JUDGMENT OF THE GENERAL COURT (Fifth Chamber, Extended Composition)

20 September 2019 ( *1 )

(REACH — Evaluation of substances — Triclosan — ECHA decision requesting further information — Article 51(6) of Regulation (EC) No 1907/2006 — Action brought before the Board of Appeal — Task of the Board of Appeal — Adversarial nature of the procedure — Scope of the review — Intensity of the review — Powers of the Board of Appeal — Article 93(3) of Regulation No 1907/2006 — First sentence of Article 47(1) of Regulation No 1907/2006 — Relevant information — Proportionality — Article 25 of Regulation No 1907/2006 — Annex XIII to Regulation No 1907/2006 — Data obtained under relevant circumstances — Persistence — Neurotoxicity — Reproductive toxicity — Article 12(1) of Regulation (EC) No 771/2008 — Delay in the submission of a scientific opinion)

In Case T‑125/17,

BASF Grenzach GmbH, established in Grenzach-Wyhlen (Germany), represented initially by K. Nordlander and M. Abenhaïm, lawyers, and subsequently by K. Nordlander and K. Le Croy, Solicitor,

applicant,

v

European Chemicals Agency (ECHA), represented initially by M. Heikkilä, W. Broere and T. Röcke, and subsequently by M. Heikkilä, W Broere and C. Jacquet, acting as Agents,

defendant,

supported by

Kingdom of Denmark, represented initially by C. Thorning and M. Wolff, and subsequently by M. Wolff, J. Nymann-Lindegren and P. Ngo, acting as Agents,

by

Federal Republic of Germany, represented initially by T. Henze and D. Klebs, and subsequently by D. Klebs, acting as Agents,

and by

Kingdom of the Netherlands, represented by M. Bulterman and C. Schillemans, acting as Agents,

interveners,

ACTION under Article 263 TFEU for the partial annulment of Decision A‑018‑2014 of the Board of Appeal of the ECHA of 19 December 2016 in so far as it partially dismissed the applicant’s appeal against the ECHA decision of 19 September 2014 to request further information about the substance Triclosan (CAS 3380‑34‑5) and in which it fixed the deadline for presenting that information as 26 December 2018,

THE GENERAL COURT (Fifth Chamber, Extended Composition),

composed of D. Gratsias, President, I. Labucka, S. Papasavvas, A. Dittrich (Rapporteur) and I. Ulloa Rubio, Judges,

Registrar: N. Schall, Administrator,

having regard to the written part of the procedure and further to the hearing on 12 December 2018,

gives the following

Judgment

I. Background to the dispute and the contested decision

1 Triclosan (CAS 3380‑34‑5) is a broad-spectrum antibacterial that is approved for use as a preservative in certain types of cosmetic products. It is registered solely for cosmetic use under 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, corrigendum OJ 2007 L 136, p. 3).

2 The applicant, BASF Grenzach GmbH, manufacturer of Triclosan, is the sole registrant of that substance within the meaning of Article 3(7) of Regulation No 1907/2006.

3 In 2012, Triclosan was included in the Community rolling action plan for evaluation within the meaning of Article 44 of Regulation No 1907/2006 due to grounds for concern relating to its persistent, bioaccumulative and toxic properties as well as its potential for endocrine disruption.

4 In accordance with Article 45 of Regulation No 1907/2006, the competent authority of the Kingdom of the Netherlands was appointed to carry out the evaluation of Triclosan, in cooperation with the competent authority of the Kingdom of Denmark. Together, pursuant to Article 46(1) of Regulation No 1907/2006, those authorities prepared a draft decision for the applicant, in which requests for further information about Triclosan were made.

5 On 20 March 2013, pursuant to Article 50(1) of Regulation No 1907/2006, the draft decision was notified to the applicant.

6 On 23 April 2013, the applicant provided its comments on the draft decision.

7 The competent authority of the Kingdom of the Netherlands took account of the applicant’s comments and revised the draft decision, in accordance with Article 50(1) of Regulation No 1907/2006.

8 On 6 March 2014, in accordance with Article 52(1) of Regulation No 1907/2006, the revised draft decision and the applicant’s comments were notified to the competent authorities of the other Member States and to the European Chemicals Agency (ECHA).

9 Four competent authorities of those other Member States and the ECHA submitted proposals for amendment, pursuant to Article 51(2) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation.

10 After having reviewed those proposals, the competent authority of the Kingdom of the Netherlands amended the draft decision, pursuant to the first sentence of Article 51(4) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation.

11 On 22 April 2014, the amended draft decision was referred to the Member State Committee, pursuant to the second sentence of Article 51(4) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation.

12 The applicant provided comments on those proposals for amendment, which were taken into account by the Member State Committee (Article 51(5) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation).

13 On 12 June 2014, pursuant to Article 51(6) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation, the Member State Committee reached a unanimous agreement on the amended draft decision.

14 On 19 September 2014, the ECHA adopted Decision SEV-D-2114285478-33-01/F on the evaluation of Triclosan (‘the ECHA decision’) on the basis of Article 51(6) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation. By that decision, it requested the applicant to produce in particular the following information: – simulation testing of Triclosan on ultimate degradation in fresh surface water (lake or river) and sea water, performed as a pelagic test, that is to say in water only, without addition of suspended solids, at an environmentally relevant temperature of at most 12 degrees centigrade, in accordance with EU test method C.25 and Organisation for Economic Cooperation and Development (OECD) test guidelines 309 for the Testing of Chemicals (‘the persistence test’); – an enhanced developmental neurotoxicity study, in accordance with OECD test guidelines 426 for the Testing of Chemicals, with relevant elements of the extended one-generation reproductive toxicity study, in accordance with OECD test guidelines 433 for the Testing of Chemicals, which involved testing on rats (‘the enhanced neurotoxicity rat study’); – a fish sexual development test, in accordance with OECD test guidelines 234 for the Testing of Chemicals, on zebrafish or Japanese medaka (‘the fish test’).

15 By its decision, the ECHA also asked the applicant to provide the information available on the effects of Triclosan on the cardiovascular system of certain laboratory animals and humans as well as further information on the ‘wide dispersive indoor use of reactive substances in open systems’ emission scenario.

16 The ECHA decision fixed 26 September 2016 as the deadline for providing the information requested.

17 On 17 December 2014, the applicant brought an action against the ECHA decision before the Board of Appeal of that agency, pursuant to Article 51(8) of Regulation No 1907/2006, applicable mutatis mutandis in accordance with Article 52(2) of that regulation, and with Article 91(1) of that regulation.

18 In accordance with Article 91(2) of Regulation No 1907/2006, the action against the ECHA decision had suspensory effect.

19 On 2 April 2015, the ECHA lodged the defence before the Board of Appeal.

20 On 6 October 2015, PETA International Science Consortium Ltd was granted leave to intervene before the Board of Appeal in support of the form of order sought by the applicant.

21 On 12 January 2016, PETA International Science Consortium lodged its statement in intervention before the Board of Appeal. On 22 February 2016, the ECHA and the applicant submitted their observations on that statement. The applicant enclosed an expert opinion as an annex to its observations.

22 A hearing before the Board of Appeal was held on 9 June 2016. At that hearing, the ECHA submitted three studies by which it sought to refute the expert opinion submitted by the applicant as part of its observations on the statement in intervention. That board allowed the parties to submit their observations on that opinion and on the three studies submitted by the ECHA after the hearing.

23 On 19 December 2016, the Board of Appeal adopted Decision A‑018‑2014 (‘the contested decision’). By that decision, it annulled the ECHA decision in so far as the latter had obliged the applicant to provide information about the effects of Triclosan on the cardiovascular system (see paragraph 15 above) and dismissed the action as to the remainder. In addition, it fixed 26 December 2018 as the deadline for the submission of the information referred to in paragraph 14 above.

II. Procedure before the Court and forms of order sought

24 By application lodged at the Registry of the Court on 28 February 2017, the applicant brought this action.

25 By a separate document lodged at the Court Registry on the same day, the applicant brought an application for interim measures, by which it claimed, in essence, that the President of the General Court should order the immediate suspension of the implementation of the contested decision, pending a decision on the application for interim measures, suspend the implementation of the contested decision in so far as it concerns the persistence test, the enhanced neurotoxicity rat study and the fish test, and order, consequently, the extension of the prescribed period to provide the results of the tests and of the study for the duration of the suspension. The application for interim measures was dismissed by order of 13 July 2017, BASF Grenzach v ECHA (T‑125/17 R, not published, EU:T:2017:496), because the applicant had failed to establish urgency, and the costs of that procedure were reserved. The appeal against that order was dismissed by order of 28 May 2018, BASF Grenzach v ECHA (C‑565/17 P(R), not published, EU:C:2018:340).

26 By a document lodged at the Court Registry on 18 April 2017, PETA International Science Consortium sought leave to intervene in the present case in support of the form of order sought by the applicant. By order of 12 December 2017, BASF Grenzach v ECHA (T‑125/17, not published, EU:T:2017:931), that application was rejected.

27 By documents lodged at the Court Registry on 16, 18 and 31 May 2017, the Federal Republic of Germany, the Kingdom of the Netherlands and the Kingdom of Denmark sought leave to intervene in the present proceedings in support of the form of order sought by the ECHA. By decisions of the President of the Chamber of 21 June 2017, those Member States were granted leave to intervene.

28 On 1 June 2017 the ECHA lodged the defence.

29 On 20 July 2017 the applicant lodged the reply.

30 On 7 September 2017 the ECHA lodged the rejoinder.

31 On 1 September 2017, the Kingdom of Denmark and the Kingdom of the Netherlands lodged their statements in intervention. On 4 September 2017, the Federal Republic of Germany lodged its statement in intervention. On 31 October 2017, the ECHA and the applicant submitted their observations on those statements.

