Opinion of Advocate General Emiliou delivered on 23 October 2025.###

1.

The present request for a preliminary ruling, submitted by the Consiglio di Stato (Council of State, Italy), concerns the interpretation of the criteria for determining the presence of dangerous substances within the meaning 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 (commonly referred to as the ‘Seveso-III Directive’). ( 2 )

2.

Directive 2012/18 is the third version of the ‘Seveso’ directive, ( 3 ) which takes its name from an industrial disaster that occurred near the town of Seveso (Italy) in 1976. Being one of the worst environmental disasters in history, it prompted the then EEC legislature to adopt rules intended to prevent such disasters and to mitigate their consequences.

3.

In a nutshell, Directive 2012/18 imposes various obligations on establishments where dangerous substances are present in quantities equal to or above those set out in Annex I thereto. Depending on the quantities present, establishments can be classified as ‘lower-tier’ or ‘upper-tier’ (which triggers additional obligations).

4.

The issue raised in the present case is, therefore, of considerable importance within the scheme of Directive 2012/18, since it has a direct impact on the classification of the establishments that fall within the scope of the directive and, in such cases, on the type of obligations that those establishments must comply with.

5.

The present Opinion mainly concerns the interpretation of point 12 of Article 3 of Directive 2012/18, which sets out the definition of ‘presence of dangerous substances’, whose text is reproduced in point 18 below.

6.

In the present Opinion, I will also refer to recitals 1 to 6, 26 and 29 and Articles 1, 7, 8 and 10 to 12 of the directive. By contrast, I shall not refer to the provisions of Directive 2008/98/EC ( 4 ) and of Directive 2010/75/EU. ( 5 ) Although mentioned in the first question referred, those directives do not appear relevant in the present proceedings.

7.

Directive 2012/128 has been transposed into Italian law by decreto legislativo 26 giugno 2015, n. 105 – Attuazione della direttiva 2012/18/UE relativa al controllo del pericolo di incidenti rilevanti connessi con sostanze pericolose (Legislative Decree No 105 of 26 June 2015 – Implementation of Directive 2012/18/EU on the control of major-accident hazards involving dangerous substances) (‘Legislative Decree No 105’). ( 6 )

8.

The applicant in the main proceedings (Società Eredi Raimondo Bufarini Srl – Servizi Ambientali; ‘Bufarini’) is a company operating a (hazardous and non-hazardous) liquid waste treatment establishment in Falconara Marittima (Italy), under an integrated environmental permit issued by the province of Ancona (Italy). By virtue of that permit, Bufarini can store up to 800 tonnes of hazardous waste and treat up to 200 tonnes of waste of that type per day.

9.

In a report published in 2020, the Comitato tecnico regionale delle Marche (regional technical committee, Marche, Italy; ‘the RTC’) came to the conclusion that the establishment operated by Bufarini, in the light of its capacity to store and treat dangerous substances, fell within the scope of Legislative Decree No 105. On the basis of that report, the RTC gave Bufarini formal notice to submit, within 60 days, the notification and report provided for in that legislation.

10.

In the absence of adequate compliance measures by the undertaking, the RTC, by decision dated 24 November 2020, issued a new letter of formal notice to Bufarini, requiring the submission of the documentation previously requested or, in the alternative, the physical restriction of the use of certain tanks located within its installation. The RTC adopted the position that, for the purpose of determining the regulatory regime applicable to an establishment such as that operated by Bufarini under Directive 2012/18, reference must be made to the maximum quantity of dangerous substances that may be stored or processed under foreseeable conditions. In its view, the mere temporary presence of such substances on site is not, in itself, sufficient to serve as the basis for that assessment.

11.

Bufarini disagreed with that position. In its view, its plant does no fall within the scope of Legislative Decree No 105. It points out that it has put in place a system for managing stocks and checking that the limits set out in the legislation are not exceeded.

12.

