European Commission

Jacques McMillanEnterprise Directorate-General

Legal aspects linked to internal market

EUROPEAN CONFERENCE ON

MARKET SURVEILLANCE PROGRAMMING

Brussels, 10 March 2005

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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, R&TT

equipment, Gas appliances, Low Voltage Equipment, EMC,

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• Better Regulation process:

- industry needs a simple and transparent legal framework;

- EU must ensure coherent & consistent implementationand application of existing internal market instruments.

• A more consistent implementation of the New Approachwill support our efforts to encourage international

alignment with the EU regulatory framework.

The New Approach Revision

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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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• 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 2004-1

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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 mechanismapplying 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