ORDER OF THE PRESIDENT OF THE GENERAL COURT
8 April 2011 (*)
(Application for interim measures – Directive 91/414/EEC – Decision concerning the non-inclusion of diphenylamine in Annex I to Directive 91/414 – Other application for suspension of operation of a measure – Lack of urgency)
In Case T‑71/10 R II,
Xeda International SA, established in Saint‑Andiol (France), represented by C. Mereu and K. Van Maldegem, lawyers,
European Commission, represented by P. Ondrusek and F. Wilman, acting as Agents, and by J. Stuyck and A.-M. Vandromme, lawyers,
APPLICATION for suspension of operation of Commission Decision 2009/859/EC of 30 November 2009 concerning the non-inclusion of diphenylamine in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (OJ 2009 L 314, p. 79),
THE PRESIDENT OF THE GENERAL COURT
makes the following
Facts, procedure and forms of order sought
1 By order of 30 April 2010 in Case T‑71/10 R Xeda International v Commission, not published in the ECR (‘the order of 30 April 2010’), the President of the Court dismissed the application for interim measures lodged by the applicant, Xeda International SA, for suspension of operation of Commission Decision 2009/859/EC of 30 November 2009 concerning the non-inclusion of diphenylamine in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (OJ 2009 L 314, p. 79) (‘the contested decision’).
2 That dismissal was based, in essence, on the applicant’s failure to establish the seriousness of the financial loss alleged. In the order of 30 April 2010, the President of the Court held that that loss, representing between 1% and 10% of the overall turnover of the group of companies of which it is the parent company, was well under the 10% seriousness threshold applied in the order of the President of the Court of Justice in Case C‑474/00 P(R) Commission v Bruno Farmaceutici and Others  ECR I‑2909, paragraphs 106 to 109.
3 As the applicant was relying on the order of the President of 28 April 2009 in Case T‑95/09 R United Phosphorus v Commission, not published in the ECR (‘the United Phosphorus order’), it was pointed out that, in the case under consideration, there was no specific circumstance comparable to those which had characterised the case which gave rise to the United Phosphorus order and had justified the finding, notwithstanding the nature, in principle reparable, of the financial harm pleaded, that there was urgency capable of justifying the granting of the interim measures sought (order of 30 April 2010, paragraphs 47 and 48).
4 In that regard the President of the Court recalled, in paragraph 47 of the order of 30 April 2010, that he had considered decisive the fact that, ‘five weeks after the adoption of the disputed [non-inclusion] decision and almost three months before the lodging of its application for interim measures’, United Phosphorus had commenced the accelerated assessment procedure provided for by Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414 as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (OJ 2008 L 15, p. 5), ‘in which its prospects of success appeared to be greater than in the procedure which led to the disputed [non-inclusion] decision, due to the fact that, in that accelerated procedure, [United Phosphorus] had been able to present all the recent scientific data which had, improperly, not been taken into account in the procedure which led to the disputed decision, in disregard of the latest developments in science and the state of current scientific and technical knowledge’. Moreover, the European Commission had acknowledged that ‘the accelerated assessment procedure was liable to be completed only a few months after the date laid down for the withdrawal of the disputed products from the market’, which had led the President of the Court to conclude that ‘it would be unreasonable to allow the prohibition of the marketing of a product in respect of which it was not improbable that its marketing would be authorised only a few months later’.
5 In the present case, by contrast, the applicant had merely indicated that it ‘was preparing’ to submit a new dossier with a view to having it evaluated under the accelerated assessment procedure pursuant to Regulation No 33/2008, with the result that it was not at all in the same specific procedural situation as United Phosphorus. It therefore did not seem possible that the accelerated assessment procedure, which the applicant had merely ‘contemplated undertaking’, was liable to be completed a few months after the date imposed for the withdrawal from the market of plant protection products containing diphenylamine, namely 30 May 2010 (order of 30 April 2010, paragraphs 50 and 51).
6 Furthermore, the applicant had not criticised either the European Food Safety Authority (EFSA) or the Commission for having prevented it from presenting recent scientific data in the procedure which led to the contested decision, with the result that its prospects of success did not appear to be greater in the envisaged accelerated assessment procedure, on the ground that that procedure would have afforded it the opportunity to present new scientific data which was improperly not taken into account in the procedure which led to the contested decision, in disregard of the latest developments in science and the state of current scientific and technical knowledge (order of 30 April 2010, paragraph 52).
7 Subsequently to the order of 30 April 2010, on 27 May 2010 the applicant submitted a new dossier on diphenylamine under the accelerated assessment procedure provided for by Regulation No 33/2008. That dossier focused in particular on the concern which had led to the non-inclusion of diphenylamine, namely the possible formation of nitrosamines during storage of the active substance and during processing of treated apples (recital 5 of the contested decision).
