Judgment;Summary — ECLI:EU:C:2021:368
Date: 2021-05-06
Language of the case: Italian
Court formation: First Chamber
Subject matter: Competition;External relations;Commercial policy;Approximation of laws;Freedom to provide services;Fundamental rights;Charter of Fundamental Rights
Procedure: Reference for a preliminary ruling
Origin: Italy

Summary C-142/20 - 1 
Case C-142/20 
Summary of the request for a preliminary ruling pursuant to Article 98(1) of 
the Rules of Procedure of the Court of Justice 
Date lodged: 
26 March 2020 
Referring court: 
Consiglio di Giustizia Amministrativa per la Regione Siciliana 
(Italy) 
Date of the decision to refer: 
26 February 2020 
Appellant: 
Analisi G. Caracciolo s.r.l. 
Respondents: 
Regione Siciliana – Assessorato regionale della salute – 
Dipartimento regionale per la pianificazione (Sicily Regional 
Authority – Regional Department of Health – Regional Planning 
Unit) 
Regione Sicilia – Assessorato della salute – Dipartimento per le 
attività sanitarie e osservatorio (Sicily Regional Authority – 
Regional Department of Health – Health Unit and Observatory) 
Accredia (Italian accreditation body) 
Azienda sanitaria provinciale di Palermo (Palermo Provincial 
Health Authority) 
      
Subject of the action in the main proceedings 
Appeal before the Consiglio di Giustizia amministrativa per la Regione siciliana 
(Council of Administrative Justice for Sicily) against the judgment of the 
Tribunale amministrativo regionale per la Sicilia (Regional Administrative Court, 
Sicily) by which that court rejected the action brought by Laboratorio Analisi 
EN 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING - CASE C-142/20 
 
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G. Caracciolo s.r.l. contesting its exclusion from the ‘Regional list of laboratories 
conducting analyses in connection with self-testing procedures for food 
businesses’ on the ground that it is not accredited with the single national 
accreditation body. 
Subject-matter and legal basis of the reference 
Compatibility of Article 40 of legge del 7 luglio 2009, n. 88 (Law No 88 of 7 July 
2009) with Regulation (EC) No 765/2008 and, in the alternative, the validity of 
that regulation in the light of Articles 56 and 102 TFEU and Articles 20 and 21 of 
the Charter of Fundamental Rights of the European Union. 
Questions referred 
(1) 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 agreements, 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? 
(2) In the light of Article 56 TFEU, Articles 20 and 21 of the Charter of 
Fundamental Rights of the European Union 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? 
Provisions of EU law relied on 
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 
(‘Regulation No 765/2008’), and in particular Article 4(1), (5) and (7), Articles 6 
and 7(1), second subparagraph, Articles 8 to 11 and recitals 1, 15, 19 and 20 
thereof. 
Articles 56 and 102 TFEU. 
Articles 20 and 21 of the Charter of Fundamental Rights of the European Union 
(the ‘Charter’). 
ANALISI G. CARACCIOLO 
 
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Provisions of national law cited 
Law No 88 of 7 July 2009 – Provisions for the fulfilment of obligations resulting 
from Italy’s membership of the European Communities – Community Law 2008 
(‘Law No 88/2009’). In particular, paragraphs 1 and 2 of Article 40, entitled 
‘Provisions for the accreditation of laboratories for self-testing in the food 
industry’, state that laboratories not attached to food businesses, which carry out 
analyses in connection with self-testing procedures for food businesses, and 
laboratories attached to food businesses, which carry out those analyses on behalf 
of other food businesses owned by different legal entities, must be accredited, in 
accordance with standard UNI CEI EN ISO/IEC 17025, by an accreditation body 
recognised and operating in accordance with standard UNI CEI EN ISO/IEC 
17011. Under paragraph 3 of that article, the criteria and methods for the listing, 
updating and delisting of laboratories, and the uniform procedures for inspections 
regarding compliance by laboratories with the abovementioned requirements, are 
established by a special agreement between Italy’s central government and its 
regions. 
Legge del 23 luglio 2009, n. 99 – Disposizioni per lo sviluppo e 
l’internazionalizzazione delle imprese, nonché in materia di energia (Law No 99 
of 23 July 2009 – Measures for the development and internationalisation of 
companies, including in the energy sector) (‘Law No 99/2009’). In particular, 
Article 4, implementing Chapter II of Regulation No 765/2008, provides, in 
paragraph 1 thereof, that the Ministry of Economic Development, in agreement 
with the ministers concerned, is to adopt by decree the requirements for the 
organisation and functioning of the single national entity authorised to act as an 
accreditation body, in accordance with the abovementioned regulation, and for the 
setting of accreditation fees and arrangements for the supervision of the body by 
the ministries concerned. Article 4(2) states that the Minister for Economic 
Development, in agreement with the ministers concerned, is then to appoint by 
decree the single Italian body authorised to perform accreditation. Moreover, it 
should be noted that the Ministry of Economic Development is the national 
authority responsible for accreditation and the national point of contact with the 
European Commission. 
Decreto del Ministro dello sviluppo economico del 22 dicembre 2009 (Decree of 
the Minister for Economic Development of 22 December 2009). This Decree 
names Accredia as Italy’s single national accreditation body. Article 1 of the 
decree governs the organisation and functioning of that body and establishes the 
criteria for setting accreditation fees and the arrangements for supervision of the 
body by the ministers concerned. Article 3 states that the Italian national 
accreditation body is to operate on a non-profit basis; to ensure that accreditation 
is carried out in the public interest; does not offer activities or services carried out 
by conformity assessment bodies, or provide consultancy services; does not own 
shares and does not have a financial or management interest in conformity 
assessment bodies; meets the necessary requirements to be a member of the 
European accreditation infrastructure referred to in Article 14 of Regulation No 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING - CASE C-142/20 
 
