Fons Iuris
Torna alla ricerca
Corte di giustizia UEsentenza

Corte di giustizia UE n. 1907/2023

ECLI:EU:T:2023:876
Testo integrale del provvedimento

Testo integrale del provvedimento

[OSCURATO:PERSONA] ([OSCURATO:PERSONA])

22 December 2023 ( * ) (Action for annulment – REACH – Establishment of a list of substances identified for eventual inclusion in Annex XIV to [OSCURATO:PERSONA] (EC) No 1907/2006 – Letter requesting that the [OSCURATO:PERSONA] ask ECHA to re-examine the inclusion of phenanthrene on that list – [OSCURATO:PERSONA] refusal to make a request to ECHA to prepare a dossier in accordance with Annex XV to [OSCURATO:PERSONA] 1907/2006 – Act not open to challenge – Inadmissibility)

[OSCURATO:PERSONA] T‑121/23,

[OSCURATO:PERSONA] & [OSCURATO:PERSONA] BVBA,

established in Antwerp (Belgium), represented by H. Estreicher, A. Bartl and M. Escorneboueu, lawyers, applicant, v

[OSCURATO:PERSONA],

represented by K. Mifsud-Bonnici and E. Mathieu, acting as Agents, and

[OSCURATO:PERSONA] (ECHA),

represented by M. Heikkilä, W. Broere and S. Mahoney, acting as Agents, defendants,

[OSCURATO:PERSONA] ([OSCURATO:PERSONA]),

composed of J. [OSCURATO:PERSONA], [OSCURATO:PERSONA], C. [OSCURATO:PERSONA] and J. Laitenberger (Rapporteur), [OSCURATO:PERSONA],

[OSCURATO:PERSONA]: V. [OSCURATO:PERSONA],

having regard to the written part of the procedure, in particular: – the application lodged at the [OSCURATO:PERSONA] on 3 March 2023, – the plea of inadmissibility raised by the [OSCURATO:PERSONA] by separate document lodged at the [OSCURATO:PERSONA] on 30 May 2023, – the plea of inadmissibility raised by ECHA by separate document lodged at the [OSCURATO:PERSONA] on 5 June 2023, – the applicant’s observations on the pleas of inadmissibility, lodged at the [OSCURATO:PERSONA] on 14 July 2023, makes the following

[OSCURATO:PERSONA]

1 By its action under [OSCURATO:PERSONA] 263 TFEU, the applicant, [OSCURATO:PERSONA] & [OSCURATO:PERSONA] BVBA, seeks annulment of the letter of the [OSCURATO:PERSONA] of 21 December 2022 (‘the contested act’), by which that institution refused to make a request to the [OSCURATO:PERSONA] (ECHA) to prepare a dossier in accordance with Annex XV to [OSCURATO:PERSONA] (EC) No 1907/2006 of the [OSCURATO:PERSONA] and of the [OSCURATO:PERSONA] of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of [OSCURATO:PERSONA] (REACH), establishing a [OSCURATO:PERSONA], amending [OSCURATO:PERSONA] 1999/45/EC and repealing [OSCURATO:PERSONA] (EEC) No 793/93 and [OSCURATO:PERSONA] (EC) No 1488/94 as well as [OSCURATO:PERSONA] 76/769/EEC and [OSCURATO:PERSONA] 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1, corrigendum OJ 2007 L 136, p. 3), for the purposes of re-examining its [OSCURATO:PERSONA] ED/88/2018 of 19 December 2018, by which that body included phenanthrene on the list of substances identified as being of very high concern provided for in [OSCURATO:PERSONA] 59 of [OSCURATO:PERSONA] 1907/2006 (‘the candidate list’).

Background to the dispute 2 On 19 December 2018, ECHA issued [OSCURATO:PERSONA] ED/88/2018. 3 On 21 March 2019, the applicant brought an action for annulment of [OSCURATO:PERSONA] ED/88/2018 before the [OSCURATO:PERSONA]. 4 [OSCURATO:PERSONA] dismissed that action by judgment of 9 June 2021,

[OSCURATO:PERSONA] & [OSCURATO:PERSONA]

v

ECHA

(T‑177/19, not published, EU:T:2021:336). 5 On 4 April 2022, the [OSCURATO:PERSONA] (‘Concawe’), of which the applicant is a member, sent the [OSCURATO:PERSONA] a letter in which it provided various scientific studies and stated the following: ‘Altogether, this information constitutes new, reliable, relevant and decisive data which clearly demonstrate the non-persistent character of phenanthrene in sediment.

Given i) the [judgment of 9 June 2021,

[OSCURATO:PERSONA] & [OSCURATO:PERSONA]

v

ECHA

(T‑177/19, not published, EU:T:2021:336)] and ii) the new, relevant, reliable and decisive data submitted with this letter, Concawe and its members hereby formally request that the [OSCURATO:PERSONA] asks ECHA to fully re-examine the identification of phenanthrene as a Substance of [OSCURATO:PERSONA] in light of the new information which shows that phenanthrene does not meet the criteria for identification as [a very persistent and very bioaccumulative (“vPvB”) substance] under [[OSCURATO:PERSONA] 1907/2006].

Concawe understands that the [OSCURATO:PERSONA] would initiate this request for ECHA’s re-examination of the identification of phenanthrene under [OSCURATO:PERSONA] 59 of [[OSCURATO:PERSONA] 1907/2006].’ 6 On 5 August 2022, the [OSCURATO:PERSONA] sent a letter to ECHA in which it provided the scientific studies referred to in the previous paragraph and which stated the following: ‘[OSCURATO:PERSONA] would … like to consult ECHA for an assessment of the submitted information and, in accordance with [OSCURATO:PERSONA] 77(1) of [[OSCURATO:PERSONA] 1907/2006], asks ECHA to investigate whether the attached information constitutes indeed new, reliable and relevant scientific information that, in a weight of evidence approach, raises doubt about the … identification of phenanthrene [as a substance of very high concern (“SVHC”)]. … Based on this assessment, the [OSCURATO:PERSONA] will decide on the appropriate next steps to follow, including the possibility of requesting ECHA to prepare a dossier that conforms to the provisions of … [OSCURATO:PERSONA] 59 [of [OSCURATO:PERSONA] 1907/2006] that takes into account an updated body of evidence.’ 7 On 4 November 2022, the Secretariat of ECHA sent a letter to the [OSCURATO:PERSONA] (‘the ECHA report’) in which it stated that it had made an assessment of the new information and ‘conclud[ed] that the new information provided by [Concawe] … [did] not impact the earlier assessment made by ECHA [([OSCURATO:PERSONA])] on the [very persistent] properties of the substance and would not give any grounds for revisiting the identification of phenanthrene as an SVHC due to its vPvB properties’. 8 On 21 December 2022, the [OSCURATO:PERSONA] sent the contested act to Concawe, to which it annexed the ECHA report.

In particular, it stated that, given ECHA’s conclusions, ‘the [OSCURATO:PERSONA] services consider there is no need to discuss necessary steps to remove phenanthrene from the [candidate list]’.

Forms of order sought 9 The applicant claims that the [OSCURATO:PERSONA] should: – annul the contested act; – order the [OSCURATO:PERSONA] and ECHA to pay the costs. 10 [OSCURATO:PERSONA] contends that the [OSCURATO:PERSONA] should: – dismiss the action as inadmissible; – order the applicant to pay the costs. 11 ECHA contends that the [OSCURATO:PERSONA] should: – declare the action inadmissible; – order the applicant to pay the costs.

Law 12 [OSCURATO:PERSONA] 130(1) and (7) of the Rules of Procedure of the [OSCURATO:PERSONA], the [OSCURATO:PERSONA] may give a decision on inadmissibility without going to the substance of the case if a defendant makes an application asking it to do so. 13 In the present case, as the [OSCURATO:PERSONA] and ECHA have requested a ruling on the inadmissibility of the action, the [OSCURATO:PERSONA], finding that it has sufficient information from the documents in the case file, has decided to give a ruling on that request without taking further steps in the proceedings. 14 In support of their pleas of inadmissibility, the [OSCURATO:PERSONA] and ECHA submit, inter alia, that the action must be dismissed as inadmissible in so far as the contested act is not a challengeable act. 15 By contrast, the applicant claims that the contested act is a challengeable act. 16 First, it maintains that the contested act is not a preparatory measure, but that it lays down the definitive position of the [OSCURATO:PERSONA] and ECHA. 17 According to the applicant, ECHA de facto re-evaluated the inclusion of phenanthrene in the candidate list, in the light of the information provided by Concawe, which ECHA found to be new, relevant and reliable, but concluded that that information would not support the removal of the substance at issue from the list in question.

