Judgment;Summary — ECLI:EU:C:2025:982
Date: 2025-12-18
Language of the case: English
Court formation: Second Chamber
Procedure: Action for annulment;Appeal
Origin: Germany;Spain;United Kingdom;Ireland;Italy;Poland

OPINION OF ADVOCATE GENERAL EMILIOU delivered on 12 June 2025 (1) Case C‑731/23 P Nicoventures Trading Ltd, British American Tobacco (Germany) GmbH, British American Tobacco Italia SpA (BAT Italia), British American Tobacco Polska Trading sp. z o.o., British American Tobacco España SA, P.J. Carroll & Company Ltd v European Commission ( Appeal – Public Health – Directive 2014/40/EU – Delegated Directive (EU) 2022/2100 – Heated tobacco products – Article 263 TFEU – Standing – Individual concern – Plaumann case-law – Systematisation and reconsideration of the case-law – Closed-group test ) I. Introduction 1. ‘Before the law stands a doorkeeper. A man from the country comes to this doorkeeper, and asks for admission to the law. But the doorkeeper says that he cannot grant him admission now. The man reflects, and then asks if he will therefore be permitted to enter later. “It is possible,” the doorkeeper says, “but not now.” … The man from the country had not expected such difficulties; the law is after all meant to be accessible to everybody at all times, he thinks’. 2. This passage from Franz Kafka’s short story, Before the Law, (2) seems to me quite appropriate to reflect the difficulty that applicants face when attempting to, first, understand whether they are ‘individually concerned’ by an EU act within the meaning of Article 263 TFEU and, then, establish that before the EU Courts. 3. The basic test for the requirement of individual concern was – as it is well known – first developed in 1963 in the Plaumann case: persons other than those to whom a measure is addressed may claim to be ‘individually concerned’, within the meaning of the fourth paragraph of Article 263 TFEU, only if that measure affects them by reason of certain attributes which are peculiar to them or by reason of circumstances in which they are differentiated from all other persons and by virtue of those factors distinguishes them individually just as in the case of the person addressed (‘the Plaumann formula’). (3) 4. In the subsequent case-law, that formula was not only constantly confirmed, but it also applied in a rather rigorous manner by the Court (‘the Plaumann case-law’). The Court did so despite some proposals coming from within the institution to amend it, and the (at times, rather harsh) criticism voiced in legal scholarship. Even though the main criticism levelled to the Plaumann case-law is that of being too restrictive, observers also lament its obscurity and complexity, as well as some inconsistencies in its application over the years. 5. The present case offers the Court the opportunity to revisit that case-law. The appellants seek to set aside the order of 20 September 2023, Nicoventures Trading and Others v Commission, (4) in which the General Court had declared their action for annulment against Delegated Directive (EU) 2022/2100 (5) inadmissible on the ground that the appellants were directly, but not individually, concerned by it. 6. My analysis will show that, under a strict and formalistic application of the Plaumann case-law, the appellants in the present case might not be considered to be ‘individually concerned’ by the contested measure, whereas they would be under a more supple and realistic application thereof. In fact, my opinion is that the fair outcome of the case would be precisely that: they should be able to challenge the contested measure before the EU Courts. Considering them as not being ‘individually concerned’ by that measure may perhaps be in line with certain precedents of the EU Courts but, in my view, it would be inconsistent with a sound interpretation of the fourth paragraph of Article 263 TFEU, a fortiori in the post-Lisbon EU legal system. 7. Against that background, the present Opinion aims, most of all, to propose to the Court of Justice that, some 60 years after the delivery of the judgment in Plaumann, the time is ripe for considering whether and, if so, to what extent, the doorkeeper should open the door of the law. II. Factual and legal background to the dispute 8. The background to the dispute is set out in paragraphs 2 to 6 of the order under appeal. For the purposes of the present proceedings, it may be summarised as follows. 9. Nicoventures Trading Ltd, British American Tobacco (Germany) GmbH, British American Tobacco Italia SpA (BAT Italia), British American Tobacco Polska Trading sp. z o.o., British American Tobacco España, SA and P.J. Carroll & Company Ltd (‘the appellants’) belong to the British American Tobacco group (‘the BAT group’), which manufactures and markets tobacco products. The appellants are active in the development and commercialisation of non-combustible products, including heated tobacco products, in the European Union. 10. Directive 2014/40/EU (6) regulates the placing on the market of tobacco products. To that end, it seeks to approximate the laws, regulations and administrative provisions of the Member States concerning, inter alia, the ingredients, labelling and packaging of tobacco products. 11. Article 7(1) and (7) of Directive 2014/40 provides that Member States are to prohibit the placing on the market of tobacco products with a characterising flavour and of those containing flavourings in any of their components. Article 7(12) of that directive, before it was amended by the contested measure, exempted tobacco products other than cigarettes and roll-your-own tobacco from the prohibitions laid down in paragraphs 1 and 7 of that provision. Similarly, the first subparagraph of Article 11(1) of Directive 2014/40, before it was amended by the contested measure, provided that the Member States could exempt tobacco products for smoking other than cigarettes, roll-your-own tobacco and waterpipe tobacco from certain obligations concerning the labelling of tobacco products and the mandatory affixing on the packaging of certain warnings, information messages and combined health warnings. In addition, Article 7(12) and Article 11(6) of that directive provide that the European Commission is to adopt delegated acts to withdraw the exemptions referred to in Article 7 or the possibility of granting the exemptions referred to in Article 11 for a particular product category, if there is a substantial change of circumstances as established in a report drawn up by the Commission. 12. On 15 June 2022, the Commission, in accordance with Directive 2014/40, published a report establishing a substantial change of circumstances for heated tobacco products. Following that report, the Commission adopted the contested measure on 29 June 2022. Article 1 of the contested measure amended Article 7(12) and Article 11(1) of Directive 2014/40. As from 23 October 2023 – the date by which the measures provided for in the contested measure must have been transposed – heated tobacco products were no longer subject to the exemptions laid down in Articles 7 and 11 of Directive 2014/40. III. Procedure before the General Court and the order under appeal 13. By their action under Article 263 TFEU before the General Court, the applicants sought the annulment of the contested measure, putting forward two pleas in law in support of their action. For its part, the Commission submitted a plea of inadmissibility of the action. 14. By the order under appeal, the General Court declared the action inadmissible and ordered the appellants to pay the costs. As mentioned above, the General Court found that the appellants were directly, but not individually, concerned by the contested measure. IV. Procedure before the Court of Justice and the forms of order sought 15. In their appeal before the Court, the appellants ask it to (i) set aside the order under appeal; (ii) if the state of the proceedings so permit, reject the plea of inadmissibility, declare the action admissible and refer the case back to the General Court to rule on the substance; and (iii) order the Commission to pay the costs of the proceedings. 16. The Commission asks the Court of Justice to reject the appeal and order the appellants to bear the costs. 17. By decision of the President of the Court of 25 April 2024, the French Republic was allowed to intervene in support of the form of order sought by the Commission. V. Assessment 18. At the outset, it may be helpful to recall that, pursuant to Article 263 TFEU, non-privileged applicants can challenge EU acts which produce legal effects when the act (i) is addressed to them; (ii) is of direct and individual concern to them; or (iii) is a regulatory act not entailing implementing measures and is of direct concern to them. The present case regards the second instance above, and only the interpretation of the ‘individual concern’ requirement. 19. In support of their appeal, the appellants rely on a single ground of appeal, divided into two parts, alleging errors of law made by the General Court in the assessment of whether they are individually concerned by the contested measure. 20. Before assessing the appellants’ arguments (Sections B and C below), I find it useful to discuss, in general, the Plaumann case-law (Section A). A. Preliminary remarks: on the past, present and future of the Plaumann case-law 21. In this section of the Opinion, first, I shall attempt to systematise the Plaumann case-law. Second, I will discuss the criticism against that case-law. Third, I will explain why I am of the view that the basic idea behind the Plaumann formula is broadly correct and, consequently, that it should not be abandoned. Lastly, I will explain that, at times, the concrete application of that test has been excessively strict and inconsistent. Accordingly, I shall propose to the Court of Justice to deliver a landmark ruling in which it re-examines, clarifies and possibly fine-tunes the application of the Plaumann case-law. 1. The Plaumann case-law, as the law currently stands 22. As explained in the introduction, since the judgment in Plaumann, the Court has consistently found that persons other than the addressees of a measure are ‘individually concerned’ where that measure affects them by reason of certain attributes which are peculiar to them, or by reason of circumstances in which they are differentiated from all other persons, and by virtue of those factors distinguishes them individually just as in the case of the addressees. (7) 23. This means, quite clearly, that the applicant need not be the only person affected by the contested measure in order to be considered individually concerned by it. However, the applicant should establish the existence of a situation which, from the point of view of the contested provision, differentiates him or her from all other persons affected by the measure. (8) 24. Applicants are, in principle, not considered to be individually concerned by measures which apply to objectively determined situations and produce legal effects with respect to categories of persons viewed generally and in the abstract. (9) Nevertheless, the fact that a contested measure has a legislative nature or a general scope does not of itself prevent it from being of individual concern to some of the persons affected. (10) 25. For example, that is the case where applicants are expressly mentioned as being concerned in the act itself, so that that act is, simultaneously, a measure of general application in that it affects a category of addressees determined in a general and abstract manner, and a bundle of individual decisions affecting the persons named therein. (11) 26. In addition, a measure that affects a group of persons on the basis of general and abstract criteria, even in the absence of any express reference to specific persons, may still be of individual concern to some of the persons affected. As the Court has held, where a measure affects a group of persons who were identified or identifiable when that measure was adopted, by reason of criteria specific to the members of the group, those persons might be individually concerned by that measure inasmuch as they form part of a limited class of persons affected. (12) In essence, this means that, within the general circle of the persons that fall within the scope ratione personae of the measure, it is possible to identify a subset of one or more persons that exhibits peculiar characteristics differentiating them from the others. (13) I shall refer to this test as the ‘closed-group’. (14) 27. To be clear, the mere possibility of determining more or less precisely the number, or even the identity, of the persons to whom a measure applies by no means implies that it must be regarded as being of individual concern to them as long as that measure is applied by virtue of an objective legal or factual situation defined by it. (15) Something more is therefore required for a potential applicant to be considered to be individually concerned. 28. It seems to me that, on the basis of the closed-group test, the Court has accepted individual concern in four types of situation. That is the case where the applicant is affected by an EU act because that act might have (i) failed to take into account the position of the applicant; (ii) infringed a substantive right of the applicant; (iii) infringed a procedural right of the applicant; and (iv) produced significant adverse effects on a legitimate interest of the applicant. 29. Before providing more detail in that respect, I wish to clarify two points. First, I am using the verb ‘might’, since whether the challenged act has actually infringed a right or unduly affected a legitimate interest of the applicant is – quite obviously – an issue that pertains to the merits of the action and not the admissibility thereof. For an applicant it is enough to establish that, in the light of the elements of law and fact provided, it is possible that its right may be infringed or its legitimate interest unduly affected. (16) 30. Second, by ‘legitimate interest’, I refer, broadly speaking, to situations protected under EU law that cannot be qualified as relating to subjective rights stricto sensu. (17) That term corresponds to situations in which EU law guarantees the applicant a freedom (or liberty) or grants him or her a power or an immunity. (18) To give but one example, economic operators can, under certain circumstances, act before the EU judiciary to safeguard their interests affected by EU measures that might distort competition in the internal market. (19) 31. Coming back to the situations referred to in point 28 above, I observe that a first strand of case-law concerns the cases in which the Court found the applicants to be individually concerned to challenge an act whose adoption required, under the applicable legislation, the institution in question to consider the position of some specific group of persons of which the applicant was part. (20) These decisions represent the logical extension of the case-law mentioned in point 25 above. Their rationale is clear: some persons concerned may not have been named in the act but their special position has, nonetheless, been explicitly singled out by the legislature itself. 32. A second strand of case-law includes the cases in which the applicants were allowed to challenge an EU act which, unlike for the majority of the persons concerned, had a retrospective impact on acquired rights or on ongoing legal relationships of the applicants. (21) This line of case-law can be regarded, in my view, as a consequence of a number of general principles of EU law: legal certainty, predictability, prohibition of retroactivity, protection of legitimate expectations. It goes without saying that no person in the European Union can expect EU legislation to remain immutable. At the same time, however, individuals who aligned their conduct to existing laws should have some confidence in the stability of legal positions crystallised in the past and of legal relationships already entered into, unless exceptional circumstances justify otherwise.(22) 33. A third strand of case-law concerns procedural rights of the applicants that might have been infringed in some EU procedures, such as those set out in the EU rules on State aid control. For example, that is the case where the Commission wrongly clears an aid measure during its preliminary investigation, thereby depriving the interested parties of the possibility to be heard during the in-depth phase of the investigation. In those cases, the interested parties have consistently been considered to be individually concerned by the Commission decision. (23) If EU legislation grants certain parties specific procedural rights, it is logical that any dispute concerning the breach of those rights is heard directly by the EU judiciary where the procedure is entirely governed by EU law and run at EU level. 34. This group of cases also includes those in which the Court accepted individual concern in respect of an applicant challenging an EU act that, although not addressed to them, was issued at the end of a procedure prompted by, and largely based on, their interaction with the EU institution in question. (24) In those cases, it is possible that the applicant did not enjoy specific procedural rights under the relevant EU legislation. Nevertheless, given the applicant’s crucial role in the procedure, the institution in question may have infringed one of the rights that they derived from the right to good administration (now enshrined in Article 41 of the Charter). 