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Accreditation and market surveillance
The purpose of this Regulation is to provide a common framework for the accreditation infrastructures within the European Union (EU) and, as a consequence, to facilitate movement of goods between the Member States. Correct operation of the accreditation infrastructures is essential in guaranteeing control of product conformity assessment bodies and surveillance of the products and economic operators on the European market.
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (Text with EEA relevance).
This Regulation envisages the laying down of clear rules on the organisation and operation of accreditation, in the Member States, of conformity assessment bodies performing assessment of any substance, preparation or other product, transformed or not, to be placed on the Community market.
It is important to guarantee a high level of market surveillance in order to satisfy the requirements of protection of public interests such as health and safety in general, health and safety in the workplace, protection of consumers, the environment and security.
These rules reinforce the existing system, without weakening existing instruments such as the General Product Safety Directive, which has on the whole been successful.
This Regulation provides a framework for European accreditation policy. For the first time it establishes a common legal basis for accreditation, therefore providing a comprehensive legal framework for regulating the organisation of accreditation within the European Economic Area (EEA) from 1 January 2010.
Whether voluntary or compulsory, accreditation is recognised as the last level of control of the suitability of conformity assessment services. Accreditation has no commercial purpose, since this would reduce its value and credibility.
Accreditation is characterised by the following:
- there is only one accreditation body per Member State
- there is no competition between accreditation bodies and conformity assessment bodies;
- accreditation is carried out by a public authority;
- accreditation bodies operate on a not-for-profit basis and comply with the principles of impartiality and objectivity.
The European cooperation for Accreditation (EA) shall be responsible for managing the peer assessment which monitors the responsibilities and functioning of the national accreditation bodies. Through this peer evaluation system, the EA contributes to the quality of the services provided by national accreditation bodies and therefore to the mutual acceptance of conformity certificates throughout the EU and the rest of the world.
Member States guarantee effective surveillance of their market. They are required to organise and carry out close monitoring so that the products covered by Community harmonisation legislation meet the requirements for protection of public interests such as health or safety.
The competent market surveillance authorities in each Member State monitor products on the Community market. They are responsible for:
- monitoring compliance with product safety requirements;
- following up complaints or reports on product-related risks;
- monitoring accidents and damage to health suspected to have been caused by these products;
- verifying corrective action has been taken;
- following up and updating scientific and technical knowledge concerning safety issues;
- following up on the notification of dangerous products on RAPEX.
The Member States must cooperate with each other and ensure that information is exchanged between them and the Commission and the relevant Community agencies.
Market surveillance authorities must perform appropriate checks on the characteristics of products - through documentary, physical and laboratory checks - and may require economic operators to make available the necessary information and enter their premises to better perform, totally independently, their surveillance task.
If the authorities identify a product as presenting a risk, they shall alert users by taking the appropriate measures. If it presents a serious risk Member States ensure that:
- the product details are changed on RAPEX;
- the product is recalled or withdrawn;
- the product is modified and the risk removed.
In cases of risk, Member States must inform the economic operator in question and the Commission of their decision without delay, stating precisely the reasons for this.
Where controls on products entering the Community market are concerned, the Member States provide their customs authorities with all the means necessary to ensure that the appropriate checks are carried out on the product’s safety before it is released for free circulation. In the event of serious danger, assumed or actual, or in the absence of the necessary accompanying documents, the customs authorities must suspend release for free circulation of the product in question.
The market surveillance authorities and the customs authorities cooperate to ensure effective control of product safety.
Certain activities planned for the application of this Regulation may be financed by the Union.
This Regulation repeals Regulation (EC) No 339/93 as of 1 January 2010.
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
Regulation (EC) No 765/2008
OJ L 218 of 13.8.2008
- For more details, visit the DG Enterprise and Industry website on mutual recognition