Thus, the applicant claims that the assessment carried out by ECHA amounts to a decision under [OSCURATO:PERSONA] 59 of [OSCURATO:PERSONA] 1907/2006, which ECHA is competent to adopt only on condition that the [OSCURATO:PERSONA] reaches a unanimous agreement.

However, according to the applicant, ECHA issued that decision without following the procedure set out in [OSCURATO:PERSONA] 59 of [OSCURATO:PERSONA] 1907/2006.

The applicant thus claims that the contested act lays down the definitive and unequivocal decision of the [OSCURATO:PERSONA] and ECHA to refuse to remove phenanthrene from the candidate list, on the basis of the specific evidence submitted by Concawe.

Accordingly, no further decision can be expected from them following the issuance of the contested act. 18 Furthermore, although the applicant does not call into question the possibility that, in the future, the classification of phenanthrene could be revised on the basis of new evidence, it nevertheless submits that, by the effects of the contested act, that classification cannot be revised exclusively on the basis of the new evidence submitted by Concawe, as it would, precisely, no longer be new. 19 Secondly, the applicant submits that the contested act is binding on third parties.

It states that the maintained obligation to provide a safety data sheet is not a result of [OSCURATO:PERSONA] ED/88/2018, but of the contested act.

That act is, in essence, a new decision taken in the light of the evidence provided by Concawe and concluding that phenanthrene should remain on the candidate list. 20 Thirdly, the applicant claims that the contested act produces legal effects distinct from [OSCURATO:PERSONA] ED/88/2018 in so far as that act constitutes a reply to a request submitted by Concawe, in which substantial new facts were brought to the attention of the [OSCURATO:PERSONA] and ECHA. 21 Fourthly, the applicant submits that it had a procedural right to seek reconsideration of [OSCURATO:PERSONA] ED/88/2018.

Thus, its states that, first, in paragraph 115 of the judgment of 9 June 2021,

[OSCURATO:PERSONA] & [OSCURATO:PERSONA]

v

ECHA

(T‑177/19, not published, EU:T:2021:336), the [OSCURATO:PERSONA] ruled that ECHA can and, where necessary, must carry out a re-examination on the basis of new, relevant information and that, secondly, there are no limitations as to who may provide such new information.

The obligation to take into consideration new evidence is thus, according to the applicant, the source of a procedural right for it, as well as for anyone who would submit new evidence meeting the above standard.

The applicant asserts that the very existence of such a procedural right is demonstrated by the fact that the [OSCURATO:PERSONA] agreed to examine the new evidence in view of a reconsideration of [OSCURATO:PERSONA] ED/88/2018. 22 It is necessary to examine whether the contested act constitutes a challengeable act.

The claim for annulment of the contested act Preliminary observations 23 In the first place, it should be observed that no provision of [OSCURATO:PERSONA] 1907/2006 specifies the procedure for re-examining a substance that has previously been included in the candidate list if, on the basis of new data, the criteria set out in [OSCURATO:PERSONA] 57 of [OSCURATO:PERSONA] 1907/2006 are no longer satisfied for that substance. 24 [OSCURATO:PERSONA] 1907/2006 does not contain express provisions concerning the possibility of re-examining the inclusion of a substance in the candidate list under [OSCURATO:PERSONA] 59 of [OSCURATO:PERSONA] 1907/2006, it should be recalled that any decision adopted on the basis of that provision can, as a general rule, be re-examined in the light of new information available without any express provision being required.

In that regard, it should be observed that [OSCURATO:PERSONA] 58(8) of [OSCURATO:PERSONA] 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 [OSCURATO:PERSONA] 57 of that regulation.

That provision presupposes that ECHA can and, where necessary, must carry out a re-examination on the basis of new, relevant information.

Given that the identification of a substance under Articles 57 and 59 of [OSCURATO:PERSONA] 1907/2006 is carried out with a view to the eventual inclusion thereof in Annex XIV, the right and, where appropriate, the obligation to carry out a re-examination on the basis of new information applies a fortiori, inter alia also during the period between, first, the identification of a substance under [OSCURATO:PERSONA] 57 of [OSCURATO:PERSONA] 1907/2006 and its inclusion in the candidate list and, secondly, the subsequent inclusion in Annex

XIV. Consequently, any new information arising from a study that was still ongoing at the time of the identification of a substance as being of very high concern is therefore likely to be taken into account, where appropriate, even after the identification laid down in Articles 57 and 58 of [OSCURATO:PERSONA] 1907/2006, and before the subsequent inclusion of that substance in Annex XIV (judgments of 16 December 2020, PlasticsEurope v

ECHA

, T‑207/18, EU:T:2020:623, paragraphs 53 and 54, and of 9 June 2021,

[OSCURATO:PERSONA] & [OSCURATO:PERSONA]

v

ECHA

, T‑177/19, not published, EU:T:2021:336, paragraphs 114 and 115). 25 It is also apparent from the case-law that there is a general principle of law that, in principle, a body which has power to adopt a particular legal measure also has power to abrogate or amend it by adopting an actus contrarius , unless such power is expressly conferred upon another body (judgment of 20 November 2002, Lagardère and Canal+ v

[OSCURATO:PERSONA]

, T‑251/00, EU:T:2002:278, paragraph 130). 26 In accordance with the rule of parallelism of procedural requirements and of the actus contrarius , an amendment to a decision must take place in the same way as the initial decision (judgment of 14 December 2006, Gagliardi v

OHIM – [OSCURATO:PERSONA] (MANŪ [OSCURATO:PERSONA])

, T‑392/04, not published, EU:T:2006:400, paragraph 53). 27 In the second place, it should be recalled that, according to settled case-law, only measures the legal effects of which are binding on, and capable of affecting the interests of, the applicant by bringing about a distinct change in his or her legal position are acts or decisions which may be the subject of an action for annulment (see judgments of 12 September 2006, [OSCURATO:PERSONA] and Others v

[OSCURATO:PERSONA]

, C‑131/03 P, EU:C:2006:541, paragraph 54, and of 13 October 2011, [OSCURATO:PERSONA] and Germany v

[OSCURATO:PERSONA]

, C‑463/10 P and C‑475/10 P, EU:C:2011:656, paragraph 37).

In order to determine whether the contested act produces binding legal effects, it is necessary to examine the substance of that act and to assess those effects on the basis of objective criteria, such as the content of that act, taking into account, as appropriate, the context in which it was adopted and the powers of the institution which adopted the act (see judgment of 20 February 2018, Belgium v

[OSCURATO:PERSONA]

, C‑16/16 P, EU:C:2018:79, paragraph 32 and the case-law cited). 28 Furthermore, an act of the [OSCURATO:PERSONA] which amounts to a rejection must be appraised in the light of the nature of the request to which it constitutes a reply (see order of 13 March 2007, [OSCURATO:PERSONA] and Others v

[OSCURATO:PERSONA]

, C‑150/06 P, not published, EU:C:2007:164, paragraph 22 and the case-law cited).

In particular, a refusal constitutes an act in respect of which an action for annulment may be brought under [OSCURATO:PERSONA] 263 TFEU provided that the act which the institution refuses to adopt could itself have been contested under that provision (see judgment of 22 October 1996,

[OSCURATO:PERSONA]

v

[OSCURATO:PERSONA]

, T‑330/94, EU:T:1996:154, paragraph 32 and the case-law cited). 29 It is in the light of those considerations that the [OSCURATO:PERSONA] must examine whether the contested act constitutes a challengeable act.