35. Finally, a fourth strand of case-law regroups the cases in which the Court has considered to be individually concerned applicants whose position on the market was seriously affected by the challenged act. Those cases have typically concerned the fields of competition law, State aid, merger control and anti-dumping, but also agriculture. (25) In those areas, the institution in charge can make use of its quasi-legislative, executive or enforcement powers, usually at the end of an ad hoc administrative procedure, in order to address a very concrete situation (involving evaluations of fact and law), which concerns one of more identified or identifiable persons. (26) Moreover, this group of cases includes those where an institution has – again, in response to a very concrete situation, and following a specific procedure – adopted an act that, at least at a formal level, has a legislative nature and scope, whilst having some decision-making content. (27) 36. In such cases, the persons directly concerned by the decision-making content are obviously in a rather distinct position. In addition, the possibility that the institution might favour the activities of one or more (identified or identifiable) persons almost inevitably implies that the activities of one or more (identified or identifiable) persons are correspondingly disfavoured, or vice versa. (28) It stands to reason that the persons negatively affected are, under certain circumstances, permitted to challenge the EU measure in question directly before the EU Courts. By contrast, as it will be discussed in the next part of this section, the Court has not accepted a criterion based on ‘serious affectation’ with regard to EU acts that are, both in form and in substance, of a general nature and, thus, the product of genuine policymaking activities. 37. Having briefly outlined the main tenets of the Plaumann case-law, I shall now turn to its most common critique. 2. The criticism against the Plaumann formula 38. It is not an overstatement to say that the judgment in Plaumann is one of the most widely debated Court decisions of its history spanning roughly 70 years. It is likewise undeniable that it is also one of the most harshly criticised, especially by observers from civil society and academia. (29) 39. The criticism often focuses on the restrictive effect of the case-law developed under that judgment. ‘An almost insurmountable barrier [to overcome]’, or ‘[a net] which none slips through’, based on ‘an economic unrealistic [test]’, offering ‘little [guidance]’ to the parties and ‘leading to absurd outcomes’: a comprehensive reading of commentaries to the Plaumann case-law offers a litany of hyperboles. (30) 40. However, it is equally true that a comprehensive analysis of the case-law appears to paint a rather gloomy picture, as if very little could matter when establishing individual concern. Indeed, the EU Courts have stated that, in and of themselves, the following elements do not justify a finding of ‘individual concern’: (i) the applicant is the only, or one of the few, persons affected by the contested act; (31) (ii) the applicant is affected by the contested act in a particularly severe manner; (32) (iii) the applicant could participate, or has actually participated, in the procedure which led to the adoption of the contested act; (33) (iv) the contested act produces ‘different specific effects on the various persons to whom it applies’; (34) (v) the contested act includes limitations and derogations to the rules of general application, or provisions of a transitional nature concerned with a closed group of economic operators; (35) and (vi) specific provisions of EU law required the acting institution ‘to take account of the consequences of the measure which it envisages adopting for the situation of certain individuals’. (36) 41. In particular, authors lament the impossibility for individuals and associations to act as public defenders against measures that harm a class of people. In that regard, they often refer to a paradox created by the test: the more diffuse and harmful a measure (such as is often the case with environmental measures), the more unlikely that one or more (natural or legal) persons will be found individually concerned under the Plaumann case-law. (37) The recent judgment in Carvalho (concerning EU measures on climate change) is pointed out as an illustration of that point. (38) 42. Another line of criticism of the Plaumann case-law concerns its alleged obscurity which, in turn, leads to inconsistent decisions. In the view of some authors, the actual application of the Plaumann formula was more focused on the formal elements of the challenged act in some cases, and on the substantive obligations flowing from the act in others. In many judgments, including the ‘leading’ ones, the statement of reasons on this matter is not an example of clarity. That hermeneutic heterogeneity and ambiguity resulted – it is argued – in a rather fragmented and casuistic body of decisions, whose common thread is hard to discern. That is why the assessment of the admissibility of actions under Article 263 TFEU by private applicants often requires lengthy discussions in the EU Courts’ decisions. (39) 43. The above criticism was largely shared by Advocate General Jacobs who, in his Opinion in UPA, explained in detail why he was of the view that the Court had to revisit the Plaumann case-law and, to that end, suggested the adoption of a new test for individual concern: ‘a person is to be regarded as individually concerned by [an EU] measure where, by reason of his particular circumstances, the measure has, or is liable to have, a substantial adverse effect on his interests’. (40) 44. Shortly after the delivery of that Opinion, the (now) General Court gave its judgment in Jégo-Quéré, which came to similar conclusions regarding the need to re-consider the case-law, ruling that, ‘in order to ensure effective judicial protection for individuals, a natural or legal person is to be regarded as individually concerned by [an EU] measure of general application that concerns him directly if the measure in question affects his legal position, in a manner which is both definite and immediate, by restricting his rights or by imposing obligations on him’. (41) 45. However, the Court of Justice did not endorse the analyses and proposals of either the Advocate General or the General Court. In its judgment in UPA, the Court of Justice (i) confirmed the Plaumann formula; (ii) emphasised that the ‘complete system of legal remedies’ provided for in the Treaties lies, in particular, on the complementary roles played by actions for annulment and preliminary rulings procedures; (iii) made clear that it is for the Member States to establish a system of legal remedies and procedures which ensure respect for the right to effective judicial protection; (iv) acknowledged that the conditions of admissibility of an action brought by individuals must be interpreted in the light of the principle of effective judicial protection, whilst at the same time pointing out that that could not lead de facto to set aside those conditions, which are expressly laid down in the Treaties; and (v) declared that, while it is possible to envisage a system of judicial review of the legality of EU measures of general application different from that established by the founding Treaty, it is for the Member States, as drafters of the Treaties, to reform the system in force. (42) 46. In the next part of this section, I shall explain why – despite some of the criticism just discussed having some merit – I am of the view that the Plaumann formula is, to date, still acceptable and, consequently, need not be abandoned by the Court. 3. In defense of the Plaumann formula (a) What alternatives? 47. At the outset, I must point out that the criticism to which the Plaumann formula has been subject is often ‘outcome driven’: put simply, the test is too strict and, thus, cannot be correct (or, alternatively, it is not appropriate). However, only rarely do commentators venture to explain where the Court errs in its interpretation of the fourth paragraph of Article 263 TFEU and how the requirement of ‘individual concern’ should be interpreted instead. When an alternative test is in fact proposed, it is either one that takes inspiration from the provisions in force at national level, or one that resembles (to a greater or lesser degree) those proposed by Advocate General Jacobs and the General Court mentioned in points 43 and 44 above. (43) 48. With regard to the rules of locus standi at Member State level, I must say that, as far as those most commonly referred to are concerned, (44) they are governed by provisions formulated rather differently from the fourth paragraph of Article 263 TFEU, operating within systems of justice that, unlike the EU system, are self-contained. (45) 49. As regards the tests proposed by Advocate General Jacobs and the General Court, and those inspired by them, they indeed have some considerable merits. In particular, they would enable the Court of Justice, when seeking to establish whether the applicant’s position is distinctive enough, to take into account, in each case, (i) the variety of circumstances of law and fact that might be relevant, and (ii) the seriousness of the impact that a challenged measure produces. In addition, on a theoretical level, it is difficult to disagree with the idea that the individuals who suffer substantial adverse effects or that are definitely and immediately prejudiced by an EU measure should usually be able to challenge that measure. 50. However, the Court has decided not to follow such tests. I also see two major drawbacks to them. 51. First, those tests have some structural limits that are difficult to overcome. The formulas suggested are, to some extent, hardly predictable since they all rely on a case-by-case assessment. They are also based on adjectives (substantial, definite, immediate) which are not very precise in themselves and, consequently, could be interpreted and applied rather differently. The requirement of individual concern, in practice, becomes a matter of ‘degree’ of effect. In such a case the question of where to draw the line between an impact that can be considered as substantial enough and one that cannot may end up being, in many cases, a subjective choice. 52. Second, it is not obvious that those tests can be read in the fourth paragraph of Article 263 TFEU. This leads me to my next point. (b) A textual and historical reading of Article 263 TFEU 53. It seems to me that the Plaumann formula is a more authentic and reasonable interpretation of the term ‘individual’, which is used in nearly all the language versions of the Treaty. In the ordinary language, the most common synonyms of the term ‘individual’ are single, specific, particular, distinctive and separate. 54. I fully agree that, in respect of a given EU act, more than one person may find him- or herself in a situation which is so peculiar that it could be considered to be unique or nearly unique. At the same time, however, I think it goes too far to say – as the General Court did in the judgment in Jégo-Quéré v Commission – that ‘the number and position of other persons who are likewise affected by the [challenged] measure, or who may be so, are of no relevance’ with regard to the question as to whether an applicant is individually concerned by the measure. (46) Put very simply and schematically: one person may be special, 10 persons can probably also all be special, but I would need very strong arguments to be convinced that each and every one in a group of 1 thousand or 1 million persons could be special for the purposes of the fourth paragraph of Article 263 TFEU. To my mind, the greater the number of the persons alleging a special effect, the less likely that they can all be considered to be ‘individually concerned’: the measure in question appears to apply in general on the basis of abstract criteria. (47) 55. A historical interpretation of the term ‘individual’ also corroborates a relatively restrictive reading of it. It should not be forgotten that, under Article 33(2) of the (now defunct) ECSC Treaty, private applicant were entitled to challenge ‘individual decisions and recommendations concerning them, or … general decisions and recommendations which they deem to involve an abuse of power affecting them’. (48) The drafters of the Treaty of Paris meant to allow private applicants to challenge decisions which were, in essence, individual decisions whilst being disguised as acts of more general application. (49) However, in its first rulings, the Court embraced a broad interpretation of standing of private applicants. (50) As a result, it would appear that, when negotiating the Treaty of Rome, the drafters adopted on purpose a more stringent text on standing. (51) Historical documents indicate that the idea was (once again) to allow non-privileged applicants to challenge only decisions that concerned them individually, including where those were ‘disguised’ as regulations or as decisions addressed to third parties. (52) 56. Interestingly, the issue of a possible relaxation of the requirement of ‘individual concern’ through a Treaty amendment was raised before and during various intergovernmental conferences. However, the drafters of the Treaties – obviously fully aware of the ‘granitic’ nature of the Plaumann case-law – ultimately decided not to make any change in that respect. For example, the discussion circle on the Court of Justice, set up during the 2002-2003 Convention on the Future of Europe, was split as to whether the requirement of individual concern had to be repealed (or amended), whereas the majority of its members agreed on other changes to the provision. (53) In fact, only the latter changes found their way into the proposed treaty establishing a Constitution for Europe first, and into the Treaty of Lisbon next. (54) 57. The Court noted as much in its judgment in Inuit Tapiriit Kanatami and Others v Parliament and Council, in which the applicants had explicitly asked it to reconsider the Plaumann formula and replace it with a criterion of ‘substantial adverse effect’. In particular, the Court found ‘nothing to suggest that the authors of the Treaty of Lisbon had any intention of altering the scope of the conditions of admissibility already laid down in the fourth paragraph of Article [263 TFEU]’. (55) 58. Nor is there – I would add – any textual or historical element which may suggest that the drafters of the Treaties intended (when the Treaty of Rome was adopted or subsequently amended), by dint of (current) Article 263 TFEU, to enable private applicants to lodge a form of actio popularis (56) or a constitutional complaint, (57) or to grant them a special right to bring proceedings for alleged breaches of their fundamental rights. (58) 59. Apart from these textual and historical elements, there is also a systemic element favouring a cautious reading of the requirement of individual concern. (c) A systemic reading of Article 263 TFEU 60. The EU judicial system has a peculiar two-pillar structure which follows from the fact that the European Union is neither a typical international organisation nor a nation State. (59) That peculiarity is revealed, in the first place, by Article 19(1) TEU, which – mandating the Court of Justice of the European Union’s mission to ‘ensure that in the interpretation and application of the Treaties the law is observed’ – states that ‘Member States shall provide remedies sufficient to ensure effective legal protection in the fields covered by Union law.’ It follows from that provision that national courts are meant to be, for citizens seeking protection of the rights they derive under EU law, the EU Courts of ordinary jurisdiction. (60) 61. In addition, pursuant to Article 13(2) TEU, each institution of the European Union must ‘act within the limits of the powers conferred on it in the Treaties, and in conformity with the procedures, conditions and objectives set out in them’. That provision must be read in the light of the principle of institutional balance, a key characteristic of the institutional structure of the European Union, which requires that each of the institutions exercise its powers with due regard for the powers of the other institutions. (61) As far as the Court of Justice of the European Union is concerned, it cannot be overlooked that it has been endowed with a clearly defined jurisdiction: under Article 274 TFEU, ‘save where jurisdiction is conferred on the Court of Justice of the European Union …, disputes to which the Union is a party shall not on that ground be excluded from the jurisdiction of the courts or tribunals of the Member States.’ 