CJEU Case C-142/20 / Judgment
Key facts of the case:

Reference for a preliminary ruling – Approximation of laws – Regulation (EC) No 765/2008 – Requirements for accreditation and market surveillance relating to the marketing of products – Single national accreditation body – Issuing of the accreditation certificate to conformity assessment bodies – Accreditation body having its seat in a third State – Article 56 TFEU – Article 102 TFEU – Articles 20 and 21 of the Charter of Fundamental Rights of the European Union – Validity.

Outcome of the case:

On those grounds, the Court (First Chamber) hereby rules:

Article 4(1) and (5) as well as Article 7(1) of 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 Council Regulation (EEC) No 339/93 must be interpreted as precluding the interpretation of national legislation according to which accreditation may be performed by bodies other than the single national accreditation body, within the meaning of that regulation, which have their seat in a third State, even where those bodies ensure compliance with international standards and demonstrate, inter alia by means of mutual recognition arrangements, that they have a qualification equivalent to that of the said single accreditation body.

Consideration of the second question referred for a preliminary ruling has revealed nothing capable of affecting the validity of the provisions of Chapter II of Regulation No 765/2008 in the light of Articles 56 and 102 TFEU as well as Articles 20 and 21 of the Charter of Fundamental Rights of the European Union.
Paragraphs referring to EU Charter
22) Laboratory Caracciolo brought an appeal against that judgment before the referring court. It argued that conferring such competence on Accredia infringed Article 56 TFEU relating to the freedom to provide services and Article 102 TFEU concerning the principle of free competition, as well as the principles of equality and non-discrimination, enshrined in Articles 20 and 21 of the Charter of Fundamental Rights of the European Union (‘the Charter’).

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24) The referring court does not share the interpretation proposed by Laboratory Caracciolo. That court considers that Italian law complies with Regulation No 765/2008, in that it provides that only Accredia may issue accreditation. However, it considers that a request for a preliminary ruling is necessary in order to ascertain, in particular, whether an interpretation of the national provisions which would allow a body other than Accredia to perform accreditation would be compatible with Regulation No 765/2008 and whether that regulation allows bodies established in third countries, in so far as they offer appropriate professional safeguards, to carry out the accreditation activity at issue in the main proceedings. If not, that court is uncertain as to the validity of that regulation in the light of Articles 56 and 102 TFEU as well as Articles 20 and 21 of the Charter, in that it allows only a single national body to perform accreditation.

25) It is in that context that the Consiglio di Giustizia amministrativa per la Regione Siciliana (Council of Administrative Justice, Region of Sicily) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:

'Does Regulation (EC) No 765/2008 preclude a provision of national law (such as Article 40 of Law No 88/2009) being interpreted as allowing accreditation to be carried out by bodies not established in a Member State of the European Union – and therefore without the party concerned being required to apply to the single accreditation body – where such bodies in any event ensure that standards UNI CEI EN ISO/IEC 17025 and UNI CEI EN ISO/IEC 17011 are complied with and demonstrate (by means of mutual recognition [arrangements], for example) possession of a qualification which is essentially the same as that of the single bodies referred to in Regulation (EC) No 765/2008?

In the light of Article 56 TFEU, Articles 20 and 21 of the [Charter] and Article 102 TFEU – in so far as it establishes essentially a national monopoly in respect of accreditation by the “single body” system – does Regulation (EC) No 765/2008 infringe the principles of primary EU law and, in particular, the principles of freedom to provide services and non-discrimination, the prohibition of unequal treatment and competition rules that prohibit monopoly situations?’

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46) By its second question, the referring court asks the Court, in essence, to assess the validity of the provisions of Chapter II of Regulation No 765/2008 in the light of Articles 56 and 102 TFEU as well as Articles 20 and 21 of the Charter, in so far as they provide that accreditation is performed exclusively by the single national body, within the meaning of that regulation.

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59) Finally, the admissibility of the part of the second question relating to the validity of the provisions of Chapter II of Regulation No 765/2008 in the light of Articles 20 and 21 of the Charter, which enshrine the principle of equality and the principle of non-discrimination, is disputed by the Spanish and Austrian Governments in their written observations before the Court, in so far as the grounds on which the referring court considers that those provisions have been infringed are not apparent from the order for reference. The Council of the European Union shares that view, but does not challenge the admissibility of that part of the second question.

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62) However, in view of the grounds set out in paragraphs 47 to 59 above, justifying the validity, in the light of Articles 56 and 102 TFEU, of the provisions of Regulation No 765/2008 providing that accreditation is performed exclusively by the single national body, Articles 20 and 21 of the Charter cannot usefully be relied on to call into question the fundamental obligation for conformity assessment bodies to be accredited by that body, enjoying public powers, in the Member State in which they are established.

63) In the light of the foregoing, it must be concluded that consideration of the second question has revealed nothing capable of affecting the validity of the provisions of Chapter II of Regulation No 765/2008 in the light of Articles 56 and 102 TFEU as well as Articles 20 and 21 of the Charter.