The existence of a refusal to adopt a challengeable act 30 It should be noted that, as regards the content of the contested act, the [OSCURATO:PERSONA] stated that its services had considered, on the basis of an ECHA report, that ‘there [was] no need to discuss necessary steps to remove phenanthrene from the [candidate list]’. 31 The contested act follows a request made by Concawe to the [OSCURATO:PERSONA] that, in the light of new information, the latter ask ECHA to re-examine in full the identification of phenanthrene as a substance of very high concern in accordance with the procedure laid down in [OSCURATO:PERSONA] 59 of [OSCURATO:PERSONA] 1907/2006. 32 It follows that the contested act consists in a refusal by the [OSCURATO:PERSONA] to initiate the procedure laid down in [OSCURATO:PERSONA] 59(2) of [OSCURATO:PERSONA] 1907/2006. 33 In the light of the case-law cited in paragraph 28 above, the contested act could therefore constitute a challengeable act only if the request which the [OSCURATO:PERSONA] has the ability to submit to ECHA, under [OSCURATO:PERSONA] 59(2) of [OSCURATO:PERSONA] 1907/2006, could also be the subject of an action for annulment. 34 In that regard, in the first place, the contested act, in so far as it refers to the ‘necessary steps to remove phenanthrene from the [candidate list]’, shows that the [OSCURATO:PERSONA] did not consider it necessary to adopt a measure at the beginning of the procedure laid down in [OSCURATO:PERSONA] 59(2) of [OSCURATO:PERSONA] 1907/2006. 35 In the second place, it should be pointed out that, under the rule of parallelism of procedural requirements referred to in paragraph 26 above, if a substance no longer meets the criteria set out in [OSCURATO:PERSONA] 57 of [OSCURATO:PERSONA] 1907/2006, the procedure described in [OSCURATO:PERSONA] 59 of [OSCURATO:PERSONA] 1907/2006 must be followed in order to remove it from the list. 36 In that regard, first of all, it is apparent from [OSCURATO:PERSONA] 59(2) and (3) of [OSCURATO:PERSONA] 1907/2006 that the procedure for the identification of substances of very high concern and for the inclusion of those substances in the candidate list begins either by a request from the [OSCURATO:PERSONA] to ECHA to prepare a dossier in accordance with Annex XV to that regulation, or as a result of the preparation of a dossier by a [OSCURATO:PERSONA] in accordance with that annex. 37 Next, pursuant to [OSCURATO:PERSONA] 59(4) of [OSCURATO:PERSONA] 1907/2006, the Annex XV dossier is to be published on the ECHA website with a deadline for submitting comments. 38 Lastly, according to [OSCURATO:PERSONA] 59(6) to (8) of [OSCURATO:PERSONA] 1907/2006, if ECHA does not receive or make any comments, it is to include that substance in the candidate list.

By contrast, where comments have been received or made, ECHA is to refer the dossier to the [OSCURATO:PERSONA].

In that regard, if, within 30 days of the referral, the [OSCURATO:PERSONA] reaches a unanimous agreement on the identification of a substance as being of very high concern, ECHA is to include the substance concerned in the candidate list.

Otherwise, the [OSCURATO:PERSONA] is to prepare a draft proposal on the identification of the substance within three months of receipt of the opinion of the [OSCURATO:PERSONA].

A final decision on the identification of the substance as being of very high concern is then to be taken by the [OSCURATO:PERSONA] in accordance with the regulatory procedure with scrutiny provided for in [OSCURATO:PERSONA] 5a of [OSCURATO:PERSONA] 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the [OSCURATO:PERSONA] (OJ 1999 L 184, p. 23), as amended. 39 It follows that the request, which the [OSCURATO:PERSONA] has the ability to submit to ECHA, under [OSCURATO:PERSONA] 59(2) of [OSCURATO:PERSONA] 1907/2006, does not constitute a challengeable act, by reason of the fact that it is prior to the preparation, by that agency, of a dossier in accordance with Annex XV to that regulation and therefore to the implementation of the re-examination procedure resulting from the rule of parallelism of procedural requirements and of the actus contrarius , which, moreover, the applicant does not dispute. 40 Therefore, the contested act consists in a refusal to adopt an act that is not open to challenge for the purposes of [OSCURATO:PERSONA] 263 TFEU. 41 In the third place, that conclusion is not called into question by the applicant’s claim that the assessments made in the contested act are definitive. 42 In that regard, first, the applicant’s assertion that the [OSCURATO:PERSONA] and ECHA de facto adopted a decision to re-examine [OSCURATO:PERSONA] ED/88/2018 is unfounded. [OSCURATO:PERSONA] merely consulted ECHA, as it was entitled to do, on the information submitted by Concawe, in accordance with [OSCURATO:PERSONA] 77(1) of [OSCURATO:PERSONA] 1907/2006.

In so doing, the [OSCURATO:PERSONA] and ECHA did not therefore in any way conduct, implicitly or explicitly, a re-examination of [OSCURATO:PERSONA] ED/88/2018, which must be conducted in accordance with the procedure set out in [OSCURATO:PERSONA] 59 of [OSCURATO:PERSONA] 1907/2006.

The contested act thus merely constitutes a refusal by the [OSCURATO:PERSONA] to make a request to ECHA to prepare a dossier in accordance with Annex XV to that regulation.

On that point, the [OSCURATO:PERSONA] has, under [OSCURATO:PERSONA] 59(2) of [OSCURATO:PERSONA] 1907/2006, the option of making or not making such a request to ECHA, which is a prior procedural act and which, in the present case, precedes a re-examination of [OSCURATO:PERSONA] ED/88/2018. 43 Moreover, contrary to what the applicant claims, the contested act, adopted by the [OSCURATO:PERSONA], does not create any legal effects distinct from [OSCURATO:PERSONA] ED/88/2018, adopted by ECHA, since the contested act in no way replaces [OSCURATO:PERSONA] ED/88/2018, which therefore continues to produce its own effects. 44 Secondly, it should be noted that the [OSCURATO:PERSONA] is not itself empowered to re-examine an ECHA decision to include a substance in the candidate list. 45 According to [OSCURATO:PERSONA] 59 of [OSCURATO:PERSONA] 1907/2006, expressly referred to by Concawe in its request for re-examination, the [OSCURATO:PERSONA] is only empowered to make a request to ECHA to prepare a dossier, in accordance with the relevant sections of Annex XV to that regulation, with a view to identifying, in accordance with the procedure laid down in paragraphs 2 to 10 of that article, substances meeting the criteria set out in [OSCURATO:PERSONA] 57 of that regulation and establishing a candidate list for eventual inclusion in Annex XIV to that regulation. 46 Thirdly, the applicant’s argument, referred to in paragraph 18 above, that the information that it submitted to the [OSCURATO:PERSONA] for review could no longer be regarded as new cannot succeed. [OSCURATO:PERSONA] did not carry out a review in the present case and was not entitled to do so.

Furthermore, the novelty of the information submitted by the applicant with a view to requesting once more a review should be assessed solely in the light of the information that was taken into account for the purposes of the adoption of [OSCURATO:PERSONA] ED/88/2018, that is to say when phenanthrene was included in the candidate list of substances. 47 Consequently, irrespective of the fact that the contested act precludes the initiation of the re-examination procedure, the response that it contains consists in a refusal to adopt an act that is not open to challenge and that is based on assessments that are not definitive.

The contested act cannot therefore, as such, be the subject of an action for annulment.

The existence of possible procedural rights granted to the applicant 48 It should be borne in mind that, according to the case-law, where a provision confers on certain persons the right to make a request to the [OSCURATO:PERSONA] to initiate a procedure, in particular with a view to adopting an act, or where it provides that those persons enjoy procedural safeguards during such a procedure, the [OSCURATO:PERSONA] refusal to initiate that procedure constitutes a challengeable act.

That refusal brings an end to the procedure initiated by the persons in question on the basis of that provision.

Such a refusal expresses the [OSCURATO:PERSONA] definitive position and produces binding legal effects and may therefore be the subject of an action for annulment (see order of 8 April 2021, CRII-GEN and Others v

[OSCURATO:PERSONA]

, T‑496/20, not published, EU:T:2021:179, paragraph 26 and the case-law cited). 49 It is therefore necessary, in the present case, to examine whether, in the context of the procedure described in [OSCURATO:PERSONA] 59 of [OSCURATO:PERSONA] 1907/2006, the applicant was entitled to submit to the [OSCURATO:PERSONA] a request for it to initiate the procedure, so that the refusal to initiate that procedure would constitute the adoption of a definitive position by the [OSCURATO:PERSONA] producing binding legal effects vis-à-vis the applicant within the meaning of the case-law referred to in the previous paragraph. 50 In the first place, it is not apparent from the wording of [OSCURATO:PERSONA] 59(2) of [OSCURATO:PERSONA] 1907/2006 that the EU legislature intended to confer on individuals, such as the applicant, the right to request the initiation of the procedure for including a substance in the candidate list or the right to request a re-examination of that inclusion. 51 According to that provision, only a [OSCURATO:PERSONA] or ECHA, at the request of the [OSCURATO:PERSONA], may submit a dossier drawn up in accordance with Annex XV in order to propose that a substance be identified as being of very high concern and included in the candidate list. 52 Thus, under the rule of parallelism of procedural requirements mentioned in paragraph 26 above, only a [OSCURATO:PERSONA] or ECHA, at the request of the [OSCURATO:PERSONA], may submit a dossier drawn up in accordance with Annex XV in order to propose that the inclusion of a substance in the candidate list be re-examined. 53 By contrast, the rule of parallelism of procedural requirements cannot justify the grant of a subjective right, to the applicant or to Concawe, to require the [OSCURATO:PERSONA] to make a request to ECHA to prepare a dossier in accordance with Annex XV or to require a [OSCURATO:PERSONA] to prepare such a dossier. 54 It follows that [OSCURATO:PERSONA] 59 of [OSCURATO:PERSONA] 1907/2006 cannot constitute the basis of a request by a natural or legal person to compel the [OSCURATO:PERSONA] to make a request to ECHA to prepare a dossier in accordance with Annex XV and therefore that the applicant has no right to require the [OSCURATO:PERSONA] to make a request to ECHA to prepare and submit a dossier in accordance with Annex

