ORDER OF THE COURT (Sixth Chamber)

19 July 2017 ([\*](#Footnote*))

(Appeal — Article 181 of the Rules of Procedure of the Court of Justice –– Regulation (EU) No 528/2012 — Making available on the market and use of biocidal products — Article 95 — European Chemicals Agency (ECHA) — Publication of a list of active substances — Inclusion of a company as a supplier of an active substance)

In Case C‐666/16 P,

APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 21 December 2016,

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

**Ecolab Deutschland GmbH,** established in Monheim (Germany), represented by M. Grunchard and K. Van Maldegem, avocats, and by P. Sellar, Advocate,

appellants,

the other party to the proceedings being:

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

defendant at first instance,

THE COURT (Sixth Chamber),

composed of E. Regan, President of the Chamber, A. Arabadjiev and C.G. Fernlund (Rapporteur), Judges,

Advocate General: E. Sharpston,

Registrar: A. Calot Escobar,

having decided, after hearing the Advocate General, to give a decision by reasoned order, pursuant to Article 181 of the Rules of Procedure of the Court of Justice,

makes the following

**Order**

1        By their appeal, Lysoform Dr. Hans Rosemann GmbH (‘Lysoform’) and Ecolab Deutschland GmbH (‘Ecolab’) request that the Court of Justice set aside the order of the General Court of the European Union of 12 October 2016, *Lysoform Dr. Hans Rosemann and Others* v *ECHA* (T‐543/15, not published, ‘the order under appeal’, EU:T:2016:612), whereby the General Court dismissed as inadmissible their action for annulment of the decision of the European Chemicals Agency (ECHA) of 17 June 2015 concerning the inclusion of Oxea GmbH, established in Germany, as supplier of an active substance on the list referred to in Article 95(1) of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ 2012 L 167, p. 1), (‘the decision at issue’).

**Background to the dispute**

2        It is apparent from paragraphs 1 to 19 of the order under appeal that Lysoform and Ecolab are members of the working group called ‘Alcohol Task Force’. That working group was created in order to share the costs related to the submission of a review dossier concerning propyl alcohol in accordance with the EU legislation on biocidal products. After those companies notified that substance to the European Commission, the latter designated the Federal Republic of Germany as Rapporteur Member State for the purposes of examining that substance as an active substance. In their capacity as notifying companies, Lysoform and Ecolab submitted a dossier to the Rapporteur Member State.

3        On 29 January 2008, the Rapporteur Member State informed Lysoform and Ecolab that their dossier was complete.

4        On 21 August 2008 and 5 November 2008, the Rapporteur Member State asked for an *in vivo* study, ‘the Comet Assay study’, to be produced.

5        It is apparent from paragraph 9 of the order under appeal that, as at the date of that order, the dossier on propyl alcohol submitted by Lysoform and Ecolab was still being assessed.

6        Oxea is a member of a working group called ‘ASD Consortium Alcohol’. In September 2013, that working group contacted Lysoform and Ecolab with a view to possibly sharing data in accordance with Articles 62 and 63 of Regulation No 528/2012. That request did not concern the Comet Assay test, but an inhalation toxicity study. ASD Consortium Alcohol acquired a letter of access to the inhalation toxicity study.

7        On 24 September 2014, ECHA published the list of the active substances provided for in Article 95(1) of Regulation No 528/2012 (‘the active substances list’). Lysoform and Ecolab, as well as the other members of the Alcohol Task Force, were included on that list as suppliers of propyl alcohol as of February 2014.

8        On 25 January 2015, Oxea asked ECHA to be included on the active substances list as a supplier of propyl alcohol.

9        By the decision at issue, ECHA granted that request.

10      On 26 June 2015, ECHA updated the active substances list.

11      On 28 July 2015, Lysoform and Ecolab asked ECHA to state whether it was of the view that the Comet Assay study was not necessary for the inclusion of Oxea on the active substances list as a supplier of propyl alcohol, which ECHA confirmed by letter of 18 August 2015.

12      On 28 August 2015, Lysoform and Ecolab lodged a notice of appeal against the decision at issue before the Board of Appeal of ECHA.

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

**The procedure before the General Court and the order under appeal**

14      By application lodged at the General Court Registry on 18 September 2015, Lysoform and Ecolab brought an action for annulment of the decision at issue.

15      By the order under appeal, the General Court dismissed the action as inadmissible and ordered Lysoform and Ecolab to bear their own costs, and to pay those incurred by ECHA except for those relating to the applications for leave to intervene.

