ECLI:EU:C:2026:561

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JUDGMENT OF THE COURT (Fourth Chamber)

9 July 2026 (*)

( Reference for a preliminary ruling – Environment – Control of major-accident hazards involving dangerous substances – Directive 2012/18/EU – Article 2 – Scope – Article 3(12) – Concept of ‘presence of dangerous substances’ – Continuous monitoring of substances actually present within an establishment – Anticipated or reasonably foreseeable presence – Determination by reference to the maximum quantities of substances indicated in the operating permit )

In Case C‑224/24,

REQUEST for a preliminary ruling under Article 267 TFEU from the Consiglio di Stato (Council of State, Italy), made by decision of 21 March 2024, received at the Court on 25 March 2024, in the proceedings

Società Eredi Raimondo Bufarini Srl – Servizi Ambientali

Ministero dell’Interno,

Ministero della Transizione Ecologica,

Comitato tecnico regionale delle Marche,

Coordinamento per l’uniforme applicazione sul territorio nazionale di cui all’art. 11 del D.Lgs. 105/2015,

intervening parties:

Regione Marche,

FP,

THE COURT (Fourth Chamber),

composed of I. Jarukaitis (Rapporteur), President of the Chamber, K. Lenaerts, President of the Court, acting as Judge of the Fourth Chamber, M. Condinanzi, N. Jääskinen and R. Frendo, Judges,

Advocate General: N. Emiliou,

Registrar: A. Calot Escobar,

having regard to the written procedure,

after considering the observations submitted on behalf of:

– Società Eredi Raimondo Bufarini Srl – Servizi Ambientali, by L. Filippucci, avvocato,

– the European Commission, by L. Di Masi, J. Jokubauskaitė and D. Milanowska, acting as Agents,

after hearing the Opinion of the Advocate General at the sitting on 23 October 2025,

gives the following

Judgment

1 This request for a preliminary ruling concerns the interpretation of Article 3(12) and Article 7 of Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012 on the control of major-accident hazards involving dangerous substances, amending and subsequently repealing Council Directive 96/82/EC (OJ 2012 L 197, p. 1).

2 The request has been made in proceedings between Società Eredi Raimondo Bufarini Srl – Servizi Ambientali, a company incorporated under Italian law, on the one hand, and the Ministero dell’Interno (Ministry of the Interior), the Ministero della Transizione Ecologica (Ministry of Ecological Transition), the Comitato tecnico regionale delle Marche (regional technical committee, Marche, Italy) (‘the technical committee’), and the Coordinamento per l’uniforme applicazione sul territorio nazionale di cui all’art. 11 del D. Lgs 105/2015 (coordination service for the uniform application on national territory provided for in Article 11 of Legislative Decree No 105/2015), on the other, concerning the decision, taken by the technical committee, to give formal notice to that company to submit documents relating to the control of major-accident hazards involving dangerous substances.

Legal context

European Union law

The FEU Treaty

3 Article 191 TFEU provides:

‘1. Union policy on the environment shall contribute to pursuit of the following objectives:

– preserving, protecting and improving the quality of the environment,

– protecting human health,

– prudent and rational utilisation of natural resources,

– promoting measures at international level to deal with regional or worldwide environmental problems, and in particular combating climate change.

2. Union policy on the environment shall aim at a high level of protection taking into account the diversity of situations in the various regions of the Union. It shall be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay.

…’

4 Article 192(1) TFEU states:

‘The European Parliament and the Council [of the European Union], acting in accordance with the ordinary legislative procedure and after consulting the [European] Economic and Social Committee and the [European] Committee of the Regions, shall decide what action is to be taken by the Union in order to achieve the objectives referred to in Article 191.’

Directive 2008/98/EC

5 Article 23 of Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ 2008 L 312, p. 3), entitled ‘Issue of permits’, provides, in paragraph 1 thereof:

‘Member States shall require any establishment or undertaking intending to carry out waste treatment to obtain a permit from the competent authority.

Such permits shall specify at least the following:

(a) the types and quantities of waste that may be treated;

(b) for each type of operation permitted, the technical and any other requirements relevant to the site concerned;

(d) the method to be used for each type of operation;

(e) such monitoring and control operations as may be necessary;

…’

Directive 2010/75/EU

6 Article 4 of Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (OJ 2010 L 334, p. 17), entitled ‘Obligation to hold a permit’, states:

‘1. Member States shall take the necessary measures to ensure that no installation or combustion plant, waste incineration plant or waste co-incineration plant is operated without a permit.

…’

7 Chapter II of that directive, entitled ‘Provisions for activities listed in Annex I’, includes Article 12 of that directive, entitled ‘Applications for permits’, which provides:

‘1. Member States shall take the necessary measures to ensure that an application for a permit includes a description of the following:

(a) the installation and its activities;

(b) the raw and auxiliary materials, other substances and the energy used in or generated by the installation;

…’

8 Part 5 of Annex I to that directive includes waste management among the activities covered by that directive.

Directive 2012/18

9 Recitals 2 to 4, 6, 12, 15 and 16 of Directive 2012/18 state:

‘(2) Major accidents often have serious consequences … Moreover the impact can extend beyond national borders. This underlines the need to ensure that appropriate precautionary action is taken to ensure a high level of protection throughout the Union for citizens, communities and the environment. There is therefore a need to ensure that the existing high level of protection remains at least the same or increases.

