BASF and REACH & colours v ECHA (Research and technological development - Requirement for joint submission of data - Judgment) [2019] EUECJ T-806/17 (03 October 2019)

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(REACH — Article 11 of Regulation (EC) No 1907/2006 — Article 3(3) of Implementing Regulation (EU) 2016/9 — Requirement for joint submission of data — Joint submission with possibility of a complete opt-out — Administrative practice of ECHA requiring an agreement on the terms for making a joint submission with the lead registrant for a registered substance — Failure to reach an agreement — Dispute resolution mechanism applied by analogy — Decision granting access to a joint submission — Legal basis — Broad discretion of ECHA — Manifest error of assessment — Obligation to state reasons — Legal certainty)

REACH & colours Kereskedelmi és Szolgáltató Kft. (REACH & colours Kft.), established in Budapest (Hungary),

European Chemicals Agency (ECHA), represented by M. Heikkilä, C. Jacquet, and T. Basmatzi, acting as Agents,

ACTION under Article 263 TFEU for the annulment of Decision DSH-30-3-0123-2017 of ECHA of 2 October 2017 granting Sustainability Support Services (Europe) AB access to the joint submission lodged by REACH & colours, as lead registrant for the substance hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-(diethylamino)-1, 3, 5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate), EC No 255-217-5 and CAS No 41098-56-0,

composed of S. Papasavvas, acting as President, D. Spielmann and O. Spineanu-Matei (Rapporteur), Judges,

1 The present case has been brought in the context of the procedure for the joint submission of data for registered substances established by Article 11 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1, corrigendum OJ 2007 L 136, p. 3; ‘the Reach Regulation’).

2 In accordance with Article 5 of the REACH Regulation, all substances manufactured or placed on the market in the European Union must be registered.

3 Under Articles 6 and 7 of the REACH Regulation, submissions for registration are submitted to the European Chemicals Agency (ECHA).

4 According to Article 10 of the REACH Regulation, each registration comprises a technical dossier and, when required, a chemical safety report. That provision also defines the categories of information that the technical dossier and report in question must contain.

5 For the purposes of observance of the ‘one substance, one registration’ principle in the REACH Regulation, Article 11 of that regulation lays down an obligation for all potential registrants of the same substance to submit information jointly to ECHA (‘the joint submission obligation’).

6 The second subparagraph of Article 11(1) of the REACH Regulation requires, in particular, that certain information and any relevant indication covered by the joint submission obligation be submitted by a single registrant, called the ‘lead registrant’, with the agreement of the other assenting registrant(s). Each registrant must then submit separately the information relating, in particular, to the identity of the substance, identified uses and exposure.

7 A registrant may, however, pursuant to Article 11(3) of the REACH Regulation, choose to submit information separately that the lead registrant could submit (‘complete opt-out’), in three cases, namely: (i) it would be disproportionately costly for him to submit this information jointly; (ii) submitting the information jointly would lead to disclosure of information which he considers to be commercially sensitive and is likely to cause him substantial commercial detriment; or, (iii) he disagrees with the lead registrant on the selection of this information. In any of those cases, the registrant is to submit, along with the dossier, an explanation as to why the costs would be disproportionate, why disclosure of information was likely to lead to substantial commercial detriment or an explanation as to the nature of the disagreement, as the case may be.

8 From a technical point of view, in order to submit the data in question, ECHA put in place an IT system, namely REACH-IT. In order to be eligible for access, registrants must have access to an alphanumeric code (‘the security token’).

9 Prior to the entry into force of Commission Implementing Regulation (EU) 2016/9 of 5 January 2016 on joint submission of data and data-sharing in accordance with the REACH Regulation (OJ 2016 L 3, p. 41; ‘the implementing regulation’), the security token was supplied by ECHA. Where the registrants were not able to agree on the terms for registering a substance when making a joint submission, the REACH-IT system enabled them to register that substance separately. Moreover, in the event that they wished to submit all relevant information separately, which option is open to them under a complete opt-out, ECHA requested them to submit a separate registration instead of joining an existing joint submission.

10 Following the entry into force of the implementing regulation, ECHA made technical amendments to the REACH-IT system, so as to ensure that it is no longer technically possible for a registrant to submit a separate file when a registration already exists for the same substance. Registrants must henceforth be party to the same registration in which they may submit information jointly or separately. Those amendments became effective on 21 June 2016.

11 The amendments to the REACH-IT system therefore had the effect of granting a privileged position to the first registrant of a substance, acting in its capacity as lead registrant, in relation to the subsequent registrants of the same substance. A registrant who intended to submit all the information required separately, in accordance with Article 11(3) of the REACH Regulation (‘the registrant seeking a complete opt-out’), was required to obtain the security token of the lead registrant in order to be able to join in the registration of the substance in the REACH-IT system and thus submit its own information in the context of the sole registration of that substance (‘the previous administrative practice of ECHA’).

