This ruling is the outcome of legal proceedings concerning the accreditation of a group of Italian laboratories by an accreditation body based in the United States. Italy’s national accreditation body – Accredia – has referred the matter to the European Court of Justice (C‑142/20) because Accredia believes that accreditation in Italy should be carried out by the national accreditation body. The ruling applies to the entire EU and the European Economic Area (Norway, Iceland and Liechtenstein).
American accreditation bodies are also active in the Netherlands. “Many parties are unhappy with that. We as well. Within the EU and the EA, we set high standards for quality. This ruling provides us with the basis for taking action,” says Roeland Nieuweboer, chairman of the Board of Directors of the RvA. “We will shortly inform the few conformity assessment bodies in the Netherlands that have been accredited by an accreditation body outside the European Union.”
What does the ruling of the European Court mean for the granting of accreditation in the Netherlands?
Firstly, the European Court of Justice confirms the importance and application of EC Regulation 765/2008 in all Member States. This means that the RvA performs its duties as the national accreditation body of the Netherlands in accordance with this regulation. An exception to this is an accreditation application for an activity that is not part of the RvA’s field of activity.
In addition, the Court clarifies that the application of Regulation 765/2008 is not affected by private equivalence agreements concluded by national accreditation bodies within the EU with accreditation bodies established outside the EU.
The Court considers that such an agreement does not provide for compliance with Regulation 765/2008 by any accreditation body established outside the EU.
Competition principle is not violated
Another question that the European Court of Justice has answered is whether the exclusion of foreign accreditation bodies constitutes a violation of the European principles of competition and the freedom to provide services.
The European Court of Justice has clarified that the national accreditation body carries out a public activity, outside a commercial context. And that it operates on a non-profit basis and that accreditation activities must respect the principle of non-competition. Referring to Regulation 765/2008, the Court considers that the national accreditation body cannot therefore be regarded as an “undertaking” under EU law and therefore does not fall within the scope of the European principles of competition and freedom to provide services. The Court also considers that the provisions on the prohibition of abuse of a dominant position do not apply to national accreditation bodies.