ORDER OF THE GENERAL COURT (Fourth Chamber)

18 February 2026 (*)

( Action for annulment – Environment – Urban wastewater treatment – Articles 1, 2, 9, 10 and 30 of, and Annex III to, Directive (EU) 2024/3019 – Extended producer responsibility for medicinal products for human use and cosmetic products – Standing to bring proceedings – Lack of individual concern – Inadmissibility )

In Case T‑158/25,

Fédération européenne d’associations et d’industries pharmaceutiques (EFPIA), established in Luxembourg (Luxembourg), represented by C. García Molyneux, Z. Bertrand, lawyers, and B. Kelly, Solicitor,

applicant,

v

European Parliament, represented by L. Taïeb, W. Kuzmienko and A. Droin, acting as Agents,

and

Council of the European Union, represented by A. Maceroni and O. Segnana, acting as Agents,

defendants,

THE GENERAL COURT (Fourth Chamber),

composed of G. De Baere, President, J. Svenningsen (Rapporteur) and D. Jočienė, Judges,

Registrar: V. Di Bucci,

makes the following

Order

1        By its action under Article 263 TFEU, the applicant, the Fédération européenne d’associations et d’industries pharmaceutiques (EFPIA), seeks, principally, the annulment of Article 1, Article 2(19), (20) and (26), Articles 9 and 10, and points (c) and (g) of the second subparagraph of Article 30(1) of, and Annex III to, Directive (EU) 2024/3019 of the European Parliament and of the Council of 27 November 2024 concerning urban wastewater treatment (OJ L, 2024/3019) (‘the contested provisions’), and, in the alternative, the annulment of that directive in its entirety.

 Background to the dispute

2        The applicant is an association the members of which are innovative pharmaceutical companies that hold marketing authorisations in respect of medicinal products for human use in the European Union and national associations representing those companies.

3        Directive 2024/3019 provides for a recast of Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ 1991 L 135, p. 40), as amended by Regulation (EC) No 1137/2008 of the European Parliament and of the Council of 22 October 2008 (OJ 2008 L 311, p. 1), by introducing an obligation for Member States to ensure that certain discharges from urban wastewater treatment plants comply with the requirements for quaternary treatment.

4        Quaternary treatment, also established by Directive 2024/3019 and defined in Article 2(14) thereof, is a means of treating urban wastewater by a process taking place after traditional treatment (primary, secondary and tertiary), which reduces a broad spectrum of micropollutants in urban wastewater.

5        Given that quaternary treatment involves additional costs, Directive 2024/3019 relies on the polluter-pays principle in order to cover them.

6        In that regard, recital 20 of Directive 2024/3019 states that pharmaceuticals and cosmetic residues currently represent the main sources of micropollutants found in urban wastewater requiring quaternary treatment.

7        Article 9(1) of Directive 2024/3019 introduces a system of extended producer responsibility (‘the EPR system’) for two categories of products listed in Annex III to that directive, namely medicinal products for human use falling within the scope of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67), and cosmetic products falling within the scope of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ 2009 L 342, p. 59).

8        Article 9(2)(a) and (b) of Directive 2024/3019 provides for two exemptions from the EPR system, namely (i) an exemption for producers in respect of which the total quantity of substances contained in products placed on the EU market amounts to small quantities, that is to say, less than one tonne per year, and (ii) an exemption for producers in respect of which the substances contained in the products they place on the market are rapidly biodegradable in wastewater or do not generate micropollutants in wastewater at the end of their life.

9        Article 9(3) of Directive 2024/3019 provides that Member States are to ensure that producers of medicinal products for human use and cosmetic products exercise their extended producer responsibility collectively through an organisation that fulfils the minimum requirements set out in Article 10 of that directive.

10      Article 10 of Directive 2024/3019 lists the minimum requirements for producer responsibility organisations which Member States must lay down.

11      Article 10(5) of that directive provides, specifically, that ‘Member States shall organise regular dialogues on [the] implementation [of the EPR system]’ and ‘shall ensure that those dialogues involve relevant stakeholders and, where relevant, associations of stakeholders involved in the implementation of extended producer responsibility, including producers and distributors, producer responsibility organisations, private or public operators of urban wastewater treatment plants, local authorities and civil society organisations’.

12      Article 30 of Directive 2024/3019 provides that, by 31 December 2033, and then by 31 December 2040, the European Commission shall carry out an evaluation of that directive based on a number of elements and assess the possibility of adapting the list of products covered by the EPR system.