32 On a proposal from the Second Chamber, the Court decided, pursuant to Article 28 of its Rules of Procedure, to assign the case to a Chamber sitting in extended composition.

33 On a proposal from the Judge-Rapporteur, the Court (Fifth Chamber) decided to open the oral part of the procedure and, by way of measures of organisation of procedure pursuant to Article 89 of the Rules of Procedure, to submit written questions to the ECHA, and to request it to produce the administrative file. The ECHA responded to those questions and that request within the period specified.

34 The applicant, the ECHA, the Kingdom of Denmark, the Federal Republic of Germany and the Kingdom of the Netherlands presented oral argument and replied to questions put by the Court at the hearing on 12 December 2018.

35 In its pleadings, the applicant presented an argument alleging that the requests for information on carrying out studies involving tests on animals did not comply with the principle of proportionality, due to the fact that the conduct of those studies could entail a prohibition on the marketing of products in which Triclosan is used, in accordance with the provisions of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ 2009 L 342, p. 59).

36 For its part, during the hearing, the ECHA withdrew part of its arguments which it had put forward in relation to the first plea in law.

37 The applicant claims that the Court should: – annul the contested decision, in so far as the Board of Appeal partially dismissed the action brought against the ECHA decision, and fixed 26 December 2018 as the deadline for presenting further information about the substance Triclosan; – order the ECHA and the interveners to bear its costs, in addition to their own costs.

38 The ECHA and the Kingdom of the Netherlands contend that the Court should: – dismiss the application; – order the applicant to pay the costs.

39 The Kingdom of Denmark and the Federal Republic of Germany contend that the Court should dismiss the application.

III. Law

40 In the contested decision, the Board of Appeal examined, in the first place, the pleas developed by the applicant in the context of the action before it which referred to the request to conduct the persistence test, in the second place, those referring to the request to conduct the enhanced neurotoxicity rat test, in the third place, those referring to the request to conduct the fish test and, in the fourth place, those referring to the request to submit available information concerning the effects of Triclosan on the cardiovascular system.

41 In support of the present action, the applicant puts forward two pleas in law.

42 The first plea alleges that the Board of Appeal breached essential procedural requirements. It is based on two parts, the first alleging that that board applied an erroneous standard of review of the ECHA decision and the second alleging that that board failed to examine key studies and scientific dossiers which were included in the ECHA dossier and which the applicant had sent it.

43 The second plea alleges that the Board of Appeal failed to take into account animal welfare and breached the principle of proportionality. It consists of three parts. The first concerns the request to conduct the enhanced neurotoxicity rat study, the second to conduct the fish test and the third to conduct the persistence test.

44 The applicant’s arguments are examined according to the order of the considerations of the contested decision to which they refer. Therefore, as a first step, the arguments put forward in the context of the first plea and the third part of the second plea will be examined. Those arguments concern the dismissal of the action before the Board of Appeal in so far as it related to the request to conduct the persistence test. As a second step, the arguments put forward in the context of the first plea and the first part of the second plea will be analysed. Those arguments concern the dismissal of that action in so far as it related to the request to conduct the enhanced neurotoxicity rat study. As a third step, the arguments put forward in the context of the first plea and the second part of the second plea will be examined. Those arguments concern the dismissal of that action in so far as it related to the request to conduct the fish rest.

45 As a fourth step, the argument alleging that the Board of Appeal did not apply a consistent standard of review in the entirety of the contested decision, that the applicant puts forward in the context of the first part of the first plea, will be analysed. As a fifth step, the argument alleging a breach of the rights of the defence which the applicant puts forward in the context of the first plea will be examined. Finally, as a sixth step, account will be taken of the argument relating to the provisions of Regulation No 1223/2009 which the applicant puts forward in the context of its pleadings during the hearing (paragraph 35 above).

A. The arguments concerning the rejection of the action before the Board of Appeal in so far as it related to the request to conduct the persistence test

46 In its decision, the ECHA requested the applicant to conduct the persistence test. According to the considerations in that decision, that request to provide further information about Triclosan was justified by the fact that there existed a potential risk of Triclosan being persistent in marine or fresh water environments, that that question should be clarified, that it was not possible to clarify it on the basis of available information and that the persistence test would allow useful information to be obtained in that regard.

47 In the context of the action before the Board of Appeal, the applicant claimed that the ECHA was not entitled to request the persistence test to be conducted. In that regard, it puts forward five pleas, alleging, firstly, inter alia an infringement of Annex XIII to Regulation No 1907/2006, secondly, an infringement of the first sentence of Article 47(1) of that regulation, thirdly, an infringement of Article 130 thereof, fourthly, a breach of the principle of proportionality and, fifthly, a breach of the principle of sound administration, which were rejected in their entirety for the reasons set out in paragraphs 28 to 115 of the contested decision.

48 In the context of the present action, the applicant contests the findings on which the Board of Appeal based the dismissal of the action before it in so far as it referred to the request to conduct the persistence test. As a first step, the applicant’s arguments calling into question the findings on which the Board of Appeal based the rejection of the second plea in the action before it, alleging an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006 will be examined. As a second step, the applicant’s arguments calling into question the findings on which the Board of Appeal based the rejection of the first plea in the action before it, alleging, in particular, an infringement of Annex XIII to Regulation No 1907/2006 will be examined. As a third step, the applicant’s arguments alleging that the Canadian authorities reached the conclusion that Triclosan lacked both the persistence property and the bioaccumulation property will be examined.

1. The arguments calling into question the rejection, by the Board of Appeal, of the second plea in the action before it

49 In the context of the second plea in the action before the Board of Appeal, the applicant claimed that the ECHA had infringed the first sentence of Article 47(1) of Regulation No 1907/2006. In that context, it claimed in particular that the ECHA had failed to take account of relevant information showing that Triclosan was largely eliminated from water leaving sewage treatment plants, not only due to its absorption, but also to its mineralisation. That substance is quickly eliminated from the water phase and absorbed in sediment, which suggests a potentially relatively significant elimination in the aquatic environment. In the context of that plea, the applicant also put forward arguments relating to the weight of evidence determination of the available data.

50 In paragraphs 57 to 65 of the contested decision, the Board of Appeal examined those arguments.

51 First of all, in paragraph 58 of the contested decision, the Board of Appeal stated that, although, under the first sentence of Article 47(1) of Regulation No 1907/2006, the ECHA was required to take into account all the relevant information submitted, that did not imply that that agency would necessarily arrive at the same conclusions as the applicant.

52 In paragraphs 59 to 61 of the contested decision, concerning, firstly, the applicant’s argument alleging that the ECHA had not taken account of information indicating that Triclosan would largely be eliminated from wastewater by sewage treatment plants, the Board of Appeal held that, although, according to the findings in the ECHA decision, Triclosan was largely eliminated from wastewater by sewage treatment plants, that was not the case with respect to all of that substance, which seemed to be ubiquitous in certain fresh surface water and the concentration of that substance in the maritime environment remained relatively high. It concluded that, contrary to what was submitted by the applicant, the relevant information had been taken into account but that, in the ECHA decision, a conclusion other than that supported by the applicant was drawn from that information.

53 Regarding, secondly, the applicant’s argument alleging that the ECHA had not taken account of the fact that Triclosan rapidly binds with suspended particulate matter and was, consequently, eliminated from the water phase to a large extent, the Board of Appeal held, in paragraphs 62 and 63 of the contested decision, that it concerned comments relating to the dissipation of Triclosan already put forward during the proceedings before the ECHA and that, in that agency’s decision, an explicit and extensive response had already been given to those comments. In paragraph 64 of the contested decision, in response to the applicant’s argument alleging that there should have been an answer to the question whether Triclosan was persistent in determining the evidential weight of the information available, it held that, in accordance with Annex XI to Regulation No 1907/2006, the determination by means of the weight of evidence approach could be used to adapt standard information requirements for registration purposes. However, according to it, even where such an approach has been applied for the purposes of registering a substance, in the context of the evaluation of that substance, further information could be requested in order to clarify whether there are any concerns in that regard, on condition that the ECHA correctly exercised its discretion, by taking account, in particular, of all of the relevant information which had been submitted concerning the substance at issue.

54 The applicant contests those assessments by claiming, as a first step, that the Board of Appeal failed to fulfil the task imposed on it in the context of an action before it, as a second step, that it failed to take into account the fact that, in the evaluation of substances, it is necessary to carry out the weight of evidence determination of the available information and, finally, as a third step, that the intensity of the review conducted by that board was insufficient.

(a) The arguments alleging that the Board of Appeal disregarded the task imposed on it in the context of an action before it

55 In the context of the first part of the first plea in law, the applicant claims that, in paragraph 64 of the contested decision, the Board of Appeal disregarded its review task. It claims that that board merely reviewed the lawfulness of the ECHA decision, restricted to the manifest error of assessment. In particular, it refused to examine the scientific data which it had invoked and to take their relevance into account. According to it, that board should have itself carried out a full administrative review. Such a review would have involved not only a legal review of the ECHA decision, but also a re-examination of the scientific assessments underlying that decision, in the light of the most relevant data and, where appropriate, data which became apparent during the appeal proceedings. Moreover, according to the applicant, under the principle of functional continuity, that board, which may exercise any power which lies within the competence of the ECHA, was required to examine whether, in the light of all the relevant matters of law and fact, a new decision with the same operative part as the ECHA decision could be lawfully adopted. In the context of such an examination, the board in question is subject to the same substantive obligations and the same burden of proof to which the ECHA had been subject in the context of its review. The review carried out by the Board of Appeal should therefore have been based also on the elements which had been submitted during the proceedings before it.