XV. 55 Contrary to what the applicant claims, that conclusion is not invalidated by paragraph 115 of the judgment of 9 June 2021,

[OSCURATO:PERSONA] & [OSCURATO:PERSONA]

v

ECHA

(T‑177/19, not published, EU:T:2021:336), which states that ECHA can and, where necessary, must carry out a re-examination on the basis of new, relevant information. 56 Paragraph 115 of the judgment of 9 June 2021,

[OSCURATO:PERSONA] & [OSCURATO:PERSONA]

v

ECHA

(T‑177/19, not published, EU:T:2021:336), merely provides, first, that, in the absence of a dossier prepared in accordance with Annex XV, re-examination on the basis of new and relevant information is a possibility for ECHA and, in particular, its [OSCURATO:PERSONA], and, secondly, that such a re-examination is obligatory if, where necessary, a dossier is prepared in accordance with Annex XV by ECHA or a [OSCURATO:PERSONA]. 57 Thus, the judgment of 9 June 2021,

[OSCURATO:PERSONA] & [OSCURATO:PERSONA]

v

ECHA

(T‑177/19, not published, EU:T:2021:336), does not recognise any procedural right in favour of individuals allowing them to require the [OSCURATO:PERSONA] to submit a request to ECHA under [OSCURATO:PERSONA] 59(2) of [OSCURATO:PERSONA] 1907/2006.

It is for the [OSCURATO:PERSONA] or the [OSCURATO:PERSONA] alone to examine whether to make such a request. 58 In the second place, it is true that [OSCURATO:PERSONA] 59(4) of [OSCURATO:PERSONA] 1907/2006 states that, following the publication on its website of a notice that an Annex XV dossier has been prepared for a substance, interested parties are to be invited to submit comments to ECHA on the Annex XV dossier. 59 However, it has already been held that [OSCURATO:PERSONA] 59(4) of [OSCURATO:PERSONA] 1907/2006 did not guarantee a right to be heard to interested parties.

That provision merely provides for a public consultation that does not confer on interested parties any specific procedural right other than the right to submit comments.

Thus, ECHA is not required, under that provision, to hear an individual who might be affected by the decision taken at the end of the administrative procedure (see, to that effect, judgment of 9 June 2021,

[OSCURATO:PERSONA] & [OSCURATO:PERSONA]

v

ECHA

, T‑177/19, not published, EU:T:2021:336, paragraphs 243 and 244). 60 In any event, first, the applicability of [OSCURATO:PERSONA] 59(4) of [OSCURATO:PERSONA] 1907/2006 presupposes, according to the very wording of that provision, that an Annex XV dossier has been prepared by ECHA at the request of the [OSCURATO:PERSONA] or by a [OSCURATO:PERSONA].

However, that is not the case here. 61 Secondly, an operator who wishes to have a substance removed from the candidate list and who, to that end, contacts the [OSCURATO:PERSONA] or a [OSCURATO:PERSONA], must submit its observations to that institution or to the [OSCURATO:PERSONA] concerned on the data that, in its view, justify that removal. 62 It follows that [OSCURATO:PERSONA] 59(4) of [OSCURATO:PERSONA] 1907/2006 contains no procedural safeguard such as to render the present action admissible. 63 According to the applicant, such a conclusion is precluded by the fact that the refusal or a request for re-examination of the inclusion of a substance in the candidate list constitutes, even if only de facto, a decision to maintain that substance on the candidate list.

If it were not possible to challenge such a decision, the producers, suppliers and users of the substance concerned would be deprived of effective judicial protection. 64 On that point, it should be noted that, if it were to be accepted, the applicant’s argument would amount to the creation of an unprecedented procedure by case-law.

Having regard to the principles of institutional balance and conferral of powers, as enshrined in [OSCURATO:PERSONA] 13(2) TEU (see, to that effect, judgment of 25 October 2017,

[OSCURATO:PERSONA]

v

[OSCURATO:PERSONA] (WRC

‑ 15) , C‑687/15, EU:C:2017:803, paragraph 40 and the case-law cited), the [OSCURATO:PERSONA] does not have the power to adjust the provisions of [OSCURATO:PERSONA] 1907/2006. 65 In the absence, as the law currently stands, of a specific provision in [OSCURATO:PERSONA] 1907/2006, the [OSCURATO:PERSONA] or the [OSCURATO:PERSONA] are the only ones empowered to initiate or not to initiate the procedure for re-examining the inclusion of a substance in the candidate list, which precludes the right of a natural or legal person to require them to adopt a position on their request for re-examination or, where such a position has been adopted by the [OSCURATO:PERSONA], to bring an action for annulment. 66 In that regard, the fact that the [OSCURATO:PERSONA] did not reject, without a prior examination, the information provided by the applicant, but that, in the interests of diligence, it consulted ECHA on the basis of [OSCURATO:PERSONA] 77 of [OSCURATO:PERSONA] 1907/2006 concerning that information, cannot have the effect of compelling that institution to make a request to ECHA to prepare and to submit a dossier in accordance with Annex

XV. 67 The application for annulment of the contested act is therefore dismissed as inadmissible.

The ECHA report 68 In so far as the applicant also seeks the annulment of the ECHA report considered in isolation, which is not expressly apparent from its written pleadings, it should be noted that that report is not a challengeable act pursuant to [OSCURATO:PERSONA] 263 TFEU. 69 First, that report merely provides scientific and technical advice requested by the [OSCURATO:PERSONA] in accordance with [OSCURATO:PERSONA] 77(1) of [OSCURATO:PERSONA] 1907/2006, which stipulates that ECHA is to provide the EU institutions with the best possible scientific and technical advice on questions which are referred to it and which fall within its remit. [OSCURATO:PERSONA] 77(1) of [OSCURATO:PERSONA] 1907/2006 does not limit the scope of those requests in so far as they concern chemicals and fall within the remit of ECHA, which is indeed the case here.

In addition, the scope of the [OSCURATO:PERSONA] request was indeed clarified in the [OSCURATO:PERSONA] letter of 5 August 2022.

The applicant is therefore wrong to assert that [OSCURATO:PERSONA] 77(2) of [OSCURATO:PERSONA] 1907/2006, which sets out the tasks of the Secretariat of ECHA, precludes a referral to ECHA in a situation such as that in the present case. 70 Secondly, it should be noted that, in its report, ECHA issues a technical and scientific opinion that is not binding on the [OSCURATO:PERSONA] and that is intended to assist the [OSCURATO:PERSONA] in adopting a measure that has no binding legal effects such as to affect the interests of the applicant.

It is in that context that, in its request to ECHA of 5 August 2022, the [OSCURATO:PERSONA] stated that, based on that agency’s assessment, it would decide on the appropriate next steps to follow (see paragraph 6 above). 71 Thirdly, for reasons similar to those set out in paragraphs 41 to 46, the ECHA report does not definitively establish that agency’s position.

If a [OSCURATO:PERSONA] were to prepare a dossier in accordance with [OSCURATO:PERSONA] XV or if the [OSCURATO:PERSONA] were to make a request to ECHA to prepare such a dossier, that agency would have to process such dossiers pursuant to [OSCURATO:PERSONA] 59 of [OSCURATO:PERSONA] 1907/2006.

In that context, the ECHA report, called into question by the applicant, is not binding on that agency and, in particular, on its [OSCURATO:PERSONA]. 72 It follows that the action must be dismissed as inadmissible for lack of a challengeable act.

Costs 73 [OSCURATO:PERSONA] 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.

Since the applicant has been unsuccessful, it must, in accordance with the forms of order sought by the [OSCURATO:PERSONA] and ECHA, be ordered to bear its own costs and to pay the costs incurred by those parties.

On those grounds,

[OSCURATO:PERSONA] ([OSCURATO:PERSONA])

hereby orders: 1. The action is dismissed as inadmissible. 2. [OSCURATO:PERSONA] & [OSCURATO:PERSONA] BVBA shall bear its own costs and pay those incurred by the [OSCURATO:PERSONA] and the [OSCURATO:PERSONA] (ECHA). Luxembourg, 22 December 2023.