 Forms of order sought

13      The applicant claims that the Court should:

–        principally, annul the contested provisions;

–        in the alternative, annul Directive 2024/3019 in its entirety;

–        order the European Parliament and the Council of the European Union to pay the costs.

14      In their pleas of inadmissibility, the Parliament and the Council contend that the Court should:

–        dismiss the action as inadmissible;

–        order the applicant to pay the costs.

15      In its observations regarding the pleas of inadmissibility, the applicant claims that the Court should:

–        reject the pleas of inadmissibility;

–        order the Parliament and the Council to pay the costs.

 Law

16      Under Article 130(1) of the Rules of Procedure of the General Court, the Court may give a decision on inadmissibility without going to the substance of the case if a defendant submits an application asking it to do so. Under Article 130(7) of those rules, the Court is to decide on the application as soon as possible or, where special circumstances so justify, reserve its decision on that application until it rules on the substance of the case.

17      In the present case, as the Parliament and the Council have applied for a decision on inadmissibility, the Court, considering that it has sufficient information from the material in the case file, has decided to give a decision on those applications without taking further steps in the proceedings.

18      It should be recalled that the fourth paragraph of Article 263 TFEU provides for two situations in which natural or legal persons are accorded standing to institute proceedings against an act which is not addressed to them. First, such proceedings may be instituted if the act is of direct and individual concern to those persons. Second, such persons may bring proceedings against a regulatory act not entailing implementing measures if that act is of direct concern to them (judgment of 13 March 2018, European Union Copper Task Force v Commission, C‑384/16 P, EU:C:2018:176, paragraph 32).

19      Directive 2024/3019, which was adopted on the basis of Article 192(1) TFEU in accordance with the ordinary legislative procedure, is a legislative act within the meaning of Article 289(3) TFEU, with the result that the examination of the admissibility of the present action does not fall within the second situation referred to in paragraph 18 above, since the third limb of the fourth paragraph of Article 263 TFEU relates to regulatory acts, which, according to the case-law, are acts of general application other than legislative acts (see, to that effect, judgment of 3 October 2013, Inuit Tapiriit Kanatami and Others v Parliament and Council, C‑583/11 P, EU:C:2013:625, paragraphs 60 and 61).

20      Accordingly, the applicant falls within the first situation referred to in paragraph 18 above and must be directly and individually concerned by the contested provisions.

21      It should be noted that, principally, the applicant seeks the annulment of the contested provisions in so far as they establish the EPR system. Therefore, it is in the light of the scope of that system as defined in Annex III to Directive 2024/3019 that it is necessary to examine whether the applicant is individually concerned by the contested provisions.

22      In that regard, the case-law states that actions brought by associations are admissible in three well-defined situations: first, where a legal provision expressly grants a series of procedural powers to trade associations; second, where the association represents the interests of its members, who would themselves be entitled to bring proceedings; and, third, where the association is distinguished individually because its own interests as an association are affected, in particular because its position as negotiator has been affected by the act in respect of which annulment is sought (see order of 8 May 2019, Carvalho and Others v Parliament and Council, T‑330/18, not published, EU:T:2019:324, paragraph 51 and the case-law cited).

23      In the present case, it should be noted that the applicant claims to have standing to bring proceedings not in its own name on the basis of the first and third situations referred to in paragraph 22 above, but solely on behalf of its members on the basis of the second situation referred to in that paragraph.

24      In particular, the applicant submits, first, that the innovative pharmaceutical companies which are its members are directly and individually concerned by the contested provisions and, second, that the national associations which are its members are distinguished individually because their own interests as associations are affected.

 The applicant’s standing to bring proceedings on behalf of the innovative pharmaceutical companies which are its members

25      As regards the question whether the innovative pharmaceutical companies which are members of the applicant are directly and individually concerned by the contested provisions, it is appropriate to examine, first of all, the condition relating to individual concern.

26      In the first place, the Parliament and the Council point out that, in the case of an act of general application, it is not sufficient for an applicant to show that it belongs to a closed class in order to demonstrate that it is individually concerned by the contested measure.

27      In the second place, in essence, the Parliament and the Council contend that any economic activity may be subject to various barriers to entry, but this does not mean that the number of operators likely to carry out a given activity is necessarily fixed. Thus, according to them, the requirement to obtain a marketing authorisation does not, in itself, have any impact on the contested provisions, since their application is based on an objective criterion, namely that of being a producer of medicinal products for human use or cosmetic products.

28      In the third place, the Parliament and the Council dispute the applicant’s assertion that the EPR system retroactively alters the rights of the innovative pharmaceutical companies which are its members and which have obtained a marketing authorisation. By that argument, the applicant merely criticises the financial burden arising from the new rules contained in the contested provisions.

