRODUCT INFORMATION PUBLIC PRODUCT INFORMATION PUBLIC 22

23. Which DIRECTIVES will be covered today ? 94/25/EC – Recreational Craft Directive 2001/95/EC – General Product Safety Directive 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 – ATEX ... to be continued 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  23

24. YOUR ACCESS to the SYSTEM www.icsms.org Email support: support@icsms.org 24

25. 25

26. PUBLIC AREA 26

27. Click „Internal“button INTERNAL AREA 27

28. PRODUCT SEARCH - EXAMPLE 1 Search criteria: „*Breathing*“  Directive  Click button 28

29. PRODUCT SEARCH - List of results 2 29

30. A PRODUCT INFORMATION DATA SET 30

31. A PRODUCT INFORMATION DATA SET cont‘ed 31

32. STANDARDS 32

33. TESTING 33

34. TREATMENT 34

35. Users from other States Users from other States N A T I O N A L - U K I N T E R N A T I O N A L - U K Users from UK Users from UK STATUS of a DATA SET 35

36. Main advantages to UK of using ICSMS • Can replace part of national internal system -– stop duplication of investigations • Easier exchange of information with other Member States – less duplication of forms • Hypertext access to technical reports & contact person from other member states – reduced duplication of effort • Easy use of photographs – automatically sized • Efficient co-operation with CUSTOMS authorities - still some issues to resolve • An attractive means to inform Employers, workers and the public about unsafe products • ICSMS is being considered as the main system to link member states’ systems together for GPSD (DG SANCO) 36

37. Information required if problem found Use ‘Safeguard’ information as an aide memoir • Confirm manufacturer with what is on the plate and on the Declaration of Conformity/instructions if available. • Obtaining copy of manufactures instructions/information including contact address, web page, phone numbers etc • If supplied from inside or outside EEA ? • Details of supply chain incl to elsewhere in EEA • Equipment type/date of manufacture/notified body used • Other models/product names of same design • Use of equipment, incl fluid used, estimate of pressure and temperature range (both fluid and environment) • Photograph of equipment & manufactures plate/EC mark 37

38. Outcome of UK approach • Success of UK market surveillance shown by low incidence of accidents caused by unsafe products • All workplace accidents in the UK are 1.3 per 100,000 • Reduction in accidents is due to the mix of product and user inspection and the safety culture we developed over the last 30yrs – • but we are looking to be more effective and efficient and learn from each other across the EEA 38

39. How I see the future • Not to overload business/regulators • Not to make prescriptive legislation – outcomes based on analysis of risks – more synergy between Directives • Flexible control of risk • Limit third party conformity assessment - except for special or high hazards as in the PED • Encourage Quality Assurance, esp TQM – it has demonstrated it can improve safety • Improve cooperation between EU member states through ADCOs, MACHEX and joint projects 39