16      In order to rule on the plea of inadmissibility before it, the General Court examined whether the applicants could be considered directly concerned by the decision at issue, within the meaning of the fourth paragraph of Article 263 TFEU.

17      In paragraph 33 of the order under appeal, the General Court referred to the settled case-law according to which for a person to be directly concerned by an EU measure, the measure must, first, directly affect his legal situation and, secondly, 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.

18      The General Court examined whether the decision at issue produces effects with regard to the applicants’ legal situation. On the grounds set out in paragraphs 38 to 75 of the order under appeal, it decided, in paragraph 76 of that order, to reject the applicants’ arguments seeking to demonstrate direct concern within the meaning of the fourth paragraph of Article 263 TFEU.

19      After finding, in paragraphs 78 to 81 of the order under appeal, that the decision at issue did not amount to a regulatory act which does not entail implementing measures within the meaning of the fourth paragraph of Article 263 TFEU, the General Court dismissed the action in its entirety as inadmissible.

**Forms of order sought and procedure before the Court of Justice**

20      Lysoform and Ecolab claim that the Court of Justice should:

–        set aside the order under appeal;

–        rule on admissibility and refer the case back to the General Court to rule on the merits of the case;

–        in the alternative, refer the case back to the General Court to rule on the admissibility of the appellants’ application for annulment of the decision at issue and, as appropriate, thereafter to rule on the merits of the case;

–        order ECHA to pay the costs.

21      ECHA contends that the Court of Justice should dismiss the appeal and order Lysoform and Ecolab to pay the costs.

22      By document registered at the Court Registry on 4 April 2017, on the basis of the second paragraph of Article 40 of the Statute of the Court of Justice of the European Union, BASF SE and Oxea applied for leave to intervene in support of the form of order sought by ECHA.

**The appeal**

23      Under Article 181 of its rules of procedure, where an appeal is, in whole or in part, manifestly inadmissible or manifestly unfounded, the Court of Justice may at any time, acting on a proposal from the Judge-Rapporteur and after hearing the Advocate General, decide by reasoned order to dismiss the appeal in whole or in part, without opening the oral procedure.

24      That provision must be applied in the present case.

25      In support of their appeal, Lysoform and Ecolab put forward three grounds of appeal.

*The first ground of appeal*, alleging an infringement of Article 130(1) of the Rules of Procedure of the General Court

26      Lysoform and Ecolab complain that the General Court infringed Article 130(1) of its rules of procedure in rejecting, in paragraphs 49 to 68 of the order under appeal, their arguments relating to an infringement of their rights stemming from Article 63 of Regulation No 528/2012. They submit that, pursuant to Article 130(1) of the Rules of Procedure of the General Court, the defendant must refrain from ‘going to the substance of the case’ when he raises a plea of inadmissibility. He should, therefore, restrict himself to arguments relating to direct or individual concern and to the concept of a ‘regulatory act’ without discussing the actual merits of the application or a potential defence. ECHA infringed that rule, however, in putting forward in its plea of inadmissibility arguments relating to the substance of the case.

27      In order to adjudicate on that plea, the General Court ruled on those arguments on the substance of the case, since it held, in paragraph 59 of the order under appeal, that Oxea’s dossier was complete and it complained, in paragraph 60 of that order, that Lysoform and Ecolab failed to produce evidence to show the contrary.

28      However, the Court of Justice points out that Article 130(1) of the Rules of Procedure of the General Court provides that ‘a defendant applying to the General Court for a decision on inadmissibility or lack of competence without going to the substance of the case shall submit the application by a separate document within the time limit referred to in Article 81’. It is apparent from those clear and unambiguous words that, in advancing a plea of inadmissibility in the form specified in that provision, a defendant requests the General Court to rule on inadmissibility ‘without going to the substance of the case’, that is, without the written part of the procedure following its normal course by the submission of a defence.

29      The plea of inadmissibility provided for in both Article 151 of the Rules of Procedure of the Court of Justice and Article 130 of the Rules of Procedure of the General Court makes it possible, for reasons of economy of procedure, to confine the debate and examination, at an early stage in the proceedings, to the question whether the action at issue is admissible. Thus, it is possible, as a result of that plea, to avoid a situation in which the parties’ pleadings and the court’s examination go into the substance of the case, even though the action is inadmissible (judgment of 17 December 2009, *Review M* v *EMEA*, C‐197/09 RX‐II, EU:C:2009:804, paragraph 48).