29      The applicant, for its part, submits, first of all, that it and the national associations which are its members represent innovative pharmaceutical companies that fall within a specific group of producers, namely those which meet the definition of ‘producer’ in Article 2(19) of Directive 2024/3019 and have gone through the marketing authorisation procedure provided for in Directive 2001/83 or in Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1). The applicant claims that this sets those companies apart from all other operators covered by Article 9 of Directive 2024/3019.

30      In that context, the applicant maintains that that group was known at the time when Directive 2024/3019 was adopted and that, within that group, there is another, smaller group of producers of medicinal products for human use containing the active substances listed in Annex I to that directive.

31      Next, the applicant submits that the innovative pharmaceutical companies which are its members are in a very similar situation to that of the applicants in the cases which gave rise to the judgments of 22 June 2006, Belgium and Forum 187 v Commission (C‑182/03 and C‑217/03, EU:C:2006:416), and of 27 February 2014, Stichting Woonpunt and Others v Commission (C‑132/12 P, EU:C:2014:100), in which the Court of Justice held that a class may be limited and individually concerned where membership of that class depends on prior authorisation or other individualised legal acts.

32      Lastly, according to the applicant, the contested provisions retroactively alter the legal and financial situations of the innovative pharmaceutical companies which are its members. It argues that such situations were recognised in the Opinion of Advocate General Emiliou in Nicoventures Trading and Others v Commission (C‑731/23 P, EU:C:2025:435) as demonstrating individual concern.

33      It should be recalled that 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 to whom such a measure is addressed (judgments of 15 July 1963, Plaumann v Commission, 25/62, EU:C:1963:17, p. 107, and of 13 March 2018, European Union Copper Task Force v Commission, C‑384/16 P, EU:C:2018:176, paragraph 93).

34      In that regard, it is settled case-law that the fact that a contested measure is legislative in nature or of general application does not in itself prevent it from being of individual concern to some of the persons affected (see, to that effect, judgment of 18 May 1994, Codorniu v Council, C‑309/89, EU:C:1994:197, paragraph 19, and order of 26 March 2021, SATSE v Commission, T‑484/20, not published, EU:T:2021:172, paragraph 52).

35      Similarly, it has been accepted in the case-law that, 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 traders (see, to that effect, judgment of 27 February 2014, Stichting Woonpunt and Others v Commission, C‑132/12 P, EU:C:2014:100, paragraph 59).

36      On the other hand, where a measure applies to objectively determined situations and produces legal effects with respect to categories of persons envisaged in a general and abstract manner, the persons belonging to those categories are not regarded as individually concerned by that measure (see 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), even if it is possible to determine more or less precisely the number, or even the identity, of the persons to whom a measure applies (judgment of 12 July 2022, Nord Stream 2 v Parliament and Council, C‑348/20 P, EU:C:2022:548, paragraph 157).

37      In the present case, the applicant relies on the case-law referred to in paragraph 35 above in order to establish that the innovative pharmaceutical companies which are its members are individually concerned.

38      Therefore, it is necessary to ascertain whether, as the applicant submits, the contested provisions affect the closed group or limited class to which it claims the innovative pharmaceutical companies which are its members belonged when Directive 2024/3019 was adopted, by reason of criteria specific to the members of that group.

39      At the outset, it must be observed that the contested provisions do not expressly refer to any specific operator as being subject to the EPR system.

40      On the contrary, that extended responsibility is determined in a general and abstract manner, referring to producers of medicinal products for human use falling within the scope of Directive 2001/83 and to producers of cosmetic products falling within the scope of Regulation No 1223/2009, as is apparent from a combined reading of Article 9(1) of, and Annex III to, Directive 2024/3019.

41      Therefore, the EU legislature did not refer specifically to any of the companies which are members of the applicant or even to the category of innovative pharmaceutical companies.

42      It must therefore be examined whether the closed group or limited class to which – according to the applicant – the innovative pharmaceutical companies which are its members belong was nevertheless identifiable when Directive 2024/3019 was adopted, by reason of criteria specific to the members of that category.

43      In that regard, first, it must be observed that neither Directive 2024/3019 nor its travaux préparatoires suggest that the EU legislature intended, or was required, to take into consideration the specific situation of innovative pharmaceutical companies.

44      It is apparent from recital 20 of Directive 2024/3019 that the EU legislature considered that extended producer responsibility should apply to producers of two categories of products which represent the main sources of micropollutants found in urban wastewater requiring quaternary treatment.