56 In support of its arguments, the applicant claims that, firstly, under Article 76(1)(h) of Regulation No 1907/2006, the Board of Appeal is part of the ECHA. Secondly, the rationale for the internal review mechanism is to ensure the scientific quality and regulatory legitimacy of the ECHA decisions. Thirdly, that board is responsible for examining the appeal as effectively and efficiently as possible. Fourthly, such an approach would allow that board to carefully and impartially examine all the relevant elements of the present case, on the basis of the most relevant scientific data and in accordance with the principles of excellence, independence and transparency. Fifthly, that board has the same capacity to investigate as the Board of Appeal of the European Union Intellectual Property Office (EUIPO). Under Article 12(1) and (2) of Commission Regulation (EC) No 771/2008 of 1 August 2008 laying down the rules of organisation and procedure of the Board of Appeal of the ECHA (OJ 2008 L 206, p. 5), the latter is allowed to take account of scientific facts post-dating the ECHA decision. That allows it to adapt its review and to take into account the most recent scientific research in the field. Sixthly, the appeals against the decisions requesting further information in the context of the evaluation of substances are governed by the same rules as appeals against other ECHA decisions. Seventhly, in accordance with Article 93(3) of Regulation No 1907/2006 and the principle of functional continuity, the Board of Appeal may exercise any power that lies within ECHA’s competence. It could thus have modified the ECHA decision or replaced it with its own decision. Eighthly, appeals before the Board of Appeal have suspensory effect. Ninthly, the approach followed in the contested decision creates a gap in the decision-making process which the EU Courts and the EU legislature sought to avoid.

57 The ECHA and the interveners contest those arguments.

58 First of all, before responding to the applicant’s arguments, it is necessary to analyse the scope and intensity of the review that the Board of Appeal is required to carry out of ECHA decisions and, in particular, of decisions requesting further information in the context of the evaluation of substances.

(1) The scope and intensity of the review conducted by the Board of Appeal

(i) The scope of the review

59 It should be noted, at the outset, that none of the provisions of Regulation No 1907/2006, or of Regulation No 771/2008, expressly provide that, in the context of an action before it against a decision of the ECHA requesting further information in the evaluation of a substance, the Board of Appeal is to conduct a ‘de novo’ evaluation as envisaged by the applicant, that is to say an evaluation of the question whether, at the time when it rules on the action, in the light of all the relevant elements of fact and law, in particular scientific issues, a new decision with the same operative part as the decision contested before it may be lawfully adopted.

60 By contrast, it follows from the provisions of Regulation No 1907/2006 and of Regulation No 771/2008 that, in the context of such an action, the Board of Appeal is to confine itself to examining whether the arguments put forward by the applicant are such as to demonstrate the existence of an error vitiating the contested decision.

61 In the first place, it must be noted that the procedure before the Board of Appeal has an adversarial nature.

62 Article 93(4) of Regulation No 1907/2006 provides that the rules on procedures before the Board of Appeal are fixed by the European Commission in accordance with the procedure referred to in Article 133(4) of that regulation. Therefore, it is the rules included in Regulation No 771/2008 which govern the procedure before that board.

63 As regards the rules on procedures before the Board of Appeal, it must be noted, in particular, that, under Article 6(1)(e) and (f) of Regulation No 771/2008, the notice of appeal must include the pleas in law and the arguments of fact and law relied on and, where relevant, production of evidence and a statement explaining the facts for which the evidence is offered in support. Under Article 7(1) and (2)(b) and (c) of that regulation, the ECHA must lodge a defence which fulfils those requirements. Finally, Article 12 of that regulation, entitled ‘Examination of appeals’, provides, in paragraphs 1 and 2 thereof, that no further evidence may be introduced after the first exchange of written pleadings, unless the delay is duly justified, and that no new plea in law may be introduced after the first exchange of written pleadings unless the Board of Appeal decides that it is based on new matters of law or of fact that come to light in the course of the proceedings.

64 The rules of procedure laid down in Regulation No 771/2008 provide therefore for the organisation, before the Board of Appeal, of an inter partes hearing between the applicant, which contests an ECHA decision, and the latter as defendant, on the basis of pleas, arguments and evidence produced, in principle, during the first round of written pleadings. Those provisions of that regulation are general provisions which apply to all decisions of the Board of Appeal, regardless of the nature of the decision contested before it.

65 As an interim conclusion, it must thus be noted that the subject of the procedure before the Board of Appeal of the ECHA is determined by the pleas put forward by the applicant in the context of the action before that board. In the examination of the merits of such an action, that board confines itself therefore to an examination of whether the pleas put forward by the applicant are capable of demonstrating that the decision contested before it is vitiated by an error, and the pleas which must be raised of its own motion.

66 The adversarial nature of the proceedings before the Board of Appeal is not called into question by Article 93(3) of Regulation No 1907/2006, which provides that the Board of Appeal may exercise any power which lies within the competence of the Agency or remit the case to the competent body of the Agency for further action. That provision governs solely the Board of Appeal’s powers after having held that an action before it was well founded. By contrast, it does not govern the review carried out by that board in relation to the merits of an action before it.

67 Moreover, it cannot be deduced from the fact that, under Article 76(1)(h) of Regulation No 1907/2006, the Board of Appeal is an integral part of the ECHA and that the provisions on which the ECHA relies when it rules at first instance refer to the ‘Agency’, that that board is required to follow the same procedure as the ECHA where the latter rules at first instance, in accordance with the same rules of procedure.

68 It follows from the scheme of Regulation No 1907/2006 that the rules of procedure addressing the ‘Agency’, which apply to the ECHA where it adopts a decision at first instance, are not intended to apply directly to the Board of Appeal.

69 As is shown by the example of the rules of procedure governing the adoption of a decision requesting further information in the context of the evaluation of a substance, a direct application of those procedural rules to the Board of Appeal would produce results contrary to the objectives pursued by Regulation No 1907/2006.

70 In that context, it should be recalled that, where a competent authority of a Member State, which was designated in order to implement the procedure for assessing a substance indicated in the Community rolling action plan as a result of concerns relating to its persistence, bioaccumulation and toxicity properties (‘the designated authority’), considers that further information is necessary, in accordance with Article 46(1) of Regulation No 1907/2006, it is to establish a draft decision within 12 months of the publication of the Community rolling action plan on the ECHA’s website for substances to be evaluated that year. The decision is then to be taken in accordance with the procedure laid down in Articles 50 and 52 of that regulation.

71 Article 50 of Regulation No 1907/2006 governs the rights of registrants and downstream users. Article 50(1) thereof provides that the ECHA is to submit the draft decision to the registrants or downstream users concerned. If the registrants or downstream users wish to present comments, they are to submit them to the ECHA within 30 days of receipt. The latter is in turn to inform the designated authority of the submission of the comments without delay. That authority is to take into account all comments received and may amend the draft decision as a result.

72 Under Article 52(1) of Regulation No 1907/2006, the designated authority is to circulate its draft decision, together with any comments by the registrant or downstream user, to the ECHA and to the competent authorities of the Member States.

73 According to Article 52(2) of Regulation No 1907/2006, the provisions of Article 51(2) to (8) of that regulation, concerning the decision-making process for dossier evaluation, apply mutatis mutandis to the adoption of decisions requesting further information in the context of the evaluation of a substance.

74 Under Article 51(2) of Regulation No 1907/2006, the Member States may propose amendments to the draft decision within 30 days of circulation. If no proposed amendment is sent to the designated authority, under Article 51(3) of that regulation, as applicable in accordance with Article 52(2) of that regulation, the ECHA is to take the decision in the version notified.

75 When the designated authority receives proposals for amendment it may amend the draft decision in accordance with the first sentence of Article 51(4) of Regulation No 1907/2006, as applicable in accordance with Article 52(2) of that regulation. Within 15 days after the 30-day period provided for the submission of comments, that authority is to refer a draft decision, together with any amendments proposed, to the Member State Committee and to the ECHA, in accordance with the second sentence of Article 51(4) of that regulation. Under Article 51(5) of the regulation in question, as applicable in accordance with Article 52(2) of that regulation, it is to also send it to registrants or downstream users concerned, who may submit comments. If, within 60 days of the referral, the Member State Committee reaches a unanimous agreement on the draft decision, in accordance with Article 51(6) of the regulation concerned, as applicable in accordance with Article 52(2) of that regulation, the ECHA is to take its decision accordingly.

76 By contrast, if the Member State Committee does not reach a unanimous agreement, under Article 51(7) of Regulation No 1907/2006, as applicable in accordance with Article 52(2) of that regulation, the Commission is to prepare a draft decision to be taken in accordance with the procedure referred to in Article 133(3) of that regulation.

77 Therefore, if, in an action against a decision requesting further information in the context of the evaluation of a substance, the Board of Appeal was required to follow the same procedure as the ECHA where the latter rules at first instance, due to the fact that it is part of the ‘Agency’, that would mean that that board could adopt a decision only in the event of prior unanimous agreement within the Member State Committee for the purposes of Article 51(6) of Regulation No 1907/2006.

78 Such an approach is not compatible with the legislator’s objective to allow a review, by the Board of Appeal, of decisions requesting further information in the context of the evaluation of a substance.

79 Similar considerations apply to the procedure governing the adoption of decisions taken in accordance with the dossier evaluation, with respect to which Article 51 of Regulation No 1907/2006 applies directly.

