JUDGMENT OF THE GENERAL COURT (Fifth Chamber)

9 July 2025 (*) (1)

( REACH – Substances of very high concern – Establishment of a candidate list for eventual inclusion in Annex XIV to Regulation (EC) No 1907/2006 – Decision identifying melamine as a substance meeting the criteria laid down for inclusion in the list – Obligation to state reasons – Right to be heard – Ultra vires – Article 57 of Regulation No 1907/2006 – Manifest error of assessment – Proportionality – Precautionary principle – Misuse of powers )

In Case T‑167/23,

LAT Nitrogen Piesteritz GmbH, formerly Borealis Agrolinz Melamine Deutschland GmbH, established in Lutherstadt Wittenberg (Germany),

Cornerstone Chemical Co., established in Metairie, Louisiana (United States),

represented by R. Cana, E. Mullier and Z. Romata, lawyers,

applicants,

supported by

Grupa Azoty Zakłady Azotowe Puławy S.A., established in Puławy (Poland),

OCI Nitrogen BV, established in Sittard‑Geleen (Netherlands),

Methanol Holdings (Trinidad) Ltd, established in Couva (Trinidad and Tobago),

represented by R. Cana, E. Mullier and Z. Romata, lawyers,

and by

Fritz Egger GmbH & Co. OG, established in St. Johann in Tirol (Austria), and the other interveners whose names are set out in the annex, (2) represented by D. Strobl and M. Ahlhaus, lawyers,

interveners,

v

European Chemicals Agency (ECHA), represented by M. Heikkilä, N. Herbatschek and A. Hautamäki, acting as Agents,

defendant,

supported by

Federal Republic of Germany, represented by J. Möller and N. Scheffel, acting as Agents,

and by

European Commission, represented by D. Milanowska and K. Mifsud‑Bonnici, acting as Agents,

interveners,

THE GENERAL COURT (Fifth Chamber),

composed of J. Svenningsen, President, C. Mac Eochaidh and J. Martín y Pérez de Nanclares (Rapporteur), Judges,

Registrar: I. Kurme, Administrator,

having regard to the written part of the procedure,

further to the hearing on 2 October 2024,

gives the following

Judgment

1        By their action under Article 263 TFEU, the applicants, LAT Nitrogen Piesteritz GmbH, formerly Borealis Agrolinz Melamine Deutschland GmbH, and Cornerstone Chemical Co., seek the annulment of Decision D(2022)9120-DC of the European Chemicals Agency (ECHA) of 16 December 2022, in so far as that decision identifies melamine as a substance of very high concern for the purposes of Article 57 of 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; ‘the contested decision’).

I.      Background to the dispute

2        The applicants are two undertakings which produce melamine.

3        On 26 August 2022, the competent authority of the Federal Republic of Germany submitted a dossier in accordance with Annex XV to Regulation No 1907/2006 in favour of the identification of melamine as a substance of very high concern, in so far as that substance met the criteria set out in Article 57(f) of Regulation No 1907/2006 (‘the dossier drawn up in accordance with Annex XV’).

4        On 2 September 2022, ECHA, pursuant to Article 59(4) of Regulation No 1907/2006, invited all the interested parties to submit their comments on the dossier drawn up in accordance with Annex XV, by 17 October 2022. LAT Nitrogen Piesteritz, through the European Melamine Producers Association (EMPA), submitted its comments on 17 October 2022.

5        As it had received comments on the identification of melamine, ECHA forwarded the dossier to the Member State Committee (‘MSC’) in accordance with Article 59(7) of Regulation No 1907/2006.

6        At its 80th meeting, held between 13 and 15 December 2022, the MSC reached a unanimous agreement on the identification of melamine as a substance of very high concern. The grounds of the agreement were set out in the support document relating to melamine (‘the support document’).

7        On 16 December 2022, in accordance with Article 59(8) of Regulation No 1907/2006, ECHA adopted the contested decision, which provided for the inclusion of melamine in the candidate list for eventual inclusion in Annex XIV to Regulation No 1907/2006, as referred to in Article 59(1) of that regulation (‘the candidate list’), on the ground that it gave rise to an equivalent level of concern to those of other substances listed in Article 57(a) to (e) of Regulation No 1907/2006 and had probable serious effects on human health and the environment, within the meaning of Article 57(f) of Regulation No 1907/2006.

8        The contested decision came into force and was published on ECHA’s website on 17 January 2023. On the same date, ECHA updated the candidate list, published on its website, in accordance with Article 59(10) of Regulation No 1907/2006, in order to include melamine, in that list, as a substance of very high concern.

II.    Forms of order sought

9        The applicants, supported by Fritz Egger GmbH & Co. OG and the other legal persons whose names are set out in the annex, claim that the Court should:

–        annul the contested decision in so far as it includes melamine in the candidate list;

–        order ECHA to pay the costs.

10      Grupa Azoty Zakłady Azotowe Puławy S.A., OCI Nitrogen BV and Methanol Holdings (Trinidad) Ltd, intervening in support of the form of order sought by the applicants, submit that the Court should:

–        grant the form of order sought by the applicants;

–        order ECHA to pay the costs incurred by them.

11      ECHA contends that the Court should:

–        dismiss the action;

–        order the applicants to pay the costs of the main parties;

–        order Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Methanol Holdings (Trinidad) and Fritz Egger and the other legal persons whose names are set out in the annex to bear their own costs.

12      The Federal Republic of Germany and the European Commission, intervening in support of the form of order sought by ECHA, submit that the Court should:

–        dismiss the action;

–        order the applicants to pay the costs.

III. Law

13      In support of their action, the applicants put forward seven pleas in law alleging that ECHA (i) infringed Article 57(f) of Regulation No 1907/2006 and made manifest errors of assessment; (ii) infringed the obligation to state reasons; (iii) infringed the principle of proportionality; (iv) infringed the precautionary principle; (v) infringed their right to be heard; (vi) acted ultra vires and infringed Article 59(8) of Regulation No 1907/2006 and (vii) misused its powers.

14      It is necessary to begin by examining the pleas concerning the formal legality of the act, before those relating to its validity. Thus, the pleas shall be examined in the following order: the second, sixth and fifth pleas, followed by the first, third, fourth and seventh pleas.

A.      The second plea in law, alleging infringement of the obligation to state reasons

15      The applicants, supported by Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Methanol Holdings (Trinidad) and by Fritz Egger and the other legal persons whose names are set out in the annex, submit that the contested decision does not state the reasons on which it is based, since ECHA has not established that the alleged effects of melamine on human health are probable, nor has it attempted to verify the equivalence of the respective levels of concern raised by the substance, on the one hand, and the substances meeting the criteria set out in Article 57(a) to (e) of Regulation No 1907/2006, on the other. The applicants’ involvement in the procedure for the adoption of the contested decision does not, in their view, allow ECHA to circumvent the requirement to state reasons.

16      ECHA, supported by the Federal Republic of Germany and the Commission, disputes those arguments.

17      It should be noted that, pursuant to Article 296 TFEU, legal acts are to state the reasons on which they are based. The purpose of the obligation to state the reasons on which an act adversely affecting an individual is based, which is a corollary of the principle of respect for the rights of the defence, is (i) to provide the person concerned with sufficient information to make it possible to ascertain whether the act is well founded or whether it is vitiated by a defect which may permit its legality to be contested before the Courts of the European Union and (ii) to enable the latter to review the legality of that act (see judgment of 20 September 2019, ICL-IP Terneuzen and ICL Europe Coöperatief v Commission, T‑610/17, EU:T:2019:637, paragraph 45 and the case-law cited).

18      The statement of reasons must, however, be appropriate to the act at issue and the context in which it was adopted. The requirements to be satisfied by the statement of reasons depend on the circumstances of each case, in particular the content of the measure in question, the nature of the reasons given and the interest which the addressees of the measure, or other parties to whom it is of direct and individual concern, may have in obtaining explanations. It is not necessary for the reasoning to go into all the relevant facts and points of law, since the question whether the statement of reasons is sufficient must be assessed with regard not only to its wording but also to its context and to all the legal rules governing the matter in question. In particular, the reasons given for a measure adversely affecting a person are sufficient if it was adopted in circumstances known to that person which enable him to understand the scope of the measure concerning him (see judgment of 20 September 2019, ICL-IP Terneuzen and ICL Europe Coöperatief v Commission, T‑610/17, EU:T:2019:637, paragraph 46 and the case-law cited).

19      It should also be recalled that the obligation to state reasons is an essential procedural requirement which must be distinguished from the question whether the reasons given are correct, the latter being a matter going to the substantive legality of the contested measure (see judgment of 20 September 2019, ICL-IP Terneuzen and ICL Europe Coöperatief v Commission, T‑610/17, EU:T:2019:637, paragraph 47 and the case-law cited).

20      In the present case, it must be stated that the arguments raised by the applicants in support of their second plea seek to challenge the substantive legality of the contested decision. As ECHA has submitted, the applicants refer, in the context of the present plea, to the seventh and eighth parts of their first plea, alleging infringement of Article 57(f) of Regulation No 1907/2006 and manifest errors of assessment, by which they complain that ECHA failed to establish that the alleged effects of melamine on human health were ‘probable’ and that it failed to examine whether the level of concern deemed to be raised by the substance was ‘equivalent’ to that caused by the substances meeting the criteria in Article 57(a) to (e) of Regulation No 1907/2006.

21      Thus, they criticise ECHA for failing to carry out certain analyses, which, in their view, led it to make manifest errors of assessment, but they do not claim that they were not put in a position to understand why ECHA had identified melamine as a substance of very high concern.

22      In any event, it should be noted that the contested decision, read in conjunction with the support document, provides sufficient information to enable the applicants to understand and challenge the reasons which justified the identification of melamine as a substance of very high concern, and to enable the Court to review the legality of that decision.

23      The second plea must therefore be rejected.

B.      The sixth plea in law, alleging that ECHA acted ultra vires and infringed Article 59(8) of Regulation No 1907/2006

24      The applicants, supported by Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Methanol Holdings (Trinidad) and by Fritz Egger and the other legal persons whose names are set out in the annex, claim that ECHA acted ultra vires and infringed Article 59(8) and Article 85(8) of Regulation No 1907/2006. In their view, ECHA wrongly considered, under the voting rules laid down in Article 19(5) of the MSC Rules of Procedure of 25 March 2021, that the decision to identify melamine as a substance of very high concern had been unanimously approved by the MSC, even though four Member States had abstained from voting.

25      ECHA, supported by the Federal Republic of Germany and the Commission, disputes those arguments.

26      The sixth plea can be divided into three parts, alleging (i) that Article 19(5) of the MSC Rules of Procedure is unlawful; (ii) that there was a lack of unanimous agreement; and (iii) infringement of Article 85(8) of Regulation No 1907/2006.

1.      The first part of the sixth plea, alleging that Article 19(5) of the MSC Rules of Procedure is unlawful

27      The applicants submit that no provision of Regulation No 1907/2006 provides that a member of the MSC can abstain from voting and that such a vote would be considered a unanimous agreement of the MSC. Only Article 19(5) of the MSC Rules of Procedure of 25 March 2021 provides that abstentions by MSC members present in person or represented by a proxy do not prevent the MSC’s adoption of tasks which require unanimity.

28      According to the applicants, where Regulation No 1907/2006 allows ECHA bodies to adopt voting rules, that is expressly set out in the provisions of that regulation, which is not the case with the MSC. In that respect, Article 85(9) of Regulation No 1907/2006, which establishes the list of matters which the rules of procedure of the Committees, including the MSC, may concern, does not provide for the adoption of rules on voting arrangements.

29      As a preliminary point, it is necessary to reject ECHA’s argument that the applicants’ criticism in respect of Article 19(5) of the MSC Rules of Procedure goes beyond the scope of the present dispute.

30      The applicants submit that the contested decision is vitiated by an infringement of essential procedural requirements since it was adopted on the basis of a provision of the MSC Rules of Procedure that does not comply with the superior rule of law, in this case Regulation No 1907/2006.

31      In so doing, they rely, in essence, on a plea of illegality in respect of Article 19(5) of the MSC Rules of Procedure.

32      According to the applicants, the illegality of that provision stems, first, from the fact that the MSC was not competent to lay down the voting rules in its Rules of Procedure and, second, from the content of that provision.

33      In the first place, as regards the MSC’s power to lay down the voting rules in its rules of procedure, it must, first, be noted, as observed by ECHA, that Article 85(9) of Regulation No 1907/2006 provides that the rules of procedure of its committees, which include the MSC, ‘in particular’ lay down the procedures for replacing members, the procedures for delegating certain tasks to working groups, the creation of working groups and the establishment of a procedure for the urgent adoption of opinions. Thus, the list of issues which may be dealt with by the provisions of the rules of procedure, laid down in that provision, is not exhaustive, with the result that it cannot be inferred merely from reading Article 85(9) of Regulation No 1907/2006 that there is an illegality affecting Article 19(5) of the MSC Rules of Procedure.

34      Second, it is true that Article 82 of Regulation No 1907/2006 expressly provided that ECHA’s Management Board is to adopt its voting rules. However, for the same reason as that set out in paragraph 33 above, it cannot be inferred from that that ECHA Committees, including the MSC, could not do the same, in the absence of a similar express reference in Regulation No 1907/2006.

35      It should be added that, apart from Article 59(8) of Regulation No 1907/2006, which provides that decisions identifying substances of very high concern are to be adopted by unanimous agreement of the MSC, no other provision of that regulation relates to voting procedures within the MSC. The rule laid down in Article 59(8) of Regulation No 1907/2006 does not address all the considerations relating to the organisation of a vote, such as the quorum to be reached and the consequences of a quorum not being reached or, as is at issue in the present case, the way in which abstentions are capable of affecting the outcome of the vote.

36      Since Regulation No 1907/2006 governs only the issue of the type of majority to be achieved for the adoption of a decision identifying substances of very high concern, it was necessary to lay down the other voting rules in the MSC Rules of Procedure, in order to avoid the risk that the MSC might find itself faced with a legal vacuum. The establishment of such rules contributes, moreover, to ensuring that they are predictable and enables the addressees of the acts adopted to be aware of them and, as in the present case, to challenge them before the Courts of the European Union. Those rules therefore help to preserve legal certainty.

37      Consequently, the MSC did have the power to lay down, in its Rules of Procedure, its voting rules.

38      In the second place, as regards the content of Article 19(5) of the MSC Rules of Procedure, it should be noted that that provision provides that abstentions by members present in person or represented by a proxy do not prevent the MSC’s adoption of tasks which require unanimity.

39      That rule codified the procedural practice followed by the MSC, which drew inspiration from Article 238(4) TFEU. According to the latter provision, relating to votes taking place within the Council of the European Union, abstentions by members present in person or represented do not prevent the adoption by the Council of acts which require unanimity (see, to that effect, judgment of 30 April 2015, Hitachi Chemical Europe and Others v ECHA, T‑135/13, EU:T:2015:253, paragraph 132).

40      In those circumstances and in the absence of any argument put forward by the applicants to explain why the MSC was not entitled to draw inspiration from Article 238(4) TFEU for the establishment of its own voting rules, it should be noted that Article 19(5) of the MSC Rules of Procedure does not appear to be the manifestation of that committee acting ultra vires.

41      Furthermore, as regards the argument of Fritz Egger and the other legal persons whose names are set out in the annex, to the effect that, in essence, the rule laid down in Article 19(5) of the MSC Rules of Procedure unlawfully restricts the exercise of the powers of the Commission, the Council and the European Parliament, that argument must be rejected, without there being any need to assess its admissibility.

42      The argument put forward by Fritz Egger and the other legal persons whose names are set out in the annex is based on the incorrect premiss that an abstention must be treated as a refusal of the proposal discussed. The Court of Justice has already had the opportunity to state that abstention must be understood in its usual sense as a refusal to adopt a position on a given proposal (see, to that effect, judgment of 3 June 2021, Hungary v Parliament, C‑650/18, EU:C:2021:426, paragraph 84).

43      In that regard, and contrary to what is claimed by the applicants, the fact that the Court of Justice has expressed its views on that subject in a case concerning a vote in the Parliament under the fourth paragraph of Article 354 TFEU, when the Parliament is called upon to take a decision under Article 7 TEU, is not such as to render irrelevant the definition of abstention given. In that sense, once the context in which that concept applies is the same, namely the organisation of a vote, the definition given by the Court is relevant.

44      The EU legislature chose, in the context of Article 238(4) TFEU, to consider that the act of refraining from taking a position should not prevent the adoption of decisions requiring unanimous agreement. Since Article 19(5) of the MSC Rules of Procedure is based on that provision, it cannot be argued that it runs counter to fundamental democratic principles and prejudices the powers of the Commission, the Council or the Parliament.

45      In the light of all of the foregoing, the plea of illegality raised in respect of Article 19(5) of the MSC Rules of Procedure and, consequently, the first part of the sixth plea, must be rejected.

2.      The second part of the sixth plea, alleging a lack of unanimous agreement

46      The applicants highlight the fact that the Republic of Austria, which abstained, submitted a written statement in support of its abstention; in their view, that shows that it did not agree with the contested decision.

47      It is common ground between the parties that four Member States abstained from participating in the vote which led to the identification of melamine as a substance of very high concern: the Czech Republic, the Kingdom of Denmark, Hungary and the Republic of Austria.

48      It is also common ground that the Republic of Austria provided a written statement justifying its abstention. That statement was annexed to the minutes of the 80th meeting of the MSC.

49      It follows from that statement that, for the Republic of Austria, the answer to the question as to, on the date of the discussion, what risk management measure would follow, where appropriate, the identification of melamine as a substance of very high concern was unclear. The Republic of Austria added, in that statement, that, consequently, notwithstanding the question of whether melamine met the criteria set out in Article 57(f) of Regulation No 1907/2006, it was of the opinion that melamine was not appropriate for eventual inclusion in Annex XIV within the meaning of Article 59(1) of that regulation. For those reasons, it indicated that it had decided to abstain from voting.

50      It is true that the content of that statement suggests that the Republic of Austria had doubts as to the solution that was envisaged.

51      Nevertheless, the content of that statement reflects, above all, the decision taken by the Republic of Austria to abstain from voting even though it knew that such abstention would have no impact on the process for the MSC’s adoption of tasks requiring unanimity, as expressly provided for in Article 19(5) of the MSC Rules of Procedure (see paragraph 38 above). Consequently, the statement by the Republic of Austria, which could have chosen formally to oppose the adoption of the contested decision, but did not do so, cannot be interpreted as a vote of disagreement.

52      In those circumstances, it must be concluded that, as ECHA submits, the Republic of Austria’s statement reflects only its intention to abstain from taking part in the vote on the identification of melamine as a substance of very high concern.

53      As noted in paragraphs 38 and 51 above, it follows from Article 19(5) of the MSC Rules of Procedure that abstentions by members present in person or represented by a proxy do not prevent the MSC’s adoption of tasks which require unanimity.

54      Accordingly, ECHA did not err in law in finding that, notwithstanding the abstention of four Member States, the identification of melamine as a substance of very high concern had been unanimously agreed by the MSC, for the purposes of Article 59(8) of Regulation No 1907/2006.

55      The second part of the sixth plea must therefore be rejected.

3.      The third part of the sixth plea, alleging infringement of Article 85(8) of Regulation No 1907/2006

56      According to the applicants, a disregard of abstentions in order to determine whether a unanimous vote has taken place is contrary to Article 85(8) of Regulation No 1907/2006. In that regard, although the minutes of the 80th meeting of the MSC refer to the agreement on the identification of melamine as a substance of very high concern and to the existence of abstentions, the MSC agreement does not, however, set out the divergent opinions or acknowledge the consequences of the abstention by four MSC members.

57      Article 85(8) of Regulation No 1907/2006 provides that, when preparing an opinion, each Committee is to use its best endeavours to reach a consensus. That provision states that, if such a consensus cannot be reached, the opinion shall consist of the position of the majority of members, including their grounds, and that the minority position or positions, including their grounds, is also to be published.

58      That provision therefore refers to the opinions which may be issued by ECHA Committees, of which the MSC forms part. As follows from that provision, although it is expected from each committee that, as far as possible, the opinion that is issued is the result of a consensus, the fact that a consensus is not reached in no way prevents such an opinion from being issued.

59      By contrast, in the context of Article 59(8) and (9) of Regulation No 1907/2006, it is not provided that a simple opinion of the MSC may lead to the identification of a substance as a substance of very high concern. Indeed, it is necessary to obtain the unanimous agreement of the MSC. That agreement is, moreover, formalised in a document entitled ‘Agreement of the Member State Committee on the identification of a substance as a substance of very high concern’.

60      In addition, it follows from Article 59(9) of Regulation No 1907/2006 that an opinion of the MSC is to be drawn up and sent to the Commission in a situation where, precisely, the MSC fails to reach a unanimous agreement. In view of the fact that, in such a situation, the Commission is to prepare a draft proposal on the identification of the substance within three months of receipt of that opinion, it is useful, if not essential, for the Commission to have all the available information in order to prepare that draft. In that context, the obligation imposed by Article 85(8) of Regulation No 1907/2006 to have, within the opinion of the MSC, the position of the majority of the members, including their grounds, but also that of the minority position or positions, makes complete sense.

61      It follows that, contrary to what the applicants claim, no infringement of Article 85(8) of Regulation No 1907/2006 can be found, since the obligation imposed in that provision does not concern the content of the agreement reached within the MSC pursuant to Article 59(8) of that regulation.

62      The third part of the sixth plea must therefore be rejected.

4.      Conclusion on the sixth plea

63      Since none of the three parts of the sixth plea is well founded, the sixth plea must be rejected in its entirety.

C.      The fifth plea in law, alleging infringement of the applicants’ right to be heard

64      The applicants, supported by Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Methanol Holdings (Trinidad), and by Fritz Egger and the other legal persons whose names are set out in the annex, complain that ECHA infringed their right to be heard, in so far as the stages of the procedure for the adoption of the contested decision did not enable them effectively to make known their views. In that regard, they consider, first, that they were unable to express their views on all the aspects of the proposal which led to the adoption of the contested decision and, second, that they were unable effectively to make known their views at the MSC meeting.

65      ECHA, supported by the Federal Republic of Germany and the Commission, disputes those arguments.

66      As a preliminary point, it should be noted that, in the context of the present plea, the applicants consider that they have a right to be heard, both under Article 41 of the Charter of Fundamental Rights of the European Union (‘the Charter’) and under Article 59(4) of Regulation No 1907/2006.