V. [OSCURATO:PERSONA]

J. [OSCURATO:PERSONA]

* Language of the case: English.

Anonimizzato ex art. 52 D.Lgs. 196/2003
[OSCURATO:PERSONA] ([OSCURATO:PERSONA]) 22 December 2023 ( * ) (Action for annulment – REACH – Establishment of a list of substances identified for eventual inclusion in Annex XIV to [OSCURATO:PERSONA] (EC) No 1907/2006 – Letter requesting that the [OSCURATO:PERSONA] ask ECHA to re-examine the inclusion of phenanthrene on that list – [OSCURATO:PERSONA] refusal to make a request to ECHA to prepare a dossier in accordance with Annex XV to [OSCURATO:PERSONA] 1907/2006 – Act not open to challenge – Inadmissibility) [OSCURATO:PERSONA] T‑121/23, [OSCURATO:PERSONA] & [OSCURATO:PERSONA] BVBA, established in Antwerp (Belgium), represented by H. Estreicher, A. Bartl and M. Escorneboueu, lawyers, applicant, v [OSCURATO:PERSONA], represented by K. Mifsud-Bonnici and E. Mathieu, acting as Agents, and [OSCURATO:PERSONA] (ECHA), represented by M. Heikkilä, W. Broere and S. Mahoney, acting as Agents, defendants, [OSCURATO:PERSONA] ([OSCURATO:PERSONA]), composed of J. [OSCURATO:PERSONA], [OSCURATO:PERSONA], C. [OSCURATO:PERSONA] and J. Laitenberger (Rapporteur), [OSCURATO:PERSONA], [OSCURATO:PERSONA]: V. [OSCURATO:PERSONA], having regard to the written part of the procedure, in particular: –        the application lodged at the [OSCURATO:PERSONA] on 3 March 2023, –        the plea of inadmissibility raised by the [OSCURATO:PERSONA] by separate document lodged at the [OSCURATO:PERSONA] on 30 May 2023, –        the plea of inadmissibility raised by ECHA by separate document lodged at the [OSCURATO:PERSONA] on 5 June 2023, –        the applicant’s observations on the pleas of inadmissibility, lodged at the [OSCURATO:PERSONA] on 14 July 2023, makes the following [OSCURATO:PERSONA] 1 By its action under [OSCURATO:PERSONA] 263 TFEU, the applicant, [OSCURATO:PERSONA] & [OSCURATO:PERSONA] BVBA, seeks annulment of the letter of the [OSCURATO:PERSONA] of 21 December 2022 (‘the contested act’), by which that institution refused to make a request to the [OSCURATO:PERSONA] (ECHA) to prepare a dossier in accordance with Annex XV to [OSCURATO:PERSONA] (EC) No 1907/2006 of the [OSCURATO:PERSONA] and of the [OSCURATO:PERSONA] of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of [OSCURATO:PERSONA] (REACH), establishing a [OSCURATO:PERSONA], amending [OSCURATO:PERSONA] 1999/45/EC and repealing [OSCURATO:PERSONA] (EEC) No 793/93 and [OSCURATO:PERSONA] (EC) No 1488/94 as well as [OSCURATO:PERSONA] 76/769/EEC and [OSCURATO:PERSONA] 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1, corrigendum OJ 2007 L 136, p. 3), for the purposes of re-examining its [OSCURATO:PERSONA] ED/88/2018 of 19 December 2018, by which that body included phenanthrene on the list of substances identified as being of very high concern provided for in [OSCURATO:PERSONA] 59 of [OSCURATO:PERSONA] 1907/2006 (‘the candidate list’). Background to the dispute 2 On 19 December 2018, ECHA issued [OSCURATO:PERSONA] ED/88/2018. 3 On 21 March 2019, the applicant brought an action for annulment of [OSCURATO:PERSONA] ED/88/2018 before the [OSCURATO:PERSONA]. 4 [OSCURATO:PERSONA] dismissed that action by judgment of 9 June 2021, [OSCURATO:PERSONA] & [OSCURATO:PERSONA] v ECHA (T‑177/19, not published, EU:T:2021:336). 5 On 4 April 2022, the [OSCURATO:PERSONA] (‘Concawe’), of which the applicant is a member, sent the [OSCURATO:PERSONA] a letter in which it provided various scientific studies and stated the following: ‘Altogether, this information constitutes new, reliable, relevant and decisive data which clearly demonstrate the non-persistent character of phenanthrene in sediment. Given i) the [judgment of 9 June 2021, [OSCURATO:PERSONA] & [OSCURATO:PERSONA] v ECHA (T‑177/19, not published, EU:T:2021:336)] and ii) the new, relevant, reliable and decisive data submitted with this letter, Concawe and its members hereby formally request that the [OSCURATO:PERSONA] asks ECHA to fully re-examine the identification of phenanthrene as a Substance of [OSCURATO:PERSONA] in light of the new information which shows that phenanthrene does not meet the criteria for identification as [a very persistent and very bioaccumulative (“vPvB”) substance] under [[OSCURATO:PERSONA] 1907/2006]. Concawe understands that the [OSCURATO:PERSONA] would initiate this request for ECHA’s re-examination of the identification of phenanthrene under [OSCURATO:PERSONA] 59 of [[OSCURATO:PERSONA] 1907/2006].’ 6 On 5 August 2022, the [OSCURATO:PERSONA] sent a letter to ECHA in which it provided the scientific studies referred to in the previous paragraph and which stated the following: ‘[OSCURATO:PERSONA] would … like to consult ECHA for an assessment of the submitted information and, in accordance with [OSCURATO:PERSONA] 77(1) of [[OSCURATO:PERSONA] 1907/2006], asks ECHA to investigate whether the attached information constitutes indeed new, reliable and relevant scientific information that, in a weight of evidence approach, raises doubt about the … identification of phenanthrene [as a substance of very high concern (“SVHC”)]. … Based on this assessment, the [OSCURATO:PERSONA] will decide on the appropriate next steps to follow, including the possibility of requesting ECHA to prepare a dossier that conforms to the provisions of … [OSCURATO:PERSONA] 59 [of [OSCURATO:PERSONA] 1907/2006] that takes into account an updated body of evidence.’ 7 On 4 November 2022, the Secretariat of ECHA sent a letter to the [OSCURATO:PERSONA] (‘the ECHA report’) in which it stated that it had made an assessment of the new information and ‘conclud[ed] that the new information provided by [Concawe] … [did] not impact the earlier assessment made by ECHA [([OSCURATO:PERSONA])] on the [very persistent] properties of the substance and would not give any grounds for revisiting the identification of phenanthrene as an SVHC due to its vPvB properties’. 8 On 21 December 2022, the [OSCURATO:PERSONA] sent the contested act to Concawe, to which it annexed the ECHA report. In particular, it stated that, given ECHA’s conclusions, ‘the [OSCURATO:PERSONA] services consider there is no need to discuss necessary steps to remove phenanthrene from the [candidate list]’. Forms of order sought 9 The applicant claims that the [OSCURATO:PERSONA] should: –        annul the contested act; –        order the [OSCURATO:PERSONA] and ECHA to pay the costs. 10 [OSCURATO:PERSONA] contends that the [OSCURATO:PERSONA] should: –        dismiss the action as inadmissible; –        order the applicant to pay the costs. 11 ECHA contends that the [OSCURATO:PERSONA] should: –        declare the action inadmissible; –        order the applicant to pay the costs. Law 12 [OSCURATO:PERSONA] 130(1) and (7) of the Rules of Procedure of the [OSCURATO:PERSONA], the [OSCURATO:PERSONA] may give a decision on inadmissibility without going to the substance of the case if a defendant makes an application asking it to do so. 13 In the present case, as the [OSCURATO:PERSONA] and ECHA have requested a ruling on the inadmissibility of the action, the [OSCURATO:PERSONA], finding that it has sufficient information from the documents in the case file, has decided to give a ruling on that request without taking further steps in the proceedings. 14 In support of their pleas of inadmissibility, the [OSCURATO:PERSONA] and ECHA submit, inter alia, that the action must be dismissed as inadmissible in so far as the contested act is not a challengeable act. 15 By contrast, the applicant claims that the contested act is a challengeable act. 16 First, it maintains that the contested act is not a preparatory measure, but that it lays down the definitive position of the [OSCURATO:PERSONA] and ECHA. 17 According to the applicant, ECHA de facto re-evaluated the inclusion of phenanthrene in the candidate list, in the light of the information provided by Concawe, which ECHA found to be new, relevant and reliable, but concluded that that information would not support the removal of the substance at issue from the list in question. Thus, the applicant claims that the assessment carried out by ECHA amounts to a decision under [OSCURATO:PERSONA] 59 of [OSCURATO:PERSONA] 1907/2006, which ECHA is competent to adopt only on condition that the [OSCURATO:PERSONA] reaches a unanimous agreement. However, according to the applicant, ECHA issued that decision without following the procedure set out in [OSCURATO:PERSONA] 59 of [OSCURATO:PERSONA] 1907/2006. The applicant thus claims that the contested act lays down the definitive and unequivocal decision of the [OSCURATO:PERSONA] and ECHA to refuse to remove phenanthrene from the candidate list, on the basis of the specific evidence submitted by Concawe. Accordingly, no further decision can be