80 In that context, it should also be noted that, contrary to what is provided in relation to the boards of appeal of other agencies, such as the Board of Appeal of the EUIPO, the rules applicable to the Board of Appeal of the ECHA do not contain any provisions providing that the provisions relating to procedures before the unit which adopted the decision subject to appeal apply mutatis mutandis to appeal proceedings (concerning the rules applicable to the Board of Appeal of EUIPO, see paragraph 96 below).

81 In the second place and in any event, it should be noted that an action before the Board of Appeal against an ECHA decision requesting further information in the context of the evaluation of a substance may only aim to examine whether the evidence submitted by the applicant is capable of demonstrating that that decision is vitiated by error.

82 An ECHA decision requesting further information in the context of the evaluation of a substance is to be adopted on the basis of Article 46(1) of Regulation No 1907/2006, which is included in chapter 2 of Title VI of that regulation concerning the evaluation of substances, and of Article 50(1), Article 52 and Article 51(2) to (6) of that regulation, as applicable mutatis mutandis in accordance with Article 51(2) of that regulation.

83 As is apparent from Articles 44 to 48 of Regulation No 1907/2006, read in the light of recitals 66 to 68 of that regulation, the process for assessing substances, which encompasses the adoption of a decision requesting further information in the evaluation of a substance, is intended to achieve a more detailed evaluation of substances which are considered to be priority in the light of the risks they are likely to pose for human health and for the environment. Such an evaluation, which is conducted by the designated authority taking into account the precautionary principle (the second sentence of Article 1(3) of that regulation), must be entrusted to scientific experts.

84 As is apparent from Article 46(1) and Article 52 of Regulation No 1907/2006, read in conjunction with Article 51(2) to (8) of that regulation, the procedure for the adoption of a decision requesting further information is initiated on the basis of a draft established by the designated authority, if the latter considers that further information is necessary. As stated in paragraph 75 above, that proposal culminates in a decision of the ECHA in the event of agreement for the purposes of Article 51(3) or (6) of that regulation, applicable mutatis mutandis in accordance with Article 52(2) of that regulation, namely where no comments are made about the proposal for a decision by the Member States or by the ECHA, or, where such a comment is made, in the event of unanimous agreement within the Member State Committee.

85 Such a decision is therefore developed in a context of uncertainty and based on the scientific assessments of scientific experts of a Member State’s designated authority and of the competent authorities of the other Member States. It must be noted that it does not follow from the provisions of Regulation No 1907/2006, or from those of Regulation No 771/2008, that it is necessary to repeat that scientific assessment in the context of the appeal proceedings before the Board of Appeal. On the contrary, as stated in paragraphs 68 to 79 above, it follows from the scheme of the procedural provisions governing the adoption of decisions requesting further information that Articles 46 and 50 to 52 of Regulation No 1907/2006 are not directly applicable to proceedings before the Board of Appeal.

86 Consequently, an action before the Board of Appeal against an ECHA decision requesting further information in the context of the evaluation of a substance may only seek to examine whether the evidence submitted by the applicant is capable of showing that that decision is vitiated by error. Therefore, in the context of such an action, the applicant may not confine itself to claiming that the result of the assessment on which that decision is based should have been different, but it must put forward arguments to show the existence of errors vitiating the scientific assessment on which the decision in question is based.

(ii) The intensity of the review

87 As regards the intensity of the review carried out by the Board of Appeal, it should be noted that, admittedly, in an action for annulment under Article 263 TFEU, the review carried out by the EU Courts is limited where it involves the assessment of highly complex scientific and technical facts. Regarding such assessments, the EU Courts are limited to reviewing whether they are vitiated by a manifest error, a misuse of powers or whether the author of the decision clearly exceeded the limits of its discretion (see judgment of 21 July 2011, Etimine, C‑15/10, EU:C:2011:504, paragraph 60 and the case-law cited).

88 However, that case-law does not apply to the review carried out by the Board of Appeal of the ECHA. In that regard, concerning the members of that agency, it should be noted that, under the second subparagraph of Article 1(1) of Regulation No 771/2008, at least one of its members is to be legally qualified and at least one member to be technically qualified, in accordance with Commission Regulation (EC) No 1238/2007 of 23 October 2007 on laying down rules on the qualifications of the members of the Board of Appeal of the ECHA (OJ 2007 L 280, p. 10). Under Article 1(2) of that regulation, the technically qualified members are to hold a university degree or an equivalent qualification and to have substantial professional experience in hazard assessment, exposure assessment or risk management with regard to human health or environment risks of chemical substances or in related fields. It must be deduced from those provisions that the legislature intended to provide the ECHA with the necessary expertise to allow it to itself carry out assessments of highly complex scientific facts.

89 Therefore, the review, by the Board of Appeal, of scientific assessments in an ECHA decision is not limited to verifying the existence of manifest errors. On the contrary, in that regard, by relying on the legal and scientific competences of its members, that board must examine whether the arguments put forward by the applicant are capable of demonstrating that the considerations on which that decision of the ECHA is based are vitiated by error.

(2) The arguments put forward by the applicant

90 It is necessary to examine the arguments put forward by the applicant by taking into account the previous considerations relating to the scope and intensity of the review carried out by the Board of Appeal.

91 In the first place, the applicant claims that, under Article 93(3) of Regulation No 1907/2006, functional continuity exists between the Board of Appeal and the ECHA where that agency rules at first instance which is comparable to that existing between the Boards of Appeal of the EUIPO and the units of that office, and that, as a result of that functional continuity, in the context of an action before it against a decision of the ECHA, the Board of Appeal of that agency is required to conduct a full re-examination of all the questions, in particular scientific questions, addressed in the decision contested before it.

92 In that regard, firstly, it should be recalled, as was stated in paragraphs 60 to 80 above, that in the context of the examination of the merits of the action before the Board of Appeal, the procedural rules for the adoption of an ECHA decision where that agency is ruling at first instance are not directly applicable. By contrast, that board applies rules of procedure provided for by Regulation No 1907/2006 and Regulation No 771/2008, which are designed specifically for proceedings before it, and is thus limited to examining, in adversarial proceedings, whether that decision is vitiated by error. In any event, as stated in paragraphs 81 to 86 above, at least in an appeal against an ECHA decision requesting further information in the context of the evaluation of a substance, the Board of Appeal is limited to such an examination.

93 Secondly, it should be noted that, as was stated in paragraph 66 above, Article 93(3) of Regulation No 1907/2006 governs solely the Board of Appeal’s powers after having concluded that an action before it was well founded, and not the scope of the review carried out by that board with regard to the merits of an action brought before it.

94 Thirdly, as regards the applicant’s arguments based on the case-law concerning the Boards of Appeal of the EUIPO, it should be noted that, admittedly, according to the case-law, as a result of the appeal before it, the Board of Appeal of the EUIPO is called upon to carry out a new, full examination, in terms of both law and fact, of the merits of the request or of the dispute brought before the department hearing the application at first instance (see, to that effect, judgment of 13 March 2007, OHIM v Kaul, C‑29/05 P, EU:C:2007:162, paragraph 57). A Board of Appeal of the EUIPO may therefore not confine itself to examining whether, in the light of the arguments put forward by the applicant, the decision of the department of the EUIPO hearing the application at first instance is vitiated by error, but it is required to examine whether a new decision with the same operative part as the decision subject to appeal before it may be lawfully adopted at the time of the appeal ruling. Therefore, the extent of the examination which the Board of Appeal must conduct in respect of the decision under appeal is not, in principle, determined by the grounds relied on by the party who has brought the appeal (judgments of 23 September 2003, Henkel v OHIM — LHS (UK) (KLEENCARE), T‑308/01, EU:T:2003:241, paragraphs 26 and 29, and of 16 March 2005, L’Oréal v OHIM — Revlon (FLEXI AIR), T‑112/03, EU:T:2005:102, paragraph 36).

95 However, contrary to what is claimed by the applicant, that case-law cannot be transposed to the Board of Appeal of the ECHA. The nature and scope of the examination carried out by the boards of appeal of EUIPO are highly dependent on the legislative and regulatory context in which it takes place, which is very different from that of the Board of Appeal of the ECHA.

96 In that context, first of all, it should be noted that, in the system established by Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark (OJ 2017 L 154, p. 1), the provisions governing proceedings before the units and divisions of the EUIPO apply mutatis mutandis to appeal proceedings before the Board of Appeal. That applies to the general provisions provided for in Chapter IX, Section 1 of Regulation 2017/1001, and in particular to Article 95 of that regulation, which provides that the EUIPO is to examine the facts of its own motion, except in proceedings relating to relative grounds for refusal and invalidity proceedings pursuant to Article 59 of that regulation. Likewise, it should be noted that Article 48 of Commission Delegated Regulation (EU) 2018/625 of 5 March 2018 supplementing Regulation (EU) 2017/1001 of the European Parliament and of the Council on the European Union trade mark, and repealing Delegated Regulation (EU) 2017/1430 (OJ 2018 L 104, p. 1) provides that, unless otherwise provided, the provisions relating to proceedings before the instance of the EUIPO which adopted the decision subject to appeal are to be applicable to appeal proceedings mutatis mutandis.

97 By contrast, as regards the ECHA, not only must it be noted that, as was stated in paragraphs 68 to 79 above, the provisions governing the procedure for the adoption of decisions by that agency at first instance are not applicable to appeal proceedings before the Board of Appeal, but it should also be noted that the rules applicable to that board do not contain a provision comparable to Article 48 of Delegated Regulation 2018/625, which provides that the rules of procedure governing the adoption of a decision by the ECHA where the latter rules at first instance are applicable mutatis mutandis to proceedings before that board.