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765/2008; and does not compete with conformity assessment bodies or other 
national accreditation bodies. 
Accordo Stato-Regioni dell’8 luglio 2010 (Agreement of 8 July 2010 between 
Italy’s central government and regions). Articles 1 and 2 of that agreement 
reproduce the provisions of Article 40(1) and (2) of Law No 88/2009. Under 
Article 3 of the agreement, regional authorities are required to register in 
appropriate lists the laboratories in their territory accredited in accordance with 
Article 2(1), as well as laboratories not yet accredited but which have provided 
evidence that the accreditation process is under way; this must be completed 
within a maximum of 18 months of submitting the relevant application to the 
regional authority. Where a laboratory is included in the lists, the activity in 
question may be carried out nationwide. The regional authorities are required to 
publish updated lists each year. 
Outline of the facts and the main proceedings 
1 By decree of its Chief Executive of 9 April 2014, the regional authority added the 
appellant, Laboratorio Analisi G. Caracciolo s.r.l., to the ‘Regional list of 
laboratories carrying out analyses in connection with self-testing procedures for 
food businesses’ (‘the regional list’), since it was accredited according to standard 
UNI CEI EN ISO/IEC 17025 by an accreditation body recognised and operating 
in accordance with standard UNI CEI EN ISO/IEC 17011. 
2 At the time of the regional listing, the appellant was in the process of being 
accredited with Accredia, but later decided to obtain accreditation from Perry 
Johnson Laboratory Accreditation Inc. (‘PJLA’), which is based in the United 
States. Accredia and PJLA are both accreditation bodies recognised by the 
abovementioned provisions. 
3 The updated regional list was published by decree of the Chief Executive of 
9 March 2017. It did not include the appellant since, according to the Palermo 
Provincial Health Authority’s report of 4 July 2016, it was not accredited by the 
accreditation body Accredia. 
4 The appellant challenged the decree and the report before the Tribunale 
amministrativo regionale per la Sicilia (Regional Administrative Court, Sicily), 
which rejected its action. 
5 The appellant then appealed before the Council of Administrative Justice for 
Sicily, the referring court. 
The essential arguments of the parties to the main proceedings 
6 The appellant submits that the exclusive basis on which Accredia operates as an 
accreditation body infringes, inter alia, the provisions of EU competition law 
ANALISI G. CARACCIOLO 
 