12 For situations in which the registrants did not reach a decision on the conditions for the grant of the security token, ECHA decided to resort, by analogy, to the dispute resolution mechanism which it had put in place in order to adopt decisions under Article 27(6) and Article 30(3) of the REACH Regulation on the sharing of data. In procedural terms, those provisions provide for a remedy before the Board of Appeal of ECHA. In order to decide whether such a mechanism should be applied by analogy to disputes relating to joint submissions, ECHA relied on Article 11 of that regulation, as implemented by Article 3(3) of the implementing regulation.

13 Thus, ECHA proposes a dispute resolution mechanism between a registrant seeking a complete opt-out and the lead registrant in respect of the conditions under which the lead registrant must provide the former with a security token (‘the dispute resolution mechanism’). Under that mechanism, ECHA is to examine the efforts made by the companies concerned and, if it takes the view that the registrant seeking a complete opt-out has done all he could in order to reach an agreement with the lead registrant, it is to provide it with a security token. Therefore, a registrant can still seek a complete opt-out while being party to the sole registration of the substance concerned.

14 The first applicant, BASF SE, is the lead registrant for the substance disodium 4,4'-bis[(4-anilino-6-morpholino-1, 3, 5-triazin-2-yl)amino]stilbene-2,2'disulphonate with EC number 240-245-2 and CAS number 16090-02-1 (‘disodium’).

15 The second applicant, REACH & colours Kereskedelmi és Szolgáltató Kft. (REACH & colours Kft.), is the lead registrant for the substance hexasodium 2,2'[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-(diethylamino)-1, 3, 5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate), EC No 255-217-5 and CAS No 41098-56-0 (‘hexasodium’).

16 The applicants are part of the group of producers of optical brighteners used in the pulp and paper industry.

17 Disodium and hexasodium (‘the two substances’) are two of the 14 stilbene optical brighteners which were registered by joint submission in accordance with the REACH Regulation under the ‘category approach’ by the producers forming part of the group referred to in paragraph 16 above.

18 On 18 January 2017, all the registrants of the two substances received communications from ECHA. In those communications, ECHA requested them to make a single joint submission for each substance and referred to the legal consequences which the continued infringement of the joint submission obligation would have entailed after the expiry of the time limit laid down by the implementing regulation, one of which was the annulment of the individual registrations (‘the communications of 18 January 2017’).

19 The communications of 18 January 2017 referred, inter alia, to the individual registration of the two substances by Sustainability Support Services (Europe) AB (‘SSS’) and indicated that, by virtue of the ‘one substance, one registration’ principle, registrants were to be subject to a joint submission for each substance by 25 July 2017 at the latest.

20 On 26 January 2017, referring to the communications of 18 January 2017, the applicants, as the lead registrants of the two substances, contacted SSS and requested it to join the joint submission for each of those substances and to contribute to the costs associated therewith.

21 In the exchanges which took place between the applicants and SSS following the communications of 18 January 2017, the latter informed them, inter alia, that it intended to choose the option of a complete opt-out for each of the two substances. It therefore requested them to provide it with the security tokens enabling it to join its individual registrations to the existing registrations for each of the two substances, without contributing to the costs of the data submitted jointly, and to inform it of the related administrative costs.

22 On 17 July 2017, its subsequent exchanges with the applicants not having resulted in any agreement, SSS initiated two procedures with ECHA concerning access to the joint submission of the two substances. It claimed that there was no agreement with the applicants, and requested ECHA to provide it with the security tokens which could have enabled them to join their individual registrations to the existing registration while choosing the option of a complete opt-out for each of the two substances.

23 In the context of the dispute resolution mechanism (see paragraphs 12 and 13 above), ECHA took the view that the applicants, who were the lead registrants of the two substances, had not complied with the obligation to make every effort to reach a fair, transparent and non-discriminatory agreement on the provision of security tokens, as provided for in the implementing regulation.

24 Thus, by decisions of 2 October 2017, registered under the references DSH-30-3-0123-2017 and DSH-30-3-0122-2017, ECHA granted SSS access, respectively, to the joint submission lodged by the second applicant, as the lead registrant for hexasodium (‘the contested decision’), and access to the joint submission lodged by the first applicant, as the lead registrant for disodium (‘the contested decision in Case T‑805/17’).

25 On 20 December 2017, at the same time as the present action brought before the General Court on 11 December 2017, the applicants brought actions against the decisions of 2 October 2017 before the Board of Appeal of ECHA, registered under references A-015-2017, in respect of the first applicant’s appeal, and A-016-2017, as regards the applicants’ collective action. Those actions are based on the same pleas and arguments as those put forward in the present proceedings before the General Court.

26 As regards the admissibility of the administrative actions, the applicants had argued that ‘the Contested Decision was adopted based on Article 11 of the REACH Regulation and Article 3 of the Implementing Regulation following the procedure implemented for the purposes of Articles 27 and 30 of [that regulation, as a result of which] Article 91(1) of the REACH Regulation [was] applicable and that the Board of Appeal [was] competent to rule on appeals brought against “joint submission dispute” decisions such as the Contested Decision[s] as part of its competence to rule on [the ECHA decision(s) of 2 October 2017] adopted on the basis of Articles 27 and 30 [of that regulation]’.

