(Actions for annulment— Inclusion as supplier of an active substance on the list provided for in Article95 of Regulation (EU) No528/2012
Tribunal de Justicia de la Unión Europea

(Actions for annulment— Inclusion as supplier of an active substance on the list provided for in Article95 of Regulation (EU) No528/2012

Fecha: 12-Oct-2016

ORDER OF THE GENERAL COURT (Fifth Chamber)

12 October 2016(*)

(Actions for annulment— Inclusion as supplier of an active substance on the list provided for in Article95 of Regulation (EU) No528/2012— Lack of direct concern— Inadmissibility)

In Case T‑669/15,

Lysoform Dr. Hans Rosemann GmbH, established in Berlin (Germany),

Ecolab Deutschland GmbH, established in Monheim (Germany),

Schülke & Mayr GmbH, established in Norderstedt (Germany),

Diversey Europe Operations BV, established in Amsterdam (Netherlands),

represented by K.Van Maldegem, M.Grunchard and P.Sellar, lawyers,

applicants,

v

European Chemicals Agency (ECHA), represented by M.Heikkilä and C.Buchanan, acting as Agents, and by P.Oliver,

defendant,

ACTION pursuant to Article263 TFEU for annulment of the decision of ECHA of 16 July 2015 concerning the inclusion of the company BASF SE, established in Germany, as supplier of an active substance on the list referred to in Article95(1) of Regulation (EU) No528/2012 of the European Parliament and of the Council of 22May 2012 concerning the making available on the market and use of biocidal products (OJ 2012 L167, p.1),

THE GENERAL COURT (Fifth Chamber),

composed, at the time of deliberation, of A.Dittrich (Rapporteur), President, J.Schwarcz and V.Tomljenović, Judges,

Registrar: E.Coulon,

makes the following

Order

Background to the dispute

1Pursuant to Article16(2) of Directive 98/8/EC of the European Parliament and of the Council of 16February 1998 concerning the placing of biocidal products on the market (OJ 1998 L123, p.1), the European Commission was tasked with commencing a 10-year programme of work for the systematic examination of all existing active biocidal substances, namely those that were already on the EU market prior to 14May 2000 as substances used in biocides.

2The active biocidal substance Propan-1-ol (‘propyl alcohol’) is included in that work programme.

3The applicants, Lysoform Dr. Hans Rosemann GmbH, Ecolab Deutschland GmbH, Schülke & Mayr GmbH and Diversey Europe Operations BV, are members of a working group called ‘Alcohol Task Force’, created in 2001, in order to collaborate and share the costs and efforts related to the submission of a review dossier concerning propyl alcohol at EU level. As members of that group, they notified that substance to the Commission for a review before 31July 2007, in accordance with Article4(1) of Commission Regulation (EC) No1896/2000 of 7September 2000 on the first phase of the programme referred to in Article16(2) of Directive 98/8 (OJ 2000 L228, p.6).

4The notification of propyl alcohol by the applicants was accepted by the Commission in accordance with Article4(2) of that regulation.

5Germany was designated as Rapporteur Member State for the purpose of the review of propyl alcohol as an active substance pursuant to Article7 of Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year programme referred to in Article16(2) of Directive 98/8 (OJ 2007 L325, p.3).

6In their capacity as notifying companies, the applicants submitted to the Rapporteur Member State the dossier required for the purpose of the review of propyl alcohol by that Member State.

7On 29January 2008, the Rapporteur Member State informed the applicants that their dossier was complete.

8By letters dated 21 August and 5November 2008, in the context of the review of propyl alcohol, the Rapporteur Member State asked the applicants to produce a study on vertebrates carried out in vivo on liver, stomach and blood cells of rats (‘the Comet Assay study’). The applicants provided that study in the course of 2011.

9The dossier on propyl alcohol submitted by the applicants is still being assessed.

10Since Regulation (EU) No528/2012 of the European Parliament and of the Council of 22May 2012 concerning the making available on the market and use of biocidal products (OJ 2012 L167, p.1), which replaced Directive 98/8, came into force, certain tasks relating to the operation of that regulation are entrusted, pursuant to Article 74 of that regulation, to the European Chemicals Agency (ECHA), set up by Regulation (EC) No1907/2006 of the European Parliament and of the Council of 18December 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) No793/93 and Commission Regulation (EC) No1488/94 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 L396, p.1, corrigendum OJ 2007 L136, p.3). For those purposes, Article75 of Regulation No528/2012 set up within ECHA a biocidal products committee.

