ECLI:EU:C:2026:688

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OPINION OF ADVOCATE GENERAL

KOKOTT

delivered on 3 September 2026 (1)

Case C‑193/25

Republic of Poland

European Parliament and

Council of the European Union

( Action for annulment – Directive (EU) 2024/3019 – Urban wastewater treatment – Quaternary treatment to remove micropollutants – Extended producer responsibility borne by producers of pharmaceuticals and cosmetics – Polluter-pays principle – Equal treatment – Proportionality – Exercise of discretion – Taking into account of the relevant basic facts – Clear and unambiguous setting out of the exercise of discretion and of the taking into account of the relevant basic facts in judicial proceedings – Manifest error of assessment – Obligation to state reasons )

Table of contents

I. Introduction

II. Legal framework

III. Forms of order sought

IV. Legal assessment

A. Admissibility of the action

1. Severability of the financing provisions

2. Severability of the rules on the responsibility of producers of pharmaceuticals and cosmetics

3. Interim conclusion

B. First plea in law: Polluter-pays principle and equal treatment

1. Other sources of micropollutants

2. Toxic load

(a) Sources and calculation

(b) Assessment of toxic load attributable to pharmaceuticals

3. Selection of pharmaceuticals and cosmetics

4. The responsibility of other participants in the supply chain

5. Other arguments advanced by the institutions

6. Interim conclusion

C. Second plea in law: Proportionality and obligation to state reasons

1. Necessity: Inclusion of other producers

2. Whether commensurate: Costs of quaternary treatment

3. Whether commensurate: The burden on the producers of generic medicinal products

4. Exemption

5. Interim conclusion

V. Costs

VI. Conclusion

I. Introduction

1. The old Wastewater Directive, (2) which will remain applicable until 1 August 2027, provides for three stages of wastewater treatment. The new Wastewater Directive (3) supplements those stages with a quaternary treatment to remove what are known as micropollutants, which is to be introduced in certain agglomerations. An 80% share of the costs of that additional treatment is to be covered by the producers of pharmaceuticals and cosmetics. The present action brought by Poland challenges that extended producer responsibility. Other direct actions brought by undertakings and associations concerned have been dismissed as inadmissible by the General Court, (4) and the High Court (Ireland) recently made a request for a preliminary ruling on the validity of that arrangement to the Court of Justice. (5)

2. While the EU legislature bases that extended producer responsibility on the conviction that pharmaceuticals and cosmetics are by far the most important source of micropollutants in wastewater, Poland questions that assessment. That Member State therefore submits that the extent of the responsibility and the associated costs fail to observe the polluter-pays principle and discriminate against the producers concerned. Poland further asserts that the EU legislature did not sufficiently verify whether and demonstrate that the principle of proportionality has been observed.

II. Legal framework

3. The new Wastewater Directive, like the old one, contains rules on the collection, treatment and discharge of urban wastewater and further provides that, in certain agglomerations, wastewater is subject to primary, secondary and further treatment.

4. Article 8 of the new Wastewater Directive further requires the Member States to introduce in various agglomerations, in stages until 2045, quaternary treatment of wastewater to remove micropollutants, which are defined in Article 2(17) with reference to the REACH Regulation (6) and the CLP Regulation. (7)

5. Article 9 of the new Wastewater Directive provides for extended producer responsibility for that quaternary treatment:

‘1. Member States shall take measures to ensure that by 31 December 2028, producers who place any of the products listed in Annex III on the market have extended producer responsibility.

Such measures shall ensure that those producers cover:

(a) at least 80% of the full costs for complying with the requirements set out in Article 8, including the investment and operational costs for the quaternary treatment of urban wastewater to remove micropollutants resulting from the products they place on the market and from the residues of those products, and for the monitoring of micropollutants referred to in Article 21(1), point (a);

(b) the costs for gathering and verifying data on products placed on the market; and

2. Member States shall exempt producers from their extended producer responsibility under paragraph 1 where the producers can demonstrate any of the following:

(a) the quantity of the substances contained in the products they place on the Union market is below 1 tonne per year;

(b) 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.

3. …

4. …

5. The Commission is empowered to adopt implementing acts to establish detailed criteria on the uniform application of the condition laid down in paragraph 2, point (b), to specific categories of product and their biodegradability or hazardousness. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 28(2) no later than 31 December 2027.’

6. Article 9(3) and Article 10 of the new Wastewater Directive concern the implementation of extended producer responsibility. Producers are to exercise that responsibility jointly through organisations established for the purpose.

7. In recital 20 of the new Wastewater Directive, extended producer responsibility is explained as follows:

‘The quaternary treatment necessary to remove micropollutants from urban wastewater will involve additional costs, such as costs related to monitoring and the cost of new advanced equipment to be installed in certain urban wastewater treatment plants. In order to cover those additional costs and in accordance with the polluter-pays principle expressed in Article 191(2) TFEU, it is essential that the producers placing on the Union market products containing substances which, at the end of their life, are found as micropollutants in urban wastewater take responsibility for the additional treatment required to remove those substances, generated in the context of their professional activities. A system of extended producer responsibility is the most appropriate means to achieve this, as it would limit the financial impact on the taxpayer and water tariffs, while providing an incentive to develop greener products. … Pharmaceuticals and cosmetic residues currently represent the main sources of micropollutants found in urban wastewater requiring quaternary treatment. Therefore, extended producer responsibility should apply to those two product groups. On the basis of the results of the urban wastewater monitoring and the most recent scientific data, the Commission should regularly evaluate whether other products should be included in the extended producer responsibility system.’

III. Forms of order sought

8. The Republic of Poland brought the present action against extended producer responsibility for quaternary treatment on 10 March 2025, seeking that the Court adopt the following form of order:

– annul Article 9(1) of the new Wastewater Directive, in conjunction with Annex III to that directive;

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

– in the alternative, should the Court find that the provisions at issue cannot be severed from the other provisions on extended producer responsibility without changing the substance thereof, the Republic of Poland claims that the Court should annul all provisions relating to extended producer responsibility, that is to say, Article 2(20), Article 9, Article 10, and points (c) and (g) of the second subparagraph of Article 30(1) of the new Wastewater Directive, as well as Annex III to that directive.

9. The European Parliament claims that the Court should:

– dismiss the action as inadmissible;

– in the alternative, dismiss the action as unfounded;

– order the applicant to pay the costs.

10. The Council of the European Union claims that the Court should:

– dismiss the present action in its entirety as unfounded; and

– order the Republic of Poland to pay the costs.

11. The European Commission intervened in the case in support of the Parliament and the Council, aligning itself with the form of order sought by the Council.

12. The parties submitted written observations. In accordance with Article 76(2) of the Rules of Procedure of the Court of Justice, the Court deemed it unnecessary to hold a hearing on the ground that it considered itself to have sufficient information.

IV. Legal assessment

13. By its first plea in law, Poland submits that imposing extended producer responsibility solely on the producers of pharmaceuticals and cosmetics fails to observe the polluter-pays principle and the principle of equal treatment. The second plea in law alleges failure to observe the principle of proportionality in combination with failure to comply with the obligation to state reasons on the ground that the impact of the legislation was not sufficiently assessed and set out. First, however, the Parliament’s objections regarding the admissibility of the action must be addressed.

A. Admissibility of the action

14. The Parliament submits that the Republic of Poland’s principal head of claim is inadmissible on the ground that Article 9(1) of and Annex III to the new Wastewater Directive cannot be severed from the other provisions of Articles 9 and 10. The Parliament further submits that the claim in the alternative is also inadmissible because quaternary treatment cannot be severed from the financing thereof.

15. Partial annulment of an EU act is possible only if the elements for which annulment is sought may be severed from the remainder of the act. In that regard, the Court has repeatedly held that the requirement of severability is not satisfied where the partial annulment of an act would have the effect of altering its substance or core. (8)

16. I consider it appropriate first to examine the severability of the financing provisions which are the subject of the claim in the alternative but are also indirectly affected by the principal head of claim, and then to discuss the severability of the special rules providing for the responsibility of producers of pharmaceuticals and cosmetics, which Poland challenges by its principal head of claim.

1. Severability of the financing provisions

17. The substance or core of the new Wastewater Directive would certainly not be altered if the extended responsibility of the producers of pharmaceuticals and cosmetics or the associated financing provisions for quaternary treatment were repealed in their entirety. The requirements regarding the treatment of wastewater would remain unaffected.

18. Both Poland’s principal head of claim and the claim in the alternative, if successful, would, however, shift the burden of the additional, quaternary treatment from the undertakings concerned onto the general public. It cannot be ruled out that the EU legislature would have dispensed with the quaternary treatment obligation if that were the case.