30      On the other hand, where the action is declared admissible because the plea of inadmissibility is rejected or where a decision on that plea is reserved for the final judgment, there must be an exchange of arguments on the substance of the application at a subsequent stage. The provisions referred to above expressly provide that the President is to prescribe new time limits for further steps in the proceedings if an application for a ruling on a plea of inadmissibility is dismissed or the decision on that application is reserved (judgment of 17 December 2009, *Review M* v *EMEA*, C‐197/09 RX-II, EU:C:2009:804, paragraph 49).

31      In addition, the Court points out that, in the absence of any provision of the Rules of Procedure expressly providing to the contrary, the defendant is free to choose its arguments and cannot, therefore, when lodging a plea of inadmissibility in accordance with Article 130(1) of the Rules of Procedure of the General Court, be prohibited from addressing the substance of the case.

32      Admittedly, it would be incompatible with the rationale of the rules on the plea of inadmissibility to require the defendant raising such a plea to put forward, as a matter of prudence, its arguments on the substance of the case (judgment of 17 December 2009, *Review M* v *EMEA*, C‐197/09 RX-II, EU:C:2009:804, paragraph 50).

33      However, it may, in certain situations, be useful, even necessary, for that defendant to address the substance of the case in its plea of inadmissibility. That is true, in particular, if there is a close connection between the pleas of inadmissibility and the substance of the action, or a close relationship between the question of admissibility of the various claims and the substance of the action (see, to that effect, judgments of 27 October 1977, *Giry* v *Commission*, 126/75, 34/76 and 92/76, EU:C:1977:169, paragraph 3, and of 15 March 1984, *Tradax Graanhandel* v *Commission*, 64/82, EU:C:1984:106, paragraph 12).

34      It is, therefore, apparent from the foregoing that the first ground of appeal is based on a manifestly erroneous interpretation of Article 130(1) of the Rules of Procedure of the General Court. Consequently, the present ground of appeal must be rejected as manifestly unfounded.

 The second ground of appeal, alleging an infringement of Article 130(7) of the Rules of the Procedure of the General Court

35      Lysoform and Ecolab submit that the General Court ought to have reserved its decision on the plea of inadmissibility until it ruled on the substance of the case, as it was allowed to do under Article 130(7) of its rules of procedure. The issue of whether Oxea’s dossier was complete constitutes the basis of the present case. Resolving that issue required full elaboration of arguments (written and oral) thereon.

36      However, it must be borne in mind that Article 130(7) of the Rules of Procedure of the General Court provides that the General Court ‘shall 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’. It is apparent from the clear and unambiguous words of that provision that the General Court is under no duty to hold a hearing and that it has exclusive jurisdiction to decide whether to rule immediately on the objection of inadmissibility or to reserve its decision for the final judgment if special circumstances so require. The General Court has, in that regard, a wide discretion (see, by analogy, orders of 7 December 2004, *Internationaler Hilfsfonds* v *Commission*, C‐521/03 P, not published, EU:C:2004:778, paragraph 25; of 21 November 2005, *SNF* v *Commission*, C‐482/04 P, not published, EU:C:2005:706, paragraph 30; and of 30 March 2006, *EFfCI* v *Parliament and Council*, C‐113/05 P, not published, EU:C:2006:222, paragraph 26).

37      It follows that in deciding in the present case to give its decision on the single plea of inadmissibility raised by ECHA, without reserving that decision until it ruled on the substance of the case, on the ground that it had sufficient information from the documents before it, the General Court correctly applied Article 130(7) of its rules of procedure.

38      The second ground of appeal must, therefore, be rejected as manifestly unfounded.

*The third ground of appeal, alleging no access to justice and a failure to comply with the obligation to state reasons*

39      First, Lysoform and Ecolab submit that the refusal of the General Court to allow an oral hearing and/or other steps of written procedure denied them all effective judicial protection, because they have no legal remedy at the national level against the decision at issue. Secondly, they submit that the General Court failed to state reasons for its refusal to reserve its decision on the plea of inadmissibility until it ruled on the substance of the case.

40      As regards that second point, it suffices to note that it is apparent from the grounds stated in paragraphs 27 to 82 of the order under appeal, that the General Court set out to the requisite legal standard the reasons for which it had sufficient information from the documents before it and decided to give its decision without taking further steps in the proceedings. Consequently, the argument that the General Court failed to comply with its obligation to state reasons is manifestly unfounded.