11According to the first sentence of the first subparagraph of Article95(1) of Regulation No528/2012, under the conditions laid down therein, ECHA has made publicly available, since 1September 2013, a regularly updated list of all the active substances and all the substances generating an active substance (‘the relevant list’).

12In September 2013, wishing to make propyl alcohol also available on the market, BASF SE, in its capacity as member of an alternative working group called ASD Consortium Alcohol, contacted the applicants through that group with a view to possibly sharing data in accordance with Articles62 and 63 of Regulation No528/2012. More specifically, it asked for access to an inhalation toxicity study relating to propyl alcohol. However, it did not ask for access to the Comet Assay test, despite the applicants having informed it of the request of the Rapporteur Member State in that respect. Subsequently, ASD Consortium Alcohol acquired a letter of access to the inhalation toxicity study.

13On 10 October 2013, BASF submitted a request to ECHA in accordance with Article62(2) of Regulation No528/2012 concerning available studies on propyl alcohol.

14On 24September 2014, ECHA published the relevant list. The applicants, as well as all the other members of the Alcohol Task Force, were listed at that date on that list, which includes propyl alcohol, as suppliers of propyl alcohol as of February 2014.

15On 5 March 2015, BASF asked ECHA to be included on that list as a supplier of propyl alcohol, in accordance with the second subparagraph of Article95(1) of Regulation No528/2012.

16By decision of 16 July 2015, ECHA included BASF on the relevant list (‘the contested decision’). That decision was neither published nor sent to the applicants. The relevant list was updated by ECHA on 31 July 2015.

17On 28July 2015, the applicants asked ECHA to state whether it was of the view that the Comet Assay study was not necessary for the inclusion of BASF on the relevant list. By letter dated 18August 2015, ECHA confirmed that it indeed held that view.

18On 28August 2015, the applicants lodged a Notice of Appeal against the contested decision before the Board of Appeal of ECHA.

19By decision of 25September 2015, the President of that Board dismissed the appeal as manifestly inadmissible.

Procedure and forms of order sought

20By application lodged at the Court Registry on 9 October 2015, the applicants brought the present action.

21By separate document lodged at the Court Registry on 20November 2015, the applicants made an application for suspension of operation of the contested decision. That application was dismissed by order of the President of the General Court of 17December 2015.

22By documents lodged at the Court Registry on 21 March 2016, Oxea GmbH and BASF applied for leave to intervene in support of the form of order sought by ECHA.

23By document lodged at the Court Registry on 18February 2016, ECHA raised a plea of inadmissibility.

24The applicants claim that the Court should:

–declare the action admissible;

–annul the contested decision;

–order ECHA to pay the costs.

25ECHA contends that the Court should:

–dismiss the action as inadmissible;

–order the applicants to pay the costs.

Law

26Under Article130(1) of the Rules of Procedure of the General Court, the Court may, if the defendant so requests, rule on inadmissibility or lack of competence without going to the substance of the case. In such a case, under Article130(7) of the Rules of Procedure, the Court is to decide on the application as soon as possible or, where special circumstances so justify, reserve its decision until it rules on the substance of the case.

27In the present case, the Court considers that it has sufficient information from the documents before it and decides to give its decision without taking further steps in the proceedings.

28The pleas of inadmissibility raised by ECHA allege that the applicants are not directly concerned and that the contested decision, which is not a regulatory act within the meaning of the fourth paragraph of Article263 TFEU, is not of individual concern to the applicants.

29In that respect, it must be stated that, under the fourth paragraph of Article263 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.

30In the present case, it is common ground that the contested decision is addressed solely to BASF.

31In these circumstances, the present action for annulment is admissible, in accordance with that provision, only if the applicants are directly and individually concerned by the contested decision or if they are directly concerned by that decision and the latter amounts to a regulatory act which does not entail implementing measures.

32As regards ‘direct concern’, the applicants claim that the criterion for ‘direct concern’ is met in the present case, since the contested decision had a negative effect on their legal situation.

33According to settled case-law, for a person to be directly concerned by an EU measure, the measure must, first, directly affect his legal situation and, second, leave no discretion to the addressees of that measure who are entrusted with the task of implementing it, such implementation being purely automatic and resulting from EU rules without the application of other intermediate rules. The same applies where the possibility for addressees not to give effect to the EU measure is purely theoretical and their intention to act in conformity with it is not in doubt (judgment of 5May 1998, Dreyfus v Commission, C‑386/96P, EU:C:1998:193, paragraphs43 and 44).