62. The above provisions show that there are (quite obviously) limits to what the Court of Justice can read, in the provisions of the Treaties, concerning the boundaries of its jurisdiction under Article 263 TFEU. They also manifest the existence of an undissociable link and mutual interdependence between the EU judiciary and the Member States’ judiciary. (62) 63. As the Court stated in Opinion 1/09 ‘the guardians of [the EU] legal order and the judicial system of the European Union are the [Court] and the courts and tribunals of the Member States’; and the national courts, in collaboration with the Court, fulfil ‘a duty entrusted to them both of ensuring that in the interpretation and application of the Treaties the law is observed’. (63) 64. In fact, the control of legality of EU acts rests on two complementary sets of judicial procedures: direct actions (among which, most notably, the action for annulment) and the preliminary ruling procedure on validity. As the Court has consistently emphasised in its case-law, the Treaties have established through Articles 263 and 277 TFEU, (64) on the one hand, and Article 267 TFEU, on the other, that ‘a complete system of legal remedies and procedures designed to ensure judicial review of the legality of European Union acts’. (65) This peculiar structure has been considered by the ECtHR, in essence, to satisfy the standards required by the ECHR in the well-known Bosphorus case. (66) 65. For all those reasons, I am not convinced that the Plaumann formula reflects an incorrect interpretation of the individual concern requirement set out in the fourth paragraph of Article 263 TFEU. The alternative interpretations proposed, judicially or extra-judicially, of that requirement (i) do not offer a sufficient degree of legal certainty, and (ii) are not fully in line with the origin, spirit and wording of the Treaty provision. Lastly, I am also of the view that it is not unreasonable that, in many cases, issues of validity of EU acts should first be brought before the national courts, which operate as a filter to decide whether those issues – being prima facie not frivolous – should be referred to the Court under Article 267 TFEU. 66. Having said that, does it mean that – paraphrasing Voltaire’s Candide (67) – all is for the best in the case-law of the Court on ‘individual concern’ and the European Union has the best of all possible judicial systems? 67. I do not think so. 4. The Plaumann case-law revisited 68. I am of the view that, despite the Plaumann formula being sound, the case-law is far from being clear and, moreover, certain interpretations of that formula have been excessively restrictive and cannot be reconciled with a reasonable reading of the fourth paragraph of Article 263 TFEU, even more so in the European Union of 2025. I shall hence make three suggestions now to the Court and then conclude with some final remarks on why reconsidering the Plaumann case-law would be feasible, desirable and timely. (a) Systematisation of the case-law 69. My first suggestion to the Court is to systematise the case-law in order to give both potential applicants and the General Court more clarity as to the various circumstances in which persons may be considered ‘individually concerned’ by an EU act. It is not unusual for the Court of Justice to give a landmark judgment in which it updates and draws together several lines of case-law in order to offer a coherent and exhaustive framework on a given issue of a procedural nature. (68) 70. To a non-EU law specialist, it may be surprising that, in many decisions of the EU Courts, the assessment of the admissibility of the action requires a lengthy and complex discussion. Admissibility should ideally be something relatively easy to verify. There is something inherently odd in a system where many cases require a longer analysis of the admissibility of the action and a much shorter one of the merits thereof. (69) 71. It is probably the complexity of this matter that led to the Boehringer case-law, in which the Court accepted that, when justified by the proper administration of justice, it is possible to dismiss an action lodged under Article 263 TFEU on the merits, without ruling on an objection of inadmissibility raised by another party. (70) This case-law offers a pragmatic solution to the issues stemming from such complexity. However, although defensible on grounds of judicial economy, it would probably have no reason to exist in a less complex system. 72. The uncertainty deriving from the complexity of the analysis of the individual concern may also raise an issue under the TWD Textilwerke Deggendorf case-law. In that case-law, the Court has, in essence, held that it would be against the principle of legal certainty to permit a person, who could have undoubtedly challenged an EU act before the EU Courts and who has let the mandatory time limit laid down in that regard by Article 263 TFEU to expire, to call into question the lawfulness of that act before the national court in an action brought against the measures taken by the national authorities in implementing that act. Any other course of action would enable the applicant to undermine the definitive character that the contested act necessarily assumes, once the time limit laid down for bringing proceedings has expired. Accordingly, a request for a preliminary ruling on the validity of such an act is, in those circumstances, inadmissible. (71) 73. I think it is fair to say that, despite giving the persons in question the benefit of the doubt (‘undoubtedly’), the analysis required under the TWD Textilwerke Deggendorf case-law is not easy to carry out. (72) This means, quite obviously, that in many cases the persons concerned by the measure must, to be on the safe side, bring two sets of proceedings: one before the national courts and one before the EU Courts. (73) That is what has happened, in fact, in the present proceedings. (74) The multiplication of proceedings on the same matter, with the ensuing higher costs for both the parties and society, is something that should not happen, for obvious reasons. 74. Consequently, I am of the view that there are particularly good reasons for the Court to bring more clarity in its case-law on the requirement of individual concern, by means of a landmark judgment. I hope the systematisation proposed above could be of some assistance to the Court to that end. To be clear, that systematisation is not meant to be an exhaustive illustration of all possible situations which may trigger ‘individual concern’ under the fourth paragraph of Article 263 TFEU, but only to reflect the existing case-law. Indeed, as Advocate General Bobek stated in his Opinion in Nord Stream 2, ‘[the Plaumann] test is certainly strict, but, at least on the face of it, also relatively open and flexible’. (75) The requirement of individual concern depends not only on the specific position of the applicant, but also on the form and content of the act, as well as on the procedure through which the act is adopted. For example, as the so-called Aarhus Regulation (76) shows, EU legislation can create new categories of persons ‘individually concerned’ by certain acts of the EU institutions. (77) 75. So, although any present systematisation of the case-law will not exclude that, in the future, the Court might find other cases in which a group of persons may be individually concerned by a given type of EU act, it would nonetheless offer clear guidance on the current state of the law not only to potential applicants, but also to the General Court. (b) Refining the closed-group test 76. In Part 3 above, I have explained why I am of the view that the Plaumann formula constitutes a plausible interpretation of the requirement of individual concern set out in the fourth paragraph of Article 263 TFEU. In the light of that, I also find the closed-group test to be a reasonable application of the Plaumann formula. I recall that according to that test, typically employed for measures of a general nature, where the measure affects a group of persons who were identified or identifiable when that measure was adopted, by reason of criteria specific to the members of the group, those persons might be individually concerned by that measure inasmuch as they form part of a limited class of persons affected. 77. It is hard to contest the view that, if the persons concerned by an EU act were neither identified nor identifiable, that act has been adopted to address a given set of circumstances conceived in the abstract, on the basis of considerations of general policy. At the same time, I also find it reasonable that the mere fact that all the persons affected by an EU act were, when that act was adopted, identified or identifiable is not by itself sufficient for those persons to be considered individually concerned. It is, in fact, not unusual that, in a given market, there are only few operators that are well known to the authorities and the public. The test of individual concern cannot apply differently if the act concerns, for example, the provisions of services by lawyers or doctors, or the manufacturing of large aircrafts or military armoured vehicles. It may, nonetheless, be different where, although drafted in general terms and applying without distinction to all persons concerned, the measure is essentially tailor-made to the situation of one or more specific persons. (78) 78. As stated in point 27 above, something more than the mere fact that the persons affected are identified or identifiable is, thus, necessary. That is why the case-law requires those persons to be part of a closed group that, in respect of the contested provision, has some distinctive characteristics. This is in line with the rationale of the provision that, as explained, has always been to deal with the situation in which an EU act has an impact on the legal position of one or more persons that goes beyond the impact that such an act has on the rest of the persons affected. That difference of impact on the individually concerned persons and the non-individually concerned persons cannot be (only or mainly) one of degree but should depend (at least to a large extent) on its nature. (79) 79. As I see it, the thread which runs through the cases in which individual concern was accepted consists in the fact that the acting institution either has (explicitly or implicitly), or should have – on the basis of some specific provisions, or of some general principles of EU law – taken into account the peculiar position of the applicants before adopting the contested act. That is so, in essence, where the policy reasons which prompted the institution to act had to be reconciled with the rights and interests of certain subjects that, for some specific reason, cannot be wholly assimilated to those of the other persons affected. The fact that the institution in question was unaware of the number or identity of those persons is irrelevant, as long as it would have been in a position to obtain the necessary information. (80) It seems to me that the four instances referred to in point 28 above provide good examples in that respect. 80. I am obviously aware that there are some judgments of the Court which seem to go against that finding. (81) However, those cases are rather peculiar and the Court’s statements on this matter cannot be generalised. The cases in question concerned actions lodged not by private persons acting to protect their rights, but by a regional authority (one of the three territories forming the Kingdom of the Netherlands) that merely acted in the general interest, as an entity responsible for economic and social affairs within its jurisdiction, against a measure which had a rather limited impact on its economy. (82) In that regard, I would recall that, according to well-established case-law, the mere fact that a region or other public local entity has some competence – as a body competent for economic, social or environmental matters in its territory – with regard to the matter regulated by an EU measure of general application cannot, of itself, be sufficient for that region to be regarded as ‘concerned’ within the meaning of the fourth paragraph of Article 263 TFEU. (83) What is more, in the cases in question the relevant EU legislation only included vague and generic references to the need, for the acting institution, to take into account, among the various factors to consider, the impact of the planned measure on the areas affected. (84) And, as the Court found, the impact that the challenged measure produced on the territory under the applicant’s jurisdiction was no different than that produced on the other territories affected. (85) 81. Therefore, I do not think that those judgments are such as to call into question my considerations above. In fact, a far-reaching reading would not only be hard to reconcile with the rest of the Plaumann case-law, but it would also be problematic from a systemic point of view. Indeed, if an EU institution is obliged by law to consider the position of one or more specific persons, those persons have a corresponding right that their position be considered. Naturally, ubi ius ibi remedium: wherever there is a right, there is a remedy. Thus, the persons concerned should have the capacity to ensure the protection of the right before a court, by challenging the measure that allegedly failed to take into account their position, or did so erroneously. In fact, it is this very right (of being considered) that – to recall the Plaumann formula – distinguishes the applicants ‘individually just as in the case of the person addressed’. (86) In essence, by adopting a given measure, the acting institution may have not only laid down general and abstract rules applicable to an undetermined number of persons, but also dealt with the position of one or more identified or identifiable persons, as if it had addressed to them an act with some specific decision-making content. 82. That being said, there is an element of the closed-group test which I find rather perplexing. 83. In some decisions, the EU Courts required (or appeared to require) that the category of persons particularly affected by the contested measure, to which the applicant alleges to belong, is composed of a fixed number of persons that cannot be enlarged after the adoption of the contested measure (‘the future element’). (87) 84. I have two reservations in that respect. 85. First, at the theoretical level, the future element does not seem to be in line with the logic underpinning of the Plaumann case-law. Essentially, it requires comparing the position of a given applicant (or a group of persons to which he or she belongs), on the one side, with the position of the persons who, at some point in the future, may be affected by the contested measure, on the other side. 86. Nevertheless, that is not the comparison which the Plaumann case-law requires of the EU judiciary. There are two factors in the ‘individual concern’ equation: (i) the generality of the persons affected by the contested measure, to be identified in abstracto, on the basis of the scope ratione personae of that measure (‘the generality’), and (ii) a subset thereof, that is, a smaller group of persons affected (to which the applicant belongs), that, because of some peculiar characteristics, can allegedly be distinguished from the generality (‘the limited class’). (88) 87. The existence of the limited class must be assessed in concreto, taking into account all the elements, of law and fact, which may characterise the position of the persons belonging to it. Indeed, the Plaumann formula expressly directs the EU Courts to examine the applicant’s specific ‘attributes’ and ‘circumstances’. In fact, the Court has made clear that (i) individual concern must be established ‘on the basis of the specific situation of [the] individual compared to all other persons’; (89) and (ii) that comparison must be made ‘from the point of view of the contested provision’, (90) ‘at the date of the contested [provision]’. (91) 88. If that is so, what is crucial in the analysis is to establish whether there is a difference in the nature of the impact that the contested measure has in respect of the two groups (generality versus limited class). The role or weight that the future element should have in the context of that analysis remains rather unclear to me. 89. In particular, I struggle to understand why the capacity of one or more persons to challenge a given act that was adopted, without (allegedly) the EU institution in question having duly taken into account their special position, should depend on the hypothetical future conduct of other individuals (those who, for instance, may undertake a given activity, start a given business or move to a given territory within the European Union). In a community of law that – as I will explain later – reflects the basic ideas of liberal democracies based on a free and open market economy, which emphasise individual autonomy and protect fundamental rights, it is extremely rare that a category of persons carrying out an activity is unchangeable in the future. (92) 90. The future element follows, in my view, from a misapplication of the Plaumann case-law. It is the result of an analysis skewed towards the personal scope of the challenged measure, which pays insufficient consideration to the actual characteristics of the subset thereof. This means giving decisive weight to elements of a theoretical and hypothetical nature at the expense of an existing real situation. To my mind, such an approach can hardly be reconciled with the Court’s case-law cited in point 87 above. 91. Second, from a practical point of view, I am not sure that it may be reasonable and useful to consider the future element. 92. True, the future element is a characteristic which is inherent in all those situations in which the criterion that sets the limited class apart from the generality pertains to past events, as for example in the situations referred to in point 32 above. However, in such cases, there is no added value for the Court to verify that element, precisely because it is inevitably present. 93. In the other cases too – that is, where the criterion that sets the limited class apart does not relate to past events – the review of that element may be misleading or to no avail. 