(3) … While overall the existing provisions are fit for purpose, some changes are required in order to further strengthen the level of protection, in particular with regard to the prevention of major accidents. …

(4) It is therefore appropriate to replace [Council Directive 96/82/EC of 9 December 1996 on the control of major-accident hazards involving dangerous substances (OJ 1997 L 10, p. 13)] in order to ensure that the existing level of protection is maintained and further improved, by making the provisions more effective and efficient, and where possible by reducing unnecessary administrative burdens by streamlining or simplification, provided that safety and environmental and human health protection are not compromised. At the same time, the new provisions should be clear, coherent and easy to understand to help improve implementation and enforceability, while the level of protection of human health and the environment remains at least the same or increases. …

…

(6) Major accidents can have consequences beyond frontiers, and the ecological and economic costs of an accident are borne not only by the establishment affected, but also by the Member States concerned. It is therefore necessary to establish and apply safety and risk-reduction measures to prevent possible accidents, to reduce the risk of accidents occurring and to minimise the effects if they do occur, thereby making it possible to ensure a high level of protection throughout the Union.

…

(12) Operators should have a general obligation to take all necessary measures to prevent major accidents, to mitigate their consequences and to take recovery measures. Where dangerous substances are present in establishments above certain quantities the operator should provide the competent authority with sufficient information to enable it to identify the establishment, the dangerous substances present and the potential dangers. The operator should also draw up and, where required by national law, send to the competent authority a major-accident prevention policy (MAPP) setting out the operator’s overall approach and measures, including appropriate safety management systems, for controlling major-accident hazards. When the operators identify and evaluate the major-accident hazards, consideration should also be given to the dangerous substances which may be generated during a severe accident within the establishment.

…

(15) In order to demonstrate that all that is necessary has been done to prevent major accidents, and to prepare emergency plans and response measures, the operator should, in the case of establishments where dangerous substances are present in significant quantities, provide the competent authority with information in the form of a safety report. That safety report should contain details of the establishment, the dangerous substances present, the installation or storage facilities, possible major-accident scenarios and risk analysis, prevention and intervention measures and the management systems available, in order to prevent and reduce the risk of major accidents and to enable the necessary steps to be taken to limit the consequences thereof. …

(16) To prepare for emergencies, in the case of establishments where dangerous substances are present in significant quantities, it is necessary to establish internal and external emergency plans and to establish procedures to ensure that those plans are tested and revised as necessary and implemented in the event of a major accident or the likelihood thereof. The staff of an establishment should be consulted on the internal emergency plan and the public concerned should have the opportunity to give its opinion on the external emergency plan. …’

10 Article 1 of Directive 2012/18, entitled ‘Subject matter’, provides:

‘This Directive lays down rules for the prevention of major accidents which involve dangerous substances, and the limitation of their consequences for human health and the environment, with a view to ensuring a high level of protection throughout the Union in a consistent and effective manner.’

11 Article 2 of that directive, entitled ‘Scope’, states, in paragraph 1 thereof:

‘This Directive shall apply to establishments as defined in Article 3(1).’

12 Article 3 of that directive contains, in paragraphs 1 to 3, 5 and 8 to 12 thereof, the following definitions:

‘For the purposes of this Directive the following definitions shall apply:

1. “establishment” means the whole location under the control of an operator where dangerous substances are present in one or more installations, including common or related infrastructures or activities; establishments are either lower-tier establishments or upper-tier establishments;

2. “lower-tier establishment” means an establishment where dangerous substances are present in quantities equal to or in excess of the quantities listed in Column 2 of Part 1 or in Column 2 of Part 2 of Annex I, but less than the quantities listed in Column 3 of Part 1 or in Column 3 of Part 2 of Annex I, where applicable using the summation rule laid down in note 4 to Annex I;

3. “upper-tier establishment” means an establishment where dangerous substances are present in quantities equal to or in excess of the quantities listed in Column 3 of Part 1 or in Column 3 of Part 2 of Annex I, …

…

5. “new establishment” means

…

(b) a site of operation that falls within the scope of this Directive, or a lower-tier establishment that becomes an upper-tier establishment or vice versa, on or after 1 June 2015 due to modifications to its installations or activities resulting in a change in its inventory of dangerous substances;

…

8. “installation” means a technical unit within an establishment and whether at or below ground level, in which dangerous substances are produced, used, handled or stored; …

9. “operator” means any natural or legal person who operates or controls an establishment or installation or, where provided for by national legislation, to whom the decisive economic or decision-making power over the technical functioning of the establishment or installation has been delegated;

10. “dangerous substance” means a substance or mixture covered by Part 1 or listed in Part 2 of Annex I, including in the form of a raw material, product, by-product, residue or intermediate;

11. “mixture” means a mixture or solution composed of two or more substances;

12. “presence of dangerous substances” means the actual or anticipated presence of dangerous substances in the establishment, or of dangerous substances which it is reasonable to foresee may be generated during loss of control of the processes, including storage activities, in any installation within the establishment, in quantities equal to or in excess of the qualifying quantities set out in Part 1 or Part 2 of Annex I’.

13 Article 5 of Directive 2012/18, entitled ‘General obligations of the operator’, provides, in paragraph 1 thereof:

‘Member States shall ensure that the operator is obliged to take all necessary measures to prevent major accidents and to limit their consequences for human health and the environment.’