34In that respect, as regards the second criterion to assess whether a person is directly affected by a decision, that is to say whether that decision gives the addressee in charge of its implementation any discretion, it must be observed that the contested decision provides for the direct inclusion of BASF on the relevant list, without tasking a third party with its implementation.

35Therefore, the Court needs to assess only the first criterion of the concept of ‘direct concern’, namely whether the measure in question affects the applicants’ legal situation.

36In that regard, it has been held that the mere fact that a measure may exercise an influence on the applicants’ substantive position does not suffice for them to be regarded as directly concerned (see order of 18February 1998, Comité d’entreprise de la Société française de production and Others v Commission, T‑189/97, EU:T:1998:38, paragraph48 and the case-law cited), as the legal situation must, in any event, be clearly differentiated from the applicants’ factual circumstances (see, to that effect, judgment of 27June 2000, Salamander and Others v Parliament and Council, T‑172/98 and T‑175/98 to T‑177/98, EU:T:2000:168, paragraph62).

37In the present case, the applicants have not shown that their legal situation has been affected by the contested decision.

The applicants’ right to market propyl alcohol

38As regards the applicants’ legal situation, ECHA contends that the contested decision does not prevent them from placing on the market biocidal products containing propyl alcohol.

39In that respect, it must be noted that, in accordance with the first subparagraph of Article95(1) of Regulation No528/2012, ECHA makes publicly available a regularly updated list of all active substances and all substances generating an active substance, for which a dossier complying with Annex II to that regulation or with Annex IIA or IVA to Directive 98/8 and, where relevant, Annex IIIA to that directive (‘the full dossier on the substance’) has been submitted and accepted or validated by a Member State in the context of a procedure provided for by that regulation or that directive. For each of those substances, the list also includes the name of all the persons having submitted such a dossier or submitted information to ECHA in accordance with the second subparagraph of paragraph1 above, and mentions their role as specified in that subparagraph and the product-type or product-types for which they have submitted a dossier or submitted information, as well as the date of inclusion of the substance on the list.

40Furthermore, on account of Article95(2) of Regulation No528/2012, as of 1September 2015, a biocidal product consisting of, containing or generating a relevant substance which is included in the list referred to in paragraph1 of that article can be made available on the market only if either the supplier of the substance or the supplier of the product is included in the list referred to in paragraph1 of that article for the product-type or product-types to which the product belongs.

41More specifically, the persons provided for in Article95(1) of Regulation No528/2012 are participants for the purposes of the second paragraph of Article2 of Regulation No 1451/2007, namely producers, formulators and associations who have submitted a notification request which was accepted by the Commission in accordance with Article4(2) of Regulation No1896/2000.

42In that respect, it must be noted that Regulation No1451/2007 was repealed by Article23 of Commission Delegated Regulation (EU) No1062/2014 of 4August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation No528/2012 (OJ 2014 L294, p.1), and that the latter was in force at the date of the contested decision.

43It is correct that Article2(c) of Regulation No1062/2014 also defines the concept of ‘participant’. Thus, it follows from that provision that a ‘participant’ is a person who has submitted an application for a substance/product-type combination included in the review programme, or has submitted a notification found compliant in accordance with Article17(5) of that regulation, or on whose behalf such application or notification has been submitted. The concept of ‘application for a substance/product-type combination included in the review programme’ is defined in Article2(b) of that regulation.

44Nevertheless, according to the second paragraph of Article23 of Regulation No1062/2014, references to Regulation No1451/2007 must be construed as references to Regulation No1062/2014.

45The same is true for the concept of ‘participant’ within the meaning of Regulation No1451/2007, the latter corresponding in essence to the concept that stems from Regulation No1062/2014.

46In the present case, because they notified propyl alcohol to the Commission before 31July 2007, that institution having accepted the notification, the applicants became participants in the review programme of that active substance under the second paragraph of Article2 of Regulation No1451/2007. Since Regulation No1062/2014 came into force, they have maintained that status by reason of Article2(c) of that regulation.

47Therefore, on account of their inclusion on the relevant list as suppliers of propyl alcohol with effect from February 2014, they have the right to market that active substance on the EU market in their capacity as participants in the review programme of that active substance.

48Furthermore, that right has not been affected by the contested decision. Indeed, the inclusion of BASF on the relevant list does not prevent the applicants from placing on the market the active substance at issue.