27 By decision of 23 March 2018, registered under reference A-011-2017 and made in the context of another case showing strong similarities with the present case (‘the decision given in Case A-011-2017’), the Board of Appeal of ECHA dismissed as inadmissible the action brought therein.

28 In particular, in the decision given in Case A-011-2017, the Board of Appeal found, first, that the fact that Article 11 of the REACH Regulation, which was the only legal basis relied on in support of that decision, was not expressly referred to in Article 91(1) of the REACH Regulation, which lists the decisions that may be challenged before ECHA, meant that it was not competent to rule on the action in question.

29 Furthermore, as regards the right to an effective remedy, the Board of Appeal stated that, in accordance with Article 94(1) of the REACH Regulation, an action could be brought before the General Court ‘in cases where no right of appeal lies before the Board [of Appeal]’ and added that its jurisdiction, as laid down in that regulation, cannot be altered by an incorrect statement concerning a legal remedy referred to in a decision of ECHA.

30 Secondly, the Board of Appeal found that ECHA did not have any discretion to provide a registrant seeking a complete opt-out under Article 11(3) of the REACH Regulation with a security token. It stated that, on the other hand, ECHA ‘must, when requested, give the “token” to any registrant who informs it of its decision to rely on a complete opt-out in accordance with Article 11(3)’. In that regard, it found that it was not necessary to have a dispute resolution mechanism relating to joint submissions.

31 Following the decision in Case A-011-2017, in the first place, on 20 April 2018, the Board of Appeal of ECHA decided to stay the proceedings brought before it against the decisions of 2 October 2017 and registered under reference A-015-2017 and A-016-2017. According to the Board of Appeal, it was necessary to stay those proceedings pending the decisions of the Court in Case T‑805/17 and in the present case.

32 In the second place, pursuant to the replies to the Court’s questions, more generally, ECHA amended its procedure in order to implement all of the principal findings set out in the decision given in Case A-011-2017. To that end, it now automatically issues a security token to any registrant who informs it of its decision to seek a complete opt-out so that it can submit the information required in connection with the existing registration of a substance. Therefore, contrary to its previous practice, ECHA does not require the registrant seeking a complete opt-out from submitting a request for the settlement of a dispute in relation to a joint submission, following which it should have demonstrated that it had done everything possible to reach an agreement with the lead registrant before the security token was issued to it by ECHA.

33 By application lodged at the Court Registry on 11 December 2017, the applicants brought the present action.

34 By a separate document, which was lodged at the Court Registry on 1 March 2018, ECHA raised an objection of inadmissibility under Article 130 of the Rules of Procedure of the General Court. The applicants lodged their observations on that objection on 3 May 2018.

35 By letter of 4 April 2018, ECHA informed the Court of the decision given in Case A-011-2017, which it considered relevant for the purposes of the present case, adopted by the Board of Appeal of ECHA after the objection was lodged. By decision of the President of the Sixth Chamber, that letter and the decision annexed to that letter were placed on the file.

36 In the context of a measure of organisation of procedure adopted on the basis of Article 89 of the Rules of Procedure, the General Court (Sixth Chamber) asked the parties about the consequences that such a decision could have had on the present case. The parties complied within the time limit set.

37 By order of 13 July 2018, BASF and REACH & colours v ECHA (T‑806/17, not published), the General Court (Sixth Chamber), on the basis of Article 130(7) of the Rules of Procedure, reserved the decision on that objection and the decision on costs for the final judgment.

39 The applicants did not lodge a request to be heard at a hearing within the prescribed period. ECHA stated that it did not wish to be heard.

40 In the context of a measure of organisation of procedure adopted on the basis of Article 89 of the Rules of Procedure, the General Court (Sixth Chamber), first, requested ECHA to state whether it was maintaining its objection in so far as it concerned the jurisdiction of the Court to make a ruling and, second, asked the parties about the consequences of the new administrative practice of ECHA concerning the grant of the security token in the present case. The parties complied with that measure within the time allowed.

41 In response to the measure of organisation of procedure, ECHA stated that it was withdrawing the objection raised in so far as it related to the jurisdiction of the Court to rule on the present action.

44 In their observations on the objection, the applicants repeat the claims set out in the application and further ask that the Court dismiss that objection.

46 ECHA submits that the action is inadmissible, on the ground, first, that in essence, jurisdiction to adjudicate on the present case ‘primarily’ belongs to its Board of Appeal, and not the Court, and, secondly, on account of the lack of standing of the first applicant, which was mentioned in error as the addressee of the contested decision.

47 As a preliminary point, it should be noted that, although, in the objection raised, ECHA was uncertain as to the jurisdiction of the Court to hear the present action, it based its argument, in essence, on the existence of an internal legal remedy to challenge, ‘primarily’, the contested decision. Thus, it should be noted that the first plea of inadmissibility raised in the present case concerned the failure to exhaust domestic remedies which, in so far as they were mandatory, renders inadmissible any immediate and direct action before the General Court (see, to that effect, judgment of 11 December 2014, Heli-Flight v EASA, T‑102/13, EU:T:2014:1064, paragraphs 22 to 31).