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(Article 102 TFEU), freedom to provide services (Article 56 TFEU), as well as 
the principle of non-discrimination enshrined in Articles 20 and 21 of the Charter. 
7 The accreditation activities performed by PJLA should in fact be regarded as 
wholly equivalent to those performed by Accredia, since the two bodies, both 
members of the International Laboratory Accreditation Cooperation (ILAC), have 
signed a mutual recognition agreement and fully adhere to the same safety and 
inspection standards. 
8 Furthermore, according to the appellant, Article 40 of Law No 88/2009 – which 
the applicant argues is a lex specialis, such that this provision may be applied 
independently of the provisions of Regulation No 765/2008, since Law No 
88/2009 directly implements EU directives – simply requires accreditation to be 
carried out according to UNI CEI EN ISO/IEC 17025 and the accreditation body 
to be recognised and operate in accordance with UNI CEI EN ISO/IEC 17011. 
PJLA satisfies both of those requirements. Therefore, national legislation also 
allows accreditation to be carried out by bodies other than the single national 
body, in this case Accredia. As a result, a laboratory is permitted to apply for 
accreditation from PJLA. 
9 The applicant considers that Regulation No 765/2008 must be interpreted in 
conformity with primary EU law, in particular Articles 56 and 102 TFEU and 
Articles 20 and 21 of the Charter, and that if the referring court should identify 
any conflict between those provisions, the question of the validity of the 
Regulation must be referred to the Court of Justice. 
10 PJLA intervened in support of the appellant, submitting that Accredia’s monopoly 
prevents it from operating in Italy and that the extraterritorial application of the 
provisions of EU competition law is allowed where a restrictive practice has an 
appreciable effect within the EU, irrespective of where the operators involved are 
located. 
11 Accredia contests the merits of the appellant’s grounds of appeal, first objecting to 
the reference for a preliminary ruling to the Court of Justice on the ground that it 
is apparent from Regulation No 765/2008 that the accreditation activity performed 
by the single body is a public function designated by the State, and not an 
economic activity, and second, arguing that the provisions of EU law that the 
appellant alleges have been infringed only apply to nationals and economic 
operators of the Member States, and therefore not to a body such as PJLA, which 
is established in a third country. 
12 The regional authority submits that a reference for a preliminary ruling to the 
Court of Justice cannot be made, since in the main proceedings the need to protect 
public health takes precedence over the alleged infringement of the principle of 
EU law of guaranteeing freedom of access to the market and free competition. 
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Succinct presentation of the reasons for the reference for a preliminary 
ruling 
13 The referring court considers that the Italian legislation in question has fully 
transposed Regulation No 765/2008 into national law, by providing for a single 
national accreditation body (Accredia), and that it is therefore not possible to 
extend the activity of providing accreditation to other bodies, such as PJLA. 
14 Specifically, Law No 88/2009 and Regulation No 765/2008 must be interpreted 
from the perspective of integration/coordination rather than derogation/conflict, 
given the direct applicability of the regulation in question. In the light of that 
regulation, Article 40 of Law No 88/2009 must thus be understood to refer to 
operators acting within the ‘single body’ system, which is also confirmed by 
Article 4 of Law No 99/2009. 
15 While the referring court considers that interpretation to be correct, it is 
nevertheless uncertain whether Regulation No 765/2008 precludes an 
interpretation of Italian legislation to the effect that accreditation may also be 
carried out by bodies, such as PJLA, which are not established in the European 
Union but have equivalent levels of qualification to those of the single body. 
16 If so, the referring court asks, in the alternative, whether Regulation No 765/2008, 
by imposing a statutory monopoly on accreditation, is compatible with the EU law 
principles of freedom to provide services (Article 56 TFEU), protection of 
competition (Article 102 TFEU) equal treatment and non-discrimination 
(Articles 20 and 21 of the Charter), and thus whether it is valid. 
17 As regards Article 56 TFEU in particular, the referring court refers to the case-law 
of the Court of Justice according to which Article 56 TFEU precludes the 
application of any national rules which have the effect of making the provision of 
services between Member States more difficult than the provision of services 
purely within a Member State. Article 56 TFEU requires the abolition of any 
restriction on the freedom to provide services imposed on the ground that the 
service provider is established in a Member State other than that in which the 
service is provided. Restrictions on the freedom to provide services are national 
measures which prohibit, impede or render less attractive the exercise of that 
freedom (judgment of 25 July 2018, TTL, C-553/16, EU:C:2018:604, paragraphs 
45 and 46 and the case-law cited). The freedom to provide services conferred by 
Article 56 TFEU on Member State nationals includes ‘passive’ freedom to 
provide services, namely the freedom for recipients of services to go to another 
Member State in order to receive a service there, without being hindered by 
restrictions (judgment of 9 March 2017, Piringer, C-342/15, EU:C:2017:196, 
paragraph 35). 
18 As to Article 102 TFEU, the referring court refers to the case-law of the Court of 
Justice according to which the definition of the relevant market, in the application 
of Article 102 TFEU, is a prerequisite of any assessment of whether the 
ANALISI G. CARACCIOLO 
 
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undertaking concerned holds a dominant position (judgment of 30 January 2020, 
Generics (UK) Ltd and Others v Competition and Markets Authority, C-307/18, 
EU:C:2020:52, paragraphs 127, 128 and 129). 
19 The referring court considers that the monopoly system for accreditation activities 
does not infringe Article 102 TFEU, since Accredia cannot be treated in the same 
way as an undertaking, is non-profit-making and performs an essential public 
function. Furthermore, PJLA, as an entity established in a third country, cannot 
invoke the provisions of EU law. 
20 However, the referring court has doubts as to the compatibility with Article 102 
TFEU of the monopoly established by the single body system, in relation to the 
freedom to provide on a competitive basis accreditation services within the EU.