94. On the one hand, it could lead to some inconsistencies: an applicant that, with respect to a given measure, is actually in a distinctively different position from that of the generality (i) may still be individually concerned even if some other persons are in the same position, but (ii) could not be individually concerned if some other person may possibly be in a similar position in the future. The reason for drawing such a distinction escapes me. 95. On the other hand, I wonder whether a correct identification of the limited class (that is, one made in concreto by assessing all relevant elements of law and fact) will not – yet again – render the review of the future element otiose. 96. For example, in the present case, the General Court focused its analysis on undertakings involved in the production and sale of heated tobacco products by looking at the material and personal scope of the contested measure. Undoubtedly, both the applicants and any undertaking that will be active in the future in the market concerned are comparable in that they will all be subject to the same rules and, therefore, ‘suffer’ from the limitations on their activities introduced by the contested measure. 97. However, are current operators and future operators active in that market truly in a similar position, for the purposes of the fourth paragraph of Article 263 TFEU? In my view, that is clearly not the case. 98. As I will explain in more detail when assessing the appellants’ ground of appeal, the appellants are among the undertakings that introduced a novel product in the EU market and, to that end, made significant investments, including the development of a new technology, the creation of new distribution channels, and the campaign to make the product known and attractive to customers. In addition, the contested measure was – put simply – introduced for the very reason that the applicants were quite successful in their endeavours and, thus, the sale of the new product increased significantly within a relatively short period of time. What is more, that growth – and, hence, the necessity and appropriateness of introducing the contested measure – was established, by the Commission, by using the sales data provided, inter alia, by the applicants themselves. 99. How could undertakings which may, one day, enter this market – for example, free riding on the investments made by the appellants – be considered to be in a position that is truly similar to that of the appellants? 100. Concluding on this point, I am of the view that the future element can hardly be reconciled with the main tenets of the Plaumann case-law and, moreover, it could be easily misinterpreted and misapplied. That is why I propose that the Court of Justice confirms the closed-group test but abandons the requirement that the group of persons in question cannot be enlarged after the adoption of the challenged act. (c) An equivalent treatment of all persons in respect of all rights 101. My third and final suggestion to the Court is to engage in a more coherent application of the Plaumann case-law in the various cases brought before it, regardless of the type of applicant or rights or interests affected. Indeed, it seems to me that the principles under the Plaumann case-law have been applied more rigorously at times and more leniently at others, in cases that – at least when viewed with today’s eyes – are largely similar. Arguably, where that was justifiable in the European Economic Community of 1963, it is no longer so in the European Union of 2025. 102. Until the late 1980s or early 1990s, the then Communities mainly dealt with trade and economy. Most cases landing on the Plateau de Kirchberg concerned matters such as free movement, competition, commercial policy and trade defence, customs, agriculture and fisheries. (93) It is thus unsurprising that the Plaumann case-law was more receptive to possible breaches of economic rights put forward by persons who were economically active: workers, self-employed or companies. After all, the main objective of the Communities at that time was to create a common market. 103. In the European Union of 2025, the situation has considerably evolved. In order to achieve its overarching objectives (promote peace, its values and the well-being of its peoples), the European Union is required not only to establish and strengthen an internal market, but also to, inter alia, ‘offer its citizens an area of freedom, security and justice’, ‘work for sustainable development’, ‘aiming at full employment and social progress, and a high level of protection and improvement of the quality of the environment’, and ‘promote scientific and technological advance’. Increasing European people’s economic welfare is no longer the (one and only) lodestar guiding the European Union. 104. Thus, EU citizens’ economic rights cannot have a primi inter pares standing in the EU legal system, being of equal importance to rights and freedoms of another nature (civil, political, social, etc.). It follows from well-established case-law that, within the EU legal order, no category of rights has priority over another. (94) Where different rights are at stake, their requirements must be, as much as possible, reconciled by striking a fair balance between them. (95) In the case of direct conflict, which rights prevail depends on the specific circumstances at issue. (96) 105. Additionally, I hardly need to point out that the EU citizens’ intention to pursue their common interests through the creation of a legal person is protected by the Charter, both when those interests are of an economic nature or of another nature. (97) 106. It follows from the above that a certain re-balancing of the manner in which the Plaumann case-law is applied in the various cases may be necessary. Namely, when examining individual concern, (i) non-profit entities (such as associations and non-governmental organisations (98)) should generally be considered by the same standards applied to profit-making entities (such as companies), and (ii) it should be of no relevance whether the applicants’ rights or interests affected by the contested measures are of an economic nature or of a different nature. 107. I will now give two hypothetical examples to show what that could mean in practice. 108. First, an EU measure which, in order to protect fish stocks, prohibits, for a significant period of time, the most lucrative catches in the maritime areas around the Remota Insula island might, in my view, individually concern the local association of small fishermen – representing the interest of all people whose livelihood entirely depends on their fishing activities – but not any other categories of persons which are also affected by the measure to various degrees: the inhabitants of the island, the local restaurant owners and large companies active in the fish industry (who could easily send their boats elsewhere). 109. Second, an EU measure which severely affects the animal species avis avium, living in the Natura 2000 site of Antiqua Silva, may not individually concern the various persons residing nearby, bird-watching amateurs or international environmental associations. However, that measure is certainly affecting in a very distinctive way a local association whose statutory mission is, precisely, the protection of avis avium in the Antiqua Silva site. 110. In each of those cases the difference in the manner in which the EU measure in question affects the imaginary association and that in which it affects other persons is not one of degree but concerns the nature of that measure’s effect. The interest affected may (first example) or may not (second example) be of an economic nature. In both cases, the measure strikes at the heart of the association’s activity, affecting an interest which goes above and beyond that of the persons who belong to that association. Accordingly, the association should have standing given the impact that the hypothetical measure has on its own interests as an association, in accordance with the case-law referred to in footnote 98 above. Considering those legal persons as not being individually affected by those measures – just because they are not the only ones being affected and/or they do not have a de jure or de facto monopoly over the protection of the interests at stake – would be not only formalistic but also detached from reality. 111. I do not see any material difference between those hypothetical cases and, for example, proceedings brought by companies which are neither the addressees of, nor mentioned in, decisions adopted under the EU antitrust and State aid rules, but are instead potential or actual competitors or business partners of the companies concerned by those decisions. 112. In conclusion, my three suggestions to the Court are as follows: (i) to systematise the Plaumann case-law in order to provide potential applicants and the General Court more clarity; (ii) to refine the closed-group test, abandoning an overly strict application thereof; and (iii) to ensure an equivalent consideration of all persons in respect of all rights. In the next three subparts of this Opinion, I will explain why revisiting the Plaumann case-law would, in my view, be feasible, desirable and timely. (d) Final remarks (I): why reconsidering the Plaumann case-law is feasible 113. Unlike the tests proposed by Advocate General Jacobs, the General Court and part of legal scholarship, my suggestions concerning the interpretation of the fourth paragraph of Article 263 TFEU do not depart from the judgment in Plaumann. Nor am I proposing to repeal or substantially amend the closed-group test, which the EU Courts have consistently employed to establish individual concern in the case of measures of general application. 114. My suggestions are, in fact, of a systematic nature and are relatively modest in scope. The Court of Justice may endorse them whilst remaining comfortably within the perimeter traced by the existing case-law, including leading and recent cases such as UPA, Inuit or Carvalho. Only a rather limited and peripheral line of case-law would be abandoned. 115. In the light of the above, I also believe that any concern that my suggestions would ‘open the floodgates’, leading to an explosion of the EU Courts’ dockets, would be largely exaggerated. First, one should not overlook the fact that persons satisfying the requirement of individual concern must also meet the requirement of ‘direct concern’ and prove that they have an ‘interest’ in bringing proceedings. (99) Moreover, I hardly need to add that applicants have a well-defined period to challenge an EU act: they must do so within two months from the date of publication of the act, of its notification to them or of the day on which they became aware of it. (100) Second, the relative increase in the number of cases that may be admissible would be, I believe, more than compensated by the Court of Justice of the European Union’s resources that would be spared thanks to a clear systematisation of the matter. Third, with the General Court composed of 54 judges, a modest increase in the caseload should be perfectly manageable. (101) Fourth and last (but not least), when reviewing the validity of EU acts, the Court of Justice leaves a relatively wide margin of discretion to the EU institutions with regard to policy choices and complex technical assessments (a so-called marginal review by the Court). (102) It follows that, even among the cases that will be considered admissible, there will be a not-insignificant part that, on the merits, might be dealt with rapidly, since the institution in question has not exceeded the boundaries of its discretion, which would have resulted in a manifest error of assessment. (e) Final remarks (II): why reconsidering the Plaumann case-law is desirable 116. In my view, there is an advantage which is additional to those already discussed above. It results from the enhanced role that some associations may have in disputes brought directly before the EU Courts. 117. As Advocate General Sharpston observed, in essence, a system that encourages people to channel disputes related to collective interests (such as environmental protection) through associations ‘recognise[s] that these organisations do not overload or paralyse the courts. Rather, [it brings] together the claims of many individuals in a single action … [thereby creating] a filter which, in the long run, assists the work of the courts.’ In addition – she noted – ‘these associations often have technical knowledge that individuals generally lack [and] bringing this technical information into the process is advantageous, because it puts the court in a better position to decide the case.’ (103) 118. I do not have much to add to those very reasonable considerations. A strengthened role for associations is also an aspect which will, to some extent, remedy the paradox mentioned in point 41 above, according to which the more general and collective the nature of the interest at stake and harmful the measure, the more unlikely that applicants will be found individually concerned under the Plaumann case-law. 119. Nevertheless, I have some sympathy for the arguments of Advocate General Cosmas, according to whom a relaxation by the Court of the standing criteria to the benefit of associations could (i) be abused, as natural persons without locus standi might try to circumvent that procedural impediment by setting up a specific and dedicated association to be used as a procedural vehicle, and (ii) make possible challenges by a potentially large and indefinite number of associations. (104) 120. Those objections can, however, easily be overcome. First, it would surely be appropriate to require the association in question to be genuine and prove its past activity. (105) Second, it would not be enough for an association to be generally active in the area affected by the contested measure, or that the association’s aims encompass the protection of the interest allegedly affected by that measure. Indeed, such an approach would enlarge excessively the scope of the associations concerned, in clear contradiction of the rationale behind the Plaumann case-law. As explained, it would be necessary to ascertain that the contested measure can have a significant impact on the core activity of the association, as defined in its statute. 121. In fact, it appears that, in a number of Member States, national courts have interpreted their procedural rules (including those on standing, as the case may be) so as to allow challenges to measures which allegedly harmed collective interests, especially when brought by representative associations. Some of the judgments delivered in those cases are particularly remarkable in respect of how far they went in protecting the public interest unduly affected by the contested measures. (106) 122. In addition, the ECtHR has also recently moved in that direction. In fact, I think that the Court could draw some inspiration from the rulings, delivered in April 2024 by the Grand Chamber of the ECtHR, in three cases concerning climate change. Whilst it held that the complaints lodged by the individual applicants were inadmissible, the ECtHR found that an association had the right to bring a complaint. (107) In essence, the Strasbourg Court found that, given the collective nature of the interest protected by the applicants, it was important to make allowance for recourse to legal action by associations instead of exclusively relying on proceedings brought by each individual on his or her own behalf. However, the ECtHR required, to that end, three criteria to be fulfilled by the applicant, namely that the association should demonstrate that (i) it is lawfully established in the jurisdiction concerned or has standing to act there; (ii) it pursues a dedicated purpose in accordance with its statutory objectives within that jurisdiction; and (iii) it could be regarded as genuinely qualified and representative to act on behalf of members or other affected individuals within the jurisdiction. 123. It seems to me that those three criteria correspond, mutatis mutandis, to those that I suggested in point 120 above, concerning the need to review the association’s core mission under its statute and verify the genuine nature of its activities. For the reasons exposed in points 101 to 112 above, the approach suggested appears to fit well within the Plaumann case-law. 124. In this context, I would also add in passing that other international tribunals also admit similar actions. For example, in May 2024, the International Tribunal for the Law of the Sea also delivered an advisory opinion on climate change. It first confirmed its jurisdiction to rule, on the basis of Article 21 of its statute, despite the contrary views of some participants in the proceedings, and then went on to rule that that the parties to the United Nations Convention on the Law of the Sea have specific obligations, that is, ‘to take all necessary measures to prevent, reduce and control marine pollution from anthropogenic [Greenhouse Gases] emissions’. (108) 125. One could wonder whether an overly restrictive application of the rules on standing under the fourth paragraph of Article 263 TFEU may not make it less likely that the Court could hear disputes raising issues of a similar kind. Privileged applicants are often unlikely to challenge measures of general application before the EU Courts since they typically participated, either directly (EU institutions) or indirectly (Member States, as members of the Council), in the adoption of the contested act. 126. Therefore, in most cases, the Court’s ability to hear such cases depends on the goodwill of the national courts before which a private party has brought proceedings, usually with the very aim of triggering a reference under Article 267 TFEU. There is, naturally, no certainty that that will happen, and the procedure to could also be lengthy. That would be most unfortunate, since such issues are bound to have a significant importance in the European Union’s future action in some areas in which the Court has played a pioneering role in the past. (109) (f) Final remarks (III): why reconsidering the Plaumann case-law is timely 127. Legal certainty, which requires a high level of clarity and stability of the law, is a principle of constitutional importance in most legal systems, and its protection is a core mission of any court or tribunal. However, in all legal systems there comes a moment when the highest courts may have to question certain assumptions and revisit well-established case-law. Is the case-law still in line with the fundamentals of the legal system as a whole, and does it reflect the values and beliefs of the polity of whose it is expression? 