48 Since ECHA has withdrawn the objection raised in so far as, in essence, it referred to the failure to exhaust domestic remedies, only the second plea of inadmissibility raised by it, alleging that the first applicant does not have standing, need be examined.

49 In that regard, ECHA submits that the present action must be declared inadmissible as regards the first applicant, on the ground that it is neither the addressee of the contested decision nor directly and individually concerned and that its name in the list of addressees of the contested decision is the result of an administrative error. In its view, and despite the appearances, that decision must be considered not to have been addressed to the first applicant.

51 At the outset, it should be recalled that, in accordance with the fourth paragraph of Article 263 TFEU, any natural or legal person may, under the conditions laid down in the first and second paragraphs of that article, institute proceedings against an act addressed to that person or which is of direct and individual concern to them, and against a regulatory act which is of direct concern to them and does not entail implementing measures.

52 In the present case, it should be noted that, although the contested decision grants SSS access to the joint submission lodged by the second applicant as the lead registrant for hexasodium, the sole addressee of that decision is the first applicant, to which that decision was also notified.

53 ECHA acknowledges that the name of the first applicant was erroneously inserted in the contested decision. It did not, however, make use of the option available under Article 93(1) of the REACH Regulation to correct such an error.

54 It follows that, as a formal addressee of the contested decision, the first applicant has standing to bring proceedings in respect thereof (see, to that effect and by analogy, judgment of 21 January 2016, SACBO v Commission and INEA, C‑281/14 P, not published, EU:C:2016:46, paragraph 34).

55 Moreover, in the case of a single action, where ECHA acknowledges that the second applicant has standing to bring proceedings since it is referred to by name as the lead registrant for hexasodium, there is in any event no need to examine the locus standi of the first applicant in order to find the action admissible (see, to that effect, judgment of 9 June 2016, Magic Mountain Kletterhallen and Others v Commission, T‑162/13, not published, EU:T:2016:341, paragraph 41 and the case-law cited).

57 In support of the action, the applicant relies on four pleas in law: The first plea comprises two parts, alleging, respectively, failure to take account of the relevant facts of the case and clerical errors vitiating the contested decision. The second plea alleges manifest errors of assessment, the third, breach of the principle of legal certainty and, the fourth, breach of the obligation to state reasons.

58 In so far as the line of argument put forward in the context of the first part of the first plea overlaps with that put forward in support of the second plea, alleging manifest errors of assessment, the Court considers it appropriate to examine them together, after the fourth plea, which it is appropriate to examine first, and the second part of the first plea in law.

59 The applicants submit that the contested decision is vitiated by a failure to state reasons, in that ECHA has not provided the slightest explanation as to why it failed to take account, in the context of the assessment of the efforts made by the companies concerned to reach an agreement on access to the joint submission, of the correspondence with SSS which took place before January 2017, in spite of their arguments relating to the importance of that correspondence in the evolution of relations between those companies.

60 ECHA objects that the contested decision contains the grounds on the basis of which it found that the correspondence prior to 2017 was not relevant for the evaluation it was called upon to carry out.

61 In that regard, it must be recalled that, in accordance with settled case-law, the statement of reasons required by the second paragraph of Article 296 TFEU must be appropriate to the measure at issue and must disclose in a clear and unequivocal fashion the reasoning followed by the institution which adopted the measure in question in such a way as to enable the persons concerned to ascertain the reasons for the measure and to enable the court with jurisdiction to exercise its power of review. The requirement to state reasons must be assessed according to the circumstances of the case. It is not necessary for the reasoning to go into all the relevant facts and points of law, since the question whether the statement of reasons for a measure meets the requirements of the second paragraph of Article 296 TFEU must be assessed with regard not only to its wording but also to its context and to all the legal rules governing the matter in question. In particular, the relevant institution is not obliged to adopt a position on all the arguments relied on by the parties concerned, but it is sufficient if it sets out the facts and the legal considerations having decisive importance in the context of the decision (see judgment of 30 April 2014, Hagenmeyer and Hahn v Commission, T‑17/12, EU:T:2014:234, paragraph 173 and the case-law cited).

62 It is also settled case-law that the obligation to provide a statement of reasons laid down in Article 296 TFEU is an essential procedural requirement which must be distinguished from the question whether the grounds are well founded, which is concerned with the substantive legality of the measure at issue. The reasoning of a decision consists in a formal statement of the grounds on which that decision is based. If those grounds are vitiated by errors, the latter will vitiate the substantive legality of the decision, but not the statement of reasons in it, which may be adequate even though it sets out reasons which are incorrect. It follows that objections and arguments intended to establish that a measure is not well founded are irrelevant in the context of a ground of appeal alleging an inadequate statement of reasons or a lack of such a statement (see judgment of 30 June 2016, Al Matri v Council, T‑545/13, not published, EU:T:2016:376, paragraph 143 and the case-law cited).