8 In those circumstances, the applicant, by document lodged at the Registry of the General Court on 11 February 2011, brought the present application for interim relief, in which, pursuant to Article 109 of the Rules of Procedure of the General Court, it claims that the President of the Court should:
– suspend the operation of the contested decision pursuant to Article 105(2) of the Rules of Procedure of the Court until it has ruled on the main action or until a decision is taken on the new dossier on diphenylamine under the accelerated assessment procedure, which decision is expected in December 2011;
– order the Commission to take the necessary measures to ensure the reinstatement of the applicant’s national authorisations for diphenylamine;
– grant any other interim measures as appropriate and, if necessary, hold an oral hearing;
– order the Commission to pay the costs.
9 In its written observations, lodged at the Registry of the Court on 28 February 2011, the Commission contends that the President of the Court should:
– declare the second application for interim measures inadmissible or unfounded;
– reject the head of claim that it be ordered to take the necessary measures to ensure the reinstatement of the applicant’s national authorisations for diphenylamine;
– order the applicant to pay the costs.
10 After the Commission had lodged its observations, the applicant was granted leave to submit a reply to those observations, which it did by pleading lodged on 4 March 2011. Subsequently, by document of 16 March 2011, the Commission responded to that reply.
11 Having regard to the documents in the case, the President of the Court considers that he has all the material needed in order to rule on the present application for interim measures and that it is not expedient first to hear oral argument from the parties.
12 Under Article 109 of the Rules of Procedure, rejection of an application for interim measures is not to bar the party who made it from making a further application on the basis of new facts.
13 According to settled case-law, ‘new facts’ within the meaning of that provision should be taken to mean facts which appear after the order dismissing 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 the President of the General Court in Case T-420/05 R II Vischim v Commission  ECR II-4085, paragraph 54 and the case-law cited).
14 In the present case, the applicant relies on three new factors which arose after the order of 30 April 2010.
15 First, it reiterates that on 27 May 2010 it submitted a new dossier on diphenylamine under the accelerated assessment procedure. The positive feedback from the Rapporteur Member State shows that that application is progressing well and the accelerated procedure may be completed by November 2011, that is, six months after the grace period for disposing of existing stocks granted under Article 3 of the contested decision.
16 Second, the applicant states that the Member States, acting pursuant to Article 2 of the contested decision, have already withdrawn its authorisations for plant protection products containing diphenylamine and that, although existing stocks were used until recently, such use will no longer be possible for the coming season from June to September 2011, diphenylamine being used for the post-harvest treatment of apples.
17 Third, in the applicant’s submission, the urgency is further compounded by the imminent non-inclusion decision relating to its only other post-harvest treatment product, namely ethoxyquin, used on pears. This will result in the immediate withdrawal of all its national authorisations for products containing that active substance and the elimination of any grace period to dispose of existing stocks, which in turn will exacerbate the adverse effects of the contested decision on the applicant.
18 Regarding the first two factors relied on by the applicant, which it is appropriate to consider together, it should be borne in mind that the particular nature of the procedural situation which was the subject-matter of the United Phosphorus order lay in the fact that United Phosphorus had commenced both the accelerated assessment procedure (16 December 2008) and the procedure for interim measures (9 March 2009) in a timely manner, with the result that the United Phosphorus order, adopted on 28 April 2009, could be delivered before the deadline laid down for the withdrawal of national authorisations for plant protection products containing napropamide, which was 7 May 2009. That order thus effected a genuine suspension of the operation of the measure requiring the Member States to withdraw those national authorisations before 7 May 2009.
19 In paragraph 77 of the United Phosphorus order, the reasons given for the granting of suspension of operation were that the accelerated assessment procedure undertaken by United Phosphorus might be concluded ‘only a few months after … the deadline [imposed] on Member States for the withdrawal of authorisations for plant protection products containing napropamide’, with the result that ‘[i]t would be unreasonable to allow the prohibition of the marketing of a product in respect of which it [was] not improbable that its marketing [would] be authorised only a few months later’.
20 In the present case, by contrast, the accelerated assessment procedure was commenced only on 27 May 2010, that is, six months after the adoption of the contested decision and three months after the first application for interim measures was lodged. The present application for interim measures was lodged only on 11 February 2011, that is, over a year after the adoption of the contested decision. Article 2 of the contested decision, however, required Member States to withdraw national authorisations for plant protection products containing diphenylamine by 30 May 2010, and the applicant specifically indicated that all of those authorisations had in fact been withdrawn by that date. In those circumstances, as the obligation to withdraw authorisations has been fully complied with, there is no point in having the President of the Court order suspension of the operation of the provision requiring Member States to withdraw the national authorisations in question by 30 May 2010.
21 Moreover, after the withdrawal of all national authorisations for the marketing of products containing diphenylamine, even suspension of operation of Article 1 of the contested decision, under which diphenylamine is not to be included in Annex I to Directive 91/414, would not be of any practical use to the applicant. The applicant itself stated that, in such a situation where there are no national authorisations, should the main proceedings culminate in annulment of the contested decision, it will have to obtain fresh national authorisations in order to be able to market its diphenylamine-based products once again, noting that those time-consuming procedures could take up to two years. However, there are no grounds for believing that the new national authorisations would be obtained any faster if operation of Article 1 of the contested decision were suspended.