128. In that regard, the ECtHR refers to the ECHR as a living instrument. The Court borrowed that expression, and used it in relation to the Charter, which it referred to as ‘a living instrument which must be interpreted in the light of present-day conditions and of the ideas prevailing in democratic States today … with the result that regard must be had to changes in values and ideas, both in terms of society and legislation, in the Member States’. (110) 129. I hardly need to point out that revisiting well-established case-law does not mean– necessarily overturning or repealing it; it may only mean reviewing the key principles established therein with a fresh look, in the light of the new legal and social context. Recently, for example, the Court proceeded to revisit its long-standing CILFIT case-law in Consorzio Italian Management. (111) The Court eventually chose to confirm the overall approach on the matter, whilst providing a number of clarifications and making certain adjustments to it. (112) 130. In my view, the time is now for the Court to revisit its Plaumann case-law. Not only because the present case offers an opportunity to do so but, first and foremost, because – as mentioned above – the current legal system is profoundly different from that in force when the judgment in Plaumann was delivered. 131. It is not so much the growth in the membership or geographic extension or the enlargement of the competences and the strengthening of the institutions’ powers that has changed between the European Economic Community of 1963 and the European Union of 2025. It is the very fabric which the (now) European Union is made of that has changed over that period. The then European Economic Community was set up mainly as an economic organisation, and there was no explicit reference to fundamental rights or the rule of law in the founding Treaty. (113) Strict requirements for direct access of private litigants to the Community judiciary made perfect sense within that context. 132. In a judgment delivered shortly after that in Plaumann, the Court gave short shrift to the argument of the applicants that ‘if recourse to [then Article 173 EEC] were to be refused by reason of a restrictive interpretation of its wording, individuals would thus be deprived of all protection by the courts both under Community law and under national law, which would be contrary to the fundamental principles governing all the Member States’. The Court considered it unnecessary to even discuss that argument, since that would ‘override the clearly restrictive wording of Article 173, which it is the Court’s task to apply’. (114) This minimalistic judicial approach would be unthinkable today. 133. It should not be overlooked, in this context, that the judgment in Plaumann was delivered a few months after that in van Gend & en Loos and one year before that in Costa v ENEL. (115) The establishment of the autonomy of the (then) EEC legal order – at that time freshly declared to constitute ‘a new legal order of international law’ (116) – was an edifice whose construction had barely started. 134. Over the following decades, however, the Court progressively introduced, within the (then) EEC legal system, principles such as democracy, respect for fundamental rights and the rule of law. (117) The Court’s approach was then ‘constitutionalised’ by the Member States through successive Treaty amendments. The culmination of that process led to the adoption of the Treaty of Lisbon which, in particular, (i) elevated democracy, respect of fundamental rights and rule of law to the level of values on which the European Union is founded in Article 2 TEU; (ii) transformed the Charter into a binding instrument of primary law; and (iii) introduced in the Treaties a number of principles reflecting the democratic nature of the European Union. I refer, in particular, to those encouraging a more significant participation of citizens, their representative associations and, more generally, civil society to the democratic life of the European Union. (118) 135. These constitutional changes cannot be overlooked when issues concerning individuals’ access to justice arise. In particular, the principle of the rule of law (Article 2 TEU) and the fundamental right to effective legal protection (Article 19(1) TEU and Article 47 of the Charter) must be given flesh and bones. 136. It certainly remains true that, as stated in settled case-law, the EU Courts ‘may not, without going beyond their jurisdiction, interpret the conditions under which an individual may institute proceedings against an act of the Union in a way which has the effect of setting aside those conditions, which are expressly laid down in the FEU Treaty, even in the light of the principle of effective judicial protection’. (119) In fact, as the Court has repeatedly held, the codification of the principle of effective judicial protection in Article 47 of the Charter ‘is not intended to change the system of judicial review laid down by the Treaties, and particularly the rules relating to the admissibility of direct actions brought before the [EU Courts]’. (120) 137. At the same time, however, the Court has explicitly recognised that the rules concerning its jurisdiction and, more generally, access of private parties to justice must be interpreted, as far as possible, in the light of the principles of effective judicial protection and of the rule of law. It was so before the Treaty of Lisbon (121) and it is a fortiori true now that those principles have been expressly codified. 138. In a number of recent cases, in fact, the Court has relied on those principles when interpreting the EU rules concerning (i) the limits of the Court of Justice of the European Union’s jurisdiction in the field of common foreign and security policy under Article 24(1) TEU and Article 275 TFEU; (122) (ii) the concept of ‘legal person’ within the meaning of the fourth paragraph of Article 263 TFEU; (123) and (iii) legal representation of private parties in direct actions before the EU Courts, under the Statute of the Court of Justice of the European Union and the Rules of Procedure of the General Court. (124) 139. Exploiting the full potential of the principle of effective judicial protection is something that the Court of Justice has requested national courts to do in order to ensure access to justice to individuals and their representative associations. Indeed, in a number of cases the Court went quite far in requiring national courts to interpret their procedural rules in conformity with the relevant EU provisions or to set aside those rules when hampering the full effectiveness of EU law. (125) 140. I have to agree with Advocates General Jääskinen and Bobek that a consistent approach on this matter is necessary: what is required of the national courts must also be required of the EU Courts. (126) A timid approach to the application of the principle of effective judicial protection by the Court in that regard could give the impression of double standards. (127) 141. One needs no crystal ball to forecast that, in the World 2.0, the main risks that the EU citizens will be exposed to will not be (only or mainly) of an economic nature, but may well concern rights and freedoms such as those relating to human dignity, freedom of expression, privacy and personal health. Similarly, the European Union may have to overcome numerous challenges to safeguard and promote its values, including democracy, solidarity, rule of law and environmental protection. The mission of the Court of Justice of the European Union will remain the same, but the issues brought before it will certainly be (even more so than today) unlike the majority of those it had to deal with under the then EEC or EC Treaties. Against that background, it stands to reason that certain cases which will require a careful assessment of the manner in which the European Union has exercised its competences – striking a balance between competing objectives – should be heard directly by the EU Courts. 142. In his Opinion in UPA, Advocate General Jacobs explained in detail why he was of the view that, for a number of reasons, a direct action before the EU Courts was better suited than a reference for a preliminary ruling to ensure a thorough review of the validity of an EU act. (128) To my mind, those reasons – which need not be discussed here – still remain largely valid today. 143. Furthermore, my proposal would alleviate the problem – emphasised by Advocate General Wathelet – that, even after the amendments made by the Treaty of Lisbon to Article 263 TFEU, there may be cases in which no action at national level is available for bringing such issues before a national court. (129) In those cases, the dogma that the Treaties have established a complete system of legal remedies and procedures designed to ensure judicial review of the legality of EU acts (130) is – to use an oxymoron – not an absolute truth. 144. Filling those gaps would also be of the utmost importance were the European Union to accede to the ECHR, as required by Article 6(2) TEU. As the ECtHR has consistently stated, Article 6 ECHR concerning the right to a fair trial is a provision, inter alia, (i) laying down one of the fundamental principles of any democratic society; (ii) that cannot be interpreted restrictively; (iii) which guarantees not rights that are ‘theoretical or illusory’ but rights that are ‘practical and effective’; and (iv) whose requirements must be met in all cases. (131) In the light of the ECtHR judgment in Klimaseniorinnen, (132) and given the correlation between Article 47 of the Charter and Article 6 ECHR, a reflection on this matter would seem particularly timely. Indeed, after the successful conclusion of the negotiations of a revised agreement in March 2023 (133) and the delivery of the judgment of the Court in KS and KD, (134) some observers take the view that the path towards accession might be open again. (135) 145. It is in the light of the above considerations that I shall now turn to the arguments put forward by the appellants in the present case. B. First part of the ground of appeal 1. Arguments of the parties 146. By the first part of their ground of appeal, directed against paragraphs 45 to 52 of the order under appeal, the appellants argue that the General Court misinterpreted the fourth paragraph of Article 263 TFEU and mischaracterised the facts in holding that the contested regulation was not of their individual concern and that consequently their action for annulment was inadmissible. In their view, the General Court erred in its assessment of the legal significance of the evidence on which they had relied before it and in concluding that the evidence was insufficient to establish individual concern. According to the appellants, the General Court did not carry out an overall analysis of the appellants’ situation, but assessed each of the elements adduced by them separately. This approach is – they contend – contrary to settled case-law, according to which it is necessary to identify the body of evidence or the set of factual and legal factors capable of distinguishing the applicant from the other persons affected. 147. The Commission takes the view that the first part of the appellants’ ground of appeal is unfounded. It argues, in particular, that the fact that the General Court examined the arguments raised by the appellants in a systematic and structured manner does not mean that it failed to take into account the body of evidence in its entirety. The Commission submits that, in the first instance, the appellants relied on a relatively limited number of arguments to support their claim of individual concern, in essence (i) that they formed a closed class of economic operators, identifiable and actually identified when the delegated directive was adopted by reason of declarations and notifications made under Articles 5 and 19 of Directive 2014/40; and (ii) that the delegated directive would be liable to have a substantial effect on their market position. Those two arguments are – the Commission contends – accurately addressed in the order under appeal. Moreover, the Commission argues that the appellants are wrong to suggest that the General Court held that the contested measure produces the same effect on all operators. In fact, according to the Commission the General Court found that such a measure affects operators which have an authorisation to market heated tobacco products in the same way as those operators which do not have such an authorisation, but which intend to place such products on the market. 148. The French Government supports the arguments put forward by the Commission. In particular, it emphasises that the mere fact that the appellants belong to an identified group of operators does not, in itself, prove that they are individually concerned by the contested measure. That is a measure – the French Government adds – of general application in so far as it applies to all operators involved or interested in marketing heated tobacco products, regardless of whether or not they have obtained or applied for a marketing authorisation. 2. Analysis 149. I am of the view that this part of the ground of appeal is well founded since the General Court erred in its interpretation and application of the fourth paragraph of Article 263 TFEU. After briefly summarising the relevant passages of the order under appeal (a), I will explain why the statement of reasons included therein on the requirement of individual concern is unconvincing (b). I will explain why, had the General Court applied the Plaumann case-law correctly, it would have come to a different conclusion in that regard. (a) The order under appeal 150. In paragraphs 34 to 46 of the order under appeal, the General Court first recalled the basic tenets of the Plaumann case-law. It then went on to discuss briefly the relevant aspects of the system laid down in Directive 2014/40 for the sale of tobacco products within the EU market. In that context, it emphasised that ‘manufacturers and importers may place on the market only tobacco products which comply with the requirements of that directive and which have been the subject of the declarations and notifications provided for therein, and, as the case may be, of the authorisations required by the Member States which have introduced an authorisation system’. In that respect, the obligations which apply, in particular, to manufacturers and importers of novel tobacco products are set out – as the General Court pointed out – in Articles 5 and 19 of Directive 2014/40. 151. Subsequently, the General Court examined whether the fact that the appellants had made those declarations and notifications to the competent authorities and, in addition, that some of them had been granted marketing authorisations for heated tobacco products with characterising flavours (in the Member States which have introduced an authorisation system), was an element sufficient to distinguish them individually for the purposes of the Plaumann case-law. 152. The General Court answered that question in the negative. 153. To begin with, that court held that the sole fact that the operators which had made a declaration or notification or hold an authorisation were identifiable at the time of the adoption of the contested measure could not suffice, where that measure applied by virtue of general and abstract considerations. In that regard, the General Court noted that the Commission was not required to take particular account of their situation when adopting the contested measure. Moreover, the General Court stated that the fact that only a small number of undertakings were currently affected by the contested measure could also not be discounted. 154. In addition, the General Court found that, although ‘the absolute prohibition on marketing heated tobacco products with characterising flavours laid down in the contested measure [would] necessarily have the effect of calling into question the authorisations held by some of the applicants’, that element could not ‘be regarded as differentiating the position of the holders of those authorisations’. The reason for that was – according to the General Court – that the authorisations in question did not confer on their holders ‘acquired rights’. The effects of the contested measure were produced – that court noted – in respect of all current and future market operators. Furthermore, the General Court observed that the authorisations issued by Member States were ‘granted without exclusivity, on the sole basis of the compliance of the products, just as no exclusivity results from the declarations or notifications made by operators’. 