expected from them following the issuance of the contested act. 18 Furthermore, although the applicant does not call into question the possibility that, in the future, the classification of phenanthrene could be revised on the basis of new evidence, it nevertheless submits that, by the effects of the contested act, that classification cannot be revised exclusively on the basis of the new evidence submitted by Concawe, as it would, precisely, no longer be new. 19 Secondly, the applicant submits that the contested act is binding on third parties. It states that the maintained obligation to provide a safety data sheet is not a result of [OSCURATO:PERSONA] ED/88/2018, but of the contested act. That act is, in essence, a new decision taken in the light of the evidence provided by Concawe and concluding that phenanthrene should remain on the candidate list. 20 Thirdly, the applicant claims that the contested act produces legal effects distinct from [OSCURATO:PERSONA] ED/88/2018 in so far as that act constitutes a reply to a request submitted by Concawe, in which substantial new facts were brought to the attention of the [OSCURATO:PERSONA] and ECHA. 21 Fourthly, the applicant submits that it had a procedural right to seek reconsideration of [OSCURATO:PERSONA] ED/88/2018. Thus, its states that, first, in paragraph 115 of the judgment of 9 June 2021, [OSCURATO:PERSONA] & [OSCURATO:PERSONA] v ECHA (T‑177/19, not published, EU:T:2021:336), the [OSCURATO:PERSONA] ruled that ECHA can and, where necessary, must carry out a re-examination on the basis of new, relevant information and that, secondly, there are no limitations as to who may provide such new information. The obligation to take into consideration new evidence is thus, according to the applicant, the source of a procedural right for it, as well as for anyone who would submit new evidence meeting the above standard. The applicant asserts that the very existence of such a procedural right is demonstrated by the fact that the [OSCURATO:PERSONA] agreed to examine the new evidence in view of a reconsideration of [OSCURATO:PERSONA] ED/88/2018. 22 It is necessary to examine whether the contested act constitutes a challengeable act. The claim for annulment of the contested act Preliminary observations 23 In the first place, it should be observed that no provision of [OSCURATO:PERSONA] 1907/2006 specifies the procedure for re-examining a substance that has previously been included in the candidate list if, on the basis of new data, the criteria set out in [OSCURATO:PERSONA] 57 of [OSCURATO:PERSONA] 1907/2006 are no longer satisfied for that substance. 24 [OSCURATO:PERSONA] 1907/2006 does not contain express provisions concerning the possibility of re-examining the inclusion of a substance in the candidate list under [OSCURATO:PERSONA] 59 of [OSCURATO:PERSONA] 1907/2006, it should be recalled that any decision adopted on the basis of that provision can, as a general rule, be re-examined in the light of new information available without any express provision being required. In that regard, it should be observed that [OSCURATO:PERSONA] 58(8) of [OSCURATO:PERSONA] 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 [OSCURATO:PERSONA] 57 of that regulation. That provision presupposes that ECHA can and, where necessary, must carry out a re-examination on the basis of new, relevant information. Given that the identification of a substance under Articles 57 and 59 of [OSCURATO:PERSONA] 1907/2006 is carried out with a view to the eventual inclusion thereof in Annex XIV, the right and, where appropriate, the obligation to carry out a re-examination on the basis of new information applies a fortiori, inter alia also during the period between, first, the identification of a substance under [OSCURATO:PERSONA] 57 of [OSCURATO:PERSONA] 1907/2006 and its inclusion in the candidate list and, secondly, the subsequent inclusion in Annex XIV. Consequently, any new information arising from a study that was still ongoing at the time of the identification of a substance as being of very high concern is therefore likely to be taken into account, where appropriate, even after the identification laid down in Articles 57 and 58 of [OSCURATO:PERSONA] 1907/2006, and before the subsequent inclusion of that substance in Annex XIV (judgments of 16 December 2020, PlasticsEurope v ECHA , T‑207/18, EU:T:2020:623, paragraphs 53 and 54, and of 9 June 2021, [OSCURATO:PERSONA] & [OSCURATO:PERSONA] v ECHA , T‑177/19, not published, EU:T:2021:336, paragraphs 114 and 115). 25 It is also apparent from the case-law that there is a general principle of law that, in principle, a body which has power to adopt a particular legal measure also has power to abrogate or amend it by adopting an actus contrarius , unless such power is expressly conferred upon another body (judgment of 20 November 2002, Lagardère and Canal+ v [OSCURATO:PERSONA] , T‑251/00, EU:T:2002:278, paragraph 130). 26 In accordance with the rule of parallelism of procedural requirements and of the actus contrarius , an amendment to a decision must take place in the same way as the initial decision (judgment of 14 December 2006, Gagliardi v OHIM – [OSCURATO:PERSONA] (MANŪ [OSCURATO:PERSONA]) , T‑392/04, not published, EU:T:2006:400, paragraph 53). 27 In the second place, it should be recalled that, according to settled case-law, only measures the legal effects of which are binding on, and capable of affecting the interests of, the applicant by bringing about a distinct change in his or her legal position are acts or decisions which may be the subject of an action for annulment (see judgments of 12 September 2006, [OSCURATO:PERSONA] and Others v [OSCURATO:PERSONA] , C‑131/03 P, EU:C:2006:541, paragraph 54, and of 13 October 2011, [OSCURATO:PERSONA] and Germany v [OSCURATO:PERSONA] , C‑463/10 P and C‑475/10 P, EU:C:2011:656, paragraph 37). In order to determine whether the contested act produces binding legal effects, it is necessary to examine the substance of that act and to assess those effects on the basis of objective criteria, such as the content of that act, taking into account, as appropriate, the context in which it was adopted and the powers of the institution which adopted the act (see judgment of 20 February 2018, Belgium v [OSCURATO:PERSONA] , C‑16/16 P, EU:C:2018:79, paragraph 32 and the case-law cited). 28 Furthermore, an act of the [OSCURATO:PERSONA] which amounts to a rejection must be appraised in the light of the nature of the request to which it constitutes a reply (see order of 13 March 2007, [OSCURATO:PERSONA] and Others v [OSCURATO:PERSONA] , C‑150/06 P, not published, EU:C:2007:164, paragraph 22 and the case-law cited). In particular, a refusal constitutes an act in respect of which an action for annulment may be brought under [OSCURATO:PERSONA] 263 TFEU provided that the act which the institution refuses to adopt could itself have been contested under that provision (see judgment of 22 October 1996, [OSCURATO:PERSONA] v [OSCURATO:PERSONA] , T‑330/94, EU:T:1996:154, paragraph 32 and the case-law cited). 29 It is in the light of those considerations that the [OSCURATO:PERSONA] must examine whether the contested act constitutes a challengeable act. The existence of a refusal to adopt a challengeable act 30 It should be noted that, as regards the content of the contested act, the [OSCURATO:PERSONA] stated that its services had considered, on the basis of an ECHA report, that ‘there [was] no need to discuss necessary steps to remove phenanthrene from the [candidate list]’. 31 The contested act follows a request made by Concawe to the [OSCURATO:PERSONA] that, in the light of new information, the latter ask ECHA to re-examine in full the identification of phenanthrene as a substance of very high concern in accordance with the procedure laid down in [OSCURATO:PERSONA] 59 of [OSCURATO:PERSONA] 1907/2006. 32 It follows that the contested act consists in a refusal by the [OSCURATO:PERSONA] to initiate the procedure laid down in [OSCURATO:PERSONA] 59(2) of [OSCURATO:PERSONA] 1907/2006. 33 In the light of the case-law cited in paragraph 28 above, the contested act could therefore constitute a challengeable act only if the request which the [OSCURATO:PERSONA] has the ability to submit to ECHA, under [OSCURATO:PERSONA] 59(2) of [OSCURATO:PERSONA] 1907/2006, could also be the subject of an action for annulment. 34 In that regard, in the first place, the contested act, in so far as it refers to the ‘necessary steps to remove phenanthrene from the [candidate list]’, shows that the [OSCURATO:PERSONA] did not consider it necessary to adopt a measure at the beginning of the procedure laid down in [OSCURATO:PERSONA] 59(2) of [OSCURATO:PERSONA] 1907/2006. 