Help Print this page 

Summaries of EU Legislation

Title and reference
Accreditation and market surveillance

Summaries of EU legislation: direct access to the main summaries page.
Multilingual display
Text

Accreditation and market surveillance

 

SUMMARY OF:

Regulation (EC) No 765/2008 — setting out the requirements for accreditation and market surveillance relating to the marketing of products

WHAT IS THE AIM OF THE REGULATION?

  • It lays down common rules for accrediting bodies that ensure non-food products in the European Union (EU) conform to certain requirements.
  • It establishes a surveillance system to guarantee a high level of safety of those products and in general their compliance with applicable requirements.
  • It also sets rules in regard to controls on imports from outside the EU; and establishes the general principles for CE marking*.

KEY POINTS

National accreditation bodies

  • EU countries must:
    • appoint a single not-for-profit national accreditation organisation;
    • ensure the organisation has sufficient finance and staff to carry out its duties;
    • monitor the organisation to ensure it fulfils the requirements given;
    • communicate the relevant details to the European Commission which draws up a publicly available list of the various national organisations.
  • National accreditation bodies must:
    • determine whether individual conformity assessment organisations* are competent to do their work and monitor their performance;
    • restrict, suspend or withdraw accreditation certificates for assessment organisations that become unable to carry out their duties;
    • be objective and impartial with efficient management and appropriate internal controls in place;
    • agree to peer evaluation;
    • inform other national accreditation bodies of their conformity assessment activities;
    • make regularly publicly available information on their work.
  • The European co-operation for Accreditation (EA) manages the peer evaluations to ensure the quality of the services the national accreditation bodies provide.

EU market surveillance and import controls

  • EU countries must:
    • organise and carry out market surveillance to ensure the safety of products;
    • withdraw, restrict or ban products that could damage the health or safety of users and immediately inform the Commission of the action they have taken;
    • establish procedures for handling and dealing with complaints;
    • ensure national market surveillance authorities are appointed and provided with sufficient resources to carry out their tasks;
    • ensure national market surveillance authorities cooperate and exchange information with each other;
    • establish rules on penalties, which may include criminal sanctions, for serious breaches of the law.
  • Market surveillance authorities must:
    • carry out appropriate checks on a sufficient scale, taking account of risk assessments, complaints and other information;
    • alert users in their own country of any dangers they discover;
    • inform the EU’s rapid information system (RAPEX) of any serious risks;
    • exchange information on product compliance via a common EU database;
    • cooperate with authorities in other EU countries.
  • National customs authorities may prevent an imported product from being sold in the EU if they believe it poses a serious risk to health, safety, the environment or any other public interest.
  • CE marking may only be attached to a product by a manufacturer or someone mandated to operate on their behalf, provided it satisfies all the conformity standards.

FROM WHEN DOES THE REGULATION APPLY?

It has applied since 1 January 2010.

BACKGROUND

  • It is essential that non-food products that can move freely between EU countries do not pose a danger to the public, the environment or general security.
  • Accreditation is part of an overall system that includes conformity assessment and market surveillance. Provisions in the regulation for the latter complement those set out in other pieces of EU legislation.
  • For more information, see:

* KEY TERMS

CE marking: a marking manufacturers use to indicate the item meets EU legal conformity standards.

Conformity assessment body: a body that performs activities which include calibration, testing, certification and inspection.

MAIN DOCUMENT

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 (OJ L 218, 13.8.2008, pp. 30-47)

RELATED DOCUMENTS

Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, pp. 4-17)

Successive amendments to Directive 2001/95/EC have been incorporated into the original document. This consolidated version is of documentary value only.

Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, pp. 82-128)

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 (OJ L 218, 13.8.2008, pp. 21-29)

last update 14.02.2017

Top