19. According to the case-law of the Court, the question whether partial annulment would alter the substance of the EU act is an objective criterion, and not a subjective criterion linked to the political intention of the authority which adopted the act at issue. (9) Nevertheless, fundamental political compromises made in the legislative process must not be distorted by way of a partial challenge. Such a challenge is therefore precluded where it is demonstrated that the act would not have been adopted without the contested provision. In that event, the success of the action would entail alteration of the substance of the act and the action would be inadmissible.

20. Although the Parliament has referred to the importance of the polluter-pays principle and of extended producer responsibility, it has not demonstrated that the EU provisions on the financing of quaternary treatment were an indispensable condition for reaching political agreement on the new Wastewater Directive or for introducing quaternary treatment.

21. Therefore, the financing rules as a whole may be severed from the other provisions of the new Wastewater Directive. The claim in the alternative would therefore be admissible, and the possible effects of the principal head of claim on the financing of quaternary treatment would not preclude the severability of the contested provisions.

2. Severability of the rules on the responsibility of producers of pharmaceuticals and cosmetics

22. The Parliament’s objection regarding the severability of the provisions challenged by the principal head of claim is rather technical in nature. If successful, the principal head of claim would remove the provisions which impose 80% of the costs of quaternary treatment on the producers of pharmaceuticals and cosmetics but would not formally adversely affect the remaining provisions concerning extended producer responsibility, in particular the rules on its implementation through producer organisations.

23. In principle, the Parliament is correct in stating that those remaining provisions would no longer serve any direct function in that event, as there would be no producers left to bear extended responsibility.

24. Nevertheless, it is useful to separate the specific allocation of responsibility for 80% of the costs to the producers of pharmaceuticals and cosmetics from the rules on the implementation of that responsibility. That is because, if the principal head of claim were successful, the EU legislature could, having regard to the judgment, again designate producers to which those implementing rules would be applied.

3. Interim conclusion

25. It follows that the Poland’s principal head of claim is admissible. There is therefore no need for a decision on the claim in the alternative, which is also admissible in principle.

B. First plea in law: Polluter-pays principle and equal treatment

26. Pursuant to Article 191(2) TFEU, the polluter-pays principle is one of the principles of the environmental policy of the European Union. According to that principle, the person who has caused pollution must bear the costs of eliminating it. (10) Its application creates an incentive to prevent environmental pollution. (11) Moreover, the polluter-pays principle can distribute the costs of removing pollution more fairly by dint of assigning them to the person who caused it and relieving those who played no part in causing it. (12) The Court of Justice at least initially saw that as an expression of the principle of proportionality. (13) After all, it would be inappropriate to assign the costs of pollution not to the person causing it but to someone who did not create it.

27. Accordingly, the Court considers, first, that it would be incompatible with the polluter-pays principle if the persons who have contributed to causing pollution escaped their financial obligations, such as those under the Waste Framework Directive. (14) Second, nobody should be required to take on burdens for the elimination of pollution to which they have not contributed. (15)

28. In allocating the costs of pollution according to causal contributions, the polluter-pays principle is simultaneously a specific expression of the principle of equal treatment or non-discrimination, which is enshrined also in Article 20 of the Charter of Fundamental Rights of the European Union. By virtue of that principle, comparable situations must not be treated differently and different situations must not be treated in the same way, unless such treatment is objectively justified. (16) Where costs are imposed on certain parties in implementation of the polluter-pays principle, the causal contribution is the relevant criterion for comparability and for any potential justification. (17)

29. The institutions involved in the proceedings nevertheless rightly emphasise that in the exercise of the powers conferred on it the EU legislature has a broad discretion where, as in the present case, its action involves political, economic and social choices and where it is called on to undertake complex assessments and evaluations. (18) Only if a measure adopted in that field is manifestly inappropriate in relation to the objective which the EU legislature is seeking to pursue (19) or if it is based on a different manifest error of assessment (20) can such a measure be unlawful. In such a context, the EU judicature cannot substitute its assessment of scientific and technical facts for that of the EU legislature, on which alone the Treaty has placed that task. (21)

30. However, even where that judicial review is of limited scope, it still requires that the EU institutions that have adopted the act in question must be able to show before the Court that in adopting the act they actually exercised their discretion. That, in turn, presupposes that all the relevant factors and circumstances of the situation which the act was intended to regulate were taken into consideration. (22) That being said, the EU legislature’s broad discretion applies not only to the nature and scope of the measures to be taken but also, to some extent, to the finding of the basic facts. (23) Accordingly, alongside the grounds stated for the act, the Court examines whether the EU institutions are able to set out clearly and unequivocally in judicial proceedings the exercise of discretion and of the taking into account of the relevant basic facts. (24)

31. It is common ground among the parties that pharmaceuticals and cosmetics contribute to the contamination of wastewater with micropollutants but are not the only sources of micropollutants. However, Poland states that it is not justifiable to impose 80% of the costs of quaternary treatment on those two groups of producers.

32. The institutions involved in the proceedings, on the other hand, argue with reference in particular to section 6.5 of the Commission’s impact assessment (25) that the available scientific data, which were analysed first by the Commission and subsequently by the Parliament and the Council, clearly show that pharmaceuticals and cosmetics are the very products which constitute the main sources of micropollutants. The key information is given in section 4.3 of the feasibility study, (26) which was enclosed with the impact assessment. The feasibility study indicates that pharmaceuticals and cosmetics account for 73% of micropollutant quantities entering wastewater treatment plants. It also weights the associated toxic load of the wastewater by reference to two indicators. On the basis of the chronic toxicity indicator, that calculation attributes 65% of the toxic load to those two product groups. Weighting the load on the basis of the predicted no-effect concentration (PNEC) indicator takes that figure up to 92%. As the name suggests, that indicator refers to the concentration in water of the micropollutant concerned that is not expected to have any adverse impact.

33. Poland, convincingly in my view, refutes that justification for the contested arrangement pertaining to costs. The Member State provides indications that the share of micropollutants in wastewater which must be attributed to other product groups has been underestimated (see section 1 below). It further submits that the figures for the toxic load attributable to pharmaceuticals and cosmetics which were referred to in the legislative process are unverifiable, since their sources are not indicated, or that they are vitiated by serious errors (see section 2 below). The travaux préparatoires for the legislation give the impression that producers of pharmaceuticals and cosmetics were chosen for extended producer responsibility without any scientific comparison with other producer groups (see section 3 below). Poland’s argument that doctors or consumers should bear the costs instead of producers is less convincing, however (see section 4 below). The institutions involved in the proceedings provide no satisfactory responses to the objections discussed in sections 1 to 3 (see, in particular, section 5 below).

1. Other sources of micropollutants

34. Poland submits, first, that there are strong indications of other sources of micropollutants in wastewater alongside pharmaceuticals and cosmetics. In support of that assertion, the Member State refers to a summary report marked as confidential (27) and various individual studies.

35. The institutions, however, correctly refer to the fact that the summary report was not yet available when the new Wastewater Directive was adopted and therefore could not have been taken into account. By its nature, moreover, it contains no new findings of its own, instead primarily collating the findings of other studies. Nevertheless, the arguments developed in the summary report are of interest to the present proceedings, and Poland therefore refers to them in support of its pleas in law. For example, the summary report emphasises that there are various sources of micropollutants in wastewater, and that pharmaceuticals have only been the subject of the most intensive study. It also states that certain figures in the impact assessment concerning pharmaceuticals’ share of responsibility cannot be verified. (28)

36. The Parliament and the Commission further state that the other studies cited by Poland are largely inapplicable to the facts of the present case because of their different scope or subject matter. They submit that none of those studies provides robust, detailed and peer-reviewed evidence to the effect that other sectors undoubtedly should come within the scope of extended producer responsibility.

37. Indeed, none of the individual studies explicitly finds that other sectors undoubtedly should come within the scope of extended producer responsibility. Making such a finding is also not at all the research objective of those studies.

38. As regards the individual studies relied on, the Commission submits that four of them contain information on the pollution of waters with micropollutants rather than information on input to wastewater treatment plants. (29) The micropollutants detected in that manner therefore do not necessarily come from wastewater. The extent to which they would be covered by quaternary treatment is therefore unknown.

39. Two studies examined only certain wastewater networks, (30) and one study specifically concerned stormwater runoff, (31) and therefore a special situation. Those three studies therefore contain no representative findings regarding the contamination of wastewater with micropollutants, for which quaternary treatment is being introduced.