14 Article 7 of that directive, entitled ‘Notification’, states:

‘1. Member States shall require the operator to send a notification to the competent authority containing the following information:

…

(d) information sufficient to identify the dangerous substances and category of substances involved or likely to be present;

(e) the quantity and physical form of the dangerous substance or substances concerned;

…

2. The notification or its update shall be sent to the competent authority within the following [time limits]:

(a) for new establishments, a reasonable period of time prior to the start of construction or operation, or prior to the modifications leading to a change in the inventory of dangerous substances;

…

4. The operator shall inform the competent authority in advance of the following events:

(a) any significant increase or decrease in the quantity or significant change in the nature or physical form of the dangerous substance present, as indicated in the notification provided by the operator pursuant to paragraph 1, or a significant change in the processes employing it;

(b) modification of an establishment or an installation which could have significant consequences in terms of major-accident hazards;

…’

15 Article 8 of that directive, entitled ‘Major-accident prevention policy’, is worded as follows:

‘1. Member States shall require the operator to draw up a document in writing setting out the major-accident prevention policy (MAPP) and to ensure that it is properly implemented. The MAPP shall be designed to ensure a high level of protection of human health and the environment. It shall be proportionate to the major-accident hazards. …

2. The MAPP shall be drawn up and, where required by national law, sent to the competent authority within the following [time limits]:

(a) for new establishments, a reasonable period of time prior to the start of construction or operation, or prior to the modifications leading to a change in the inventory of dangerous substances;

…’

16 Article 10 of that directive, entitled ‘Safety report’, provides, in paragraph 1 thereof, that Member States are to require the operator of an ‘upper-tier establishment’ to produce a safety report in order to demonstrate, in particular, that a MAPP has been put into effect, that major-accident hazards and possible major-accident scenarios have been identified, that the necessary measures have been taken to prevent such accidents and to limit their consequences, and the safety and reliability of the design, construction, operation and maintenance of the installations concerned. According to Article 10(3) and (5), first, new establishments are to send the safety report within a reasonable period of time prior to the start of construction or operation, or prior to the modification leading to a change in the inventory of dangerous substances and, secondly, the operator is to periodically review and where necessary update the safety report. Moreover, in accordance with Article 10(6), the competent authority is to communicate the conclusions concerning that report to the operator and, where appropriate, prohibit the bringing into use, or the continued use, of the establishment concerned.

17 Article 11 of Directive 2012/18, entitled ‘Modification of an installation, an establishment or a storage facility’, states:

‘In the event of the modification of an installation, establishment, storage facility, or process or of the nature or physical form or quantity of dangerous substances which could have significant consequences for major-accident hazards, or could result in a lower-tier establishment becoming an upper-tier establishment or vice versa, Member States shall ensure that the operator reviews, and where necessary updates the notification, the MAPP, the safety management system and the safety report and informs the competent authority of the details of those updates in advance of that modification.’

18 Article 12 of that directive, entitled ‘Emergency plans’, provides, in paragraph 1(a) and (b) thereof, that Member States are to ensure that, for all ‘upper-tier establishments’, the operator draws up an internal emergency plan for the measures to be taken inside the establishment and supplies the necessary information to the competent authority, to enable the latter to draw up external emergency plans, and provides, in paragraph 2(a) thereof, that operators of new establishments are to comply with those obligations within a reasonable period of time prior to the start of operation, or prior to the modification leading to a change in the inventory of dangerous substances.

19 Annex I to that directive, entitled ‘Dangerous substances’, provides:

‘Dangerous substances covered by the hazard categories listed in Column 1 of Part 1 of this Annex are subject to the qualifying quantities set out in Columns 2 and 3 of Part 1.

Where a dangerous substance is covered by Part 1 of this Annex and is also listed in Part 2, the qualifying quantities set out in Columns 2 and 3 of Part 2 apply.

…’

20 Notes 3 and 5 to Annex I of that directive are worded as follows:

‘3. …

The quantities to be considered for the application of the relevant Articles are the maximum quantities which are present or are likely to be present at any one time. …

…

5. In the case of dangerous substances which are not covered by Regulation (EC) No 1272/2008 [of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1)], including waste, but which nevertheless are present, or are likely to be present, in an establishment and which possess or are likely to possess, under the conditions found at the establishment, equivalent properties in terms of major-accident potential, these shall be provisionally assigned to the most analogous category or named dangerous substance falling within the scope of this Directive.’

Italian law

21 Directive 2012/18 was transposed into Italian law by decreto legislativo n. 105 – Attuazione della direttiva 2012/18/UE relativa al controllo del pericolo di incidenti rilevanti connessi con sostanze pericolose (Legislative Decree No 105 – Implementation of Directive 2012/18/EU on the control of major-accident hazards involving dangerous substances) of 26 June 2015 (GURI No 161 of 14 July 2015, Ordinary Supplement No 38; ‘Legislative Decree No 105/2015’). That legislative decree indicates that it is not to apply to establishments in which dangerous substances do not exceed the low threshold that it establishes. By contrast, where the presence of dangerous substances is between the lower and upper thresholds, the provisions of that legislative decree relating to ‘lower-tier establishments’ are to apply. Furthermore, that legislative decree is to apply in its entirety to ‘upper-tier establishments’.