67      The present plea may therefore be divided into three parts, alleging, first, infringement of Article 41 of the Charter, second, an error of law as regards the scope of Article 59(4) of Regulation No 1907/2006 and, third, infringement of the applicants’ right under Article 59(4) of that regulation.

1.      The first part of the fifth plea, alleging infringement of Article 41 of the Charter

68      It should be recalled that Article 41 of the Charter, which guarantees the right to good administration, provides for the right of every person to be heard before any individual measure which would affect him or her adversely is taken. Respect for the right to be heard is, in all proceedings initiated against a person which are liable to culminate in a measure adversely affecting that person, a fundamental principle of EU law which must be guaranteed even in the absence of rules governing the proceedings in question. That principle requires that the addressees of decisions which significantly affect their interests should be placed in a position in which they can effectively make known their views on the accusation made against them forming the basis of the contested measure (see judgment of 30 June 2021, Global Silicones Council and Others v Commission, T‑226/18, not published, EU:T:2021:403, paragraph 314 and the case-law cited).

69      By contrast, in the case of acts of general application, neither the process of drafting them nor those acts themselves require, in accordance with the general principles of EU law, such as the right to be heard, consulted or informed, the participation of the persons affected. That is not the case only where an express provision of the legal context governing the adoption of that act confers a procedural right on a person affected (see judgment of 30 June 2021, Global Silicones Council and Others v Commission, T‑226/18, not published, EU:T:2021:403, paragraph 315 and the case-law cited).

70      Thus, Article 41 of the Charter, in so far as it concerns the right to be heard, applies only during the phase of adoption of an act adversely affecting the person concerned and of individual scope (judgment of 30 June 2021, Global Silicones Council and Others v Commission, T‑226/18, not published, EU:T:2021:403, paragraph 316).

71      It is common ground, however, that the contested decision is not an act of individual scope but, on the contrary, is of general application.

72      In those circumstances, the applicants cannot rely on the right to be heard as guaranteed by Article 41 of the Charter.

73      The first part of the fifth plea must therefore be rejected.

2.      The second part of the fifth plea, alleging an error of law as regards the scope of Article 59(4) of Regulation No 1907/2006

74      The parties disagree on the scope of Article 59(4) of Regulation No 1907/2006. While the applicants, supported by Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Methanol Holdings (Trinidad), and by Fritz Egger and the other legal persons whose names are set out in the annex, consider that they have a genuine right to be heard under that provision, ECHA, supported by the Federal Republic of Germany and the Commission, considers that that provision establishes only a right to submit comments.

75      In that regard, in the first place, it should be noted that, even though the French-language version of Article 59(4) of Regulation No 1907/2006 refers to the right of interested parties to submit ‘informations’ (information), the right of those parties consists of a broader right to submit ‘comments’. That interpretation is confirmed by the English-, Spanish-, Italian- and German-language versions of that provision, which refer to ‘comments’, ‘observaciones’, ‘osservazioni’ and ‘Bemerkungen’ respectively. That interpretation is also confirmed by the interpretation adopted by ECHA both in its practice and in its pleadings submitted to the Court.

76      As regards the judgment of 9 June 2021, Exxonmobil Petroleum & Chemical v ECHA (T‑177/19, not published, EU:T:2021:336), it is true that its English-language version refers to a ‘right to submit information’. However, the reference to the word ‘information’ rather than to the word ‘comments’ is due solely to the literal translation of the French-language version of paragraph 244 of that judgment, which reproduces the content of the provision in question. In that judgment, the Court did not intend to limit the type of comments that interested parties were entitled to make in the context of the public consultation. On the contrary, it is apparent from paragraphs 246 to 248 of the abovementioned judgment that the undertakings concerned had had the opportunity to submit comments, both during that public consultation and during the MSC meeting.

77      In the second place, as regards the question of whether Article 59(4) of Regulation No 1907/2006 confers, on the interested parties, a genuine right to be heard, it is true that, as submitted by Fritz Egger and the other legal persons whose names are set out in the annex, the Court stated, in paragraph 85 of the judgment of 11 May 2017, Deza v ECHA (T‑115/15, EU:T:2017:329), that it followed from the wording of Article 59(2) to (5) of Regulation No 1907/2006 that the purpose of the identification procedure for the substances referred to in Article 57 of Regulation No 1907/2006 was to ensure that Member States and interested parties to that procedure could be heard before the drafting of a decision to include a substance in the candidate list.

78      In that regard, although ECHA, in response to the statement in intervention of Fritz Egger and of the other legal persons whose names are set out in the annex, attempts to place that declaration by the Court in its context, emphasising that Article 59(2) to (5) of Regulation No 1907/2006 refers to the possibility for Member States and interested parties to comment on the identification of the substance concerned, the fact remains that, in paragraph 91 of the judgment of 11 May 2017, Deza v ECHA (T‑115/15, EU:T:2017:329), the Court concluded that there had been no infringement of the applicant’s right to be heard.

79      However, there is no need to conclude from that that the Court intended to recognise that the interested parties enjoyed a genuine right to be heard under Article 59(4) of Regulation No 1907/2006.

80      First, it should be noted that the Court was not asked to rule on the question of whether Article 59(4) of Regulation No 1907/2006 conferred on the interested parties a right to be heard, but that it had before it a broader question, namely whether, in the instant case, the entire procedure laid down in Article 59 of Regulation No 1907/2006 had been complied with. More specifically, the main issue concerned the manner in which several proposals for identifying a substance as a substance of very high concern within the meaning of Article 57 of that regulation had to be presented, be they different substances or different properties of the same substance referred to in that article (judgment of 11 May 2017, Deza v ECHA, T‑115/15, EU:T:2017:329, paragraph 86).

81      Second, in order to reach the conclusion set out in paragraph 91 of the judgment of 11 May 2017, Deza v ECHA (T‑115/15, EU:T:2017:329), the Court found, in paragraph 90 of that judgment, that the dossier regarding the substance in question in that case had indeed been the subject of the comments procedure provided for in Article 59(4) and (5) of Regulation No 1907/2006, and that it was not disputed between the parties that the interested parties, including the applicant, had in fact had an opportunity to submit their comments.

82      Furthermore, it should be noted that, in the judgment of 9 June 2021, Exxonmobil Petroleum & Chemical v ECHA (T‑177/19, not published, EU:T:2021:336, paragraph 243), the Court stated that Article 59(4) of Regulation No 1907/2006 did not guarantee a right to be heard to interested parties. It also follows from paragraphs 243 and 244 of that judgment that that provision merely provided for a public consultation that did not confer on interested parties any specific procedural right other than the right to submit comments. Thus, ECHA was not required, under that provision, to hear an individual who might be concerned by the decision taken at the end of the administrative procedure.

83      In the order of 22 December 2023, Exxonmobil Petroleum & Chemical v Commission and ECHA (T‑121/23, not published, EU:T:2023:876, paragraph 59), the Court referred to the judgment of 9 June 2021, Exxonmobil Petroleum & Chemical v ECHA (T‑177/19, not published, EU:T:2021:336), in order to infer from it that Article 59(4) of Regulation No 1907/2006 contained no procedural safeguard such as to render the action admissible (order of 22 December 2023, Exxonmobil Petroleum & Chemical v Commission and ECHA, T‑121/23, not published, EU:T:2023:876, paragraph 62).

84      In any event, the Court had the opportunity to confirm its case-law according to which, in the context of the application of the provisions of Regulation No 1907/2006, a public consultation does not confer on interested parties specific procedural rights, but only the right to submit comments (see, to that effect, judgments of 30 June 2021, Global Silicones Council and Others v Commission, T‑226/18, not published, EU:T:2021:403, paragraph 321, and of 15 September 2021, Laboratoire Pareva and Biotech3D v Commission, T‑337/18 and T‑347/18, EU:T:2021:594, paragraphs 220 to 223).

85      In the third place, as regards the instructions for public consultations on draft decisions on the identification of substances of very high concern published on ECHA’s website (‘ECHA’s instructions’), it is necessary to ascertain whether, as the applicants claim, those instructions have the effect of unlawfully limiting the comments that interested parties may submit in the context of the public consultation.

86      First, as regards the comments on harmonised classification and labelling that are included in 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 No 1907/2006 (OJ 2008 L 353, p. 1), and which may serve as a basis for proposals for the identification of substances of very high concern, the instructions state that comments seeking to challenge that classification and that labelling will not be taken into consideration in that context.

87      Such an instruction cannot be interpreted as excluding any comment on those elements and, in particular, on their impact on the procedure for the identification of substances of very high concern, but as seeking to prevent interested parties from taking advantage of the public consultation on the identification of a substance as a substance of very high concern in order to challenge a decision that was taken in the context of a different procedure, in the present case, the procedure provided for by Regulation No 1272/2008 and which led to a certain classification and certain labelling of the substance in question. In other words, ECHA wished to prevent attempts at abuse of process.

88      In those circumstances, ECHA’s instruction must be understood as a reminder of the legal framework for the public consultation on proposals for the identification of substances of very high concern and not as an attempt to limit unlawfully the comments that may be submitted by interested parties, in accordance with Article 59(4) of Regulation No 1907/2006.

89      Second, as regards comments or further information on the uses, volumes per use, exposure, alternatives and risks associated with the proposed substance, it must be noted that ECHA’s instructions expressly envisage the possibility for interested parties to submit such comments and information, but state that they will not be used to confirm the identification of a substance of very high concern. ECHA’s instructions add that such comments and information will nevertheless be useful for the next stage of the authorisation process, in order to help ECHA decide if the substance should be recommended for inclusion in the authorisation list in Annex XIV to Regulation No 1907/2006.

90      It is therefore necessary to reject the applicants’ argument that ECHA objected to their submission of such comments and, consequently, the applicants’ argument that ECHA unlawfully limits the comments that may be submitted by interested parties, in accordance with Article 59(4) of Regulation No 1907/2006, must also be rejected.

91      In any event, the applicants do not dispute that they submitted comments on the monitoring data relating to the presence of melamine in water.

92      As regards the applicants’ argument complaining that ECHA stated, in its instructions, that the comments and further information referred to in paragraph 89 above would not be used to confirm the identification of a substance of very high concern, that is a separate question from that of whether the applicants were in fact able to submit their comments, in accordance with Article 59(4) of Regulation No 1907/2006. The applicants’ argument put forward in that regard is, therefore, ineffective in the context of the examination of the present plea.

93      It follows from the foregoing that Article 59(4) of Regulation No 1907/2006 does not confer, on interested parties, a right to be heard, but the right to submit comments, and that ECHA’s instructions do not lay down rules which unduly limit the right thus granted to interested parties.

94      Consequently, the second part of the fifth plea must be rejected.

3.      The third part of the fifth plea, alleging infringement of the right recognised in Article 59(4) of Regulation No 1907/2006

95      It should be noted, first of all, that it is common ground between the parties that, first, ECHA organised a public consultation on the dossier drawn up in accordance with Annex XV, as required by Article 59(4) of Regulation No 1907/2006, second, the applicants did submit comments in the context of that consultation and, third, the applicants participated in the MSC meeting.

96      Next, as follows from paragraphs 74 to 93 above, ECHA did not infringe, during the public consultation, that is, during the stage preceding the MSC meeting, the applicants’ right to submit comments under Article 59(4) of Regulation No 1907/2006.

97      Lastly, the question arises as to whether the applicants were able to submit all the comments which they considered useful during the MSC meeting.

98      In that regard, it is, first of all, necessary to specify what role the applicants played at the MSC meeting.

99      Under Article 85(4) of Regulation No 1907/2006, stakeholders may also be invited to attend meetings as observers, as appropriate, at the request of ECHA’s Committee members or ECHA’s Management Board.

100    The status of observers has been defined by ECHA. It thus published, on 18 December 2020, a code of conduct for observers at ECHA meetings (‘the code of conduct for observers’). It follows that the role of observers is, first, to provide, on request, technical and scientific data based on their expertise and knowledge and, second, to contribute to the flow of information from ECHA and its bodies to undertakings. Furthermore, the code of conduct for observers states that observers may participate in meetings of the MSC at the discretion of the Chair and will not be able to attend any closed sessions of those meetings. Lastly, observers are invited to signal in advance to the Chair and, at the latest, at the beginning of the meeting, the points on which they wish to intervene. It is stated that those interventions must be brief and respect the time allocated by the Chair.

101    It follows that observers intervene on an ad hoc basis during the meetings of the MSC, either in order to answer questions put to them by the members of the MSC or in order to express their comments on points decided in advance. However, it is not envisaged that observers will able to express their views exhaustively on all the points discussed at those meetings or on all the evidence gathered during the procedure for the identification of a substance as a substance of very high concern.

102    Thus, in the same way that Article 59(4) of Regulation No 1907/2006 does not provide for a right other than the right to submit comments during the public consultation, Article 85(4) of that regulation and observer status as defined by ECHA do not confer, on the interested parties participating in the MSC meeting, a right to be heard. They merely give those parties the opportunity to submit comments on specific points which may be determined in advance.

103    It is in the light of those considerations that the arguments put forward by the applicants must be examined.

104    In the first place, the applicants criticise ECHA for not having published, before the MSC meeting, the RCOM document, namely the document containing the responses of the competent German authority to the comments made during the public consultation.

105    In response to a question put by the Court by way of measures of organisation of procedure, the applicants stated that they were criticising ECHA for not having published the RCOM document or communicating it directly to them.

106    ECHA, for its part, stated, in response to a question put by the Court by way of measures of organisation of procedure, that a non-confidential version of that document had been made accessible to observers on 30 November 2022 via a platform called ‘Interact Meetings’. The observers present included the European Chemical Industry Council (Cefic), which was one of ECHA’s regular observers. ECHA notes that Cefic was accompanied by an expert who represented the EMPA, of which LAT Nitrogen Piesteritz is a member. ECHA infers from that that Cefic must have shared the RCOM document with the EMPA expert.

107    When questioned at the hearing, the applicants stated that they were focusing their criticism on the fact that they were unable to comment on the RCOM document. Thus, while acknowledging that the RCOM document had been made available to them on ECHA’s platform and that their representative had had access to it before the MSC meeting, they stated that that representative had had to sign a declaration of confidentiality which prevented him from sharing the RCOM document with the applicants.

108    However, as ECHA stated, in essence, during the hearing, while it is true that a declaration of confidentiality must be signed by observers who participate in ECHA meetings and who consult the documents made accessible via the ‘Interact Meetings’ platform, section 5 of the code of conduct for observers expressly provides that they may share, with their constituencies, non-confidential documents to which they have access.

109    Since the applicants’ representative, who acted as an observer at the MSC meeting, did have access to the RCOM document and was able to forward it to the applicants, under certain conditions, the applicants’ complaint as set out in paragraphs 104 and 105 above cannot succeed.

110    In the second place, the applicants claim that they were unable to submit their comments on the study by Suchý, P., Novák, P., Zapletal, D. and Stravoká, E., ‘Effect of melamine-contaminated diet on tissue distribution of melamine and cyanuric acid, blood variables, and egg quality in laying hens’, British Poultry Science, 2014 (‘the study on birds’). According to the applicants, the problem lies in the fact that that study was not part of the dossier drawn up in accordance with Annex XV, that it had not been communicated to them before the MSC meeting and that they did not have the opportunity to submit their comments on that study either during or after the MSC meeting.

111    The study on birds was introduced in the support document following comments received during the public consultation of interested parties.

112    In that regard, the Court has already held that the effectiveness of the provisions of Article 59 of Regulation No 1907/2006 would have been undermined if ECHA had been obliged to organise a new public consultation on the ground that it intended to rely on elements resulting from the first public consultation on which not all the interested parties had been able to comment. Such a requirement, which is not provided for in Regulation No 1907/2006, could have encouraged interested parties to submit new elements for each additional public consultation and thus permanently prevent the adoption of any decision by ECHA (judgment of 9 June 2021, Exxonmobil Petroleum & Chemical v ECHA, T‑177/19, not published, EU:T:2021:336, paragraph 245).

113    In the present case, the situation is somewhat different, since the study on birds was not provided by one of the interested parties during the public consultation, but was introduced in the support document in response to comments made during that public consultation. As is apparent from the minutes of the MSC meeting, the new data introduced in the support document, namely, inter alia, the study on birds, were added in the context of the response to the comments received.

114    Nevertheless, the fact that the study on birds was not produced by an interested party is irrelevant. First, the result is the same, since the support document is based on scientific evidence on which all the interested parties were unable to submit comments. Second, the study on birds was produced in response to comments received. Thus, the objective was to take into account, and provide a substantiated response to, the comments submitted during the public consultation, which is consistent with the principle of good administration.

115    In any event, the study on birds did not play a decisive role in the identification of melamine as a substance of very high concern. Although the effects of melamine on birds were classified as important (see section 6.3.2.5 of the support document), the fact remains that other effects on the environment, such as those observed on fish and aquatic invertebrates, were also found to be serious, with the result that, taken together, the effects of melamine on the environment were considered to be serious. Consequently, even if the findings relating to the effects of melamine on birds were to be disregarded, that fact alone would not be sufficient to call into question the conclusion that melamine is capable of having serious effects on the environment.

116    Consequently, the applicants’ argument cannot succeed.

117    As regards the argument of Fritz Egger and the other legal persons whose names are set out in the annex, to the effect that the competent national authority and ECHA are not authorised to introduce the study on birds, that argument is based on the content of section 3.4 of the document entitled ‘Working procedures of the Member State Committee in the identification of substances of very high concern’ of 17 June 2021.

118    However, the fact that section 3.4 of the document entitled ‘Working procedures of the Member State Committee in the identification of substances of very high concern’ of 17 June 2021 provides that the dossier drawn up in accordance with Annex XV should be updated due to any relevant new information or additional data received during the consultation period cannot be interpreted as limiting the taking into account of new data solely to the information and data provided by the interested parties during the public consultation. On the contrary, by introducing the study on birds in response to the comments received during the public consultation, the competent national authority responsible for preparing the draft support document fully complied with the content of that section.

119    As regards the report published by the Miljødirektoratet (Environment Agency, Norway) in 2020, entitled ‘Screening programme 2019 – Suspected PBT compounds’, which was produced during the MSC meeting and subsequently mentioned in the support document, it must be stated that, contrary to what the applicants claim, that report was not produced during the public consultation, but was already part of the dossier drawn up in accordance with Annex XV, as is apparent from page 67 of that dossier. Therefore, the applicants had the opportunity to submit comments on that report during that public consultation, or even during the MSC meeting.

120    In the third place, as regards the comments provided by the applicants’ representative at the MSC meeting, it must be noted, as a preliminary point, that the presence of interested parties at the MSC meeting is not mandatory, but occurs upon invitation by ECHA, in accordance with Article 85(4) of Regulation No 1907/2006. In addition, as established in paragraph 101 above, the involvement of observers during the MSC meeting is limited. Lastly, the applicants were required to comply with the code of conduct for observers.

121    Thus, first, as regards the fact that the applicants’ representative was not authorised to submit his slides, it is sufficient to note that that fact alone does not mean that he was unable to submit his comments. Moreover, it should be noted that the applicants’ representative could have anticipated that refusal, since the code of conduct for observers expressly states that PowerPoint presentations are not accepted except in exceptional cases.

122    Second, as regards the fact that only three of the nine topics were discussed in the presence of the applicants’ representative, apart from that argument lacking detail, it must be noted, first, that the role of observers at MSC meetings does not mean that they can express their views on all the topics under discussion and, second, that the code of conduct for observers expressly states that the Chair may decide to reserve topics for closed sessions, at any time during a meeting.

123    On the latter point, it is also necessary to reject the arguments of Fritz Egger and of the other legal persons whose names are set out in the annex, to the effect that the MSC’s task as defined by ECHA does not in any way justify the holding of closed sessions, since those arguments are not sufficiently substantiated.

124    The argument that the question arises as to which topics were discussed during the closed sessions cannot succeed. According to ECHA’s document entitled ‘Closed and open sessions of the plenary meetings of the Member State Committee’ of 7 March 2013, those topics are actually determined in the agenda for the meeting. That agenda is normally published on ECHA’s website. Consequently, in order to have any chance of succeeding, the argument of Fritz Egger and of the other legal persons whose names are set out in the annex should not have related to the question of which topics were discussed in closed session, but rather to the question of whether the topics discussed in closed session had been correctly identified in the agenda for the MSC meeting.

125    Third, as regards the argument relating to the content of the minutes of the MSC meeting, to the effect that the intervention of the applicants’ representative is not reflected in those minutes, it must be held that that argument is ineffective. It has no connection with the question of whether the applicants were able to submit comments during the MSC meeting. Moreover, the minutes constitute a summary record of the MSC meeting and not a document serving as a basis for the adoption of the contested decision. Lastly, the code of conduct for observers expressly states that the inclusion of key points of observer interventions is only a possibility.

126    In the light of all of the foregoing, the third part of the fifth plea must be rejected.

4.      Conclusion on the fifth plea

127    It follows from all of the foregoing that the applicants are not justified in claiming that they had, in the context of the procedure for the identification of a substance of very high concern, a right to be heard under Article 41 of the Charter or Regulation No 1907/2006, or in claiming that, in the present case, their right to submit comments was infringed.

128    The fifth plea must therefore be rejected in its entirety.

D.      The first plea in law, alleging infringement of Article 57(f) of Regulation No 1907/2006 and manifest errors of assessment

129    In their first plea, the applicants rely on eight manifest errors of assessment on the part of ECHA. Thus, in their view, ECHA made a manifest error of assessment by:

–        relying on properties, not constituting ‘hazards’, that are deemed to satisfy the condition of ‘effects’ for the purposes of the application of Article 57(f) of Regulation No 1907/2006;

–        wrongly concluding that the specific target organ toxicity repeated exposure category 2 properties (‘STOT RE 2 properties’) and the category 2 carcinogenic properties (‘Carc 2 properties’) constituted ‘effects’ within the meaning of Article 57(f) of Regulation No 1907/2006;

–        wrongly concluding that the substance at issue had ‘serious’ effects on the environment;

–        failing to take into account certain information and by considering that the available evidence validly supported the conclusions reached on the environmental fate properties of the substance at issue;

–        basing the contested decision on ‘yet unknown effects’;

–        failing to establish that the alleged effects constituted ‘serious effects’;

–        failing to establish that the alleged effects were ‘probable’;

–        failing to examine whether the level of concern deemed to be posed by the substance was ‘equivalent’ to that posed by the substances meeting the criteria in Article 57(a) to (e) of Regulation No 1907/2006.

130    Thus, the applicants criticise the analysis carried out by ECHA, in so far they allege that it made manifest errors of assessment as regards the properties of melamine that were used for the purposes of its examination, the effects of melamine that were considered, the evidence that was taken into account and the level of concern raised by the substance.