98 Next, it is true that the case-law concerning the Board of Appeal of the EUIPO cited in paragraph 94 above is based in particular on the second sentence of Article 71(1) of Regulation 2017/1001, according to which that board may either exercise any power within the competence of the department which was responsible for the decision appealed or remit the case to that department for further prosecution. According to that case-law, that provision contains an indication not only as to the possible content of a decision of the Board of Appeal of the EUIPO, but also as to the extent of the examination which it must conduct of the decision under appeal (judgment of 23 September 2003, KLEENCARE, T‑308/01, EU:T:2003:241, paragraph 24).

99 However, contrary to what is claimed by the applicant, the mere fact that the wording of the second sentence of Article 71(1) of Regulation 2017/1001 is similar to that of Article 93(3) of Regulation No 1907/2006 does not permit that case-law to be transposed to the Board of Appeal of the ECHA.

100 In that context, it should be noted that the second sentence of Article 71(1) of Regulation 2017/1001 is preceded by a first sentence from which it follows that the Board of Appeal of the EUIPO is to exercise the powers provided for in the second sentence of that paragraph ‘following the examination as to the allowability of the appeal’. According to its wording, Article 71(1) of that regulation refers therefore to the question of which powers that board has after having found that an action before it was well founded.

101 However, it follows from the regulatory context of Article 71(1) of Regulation 2017/1001 that, in proceedings before the Board of Appeal of the EUIPO, the provisions governing proceedings before the units and divisions of the EUIPO apply (see paragraph 96 above) and that that board is thus required to examine whether a new decision with the same operative part as the decision under appeal before it may be lawfully adopted at the time of the appeal ruling. Therefore, the case-law referred to in paragraph 98 above must be read in the light of the regulatory context of Article 71(1) of Regulation 2017/1001. It cannot therefore be deduced from that case-law that Article 93(3) of Regulation No 1907/2006, which is in a different regulatory context, must be interpreted as determining in itself the scope of the review which must be conducted by the Board of Appeal of the ECHA in the context of the examination of the merits of an action before it.

102 Finally, it should be noted that the nature of the tasks of the EUIPO and of the decisions of that office is not comparable to that of the tasks and decisions of the ECHA. As is apparent from recital 27 of Regulation 2017/1001, it is for the EUIPO to take administrative implementation measures at Union level that trade mark law requires for each trade mark. As can be deduced from recitals 40 and 41 of that regulation, those implementation measures imply, in particular, that the EUIPO decides on applications for registration of a European Union trade mark and on cases initiated by third parties to oppose such registration or have it cancelled. As regards the ECHA, it is required, according to recital 15 of Regulation No 1907/2006, to centrally ensure effective management of the technical, administrative and scientific aspects of the system of protection of human health and the environment established by that regulation against risks connected with the manufacture, distribution and use of chemical substances. In particular, it results from recitals 16 to 21 of that regulation that one of the core principles of that system, which is to be implemented by the ECHA, is the obligation for producers and importers of chemical substances to provide all the relevant and available information on the dangers posed by those substances and to promote appropriate risk management measures. It is in the context of those obligations that decisions requesting further information adopted by the ECHA should be considered.

103 In the light of those differences, adequate legal protection against such decisions is not necessarily ensured by making the review thereof by the Board of Appeal of the ECHA subject to the requirements applicable to the review conducted by the Boards of Appeal of the EUIPO. As can be deduced from recital 42 of Regulation 2017/1001, in order to guarantee effective and efficient treatment of applications and disputes to be ruled on by the EUIPO, it can be justified to consider that it is for the Boards of Appeal of that office to re-examine, on their merits, those applications and disputes, substituting, in that regard, the first instance of the EUIPO. By contrast, where an administrative decision imposes obligations on individuals, such as a decision of the ECHA based on Article 46(1) and Article 52 of Regulation No 1907/2006, read in conjunction with Article 51(2) to (8) of that regulation, the legal protection of those individuals vis-à-vis that decision does not justify such a substitution, but merely requires that the Board of Appeal verify whether the decision at issue is vitiated by an error.

104 In the second place, it is necessary to reject the applicant’s argument alleging that, under Article 76(1)(h) of Regulation No 1907/2006, the Board of Appeal is an integral part of the ECHA. As is set out in paragraphs 59 to 86 above, the fact that that board is a body of the ECHA and not a body separate from that agency cannot, in itself, prejudge the nature and scope of the examination it is to conduct, regardless of the provisions defining the competences of that body and the rules of procedure applicable to it, of the nature of decisions subject to its review and the objectives of legal protection which it upholds.

105 In the third place, it is necessary to examine the applicant’s arguments alleging that the Board of Appeal has capacity to investigate allowing it to adopt a decision based on a review on both facts and points of law of questions addressed by the ECHA where that agency rules at first instance.

106 Firstly, it is necessary to reject the applicant’s argument alleging that the Board of Appeal has the same capacity to investigate as the ECHA where that agency rules at first instance. In that regard, it suffices to note that, as is apparent from paragraphs 59 to 86 above, in the light of the adversarial nature of the proceedings before that board and the fact that, in the context of the examination of the merits of the action before it, the rules of procedure applicable to the ECHA where that agency rules at first instance do not apply, it cannot be concluded that that board has the same capacity to investigate as the ECHA where that agency rules at first instance.

107 Secondly, the applicant claims that Article 12(1) of Regulation No 771/2008, which permits the Board of Appeal to take account of evidence which was presented for the first time during the appeal proceedings, confirms that that board is required to itself carry out a re-examination of the scientific assessments justifying the request for further information.

108 That interpretation of Article 12(1) of Regulation No 771/2008 cannot be accepted.

109 Firstly, Article 12(1) of Regulation No 771/2008 must be read in conjunction with Article 6(1)(f) of that regulation. Under Article 6(1)(f) of that regulation, in principle, the nature of any evidence offered and the facts for which the evidence is offered in support must already be included in the notice of appeal. As is apparent from a combined reading of Article 6(1)(f) and Article 12(1) of the regulation at issue, in principle, the parties may not submit further evidence after the first exchange of pleadings. An exception is however provided for the submission of new evidence in respect of which the delay is duly justified. Article 12(1) of that regulation is thus restricted to deciding in which circumstances, in adversarial proceedings before the Board of Appeal, an offer of evidence which was not already in the notice of appeal may still be submitted at a later stage of those proceedings.

110 Secondly, it should be pointed out that Article 12(1) of Regulation No 771/2008 cannot be regarded as a rule like Article 95(2) of Regulation 2017/1001 concerning the EUIPO, which provides that that ‘office may disregard facts or evidence which are not submitted in due time by the parties concerned’.

111 Article 95(2) of Regulation 2017/1001 is one of the rules of procedure which are applicable not only to the department of the EUIPO ruling at first instance, but also to the board of appeal of that agency. By contrast, Article 12(1) of Regulation No 771/2008 concerns only the procedure before the Board of Appeal, and is limited to specifying the cases in which an offer of evidence not included in the notice of appeal may still be considered to be admissible.

112 Therefore, in the light of the wording of Article 12(1) of Regulation No 771/2008, and of the context of that provision, contrary to what is claimed by the applicant, it cannot be deduced that the Board of Appeal is required, in an action before it, to re-examine the scientific assessments which justified the request to provide further information.

113 The applicant’s argument relating to Article 12(1) of Regulation No 771/2008 must therefore be rejected.

114 Thirdly, it must be noted that the approach advocated by the applicant, according to which, in an action before it, the Board of Appeal must conduct its own inquiry, is not, in any event, compatible with the provisions of Regulation No 1907/2006 and with the objectives pursued by the provisions of that regulation relating to the evaluation of substances.

115 As is apparent from paragraphs 81 to 86 above, a decision requesting further information is adopted, in a context of uncertainty about the risks posed by the substance in question, on the basis of a draft prepared by the designated authority of a Member State. As was stated in paragraphs 70 to 76 above, the rules of Regulation No 1907/2006 on the procedure for adopting such an ECHA decision grants a significant role to the competent authorities of the Member States. They seek to involve Member State experts in the decision-making process, in order to make use of the available expertise at Member State level concerning the different scientific questions raised during the evaluation of a substance. Furthermore, as follows from the provisions at issue and from recital 67 of that regulation, the procedure laid down for substance and dossier evaluation is based on the principle that a unanimous agreement within the Member State Committee concerning draft decisions (or an agreement between the Member States and the ECHA) should provide the basis for an efficient system that respects the principle of subsidiarity. In that context, it is useful to note that, under Article 51(7) of that regulation, which is directly applicable to decisions taken for dossier evaluation and is applicable mutatis mutandis to decisions on substance evaluation under Article 52(2) of that regulation, in the absence of such an agreement, the decision on dossier or substance evaluation may not be adopted at ECHA level, but must be adopted by the Commission.

116 The approach advocated by the applicant, which would involve the Board of Appeal itself conducting an examination of the scientific assessments on which a request for further information is based, by carrying out its own investigation, does not take sufficient account of the objectives of that procedure. By contrast, the approach followed by the Board of Appeal, which consists in confining itself, in the context of the examination of the merits of an action before it, to reviewing whether, in the light of the arguments put forward by the applicant, the considerations on which the decision contested before it is based are vitiated by errors, is compatible with those objectives.

117 That conclusion is not called into question by the fact that, where the examination of pleas put forward by the applicant in adversarial proceedings provided for by Regulation No 771/2008 shows that an ECHA decision is vitiated by error, under Article 93(3) of Regulation No 1907/2006, it is for the Board of Appeal to decide whether to refer the case to the competent body of that agency or whether it adopts a final decision itself.