22 Article 3(n) of Legislative Decree No 105/2015 defines the concept of ‘presence of dangerous substances’ using wording identical to that used in Article 3(12) of Directive 2012/18.

23 Article 13 of that legislative decree, reproducing, in essence, the wording of Article 7 of Directive 2012/18 provides, in paragraphs 1 and 2 thereof, for an obligation for the operator of an establishment to send, in accordance with the procedure set out in Article 13(5), a notification, drawn up in accordance with the form in Annex 5 to that legislative decree, containing the items of information listed in Article 13(2).

The dispute in the main proceedings and the questions referred for a preliminary ruling

24 The applicant in the main proceedings operates a hazardous and non-hazardous liquid waste treatment plant at Falconara Marittima (Italy), under an integrated environmental permit issued on 5 September 2012 by the province of Ancona (Italy), which allows it to store up to 800 tonnes of hazardous waste and treat up to 200 tonnes of waste of that type per day.

25 On 18 February 2020, a working group established within the technical committee, acting as the competent authority, within the meaning of Directive 2012/18, found that the establishment of the applicant in the main proceedings could not be excluded from the scope of the Italian legislation on the control of major-accident hazards involving dangerous substances, in particular from that of Legislative Decree No 105/2015.

26 Consequently, by decision of 28 May 2020, the technical committee gave the applicant in the main proceedings formal notice to submit the notification provided for in Article 13 of that legislative decree and the safety report also referred to in that legislative decree.

27 After a new review procedure, the technical committee, by decision of 24 November 2020, reiterated that formal notice and indicated that, if it did not comply, the applicant in the main proceedings had to physically restrict the use of certain tanks located within its establishment, so as to avoid exceeding the limits provided for by Legislative Decree No 105/2015.

28 The applicant in the main proceedings challenged that decision before the Tribunale amministrativo regionale per le Marche (Regional Administrative Court, Marche, Italy), which dismissed its action by judgment of 23 June 2021.

29 The applicant in the main proceedings brought an appeal against that judgment before the Consiglio di Stato (Council of State, Italy), which is the referring court, claiming that the Italian legislation concerned was contrary to EU law on the control of major-accident hazards involving dangerous substances and asking that court, therefore, to refer a question on the interpretation of Article 3(12) of Directive 2012/18 to the Court of Justice for a preliminary ruling.

30 By decision of 25 January 2022, the referring court decided to stay the proceedings and to make a first request to the Court of Justice for a preliminary ruling in the main proceedings. By that request, the referring court referred three questions to the Court of Justice for a preliminary ruling, the first two of which concerned the interpretation of Article 267 TFEU as regards, first, the right of a national court of last instance to refrain from referring a question to the Court of Justice for a preliminary ruling where it considers that the interpretation of the provision of EU law concerned leaves no scope for any reasonable doubt and, secondly, whether national legislation which allows such a national court to incur civil and disciplinary liability on account of the rejection, by that court, of a request, made by one of the parties to the dispute before it, to make a reference to the Court of Justice for a preliminary ruling, is consistent with Article 267. The third question referred for a preliminary ruling, raised in case the Court answered the first two questions in the affirmative, concerned the compliance with Article 3(12) of Directive 2012/18 of a practice aimed at determining the quantities of dangerous substances present within a waste treatment plant.

31 By order of 15 December 2022, Società Eredi Raimondo Bufarini (C‑144/22, EU:C:2022:1013), the Court answered the first question by holding, in essence, that Article 267 TFEU must be interpreted as meaning that a national court or tribunal against whose decisions there is no judicial remedy under national law may refrain from referring to the Court a question concerning the interpretation of EU law and take upon itself the responsibility for resolving it where the correct interpretation of EU law is so obvious as to leave no scope for any reasonable doubt. The question whether such a possibility exists must be assessed on the basis of the characteristic features of EU law, the particular difficulties to which its interpretation gives rise and the risk of divergences in judicial decisions within the European Union.

32 The Court specified that, in that connection, that such a national court or tribunal is not required to establish in detail that the other courts or tribunals of last instance of the Member States and the Court would give the same interpretation of the provisions of EU law concerned, but must have obtained the conviction, according to an assessment which takes account of the abovementioned factors, that the matter would be equally obvious to those other national courts or tribunals and to the Court.

33 Moreover, the Court held, in that order, that the second question, referred to in paragraph 30 of the present judgment, was inadmissible, since it bore no relation to the subject matter of the main proceedings and that, in the light of the answer to the first question referred, it was not necessary to answer the third question.

34 By the present request for a preliminary ruling, the referring court decided, in the context of the same main proceedings, to again refer questions on the interpretation of Directive 2012/18 to the Court of Justice. It considers that there remains reasonable doubt as regards the interpretation of the provisions of that directive.

35 The applicant in the main proceedings submits, in that connection, before the referring court, that, under EU law on the control of major-accident hazards involving dangerous substances, the operator of a waste treatment plant must be able to prove that the presence of such substances within its establishment never reaches the lower threshold, within the meaning of Directive 2012/18, by means of a management system that allows for continuous monitoring of the substances present within that plant. It argues that the Italian legislation which does not allow such an approach is therefore contrary to that directive.

36 The referring court considers the interpretation of the concept of ‘presence of dangerous substances’ in Article 3(12) of Directive 2012/18 to be decisive for the resolution of the dispute before it, in particular as regards the possibility of examining the presence of such substances by means of the system referred to by the applicant in the main proceedings.