1.      Preliminary observations

131    Article 57 of Regulation No 1907/2006 provides as follows:

‘The following substances may be included in Annex XIV in accordance with the procedure laid down in Article 58:

(a)      substances meeting the criteria for classification in the hazard class carcinogenicity category 1A or 1B in accordance with section 3.6 of Annex I to Regulation (EC) No 1272/2008;

(b)      substances meeting the criteria for classification in the hazard class germ cell mutagenicity category 1A or 1B in accordance with section 3.5 of Annex I to Regulation (EC) No 1272/2008;

(c)      substances meeting the criteria for classification in the hazard class reproductive toxicity category 1A or 1B, adverse effects on sexual function and fertility or on development in accordance with section 3.7 of Annex I to [Regulation (EC)] No 1272/2008;

(d)      substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII of this Regulation;

(e)      substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII of this Regulation;

(f)      substances – such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or (e) – for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59.’

132    Thus, Article 57(a) to (c) of Regulation No 1907/2006 covers, first of all, substances meeting the criteria for classification in the hazard class carcinogenicity, mutagenicity or reproductive toxicity (‘CMR substances’) category 1A or 1B, in accordance with sections 3.5 to 3.7 of Annex I to Regulation No 1272/2008. Next, Article 57(d) and (e) of that regulation covers substances which are persistent, bioaccumulative and toxic (‘PBT substances’) and those which are very persistent and very bioaccumulative (‘vPvB substances’), in accordance with the criteria set out in Annex XIII to Regulation No 1907/2006. Those criteria are based on the assessment of the hazards presented by those substances. Lastly, Article 57(f) of that regulation covers all other substances which do not fulfil any of the foregoing criteria but ‘for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e), and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59’ (judgment of 15 March 2017, Polynt v ECHA, C‑323/15 P, EU:C:2017:207, paragraph 24).

133    It is thus apparent from Article 57(f) of that regulation that, for a substance, other than CMR, PBT or vPvB substances, to be identified as being of very high concern, it must be established, on the basis of scientific evidence (i) that that substance has probable serious effects on human health or the environment and (ii) that those effects give rise to an equivalent level of concern to those of CMR, PBT or vPvB substances. Those conditions are cumulative, so that the identification of a substance as being of very high concern must be rejected if either of those conditions is not met (judgment of 9 November 2023, Chemours Netherlands v ECHA, C‑293/22 P, not published, EU:C:2023:847, paragraph 33).

134    The first of those conditions, which concerns the serious nature of the effects of the substance on human health or the environment, requires an analysis of the hazards arising from the intrinsic properties of that substance. The second condition, which concerns the determination of an equivalent level of concern to those of CMR, PBT or vPvB substances, requires a range of factors to be taken into consideration, wider than those relevant to the categorisation of the effects and intrinsic properties of a substance (judgments of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA, C‑324/15 P, EU:C:2017:208, paragraphs 27 and 36, and of 9 November 2023, Chemours Netherlands v ECHA, C‑293/22 P, not published, EU:C:2023:847, paragraph 34).

135    It is apparent from that case-law that, when assessing whether the level of concern to which the substance in question gives rise is equivalent to that of CMR, PBT or vPvB substances, ECHA may take into consideration information which goes beyond the data relating to the intrinsic properties of the substance concerned (judgment of 9 November 2023, Chemours Netherlands v ECHA, C‑293/22 P, not published, EU:C:2023:847, paragraph 35).

136    As regards the scope of review by the EU judicature, it should be noted that, according to the case-law, in a complex and evolving area of technology such as that in the present case, the competent EU authorities have a broad discretion, in particular as to the assessment of highly complex scientific and technical facts, in order to determine the nature and scope of the measures which they adopt, whereas review by the EU judicature has to be limited to verifying whether there has been a manifest error of assessment or a misuse of powers, or whether those authorities have manifestly exceeded the limits of their discretion (see judgments of 21 July 2011, Etimine, C‑15/10, EU:C:2011:504, paragraph 60 and the case-law cited, and of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 52 and the case-law cited).

137    In those circumstances, according to settled case-law, in order to establish that such an authority committed a manifest error in assessing complex facts such as to justify the annulment of the act in question, the evidence adduced by the applicant must be sufficient to make the factual assessments used in the act implausible (see judgment of 9 September 2011, France v Commission, T‑257/07, EU:T:2011:444, paragraph 86 and the case-law cited).

138    In such a context, the EU judicature cannot substitute its assessment of scientific and technical facts for that of the EU authorities on which alone the FEU Treaty has placed that task (see judgments of 21 July 2011, Etimine, C‑15/10, EU:C:2011:504, paragraph 60 and the case-law cited, and of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 52 and the case-law cited).

139    Also according to the case-law, the broad discretion of the EU authorities, which implies limited judicial review of its exercise, 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. However, even though such judicial review is of limited scope, it requires that the EU authorities which have adopted the act in question must be able to show before the EU judicature 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 the act was intended to regulate (see judgments of 8 July 2010, Afton Chemical, C‑343/09, EU:C:2010:419, paragraphs 33 and 34 and the case-law cited, and of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 53 and the case-law cited).

140    It is therefore for the EU judicature to establish, in the light of the factors relied on by the applicant, whether the evidence relied on is factually accurate, reliable and consistent, whether that evidence contains all the information which must be taken into account in order to assess a complex situation, and whether it is capable of substantiating the conclusions drawn from it (see, to that effect, judgments of 22 November 2007, Spain v Lenzing, C‑525/04 P, EU:C:2007:698, paragraph 57; of 6 November 2008, Netherlands v Commission, C‑405/07 P, EU:C:2008:613, paragraph 55; and of 9 September 2011, France v Commission, T‑257/07, EU:T:2011:444, paragraph 87).

2.      The first part of the first plea, alleging a manifest error of assessment, in that ECHA relied on properties, not constituting ‘hazards’, which were deemed to satisfy the condition of ‘effects’ for the purposes of the application of Article 57(f) of Regulation No 1907/2006

141    In the context of the first part of the first plea, the applicants submit, in essence, that, for the purposes of the application of Article 57(f) of Regulation No 1907/2006, the intrinsic properties that can be taken into consideration are only those capable of having serious effects on human health or the environment and which therefore represent a hazard to human health or the environment. In that regard, they consider that the concept of ‘hazard’ within the meaning of sections 1 to 4 of Annex I to Regulation No 1907/2006 is intrinsically and expressly linked to the classification of hazards as established by Regulation No 1272/2008. They note that none of the categories of hazards defined by Regulation No 1272/2008 covers the environmental fate properties of a substance. They argue that ECHA thereby made a manifest error of assessment by associating, with the environmental fate properties of melamine, ‘effects’ meeting the criteria laid down in Article 57(f) of Regulation No 1907/2006, even though those properties are not related to hazards.

142    ECHA, supported by the Federal Republic of Germany and the Commission, disputes those arguments.

143    In that regard, it should be noted that it follows from the case-law that Article 57(f) of Regulation No 1907/2006 requires that the effects of the substance on human health or the environment are capable of being regarded as ‘serious’, on account of, for example, their significance or their irreversible nature. The examination of that condition is based on an assessment of the hazards to human health or to the environment, on the basis of the information in the relevant parts of sections 1 to 4 of Annex I to Regulation No 1907/2006, as stated in section II of Annex XV to that regulation. It is therefore clear that Article 57(f) of that regulation requires an analysis of the hazards arising from the intrinsic properties of the substance under consideration (judgments of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA, C‑324/15 P, EU:C:2017:208, paragraph 27, and of 23 February 2022, Chemours Netherlands v ECHA, T‑636/19, not published, EU:T:2022:86, paragraph 35).

144    It is true that, as the applicants submit, sections 1 to 3 of Annex I to Regulation No 1907/2006 expressly refer to Regulation No 1272/2008. Thus, section 1 states that ‘the objectives of the human health hazard assessment shall be to determine the classification of a substance in accordance with Regulation … No 1272/2008’. Similarly, section 2 provides that ‘the objective of the hazard assessment for physicochemical properties shall be to determine the classification of a substance in accordance with Regulation … No 1272/2008’. Lastly, section 3 provides that ‘the objective of the environmental hazard assessment shall be to determine the classification of a substance in accordance with Regulation … No 1272/2008’. As regards section 4, a distinction must be drawn between persistent and bioaccumulative substances, on the one hand, and toxic substances, on the other. Whereas a substance may be regarded as toxic if it meets some of the criteria set out in Regulation No 1272/2008, the assessment of whether a substance is persistent and bioaccumulative is carried out in the light of criteria directly established by Annex XIII to Regulation No 1907/2006, without reference to Regulation No 1272/2008.

145    Similarly, it should be noted that Article 57(a) to (c) of Regulation No 1907/2006 provides for the identification, as substances of very high concern, of substances meeting certain classification criteria for CMR substances laid down by Regulation No 1272/2008.

146    It must be inferred from this that Regulation No 1272/2008 plays an important role in the identification of substances of very high concern under Article 57 of Regulation No 1907/2006.

147    However, it should be noted, first, that Regulation No 1272/2008 does not cover the identification of substances of very high concern with a view to their eventual inclusion in Annex XIV to Regulation No 1907/2006 and, second, that the Court of Justice has stated, in the context of the application of Article 57(f) of Regulation No 1907/2006, that inclusion in a hazard class under Regulation No 1272/2008 was neither a necessary condition, nor a sufficient condition in that regard (see, to that effect, judgment of 15 March 2017, Polynt v ECHA, C‑323/15 P, EU:C:2017:207, paragraph 28).

148    Furthermore, although ECHA may take into account certain properties for which Annex XIII to Regulation No 1907/2006 lays down criteria to which Article 57(d) and (e) of that regulation refers (judgment of 23 February 2022, Chemours Netherlands v ECHA, T‑636/19, not published, EU:T:2022:86, paragraph 163), the Court has already held that the criteria laid down in Annex XIII cannot, as such, guide ECHA or the Commission in the identification of the substances referred to in Article 57(f) of that regulation (see, to that effect, judgment of 10 November 2021, Sasol Germany and Others v Commission, T‑661/19, not published, EU:T:2021:779, paragraph 37).

149    Lastly, it should be noted that it follows from the case-law that Article 57(f) of Regulation No 1907/2006 provides for an independent mechanism that makes it possible to identify, as being of very high concern, substances which have not already been designated as such under that provision (judgment of 15 March 2017, Polynt v ECHA, C‑323/15 P, EU:C:2017:207, paragraph 25).

150    In that regard, the fact that that provision refers, for the purpose of determining the equivalent level of concern, to the substances referred to in Article 57(a) to (e) of Regulation No 1907/2006, does not mean that a substance must meet the identification criteria for those substances in order to be identified as a substance of very high concern under Article 57(f) of Regulation No 1907/2006 (judgment of 23 February 2022, Chemours Netherlands v ECHA, T‑636/19, not published, EU:T:2022:86, paragraph 92).

151    It follows from all of those considerations that, for the purpose of identifying a substance as being of very high concern under Article 57(f) of Regulation No 1907/2006, ECHA is not limited solely to the hazard classes established by Regulation No 1272/2008 or by the criteria specifically laid down in Annex XIII to Regulation No 1907/2006.

152    By contrast, as noted in paragraph 134 above, it is necessary for ECHA to analyse the hazards arising from the intrinsic properties of the substance the identification of which as a substance of very high concern is envisaged. The concept of ‘hazard’ describes any product or procedure ‘capable’ of having an adverse effect on human health (see judgment of 20 September 2019, PlasticsEurope v ECHA, T‑636/17, EU:T:2019:639, paragraph 98 and the case-law cited) or for the environment.

153    In that regard, the Court has already held that Article 57(f) of Regulation No 1907/2006 does not prohibit a combination of several effects in order to establish their seriousness. The use of the plural in the expression ‘serious effects’ clearly indicates that several different effects may be taken into account. The impact on human health or on the environment is not necessarily less serious if it results only from several effects taken together (see, to that effect, judgment of 23 February 2022, Chemours Netherlands v ECHA, T‑636/19, not published, EU:T:2022:86, paragraph 98). It must be inferred from that that Article 57(f) of Regulation No 1907/2006 does not require that, in order to contribute to the identification of a substance as being of very high concern, an intrinsic property must, as such and taken in isolation, be capable of having a serious effect. However, it is necessary that it has an effect which, in combination with other effects linked to other intrinsic properties of that substance, is capable of having a serious effect on human health or the environment.

154    On that point, the applicants submit that the environmental fate properties of melamine, in particular its persistence and mobility, do not, as such, have any effects on human health or the environment, since they entail only the distribution or presence of that substance.

155    However, the very fact that, because of its environmental fate properties, a substance can easily be distributed and present in the environment is indeed an effect, since those are the consequences associated with its intrinsic properties. In any event, the applicants’ argument is contradicted by the wording of Article 57(f) of Regulation No 1907/2006 itself, since it is apparent from that wording that persistent and bioaccumulative substances can be regarded as substances having serious effects on human health or the environment. Persistence and bioaccumulation are indeed properties linked to the environmental fate of a substance.

156    In those circumstances, the effects associated with the environmental fate properties of a substance, such as its persistence, mobility and potential for long-range transport, may be taken into consideration in order to determine whether a substance may have serious effects on human health or the environment which give rise to an equivalent level of concern, in accordance with Article 57(f) of Regulation No 1907/2006.

157    It should also be noted that, in the context of paragraphs 106, 191 and 209 of the judgment of 23 February 2022, Chemours Netherlands v ECHA (T‑636/19, not published, EU:T:2022:86), the Court confirmed the fact that very high persistence, mobility, low adsorption potential and high water solubility making the substance fully bioavailable for uptake via drinking water were intrinsic properties that could be considered in order to verify that the conditions laid down in Article 57(f) of Regulation No 1907/2006 were satisfied.

158    In that context, it is not necessary to examine the definition of the concept of ‘intrinsic properties’ that was adopted in the judgment of 23 November 2022, CWS Powder Coatings and Others v Commission (T‑279/20, T‑283/20 and T‑288/20, under appeal, EU:T:2022:725) and relied on by the applicants. In any event, apart from the fact that that judgment concerns a case in which Regulation No 1272/2008 applies, the definition of the concept of ‘intrinsic properties’ provided in paragraph 138 of that judgment, namely that it must be interpreted in its literal sense as referring to the ‘properties which a substance has in and of itself’, does not exclude the environmental fate properties of a substance. The way in which a substance will interact with its environment does depend on its intrinsic properties.

159    Therefore, the applicants cannot validly claim that ECHA made a manifest error of assessment in finding that the environmental fate properties of melamine had effects that could contribute to a finding that melamine had to be identified as a substance of very high concern under Article 57(f) of Regulation No 1907/2006.

160    The first part of the first plea must therefore be rejected.

3.      The second part of the first plea, alleging a manifest error of assessment in that ECHA wrongly concluded that the STOT RE 2 and Carc 2 properties constituted ‘effects’ within the meaning of Article 57(f) of Regulation No 1907/2006

161    In the context of the second part of the first plea, the applicants, supported by Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Methanol Holdings (Trinidad) and by Fritz Egger and the other legal persons whose names are set out in the annex, raise the following four main complaints:

–        ECHA relied solely on the classification of melamine under Regulation No 1272/2008 in order to draw conclusions on the seriousness of its effects;

–        the urinary tract toxicity and carcinogenicity of melamine are not due to its intrinsic properties;

–        ECHA ignored the fact that health safety standards and tolerable daily intakes had been set to limit the concentration of melamine in drinking water;

–        ECHA failed to establish the seriousness of the reproductive toxicity of melamine.

162    ECHA, supported by the Federal Republic of Germany and the Commission, disputes those arguments.

163    The examination of the second part of the first plea leads the Court to verify the first of the conditions laid down in Article 57(f) of Regulation No 1907/2006, as defined in paragraph 133 above, namely the condition relating to the probable serious effects of melamine on human health. The probable serious effects on the environment will be examined in the context of the third part of the first plea.

(a)    The first complaint, alleging that ECHA relied solely on the classification of melamine under Regulation No 1272/2008 in order to draw conclusions on the seriousness of its effects

164    The applicants, supported by Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Methanol Holdings (Trinidad) and by Fritz Egger and the other legal persons whose names are set out in the annex, submit that ECHA could not validly satisfy the obligation to examine the ‘serious’ nature of the effects of the substance, which is imposed on ECHA by Article 57(f) of Regulation No 1907/2006, by referring only to the STOT RE 2 and Carc 2 properties of melamine.

165    As stated in paragraph 143 above, Article 57(f) of Regulation No 1907/2006 requires that the effects of the substance on human health or the environment are capable of being regarded as ‘serious’, on account of, for example, their significance or their irreversible nature. The examination of that condition is based on an assessment of the hazards to human health or to the environment, on the basis of the information in the relevant parts of sections 1 to 4 of Annex I to Regulation No 1907/2006, as stated in section II of Annex XV to that regulation. It is therefore clear that Article 57(f) of that regulation requires an analysis of the hazards arising from the intrinsic properties of the substance under consideration.

166    In that regard, the classification of a substance under Annex I to Regulation No 1272/2008 constitutes a relevant, but not decisive, element. Where a substance falls within one of the hazard classes in respect of human health or the environment provided for in that regulation, that circumstance may be sufficient to show the probability of ‘serious effects to human health or the environment’. Inclusion in a hazard class is nevertheless neither a necessary condition, nor a sufficient condition in this regard (judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA, C‑324/15 P, EU:C:2017:208, paragraph 28).

167    In the present case, it is common ground between the parties that melamine has been classified as a substance with STOT RE 2 and Carc 2 properties since the adoption of Commission Delegated Regulation (EU) 2022/692 of 16 February 2022 amending, for the purposes of its adaptation to technical and scientific progress, Regulation No 1272/2008 (OJ 2022 L 129, p. 1).

168    It is also common ground that the support document refers to those classifications. However, contrary to what the applicants submit, ECHA did not rely solely on those classifications in order to infer the existence of probable serious effects on human health.

169    On that point, it should be noted that, in section 4 of the support document, ECHA presented the effects that melamine was capable of having on human health by referring to several scientific studies. It is true that, in so doing, ECHA concluded that the effects thus identified had led to the classifications of melamine as a substance with STOT RE 2 and Carc 2 properties. Nevertheless, there is no reason to infer from that that ECHA relied solely on those classifications. On the contrary, it is apparent from section 4 of the support document that ECHA addressed several aspects of the impact of melamine on human health. Thus, it examined whether the effects of melamine had a safety threshold and also considered the reproductive toxicity of melamine. In addition, as is apparent from the summary of the support document (page 7 of that document) and from the conclusions (page 72 of that document), ECHA considered that the urinary tract toxicity and carcinogenicity of melamine were serious because, first, they were significant in themselves, second, they were irreversible and, third, they were significant in combination with the environmental fate properties of melamine that were capable of causing irreversible contamination of the environment.

170    In those circumstances, the applicants have not demonstrated that ECHA relied solely on the classifications of melamine as a substance with STOT RE 2 and Carc 2 properties in order to conclude that there were probable serious effects on human health, with the result that the first complaint must be rejected.

171    In any event, contrary to what the applicants suggest, the case-law cited in paragraph 166 above does not require ECHA to carry out an analysis, in terms of the effects of a substance, which disregards the conclusions reached on such effects in the context of the application of Regulation No 1272/2008. Such an approach would, moreover, be contrary to the principles of good administration and legal certainty, since it would require ECHA artificially to disregard the analysis already carried out in respect of the effects of a substance.

(b)    The second complaint, alleging that the urinary tract toxicity and carcinogenicity of melamine are not due to its intrinsic properties

172    According to the applicants, the classifications as a substance with STOT RE 2 and Carc 2 properties are not based, in the present case, on the intrinsic properties of melamine. Melamine was classified as toxic and carcinogenic under Regulation No 1272/2008 on the basis of effects attributed to its precipitation and to the formation of stones in the urinary tract, taken as the first key event of that substance’s mode of action. Thus, the potential toxic effects on the urinary tract are the sequelae of stone formation. In other words, they are secondary effects which could occur only after the formation of uroliths in the urinary tract and because of melamine’s reaction with uric acid in urine.

173    When questioned, at the hearing, on the scope of their line of argument, the applicants stated, in essence, that the judgment of 23 November 2022, CWS Powder Coatings and Others v Commission (T‑279/20, T‑283/20 and T‑288/20, under appeal, EU:T:2022:725), had been delivered after the adoption of Delegated Regulation 2022/692, but before the adoption of the contested decision in the present case. In those circumstances, they submit that ECHA was required to take into consideration the findings in that judgment when determining whether melamine could be considered to have intrinsic properties capable of having serious effects on human health. In that regard, they consider that, if the Court were to confirm that the concept of ‘intrinsic properties’, as adopted in that judgment, had to be applied in the present case, ECHA should have concluded that melamine did not have intrinsic properties that were capable of having serious effects on human health.

174    First, it should be noted that, ultimately, the applicants’ line of argument amounts to challenging the classifications of melamine as a substance with STOT RE 2 and Carc 2 properties, as set out in Delegated Regulation 2022/692. They submit, in essence, that, if, in the procedure leading to the adoption of the contested decision, ECHA had examined the intrinsic properties of melamine in the light of the findings in the judgment of 23 November 2022, CWS Powder Coatings and Others v Commission (T‑279/20, T‑283/20 and T‑288/20, under appeal, EU:T:2022:725), it would have come to the conclusion that melamine did not have intrinsic properties that were toxic to the urinary tract and carcinogenic.

175    Nevertheless, in the context of a procedure for the identification of a substance as a substance of very high concern as provided for in Regulation No 1907/2006, ECHA is not empowered to review the classifications made on the basis of Regulation No 1272/2008.

176    Thus, ECHA cannot be expected to verify whether the harmonised classification and labelling of the substance in question that were decided in accordance with the provisions of Regulation No 1272/2008 are still relevant. Moreover, that would amount to circumventing the review procedure expressly provided for in Article 37(6) of Regulation No 1272/2008.

177    In that regard, if the applicants consider that the principles identified in the judgment of 23 November 2022, CWS Powder Coatings and Others v Commission (T‑279/20, T‑283/20 and T‑288/20, under appeal, EU:T:2022:725), constitute new information capable of leading to a change in the elements of harmonised classification and labelling of melamine, it is for them, in accordance with Article 37(6) of Regulation No 1272/2008, to submit a proposal for harmonised classification and labelling of melamine to the competent authority in one of the Member States in which the substance is placed on the market.