63 In the present case, first, it is clear from the contested decision that the reason why ECHA decided to grant SSS access to the joint submission for hexasodium was the impasse in which the negotiations between the companies concerned were at, as a result of the second applicant’s failure to respond to SSS’s successive requests relating to the access price for that joint submission. After noting that the price offer and the breakdown of costs of access to the joint submission were a starting point for the negotiations, ECHA stated that it took the view that the absence of any proposal from the second applicant concerning the access costs had made the negotiations impossible. Accordingly, it stated that, after the assessment of the evidence submitted by the companies concerned in order to substantiate the efforts made to reach an agreement on access to the joint submission for hexasodium, it had concluded that the second applicant had not complied with its obligation to make every effort to reach a fair, transparent and non-discriminatory agreement on the supply of the security token, as provided for in the implementing regulation.

64 It is therefore apparent from the contested decision that ECHA, on the one hand, put the applicants in a position to understand why it had decided to grant SSS access to the joint submission for hexasodium, and, on the other hand, enabled the Court to exercise its power of review.

65 Secondly, contrary to what the applicants claim, the contested decision also provides explanations relating to the failure to take into account negotiations between the companies concerned before 2017.

66 Thus, it is apparent from the contested decision and, in particular, from the section entitled ‘Factual background’, that ‘the evidence submitted by [the second applicant] on the previous negotiations [was] not relevant to the access of the joint submission [for hexasodium]’ since it related to another registration. In addition, in the part of that decision headed ‘Assessment’, ECHA noted that ‘from the [second applicant]’s submitted evidence it appear[ed] that both [of the companies concerned had] been involved in long, ongoing discussion regarding the settlement of pending invoices related to another registration that [was] already part of another joint submission’, but that ‘this fact should not have hindered the present negotiations, where the [second] Claimant requested access to the joint submission’.

67 It follows from the foregoing that the contested decision sets out to the requisite legal standard the grounds on the basis of which ECHA took the view that the evidence relating to the fact that negotiations were held, prior to 2017, for the purpose of a joint submission for hexasodium was irrelevant.

The second part of the first plea, alleging clerical errors vitiating the contested decision

69 The applicants submit that, first, by making incorrect findings of fact as to the identity of the first applicant and on the date on which the reply to its request for information was submitted and, secondly, by making clerical errors, ECHA relied on an incorrect assessment of the facts in breach of the right to good administration set out in Article 41 of the Charter of Fundamental Rights of the European Union.

70 ECHA acknowledges the clerical errors referred to by the applicants, but maintains that those errors cannot justify the annulment of the contested decision, in so far as they have no effect on the assessments made in that decision. As regards the failure to take into account the efforts made by the companies concerned before 2017, it takes the view that the applicants are in fact alleging an error of assessment, which is the subject of the second plea in law.

71 In the present case, it must be held that ECHA erred in the contested decision, first, by referring to the first applicant as the lead registrant for hexasodium instead of the second applicant, secondly, by wrongly referring to the date of 8 August 2017 instead of 7 August 2017 as the date on which the second applicant produced the documentary evidence relating to the dispute concerning access to the joint submission for hexasodium and, thirdly, by using the plural as regards the subject matter of the access granted to SSS, even though just a single substance and a single joint submission were at issue. ECHA submits, by putting forward arguments which are not entirely without foundation, that those errors are due to the strong similarities between the two sets of proceedings brought by SSS before ECHA relating to access to the joint submissions for the two substances.

72 As regrettable as they may be, it should be noted that the clerical errors at issue do not affect the factual inferences made by ECHA. The second part of the first plea must therefore be rejected.

The first part of the first plea and the second plea in law, alleging manifest errors of assessment

73 The first part of the first plea and the second plea in law allege several manifest errors of assessment In particular, the applicants submit that ECHA exceeded the limits of its discretion, first, in that it failed to assess all the elements and circumstances relevant to the dispute in question in breach of the right to good administration set out in Article 41 of the Charter of Fundamental Rights, secondly, in that it concluded that SSS had made more effort than the second applicant to reach an agreement, thirdly, in that it did not take into account the facts specific to that dispute, and fourthly, in that it failed to take into account the infringement by SSS of Article 25 of the REACH Regulation.

75 As regards the right to good administration, the case-law has made it clear that, in accordance with that principle, it was for the administration to examine carefully and impartially all the relevant facts of a case and to gather all the factual and legal material necessary for the exercise of its discretion, and to ensure the proper conduct and the efficiency of the procedures it was implementing (judgment of 30 January 2018, Przedsiębiorstwo Energetyki Cieplnej v ECHA, T‑625/16, not published, EU:T:2018:44, paragraph 89).

76 As regards ECHA’s powers in the context of the registration of substances, it should be noted that, having regard to recital 15 and Article 75(1) of the REACH Regulation, ECHA was established ‘for the purposes of managing and in some cases carrying out the technical, scientific and administrative aspects of this Regulation and to ensure consistency at [European Union] level’.

