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?