JUDGMENT OF THE GENERAL COURT (Fifth Chamber)

9 July 2025 (*)

( 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 – Right to be heard – Principle of good administration – Article 57 of Regulation No 1907/2006 – Manifest error of assessment – Ultra vires – Proportionality )

In Case T‑163/23,

Fritz Egger GmbH & Co. OG, established in St. Johann in Tirol (Austria), and the other applicants whose names are set out in the annex, (1) represented by M. Ahlhaus, lawyer,

applicants,

supported by

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

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

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

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

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

and by

Sonae Arauco, SA, established in Madrid (Spain), and the other interveners whose names are set out in the annex, (2) represented by F. Niermeier 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 K. Mifsud‑Bonnici and D. Milanowska, 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, Fritz Egger GmbH & Co. OG and the other legal persons whose names are set out in the annex, 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 eight undertakings established in Belgium, Germany, Austria and Switzerland, and are regarded as downstream users of melamine within the meaning of Article 3(13) of Regulation No 1907/2006.

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. The applicants, through the European Melamine Producers Association (EMPA) and the European Panel Federation (EPF), submitted their 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 claim that the Court should:

–        annul the contested decision;

–        order ECHA to pay the costs.

10      LAT Nitrogen Piesteritz GmbH, formerly Borealis Agrolinz Melamine Deutschland GmbH, Grupa Azoty Zakłady Azotowe Puławy S.A., OCI Nitrogen BV and Cornerstone Chemical Co., 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      Sonae Arauco, SA, and the other legal persons whose names are set out in the annex, intervening in support of the form of order sought by the applicants, submit that the Court should:

–        annul the contested decision.

–        order ECHA to pay the costs incurred by them.

12      ECHA contends that the Court should:

–        dismiss the action;

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

–        order LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical, Sonae Arauco and the other legal persons whose names are set out in the annex to bear their own costs.

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

–        dismiss the action;

–        order the applicants to pay the costs.

III. Law

14      In support of their action, the applicants raise five pleas in law, alleging (i) infringement of the principle of good administration; (ii) infringement of Article 57(f) of Regulation No 1907/2006, resulting from a manifest error of assessment and from ECHA acting ultra vires; (iii) infringement of Article 57(f) of Regulation No 1907/2006, resulting from a manifest error of assessment and a failure to demonstrate that the conditions laid down by that provision had been met; (iv) infringement of their rights to be heard and to submit comments; and (iv) infringement of the principle of proportionality.

15      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 fourth and first pleas, followed by the second, third and fifth pleas.

16      First of all, the general argument put forward by Sonae Arauco and the other legal persons whose names are set out in the annex, to the effect that, as follows from Annex I.1 to their statement in intervention, ECHA misrepresented the arguments relied on in the application, must be rejected as inadmissible. In so doing, they merely make a general reference to Annex I.1.

17      According to the case-law, applicable by analogy to statements in intervention, 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 (see judgment of 15 September 2021, Laboratoire Pareva and Biotech3D v Commission, T‑337/18 and T‑347/18, EU:T:2021:594, paragraph 77 and the case-law cited).

A.      The fourth plea in law, alleging infringement of the applicants’ right to be heard and of their right to submit comments

18      The applicants, supported by LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical, Sonae Arauco and the other legal persons whose names are set out in the annex, submit that their rights to be heard and to submit comments on new evidence, which was produced only before the MSC, were infringed. In essence, they submit that they were not heard on all the matters of fact and law underlying the contested decision.

19      When questioned at the hearing on the scope of their plea, the applicants stated that they were relying on an infringement of Article 59(4) of Regulation No 1907/2006.

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

21      As a preliminary point, it should be noted that the applicants consider that they have a genuine right to be heard, guaranteed by Article 59(4) of Regulation No 1907/2006.

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

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

23      The parties disagree on the scope of Article 59(4) of Regulation No 1907/2006. While the applicants, supported by LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical, and by Sonae Arauco 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.

24      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.

25      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.

26      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 the applicants submit, 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.

27      In that regard, although ECHA, in response to the statement in intervention of Sonae Arauco and of the other legal persons whose names are set out in the annex, attempts to place that statement 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.

28      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.

29      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).

30      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.

31      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.

32      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 this 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).

33      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).

34      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.

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

2.      The second part of the fourth plea, alleging infringement of the right recognised in Article 59(4) of Regulation No 1907/2006

36      It should be noted, first of all, that it is common ground between the parties that 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, and that the applicants, through the EMPA and the EPF, did submit comments in the context of that consultation.

37      However, first, the applicants argue that their right to submit comments was infringed in so far as they were unable to comment on the amendments, which were nevertheless substantial, made to the dossier drawn up in accordance with Annex XV when the support document was adopted.

38      That argument must be rejected on two grounds. On the one hand, the applicants have not specified the passages in the support document which differ from the dossier drawn up in accordance with Annex XV, and on which they consider that they should have been given the opportunity to submit comments. Moreover, if they intend to refer to the passages which they criticise in the context of the third part of the third plea, it must be stated the latter part is rejected (see paragraph 252 below), with the result that the line of argument put forward in the context of the present plea cannot succeed either.

39      On the other hand and in any event, the amendments made in the support document reflect only the evolution of the considerations generated by the public consultation and are inherent in a procedure, such as that laid down in Article 59 of Regulation No 1907/2006, that takes place in several stages (see, to that effect, judgment of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA, T‑93/10, EU:T:2013:106, paragraph 29). In those circumstances, it cannot be expected that the support document reproduce, without amendments, the findings and conclusions in the dossier drawn up in accordance with Annex XV. Nor can ECHA be expected to allow interested parties, such as the applicants, to submit their comments on the planned amendments when such a requirement is not laid down under Article 59 of Regulation No 1907/2006.

40      Second, the applicants submit that their right to submit comments was infringed, since the support document relied 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’), which was not produced during the public consultation, but was produced by the dossier submitter or by a member of the MSC in response to comments made during that public consultation.

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

42      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).

43      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.

44      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.

45      Consequently, the applicants’ argument cannot succeed.

46      The other arguments put forward by the applicants in order to demonstrate that it is not possible for ECHA to introduce, in the support document, a new study which was not produced during the public consultation cannot call into question that conclusion.

47      First, the applicants submit that no provision of Regulation No 1907/2006 allows the MSC to be given the right to produce or introduce new scientific evidence, since its role is limited to evaluating the proposal submitted to it and to reaching an agreement, or to referring the case to the Commission.

48      That argument is not persuasive. As provided for in Article 76(1)(e) of Regulation No 1907/2006, the MSC is responsible for resolving potential divergences of opinions on proposals for identification of substances of very high concern to be subjected to the authorisation procedure. Consequently, its role cannot be regarded as limited to evaluating that proposal and to reaching an agreement. In those circumstances, there is nothing to prevent the MSC from accepting the introduction of new scientific evidence in order to respond to the comments submitted during the public consultation.

49      In addition, the fact that comments were made, as regards the toxicity of melamine to terrestrial organisms, during the public consultation suggests that there were differences of opinion on that subject, if only on whether it was appropriate to address it in the context of the support document. In those circumstances, ECHA or the MSC cannot be criticised for having addressed that subject following that public consultation and for having provided a substantiated response to it in the support document.

50      Second, the applicants claim that, if it were accepted that the dossier submitter were entitled to introduce new scientific evidence, it would be possible to circumvent the main objectives of the public consultation referred to in Article 59(4) of Regulation No 1907/2006. They argue that the submitter is not permitted to introduce new evidence or a new justification for maintaining a dossier that proves to be incomplete following the public consultation.