Consequently, Bufarini challenged the decision of the RTC before the Tribunale Amministrativo Regionale per le Marche (Regional Administrative Court, Marche, Italy). By judgment of 23 June 2021, that court dismissed the action.

13.

Bufarini brought an appeal against that judgment before the Consiglio di Stato (Council of State). In 2022, that court stayed the proceedings and submitted three questions to the Court of Justice for a preliminary ruling. The third question referred concerned the interpretation of point 12 of Article 3 of Directive 2012/18.

14.

Those questions were the subject of Case C‑144/22, decided by the Court of Justice by its order of 15 December 2022, Società Eredi Raimondo Bufarini. ( 7 ) In that order, the Court found, however, that there was no need to answer the third question, as it had been raised only in case the Court had answered the first question (which concerned the scope of the obligation to make a reference under the third paragraph of Article 267 TFEU) in the affirmative, which it did not.

15.

In the context of the same national proceedings, on 21 March 2024, the Consiglio di Stato (Council of State) decided to stay the proceedings again and to make a second reference to the Court of Justice for a preliminary ruling. The questions referred in the present proceedings are the following:

16.

Written observations have been submitted by Bufarini and the European Commission.

17.

By its first question, the referring court seeks to clarify the definition of ‘presence of dangerous substances’ set out in point 12 of Article 3 of Directive 2012/18 and, more specifically, the meaning of the term ‘anticipated presence’ included therein.

18.

That provision reads as follows:

‘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 exceeding the qualifying quantities set out in Part 1 or Part 2 of Annex I’. ( 8 )

19.

It follows that dangerous substances, within the meaning of that directive, are considered to be present in an establishment – provided their quantities are equal to or above those set out in Annex I thereto – in three situations: (i) when they are actually present; (ii) when their presence can be anticipated; or (iii) when it is reasonable to foresee that they may be generated during loss of control of the processes within the establishment.

20.

The classification of an establishment under one of the three scenarios must, in principle, be carried out prior to the commencement of any activities involving the treatment of dangerous substances. As indicated above, it is the second of those situations that is relevant in the present case.

21.

In essence, the question is whether the national authorities (that is, the RTC) were correct in considering that, in a case such as that at issue in the main proceedings, the quantities ‘anticipated’ should be determined on the basis of the maximum capacity of the establishment, according to the environmental permit. That position has also been defended by the Commission in the present proceedings.

22.

By contrast, Bufarini is of the view that, for the determination of the ‘anticipated presence’ of dangerous substances, an operator can rely on a mechanism which provides for constant monitoring of the quantity of dangerous substances present in the installation and ensures that the thresholds set out in Directive 2012/18 are not exceeded. It emphasises that its establishment stores and processes both dangerous and non-dangerous substances.

23.

It should be noted that Directive 2012/18 does not define the term ‘anticipated’, nor does it provide any further clarification as to its meaning. This lack of a precise definition raises questions as to how competent authorities are to assess the ‘anticipated’ presence of dangerous substances for the purposes of classification under the directive.

24.

In the absence of an explicit definition, the interpretation of ‘anticipated’ must therefore be guided by the wording of the provision, as well as by the objectives and general scheme of the directive.

25.

As regards the wording of the provision, I would point out that, in ordinary language, the term ‘anticipated’ is generally understood as a synonym of terms such as ‘expected’, ‘imagined’, ‘planned’, ‘predicted’ and ‘foreseen’. A comparison of the various language versions of the directive confirms this finding. ( 9 )

26.

In the light of that, a literal interpretation of point 12 of Article 3 of Directive 2012/18 does not appear to support the position adopted by the RTC and defended by the Commission, namely that ‘anticipated presence’ should be equated with maximum capacity. What the text of the provision appears to require is, as a minimum, a reasonable likelihood that the dangerous substances in question may be present at a given point in time in quantities above those set out in Annex I.

27.