77 In that regard, it is apparent from Article 20 of the REACH Regulation, relating to its tasks in connection with the registration of substances, that, upon receipt of a registration dossier, ECHA allocates to that registration a submission number corresponding to the date of receipt. ECHA is subsequently to undertake a completeness check of each registration in order to ascertain whether all the elements required under Articles 10 and 12 or under Articles 17 or 18 of that regulation were provided, and whether the registration fee referred to in Article 6(4), Article 7(1) and (5), Article 17(2) or Article 18(2) of that regulation has been paid. The completeness check shall not include an assessment of the quality or the adequacy of any data or justifications submitted. If a registration is incomplete, ECHA is to inform the registrant as to what further information is required in order for the registration to be complete, while setting a reasonable deadline for this. The registrant is to complete his registration and submit it to ECHA within the deadline set. ECHA is to confirm the submission date of the further information to the registrant. It is to perform another completeness check, taking account of the further information submitted. It is to reject the registration if the registrant fails to complete his registration within the deadline set. Once the registration is complete, ECHA is to assign a registration number to the substance concerned and a registration date, which shall be the same as the submission date.

78 Although it is not apparent from either the REACH Regulation or the implementing regulation that ECHA enjoys any discretion in granting a registrant seeking a complete opt-out under Article 11(3) of that regulation access to a joint submission for a substance, it had the power, under its former administrative practice (see paragraphs 11 and 12 above), which, moreover, is not disputed by the parties, to assess, in the context of the dispute resolution mechanism, the efforts deployed by the companies concerned to reach an agreement on access to such a joint submission.

79 However, irrespective of the assessment of the efforts made by the companies concerned to reach an agreement relating to access to a joint submission for a substance, ECHA’s discretion cannot exceed that expressly laid down in the REACH Regulation, relating to the review of the completeness of the information submitted (see paragraph 77 above).

80 Article 11 of the REACH Regulation imposes only on registrants of the same substance certain obligations relating to registration and cannot be interpreted as allowing ECHA to refuse access to a joint submission for a substance which has already been registered in respect of a new registrant of the same substance.

81 It is in the light of the foregoing considerations that the Court must examine the applicants’ arguments relating to the manifest errors of assessment allegedly committed by ECHA and vitiating the contested decision.

82 In the first place, the applicants submit that, in the contested decision, ECHA failed to take account, in breach of Article 25 of the REACH Regulation, of the rule relating to the non-duplication of trials. It should be noted in that regard that, under the REACH system, although it is incumbent on ECHA to check the compliance of a registration dossier, that examination is carried out only in the context of the evaluation of that dossier in accordance with Article 41 of that regulation and not at the time of submission of that dossier, or of the assessment of the efforts made by the companies concerned in order to reach an agreement relating to access to the joint submission under the dispute resolution mechanism.

83 The legislature established a specific mechanism for examining whether the registration dossiers complied with the requirements of Article 25 of the REACH Regulation, namely that laid down in Article 41 of that regulation. Thus, under Article 41(1), ECHA may examine any registration in order to check whether the conditions relating, inter alia, to the information contained in the technical dossiers and to the explanations submitted in accordance with Article 11(1) of that regulation comply with the relevant rules. If it takes the view that the dossier subject to review is not consistent with the relevant information requirements, it is incumbent upon it to initiate the procedure provided for in Article 41(3) of that regulation, under which it may prepare a draft decision inviting the registrant(s) to communicate any information necessary to enable it to be recorded in accordance with the relevant information requirements. That same provision provides that the final decision in the matter, which must also specify adequate time limits for the submission of the further information regarded as necessary, is to be taken in accordance with the procedure laid down in Articles 50 and 51 of the REACH Regulation.

84 On the other hand, in the context of the dispute resolution mechanism (see paragraphs 12 and 13 above), ECHA is to assess the efforts made by the companies concerned to reach an agreement relating to access to a joint submission The second applicant’s claim that the contested decision incorrectly disregarded the prohibition on the duplication of tests on animals cannot therefore be a relevant factor.

85 Accordingly, the applicants’ argument relating to an error of assessment by ECHA in failing to take account of the infringement by SSS of Article 25 of the REACH Regulation must be rejected as ineffective.

86 In the second place, as regards the applicants’ other arguments relating to the assessment by ECHA of the circumstances of the case and of the efforts of the companies concerned to reach an agreement on access to joint submission, they must also be rejected. It must be borne in mind that the main ground on which ECHA based the contested decision is the finding of the impasse in which the negotiations between those companies resulted, as a result of the second applicant’s failure to respond to SSS’s successive requests relating to the price for access to the joint submission for hexasodium for its individual registration.

87 As set out in the analysis of the fourth plea in law (see paragraph 63 above), ECHA’s conclusion that the second applicant had not complied with its obligation to make every effort to reach a fair, transparent and non-discriminatory agreement on the supply of the security token, as provided for in the implementing regulation, is based on its failure to submit a proposal following SSS’s requests concerning the costs of access to the joint submission for hexasodium for its individual registration making it impossible to move forward with the negotiations.

