European Market Surveillance programming conference Brussels 10-11 March 2005

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European Market Surveillance programming
conferenceBrussels 10-11 March 2005

• Market Surveillance and enforcement provisions in
  the new General Product Safety Directive
  GPSDBernardo DeloguHead of Unit Product and
  Service Safety, DG Sanco

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Objectives of the presentation

• To summarise the main provisions of the new GPSD
• To highlight what is new in the revised GPSD, in
  particular in relation to enforcement
• To present the GPSD provisions concerning market
  surveillance and enforcement

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The new General Product Safety Directive (1/2)

• A horizontal regulatory framework for non-food
  consumer products
• It is intended to harmonize general safety
  requirements and ensure a consistent and high
  level of consumer health and safety protection

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The general Product Safety directive (2/2)

• It includes
• A general safety requirement generic4 safety
  criteria
• Conformity assessment criteria reference to
  standards
• additional obligations on producers and
  distributors
• Provisions on market surveillance and enforcement
  
• Provisions on administrative co-operation and
  exchange of information (in particular the RAPEX
  system)
• Provisions for rapid measures by the Commission
  in case of serious risks

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Scope of the GPSD

• It regulates the safety of non-food consumer
  products not covered by other Community legal
  instruments
• It completes and complements vertical Directives
  and other relevant Community legal instruments

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Objectives of the new GPSD

• To clarify the GPSD scope
• To reinforce and complete the obligations of
  products and distributors (e.g. recalls,
  information of authorities)
• To reinforce the harmonization potential by a
  reference to European standards
• To reinforce the obligation on the Member States
  for market surveillance and enforcement
• To establish a framework for administrative
  co-operation and reinforce RAPEX
• To streamline Commission powers for rapid
  measures
• To ensure access to information

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Provisions of the GPSD on market surveillance and
enforcement

• Market surveillance/ enforcement/ ad-co
  provisions of GPSD are comprehensive and detailed
  
• They represent a useful reference also for
  surveillance enforcement and co-operation under
  other Directives
• All stakeholders have a part to play in the
  application of such provisions

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Role of Producers and Distributors

• To ensure traceability of products and
  post-marketing monitoring
• To provide information on dangerous products to
  surveillance authorities
• To take action to prevent risks posed by
  dangerous products
• To co-operate with enforcement authorities

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Obligations of the Member States

• General enforcement obligation
• Obligation to establish authorities for
  surveillance and enforcement, which must have and
  use the necessary powers
• Obligation to attribute well defined tasks and to
  define organisational and internal co-operation
  arrangements (to be communicated to the
  Commission and the other MS)

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Sanctions

• Effective, proportionate and dissuasive sanctions
  must be implemented
• Rules on sanctions must be notified to the
  Commission

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Powers of the Enforcement Authorities

• In particular
• To require information, take samples, organise
  checks up to the final stage of use or
  consumption
• To require warnings, to be marked in the language
  of the MS where the product is marketed
• To subject marketing of a product to prior safety
  conditions
• To order publication of warnings
• To ban supply pending safety checks and
  assessment
• To ban marketing, order or organise withdrawal
  from the market, order on organise with
  producers/ distributors recalls

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Voluntary action

• Voluntary action must be encouraged
• The authorities should as far as possible
  coordinate action with producers and distributors
• Codes of good practice should be promoted

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Proportionality and Precautionary Principles

• Enforcement powers must be implemented in a
  manner proportional to the seriousness of the
  risk
• Account must be taken of the precautionary
  principle

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Internal coordination within MS

• The GPSD establishes the objective of effective
  market surveillance guaranteeing a high level of
  protection
• This objective entails internal coordination
  between competent authorities
• Effective approaches, means and procedures must
  be put in place
• Examples of good practices are given general
  surveillance programmes, follow-up of scientific
  developments, periodical review and assessment of
  surveillance systems etc.

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Relationship with stakeholders andAccess to
information

• Procedures to receive and follow-up complaints of
  stakeholders on product safety and market
  surveillance must be put in place by the
  authorities
• Procedures for collaboration with producers and
  distributors must also be put in place by the
  authorities
• Information on product safety and risks must be
  available to the public, as a general principle

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Conclusions

• The GPSD deals extensively with market
  surveillance and enforcement aspects
• The GPSD provides for common objectives and sets
  the elements of a co-ordinated approach
• There is no single model for the implementation
  of the provisions on surveillance and enforcement
• Effective implementation of GPSD surveillance and
  enforcement provisions are a pre-condition for
  fruitful ad-co-operation
• The Commission will carefully assess the
  implementation