40. Attention should be drawn, however, to the 2022 study by Finckh et al. (32) cited by Poland, which examined 52 wastewater treatment plants in various Member States. The study was published in a renowned specialist journal, which usually subjects contributions to peer review. The Commission also does not dispute the quality of the study; in fact, it states that it was included in the travaux préparatoires for the legislation at issue. Indeed, one study highlighted by the Commission, (33) which is also cited in the impact assessment and in the feasibility study, repeatedly and approvingly refers to the study by Finckh et al. (34)

41. The study by Finckh et al. explicitly establishes that pesticides and biocides are primarily of concern. The study does also highlight pharmaceuticals, but in significantly smaller number. (35) The Commission’s claim that pharmaceuticals appear to be the main category of micropollutants contributing to toxicity according to that study is therefore incomprehensible.

42. Another study into eight wastewater treatment plants in Denmark (36) confirms that various micropollutants were found in wastewater. It does suggest that the producers of pharmaceuticals bear particular responsibility, as three pharmaceuticals were found in hazardous concentrations across a wide area. Although five pesticides were also found in hazardous concentrations, only one of them was widespread while the others occurred only sporadically, which indicates specific local features.

43. However, at least the study by Finckh et al. casts doubt on the limitation of extended producer responsibility to pharmaceuticals and cosmetics. The institutions have not expressly set out, either in the travaux préparatoires for the legislation or in the proceedings before the Court, why the EU legislature has not imposed extended producer responsibility on the producers of pesticides in particular.

2. Toxic load

44. The references to other sources of micropollutants would not be decisive in the present proceedings, however, if the findings of the impact assessment regarding toxic load were beyond doubt. Those findings show that pharmaceuticals and cosmetics bear by far the predominant responsibility for that pollution. The impact assessment finds that they account for 73% of the input load to wastewater treatment plants, 65% (pharmaceuticals 48% and cosmetics 17%) of the toxic load weighted on the basis of the chronic toxicity indicator, and even 92% (pharmaceutics 66% and cosmetics 26%) of the toxic load weighted on the basis of the PNEC indicator. (37)

45. It is true that the situation is not entirely clear in the case of toxic load weighted by chronic toxicity, as a larger share of responsibility – 28% – is attributed to plastic additives than to cosmetics. In the case of that indicator, incidentally, pesticides account for a 0% share.

46. Nevertheless, in particular given the 92% toxic load weighted by PNEC, it appears that a manifest error of assessment can be ruled out in limiting extended producer responsibility to the producers of pharmaceuticals and cosmetics. That is because, by that calculation, all other products together account for only 8% of that toxic load. The largest remaining share, 3%, is attributed to plastic additives, while pesticides account for only 2%.

47. However, Poland has complained, first, that the basis for the calculation of PNEC-weighted toxic load was not disclosed (see section (a) below). Following the Commission’s provision of information on that point outside the present judicial proceedings, Poland demonstrates that the calculation is subject to considerable doubt where pharmaceuticals are concerned (see section (b) below) and that, in the case of cosmetics, there are doubts as to the attribution of certain substances to that sector (see section (c) below).

(a) Sources and calculation

48. Poland begins by objecting that no further sources are given for the PNEC-weighted toxic load – neither in the impact assessment nor in the feasibility study. Nor have the institutions involved in the proceedings provided such sources, but have instead referred only to the impact assessment and the feasibility study.

49. The impact assessment (38) relies primarily on the feasibility study (39) to substantiate those figures. However, the feasibility study does not in fact specify any source for those figures or explain how they were arrived at.

50. At one relevant point, the impact assessment does mention two other studies alongside the feasibility study to substantiate the finding that substances used in pharmaceuticals and cosmetics account for the majority of micropollutant inputs and toxicity in wastewater treatment plants, which, it suggests, justifies additional investment in advanced treatment processes for micropollutants. (40) However, it is not clear that those two studies concern those matters at all. One of them concerns the removal of nutrients from wastewater. (41) The title of the other study, which appears not to have been published, indicates that it is concerned with individual systems or other appropriate systems of wastewater treatment, (42) as provided for in Article 3(1) of the old Wastewater Directive. Nor do the other studies stated in the bibliography of the impact assessment demonstrate any recognisable connection to the figures on toxic load from micropollutants.

51. In summary, neither the reasoning set out for the new Wastewater Directive nor the submissions made by the institutions in the proceedings before the Court make it clear what the basis is for the findings regarding PNEC-weighted toxic load attributable to pharmaceuticals and cosmetics.

(b) Assessment of toxic load attributable to pharmaceuticals

52. In any event, Poland does provide that information in its reply. On 17 April 2025, in response to a request for access to documents, the Commission, outside the present judicial proceedings, disclosed the basis for the share attributable to pharmaceuticals and cosmetics in respect of the PNEC-weighted toxic load which was used in the legislative procedure (92%). (43)

53. On the basis of that information, Poland raises legitimate concerns as to the accuracy of the figure used for pharmaceuticals, thus alleging a manifest error of assessment or a manifestly inadequate determination of the relevant basic facts.

54. While that submission on the part of Poland is new, it is not out of time for the purposes of Article 127(1) of the Rules of Procedure. That is because it concerns matters of fact and of law which, for Poland – though not for the Commission – became apparent only after the action had been brought on 10 March 2025, that is to say, in the course of the proceedings. Poland therefore may, under Article 128(1) of the Rules of Procedure, introduce that evidence in its reply.

55. According to the information disclosed, the figures for the PNEC indicator, which attribute 66% of the responsibility to pharmaceuticals and 26% to cosmetics, came from the Joint Research Centre (JRC). In the rejoinder, the Parliament states that they originally came from a provider of publicly accessible databases, (44) which is also given as a source in the feasibility study, albeit in relation to a different issue. (45)

56. On the basis of those data, Poland objects in particular to the figures used in respect of four pharmaceuticals: telmisartan (treatment of high blood pressure), dipyridamole (prevention of thrombosis and embolism), candesartan (high blood pressure and heart failure), and amiodarone (cardiac arrhythmias).

57. The 66% share of the PNEC-weighted toxic load attributable to pharmaceuticals was calculated by first dividing the estimated concentration of the relevant micropollutant by its PNEC value. (46) Since both values are expressed in nanograms per litre (ng/l), the result of that division is not attached to a unit of measurement.

58. The summation of those results for all substances describes the total toxic load. The share attributable to each sector is calculated by adding up the toxic load values for the various substances attributed to the sector in question and expressing the result as a proportion of the total load.

59. It is apparent from the information disclosed that the Commission, by that method, calculated a total load of 8 830 and a load attributable to pharmaceuticals of 5 840, which corresponds to around 66%.

60. Poland contends that the PNEC values used for the four pharmaceuticals named above were far too low, that is to say, it was assumed that an adverse impact was already to be expected at concentrations that were too low. Conversely, a higher value would result in a lower load, assuming the same actual micropollutant concentration in wastewater, as the concentration is divided by that value. That would reduce that micropollutant’s share of the total load value but also reduce that value overall.

61. In fact, it emerges that both the share of the PNEC-weighted total load in wastewater attributable to pharmaceuticals and the total load itself would be significantly lower if the PNEC values used were those which the database provider referred to by the Parliament sets out in its ‘factsheets’, (47) rather than the PNEC values from the information disclosed. Notably, the values given by the JRC and the factsheet values can be found together in another database maintained by the abovementioned database provider. (48) It is not clear from those databases, from the travaux préparatoires or from the arguments submitted by the institutions why the lower of those values was used for allocating extended producer responsibility.

62. The following table sets out the relevant values from the JRC list and the database factsheets and the resultant toxic load values.

Pharmaceutical	Concentration in wastewater (ng/l)	PNEC (JRC) (ng/l)	Toxic load (conc./PNEC)	PNEC (factsheet) (converted from μg/l to ng/l)	Toxic load (conc./ PNEC)
Telmisartan	1 993	0.55	3 623	49 000 (49)	0.04
Dipyridamole	4 100	5.3	774	23 600 (50)	0.17
Candesartan	1 266	3.1	408	100 000 (51)	0.01
Amiodarone	375	1.1	340	1 200 (52)	0.31

63. The table shows that, according to the JRC figures, those four pharmaceuticals alone contribute 5 145, or 58%, to the total toxic load of 8 830; that corresponds to 88% of the toxic load attributed to all pharmaceuticals together (5 840). As the calculation disclosed takes into account a total of 348 pharmaceutical active substances and the feasibility study mentions none of those four pharmaceuticals as particularly problematic, (53) that fact alone casts doubt on the EU legislature’s assessment.