51      That argument is also not persuasive. First of all, it must be noted that there is a certain contradiction in the applicant’s line of argument, because they accept that scientific evidence provided by interested parties during the public consultation can be taken into consideration, even if all the interested parties have not submitted comments on that evidence. However, such evidence can also be used to reinforce certain findings or conclusions reached in the dossier drawn up in accordance with Annex XV. Thus, there is no fundamental difference between scientific evidence submitted by an interested party and scientific evidence produced in response to comments received that would justify the former being taken into account, but not the latter.

52      Next, it must be noted that the study on birds was introduced in order to provide a substantiated response to comments received during the public consultation. It was therefore not a question of remedying the serious shortcomings of a dossier, or of circumventing the objectives of the public consultation, but of supplementing the dossier on a very specific point.

53      In that regard, the applicants’ argument that the author of a dossier could deliberately omit existing scientific data concerning decisive or critical points, and thus cause an objection to be raised on that point during the public consultation, and then submit the data after that public consultation, is purely speculative.

54      Furthermore, the Court has already accepted that ECHA was entitled to rely, for the identification of a substance, on elements not mentioned in the dossier drawn up in accordance with Annex XV (see, to that effect, judgments of 7 March 2013, Rütgers Germany and Others v ECHA, T‑94/10, EU:T:2013:107, paragraphs 84 to 88; of 7 March 2013, Cindu Chemicals and Others v ECHA, T‑95/10, EU:T:2013:108, paragraphs 91 to 95; and of 7 March 2013, Rütgers Germany and Others v ECHA, T‑96/10, EU:T:2013:109, paragraphs 85 to 89). Moreover, to accept the opposite view would be to disregard the fact that the procedure laid down in Article 59 of Regulation No 1907/2006, consisting of the identification of the substances referred to in Article 57 of that regulation, takes place in several stages (judgments of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA, T‑93/10, EU:T:2013:106, paragraph 29; of 7 March 2013, Cindu Chemicals and Others v ECHA, T‑95/10, EU:T:2013:108, paragraph 37; and of 7 March 2013, Rütgers Germany and Others v ECHA, T‑96/10, EU:T:2013:109, paragraph 31), but also to deprive the public consultation of any useful effect, since ECHA would then be legally prevented from taking into consideration the elements presented during that phase (see, to that effect, judgment of 9 June 2021, Exxonmobil Petroleum & Chemical v ECHA, T‑177/19, not published, EU:T:2021:336, paragraph 236).

55      Lastly, the applicants maintain that, if they had had the opportunity to comment on the study on birds, they would have been able to develop arguments in favour of a different conclusion in connection with the assessment of the effects on the environment in the terrestrial sphere.

56      In so doing, they seek to demonstrate that the result might have been different if they had been heard, and thus attempt to rely on the case-law developed in relation to the right to be heard (see, to that effect, judgment of 12 July 2023, IFIC Holding v Commission, T‑8/21, EU:T:2023:387, paragraph 123 and the case-law cited).

57      Apart from the fact that that case-law is not relevant in the present case, since the applicants do not have a right to be heard, it should be noted that 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.

58      Third, the applicants submit that their right to submit comments was infringed since they did not participate in the MSC meeting. In addition, they state no representative of the EPF attended that meeting as an observer.

59      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.

60      Thus, without it being necessary to consider whether the applicants had to submit and submitted a request in order to participate in the MSC meeting as observers, it is sufficient to note, first, that an invitation to an MSC meeting is merely a possibility left to the discretion of the members of the MSC and, second, that that participation differs from the right to submit comments as provided for in Article 59(4) of Regulation No 1907/2006. Consequently, the applicants are not entitled to claim that their right to submit comments was infringed in so far as they did not participate in the MSC meeting.

61      In the third place, LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical raise additional arguments in order to demonstrate that the applicants’ rights to be heard and to submit comments were infringed.

62      First, the interveners submit that the interested parties were not given the opportunity to submit their comments on the report published by the Miljødirektoratet (Environment Agency, Norway) in 2020, entitled ‘Screening programme 2019 – Suspected PBT compounds’, since it was produced during the public consultation.

63      It must be stated that, contrary to what is submitted by LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical, 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.

64      Second, LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical submit that, during the public consultation, ECHA unduly restricted the points on which they could submit their comments. Similarly, at the meeting of the MSC, the intervention of their representative was unduly limited. They infer from that that their right to be heard was infringed.

65      In that regard, it should be noted that, in so doing, LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical raise a new plea in law, alleging infringement of their own right to be heard.

66      According to the case-law, although Article 142(1) and (3) of the Rules of Procedure of the General Court gives the intervener the right to set out arguments as well as pleas independently, that is in so far as that 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).

67      It is true that the arguments raised by LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical are not entirely unconnected with the fourth plea raised by the applicants since those arguments relate to the right to be heard.

68      However, even if it were accepted that the arguments raised by LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical are admissible on that basis, it should be recalled that infringement of an individual right may be relied on only by the person whose right has allegedly been infringed, but not by third parties (see, to that effect, judgment of 19 September 2019, Zhejiang Jndia Pipeline Industry v Commission, T‑228/17, EU:T:2019:619, paragraphs 31 and 36 and the case-law cited).

69      In those circumstances, a plea alleging infringement of the interveners’ right to be heard or of their right to submit comments is inadmissible. Otherwise, it would mean that the contested decision could be annulled on the basis of the infringement of the right of third parties.

70      It follows from all of the foregoing that the second part of the fourth plea must be rejected.

3.      Conclusion on the fourth plea

71      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 Regulation No 1907/2006, or in claiming that, in the present case, their right to submit comments was infringed.

72      The fourth plea must therefore be rejected in its entirety.

B.      The first plea in law, alleging infringement of the principle of good administration

73      The applicants, supported by LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical, and by Sonae Arauco and the other legal persons whose names are set out in the annex, complain that ECHA failed to establish the legal basis for the contested decision with a level of detail that would satisfy the conditions laid down in Article 57(f) of Regulation No 1907/2006 and thus infringed the principle of good administration. In that sense, they argue that neither the dossier drawn up in accordance with Annex XV nor the support document satisfy the conditions for the identification of substances of very high concern on the basis of Article 57(f) of Regulation No 1907/2006.

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

75      In support of their first plea, the applicants claim, in essence, that ECHA did not formally compare the level of concern raised by melamine with that raised by the other substances referred to in Article 57(a) to (e) of Regulation No 1907/2006. That formal comparison is provided for by the basic model of dossiers drawn up in accordance with Annex XV to that regulation relating to proposals for classification of substances of very high concern (‘the basic model’) and by the document entitled ‘Identification of substances as substances of very high concern due to equivalent level of concern to [substances that are carcinogenic, mutagenic or toxic for reproduction] – (Article 57(f)) – sensitisers as an example’ (‘the guidance document’). They infer from that that there was an infringement of the principle of good administration, since ECHA departed from its usual practice, as well as an infringement of their legitimate expectations.

76      As a preliminary point, it should be noted that the applicants stated, in the reply, that the arguments put forward in respect of the first plea focused on the formal requirements that they allege ECHA failed to comply with despite its established administrative practice. It is therefore not a question, in the context of the first plea, of ascertaining whether, in fact, the level of concern raised by melamine was equivalent to that raised by the other substances referred to in Article 57(a) to (e) of Regulation No 1907/2006.