178    Second, it must be noted that the subject matter of the present action relates to ECHA’s decision by which melamine was identified as a substance of very high concern, but does not relate to Delegated Regulation 2022/692 in so far as it introduces harmonised classification and labelling of melamine in accordance with Regulation No 1272/2008.

179    In addition, measures of the EU institutions are, in principle, presumed to be lawful and accordingly produce legal effects until such time as they are withdrawn, annulled in an action for annulment or declared invalid following a reference for a preliminary ruling or a plea of illegality (see judgment of 5 October 2004, Commission v Greece, C‑475/01, EU:C:2004:585, paragraph 18 and the case-law cited).

180    In the present case, Delegated Regulation 2022/692 was not withdrawn by the Commission and was neither annulled nor declared invalid by the Court of Justice in so far as it introduced a harmonised classification and labelling of melamine in accordance with Regulation No 1272/2008.

181    In those circumstances, Delegated Regulation 2022/692 produces legal effects which enjoy a presumption of legality.

182    Thus, by asking the Court to analyse the intrinsic properties of melamine in the light of the findings in the judgment of 23 November 2022, CWS Powder Coatings and Others v Commission (T‑279/20, T‑283/20 and T‑288/20, under appeal, EU:T:2022:725), in order to establish that those properties are neither toxic to the urinary tract nor carcinogenic, the applicants ask the Court to assess the findings made by ECHA in the context of the procedure that led to the adoption of Delegated Regulation 2022/692.

183    However, it cannot be accepted that, in the present action, the applicants raise arguments capable of having legal consequences for an act which benefits from a presumption of legality, especially since they had the possibility of bringing an action for annulment of Delegated Regulation 2022/692 in so far as the latter had introduced harmonised classification and labelling of melamine in accordance with Regulation No 1272/2008.

184    The applicants’ arguments must therefore be rejected and it must be held that it is established that the intrinsic properties of melamine indicate that it is capable of being toxic to the urinary tract and carcinogenic.

185    Furthermore, the applicants’ argument that the formation of kidney stones is a common medical problem which is not specific to exposure to melamine must be rejected as ineffective. Even if other factors may explain the formation of kidney stones, that has no impact on the fact that melamine may also cause them.

186    Consequently, ECHA did not make a manifest error of assessment in finding that melamine was capable of being toxic to the urinary tract and carcinogenic on account of its intrinsic properties.

187    In those circumstances, the second complaint is rejected.

(c)    The third complaint, alleging that ECHA ignored the fact that health safety standards and tolerable daily intakes had been set in order to limit the concentration of melamine in drinking water

188    The applicants state that health safety standards for melamine in drinking water were proposed in Germany and the Netherlands. According to the applicants, the data provided during the public consultation confirmed that those standards were not exceeded in the water samples taken in the context of European monitoring studies, which, they state, was acknowledged in the dossier drawn up in accordance with Annex XV, but removed from the support document.

189    Furthermore, in their view, ECHA should have taken account of the existence of health safety standards and tolerable daily intakes established by the World Health Organization (WHO) and the European Food Safety Authority (EFSA) to assess the existence of probable serious effects of melamine on human health.

190    The applicants add that the establishment of safety thresholds is an essential element of the hazard assessment of substances and therefore constitutes scientific evidence and a relevant factor that must be taken into consideration under Article 57(f) of Regulation No 1907/2006. They argue that ECHA did not challenge the validity or derivation methods of the tolerable daily intakes or drinking water standards and therefore made a manifest error of assessment by not taking them into consideration as relevant factors.

191    In that regard, it must be noted that, given that the identification of substances of very high concern is carried out on the basis of the hazards linked to the intrinsic properties of the substance, Article 57 of Regulation No 1907/2006 does not require, in respect of the substances concerned, a risk assessment to be carried out analogous to that required, in the context of the evaluation procedure, under section 6 of Annex I to that regulation, or, in the context of the authorisation procedure, under Article 64(4) of that regulation, or, in the context of the restriction procedure, under Article 70 of that regulation (see judgment of 10 November 2021, Sasol Germany and Others v Commission, T‑661/19, not published, EU:T:2021:779, paragraph 61 and the case-law cited).

192    It is true that that Annex XV to Regulation No 1907/2006, which lays down the general principles for preparing dossiers to propose and justify the identification of a substance of very high concern, contains section II, entitled ‘Content of dossiers’, point 2 of which states that ‘the available use and exposure information … shall be provided’ in the document proposing the identification of a substance of very high concern. Nevertheless, it is apparent from that point that that information is not part of the justification for the identification proposal. According to the information under the heading ‘Justification’, in point 2 of section II of Annex XV to that regulation, such a justification must relate to an assessment of the hazards of a substance and not to the risks linked with its use. In those circumstances, taking exposure data into consideration does make it possible to refine the material on the basis of which recourse to the authorisation procedure appears to be the most appropriate course (see, to that effect, judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA, C‑324/15 P, EU:C:2017:208, paragraph 41). Nevertheless, those data cannot be regarded as relevant for the purpose of identifying a substance under Article 57(f) of that regulation, with the result that they must compulsorily and necessarily be taken into consideration in that regard (see, to that effect, judgment of 10 November 2021, Sasol Germany and Others v Commission, T‑661/19, not published, EU:T:2021:779, paragraph 58).

193    In any event, it follows from Article 60(2) of Regulation No 1907/2006 that the fact that the negative effects associated with the use of a substance can be controlled adequately does not preclude its identification as a substance of very high concern. That is also confirmed by Article 58(2) of Regulation No 1907/2006, under which uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific EU legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance concerned, the risk is properly controlled (see judgment of 23 February 2022, Chemours Netherlands v ECHA, T‑636/19, not published, EU:T:2022:86, paragraph 263 and the case-law cited).

194    Therefore, the existence of health safety standards established in Germany and in the Netherlands aimed at controlling the concentration of melamine in drinking water is irrelevant at the stage of verifying whether melamine has intrinsic properties capable of having serious effects on human health. Similarly, the tolerable daily intakes established by the WHO and EFSA are irrelevant at that stage.

195    The third complaint must therefore be rejected.

(d)    The fourth complaint, alleging that ECHA failed to establish the seriousness in respect of reproductive toxicity

196    The applicants submit that the MSC agreement refers to additional probable effects of melamine on testicles and sperm, as observed in an extended one-generation reproductive toxicity study conducted on rats (‘the reproductive toxicity study conducted on rats’), but not to probable serious effects, as required by Article 57(f) of Regulation No 1907/2006.

197    The applicants further note that the support document purports to ‘falsely amplify’ the significance of the reproductive toxicity effects of melamine, without any justification or evidence as to why those effects would suddenly be relevant. In the applicants’ view, melamine has no effect on the fertility of rats and there is no evidence of heritable genetic damage.

198    In the first place, the applicants refer to the risk management options analysis of the competent French authority (‘the RMOA’) of 16 May 2023, in order to demonstrate that ECHA was wrong to conclude that melamine could have effects on the population even though there were no effects on the fertility of rats.

199    First, contrary to what ECHA contends, the RMOA can be taken into consideration.

200    It is indeed true that that study post-dates the contested decision. However, it follows from the case-law that the legality of an EU measure must be assessed on the basis of the facts and the law as they stood at the time when the measure was adopted. In particular, the complex assessments made by the author of that measure must be examined solely on the basis of the information available to it at the time when those assessments were made (judgment of 31 January 2024, Symphony Environmental Technologies and Symphony Environmental v Parliament and Others, T‑745/20, EU:T:2024:45, paragraph 154).

201    However, in so far as the production of an annex is not an attempt to alter the legal and factual framework previously submitted to ECHA for the purposes of the adoption of the contested decision, but contributes to a line of argument in the simple exercise of the rights of the defence, such an annex may be taken into consideration (see, by analogy, judgment of 7 May 2009, NVV and Others v Commission, T‑151/05, EU:T:2009:144, paragraph 63).

202    In the present case, it should be noted that the assessments contained in the RMOA, disputed between the parties, relate to the reproductive toxicity study conducted on rats, which was referred to in the support document. Thus, those assessments do not alter the legal and factual framework previously submitted to ECHA and account must be taken of the RMOA.

203    Second, it should be noted that the RMOA considers, in essence, that although the harmful effects of melamine on reproduction that were observed in rodents do not affect their fertility, that is not, however, the case as regards reproduction in humans, on account of various spermatic parameters.

204    Consequently, contrary to what the applicants claim, the RMOA cannot be relied on in order to demonstrate that melamine has no effects in humans.

205    In the second place, it should be noted that, in the dossier drawn up in accordance with Annex XV, it was stated, in sections 4 and 6.3.2.3, that the reproductive toxicity study conducted on rats had made it possible to observe adverse histopathological changes in animal testicles and abnormal sperm cell morphology (detached head). It was established that the effects of melamine that were observed in the testicles and sperm of experimental animals were of concern and warranted classification, but that the severity of those findings on testicles was generally low and that no adverse effects on fertility parameters were observed. It was concluded that self-classification in the category ‘Repr 2’, namely in the category of substances with category 2 reproductive toxicity properties, was considered the most appropriate.

206    In the support document, the same assessments were repeated in section 4. However, unlike the dossier drawn up in accordance with Annex XV, section 6.3.2.3 of the support document mentions only the comments made in the reproductive toxicity study conducted on rats, thus excluding the conclusions on the seriousness of those findings and on self-classification. In addition, the support document identified that a probable serious effect on human health was that of reproductive toxicity.

207    In that regard, it must be noted that the applicants do not dispute the findings made in the light of the reproductive toxicity study conducted on rats. However, they do dispute the conclusion in the support document, to the effect that there is evidence of probable serious effects on human health due to the reproductive toxicity of melamine.

208    ECHA, for its part, submits that the applicants have taken out of context the statement that the severity of the findings on testicles was generally low and that no adverse effects on fertility parameters had been observed. According to ECHA, that statement was made solely in response to the applicants’ comments on the self-classification of melamine under Regulation No 1272/2008.

209    When questioned at the hearing as to whether there was any contradiction for ECHA to insist on the independence of the procedures laid down in Regulations No 1907/2006 and No 1272/2008 and on the fact that it would not take into consideration the comments made with regard to the harmonised classification and labelling of a substance (see paragraph 86 above), to then assert that the statement referred to in paragraph 208 above had been made solely in connection with the self-classification of melamine under Regulation No 1272/2008, ECHA argued that there was no contradiction since the classification of melamine in category ‘Repr 2’ was not the subject of harmonised classification, with the result that that point was still open to discussion.

210    Nevertheless, if the statement that the severity of the findings on testicles was generally low and no adverse effect on fertility parameters had been observed was made solely in response to the applicants’ comments, then it should be noted that, as the applicants submit, the support document does not contain any explanation as to how the comments made in respect of rats supported the conclusion that there were probable serious effects on human health, in accordance with Article 57(f) of Regulation No 1907/2006.

211    In that regard, although adverse effects were found in animal testicles, which has not been disputed by the applicants, that statement alone is not sufficient to infer the existence of probable serious effects on human health. In particular, it was necessary for ECHA to explain the expected effects on sexual functions and fertility in humans, in the same way as it had explained the expected effects of melamine on the urinary tract. Those explanations were made all the more necessary since, first, ECHA nevertheless concluded that there were no serious effects on testicles or adverse effects on fertility parameters, without distinguishing between rats and humans, and, second, the dossier drawn up in accordance with Annex XV had not used reproductive toxicity as a probable serious effect on human health, unlike the support document.

212    Furthermore, it should be noted that, although ECHA claims that reproductive toxicity was serious for the same reasons as for the urinary tract toxicity and carcinogenicity of melamine, namely because it was significant in itself, irreversible and significant also in combination with the environmental fate properties of the substance at issue, that is not sufficiently clear from the support document. Although that is briefly mentioned in the summary of the support document (page 7), no evidence in that regard is developed in section 4 of that document, the content of which, as regards reproductive toxicity, has been reproduced almost in full in paragraph 205 above. By comparison, in the same section, the significant and irreversible effects of melamine on the urinary tract were set out. Thus, in that section, reference is made, inter alia, to the persistence of certain stones in the urinary tract, despite the administration of conventional treatments, the persistence of certain abnormalities in the kidneys of children after exposure to melamine and concerns about the long-term effects, in humans, of kidney lesions due to melamine, such effects being observed at a young age.

213    Lastly, the fact, even if established, that melamine was classified by the applicants as a reproductive toxicity category 2 substance, as alleged by ECHA, is not sufficient to establish the probable serious effects of melamine on human health on account of reproductive toxicity, since, first, ECHA stated, at the hearing, that that classification had not yet been harmonised (see paragraph 209 above), and, second, and in any event, as noted in paragraph 166 above, the classification of a substance in Annex I to Regulation No 1272/2008 is a relevant but not decisive factor.

214    In those circumstances, the fourth complaint raised by the applicants must be upheld and it must be concluded that ECHA did not sufficiently substantiate its findings on the seriousness of the reproductive toxicity of melamine.

(e)    Conclusion on the second part of the first plea

215    In the light of all of the foregoing, it must be held that ECHA did not make a manifest error of assessment in finding that there were probable serious effects on human health on account of the urinary tract toxicity and carcinogenicity of melamine. However, it has not established to the requisite legal standard the existence of probable serious effects on human health on account of the reproductive toxicity of melamine.

216    The second part of the first plea must therefore be upheld in part.

4.      The third part of the first plea, alleging a manifest error of assessment in that ECHA wrongly concluded that the substance produced ‘serious’ effects on the environment

217    In the context of the third part of the first plea, the applicants, supported by Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Methanol Holdings (Trinidad) and by Fritz Egger and the other legal persons whose names are set out in the annex, raise three main complaints. The first relates to the reproductive toxicity of melamine, the second to the effects of melamine on fish and aquatic invertebrates and the third to the endocrine disrupting properties of melamine.

218    ECHA, supported by the Federal Republic of Germany and the Commission, disputes those arguments.

(a)    The first complaint, relating to reproductive toxicity

219    The applicants, supported by Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Methanol Holdings (Trinidad) and by Fritz Egger and the other legal persons whose names are set out in the annex, submit that ECHA was not entitled to identify the effects observed on the testicles and sperm of experimental animals as relevant for the purpose of identifying the probable serious effects on the environment. They argue that the effects of reproductive toxicity, as with the effects of urinary tract toxicity and carcinogenicity, were not assessed. Likewise, their seriousness and probability were not established. The applicants submit that ECHA wrongly considered, and without justification, that the effects on testicles observed in a key study on rats affected the reproductive function of mammals, whereas it was acknowledged, in the dossier drawn up in accordance with Annex XV, that the severity of the findings on testicles was generally low and that adverse effects on fertility parameters were not observed.

220    For reasons similar to those put forward in connection with the fourth complaint of the second part of the present plea (see paragraphs 205 to 214 above), it must be held that ECHA has not sufficiently substantiated its conclusions on the seriousness of the effects of the reproductive toxicity of melamine on the environment.

221    It should be noted that, in section 5 of the support document, which deals with the environmental hazard assessment, the effects of melamine on fish, aquatic invertebrates, algae, aquatic plants and birds are examined. No part of section 5 therefore deals with rats or, more generally, rodents and other mammals.

222    Accordingly, it was only in section 6.3.2.5 of the support document, which, because of its function as a conclusive section, should have presented only a brief summary of the analysis carried out in the preceding sections, that ECHA put forward evidence to demonstrate how the reproductive toxicity of melamine represented a probable serious effect on the environment.

223    In that regard, the support document states that the observed testicular and sperm effects in experimental animals, namely rats, are considered relevant for the purpose of identifying probable serious effects on the environment. They can affect reproduction and can affect the population level. In that regard, the support document adds that rats are rodents and that rodents represent approximately 42% of mammalian species. It is stated that rodents play an important role in the environment, for example in the dispersal of seeds and spores, pollination, energy and nutrient cycling and in modifying plant succession and species composition. Lastly, rodents are a source of food for many predators.

224    It must be noted that, although adverse histopathological changes in animal testicles and abnormal sperm cell morphology (detached head) were indeed observed, which is not disputed, moreover, by the applicants, and that those effects were classified by ECHA as being of concern, ECHA nevertheless stated, in section 4 of the support document, that the severity of those findings on testicles was generally low and that no adverse effects on fertility parameters had been observed.

225    In addition, in the rejoinder, ECHA stated that the link between sperm abnormalities and fertility is not established for all rodents and even less for other species considered relevant on page 7 of the support document, in particular predators. It added, however, that species present in the environment could have lower fertility and reproduction strategies differing from those of rats, so that the effects on sperm could have an impact on the size of their population.

226    When questioned on that point at the hearing, ECHA stated that, first, the effects on reproduction included both effects on sexual functions and effects on fertility. That was, it stated, the reason why, despite the absence of observed effects on the fertility of experimental rats, melamine was considered to be toxic for reproduction, in so far as it could affect the sexual functions of rats. Second, in ECHA’s view, account should be taken of the fact that the fertility parameters of experimental rats are not the same as those of other rodents, which prevented any impact on the fertility of other species from being ruled out.

227    Nevertheless, it must be stated that such explanations do not appear in the support document. In particular, the support document does not distinguish between experimental rats and other rodents. On the contrary, it seems rather to equate them when it states that rats are rodents and that rodents represent approximately 42% of mammalian species. Nor is it stated that, although effects on the fertility of experimental rats have not been observed, that does not however rule out the possibility that such effects may be observed in other species of rodents.

228    In any event, a mere reading of the stated passages of the support document does not make it possible to understand how the finding that the degree of severity of the effects of melamine on rat testicles was low and that there was no adverse effect on fertility parameters nevertheless led ECHA to conclude that there could be effects on rodent reproduction and that those effects had to be classified as serious for the environment.

229    In addition, ECHA’s explanations set out in paragraphs 128 and 129 of the rejoinder add to the confusion. ECHA refers to the effects that melamine may have on the reproduction of predators. However, when questioned on that point at the hearing, ECHA explained that predators are impacted in that they feed on rodents that have absorbed melamine, which, in ECHA’s view, is likely to increase the rate of melamine ingested by predators. However, the link between such absorption and the actual impact on predators, in particular on their reproduction, is neither explicitly mentioned in the support document nor supported by studies.

230    It must therefore be held that ECHA has not sufficiently substantiated its conclusions on the seriousness of the reproductive toxicity of melamine. The first complaint must therefore be upheld.

(b)    The second complaint, relating to the effects of melamine on fish and aquatic invertebrates

231    In the first place, as regards the effects of melamine on fish, first, for the same reasons as those put forward in the third complaint in the second part of the present plea (see paragraphs 188 to 194 above), the applicants’ argument that ECHA was wrong not to take into account the existence of health safety standards and tolerable daily intakes must be rejected at the present stage.

232    Second, as regards the absence of bioaccumulation in fish and, more generally, in aquatic organisms, alleged by the applicants, it should be noted that the support document does indeed conclude, in section 3.4, that there is no such bioaccumulation. Thus, the bioaccumulation of melamine is not among the intrinsic properties on the basis of which that substance was identified as a substance of very high concern in the support document, in the contested decision and in the disputed entry in the candidate list.

233    In addition, apart from the fact that they assert that melamine is not bioaccumulative, the applicants do not develop their comments in order to explain how that is capable of rendering implausible ECHA’s conclusion as to the existence of probable serious effects on the environment linked to the effects found in fish. They merely state that that absence of bioaccumulation renders ECHA’s arguments on the probable serious effects implausible.

234    Article 57(f) of Regulation No 1907/2006 does not require a substance to be bioaccumulative in order to be identified as a substance of very high concern (judgment of 23 February 2022, Chemours Netherlands v ECHA, T‑636/19, not published, EU:T:2022:86, paragraph 63).

235    Therefore, the applicants are not justified in relying on the mere absence of bioaccumulation as a factor to call into question ECHA’s conclusions on the existence of probable serious effects on the environment.

236    In so far as it must be understood that, by their argument, the applicants seek to claim that, in the absence of bioaccumulation, aquatic organisms are not sufficiently exposed for adverse effects to appear, it must be rejected on the basis of the case-law referred to in paragraphs 191 and 192 above.

237    Third, it should be noted that section 5.1.1.1 of the support document, which relates to the short-term toxicity of melamine in fish, refers to feeding studies which identified several adverse effects of melamine on fish, such as skin darkening, tubular degeneration in the kidneys or single cell necrosis in the liver. It is concluded that melamine has a low degree of toxicity to fish and that, when concentrations of melamine are higher, sub-lethal effects appear. Section 5.1.1.2 of the support document, which, for its part, relates to the long-term toxicity of melamine to fish, refers to studies on exposure over water and to feeding studies which show that melamine affects fish survival and growth. It also has effects on the colour of their skin and on their level of erythrocytes, leukocytes and haemoglobin. It is concluded that melamine has a moderate degree of toxicity to fish.

238    First of all, the applicants argue that the effects thus found in fish were not classified as serious in the support document.

239    It is true that the support document does not expressly describe the effects thus found as being serious. However, it is apparent from the conclusions set out in section 6.3.2.5 of that document that ECHA considered those effects to be serious. Thus, ECHA states that, although the studies do not reveal any effects on fish mortality, sub-lethal effects were observed. Similarly, in long-term studies, sub-lethal effects were observed in the kidneys, liver and gills. ECHA concluded generally, taking into account all the identified effects on the environment, that such effects, as well as yet unknown effects, could occur in the environment and lead to irreversible effects on the population, due to long-term exposure, taking into account continuous exposure via water and potentially increasing concentrations.

240    It cannot be disputed that effects classified as sub-lethal or irreversible are serious effects, and therefore the applicants’ argument cannot succeed.

241    Next, the applicants call into question the relevance of the study by Pirarat, N., Katagiri, T., Chansue, N., Ponpornpisit, A., Endo, M. and Maita, M., ‘The Pathological Effects of Melamine and Cyanuric Acid in the Diet of Walking Catfish (Clarius batrachus)’, Journal of Comparative Pathology, 2012 (‘the first study on fish’), and the study by Reimschuessel, R., Gieseker, C.M., Miller, R.A., Ward, J., Boehmer, J., Rummel, N., Heller, D.N., Nochetto, C., de Alwis, G.K., Bataller, N., Andersen, W.C., Turnipseed, S.B., Karbiwnyk, C.M., Satzger, R.D., Crowe, J.B., Wilber, N.R., Reinhard, M.K., Roberts, J.F. and Witkowski, M.R., ‘Evaluation of the renal effects of experimental feeding of melamine and cyanuric acid to fish and pigs’, American Journal of Veterinary Research, 2008 (‘the second study on fish’); ECHA relied on both of those studies to establish the effects of melamine on fish due to short-term exposure.