64. If the PNEC values from the factsheets were used as a basis instead, the four pharmaceuticals together would contribute less than 1 – or 0.53, to be precise – to the PNEC-weighted toxic load. That would also reduce the total toxic load to 3 685 and the load attributable to all pharmaceuticals to 695, which would be only a 19% share. The four pharmaceuticals specified would account for only a 0.014% share. By contrast, the share attributable to cosmetics would rise from 26% to 63%. (54) The share attributable to plastic additives would rise from 3% to 7.2%, and pesticides would go from a 2% share to 4.7%.

65. The doubts arising from those calculations as regards the determination of the relevant basic facts are confirmed in the study by Pistocchi et al., which is highlighted by the Commission. (55) The study warns that the PNEC value of substances which make a significant contribution only in terms of PNEC-weighted toxic load (but not in other forms of toxic load) may be set at an excessively conservative level and should be reconsidered. (56) That phenomenon is evident in the case of the active substance cited as an example in that study, namely telmisartan, as it alone accounts for more than 50% of the PNEC-weighted toxic load attributed to all 348 pharmaceuticals.

66. However, neither the impact assessment nor the feasibility study nor the institutions’ submissions in the present proceedings contain any indication to suggest that the value in question or any other values were in fact checked for PNEC values that were too low before the Commission incorporated their contribution into the basis for the decision-making.

67. It does not necessarily follow that the figures in the feasibility study for the PNEC-weighted toxic load are incorrect, as it may in fact be the lower PNEC values which are relevant.

68. However, the institutions have not set out clearly and unequivocally that they have taken account of and assessed those doubts. Moreover, those doubts are of sufficient weight, with the result that the institutions should not have ignored them without further justification in the context of their discretion to select the basic facts. The exercise of their discretion in determining and assessing those basic facts is therefore vitiated by a manifest error.

69. Poland alleges manifest errors of assessment or inadequate determination of the basic facts also in relation to cosmetics. Those objections do not relate to the PNEC values used, however, but to the attribution of certain substances to the cosmetics sector.

70. In its application, Poland refers to a cosmetics industry document according to which cosmetics account for less than 0.5% of the toxic load weighted by chronic toxicity and less than 1% of the PNEC-weighted toxic load, and not 17% and 26%, respectively. (57) While the institutions do not dispute those figures, the document in question contains only assertions, without making it clear how they are arrived at or how they relate to the figures from the legislative process.

71. However, the data disclosed by the Commission in the meantime have allowed Poland to develop that line of argument in its reply.

72. Poland submits in particular that, according to the information disclosed, more than half of the toxic load attributable to cosmetics (16% from a total of 26%) comes from the substance permethrin. It argues, however, that that substance is not used in cosmetics but as a pharmaceutical.

73. The Parliament contends that permethrin is indeed used in cosmetics and refers to a Commission database in support of that assertion. However, that database returns no results in searches for the term ‘permethrin’ or for its CAS number. (58) That being said, there is also a factsheet for permethrin from the abovementioned database provider. It lists 55 uses, including four in the area of ‘personal care’. (59)

74. Nevertheless, there are also many other uses given in that factsheet which may result in the presence of permethrin in wastewater. It is therefore doubtful whether the toxic load in wastewater which may be traced to that substance can be attributed wholly or even in large part to the cosmetics industry. Given that the predominant share of the responsibility ascribed to that sector is at issue, the institutions would have had to pay particular attention to that aspect in the legislative process. There is no indication that they did so.

75. The same applies to three fatty acids (oleic acid, palmitic acid and myristic acid), which account for an 8% share of the 26% share of responsibility attributed to cosmetics producers. Poland states that, though they are used in cosmetics, they are also present in large quantities in foodstuffs.

76. The Parliament does not dispute that but argues that it is permissible to assign each substance to only one sector. However, it is not reasonable to ascribe a considerable share of the responsibility for the toxic load in wastewater to a particular sector on the ground of the use of substances even though it is unclear to what extent that sector is responsible for the quantities of those substances present in the wastewater.

77. The Parliament also submits that it is unlikely that a contribution would have to be paid for the use of fatty acids. Given that they are readily biodegradable, it states, the Commission will probably exempt them in implementing provisions from the obligation to contribute.

78. Irrespective of whether those fatty acids will in fact be made exempt in future, that possibility cannot justify ascribing 8% of the PNEC-weighted toxic load to producers of cosmetics on account of those fatty acids. Even if they do not have to pay a contribution for those fatty acids, they and the producers of pharmaceuticals are allocated an 80% share of the costs of quaternary treatment in Article 9(1)(a) of the new Wastewater Directive as a result. If those substances are made exempt, the producers of cosmetics using other substances with a low toxic load will bear a correspondingly greater part of that share. Poland’s objection thus rightly questions whether that share is fully justified.

79. Consequently, the findings regarding the PNEC-weighted toxic load in wastewater attributable to cosmetics are based at least on a manifestly inadequate determination of the relevant basic facts or even on a manifest error of assessment.

3. Selection of pharmaceuticals and cosmetics

80. The impact on the legislative process of those manifest errors in the determination of the relevant basic facts or even in their assessment is confirmed by another objection raised by Poland in its reply. Poland complains that pharmaceuticals and cosmetics had already been predetermined as responsible products in the feasibility study. It asserts that their selection for extended producer responsibility was therefore not founded on a science-based comparison of all sources of micropollutants.

81. If that argument were to be regarded as a new claim, it would be out of time under Article 127(1) of the Rules of Procedure of the Court of Justice. The circumstance at issue, at least in respect of pharmaceuticals, emerges directly from the feasibility study itself, (60) and so was already known when the action was brought.

82. That being said, I consider that Poland, in making that argument, is merely reinforcing the plea in law it has made from the start, that is to say, that the producers of pharmaceuticals were ascribed extended producer responsibility without sufficient scientific justification. A new argument of that nature for a plea already raised may still be introduced in the course of the proceedings. (61)

83. Substantively, it concerns another aspect of the inadequate setting out of facts or the errors of assessment which have already been discussed in the preceding sections. In the preparations regarding extended producer responsibility, no scientific investigation was published to show that producers of pharmaceuticals and cosmetics bear by far the predominant responsibility for micropollutants in wastewater, as the feasibility study claims. Rather, for pharmaceuticals, that responsibility was already assumed in the feasibility study, possibly because their contribution to environmental pollution was already known as a problem. The feasibility study was intended merely to identify another sector which could be included in the extended producer responsibility system. (62)

84. Poland claims that producers of cosmetics were assumed in the feasibility study also to be a sector bearing responsibility. However, the feasibility study states that that sector was identified as a candidate on the grounds of an additional literature review. (63) What is true is that the feasibility study does not set out at that point why those products should entail a greater share of responsibility than other products, such as pesticides, which the study by Finckh et al. highlights, (64) or plastic additives, which contribute to the chronic toxic load more than cosmetics. (65)

85. The decision to select pharmaceuticals and cosmetics is explained only by the findings of the feasibility study regarding the PNEC-weighted toxic load in wastewater, which are discussed above. As already set out, however, those findings are based on a manifest error of determination or of assessment in calculating the toxic load.

4. The responsibility of other participants in the supply chain

86. Poland also raises the question whether it is justifiable to impose extended producer responsibility on producers of pharmaceuticals and cosmetics rather than on other participants in the supply chain, such as prescribing doctors or consumers. However, no manifest error of assessment is apparent in that respect.

87. Placing the burden on producers is consistent with the principle laid down in Article 191(2) TFEU alongside the polluter-pays principle, to the effect that environmental damage should as a priority be rectified at source. The source of the contamination of wastewater with micropollutants lies in their production. Where producers are made to bear the costs of eliminating that contamination, they are first and foremost encouraged to consider more environmentally friendly substitute materials. If that is not possible or desirable, they can incorporate those costs into their prices and so pass the burden on to their customers and to consumers, who may, in turn, consider alternatives.

88. That argument made by Poland must therefore be rejected.

5. Other arguments advanced by the institutions

89. The institutions likewise put forward a number of other arguments, but those arguments do not alter the findings made so far.

90. They submit that extended producer responsibility does not encompass the costs of the treatment stages previously provided for, although those stages already remove a significant proportion (66) of the micropollutants contained in wastewater. However, there are no indications in the file on the basis of which it may be estimated whether and on what scale the producers of pharmaceuticals and cosmetics should contribute to the costs of those treatment stages. At least initially, those treatment stages were introduced in order to eliminate entirely different pollutants.

91. The institutions also state that Article 9(1)(a) of and Annex III to the new Wastewater Directive do not impose the full costs of quaternary treatment on the producers of pharmaceuticals and cosmetics but ‘only’ 80% of them. However, that does not alter the fact that the determination of that share is based on manifest errors in the exercise of discretion.