77      The applicants’ first plea is based on the premiss that the support document does not contain an analysis of the levels of concern raised by melamine and by the other substances referred to in Article 57(a) to (e) of Regulation No 1907/2006.

78      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, since melamine is classified as a substance with specific target organ toxicity properties at repeated exposure category 2 (‘STOT RE 2 properties’), it meets the toxicity criteria for persistent, bioaccumulative and toxic substances (‘PBT substances’) within the meaning of Annex XIII to that regulation.

79      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 very persistent and very bioaccumulative substances (‘vPvB substances’) and may also be raised by persistent and mobile substances such as melamine.

80      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.

81      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.

82      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.

83      In those circumstances, contrary to what the applicants submit, ECHA did examine the level of concern raised by melamine in comparison with that raised by the other substances referred to in Article 57(a) to (e) of Regulation No 1907/2006.

84      That conclusion cannot be called into question by the arguments put forward by the applicants.

85      In the first place, the applicants put forward a series of arguments criticising ECHA for not having provided more explanations as to why melamine could have given 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. In particular, they consider that the support document did not provide any argument explaining why the difficulties in putting an end to exposure and removing the substance from the environment were equivalent to the concerns relating to PBT substances or vPvB substances when melamine had not been considered bioaccumulative. They also submit that, as regards the other properties of melamine and the related effects on the environment, neither the dossier drawn up in accordance with Annex XV nor the support document provided a comparison with the substances referred to in Article 57(a) to (e) of that regulation.

86      In so doing, they are in fact seeking to challenge the assessment carried out by ECHA which they consider, in essence, to be insufficient. Those arguments are therefore ineffective in the context of the present plea, as defined in paragraph 76 above.

87      In the second place, according to the applicants, neither the dossier drawn up in accordance with Annex XV nor the support document complied with the requirements laid down in the basic model and the guidance document for the purposes of the analysis of the equivalent level of concern, with the result that, in their view, ECHA departed from its usual practice and infringed the principle of good administration.

88      First, it should be noted that the applicants do not call into question the fact that the formal structure of the support document, as with that of the dossier drawn up in accordance with Annex XV, does comply with the formal structure established in the basic model. In that respect, they acknowledge that the dossier drawn up in accordance with Annex XV and the support document contain a section, namely section 6.3, entitled ‘Assessment under Article 57(f)’ of Regulation No 1907/2006. Section 6.3 of the dossier drawn up in accordance with Annex XV and of the support document does not depart, in its purely formal presentation, from what is provided for in the basic model.

89      Second, it must be stated that, as regards the basic model, although it gives general indications as to the type of comments to be provided in the context of section 6.3 of the dossier drawn up in accordance with Annex XV and of the support document, it is not intended, and cannot, provide an exhaustive list of all the points to be specifically addressed in the context of the dossier drawn up in accordance with Annex XV and of the support document. In that respect, it provides general rules which the competent national authorities and ECHA are required to apply by adapting them to the specific examination which they must carry out. That is particularly reflected in the broad wording of the discussion points that are envisaged when the level of concern raised by a substance with regard to human health or the environment is to be assessed. It follows, first, that it is for the competent national authorities and ECHA to assess, in a specific case, the relevance of the discussion points identified in the basic model and, second, that the list of those discussion points that is provided is not, in any event, exhaustive.

90      As regards the need to draw up a table summarising the analysis of the equivalent level of concern as alleged by the applicants, it should be noted that the basic model does not in any way make it an obligation, but it is merely a possibility, as follows from the very wording of the basic model, which states ‘see also example table(s) of how the equivalent level of concern assessment may be summarised and presented in Annex VIII’ of that model.

91      Third, as regards the guidance document, it states that it was drawn up in order to assist the work of analysing the levels of concern. To that effect, it identifies factors that may be taken into consideration, but it does not in any way follow that ECHA or the competent national authorities are under an obligation to examine the equivalent level of concern in the light of all of the factors thus determined and solely in the light of those factors. On the contrary, it is stated that that guidance document established factors that may be taken into account when assessing the equivalent level of concern.

92      As regards the requirement to draw up a table in order to compare the levels of concern as alleged by the applicants, it must be noted that, as with the basic model, the guidance document did not establish such an obligation. In that regard, the comparison table presented in the guidance document to which the applicants refer constitutes a table summarising the questions to be asked and the links to be established on the basis of the answers obtained in order to assist in the analysis of the level of concern. However, it is not stated that such a table is required in the preparation of the dossier drawn up in accordance with Annex XV or of the support document.

93      Consequently, even assuming that, in accordance with the principle of good administration, ECHA was required to comply with its usual practice and even if it were possible to infer, from the basic model and from the guidance document, that there was a ‘usual’ practice on the part of ECHA, no infringement can, in any event, be found in the present case.

94      In the third place, in so far as the applicants and Sonae Arauco and the other legal persons whose names are set out in the annex rely on the manner in which ECHA analysed the level of concern raised by 2,3,3,3‑tetrafluoro‑2‑(heptafluoropropoxy)propionic acid, its salts and its acyl halides (and their isomers and combinations thereof) in order to demonstrate that the examination carried out in the present case did not comply with the formal requirements imposed on it, it is sufficient to recall that ECHA is not bound by its precedents (see, to that effect, judgment of 29 March 2023, Nouryon Industrial Chemicals and Others v Commission, T‑868/19, under appeal, EU:T:2023:168, paragraph 35 (not published) and the case-law cited). Thus, although ECHA chose to draw up a table as part of its analysis of the equivalent level of concern of 2,3,3,3‑tetrafluoro‑2‑(heptafluoropropoxy)propionic acid, its salts and its acyl halides (and their isomers and combinations thereof), that does not mean that it was obliged to do so in the context of the analysis of the level of concern raised by all the other substances of which it has to be aware.

95      In the fourth place, the applicants submit that, by departing from its usual practice, ECHA infringed the principle of the protection of their legitimate expectations.

96      In that regard, it must be recalled that the principle of the protection of legitimate expectations is one of the fundamental principles of the European Union. The right to rely on that principle assumes that three conditions are satisfied. First, precise, unconditional and consistent assurances originating from authorised and reliable sources must have been given to the person concerned by the administration. Second, those assurances must be such as to give rise to a legitimate expectation on the part of the person to whom they are addressed. Third, the assurances given must comply with the applicable rules (see judgment of 19 December 2019, Probelte v Commission, T‑67/18, EU:T:2019:873, paragraph 109 and the case-law cited).

97      It must be stated that, in support of their line of argument, the applicants do not rely on precise assurances given to them by ECHA, but on the legitimate expectation which they had that ECHA would follow its usual practice. In those circumstances, they do not satisfy the conditions laid down by the case-law cited in paragraph 96 above. In any event, as concluded in paragraph 93 above, even if the basic model and the guidance document established ECHA’s ‘usual’ practice, there was no infringement of that practice in the present case, with the result that the applicants cannot infer that their legitimate expectations were infringed.

98      In the fifth and last place, LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical state that Part II of the dossier drawn up in accordance with Annex XV contains information on uses, but that no information on exposure and alternative substances was provided. They infer from that that ECHA should not have considered that dossier to be complete.

99      In that regard, it is sufficient to note that the dossier drawn up in accordance with Annex XV does contain a Part II, containing the available information on use, exposure and alternative substances and techniques. It is true that Part II does not appear to identify alternative substances or techniques for melamine. Nevertheless, it is not required that such substances or techniques are actually determined for the purpose of identifying a substance as being of very high concern. It is necessary, however, if information is available in that regard, that it be reproduced.

