European Commission Jacques McMillan Enterprise Directorate-General Legal aspects linked to internal market EUROPEAN CONFERENCE ON MARKET SURVEILLANCE PROGRAMMING Brussels, 10 March 2005

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

3 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, R&TT equipment, Gas appliances, Low Voltage Equipment, EMC,

4 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. The New Approach Revision

5 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)

6 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 Ongoing activities - Draft CERTIF

7 Market Surveillance Market surveillance could be organised at three levels

8 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.)

9 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

10 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

11 Market Surveillance EFFECTIVE SAFEGUARD CLAUSE create a uniform safeguard mechanism applying 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

12 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

13 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