155. Finally, the General Court stressed that Directive 2014/40 provided that various delegated acts could specify or amend the conditions for marketing tobacco products falling within its scope, including withdrawing the exemptions in question. It follows – the General Court held – that ‘the authorisations to market heated tobacco products with characterising flavours granted to some of the applicants, like the right to market such products following a declaration or a notification, could not be regarded as having been acquired indefinitely’. (b) The errors of law in the order under appeal 156. At the outset, it may be useful to point out that it is common ground that the contested measure is, in principle, an act of general application, since it affects a number of market operators (manufacturers and importers of tobacco products and, in particular, of heated tobacco products) identified in a general and abstract manner. It is equally undisputed that no specific operator is expressly referred to in the contested measure or in the main act which that measure amends, namely Directive 2014/40. 157. In the light of that, I find it reasonable that, in the order under appeal, the General Court stated that, to be considered individually concerned by the contested measure, the appellants had to prove that they passed the closed-group test. To that end, the General Court went on to examine – again, correctly in my view – whether, at the time the measure was adopted, the appellants (i) were among the persons that could be identified as affected by it; and (ii) belonged to a limited class of operators who could be sufficiently distinguished from the rest of the persons affected. 158. Having considered the elements adduced by the parties to the proceedings, the General Court came to the conclusion that (i) the appellants were indeed among the persons that could be identified as being affected by the measure but (ii) they could not be sufficiently distinguished from all other economic operators concerned by that measure. 159. Whereas the first conclusion reached by the General Court is plainly correct, the second is – in my view – problematic on numerous grounds. That is not to say that the General Court’s findings are not supported by certain judgments of the EU Courts. Nevertheless, it seems to me rather clear that, when the body of case-law is considered in its entirety, and applied in a realistic and non-formalistic manner, those findings cannot be upheld. 160. It is true that, as the General Court noted, the appellants are affected by the contested measure because they are undertakings engaged in an economic activity (manufacture and/or marketing of heated tobacco products) which can be carried out, both now and in the future, by any undertaking wishing to operate in that market. Accordingly, at an abstract level of analysis – that is, when only looking at the scope ratione personae of the contested measure – it is correct that the impact of the contested measure on the appellants’ activities is not dissimilar to that on any present and future market operator. In essence, the measure will make it impossible to sell flavoured products in the EU market, and will oblige the undertakings acting in that market to include certain warnings on the packaging. 161. However, when the General Court’s analysis proceeded to consider the actual position of the appellants – to check whether a limited class of persons affected existed – it did so in a manner which was, in my view, both incomplete and not thorough. As I see it, the General Court has (i) erroneously assessed the significance of certain elements put forward by the appellants and (ii) failed to consider other elements the appellants had relied on. 162. In fact, it seems to me that – at a general level – the present case corresponds to what I consider to be the underlying logic of the Plaumann case-law: to allow persons to challenge acts in respect of which the acting institution has (explicitly or implicitly), or should have, taken into account their peculiar position before the adoption. (136) More specifically, when the appellants’ position, both in law and in fact, is examined against past case-law, numerous common features emerge with cases in which the EU Courts have found the applicants to be individually concerned. 163. First, in the present case it can hardly be contested that, under the applicable legislation, the Commission had, when adopting the contested act, to take into account the situation of a specific category of market operators, namely those manufacturing and marketing a novel tobacco product in respect of which the exemptions were withdrawn. (137) It is the combined sale of those operators, and the age of their customers – calculated on the basis of the data provided by the undertakings themselves – that, according to the Commission,(138) triggered the withdrawal of the exemptions. 164. It is common ground that, in the present case, the Commission has taken into account, inter alia, the sales made by the appellants and the share of young consumers in the customer base before adopting the contested measure. (139) Whether it did so correctly is, however, subject to dispute and constitutes one of the appellants’ pleas at first instance. That is an element which the present case has in common with the cases referred to in point 31 above. 165. Second, the present case also resembles some of the cases in which the EU Courts have – as explained in point 32 above – accepted individual concern with respect to persons having proved that the challenged measure had an impact on an acquired right. Indeed, as the General Court stated in paragraph 47 of the order under appeal, ‘there is no doubt that the absolute prohibition on marketing heated tobacco products with characterising flavours laid down in the contested measure will necessarily have the effect of calling into question the authorisations [granted by Member States’ authorities, as permitted by Article 19(3) of Directive 2014/40,] held by some of the applicants’. 166. In that regard, I do not agree with the General Court, which considered the holding of such authorisations to be irrelevant, on the ground that they (i) were not required in some Member States; (ii) were granted without exclusivity; and (iii) could not be considered to ‘[have] been acquired indefinitely’, since the provisions of Directive 2014/40 permitted the Commission to withdraw the exemptions granted to heated tobacco products. Indeed, I find none of those considerations to be persuasive. 167. To begin with, I fail to see why the fact that certain Member States chose not to introduce a system of prior authorisation for the marketing of novel tobacco products is a disqualifying factor. In an area of shared competence, in which the EU legislature has only partially harmonised the field, leaving Member States the freedom to regulate certain specific matters (within the limits laid down in the relevant EU provisions, in casu Article 19 of Directive 2014/40), there is no reason to consider that only the rights granted by the EU authorities and/or concerned with the whole EU territory warrant specific protection at EU level. If a given EU measure infringes an acquired right of a person, that person should be able to challenge the measure in question, regardless of the origin of the right or its territorial scope. 168. In addition, whether the rights allegedly infringed by the contested measure are exclusive or not is, to my mind, irrelevant under the fourth paragraph of Article 263 TFEU. As explained in points 23 to 26 above, under the Plaumann case-law an applicant need not be the only person affected by the challenged measure, nor the only one affected in a distinctive manner. Indeed, it is enough that he or she is part of a limited class of persons who are so affected. The fact that the rights are exclusive is, quite obviously, an element that may be relevant in the analysis of ‘individual concern’ (as was the case, for example, in the judgment in Infront, (140) referred to in the order under appeal), but it is surely not a sine qua non condition (as evidenced by cases such as Stichting Woonpunt, (141) a judgment also mentioned in the order under appeal). 169. Finally, the requirement that the right is indefinitely acquired is also puzzling from a conceptual point of view. I hardly need to point out, in that regard, that, within certain limits, the national and EU legislatures can always adopt measures that alter the duration, scope or nature of the rights that persons enjoy under existing legislation. Consequently, I assume that, in that passage of the order under appeal, the General Court intended to emphasise the fact that the appellants were (or should have been) aware that the exceptions granted to heated tobacco products could, in accordance with the provisions of Directive 2014/40, be withdrawn once certain conditions were satisfied. However, in their action before the General Court, the appellants have argued that (i) the provisions of that directive which permitted the withdrawal of the exemptions were not applicable in respect of novel tobacco products; and (ii) in any event, the conditions set out therein for the withdrawal were not satisfied in the case at hand. It seems to me that the appellants should be entitled to have the EU Courts assess those claims. An incidental and indirect review of those claims, which the General Court made in passing (in paragraph 50 of the order under appeal) while ruling on the admissibility of the action, is certainly not in line with the appellants’ right to effective judicial protection. 170. In fact, the present case is to some extent similar to the one which gave rise to the judgment in Belgium and Forum 187 v Commission, in which the Court of Justice found various undertakings holding an authorisation which could no longer be renewed as a result of the challenged EU act to be individually concerned under the fourth paragraph of Article 263 TFEU. (142) 171. Third, the present case has a close similarity with the cases – recalled in points 33 and 34 above – in which individual concern has been accepted in respect of persons who played a crucial role in the procedure leading to the adoption of the challenged act. In particular, the appellants’ position is, in my view, equivalent to that of the undertakings whose information was used in order to calculate crucial parameters in the course of anti-dumping procedures. (143) 172. This is an element which the General Court ignored, despite the fact that one of the two grounds of annulment put forward by the appellants concerned precisely the use made by the Commission of the data provided by the appellants. Since the BAT group is one of the two leading manufacturers and sellers of heated tobacco products in the EU market, the data provided by it were clearly given a very significant weight in the calculations made by the Commission to determine whether there was a substantial change of circumstances for the purpose of Directive 2014/40. The appellants should, thus, be entitled to have those calculations verified by the EU Courts. 173. Fourth, the contested measure is not an act of the EU legislature, making use of its policymaking powers, to regulate, in a general and abstract manner, a given economic activity. Indeed, the contested measure is a regulatory act, adopted by the Commission, on the basis of the powers delegated to it by the EU legislature, through a procedure not legislative in nature, prompted by a very specific situation (the growth in the sales of heated tobacco products). Thus, despite its quasi-legislative nature, the contested measure clearly has some decision-making content (similarly to an administrative decision). Accordingly, the present case seems to me to fall squarely within the strand of case-law referred to in points 35 and 36 above, which concerns the situations in which the EU Courts have accepted that persons whose position on the market was seriously affected by the challenged measures had standing to challenge them. 174. The appellants’ claim that the contested measure affected their position on the market in a serious manner is, at least prima facie, reasonable given the size of their sales of flavoured heated tobacco products in the EU market. I would nonetheless go further than that and find that, also from this perspective, they were affected in a rather singular manner. 175. At first instance, the appellants had indicated (and provided relevant evidence of) the magnitude of the investments made in the past years with regard to heated tobacco products. However, the General Court ignored – in my view, erroneously – that element altogether. It is, in fact, uncontested that the applicants are among the (very few) undertakings which introduced in the EU market a novel tobacco product. To that end, they had to make significant investments in order to, inter alia, develop a new technology, create new distribution channels and make the product known and attractive to customers. It would not be incorrect to say that the contested measure was – as I stated in point 98 above – introduced for the very reason that the applicants were quite successful in doing that and, as a consequence, the sale of the product in question had a sharp increase within a relatively short period of time. 176. Against that backdrop, considering the undertakings which have recently entered, or will enter in the future, in the EU market of heated tobacco products – possibly free-riding on the investments made by undertakings such as the appellants – to be in a situation that is comparable to that of appellants is, in economic terms, nonsensical. 177. The above considerations show that, in the light of the Plaumann case-law, there are four distinct reasons why the appellants should have been considered to be individually concerned by the contested measure. Quite possibly, each of those reasons could be enough to that end. That would be a fortiori true if those reasons were considered together, which – as the appellants emphasise – the EU Courts have consistently done. (144) 178. I thus conclude that the first part of the appellants’ ground of appeal is well founded. C. Second part of the ground of appeal 1. Arguments of the parties 179. The second part of the appellants’ ground of appeal takes issue with paragraphs 54 and 55 of the order under appeal, in which the General Court addresses their argument according to which they should be considered individually concerned on the basis of a substantial effect on market position test. The appellants emphasise that (i) there are only two significant operators in the EU market for heated tobacco products, which sell virtually all of the heated tobacco products purchased in the European Union (over 99%), and (ii) the BAT group’s heated tobacco products portfolio within the European Union is heavily skewed towards flavoured products (approximately 70% of their sales). 180. The Commission and the French Government consider those arguments to be insufficient to substantiate a finding of ‘individual concern’. The impact of the contested measure on appellants’ market position, even if it were substantial, would not, by and of itself, justify such a finding. 2. Analysis 181. As I have concluded that the first part of the appellants’ ground of appeal is well founded, there is obviously no need to deal with the second part of that ground. In any event, it is clear that, for the reasons set out in points 35, 36 and 173 to 176 above, the second part of the appellants’ ground of appeal is also, in my view, well founded. 182. Nevertheless, should the Court of Justice disagree with my assessment of the first part of the ground of appeal, it would mean that the second part of that ground should also be rejected as unfounded. In such a case I would, therefore, have to agree with the Commission and the French Government that the mere fact that the contested measure affects, in a particularly severe manner, the economic activities of the appellants – because of their significant market share within the EU market and/or of the importance of the products concerned among those in their portfolio – is not, by itself, an element which justifies considering them individually concerned under the fourth paragraph of Article 263 TFEU. (145) VI. Consequences of the assessment 183. The applicants’ ground of appeal being well founded, the order under appeal should be set aside. 184. In accordance with the first paragraph of Article 61 of the Statute of the Court of Justice of the European Union, the Court of Justice may, after setting aside a decision of the General Court, refer the case back to the General Court for judgment or, where the state of the proceedings so permits, it may itself give final judgment in the matter. 185. In the present case, I am of the view that the state of the proceedings permits the Court of Justice to take a final position on the admissibility of the action for annulment brought by the appellant before the General Court. 186. In points 18 to 33 of the order under appeal, the General Court dismissed the plea of inadmissibility raised by the Commission in so far as that institution had argued that the applicants were not directly concerned by the contested measure. That part of the order has not been subject to an appeal and is thus definitive. 