242    Nevertheless, as ECHA observes, the applicants do not dispute the reliability score of 2, according to the Klimisch scoring system (as described in an article by Klimisch, H.-J., Andreae, M. and Tillmann, U., ‘A Systematic Approach for Evaluating the Quality of Experimental Toxicological and Ecotoxicological Data’, Regulatory Toxicology and Pharmacology, Elsevier, 1997, Vol. 25, pp. 1 to 5), attributed to the first study on fish.

243    The first study on fish is therefore considered by ECHA to be reliable with restrictions, in so far as it is a study ‘(mostly not performed according to [good laboratory practices] (GLP), in which the test parameters documented do not totally comply with the specific testing guideline, but are sufficient to accept the data or in which investigations are described which cannot be subsumed under a testing guideline, but which are nevertheless well documented and scientifically acceptable’, according to the definition in Chapter R.4, entitled ‘Evaluation of available information’, of ECHA’s Guidance on Information Requirements and Chemical Safety Assessment of December 2011.

244    As regards the second study on fish, it should be noted that ECHA attributed to it the reliability score of 3 according to the Klimisch scoring system, which is not disputed by the applicants. That means that the study is not considered reliable in so far it is a study ‘in which there were interferences between the measuring system and the test substance or in which organisms/test systems were used which are not relevant in relation to the exposure ([for example,] unphysiological pathways of application) or which were carried out or generated according to a method which is not acceptable, the documentation of which is not sufficient for assessment and which is not convincing for an expert judgment’.

245    The applicants do not claim that the conclusions reached by ECHA in the light of those two studies were reached without taking into account the reliability scores awarded to those studies. The applicants’ argument cannot therefore succeed.

246    Furthermore, the applicants submit that the objective of the first and second studies on fish was to replicate criminal adulteration of fish feed by using extremely high doses of melamine that were not environmentally relevant. Therefore, the probability of those effects occurring under normal environmental conditions was, in their view, virtually nil.

247    In that regard, it should be noted that it is not apparent from section 5.1.1.1 of the support document that the first and second studies on fish, which are indeed food studies, sought to replicate criminal adulteration of fish feed. Such a situation cannot, however, be ruled out since, by contrast, that is the case with the feeding studies referred to in section 5.1.1.2 of that document. That is also the case, moreover, with regard to the feeding studies referred to in section 5.1.2.2 of that document as regards aquatic invertebrates.

248    Such a situation is all the more plausible since melamine does not normally form part of the diet of fish. In that regard, it should be noted that, in section 5.1.1.2 of the support document, ECHA stated that no information on the use of melamine in food used in aquaculture was available and that, if melamine was actually used in that context, that was probably outside the European Union, which could therefore have been relevant as regards imported fish.

249    Nevertheless, it must be pointed out that, in order to satisfy the first condition laid down in Article 57(f) of Regulation No 1907/2006, ECHA is not required to demonstrate the probability that the effects of the substance will actually occur under normal environmental conditions, but rather to demonstrate that serious effects on the environment may occur. In the present case, ECHA has adduced sufficient scientific evidence demonstrating that, when melamine enters into the composition of the diet of fish, adverse effects are observed.

250    The applicants’ argument must therefore be rejected.

251    Lastly, the applicants submit, in essence, that there is a contradiction between classifying the effects observed in fish as serious, on the one hand, and the overall conclusion of low acute toxicity and moderate chronic toxicity to fish, and the finding that the ecotoxicity data do not establish consistency with the toxicity criterion as specified in section 1.1.3.a of Annex XIII to Regulation No 1907/2006, on the other.

252    In that regard, first, it should be noted that the support document does conclude that the toxicity criterion as specified in section 1.1.3.a of Annex XIII to Regulation No 1907/2006 is not fulfilled. A substance fulfils such a criterion when the long-term no observed effect concentration (NOEC) or EC10 for marine or freshwater organisms is less than 0.01 mg/l.

253    Nevertheless, that criterion is relevant in order to identify PBT and vPvB substances. It must be noted that it follows from Article 57(f) of Regulation No 1907/2006 that substances with characteristic properties of PBT or vPvB substances which do not fulfil the criteria set out in Annex XIII to that regulation may be identified as substances of very high concern under certain conditions (see paragraph 132 above).

254    Therefore, it is not contradictory to find that the toxicity criterion laid down in Section 1.1.3.a of Annex XIII to Regulation No 1907/2006 is not fulfilled, but that melamine has probable serious effects on the environment.

255    Nor is it contradictory to state, on the one hand, that the effects of melamine on fish may be serious, while concluding, on the other hand, that there is a low acute toxicity and moderate chronic toxicity to fish. As ECHA submits, without being properly contradicted by the applicants, several scientific studies have observed toxicity of melamine to fish and that toxicity may be serious at population level or in combination with the environmental fate properties of melamine. In that regard, the applicants have not denied that melamine has effects on the skin colouring of fish and on their growth and may have sub-lethal effects on some of their organs.

256    The applicants’ argument must therefore be rejected.

257    Fourth, the applicants claim that the effects observed in fish were observed only because of extremely high concentrations of melamine.

258    That argument, which relates to the conditions of use and exposure to melamine, must be rejected on the basis of the case-law cited in paragraph 192 above.

259    For the sake of completeness, it should be noted that, in the reply, the applicants have not disputed ECHA’s assertion, made in the defence, that toxicity to fish was observed at concentrations commonly used in standard tests. In addition, it should be noted that ECHA provided detailed explanations in response to the argument formulated in general terms by the applicants. Lastly, the applicants clarify their argument in the reply by stating that the problem lies in the fact that the effects occurred at concentrations which are insufficient for harmonised classification and labelling under Regulation No 1272/2008 and for the classification of the substance as toxic within the meaning of Chapter R.11 of ECHA’s Guidance on Information Requirements and Chemical Safety Assessment.

260    In so doing, first, the applicants have not sufficiently demonstrated that ECHA made a manifest error of assessment as regards the concentrations of melamine used for the purpose of assessing its effects on fish. Second, for reasons similar to those set out in paragraph 253 above, it is irrelevant that the concentrations were insufficient for the harmonised classification and labelling under Regulation No 1272/2008, or for the classification of the substance as toxic under Chapter R.11 of ECHA’s Guidance on Information Requirements and Chemical Safety Assessment.

261    The applicants’ argument must therefore be rejected.

262    In the second place, as regards the effects of melamine on aquatic invertebrates, the applicants put forward arguments similar to those put forward on the effects of melamine on fish.

263    First, for the same reasons as those set out in paragraphs 252 to 255 above, it is necessary to reject the applicants’ argument that the relevance of the alleged effects on aquatic invertebrates is contradicted by the overall conclusion of low acute toxicity to aquatic invertebrates and by the finding that the ecotoxicity data do not establish consistency with the toxicity criterion as specified in section 1.1.3.a of Annex XIII to Regulation No 1907/2006.

264    Second, the applicants claim that the effects found in aquatic invertebrates were not classified as serious.

265    In that regard, it should be noted that section 5.1.2.1 of the support document, which relates to the short-term toxicity of melamine to aquatic invertebrates, refers to effects on mobility and behaviour and concludes that there is a low degree of toxicity to aquatic invertebrates. As regards section 5.1.2.2 of the support document, which concerns the long-term toxicity of melamine to aquatic invertebrates, it refers to studies on exposure via water and to feeding studies which reveal the effects of melamine on survival and growth when invertebrates are fed with food containing high doses of melamine. It is concluded that there is a low degree of toxicity to aquatic invertebrates, with effects appearing at high concentrations. Section 6.3.2.5 of that document reproduces, in essence, the findings made in the context of the examination of the long-term toxicity of melamine to aquatic invertebrates. In addition, account must be taken of the overall conclusion set out and recalled in paragraph 239 above.

266    It must be inferred from that that the impact of melamine on the mobility and behaviour of aquatic invertebrates was not considered to be a serious effect. By contrast, the effects of melamine on the survival and growth of those invertebrates must, for the same reasons as those set out in paragraph 240 above, be regarded as serious.

267    The applicants’ argument must therefore be rejected.

268    Having regard to all of the foregoing, the second complaint must be rejected.

(c)    The third complaint, relating to the endocrine disrupting properties of melamine

269    The applicants submit that the considerations relating to the assessment of the endocrine disrupting properties of melamine are not capable of supporting a conclusion based on the legal criteria established by Article 57(f) of Regulation No 1907/2006.

270    In that regard, it is sufficient to note that, as has been acknowledged by ECHA, such properties were not considered to be probable serious effects on the environment. The main purpose of the statement in the support document is to provide information as to the fact that an analysis is ongoing.

271    The third complaint is, therefore, ineffective and must, consequently, be rejected.

(d)    Conclusion on third part of the first plea

272    In the light of all of the foregoing, it must be held that ECHA did not make a manifest error of assessment in finding that there were probable serious effects as regards fish and aquatic invertebrates. However, it did not sufficiently substantiate its conclusions on the seriousness of the reproductive toxicity of melamine.

273    The third part of the first plea must therefore be upheld in part.

5.      The fourth part of the first plea, alleging a manifest error of assessment in that ECHA did not rely on certain information and considered that the available evidence validly supported the conclusions reached on the environmental fate properties of the substance at issue

274    In the fourth part of the first plea, the applicants, supported by Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Methanol Holdings (Trinidad) and by Fritz Egger and the other legal persons whose names are set out in the annex, raise six main complaints, alleging, respectively:

–        a manifest error of assessment as regards the adsorption and desorption properties of melamine;

–        a failure to take into account the results of the study by Pote, D.H. et al., ‘Effect of Drying and Rainfall Intensity on Cyromazine Loss from Surface-Applied Caged-Layer Manure’, Journal of Environmental Quality 23, 1994 (‘the Pote et al. study’);

–        a failure to take into account the impact of the ionizing properties of melamine on the derived ‘log Koc’ values;

–        a failure to take into account the distribution of melamine from water to soil and failure to take into account data related to that substance, and a manifest error of assessment in relying on generic considerations instead of data relating to the substance at issue;

–        a manifest error of assessment vitiating the conclusion that melamine is ‘widespread’ or ubiquitous in water or that there is ‘continuous exposure via water and potentially increasing concentrations’.

275    Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Methanol Holdings (Trinidad) also raise an additional argument which will be dealt with separately and which is linked to the publication of Collard, M., Camenzuli, L., Lyon, D., Saunders, D., Vallotton, N. and Curtis-Jackson, P., ‘Persistence and Mobility (defined as organic-carbon partitioning) do not correlate to the detection of substances found in surface and groundwater: Criticism of the regulatory concept of persistent and mobile substances’, Science of the Total Environment, 2023.

276    ECHA, supported by the Federal Republic of Germany and the Commission, disputes those arguments.

277    As a preliminary point, it must be noted that, in the context of the application of Regulation No 1907/2006, mobility is not a criterion for identifying substances of very high concern in the same way as the characteristic properties of CMR, PBT or vPvB substances referred to in Article 57(a) to (e) of that regulation. Similarly, in the version in force at the time when the contested decision was adopted, Regulation No 1272/2008 did not cover ‘mobile’ substances. By contrast, as noted in paragraph 156 above, the mobility of a substance may constitute an intrinsic property of that substance which may be taken into consideration in order to determine whether it is capable of having serious effects on human health or the environment.

(a)    The first complaint, alleging a manifest error of assessment as regards the adsorption and desorption properties of melamine

278    In the first place, the applicants complain, in essence, that ECHA assessed the mobility of melamine solely on the basis of the ‘log Koc’ model.

279    As a preliminary point, it should be noted that the ‘log Koc’ model makes it possible to measure the adsorption potential of a substance on solid surfaces, that is, its retention capacity on solid surfaces. The higher the ‘log Koc’ value, the higher the adsorption to solids. The lower the value, the more the substance has an affinity with water rather than with solids and is therefore distributed and mobile in water.

280    In the present case, the ‘log Koc’ value of melamine in its non-ionic form is less than 2, whereas its ‘log Koc’ value in its ionic form is less than 3.5, which is not called into question by the applicants in the context of their action.

281    Such values mean that melamine can be regarded as mobile in its non-ionic form. By contrast, in its ionic form, it is not mobile or slightly mobile. ECHA therefore concluded that melamine had low adsorption potential.

282    In section 3.2.1 of the support document, ECHA explained why the ‘log Koc’ value is used to assess the mobility of melamine for the environment. On that point, ECHA sets out the advantages of the log Koc model over other methods. In particular, it is emphasised that the ‘log Koc’ model enables an assessment of the adsorption behaviour of a substance by providing a measure of adsorption potential which can be compared with other substances and is not dependent on the properties of the specific matrix to which it is adsorbed. Conversely, adsorption to specific media (soil, sediment, sewage sludge) can be described via specific adsorption coefficients. However, in order to have an overview of the adsorption behaviour of a substance in different soils, sediment and sewage sludge, there need to be various specific adsorption coefficients in order to reach a conclusion.

283    It must be noted that, in so doing, contrary to what the applicants argue, ECHA did verify whether the ‘log Koc’ model was the most appropriate model for assessing the mobility of melamine and provided the explanations as to why it considered that to be the case.

284    In addition, contrary to what the applicants claim, ECHA did take into account other information before drawing its conclusions on the mobility of melamine in the environment. In that regard, ECHA examined the relevance of the ionising properties of melamine on the basis of the ‘log Koc’ model, as follows from the reference to the study by Grathwohl, P., ‘Influence of organic matter from soils and sediments from various origins on the sorption of some chlorinated aliphatic hydrocarbons: implications on Koc correlations’, Environmental Science & Technology, 1990, and from the reference to the study by Claßen, D., ‘Studien zum Einfluss einer chemischen Ladung auf Sorption, Schicksal und Bildung nicht-extrahierbarer Rückstände organischer Chemikalien im Boden’ (Studies on the influence of a chemical charge on sorption, fate and formation of non-extractable residues of organic chemicals in soil), Universitätsbibliothek der RWTH Aachen, 2019. It also referred to the results of the experimental study by Wang, P.X., Li, H.T., Zhang, L. and Liu, J.M., ‘The clinical profile and prognosis of Chinese children with melamine-induced kidney disease: a systematic review and meta-analysis’, BioMed Research International, 2013 (‘the Wang et al. study’), which examined the adsorption of melamine in 5 typical Chinese agricultural soils with a pH of between 5.56 and 7.45. Lastly, ECHA took account of volatilisation, namely the tendency of a substance to evaporate from the water phase, in section 3.2.2 of the support document, and distribution modelling, in section 3.2.3 of the support document.

285    The applicants’ argument must therefore be rejected.

286    In the second place, the applicants submit that ECHA favoured modelling over empirical data, even though Regulation No 1907/2006 does not, in their view, require all possible environmental conditions to be taken into account, but only the most relevant. The use of modelling data for melamine has, according to the applicants, resulted in ECHA’s underestimation of its adsorption when, under controlled conditions, it has been observed that melamine was adsorptive. In that regard, they refer to the study by Schumann, P., Müller, D., Eckardt, P. et al., ‘Pilot-scale removal of persistent and mobile organic substances in granular activated carbon filters and experimental predictability at lab-scale’, Science of the Total Environment, 2023.

287    Nevertheless, although the applicants submit that ECHA should have taken into account the most relevant environmental conditions, it must be noted that they have not explained how the fact that ECHA used a method enabling it to assess a wide range of environmental conditions, rather than only some of them, constitutes a manifest error of assessment.

288    Lastly, as regards the study by Schumann, P., Müller, D., Eckardt, P. et al., ‘Pilot-scale removal of persistent and mobile organic substances in granular activated carbon filters and experimental predictability at lab-scale’, Science of the Total Environment, 2023, it should be noted that not only do the applicants confine themselves to making a general reference to that study, which is cited only in a footnote to the reply, but they have also not established that the data set out in that study should have been known to ECHA at the time when it adopted the contested decision; nor have the applicants shed a different light on the data taken into account by ECHA, in accordance with the requirements laid down by the case-law cited in paragraphs 200 and 201 above. That study must therefore be rejected.

289    In the third place, in their observations on the supplementary statement in intervention lodged by the Federal Republic of Germany, the applicants complain that ECHA failed to address the findings in the report by the European Centre for Ecotoxicology and Toxicology of Chemicals (Ecetoc), entitled ‘Persistent chemicals and water resources protection’, published in 2021 (‘the Ecetoc report’), which identify the limitations of the ‘log Koc’ model. In general terms, the applicants argue that the ‘log Koc’ value cannot still in itself be the determining factor in assessing the mobility of a substance.

290    The applicants also refer to section 4.4.2.3 of Annex I to Regulation No 1272/2008, as amended by Commission Delegated Regulation (EU) 2023/707 of 19 December 2022 (OJ 2023 L 93, p. 7), which states that ‘a weight of evidence determination using expert judgment shall be applied, by comparing all relevant and available information listed in Section 4.4.2.3 with the criteria set out in Sections 4.4.2.1 and 4.4.2.2’ and ‘that weight of evidence shall be applied in particular where the criteria set out in Sections 4.4.2.1 and 4.4.2.2 cannot be applied directly to the available information.’ They infer from that that other data must be taken into account in order to assess the mobility of the substance, where the ‘log Koc’ model is not a direct indicator of the mobility properties of that substance.

291    As regards the Ecetoc report, it is true that, as the applicants submit, it concludes that the ‘log Koc’ model is too simplistic and does not incorporate the complex sorption behaviour that chemicals may undergo in soils and sediments, or the rate of loading or application of chemicals. That report therefore proposes that approaches be used that differ from that model.

292    Without it being necessary to examine the content of the Ecetoc report or the relevance of Regulation No 1272/2008, as amended by Delegated Regulation 2023/707, it is sufficient to note that, as pointed out in paragraph 284 above, ECHA took into account factors other than the ‘log Koc’ value in order to assess the mobility of melamine in the environment.

293    In those circumstances, the applicants’ argument must be rejected.

294    In the light of the foregoing, the first complaint must be rejected.

(b)    The second complaint, alleging a failure to take into account the results of the Pote et al. study

295    The applicants complain, in essence, that ECHA ignored the Pote et al. study even though it was relevant for assessing the mobility of melamine in soils.

296    In that regard, as follows from the case-law cited in paragraphs 137 and 138 above, in order to establish that ECHA made a manifest error of assessment, the applicants must adduce sufficient evidence to make the factual assessments used in the contested decision implausible. However, it is not for the EU judicature to carry out an assessment of scientific and technical facts that would replace that of ECHA.

297    Furthermore, the Court of Justice has already held that the fact that ECHA disregarded the irrelevant elements of a reliable study, or elements that would not, in any event, have been capable of altering the overall assessment in such a way that the final decision was implausible, cannot constitute a manifest error of assessment (see, to that effect, judgment of 9 March 2023, Plastics Europe v ECHA, C‑119/21 P, EU:C:2023:180, paragraph 52).

298    In the present case, ECHA does not dispute that it disregarded the Pote et al. study. The explanations provided to justify that position were developed in the RCOM document.

299    The RCOM document states, first of all, that the Pote et al. study is a lysimeter study which examines a single set of environmental conditions, namely the loss of cyromazine in a specific soil, manure. Next, it states that the Pote et al. study is irrelevant because its limit of detection, namely 5 μg/l, is not sufficiently sensitive compared to the analytical methods applied in other more recent studies. Lastly, the RCOM document notes that that study does not allow a conclusion to be drawn as to the adsorption potential of melamine, since it cannot distinguish between the different types of dissipation of a substance in the environment, namely the potential for degradation and adsorption.

300    To that, it should be added that, in the support document, ECHA explained the limits of lysimeter studies, namely, in essence, that they require, in order to have an overview of the adsorption behaviour of a substance in different soils, sediments and sewage sludge, various specific adsorption coefficients.

301    The applicants accept that the Pote et al. study did not distinguish between degradation and removal through adsorption and did not provide any directly usable value for the adsorption potential of melamine. However, they consider that a lysimeter study based on the Organisation for Economic Co-operation and Development (OECD) Guidelines for the Testing of Chemicals (Test No 22) is not intended to, or aimed at, distinguishing between adsorption and degradation, since the sole purpose is to determine the leachability of a substance, which is, in fact, a combination of both. Moreover, they accept that the Pote et al. study applied the limit of detection that existed at the time, namely in the mid-1990s. However, they consider that the 5 μg/l limit of detection applied to melamine was clearly sufficient for the purpose of carrying out that study, given the initial cyromazine concentration. Lastly, they consider that the purpose of that study was not to study the migration behaviour just in manure, but in soil itself.

302    In so doing, the applicants have not put forward sufficient arguments to dispute the weaknesses of the Pote et al. study that were identified in the RCOM document, or to demonstrate that ECHA was manifestly wrong to reject that study.

303    First, even though the Pote et al. study was carried out in accordance with the OECD Guidelines for the Testing of Chemicals (Test No 22), the fact remains that that study did not distinguish between degradation and adsorption, which, in ECHA’s view, prevented a conclusion from being drawn as to the adsorption potential of melamine. The applicants have not explained why, despite the absence of a distinction between degradation and adsorption, it is clear that ECHA should have considered that it was still possible to draw a satisfactory conclusion on the adsorption potential of melamine.

304    Second, the fact that the limit of detection applied in the Pote et al. study was sufficient, in view of the initial concentration of cyromazine, even if proved, is not capable of demonstrating that ECHA made a manifest error of assessment, since the criticism related to the fact that that limit was not relevant when compared with the limits of detection currently applied in similar studies. In that regard, it must be stated that the applicants have not attempted to explain that the limit of detection applied in the Pote et al. study was as sensitive as that applied in certain more recent studies.

305    Third, the applicants’ assertion that the purpose of the Pote et al. study was to study migratory behaviour in soil itself, and not only in manure, is contradicted by the objective set out in the relevant study itself, which was to quantify cyromazine in run-off and ground water from pastures treated with manure. Moreover, the study in question itself draws attention to the fact that, although no threat to the quality of groundwater beneath pastures treated with manure has been identified, that does not mean that the same is true for other types of soil. Consequently, the Pote et al. study sought to limit its conclusions to a particular type of soil, with the result that, even if ECHA had taken that study into account, it would not have been relevant to reach a conclusion on the general behaviour of melamine in the environment.

306    In those circumstances, the applicants have not succeeded in demonstrating that ECHA made a manifest error of assessment in disregarding the Pote et al. study. Accordingly, the second complaint must be rejected.