45      Recital 20 of Directive 2024/3019 also highlights the fact that the EPR system should apply regardless of how the two categories of products in question are manufactured or distributed.

46      Moreover, the applicant has not demonstrated that there is a specific provision, either higher-ranking or of secondary legislation, which would have required the EU legislature, during the process of adopting Directive 2024/3019, to take any particular account of the situation of innovative pharmaceutical companies vis-à-vis the situation of other producers covered by Annex III to that directive (see, by analogy, judgment of 2 March 2010, Arcelor v Parliament and Council, T‑16/04, EU:T:2010:54, paragraph 102).

47      Thus, the contested provisions are of general application and apply to categories of persons envisaged in a general and abstract manner, namely to any producer of medicinal products for human use or cosmetics.

48      Second, contrary to what the applicant claims in referring to the judgments of 22 June 2006, Belgium and Forum 187 v Commission (C‑182/03 and C‑217/03, EU:C:2006:416), and of 27 February 2014, Stichting Woonpunt and Others v Commission (C‑132/12 P, EU:C:2014:100), the contested provisions do not call into question any acquired right on which the innovative pharmaceutical companies which are members of the applicant might rely.

49      In that regard, the situation of the innovative pharmaceutical companies which are members of the applicant differs substantially from that of the applicants in the two cases which gave rise to the judgments referred to in paragraph 48 above.

50      In the case which gave rise to the judgment of 22 June 2006, Belgium and Forum 187 v Commission (C‑182/03 and C‑217/03, EU:C:2006:416), the applicant’s individual concern arose, inter alia, from the fact that the decision by which the Commission declared an existing aid scheme incompatible with the internal market and ordered its cessation had the effect of depriving some of the applicant’s members of their right to maintain a tax scheme until its initial expiry date.

51      In the case which gave rise to the judgment of 27 February 2014, Stichting Woonpunt and Others v Commission (C‑132/12 P, EU:C:2014:100), the applicants’ individual concern arose from the fact that the Commission’s decision, by accepting commitments from the Kingdom of the Netherlands, had the effect of amending an existing aid scheme that benefited the applicants, concerning exclusively the companies benefiting from approval, the number and identity of which were precisely determined at the time when that decision was adopted and made the exercise of those parties’ activities less favourable than had previously been the case.

52      By contrast, in the present case, the fact that the innovative pharmaceutical companies which are members of the applicant hold marketing authorisations is irrelevant, since the contested provisions do not in any way call those authorisations – and, therefore, their acquired rights – into question (see, to that effect and by analogy, judgment of 30 October 2025, Fugro v Council, C‑146/24 P, not published, EU:C:2025:841, paragraph 43).

53      Even if that were the case, it should be pointed out that the existence of an actual or individual right, including that conferred by a provision of general application, the scope or exercise of which is potentially affected by the contested measure, is not as such capable of distinguishing the rightholder individually, in particular where other operators may enjoy similar rights and hence be in the same situation as that rightholder (see, to that effect and by analogy, order of 7 September 2010, Etimine and Etiproducts v Commission, T‑539/08, EU:T:2010:354, paragraph 104), as is the case regarding all producers of products covered by Annex III to Directive 2024/3019.

54      Third, the applicant has failed to identify in a convincing manner the closed group or limited class to which the innovative pharmaceutical companies which are its members allegedly belong.

55      While it is true that the applicant submits that the innovative pharmaceutical companies which are its members belong to a closed group or limited class, the fact remains that it also submits that, within that group, there is an even smaller group of producers of medicinal products for human use which contain the active substances listed in Annex I to Directive 2024/3019.

56      Moreover, in that regard, it suffices to observe that the applicant merely asserts the existence of that subgroup without adducing any evidence that would make it possible to identify the companies which are part of it, to assess its standing to bring proceedings or to demonstrate that the applicant represents its specific interests.

57      Fourth, the applicant’s claim that the innovative pharmaceutical companies which are its members are more financially impacted than other producers covered by Annex III to Directive 2024/3019, in particular producers of cosmetic products, is not sufficient to distinguish them individually from those other producers, since the application of the contested provisions takes effect by virtue of an objectively determined situation (see, to that effect, judgment of 2 March 2010, Arcelor v Parliament and Council, T‑16/04, EU:T:2010:54, paragraph 106 and the case-law cited).

