Laboratoire Pareva and Biotech3D v Commission (Biocidal products - Active substance PHMB - Order) [2018] EUECJ T-347/18

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(Interim relief — Regulation (EU) No 528/2012 — Biocidal products — Active substance PHMB (1415; 4.7) — Approval refused — Application for interim measures — New application — No new facts — Inadmissibility)

Laboratoire Pareva, established in St. Martin de Crau (France), represented by K. Van Maldegem and S. Engelbert, lawyers,

European Commission, represented by R. Lindenthal and K. Mifsud-Bonnici, acting as Agents,

APPLICATION pursuant to Articles 278 TFEU and 279 TFEU seeking, first, suspension of operation of Commission Implementing Regulation (EU) 2018/613 of 20 April 2018 approving PHMB (1415; 4.7) as an existing active substance for use in biocidal products of product-types 2 and 4 (OJ 2018 L 102, p. 1), and, secondly, the adoption of any other appropriate interim measure,

Background to the dispute, procedure and forms of order sought by the parties

1 The applicant, Laboratoire Pareva, is a manufacturer of the substance polyhexamethylene biguanide hydrochloride (‘PHMB (1415; 4.7)’) in the European Union.

2 By order of 24 August 2018, Laboratoire Pareva and Biotech3D v Commission (T‑337/18 R and T‑347/18 R, not published, ‘the first order for interim measures’, EU:T:2018:587), the President of the General Court dismissed the application for interim measures lodged by the applicant (‘the first application for interim relief’), seeking, inter alia, suspension of operation of Commission Implementing Regulation (EU) 2018/613 of 20 April 2018 approving PHMB (1415; 4.7) as an existing active substance for use in biocidal products of product-types 2 and 4 (OJ 2018 L 102, p. 1; ‘the contested regulation’).

3 The dismissal of the first application for interim measures was based on analysis of the elements relating to the conditions for the grant of interim measures, namely, the existence of a prima facie case, urgency and the balance of interests, which led to a finding that the balance of interests weighed in favour of the refusal of the requested suspension of operation.

4 By document lodged at the Court Registry on 28 September 2018, the applicant submitted a new application for interim measures, based on the alleged existence of new facts within the meaning of Article 160 of the Rules of Procedure of the General Court, in which it claims, in essence, that the President of the General Court should:

– grant any other interim measure that may be deemed appropriate and hold an oral hearing if that is deemed necessary;

5 In its observations on the new application for interim measures, lodged at the Court Registry on 9 October 2018, the Commission contends, in essence, that the President of the General Court should:

– dismiss the new application for interim measures as inadmissible or, in the alternative, as unfounded;

6 Having regard to the documents in the case file, the President of the General Court considers that he has all the information required to rule on the new application for interim measures, without there being any need first to hear oral argument from the parties.

7 Under Article 160 of the Rules of Procedure, the refusal of an application for an interim measure shall not bar the main party who made it from making a further application on the basis of new facts.

8 In so far as the new application for interim measures is based on the alleged existence of new facts, it can be declared admissible only if the conditions prescribed in Article 160 of the Rules of Procedure are met (see order of 13 June 2016, ICA Laboratories and Others v Commission, T‑732/15 R II, not published, EU:T:2016:416, paragraph 19 and the case-law cited).

9 According to settled case-law, ‘new facts’ within the meaning of Article 160 of the Rules of Procedure should be taken to mean facts which come to light after the order rejecting the first application for interim measures was adopted or which the applicant was not capable of invoking in the first application or during the proceedings leading to the first order, and which are relevant to the assessment of the case in question (see order of 13 June 2016, ICA Laboratories and Others v Commission, T‑732/15 R II, not published, EU:T:2016:416, paragraph 20 and the case-law cited).

10 In the present case, the applicant identifies, in its new application for interim measures, two elements which are new facts within the meaning of Article 160 of the Rules of Procedure and relies on them in support of this application:

– the existence of the proposal for harmonised classification and labelling concerning PHMB (1415; 4.7), sent on 1 February 2018 by the French authorities to the European Chemicals Agency (ECHA) (‘the classification proposal’);

– the correction of errors on the website of the company Mareva, on the applicant’s own website and in the trade register, as regards the applicant’s capital structure (‘the correction of errors in the presentation of the capital structure’).