(c)    The third complaint, alleging a failure to take into account the impact of the ionizing properties of melamine on the derived ‘log Koc’ values

307    As follows from paragraph 280 above, the ‘log Koc’ value of melamine in its non-ionic form differs from that in its ionic form. While the ‘log Koc’ value of melamine in its non-ionic form, which is less than 2, means that the substance is mobile, its ‘log Koc’ value in its ionic form, which is less than 3.5, is interpreted as meaning that melamine is, at the very least, less mobile.

308    That difference is highlighted by the applicants in order to argue that ECHA made a manifest error of assessment in concluding that melamine is mobile. In that regard, they complain that ECHA favoured the ‘log Koc’ value of the non-ionic form of melamine without taking into account the relevant environmental conditions, namely the fact that European soils are generally acidic. If that had been the case, ECHA would have found that, in contact with such soils, melamine ionises, so that it is the ‘log Koc’ value of less than 3.5 that would have been used.

309    In so doing, the applicants complain that ECHA failed to take sufficient account of the ionising properties of melamine and, consequently, favoured the ‘log Koc’ value of the non-ionic form of melamine. In particular, they complain that ECHA did not consider the Wang et al. study to be a relevant factor.

310    That assertion is, however, contradicted by the support document itself, which does refer to the Wang et al. study and sets out the results of that study.

311    In addition, it should be noted that, in the reply, the applicants have not disputed the assertion made by ECHA in the defence, to the effect that the applicants limit their arguments to certain environmental conditions, namely acidic soils, without taking into account other relevant conditions, such as alkaline soils or the aquatic environment, which may have a higher pH. Moreover, although the applicants state that the testing and information requirements of Regulation No 1907/2006 do not cover all possible environmental conditions, they have not explained, however, beyond the broad argument that European soils are generally acidic, the reasons why acidic soils should be preferred to other soil types (see also paragraph 287 above).

312    As follows from the case-law cited in paragraph 137 above, it was for the applicants to adduce sufficient evidence to make the factual assessments used in the contested decision implausible.

313    In any event, first, the fact that ECHA did not confine itself to certain soil types does not appear to be manifestly incorrect, since it sought to assess the environmental fate, taken as a whole, of melamine. Second, ECHA explained why it had considered that the non-ionic form of melamine was present in larger quantities than the ionic form of melamine, without, however, neglecting the fate of the ionic form of melamine. Lastly, in view of the ‘log Koc’ values used, both for the ionic form and for the non-ionic form of melamine, the conclusion that melamine has a low adsorption potential does not demonstrate a manifest error of assessment.

314    It is necessary, therefore, to reject the applicants’ third complaint.

(d)    The fourth complaint, alleging (i) a failure to take into account the distribution of melamine from water to soil, (ii) a failure to take into account data relating to that substance, and (iii) a manifest error of assessment resulting from the use of generic considerations instead of data relating to the substance at issue

315    The applicants complain that ECHA made a manifest error of assessment in concluding that concentrations of melamine are increasing in the environment.

316    As a preliminary point, it should be noted that, as ECHA submits, the support document does not conclude that concentrations of melamine are increasing in the environment. It states that melamine has the potential for widespread contamination of the aquatic environment due to its intrinsic properties. That is apparent, for example, from the summary of the manner in which the substance meets the conditions laid down in Article 57 of Regulation No 1907/2006, set out in the support document, which states, in essence, that, because of its intrinsic properties of high water solubility and low volatility, and its low potential for adsorption, combined with other intrinsic properties, in particular its long environmental half-life, melamine has the potential for widespread contamination of the aquatic environment.

317    That is apparent not only from the findings in section 3.2.5 of the support document, according to which the evidence shows that melamine is capable of accumulating in both surface water and groundwater, but also from the conclusions set out in section 6.3.2.1 of the support document, according to which, due to its high persistence, the rate of melamine present in the environment is expected to increase over time if continuous exposure occurs.

318    As regards the arguments raised by the applicants, the following should be noted.

319    First, as regards the EMPA report ‘Melamine in the environment’ of 2 February 2022 (‘the EMPA report’) and the monitoring data relied on by the applicants in support of the assertion referred to in paragraph 315 above, it must be stated, as ECHA has done, that the applicants have not explained how that report and those data make ECHA’s conclusion implausible. The applicants merely submit that that report and those data demonstrate that ECHA’s conclusion is speculative and implausible, without further developing their comments.

320    Second, similarly, as regards the modelling data, although the applicants claim that it is apparent from those data that, released at 100% in water, 99.7% of melamine remains there and 0.34% goes into sediments and, released at 100% in soil, 88.3% of melamine remains there and 11.6% is disseminated in water, they have not explained how such data can call into question ECHA’s conclusion.

321    Third, as regards the study by Neuwald, I.J., Hubner, D., Wiegand, H.L., Valkov, V., Borchers, U., Nodler, K., Scheurer, M., Hale, S.E., Arp, H.P.H. and Zahn, D., ‘Occurrence, Distribution, and Environmental Behavior of Persistent, Mobile, and Toxic (PMT) and Very Persistent and Very Mobile (vPvM) Substances in the Sources of German Drinking Water’, Environmental Science & Technology, 2022 (‘the Neuwald et al. study’), that study shows that, for melamine, median concentrations in bank filtrate were at least one order of magnitude lower than in surface water, but the differences between both sample sets were not shown to be statistically significant.

322    In the support document and in the defence, ECHA states that the authors of the Neuwald et al. study themselves noted that their observation, as set out in paragraph 321 above, was not statistically significant and that such a lack of statistical significance was an indication of insufficient removal of melamine from water.

323    At the hearing, the applicants explained that the focus should be on the raw data used by the authors of the Neuwald et al. study rather than on their conclusions. In that regard, the applicants consider that those data show that melamine can be removed from bank filtrates, which is evidence of soil-sediment retention, a factor which, they argue, should have been taken into consideration by ECHA.

324    It is not for the Court, without disregarding the limits of its judicial review as set out in paragraph 138 above, to examine the raw data used in a study in order to ascertain whether those data support the applicants’ arguments.

325    Since, in addition, the applicants have not adduced any evidence or put forward arguments capable of challenging ECHA’s conclusion that it is also apparent from the Neuwald et al. study that the elimination of melamine from water is insufficient, their argument must be rejected.

326    Fourth, the applicants dispute the conclusion in the support document that the models described cannot be interpreted as meaning that the ‘soil compartment is a safe sink for emissions of melamine’. In their view, the data directly contradict that conclusion, since Tables 10, 11 and 13 in section 3.2.3 of the support document show that that substance remains in soil or sediment. It is only the data in Table 12 that, they argue, support the conclusion relating to melamine remaining in water.

327    In so doing, the applicants ask the Court to carry out its own assessment of the data in Tables 10 to 13 of section 3.2.3 of the support document. In addition, the applicants have not provided the Court with any initial explanation to enable it to understand how the data presented in those tables support their arguments. Thus, a verification of whether the data in Tables 10, 11 and 13 show that melamine remains in soil or sediment would amount to carrying out an analysis of the scientific and technical facts on which ECHA relied in order to adopt the contested decision, which goes beyond the jurisdiction of the EU judicature, as recalled in the case-law cited in paragraph 138 above.

328    Lastly, it should be noted that, in accordance with the case-law referred to in paragraph 137 above, it was for the applicants to adduce sufficient evidence to make the factual assessments that were relied on implausible, which they have manifestly failed to do.

329    In the light of all of those considerations, the fourth complaint must be rejected.

(e)    The fifth complaint, alleging a manifest error of assessment vitiating the conclusion that melamine is ‘widespread’ or ubiquitous in water or that there is ‘continuous exposure via water and potentially increasing concentrations’

330    The applicants submit that ECHA made a manifest error of assessment in concluding that melamine is widespread or ubiquitous in water or that there is continuous exposure via water and potentially increasing concentrations. The applicants argue that they have submitted substantive and substantial information demonstrating that melamine is not a ubiquitous substance in the environment.

331    As a preliminary point, it should be noted, as ECHA has done, that the support document concluded that melamine had a widespread presence in the aquatic environment. That is apparent, in particular, from the summary of how that substance meets the conditions laid down in Article 57 of Regulation No 1907/2006, set out in the support document (page 9 of the support document), and from sections 3.2.4, 3.2.5 and 6.3.2.1 of that document. Nevertheless, for the purposes of identifying melamine as a substance of very high concern, ECHA took into account the increased or widespread distribution potential of melamine due to its intrinsic properties and not the fact that the presence of melamine was widespread, ubiquitous or increasing in the environment. That is apparent, in particular, from the summary of how that substance meets the conditions laid down in Article 57 of Regulation No 1907/2006, set out in the support document (page 9 of the support document), and from section 6.3.3 of that document.

332    As regards the arguments put forward by the applicants, the following should be noted.

333    First, the applicants submit that the available data establish that, once the substance has been detected, it is very likely that its detection is the result of ‘point’ emissions and not because melamine is a general and widespread contaminant of drinking water. They refer, in that regard, to the Neuwald et al. study and the comments which they had made during the public consultation, on the study by Kolkman, A., Vughs, D., Sjerps, R., Kooij, P.J.F., van der Kooi, M., Baken, K., Louisse, J. and de Voogt, P., ‘Assessment of Highly Polar Chemicals in Dutch and Flemish Drinking Water and Its Sources: Presence and Potential Risks’, ACS ES&T Water, 2021 (‘the Kolkman et al. study’).

334    First, as regards the Neuwald et al. study, it should be noted that ECHA does not dispute that it is apparent from that study that, in the majority of cases, the sampling sites where melamine had been detected were related to local sources of emissions, such as industrial plants, in other words, there were hotspot sites. That was, moreover, acknowledged in the support document.

335    Nevertheless, it must be noted that, in order to reach the finding that there was a widespread presence of melamine in the aquatic environment, ECHA relied on several studies. The applicants have not explained how the conclusions of the Neuwald et al. study, which, moreover, are based on a limited number of samples taken in a single country, are capable of rendering implausible ECHA’s assessment of all the information available to it.

336    Second, as regards the Kolkman et al. study, it is sufficient to note that, as ECHA maintains, the support document draws a limited conclusion from that study. Thus, it is indeed mentioned that that study showed that concentrations of melamine above 1.0 μg/l had been found in surface water samples in Flanders (Belgium) and in the Netherlands. However, even if the data from that study were not reliable, which, in any event, the applicants have not succeeded in demonstrating in the absence of specific arguments put forward in that regard, it should be noted that it was not on the basis of that study alone that ECHA reached the conclusion that melamine was widespread in the aquatic environment, and therefore the applicants’ argument cannot succeed.

337    Second, as regards the EMPA report, the applicants complain that ECHA failed to assess or examine the relevance of the results of that report in the light of the comments which the applicants had put forward during the public consultation.

338    The applicants submit, in essence, that ECHA merely repeated the report’s finding that, although melamine is frequently detected in surface water in Germany and the Netherlands, those findings demonstrate that it is not always present in the surface water in those two countries (beyond the corresponding limits of detection) and that it is not a substance that is ubiquitous in surface water in Germany and the Netherlands. They argue that, in so doing, ECHA ignored the fact that it could also be inferred that there was no evidence of a current increase in concentrations of melamine in the environment or of an upward trend.

339    It is sufficient to note that, as stated in paragraph 316 above, ECHA did not conclude that there was a current increase in concentrations of melamine in the environment, but that there was the potential for widespread contamination of the aquatic environment due to the intrinsic properties of melamine, with the result that there is no clear contradiction with the information provided in the EMPA report.

340    Third, the applicants submit that the conclusions of report 287, drawn up by the International Commission for the Protection of the Rhine, of 2022, entitled ‘Reducing micropollutants in the Rhine catchment area – Monitoring and evaluation system’ (‘report 287’), reveal a clear downward trend in the presence of melamine in the Rhine, which demonstrates that, contrary to what is stated in the support document, melamine is not expected to increase.

341    ECHA contends that, in so doing, the applicants did not take into account the limits of report 287 that were highlighted in the RCOM document.

342    In that regard, it should be noted that the RCOM document stated the reasons why report 287 could not be taken into consideration. Thus, it mentioned the fact that, in certain regions, waters had not been analysed for melamine. In addition, the duration of the analysis had been considered to be too short, which hindered, to a certain extent, statistical power and the identification of trends and did not allow conclusions to be drawn on the upward or downward trends in the presence of melamine in the aquatic environment. Similarly, the limited size of the sampling and the size of the site were problematic.

343    It must be observed that the applicants have not put forward any specific arguments to challenge the criticisms made in the RCOM document with regard to report 287.

344    The only argument which they put forward in that regard is the fact that report 287 was treated differently to other studies, for example the Kolkman et al. study, on the pretext that it did not support ECHA’s conclusions.

345    In so doing, they have not criticised the reasons put forward in the RCOM document for the rejection of report 287, and therefore they have not established how, in their view, ECHA made a manifest error of assessment in considering that report to be irrelevant.

346    Furthermore, when questioned on that point at the hearing, ECHA explained that the studies used in the support document demonstrated the presence of melamine in the environment, whereas report 287 sought to demonstrate a trend, namely a decrease in the presence of melamine in the environment. ECHA argued that, in order to do so, that report would have had to be based on much more robust data, covering a longer period and more samples.

347    As regards the study by the consultancy firm Arcadis, ‘Brononderzoek drinkwaterrelevante stiffen: Tien stoffen in het Rijnstroomgebied Rijkswaterstaat WVL’ (Research on sources of drinking water: ten substances in the Rhine Rijkswaterstaat WVL river basin) of 16 December 2022, which, according to the applicants, confirms the downward trend of melamine in the Rhine, it should be noted that they rely on it essentially to confirm the conclusions of report 287, but have not claimed that that study was based on data of which ECHA should have been aware when it adopted the contested decision. Moreover, in view of the date of that study, ECHA could not have been aware of it when it adopted the contested decision. Consequently, if that study were to be taken into consideration independently, that would alter the legal and factual framework previously submitted to ECHA for the purpose of the adoption of the contested decision, which is contrary to the case-law cited in paragraphs 200 and 201 above.

348    Fourth, the applicants submit that, even when melamine was detected in water, it was at concentrations that are orders of magnitude below health safety levels.

349    That argument must be rejected on the basis of the same considerations as those set out in paragraphs 191 to 194 above.

350    Fifth, the applicants complain that ECHA failed to take account of the fact that the presence of melamine in the environment could also have been due to the use of other substances or compounds.

351    That argument cannot succeed. First, it is apparent from the support document that ECHA did take into account that the presence of melamine in the environment may be due to other substances, such as cyromazine and hexa(methoxymethyl)melamine. Second, and in any event, the fact that the presence of melamine in the environment could be due to the use of other substances is irrelevant when determining whether the substance is a substance of very high concern. At that stage, what matters is an examination of the hazards posed by the presence of melamine in the environment.

352    Sixth, while stating that the monitoring data from the ‘NORMAN EMPODAT’ database show that melamine has been detected in different surface waters in Europe below the set drinking water standards, but not everywhere, so that it cannot be regarded as ubiquitous, the applicants consider that those data are questionable.

353    It should be borne in mind that it is not for the Court to seek and identify, in the annexes, the pleas and arguments on which it may consider the action to be based, since the annexes have a purely evidential and instrumental function (judgments of 28 June 2005, Dansk Rørindustri and Others v Commission, C‑189/02 P, C‑202/02 P, C‑205/02 P to C‑208/02 P and C‑213/02 P, EU:C:2005:408, paragraph 97, and of 14 December 2005, Honeywell v Commission, T‑209/01, EU:T:2005:455, paragraph 57).

354    In the present case, the applicants refer to the findings of Rudolf Hensel GmbH presented during the public consultation, to which, they argue, ECHA did not attach sufficient interest, and submit that, for example, those findings demonstrate that no standardised analytical method was applied or that there were other limitations, and that the monitoring data from the ‘NORMAN EMPODAT’ database should therefore not have been accepted as valid according to the validation protocols of that database.

355    In so doing, the applicants make a general reference in respect of the annexes to their pleadings, and to a document published on the internet, without sufficiently explaining the basis for their criticisms. In particular, they have not specified the problems caused by the alleged absence of a standardised analytical method, or those relating to limitations, which, moreover, are not identified. In addition, the reference to the validation protocols of the ‘NORMAN EMPODAT’ database is too vague, with the result that the Court is not in a position to determine which rules of those protocols were not complied with. Thus, without any specific explanation as to the shortcomings of the monitoring data of the ‘NORMAN EMPODAT’ database and as to the absence of any link with the validation protocols of that database, the applicants’ argument cannot succeed.

356    In view of all of the foregoing, the fifth complaint must be rejected.

(f)    The sixth complaint, alleging a manifest error in the assessment of the information relating to the potential for long-range transport

357    According to the applicants, ECHA made a manifest error of assessment in its examination of the information relating to the potential for long-range transport of melamine by basing its decision on the OECD’s long-range transport potential screening tool (‘the OECD LRTP screening tool’).

358    As a preliminary point, it should be noted, as observed by ECHA, that, in order to assess the potential for long-range transport of melamine, ECHA did not rely solely on the OECD LRTP screening tool. As is apparent from the support document, ECHA took into account both the high water solubility of melamine, its low volatility from water, its low potential for adsorption, its degradation behaviour and the results of the OECD LRTP screening tool in reaching the conclusion that melamine was capable of travelling long distances in the aqueous phase. In addition, it must be pointed out that ECHA stated that, even if its predictions regarding the potential for long-range transport of melamine were to be regarded as approximate and conservative, the fact remains that the results clearly indicated that melamine was capable of reaching regions very far away from its initial point of emission.

359    As regards the arguments put forward by the applicants, the following should be noted.

360    First, as regards the study by Li, Z. and McLachlan, M.S., ‘Comparing non-targeted chemical persistence assessed using an unspiked OECD 309 test to field measurements’, Environmental Science: Processes & Impacts Journal, 2020, the applicants argue that they put forward that study in order to demonstrate that changing one input parameter of the OECD LRTP screening tool had a major impact on the results obtained, so that those results were very unreliable.

361    That argument must be rejected. As ECHA submits, the change of an input parameter in a screening tool is capable of substantially altering the results, without that meaning that that tool is unreliable. In any event, the applicants’ argument remains vague, since they have not explained why a screening tool would lose reliability if the results obtained from it are significantly altered when an input parameter is changed.

362    Second, the applicants complain that ECHA failed to assess the usefulness of the OECD LRTP screening tool in respect of melamine.

363    It should be noted that the support document clearly identified certain limits in the use of that tool, such as the fact that ECHA did not have data from simulation studies on degradation half-life in each environmental sphere, a parameter used in the OECD LRTP screening tool. In addition, ECHA took into account, as noted in paragraph 358 above, the fact that its predictions regarding the potential for long-range transport of melamine could be regarded as approximate and conservative, precisely because of the lack of information on the degradation half-life of melamine.

364    Therefore, ECHA did take into account the limitations of the OECD LRTP screening tool due to the particular features of the existing data for melamine.

365    Third, the applicants submit that melamine is an ionising organic chemical, with the result that the OECD LRTP screening tool is irrelevant, since it is an instrument for detecting non-ionising organic chemicals.

366    In that regard, it should be noted that the applicants have not disputed that melamine existed in ionic and non-ionic form. Accordingly, in order for their argument to have a chance of succeeding, it would have been necessary for them to explain why it was clear that ECHA should not have taken into account the OECD LRTP screening tool, when a non-ionic form of melamine existed, or explain the limitations of ECHA’s assessment of the potential for long-range transport of melamine due to the existence of those two forms.

367    In any event, even if the OECD LRTP screening tool were irrelevant for assessing the potential for long-range transport of melamine in its ionic form, its results remained relevant, since melamine in its non-ionic form could be found in the environment and could therefore have an effect on the latter.

368    Fourth, in response to the argument put forward by ECHA that it reached the same conclusion as regards the persistence and mobility of melamine without taking into account the OECD LRTP screening tool, the applicants complain that ECHA failed to explain how it arrived at such a result.

369    On that point, it is sufficient to note that, as stated in paragraph 358 above, ECHA did not rely solely on the OECD LRTP screening tool, but took into account both the high water solubility of melamine, its low volatility from water, its low potential for adsorption and its degradation behaviour. In those circumstances, the applicants were in a position to understand that other factors had been taken into account by ECHA, with the result that, even without taking into account the OECD LRTP screening tool, it would have arrived at the same result.

370    Fifth and lastly, the applicants’ argument that ECHA changed the basis for identifying melamine as a substance of very high concern must be rejected. The applicants have not explained with sufficient clarity what exactly they wish to criticise ECHA for, nor have they put forward the evidence enabling them to reach such a conclusion.

371    Having regard to all of the foregoing, the sixth complaint must be rejected.

(g)    The argument put forward by Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Methanol Holdings (Trinidad)

372    Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Methanol Holdings (Trinidad) submit that, in the publication by Collard, M., Camenzuli, L., Lyon, D., Saunders, D., Vallotton, N. and Curtis-Jackson, P., ‘Persistence and Mobility (defined as organic-carbon partitioning) do not correlate to the detection of substances found in surface and groundwater: Criticism of the regulatory concept of persistent and mobile substances’, Science of the Total Environment, 2023, the authors concluded that, on the basis of their critical assessment of previous scientific publications relating to persistent and mobile substances, there was no statistically significant difference in the presence of non-persistent and mobile particles compared to particles in surface water, groundwater and drinking water. In addition, their analysis revealed that other factors, such as emission rates and proximity to emission sources, determined the rate of detection of chemicals in surface water, groundwater and drinking water. As a result, the exposure data was relevant, but ECHA failed to fulfil its obligation to take them into account.

373    It should be noted that the argument is imprecise. Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Methanol Holdings (Trinidad) have not identified with sufficient clarity the elements of the contested decision which they seek to call into question in the light of that publication. In that regard, although the critical assessment by the authors of that publication related to two studies referred to in the support document, including the Kolkman et al. study, that is not sufficient, in the absence of details in the statement in intervention, to understand precisely what is alleged in respect of those studies and the impact that any methodological flaws affecting those two studies could have on ECHA’s assessment, which is based on a set of scientific studies.

374    In those circumstances, the argument of Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Methanol Holdings (Trinidad), which fails to comply with the requirements of Article 145(2) of the Rules of Procedure of the General Court, is rejected as inadmissible.

(h)    Conclusion on the fourth part of the first plea

375    In the light of all of the foregoing, the applicants have not succeeded in demonstrating that ECHA made a manifest error of assessment as regards the environmental fate properties of melamine.

