Product Safety Step by Step

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Product Safety Step by Step
Phare Business Support Programme III of the
European Union UEAPME - SME FIT II
This project is funded by the European Union
under the Phare Business Support Programme and
implemented by UEAPME and its partners. The
content of this document does not necessarily
reflect the opinion of the European Commission.
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Agenda

• Introduction
• Product Safety Step by Step
• Product liability

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Introduction

• Only safe products circulate freely within the EU
  
• Unsafe products harm consumers and companies
• Multitude of legal provisions at EU and national
  level
• SMEs need advice and assistance

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Product Safety Step by Step
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Step 1 Identify applicable legislation

• Is product covered/harmonised by EU-law?
• Not harmonised/Old Approach/New Approach
• New Approach Directives - Training Tool chapter
  II C

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New Approach Directives providing for CE-marking

• Machinery (2006/42/EC old 98/37/EC)
• Pressure equipment (97/23/EC)
• Simple pressure vessels (87/404/EEC)
• Toys (88/378/EEC)
• Construction products (89/106/EEC)
• Electromagnetic compatibility (2004/108/EC)
• Personal protective equipment (89/686/EEC)
• Non-Automatic Weighing instruments (90/384/EEC)

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New Approach Directives providing for CE-marking

• Medical Devices (93/42/EEC)
• Active implantable medical devices (90/385/EEC)
• In vitro diagnostic medical devices (98/79/EC)
• Gas appliances (90/396/EEC)
• Explosives for civil use (93/15/EEC)
• Products for potentially explosive atmospheres
  (94/9/EC)
• Recreational crafts (94/25/EC)
• Lifts (95/16/EC)
• Radio telecommunications terminal equipment
  (99/5/EC)

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New Approach Directives providing for CE-marking

• Cableway installations (2000/9/EC)
• Measuring instruments (2004/22/EC)
• Low voltage equipment (2006/95/EC)
• Eco-design requirements for energy-using products
  (2005/32/EC)
• Household electric refrigerators and freezers
  (96/57/EC)
• Noise emission by equipment for use outdoors
  (2000/14/EC)
• Ballasts for fluorescent lighting (2000/55/EC)
• Hot water boilers (92/42/EEC)

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New Approach Directives not requiring CE

• Packaging and packaging waste (94/62/EC)
• Interoperability of high-speed rail system
  (96/48/EC)
• Interoperability of conventional rail system
  (2001/16/EC)
• Marine equipment (96/98/EC)
• Transportable pressure equipment (1999/36/EC)
• General Product Safety Directive (2001/95/EC)

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Step 1 Identify applicable legislation
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Not harmonised

• Mutual recognition principle
• MS have to accept products lawfully
  manufactured/marketed in another MS
• Restrictions allowed if
• necessary for a reason of public interest (e.g.
  consumer protection) and
• Proportionate
• Regulation (EC) No 764/2008 applicable from 13
  May 2009
• Be aware of the GPSD (2001/95/EC)

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Old Approach

• Detailed requirements/compliance guarantees free
  access to EU-market
• E.g. motor vehicles, chemicals and cosmetics

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New Approach

• Legislation contains essential requirements
• Voluntary application of harmonised standards
  (presumption of conformity)
• Free movement clause
• Safeguard clause

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New Approach Directives applicable

• Machinery
• Low voltage equipment
• Electromagnetic compatibility
• Noise emission by equipment for outdoor use
• Eco-design for energy using products (if
  implementing measure)

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Step 2 Identify your role and responsibilities

• Manufacturer
• Authorised representative
• EU-Importer
• Assembler
• Distributor
• Employer
• User

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Step 3 Comply with essential requirements

• Harmonisation limited to essential requirements
• Provided for in the Directive (usually Annex I)

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Step 4 Use appropriate technical solution

• Harmonised standards provide presumption of
  conformity
• Alternative technical solution possible

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Step 5 Use relevant conformity assessment

• Procedure to follow laid down in Directives

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Step 5 Use relevant conformity assessment

• Machinery Directive
• Machinery not referred to in Annex IV internal
  production control
• Machinery referred to in Annex IV and
  manufactured in accordance with harmonised
  standards internal production control/EC
  type-examination plus internal production
  control/full quality assurance procedure
• Machinery referred to in Annex IV and not
  manufactured in accordance with harmonised
  standards EC type-examination plus internal
  production control/full quality assurance
  procedure

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Identify a Notified Body
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Step 6 Draw up technical documentation and EC
declaration of conformity

• E.g. Machinery Directive (Annex VII)
• Construction file
• Internal measures implemented to ensure
  conformity in case of series manufacture
• Instructions Official language of MS of use
• Documentation to be kept at least 10 years
• Located in-/outside EU but available on request
• Failure to present may be ground for doubting
  conformity

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Step 7 Affix CE marking correctly
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Step 7 Affix CE marking correctly

• Product conforms to all applicable Directives and
  conformity assessment procedures completed
• Not a mark of origin
• To be affixed to all products covered by a
  Directive providing for CE marking
• No voluntary CE marking (e.g. foodstuff)
• No guarantee of safety or quality
• Detailed provisions in Directive(s)

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Step 8 Know your product and take corrective
actions

• Be aware of risks your product may pose
• Risk assessment, traceability, complaints, market
  observation
• Take appropriate action to avoid risks
• Change design/production method, better
  instruction, recall, withdrawal
• Notify dangerous products (RAPEX)

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Step 9 Monitor legal developments

• Legal framework changes regularly
• E.g. Toys, construction products, decision on a
  common framework for the marketing of products,
  regulation setting out the requirements for
  accreditation and market surveillance, regulation
  on mutual recognition
• Make your voice heard

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Step 10 Fight unjustified trade barriers

• National remedies
• SOLVIT
• Infringement procedures
• Interactive policy making

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Thank you!
Phare Business Support Programme III of the
European Union UEAPME - SME FIT II

• Markus Stock
• Austrian Federal Economic Chamber
• markus.stock_at_wko.at