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




          Product Safety Step by Step




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.
Agenda


 Introduction

 Product Safety Step by Step

 Product liability
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
Product Safety Step by Step
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
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)
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)
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)
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)
Step 1: Identify applicable legislation
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)
Old Approach




      Detailed requirements/compliance guarantees free
       access to EU-market

      E.g. motor vehicles, chemicals and cosmetics
New Approach

      Legislation contains essential requirements

      Voluntary application of harmonised standards
       (presumption of conformity)

      Free movement clause

      Safeguard clause
    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)
    Step 2: Identify your role and responsibilities


   Manufacturer
   Authorised representative
   EU-Importer
   Assembler
   Distributor
   Employer
   User
Step 3: Comply with essential requirements

 Harmonisation limited to essential requirements

 Provided for in the Directive (usually Annex I)
Step 4: Use appropriate technical solution


 Harmonised standards provide presumption of conformity


 Alternative technical solution possible
Step 5: Use relevant conformity assessment

 Procedure to follow laid down in Directives
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
Identify a Notified Body
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
Step 7: Affix CE marking correctly
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)
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)
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
Step 10: Fight unjustified trade barriers

 National remedies

 SOLVIT

 Infringement procedures

 Interactive policy making
           Phare Business Support Programme III
                   of the European Union
                    UEAPME - SME FIT II




                 Thank you!
Markus Stock
Austrian Federal Economic Chamber
markus.stock@wko.at