100    In the light of all of the foregoing, the first plea must be rejected.

C.      The second plea in law, alleging infringement of Article 57(f) of Regulation No 1907/2006, resulting from a manifest error of assessment and misuse of powers

101    The second plea is divided into three parts, alleging, first, a manifest error of assessment as regards the serious effects on human health; second, a manifest error of assessment as regards the serious effects on the environment, and, third, misuse of powers.

1.      Preliminary observations

102    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.’

103    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 (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1). Next, Article 57(d) and (e) of Regulation No 1907/2006 covers PBT and vPvB substances, in accordance with the criteria set out in Annex XIII to that regulation. 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).

104    It is thus apparent from Article 57(f) of Regulation No 1907/2006 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).

105    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).

106    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).

107    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).

108    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).

109    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).

110    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).

111    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 second plea, alleging a manifest error of assessment as regards the serious effects on human health

112    In the first part of the second plea, the applicants submit, in essence, that, first of all, in the support document, the urinary tract toxicity and carcinogenicity of melamine were identified solely on the basis of its classification as a substance with STOT RE 2 properties and its classification as a substance with category 2 carcinogenic properties (‘Carc 2 properties’). Next, although they do not raise a plea of illegality in respect 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), they dispute the analysis of the intrinsic properties of melamine made in Delegated Regulation 2022/692, 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). Lastly, they consider that ECHA did not explain how the reproductive toxicity of melamine led to probable serious effects on human health.

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

114    The first part of the second plea can be divided into three complaints, alleging, first, that ECHA relied solely on the classification of melamine under Regulation No 1272/2008 in order to establish the urinary tract toxicity and carcinogenicity of melamine; second, that ECHA should have analysed 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); and, third, that ECHA failed to establish the seriousness of reproductive toxicity.

115    Lastly, it is necessary to examine the argument raised by LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical concerning the reversible nature of the effects of melamine.

(a)    The first complaint, alleging that ECHA relied solely on the classification of melamine under Regulation No 1272/2008 in order to establish the urinary tract toxicity and carcinogenicity of melamine

116    The applicants complain that ECHA failed to consider all the relevant information in order to determine whether the concerns expressed in the dossier drawn up in accordance with Annex XV were based on the intrinsic properties of melamine. In that regard, they submit, in essence, that ECHA should have carried out its own assessment in order to ascertain whether there was sufficient evidence of melamine having probable serious effects on human health.

117    In essence, the applicants complain that ECHA relied solely on the classifications of melamine as a substance with STOT RE 2 and Carc 2 properties in order to establish the urinary tract toxicity and carcinogenicity of that substance.

118    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).

119    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).

120    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 Delegated Regulation 2022/692.

121    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.

122    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.

123    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.

124    In any event, the case-law cited in paragraph 119 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 ECHA should have analysed 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)

125    The applicants submit that melamine does not have intrinsic properties allowing classification as a substance with STOT RE 2 and Carc 2 properties. In that regard, that classification is, in their view, based solely on effects unrelated to its intrinsic properties.

126    In response to an observation made by the Commission, the applicants deny that they raised a plea of illegality against Delegated Regulation 2022/692. However, they submit that ECHA should have examined, 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), whether it was possible to conclude that it was indeed the intrinsic properties of melamine that produced adverse effects on human health or whether ECHA should simply have disregarded the classifications resulting from Delegated Regulation 2022/692 when analysing the probable serious effects of melamine on human health.

127    Nevertheless, first, 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.

128    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.

129    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.

130    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.

131    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).

132    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.

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

134    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.

135    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.

136    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.

137    Furthermore, the applicants rely on the fact that the harmonised classifications resulting from Delegated Regulation 2022/692 were not, in their view, applicable before 23 November 2023. In so far as it must be inferred from their argument that, in their submission, ECHA should not have taken account of those classifications since they were not applicable before 23 November 2023, that argument must be rejected as ineffective.

138    As the Federal Republic of Germany submits, it is apparent from recital 7 of Delegated Regulation 2022/692 that the sole purpose of the deferred application of harmonised classifications is to allow suppliers to adapt the labelling and packaging of substances and mixtures to the new or updated classifications and to sell their existing stocks that are subject to the pre-existing regulatory requirements. That period is also necessary to allow suppliers sufficient time to take the actions required to ensure continuing compliance with other legal requirements following the changes made under that regulation. That recital adds, however, that suppliers should have the possibility to apply the new or updated harmonised classifications, and to adapt the labelling and packaging accordingly, on a voluntary basis before the date of application of that regulation, to ensure a high level of protection of human health and of the environment and to provide sufficient flexibility to suppliers.

139    Thus, the deferred application cannot have any effect on the fact that ECHA takes into account the harmonised classifications in order to examine the probable serious effects of melamine on human health.

140    In the light of all of the foregoing, the second complaint must be rejected.

(c)    The third complaint, alleging that ECHA failed to establish the seriousness of reproductive toxicity

141    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 does not explain how such effects are probable serious effects, as required by Article 57(f) of Regulation No 1907/2006.

142    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.

143    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.

144    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. They consider, however, that the support document does not explain how such effects are probable serious effects, as required by Article 57(f) of Regulation No 1907/2006.

145    Contrary to ECHA’s assertion, the support document does not contain any explanation as to how the observations 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.

146    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.

147    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 142 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.

148    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 and, second, and in any event, as noted in paragraph 119 above, the classification of a substance in Annex I to Regulation No 1272/2008 is a relevant but not decisive factor.

149    In those circumstances, the third 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.

(d)    The argument put forward by LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical concerning the reversible nature of the effects of melamine

150    LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical consider, in essence, that scientific evidence demonstrates the reversible nature of the formation of stones in the urinary tract, with the result that the effects of melamine on human health cannot be classified as ‘serious’.

151    In that regard, it should be noted that, 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.

152    In any event, 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.

153    Consequently, the argument raised by LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical is not capable of calling into question ECHA’s conclusion on the seriousness of the effects of melamine on human health.

(e)    Conclusion on first part of the second plea

154    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.

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

3.      The second part of the second plea, alleging a manifest error of assessment as regards the serious effects on the environment

156    The applicants, supported by LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical and by Sonae Arauco and the other legal persons whose names are set out in the annex, submit, in essence, that the ECHA was wrong to rely on the mobility of melamine in order to find that that substance had probable serious effects on the environment. They argue that the mobility criterion is not based on the intrinsic properties of melamine, but on the exposure of that substance and its potential presence in the aquatic environment. The mere fact that melamine might appear in the aquatic environment is not, however, linked to any intrinsic property of that substance, but results from its presumed persistence, which alone would clearly not support the mobility criterion or a presumed presence in the water cycle.

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

158    In the first place, both the applicants and LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical and Sonae Arauco and the other legal persons whose names are set out in the annex submit, in essence, that mobility cannot be regarded as an intrinsic property capable of having serious effects on human health or the environment which give rise to an equivalent level of concern, within the meaning of Article 57(f) of Regulation No 1907/2006.

159    In that regard, LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical 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.

160    In that regard, as recalled in paragraph 118 above, 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).

161    It is true that, as LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical 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.

162    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.

163    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.

164    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).

165    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).

166    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).

167    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).

168    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.

169    By contrast, as noted in paragraph 105 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.

170    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.

171    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.

