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Accreditation and market surveillance - EUR-Lex

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Accreditation and market surveillance - EUR-Lex

The purpose of this Regulation is to provide a common framework for accreditation within the European Union (EU) and, as a consequence, to facilitate movement of goods between the Member States. Accreditation is the final public control step within the conformity evaluation system and attests to the technical competence of the conformity evaluation bodies.

The Regulation also sets out the framework for monitoring products in the European market to guarantee that they meet requirements, thus ensuring a high level of protection of public interests. It also contains rules on CE marking.


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 lays down clear rules on the organisation and operation of accreditation, in the Member States, of conformity assessment bodies responsible for performing evaluation tasks to ensure conformity with the applicable requirements. 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 public control of the suitability of conformity assessment bodies. 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 co-operation 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.

Market surveillance

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:

  • a notification is created for the product 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.

CE marking is the only marking which attests to a product's conformity with European legislation when this marking is required. The manufacturer is responsible for affixing it, thus ensuring that the requirements are complied with. Penalties, including criminal penalties, are in place in the case of unauthorised use of the marking.

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.



Entry into force

Deadline for transposition in the Member States

Official Journal

Regulation (EC) No 765/2008



OJ L 218 of 13.8.2008


Proposal for a Regulation of the European Parliament and of the Council on market surveillance of products and amending Council Directives 89/686/EEC and 93/15/EEC, and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 1999/5/EC, 2000/9/EC, 2000/14/EC, 2001/95/EC, 2004/108/EC, 2006/42/EC, 2006/95/EC, 2007/23/EC, 2008/57/EC, 2009/48/EC, 2009/105/EC, 2009/142/EC, 2011/65/EU, Regulation (EU) No 305/2011, Regulation (EC) No 764/2008 and Regulation (EC) No 765/2008 of the European Parliament and of the Council - [COM(2013) 75 final]: The Commission proposes revising the rules currently in force, resulting from Directive 2001/95/EC (known as the DGSP) on the general security of products, Regulation (EC) 765/2008 on market surveillance and harmonisation sectoral legislation. The overlapping of rules is a source of confusion for economic operators and national authorities. The proposal intends to simplify the current surveillance system for non-food consumer products in the internal market in order to unify, as far as possible, the rules applicable to all products. The main objectives are the following:

  • combine all rules on market surveillance into a single legal instrument which is applicable to all sectors;
  • avoid duplication of effort in future provisions;
  • organise a single surveillance procedure; the proposal promotes a single alert notification via the Union's rapid exchange of information system (RAPEX) for dangerous products;
  • clearly define the surveillance procedure for the market, distinguishing chronologically between the different procedure steps (equality, publication of information, notification, etc.).

Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC (Text with EEA relevance) [OJ L 218 of 13.8.2008].