Accredia / Single market / The EU Court of Justice: in Europe only the National Accreditation Body can perform accreditation

The EU Court of Justice: in Europe only the National Accreditation Body can perform accreditation

12 May 2021

Ruling of the EU Court of Justice on the interpretation and application of the EC Regulation 765/2008 in all Member States: in Europe, accreditation, with public authority status, can only be performed by the single National Accreditation Body.

The final chapter of the legal case “Analisi G. Caracciolo Srl “, which involved Accredia – the Italian Accreditation Body, was written last May 6 with the ruling of the European Court of Justice C-142/2020.

The EU Court of Justice issued a definitive ruling on the case by which, on February 26, 2020, the Administrative Justice Council for the Sicilian Region, with regard to the appeal presented against the ruling of the TAR (Regional Administrative Court) by the laboratory “Analisi G. Caracciolo”, decided not to pronounce but to have recourse to the Court.

The EU Court of Justice reaffirmed the significance and the application of EC Regulation 765/2008 in all Member States, in response to the questions submitted by the Administrative Justice Council for the Sicilian Region.


In the EU, accreditation can only be carried out by Accreditation Bodies that comply with the Regulation

The first question asked whether the European Regulation 765/2008 could be interpreted in such a way as to allow the performance of accreditation activities within the territory of the Union also by a body which is not based in an EU country, in cases where it was able to demonstrate possession of a qualification similar to such Accreditation Bodies, also by means of signing the mutual recognition agreements.

The EU Court of Justice confirmed the sense of Article 4, paragraphs 1 and 5, and Article 7, paragraph 1, of EU Regulation 765/2008: accreditation activities cannot be conducted by bodies other than the single National Accreditation Body, designated in accordance with the same Regulation.

Other Accreditation Bodies, based in a third state, even if they guarantee compliance with international standards and demonstrate through the signing of the mutual recognition agreements (e.g. ILAC MRA) that they possess a qualification which is equivalent to that of a single Accreditation Body, cannot issue accreditations in Europe, and national legislation cannot provide for different interpretations.


Non-equivalence of non-EU Accreditation Bodies and exercise of public authorities

In addition to this first interpretation, the EU Court of Justice clarified that being a signatory to the non-EU international mutual recognition agreements (such as ILAC) does not ensure that the Accreditation Body fulfills the requirements contained in the EU Regulation 765/2008.

It is true that the signatories to the mutual recognition agreements, in particular the ILAC one, must demonstrate that they comply with the international ISO standards relating to the requirements imposed on Accreditation Bodies of organizations and laboratories worldwide (17000 series), as well as the additional requirements, especially in terms of experience.

However these requirements do not correspond to those established by the European Regulation, relating particularly to the fact that, in compliance with Article 4, paragraph 5, these National Accreditation Bodies carry out an activity of public authority in accordance with the requirements listed in Article 8 of the Regulation, in particular the requirements of independence, impartiality and competence.


The institution of European accreditation does not violate the principle of competition

The second issue concerned the examination of the legitimacy of the Regulation when establishing a single Accreditation Body in every EU country, in alleged violation of the European principles of competition, freedom to provide services, non-discrimination and prohibition of unequal treatment.

The EU Court of Justice, referring to Article 4, paragraphs 5 and 7, and Article 6 of EU Regulation 765/2008, read in the light of recital 15, clarified that the National Accreditation Body performs an activity of public authority, outside any commercial context, that it operates on a non-profit basis and that accreditation activities must respect the principle of non-competition. Therefore, according to EU law, such a body cannot be considered an “enterprise”, and cannot fall within the scope of application of the provisions relating to the prohibition of abuse of a dominant position.


The judicial background of the Accredia case – “Analisi G. Caracciolo ” laboratory

The “Analisi G. Caracciolo” laboratory decided to appeal to the Administrative Justice Council for the Sicilian Region, contesting the decision of the Sicilian Regional Administrative Court (n. 951/2017) which confirmed the legitimacy of the Regional Decree of March 9, 2017, by which it had been excluded from the list of authorized laboratories, as it lacked the necessary precondition of being accredited by Accredia. The laboratory had requested the annulment of the Decree of 9 March 2017 whereby it was excluded from the list, claiming to be in possession of an accreditation certificate issued by Perry Johnson Laboratory Accreditation Inc., an Accreditation Body based in the United States of America.

The Regional Administrative Court upheld Accredia’s appeal, in line with the provisions of EU Regulation 765/2008, which establishes the rules on the conduct of accreditation activities in all EU countries. It should be remembered that it is precisely this Regulation that establishes that for each country there must be only one Accreditation Body. The Accreditation Body must also be a member of the European body EA (European co-operation for Accreditation) recognized by the European Commission, and must have successfully passed peer evaluations, to ensure the equivalence of the services provided in all Member States. The Regulation, as stated in Articles 6 and 7, obliges interested parties to refer to “the National Accreditation Body of the Member State in which they are based” and not to a third country body.

The laboratory, asserting the illegality of the exclusion and of the subsequent decision of the Regional Administrative Court, decided to appeal to the Administrative Justice Council. The appeal was dismissed and the Administrative Justice Council for the Sicilian Region decided to have recourse to the European Court of Justice on the important issues in question.