The arguments based on infringement of the rights stemming from Article63 of Regulation No528/2012

49In order to substantiate the effect on their legal situation, the applicants claim that the Comet Assay study was necessary to complete BASF’s dossier on propyl alcohol. Therefore, that company had to negotiate access to that study. Had that negotiation been inconclusive, ECHA would have had to adopt a decision on the basis of Article63 of Regulation No528/2012 thus enabling BASF to refer to that study. Such a decision could have been challenged by the applicants before the Board of Appeal of ECHA.As for the contested decision, it deprives the applicants of the right to challenge a decision made on the basis of Article 63. Furthermore, by including BASF on the relevant list, without the need for that company to negotiate access to the Comet Assay study, the contested decision deprived the applicants of the right to a fair compensation such as that laid down in Article63.

50In that respect, in the first place, it must be noted that the applicants submit arguments relating to the rights stemming from Article63 of Regulation No528/2012 to contest a decision on the basis of the second subparagraph of Article95(1) of that regulation.

51As follows from the latter provision, a person established within the Union who manufactures or imports a relevant substance, on its own or in biocidal products, or who manufactures or makes available on the market a biocidal product consisting of, containing or generating that relevant substance (‘the alternative supplier’), may at any time submit to ECHA either a full dossier for that relevant substance, or a letter of access to a full dossier, or a reference to a full dossier on the substance in relation to which all data protection periods have expired.

52Having requested to be included on the relevant list, without having taken part in the review programme, BASF is such an alternative supplier.

53In the second place, it must be noted that, according to recital 57 of Regulation No528/2012, it is essential to minimise the number of tests on animals and for testing with biocidal products, or active substances contained in biocidal products, to be carried out only when the purpose and use of a product so require. In this light, Article62(1) of that same regulation states that, in order to avoid animal testing, testing on vertebrates should be carried out only as a last resort. Tests on vertebrates are not to be repeated for the purposes of that regulation.

54Thus, when another person who requests to be included on the relevant list must produce a test or a study on vertebrates in order to complete his dossier on an active substance, Article62(2) of Regulation No 528/2012 requires him to make enquiries with ECHA to establish whether such tests or studies have already been submitted to ECHA. If that is the case, the person wishing to be included on the relevant list must ask the proprietor for all the data stemming from the tests and studies on vertebrates as well as the permission to refer to the data in order to complete his dossier.

55For that purpose, Article63(1) of Regulation No528/2012 states that the data owner and the prospective applicant must make every effort to reach an agreement on the sharing of the data requested by the latter.

56If, however, no agreement is reached, with respect to data involving tests or studies on vertebrates, according to Article63(1) of Regulation No528/2012, ECHA gives permission to the prospective applicant, in accordance with the second subparagraph of Article63(3) of that regulation, to refer to the requested tests or studies on vertebrates, provided that the prospective applicant demonstrates that every effort has been made to reach an agreement and that he has paid the data owner a share of the costs incurred.

57In other words, it follows from Articles62, 63 and the second subparagraph of Article95(1) of Regulation No528/2012 that a participant in the review programme can request a fair compensation for use of data from studies on vertebrates, in accordance with Article63(3) of that regulation, inasmuch as a reference to data which he owns is necessary to complete the dossier of the alternative supplier under the second subparagraph of Article95(1) of that regulation.

58In the present case, the applicants have not shown that a reference to data appearing in the Comet Assay study was necessary to complete the dossier submitted by BASF to ECHA pursuant to that latter provision.

59As is apparent from paragraph38 of its plea of inadmissibility, ECHA submits that BASF’s dossier was complete without the Comet Assay study. The reason a reference to that study was not necessary is because the companies had submitted three negative in vitro tests to comply with end points8.5.1, 8.5.2 and 8.5.3 of Annex II to Regulation No528/2012 and, consequently, an in vivo test was not required, in accordance with end point 8.6, third indent, of Annex II to that regulation. The negative in vitro tests meant that the requirement for an ‘additional data set’ referred to in end point 8.6 of Annex II to that regulation was not triggered.

60Nevertheless, the applicants have not put forward any concrete element capable of calling into question ECHA’s submission in paragraph38 of its plea of inadmissibility. Indeed, they have not established that the tests and studies submitted by BASF to complete its dossier in accordance with the second subparagraph of Article95(1) of Regulation No528/2012 did not meet the requirements of the annexes referred to in that article.