41      As regards the arguments relating to an infringement of the principle of effective judicial protection, it should be borne in mind that, in the system for reviewing the legality of EU acts, the fourth paragraph of Article 263 TFEU provides for two situations in which natural or legal persons are accorded standing to institute proceedings against an act which is not addressed to them. First, such proceedings may be instituted if the act is of direct and individual concern to those persons. Secondly, they may bring proceedings against a regulatory act not entailing implementing measures if that act is of direct concern to them (judgment of 21 December 2016, *Council* v *Front Polisario*, C‐104/16 P, EU:C:2016:973, paragraph 130).

42      It must also be borne in mind that the condition that a natural or legal person must be directly concerned by the decision being challenged, as provided for in the fourth paragraph of Article 263 TFEU, requires two cumulative criteria to be met, namely, first, the contested measure must directly affect the legal situation of the individual and, secondly, it must leave no discretion to its addressees, 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 (see, to that effect, order of 6 March 2014, *Northern Ireland Department of Agriculture and Rural Development* v *Commission*, C‐248/12 P, not published, EU:C:2014:137, paragraph 21 and the case-law cited).

43      Admittedly, the conditions of admissibility laid down in the fourth paragraph of Article 263 TFEU are interpreted by the Court of Justice in the light of the principle of effective judicial protection. However, that interpretation cannot have the effect of setting aside those conditions, which are expressly laid down in the FEU Treaty, without going beyond the jurisdiction conferred by that treaty on the EU Courts (judgment of 25 July 2002, *Unión de Pequeños Agricultores* v *Council*, C‐50/00 P, EU:C:2002:462, paragraph 44; order of 30 March 2006, *EFfCI* v *Parliament and Council*, C‐113/05 P, not published, EU:C:2006:222, paragraph 56; and judgment of 28 April 2015, *T & L Sugars and Sidul Açúcares* v *Commission*, C‐456/13 P, EU:C:2015:284, paragraph 44).

44      Consequently, in rejecting in paragraph 76 of the order under appeal, Lysoform and Ecolab’s line of argument seeking to demonstrate direct concern within the meaning of the fourth paragraph of Article 263 TFEU, the General Court did not fail to have regard to the principle of effective judicial protection, but correctly applied the conditions provided for in that provision of the Treaty.

45      The third ground of appeal is, therefore, manifestly unfounded.

46      It follows from all the foregoing considerations that the appeal brought by Lysoform and Ecolab must be dismissed as being manifestly unfounded.

 Application to intervene

47      Pursuant to Article 129(2) of the Rules of Procedure of the Court of Justice, intervention is to be ancillary to the main proceedings. It is to become devoid of purpose if the case is removed from the register of the Court, in particular where the application is declared inadmissible.

48      Consequently, there is no longer any need to rule on the application to intervene of BASF and Oxea.

**Costs**

49      In accordance with the Article 184(2) of the Rules of Procedure of the Court, where the appeal is unfounded, the Court is to make a decision as to costs. Under Article 138(1) of those rules of procedure, applicable to the procedure on appeal by virtue of Article 184(1) thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.

50      Since ECHA has applied for costs to be awarded against Lysoform and Ecolab, and the latter have been unsuccessful, Lysoform and Ecolab must be ordered to pay the costs.

51      Under Article 142 of the Rules of Procedure of the Court, which applies to the procedure on appeal pursuant to Article 184(1) of those rules, where a case does not proceed to judgment the costs are to be in the discretion of the Court.

52      In the present case, Lysoform and Ecolab, ECHA, BASF and Oxea are each to bear their own costs relating to the application for leave to intervene.

On those grounds, the Court (Sixth Chamber) hereby orders:

1.      **The appeal is dismissed.**

2.      **Lysoform Dr. Hans Rosemann GmbH and Ecolab Deutschland GmbH shall pay the costs.**

3.      **Lysoform Dr. Hans Rosemann GmbH, Ecolab Deutschland GmbH, the European Chemicals Agency (ECHA), BASF SE and Oxea GmbH shall each bear their own costs relating to the application for leave to intervene.**

Luxembourg, 19 July 2017.

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| A. Calot Escobar | | E. Regan |

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| Registrar | | President of the Sixth Chamber |

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[\*](#Footref*)      Language of the case: English.