88 In that regard, it must be pointed out that the applicant does not at any time maintain that it sent a proposal concerning the costs of access to the joint submission for hexasodium to SSS for its individual registration. On the other hand, it stresses, first, the relevance and importance in the general scheme of the relationship between the companies concerned, on the one hand, of the steps it had taken in 2010 and 2011, carried out as the lead registrant of hexasodium and contemporaneous with the registration of that substance, and, on the other, of the relationships existing between those companies arising from an agreement relating to another registration of hexasodium by SSS, in the context of which SSS failed to fulfil its contractual obligations towards the second applicant. Secondly, as regards the efforts made after the communications of 18 January 2017, the second applicant submits that, since the number of messages sent by those companies was the same (three messages sent by the second applicant and three messages sent by SSS) and the companies in question each requested additional information which the other had failed to provide, the lack of communication during a certain period should not be ascribed to just one of them.

89 As ECHA mentioned in the contested decision, the presentation of the price offer for access to the joint submission constituted the starting point for the negotiations concerning the individual registration of SSS for hexasodium. Therefore, in the absence of such an offer, the steps taken by the second applicant, even if it were to be accepted that they had been taken and were more numerous than those of SSS, become irrelevant in the light of the result which the companies concerned were required to achieve, in accordance with the communications of 18 January 2017, namely to list all the separate hexasodium registrations under the single registration of that substance by 25 July 2017 at the latest.

90 Furthermore, although the procedure applied by ECHA in the present case and which led to the adoption of the contested decision had followed, by analogy, the stages of the procedure which ECHA had intended for the purpose of adopting decisions on the disagreements relating to the sharing of data under, inter alia, Article 30(3) of the REACH Regulation, the fact remains that the rights and obligations of the companies concerned under that article are different from those flowing from Article 11 of that regulation, which constitutes the legal basis of that decision.

91 Thus, Article 30 of the REACH Regulation governs the sharing of data on animal tests in order to avoid any duplication and, in particular, to reduce tests on vertebrate animals, in accordance with recitals 49 to 51 of that regulation. The sharing of information must occur, where this is requested by any registrant, in particular in the case of information involving tests on vertebrate animals, under conditions that ensure a fair compensation for the company that has undertaken the tests. Where the companies concerned do not arrive at an agreement on the conditions for the sharing of such data, ECHA may decide, pursuant to Article 30(3) of that regulation, if necessary, either that the trial must be repeated or to permit the other members of the Substance Information Exchange Forum (SIEF) to make reference to those data in their registration dossiers. In the latter case, the registrant which carried out the tests shall have a claim on the other participant(s) for an equal share of the cost, provided he makes the full study report available to the other participant(s), which shall be enforceable in the national courts.

92 By contrast, under Title II of the REACH Regulation on the registration of substances, in Chapter 1, entitled ‘General obligation to register and information requirements’, Article 11 introduces a requirement for a single registration of substances that is broader in scope and more general than the obligation relating to the sharing of data on tests, set out in Article 30 of that regulation, which is placed in Title III of that regulation, on the exchange of data and the avoidance of unnecessary testing.

93 Although the joint submission obligation provided for in Article 11 of the REACH Regulation may co-exist with the obligation to share existing data under Articles 27 and 30 of that regulation, and although the registrants of a given substance must reach an agreement on the conditions, first, for that submission, and, secondly, for the sharing of data on the occasion of that submission, the two obligations are nonetheless independent and take effect at successive times in the procedure for registration of substances.

94 Although the joint submission obligation necessarily precedes the obligation to share data, it does not, however, entail that obligation. Thus, in the event of a complete opt-out under Article 11(3) of the REACH Regulation, as in the present case, the registrant seeking a complete opt-out is not required to come to an agreement with the lead registrant of the substance already registered on the terms for the sharing of the data, since any such sharing is, in any event, excluded by the derogation itself.

95 Therefore, even if access to a joint submission entails, under the administrative practice of ECHA (see paragraph 11 above), that the registrants seeking a complete opt-out obtain a security token granting them access to the submission of the lead registrant, the fact remains that the latter will have no claim over those registrants and, accordingly, will not be able to prevent that access. The only claim that the lead registrant could make against a registrant seeking a complete opt-out, under the previous administrative practice of ECHA, applicable in the present case, was in relation to the administrative costs of the security token.

96 In those circumstances and in so far as, in the exchanges that took place between the companies concerned following the communications of 18 January 2017, SSS informed the second applicant of its intention to seek a complete opt-out and requested the latter to indicate to it, inter alia, the administrative costs relating to the security token enabling it to join its individual registration to the existing registration for hexasodium (see paragraph 21 above), the second applicant cannot validly claim that ECHA should have rejected the application for access to SSS’s joint submission in the absence of any reply relating to the costs of that access and from the perspective of the sanctions that might be imposed on SSS pursuant to those communications (see paragraph 18 above).

