ORDER OF THE PRESIDENT OF THE GENERAL COURT
20 January 2023 (*)
(Interim relief – Food safety – Novel foods – Regulation (EU) 2015/2283 – Marketing authorisation for Alphitobius diaperinus larva – Application for suspension of operation of a measure – No urgency)
In Case T‑500/22 R,
Vleuten Insects vof, established in Hoogeloon (Netherlands),
New Generation Nutrition BV, established in Helvoirt (Netherlands),
represented by N. Carbonnelle, lawyer,
applicants,
v
European Commission, represented by B. Rous Demiri and F. van Schaik, acting as Agents,
defendant,
THE PRESIDENT OF THE GENERAL COURT
makes the following
Order
1 By their application based on Articles 278 and 279 TFEU, the applicants, Vleuten Insects vof and New Generation Nutrition BV, seek suspension of the operation of Commission Implementing Decision C(2022) 3478 final of 2 June 2022 terminating the procedure for authorising the placing on the market of Alphitobius diaperinus larva as a novel food without updating the Union list of novel foods (‘the contested decision’).
Background to the dispute, procedure and forms of order sought by the parties
2 The applicants are agro-food companies incorporated under Netherlands law. The first applicant, Vleuten Insects, rears and commercialises several species of insects, including Alphitobius diaperinus larvae as food intended for human consumption. The second applicant, New Generation Nutrition, produces insect-based animal feed and develops insect-based food products.
3 On 31 December 2018, Vleuten Insects, represented by New Generation Nutrition, submitted an application for marketing authorisation in the European Union for Alphitobius diaperinus larva as a novel food, in accordance with Article 10(1) of Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ 2015 L 327, p. 1). Since Vleuten Insects had lawfully placed Alphitobius diaperinus larva on the EU market before 1 January 2018, it was able to benefit from a transitional measure under Article 35(2) of Regulation 2015/2283 and was therefore able to continue to place that larva on the market until a decision on the application for authorisation to place that larva on the market in the European Union was taken by the Commission in accordance with Articles 10 to 12 of that regulation.
4 On 7 January 2019, after initiating the procedure for reviewing the validity of the application for authorisation, in accordance with the procedure laid down in Article 6 of Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation 2015/2283 (OJ 2017 L 351, p. 64), the Commission sent New Generation Nutrition, as the representative of Vleuten Insects, a request for information explaining that the necessary technical solutions had been provided and that it was possible to make the necessary modifications to the files considered confidential.
5 On 25 February 2021, the Commission sent New Generation Nutrition a second request for information asking it to provide additional information.
6 On 11 March 2021, the applicants replied to the request of 7 January 2019, which they had not been aware of before 25 February 2021, and informed the Commission that they considered the application for authorisation to be complete, that they wished to keep some documents confidential and that the corresponding information was included in the application.
7 On 15 March 2021, the Commission sent the applicants a third request for additional information concerning the administrative and scientific data in question.
8 The applicants did not provide any additional information for the further assessment of the validity of their application.
9 On 2 June 2022, the Commission, taking the view that the application for authorisation did not contain a complete description of the production process or detailed data on the composition of the novel food and, consequently, did not satisfy the requirements laid down in Article 10(2) of Regulation 2015/2283 and Articles 3 and 5 of Implementing Regulation 2017/2469, by the contested decision, terminated the procedure for authorising the placing on the market of Alphitobius diaperinus larva as a novel food without updating the Union list of foods.
10 By application lodged at the Court Registry on 16 August 2022, the applicants brought an action for annulment of the contested decision.
11 By a separate document, lodged at the Court Registry on the same date, the applicants lodged the present application for interim relief, in which they claim that the President of the Court should:
– order that the operation of the contested decision be suspended;
– order the Commission to pay the costs.
12 In its observations on the application for interim relief, which were lodged at the Court Registry on 1 September 2022, the Commission contends that the President of the Court should:
– dismiss the application for suspension of operation;
– reserve the costs.
Law
General considerations
13 It is apparent from reading Articles 278 and 279 TFEU together with Article 256(1) TFEU that the judge hearing an application for interim measures may, if he or she 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, pursuant to Article 156 of the Rules of Procedure of the General Court. 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 the judge hearing an application for interim relief may order the suspension of operation of an act challenged before the Court or prescribe any interim measures (order of 19 July 2016, Belgium v Commission, T‑131/16 R, EU:T:2016:427, paragraph 12).
14 The first sentence of Article 156(4) of the Rules of Procedure provides that applications for interim relief are to ‘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 measure applied for’.
