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Health and Safety Executive
Health and Safety Executive
Market Surveillance The
UK Experience
Steve Shaw
UK Health and Safety Executive
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
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
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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
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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
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
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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
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Market Surveillance of industrial products
• In UK 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 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
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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
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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)
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• Check: documentation & obvious defects
• Investigate: matters of evident concern
• Enforcement: proportionate to risk
Market Surveillance
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Three stage approach to examination by general inspectors of new equipment found in workplace:
• 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
Market Surveillance
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
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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
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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.
Entry
RAPEX
Local MSAuthority
National Focal Point
(NFP)Validation
Case No Validation
Translation
Local MSAuthorityLocal MS
Authority
RAPEX
Entry
RAPEX
Local MSAuthority
National Focal Point
(NFP)
Validation
Case No Validation
Translation
Local MSAuthorityLocal MS
Authority
ICSMS Interface
RAPEX + ICSMS
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.
European Market and ICSMS
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.
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
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
Which DIRECTIVES are covered today
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
Safeguard or RAPEX Notification
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.)
New Approach
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
Other ways to inform MS
• Individually using contacts from ADCO where only a few MS have the same products
• At EU meetings – ADCO
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
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
What is the Safeguard Procedure
Member states’ NA responsible for the Machinery Directive uploads the documents onto CIRCA
Member State’s NA sends it electronically to its Official Representative to the EU in Brussels and copies to Directorate contact in the European Commission.
Commission convenes an investigation with input by experts and the manufacturer /supplier to decide if authority action was correct. Decision is binding on Member States
If Commission agrees with enforcement action, Commission’s formal opinion is sent to Member States EA via official representatives. Commission uploads decision onto CIRCA
Member States EA uploads PSA onto CIRCA
If Commission disagrees with enforcement action, member state’s NA is informed of decision via official representative and Commission Opinion is uploaded on to CIRCA.
Enforcement and restriction action taken by Member State that resulted in the PSA will be rescinded
NA assesses the package and decides if they agree with EA decision on PSA or ISA. PSA ISA
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
Thank You
Any Questions?