Market surveillance
The objective of market surveillance is to ensure that only safe products are placed on the Community market. In practice, market surveillance comprises of a series of interlinked activities and measures taken by national authorities to ensure that products placed on the Community market comply with all the requirements set out in the relevant Community harmonisation legislation and that they do not endanger health, safety or any other aspect of public interest protection.
Market surveillance is organised and performed at national level, where each Member State is responsible for surveillance activities on its territory, including taking any necessary action to bring non-compliant products into compliance, to impose restrictive measures (bans, withdrawals) and to apply sanctions.
The Regulation 765/2008 on market surveillance and accreditation
General scope
Market surveillance is part of the enforcement of the New Legislative Framework where Regulation (EC) 765/2008 
[160 KB] sets out the requirements for accreditation and market surveillance relating to the marketing of products. As the last step of national control, market surveillance is essential for European consumers to be able to benefit from an equivalent level of protection throughout the single market, regardless of the country they live in or the origin of the product. In addition, market surveillance benefits all actors of the supply chain: manufacturers, importers, authorised representatives and even distributors, because it eliminates unscrupulous economic operators. Consequently market surveillance helps to reduce unfair competition, and provides a level playing field for all.
Market surveillance organisation
The Regulation (EC) 765/2008 [160 KB] contains explicit requirements for Member States to carry out and organise market surveillance activities. However, the principle of subsidiarity continues to apply, which means that it is for each Member State to organise their internal administrative structures and surveillance activities so as to fulfil their obligations.
Market surveillance is organised and performed at two main stages:
- First, national surveillance authorities monitor that products placed on their market comply with the provisions of Community harmonisation legislation transposed into the national legislation.
- Second, national surveillance authorities take action, when necessary, either to bring non-compliant products into compliance, to remove unsafe products from the market and /or to ban them, or in justified cases to destroy them.
In critical cases, there is also a third stage where authorities may apply sanctions consistent with the severity of the case.
National measures
Regulation (EC) 765/2008 [160 KB] on accreditation and market surveillance sets out clear obligations for market surveillance authorities, stipulating that they must have the necessary powers, resources and knowledge to properly perform their function. The Regulation outlines the requirement to have in place necessary procedures for follow-up of complaints, monitoring accidents, verifying that corrective action has been taken and for follow-up of scientific and technical knowledge concerning safety issues. In addition, Member States must implement and periodically update their market surveillance programmes and review and assess the functioning of their surveillance activities at least every four years.
The Regulation also defines market surveillance measures to be carried out by the surveillance authorities. These include: to organise random and spot checks; to require all necessary documentation from the manufacturer in order to be able to evaluate product conformity; when justified, to enter the manufacturer's premises and take samples for testing, and in extreme cases to destroy products. If authorities find hazards, they have the responsibility to alert other potential users of those products to reduce the risk of any further injury or damage. Products which present a serious risk, requiring rapid reaction, must be recalled from the market and measures must be taken in order to ensure that they do not end up on the market.
Information and communication at EU and national levels
Effective cross-border co-operation between market surveillance authorities is essential to ensure the same high level of surveillance throughout the European Union. Information exchange, pooling of resources and co-operation between Member States authorities is necessary for ensuring efficient, comprehensive and consistent market surveillance:
- Exchange of information - Community Rapid Information System:
If a surveillance authority spots a product presenting a serious risk and which could have an effect outside the territory of the Member State, there is an obligation for that authority to inform the European Commission of any measures it has taken or intends to take to withdraw or restrict the placing on the market of that product, including any voluntary measures. The information is thereafter transmitted to all EU Member States by using the Community Rapid Information System (RAPEX). Currently RAPEX is used only for consumer products presenting a serious risk. However, following the implementation of Regulation 765/2008 [160 KB] this tool will be adapted to include also other products.
- General information support system:
The European Commission will develop a system for information exchange which will include best practices, joint actions results, details of non-compliant products and information on national market surveillance programmes etc. This system will also reflect RAPEX notifications.
- Co-operation at EU level and national level:
The Regulation includes clear obligations for Member States to cooperate at internal (Member State ) level between different authorities, with other Member States and with the European Commission and any relevant Commission agencies.
- Sharing of resources:
Initiatives to share best practice and resources will facilitate the functioning of market surveillance. This could include e.g. training, exchange of personnel, exchange of experience, common projects and information campaigns, as well as joint visit programmes.
- Administrative Co-operation Groups:
DG Enterprise and Industry has created and facilitates discussions within Directive-specific Administrative Co-operation Groups (AdCo), comprising of market surveillance experts. These fora enable national market surveillance experts to meet, share information and co-operate on practical matters related to the implementation of specific Directives.
- Co-operation with the competent authorities of third countries:
Information exchange with competent authorities in third countries is encouraged, including all activities linked to sharing of resources.
Additional EU legislation on market surveillance
In addition to Regulation (EC) 765/2008, Decision 768/2008/EC on a common framework for the marketing of products [235 KB] contains provisions on market surveillance, including obligations of the economic operators, and traceability and safeguard mechanisms. Furthermore, the Directive 2001/95/EC on General product safety (GPSD) [254 KB] (managed by DG SANCO), contains provisions on how to ensure safe consumer products. For instance, GPSD provides the legal basis for RAPEX.
The majority of the EU sectoral legislation foresees the use of a safeguard procedure. It obliges Member States to inform when they take measures restricting the free circulation of a product presenting a risk (or a serious risk) or when they intend to take restrictive measures because they have sufficient reason to believe that the product concerned presents a risk. This obligation exists in parallel to the RAPEX notification obligation established in Article 12 of the GPSD, which applies to measures adopted in relation to products (regardless of whether they are covered by Community harmonisation legislation or not) presenting a serious risk.
Furthermore, the Member States are obliged to take restrictive measures against products which are found to be unsafe/non-compliant. For example, if a product which should be affixed with the CE marking is found to be missing the marking, the market surveillance authorities can rule the product as non-compliant. The safeguard procedure then allows the European Commission to check the grounds for these national measures restricting the free movement of goods and take a decision if the national measure is justified or not.
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