35 In the second place, it should be pointed out that, under the rule of parallelism of procedural requirements referred to in paragraph 26 above, if a substance no longer meets the criteria set out in [OSCURATO:PERSONA] 57 of [OSCURATO:PERSONA] 1907/2006, the procedure described in [OSCURATO:PERSONA] 59 of [OSCURATO:PERSONA] 1907/2006 must be followed in order to remove it from the list. 36 In that regard, first of all, it is apparent from [OSCURATO:PERSONA] 59(2) and (3) of [OSCURATO:PERSONA] 1907/2006 that the procedure for the identification of substances of very high concern and for the inclusion of those substances in the candidate list begins either by a request from the [OSCURATO:PERSONA] to ECHA to prepare a dossier in accordance with Annex XV to that regulation, or as a result of the preparation of a dossier by a [OSCURATO:PERSONA] in accordance with that annex. 37 Next, pursuant to [OSCURATO:PERSONA] 59(4) of [OSCURATO:PERSONA] 1907/2006, the Annex XV dossier is to be published on the ECHA website with a deadline for submitting comments. 38 Lastly, according to [OSCURATO:PERSONA] 59(6) to (8) of [OSCURATO:PERSONA] 1907/2006, if ECHA does not receive or make any comments, it is to include that substance in the candidate list. By contrast, where comments have been received or made, ECHA is to refer the dossier to the [OSCURATO:PERSONA]. In that regard, if, within 30 days of the referral, the [OSCURATO:PERSONA] reaches a unanimous agreement on the identification of a substance as being of very high concern, ECHA is to include the substance concerned in the candidate list. Otherwise, the [OSCURATO:PERSONA] is to prepare a draft proposal on the identification of the substance within three months of receipt of the opinion of the [OSCURATO:PERSONA]. A final decision on the identification of the substance as being of very high concern is then to be taken by the [OSCURATO:PERSONA] in accordance with the regulatory procedure with scrutiny provided for in [OSCURATO:PERSONA] 5a of [OSCURATO:PERSONA] 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the [OSCURATO:PERSONA] (OJ 1999 L 184, p. 23), as amended. 39 It follows that the request, which the [OSCURATO:PERSONA] has the ability to submit to ECHA, under [OSCURATO:PERSONA] 59(2) of [OSCURATO:PERSONA] 1907/2006, does not constitute a challengeable act, by reason of the fact that it is prior to the preparation, by that agency, of a dossier in accordance with Annex XV to that regulation and therefore to the implementation of the re-examination procedure resulting from the rule of parallelism of procedural requirements and of the actus contrarius , which, moreover, the applicant does not dispute. 40 Therefore, the contested act consists in a refusal to adopt an act that is not open to challenge for the purposes of [OSCURATO:PERSONA] 263 TFEU. 41 In the third place, that conclusion is not called into question by the applicant’s claim that the assessments made in the contested act are definitive. 42 In that regard, first, the applicant’s assertion that the [OSCURATO:PERSONA] and ECHA de facto adopted a decision to re-examine [OSCURATO:PERSONA] ED/88/2018 is unfounded. [OSCURATO:PERSONA] merely consulted ECHA, as it was entitled to do, on the information submitted by Concawe, in accordance with [OSCURATO:PERSONA] 77(1) of [OSCURATO:PERSONA] 1907/2006. In so doing, the [OSCURATO:PERSONA] and ECHA did not therefore in any way conduct, implicitly or explicitly, a re-examination of [OSCURATO:PERSONA] ED/88/2018, which must be conducted in accordance with the procedure set out in [OSCURATO:PERSONA] 59 of [OSCURATO:PERSONA] 1907/2006. The contested act thus merely constitutes a refusal by the [OSCURATO:PERSONA] to make a request to ECHA to prepare a dossier in accordance with Annex XV to that regulation. On that point, the [OSCURATO:PERSONA] has, under [OSCURATO:PERSONA] 59(2) of [OSCURATO:PERSONA] 1907/2006, the option of making or not making such a request to ECHA, which is a prior procedural act and which, in the present case, precedes a re-examination of [OSCURATO:PERSONA] ED/88/2018. 43 Moreover, contrary to what the applicant claims, the contested act, adopted by the [OSCURATO:PERSONA], does not create any legal effects distinct from [OSCURATO:PERSONA] ED/88/2018, adopted by ECHA, since the contested act in no way replaces [OSCURATO:PERSONA] ED/88/2018, which therefore continues to produce its own effects. 44 Secondly, it should be noted that the [OSCURATO:PERSONA] is not itself empowered to re-examine an ECHA decision to include a substance in the candidate list. 45 According to [OSCURATO:PERSONA] 59 of [OSCURATO:PERSONA] 1907/2006, expressly referred to by Concawe in its request for re-examination, the [OSCURATO:PERSONA] is only empowered to make a request to ECHA to prepare a dossier, in accordance with the relevant sections of Annex XV to that regulation, with a view to identifying, in accordance with the procedure laid down in paragraphs 2 to 10 of that article, substances meeting the criteria set out in [OSCURATO:PERSONA] 57 of that regulation and establishing a candidate list for eventual inclusion in Annex XIV to that regulation. 46 Thirdly, the applicant’s argument, referred to in paragraph 18 above, that the information that it submitted to the [OSCURATO:PERSONA] for review could no longer be regarded as new cannot succeed. [OSCURATO:PERSONA] did not carry out a review in the present case and was not entitled to do so. Furthermore, the novelty of the information submitted by the applicant with a view to requesting once more a review should be assessed solely in the light of the information that was taken into account for the purposes of the adoption of [OSCURATO:PERSONA] ED/88/2018, that is to say when phenanthrene was included in the candidate list of substances. 47 Consequently, irrespective of the fact that the contested act precludes the initiation of the re-examination procedure, the response that it contains consists in a refusal to adopt an act that is not open to challenge and that is based on assessments that are not definitive. The contested act cannot therefore, as such, be the subject of an action for annulment. The existence of possible procedural rights granted to the applicant 48 It should be borne in mind that, according to the case-law, where a provision confers on certain persons the right to make a request to the [OSCURATO:PERSONA] to initiate a procedure, in particular with a view to adopting an act, or where it provides that those persons enjoy procedural safeguards during such a procedure, the [OSCURATO:PERSONA] refusal to initiate that procedure constitutes a challengeable act. That refusal brings an end to the procedure initiated by the persons in question on the basis of that provision. Such a refusal expresses the [OSCURATO:PERSONA] definitive position and produces binding legal effects and may therefore be the subject of an action for annulment (see order of 8 April 2021, CRII-GEN and Others v [OSCURATO:PERSONA] , T‑496/20, not published, EU:T:2021:179, paragraph 26 and the case-law cited). 49 It is therefore necessary, in the present case, to examine whether, in the context of the procedure described in [OSCURATO:PERSONA] 59 of [OSCURATO:PERSONA] 1907/2006, the applicant was entitled to submit to the [OSCURATO:PERSONA] a request for it to initiate the procedure, so that the refusal to initiate that procedure would constitute the adoption of a definitive position by the [OSCURATO:PERSONA] producing binding legal effects vis-à-vis the applicant within the meaning of the case-law referred to in the previous paragraph. 50 In the first place, it is not apparent from the wording of [OSCURATO:PERSONA] 59(2) of [OSCURATO:PERSONA] 1907/2006 that the EU legislature intended to confer on individuals, such as the applicant, the right to request the initiation of the procedure for including a substance in the candidate list or the right to request a re-examination of that inclusion. 51 According to that provision, only a [OSCURATO:PERSONA] or ECHA, at the request of the [OSCURATO:PERSONA], may submit a dossier drawn up in accordance with Annex XV in order to propose that a substance be identified as being of very high concern and included in the candidate list. 52 Thus, under the rule of parallelism of procedural requirements mentioned in paragraph 26 above, only a [OSCURATO:PERSONA] or ECHA, at the request of the [OSCURATO:PERSONA], may submit a dossier drawn up in accordance with Annex XV in order to propose that the inclusion of a substance in the candidate list be re-examined. 53 By contrast, the rule of parallelism of procedural requirements cannot justify the grant of a subjective right, to the applicant or to Concawe, to require the [OSCURATO:PERSONA] to make a request to ECHA to prepare a dossier in accordance with Annex XV or to require a [OSCURATO:PERSONA] to prepare such a dossier. 