172    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.

173    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 indeed depend on its intrinsic properties.

174    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.

175    That conclusion cannot be called into question by the applicants’ argument, to the effect that, in essence, the mobility of a substance depends on the environment in which it operates and on the fact that it has reached that environment, which does not relate to its intrinsic properties. It is true that, depending on the environment in which it is situated, a substance will be able to evolve differently. Nevertheless, it is indeed because of its intrinsic properties that a substance will interact in a particular manner in one environment and in a different manner in another environment, or that it will not interact in the same way as another substance which is nevertheless present in the same environment.

176    In the second place, in response to an argument put forward by the Commission, the applicants claim that mobility is not assessed on the basis of a methodology that makes it possible to obtain a result directly linked to the assessed property. In the support document, the property of mobility is, according to the applicants, presumed by its low tendency to be adsorbed by the organic material indicated by its ‘log Koc’ value. In their view, that is not sufficient to show that the substance meets the conditions to be regarded as ‘mobile’.

177    It must be stated that, although the applicants complain that ECHA relied solely on the ‘log Koc’ value of melamine in order to assess its mobility, they have not put forward any specific arguments to demonstrate that, in so doing, ECHA made a manifest error of assessment.

178    As follows from the case-law cited in paragraphs 110 and 111 above, it is for the applicants to adduce evidence such as to make the factual assessments used by ECHA implausible.

179    Since the applicants have not adduced any evidence to render implausible ECHA’s assessments as to the mobility of melamine evaluated in the light of its ‘log Koc’ value, their argument must be rejected.

180    In any event, 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, 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.

181    In the third place, LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical consider that the monitoring data referred to in the support document show that melamine is present in the aquatic environment, but that those data are not capable of establishing that the substance is mobile.

182    As follows, in essence, from the case-law cited in paragraph 17 above, it is not for the Court to seek and identify, in the annexes, the pleas and arguments on which it may consider the interveners’ arguments to be based.

183    In the present case, LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical 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.

184    In so doing, the interveners 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 interveners’ argument cannot succeed.

185    In those circumstances, the second part of the second plea must be rejected.

4.      The third part of the second plea, alleging misuse of powers

186    The applicants, supported by LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical and by Sonae Arauco and the other legal persons whose names are set out in the annex, submit that, by identifying melamine as a substance of very high concern even though it did not meet the requirements laid down in Article 57(f) of Regulation No 1907/2006, ECHA exceeded the powers conferred on it by Article 59 of Regulation No 1907/2006 and abused those powers.

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

188    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).

189    In the present case, first, the applicants submit, in essence, that ECHA misused its powers by adopting criteria that were not based on the intrinsic properties of melamine. Apart from the fact that that argument has no factual basis, since it has been established, in the context of the analysis of the first and second parts of the present plea, that ECHA did rely on the intrinsic properties of melamine in order to verify whether it satisfied the conditions laid down in Article 57(f) of Regulation No 1907/2006, that argument is ineffective in the context of the present plea. Even if well founded, it would not demonstrate that the contested decision was adopted for a purpose other than that of identifying melamine as a substance of very high concern.

190    Second, the applicants submit that the contested decision cannot be retroactively justified by Commission Delegated Regulation (EU) 2023/707 of 19 December 2022 amending Regulation No 1272/2008 (OJ 2023 L 93, p. 7), which included the criterion of mobility in Regulation No 1272/2008. Not only was the criterion of mobility not included as a hazard class referred to in Annex I to Regulation No 1272/2008, but, in addition, the Commission misused its powers when adopting Delegated Regulation 2023/707.

191    That argument must also be rejected as ineffective on two grounds. First, as the applicants acknowledge, the contested decision was not adopted on the basis of that regulation. Consequently, any illegality that might affect Delegated Regulation 2023/707 cannot have any effect on the contested decision. Second, that argument does not illustrate how the contested decision was adopted for a purpose other than that of identifying melamine as a substance of very high concern.

192    The third part of the second plea must therefore be rejected as ineffective.

5.      Conclusion on the second plea

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

194    However, the remainder of the second plea must be rejected, since (i) the applicants have not demonstrated that ECHA made a manifest error of assessment in that melamine could have serious effects on human health because of its urinary tract toxicity and its carcinogenicity, and on the environment, and (ii) their line of argument relating to misuse of powers is ineffective.

D.      The third plea in law, alleging infringement of Article 57(f) of Regulation No 1907/2006, resulting from a manifest error of assessment and from a failure to demonstrate that the conditions laid down by that provision were satisfied

195    The applicants, supported by LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical and by Sonae Arauco and the other legal persons whose names are set out in the annex, complain that ECHA infringed Article 57(f) of Regulation No 1907/2006 in so far as it did not establish that melamine could have serious effects on the environment and human health at an equivalent level of concern to that of the substances with the hazardous properties referred to in Article 57(a) to (e) of Regulation No 1907/2006.

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

197    The third plea can be divided into three parts, alleging:

–        a manifest error of assessment as regards the assessment of the effects of melamine on human health;

–        a manifest error of assessment as regards the assessment of the effects of melamine on the environment;

–        a manifest error of assessment in that the support document amended the conclusions of the dossier drawn up in accordance with Annex XV.

1.      The first part of the third plea, alleging a manifest error of assessment as regards the assessment of the effects of melamine on human health

198    As a preliminary point, it should be noted that, in the context of that part of the plea, the applicants mix the analysis of the two conditions laid down in Article 57(f) of Regulation No 1907/2006, as recalled in paragraph 104 above. They submit that ECHA did not take into account all the relevant factors, whether in order to analyse the seriousness of the effects caused by melamine or to examine the level of concern raised by that substance.

199    In the first place, in so far as the applicants complain that ECHA failed to take into account all the relevant factors in the analysis of the seriousness of the probable effects of melamine on human health, the following should be noted.

200    First, 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).

201    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).

202    In any event, is apparent 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).

203    Therefore, contrary to what the applicants submit, 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 World Health Organization (WHO) and the European Food Safety Authority (EFSA), relied on by LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical, are irrelevant at that stage.

204    Similarly, the fact that the effects of melamine can occur only if a certain threshold is exceeded or the fact that the presence of melamine in water decreases, relied on by both the applicants and LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical and by Sonae Arauco and the other legal persons whose names are set out in the annex, fall within the conditions of use and exposure to the substance, which are irrelevant when assessing the hazards linked to the intrinsic properties of a substance (see, to that effect and by analogy, judgment of 21 July 2011, Nickel Institute, C‑14/10, EU:C:2011:503, paragraphs 81 and 82).

205    Second, the applicants complain that ECHA ignored the scientific opinion of Professor Dr. Mersch-Sundermann on the estimation of health risks caused by human exposure to melamine (‘the opinion of Dr Mersch-Sundermann’), even though it had been submitted to the Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (Federal Institute for Occupational Health and Safety, Germany).

206    In that regard, it should be noted, first, that the applicants adduce evidence that the opinion of Dr Mersch-Sundermann was indeed sent to the competent national authority before the dossier drawn up in accordance with Annex XV was drafted and, second, that the bibliographical list annexed to that dossier did not mention that opinion.

207    However, it is not apparent either from the comments submitted by EMPA or from those submitted by the EPF (see paragraph 4 above) that the applicants drew ECHA’s attention to the fact that the opinion of Dr Mersch-Sundermann did not appear to have been taken into consideration by the competent national authority. Similarly, they did not submit that opinion in the context of the public consultation.