This is further supported by the text of Article 7(1) of Directive 2012/18, requiring operators to send a notification to the competent authority which includes, among other things, ‘information sufficient to identify the dangerous substances and category of substances involved or likely to be present’, and ‘the quantity and physical form of the dangerous substance or substances concerned’. ( 10 ) Similarly, Note 3 to Annex I to Directive 2012/18 states that ‘the quantities to be considered for the application of the relevant Articles [of the directive] are the maximum quantities which are present or are likely to be present at any one time.’ ( 11 )

28.

My understanding of the term ‘anticipated’ is also more in line with the text of point 12 of Article 3 of Directive 2012/18 in relation to the third situation in which dangerous substances are considered to be present in an establishment: when ‘it is reasonable to foresee [that they] may be generated during loss of control of the processes … within the establishment’. That part of the provision also suggests that the mere theoretical possibility that dangerous substances could be present in quantities equal to or above those set out in Annex I is not enough to trigger the application of Directive 2012/18.

29.

In any event, if the application of the directive were intended to be triggered by the mere capacity of an establishment to store, process or generate dangerous substances, it is reasonable to expect that the EU legislature would have framed the relevant provisions accordingly. The use of the expression ‘anticipated presence’ to convey the concept of maximum overall capacity appears linguistically and conceptually imprecise, particularly in the context of a legislative instrument whose provisions were, in the view of the EU legislature itself, intended to be ‘clear, coherent and easy to understand to help improve implementation and enforceability’. ( 12 )

30.

The interpretation of the term ‘anticipated’ suggested by the RTC and the Commission is not borne out by a contextual or teleological interpretation of the provisions of Directive 2012/18 either.

31.

As regards context, I am not convinced by the arguments put forward by the Commission that a capacity-based interpretation of the term ‘anticipated’ is necessary in so far as several obligations laid down in Directive 2012/18 need to be fulfilled in advance, that is, before the dangerous substances are present in the establishment for the first time. The Commission refers, in particular, to the obligations to draw up and implement a major-accident prevention policy (Article 8 thereof), to produce a safety report (Article 10 thereof) and to draw up an emergency plan and provide related information to the competent national authorities (Article 12 thereof). ( 13 )

32.

This argument appears somewhat circular, as it is premissed on the assumption that the provisions in question must apply to any establishment that is unable to predict, ex ante, the precise quantities of dangerous substances present at any given time. In my view, this assumption is unfounded. Provided that the thresholds established in Annex I are not exceeded, the inability to estimate in advance the exact quantities of substances treated at any moment is irrelevant. Accordingly, the Commission’s concerns regarding the application of Articles 8, 10, and 12 of Directive 2012/18 cannot, in principle, materialise.

33.

The Commission’s argument based on the text of Article 7(4) and Article 11 of Directive 2012/18 is equally unpersuasive. The Commission points out that, under those provisions, operators have to communicate to the competent authority significant increases or decreases in the quantity of the dangerous substance present before they take place, and, as the case may be, take appropriate measures. That is not feasible – the Commission emphasises – in relation to increases that are unforeseen and occur suddenly because of a malfunction in a monitoring process.

34.

In my view, those provisions do not offer any insight into the proper interpretation of point 12 of Article 3 of Directive 2012/18. As is shown by the wording and context of Article 7(4)(a) and Article 11 of Directive 2012/18, those provisions concern long-term increases or decreases in the quantity of dangerous substances present in the establishment.

35.

Unintended and transitory situations which may bring the quantities of dangerous substances stored, processed or generated above the levels notified to the authorities (and, as the case may be, above the levels allowed by the permit) may potentially occur in many, if not all, establishments. That is true also for those that comply with all the obligations laid down in the directive. It is abundantly clear that, in those situations, the operators are not required to review or update the notification, the major-accident prevention policy and so forth.

36.