22 Nor can the lack of national authorisations for the marketing of products containing diphenylamine be remedied by granting the applicant’s request to have the Commission ordered to take the measures necessary to ensure that those national authorisations are reinstated. The applicant has not identified which rules would authorise the Commission not to apply the abovementioned time-consuming procedures and to require Member States to reinstate immediately national authorisations which have long been cancelled, even though the scheme introduced by Directive 91/414 provides for a clear distinction between a European Union-wide authorisation for an active substance liable to be included in plant protection products and national-level authorisations for the various plant protection products containing such a substance.
23 That finding is not contradicted by the United Phosphorus order, which ordered the Commission to take comparable measures in relation to the national authorities in order to guarantee that the suspension of operation granted would be fully effective. It must be remembered that the United Phosphorus order was dated 28 April 2009 and that the deadline fixed for the withdrawal of national authorisations for the plant protection products in question was 7 May 2009. It was thus only as a precautionary measure and only if a Member State had withdrawn such an authorisation prematurely, that is, before 7 May 2009, that the Commission was ordered, in essence, to draw the attention of that Member State to the suspension of operation granted and to convince it of the appropriateness of reinstating that authorisation, without that order to the Commission, in the United Phosphorus order, having any binding effect on the Member State concerned.
24 It should be noted, in relation to the applicant’s once again referring to the imminent expiry of the grace period granted under Article 3 of the contested decision for the disposal of existing stocks of plant protection products containing diphenylamine, that Article 3, in providing that the grace period granted by a Member State ‘shall be as short as possible’, does not allow for a suspension of operation. Since that article also provides that the grace period ‘shall expire on 30 May 2011 at the latest’, account must be taken of the fact that that deadline allows for the disposal of products which are not covered by a national marketing authorisation. Consequently, that deadline must be applied strictly and must not in any event be exceeded, particularly in the circumstances of the present case.
25 It is true that, in his order of 25 November 2010 in Case T‑95/09 R III United Phosphorus v Commission, not published in the ECR, paragraph 14, the President of the Court observed that the marketing of the active substance in question would be reauthorised ‘only eight months after the expiry of the period of grace’. That reference to the grace period must, however, be placed in its context. Unlike the present case, it was intended to illustrate the consequences of granting a second extension of a suspension of operation of a measure in a situation where the Commission was preparing to authorise the substance in question definitively, whilst the initial granting of suspension of operation of the measure had been justified by reference to the only deadline imposed for the withdrawal of authorisations for products containing napropamide (see paragraph 19 above).
26 Furthermore, unlike the situation which gave rise to the United Phosphorus order, the Commission and the applicant in the present case are not in agreement as to the relative imminence of the likely date of completion of the accelerated assessment procedure commenced on 27 May 2010. Whilst the applicant takes the view that that procedure could be completed by November 2011 or before the end of 2011, the Commission believes that it will not be able to adopt a measure before April or June 2012 at the earliest. The Commission states that EFSA has not yet presented its final conclusions on diphenylamine and that, in any event, that presentation, expected at the end of the year or the start of next year, will be merely the beginning of the decision-making procedure for the Commission, which will still have to submit a draft assessment report to the Standing Committee on the Food Chain and Animal Health. In the Commission’s view, it is therefore unrealistic to expect that diphenylamine could be included only a few months after May 2011, as the applicant alleges.
27 It follows from all the foregoing that the fact that the applicant has commenced an accelerated assessment procedure for diphenylamine, the fact that all national marketing authorisations for plant protection products containing diphenylamine have in the meantime been withdrawn and the fact that the grace period for disposing of existing stocks of those products is due to expire imminently do not affect the President of the Court’s findings in the order of 30 April 2010.
28 In those circumstances, nor is the third factor relied on by the applicant pursuant to Article 109 of the Rules of Procedure, namely the imminent decision not to include ethoxyquin, in itself such as to make out the seriousness of the loss alleged. Even if the loss arising from the non-inclusion of ethoxyquin could be taken into consideration in the present context, even though ethoxyquin and diphenylamine are used on different fruits, it is common ground that the combined losses for both active substances would amount to between 1% and 10% of the Xeda group’s total turnover for 2009. Yet those losses remain well below the 10% seriousness threshold applied in the order in Commission v Bruno Farmaceutici and Others (see paragraph 2 above), without its being necessary to examine the potential impact of the Xeda group’s plans to replace ethoxyquin, or even diphenylamine, with a substance made using [confidential]. (1)
29 It follows that the second application for interim measures must also be dismissed on grounds of lack of urgency.
On those grounds,
THE PRESIDENT OF THE GENERAL COURT
1. The application for interim measures is dismissed.
2. Costs are reserved.
Luxembourg, 8 April 2011.