376    The fourth part of the first plea must therefore be rejected.

6.      The fifth part of the first plea, alleging a manifest error of assessment in that ECHA based the contested decision on ‘yet unknown effects’

377    The applicants, supported by Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Methanol Holdings (Trinidad), and by Fritz Egger and the other legal persons whose names are set out in the annex, claim that the yet unknown effects of melamine cannot be regarded as serious or, consequently, be used to determine to the requisite legal standard whether the substance has serious effects on human health. Therefore, yet unknown effects cannot, in their view, constitute a legal basis for the identification of a substance as a substance of very high concern.

378    ECHA, supported by the Federal Republic of Germany and the Commission, disputes those arguments.

379    It should be noted that, contrary to what the applicants claim, the support document did not identify ‘yet unknown effects’ as ‘probable serious effects’, nor did it use such effects in order to conclude that melamine could have serious effects on human health.

380    In that regard, first, it must be stated that the parts of the support document mentioned by the applicants as containing such findings (pages 10, 66, 68 and 75) concern the probable effects of melamine on the environment and not on human health.

381    Second, the reference to those ‘yet unknown effects’ is not intended to demonstrate the probable serious effects of melamine on human health or the environment, but the level of concern raised by melamine. That is reflected in the wording of the conclusions containing that statement, which indicates that the intrinsic properties of that substance give rise to concerns that the identified probable serious effects or yet unknown effects could occur in the environment and lead to irreversible population-relevant effects (section 6.3.2.5 of the support document).

382    The fifth part of the first plea must therefore be rejected.

7.      The sixth part of the first plea, alleging a manifest error of assessment in that ECHA failed to establish that the alleged effects constitute ‘serious effects’

383    The applicants, supported by Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Methanol Holdings (Trinidad) and by Fritz Egger and the other legal persons whose names are set out in the annex, maintain that ECHA has not demonstrated that the alleged effects result from intrinsic properties of the substance, and that ECHA relied on exposure considerations in order to establish the seriousness of the substance.

384    First, they argue that the effects can be serious within the meaning of Article 57(f) of Regulation No 1907/2006 only if they constitute hazards which are demonstrated to arise from the intrinsic properties of the substance. In that regard, the seriousness of the effects of a substance is not dependent on exposure to that substance, but must be intrinsic to it. However, exposure must be taken into account when assessing whether those effects – established on the basis of scientific evidence – give rise to an equivalent level of concern.

385    In the present case, the applicants submit that the alleged effects on human health are not serious, since, as the Risk Assessment Committee confirmed in its opinion, the mode of action of melamine is threshold-based.

386    Thus, ECHA has not, in their view, demonstrated, on the basis of scientific evidence, that the substance at issue is capable of causing probable serious effects, since the classification, as a ‘serious’ effect, of an effect that is not serious cannot be attributed to exposure to that substance. Moreover, by disregarding the conclusion of the Risk Assessment Committee, ECHA did not ensure consistency between its involvement in the inclusion of melamine in the candidate list and the procedure for harmonised classification of melamine, as required by Article 7 TFEU and Article 13(1) TEU.

387    Second, the applicants complain that ECHA wrongly concluded that the reversible effects had to be regarded as irreversible solely because of continuous exposure. That approach is contrary to the distinction drawn in the case-law between the assessment of hazards and risks and the assessment of ‘serious effects’ under Article 57(f) of Regulation No 1907/2006.

388    ECHA, supported by the Federal Republic of Germany and the Commission, disputes those arguments.

389    In the first place, it should be noted that the applicants’ line of argument starts from the incorrect premiss that the probable serious effects of melamine on human health are not due to its intrinsic properties. As follows from paragraph 215 above, it has been established that ECHA did not make a manifest error of assessment in finding that the probable serious effects of melamine on human health were due to its intrinsic properties.

390    In those circumstances, the applicants’ argument that ECHA relied not on the intrinsic properties of melamine, but on exposure to that substance, in order to infer the seriousness of the effects, must be rejected as unfounded.

391    In any event, contrary to the applicants’ submission, the considerations relating to exposure to a substance are not limited to verifying the existence of an equivalent level of concern, which is the second condition laid down in Article 57(f) of Regulation No 1907/2006.

392    As is apparent from paragraphs 208 to 210 of the judgment of 23 February 2022, Chemours Netherlands v ECHA (T‑636/19, not published, EU:T:2022:86), the considerations relating to exposure to a substance such as might result from the intrinsic properties of that substance form part of an examination of the hazards arising from the intrinsic properties of a substance. In that case, it is not a question of assessing the actual and specific exposure to that substance, but rather the potential exposure on account of its intrinsic properties.

393    Moreover, as ECHA states, in essence, in order to identify the intrinsic properties of a substance, it is necessary to rely on exposure scenarios, irrespective of actual or possible exposure in real life. As ECHA and the Commission have stated, the concept of ‘intrinsic properties’ requires that the interactions of the substance concerned with other elements be taken into consideration. For example, the chemical reactivity of a substance depends on its propensity to interact with other substances. Similarly, the hydrophilicity of a substance depends on its capacity to dissolve in water, in the same way that the melting or boiling point of a substance depends on the temperature to which it is subjected. Those circumstances do not mean that chemical reactivity, hydrophilicity or boiling point are not intrinsic properties of the substance concerned. A strict reading of the concept of intrinsic properties requires that only the chemical composition or molecular structure of a substance constitute its intrinsic properties. However, in themselves and without interaction, such properties have no effect.

394    Thus, exposure to a substance cannot be ignored in order to study its intrinsic properties and, therefore, their seriousness.

395    In the second place, for reasons similar to those set out in paragraphs 191 to 194 above, the applicants’ argument that the alleged effects of melamine on human health are not serious, because they are based on thresholds, must be rejected.

396    In the third place, as regards the applicants’ argument relating to the reversible nature of the effects of melamine, that argument must be understood as meaning that, since the effects of melamine are reversible, they cannot be regarded as serious.

397    First, while it is true that effects may be regarded as serious on account of, for example, their significance and irreversible nature (see, to that effect, judgment of 15 March 2017, Polynt v ECHA, C‑323/15 P, EU:C:2017:207, paragraph 27), it should be noted that Article 57(f) of Regulation No 1907/2006 does not lay down any criterion and therefore does not provide any clarification as regards the determination of the serious nature of the effects of a substance. In that regard, that provision requires only that there be scientific evidence of that serious nature (judgment of 9 November 2023, Chemours Netherlands v ECHA, C‑293/22 P, not published, EU:C:2023:847, paragraph 64). Consequently, ECHA is not required to demonstrate the irreversible nature of the effects of a substance for the purposes of its identification as a substance of very high concern.

398    Second, the applicants have not identified the effects of melamine which are reversible and which cannot, in those circumstances, be classified as serious. In any event, as follows from paragraph 212 above, although it is true that, in section 4 of the support document, it is stated that certain stones caused by the presence of melamine could be resorbed as a result of the administration of treatments, it is nevertheless stated in that section that a number of stones caused by melamine were resistant to conventional treatments and that other persistent effects of melamine on human health were observed.

399    In the light of all the foregoing, the sixth part of the first plea must be rejected.

8.      The seventh part of the first plea, alleging a manifest error of assessment in that ECHA failed to establish that the alleged effects were ‘probable’

400    The applicants, supported by Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Methanol Holdings (Trinidad) and by Fritz Egger and the other legal persons whose names are set out in the annex, submit that ECHA did not attempt to examine whether the alleged effects of melamine were ‘probable’. The alleged effects on human health are threshold-based and the applicants argue that they have demonstrated that the likelihood of reaching the threshold via reasonably expected uses or dietary exposure is practically nil.

401    ECHA, supported by the Federal Republic of Germany and the Commission, disputes those arguments.

402    As already been pointed out in paragraph 249 above, in order to satisfy the first condition laid down in Article 57(f) of Regulation No 1907/2006, ECHA is not required to demonstrate the probability that the effects of the substance will actually occur, but rather is required to demonstrate that serious effects on human health or the environment may occur.

403    In the present case, as follows from the examination of the preceding parts, ECHA has demonstrated that the intrinsic properties of melamine could have serious effects on human health and the environment.

404    The seventh part of the first plea must therefore be rejected.

9.      The eighth part of the first plea, alleging a manifest error of assessment in that ECHA did not examine whether the level of concern deemed to be posed by the substance at issue was ‘equivalent’ to the level of concern caused by substances meeting the criteria of Article 57(a) to (e) of Regulation No 1907/2006

405    The applicants, supported by Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Methanol Holdings (Trinidad) and by Fritz Egger and the other legal persons whose names are set out in the annex, complain that ECHA did identify the level of concern, but failed to assess its equivalence.

406    Fritz Egger and the other legal persons whose names are set out in the annex also consider that, in so doing, ECHA infringed the principle of good administration and the applicants’ legitimate expectations.

407    ECHA, supported by the Federal Republic of Germany and the Commission, disputes those arguments.

408    In the first place, it should be recalled that the second condition requires neither that the substance at issue to be identified under Article 57(f) of Regulation No 1907/2006 share the same intrinsic properties as the substances referred to in Article 57(a) to (e) of that regulation, nor that the concerns raised by that substance be identical to the concerns raised by each category of substances referred to in Article 57(a) to (e) of Regulation No 1907/2006. Any other interpretation would make Article 57(f) of that regulation a mere duplication of the provisions of Article 57(a) to (e) of that regulation and, in particular, would run counter to the purpose of Regulation No 1907/2006, set out in Article 1(1) of that regulation, namely that of ensuring a high level of protection of human health and the environment (see judgment of 10 November 2021, Sasol Germany and Others v Commission, T‑661/19, not published, EU:T:2021:779, paragraph 124 and the case-law cited).

409    In the present case, it should be noted, first, that, in section 6.3.1.1 of the support document, it is stated, in essence, that the results of the inherent biodegradation tests are sufficient to demonstrate that melamine is persistent in the environment for the purposes of the persistence criterion laid down in Annex XIII to Regulation No 1907/2006. Second, in section 6.3.1.5 of that document, it is considered that melamine, which is classified as a substance with STOT RE 2 properties, meets the toxicity criteria for PBT substances for the purposes of Annex XIII to that regulation.

410    Third, in section 6.3.2.8 of the support document, it is concluded, in essence, that, given the high persistence of melamine and the lack of natural removal processes, it is difficult to remove melamine from the environment. Thus, the properties of that substance give rise to concerns as to the fact that yet unknown effects on the environment may develop after long-term exposure. Such concerns form part of the concerns raised by PBT and vPvB substances and may also be raised by persistent and mobile substances such as melamine.

411    Fourth, the determination of the equivalent level of concern is also examined in section 6.3.3 of the support document. The introduction to that section indicates that melamine is considered to be a substance of very high concern in accordance with Article 57(f) of Regulation No 1907/2006 as there is scientific evidence of probable serious effects of melamine on the environment and on human health which give rise to an equivalent level of concern to that raised by other substances referred to in Article 57(a) to (e) of that regulation.

412    Following that introduction, conclusions are presented concerning, inter alia, the intrinsic properties of melamine, the concerns raised by the properties of that substance and by its irreversible and increasing presence in the environment, the difficulties associated with decontamination of the aquatic environment and drinking water sources, the effects on human health and on the environment, and societal concerns. Lastly, an overall assessment of the concerns and a summary of the equivalent level of concern were provided.

413    In conclusion, the support document states that the intrinsic properties of melamine that give rise to an equivalent level of concern are its very high persistence, high mobility in water, potential for transport over long distances and toxicity.

414    In those circumstances, it cannot be alleged, as the applicants do, that ECHA did not ‘even’ attempt to substantiate the equivalence.

415    In the second place, it is necessary, in the context of the examination of the present part of the plea, to respond to the arguments put forward by the applicants, to the effect that there is a safety threshold for melamine which ECHA should have taken into consideration, those arguments having been rejected at the stage of the examination of the first condition laid down in Article 57(f) of Regulation No 1907/2006 (see paragraphs 194 and 231 above). As ECHA has stated, those arguments, put forward principally in the context of the second manifest error of assessment, but also in the context of the third manifest error of assessment, fall within the scope of the analysis of the second condition laid down in Article 57(f) of Regulation No 1907/2006.

416    It should be noted that Regulation No 1907/2006 seeks to reserve the authorisation procedure to certain substances, identified as being of very high concern, not only on account of the seriousness of their dangerous effects on human health or on the environment, but also having regard to other factors. The latter may include, apart from the probability that the serious effects of a substance may occur under the normal conditions of use of that substance, the difficulty of adequately assessing the risks posed by those substances when it is impossible to determine, with the necessary certainty, a derived no-effect level or a predicted no-effect concentration, or indeed the level of concern that those substances engender in the public, the number of persons affected, and the impact of those effects on the lives, and in particular, the professional lives, of the persons affected (judgment of 15 March 2017, Hitachi Chemical Europe and Polynt v ECHA, C‑324/15 P, EU:C:2017:208, paragraph 39).

417    In addition, it must be noted that ECHA has a discretion but is not obliged to take into account information other than that concerning the intrinsic properties of the substances concerned (see judgment of 23 February 2022, Chemours Netherlands v ECHA, T‑636/19, not published, EU:T:2022:86, paragraph 192 and the case-law cited).

418    In that regard, it must be noted that the support document, in section 4 thereof, does mention the existence of tolerable daily intakes established by EFSA and the WHO in 2010 and 2009 respectively. The support document states that those tolerable daily intakes had been determined on the basis of animal data, since the human data were not considered to be sufficiently reliable to set such an intake. Furthermore, the support document notes that the Risk Assessment Committee considered that there were considerable uncertainties regarding the effects in humans at low-dose melamine exposure. Lastly, the support document states that EFSA clarified that the tolerable daily intake for melamine was not appropriate for the protection of consumer health in the event of concomitant exposure to melamine with other substances, including cyanuric acid. Similarly, section 6.3.2.8 of the support document indicates that the WHO stated that the tolerable daily intake for melamine was specific for exposure to melamine alone.

419    The applicants complain, in essence, that ECHA did not take sufficient account of the fact that the WHO and EFSA had set tolerable daily intakes, and that ECHA failed to take account of the existence of health safety standards that had nevertheless been established by taking into consideration the concomitant exposure with cyanuric acid and by adopting a tolerable daily intake lower than that set by EFSA. They consider, moreover, that the epidemiological data submitted during the public consultation demonstrate that the formation of stones at low exposure has not been demonstrated and is implausible and that they provided calculations clearly illustrating the protective nature of the tolerable daily intakes.

420    First, it should be noted, as ECHA has done, that the comments to which the applicants refer, namely those of EMPA and of the Melamine REACH Consortium on the February 2020 proposal for the harmonised classification and labelling of melamine, do not contain, on pages 35 and 36, epidemiological data showing that the formation of stones at low exposure has not been demonstrated and is implausible. Pages 35 and 36 contain only comments submitted in order to criticise the reliability of the studies on which the proposal for harmonised classification and labelling of melamine is intended to be based.

421    As regards the study by Swaen, GMH., ‘Urolithiasis in children and exposure to melamine: A review of the epidemiological literature’, Toxicology Research and Application, 2019, referred to both in the reply and on page 36 of the comments by EMPA and the Melamine REACH Consortium on the February 2020 proposal for the harmonised classification and labelling of melamine, it is sufficient to note that the applicants merely refer to that study without explaining how it would be capable of calling into question the plausibility of ECHA’s factual assessments.

422    Second, as regards the tolerable daily intakes set by the WHO and EFSA and the health safety standards established more specifically by the Federal Republic of Germany and the Kingdom of the Netherlands, it should be noted that the existence of them does not mean that melamine presents no danger to human health or the environment, but only that the exposure of a consumer or the environment to that substance, at the levels considered by the WHO, EFSA and the competent national authorities, is not sufficient to conclude that there is a risk to health (see, to that effect and by analogy, judgment of 20 September 2019, PlasticsEurope v ECHA, T‑636/17, EU:T:2019:639, paragraph 67).

423    In the third and last place, Fritz Egger and the other legal persons whose names are set out in the annex allege infringement of the principle of good administration and of the applicants’ legitimate expectations.

424    According to the case-law, although Article 142(1) and (3) of the Rules of Procedure gives the intervener the right to set out arguments as well as pleas independently, that is in so far as they support the form of order sought by one of the main parties and are not entirely unconnected with the issues underlying the dispute, as established by the applicant and defendant, as that would otherwise change the subject matter of the dispute (see, to that effect, judgments of 23 February 1961, De Gezamenlijke Steenkolenmijnen in Limburg v High Authority, 30/59, EU:C:1961:2, p. 37; of 15 June 2005, Regione autonoma della Sardegna v Commission, T‑171/02, EU:T:2005:219, paragraph 152; and of 2 October 2009, Cyprus v Commission, T‑300/05 and T‑316/05, not published, EU:T:2009:380, paragraph 203).

425    Although the applicants have submitted that ECHA did not examine whether the level of concern raised by melamine was equivalent to that raised by the substances referred to in Article 57(a) to (e) of Regulation No 1907/2006, they have not complained that ECHA departed from its previous administrative practice without justification, nor have they alleged a breach of their legitimate expectations. In those circumstances, the interveners’ argument is not connected to the subject matter of the dispute as established by the main parties and changes the context of the dispute, and therefore it must be rejected as inadmissible, in accordance with the case-law cited in paragraph 424 above.

426    It follows from all of the foregoing that ECHA did not make a manifest error of assessment when assessing the equivalent level of concern in respect of melamine. The eighth part of the first plea must therefore be rejected.

10.    Conclusion on the first plea

427    It follows from all of the foregoing that ECHA made a manifest error of assessment as regards the reproductive toxicity of melamine. Accordingly, the second and third parts of the first plea must be upheld in part.

428    However, it follows from case-law that, where some of the grounds in a decision on their own provide a sufficient legal basis for the decision, any errors in the other grounds of the decision have no effect in any event on its operative part. Moreover, where the enacting terms of an ECHA decision are based on several pillars of reasoning, each of which would in itself be sufficient to justify those terms, that decision should, in principle, be annulled only if each of those pillars is vitiated by an illegality. In such a case, an error or other illegality which affects only one of the pillars of reasoning cannot be sufficient to justify annulment of the decision at issue because that error could not have had a decisive effect on the operative part adopted by the agency which adopted that decision (see judgment of 15 September 2021, France v ECHA, T‑127/20, not published, EU:T:2021:572, paragraph 33 and the case-law cited; see also, by analogy, judgment of 25 October 2017, Greece v Commission, T‑26/16, EU:T:2017:752, paragraph 70).

429    Thus, the only error found in the present case has no effect on the lawfulness, taken as a whole, of the contested decision, since the other intrinsic properties of melamine, namely its persistence, mobility, toxicity and carcinogenicity, are capable of producing serious effects on human health and the environment giving rise to an equivalent level of concern to that of the substances referred to in Article 57(a) to (e) of Regulation No 1907/2006.

430    Thus, it must be concluded that ECHA did not make a manifest error of assessment in finding that melamine met the conditions laid down in Article 57(f) of that regulation.

E.      The third plea in law, alleging infringement of the principle of proportionality

431    The applicants, supported by Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Methanol Holdings (Trinidad) and by Fritz Egger and the other legal persons whose names are set out in the annex, claim that the contested decision is not the most appropriate measure for achieving the objective legitimately pursued by the authorisation procedure, as defined in Title VII of Regulation No 1907/2006.

432    ECHA, supported by the Federal Republic of Germany and the Commission, disputes those arguments.

433    According to settled case-law, the principle of proportionality, which is one of the general principles of EU law and is set out in Article 5(4) TEU, requires that EU measures do not exceed the limits of what is appropriate and necessary in order to attain the objectives legitimately pursued by the legislation in question; when there is a choice between several appropriate measures, recourse must be had to the least onerous, and the disadvantages caused must not be disproportionate to the aims pursued (see, to that effect, judgments of 8 July 2010, Afton Chemical, C‑343/09, EU:C:2010:419, paragraph 45; of 21 July 2011, Etimine, C‑15/10, EU:C:2011:504, paragraph 124; and of 1 February 2013, Polyelectrolyte Producers Group and Others v Commission, T‑368/11, not published, EU:T:2013:53, paragraph 75).

434    As regards judicial review of the conditions referred to in paragraph 433 above, ECHA must be allowed a broad discretion in a field which entails political, economic, social and scientific choices on its part, and in which it is called upon to undertake complex assessments. The legality of a measure adopted in that field can be affected only if the measure is manifestly inappropriate having regard to the objective which the legislature is seeking to pursue (see, to that effect, judgments of 21 July 2011, Etimine, C‑15/10, EU:C:2011:504, paragraph 125, and of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 105).

435    It is apparent from Article 1(1) of Regulation No 1907/2006 that the objective of that regulation is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation. Having regard to recitals 7 and 16 of that regulation, it should be noted that the legislature established the first of those three objectives as the main objective, namely to ensure a high level of protection of human health and the environment (see, to that effect, judgments of 7 March 2013, Rütgers Germany and Others v ECHA, T‑94/10, EU:T:2013:107, paragraph 134 and the case-law cited, and of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 106 and the case-law cited).

436    As regards, more specifically, the aim of the authorisation procedure, of which the identification procedure set out in Article 59 of Regulation No 1907/2006 forms part, Article 55 of that regulation states that its aim is essentially to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that those substances are progressively replaced by suitable alternative substances or technologies where those are economically and technically viable (see judgments of 7 March 2013, Rütgers Germany and Others v ECHA, T‑94/10, EU:T:2013:107, paragraph 134 and the case-law cited, and of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 106 and the case-law cited). Furthermore, as is apparent from recital 69 of Regulation No 1907/2006, the legislature wanted particular attention to be paid to substances of very high concern (judgments of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA, T‑93/10, EU:T:2013:106, paragraph 124; of 30 April 2015, Hitachi Chemical Europe and Others v ECHA, T‑135/13, EU:T:2015:253, paragraph 120; and of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 114).

437    As regards the objective of protecting human health and the environment, it must be stated that the identification of a substance as being of very high concern serves to improve information for the public and professionals as to the risks and hazards incurred and that, consequently, such identification must be regarded as a means of enhancing that protection (see judgments of 7 March 2013, Rütgers Germany and Others v ECHA, T‑94/10, EU:T:2013:107, paragraph 136 and the case-law cited, and of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraph 108 and the case-law cited; see also, by analogy, judgment of 7 July 2009, S.P.C.M. and Others, C‑558/07, EU:C:2009:430, paragraph 49).

438    It is in the light of those considerations that it is necessary to examine the arguments put forward by the applicants.

439    In the first place, the applicants submit that ECHA was not entitled to rely on the judgment of 12 July 2005, Alliance for Natural Health and Others (C‑154/04 and C‑155/04, EU:C:2005:449), in order to claim that the applicants had to demonstrate that the contested decision was manifestly inappropriate, since that judgment concerned different sets of facts.