15 The judge hearing an application for interim relief may order suspension of operation of an act and 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 applicant’s interests, it must be made and produce its effects before a decision is reached in the main action. Those conditions are cumulative, and consequently an application for interim measures must be dismissed if any one of them is not satisfied. The judge hearing an application for interim relief is also required to undertake, when necessary, a weighing of the competing interests (see 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).
16 In the context of that overall examination, the judge hearing the application for interim relief 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 (see order of 19 July 2012, Akhras v Council, C‑110/12 P(R), not published, EU:C:2012:507, paragraph 23 and the case-law cited).
17 Having regard to the evidence in the case file, the President of the Court considers that he has all the information needed to rule on the present application for interim relief without there being any need first to hear oral argument from the parties.
18 In the circumstances of the present case, and without it being necessary to rule on the admissibility of the present application for interim relief, it is appropriate to examine first whether the condition relating to urgency is satisfied.
The condition relating to urgency
19 In order to determine whether the interim measures sought are urgent, it should be noted that the purpose of the procedure for interim relief is to guarantee the full effectiveness of the future final decision, in order to avoid a lacuna in the legal protection afforded by the EU Court. To attain that objective, urgency must generally be assessed in the light of the need for an interlocutory order to avoid serious and irreparable damage to the party requesting the interim measure. That party must demonstrate that it cannot await the outcome of the main proceedings without suffering serious and irreparable damage (see order of 14 January 2016, AGC Glass Europe and Others v Commission, C‑517/15 P-R, EU:C:2016:21, paragraph 27 and the case-law cited).
20 It is in the light of those criteria that the examination of whether the applicants have managed to demonstrate urgency is to take place.
21 In the present case, in order to demonstrate the serious and irreparable nature of the damage alleged, in the first place, the applicants claim that the contested decision deprives Vleuten Insects of the possibility of lawfully placing Alphitobius diaperinus larvae on the EU market, even though it had been authorised to market that product on that market for approximately 10 years. That impossibility would lead to a total loss of revenue deriving from the marketing of those larvae for Vleuten Insects and would irretrievably undermine Vleuten Insects’ competitive position in the edible insects emerging market segment.
22 In the second place, the applicants submit that the contested decision has serious adverse effects, not only on their business, but also on other stakeholders in the emerging innovative market for edible insects, in particular on customers of Vleuten Insects.
23 In the third place, the applicants claim that the alleged damage is irreparable, given that the time that has elapsed cannot be given back to Vleuten Insects and that it is impossible to assess potential compensation, considering the emerging nature of the edible insects’ market.
24 The Commission disputes the applicants’ arguments.
25 In the first place, as regards the alleged harm resulting from the total loss of revenue resulting from the commercialisation of Alphitobius diaperinus larvae for Vleuten Insects, it must be borne in mind that, where the harm relied upon is of a financial nature, the interim measures sought are justified where, in the absence of those measures, the applicant would be in a position that would imperil its financial viability before final judgment is given in the main action, or where its market share would be affected substantially in the light, inter alia, of the size and turnover of its undertaking and the characteristics of the group to which it belongs (see order of 12 June 2014, Commission v Rusal Armenal, C‑21/14 P-R, EU:C:2014:1749, paragraph 46 and the case-law cited). Since imminent disappearance from the market does constitute damage that is both irreparable and serious, adoption of the interim measure sought appears justified in such a situation (order of 9 June 2010, Colt Télécommunications France v Commission, T‑79/10 R, not published, EU:T:2010:228, paragraph 37).
26 Furthermore, in accordance with settled case-law, damage of a pecuniary nature cannot, otherwise than in exceptional circumstances, be regarded as irreparable since, as a general rule, pecuniary compensation is capable of restoring the aggrieved person to the situation that obtained before he or she suffered the damage. Any such damage could be recouped by the applicant’s bringing an action for compensation on the basis of Articles 268 and 340 TFEU (see order of 23 April 2015, Commission v Vanbreda Risk Benefits, C‑35/15 P(R), EU:C:2015:275, paragraph 24 and the case-law cited).
27 In order to determine whether the conditions set out in paragraph 25 above are fulfilled, the judge hearing the application for interim relief must, according to well-established case-law, 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 must produce, with supporting documentation, an accurate and comprehensive picture of its financial situation (see order of 10 July 2018, Synergy Hellas v Commission, T‑244/18 R, not published, EU:T:2018:422, paragraph 27 and the case-law cited). Furthermore, the second sentence of Article 156(4) of the Rules of Procedure expressly provides that an application for interim relief is to contain all the evidence and offers of evidence available to justify the grant of the interim measures requested.