The same should logically apply in situations where, as Bufarini argues, a mechanism is in place which constantly monitors the quantity of dangerous substances present in the establishment, so as to ensure that the limits set out in Annex I to Directive 2012/18 are not exceeded. If, by mistake, at a given point in time the limits could be exceeded, this would prompt the operator to act with a view to reducing the amount to below the limits set out in Annex I. In those cases, too, there is no long-term modification of the quantity of the dangerous substances dealt with, even where the operator does not manage to react immediately. Those situations therefore fall outside the scope of the provisions referred to by the Commission. ( 14 )

37.

With respect, then, to a teleological interpretation of the provisions of Directive 2012/18, I would observe the following.

38.

First of all, it is true that the ultimate objective of the directive is to ensure a high level of protection of human health and the environment. ( 15 ) However, its scope is restricted – as made clear by, inter alia, recitals 1 to 6 and Article 1 thereof – to the ‘prevention of major accidents … and the limitation of their consequences’. ( 16 ) It is not an instrument targeting all industrial accidents involving dangerous substances, but only those that create significant hazards for human health and the environment. It is also not aimed at reducing the risks to nil (an impossible task, naturally) or something approximating that. ( 17 )

39.

It should not be overlooked that, even in the event of a malfunctioning of monitoring mechanisms such as those described by Bufarini, which may lead to quantities of dangerous substances temporarily exceeding the thresholds set out in Annex I, such an occurrence would not, in itself, directly cause an accident, let alone a major accident. This is particularly the case where the operator retains the capacity to intervene swiftly and effectively to reduce the quantities involved and to restore safe conditions. Consequently, provided that appropriate mitigation measures are promptly implemented, the risk profile of the establishment would not be significantly heightened. This underscores the importance of considering both the technical safeguards in place and the operator’s operational response when assessing the potential risks under Directive 2012/18.

40.

In addition, that ultimate objective has to be reconciled with other public interests. In particular, as explained in recital 4 of the directive, the EU legislature also sought to ‘reduc[e] unnecessary administrative burdens by streamlining or simplification, provided that safety and environmental and human health protection are not compromised’. A similar concern is expressed in recital 18 of the directive, which refers to the need ‘where possible, to reduce administrative burdens, especially for small and medium-sized enterprises’.

41.

Accepting the Commission’s interpretation of point 12 of Article 3 of Directive 2012/18 would mean also requiring operators with a very low risk profile ( 18 ) to comply with several obligations that may be costly to implement. That administrative and financial burden seems to be disproportionate and far from a realistic approach to managing major-accident hazards. ( 19 )

42.

In the light of the principle of proportionality, it is reasonable to assume that the EU legislature adopted a pragmatic rather than an overly formalistic approach in defining the concept of ‘presence of dangerous substances’ as the parameter for determining the scope of application of Directive 2012/18 and for distinguishing between lower-tier and upper-tier establishments.

43.

Accordingly, I am of the view that the concept of ‘anticipated presence’ must be construed in a way that reflects a risk-based approach consistent with the directive’s preventive purpose, focusing on foreseeable operational conditions rather than theoretical maximum capacities. Such an interpretation aligns with the directive’s aim to prevent major accidents by requiring Member States and operators to assess the likely real presence and handling of dangerous substances, thereby facilitating proportionate and enforceable regulatory measures.

44.

I naturally share the Commission’s concerns with regard to the need to avoid situations in which operators – in bad faith or simply due to negligence – could easily elude their obligations under Directive 2012/18. An interpretation of the term ‘anticipated presence’ that would, de facto, give carte blanche to the operators to rely on their subjective expectations and estimates would undermine the effectiveness of the system of protection set up by Directive 2012/18.

45.

The applicability of Directive 2012/18 to a given establishment or its classification as a ‘lower-tier’ or ‘upper-tier’ establishment must, in my view, be based on objective data that are readily and easily verifiable by the competent authorities. Failing that, the system of inspection and penalties envisaged by the EU legislature would not function properly. ( 20 )

46.