118 In the event that the action before the Board of Appeal is well founded, Article 93(3) of Regulation No 1907/2006 confers a power of discretion on that board. In the exercise of that power, that board must assess whether the evidence it disposes of following the examination of the action allow it to adopt its own decision. Furthermore, it must take into account rules governing the procedure for the adoption of the ECHA decision where that agency rules at first instance. If that procedure grants an important role to certain actors, such as the procedure for the adoption of decisions relating to dossier and substance evaluation provides for the Member States and the Member State Committee, it must examine whether the adoption of a final decision at its level is compatible with the objectives pursued by that regulation or whether respect for the rules governing the procedure before the ECHA, where the latter rules at first instance, and the objectives pursued by those rules requires that the case be referred back to the competent body of that agency.

119 In view of the above considerations, it is necessary to reject the applicant’s arguments relating to the Board of Appeal’s capacity to investigate.

120 In the fourth place, the applicant claims that it follows from the practice of the Board of Appeal that the latter considers itself to be a functional continuation of the ECHA ruling at first instance. In that regard, it suffices to note that the findings set out in paragraphs 59 to 86 above are based directly on the relevant provisions of Regulation No 1907/2006 and of Regulation No 771/2008 and cannot therefore be called into question by the practice of that board.

121 In the fifth place, the applicant claims that Regulation No 1907/2006 and Regulation No 771/2008 make provision for identical rules for the actions against all of the ECHA decisions mentioned in Article 91(1) of Regulation No 1907/2006. In that regard, it suffices to note, as was stated in paragraph 59 above, that none of the provisions of the abovementioned regulations provides for the obligation to carry out a ‘de novo’ examination of an ECHA decision. In any event, for the reasons set out in paragraphs 81 to 86 above, such an obligation does not exist in relation to decisions requesting further information in the evaluation of a substance.

122 In the sixth place, the applicant claims that the objective of an action before the Board of Appeal is not to conduct a limited review of the lawfulness of an ECHA decision identical to that exercised by the Union Courts.

123 That argument must also be rejected as irrelevant.

124 As was stated in paragraphs 87 to 89 above, as regards the assessment of highly complex scientific and technical facts, the intensity of the review carried out by the Board of Appeal is greater than that of the review carried out by the Union Courts.

125 In the seventh place, the applicant claims that, under Article 91(2) of Regulation No 1907/2006, an action before the Board of Appeal has suspensory effect, like actions before the Board of Appeal of the EUIPO.

126 In the light of the considerations set out in paragraphs 59 to 86 above, the mere fact that actions before the Board of Appeal of ECHA have suspensory effect cannot mean that the Board of Appeal must itself carry out a new examination of the assessments of scientific and technical facts justifying a request for further information.

127 By contrast, the suspensory effect of the action before the Board of Appeal militates against such an approach.

128 In that context, it should be noted that one of the objectives pursued by Regulation No 1907/2006 is the exclusion or limitation of the manufacture and use of substances which have harmful effects on human health and the environment. The evaluation of a substance seeks therefore to determine whether it is persistent, bioaccumulative or toxic or very persistent or very bioaccumulative. The ECHA decisions requesting further information are thus necessary in order to conduct such an assessment.

129 If, as the applicant claims, the Board of Appeal should systematically conduct itself a new review of the assessments of scientific and technical facts justifying a request for further information, the length of the procedure before that board would risk being extended, which is likely to delay the establishment of the studies containing the further information which is thus necessary in order to conduct the evaluation of the substance at issue.

130 In the light of those considerations, the applicant’s argument relating to the suspensory effect of the action before the Board of Appeal must also be rejected.

131 Therefore, it is necessary to reject all of the applicant’s arguments seeking to demonstrate that, in paragraph 64 of the contested decision, the Board of Appeal failed to fulfil the task imposed on it in the context of an action against an ECHA decision.

(b) The arguments alleging that the Board of Appeal did not take into account the evidential weight of the available information

132 In the context of the third part of the second plea in law, the applicant claims that, in paragraph 64 of the contested decision, the Board of Appeal infringed Annex XIII to Regulation No 1907/2006. In that paragraph, that board wrongly considered that the weight of evidence determination of the information available did not apply to the evaluation of a substance. That approach is applicable both to the registration of a substance and the assessment thereof. Therefore, according to the applicant, before requesting the conduct of the persistence test, that board should have examined whether the weight of evidence determination of the information available allowed conclusions to be drawn concerning the risk that Triclosan is persistent. It is only in the event that such an approach did not produce conclusive results that the conduct of a further test could have been requested. The board in question did not carry out such an examination. Moreover, that annex does not indicate that the weight of evidence determination of the information available is required solely of registrants.

133 The ECHA and the interveners dispute those arguments.

134 As a first step, it is necessary to reject the arguments put forward by the applicant in so far as they seek to demonstrate that the Board of Appeal should have itself conducted a new examination by itself carrying out a weight of evidence determination of the available information. As has already been stated in paragraphs 55 to 131 above, in the context of an action before it, that board merely examines whether the arguments put forward by the applicant are capable of showing the existence of an error vitiating the decision contested before it.

135 As a second step, it is necessary to examine the applicant’s arguments in so far as they seek to demonstrate that the Board of Appeal committed an error in the context of the review it conducted relating to the ECHA decision.

136 In that regard, in the first place, it should be noted that, in itself, the Board of Appeal’s finding in the first sentence of paragraph 64 of the contested decision, according to which, in application of Annex XI to Regulation No 1907/2006, a weight of evidence approach may be adopted in order to adapt standard information requirements for the registration of a substance, is not incorrect. As is apparent from point 1.2 of that annex, in the context of the registration of a substance, if such an approach allows the existence or absence of a particular dangerous property to be confirmed, further testing on vertebrate animals for the property at issue is to be omitted and further testing not involving vertebrate animals may be omitted.

137 In the second place, in so far as the applicant claims that the Board of Appeal infringed Annex XIII to Regulation No 1907/2006, it must be noted that the second paragraph of that annex merely indicates that a weight of evidence determination based on an expert opinion is to be applied to the identification of persistent, bioaccumulative and toxic substances, and to the identification of very persistent and very bioaccumulative substances. By contrast, no express reference is made to the stage of the evaluation of substances. Therefore, the applicant’s arguments alleging an infringement of that annex must be rejected.

138 In the third place, it is necessary to examine the applicant’s arguments claiming that, if a weight of evidence approach to the available information had been applied, it would have been possible to evaluate whether Triclosan was persistent, and that, therefore, the principle of proportionality precluded the ECHA from requesting further information.

139 In that regard, firstly, it should be noted that, in the second sentence of paragraph 64 of the contested decision, the Board of Appeal took care to state that, in the evaluation of a substance, the ECHA was entitled to request further information in addition to the information required in the context of its registration, where, after having taken into account all the relevant information which had been submitted concerning the substance, that agency concluded that that additional information was necessary in order to carry out the evaluation of the substance at issue. By that sentence, it thus noted that the ECHA should take into account all the relevant information in its possession before requesting further information.

140 Secondly, it should be noted that, as has already been stated in paragraphs 59 to 86 above, proceedings before the Board of Appeal are adversarial and the scope of the examination conducted by that board is thus limited by the arguments put forward by the applicant. Therefore, supposing that, at the stage of the evaluation of a substance, the ECHA had been required to take into account the evidential weight of the available information during those proceedings, the applicant would have had to set out the reasons why the application of such an approach would have allowed a conclusion to be drawn concerning the existence or lack thereof of a risk of persistence.

141 However, in the context of the second plea in the action before the Board of Appeal, the applicant had not put forward detailed arguments to show the existence of errors affecting the ECHA’s findings justifying its conclusion that further information was necessary. That plea alleged principally an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006, according to which, in the evaluation of a substance, it is necessary to take into account, in particular, all the relevant information submitted on the substance in question. As was stated in paragraph 52 above, in paragraphs 59 to 61 of the contested decision, the Board of Appeal had responded to that principal argument. In that context, it stated that the ECHA had taken the information at issue into account, but that it had drawn a conclusion different from that drawn by the applicant.

142 Admittedly, in the context of the second plea in the action before the Board of Appeal, the applicant also invoked an argument alleging that, if the ECHA had carried out a weight of evidence determination of the available information, it would not have been able to consider it necessary to conduct the persistence test. However, in that context, it should be noted that, as that board stated in paragraphs 57 to 63 of the contested decision, in its decision, the ECHA had comprehensively set out the reasons why it considered that the information invoked by the applicant did not allow it to be concluded that there was no risk of persistence. It must be noted that, in the context of that action, the applicant did not develop arguments seeking to call into question the grounds set out in that decision, but it merely invoked that a weight of evidence determination of the available information should have been carried out.

143 In the light of the arguments put forward by the applicant in the action before the Board of Appeal, irrespective of the question whether there is an obligation to apply the weight of evidence approach to the available information in the evaluation of a substance, in any event, that board cannot be criticised for confining itself to noting, in paragraph 64 of the contested decision, that, before adopting a decision requesting further information, the ECHA should take into account all the relevant information in its possession.

144 In the fourth place, it is necessary to reject the applicant’s argument alleging that it was not for it to show that, in the light of the available information, a request for further information was not necessary. Firstly, it in no way follows from paragraph 64 of the contested decision that the Board of Appeal considered that, during the procedure leading to the adoption of the ECHA decision, it is for the registrant to show the need for the request for information. Secondly, and in any event, it should be noted that it is apparent from page 5, the second paragraph of point III.I.1 of the ECHA decision that, in the examination of whether further information on the persistence of Triclosan was necessary, that agency carried out the weight of evidence determination of the available information.