37 Furthermore, that court considers the interpretation of Article 7 of Directive 2012/18 to also be relevant in order to assess whether the competent Italian authority was required to authorise the applicant in the main proceedings to communicate the information serving to identify the presence of dangerous substances in accordance with a procedure other than that set out in the Italian legislation and, consequently, whether or not the formal notice at issue in the main proceedings is lawful. According to that court, Article 7 leaves the Member States free to choose the most appropriate method by which the operator must communicate that information. By requiring, in general, that the ‘effectiveness of the system’ is ensured, that directive does not prevent Member States from choosing one single mode of communication of that information. At the same time, the concept of ‘notification’, used in Article 7, suggests that the directive in question does not impose a specific procedure for that communication. Furthermore, in order to determine whether Member States may impose a single method for notification, the principles of free competition and freedom of establishment, on the one hand, must be balanced against the need to protect the environment and safety, on the other.

38 In those circumstances, the Consiglio di Stato (Council of State) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:

‘(1) Does the definition of “presence of dangerous substances” in Article 3(12) of [Directive 2012/18] preclude a practice whereby the determination of the quantities of dangerous substances present in a waste treatment installation is conducted through an operational procedure implemented by the operator (and possibly authorised by the permit provided for in Article 23 of [Directive 2008/98] or Article 4 of [Directive 2010/75]) which classifies waste as “mixtures” within the meaning of Article 3(11) of [Directive 2012/18] and provides for constant monitoring of the quantity of dangerous substances present in the installation and ensures that the lower and upper thresholds laid down in Column 2 and Column 3 of Annex I to [Directive 2012/18] are not exceeded?

(2) Does Article 7 of [Directive 2012/18], which provides that the operator is required to send “a notification to the competent authority” containing the information listed in Article 7(1) of that directive, interpreted in accordance with the principles of competition and freedom of establishment, preclude a provision such as Article 13(1), (2) and (5) of [Legislative Decree No 105/2015], which provides that the information must be communicated exclusively by means of “a notification drawn up in accordance with the form set out in Annex 5” (paragraph 1), “signed in the form of self-certification in accordance with the regulations in force” (paragraph 2), “sent by the operator to the recipients referred to in paragraph 1 in electronic form using the telematics services and tools made available via the inventory of establishments likely to cause major accidents referred to in Article 5(3)” or “exclusively by digitally signed certified electronic mail” (paragraph 5), thus ruling out a method of communication using “an operational procedure implemented by the operator”, providing for constant monitoring of the quantity of dangerous substances present in the installation and ensuring that the lower and upper thresholds laid down in Column 2 and Column 3 of Annex I to [Directive 2012/18] are not exceeded?’

Consideration of the questions referred

The first question

39 By its first question, the referring court asks, in essence, whether Article 3(12) of Directive 2012/18 must be interpreted as precluding a practice, possibly included in the waste management permit issued by the competent administrative authority, according to which, for the purpose of assessing the ‘presence of dangerous substances’ in an establishment, within the meaning of that provision, and of proving that the quantities thereof at no time reach the quantities indicated in Part 1 or Part 2 of Annex I to that directive, it is not permissible to rely solely on a management system implemented by the operator of that establishment ensuring the continuous monitoring of such substances actually present within it.

40 In that connection, Article 2(1) of Directive 2012/18 states that that directive applies to establishments as defined in Article 3 thereof. As is apparent from a combined reading of Article 3(1) to (3) and (10), the concept of ‘establishment’ refers to the entire location under the control of an operator where dangerous substances covered by Part 1 or Part 2 of Annex I to that directive are present in one or more installations in quantities equal to or in excess of the quantities indicated in Annex I.

41 It follows that the quantities of dangerous substances present in an establishment determine whether that establishment falls within the scope of application of Directive 2012/18. In that way, establishments in which those substances are present in quantities below the thresholds indicated in Column 2 of Part 1 or Part 2 of Annex I to that directive do not fall within its scope. Furthermore, depending on those quantities, establishments are classified as ‘lower-tier establishments’ or ‘upper-tier establishments’ within the meaning of paragraphs 2 and 3 respectively of Article 3 of that directive. That classification determines the extent of the obligations imposed, under that directive, on the Member State and operator concerned.

42 Article 3(12) of Directive 2012/18, the interpretation of which is sought by the referring court, defines the concept of ‘presence of dangerous substances’ as the actual or anticipated presence of dangerous substances in the establishment, or of dangerous substances which it is reasonable to foresee may be generated during loss of control of the processes in any installation within the establishment, in quantities equal to or in excess of the ‘qualifying quantities’ set out in Part 1 or Part 2 of Annex I.

43 That provision thereby provides for three scenarios in which dangerous substances should be considered to be ‘present’ within an establishment, namely where such substances are found to actually be present in certain quantities, where that presence is anticipated or where it is reasonably foreseeable during loss of control of the processes.

44 Since the terms ‘actual presence’, ‘anticipated presence’ and ‘dangerous substances which it is reasonable to foresee may be generated during loss of control of the processes’ are not defined by Directive 2012/18 and since that directive does not refer to the law of the Member States to do so, it is necessary, in accordance with settled case-law, to determine the meaning and scope of those terms by reference to their usual meaning in everyday language, while account is also taken of the context in which they occur and the purposes of the rules of which they form part (see, to that effect, judgments of 18 October 2011, Brüstle, C‑34/10, EU:C:2011:669, paragraphs 25 and 31 and the case-law cited, and of 12 February 2026, Stichting Koskea, C‑490/24, EU:C:2026:89, paragraph 24).