28 Furthermore, according to the case-law, the party requesting interim measures may rely only on damage suffered by himself or herself. Urgency is thus a specific question which must be examined separately for each applicant (see order of 27 July 2021, Alliance française de Bruxelles-Europe and Others v Commission, T‑285/21 R, not published, EU:T:2021:495, paragraph 50 and the case-law cited).
29 It is in the light of those considerations that the Court must examine the evidence put forward by the applicants in order to establish that they would suffer serious and irreparable damage of a financial nature if suspension of the operation of the contested decision were not ordered.
30 In the present case, it must be held that the applicants have failed to provide an accurate and comprehensive picture of the personal financial situation of each of them. In their application for interim relief, they merely assert that, in the case of Vleuten Insects, there is a risk of immediate damage due to the fact that it is impossible for it to continue marketing its product, which would lead to a total loss of the income that it would derive from that marketing in the European Union. As regards New Generation Nutrition’s financial situation, the applicants do not indicate the extent to which it would itself suffer financial loss.
31 Consequently, in the absence of specific and precise information, supported by detailed, certified documentary evidence, within the meaning of the case-law referred to in paragraph 27 above, which shows the situation in which each of the parties seeking interim measures finds itself, the judge hearing the application for interim relief is not in a position to assess whether the alleged damage can actually be regarded as serious for each applicant individually.
32 In addition, the applicants claim that the financial damage is irreparable for Vleuten Insects in the particular segment of the relevant market, since the contested decision would irretrievably undermine its competitive position.
33 In that regard, it should be noted that, according to settled case-law, harm of a financial nature may in particular be considered to be irreparable if the harm, even when it occurs, cannot be quantified (see order of 28 November 2013, EMA v InterMune UK and Others, C‑390/13 P(R), EU:C:2013:795, paragraph 49 and the case-law cited).
34 In the present case, however, the applicants do not explain what would prevent them, in the event of annulment of the contested decision, from identifying and quantifying adequately the damage alleged, in order to obtain subsequent financial compensation by means of an action for damages under Articles 268 and 340 TFEU, given that the mere possibility of bringing such an action is sufficient to demonstrate that such harm is in principle reparable (see, to that effect, order of 21 September 2015, Eden Green Vivai Piante di Verdesca Giuseppe and Others v Commission, T‑437/15 R, not published, EU:T:2015:666, paragraph 19 and the case-law cited).
35 In the second place, as regards the harm suffered by other stakeholders in the edible insects market, in particular Vleuten Insects’ customers, it must be pointed out that the serious and irreparable damage alleged by the applicants, which suspension of operation of the contested decision is intended to avoid, can be taken into account by the judge hearing an application for interim relief, in his or her consideration of the criterion of urgency, only in so far as it may be caused to the interests of the party seeking the interim relief.
36 According to settled case-law, the party seeking interim relief may not, in order to establish urgency, invoke infringement of the rights of third parties or of the general interest (see order of 18 May 2022, OG and Others v Commission, T‑101/22 R, not published, EU:T:2022:305, paragraph 30 and the case-law cited).
37 It follows that the damage, if any, which the operation of the contested decision may cause to a party other than the party seeking the interim measures can be taken into consideration by the Court hearing the application for interim relief only when balancing the interests at stake (see, to that effect, order of 13 January 2009, Occhetto and Parliament v Donnici, C‑512/07 P(R) and C‑15/08 P(R), EU:C:2009:3, paragraph 58).
38 Thus, in order to demonstrate that they are likely to suffer serious and irreparable harm themselves, the applicants cannot invoke any harm suffered by other stakeholders in the edible insects market.
39 In the third place, as regards the claim relating to the existence of irreparable harm resulting from the fact that the time elapsed could not be given back to Vleuten Insects and that it would be impossible to assess any compensation due to the emerging nature of the market in question, it must be held that, in so far as any harm that the applicants might suffer would be purely financial in nature, they do not put forward any argument or evidence capable of showing that the emerging nature of the market in question would prevent them, in the event of annulment of the contested decision, from identifying and quantifying adequately, within the meaning of the case-law cited in paragraph 33 above, the financial harm invoked, in order to obtain, as mentioned in paragraph 34 above, subsequent financial compensation by way of an action for damages under Articles 268 and 340 TFEU.
40 It follows from all of the foregoing that the application for interim relief must be dismissed as the applicants have failed to prove that the condition relating to urgency is satisfied, without it being necessary to rule on whether there is a prima facie case or to weigh up the competing interests.
41 Under Article 158(5) of the Rules of Procedure, the costs are to be reserved.
On those grounds,
THE PRESIDENT OF THE GENERAL COURT
hereby orders:
1. The application for interim relief is dismissed.
2. The costs are reserved.
Luxembourg, 20 January 2023.
E. Coulon | | M. van der Woude |