97 In any event, it must be stated that, in granting SSS access to the joint submission for hexasodium, ECHA merely ensured the implementation of Article 11(3) of the REACH Regulation in the exercise of its tasks of managing the technical and administrative aspects of the registration of substances. A contrary result would have meant, irrespective of the legality of the dispute resolution mechanism, which, moreover, has not been disputed in the present case, that ECHA was to restrict without legal basis SSS’s access to the joint submission of hexasodium.

98 It follows from all of the foregoing that ECHA did not err or infringe the right to good administration in deciding to grant SSS access to the joint submission for hexasodium and, consequently, the first part of the first plea and the second plea in law must be rejected.

99 The applicants submit that ECHA infringed the principle of legal certainty in so far as it is not certain that the security token provided to SSS, which is to enable it to become a member of the joint submission for hexasodium, enables it to consult all or part of the information contained in the second applicant’s joint submission dossier. They submit that the contested decision does not refer to SSS’s registration by way of a complete opt-out, nor does it exclude the data in the registration dossier of the second applicant from the access granted to SSS. In their view, that situation places them in an untenable position of legal uncertainty, given that, since the scope of the rights granted to SSS remain opaque, it does not know how to protect its rights and its position, even though SSS expressly stated that it was waiving its right to that access during the negotiations.

101 As a preliminary point, it should be stated that the principle of legal certainty, which is one of the general principles of EU law, requires that rules of law be ‘clear and precise and predictable in their effect’, so that interested parties can ascertain their position in situations and legal relationships governed by EU law (see judgment of 8 December 2011, France Télécom v Commission, C‑81/10 P, EU:C:2011:811, paragraph 100 and the case-law cited).

102 The principle of legal certainty means that the binding nature of any act intended to have legal effects must be derived from a provision of EU law which prescribes the legal form to be taken by that act and which must be expressly indicated therein as its legal basis (see judgment of 14 June 2016, Commission v McBride and Others, C‑361/14 P, EU:C:2016:434, paragraph 47 and the case-law cited).

103 It should be noted that the contested decision sets out not only the legal basis, but also all the parameters necessary to identify the granted access at issue, in a clear and precise manner thus enabling the applicants unequivocally to know the scope thereof.

104 A breach of the principle of legal certainty cannot be inferred, as the applicants have done, from the fact that the contested decision did not mention the scope of the access granted to SSS. As pointed out in the analysis of the second plea (see paragraphs 76 to 79 above), under the REACH Regulation, on the one hand, ECHA could only grant access to a joint submission to a registrant seeking a complete opt-out without having any discretion in that regard and, on the other hand, access to a joint submission could only allow such a registrant to submit separately the information referred to in Article 10(a)(iv), (vi), (vii) or (ix) of that regulation, as part of the registration of the same substance made by the lead registrant, without however allowing him to refer to the information submitted by the lead registrant under Article 11(1) of that regulation.

105 As regards the alleged position of uncertainty created by the quality of the information submitted by SSS in the context of the joint submission for hexasodium, it must be pointed out, as ECHA states, that, under the REACH system, it is for ECHA to assess the quality of that information when evaluating registration dossiers, in accordance with Article 41 of the REACH Regulation. In that regard, where it considers that a registrant has unnecessarily duplicated animal tests in breach of Articles 13 and 25 of that regulation, it is to inform the authorities of the Member States responsible for enforcement of the legislation, which may adopt appropriate measures. The dossier evaluation stage follows the registration stage, in which the REACH system allows neither ECHA to refuse a registration on grounds other than the incompleteness of the registration dossier (see paragraph 79 above), nor the lead registrant to object to a request for access to the joint submission made by a registrant seeking a complete opt-out or to challenge the compliance of the information provided by that registrant in support of its request.

106 It follows from the foregoing considerations that the third plea cannot be upheld and that, accordingly, the action must be dismissed in its entirety.

107 Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Furthermore, under Article 134(3) of those Rules of Procedure, the parties are to bear their own costs where each party succeeds on some heads and fails on others.

108 In the present case, ECHA was unsuccessful in its submissions that the action is inadmissible, whereas the applicants were unsuccessful in their submissions on the substance of the action. Accordingly, the parties must be ordered to bear their own costs.

2. Orders BASF SE, REACH & colours Kereskedelmi és Szolgáltató Kft. (REACH & colours Kft.) and the European Chemicals Agency (ECHA) to bear their own costs.

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You are here: BAILII >> Databases >> Court of Justice of the European Communities (including Court of First Instance Decisions) >> BASF and REACH & colours v ECHA (Research and technological development - Requirement for joint submission of data - Judgment) [2019] EUECJ T-806/17 (03 October 2019) URL: http://www.bailii.org/eu/cases/EUECJ/2019/T80617.html Cite as: ECLI:EU:T:2019:724, EU:T:2019:724, [2019] EUECJ T-806/17

Court of Justice of the European Communities (including Court of First Instance Decisions)