11 In the first place, as regards treating the existence of the classification proposal as a new fact, the applicant maintains that it was informed of that proposal only by means of the Commission’s defence in the main proceedings in case T‑337/18, Laboratoire Pareva v Commission. Thus, according to the applicant, that information should be classified as a new fact in that it was brought to the applicant’s attention after 5 June 2018, the date on which it lodged its application for interim measures.

12 In that regard, it should be recalled, first of all, that the relevant date for assessing the existence of new facts is not, as the applicant appears to maintain, the time of lodging of the application for interim measures but, as follows from the case-law referred to in paragraph 9 above, the time of adoption of the interim order, namely, in the present case, 24 August 2018.

13 Next, it should be noted that the Commission referred, in its observations on the application for interim measures lodged on 26 June 2018 in the proceedings which gave rise to the first order for interim measures, to the fact that a ‘proposal for the harmonised classification and labelling including [the applicant’s] PHMB has … been submitted by the French authority to ECHA in January 2018’. Furthermore, the defence in the main case in case T‑337/18, Laboratoire Pareva v Commission, by which the applicant claims to have been made aware of the existence of the classification proposal, was lodged on 27 July 2018 and sent to the applicant by letter of 16 August 2018, thus during the proceedings which gave rise to the first order for interim measures. Therefore, the applicant could have invoked the existence of the classification proposal in those proceedings.

14 In those circumstances, the existence of the classification proposal cannot be regarded as a new fact.

15 In the second place, as regards the classification as a new fact of the correction of errors in the presentation of the capital structure, the applicant submits that it became aware ‘during the proceedings for interim measures’ that the information relating to its capital structure, which appeared on the website of the company Mareva, on the applicant’s own website and in the trade register, was incorrect. Therefore, it maintains that it took steps to correct those errors in order to reflect its actual capital structure, namely, the fact that it is owned by a holding company with no other subsidiaries.

16 In that regard, it should be noted that the applicant had previously argued, in its application for interim measures of 5 June 2018, that it was owned by a holding company with no other subsidiaries.

17 Thus, since the applicant does not claim that there was any change in its capital structure, the only element which may be classified as a new fact is the fact that the applicant became aware of an incorrect presentation of its capital structure and that it took steps to correct it on the website of the company Mareva, on the applicant’s own website and in the trade register.

18 As regards, first, the fact that the applicant became aware of an incorrect presentation of its capital structure, it states itself that that occurred ‘during the proceedings for interim measures’.

19 Thus, in accordance with the case-law referred to in paragraph 9 above, the fact that the applicant became aware ‘during the proceedings for interim measures’ of an incorrect presentation of its capital structure cannot, in any event, constitute a new fact within the meaning of Article 160 of the Rules of Procedure.

20 Secondly, as regards the steps taken by the applicant in order to correct the presentation of its capital structure, it follows from R 28 and R 29 that it took those steps on 2 July 2018, thus during the proceedings leading to the first order for interim measures, by letter to the company Mareva, in order to urge it to make changes to its website and in the trade register. Moreover, the applicant does not state when that information was corrected.

21 Thus, the correction of errors in the presentation of the applicant’s capital structure cannot, in any event, be treated as a new fact.

22 It follows from all the foregoing that the application for interim measures must be dismissed as inadmissible, the applicant having failed to establish the existence of new facts within the meaning of Article 160 of the Rules of Procedure.

23 By virtue of Article 158(5) of the Rules of Procedure, it is appropriate to reserve the costs.

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You are here: BAILII >> Databases >> Court of Justice of the European Communities (including Court of First Instance Decisions) >> Laboratoire Pareva and Biotech3D v Commission (Biocidal products - Active substance PHMB - Order) [2018] EUECJ T-347/18_CO (25 October 2018) URL: http://www.bailii.org/eu/cases/EUECJ/2018/T34718_CO.html Cite as: [2018] EUECJ T-347/18_CO, ECLI:EU:T:2018:730, EU:T:2018:730

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