58      In that regard, the mere fact that natural or legal persons may lose even a major source of income as a result of new legislation is not sufficient to establish that that legislation applies to them individually, those persons having to adduce proof of circumstances which make it possible to consider that the harm allegedly suffered is such as to distinguish them individually from all other economic operators concerned by that legislation in the same way as they are (see, by analogy, order of 21 December 2023, Broad Far (Hong Kong) and M21 v Commission, T‑791/22, not published, EU:T:2023:875, paragraph 45 and the case-law cited).

59      In the present case, it suffices to observe that the applicant has not adduced any documentary evidence which makes it possible to consider that the harm allegedly suffered by the innovative pharmaceutical companies which are its members is such as to distinguish them individually from all other economic operators concerned by the contested provisions.

60      Accordingly, the applicant has not shown that the innovative pharmaceutical companies which are its members are individually concerned by the contested provisions.

61      That conclusion is not called into question by the argument based on the Opinion of Advocate General Emiliou in Nicoventures Trading and Others v Commission (C‑731/23 P, EU:C:2025:435), since the Court of Justice – and a fortiori the General Court in a separate case – is not bound either by that Opinion or by the reasoning on which the Advocate General based it (judgment of 25 July 2018, Société des produits Nestlé and Others v Mondelez UK Holdings & Services, C‑84/17 P, C‑85/17 P and C‑95/17 P, EU:C:2018:596, paragraph 31).

62      Furthermore, since the conditions of direct concern and individual concern are cumulative (order of 11 November 2014, Nguyen v Parliament and Council, T‑20/14, EU:T:2014:955, paragraph 55, and judgment of 16 May 2018, Netflix International and Netflix v Commission, T‑818/16, not published, EU:T:2018:274, paragraph 70), it is not necessary to ascertain whether the condition relating to the direct concern of the innovative pharmaceutical companies which are members of the applicant is satisfied.

63      In the light of those considerations, it must be concluded that the applicant is not entitled to seek the annulment of the contested provisions in so far as it represents the interests of the innovative pharmaceutical companies which are its members.

 The applicant’s standing to bring proceedings on behalf of the national associations which are its members

64      It should be recalled that, according to the case-law, an association’s ability to bring an action is based on the consideration that an action brought by the association presents procedural advantages, since it obviates the institution of numerous separate actions against the same acts, as the association has substituted itself for one or more of its members whose interests it represents, who could themselves have brought an admissible action (judgment of 15 September 2016, Molinos Río de la Plata and Others v Council, T‑112/14 to T‑116/14 and T‑119/14, not published, EU:T:2016:509, paragraph 35).

65      In addition, for the purpose of examining whether an association which brings an action on behalf of the associations which are its members has standing to bring proceedings, it is necessary to ascertain whether those associations would have standing to bring proceedings on the basis of one of the three situations referred to in paragraph 22 above (see, to that effect, order of 10 December 2004, EFfCI v Parliament and Council, T‑196/03, EU:T:2004:355, paragraphs 45 and 68).

66      In view of the fact that (i) the applicant has not claimed that procedural guarantees in favour of the national associations which are its members were provided for, either by the contested provisions or by any other provision of EU law, and (ii) the examination as to whether the innovative pharmaceutical companies which are members of the applicant, but which are also members of those national associations, are directly and individually concerned has already been carried out in paragraphs 34 to 63 above, all that remains to be examined is the applicant’s argument that the national associations which are its members are distinguished individually because their own interests are affected.

67      In that regard, the Parliament contends that the national associations which are members of the applicant are not, in the light of Article 10(5) of Directive 2024/3019, required to play a crucial role in the implementation of the EPR system. Having regard to the broad nature of consultations of interested parties across EU legislation as a whole, the Parliament maintains that participation in the dialogues provided for under that provision is not relevant for the purpose of assessing whether those associations are individually concerned within the meaning of Article 263 TFEU.

68      Furthermore, according to the Parliament, the activities of the national associations which are members of the applicant cannot confer on those associations the position of ‘negotiators’ within the meaning of the judgments of 2 February 1988, Kwekerij van der Kooy and Others v Commission (67/85, 68/85 and 70/85, EU:C:1988:38), and of 24 March 1993, CIRFS and Others v Commission (C‑313/90, EU:C:1993:111).

69      In the first place, the applicant disputes the Parliament’s interpretation of the judgments of 2 February 1988, Kwekerij van der Kooy and Others v Commission (67/85, 68/85 and 70/85, EU:C:1988:38), and of 24 March 1993, CIRFS and Others v Commission (C‑313/90, EU:C:1993:111), which it claims is based on a misreading of the criteria relating to standing established in those two judgments. It submits that the condition that an association be a ‘negotiator’ is merely a specific application of the general criterion relating to the effect on an association’s own interests. According to the applicant, the national associations which are its members fulfil that general criterion.