54 It follows that [OSCURATO:PERSONA] 59 of [OSCURATO:PERSONA] 1907/2006 cannot constitute the basis of a request by a natural or legal person to compel the [OSCURATO:PERSONA] to make a request to ECHA to prepare a dossier in accordance with Annex XV and therefore that the applicant has no right to require the [OSCURATO:PERSONA] to make a request to ECHA to prepare and submit a dossier in accordance with Annex XV. 55 Contrary to what the applicant claims, that conclusion is not invalidated by paragraph 115 of the judgment of 9 June 2021, [OSCURATO:PERSONA] & [OSCURATO:PERSONA] v ECHA (T‑177/19, not published, EU:T:2021:336), which states that ECHA can and, where necessary, must carry out a re-examination on the basis of new, relevant information. 56 Paragraph 115 of the judgment of 9 June 2021, [OSCURATO:PERSONA] & [OSCURATO:PERSONA] v ECHA (T‑177/19, not published, EU:T:2021:336), merely provides, first, that, in the absence of a dossier prepared in accordance with Annex XV, re-examination on the basis of new and relevant information is a possibility for ECHA and, in particular, its [OSCURATO:PERSONA], and, secondly, that such a re-examination is obligatory if, where necessary, a dossier is prepared in accordance with Annex XV by ECHA or a [OSCURATO:PERSONA]. 57 Thus, the judgment of 9 June 2021, [OSCURATO:PERSONA] & [OSCURATO:PERSONA] v ECHA (T‑177/19, not published, EU:T:2021:336), does not recognise any procedural right in favour of individuals allowing them to require the [OSCURATO:PERSONA] to submit a request to ECHA under [OSCURATO:PERSONA] 59(2) of [OSCURATO:PERSONA] 1907/2006. It is for the [OSCURATO:PERSONA] or the [OSCURATO:PERSONA] alone to examine whether to make such a request. 58 In the second place, it is true that [OSCURATO:PERSONA] 59(4) of [OSCURATO:PERSONA] 1907/2006 states that, following the publication on its website of a notice that an Annex XV dossier has been prepared for a substance, interested parties are to be invited to submit comments to ECHA on the Annex XV dossier. 59 However, it has already been held that [OSCURATO:PERSONA] 59(4) of [OSCURATO:PERSONA] 1907/2006 did not guarantee a right to be heard to interested parties. That provision merely provides for a public consultation that does not confer on interested parties any specific procedural right other than the right to submit comments. Thus, ECHA is not required, under that provision, to hear an individual who might be affected by the decision taken at the end of the administrative procedure (see, to that effect, judgment of 9 June 2021, [OSCURATO:PERSONA] & [OSCURATO:PERSONA] v ECHA , T‑177/19, not published, EU:T:2021:336, paragraphs 243 and 244). 60 In any event, first, the applicability of [OSCURATO:PERSONA] 59(4) of [OSCURATO:PERSONA] 1907/2006 presupposes, according to the very wording of that provision, that an Annex XV dossier has been prepared by ECHA at the request of the [OSCURATO:PERSONA] or by a [OSCURATO:PERSONA]. However, that is not the case here. 61 Secondly, an operator who wishes to have a substance removed from the candidate list and who, to that end, contacts the [OSCURATO:PERSONA] or a [OSCURATO:PERSONA], must submit its observations to that institution or to the [OSCURATO:PERSONA] concerned on the data that, in its view, justify that removal. 62 It follows that [OSCURATO:PERSONA] 59(4) of [OSCURATO:PERSONA] 1907/2006 contains no procedural safeguard such as to render the present action admissible. 63 According to the applicant, such a conclusion is precluded by the fact that the refusal or a request for re-examination of the inclusion of a substance in the candidate list constitutes, even if only de facto, a decision to maintain that substance on the candidate list. If it were not possible to challenge such a decision, the producers, suppliers and users of the substance concerned would be deprived of effective judicial protection. 64 On that point, it should be noted that, if it were to be accepted, the applicant’s argument would amount to the creation of an unprecedented procedure by case-law. Having regard to the principles of institutional balance and conferral of powers, as enshrined in [OSCURATO:PERSONA] 13(2) TEU (see, to that effect, judgment of 25 October 2017, [OSCURATO:PERSONA] v [OSCURATO:PERSONA] (WRC ‑ 15) , C‑687/15, EU:C:2017:803, paragraph 40 and the case-law cited), the [OSCURATO:PERSONA] does not have the power to adjust the provisions of [OSCURATO:PERSONA] 1907/2006. 65 In the absence, as the law currently stands, of a specific provision in [OSCURATO:PERSONA] 1907/2006, the [OSCURATO:PERSONA] or the [OSCURATO:PERSONA] are the only ones empowered to initiate or not to initiate the procedure for re-examining the inclusion of a substance in the candidate list, which precludes the right of a natural or legal person to require them to adopt a position on their request for re-examination or, where such a position has been adopted by the [OSCURATO:PERSONA], to bring an action for annulment. 66 In that regard, the fact that the [OSCURATO:PERSONA] did not reject, without a prior examination, the information provided by the applicant, but that, in the interests of diligence, it consulted ECHA on the basis of [OSCURATO:PERSONA] 77 of [OSCURATO:PERSONA] 1907/2006 concerning that information, cannot have the effect of compelling that institution to make a request to ECHA to prepare and to submit a dossier in accordance with Annex XV. 67 The application for annulment of the contested act is therefore dismissed as inadmissible. The ECHA report 68 In so far as the applicant also seeks the annulment of the ECHA report considered in isolation, which is not expressly apparent from its written pleadings, it should be noted that that report is not a challengeable act pursuant to [OSCURATO:PERSONA] 263 TFEU. 69 First, that report merely provides scientific and technical advice requested by the [OSCURATO:PERSONA] in accordance with [OSCURATO:PERSONA] 77(1) of [OSCURATO:PERSONA] 1907/2006, which stipulates that ECHA is to provide the EU institutions with the best possible scientific and technical advice on questions which are referred to it and which fall within its remit. [OSCURATO:PERSONA] 77(1) of [OSCURATO:PERSONA] 1907/2006 does not limit the scope of those requests in so far as they concern chemicals and fall within the remit of ECHA, which is indeed the case here. In addition, the scope of the [OSCURATO:PERSONA] request was indeed clarified in the [OSCURATO:PERSONA] letter of 5 August 2022. The applicant is therefore wrong to assert that [OSCURATO:PERSONA] 77(2) of [OSCURATO:PERSONA] 1907/2006, which sets out the tasks of the Secretariat of ECHA, precludes a referral to ECHA in a situation such as that in the present case. 70 Secondly, it should be noted that, in its report, ECHA issues a technical and scientific opinion that is not binding on the [OSCURATO:PERSONA] and that is intended to assist the [OSCURATO:PERSONA] in adopting a measure that has no binding legal effects such as to affect the interests of the applicant. It is in that context that, in its request to ECHA of 5 August 2022, the [OSCURATO:PERSONA] stated that, based on that agency’s assessment, it would decide on the appropriate next steps to follow (see paragraph 6 above). 71 Thirdly, for reasons similar to those set out in paragraphs 41 to 46, the ECHA report does not definitively establish that agency’s position. If a [OSCURATO:PERSONA] were to prepare a dossier in accordance with [OSCURATO:PERSONA] XV or if the [OSCURATO:PERSONA] were to make a request to ECHA to prepare such a dossier, that agency would have to process such dossiers pursuant to [OSCURATO:PERSONA] 59 of [OSCURATO:PERSONA] 1907/2006. In that context, the ECHA report, called into question by the applicant, is not binding on that agency and, in particular, on its [OSCURATO:PERSONA]. 72 It follows that the action must be dismissed as inadmissible for lack of a challengeable act. Costs 73 [OSCURATO:PERSONA] 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the applicant has been unsuccessful, it must, in accordance with the forms of order sought by the [OSCURATO:PERSONA] and ECHA, be ordered to bear its own costs and to pay the costs incurred by those parties. On those grounds, [OSCURATO:PERSONA] ([OSCURATO:PERSONA]) hereby orders: 1. The action is dismissed as inadmissible. 2. [OSCURATO:PERSONA] & [OSCURATO:PERSONA] BVBA shall bear its own costs and pay those incurred by the [OSCURATO:PERSONA] and the [OSCURATO:PERSONA] (ECHA). Luxembourg, 22 December 2023. V. [OSCURATO:PERSONA] J. [OSCURATO:PERSONA] * Language of the case: English.
Sentenza Corte di giustizia UE n. 1907/2023 — Fons Iuris — Fons Iuris