92. For that reason, the institutions’ argument that the EU legislature is entitled to have recourse to a ‘step-by-step’ approach, introducing extended producer responsibility for only certain producers to begin with, is also unconvincing. It is true that the Court of Justice has previously permitted such an approach (67) and the Commission, according to recital 20 of the new Wastewater Directive, should review whether other products should be included in the extended producer responsibility system. However, the outcome of that review remains to be seen. Even if additional sectors were to be included in future, the provisions under consideration in the present case would still have allocated 80% of the costs to producers of pharmaceuticals and cosmetics for an indefinite period. Those costs will initially be disproportionately high, as those producers will need to finance not only the pure operating costs but also investment in new facilities. At the same time, it cannot be ruled out that, in bearing that share of costs, the producers in question are being expected to assume a significant proportion of the costs of eliminating pollution for which other producers are responsible.

6. Interim conclusion

93. As far as can be seen, the Commission, the Parliament and the Council have made no remarks, either in the legislative process or in the proceedings before the Court, on a crucial step in the establishment of extended producer responsibility, that is to say, on the calculation of the shares attributable to pharmaceuticals and cosmetics to the PNEC-weighted toxic load. At the very least, therefore, the institutions have failed in their obligation clearly and unequivocally to show before the Court that in adopting the act they actually exercised their discretion. Doing so would have involved them taking into consideration all the relevant factors and circumstances of the situation which that act was intended to regulate. (68)

94. In addition, Poland has raised reasonable doubts as to the accuracy of PNEC values and the attribution of certain substances as belonging to the cosmetics sector, which are decisive when it comes to the PNEC-weighted toxic load. As those doubts were not examined during the legislative process and the institutions have also not responded to them in the judicial proceedings, the EU legislature’s assessment in that regard is vitiated by a manifest error.

95. That in itself does not establish whether the assessment was ultimately incorrect – that is to say, whether the provisions ascribing extended producer responsibility to producers of pharmaceuticals and cosmetics were based on an overestimate of those producers’ responsibility. It cannot be ruled out that the EU legislature could have used the lower PNEC values in the calculations without committing a manifest error of assessment. However, that outcome can be reached only after discretion has been exercised without manifest errors.

96. The first plea in law must therefore be upheld and Article 9(1)(a) of and Annex III to the new Wastewater Directive must be annulled.

97. In the event that the Court shares my doubts in part but is not yet convinced, it should at least consider reopening the oral procedure and give the parties the opportunity to comment on the doubts discussed. In the alternative, it could stay the present proceedings and then rule on them in conjunction with the request for a preliminary ruling in Case C‑614/26, Irish Pharmaceutical Healthcare Association and Medicines for Ireland. That request for a preliminary ruling permits a more in-depth examination of the same questions.

C. Second plea in law: Proportionality and obligation to state reasons

98. By its second plea in law, Poland alleges a failure to observe the principle of proportionality. The Member State relies on the second sentence of Article 5(1) TEU, under which that principle is applicable to the use of EU competences, and Article 5(4) TEU, which establishes that, under the principle of proportionality, the content and form of EU action are not to exceed what is necessary to achieve the objectives of the Treaties.

99. As Poland correctly states, that principle means that the actions of EU institutions must not exceed the limits of what is appropriate and necessary in order to achieve the objectives legitimately pursued by the legislation in question. It must be borne in mind in that respect that, where there is a choice between several (equally) (69) appropriate measures, recourse must be had to the least onerous, and the disadvantages caused must not be disproportionate to the aims pursued. (70) Those aims may include the implementation of the polluter-pays principle. (71)

100. In connection with the above, Poland also alleges a failure to comply with the obligation to state reasons under the second paragraph of Article 296 TFEU, as given specific expression in Article 5 of Protocol (No 2) on the application of the principles of subsidiarity and proportionality. Article 5 of that protocol states that any draft legislative act should contain a detailed statement making it possible to appraise compliance with the principle of proportionality, in particular, and some assessment of the proposal’s financial impact. Under the fifth sentence of Article 5, draft legislative acts are to take account of the need for any burden, whether financial or administrative, falling upon the European Union, national governments, regional or local authorities, economic operators and citizens, to be minimised and commensurate with the objective to be achieved.

101. Poland moreover refers to Article 191(3) TFEU and the Interinstitutional Agreement of 13 April 2016 between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making, (72) which confirm those obligations to state reasons in the legislative process.

102. The institutions nevertheless correctly submit that the EU legislature also enjoys a wide margin of discretion in assessing the principle of proportionality. Nevertheless, the institutions must clearly and unequivocally show that in adopting the act they actually exercised their discretion, which presupposes that they took into consideration all the relevant factors and circumstances of the situation which that act was intended to regulate. (73)

103. Poland submits, specifically, that limiting extended producer responsibility to the producers of pharmaceuticals and cosmetics is not the least onerous measure, as other producers should also share responsibility, but that was not sufficiently assessed (see section 1 below). It argues that the costs of quaternary treatment have been underestimated and correct calculation would reveal them to be unreasonably high (see section 2 below). Poland further submits that the EU legislature took inadequate account of the situation of producers of generic medicinal products and that of the various Member States, with the result that extended producer responsibility as currently provided for cannot achieve the incentive function of the polluter-pays principle (see section 3 below). It also states that those deficiencies are not remedied by the possibility of certain producers being made exempt from contributions, as the relevant provisions are not worded sufficiently clearly (see section 4 below).

1. Necessity: Inclusion of other producers

104. By arguing that other producers should also be included in the extended producer responsibility system, Poland adds weight to its submissions concerning the first plea in law. From the point of view of producers of pharmaceuticals and cosmetics, their having to bear an excessive share of the costs of the fourth treatment stage, even though other producers also contribute to a significant degree to the contamination of wastewater with micropollutants and therefore should bear a share of the costs, would indeed not be the least onerous measure.

105. That makes it all the more important for the institutions, either during the legislative process or at least before the Court, to have set out clearly and unequivocally the reasons for the burden on producers of pharmaceuticals and cosmetics and addressed the doubts as to the extent of their responsibility. Since I have already demonstrated, in the context of the examination of the first plea in law, that that was not done, the Court should annul the rules on the extended responsibility of producers of pharmaceuticals and cosmetics. The second plea in law must also be upheld in that regard.

106. Having said that, in the context of the second plea in law too, Poland has not adduced sufficient evidence for a definitive finding that other producers should in fact be ascribed responsibility or that the extent of the responsibility of the producers of pharmaceuticals and cosmetics has been set too high. Rather, it would be for the EU legislature to reassess those issues, but without manifest errors.

2. Whether commensurate: Costs of quaternary treatment

107. Poland also contests the estimated cost of introducing quaternary treatment. It claims that the EU legislature failed to take proper account of the burden placed on the producers of pharmaceuticals and cosmetics when it examined whether it is commensurate with the improvement of water quality. Poland thereby alleges a manifest error of assessment in the determination of the relevant basic facts.

108. That argument is contradictory if only because Poland simultaneously states that it is not opposed to the introduction of quaternary treatment and that it is opposed only to the extent of the extended producer responsibility ascribed to producers of pharmaceuticals and cosmetics. If, however, quaternary treatment is proportionate despite its cost, then it cannot be disproportionate to allocate to the persons causing the pollution the costs of eliminating the pollution.

109. Even taken in isolation, however, the argument is not effective. Although Poland cites estimates which put the costs higher than the impact assessment does, the various estimates are not fully commensurable and are inevitably still affected by considerable uncertainty.

110. The impact assessment puts the cost of quaternary treatment across the European Union at approximately EUR 1.2 billion a year, (74) including less than EUR 240 million for Germany. (75) Although Poland claims that the basis for that estimate has not been disclosed, the figures are based on an OECD model. (76)

111. Poland challenges the figures in the impact assessment by way of two estimates for Germany. According to Poland, the Umweltbundesamt (German Environment Agency) estimates the costs of introducing the system in all agglomerations with a population equivalent of more than 10 000 at EUR 885 million to EUR 1 025 million a year. Poland also refers to the Verband kommunaler Unternehmen (German Association of Local Public Utilities), which estimates the average costs of the adopted legislation in Germany at EUR 414 million a year.

112. However, the fact that those estimates differ from the impact assessment does not suffice to demonstrate a manifest error of assessment. It is in the nature of a wide margin of discretion that the assessment can arrive at a different conclusion.

113. Moreover, the various estimates are also not fully commensurable.

114. The German Environment Agency’s estimate is based on the assumption that quaternary treatment will be introduced in all agglomerations with more than 10 000 inhabitants.

