ORDER OF THE VICE-PRESIDENT OF THE COURT OF JUSTICE

16 June 2016 ( )

(Appeal — Order concerning interim measures — Environment — Consumer protection — Regulation setting maximum residue levels for guazatine — Application for suspension of operation of the regulation — Dismissal — No urgency)

In Case C‑170/16 P(R),

APPEAL under the second paragraph of Article 57 of the Statute of the Court of Justice of the European Union, brought on 24 March 2016,

ICA Laboratories Close Corp.,

ICA International Chemicals (Proprietary) Ltd,

ICA Developments (Proprietary) Ltd,

established in Century City (South Africa), represented by K. Van Maldegem, R. Crespi and P. Sellar, lawyers,

appellants,

the other party to the proceedings being:

European Commission, represented by X. Lewis and P. Ondrůšek, acting as Agents, with an address for service in Luxembourg,

defendant at first instance,

THE VICE-PRESIDENT OF THE COURT OF JUSTICE,

after hearing the Advocate General, M. Wathelet,

makes the following

Order

1 By their appeal, ICA Laboratories Close Corp., ICA International Chemicals (Proprietary) Ltd and ICA Developments (Proprietary) Ltd ask the Court to set aside the order of the President of the General Court of the European Union of 29 February 2016 in ICA Laboratories and Others v Commission (T‑732/15 R, not published, ‘the order under appeal’, EU:T:2016:129) dismissing their application for suspension of 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 contested regulation’).

Background to the dispute, the proceedings before the General Court and the order under appeal

2 The present case falls within a legal framework laid down in particular by, first, 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 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 (OJ 2009 L 309, p.1) and, secondly, 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 Directive 91/414 (OJ 2005 L 70, p. 1), a regulation which has been amended several times.

3 Under the system established by Directive 91/414 and by Regulation No 1107/2009, a plant protection product cannot be marketed in a Member State unless: (i) the active substance which it contains has first been evaluated at EU level and included in Annex I to that directive; and (ii) that product has subsequently been evaluated and registered at the level of that Member State.

4 The active substance guazatine is a contact fungicide in which citrus fruit is dipped after harvest or which is sprayed on citrus fruit in the packing line. It controls ‘sour rot’, which is a disease that affects citrus fruit, in particular fruit travelling from South Africa to the European Union.

5 That substance, 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 by the transitional regime under Directive 91/414. Subsequently, by Decision 2008/934/EC of 5 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414 and the withdrawal of authorisations for plant protection products containing these substances (OJ 2008 L 333, p. 11) and Decision 2010/455/EU of 13 August 2010 amending Decisions 2008/934 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 2010 L 216, p. 19), the Commission, in essence, laid down that guazatine was not to be included in Annex I to Directive 91/414, ordered the Member States to withdraw authorisations for plant protection products containing that substance by 31 December 2011 at the latest and set 31 March 2012 as the date of expiry of the 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.

6 As regards the maximum residue levels of pesticides (‘MRLs’), Commission Regulation (EC) No 149/2008 of 29 January 2008 amending Regulation No 396/2005 by establishing Annexes II, III and IV setting maximum residue levels for products covered by Annex I thereto (OJ 2010 L 58, p. 1) set a temporary MRL for guazatine of 5 mg/kg in relation to its use on citrus fruit.

7 Following the non-inclusion of guazatine in Annex I to Directive 91/414, the Commission requested the European Food Safety Authority (EFSA) to carry out a review of the existing MRLs for guazatine, in accordance with Article 12(1) of Regulation No 396/2005.

8 In 2010 EFSA published its conclusion on the peer review of the 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 a lack of adequate information on mammalian toxicology.

9 In May 2013, EFSA issued a reasoned opinion in which it recommended lowering the temporary MRL for guazatine from 5 mg/kg to 0.05 mg/kg in relation to its use on citrus fruit.

10 In the meantime, in November 2012 the appellants 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. Such an application sought, 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 [European Union] for reasons other than public health reasons for the specific product and specific use [or] a different level is appropriate because the existing MRL [within the European Union] was set for reasons other than public health reasons for the specific product and specific use’.

11 In accordance with Article 8 of Regulation No 396/2005, that application for an import tolerance was evaluated by the rapporteur Member State, namely the United Kingdom, which, in its evaluation report, recommended that the MRL be set at 4 mg/kg.

12 In August 2014, after examining the application for a tolerance and the United Kingdom’s evaluation report, EFSA recommended, in a second reasoned opinion, 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.

13 In October 2014, the appellants submitted a request for an administrative review to the Commission, under Article 13 of Regulation No 396/2005, but, by decision of 20 March 2015, the Commission rejected all of the criticisms of EFSA’s second opinion and concluded that there was no reason to ask EFSA to withdraw that opinion.

14 On 21 October 2015, the Commission adopted the contested regulation, by which it set the MRL for guazatine at 0.05 mg/kg in relation to its use on citrus fruit. That regulation applies from 13 May 2016; however, the former MRL is to continue to apply to all products which were lawfully produced before that date, except grapefruit and oranges.

15 On 14 December 2015, the appellants brought an action before the General Court for annulment of the contested regulation. In support of that action, they criticise the Commission, in particular, for having committed manifest errors of assessment since (i) the first and second EFSA opinions on which the contested regulation is based do not support the proposition that setting the MRL for guazatine at 5 mg/kg or 4 mg/kg is not an appropriate measure and (ii) neither of those opinions concludes that there is any risk to the consumer. In addition, in the appellants’ submission EFSA and the Commission infringed the obligation to take into consideration all the available scientific and technical information.

16 On 18 December 2015, the appellants made an application for interim measures seeking suspension of operation of the contested regulation.

17 On 29 February 2016, the President of the General Court made the order under appeal. In the context of his assessment of urgency, after finding that the harm claimed was financial and that the impact of the contested regulation had therefore to be assessed in view of the financial power of the group formed by all the appellants (‘the ICA group’), the President of the General Court, first, held in paragraphs 45 to 47 of the order under appeal that, the appellants having failed to provide information enabling him to have an accurate and comprehensive picture of the financial situation of the ICA group, grant of the interim measures sought could not be justified either as regards the alleged risk to the existence of that group or as regards an alleged significant reduction in market shares. Moreover, the President of the General Court held (i), in paragraphs 48 to 51 of the order under appeal, that, taking account of the loss of turnover put forward, the existence of the ICA group would not be at risk, (ii), in paragraphs 52 to 55 of the order under appeal, that the appellants had not demonstrated that obstacles of a structural or legal nature would prevent them from regaining a significant proportion of the market shares allegedly lost and (iii), in paragraphs 56 to 60 of the order under appeal, that, in any case, the harm allegedly caused by the contested regulation, given the highly regulated nature of the relevant market, resulted in fact from the commercial policy chosen by the appellants.

18 Having therefore held, in paragraph 61 of the order under appeal, that the condition of urgency was not met, the President of the General Court dismissed the appellants’ application for interim measures, without either ruling on the establishment of a prima facie case or weighing up the interests at stake.

Procedure before the Court of Justice and the forms of order sought

19 The appellants claim that the Court should:

– first, order suspension of the operation of the order under appeal and the contested regulation with immediate effect, before the Commission submits its observations and until judgment on the present appeal;

– secondly, set aside the order under appeal and (i) order suspension of the operation of the contested regulation and grant ‘all interim relief measures as necessary’ until the General Court rules on the action for annulment in the main proceedings or (ii), in the alternative, refer the case back to the General Court for it to rule on the application for interim measures;

– order the Commission to pay the costs of the proceedings, including those incurred before the General Court.

20 The Commission contends that the Court should dismiss the appeal and order the appellants to pay the costs.

The application for interim measures

21 By the first head of claim referred to in paragraph 19 of the present order, the appellants seek, on the basis of Articles 278 TFEU and 279 TFEU, suspension of the operation of the order under appeal and the contested regulation until the Court of Justice rules on the present appeal.

22 It should be recalled that, in accordance with Article 160(3) and (4) of the Rules of Procedure of the Court of Justice, such applications must, first, 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 and, secondly, be made by a separate document.

23 It is clear that the appellants’ application not only has not been made by a separate document, but merely states the form of order sought, without any evidence or arguments being presented to support it.

24 That being so, the appellants’ application for interim measures must be declared manifestly inadmissible.

The appeal

25 The appellants rely on seven grounds in support of their appeal.

The fifth ground of appeal, alleging an error in the assessment of the appellants’ responsibility

Arguments of the parties

26 By their fifth ground of appeal, which should be examined first of all, the appellants, referring to paragraphs 50 and 56 to 60 of the order under appeal, complain that the President of the General Court [confidential] and (iii) took the view that the reduction of the MRL for guazatine appeared to be inevitable while ignoring the fact that they had used all the regulatory mechanisms available to them to maintain a higher temporary MRL for guazatine. In addition, the appellants claim that the case-law on which the President of the General Court relies either refers to a factual context not comparable to the present instance or supports the conclusion that they have acted with the diligence required, contrary to what the President of the General Court inferred therefrom. Indeed, while the undertakings at issue in that case-law remained passive and therefore did not show the degree of diligence required, the appellants, by contrast, in particular submitted an import tolerance application.

27 The Commission disputes the appellants’ arguments.

Findings of the Court

28 In ruling on this ground of appeal, it should be recalled that, in paragraph 49 of the order under appeal, the President of the General Court found that the market for plant protection products is a highly regulated market, without that having been challenged by the appellants.

29 The Court of Justice has already held, as regards the human medicinal products market, that in the context of a highly regulated market in which the competent authorities may intervene rapidly when public health risks become apparent, for reasons which cannot always be foreseen, it is for the undertakings concerned, if they are not to bear themselves the loss resulting from such intervention, to protect themselves against its consequences by adopting an appropriate policy (see, to that effect, inter alia, order of the President of the Court of Justice of 11 April 2001 in Commission v Bruno Farmaceutici and Others, C‑474/00 P(R), EU:C:2001:219, paragraphs 108 and 109).

30 In the present instance, the President of the General Court simply inferred from the circumstances of the case that the policy chosen freely by the appellants could not be considered to be appropriate.

31 He in fact stated, in paragraph 57 of the order under appeal, that as from the adoption of Directive 91/414 providing, in 1991, for the assessment of all plant protection products with a view to keeping them on the market or not, the appellants had to have been aware of the possibility that a decision banning guazatine would be adopted and factor that possibility into the risks that an undertaking operating in the plant protection product market must normally bear. Furthermore, the President of the General Court also stated, in paragraph 58 of that order, that (i) in 2008, the marketing of guazatine and of plant protection products containing that substance was prohibited in the European Union, (ii) still in 2008, a purely provisional MRL of 5 mg/kg was set for guazatine as regards its use on citrus fruit, (iii) in 2010, EFSA published its conclusion highlighting a number of data gaps as regards the identity of guazatine and a lack of adequate information on the mammalian toxicology of guazatine and (iv) in 2013, EFSA also published an opinion recommending that the provisional MRL for guazatine should be lowered to 0.05 mg/kg as regards its use on citrus fruit.

32 Thus, it was on the basis of an assessment of the circumstances of the case, the truth of which has indeed not been called into question by the appellants, that the President of the General Court deduced that it was reasonable to expect a reduction of the temporary MRL for guazatine in respect of its use on citrus fruit.

33 [confidential]

34 [confidential]

35 Moreover, even if the means referred to by the President of the General Court for reducing that risk — namely, the formulation and production of active substances other than guazatine and the development of substitute substances — are not practicable, as the appellants assert, that does not in any way call into question the inappropriateness to the circumstances of the case, within the meaning of the case-law of the Court referred to in paragraph 29 of the present order [confidential].

36 Nor is relevance possessed in this instance by the appellants’ argument that, unlike the parties which were involved in the cases giving rise to the judgments referred to by the President of the General Court and were refused the interim measures which they sought because of a lack of diligence deriving from their passivity, such an allegation cannot be made against them in the context of the present case, since they, in particular, made an application for import tolerance. It is sufficient to note in that regard that the President of the General Court found that the appellants lacked diligence not because of their passivity [confidential].

37 Therefore, the President of the General Court did not make an error of law in holding, in paragraph 60 of the order under appeal, that [confidential], they had to bear the alleged harmful consequences which resulted for them from the adoption of the contested regulation.

38 In the light of the foregoing considerations, the fifth ground of appeal must be rejected as unfounded.

The second to fourth and the sixth and seventh grounds of appeal

Arguments of the parties

39 By their second ground of appeal, the appellants submit that, in paragraphs 42 to 44 and 51 of the order under appeal, the President of the General Court made errors of law as regards the assessment of the serious and irreparable nature of the financial harm which they claim to suffer because of the contested regulation. In particular, he was wrong to hold that the impact of that regulation had to be assessed in the light not of the imperilment of the existence of the company ICA Developments (Proprietary) alone, but of the financial power of the ICA group, including its shareholders.

40 By their third and fourth grounds of appeal, the appellants criticise the President of the General Court for having made errors of law in paragraphs 45 and 46 of the order under appeal, due to a failure to carry out an appropriate and complete review of the evidence which they provided concerning the serious and irreparable nature of the harm which they claim to suffer as a result of the contested regulation, as well as a failure to state reasons for rejecting that evidence.

41 By their sixth ground of appeal, the appellants complain that the President of the General Court was wrong to find, in paragraphs 53 and 54 of the order under appeal [confidential].

42 Finally, by their seventh ground of appeal, the appellants submit that, in paragraph 55 of the order under appeal, the President of the General Court, in the context of his assessment of the irreparable nature of the alleged harm, made an error of law in finding that publicity campaigns would enable the negative publicity engendered by the contested regulation to be overcome unless the appellants demonstrated the existence of structural or legal obstacles hindering the effectiveness of such campaigns.

43 The Commission disputes the appellants’ arguments.

Findings of the Court

44 It follows from paragraphs 28 to 38 of the present order that the President of the General Court correctly held that, in the present instance, the appellants must bear the harm allegedly suffered on account of the contested regulation, notwithstanding the possibly serious and irreparable nature of that harm.

45 Consequently, the second to fourth, sixth and seventh grounds of appeal, which concern solely the assessment of the serious and irreparable nature of the harm allegedly suffered by the appellants, are directed against considerations in the contested order which are superfluous, so that, even if those grounds were held to be well founded, that would not lead to the order being set aside.

46 Consequently, these grounds of appeal must be rejected as ineffective.

The first ground of appeal

47 By their first ground of appeal, the appellants criticise the President of the General Court for having distorted the facts submitted to him by finding, as part of the examination of urgency, in paragraph 34 of the order under appeal, that they had deplored ‘the disastrous character of [the contested regulation] for the living conditions of several thousands of South African families and employees’, whereas the procedural document filed by the appellants that is supposed to contain such a statement makes no reference at all to that. At most, the appellants referred, in their application for interim measures, to the extremely serious effects on the citrus fruit growing industry and to the jobs which depend on that sector, solely in respect of the weighing up of interests.

48 The Commission contests this ground of appeal.

49 In this connection, it is sufficient to note that, even if the President of the General Court distorted the content of the procedural document in question, such an error would be without consequences for the operative part of the order under appeal.

50 First, even if it were to be apparent that, in fact, the appellants did not raise the argument that the contested regulation was such as to cause adverse effects on third parties, the fact that the President of the General Court rejected it would manifestly have no impact on the appellants’ position.

51 Secondly, if it were to be apparent that the President of the General Court, in the context of his assessment of urgency, distorted the content of a procedural document in which the appellants put forward a plea in law in support of their assessment of the weighing up of the interests, the ground of appeal alleging such distortion is ineffective, since, in any event, the President of the General Court, as is clear from paragraph 61 of the order under appeal, rejected the application for suspension of operation of the contested regulation because of a lack of urgency, without weighing up the interests at stake.

52 The first ground of appeal must therefore be rejected as ineffective.

53 In the light of all the foregoing considerations, the appeal must be dismissed in its entirety.

Costs

54 Under Article 138(1) of the Rules of Procedure of the Court of Justice, which applies to appeal proceedings 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.

55 Since the Commission has applied for costs and the appellants have been unsuccessful in all their grounds of appeal, they must be ordered to pay the costs incurred in the present appeal proceedings.

On those grounds, the Vice-President of the Court hereby orders:

1. The appeal is dismissed.

2. ICA Laboratories Close Corp., ICA International Chemicals (Proprietary) Ltd and ICA Developments (Proprietary) Ltd shall pay the costs of the appeal proceedings.

[Signatures]