440    When questioned at the hearing on the scope of their line of argument, the applicants stated that the judgment of 12 July 2005, Alliance for Natural Health and Others (C‑154/04 and C‑155/04, EU:C:2005:449), could not be relied on by ECHA because it referred to the EU legislature.

441    That argument is ineffective, since, in the light of the case-law cited in paragraph 434 above, the applicants are, in any event, required to demonstrate that the contested decision is inappropriate in relation to the objective pursued.

442    In the second place, it must be noted that the identification of a substance as a substance of very high concern is the first stage of the authorisation scheme provided for in Title VII of Regulation No 1907/2006. In that regard, the second stage is the inclusion of the thus identified substances on the list of substances subject to authorisation set out in Annex XIV to that regulation, and the third and final stage concerns the procedure that leads, if appropriate, to the authorisation of a substance of very high concern (see, to that effect, judgment of 15 March 2017, Polynt v ECHA, C‑323/15 P, EU:C:2017:207, paragraph 22).

443    Thus, the contested decision has no immediate bearing on the use of melamine and on its presence in the environment (see, by analogy, judgment of 23 February 2022, Chemours Netherlands v ECHA, T‑636/19, not published, EU:T:2022:86, paragraph 257). Moreover, it is apparent from the procedure set out in Article 58 of Regulation No 1907/2006 that the inclusion of a substance in the candidate list does not automatically entail its inclusion in Annex XIV to that regulation (see, to that effect, judgment of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA, T‑93/10, EU:T:2013:106, paragraph 119).

444    However, as follows from paragraph 437 above, the contested decision, by identifying melamine as a substance of very high concern, contributes to the objective of protecting human health and the environment by improving information for the public and professionals.

445    In those circumstances, it is necessary to reject the applicants’ argument that the authorisation procedure established by Regulation No 1907/2006 covers only industrial sources of melamine, to the exclusion of other sources, with the result that the identification of melamine as a substance of very high concern does not address the concerns raised by exposure to melamine.

446    Such an argument is not capable of demonstrating how the identification of melamine as a substance of very high concern is manifestly inappropriate having regard to the objective pursued by the contested decision, namely to improve information for consumers and professionals with the aim of protecting human health and the environment.

447    For the same reasons, it is necessary to reject the argument, put forward by Fritz Egger and the other legal persons whose names are set out in the annex, to the effect that the identification of melamine as a substance of very high concern does not contribute to the objective of reducing melamine.

448    In the third place, the applicants submit that melamine is used as a monomer meeting the definition of an intermediate substance under Article 3(15) of Regulation No 1907/2006 in 95% of the total volume of production of melamine. Intermediates are, in their view, exempted from the authorisation requirement under Article 2(8)(b) of that regulation. Thus, they argue, the identification of melamine as a substance of very high concern is not capable of achieving the objective of making uses of the substance subject to authorisation.

449    In that regard, it must be pointed out that a substance is identified as a substance of very high concern solely on account of the hazards arising from the intrinsic properties of that substance and not because of its uses. Uses may be taken into account at the stage of the inclusion in Annex XIV to Regulation No 1907/2006, or at the stage of the granting of an authorisation pursuant to Article 60(2) or (4) of that regulation (see judgment of 23 February 2022, Chemours Netherlands v ECHA, T‑636/19, not published, EU:T:2022:86, paragraph 260 and the case-law cited).

450    As a result, contrary to what the applicants submit, even the mere fact that melamine is mainly used only as an intermediate does not render the inclusion of that substance on the candidate list inappropriate (see, by analogy, judgment of 20 September 2019, PlasticsEurope v ECHA, T‑636/17, EU:T:2019:639, paragraph 207).

451    That finding is supported by the fact that, according to the case-law of the Court of Justice, a substance may be identified as a substance of very high concern even if none of the known uses of the substance falls within the scope of the authorisation procedure laid down in Chapters 2 and 3 of Title VII of Regulation No 1907/2006 (see, to that effect, judgment of 25 October 2017, PPG and SNF v ECHA, C‑650/15 P, EU:C:2017:802, paragraphs 62, 63 and 71). It is therefore necessary to reject a fortiori the applicants’ line of argument that the contested decision is inappropriate because the substance at issue is registered only for a minimal part of its use which, following potential inclusion in Annex XIV to Regulation No 1907/2006, would be subject to an authorisation requirement.

452    For the same reasons, it is necessary to reject the argument of Fritz Egger and the other legal persons whose names are set out in the annex, to the effect that it is not appropriate to identify melamine as a substance of very high concern since it serves as an alternative to formaldehyde. Such an argument refers to the use of melamine and not to its intrinsic properties.

453    In the fourth place, the applicants state that the competent German authority which prepared the dossier drawn up in accordance with Annex XV accepted that the identification of the substance as a substance of very high concern might not be effective as a risk management measure. Moreover, the Republic of Austria abstained from voting because of the lack of any clearly identified management measure following the identification of melamine as a substance of very high concern.

454    In that regard, it is sufficient to note that the identification of a substance of very high concern does not constitute a risk management measure. Risk management measures are the measures put in place for the adequate control of the risks identified in the chemical safety assessment, as can be inferred from Article 14(6) of Regulation No 1907/2006. In other words, risk management measures are the means of action, aimed at reducing or preventing the exposure of humans (including workers and consumers) and the environment to the substance, as follows from section 5.1.1 of Annex I to that regulation.

455    In any event, in so far as the applicants’ argument must be understood as claiming that risk management measures cannot be adopted following the identification of melamine as a substance of very high concern, it is sufficient to note that the identification of a substance as a substance of very high concern is carried out solely on account of the hazards arising from the intrinsic properties of that substance.

456    The applicants’ argument must therefore be rejected.

457    In the fifth place, Fritz Egger and the other legal persons whose names are set out in the annex state that melamine emissions could have been reduced by prescribing the use of wastewater treatment techniques, which are technically feasible, already at supplier level. In that context, it would have been less restrictive and much more effective to set quantitative emission limits at the source of entry or to impose a mandatory wastewater treatment directly. In addition, reporting and monitoring obligations could have been established to ensure the effectiveness and development of wastewater treatment.

458    On that point, it should be recalled that it follows from Article 60(2) of Regulation No 1907/2006 that the fact that the negative effects associated with the use of a substance can be controlled adequately by way of risk management measures does not preclude its identification as a substance of very high concern. That is also confirmed by Article 58(2) of Regulation No 1907/2006 (see paragraph 193 above).

459    Moreover, according to the case-law, risk-management measures proposed under Article 14(6) of Regulation No 1907/2006 are not less onerous measures than the identification of a substance as being of very high concern. Such measures do not constitute appropriate measures for achieving the objective of progressively replacing substances of very high concern by suitable alternative substances or technologies, where those are economically and technically viable, or for achieving the objective of paying particular attention to substances of very high concern (see paragraph 436 above) (see, to that effect, judgments of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA, T‑93/10, EU:T:2013:106, paragraphs 124 and 125; of 30 April 2015, Hitachi Chemical Europe and Others v ECHA, T‑135/13, EU:T:2015:253, paragraphs 120 and 122; and of 30 April 2015, Polynt and Sitre v ECHA, T‑134/13, not published, EU:T:2015:254, paragraphs 114 and 116).

460    Therefore, the argument of Fritz Egger and of the other legal persons whose names are set out in the annex is not capable of demonstrating that the contested decision is manifestly inappropriate.

461    In the sixth place, the applicants submit that the main effects of the identification of a substance as a substance of very high concern are the information requirements triggered by Articles 7, 31 and 33 of Regulation No 1907/2006. Thus, in their view, it would have been more appropriate to address the concern raised by the substance in the context of Regulation No 1272/2008, which was to be amended by Delegated Regulation 2023/707, introducing new hazard classes into Regulation No 1272/2008.

462    It should be noted that the fact that ECHA decided to identify melamine as a substance of very high concern, despite the forthcoming adoption of Delegated Regulation 2023/707, falls within its broad discretion and cannot, as such, call into question the appropriateness of the contested decision. The appropriateness must be assessed, as ECHA submits, in the light of the legal framework that was applicable at the time when the contested decision was adopted, and not in the light of any future legislation. In any event, the objectives pursued by Regulations No 1907/2006 and No 1272/2008 are different, and therefore the appropriateness of the contested decision, which was adopted solely on the basis of Regulation No 1907/2006, must be examined only in the light of the latter regulation and the objectives which it seeks to pursue. The applicants’ argument must therefore be rejected.

463    In the seventh and last place, as regards the applicants’ argument that it would have been more appropriate to conclude, first of all, the ongoing discussions within ECHA’s Endocrine Disruptor Expert Group, it is sufficient to note that that argument does not seek to challenge the appropriateness of the contested decision, which must be analysed in the light of the objective pursued by its adoption, but seeks to challenge the time of its adoption and ECHA’s assessment of the equivalent level of concern.

464    In any event, it must be recalled that melamine was identified as a substance of very high concern because of its environmental fate properties, combined with adverse effects on human health and the environment, and not on the basis of its potential endocrine disrupting effects.

465    In the light of all of the foregoing, the third plea must be rejected.

F.      The fourth plea in law, alleging infringement of the precautionary principle

466    The applicants, supported by Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Methanol Holdings (Trinidad) and by Fritz Egger and the other legal persons whose names are set out in the annex, submit that ECHA erred in law by applying the precautionary principle in its assessment of the evidence.

467    According to the applicants, the precautionary principle should not be invoked as a ‘trump card’ allowing ECHA not to comply with its obligation under Article 57(f) of Regulation No 1907/2006 or with the principle of scientific excellence consisting of relying on sound scientific evidence.

468    In addition, they argue that ECHA wrongly applied the precautionary principle to alleged uncertainties relating to the presence of melamine in sources of drinking water. In that regard, ECHA made, in their view, a manifest error of assessment in concluding that melamine was increasingly present in sources of drinking water.

469    ECHA, supported by the Federal Republic of Germany and the Commission, disputes those arguments.

470    As a preliminary point, it should be noted that it is apparent from Article 1(3) of Regulation No 1907/2006 that the provisions of that regulation are based on the precautionary principle.

471    The precautionary principle entails that, where there is uncertainty as to the existence or extent of risks to human health, protective measures may be taken without having to wait until the reality and seriousness of those risks become fully apparent. Where it proves to be impossible to determine with certainty the existence or extent of the alleged risk because the results of studies conducted are inconclusive, but the likelihood of real harm to public health persists should the risk materialise, the precautionary principle justifies the adoption of restrictive measures (see judgment of 16 June 2022, SGL Carbon and Others v Commission, C‑65/21 P and C‑73/21 P to C‑75/21 P, EU:C:2022:470, paragraph 96 and the case-law cited).

472    In the present case, it must be noted that, in section 6.3.3 of the support document, ECHA analysed the existence of a societal concern. It stated, without being contradicted on that point by the applicants, that efforts to purify drinking water sources should be as low as possible. In addition, ECHA noted that the combination of melamine’s intrinsic properties, namely its persistence and mobility, renders ineffective common and widely applied water purification techniques, such as river bank filtration and soil infiltration for groundwater enrichment. Similarly, water decontamination can be carried out only by means of advanced water purification techniques, the costs of which are mainly borne by society. Lastly, due to the probable serious effects of melamine on human health, society has to bear costs related to medical treatment.

473    In the context of the present plea, the applicants merely state that health safety standards for drinking water have been imposed and that the actual monitoring data show that the concentrations of melamine in water are not increasing, but are decreasing.

474    In so doing, they present arguments similar to those already put forward in the context of their first plea, alleging infringement of Article 57(f) of Regulation No 1907/2006 and alleging manifest errors of assessment, and more particularly in the context of the complaints relating to the failure to take into account the distribution of melamine from water to soil and the data concerning the substance, and relating to the manifest error of assessment vitiating the conclusion that melamine is ‘widespread’ or ubiquitous in water or that there is ‘continuous exposure via water and potentially increasing concentrations’ examined, respectively, in paragraphs 316 to 329 and 331 to 356 above.

475    Since those complaints have been rejected and the applicants have not put forward any other arguments in support of their fourth plea, the fourth plea must be rejected.

G.      The seventh plea in law, alleging misuse of powers

476    The applicants, supported by Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Methanol Holdings (Trinidad) and by Fritz Egger and the other legal persons whose names are set out in the annex, maintain that the objective of the contested decision was to identify melamine as a substance of very high concern on the basis of its alleged properties as a persistent, mobile and toxic substance and as a very persistent and very mobile substance and, consequently, to obtain recognition of the general applicability of those properties. In their submission, that enables ECHA to obtain regulatory acceptance of those criteria within the scope of Article 57(f) of Regulation No 1907/2006 and to use, to that end, the case of melamine as a ‘test case’.

477    ECHA, supported by the Federal Republic of Germany and the Commission, disputes those arguments.

478    According to settled case-law, the concept of ‘misuse of powers’ refers to cases where an administrative authority has used its powers for a purpose other than that for which they were conferred on it. A decision may amount to a misuse of powers only if it appears, on the basis of objective, relevant and consistent indicia, to have been taken with the exclusive purpose, or at any rate the main purpose, of achieving an end other than that stated (see judgment of 19 June 2009, Qualcomm v Commission, T‑48/04, EU:T:2009:212, paragraph 161 and the case-law cited).

479    In the present case, the applicants submit, in essence, that ECHA wished to make the decision identifying melamine as a substance of very high concern a decision of principle, with the result that ECHA misused its powers.

480    In support of their argument, the applicants rely, first, on their contention that melamine is mainly used as an intermediate, with the result that 95% of its uses fall outside the scope of Title VII of Regulation No 1907/2006.

481    As follows from paragraphs 448 to 451 above, the identification of a substance as a substance of very high concern depends only on its intrinsic properties, and therefore, ultimately, its use as an intermediate is irrelevant at that stage. Thus, in so far as the identification of an intermediate as a substance of very high concern is possible, the mere fact that melamine is an intermediate cannot constitute evidence of a misuse of powers.

482    Second, the applicants observe that the harmonised classification and labelling of melamine, in accordance with Regulation No 1272/2008, were already envisaged in August 2017, but that it was not until the end of 2020, that is, after melamine had been identified for the first time as a potential persistent, mobile and toxic substance by the competent German authority, namely in May 2017, that the classifications as a substance with STOT RE 2 and Carc 2 properties were adopted. In their view, the main reason for that classification was to allow for the rapid identification of melamine as a substance of very high concern.

483    ECHA does not call into question the chronology of the facts as set out by the applicants. That being so, even if the harmonised classification and labelling of melamine took place after it had been envisaged that melamine would be identified as a persistent, mobile and toxic substance, the fact remains that melamine is the subject of the classifications, as a substance with STOT RE 2 and Carc 2 properties, that are in force. In that regard, as stated in paragraph 183 above, the applicants’ arguments cannot seek to call into question the legality of an act which did not give rise to the bringing of an action for annulment within the prescribed period.

484    In those circumstances, the applicants’ argument, namely that the scientific assessment of melamine by the competent German authority is biased, is merely speculative, as ECHA has stated.

485    Third, Fritz Egger and the other legal persons whose names are set out in the annex argue that ECHA wished to act as quickly as possible against persistent substances without complying with the corresponding legal requirements. In addition to the unlawful classification of melamine as a substance of very high concern, that phenomenon could also be observed with the introduction of new hazard classes under Regulation No 1272/2008, through the adoption of Delegated Regulation 2023/707. However, in their view, the adoption of that delegated regulation did not fall within the Commission’s powers.

486    The argument thus put forward by Fritz Egger and the other legal persons whose names are set out in the annex must be rejected as inadmissible in accordance with the case-law cited in paragraph 424 above. The present plea alleges misuse of powers by ECHA in the adoption of the contested decision, and does not allege misuse of powers by the Commission when it adopted Delegated Regulation 2023/707, which, moreover, is not the subject of the present proceedings and did not serve as a basis for the adoption of the contested decision.

487    In those circumstances, the seventh plea must be rejected.

H.      Conclusion on the action as a whole

488    Apart from the manifest error of assessment made by ECHA as regards the reproductive toxicity of melamine, none of the pleas raised by the applicants is upheld.

489    In those circumstances and in the light of the considerations set out in paragraphs 428 to 430 above, the action must be dismissed in its entirety.

IV.    Costs

490    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. In the present case, since the applicants have been unsuccessful, they must be ordered to pay the costs, in accordance with the form of order sought by ECHA.

491    Under Article 138(1) of the Rules of Procedure, the Member States and institutions which have intervened in the proceedings are to bear their own costs. The Federal Republic of Germany and the Commission shall therefore bear their own costs.

492    According to Article 138(3) of the Rules of Procedure, the Court may order an intervener other than those referred to in Article 138(1) and (2) of those rules to bear its own costs. Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Methanol Holdings (Trinidad), Fritz Egger and the other legal persons whose names are set out in the annex shall therefore bear their own costs.

On those grounds,

THE GENERAL COURT (Fifth Chamber)

hereby:

1.      Dismisses the action;

2.      Orders LAT Nitrogen Piesteritz GmbH, formerly Borealis Agrolinz Melamine Deutschland GmbH, and Cornerstone Chemical Co., to bear their own costs and pay those incurred by the European Chemicals Agency (ECHA);

3.      Orders the Federal Republic of Germany and the European Commission to bear their own costs;

4.      Orders Grupa Azoty Zakłady Azotowe Puławy S.A., OCI Nitrogen BV and Methanol Holdings (Trinidad) Ltd to bear their own costs;

5.      Orders Fritz Egger GmbH & Co. OG and the other interveners whose names are set out in the annex to bear their own costs.

Svenningsen Mac Eochaidh Martín y Pérez de Nanclares

Delivered in open court in Luxembourg on 9 July 2025.

V. Di Bucci S. Papasavvas

Registrar President

Table of contents

I. Background to the dispute

II. Forms of order sought

III. Law

A. The second plea in law, alleging infringement of the obligation to state reasons

B. The sixth plea in law, alleging that ECHA acted ultra vires and infringed Article 59(8) of Regulation No 1907/2006

1. The first part of the sixth plea, alleging that Article 19(5) of the MSC Rules of Procedure is unlawful

2. The second part of the sixth plea, alleging a lack of unanimous agreement

3. The third part of the sixth plea, alleging infringement of Article 85(8) of Regulation No 1907/2006

4. Conclusion on the sixth plea

C. The fifth plea in law, alleging infringement of the applicants’ right to be heard

1. The first part of the fifth plea, alleging infringement of Article 41 of the Charter

2. The second part of the fifth plea, alleging an error of law as regards the scope of Article 59(4) of Regulation No 1907/2006

3. The third part of the fifth plea, alleging infringement of the right recognised in Article 59(4) of Regulation No 1907/2006

4. Conclusion on the fifth plea

D. The first plea in law, alleging infringement of Article 57(f) of Regulation No 1907/2006 and manifest errors of assessment

1. Preliminary observations

2. The first part of the first plea, alleging a manifest error of assessment, in that ECHA relied on properties, not constituting ‘hazards’, which were deemed to satisfy the condition of ‘effects’ for the purposes of the application of Article 57(f) of Regulation No 1907/2006

3. The second part of the first plea, alleging a manifest error of assessment in that ECHA wrongly concluded that the STOT RE 2 and Carc 2 properties constituted ‘effects’ within the meaning of Article 57(f) of Regulation No 1907/2006

(a) The first complaint, alleging that ECHA relied solely on the classification of melamine under Regulation No 1272/2008 in order to draw conclusions on the seriousness of its effects

(b) The second complaint, alleging that the urinary tract toxicity and carcinogenicity of melamine are not due to its intrinsic properties

(c) The third complaint, alleging that ECHA ignored the fact that health safety standards and tolerable daily intakes had been set in order to limit the concentration of melamine in drinking water

(d) The fourth complaint, alleging that ECHA failed to establish the seriousness in respect of reproductive toxicity

(e) Conclusion on the second part of the first plea

4. The third part of the first plea, alleging a manifest error of assessment in that ECHA wrongly concluded that the substance produced ‘serious’ effects on the environment

(a) The first complaint, relating to reproductive toxicity

(b) The second complaint, relating to the effects of melamine on fish and aquatic invertebrates

(c) The third complaint, relating to the endocrine disrupting properties of melamine

(d) Conclusion on third part of the first plea

5. The fourth part of the first plea, alleging a manifest error of assessment in that ECHA did not rely on certain information and considered that the available evidence validly supported the conclusions reached on the environmental fate properties of the substance at issue

(a) The first complaint, alleging a manifest error of assessment as regards the adsorption and desorption properties of melamine

(b) The second complaint, alleging a failure to take into account the results of the Pote et al. study

(c) The third complaint, alleging a failure to take into account the impact of the ionizing properties of melamine on the derived ‘log Koc’ values

(d) The fourth complaint, alleging (i) a failure to take into account the distribution of melamine from water to soil, (ii) a failure to take into account data relating to that substance, and (iii) a manifest error of assessment resulting from the use of genric considerations instead of data relating to the substance at issue

(e) The fifth complaint, alleging a manifest error of assessment vitiating the conclusion that melamine is ‘widespread’ or ubiquitous in water or that there is ‘continuous exposure via water and potentially increasing concentrations’

(f) The sixth complaint, alleging a manifest error in the assessment of the information relating to the potential for long-range transport

(g) The argument put forward by Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Methanol Holdings (Trinidad)

(h) Conclusion on the fourth part of the first plea

6. The fifth part of the first plea, alleging a manifest error of assessment in that ECHA based the contested decision on ‘yet unknown effects’

7. The sixth part of the first plea, alleging a manifest error of assessment in that ECHA failed to establish that the alleged effects constitute ‘serious effects’

8. The seventh part of the first plea, alleging a manifest error of assessment in that ECHA failed to establish that the alleged effects were ‘probable’

9. The eighth part of the first plea, alleging a manifest error of assessment in that ECHA did not examine whether the level of concern deemed to be posed by the substance at issue was ‘equivalent’ to the level of concern caused by substances meeting the criteria of Article 57(a) to (e) of Regulation No 1907/2006

10. Conclusion on the first plea

E. The third plea in law, alleging infringement of the principle of proportionality

F. The fourth plea in law, alleging infringement of the precautionary principle

G. The seventh plea in law, alleging misuse of powers

H. Conclusion on the action as a whole

IV. Costs

*      Language of the case: English.

1      The present judgment is the subject of publication in extract form.

2      The list of the other interveners is annexed only to the version sent to the parties and to the addressees referred to in Article 55 of the Statute of the Court of Justice of the European Union.