Orders nº T-518/19 of Tribunal General de la Unión Europea, September 26, 2019

Resolution DateSeptember 26, 2019
Issuing OrganizationTribunal General de la Unión Europea
Decision NumberT-518/19

(Application for interim measures - Plant protection products - Regulation (EC) No 1107/2009 - Active substance chlorothalonil - Conditions of approval for placing on the market - Application for suspension of operation - Lack of urgency)

In Case T-518/19 R,

Sipcam Oxon SpA, established in Milan (Italy), represented by C. Mereu and P. Sellar, lawyers,

applicant,

v

European Commission, represented by I. Naglis and A. Dawes, acting as Agents,

defendant,

APPLICATION based on Articles 278 and 279 TFEU, seeking suspension of the operation of Commission Implementing Regulation (EU) 2019/677 of 29 April 2019 concerning the non-renewal of the approval of the active substance chlorothalonil, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (OJ 2019 L 114, p. 15),

THE PRESIDENT OF THE GENERAL COURT

makes the following

Order

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

1 The applicant, Sipcam Oxon SpA, is a company established under Italian law that produces and distributes chemical and plant protection products via its subsidiaries. Its products include herbicides, acaricides, fungicides and biological products. The applicant markets, inter alia, the active substance chlorothalonil, a fungicide used to control diseases in cereals, as well as other vegetable crops.

2 Pursuant to Annex I to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ 2011 L 153, p. 1), chlorothalonil was included among substances approved under Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ 2009 L 309, p. 1). As such, the approval of chlorothalonil was subject to the standard regulatory renewal of approval process under Article 14 of Regulation No 1107/2009.

3 In accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 (OJ 2012 L 252, p. 26), the renewal of approval was subject to an initial evaluation by the rapporteur Member State, the Kingdom of the Netherlands, and the co-rapporteur Member State, the Kingdom of Belgium.

4 On 2 September 2016, the rapporteur Member State, in consultation with the co-rapporteur Member State, submitted a draft renewal assessment report (‘RAR’) to the European Food Safety Authority (‘EFSA’) and the Commission, proposing the classification of chlorothalonil as carcinogen category 2 (‘suspected human carcinogens’ under Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1)).

5 On 24 October 2016, EFSA distributed the draft RAR to the Member States and to the applicant for comments.

6 By letter of 28 February 2017, following consideration of the comments submitted to it about the draft RAR, EFSA sent to the applicant a request for additional information.

7 In November 2017, in consideration of the comments and additional information provided by the applicant, the Commission issued a revised RAR, proposing the classification of chlorothalonil as carcinogen category 1B (‘substances presumed to have carcinogenic potential for humans’ under Regulation No 1272/2008).

8 On 4 December 2017, EFSA issued its Conclusion on the Peer Review of the Pesticide Risk Assessment of the active substance chlorothalonil (‘EFSA Conclusion’) about whether chlorothalonil could be expected to meet the approval criteria provided for in Article 4 of Regulation No 1107/2009 and sent it to the applicant and to the Commission.

9 In this document, EFSA identified a critical concern in relation to the contamination of groundwater by metabolites of chlorothalonil, stated that it cannot currently be established that the presence of metabolites of chlorothalonil in groundwater will not result in unacceptable effects on groundwater and in harmful effects on human health and that the genotoxicity concern for residues to which consumers will be exposed cannot be excluded, and identified a high risk to amphibians and fish for all the uses evaluated. Furthermore, EFSA observed that several areas of the risk assessment could not be finalised due to insufficient data in the dossier.

10 By email of 29 January 2018, the Commission invited the applicant to submit its comments on the EFSA Conclusion by 19 February 2018 at the latest.

11 By email of 16 February 2018, the applicant submitted its comments on the EFSA Conclusion.

12 On 22 March 2019, the Commission issued its final renewal report for the active substance chlorothalonil, which was finalised in the Standing Committee on Plants, Animals, Food and Feed at its meeting on 22 March 2019 in view of the non-renewal of the approval of chlorothalonil as active substance in accordance with Regulation No 1107/2009.

13 On 29 April 2019, the Commission adopted Implementing Regulation (EU) 2019/677 concerning the non-renewal of the approval of the active substance chlorothalonil, in accordance with Regulation No 1107/2009, and amending Commission Implementing Regulation No 540/2011 (OJ 2019 L 114, p. 15; ‘the contested regulation’).

14 The contested regulation establishes the non-renewal of the approval of the active substance chlorothalonil.

15 In accordance with Article 3 thereof, the contested regulation requires Member States to withdraw authorisations for plant protection products containing chlorothalonil as active substance by 20 November 2019 at the latest. Article 4 provides for a ‘grace period’ that is to expire by 20 May 2020 at the latest.

16 By application lodged at the Registry of the General Court on 22 July 2019, the applicant seeks the annulment of the contested regulation.

17 By separate document lodged at the Court Registry on 30 July 2019, the applicant lodged an application for interim measures, in which it claims that the President of the General Court should:

- suspend the contested regulation with immediate effect, pursuant to Article 157(2) of the Rules of Procedure of the General Court, pending the Court’s ruling in the main application;

- grant any other interim measures as appropriate and hold an oral hearing as needed;

- order the Commission to pay the costs.

18 In its observations on the application for interim measures, which were lodged at the Court Registry on 26 August 2019, the Commission contends that the President of the General Court should:

- dismiss the application for interim measures;

- reserve the costs until judgment in the main proceedings.

Law

General consideration s

19 It is apparent from a combined reading of Articles 278 and 279 TFEU, on the one hand, and Article 256(1) TFEU, on the other, that the judge hearing the application for interim measures may, if he considers that circumstances so require, order that application of an act contested before the General Court be suspended or prescribe any necessary interim measures, pursuant to Article 156 of the Rules of Procedure. Nevertheless, Article 278 TFEU establishes the principle that actions do not have suspensory effect, since acts adopted by the institutions of the European Union are presumed to be lawful. It is therefore only exceptionally that a judge hearing an application for interim measures may order suspension of the application of an act contested before the General Court or prescribe interim measures (order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T-476/17 R, EU:T:2018:407, paragraph 17 and the case-law cited).

20 The first sentence of Article 156(4) of the Rules of Procedure provides that applications for interim measures must ‘state the subject matter of the proceedings, the circumstances giving rise to urgency and the pleas of fact and law establishing a prima facie case for interim measure applied for’.

21 Accordingly, the judge hearing an application for interim relief may order suspension of operation of an act, or other interim measures, if it is established that such an order is justified, prima facie, in fact and in law and that it is urgent in so far as, in order to avoid serious and irreparable damage to the applicant’s interests, it must be made and produce its effects before a decision is reached in the main action. Those conditions are cumulative, so that an application for interim measures must be dismissed if either of them is absent. Where appropriate, the judge hearing such an application must also weigh the competing interests (see, to that effect, order of 2 March 2016, Evonik Degussa v Commission, C-162/15 P-R, EU:C:2016:142, paragraph 21 and the case-law cited).

22 In the context of that overall examination, the judge hearing the application has a wide discretion and is free to determine, having regard to the specific circumstances of the case, the manner and order in which those various conditions are to be examined, there being no rule of law imposing a pre-established scheme of analysis within which the need to order interim measures must be assessed (see, to that effect, order of 19 July 2012, Akhras v Council, C-110/12 P(R), not published...

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