187. Accordingly, given that the applicants must be considered both individually and directly concerned by the contested measure, it follows that their action at first instance is admissible. 188. By contrast, the state of the proceedings does not permit the Court of Justice to deal with the merits of that action. 189. In their application before the General Court, the appellants raised two pleas in law against the contested measure. In order to assess those pleas, a detailed assessment in law and in fact of the arguments put forward by all the parties to the proceedings, in the light of the evidence produced by them, would be required. Failing any such assessment in the order under appeal, it would not be appropriate for the Court of Justice to give final judgment in the present case. 190. Accordingly, the case must be referred back to the General Court and the costs reserved. VII. Conclusion 191. In the light of the foregoing, I propose that the Court of Justice should: – set aside the order of 20 September 2023, Nicoventures Trading and Others v Commission (T‑706/22, EU:T:2023:579); – declare the action to be admissible; – refer the case back to the General Court for a decision on the merits of the application; and – order that the costs be reserved. 1 Original language: English. 2 First published in 1915. Translation by M. Harman (available online, Harvard University Press website). 3 Judgment of 15 July 1963, Plaumann v Commission (25/62, ‘the judgment in Plaumann’, EU:C:1963:17, p. 107). 4 T‑706/22, ‘the order under appeal’, EU:T:2023:579. 5 Commission Delegated Directive of 29 June 2022 amending Directive 2014/40/EU of the European Parliament and of the Council as regards the withdrawal of certain exemptions in respect of heated tobacco products (OJ 2022 L 283, p. 4) (‘the contested measure’). 6 Directive of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (OJ 2014 L 127, p. 1). 7 For recent case-law, see, for example, judgments of 12 July 2022, Nord Stream 2 v Parliament and Council (C‑348/20 P, ‘the judgment in Nord Stream 2’, EU:C:2022:548, paragraph 156), and of 4 October 2024, Commission v Council and Council v Front Polisario (C‑779/21 P and C‑799/21 P, EU:C:2024:835, paragraph 107). 8 See judgment of 18 May 1994, Codorniu v Council (C‑309/89, ‘the judgment in Codorniu’, EU:C:1994:197, paragraph 22). 9 See, to that effect, judgment of 6 November 2018, Scuola Elementare Maria Montessori v Commission, Commission v Scuola Elementare Maria Montessori and Commission v Ferracci (C‑622/16 P to C‑624/16 P, EU:C:2018:873, paragraph 31 and the case-law cited). 10 See, for example, the judgment in Codorniu, paragraph 19. 11 See, to that effect, judgment of 23 April 2013, Gbagbo and Others v Council (C‑478/11 P to C‑482/11 P, EU:C:2013:258, paragraph 56). See also judgments of 29 October 1980, Roquette Frères v Council (138/79, EU:C:1980:249, paragraphs 15 and 16), and of 17 April 2008, Flaherty and Others v Commission (C‑373/06 P, C‑379/06 P and C‑382/06 P, ‘the judgment in Flaherty’, EU:C:2008:230, paragraphs 26, 27 and 41). 12 See, inter alia, judgments of 13 March 2008, Commission v Infront WM (C‑125/06 P, ‘the judgment in Infront’, EU:C:2008:159, paragraph 71), and of 27 February 2014, Stichting Woonpunt and Others v Commission (C‑132/12 P, ‘the judgment in Stichting Woonpunt’, EU:C:2014:100, paragraph 59). 13 Similarly, Hartley, T.C., The Foundations of European Union Law, 8th ed., Oxford University Press, 2014, p. 373, and Gratsias, D., ‘Άμεση δικαστική προστασία των ιδιωτών κατά το άρθρο 263 ΣΛΕΕ: Μερικές σκέψεις’, in Το Δικαστήριο της ΕΕ- Εγγυητής της εύρυθμης λειτουργίας της Ευρωπαϊκής Ένωσης και των δικαιωμάτων των πολιτών, Sakkoulas, 2016, pp. 19 to 44. 14 For the sake of completeness, I would add that, for some time, the closed-group test was applied by the Court in parallel with another (alternative) test, which is often referred to as the abstract terminology test. That test consisted essentially in checking whether the challenged act was a real decision and not an act of general application (see, for example, judgments of 5 May 1977, Koninklijke Scholten Honig v Council and Commission, 101/76, EU:C:1977:70, paragraphs 7 and 8, and of 17 June 1980, Calpak and Società Emiliana Lavorazione Frutta v Commission, 789/79 and 790/79, EU:C:1980:159, paragraphs 7 and 8). This alternative test was based on the wording of then Article 173 EC which referred to ‘a decision which, although in the form of a regulation or a decision addressed to another person, is of direct and individual concern to the [applicant]’ (emphasis added). This test was abandoned after the late 1980s since it was at odds with the Court’s case-law according to which what matters under (the current) Article 263 TFEU is the substance of an act and not its form. At any rate, that approach would now be incompatible with the new wording of Article 263 TFEU, after the Treaty of Lisbon has replaced the term ‘decision’ with the term ‘act’. 15 See, inter alia, the judgment in Nord Stream 2, paragraph 157. 16 See, to that effect, judgment of 17 January 1985, Piraiki-Patraiki and Others v Commission (11/82, ‘the judgment in Piraiki-Patraiki’, EU:C:1985:18, paragraphs 20 and 21). 17 This was clear from the very early days: see, for example, Bebr, G., Judicial Control of the European Communities, Stevens & Sons, 1962, pp. 69 to 76. 18 My terminology is largely inspired by W.N. Hohfeld’s works. From that author, see, for example, ‘Some Fundamental Legal Conceptions as Applied in Judicial Reasoning’, Yale Law Journal, Vol. 23, 1913, pp. 16 to 59, at p. 30. 19 Although EU law does not provide for any specific right in that regard, a regime of undistorted competition is essential for the establishment of the internal market (see Article 3 TEU and Protocol (No 27) on the internal market and competition), and can also be considered as a corollary of the freedom to conduct a business (set out in Article 16 of the Charter of Fundamental Rights of the European Union; ‘the Charter’). See, however, judgment of 6 November 2018, Scuola Elementare Maria Montessori v Commission, Commission v Scuola Elementare Maria Montessori and Commission v Ferracci (C‑622/16 P to C‑624/16 P, EU:C:2018:873, paragraph 43). 20 See, inter alia, judgments of 26 June 1990, Sofrimport v Commission (C‑152/88, EU:C:1990:259, paragraph 11); in Piraiki-Patraiki, paragraphs 15 to 19; and of 11 February 1999, Antillean Rice Mills and Others v Commission (C‑390/95 P, EU:C:1999:66, paragraphs 25 to 30). 21 See, for example, the judgments in Codorniu, paragraph 21; in Infront, paragraph 72; and in Stichting Woonpunt, paragraphs 61 and 62. Emphasising this point in scholarship, Craig, P. and De Burca, G., EU Law: Text, Cases, and Materials, 4th ed., Oxford University Press, 2008, p. 513. 22 That does not mean that the applicant’s position must have entirely crystallised in the past. See, for example, judgments of 27 November 1984, Agricola commerciale olio and Others v Commission (232/81, EU:C:1984:358, paragraphs 10 and 11), and in Flaherty, paragraphs 40 and 41. 23 See, for example, judgments of 19 May 1993, Cook v Commission (C‑198/91, EU:C:1993:197, paragraphs 23 to 26), and of 24 May 2011, Commission v Kronoply and Kronotex (C‑83/09 P, EU:C:2011:341, paragraphs 45 to 48). 24 See judgments of 25 October 1977, Metro SB-Großmärkte v Commission (26/76, EU:C:1977:167, paragraph 13); of 20 March 1985, Timex v Council and Commission (264/82, EU:C:1985:119, paragraphs 13 to 16); of 28 January 1986, Cofaz and Others v Commission (169/84, EU:C:1986:42, paragraphs 24 and 25); of 3 April 2003, BaByliss v Commission (T‑114/02, EU:T:2003:100, paragraphs 92 to 95); and of 11 July 2007, Alrosa v Commission (T‑170/06, EU:T:2007:220, paragraph 40). 25 See, inter alia, judgments of 16 May 1991, Extramet Industrie v Council (C‑358/89, EU:C:1991:214); of 3 April 2003, BaByliss v Commission (T‑114/02, EU:T:2003:100, paragraphs 87 to 117); of 22 December 2008, British Aggregates v Commission (C‑487/06 P, EU:C:2008:757, paragraphs 46 to 57); and of 20 January 2022, Deutsche Lufthansa v Commission (C‑594/19 P, EU:C:2022:40, paragraphs 74 to 76). 26 See, for example, judgment of 6 November 1990, Weddel v Commission (C‑354/87, EU:C:1990:371, paragraphs 20 to 23). Hartley, T.C. referred to ‘acts of quasi-judicial nature’ in this regard (as opposed to ‘acts based purely on policy and discretion’). See footnote 13 above, p. 371. 27 That was the case, in particular, of anti-dumping duties that – before the adoption of Regulation (EU) No 37/2014 of the European Parliament and of the Council of 15 January 2014 amending certain regulations relating to the common commercial policy as regards the procedures for the adoption of certain measures (OJ 2014 L 18, p. 1) – were introduced by Council regulations. See, among many, judgment of 21 February 1984, Allied Corporation and Others v Commission (239/82 and 275/82, EU:C:1984:68, paragraph 11). 28 See, for example, judgments of 30 June 1988, CIDA and Others v Council (297/86, EU:C:1988:351, paragraph 13); of 24 March 1994, Air France v Commission (T‑3/93, EU:T:1994:36, paragraph 82); and of 14 July 2022, Italy and Comune di Milano v Council and Parliament (Seat of the European Medicines Agency) (C‑106/19 and C‑232/19, EU:C:2022:568, paragraphs 69 to 72 and 76). 29 See Opinion of Advocate General Kokott in Inuit Tapiriit Kanatami and Others v Parliament and Council (C‑583/11 P, EU:C:2013:21, point 1). 30 See, inter alia, Barav, A., ‘Direct and Individual Concern: An Almost Insurmountable Barrier to the Admissibility of Individual Appeal to the EEC Court’, Common Market Law Review, 1974, p. 191; Enchelmaier, S., ‘No-One Slips Through the Net? Latest Developments, and Non-Developments, in the European Court of Justice’s Jurisprudence on Art. 230(4) EC’, Yearbook of European Law, 2005, p. 173; Craig, P. and De Burca, G., footnote 21, op. cit., p. 512; and Kombos, C.C., ‘The Recent Case Law on Locus Standi of Private Applicants under Art. 230 (4) EC: A Missed Opportunity or A Velvet Revolution?’, European Integration online Papers, No. 17, 2005. 31 See, for example, judgments of 29 January 1985, Münchener Import-Weinkellerei Binderer v Commission (147/83, EU:C:1985:26, paragraphs 10 and 13); of 11 September 2002, Pfizer Animal Health v Council (T‑13/99, EU:T:2002:209, paragraph 89); and of 1 April 2004, Commission v Jégo-Quéré (C‑263/02 P, EU:C:2004:210, paragraph 46). 32 See, for example, orders of 30 April 2003, VVG International and Others v Commission (T‑155/02, EU:T:2003:125, paragraphs 43 and 44); and of 13 November 2008, Lemaître Sécurité v Commission (T‑301/06, ‘the order in Lemaître’, EU:T:2008:495, paragraph 24). 33 See the orders in Lemaître, paragraph 25, and of 5 May 2009, WWF-UK v Council (C‑355/08 P, EU:C:2009:286, paragraphs 44 and 45), and judgment of 28 February 2002, BSC Footwear Supplies and Others v Council (T‑598/97, EU:T:2002:52, paragraph 61). 34 See order of 18 December 1997, Commission v Sveriges Betodlares and Henrikson (C‑409/96 P, EU:C:1997:635, paragraph 37), and judgment of 10 December 2002, Commission v Camar and Tico (C‑312/00 P, EU:C:2002:736, paragraph 77). 35 See judgment of 29 June 1993, Gibraltar v Council (C‑298/89, EU:C:1993:267, paragraph 18), and order of 15 September 1998, Michaïlidis and Others v Commission (T‑100/94, EU:T:1998:197, paragraph 60). 36 See judgments of 22 November 2001, Nederlandse Antillen v Council (C‑452/98, ‘the judgment in Nederlandse Antillen’, EU:C:2001:623, paragraphs 70 to 75), and of 10 April 2003, Commission v Nederlandse Antillen (C‑142/00 P, EU:C:2003:217, paragraphs 70 to 75). 37 See, for example, Gormley, L.W., ‘Judicial review in EC and EU law – Some architectural malfunctions and design improvements?’, Cambridge Yearbook of European Legal Studies, 2001, p. 174, and Winter, G., ‘Plaumann withering: standing before the EU General Court underway from distinctive to substantial concern’, European Journal of Legal Studies, 2023, p. 85. 38 Judgment of 25 March 2021, Carvalho and Others v Parliament and Council (C‑565/19 P, ‘the judgment in Carvalho’, EU:C:2021:252). 39 See, for example, Krämer, L., ‘The environment before the European Court of Justice’, in Voigt, C. (ed.), International Judicial Practice on the Environment, Cambridge University Press, 2019, p. 25, and Arnull, A., ‘Private applicants and the action for annulment since Codorniu’, Common Market Law Review, 2001, pp. 8 and 9. 40 Opinion in Unión de Pequeños Agricultores v Council (C‑50/00 P, EU:C:2002:197, points 33 to 103) (‘the Opinion in UPA’). I shall come back to some of the arguments put forward by Advocate General Jacobs in the remainder of this Opinion. 41 Judgment of 3 May 2002, Jégo-Quéré v Commission (T‑177/01, EU:T:2002:112, paragraphs 27 to 51). 42 Judgment of 25 July 2002, Unión de Pequeños Agricultores v Council (C‑50/00 P, EU:C:2002:462, paragraphs 34 to 75). 43 See, for example, the tests of ‘act adversely affecting an applicant’s interests’ proposed by Arnull, A., ‘Challenging Community acts – An introduction’, in Micklitz, H.W. and Reich, N. (eds), Public Interest Litigation Before European Courts, Nomos, 1996, p. 51,; and of ‘personal and severe concern’ proposed by Winter, G., footnote 37 above, p. 105 et seq. 44 See the examples given, inter alia, in Kombos, C., ‘Locus standi of representative groups in the shadow of Plaumann: Limitations and possible solutions’, Acta Juridica Hungarica, Vol. 47, No. 4, 2006, p. 375, and Winter, G., footnote 37 above, pp. 95 and 107. 45 As I will explain in points 60 to 64 below. 46 Judgment of 3 May 2002, Jégo-Quéré v Commission (T‑177/01, EU:T:2002:112, paragraph 51) (emphasis added). 47 Nevertheless, there may be exceptional circumstances in which a relatively large number of persons affected could be ‘individually concerned’. The Danielsson case is, in my view, the paradigmatic case of that kind. The case concerned a request for interim measures lodged by three citizens of French Polynesia who contested the lawfulness of the Commission decision, adopted under the rules of the Euratom Treaty, which, in essence, did not oppose nuclear testing by the French authorities in the Polynesian atolls of Mururoa and Fangataufa. The President of the then Court of First Instance, however, declared the request manifestly inadmissible, for lack of individual concern. He took the view that ‘even on the assumption that the applicants might suffer personal damage linked to the alleged harmful effects of the nuclear tests in question on the environment or on the health of the general public, that circumstance alone would not be sufficient to distinguish them individually … since damage of the kind they cite could affect, in the same way, any person residing in the area in question’. He went on by pointing out that the applicants had not adduced any evidence capable of showing that, prima facie, the contested decision affected them for any specific reason. See order of 22 December 1995, Danielsson and Others v Commission (T‑219/95 R, EU:T:1995:219, paragraphs 71 and 72). 48 Emphasis added. 49 See Opinion of Advocate General Lagrange in Assider v High Authority (3/54, EU:C:1954:6, p. 171). 50 See, in particular, judgments of 11 February 1955, Assider v High Authority (3/54, EU:C:1955:2, p. 69), and of 29 November 1956, Fédération charbonnière de Belgique v High Authority (8/55, EU:C:1956:11, pp. 257 and 258). 51 See judgment of 14 December 1962, Confédération nationale des producteurs de fruits and légumes and Others v Council (16/62 and 17/62, EU:C:1962:47, p. 478), and, in more detail, Opinion of Advocate General Lagrange in the same Joined Cases (EU:C:1962:40, pp. 482 and 483). 52 See, inter alia, Catalano, N., ‘La protezione giurisdizionale nel sistema del trattato C.E.E. nei confronti degli atti non normativi’, Foro Italiano, 1965, Part V, col 77. See also, with references to further contemporary documents, Boerger-De Smedt, A., ‘La Cour de Justice dans les négociations du traité de Paris instituant la CECA’, Journal of European Integration History, 2008, p. 7, and Arena, A., ‘The Community system of judicial protection: A tale of two legal revolutions’, Yearbook of European Law, 2025, pp. 13 to 20. 53 See European Convention, Final report of the discussion circle on the Court of Justice, CONV 636/03, points 17 to 27. 54 See European Convention, Praesidium, Articles on the Court of Justice and the High Court, CONV 734/03, pp. 17 to 21. 55 Judgment of 3 October 2013, Inuit Tapiriit Kanatami and Others v Parliament and Council (C‑583/11 P, EU:C:2013:625, paragraphs 69 to 71). Emphasis added. 56 As Advocate General Cosmas stated in his Opinion in Greenpeace Council and Others v Commission (C‑321/95 P, EU:C:1997:421, point 53), ‘the [EU] legal order does not recognise an actio popularis’. I would add that this is a form of action unknown in most Member States’ legal systems. See, for example, Eliantonio, M. et al., Standing up for your right(s) in Europe – A comparative study on legal standing (Locus Standi) before the EU and Member States’ courts, European Parliament, study, 2012, p. 60. 57 The distinction made between privileged applicants and non-privileged applicants goes manifestly against that idea. This type of procedure is not required under Article 6 of the European Convention on Human Rights (‘ECHR’). As the European Court of Human Rights (‘ECtHR’) has held, ‘Article 6 … does not guarantee a right of access to a court with power to invalidate or override a law enacted by the legislature’ (judgment of 24 September 2002, Posti and Rahko v. Finland, CE:ECHR:2002:0924JUD002782495, § 52). 