208    In any event, in their pleadings, the applicants merely refer to that opinion and complain that ECHA did not take it into account, but they do not explain how the opinion was manifestly decisive for the adoption of the contested decision, or how it is capable of rendering implausible the factual assessments made by ECHA.

209    In those circumstances, that argument cannot succeed.

210    Third, LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical 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.

211    It should be noted that the argument is imprecise. LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical 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 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, 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.

212    In those circumstances, the argument of LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical, which fails to comply with the requirements of Article 145(2) of the Rules of Procedure of the General Court, is rejected as inadmissible.

213    Fourth, Sonae Arauco and the other legal persons whose names are set out in the annex produced 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’), in order to demonstrate that, contrary to what ECHA stated, the presence of melamine in the aquatic environment is declining.

214    ECHA contends that, in so doing, Sonae Arauco and the other legal persons whose names are set out in the annex did not take into account the limits of report 287 that were highlighted in the RCOM document, namely the document containing the responses of the competent German authority to the comments made during the public consultation.

215    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.

216    It must be noted that, at the hearing, neither the applicants nor Sonae Arauco and the other legal persons whose names are set out in the annex put forward any specific arguments to challenge the criticisms made in the RCOM document with regard to report 287, with the result that they have not established how, in their view, ECHA made a manifest error of assessment in considering that report to be irrelevant.

217    In the second place, in so far as the applicants dispute ECHA’s analysis of the level of concern raised by melamine, the following should be noted.

218    First, the applicants claim that ECHA should have compared the effects on human health with the level of concern raised by the substances falling within the scope of Article 57(a) to (c) of Regulation No 1907/2006, as well as compare the effects on the environment with the level of concern raised by the substances referred to in Article 57(d) and (e) of that regulation.

219    However, Article 57(f) of Regulation No 1907/2006 does not require that the level of concern raised by the effects of a substance on human health be compared exclusively with the level of concern raised by the effects of the substances referred to in Article 57(a) to (c) of that regulation, or that the level of concern raised by the effects of a substance on the environment be compared only in the light of the level of concern raised by the effects of the substances referred to in Article 57(d) and (e) of that regulation.

220    If that were the case, it would mean that there is an obligation to distinguish between the equivalent level of concern raised by serious effects on human health, on the one hand, and on the environment, on the other. It has already been recognised by the Court that there is nothing in the wording of Article 57(f) of Regulation No 1907/2006 to indicate the existence of such an obligation (judgment of 23 February 2022, Chemours Netherlands v ECHA, T‑636/19, not published, EU:T:2022:86, paragraph 122).

221    The applicants’ argument must therefore be rejected.

222    Second, as regards the assessment of the level of concern raised by the probable serious effects on human health, the applicants submit, in essence, that ECHA failed to take into account all the relevant factors.

223    In the present case, it is apparent from the overview of the assessment of the concerns and from the summary of the equivalent level of concern in section 6.3.3 of the support document that the concerns identified are the potential for widespread contamination from melamine, leading to humans and environmental organisms being increasingly exposed to it, and the observed or potential effects on human health and the environment.

224    In that regard, 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).

225    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).

226    In those circumstances, the applicants are not justified in complaining that ECHA failed to take account of the health safety standards set in Germany and in the Netherlands when assessing the level of concern raised by melamine.

227    Lastly, in response to an argument put forward by the Federal Republic of Germany relating to the concerns raised by melamine on account of its co-exposure with other substances and, more specifically, cyanuric acid, the applicants submit that nothing in Article 57(f) of Regulation No 1907/2006 supports the idea that the possibility of a combined exposure with several substances may be taken into consideration for the identification of a substance as a substance of very high concern, and submit that the support document does not refer to such a conclusion.

228    In that regard, it must be noted that the support document refers to the effects which co-exposure could have on human health and on the environment. In that regard, it states that those substances may act together, so that exposures to comparatively low concentrations may have effects on human health and on the environment. That is in addition to the concern that no safe concentration can be derived.

229    As follows from the case-law cited in paragraph 224 above, the fact that it is impossible to determine, with the necessary certainty, a derived no-effect level or a predicted no-effect concentration may be taken into consideration for the assessment of the equivalent level of concern. Consequently, the applicants are wrong to claim, first, that that factor cannot be taken into consideration in the context of the application of Article 57(f) of Regulation No 1907/2006 and, second, that the support document did not accept that fact.

230    In the light of all of the foregoing, the first part of the third plea must be rejected.

2.      The second part of the third plea, alleging a manifest error of assessment as regards the assessment of the effects of melamine on the environment

231    In the first place, the applicants submit, in essence, that the support document does not sufficiently explain or establish, in the light of scientific evidence, that the effects found in fish, aquatic invertebrates and algae are serious.

232    First, as regards the seriousness of the effects found in fish, 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.

233    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.

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

235    Second, as regards the seriousness of the effects on aquatic invertebrates, 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 where 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 233 above.

236    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 234 above, be regarded as serious.

237    The applicants’ argument must therefore be rejected.

238    Third, as regards algae and aquatic plants, it is sufficient to note that the support document merely states that melamine has a low degree of toxicity (see section 5.1.3 of that document), but does not rely on those effects when determining the concerns raised by melamine (see section 6.3.2.5 of that document).

239    In the second place, the applicants submit that the support document does not demonstrate that the effects on the environment are irreversible effects.

240    In that regard, it is sufficient to note that, as follows from the case-law referred to in paragraph 151 above, 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.

241    In view of all of the foregoing, the second part of the third plea must be rejected.

3.      The third part of the third plea, alleging a manifest error of assessment in that the support document amended the conclusions of the dossier drawn up in accordance with Annex XV

242    The applicants submit that ECHA made a manifest error of assessment by amending the conclusions of the dossier drawn up in accordance with Annex XV, without the revised conclusions being supported by new or additional scientific evidence. In their view, that applies, in particular, to the conclusions reached as regards the toxicity of melamine to the urinary tract and the concerns relating to the presence of melamine in drinking water.

243    In the first place, the applicants dispute the addition made in the context of the findings relating to the toxicity of melamine (page 6 of the support document); that addition seeks to indicate that the intrinsic properties of melamine have probable serious effects on human health.

244    That said, it must be noted that the applicants criticise that addition in so far as, in their view, ECHA made a manifest error of assessment in concluding that the intrinsic properties of melamine had probable serious effects on human health. Since that argument has been rejected in the context of the analysis of the first part of the second plea, the present argument, which is directly linked to that argument, must be rejected.

245    In the second place, the applicants complain that ECHA concluded, in the support document, that the presence of melamine in drinking water gave rise to a concern in so far as it could cause serious effects if the critical dose levels were exceeded, whereas the dossier drawn up in accordance with Annex XV merely stated that the presence of melamine in drinking water could become a concern if the critical dose levels were exceeded. However, the basic data did not, in the applicants’ view, support the assertion that the presence of the substance in drinking water was therefore a concern, since the tolerable daily intake levels were far from being achieved.

246    It is true that the wording used in the support document is more affirmative than the wording in the dossier drawn up in accordance with Annex XV. However, not only did ECHA not argue, in the support document, that the tolerable daily intake levels were therefore reached, but it also did not rely on that circumstance in order to conclude that there was a concern due to the presence of melamine in the aquatic environment. In any event, whether in the dossier drawn up in accordance with Annex XV or in the support document, the general idea remains the same, namely that exceeding the critical dose levels would have been problematic in so far as, in such a scenario, the presence of melamine in drinking water would have had serious effects on human health. In those circumstances, the fact that ECHA considered that that gave rise to a concern is not vitiated by any manifest error of assessment.