45 In that connection, it should be noted, as regards, first of all, the usual meaning of those terms, first, that the ‘actual presence’ of a dangerous substance implies its actual or proven existence, secondly, that the ‘anticipated presence’ of such a substance can be understood to refer to a substance that it is foreseen or planned will be acquired or generated and, thirdly, that the presence of a dangerous substance which it is ‘reasonable to foresee’ may be generated during loss of control of the processes refers to the occurrence of an event which can reasonably be envisaged in given circumstances.

46 It follows that Article 3(12) of Directive 2012/18 refers to both the dangerous substances actually present, in certain quantities, within an establishment and to those whose presence within that establishment is foreseen or reasonably foreseeable in certain circumstances. Accordingly, the actual absence of such substances within an establishment at a given time is not sufficient in itself to exclude that establishment from the scope of application of Directive 2012/18 under Articles 2 and 3 thereof, since account should also be taken of their anticipated or reasonably foreseeable presence.

47 Next, it should be noted that that literal interpretation of Article 3(12) of Directive 2012/18 is supported by the context of that provision.

48 In particular, for the purpose of determining the quantities of dangerous substances present within an establishment, that provision refers to the ‘qualifying quantities’ set in Annex I to Directive 2012/18. In accordance with Note 3 to Annex I, the quantities to be considered for the application of the relevant articles of that directive are the maximum quantities which are present or are likely to be present within an establishment at any one time. Note 5 to Annex I also mentions, as regards their assignment to a given category of dangerous substances, substances that are present or likely to be present within an establishment.

49 Furthermore, as is apparent from recital 12 of Directive 2012/18, operators have a general obligation to take all necessary measures to prevent major accidents, to mitigate their consequences and to take recovery measures, while also taking into account the dangerous substances which may be generated during a severe accident in the establishment. In accordance with Article 5(1) and with Articles 7 and 8 of that directive, read in the light of recital 12, operators are required, for those purposes, in particular, to communicate to the competent authority the necessary information to allow it to identify the dangerous substances present or likely to be present, including their category, quantity and physical form; to inform that authority in advance in the event of significant changes that affect the aspects referred to in those provisions and to draw up and, where appropriate, send to that authority a document setting out their major-accident prevention policy.

50 Moreover, according to Articles 10 and 12 of Directive 2012/18, read in the light of recitals 15 and 16 thereof, in order to demonstrate that all that is necessary has been done to prevent major accidents, ‘upper-tier establishments’ must prepare safety reports and emergency plans specifying, inter alia, details on possible major-accident scenarios, risk analyses and prevention measures.

51 It is also apparent from the provisions referred to in paragraphs 49 and 50 of the present judgment that, in certain cases, in particular where new establishments are concerned, the documents to which they refer must be prepared and, where appropriate, submitted to the competent authority prior to the start of construction or operation of such establishments. Furthermore, that authority is to examine the safety report in advance and may, where appropriate, after such an examination, prohibit the bringing into use, or the continued use, of the establishment concerned.

52 Moreover, Article 11 of Directive 2012/18 provides that, in the event of modifications to, inter alia, establishments, installations or dangerous substances which could have significant consequences for major-accident hazards, or could result in a ‘lower-tier establishment’ becoming an ‘upper-tier establishment’ or vice versa, operators must, in advance of such modifications, review and where necessary update the notification, the MAPP, the safety management system and the safety report, and inform that authority of all the necessary details.

53 It is apparent from the content of the obligations referred to in paragraphs 49 to 52 of the present judgment that those obligations are preventative. Accordingly, compliance with those obligations requires, in order to preserve the effectiveness of the relevant provisions of Directive 2012/18 and to ensure the achievement of the objectives pursued by that directive, that those obligations are implemented sufficiently in advance to ensure a prior assessment of the risks of major accidents involving dangerous substances.

54 That preventative character therefore precludes an interpretation of Article 3(12) of Directive 2012/18 according to which the mere fact that the relevant quantities of dangerous substances are not actually present, within an establishment, at a given time relieves the operator of that establishment of the abovementioned obligations. The mechanism for controlling major accidents established by that directive is designed in such a way that fluctuations in the quantities of those substances, present or likely to be present within an establishment, are taken into account, by reference, as is apparent from paragraph 48 of the present judgment, to the maximum quantities of those substances.

55 Lastly, that literal and contextual interpretation of Article 3(12) of Directive 2012/18 also makes it possible to ensure the implementation of the objectives of that directive, which aims, in accordance with Article 1 thereof, read in the light of recitals 2 to 4 and 6 of that directive, to strengthen the level of protection in relation to the prevention of major accidents involving dangerous substances throughout the European Union in a consistent and efficient manner and to limit their consequences for human health and the environment, which presupposes the establishment and application of safety and risk reduction measures. Furthermore, recital 2 refers to the need to take ‘appropriate precautionary action’.