145 Therefore, it is necessary to reject the applicant’s arguments claiming that, in paragraph 64 of the contested decision, the Board of Appeal failed to take into account the evidential weight of the available information.

(c) The arguments alleging that the intensity of the review conducted by the Board of Appeal was not sufficient

146 In the context of the first part of the first plea, the applicant claims that, in paragraph 64 of the contested decision, the Board of Appeal committed an error by relying on the ECHA concerning the differences of scientific opinion, in so far as the latter properly exercised its discretion. In that paragraph, the Board of Appeal merely verified the absence of manifest errors of assessment on the part of the ECHA.

147 The ECHA and the interveners dispute those arguments.

148 As a first step, in so far as the applicant’s arguments seek to demonstrate that the Board of Appeal should not have merely examined whether the ECHA decision was vitiated by error, but should have examined itself whether it was necessary to adopt the request to conduct the persistence test, they must be rejected for the same reasons as those set out in paragraphs 55 to 131 above.

149 As a second step, in so far as that argument seeks to demonstrate that, in the second sentence of paragraph 64 of the contested decision, the Board of Appeal unduly limited the intensity of the review that it conducted of the scientific findings in the ECHA decision, it must also be rejected.

150 In the context of the action before the Board of Appeal, the applicant claimed that, if the ECHA had followed an approach based on the weight of evidence determination of the available information, it would not have been able to conclude that it was necessary to request the persistence test to be conducted.

151 In the second sentence of paragraph 64 of the contested decision, the Board of Appeal set out that, in the evaluation of a substance, further information could be requested in order to clarify potential concerns, on condition that the ECHA correctly exercised its discretion by taking account, in particular, of all of the relevant information which had been submitted in relation to that substance. However, it cannot be deduced from that sentence that that board rejected the applicant’s argument on the ground that that argument was not capable of showing the existence of a manifest error affecting the ECHA decision. As was stated in paragraphs 140 to 143 above, in that sentence, that board did not further examine that argument of the applicant on the ground that it was not sufficiently substantiated. In those circumstances, it cannot be deduced from that sentence that an inappropriate limitation of the intensity of the review conducted by that board led to the rejection of an argument of the applicant.

152 Therefore, the arguments alleging that, in paragraph 64 of the contested decision, the Board of Appeal committed an error by deferring to the ECHA on matters of scientific dispute and by merely verifying the absence of manifest errors of assessment cannot succeed. Therefore, all of the arguments calling into question the considerations on which the Board of Appeal based the rejection of the second plea in the action against the ECHA decision must be rejected.

2. The arguments calling into question the rejection, by the Board of Appeal, of the first plea in the action before it

153 In the context of the first plea in the action before the Board of Appeal, the applicant alleged, in particular, an infringement of the fourth paragraph of the preamble to Annex XIII to Regulation No 1907/2006, according to which the information used for the evaluation of the persistent, bioaccumulative and toxic properties of a substance and for the evaluation of very persistent and very bioaccumulative properties thereof must be based on data obtained under relevant conditions.

154 In paragraphs 40 to 51 of the contested decision, the Board of Appeal examined and rejected those arguments. In paragraph 41 of that decision, it stated that, in the light of the applicant’s arguments, it was necessary for it to examine whether the testing conditions described in the ECHA decision, namely the requirement that the testing be conducted in pelagic waters without additional suspended particulate matter, constituted relevant conditions for the purposes of the fourth paragraph of the preamble to Annex XIII to Regulation No 1907/2006. In paragraphs 42 to 45 of the contested decision, it stated that, according to the findings made in the ECHA decision, Triclosan was present in certain fresh and marine pelagic waters which did not contain large quantities of the suspended particulate matter with which it readily bound, that it was potentially persistent in such waters and that the results of testing in water-sediment systems did not allow a conclusion to be drawn as to the half-life of that substance in pelagic water. In paragraph 46 of that decision, it noted the applicant’s argument alleging that the most significant source of environmental emissions of Triclosan is the direct emission of effluent from water treatment plants into surface water, which may or may not contain high levels of solid matter and sediment. It also stated that, for that reason, the applicant considered that testing in pelagic water without the addition of suspended solids is not conducted under relevant conditions within the meaning of the fourth paragraph of the preamble to that annex. In paragraphs 47 to 50 of that decision, it responded to that argument. Firstly, it noted the definition of persistence and the fact that, under Section 1.1.1 of that annex, the persistence property of a substance depended, in particular, on its degradation in pelagic water. Secondly, it noted that, even if it was indicated in that section that the testing must be conducted in the relevant conditions, that does not mean that it was necessary to limit itself to the most frequent patterns of distribution of a substance in the environment. It noted that the request to conduct the persistence test did not pursue the objective of assessing the behaviour of Triclosan in waters containing a high content of suspended solids or sediment, but its behaviour in the specific environment mentioned in Section 1.1.1 of that annex, which includes fresh and marine pelagic waters, without large amounts of bound residue. In paragraph 51 of that decision, it concluded that, in the light of those considerations, the first plea in the action against the ECHA decision had to be rejected.

155 The applicant claims that those findings are wrong. In the context of the third part of the second plea, alleging an infringement of the principle of proportionality, it claims that, by requiring that the persistence test be conducted in pelagic water, which is contrary to the fourth paragraph of the preamble to Annex XIII to Regulation No 1907/2006, the ECHA and the Board of Appeal failed to take account of data which reflected environmentally relevant conditions. The objective of a request for information is to obtain data allowing the environmental risks to be identified and to define appropriate risk management measures. By contrast, the determination in the abstract of an intrinsic property of a substance which has an effect on the possibility of it degrading is not relevant in that context. The most significant source of environmental emissions of Triclosan is the direct emission of effluent from water treatment plants into surface water, which may or may not contain high levels of solid matter and sediment. For that reason, testing in pelagic water without the addition of suspended solids is not conducted under relevant conditions within the meaning of the fourth paragraph of the preamble to that annex.

156 The ECHA and the interveners dispute those arguments.

157 As a first step, in so far as the applicant’s arguments seek to demonstrate that, in a ‘de novo’ examination of the ECHA decision, the Board of Appeal should itself have applied the fourth paragraph of the preamble to Annex XIII to Regulation No 1907/2006, they must be rejected for the same reasons as those set out in paragraphs 55 to 131 above.

158 As a second step, it is necessary to examine the applicant’s arguments in so far as they seek to demonstrate that, in the context of its review of the ECHA decision, the Board of Appeal misconstrued the scope of the fourth paragraph of the preamble to Annex XIII to Regulation No 1907/2006.

159 In that regard, it should be noted that, as is apparent from the first sentence of paragraph 12.2 of Annex II to Regulation 1907/2006, the persistence and degradability of a substance corresponds to its environmental degradation potential, either by biodegradation, or by other processes, such as oxidation or hydrolysis.

160 According to paragraph 1.1.1 of Annex XIII to Regulation No 1907/2006, a substance fulfils the persistence criterion in any of the following situations: (a) the degradation half-life in marine water is higher than 60 days; (b) the degradation half-life in fresh or estuarine water is higher than 40 days; (c) the degradation half-life in marine sediment is higher than 180 days; (d) the degradation half-life in fresh or estuarine water sediment is higher than 120 days; (e) the degradation half-life in soil is higher than 120 days.

161 It follows that a substance must be considered to be persistent where its half-life in one of the five environments mentioned in paragraph 1.1.1 of Annex XIII to Regulation No 1907/2006 exceeds the duration stated in that paragraph. As is apparent from paragraphs (a) and (b) of that provision, some of those environments consist of fresh waters or of marine pelagic waters.

162 In that context, it must also be noted that, in the contested decision, the Board of Appeal recalled that, according to statements in the ECHA decision that the applicant had not contested, Triclosan was present in fresh and marine pelagic waters and those environments did not contain a large quantity of suspended particulate matter with which it easily bound.

163 In those circumstances, the Board of Appeal did not commit an error, in paragraphs 40 to 51 of the contested decision, when it concluded that the persistence test, which relates to the behaviour of Triclosan in fresh and marine pelagic waters, was conducted in conditions which are appropriate for the purposes of the fourth paragraph of the preamble to Annex XIII to Regulation No 1907/2006.

164 Since a substance must be considered to be persistent if its degradation half-life exceeds the period indicated in one of the five environments mentioned in point 1.1.1 of Annex XIII to Regulation No 1907/2006 (see paragraph 160 above), the examination of the persistence of Triclosan could not be limited to the environment in which the majority of its emissions take place, if there existed information that Triclosan was also present in other relevant environments such as fresh and marine pelagic waters. Therefore, the Board of Appeal was correct to reject the argument alleging that the requirement that the persistence test be conducted in pelagic water was not compatible with the fourth paragraph of the preamble to that annex.

165 Therefore, all of the applicant’s arguments calling into question the rejection, by the Board of Appeal, of the first plea in the action against the ECHA decision must be rejected.

3. The arguments relating to the Canadian authorities’ conclusions

166 In the context of third part of the second plea, the applicant claims that the ECHA and the Board of Appeal did not take into account the evidence relating to the persistence of Triclosan. On the basis of the available information, the Canadian authorities came to the conclusion that Triclosan did not demonstrate either persistence or bioaccumulation properties. Firstly, the criteria applied by the ECHA and by the Canadian authorities for identifying persistent, bioaccumulative and toxic substances are similar in so far as they pursue the same objective of protecting the environment from adverse effects of such substances. Secondly, the scientific method used by the Canadian authorities is similar to the weight of evidence approach.