247    In the third place, the applicants submit that, whereas the dossier drawn up in accordance with Annex XV concluded that the level of concern was considered to be very high in particular due to the combination of a number of elements, the support document concluded that the combination of the properties of melamine gave rise to a very high level of concern.

248    In the absence of further explanations on the part of the applicants, it is impossible for the Court to detect a contradiction between the conclusions of the dossier drawn up in accordance with Annex XV and those of the support document, and therefore that argument cannot succeed.

249    In the fourth place, the applicants submit that the support document wrongly states that human exposure to melamine may occur through the consumption and use of contaminated drinking water. ECHA disregarded the fact that a relevant level of contamination of drinking water could not have been identified at that time and that the mere fact that the use of contaminated drinking water could have led to human exposure did not demonstrate that there was any societal concern specifically linked to melamine.

250    In that regard, as ECHA observes, the existence of a societal concern was not based on actual exposure to melamine, but on the fact that the combination of its intrinsic properties, namely its persistence and mobility, rendered ineffective common and widely applied water purification techniques, such as river bank filtration and soil infiltration for groundwater enrichment. Similarly, ECHA states that 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. Consequently, the applicants’ argument must be rejected.

251    In the fifth place, as regards the applicants’ allegation that the results of the evaluation of the available evidence are inflated and therefore distorted to give the impression of more serious effects or concerns, it must be rejected as unsubstantiated.

252    It follows from all of the foregoing that the applicants have not demonstrated that ECHA made a manifest error of assessment by amending, in the support document, the conclusions of the dossier drawn up in accordance with Annex XV. The present part of the plea must therefore be rejected.

4.      Conclusion on the third plea

253    Since none of the three parts of the third plea is well founded, the third plea must be rejected.

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

254    The applicants, supported by LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical and by Sonae Arauco and the other legal persons whose names are set out in the annex, submit that the contested decision infringes the principle of proportionality, as well as the principles of foreseeability, protection of legitimate expectations and legal certainty, in that it identifies melamine as a substance of very high concern, even though, first, melamine is considered to be an appropriate alternative for other substances. Second, the identification of melamine as a substance of very high concern cannot be regarded as an appropriate measure in the light of the overall objective explicitly reported in the conclusions of the risk management option analysis (‘RMOA’) prepared by the competent national authority, namely to reduce the presence of melamine in the environment.

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

256    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).

257    As regards judicial review of the conditions referred to in paragraph 256 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).

258    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, 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).

259    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 ensuring 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).

260    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).

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

262    In the first place, the applicants submit that the contested decision is not appropriate for achieving the objective that had been set by the competent national authority, namely to reduce the presence of melamine in the environment.

263    In that regard, it should be noted that, as recalled in paragraph 258 above, the objective of Regulation No 1907/2006 is to ensure a high level of protection of human health and of the environment. The question is therefore whether, by adopting the contested decision, ECHA took a measure that was appropriate for that objective. As follows from the case-law cited in paragraph 260 above, the identification of a substance as a substance of very high concern contributes to improving the protection of human health and the environment by improving information for the public and for professionals as to the risks and hazards incurred. In those circumstances, the contested decision, which identifies melamine as a substance of very high concern, does contribute to the objective pursued by Regulation No 1907/2006.

264    As regards the fact that the competent national authority stated, in the RMOA, that the objective pursued was to reduce the presence of melamine in the environment, it should be noted that, as ECHA rightly submits, the RMOA is not a legally binding document. Moreover, it is expressly stated, in the foreword to that analysis, that the latter is a voluntary step, but not a stage in the procedures defined in Regulation No 1907/2006.Thus, it states that, since it reflects only the views of the competent national authority issuing the document, it does not preclude the Member States or the Commission from considering or initiating the risk management measures which they deem appropriate.

265    In any event, contrary to what the applicants claim, the objective pursued by the competent national authority, as set out in the RMOA, was not limited to reducing the presence of melamine in the environment, but was also to ensure information rights for consumers and the duty to report certain information in the industry’s supply chain. That is precisely the objective achieved by the identification of substances of very high concern.

266    Similarly, it must be noted that the competent national authority had also considered that the identification of melamine as a substance of very high concern would lead to a formal recognition of the properties of melamine as a substance of very high concern.

267    Consequently, the applicants are not justified in claiming that the contested decision is not appropriate for attaining the objective set by Regulation No 1907/2006, or that it is not appropriate for attaining the objectives which the competent national authority had set itself.

268    In the second place, the applicants argue that there is a contradiction in that there is a desire to adopt the contested decision with the aim of reducing the presence of melamine in the environment, yet there is a reliance on the fact that the identification of melamine as a substance of very high concern gives rise only to information obligations, in order to demonstrate the appropriateness of the contested decision.

269    First, as follows from paragraph 265 above, the objective pursued by the competent national authority was not limited to reducing the presence of melamine in the environment, but was also to identify melamine as a substance of very high concern in order to improve information for consumers and professionals.

270    Second, there is no clear contradiction between the objective of improving information for consumers and professionals on the potential hazards of a substance and the objective of reducing its presence in the environment. On the contrary, such objectives appear to be fully complementary, since the former is capable of constituting a first stage in the attainment of the latter.

271    The applicants’ argument cannot therefore succeed.

272    In the third place, the applicants submit that, in order to assess the proportionality of the contested decision, it is not necessary to separate the classification as a substance of very high concern strictly from the subsequent authorisation stage. Although the procedure laid down in Chapter I of Title VII of Regulation No 1907/2006 is undoubtedly designed so that substances identified as substances of very high concern are subject to authorisation requirements depending on the order of priority, that does not, in the applicants’ view, mean that certain substances of very high concern will remain candidates without ever being included in Annex XIV to Regulation No 1907/2006.

273    In that respect, 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).

274    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. Under Article 58(1) and (3) of that regulation, ECHA is to recommend priority substances to be included in that annex taking into account the opinion of the MSC and specifying for each substance, inter alia, the uses or categories of uses exempted from the authorisation requirement. A substance may be subject to authorisation only as a result of a decision by the Commission to include that substance in Annex XIV (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).

275    Furthermore, it should be noted that Article 58(8) of Regulation No 1907/2006 provides that substances included in Annex XIV to that regulation may be removed therefrom where, as a result of new information, they no longer meet the criteria of Article 57 of that regulation. That provision thus presupposes that ECHA can and, where necessary, must carry out a re-examination on the basis of new, relevant information (judgment of 16 December 2020, PlasticsEurope v ECHA, T‑207/18, EU:T:2020:623, paragraph 54).

276    It follows that, as ECHA has argued, when adopting a decision identifying a substance as being of very high concern, the inclusion of that substance in Annex XIV to Regulation No 1907/2006 is, at that stage, still hypothetical. Accordingly, ECHA cannot be required to take into account the objectives relating to authorisation in order to adopt a decision identifying a substance of very high concern. The fact, referred to by the applicants, that a public consultation was initiated on 7 February 2024 with a view to the inclusion of melamine in Annex XIV cannot call into question that conclusion, since it was an event subsequent to the adoption of the contested decision.

277    Sonae Arauco and the other legal persons whose names are set out in the annex criticise, however, the judgment of 7 March 2013, Bilbaína de Alquitranes and Others v ECHA (T‑93/10, EU:T:2013:106). They argue that the Court did not explain in a convincing manner why, in the light of the wording of Article 58(3) of Regulation No 1907/2006, certain substances identified as substances of very high concern should never be included in Annex XIV to that regulation.