56 In that connection, it should be noted that Directive 2012/18 was adopted on the basis of Article 192(1) TFEU on actions to be taken by the European Union in the environmental field in order to achieve the objectives referred to in Article 191 TFEU. Article 191 TFEU provides, in the first and second indents of paragraph 1 thereof, that EU policy on the environment is to contribute to pursuit of the objectives of preserving, protecting and improving the quality of the environment and protecting human health. Under Article 191(2), EU policy on the environment is to aim at a high level of protection and is to be based, in particular, on the precautionary principle and on the principle that preventive action should be taken. It follows from those provisions that the protection and improvement of the quality of the environment and the protection of human health are two closely linked components of that policy, of which Directive 2012/18 forms part. The rules established by that directive thus put into concrete terms the European Union’s obligations on the protection of the environment and human health which stem, inter alia, from Article 191(1) and (2) TFEU (see, by analogy, judgment of 25 June 2024, Ilva and Others, C‑626/22, EU:C:2024:542, paragraphs 67, 68 and 70).

57 According to the case-law of the Court, a correct application of the precautionary principle presupposes, first, identification of the potentially negative consequences for the environment of the dangerous substances concerned, and, secondly, a comprehensive assessment of the risk to the environment based on the most reliable scientific data available and the most recent results of international research. Where it proves to be impossible to determine with certainty the existence or extent of the alleged risk because of the insufficiency, inconclusiveness or imprecision of the results of studies conducted, but the likelihood of real harm to the environment persists should the risk materialise, the precautionary principle justifies the adoption of restrictive measures, provided they are non-discriminatory and objective (see, to that effect, judgment of 28 March 2019, Verlezza and Others, C‑487/17 to C‑489/17, EU:C:2019:270, paragraphs 57 and 58 and the case-law cited).

58 Accordingly, in view of the need to ensure a high level of protection and compliance with the precautionary principle, the concept of ‘presence of dangerous substances’, within the meaning of Article 3(12) of Directive 2012/18, cannot be interpreted restrictively (see, by analogy, judgment of 14 October 2020, Sappi Austria Produktion and Wasserverband ‘Region Gratkorn-Gratwein’, C‑629/19, EU:C:2020:824, paragraph 43 and the case-law cited).

59 In the light of the foregoing, it must be held that, although a system of continuous monitoring of the dangerous substances actually present at a given time within an establishment may provide valid evidence of the ‘actual presence’ of such substances within that establishment, that system does not enable, in itself, the ‘presence of dangerous substances’ within that establishment, within the meaning of Article 3(12) of Directive 2012/18, to be determined.

60 Furthermore, as regards the circumstances which constitute evidence of the ‘anticipated presence’ of dangerous substances within an establishment or of the ‘reasonably foreseeable’ presence of such substances in the event of a loss of control of the processes, within the meaning of Article 3(12), it should be recalled that, as is apparent from paragraphs 45, 46, 53 and 54 of the present judgment, those concepts relate to the dangerous substances likely to be present within that establishment, namely those whose presence is foreseen or can reasonably be envisaged and has to be assessed in advance by reference to the maximum quantities of those substances.

61 It must therefore be found that, in view of the need to reasonably predict those maximum quantities, the circumstances referred to in the preceding paragraph include the maximum capacity of the establishment concerned to store or treat dangerous substances in the light of the operating permit which the operator of that establishment holds. That permit, assessed where appropriate together with other relevant factors, enables, in principle, an objective assessment of the maximum quantities of dangerous substances present or likely to be present within that establishment.

62 That finding applies in particular as regards the permits provided for, respectively, in Article 23 of Directive 2008/98 and Article 4 of Directive 2010/75, to which both the referring court and the applicant in the main proceedings refer, and it is noted, moreover, that those directives were adopted, like Directive 2012/18, in order to implement EU environmental policy. In that connection, first, it is apparent from the wording itself of Article 23(1)(a) of Directive 2008/98 that waste management permits are to specify at least the types and quantities of waste that may be treated.

63 Secondly, in accordance with Articles 4 and 12 of Directive 2010/75, read in the light of Part 5 of Annex I to that directive, installations falling within the scope thereof, which includes those carrying out waste management, cannot be operated without a permit. The granting of such a permit entails the determination, inter alia, of the raw and auxiliary materials and other substances used in or generated by the installation concerned. Furthermore, the Court has held that the prior assessment of the effects of the activity of such an installation on the environment and on human health must be an integral part of the procedures for granting or reconsidering that permit (see, to that effect, judgment of 25 June 2024, Ilva and Others, C‑626/22, EU:C:2024:542, paragraph 105).

64 Consequently, a national court hearing a dispute concerning the applicability, to the establishment concerned, of national legislation implementing Directive 2012/18 and, in particular, the assessment of the ‘presence of dangerous substances’ within that establishment, must verify whether dangerous substances falling under Annex I to that directive are actually present within that establishment in quantities equal to or in excess of those referred to in Annex I or whether that presence is anticipated or reasonably foreseeable. That verification must be carried out taking into account all the circumstances of the individual case, ensuring compliance with the objective pursued by that directive and that its effectiveness is safeguarded.

65 Moreover, certain circumstances may constitute valid evidence of the ‘presence of dangerous substances’, within the meaning of Article 3(12) of that directive (see, by analogy, judgment of 14 October 2020, Sappi Austria Produktion and Wasserverband ‘Region Gratkorn-Gratwein’, C‑629/19, EU:C:2020:824, paragraph 45). Those circumstances include the maximum quantities of substances which an establishment may store or treat in accordance with an operating permit, especially where that permit was granted in application of legislation implementing the provisions of EU law referred to in paragraphs 62 and 63 of the present judgment.