61In that respect, they merely mentioned that the review by ECHA of a dossier such as that submitted by BASF in order to be included on the relevant list is not, and is not capable of being, ‘independent’ of the review carried out by the Rapporteur Member State in the context of Regulation No1451/2007. They submit that Article95(1) of Regulation No528/2012 requires that all the applications submitted for the purpose of inclusion on the Article95 list comply with the requirements of Annex II to that regulation or Annex IIA or IVA to Directive 98/8 and, where appropriate, to Annex IIIA to that directive. There is no rule which allows ECHA to interpret Annex II to Regulation No528/2012 or Annex IIA or IVA to that directive, or, where appropriate, its Annex IIIA, differently.

62In essence, those arguments of the applicants are evidently based on the premiss that the data required by the Rapporteur Member State during the evaluation phase of the active substance laid down in Article14 of Regulation No1451/2007 are part of ‘a full dossier on the substance’ in accordance with the second subparagraph of Article95(1) of Regulation No528/2012.

63Such an interpretation cannot however be accepted.

64Indeed, since Regulation No1451/2007 applied in the present case, according to its Article13(1), the Rapporteur Member State had to check whether the dossier was complete in accordance with Article11(1)(b) of Directive 98/8 and therefore with the requirements of Annex IVA and Annex IVB or Annex IIA, Annex IIB and, where appropriate, Annexes IIIA and IIIB to that directive. According to Article14(1) of Regulation No1451/2007, where the Rapporteur Member State took the view that a dossier was complete under Article13 of that regulation, that Member State was entitled to proceed with, where appropriate, the evaluation of the active substance within 12 months of the approval of the dossier in accordance with Article11(2) of Directive 98/8.

65The applicants have not shown, even in relation to their own dossier, that the Comet Assay study was required under Article13 of Regulation No1451/2007, in conjunction with Article11(1)(b) of Directive 98/8 and the requirements of the annexes mentioned therein.

66On the contrary, on 29January 2008, the Rapporteur Member State informed the applicants that their dossier was complete, although that study was not included in their dossier, the submission of that study having only been requested during the stage of the evaluation of propyl alcohol under Article14(1) of Regulation No1451/2007.

67The applicants’ argument relating to a right to a fair compensation, such as that which may stem from Article63(3) of Regulation No528/2012, must be rejected because the applicants failed to show that a reference to the data in the Comet Assay study was necessary for the dossier submitted by BASF to ECHA in accordance with the second subparagraph of Article95(1) of Regulation No528/2012, or that that study was necessary to complete their own dossier on propyl alcohol submitted to the Rapporteur Member State in accordance with Article13 of Regulation No1451/2007.

68The same is true of the argument that ECHA deprived the applicants of the option of challenging a possible decision taken on the basis of that same provision. Since there is no requirement to make a reference, in BASF’s dossier, to the data of the Comet Assay study, ECHA was not required to adopt a decision authorising the use of that data.

The argument based on the existence of an unfair competitive advantage

69In order to prove the conditions of admissibility as laid down in the fourth paragraph of Article263 TFEU, the applicants claim that, by adopting the contested decision, ECHA conferred an unfair competitive advantage upon BASF since it placed BASF in the same position as the applicants, which are participants and data owners, without BASF having to cover a share of the costs borne by the applicants during the review programme. The applicants’ legal and factual situation is therefore negatively affected by the contested decision.

70In that respect, it is sufficient to note that the costs borne by the applicants because of carrying out the Comet Assay study were not necessary for the applicants to have the right to market propyl alcohol. That study was not required to complete the applicants’ dossier on the basis of Article13 of Regulation No1451/2007.

71Therefore, BASF did not benefit from any ‘unfair’ competitive advantage and the applicants’ argument to this effect must be rejected.

The argument based on the existence of a State aid

72Again in order to substantiate their capacity to act under the fourth paragraph of Article263 TFEU, the applicants claim in essence that, since BASF did not have to cover a share of the costs incurred in the context of the submission of the Comet Assay study, it can sell to its customers propyl alcohol-based products at a lesser cost than the applicants. That situation should be treated in the same way as the award of a State aid, which has the effect of affecting the legal situation of the applicants.

73In that respect, it must be recalled that, for a measure to be classified as aid within the meaning of Article107(1) TFEU, all the conditions set out in that provision must be fulfilled. First, there must be an intervention by the State or through State resources. Second, the intervention must be liable to affect trade between Member States. Third, it must confer an advantage on the recipient by favouring certain undertakings or the production of certain goods. Fourth, it must distort or threaten to distort competition (see judgment of 17December 2008, Ryanair v Commission, T‑196/04, EU:T:2008:585, paragraph36 and the case-law cited).

74In the present case, except for the argument related to the existence of an alleged competitive advantage in favour of BASF pursuant to the contested decision, which has already been rebutted in paragraphs70 and 71 above, the applicants have not put forward any argument permitting the finding that the conditions laid down in Article107(1) TFEU are met.

75Therefore, the argument alleging the existence of a State aid must be rejected.

76In the light of the foregoing, the applicants’ line of argument seeking to demonstrate ‘direct concern’ in accordance with the second situation in the fourth paragraph of Article263 TFEU must be rejected.

77It follows that, independently of the question of whether the applicants are also individually concerned by the contested decision, the present action for annulment does not meet the conditions of admissibility laid down in that provision.

78Furthermore, it must be noted that, contrary to the applicants’ claims, the contested decision does not amount to a regulatory act which does not entail implementing measures for the purpose of the third situation in the fourth paragraph of Article263 TFEU.

79In that respect, it must be stated that the concept of ‘regulatory act’ must be understood as referring to any act of general application apart from legislative acts (order of 14January 2015, SolarWorld and Others v Commission, T‑507/13, EU:T:2015:23, paragraph64).

80In the present case, it must be stated from the outset that the contested decision does not apply to objectively determined situations nor produce legal effects with respect to categories of persons envisaged in general and in the abstract. The contested decision being, by contrast, solely addressed to BASF, it cannot amount to a regulatory act within the meaning of the third situation in the fourth paragraph of Article263 TFEU.

81Consequently, the applicants’ argument that a regulatory act exists within the meaning of the third situation in the fourth paragraph of Article263 TFEU must be rejected.

82In the light of all the foregoing, the action must be dismissed in its entirety as inadmissible.

Applications to intervene

83In accordance with Article142(2) of the Rules of Procedure, an intervention is ancillary to the main proceedings and is devoid of purpose, in particular, where the application is declared inadmissible.

84Consequently, there is no need to rule on the applications to intervene of Oxea and BASF.

Costs

85Under Article134(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.

86As the applicants have been unsuccessful, they must be ordered to pay their own costs and those incurred by ECHA, in accordance with the form of order sought by ECHA.

87In paragraph32 of their observations on the plea of inadmissibility, the applicants requested that ECHA be ordered to pay the costs, because it was only in that application concerning admissibility that it provided details on the justifications and grounds of the contested act, despite several requests to that effect which could have avoided proceedings being brought.

88Nevertheless, Article134(1) cannot be derogated from on the basis of such an argument.

89The applicants’ argument that ECHA ought to have provided more explanations earlier in the context of its general obligation to state reasons and its duty of transparency and that its ‘refusal’ denied the applicants their expectations and deprived them of the right to reply and defend themselves in an efficient and adequate manner in the present case cannot succeed.

90Indeed, it is common ground that, by letter of 18August 2015, ECHA confirmed that it was indeed of the opinion that the Comet Assay test was not necessary for the inclusion of BASF on the relevant list.

91The applicants have failed to show in what respect the response of ECHA was not sufficient to enable them to defend themselves in an efficient and adequate manner in the present case.

92Under Article144(10) of the Rules of Procedure, if the proceedings in the main case are concluded before the application for leave to intervene has been decided upon, the applicant for leave to intervene and the main parties must each bear their own costs relating to the application to intervene.

93In the present case, the applicants, ECHA, Oxea and BASF will therefore bear their own costs relating to the applications for leave to intervene.

On those grounds,

THE GENERAL COURT (Fifth Chamber)

hereby orders:

1.The action is dismissed as inadmissible.

2.There is no longer any need to adjudicate on the applications to intervene of Oxea GmbH and BASF SE.

3.Lysoform Dr. Hans Rosemann GmbH, Ecolab Deutschland GmbH, Schülke & Mayr GmbH and Diversey Europe Operations BV shall bear their own costs and pay those incurred by the European Chemicals Agency (ECHA) except for those relating to the applications for leave to intervene.

4.Lysoform Dr. Hans Rosemann, Ecolab Deutschland, Schülke & Mayr, Diversey Europe Operations, ECHA, Oxea and BASF shall each bear its own costs relating to the applications for leave to intervene.

Luxembourg, 12 October 2016.

E.Coulon

A.Dittrich

Registrar

President


** Language of the case: English.

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