115. By contrast, the new Wastewater Directive provides for quaternary treatment of significantly more limited scope. Under Article 8(1), only agglomerations with a population equivalent of more than 150 000 are required to introduce quaternary treatment. Under Article 8(4), agglomerations with a population equivalent of more than 10 000 are required to introduce it only if they discharge treated wastewater into areas where micropollutants represent a risk for the environment or human health according to a review which is still to be conducted pursuant to Article 8(2). That review is not due until 31 December 2030.

116. The association’s estimate is based on that provision as actually adopted, but it is vitiated by considerable uncertainty because the abovementioned review for smaller agglomerations is still to be conducted.

117. By contrast, the impact assessment is based on the Commission’s proposal for a directive, which was slightly more ambitious than the legislation as adopted, but would also not have covered all agglomerations with a population equivalent of more than 10 000.

118. The Commission had also proposed introducing quaternary treatment in all agglomerations with a population equivalent of more than 100 000. That would have resulted in higher costs.

119. When it comes to smaller agglomerations with a population equivalent of more than 10 000 which discharge treated wastewater into areas where micropollutants represent a risk for the environment or human health, the finalised legislation also differs from the Commission proposal on some details. The Commission submits that the adopted criteria are less stringent than those it originally proposed, with the result that there are fewer agglomerations requiring quaternary treatment. As Poland claims, however, Article 8(8) of the new Wastewater Directive adds a new obligation to those in the proposal, that is to say, that wastewater which is reused, such as for irrigation, must in any event undergo quaternary treatment.

120. Furthermore, the Parliament and the Commission correctly submit that the legislation as adopted grants the Member States more time to introduce quaternary treatment than the Commission had proposed. That spreads the cost of investment over a longer timeframe and the operating costs increase more slowly.

121. Lastly, the Commission had proposed allocating the costs of quaternary treatment to producers of pharmaceuticals and cosmetics in full, but the EU legislature reduced that to 80% of the costs.

122. The estimates made in the legislative process and the estimates made by the German Association of Local Public Utilities would bear comparison better if the impact assessment had been updated on the basis of the amendments made during the legislative process. Indeed, Poland sees the failure to make such updates as an error in the assessment of the proportionality.

123. However, the EU legislature is not required to conduct cost estimates for amendments to legislative proposals. Although the Commission proposal is supposed to be accompanied by corresponding estimates, amendments to the proposal require fresh estimates only where the institutions concerned consider it necessary. (77) In the present case, it was permissible for the institutions to deem the existing estimates sufficient, because the amendments to the proposal were such as to reduce the costs. (78) Furthermore, not only is the EU legislature not required to have at its disposal an impact assessment in every circumstance, but, in addition, such an impact assessment is not binding on it. As a result, the EU legislature remains free to adopt measures other than those which were the subject of the impact assessment. (79)

124. It follows that the estimate of the costs of quaternary treatment on which the EU legislature based the extended producer responsibility system remains within the bounds of its wide margin of discretion, without a manifest error having been committed, despite the estimates cited by Poland. That submission made by Poland must therefore be rejected.

3. Whether commensurate: The burden on the producers of generic medicinal products

125. Poland further contends that extended producer responsibility primarily affects the producers of generic medicinal products. It submits that generic medicinal products are prescribed often and therefore occur in the largest quantities. Despite their large quantities, however, as a result of their relatively low prices, they represent only a relatively small share of the market in terms of value. Poland argues that the much more expensive patented pharmaceuticals, on the other hand, occur in smaller quantities, with the result that their producers have to contribute significantly less to the costs of quaternary treatment, if they are not even completely exempted by the Member States from that burden pursuant to Article 9(2) of the new Wastewater Directive.

126. Furthermore, Poland correctly states that the extended responsibility of producers of generic medicinal products cannot achieve the incentive function of the polluter-pays principle. After all, the active substances in generic medicinal products or their breakdown products, which quaternary treatment is supposed to remove from the wastewater in the form of micropollutants, cannot simply be replaced with less harmful substances. On the contrary, under Article 10(2)(b) of the Medicinal Products Code, (80) a generic medicinal product must be the same as the reference medicinal product. That applies, in particular, in respect of its qualitative and quantitative composition in active substances and its pharmaceutical form. It is only on condition of that sameness that generic medicinal products enjoy a simplified authorisation procedure and can consequently be made available at significantly lower prices once the patent for the reference medicinal product has expired. If other active substances were used in a generic medicinal product, it would no longer be a generic medicinal product but a new pharmaceutical which would require a new and comprehensive authorisation.

127. I understand those objections to mean that Poland is questioning whether imposing extended producer responsibility on the producers of generic medicinal products is commensurate.

128. The third sentence of recital 20 of the new Wastewater Directive does indeed state that extended producer responsibility is intended to provide an incentive to develop greener products. No such incentive exists for the producers of generic medicinal products, as they cannot change their products. The remaining incentive for the developers of new, original medicinal products to try to avoid generating micropollutants in wastewater is relatively weak on account of the small market share and their initially much higher prices.

129. If the costs of extended producer responsibility are passed on in the prices of pharmaceuticals, patients and/or prescribing doctors could consider using other pharmaceuticals which are less polluting and therefore entail lower contributions. However, that incentive presupposes the availability in the first place of alternative pharmaceuticals which, in particular, are tolerated by patients, and are similarly effective. What is more, passing the additional costs on in prices needs to be an option in the first place. As Poland submits, that is not guaranteed in many Member States as a result of their strict regulation of pharmaceuticals pricing.

130. The benefit of extended producer responsibility, which derives from its incentive function, is therefore very limited in the case of producers of pharmaceuticals.

131. Simultaneously, Poland refers to the disadvantages against which that limited benefit must be weighed. Those do not lie directly in the fact that the producers concerned bear costs. Indeed, the third sentence of recital 20 of the new Wastewater Directive also identifies the objective of extended producer responsibility as imposing those costs on the persons causing pollution, rather than the general public. That is also an expression of the polluter-pays principle.

132. Rather, what is of concern to Poland is that those additional costs and the restrictions on pharmaceuticals pricing in many Member States may cause producers to withdraw from certain Member States, which would result in limited access to the pharmaceuticals concerned in those Member States. That, Poland asserts, shows that the EU legislature took inadequate account of the situation of the various Member States, contrary to Article 191(3) TFEU.

133. However, the EU legislature did take that risk into consideration in recital 21. It assumes that additional costs will be very low and expects the Member States to take the remaining risk into account. That also seems reasonable, as the Member States are able to influence not only the arrangements for implementing extended producer responsibility but also the regulation of pharmaceuticals pricing.

134. In summary, although the lack of incentives for producers of generic medicinal products is unsatisfactory, that is not enough, in my opinion, to establish that the EU legislature committed a manifest error in its assessment of whether ascribing extended producer responsibility to the producers of generic medicinal products was commensurate. Consequently, that submission made by Poland must also be rejected.

4. Exemption

135. Lastly, Poland challenges Article 9(2)(b) of the new Wastewater Directive. In particular, that provision permits exempting the producers of certain products from their extended producer responsibility where the producer demonstrates that the micropollutants contained in the product concerned are rapidly biodegradable or that the products do not generate micropollutants in wastewater at the end of their life.

136. Poland submits that it is unclear when those conditions are met and how producers can provide the required evidence. It argues that the provision is therefore unsuitable for mitigating the disadvantages of extended producer responsibility for producers of pharmaceuticals and cosmetics.

137. That exemption is of particular significance in respect of the necessity of extended producer responsibility. To implement the polluter-pays principle, it is not necessary to impose costs on producers whose products release no micropollutants which need to be removed from wastewater by means of quaternary treatment.

138. In that respect, it is true that those two grounds for exemption and the question of evidence permit a certain margin of interpretative discretion, but that margin is not so wide as to make those rules inapplicable. Where differences of opinion arise as to the correct interpretation, they need to be resolved by judicial means if necessary.

139. Furthermore, Article 9(5) of the new Wastewater Directive expressly empowers the Commission to adopt implementing acts to establish detailed criteria on the uniform application of the condition laid down in Article 9(2)(b) to specific categories of products and their biodegradability or hazardousness.

140. Those objections by Poland are therefore not such as to call into question the proportionality of ascribing extended producer responsibility to producers of pharmaceuticals and cosmetics.

5. Interim conclusion

141. The objections raised under the second plea in law are convincing only in so far as they support the conclusions regarding the first plea in respect of insufficient examination of the inclusion of other groups of producers during the legislative process and before the Court of Justice. They must be rejected as to the remainder.