Pursuant to Article 20(1) of Directive 2012/18, ‘Member States shall ensure that the competent authorities organise a system of inspections.’ The aim of those inspections is, first and foremost, to enable the competent authorities to ‘take the necessary measures in the event of non-compliance’ with the directive (recital 26 thereof). In addition, Article 28 of Directive 2012/18, as echoed by recital 29 thereof, requires Member States to provide for, and actually implement, penalties applicable to infringements of the national provisions adopted pursuant to that directive that are effective, proportionate and dissuasive.

47.

Against that background, I take the view that a system such as that envisaged by Bufarini could, under certain circumstances, be adequate to ensure that the ‘anticipated presence’ of dangerous substances in the establishment remains below the thresholds set out in Annex I. That system consists in the setting-up of a mechanism that monitors the quantity of dangerous substances present in the establishment at all times, enabling the operator to intervene promptly where there is a risk that the substances could exceed the thresholds set out in Annex I.

48.

It must be clearly stated that, for a system to be deemed compliant with the requirements of Directive 2012/18, it must enable the operator to intervene preventively – that is, before the quantities of dangerous substances exceed the thresholds laid down in Annex I. Any mechanism that operates solely through ex post corrective measures, and that results in the presence of dangerous substances above those thresholds with a certain degree of regularity, cannot be treated as equivalent. In such cases, the excess is not accidental but foreseeable and, as such, the application of the directive is unequivocally triggered.

49.

Moreover, such a system should also record the quantities present at all times, so that the competent authorities could, at any moment, verify whether the thresholds in question have been exceeded and, if so, obtain the necessary information (inter alia, dates, length and frequency of the occurrence(s), quantities in excess and so forth).

50.

Naturally, whether the specific mechanism set up by a given operator is accurate, reliable and effective is for the national authorities – administrative in the first place and judicial in case of a dispute – to determine.

51.

In the light of the foregoing considerations, I take the view that point 12 of Article 3 of Directive 2012/18 must be interpreted as not precluding a national practice whereby the ‘anticipated’ presence of dangerous substances within an establishment is assessed by reference to mechanisms put in place by the operator that ensure continuous monitoring of the actual quantities present. Such mechanisms must allow for prompt intervention to reduce those quantities in cases where there is a foreseeable risk of exceeding the thresholds laid down in Annex I. This approach is permissible, however, only where the mechanism keeps adequate records, thereby enabling the competent authorities to make the necessary checks.

52.

By its second question, the referring court asks whether national legislation may require that the notification referred to in Article 7(1) of Directive 2012/18 be made in one specific manner, thereby excluding forms of notification that are based on newer technologies. The referring court refers, in that respect, to the technologies used by Bufarini and other operators that have implemented monitoring mechanisms such as those discussed above.

53.

The reasons that led the referring court to submit that question are not entirely clear to me. In addition, I fail to see how an answer to that question could have an impact on the proceedings currently pending before the referring court.

54.

The issue that is at the heart of the main proceedings is, as far as I understand, what method should be used to determine whether an establishment falls within the scope of Directive 2012/18, for the reason that dangerous substances actually are, or are likely to be, present in the establishment in an amount equal to or above the limits set out in Annex I to Directive 2012/18. Bufarini argues that the method it uses in that respect is in line with the provisions of the directive. That would mean that its establishment falls outside the scope of the directive.

55.

The determination of the manner in which an operator has to make the notification provided for in Article 7 of Directive 2012/18 – assuming that that provision were applicable to Bufarini – appears to be of no relevance to the issues raised in the main proceedings. That conclusion applies a fortiori if the first question referred is answered in the manner I have proposed above.

56.

Accordingly, I consider the second question referred to be inadmissible.

57.

In conclusion, I propose that the Court answer the questions referred by the Consiglio di Stato (Council of State, Italy) as follows: