Sygn. akt T-732/15
ORDER OF THE PRESIDENT OF THE GENERAL COURT
February 2016 (*)
(Application for interim measures — Environment — Consumer protection — Regulation fixing maximum residue levels for guazatine — Application for suspension of operation of a measure — No urgency)
In Case T‑732/15 R,
ICA Laboratories Close Corp., established in Century City (South Africa),
ICA International Chemicals (Proprietary) Ltd, established in Century City,
ICA Developments (Proprietary) Ltd, established in Century City,
represented by K. Van Maldegem, R. Crespi, lawyers, and P. Sellar, Solicitor,
applicants,
v
European Commission, represented by X. Lewis and P. Ondrůšek, acting as Agents,
defendant,
APPLICATION for suspension of the operation of Commission Regulation (EU) 2015/1910 of 21 October 2015 amending Annexes III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for guazatine in or on certain products (OJ 2015 L 280, p. 2),
THE PRESIDENT OF THE GENERAL COURT
makes the following
Order
Background to the dispute
The present case falls within a legal framework laid down by, inter alia, Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1) and by Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ 2005 L 70, p. 1), which has been amended several times.
Under the system established by Directive 91/414 and by the subsequent act, namely 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), a plant protection product cannot be marketed in a Member State unless: (i) its active substance has first been evaluated at EU level and has then been included in Annex I to the directive; and (ii) the plant protection product containing that active substance has subsequently been evaluated and registered at the level of that Member State.
In order to make possible a gradual evaluation of all the active substances which were already on the European Union market in 1993, Article 8(2) of Directive 91/414 established a transitional regime during which the Commission was to commence a programme of work for the gradual examination of those substances. The active substance guazatine, which had already been sold on the EU market in 1991, was notified and evaluated in the third stage of the re-examination programme provided for in Directive 91/414. Guazatine is a contact fungicide used on citrus fruit, inter alia, as a bulk dip after harvest or in the packing line as a spray. It controls, in particular, ‘sour rot’, which is a disease that affects such fruit, in particular fruit travelling from South Africa to the European Union.
By decision of 5 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances (OJ 2008 L 333, p. 11), the Commission stated that guazatine should not be included in Annex I to Directive 91/414 and ordered the Member States to withdraw authorisations for plant protection products containing that substance by 31 December 2010 at the latest. The Commission stated that any period of grace granted by Member States for the disposal, storage, placing on the market and use of existing stocks of plant protection products containing guazatine was to expire on 31 December 2011. However, guazatine was not included in that annex, not because that substance had harmful effects, but because the notifier company had voluntarily withdrawn its support for the inclusion of that substance in that annex. Subsequently, a new notification was submitted for guazatine and, by its decision of 13 August 2010 amending Decisions 2008/934/EC and 2008/941/EC as regards the date until which authorisations may continue to be in force and the period of grace, in cases where the notifier has submitted an application in accordance with the accelerated procedure under Regulation (EC) No 33/2008 (OJ 2008 L 216, p. 19), the Commission, while maintaining the non-inclusion of that substance on the annex in question, extended until 31 December 2011 the period for Member States to withdraw those authorisations and extended until 31 December 2012 the abovementioned period of grace.
As regards the maximum residue levels of pesticides (‘MRLs’), Commission Regulation (EC) No 149/2008 of 29 January 2008 amending Regulation (EC) No 396/2005 of the European Parliament and of the Council by establishing Annexes II, III and IV setting maximum residue levels for products covered by Annex I thereto (OJ 2008 L 58, p. 1) set a temporary MRL for guazatine of 5 mg/kg in relation to its use on citrus fruit.
Following the non-inclusion of guazatine in Annex I to Directive 91/414, the Commission contacted the European Food Safety Authority (EFSA), the principal mission of which is to provide scientific advice and scientific and technical support for the European Union’s legislation and policies in all fields which have a direct or indirect impact on food and feed safety, and asked it to carry out a review of the existing MRLs for guazatine, in accordance with Article 12(1) of Regulation No 396/2005. In response to the Commission’s request, in 2010 EFSA published its ‘Conclusion on the peer review of the pesticide risk assessment of the active substance guazatine’, in which it highlighted a number of data gaps as regards the identity of the active substance and also a lack of adequate information on mammalian toxicology.
Also on the basis of Article 12(1) of Regulation No 396/2005, EFSA delivered a reasoned opinion (‘the first opinion’), in May 2013, in which it recommended the lowering of the temporary MRL for guazatine from 5 mg/kg to 0.05 mg/kg in relation to its use on citrus fruit.
In November 2012, while EFSA was drafting its first opinion, the applicants ICA Laboratories Close Corp., ICA International Chemicals (Proprietary) Ltd and ICA Developments (Proprietary) Ltd, submitted an application for an import tolerance under Article 6(2) and (4) of Regulation No 396/2005 concerning the use of guazatine on citrus fruit. The aim of such an application is, as can be seen from Article 3(g) of that regulation, the setting of an MRL for ‘imported products to meet the needs of international trade where [either] the use of the active substance in a plant protection product on a given product is not authorised in the Community for reasons other than public health reasons for the specific product and specific use [or] a different level is appropriate because the existing Community MRL was set for reasons other than public health reasons for the specific product and specific use’.
In accordance with Article 8 of Regulation No 396/2005, the application for import tolerance referred to in paragraph 8 above was evaluated by the rapporteur Member State, namely the United Kingdom, which, in its evaluation report sent to the Commission, recommended that the MRL be set at 4 mg/kg. EFSA examined the application and the evaluation report. In August 2014, it issued a reasoned opinion (‘the second opinion’) in which it recommended that the proposal of the rapporteur Member State should not be followed, but rather that the MRL should be set at 0.05 mg/kg, on the ground that the available data were not sufficient to exclude all risk for European consumers. It forwarded that opinion to the Commission and the Member States and made it available to the public.
In October 2014, the applicants sent a request to the Commission for an administrate review under Article 13 of Regulation No 396/2005. By decision of 20 March 2015, the Commission rejected all of the applicants’ criticisms of EFSA’s second opinion and concluded that there was no reason to ask EFSA to withdraw that opinion.
On 21 October 2015, the Commission adopted Regulation (EU) 2015/1910 amending Annexes III and V to Regulation No 396/2005 as regards maximum residue levels for guazatine in or on certain products (OJ 2015 L 280, p. 2, ‘the contested regulation’), in which it, inter alia, set the MRL for guazatine at 0.05 mg/kg in relation to its use on citrus fruit. The contested regulation is to apply from 13 May 2016. However, the former MRL is to continue to apply to all products which were lawfully produced before that date, except as regards grapefruit and oranges.
Procedure and forms of order sought
By application lodged at the Registry of the General Court on 14 December 2015, the applicants brought an action seeking the partial annulment of the contested regulation. In support of that action, they submit, inter alia, that the Commission committed manifest errors of assessment, since the first and second EFSA opinions on which the contested regulation is based do not support the proposition that 5 mg/kg or 4 mg/kg is not an appropriate MRL and neither of those opinions concluded that there is any risk for the consumer. Moreover, it is claimed, EFSA and the Commission infringed the obligation to take into consideration all of the available scientific and technical information.
By separate document, lodged at the Court Registry on 18 December 2015 and supplemented by an addendum of 13 January 2016, the applicants brought the present application for interim measures, in which they submit, in essence, that the President of the General Court should:
– suspend the operation of the contested regulation, under Article 157(2) of the Rules of Procedure of the General Court, until the Court has ruled on that application or, in any event, on the main action;
– order the Commission to pay the costs.
In its observations on the application for interim measures, lodged at the Court Registry on 12 January 2016, the Commission contended that the President of the General Court should dismiss that application and reserve the costs until judgment in the main proceedings. It submits that the main action, on which the application for interim relief depends, must be declared inadmissible, since the contested regulation is not of direct concern to the applicants within the meaning of the fourth paragraph of Article 263 TFEU.
The applicants responded to the Commission’s observations by pleading of 19 January 2016. The Commission adopted a final position on that pleading in a pleading of 27 January 2016.
Law
General considerations
In accordance with Article 278 TFEU and Article 279 TFEU, read in conjunction with Article 256(1) TFEU, the judge hearing an application for interim measures may, if he considers that the circumstances so require, order that the operation of a measure challenged before the General Court be suspended or prescribe any necessary interim measures. 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 in exceptional cases that the judge hearing an application for interim measures may order the suspension of operation of a measure challenged before the General Court or prescribe interim measures (see order of 11 November 2013 in CSF v Commission, T‑337/13 R, EU:T:2013:599, paragraph 21 and the case-law cited).
Furthermore, Article 156(3) 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 the interim measures applied for. Accordingly, the judge hearing an application for interim measures may order the 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 harm to the interests of the party seeking those measures, it must be made and produce its effects before a decision is reached in the main action. Those conditions are cumulative, with the result that an application for interim measures must be dismissed if any one of them is absent (see order in CSF v Commission, cited in paragraph 16 above, EU:T:2013:599, paragraph 22 and the case-law cited).
In the context of that overall examination, the judge hearing the application for interim measures enjoys a broad 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. Where appropriate, the judge hearing such an application must also weigh up the interests involved (see order in CSF v Commission, cited in paragraph 16 above, EU:T:2013:599, paragraph 23 and the case-law cited).
Having regard to the documents in the case file, the President of the General Court considers that he has all the information needed to rule on the present application for interim measures without there being any need first to hear oral argument from the parties.
In the circumstances of the present case, it is appropriate to examine first whether the condition relating to urgency is satisfied.
Urgency
In the application for interim measures, the applicants argue that they will suffer serious and irreparable harm if the operation of the contested regulation is not suspended pending judgment on the main action. They submit that they form part of a group composed of four companies, each of which is owned and directed by Mr A. Only the second applicant is directed jointly with another natural person, namely Mr S. There are no external shareholders and the group has no other source of potential funding. The fourth company, ICA Properties Limited, is not directly involved in the purchase or sale of guazatine products and therefore is not involved in the present proceedings.
According to the applicants, the first applicant acts as a holding company, primarily dealing with the overall financing and management of the other companies, and also directing the research and development of new products. The second applicant primarily deals with the marketing, distribution and registration of guazatine products and field customer technical aspects. The third applicant manufactures and formulates products based on guazatine and other active substances, while overseeing all engineering, laboratory and chemistry aspects. It operates from a factory in which it formulates its plant protection products.
As regards guazatine in particular, the applicants submit that that active substance is produced only by company A, further to a specific request by the first applicant. [Confidential]. (1) Orders of guazatine from company A are generally placed by the third applicant, which has also generally been the declared importer of the guazatine ordered when it arrives in South Africa, and has therefore normally borne the related costs. Once imported, the third applicant formulates the guazatine into plant protection products which it then sells on to the first applicant, which makes a second internal sale of the same products to the second applicant. The second applicant makes a final sale, outside the group, to customers in South Africa, Uruguay, Morocco, Argentina, Australia and Turkey. [Confidential]. Lastly, the South African distributors of citrus fruit ship the fruit to Europe and to other destinations around the world, since they cannot fly it. The citrus fruit concerned is premium fruit, commanding relatively high prices.
As regards the imminent serious and irreparable harm that the contested regulation is liable to cause them, the applicants submit that the third applicant will enter liquidation unless the operation of that regulation is suspended. The third applicant’s very existence is threatened. Its turnover and profits are dependent on the internal sales of guazatine products to the first applicant. The first applicant is in turn dependent on the sales it makes to the second applicant. The second applicant can only pay the first applicant if it, itself, has external customers. Any loss of the second applicant’s customers will therefore have a domino effect back up through the internal sales chain between the applicants. Such a loss would inevitably have serious repercussions for the viability of the third applicant.
According to the applicants, the setting of a new MRL in the European Union for guazatine will have the effect of eliminating all sales of guazatine products by the second applicant to its South African customers. For South African fruit destined for the EU market, any application of the second applicant’s guazatine products will inevitably mean that residues of guazatine on that fruit will exceed the 0.05 mg/kg limit. South African customers whose fruit is destined for the EU market will now have to stop applying guazatine products that they purchase from the second applicant. The second applicant will therefore stop making internal purchases from the first applicant because of the absence of that customer demand, while the first applicant will stop making internal purchases from the third applicant.
The applicants argue that, in theory, the sales of guazatine products could continue for South African citrus fruit destined for non-EU markets where the MRLs are sufficiently high (such as in Russia, which has an MRL of 5 mg/kg). In practice, however, those sales will cease. The reason for that is that all exported citrus fruit, regardless of its ultimate destination, is collected, sorted, sprayed, bulk-dunked, and packed in packing houses, which currently do not distinguish between export destinations until these processes have been completed. As a result, citrus fruit destined for Russia will be physically treated alongside citrus fruit destined for the European Union, which gives rise to the risk of cross-contamination of different substance residues from one fruit to another, since packing houses in South Africa do not have a system in place to prevent the contamination of other fruit destined for the EU market with guazatine residues. In any event, economically speaking, it is not a viable option for packing houses to incur the significant costs of quarantining their packing lines in such a way as to exclude guazatine cross-contamination.
The second applicant therefore expects that the new MRL in the European Union will have the effect of eliminating demand for its products from its South African customers, [confidential]. Moreover, that new MRL will also mean that the second applicant’s non-South African citrus fruit customers will cease purchasing guazatine products. Thus, its distributors in Argentina, Morocco and Turkey have already cancelled all of their orders. Only the second applicant’s Australian distributor, which has a very small onward market in Asia, [confidential].
The applicants add that, in its current portfolio, the second applicant has no alternative product to sell to customers to replace the lost guazatine product sales. It is true that one of the non-guazatine products that the third applicant formulates is based on propiconazole, a generic substance which acts against sour rot. However, it is not as effective as guazatine. In particular, unlike guazatine, propiconazole cannot protect against sour rot which develops over a 3-5 week period, that is to say, the time it takes for citrus fruit to be shipped to the European Union. In any event, the profit margin on sales of propiconazole products is small since that substance is sold by numerous companies, whereas sales of guazatine products are disproportionately profitable because the first applicant enjoys a de facto monopoly over guazatine products as a result of its contract with Company A. The second applicant is therefore able to command a high price.
The third applicant bears the main costs incurred by the applicants in the production of guazatine-based plant protection products. Its operating costs include the fixed costs related to the running and upkeep of plant and machinery, the payment of employees and the purchase of the raw materials from company A. Those costs will continue to be incurred even if demand for the guazatine products that the third applicant formulates disappears. Faced with the loss of sales of guazatine products, the third applicant cannot continue to bear those costs. It is not a sustainable business.
In addition, [confidential]. It is for that reason that the first applicant recently had to place an order for [confidential] in its name and not in that of the third applicant because of concerns about the third applicant’s viability. The value of that order amounts to approximately [confidential]. Over the next two years, similar orders will have to be made, at a purchase cost of approximately [confidential]. The purchases represent a risk, since, as a result of the loss of guazatine products, the third applicant can pay neither its operating costs nor the amounts due to company A.
The applicants submit that their ownership structure is such that there is no ‘deep pocket’ shareholder. Noting that they are owned by Mr A. and, in minor part, by Mr S., the applicants emphasise — referring to a sworn statement of Mr A. — that neither has personal wealth sufficient to tide the applicants over until final judgment in the main proceedings is given. Nor, according to the applicants, can there be a reasonable expectation that money will be lent to them by a financial institution, given that their ability to reimburse such a loan would depend on the unpredictable outcome of litigation.
The applicants further submit that, while the third applicant is not expected to survive the loss of guazatine product sales, the first and second applicants will continue to sell products which do not contain guazatine, albeit without the benefit of the third applicant’s formulations and with the probability of a reduced staff. In any event, each of the applicants will irrevocably lose its customers and its market shares. In addition, by the time the main proceedings are concluded, the only company currently producing guazatine will have ceased to produce it, with the result that the applicants will not simply be able to start repurchasing in order to relaunch their sales. This is more than a probable eventuality given the [confidential], combined with a loss of downstream customer demand for guazatine products. It cannot reasonably be expected that company A will restart production after having decided to cease it. It can also be reasonably expected that the second applicant’s customers in South Africa and outside South Africa will necessarily have moved on to an alternative solution. Even if company A could be persuaded to restart production, the applicants will have to overcome the negative publicity engendered by the contested regulation.
In response to that line of argument put forward in the application for interim measures, the Commission submits that the applicants have failed to produce any convincing and probative evidence to the effect that their economic position on the market will be affected both imminently and disastrously by the contested regulation. In particular, the applicants have failed to provide any clear and precise details of their financial situation, or to demonstrate that the loss of trade in their products containing guazatine allegedly caused by the contested regulation will result in their definitive disappearance from the market.
In that respect, first of all, it must be noted that the contested regulation, the full suspension of operation of which is sought in the application for interim measures, sets the MRLs of guazatine for a range of goods, such as fruits, vegetables, cereals, teas, spices and products of animal origin, whereas the applicants merely rely on the urgency of that suspension of operation in respect of citrus fruit alone. In addition, the applicants’ line of argument invoking the negative effects of the contested regulation on South African exports of citrus fruit and referring, inter alia in their pleading of 13 January 2016, to the disastrous character of that regulation for the living conditions of several thousands of South African families and employees, cannot be accepted in the present context. By that line of argument, the applicants do not invoke harm to their personal interests, whereas the question of urgency must be demonstrated individually (see, to that effect, order of 17 December 2015 in Lysoform Dr. Hans Rosemann and Others v ECHA, T‑543/15 R, EU:T:2015:1008, paragraph 36 and the case-law cited).
Next, it must be recalled that, according to settled case-law, the urgency of an application for interim measures must be assessed in relation to the necessity for an interim order to prevent serious and irreparable damage to the party applying for those measures. It is for that party to adduce solid evidence that it cannot wait for the outcome of the main proceedings without having to suffer harm of that kind. Although it is not necessary for the imminence of the harm to be demonstrated with absolute certainty, its occurrence must nevertheless be foreseeable with a sufficient degree of probability (see orders in CSF v Commission, cited in paragraph 16 above, EU:T:2013:599, paragraph 31 and the case-law cited, and of 27 November 2014 in SEA v Commission, T‑674/14 R, EU:T:2014:1009, paragraph 54 and the case-law cited).
In the present case, as they expressly confirmed in their pleading of 19 January 2016, the applicants invoke two categories of serious and irreparable harm: first, the third applicant is in a position that could imperil its existence before judgment is given in the main action and, secondly, all three are liable to suffer serious and irreparable financial harm as a result of the loss of market shares, customers and their exclusive supplier.
It thus appears that the harm invoked is financial (see, to that effect, order of 30 April 2010 in Xeda International and Pace International v Commission, T‑71/10 R, EU:T:2010:173, paragraph 41 and the case-law cited).
It follows from well-established case-law that damage of a purely financial nature is normally not irreparable, since financial compensation for that damage can be obtained subsequently, unless it appears that the party seeking the interim measures would find itself, without those measures, in a position that could imperil its very existence before final judgment in the main proceedings is given or that its market share would be substantially affected, having regard to, inter alia, the size and turnover of its business and the characteristics of the group to which it belongs, directly or indirectly, through its shareholders (see, to that effect, orders of 7 March 2013 in EDF v Commission, C‑551/12 P(R), ECR, EU:C:2013:157, paragraph 54; of 19 December 2013 in Lito Maieftiko Gynaikologiko kai Cheirourgiko Kentro v Commission, C‑506/13 P-R, EU:C:2013:882, paragraph 20, and of 7 December 2015 in POA v Commission, T‑584/15 R, EU:T:2015:946, paragraph 25 and the case-law cited).
It is also settled case-law that, in order to determine whether all the conditions referred to in paragraphs 35 and 38 above are fulfilled, the judge hearing the application for interim measures must have specific and precise information, supported by detailed, certified documentary evidence, which shows the situation in which the party seeking the interim measures finds itself and enables the probable consequences, should the measures sought not be granted, to be assessed. It follows that that party, in particular when it relies on the occurrence of financial damage, must produce, with supporting documentation, an accurate overall picture of its financial situation (see, to that effect, order in POA v Commission, cited in paragraph 38 above, EU:T:2015:946, paragraph 23 and the case-law cited).
In addition, the essential elements of fact and law enabling the judge hearing the application for the interim measures to establish such a picture must be set out in the text of the application for interim measures itself, since that text must be sufficient in itself to enable the defendant to prepare his observations and the judge hearing the application to rule on it, where necessary, without other supporting information. In view of the need for expeditiousness which characterises, by their very nature, proceedings for interim measures, it may reasonably be required of the party seeking interim measures, save in exceptional cases, to present, from the moment of lodging its application, all the available evidence supporting that application, so that the judge hearing the application may assess its merits on that basis (see order of 20 April 2012 in Fapricela v Commission, C‑507/11 P(R), EU:C:2012:231, paragraphs 52 to 54 and the case-law cited).
In the present case, in the application for interim measures, the applicants provide information (i) on their membership of a group of companies (‘the ICA group’) and the shareholder structure of that group and (ii) on the detailed economic relations between the members of the ICA group which will give rise to dramatic financial consequences for each of them if the interim measures sought are not granted, including the imminent threat that the third applicant will be placed in liquidation.
However, in view of the case-law cited in paragraphs 35 and 38 above, there is no need to examine the impact of the contested regulation by carrying out a separate and isolated analysis of the financial situation of each applicant company. That impact must, rather, be assessed in view of the financial power of the whole ICA group, that is to say in view of the total worldwide turnover of that group and of the financial resources, not only of the legal persons forming part of the group, but also of the natural persons who are shareholders of that company (see, to that effect, orders of 14 March 2008 in Du Pont de Nemours (France) and Others v Commission, T‑467/07 R, EU:T:2008:78, paragraph 99; of 18 June 2008 in DowAgroSciences and Others v Commission, T‑475/07 R, EU:T:2008:214, paragraphs 86 and 87, and of 10 June 2014 in Stahlwerk Bous v Commission, T‑172/14 R, EU:T:2014:558, paragraphs 20 and 33).
In addition, in their pleading of 19 January 2016, the applicants themselves confirmed that it was necessary to adopt such an overall approach, stating that the second and third applicants essentially operate as departments of the first applicant. Thus, according to the applicants, the fact that they were set up as separate entities should not detract from the fact that they are effectively one and the same entity.
It follows that not only the applicants’ roles in the ICA Group but also the financial capacities of that group as a whole constitute essential elements for the assessment of the urgency of the present application for interim measures.
It must be noted that the application for interim measures does not contain any information on the total worldwide turnover of the ICA group or any figures relating to the financial situation of Mr A and Mr S, the two shareholders of the group. The mere assertion that neither of the two shareholders has sufficient personal funds and that no bank would be willing to support the applicants cannot be regarded as a sufficient explanation of their financial situation, particularly since that assertion is based only on the sworn statement of Mr A, whereas, according to settled case-law, information intended to establish the financial situation of the party seeking an interim measure must, in principle, be supported by detailed documents, certified by an expert independent of the party seeking the interim measures, on the basis of which it is possible for the judge hearing an application for interim measures to assess the accuracy of that information (see, to that effect, order of 8 May 2012 in Investigación y Desarrollo en Soluciones y Servicios IT v Commission, T‑134/12 R, EU:T:2012:225, paragraph 16 and the case-law cited).
It was only in response to the Commission’s observations that the applicants mentioned, in their pleading of 19 January 2016, a [confidential], without, however, submitting any certified accounting documents in order to prove the accuracy of that assertion. In that respect, the auditor’s declaration (attached as an annex) setting out, over two pages, a summary account of the ICA group’s situation cannot be regarded as sufficient evidence. In any event, even the pleading of 19 January 2016 does not contain any figures relating to the specific financial situation of the shareholders A. and S.
Consequently, the applicants have not provided an accurate and comprehensive picture of the ICA group’s financial situation capable of justifying the grant of the interim measure sought, either as regards the alleged risk to the existence of that group or as regards the alleged significant change to its market shares. Taking into consideration the fact that the grant of interim measures is strictly exceptional (see paragraph 16 above), and in view of the objections on the part of the Commission, the interim measure applied for cannot be granted by the judge dealing with the application solely on the basis of the applicant’s unsupported statements (see, to that effect, order of 2 March 2011 in 1. garantovaná v Commission, T‑392/09 R, EU:T:2011:63, paragraph 47).
Moreover, even if the [confidential] could be regarded as being established, the judge hearing the application for interim measures would not be able to accept the urgency of the interim measure sought.
The sale of guazatine, the subject-matter of the present proceedings, takes place in a highly-regulated market, that of plant protection products. The authorisation system laid down provides that such a product may be marketed in a Member State only if, first, its active substance has been evaluated at EU level on the basis of the criteria set out in Directive 91/414 and has then been included in Annex I to that directive and, secondly, the plant protection product containing that active substance has subsequently been registered at national level (order in Xeda International and Pace International v Commission, cited in paragraph 37 above, EU:T:2010:173, paragraph 54). In particular, Regulation No 396/2005, concerning the fixing of MRLs in active substances such as guazatine, has been amended 75 times since its adoption.
With regard to undertakings active on another market which is also highly regulated, namely the human medicinal products market, the President of the Court of Justice rejected an application for interim measures based on a loss representing nearly two thirds of the turnover of the undertaking seeking the interim measures. While acknowledging that the financial difficulties caused to that undertaking could threaten its very existence, he nevertheless emphasised that, in a highly regulated sector where major investment is often required and the competent authorities may be led to intervene rapidly when public health risks become apparent, for reasons which cannot always be foreseen by the undertakings concerned, it is for those undertakings, if they are not themselves to bear the loss resulting from such intervention, to protect themselves against its consequences by adopting an appropriate policy (see, to that effect, order of 11 April 2001 in Commission v Bruno Farmaceutici and Others, C‑474/00 P(R), ECR, EU:C:2001:219, paragraphs 107 to 109).
That reasoning also applies to the situation of the applicants, which face a [confidential]. Furthermore, in asserting that the first and second applicants, in the event that the application for interim measures is rejected, will continue to sell non-guazatine products, the applicants themselves appear rather to believe that the ICA group could indeed survive the harm caused by the contested regulation.
It must be added that the applicants’ line of argument concerning the loss of their market share also cannot be accepted, since they have not demonstrated that obstacles of a structural or legal nature would prevent them from regaining a significant proportion of the market shares allegedly lost (see to that effect, order of 24 March 2009 in Cheminova and Others v Commission, C‑60/08 P(R), EU:C:2009:181, paragraph 64 and the case-law cited).
Although the applicants refer to a letter from company A according to which that company [confidential], it must be noted that that letter, which is attached to the sworn statement of Mr A, dates from 30 November 2015, namely two weeks before the main proceedings were initiated, and is addressed ‘To whom this may concern’. It therefore appears that that letter was not drafted within the context of normal business correspondence but was sought for the purposes of the present proceedings. In any event, in their pleading of 19 January 2016, the applicants envisage the potential ‘production of guazatine by another third party or by the applicants themselves’ with the necessary cooperation of company A. Thus, the applicants do not exclude the possibility of using that substance again, in the event that the contested regulation is annulled at the conclusion of the main proceedings. In any case, they have not explained what economic or technical reasons would prevent company A from [confidential] or to cooperate with the applicants or with another undertaking in the production of that substance.
For that reason, it must be found that the applicants have not established, to the requisite legal standard, that they risk losing irrevocably their exclusive supplier.
The applicants also submit that, even if it were possible to persuade company A to restart production of guazatine, they would not be able to mount an expensive publicity campaign in order to overcome the negative publicity engendered by the contested regulation and to combat negative perceptions. However, even if, as the applicants submit, a publicity campaign aimed at the circles concerned might be financially onerous, that line of argument is not sufficient to demonstrate, to the requisite legal standard, the existence of a structural or legal obstacle such as to prevent the applicants from regaining a significant portion of the market shares allegedly lost (see, to that effect, order in Dow AgroSciences and Others v Commission, cited in paragraph 42 above, EU:T:2008:214, paragraphs 100 and 101).
Lastly, it is necessary to recall the settled case-law that the serious and irreparable harm alleged by the party seeking interim relief must result from effects produced by the contested measure alone and not from a lack of diligence on the part of that party. According to that case-law, if it has not demonstrated the full level of diligence that ought to be demonstrated by a prudent and well-informed undertaking, the party seeking interim relief must bear even harm which it claims is liable to jeopardise its existence or to alter irrevocably its position on the market (see order in CSF v Commission, cited in paragraph 16 above, EU:T:2013:599, paragraph 32 and the case-law cited).
In the present case, it is common ground that, as from the time at which Directive 91/414 was adopted in 1991 providing for the assessment of all plant protection products with a view to keeping them on the market or not, the applicants must have been aware of the possibility that a decision banning guazatine might be adopted and factor that possibility into the risks that an undertaking operating in the plant protection product market must normally bear. Moreover, no economic operator can claim a right to property in a market share, even if he held it at a time before the introduction of a measure affecting the market, since such a market share constitutes only a momentary economic position exposed to the risks of changing circumstances (see, to that effect, order in Xeda International and Pace International v Commission, cited in paragraph 37 above, EU:T:2010:173, paragraph 58 and the case-law cited).
It must be added that, in 2008, first, the marketing of guazatine and of plant protection products containing that substance was prohibited and, secondly, a purely provisional MRL of 5 mg/kg was set for guazatine as regards its use on citrus fruit (see paragraphs 4 and 5 above). In addition, EFSA published, in 2010, its conclusion highlighting a number of data gaps as regards the identity of guazatine and a lack of adequate information on mammalian toxicology and, in 2013, an opinion recommending that the provisional MRL for guazatine should be lowered to 0.05 mg/kg as regards its use on citrus fruit (see paragraphs 6 and 7 above).
In those circumstances, the applicants had every interest in diversifying their production, [confidential]. Thus, had they acted as a prudent and well-informed undertaking, the applicants would have increased, as soon as possible, the formulation and production of the active substances other than guazatine which, according to them, they already had in their portfolio. By acting as a prudent and well-informed undertaking, the applicants would also have concentrated, in a timely manner, on the development of substitute substances in order to avoid a situation in which their customers, during the period of non-availability of guazatine, would find an ‘alternative solution’, as mentioned in paragraph 41 of the application for interim relief.
[Confidential].
It follows from all of the foregoing that the application for interim measures must be rejected because of a lack of urgency, and it is not necessary to examine the condition relating to the establishment of a prima facie case or to weigh up the interests at stake. In those circumstances, it is also not necessary to rule on the issue raised by the Commission concerning the admissibility of the main action.
On those grounds,
hereby orders:
1. The application for interim measures is dismissed.
2. The costs are reserved.
Luxembourg, 29 February 2016.
E. Coulon
M. Jaeger
Registrar
President
* Language of the case: English.
Confidential information omitted.