V. Costs

142. Under Article 138(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. As the Parliament and the Council have been unsuccessful, they must be ordered to bear their own costs and to pay the costs incurred by Poland.

143. Under Article 140(1) of the Rules of Procedure, the institutions which have intervened in the proceedings are to bear their own costs. The Commission must therefore be ordered to bear its own costs.

VI. Conclusion

144. I therefore propose that the Court of Justice should:

(1) annul Article 9(1)(a) of and Annex III to Directive (EU) 2024/3019 concerning urban wastewater treatment;

(2) order the European Parliament and the Council of the European Union to bear their own costs and to pay those incurred by the Republic of Poland;

(3) order the European Commission to bear its own costs.

1 Original language: German.

2 Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ 1991 L 135, p. 40), as amended by Council Directive 2013/64/EU (OJ 2013 L 353, p. 8).

3 Directive (EU) 2024/3019 of the European Parliament and of the Council of 27 November 2024 concerning urban wastewater treatment (recast) (OJ L, 2024/3019).

4 Orders of 18 February 2026, Accord Healthcare France and Others v Parliament and Council (Urban Wastewater I) (T‑156/25, T-157/25, T‑159/25 to T‑168/25, T‑170/25 and T‑171/25, EU:T:2026:135), EFPIA v Parliament and Council (Urban Wastewater II) (T‑158/25, EU:T:2026:138), and Cosmetics Europe v Parliament and Council (Urban Wastewater III) (T‑169/25, EU:T:2026:137). The first of those orders is the subject of appeal cases C‑411/26 P, Dermapharm and Others (OJ C, 2026/3400), and C‑412/26 P, BGP Products and Others (OJ C, 2026/3401).

5 Case C‑614/26, Irish Pharmaceutical Healthcare Association and Medicines for Ireland, judgment of the High Court of 20 May 2026 ((2026) IEHC 310).

6 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1).

7 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1).

8 Judgments of 28 June 1972, Jamet v Commission (37/71, EU:C:1972:57, paragraph 11); of 31 March 1998, France and Others v Commission (C‑68/94 and C‑30/95, EU:C:1998:148, paragraphs 256 and 257); and of 8 December 2020, Poland v Parliament and Council (C‑626/18, EU:C:2020:1000, paragraph 28).

9 Judgments of 29 March 2012, Commission v Estonia (C‑505/09 P, EU:C:2012:179, paragraph 121), and of 8 December 2020, Poland v Parliament and Council (C‑626/18, EU:C:2020:1000, paragraph 30).

10 See my Opinion in Futura Immobiliare and Others (C‑254/08, EU:C:2009:264, point 30). To that effect, in respect of the law on waste, see judgments of 7 September 2004 Van de Walle and Others (C‑1/03, EU:C:2004:490, paragraph 57), and of 25 February 2010, Pontina Ambiente (C‑172/08, EU:C:2010:87, paragraph 36).

11 Points 1 and 4(b) of the Annex to Council Recommendation 75/436/Euratom, ECSC, EEC of 3 March 1975 regarding cost allocation and action by public authorities on environmental matters (OJ 1975 L 194, p. 94), Article 9(1) of Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ 2000 L 327, p. 1), judgment of 9 July 2020, Naturschutzbund Deutschland – Landesverband Schleswig-Holstein (C‑297/19, EU:C:2020:533, paragraph 74), and my Opinion in Futura Immobiliare and Others (C‑254/08, EU:C:2009:264, points 31 and 32).

12 Points 1 and 4(b) of the Annex to Recommendation 75/436, and my Opinion in Futura Immobiliare and Others (C‑254/08, EU:C:2009:264, point 32).

13 Judgment of 29 April 1999, Standley and Others (C‑293/97, EU:C:1999:215, paragraph 52).

14 Regarding the law on waste, see judgment of 24 June 2008, Commune de Mesquer (C‑188/07, EU:C:2008:359, paragraph 72).

15 Judgment of 29 April 1999, Standley and Others (C‑293/97, EU:C:1999:215, paragraph 51).

16 Judgments of 17 September 1998, Pontillo (C‑372/96, EU:C:1998:412, paragraph 41), and of 16 July 2026, Associació Catalana de Víctimes d’Organitzacions Terroristes (ACVOT) (C‑666/24, EU:C:2026:589, paragraph 85).

17 See, to that effect, my Opinion in Futura Immobiliare and Others (C‑254/08, EU:C:2009:264, point 33).

18 Judgments of 16 December 2008, Arcelor Atlantique et Lorraine and Others (C‑127/07, EU:C:2008:728, paragraph 57); of 21 June 2018, Poland v Parliament and Council (C‑5/16, EU:C:2018:483, paragraph 112); and of 4 October 2024, Lithuania and Others v Parliament and Council (Mobility package) (C‑541/20 to C‑555/20, EU:C:2024:818, paragraph 313).

19 Judgments of 14 December 2004, Swedish Match (C‑210/03, EU:C:2004:802, paragraph 48), and of 4 October 2024, Lithuania and Others v Parliament and Council (Mobility package) (C‑541/20 to C‑555/20, EU:C:2024:818, paragraph 313).

20 See, to that effect, judgments of 25 January 1979, Racke (98/78, EU:C:1979:14, paragraph 5); of 8 July 2010, Afton Chemical (C‑343/09, EU:C:2010:419, paragraphs 28, 42 and 95); and of 11 January 2024, Friends of the Irish Environment (Fixing fishing quotas above zero) (C‑330/22, EU:C:2024:19, paragraphs 80 and 82).

21 Judgments of 8 July 2010, Afton Chemical (C‑343/09, EU:C:2010:419, paragraph 28); of 21 June 2018, Poland v Parliament and Council (C‑5/16, EU:C:2018:483, paragraph 150); and of 13 March 2019, Poland v Parliament and Council (C‑128/17, EU:C:2019:194‚ paragraph 95).

22 Judgments of 7 September 2006, Spain v Council (C‑310/04, EU:C:2006:521, paragraph 122); of 8 July 2010, Afton Chemical (C‑343/09, EU:C:2010:419, paragraph 34); of 21 June 2018, Poland v Parliament and Council (C‑5/16, EU:C:2018:483, paragraph 152); and of 4 October 2024, Lithuania and Others v Parliament and Council (Mobility package) (C‑541/20 to C‑555/20, EU:C:2024:818, paragraph 722).

23 Judgments of 7 September 2006, Spain v Council (C‑310/04, EU:C:2006:521, paragraph 121); of 8 July 2010, Afton Chemical (C‑343/09, EU:C:2010:419, paragraph 33); and of 21 June 2018, Poland v Parliament and Council (C‑5/16, EU:C:2018:483, paragraph 151).

24 Judgments of 21 June 2018, Poland v Parliament and Council (C‑5/16, EU:C:2018:483, paragraph 153); of 13 March 2019, Poland v Parliament and Council (C‑128/17, EU:C:2019:194‚ paragraph 73); and of 4 October 2024, Lithuania and Others v Parliament and Council (Mobility Package) (C‑541/20 to C‑555/20, EU:C:2024:818, paragraph 218).

25 Commission Staff Working Document, ‘Impact Assessment accompanying the document Proposal for a Directive of the European Parliament and of the Council concerning urban wastewater treatment (recast)’ (SWD(2022) 541 final, p. 21.

26 Bio Innovation Service et al., on behalf of the European Commission, ‘Feasibility of an EPR system for micro-pollutants’, 4 February 2022, pp. 48 and 49.

27 Ramboll, ‘Micropollutants in Urban Wastewater, Summary Report’, 3 March 2025 (Annex A.2 to the application).

28 See section 2(b) below.

29 Finckh, S., Carmona, E., Borchardt, D., Büttner, O., Krauss, M., Schulze, T., … & Brack, W., ‘Mapping chemical footprints of organic micropollutants in European streams’, Environment international, Vol. 183, 2024; Ullberg, M., Lavonen, E., Köhler, S.J., Golovko, O., & Wiberg, K., ‘Pilot-scale removal of organic micropollutants and natural organic matter from drinking water using ozonation followed by granular activated carbon’, Environmental Science: Water Research & Technology, Vol. 7(3), 2021, pp. 535-548; Neuwald, I., Muschket, M., Zahn, D., Berger, U., Seiwert, B., Meier, T., … & Reemtsma, T., ‘Filling the knowledge gap: A suspect screening study for 1310 potentially persistent and mobile chemicals with SFC-and HILIC-HRMS in two German river systems’, Water research, Vol. 204, 2021; and Müller, M.E., Werneburg, M., Glaser, C., Schwientek, M., Zarfl, C., Escher, B. I., & Zwiener, C., ‘Influence of emission sources and tributaries on the spatial and temporal patterns of micropollutant mixtures and associated effects in a small river’, Environmental toxicology and chemistry, Vol. 39(7), 2020, pp. 1382-1391.