278    In that regard, it is sufficient to note that the Court did not conclude that, in the light of the wording of Article 58(3) of Regulation No 1907/2006, certain substances identified as substances of very high concern should never be included in Annex XIV to that regulation. The Court merely stated that such inclusion was not automatic, which Sonae Arauco and the other legal persons whose names are set out in the annex have not succeeded in calling into question.

279    Sonae Arauco and the other legal persons whose names are set out in the annex add that interested parties enjoy only very limited legal protection in their efforts to prevent the inclusion of a substance of very high concern in Annex XIV to Regulation No 1907/2006. In their submission, according to Article 58(3) of that regulation, there are, regarding that decision, no further substance-related requirements. In particular, the requirements of Article 57 of that regulation are not amenable to judicial review at that stage of the procedure. That means that, in the context of the challenge to the present contested decision, the purposes of the entire procedure conducted under Article 55 et seq. of Regulation No 1907/2006 must be taken into consideration, including the purposes of an authorisation.

280    That argument is not, however, convincing.

281    It is possible to bring an action against a decision to include a substance in Annex XIV to Regulation No 1907/2006, in the context of which a plea alleging infringement of the principle of proportionality may be raised.

282    In the fourth place, the applicants submit that it is not appropriate to identify melamine as a substance of very high concern, since it serves as an alternative to formaldehyde.

283    In that regard, it is sufficient to recall 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).

284    Since the use of melamine as an alternative to formaldehyde specifically refers to the use of that substance and not to its intrinsic properties, the applicants’ argument cannot succeed.

285    The fact, relied on by the applicants, that Commission Regulation (EU) 2023/1464 of 14 July 2023 amending Annex XVII to Regulation No 1907/2006 as regards formaldehyde and formaldehyde releasers (OJ 2023 L 180, p. 12) was adopted in so far as, inter alia, melamine had been considered to be an alternative to formaldehyde cannot alter that conclusion, particularly since that regulation was adopted after the contested decision was adopted.

286    For the same reasons, it is necessary to reject the argument of Sonae Arauco and of the other legal persons whose names are set out in the annex, to the effect that the contested decision is inappropriate since melamine is 95% used as an intermediate, and that its use is therefore for the most part exempted from the authorisation process, in accordance with Article 2(8) of Regulation No 1907/2006.

287    In that regard, it may also be pointed out 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).

288    In the fifth place, the applicants submit that there were regulatory options that were more appropriate than the identification of melamine as a substance of very high concern in order to achieve the objective of reducing its presence in the environment.

289    In that regard, first, it must be noted that that argument starts from the incorrect premiss that the sole objective pursued was to reduce the presence of melamine in the environment. The applicants have not explained how the regulatory options to which they refer would have been capable of achieving the objective of informing consumers and professionals about the hazards of melamine in a manner that would have been more appropriate than identifying it as a substance of very high concern.

290    Second, 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 (judgment of 30 April 2015, Hitachi Chemical Europe and Others v ECHA, T‑135/13, EU:T:2015:253, paragraph 61). 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, the risk is properly controlled (judgment of 30 April 2015, Hitachi Chemical Europe and Others v ECHA, T‑135/13, EU:T:2015:253, paragraph 68).

291    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 259 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).

292    Therefore, the applicants’ argument is not capable of demonstrating that the contested decision is manifestly inappropriate.

293    In those circumstances, it is not necessary to examine the arguments of the applicants or of Sonae Arauco and the other legal persons whose names are set out in the annex, seeking to demonstrate that there were effective wastewater treatment techniques. Nor is there any need to analyse the argument that the Republic of Austria abstained on the basis that the identification of melamine as a substance of very high concern would not enable the set objective to be achieved.

294    In the sixth place, the applicants’ argument that harmonised classification and labelling in accordance with Regulation No 1272/2008 would have been more appropriate in order to achieve the objectives of providing information to consumers and professionals cannot succeed either.

295    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.

296    In the seventh and last place, the applicants link the infringements of the principle of legal certainty and of the protection of legitimate expectations to the fact that it is not possible to identify melamine as a substance of very high concern when it serves as an alternative to formaldehyde.

297    In that regard, it is sufficient to note that 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).

298    Consequently, contrary to what the applicants submit, the identification of melamine as a substance of very high concern has no impact on its use as an alternative to formaldehyde, with the result that the applicants’ arguments cannot succeed.

299    In view of all of the foregoing, the fifth plea must be rejected in its entirety.

F.      Conclusion on the action

300    As established in paragraph 193 above, ECHA made a manifest error of assessment as regards the effects on human health relating to the reproductive toxicity of melamine, with the result that the first part of the second plea must be upheld in part.

301    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).

302    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.

303    Since none of the other pleas raised by the applicants has been upheld, the action must be dismissed in its entirety.

IV.    Costs

304    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.

305    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.

306    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. LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical, as well as Sonae Arauco 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 Fritz Egger GmbH & Co. OG and the other applicants whose names are set out in the annex 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 LAT Nitrogen Piesteritz GmbH, formerly Borealis Agrolinz Melamine Deutschland GmbH, Grupa Azoty Zakłady Azotowe Puławy S.A., OCI Nitrogen BV and Cornerstone Chemical Co. to bear their own costs;

5.      Orders Sonae Arauco, SA 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 fourth plea in law, alleging infringement of the applicants’ right to be heard and of their right to submit comments

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

2. The second part of the fourth plea, alleging infringement of the right recognised in Article 59(4) of Regulation No 1907/2006

3. Conclusion on the fourth plea

B. The first plea in law, alleging infringement of the principle of good administration

C. The second plea in law, alleging infringement of Article 57(f) of Regulation No 1907/2006, resulting from a manifest error of assessment and misuse of powers

1. Preliminary observations

2. The first part of the second plea, alleging a manifest error of assessment as regards the serious effects on human health

(a) The first complaint, alleging that ECHA relied solely on the classification of melamine under Regulation No 1272/2008 in order to establish the urinary tract toxicity and carcinogenicity of melamine

(b) The second complaint, alleging that ECHA should have analysed 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 (T279/20, T283/20 and T288/20)

(c) The third complaint, alleging that ECHA failed to establish the seriousness of reproductive toxicity

(d) The argument put forward by LAT Nitrogen Piesteritz, Grupa Azoty Zakłady Azotowe Puławy, OCI Nitrogen and Cornerstone Chemical concerning the reversible nature of the effects of melamine

(e) Conclusion on first part of the second plea

3. The second part of the second plea, alleging a manifest error of assessment as regards the serious effects on the environment

4. The third part of the second plea, alleging misuse of powers

5. Conclusion on the second plea

D. The third plea in law, alleging infringement of Article 57(f) of Regulation No 1907/2006, resulting from a manifest error of assessment and from a failure to demonstrate that the conditions laid down by that provision were satisfied

1. The first part of the third plea, alleging a manifest error of assessment as regards the assessment of the effects of melamine on human health

2. The second part of the third plea, alleging a manifest error of assessment as regards the assessment of the effects of melamine on the environment

3. The third part of the third plea, alleging a manifest error of assessment in that the support document amended the conclusions of the dossier drawn up in accordance with Annex XV

4. Conclusion on the third plea

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

F. Conclusion on the action

IV. Costs

*      Language of the case: English.

1      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.

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.