66 In the light of all of those reasons, the answer to the first question is that Article 3(12) of Directive 2012/18 must be interpreted as not precluding a practice, possibly included in the waste management permit issued by the competent administrative authority, according to which, for the purpose of assessing the ‘presence of dangerous substances’ in an establishment, within the meaning of that provision, and of proving that the quantities thereof at no time reach the quantities indicated in Part 1 or Part 2 of Annex I to Directive 2012/18, it is not permissible to rely solely on a management system implemented by the operator of that establishment ensuring the continuous monitoring of such substances actually present within it.

The second question

67 By its second question, the referring court asks, in essence, whether Article 7 of Directive 2012/18 must be interpreted as precluding national legislation that requires the notification of the information concerned to the competent authority, within the meaning of Article 7, to be made exclusively by means of a form established by that legislation and following the procedure provided for therein, and that rules out the possibility of making such a notification by means of a management system implemented by the operator of an establishment and ensuring continuous monitoring of the dangerous substances actually present within it.

68 The applicant in the main proceedings submits that the present question is manifestly inadmissible, inasmuch as it is devoid of a connection with the dispute in the main proceedings.

69 It should be recalled that, in that connection, the settled case-law according to which it is solely for the national court before which the dispute has been brought, and which must assume responsibility for the subsequent judicial decision, to determine in the light of the particular circumstances of the case both the need for a preliminary ruling in order to enable it to deliver judgment and the relevance of the questions which it submits to the Court, which enjoy a presumption of relevance. Therefore, where the question referred concerns the interpretation or validity of a rule of EU law, the Court is, in principle, required to give a ruling, unless it is quite obvious that the interpretation that is sought bears no relation to the actual facts of the main action or its purpose, where the problem is hypothetical, or where the Court does not have before it the factual or legal material necessary to give a useful answer to that question (judgments of 13 July 2000, Idéal tourisme, C‑36/99, EU:C:2000:405, paragraph 20, and of 20 March 2025, Arce, C‑365/23, EU:C:2025:192, paragraph 38 and the case-law cited).

70 In the present case, it is indeed apparent from the documents before the Court that Legislative Decree No 105/2015, which is applicable to the dispute in the main proceedings, transposed into Italian law Article 7 of Directive 2012/18, which refers to the need for Member States to require the operator to send a notification to the competent authority which contains the information concerning, in particular, the establishment concerned and the dangerous substances found within it.

71 However, as is apparent from the decision to refer, the applicant in the main proceedings is challenging the lawfulness of a decision of the technical committee, acting as the competent authority, claiming that the liquid waste treatment plant that it operates does not fall within the scope of that legislative decree. The unlawfulness of that decision results from a misinterpretation, by that authority, of the concept of ‘presence of dangerous substances’, as defined by a national provision transposing Article 3(12) of Directive 2012/18 into Italian law. According to that applicant, that authority was wrong to find that a management system, such as that implemented by it, did not, in itself, make it possible to prove the absence of such substances in that plant.

72 Accordingly, there is nothing in the documents before the Court to indicate that the main proceedings concern the procedure for communicating the information required under the national provisions that transposed Article 7 of Directive 2012/18 or, in particular, the fact that those provisions set out a single method for that communication. As is apparent both from the decision to refer and from the written observations of the applicant in the main proceedings, the applicant refers to the management system which it implemented not as a procedure for notifying the items of information listed in those provisions, but as a means for proving the absence, within its establishment, of dangerous substances in the quantities required in order for Legislative Decree No 105/2015 to apply. Article 7 does not govern the means of proving the presence of dangerous substances within an establishment, but aims to give concrete expression to the obligation on operators of ‘lower-tier’ or ‘upper-tier’ establishments, within the meaning of that directive, to submit that information to the competent authority.

73 Moreover, the referring court refers to the need, in order to determine whether Member States may impose a single method for notification under Article 7 of Directive 2012/18, to balance, on the one hand, the principles of free competition and freedom of establishment and, on the other, the need to protect the environment and safety. However, it does not in any way explain how such a balancing of interests is relevant to resolution of the dispute before it.

74 It follows that to answer the second question in those circumstances would clearly amount to providing an advisory opinion on a hypothetical question, in disregard of the task assigned to the Court in the context of the judicial cooperation established by Article 267 TFEU (see, to that effect, judgment of 22 February 2022, Stichting Rookpreventie Jeugd and Others, C‑160/20, EU:C:2022:101, paragraph 84).

75 Consequently, the second question is inadmissible.

Costs

76 Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the referring court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.

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

Article 3(12) of Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012 on the control of major-accident hazards involving dangerous substances, amending and subsequently repealing Council Directive 96/82/EC

must be interpreted as not precluding a practice, possibly included in the waste management permit issued by the competent administrative authority, according to which, for the purpose of assessing the ‘presence of dangerous substances’ in an establishment, within the meaning of that provision, and of proving that the quantities thereof at no time reach the quantities indicated in Part 1 or Part 2 of Annex I to Directive 2012/18, it is not permissible to rely solely on a management system implemented by the operator of that establishment ensuring the continuous monitoring of such substances actually present within it.

[Signatures]

* Language of the case: Italian.

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