Analisi G. Caracciolo srl v Regione Siciliana - Assessorato regionale della salute - Dipartimento regionale per la pianificazione and Others.

• Jurisdiction: European Union
• Date: 06 May 2021
• Court: Court of Justice (European Union)

Provisional text

JUDGMENT OF THE COURT (First Chamber)

6 May 2021 (*)

(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)

In Case C‑142/20,

REQUEST for a preliminary ruling under Article 267 TFEU from the Consiglio di Giustizia amministrativa per la Regione Siciliana (Council of Administrative Justice, Region of Sicily, Italy), made by decision of 26 February 2020, received at the Court on 26 March 2020, in the proceedings

Analisi G. Caracciolo Srl

v

Regione Siciliana – Assessorato regionale della salute – Dipartimento regionale per la pianificazione,

Regione Sicilia – Assessorato della salute – Dipartimento per le attività sanitarie e osservatorio,

Accredia – Ente Italiano di Accreditamento,

Azienda sanitaria provinciale di Palermo,

intervening parties:

Perry Johnson Laboratory Accreditation Inc.,

THE COURT (First Chamber),

composed of J.-C. Bonichot, President of the Chamber, L. Bay Larsen, C. Toader (Rapporteur), M. Safjan and N. Jääskinen, Judges,

Advocate General: J. Richard de la Tour,

Registrar: A. Calot Escobar,

having regard to the written procedure,

after considering the observations submitted on behalf of:

– Analisi G. Caracciolo Srl and Perry Johnson Laboratory Accreditation Inc., by S. Pensabene Lionti, avvocato,

– Accredia – Ente Italiano di Accreditamento, by L. Grisostomi Travaglini and G. Poli, avvocati,

– the Italian Government, by G. Palmieri, acting as Agent, M. Russo and E. Feola, avvocati dello Stato,

– the Czech Government, by M. Smolek, T. Müller, J. Vláčil and T. Machovičová, acting as Agents,

– the Spanish Government, by L. Aguilera Ruiz and M.J. Ruiz Sánchez, acting as Agents,

– the Austrian Government, by A. Posch, acting as Agent,

– the Polish Government, by B. Majczyna, acting as Agent,

– the European Parliament, by L. Visaggio and L. Stefani, acting as Agents,

– the Council of the European Union, by A.-L. Meyer and E. Ambrosini, acting as Agents,

– the European Commission, by G. Gattinara, L. Malferrari, F. Thiran and P. Rossi, acting as Agents,

having decided, after hearing the Advocate General, to proceed to judgment without an Opinion,

gives the following

Judgment

1 This request for a preliminary ruling concerns the interpretation and validity 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 Regulation (EEC) No 339/93 (OJ 2008 L 218, p. 30).

2 The request has been made in proceedings between Analisi G. Caracciolo Srl, a laboratory conducting analyses and operating as the conformity assessment body of food businesses and carrying out its activity in Italy (‘Laboratory Caracciolo’), and the Regione Siciliana (Region of Sicily, Italy) concerning the validity of the accreditation certificate issued to that laboratory by Perry Johnson Laboratory Accreditation Inc. (‘PJLA’), a body having its seat in the United States.

Legal context

Regulation No 765/2008

3 Recitals 1, 9, 12, 13, 15, 19 and 20 of Regulation No 765/2008 state:

‘(1) It is necessary to ensure that products benefiting from the free movement of goods within the Community fulfil requirements providing a high level of protection of public interests such as health and safety in general, health and safety at the workplace, protection of consumers, protection of the environment and security, while ensuring that the free movement of products is not restricted to any extent greater than that which is allowed under Community harmonisation legislation or any other relevant Community rules. Provision should, therefore, be made for rules on accreditation, market surveillance, controls of products from third countries and the CE marking.

…

(9) The particular value of accreditation lies in the fact that it provides an authoritative statement of the technical competence of bodies whose task is to ensure conformity with the applicable requirements.