70      In the second place, the applicant submits that the assertion of the Parliament and the Council that all stakeholder associations are affected in the same way is incorrect in view of the fact that Article 10(5) of Directive 2024/3019 expressly requires Member States to ‘ensure that [dialogues] involve … associations of stakeholders involved in the implementation of extended producer responsibility’. It maintains that, moreover, Article 9(3) of that directive requires that producers of medicinal products for human use and cosmetic products exercise their extended producer responsibility collectively through producer responsibility organisations.

71      In support of that argument, first, the applicant argues that, during the procedure for the adoption of Directive 2024/3019, the role of national associations was gradually recognised by the Parliament and the Council, in particular in the light of the wording of Article 10(5) of that directive. Second, the applicant cites the example of the role in the implementation of Directive 2024/3019 that has been conferred on three national associations which are its members, namely Les Entreprises du Médicament (Leem) in France, the Irish Pharmaceutical Healthcare Association in Ireland and Vereniging Innovatieve Geneesmiddelen in the Netherlands.

72      In that regard, it should be borne in mind that, according to the case-law, an association formed for the protection of the collective interests of a category of persons cannot be regarded as being directly and individually concerned by a measure affecting the general interests of that category (see judgment of 15 September 2016, TAO-AFI and SFIE-PE v Parliament and Council, T‑456/14, EU:T:2016:493, paragraph 57 and the case-law cited).

73      In addition, associations have no right, in the legal order of the European Union, that protects the objectives of their activities from being influenced by acts of the European Union. Therefore, even if the contested provisions were to have an impact on the activities carried out by the applicant’s national associations and on their tasks as defined in their statutes, it would, in any event, be only a factual and not a legal impact (see, by analogy, orders of 28 September 2016, PAN Europe and Others v Commission, T‑600/15, EU:T:2016:601, paragraph 40, and of 7 April 2022, Bloom v Parliament and Council, T‑645/21, not published, EU:T:2022:230, paragraph 63).

74      In the present case, as regards the argument relating to the wording of Article 10(5) of Directive 2024/3019, it must be observed that that provision refers to dialogues which must involve ‘relevant stakeholders’ and, only ‘where relevant’, ‘associations of stakeholders involved in the implementation of [the EPR system]’, including, inter alia, the national associations which are members of the applicant.

75      In that regard, it must be stated that, even though Member States are under an obligation to establish dialogues on the implementation of the EPR system, it is clear that the purpose of such dialogues is to involve the actors concerned by that system in its implementation, but not to provide them with a legal instrument to compel the Member States in that implementation (see, by analogy, order of 5 November 2024, Apc Europe and Others v Commission, T‑1194/23, not published, under appeal, EU:T:2024:795, paragraph 38).

76      In addition, contrary to what the applicant claims, Article 10(5) of Directive 2024/3019 merely determines, in a general manner, the actors which are or could be involved in the dialogues concerning the implementation of the EPR system.

77      Furthermore, it is apparent from the wording of that provision that ‘associations of stakeholders involved in the implementation of [the EPR system]’, a category to which the national associations which are members of the applicant belong, will participate in those dialogues only ‘where relevant’. Thus, the participation of those national associations in the dialogues organised by the Member States is left to the discretion of those Member States and is therefore hypothetical.

78      Lastly, even if the national associations which are members of the applicant were to participate in those dialogues, they would do so in the same way as other actors covered by Article 10(5) of Directive 2024/3019, with the result that such participation would not distinguish them individually from those other actors.

79      In that context, it is also necessary to reject the applicant’s argument that, during the procedure for the adoption of Directive 2024/3019, the role of national associations was gradually recognised by the Parliament and the Council, in particular in the light of the wording of Article 10(5) of that directive, having regard to the scope of that provision as set out in paragraphs 75 to 78 above.

80      The same is true of the applicant’s argument relating to the alleged role of Leem, the Irish Pharmaceutical Healthcare Association and Vereniging Innovatieve Geneesmiddelen in the implementation of Directive 2024/3019.

81      As regards Leem and the Irish Pharmaceutical Healthcare Association, it must be observed that the applicant has produced documents dating from after the date on which the present action was brought, which show, at most, that those two associations will be involved in the process of transposing Directive 2024/3019 in the same way as other actors.