167 The ECHA and the interveners dispute those arguments.

168 As a first step, in so far as the applicant’s arguments seek to demonstrate that the Board of Appeal should have taken account of the Canadian authorities’ conclusions in the ‘de novo’ examination of the ECHA decision that it was required to conduct in the context of the action before it, they should be rejected for the same reasons as those set out in paragraphs 55 to 131 above.

169 As a second step, it is necessary to examine the applicant’s arguments relating to the Canadian authorities’ conclusions in so far as they seek to demonstrate that, in the context of the review conducted by the Board of Appeal of the ECHA decision, that board committed an error.

170 In the first place, in so far as, by its arguments, the applicant intends to demonstrate that the Board of Appeal should have found that the ECHA had infringed the first sentence of Article 47(1) of Regulation No 1907/2006 or that, in the light of the Canadian authorities’ conclusions, that agency was not entitled to request the persistence test to be conducted, they must be rejected. As was stated in paragraphs 59 to 86 above, the scope of the review conducted by that board depends on the pleas put forward by the applicant. It must be noted that, in the context of the first plea in the action before that board, the applicant did not put forward any pleas relating to the Canadian authorities’ conclusions.

171 In the second place, in so far as, by its arguments, the applicant claims that the Canadian authorities’ conclusions demonstrate that the Board of Appeal’s findings are vitiated by error, it should be noted that the applicant merely invokes the existence of those conclusions, but does not state the reasons why those conclusions are capable of calling into question the lawfulness of that board’s findings, which are based on the rules provided for by Regulation No 1907/2006. Therefore, such arguments must be rejected as not sufficiently substantiated.

172 Therefore, it is also necessary to reject the applicant’s arguments relating to the Canadian authorities’ conclusions and, therefore, the entirety of the arguments concerning the dismissal of the action before the Board of Appeal in so far as it related to the request to conduct the persistence test.

B. The arguments concerning the rejection of the action before the Board of Appeal in so far as it related to the request to conduct the enhanced neurotoxicity rat study

173 In its decision, the ECHA requested the applicant to conduct the enhanced neurotoxicity rat study. According to the considerations in that decision, that request to provide further information is justified by the fact that there were concerns concerning the potential risk of Triclosan being neurotoxic and reproductive toxic and that it was not possible to dispense with them or confirm them on the basis of available information.

174 In the context of the action against the ECHA decision before the Board of Appeal, the applicant claimed that there should have been no request to conduct that study. In that regard, it put forward four pleas, namely, the sixth plea alleging an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006, the seventh plea alleging an infringement of Article 25 of that regulation, the eighth plea alleging a breach of the principle of proportionality, and the ninth plea alleging an infringement of Article 130 of that regulation.

175 In the contested decision, the Board of Appeal examined those arguments. It examined questions of admissibility (paragraphs 117 to 131). It made several introductory remarks (paragraphs 132 to 136). It examined and rejected the seventh and eighth pleas (paragraphs 137 to 168), the sixth plea (paragraphs 169 to 203) and the ninth plea (paragraphs 204 to 220).

176 In the context of the present action, the applicant claims that certain of the considerations that the Board of Appeal advanced in those parts of the contested decision are incorrect. As a first step, the arguments relating to the rejection of the sixth plea in the action against the ECHA decision will be analysed. Those arguments allege an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006. As a second step, the arguments relating to the rejection of the seventh and eighth pleas of that action will be examined. Those arguments allege an infringement of Article 25 of that regulation and of the principle of proportionality. As a third step, the arguments calling into question that board’s findings relating to issues of admissibility will be assessed. As a fourth step, the arguments calling into question that board’s introductory comments will be analysed.

1. The arguments calling into question the rejection, by the Board of Appeal, of the sixth plea in the action before it

177 The sixth plea in the action against the ECHA decision alleged an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006. That plea was divided into two parts. The first part, which called into question the request to conduct a neurotoxicity study in its entirety, was examined and rejected by the Board of Appeal in paragraphs 186 to 199 of the contested decision. The second part, which sought more specifically to call into question the requirement to provide further evidence, namely the one-generation reproductive toxicity study, was examined and rejected by that board in paragraphs 200 to 203 of that decision.

178 The applicant considers that the Board of Appeal committed errors in the context of the examination of the two parts of the sixth plea in the action against the ECHA decision.

(a) The arguments calling into question the considerations on which the Board of Appeal based the rejection of the first part of the sixth plea in the action before it

179 The first part of the sixth plea in the action before the Board of Appeal concerned the findings of the ECHA justifying the request to conduct the neurotoxicity study in accordance with the OECD TG 426 method. In the context of that part, the applicant alleges, in particular, an infringement of the first sentence of Article 47(1) of Regulation No 1907/2006, on the ground that account had not been taken of all the relevant information concerning Triclosan. That part was structured around several complaints. The first alleged that the rat studies were not relevant and the second that, as regards the effects of Triclosan on the thyroid functions of humans, in particular, account had not been taken of the Allmyr, Cullinan and Koeppe studies or of the Witorsch report.

180 In paragraphs 187 to 199 of the contested decision, the Board of Appeal examined the first part of the sixth plea in the action against the ECHA decision.

181 In that context, in paragraph 187 of the contested decision, the Board of Appeal stated that the first complaint alleging the lack of relevance of the rat studies and certain of the arguments put forward in the context of the sixth plea in the action before it overlapped and that account was taken thereof in the context of the examination of the sixth plea.

182 In paragraphs 188 to 193 of the contested decision, the Board of Appeal rejected the arguments relating to the Allmyr, Cullinan and Koeppe studies and the Witorsch report that the applicant had developed in the context of the second complaint.

183 In the context of the present action, the applicant puts forward arguments calling into question, firstly, the Board of Appeal’s findings concerning the Allmyr, Cullinan and Koeppe studies and, secondly, its considerations concerning the Witorsch report.

(1) The arguments relating to the Board of Appeal’s findings concerning the Allmyr, Cullinan and Koeppe studies

184 In paragraph 188 of the contested decision, the Board of Appeal rejected the applicant’s argument alleging that, during the adoption of the ECHA decision, the Allmyr, Cullinan and Koeppe studies had not been taken into account, which, according to it, demonstrate that, at the relevant doses, Triclosan does not affect humans. In that regard, the Board of Appeal noted that those studies were included in the bibliography attached to the studies which was annexed to that decision, which had stated that those studies had been taken into account. By referring to its comments set out in paragraph 135 of the contested decision, the Board of Appeal stated that, in those circumstances, it should be considered that those studies had been taken into account during the adoption of the ECHA decision. In paragraph 135 of the contested decision, it had stated in particular that the ECHA was not required due to its obligation to state reasons to address, in a decision requesting further information in the context of the evaluation of a substance, every point contained in all existing or submitted studies and that, therefore, it should be considered that the ECHA had taken into account the studies mentioned in the bibliography annexed to its decision.

185 The applicant claims that the Board of Appeal’s findings developed in paragraphs 135 and 188 of the contested decision are incorrect. According to it, that board should not have confined itself to holding that the scientific studies providing data on Triclosan exposure in humans were included in the bibliography annexed to the ECHA decision. The applicant claims that that board was not entitled to merely assume that the data indicated in those studies had been taken into account or to reject its argument that Triclosan did not have effects on human health at the doses required in the enhanced neurotoxicity rat study, by relying on that sole ground.

186 The ECHA and the interveners dispute that argument.

187 As a first step, in so far as the applicant’s arguments seek to demonstrate that the Board of Appeal should not have confined itself to examining whether the ECHA decision was vitiated by error, but should have examined itself whether, in the light of the information contained in the Allmyr, Cullinan and Koeppe studies, it was necessary to request a neurotoxicity rat study to be conducted, those arguments should be rejected for the same reasons as those set out in paragraphs 55 to 131 above.

188 As a second step, it is necessary to examine the applicant’s arguments in so far as they seek to demonstrate that the Board of Appeal committed an error in the context of the review of the ECHA decision carried out by it.

189 Firstly, it is necessary to reject the applicant’s argument claiming that, in paragraph 188 of the contested decision, the Board of Appeal should have examined its argument according to which Triclosan had no effects on human health at the doses required in the enhanced neurotoxicity rat study. In that regard, it suffices to note that, as is clearly apparent from paragraph 187 of the contested decision (see paragraph 181 above), the Board of Appeal examined that argument in the context of the examination of the sixth plea in the action, since that argument and those put forward in the context of the sixth plea overlapped.

190 Secondly, the applicant claims that the Board of Appeal infringed the first sentence of Article 47(1) of Regulation No 1907/2006. According to it, that board could not confine itself to finding, in paragraph 188 of the contested decision, that the Allmyr, Cullinan and Koeppe studies were mentioned in the bibliography annexed to the ECHA decision.

191 In that regard, it should be noted that, in the context of the action before it, it was for the Board of Appeal to review whether, in the course of the procedure leading to the adoption of the ECHA decision, account had been taken of all of the relevant information which had been communicated concerning Triclosan.

192 Firstly, it should be noted that the Board of Appeal did not commit an error, in paragraph 135 of the contested decision, where it found that the ECHA had not failed to satisfy the obligation to state reasons by not addressing in its decision each point contained in all the existing or submitted studies. In any event, on page 20 of its decision, the ECHA took account of the Allmyr and Cullinan studies.

193 Secondly, it must be noted that the arguments put forward by the applicant in the action before the Board of Appeal in support of its complaint alleging an infringement of the first se