…

(12) Where Community harmonisation legislation provides for the selection of conformity assessment bodies for its implementation, transparent accreditation, as provided for in this Regulation, ensuring the necessary level of confidence in conformity certificates, should be considered by the national public authorities throughout the Community the preferred means of demonstrating the technical competence of those bodies. However, national authorities may consider that they possess the appropriate means of carrying out this evaluation themselves. In such cases, in order to ensure the appropriate level of credibility of evaluations carried out by other national authorities, they should provide the Commission and the other Member States with the necessary documentary evidence demonstrating the compliance of the conformity assessment bodies evaluated with the relevant regulatory requirements.

(13) A system of accreditation which functions by reference to binding rules helps to strengthen mutual confidence between Member States as regards the competence of conformity assessment bodies and consequently the certificates and test reports issued by them. It thereby enhances the principle of mutual recognition and therefore the provisions of this Regulation on accreditation should apply in relation to bodies carrying out conformity assessments in both the regulated and the non-regulated areas. The issue at stake is the quality of certificates and test reports irrespective of whether they fall within the regulated or the non-regulated area, and no distinction should therefore be made between those areas.

…

(15) Since the purpose of accreditation is to provide an authoritative statement of the competence of a body to perform conformity assessment activities, Member States should not maintain more than one national accreditation body and should ensure that that body is organised in such a way as to safeguard the objectivity and impartiality of its activities. Such national accreditation bodies should operate independently of commercial conformity assessment activities. It is therefore appropriate to provide that Member States ensure that, in the performance of their tasks, national accreditation bodies are deemed to exercise public authority, irrespective of their legal status.

…

(19) Competition between national accreditation bodies could lead to the commercialisation of their activity, which would be incompatible with their role as the last level of control in the conformity assessment chain. The objective of this Regulation is to ensure that, within the European Union, one accreditation certificate is sufficient for the whole territory of the Union, and to avoid multiple accreditation, which is added cost without added value. National accreditation bodies may find themselves in competition on the markets of third countries, but that must have no effect on their activities inside the Community, or on the cooperation and peer evaluation activities organised by the body recognised under this Regulation.

(20) In order to avoid multiple accreditation, to enhance acceptance and recognition of accreditation certificates and to carry out effective monitoring of accredited conformity assessment bodies, conformity assessment bodies should request accreditation by the national accreditation body of the Member State in which they are established. Nevertheless, it is necessary to ensure that a conformity assessment body is able to request accreditation in another Member State in the event that there is no national accreditation body in its own Member State or where the national accreditation body is not competent to provide the accreditation services requested. In such cases, appropriate cooperation and exchange of information between national accreditation bodies should be established.’

4 Under Article 1(1) and (2) of that regulation:

‘1. This Regulation lays down rules on the organisation and operation of accreditation of conformity assessment bodies performing conformity assessment activities.

2. This Regulation provides a framework for the market surveillance of products to ensure that those products fulfil requirements providing a high level of protection of public interests, such as health and safety in general, health and safety at the workplace, the protection of consumers, protection of the environment and security.’

5 Article 2(10) of that regulation defines ‘accreditation’ as meaning ‘an attestation by a national accreditation body that a conformity assessment body meets the requirements set by harmonised standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity’.

6 Article 2(11) of the same regulation defines the ‘national accreditation body’ as meaning ‘the sole body in a Member State that performs accreditation with authority derived from the State’.

7 Article 4 of Regulation No 765/2008, entitled ‘General principles’, provides in paragraphs 1, 2, 5 and 7 thereof:

‘1. Each Member State shall appoint a single national accreditation body.

2. Where a Member State considers that it is not economically meaningful or sustainable to have a national accreditation body or to provide certain accreditation services, it shall, as far as possible, have recourse to the national accreditation body of another Member State.

…

5. Where accreditation is not operated directly by the public authorities themselves, a Member State shall entrust its national accreditation body with the operation of...