82      As regards Vereniging Innovatieve Geneesmiddelen, it must be stated that the applicant’s argument is based on an incorrect premiss. Contrary to what the applicant claims, in the letter of 25 October 2024, the Netherlands Ministry of Infrastructure and Water Management did not state that that association was involved in the process of transposing Directive 2024/3019. That ministry merely acknowledged that the associations of producers of medicinal products and cosmetics participated in the discussions concerning Directive 2024/3019 and explained that the Government would, in the transposition of that directive, take into account the concerns expressed by them on that occasion.

83      Thus, it is apparent from the evidence adduced by the applicant in support of that argument that the interests of those three associations will be no more or less affected than the interests of any other actor which may be involved in the transposition of Directive 2024/3019.

84      As regards the applicant’s argument relating to Article 9(3) of Directive 2024/3019, it must be recalled that that provision provides that Member States are to ensure that producers who place any of the products listed in Annex III to that directive on the market exercise their extended producer responsibility collectively through a producer responsibility organisation that fulfils the minimum requirements set out in Article 10 of Directive 2024/3019.

85      In that regard, even if it is accepted that the national associations which are members of the applicant, like those representing the interests of producers of cosmetics, may, by virtue of their tasks as defined in their statutes, contribute to the establishment of producer responsibility organisations in accordance with Article 10 of Directive 2024/3019, the fact remains that Article 9(3) of that directive does not confer on those categories of associations the power to coordinate producers who place any of the products listed in Annex III to that directive on the market. Thus, in accordance with the case-law cited in paragraph 73 above, Article 9(3) of Directive 2024/3019 has only a factual and not a legal impact on the national associations which are members of the applicant, linked to the general interests of the category which they represent.

86      So far as concerns the applicant’s argument relating to its proposed interpretation of the judgments of 2 February 1988, Kwekerij van der Kooy and Others v Commission (67/85, 68/85 and 70/85, EU:C:1988:38), and of 24 March 1993, CIRFS and Others v Commission (C‑313/90, EU:C:1993:111), according to which the own interests of the national associations which are its members would be affected by the contested provisions even if those associations did not have a role as ‘negotiators’, it suffices to observe that it is apparent from the examination set out in paragraphs 74 to 85 above that the applicant has not shown that the contested provisions affect those interests. Therefore, that argument cannot succeed either.

87      In the light of those considerations, it must be concluded that, since the applicant has not established that the national associations which are its members are distinguished individually because their own interests are affected, it is not entitled to bring the present action in so far as it acts on behalf of those associations.

88      It follows from all of the foregoing that the applicant has not demonstrated that it was individually concerned by the contested provisions within the meaning of Article 263 TFEU.

89      That conclusion is not called into question by the applicant’s argument that a refusal to accord it standing to bring proceedings on the basis of an unduly restrictive interpretation of the criteria relating to such standing, laid down in the fourth paragraph of Article 263 TFEU, as suggested by the Parliament and the Council, would deprive it and its members of an effective judicial remedy.

90      In particular, the applicant claims, first, that requests for a preliminary ruling on the basis of Article 267 TFEU are to a significant degree dependent on national court discretion and are subject to procedural and temporal uncertainty. Second, it adds that the first extended producer responsibility obligations set out in the contested provisions will apply to the companies which are its members already as from 31 December 2028, with the result that it is highly unlikely that an action could be brought before a national court and a hypothetical reference for a preliminary ruling initiated, heard, and resolved by the Court of Justice in time before that date.

91      Accordingly, the applicant argues for an interpretation of the conditions laid down in the fourth paragraph of Article 263 TFEU which would allow it to be accorded standing to bring proceedings.

92      In that respect, in the first place, it should be recalled that, while it is true that the conditions of admissibility laid down in the fourth paragraph of Article 263 TFEU must be interpreted in the light of the fundamental right to effective judicial protection, such an interpretation must not have the effect of setting aside the conditions expressly laid down in that Treaty (see, to that effect, judgments of 3 October 2013, Inuit Tapiriit Kanatami and Others v Parliament and Council, C‑583/11 P, EU:C:2013:625, paragraph 98, and of 28 April 2015, T & L Sugars and Sidul Açúcares v Commission, C‑456/13 P, EU:C:2015:284, paragraph 44).

93      In the second place, according to settled case-law, where there is no judicial remedy against the decisions of a national court, that court is, in principle, to bring the matter before the Court of Justice within the meaning of the third paragraph of Article 267 TFEU where a question concerning the interpretation of the FEU Treaty is raised before it; that obligation is intended in particular to prevent a body of national case-law that is not in accordance with the rules of EU law from being established in any of the Member States (see, to that effect, judgment of 15 March 2017, Aquino, C‑3/16, EU:C:2017:209, paragraphs 33 and 42 and the case-law cited).