30 Seelig, A.H., Zahn, D., & Reemtsma, T., ‘Sources of persistent and mobile chemicals in municipal wastewater: a sewer perspective in Leipzig, Germany’, Environmental Science and Pollution Research, 2024, pp. 1-9, and Neef, J., Leverenz, D., & Launay, M.A. . ‘Performance of Micropollutant Removal during Wet-Weather Conditions in Advanced Treatment Stages on a Full-Scale WWTP’, Water 2022, Vol. 14, 2022.

31 Langeveld, J.G., Post, J., Makris, K.F., Palsma, B., Kuiper, M., & Liefting, E., ‘Monitoring organic micropollutants in stormwater runoff with the method of fingerprinting’, Water research, Vol. 235, 2023.

32 Finckh, S., Beckers, L.M., Busch, W., Carmona, E., Dulio, V., Kramer, L., … & Brack, W., ‘A risk based assessment approach for chemical mixtures from wastewater treatment plant effluents’, Environment International, Vol. 164, 2022.

33 Footnote 3 of the statement in intervention.

34 Pistocchi, A., Alygizakis, N.A., Brack, W., Boxall, A., Cousins, I.T., Drewes, J.E., Finckh, S., Gallé, T., Launay, M.A., McLachlan, M.S., Petrovic, M., Schulze, T., Slobodnik, J., Ternes, T., Van Wezel, A., Verlicchi, P., Whalley, C., ‘European scale assessment of the potential of ozonation and activated carbon treatment to reduce micropollutant emissions with wastewater’, Science of The Total Environment, Vol. 848, 2022.

35 Finckh et al., (cited in footnote 32, pp. 16 and 17): ‘The 32 consensus mixture components of high concern include 21 pesticides and biocides, 5 pharmaceuticals and 6 other compounds’.

36 Kilpinen, K., Devers, J., Castro, M., Tisler, S., Jørgensen, M.B., Mortensen, P., & Christensen, J.H., ‘Catchment area, fate, and environmental risks investigation of micropollutants in Danish wastewater’, Environmental Science and Pollution Research, Vol. 30(57), 2023.

37 Regarding that indicator, see point 32 above.

38 Pages 21 and 57.

39 Pages 48 and 49.

40 Page 57.

41 Pistocchi, A., Grizzetti, B., Nielsen, P.H., Parravicini, V., Steinmetz, H., Thornberg, D., & Vigiak, O., ‘An assessment of options to improve the removal of excess nutrients from European wastewater’, Water, Air, & Soil Pollution, Vol. 234(9), 2023, p. 595 (element 15 of Annex 10 to the impact assessment).

42 Psomas, A., ‘Support studies on specific aspects of wastewater management: Individual or other Appropriate Systems (IAS)’, Brilliants Solutions Engineering & Consulting (BRiS), 2021 (element 16 of Annex 10 to the impact assessment).

43 The published table is enclosed with the reply as Annex C.1.

44 The Network of reference laboratories, research centres and related organisations for monitoring of emerging environmental substances (NORMAN) (https://www.norman-network.com/).

45 Feasibility study, p. 19.

46 That method is explained in the abovementioned study by Pistocchi et al. (cited in footnote 34, pp. 2 and 3), though not used there to identify responsible producers or products.

47 NORMAN Substance Factsheets (https://www.norman-network.com/nds/factsheets/), see the ecotoxicity section in each instance.

48 NORMAN Ecotoxicology Database (https://www.norman-network.com/nds/ecotox/).

49 https://www.norman-network.com/nds/factsheets/show.php?susID=398, but see also https://www.norman-network.com/nds/ecotox/qualityTargetShow.php?susID=398, accessed on 29 July 2026.

50 https://www.norman-network.com/nds/factsheets/show.php?susID=10369, but see also https://www.norman-network.com/nds/ecotox/qualityTargetShow.php?susID=10369, accessed on 29 July 2026.

51 https://www.norman-network.com/nds/factsheets/show.php?susID=9281, but see also https://www.norman-network.com/nds/ecotox/qualityTargetShow.php?susID=9281, accessed on 29 July 2026.

52 https://www.norman-network.com/nds/factsheets/show.php?susID=10453, but see also https://www.norman-network.com/nds/ecotox/qualityTargetShow.php?susID=10453, accessed on 29 July 2026.

53 See pp. 16, 17 and 23.

54 See also the calculation carried out by Regulatory Science Associates, A review of the European Commission approach to allocating toxic load to human pharmaceuticals in urban wastewater, 3 June 2025, p. 10 (https://www.efpia.eu/media/d3gd5agc/rsa-efp001-002-review-of-commission-approach-to-allocating-toxic-load-to-pharmaceuticals-3-june-2025.pdf, accessed on 29 July 2026).

55 Footnote 3 of the Commission’s statement in intervention.

56 Cited in footnote 34, p. 6.

57 Annex A.3 to the application.

58 https://ec.europa.eu/growth/tools-databases/cosing/, accessed on 29 July 2026.

59 https://www.norman-network.com/nds/factsheets/show.php?susID=502, accessed on 29 July 2026.

60 Feasibility study, p. 12.

61 See judgments of 30 September 2003, Freistaat Sachsen and Others v Commission (C‑57/00 P and C‑61/00 P, EU:C:2003:510, paragraph 20), 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, paragraph 279).

62 Feasibility study, p. 12.

63 Feasibility study, p. 16.

64 See points 40 and 41 above.

65 See point 45 above.

66 According to footnote 2 of the feasibility study, the JRC estimates that approximately two thirds of the input load of micropollutants to wastewater treatment plants is unaffected by conventional urban wastewater treatment plant technologies. In other words, those stages remove about one third. By contrast, the impact assessment (p. 111) states that over 70% of micropollutants are removed by the existing treatment stages.

67 Judgment of 16 December 2008, Arcelor Atlantique et Lorraine and Others (C‑127/07, EU:C:2008:728, paragraph 57).

68 See point 30 above and the evidence cited.

69 See judgments of 23 December 2015, Scotch Whisky Association and Others (C‑333/14, EU:C:2015:845, paragraph 49); of 26 September 2018, Van Gennip and Others (C‑137/17, EU:C:2018:771, paragraph 64); and of 26 April 2022, Poland v Parliament and Council (C‑401/19, EU:C:2022:297, paragraph 83).

70 Judgments of 13 November 1990, Fédesa and Others (C‑331/88, EU:C:1990:391, paragraph 13); of 5 October 1994, Crispoltoni and Others (C‑133/93, C‑300/93 and C‑362/93, EU:C:1994:364, paragraph 41); of 12 July 2001, Jippes and Others (C‑189/01, EU:C:2001:420, paragraph 81); of 9 March 2010, ERG and Others (C‑379/08 and C‑380/08, EU:C:2010:127, paragraph 86); of 16 June 2015, Gauweiler and Others (C 62/14, EU:C:2015:400, paragraphs 67 and 91); of 30 April 2019, Italy v Council (Fishing quota for Mediterranean swordfish) (C‑611/17, EU:C:2019:332, paragraph 55); and of 4 June 2020, Hungary v Commission (C‑456/18 P, EU:C:2020:421, paragraph 41).

71 Judgment of 29 April 1999, Standley and Others (C‑293/97, EU:C:1999:215, paragraph 52).

72 OJ 2016 L 123, p. 1.

73 See point 30 above.

74 Page 56.

75 Page 122.

76 Impact assessment, p. 113.

77 Paragraphs 15 and 16 of the Interinstitutional Agreement on Better Law-Making. See judgment of 4 October 2024, Lithuania and Others v Parliament and Council (Mobility package) (C‑541/20 to C‑555/20, EU:C:2024:818, paragraph 224).

78 In that respect, the present case differs from the situation in the judgment of 4 October 2024, Lithuania and Others v Parliament and Council (Mobility package) (C‑541/20 to C‑555/20, EU:C:2024:818, paragraphs 727 and 728).

79 Judgment of 4 October 2024, Lithuania and Others v Parliament and Council (Mobility package) (C‑541/20 to C‑555/20, EU:C:2024:818, paragraphs 720 and 755).

80 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), as amended by Regulation (EU) 2023/1182 of the European Parliament and of the Council of 14 June 2023 on specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland and amending Directive 2001/83/EC (OJ 2023 L 157, p. 1).

Opinion of Advocate General Kokott delivered on 3 September 2026.###

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