ECJ prohibits “accreditation shopping” in third countries

In its judgment dated 6 May 2021 (C-142/20), the European Court of Justice (ECJ) confirmed that each Member State’s accreditation body has a monopoly on accreditation of conformity assessment bodies. It ruled that, according to Regulation (EC) 765/2008, an accreditation certificate issued by an accreditation body in a third country and not by the competent national body has no legal validity for a conformity body with only one branch.

For these conformity assessment bodies, the judgment means that it is not possible to circumvent a national accreditation body by applying to a foreign body. Accordingly, conformity assessment bodies continue to depend on a good relationship with their national accreditation body. If a conformity assessment body wishes to be accredited by a foreign accreditation body, it must first move its registered office abroad, with all of the resulting economic and tax law challenges. This judgment also applies directly to “Union testing facilities” according to Art. 21 of the new market surveillance Regulation (EU) 2019/1020.

The decision is based on the following facts:

A conformity assessment body of food businesses carrying out its activity in Italy had an accreditation certificate issued to it by a body having its seat in the United States after its Italian accrediting body refused to do so. On the basis of the US accreditation, the conformity assessment body wished to be added to the list of accredited laboratories in the Region of Sicily. This entry was denied on the grounds that the accreditation issued by a US accreditation body was not valid for a conformity assessment body headquartered in Italy.

The ECJ ruled that entry into this list could legitimately be refused because the conformity assessment body had no valid accreditation from its nationally competent accreditation body according to Art. 4 and 7 of Regulation (EC) 765/2008. The court stated that a conformity assessment body must have its national accreditation body perform its accreditation. According to the ECJ, only the national accreditation body is competent to issue accreditation certificates in its EU Member State under Regulation (EC) 765/2008, making a US accreditation invalid.

The court ruled that transfer of sole competency for accreditation to the national accreditation body as laid down in Regulation (EC) 765/2008 did not constitute a breach of the freedom to provide services found in Art. 56 TFEU nor the principle of free competition found in Art. 102 TFEU. The court also stated that a national provision that permits accreditation services by a body other than the national accreditation body is incompatible with Regulation (EC) 765/2008.