94      Furthermore, in the event that such a court does not bring the matter before the Court of Justice, it is settled case-law that a Member State’s failure to fulfil obligations may, in principle, be established under Article 258 TFEU (see, to that effect, judgment of 4 October 2018, Commission v France (Advance payment), C‑416/17, EU:C:2018:811, paragraph 107).

95      In the present case, in the first place, since the applicant has not demonstrated that it has standing to bring proceedings against the contested provisions, according it such standing would de facto entail setting aside the conditions expressly laid down in the fourth paragraph of Article 263 TFEU, which would be contrary to the case-law referred to in paragraph 92 above.

96      Moreover, it would also be contrary to the case-law cited in paragraph 92 above to accept the applicant’s argument that the present action should be found to be admissible in view of the claim that it is highly unlikely that an action could be brought before a national court and a hypothetical reference for a preliminary ruling initiated, heard, and resolved by the Court of Justice in time before 31 December 2028.

97      In the second place, it suffices to state that, in the light of the settled case-law cited in paragraphs 93 and 94 above, the applicant’s argument that a reference for a preliminary ruling is dependent on national court discretion is based on an incorrect premiss and, therefore, cannot succeed.

98      Therefore, the application for annulment of the contested provisions must be rejected as inadmissible.

99      By its second head of claim, raised in the alternative, the applicant seeks the annulment of Directive 2024/3019 in its entirety.

100    It suffices to observe that the applicant does not claim to be individually concerned by any provisions of Directive 2024/3019 other than the contested provisions. That finding is sufficient for the purpose of also dismissing the second head of claim and, accordingly, the action in its entirety, as inadmissible.

 The applications to intervene

101    On the one hand, Farmindustria, Association of the European Self-Care Industry (AESGP), Novo Nordisk A/S, Sanofi Winthrop Industrie, Boehringer Ingelheim International GmbH, Novartis Pharma GmbH and Leem have applied for leave to intervene in support of the applicant.

102    On the other, the Commission, Bundesverband der Energie- und Wasserwirtschaft (BDEW) eV and Verband Kommunaler Unternehmen (VKU) eV have applied for leave to intervene in support of the Parliament and the Council.

103    Pursuant to Article 144(3) of the Rules of Procedure, where the defendant lodges a plea of inadmissibility or of lack of competence, as provided in Article 130(1) of those rules, a decision on the application to intervene is not to be given until after the plea has been rejected or the decision on the plea reserved. Under Article 142(2) of those rules, the intervention is to become devoid of purpose, inter alia, where the application is declared inadmissible. In the present case, since the action has been dismissed as inadmissible, there is no longer any need to adjudicate on the applications to intervene.

 Costs

104    Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the applicant has been unsuccessful, it must be ordered to pay the costs in accordance with the forms of order sought by the Parliament and the Council.

105    In addition, under Article 144(10) of the Rules of Procedure, if, as in the present case, the proceedings in the main case are concluded before the application to intervene has been decided, the applicant for leave to intervene and the main parties are each to bear their own costs relating to the application to intervene. Given that the applications to intervene were not notified either to the applicant or to the Parliament and the Council and they were therefore not put in a position where they might incur costs in that regard, it must be held that Farmindustria, AESGP, Novo Nordisk, Sanofi Winthrop Industrie, Boehringer Ingelheim International, Novartis Pharma, Leem, the Commission, BDEW and VKU shall each bear their own costs relating to the applications to intervene.

On those grounds,

THE GENERAL COURT (Fourth Chamber)

hereby orders:

1.      The action is dismissed as inadmissible.

2.      There is no longer any need to adjudicate on the applications to intervene made by Farmindustria, Association of the European Self-Care Industry (AESGP), Novo Nordisk A/S, Sanofi Winthrop Industrie, Boehringer Ingelheim International GmbH, Novartis Pharma GmbH, Les Entreprises du Médicament (Leem), the European Commission, Bundesverband der Energie- und Wasserwirtschaft (BDEW) eV and Verband Kommunaler Unternehmen (VKU) eV.

3.      The Fédération européenne d’associations et d’industries pharmaceutiques (EFPIA) shall pay the costs.

4.      Farmindustria, AESGP, Novo Nordisk, Sanofi Winthrop Industrie, Boehringer Ingelheim International, Novartis Pharma, Leem, the Commission, BDEW and VKU shall each bear their own costs relating to the applications to intervene.

Luxembourg, 18 February 2026.

*      Language of the case: English.