Regulation (EC) No 765/2008 sets out the requirements for accreditation and aims to ensure that accreditation serves the public interest. The Regulation established a single European accreditation system that covers the regulated sector, where accreditation is required by legislation and the voluntary (non-regulated) sector.

The accreditation framework set up by Regulation(EC) No 765/2008 can be summarized as follows:

  • Each Member State may appoint one single national accreditation body;
  • Accreditation is to be operated as a public authority activity;
  • The responsibilities and tasks of the national accreditation body have to be clearly distinguished from those of other national authorities;
  • Accreditation is to be provided on a not-for-profit basis;
  • National accreditation bodies are not allowed to compete with other national accreditation bodies;
  • National accreditation bodies are only to be active on the territory of their own Member State.

Furthermore, a national authority shall recognize certificates and reports issued by a conformity assessment body, that is accredited by its National Accreditation Body, and the National Accreditation Body is successfully peer evaluated by EA for the relevant scope.

More information on Regulation (EC) No 765/2008 is available on EA’s website https://european-accreditation.org/about-ea/relations-with-european-commission/. 

Article 40 of Regulation (EC) No 765/2008 states that “by 1 January 2013, and every five years thereafter, the European Commission, in cooperation with the Member States, shall produce and submit to the European Parliament and the Council a report on the implementation of this Regulation”. 

 In this respect, the European Commission has adopted and published the report hereafter: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM%3A2022%3A679%3AFIN&qid=1670281584780.

The report provides an overview of the implementation of the accreditation and CE Marking provisions of Regulation (EC) No 765/2008 between 2018 and 2022. 

The report confirms that the European accreditation infrastructure created by Regulation (EC) No 765/2008 proved its important role and added value, in particular in the context of EU policies regarding the:

  • Single Market and Industrial Strategy;
  • European Green Deal;
  • Digital Transition;
  • Fight against Covid-19;
  • Sectoral policies (e.g. for machinery, construction products, pressure equipment, lifts, drones, fertilizers, food and feed, emission trading system).

The report also notes that accreditation faces the challenge of strengthening its solidity and keeping it in line with the latest state of the art. 

The report doesn’t propose any changes to the European legal framework and doesn’t constitute an evaluation of the up-to-date relevance and coherence of the accreditation and CE marking framework. 

These aspects are evaluated under the “Evaluation of the New Legislative Framework (NLF)” carried out by the Commission in 2022 (https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12654-Industrial-products-evaluation-of-the-new-legislative-framework_en).