Jacques McMillan

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EUROPEAN CONFERENCE ON MARKET SURVEILLANCE
PROGRAMMING Brussels, 10 March 2005
Jacques McMillan Enterprise Directorate-General Le
gal aspects linked to internal market
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WHY market surveillance

• GOAL
• - A uniformly high level of enforcement of
  internal market legislation
• - High level of protection
• - Non-discrimination
• - Transparent competition

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The results of NA legislation

• First New Approach Directive in 1987
• Since then more than 20 broad areas of products
  or risks are covered, including
• Machines, Lifts, Pressure equipment, Pleasure
  craft
• Medical devices, in vitro diagnostic equipment,
• Personal Protective Equipment, Toys, RTT
  equipment,
• Gas appliances, Low Voltage Equipment, EMC,

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The New Approach Revision

• Better Regulation process - industry
  needs a simple and transparent legal
  framework - EU must ensure coherent
  consistent implementation and application of
  existing internal market instruments.
• A more consistent implementation of the New
  Approach will support our efforts to encourage
  international alignment with the EU regulatory
  framework.

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The New Approach Revision

• Recommendations for Market Surveillance
• Create a common level throughout the Union
• Reinforce administrative co-operation
• Render more efficient the application of the
  safeguard clause
• Enhance the relationship with the Directive on
  General Product Safety (2001/95/EC)

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Ongoing activities - Draft CERTIF 2004-1

• Wider review of the general framework for
  Community internal market legislation based on
  Art. 95 EC Treaty
• Three pillars levels of protection - conformity
  assessment - market surveillance
• While the basic principles of the New Global
  Approaches remain unquestioned
• ? Address weaknesses in implementation
• ? Adapt some elements to developments and add
  those lacking
• ? Draw together all horizontal texts into a
  single document

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Market Surveillance

• Market surveillance could be organised at three
  levels

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Market Surveillance

• ? Essential requirements for a Community market
  surveillance framework
• - set up/reinforce national authorities
  competent for monitoring conformity of the
  relevant product
• - attribute the necessary powers and resources
• - cover the full range of products subject to
  legislation and cover all risks involved
• - determine the necessary procedures (e.g.
  monitor accidents, register and follow-up
  complaints, etc.)
• - define the necessary measures (e.g. carry out
  cheks, take samples for inspections and tests,
  etc.)

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Market Surveillance

• Community control
• inform the Commission of the national market
  surveillance arrangements
• introduce appropriate information system
  between national authorities and the Commission
• verification by the Commission and MS
  whether national systems meet the essential
  requirements at least at minimum level

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Market Surveillance

• REINFORCE CO-OPERATION
• ? create a legal base for this
  co- operation, including exchange of
  information
• ? create a permanent forum for discussion
  between national authorities
• ? develop more efficient cross-border
  administrative co-operation

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Market Surveillance

• EFFECTIVE SAFEGUARD CLAUSE
• ? create a uniform safeguard mechanism applyi
  ng to all Community Directives
• ? Ensure appropriate action at national/local
  level
• ? increase involvement of the manufacturer and
  harness expertise available in MS
• ? simplify and shorten the procedure

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Market Surveillance

• ? Close relationship with the Directive on
  General product Safety (2001/95/EC)
• ? ensure coherence with existing system under
  GPSD
• ? consider extending the use of RAPEX

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In Conclusion

• 1. Ensure homogeneity and coherence between
  common provisions for market surveillance, for
  consumer safety, product safety and safety at
  place of work, for ALL harmonisation directives
• 2. Create synergies with other initiatives such
  as GPSD and RAPEX