58 See, again, the Final report of the discussion circle on the Court of Justice (footnote 53 above), point 19. See also the judgments in Carvalho, paragraphs 47 and 49, and of 10 September 2024, KS and Others v Council and Others (C‑29/22 P and C‑44/22 P, ‘the judgment in KS and KD’, EU:C:2024:725, paragraph 73), and the order of 14 January 2021, Sabo and Others v Parliament and Council (C‑297/20 P, EU:C:2021:24, paragraph 29). 59 See, in particular, Opinion 2/13 (Accession of the European Union to the ECHR) of 18 December 2014 (EU:C:2014:2454, paragraphs 157 and 158). 60 See, with further references, my Opinion in Commission v United Kingdom (Judgment of the Supreme Court) (C‑516/22, EU:C:2023:857, point 76). 61 See, inter alia, judgment of 22 November 2022, Commission v Council (Accession to the Geneva Act) (C‑24/20, EU:C:2022:911, paragraph 83). 62 See, on that matter, Eliantonio, M. and Lees, E. (eds), The Legitimacy of EU Environmental Governance and the Role of the European Courts, Oxford University Press, 2025, especially Chapter 7. 63 Opinion 1/09 (Agreement creating a Unified Patent Litigation System) of 8 March 2011 (EU:C:2011:123, paragraphs 66 and 69). 64 Article 277 TFEU provides for the ‘plea of illegality’, which permits an incidental control of the legality of EU acts. It allows any party in proceedings in which an EU act of general application is at issue to plead the grounds of invalidity set out in the Treaty, in order to invoke the inapplicability of that act, even after the expiry of the period in which the act is open to challenge. 65 To that effect, see, inter alia, judgments of 23 April 1986, Les Verts v Parliament (294/83, ‘the judgment in Les Verts’, EU:C:1986:166, paragraph 23); in Inuit, paragraph 92; and of 15 July 2021, FBF (C‑911/19, EU:C:2021:599, paragraph 60). 66 Judgment of 30 June 2005, Bosphorus Hava Yolları Turizm ve Ticaret Anonim Şirketi v. Ireland (CE:ECHR:2005:0630JUD004503698, §§ 159 to 165). 67 François-Marie Arouet (alias Voltaire), Candide, or Optimism, first published in 1759. 68 One example in that respect is the judgment of 15 November 2016, Ullens de Schooten (C‑268/15, EU:C:2016:874). 69 Similarly, Bobek, M., ‘Why is it better to treat every provision of a directive as a (horizontally) directly effective one’, International Journal of Comparative Labour Law and Industrial Relations, 2023, p. 220. See also the Opinion in UPA, points 64 to 67. 70 With reference to the judgment of 26 February 2002, Council v Boehringer (C‑23/00 P, EU:C:2002:118, paragraph 52). See also, inter alia, judgment of 21 December 2016, Club Hotel Loutraki and Others v Commission (C‑131/15 P, EU:C:2016:989, paragraph 68). 71 Case-law that arose from the judgment of 9 March 1994, TWD Textilwerke Deggendorf (C‑188/92, EU:C:1994:90, paragraphs 17 and 18). See, more recently, judgments of 5 March 2015, Banco Privado Português and Massa Insolvente do Banco Privado Português (C‑667/13, EU:C:2015:151, paragraph 28 and the case-law cited), and of 25 July 2018, Georgsmarienhütte and Others (C‑135/16, EU:C:2018:582, paragraphs 43 and 44). 72 See, for example, Opinion of Advocate General Ruiz-Jarabo Colomer in Joined Cases Atzeni and Others (C‑346/03 and C‑529/03, EU:C:2005:256, point 88). 73 See, inter alia, judgment of 17 March 2011, AJD Tuna (C‑221/09, EU:C:2011:153), and order of 14 February 2012, AJD Tuna v Commission (T‑329/08, EU:T:2012:72). In that regard, see Mastroianni, R. and Pezza, A., ‘Striking the right balance: Limits on the right to bring an action under Article 263(4) of the Treaty on the Functioning of the European Union’, American University International Law Review, 2015, p. 743. See also, more recently, Opinion of Advocate General Ćapeta in WhatsApp Ireland v EDPB (C‑97/23 P, EU:C:2025:210, points 174 and 175). 74 The present proceedings co-exist in fact with those in Case C‑759/23, PJ Carroll and Nicoventures Trading, in which I delivered my Opinion on 30 January 2025 (C‑759/23, EU:C:2025:44), which is currently pending before the Court. 75 C‑348/20 P, EU:C:2021:831, point 191. Emphasis added. 76 Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ 2006 L 264, p. 13), as amended. 77 See Opinion of Advocate General Kokott in Joined Cases EIB v ClientEarth and Commission v EIB (C‑212/21 P and C‑223/21 P, EU:C:2022:1003, points 47 to 57). 78 See, to that effect, the judgment in Nord Stream 2, paragraphs 159 to 163. 79 See, to that effect, the judgment in Carvalho, paragraph 40. See also judgment of 2 March 2010, Arcelor v Parliament and Council (T‑16/04, EU:T:2010:54, paragraph 104). However, the seriousness of the impact of a challenged measure on the position of the applicant may well be one of the factors that, in combination with others, may be taken into account to establish individual concern. See, to that effect, judgment of 18 October 2023, Zippo Manufacturing and Zippo v Commission (T‑402/20, EU:T:2023:640, paragraph 26). 80 See, to that effect, judgments of 1 July 1965, Toepfer and Getreide-Import Gesellschaft v Commission (106/63 and 107/63, EU:C:1965:65, p. 411), and in Piraiki-Patraiki, paragraph 31. 81 See the cases referred to in footnote 36 above. 82 See, in particular, the judgment in Nederlandse Antillen, paragraphs 57 and 62 to 64. 83 See, with references to the case-law, Opinion of Advocate General Bobek in Région de Bruxelles-Capitale v Commission (C‑352/19 P, (‘the Opinion in Région de Bruxelles-Capitale’, EU:C:2020:588, point 62). 84 See Article 109 of, and Annex IV to, Council Decision 91/482/EEC of 25 July 1991 on the association of the overseas countries and territories with the European Economic Community (OJ 1991 L 263, p. 1). 85 See, in particular, the judgment in Nederlandse Antillen, paragraphs 73 and 74. 86 See point 3 above (emphasis added). 87 See, for example, judgment of 14 July 1983, Spijker Kwasten v Commission (231/82, EU:C:1983:220, paragraph 9), and orders of 28 March 1996, Kik v Council and Commission (C‑270/95 P, EU:C:1996:155, paragraph 36), and of 12 December 2003, Bactria v Commission (C‑258/02 P, EU:C:2003:675, paragraphs 35 and 36). See also the Opinions of Advocate General Lenz in Codorniu v Council (C‑309/89, EU:C:1992:406, point 38), and of Advocate General Bobek in Nord Stream 2 v Parliament and Council (C‑348/20 P, EU:C:2021:831, point 190). 88 See Opinion of Advocate General Lenz in Codorniu, points 39 and 52. 89 See the judgment of 11 February 1999, Antillean Rice Mills and Others v Commission (C‑390/95 P, EU:C:1999:66, paragraph 28) (emphasis added). 90 See the judgment in Codorniu, paragraph 22 (emphasis added). 91 See the judgment in Flaherty, paragraphs 26 and 41 (emphasis added). 92 Among many, see Craig, P. and De Burca, G., footnote 21, op. cit., p. 512. 93 See, for example, the first annual report published by the Court, in 1998 (concerning the judicial activity in 1997), in particular pp. 172 and 178. 94 See, to that effect, judgment of 9 November 2010, Volker und Markus Schecke and Eifert (C‑92/09 and C‑93/09, EU:C:2010:662, paragraph 85). 95 See, to that effect, judgment of 17 December 2020, Centraal Israëlitisch Consistorie van België and Others (C‑336/19, EU:C:2020:1031, paragraph 65). 96 See, to that effect, judgment of 4 May 2016, Philip Morris Brands and Others (C‑547/14, EU:C:2016:325, paragraphs 152 to 156). 97 See, in particular, Article 12 (‘Freedom of assembly and of association’) and Article 16 (‘Freedom to conduct a business’) of the Charter. 98 In that regard, it follows from settled case-law that actions brought by associations are admissible in three well-defined situations: first, where the association represents the interests of undertakings which would be entitled to bring proceedings in their own right and, thus, would themselves have locus standi; second, where the association is differentiated by reason of the impact on its own interests as an association; and, third, where a legal provision expressly confers on it a number of rights of a procedural nature. See Opinion of Advocate General Medina in China Chamber of Commerce for Import and Export of Machinery and Electronic Products and Others v Commission (C‑478/21 P, EU:C:2023:117, point 35 and the case-law cited). 99 This means that the modest extension of the case-law suggested will (i) mainly concern situations in which the applicant is unlikely to have access to a national court which could make a reference to the Court on the validity of the EU act in question under Article 267 TFEU (since there may not be any national measure of implementation); and (ii) exclude any use of the action for annulment as a form of actio popularis. 100 This also means that legal certainty of acts challenged would be strengthened as the EU Courts would be seised of any issue of validity within a short period of time, unlike in the cases that are brought before the Court under Article 267 TFEU, which may take several years. 101 See the Opinion of Advocate General Bobek in Région de Bruxelles-Capitale, point 142. 102 See, in more detail, my Opinion in ECB v Crédit lyonnais (C‑389/21 P, EU:C:2022:844, points 41 to 74). 103 Opinion in Djurgården-Lilla Värtans Miljöskyddsförening (C‑263/08, EU:C:2009:421, point 62). 104 Opinion in Greenpeace Council and Others v Commission (C‑321/95 P, EU:C:1997:421, point 117). 105 Similarly, Harding, C., ‘The private interest in challenging community action’, European Law Review, 1980, p. 354. 106 See, for example, Hoge Raad der Nederlanden (Supreme Court of the Netherlands), judgment of 20 September 2019, State of the Netherlands v. Stichting Urgenda (19/00135, NL:HR:2019:2007); Bundesverfassungsgericht (Federal Constitutional Court, Germany), order of 24 March 2021, Klimabeschluss (1 BvR 2656/18, 1 BvR 288/20, 1 BvR 96/20, 1 BvR 78/20, DE:BVerfG:2021:rs20210324.1bvr265618); and Conseil d’État (Council of State, France), decision of 1 July 2021, Commune de Grande-Synthe v. France (n. 427301, FR:CECHR:2021:427301.20210701). 107 ECtHR, judgment of 9 April 2024, Verein Klimaseniorinnen Schweiz and Others v. Switzerland (CE:ECHR:2024:0409JUD005360020) (‘Klimaseniorinnen’), and decisions of 9 April 2024, Duarte Agostinho and Others v. Portugal and 32 Others (CE:ECHR:2024:0409DEC003937120), and of 9 April 2024, Carême v. France (CE:ECHR:2024:0409DEC000718921). 108 Advisory Opinion of 21 May 2024, Case No. 31/2022, Request submitted by the Commission of Small Island States on climate change and international law. 109 Just to give an example, as early as 1985, the Court declared environmental protection to be ‘one of the Community’s essential objectives’ (judgment of 7 February 1985, ADBHU, 240/83, EU:C:1985:59, paragraph 13), despite the fact that there was no express reference then to the environment in the then Community Treaties. Today, ensuring a high level of protection and improvement of the quality of the environment’s features among the European Union’s aims (Article 3 TEU), and the requirements flowing from the protection of human health and the environment, must be integrated into the definition and implementation of the European Union’s other policies and activities (Articles 9 and 11 TFEU). 110 Judgment of 17 December 2020, Centraal Israëlitisch Consistorie van België and Others (C‑336/19, EU:C:2020:1031, paragraph 77). 111 Judgments of 6 October 1982, Cilfit and Others (283/81, EU:C:1982:335), and of 6 October 2021, Consorzio Italian Management and Catania Multiservizi (C‑561/19, EU:C:2021:799). 112 See my Opinion in KUBERA (C‑144/23, EU:C:2024:522, points 90 to 99). 113 See, extensively, Mancini, G.F. and Keeling, D.T., ‘Democracy and the European Court of Justice’, The Modern Law Review, 1994, No. 2, pp. 175 to 190. 114 Judgment of 1 April 1965, Sgarlata and Others v Commission (40/64, EU:C:1965:36, p. 227). 115 Judgments of 5 February 1963, van Gend & Loos (26/62, EU:C:1963:1), and of 15 July 1964, Costa (6/64, EU:C:1964:66). 116 Judgment of 5 February 1963, van Gend & Loos (26/62, EU:C:1963:1, p. 12) (emphasis added). 117 Judgments of 12 November 1969, Stauder (29/69, EU:C:1969:57, paragraph 7); of 29 October 1980, Roquette Frères v Council (138/79, EU:C:1980:249, paragraph 33); and in Les Verts, paragraph 23. 118 See, especially, Article 11 TEU and Article 15 TFEU. 119 See, most recently, the judgment in Carvalho, paragraph 69 and the case-law cited. 120 See judgment of 9 July 2020, Czech Republic v Commission (C‑575/18 P, EU:C:2020:530, paragraph 52 and the case-law cited). 121 See, for example, the judgments in Les Verts, paragraph 33; in UPA, paragraph 44; and of 3 September 2008, Kadi and Al Barakaat International Foundation v Council and Commission (C‑402/05 P and C‑415/05 P, EU:C:2008:461, paragraphs 281 and 316). 122 See, in particular, judgments of 19 July 2016, H v Council and Others (C‑455/14 P, EU:C:2016:569, paragraph 58); of 28 March 2017, Rosneft (C‑72/15, EU:C:2017:236, paragraphs 72 to 75); and in KS and KD, paragraphs 77 and 115 to 119. 123 See judgment of 22 June 2021, Venezuela v Council (Whether a third State is affected) (C‑872/19 P, EU:C:2021:507, paragraphs 48 to 52). 124 See judgment of 5 November 2019, ECB and Others v Trasta Komercbanka and Others (C‑663/17 P, C‑665/17 P and C‑669/17 P, EU:C:2019:923, paragraphs 54 to 63). 125 See, inter alia, judgments of 3 December 1992, Oleificio Borelli v Commission (C‑97/91, EU:C:1992:491, paragraph 13); of 15 October 2009, Djurgården-Lilla Värtans Miljöskyddsförening (C‑263/08, EU:C:2009:631, paragraph 45); of 8 March 2011, Lesoochranárske zoskupenie (C‑240/09, EU:C:2011:125, paragraphs 30 and 31); of 5 December 2013, Asociación de Consumidores Independientes de Castilla y León (C‑413/12, EU:C:2013:800, paragraph 13); of 29 July 2019, Torubarov (C‑556/17, EU:C:2019:626, paragraph 78); and of 17 May 2022, Unicaja Banco (C‑869/19, EU:C:2022:397, paragraphs 39 and 40). 126 See, respectively, Opinions in Joined Cases Council and Parliament v Commission and Commission v Vereniging Milieudefensie and Stichting Stop Luchtverontreiniging Utrecht (C‑401/12 P to C‑403/12 P, EU:C:2014:310, point 132), and in Région de Bruxelles-Capitale, point 117. 127 See, for example, Arnull, A., ‘The action for annulment: A case of double standards?’, in O’Keeffe, D. and Bavasso, A. (eds), Judicial review in the European Union, Kluwer, 2000, p. 185, and Krämer, L., ‘Access to environmental justice: the double standards of the ECJ’, Journal for European Environmental & Planning Law, 2017, p. 159. 128 ‑See points 45 to 48 of the Opinion in Unión de Pequeños Agricultores v Council (C‑50/00 P, EU:C:2002:197): inter alia, full exchange of submissions between the parties, larger possibility for third parties to intervene, and increased legal certainty due to the requirement to challenge the act within a short time frame. 129 Opinion in Stichting Woonpunt and Others v Commission (C‑132/12 P, EU:C:2013:335, points 59 to 63). 130 See above, points 45 and 64 of this Opinion. 131 See, inter alia, ECtHR, judgments of 9 October 1979, Airey v. Ireland (CE:ECHR:1979:1009JUD000628973, § 24); of 8 December 1983, Pretto and Others v. Italy (CE:ECHR:1983:1208JUD000798477, § 21); of 23 October 1990, Moreira de Azevedo v. Portugal (CE:ECHR:1990:1023JUD001129684, § 66); of 27 October 1993, Dombo Beheer B.V. v. the Netherlands (CE:ECHR:1993:1027JUD001444888, § 33); and of 17 January 2008, Ryakib Biryukov v. Russia (CE:ECHR:2008:0117JUD001481002, § 37). 132 See footnote 107 above. 133 Final consolidated version of the draft accession instruments as provisionally approved by the 46+1 Group at its 18th meeting, 46+1(2023)36 of 17 March 2023 (available on the Council of Europe’s website). 134 See footnote 58 above. 135 See, for example, Iglesias Sánchez, S., ‘The jurisdiction of European courts in the CFSP: Between exceptionalism and consistency of legal remedies in a Union based on the rule of law’, EU Law Live, Week-end Edition, 9 May 2025. 136 See point 79 of the present Opinion. 137 See Article 2(28), Article 5(6) and (7), Article 7(12), Article 11(6) and Article 28(2) and (3) of Directive 2014/40. 138 This point is, however, disputed by the appellants. See point 169 below. 139 See recitals 5 and 6 of the contested measure and the Commission Report referred to in recital 5 (see point 12 of the present Opinion). 140 See paragraphs 73 to 77 of the judgment (referred to in paragraph 41 of the order under appeal). 141 See paragraphs 60 to 62 of the judgment (also referred to in paragraph 41 of the order under appeal). 142 Judgment of 22 June 2006 (C‑182/03 and C‑217/03, EU:C:2006:416, paragraphs 61 to 64). 143 See, inter alia, the judgments of 20 March 1985, Timex v Council and Commission (264/82, EU:C:1985:119, paragraphs 14 and 15); of 11 July 1990, Neotype Techmashexport v Commission and Council (C‑305/86 and C‑160/87, EU:C:1990:295, paragraphs 19 and 20); and of 18 September 2014, Valimar (C‑374/12, EU:C:2014:2231, paragraphs 30 to 32). See also, more generally, Opinion of Advocate General Bot in Philips Lighting Poland and Philips Lighting v Council (C‑511/13 P, EU:C:2015:206, points 92 to 106). 144 See, to that effect, inter alia, judgments of 16 May 1991, Extramet Industrie v Council (C‑358/89, EU:C:1991:214, paragraph 17); of 18 May 2022, Uzina Metalurgica Moldoveneasca v Commission (T‑245/19, EU:T:2022:295, paragraphs 66 and 69); of 18 October 2023, Zippo Manufacturing and Zippo v Commission (T‑402/20, EU:T:2023:640, paragraphs 26 and 28); and of 20 June 2024, Euranimi v Commission (C‑252/23 P, EU:C:2024:538, paragraphs 38 to 40). 145 See points 36, 43 to 45, 57 and 78 of the present Opinion and the case-law referred to therein.