ORDER OF THE PRESIDENT OF THE GENERAL COURT
22 July 2021 (*)
(Interim measures – Regulation (EC) No 1925/2006 – Substances prohibited, restricted or under Community scrutiny – Regulation (EU) 2021/468 – Prohibition of preparations from the leaf of Aloe species containing hydroxyanthracene derivatives – Application for suspension of operation of a measure – No urgency)
In Case T‑189/21 R,
Aloe Vera of Europe BV, established in Amsterdam (Netherlands), represented by B. Van Vooren, lawyer,
applicant,
v
European Commission, represented by W. Farrell and B. Rous Demiri, acting as Agents,
defendant,
APPLICATION under Articles 278 and 279 TFEU for suspension of operation of Commission Regulation (EU) 2021/468 of 18 March 2021 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards botanical species containing hydroxyanthracene derivatives (OJ 2021 L 96, p. 6), for a period of nine months from the date of the present order,
THE PRESIDENT OF THE GENERAL COURT
makes the following
Order
Background to the dispute
1        The applicant, Aloe Vera of Europe BV, is a company incorporated under Netherlands law which is part of a group controlled by Aloe Vera of America, Inc. The applicant is a manufacturer of Aloe vera inner leaf gel containing residual hydroxyanthracene derivatives (‘HADs’).
2        Plants containing HADs are numerous and belong to different families and genera. They are widely used in food supplements and herbal medicinal products for their laxative effect.
3        On 9 October 2013, the European Food Safety Authority (EFSA) issued a scientific opinion on the scientific substantiation of a health claim related to HADs and improvement of bowel function. According to that opinion, HADs in food can improve bowel function, but long-term use and consumption at high doses are not advised due to potential safety concerns such as the danger of electrolyte imbalance, impaired function of the intestine and dependence on laxatives.
4        In 2016, in view of that opinion and of the concerns raised by Member States about the possible harmful effects associated with the consumption of food containing HADs and preparations thereof, the European Commission asked EFSA to deliver a scientific opinion on the evaluation of safety in use of HADs in food in accordance with Article 8 of Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (OJ 2006 L 404, p. 26).
5        On 22 November 2017, EFSA adopted a scientific opinion on the evaluation of the safety of HADs for use in food. In that scientific opinion, which was published on 23 January 2018, EFSA found, inter alia, that HADs, namely aloe-emodin, emodin and the structurally related substance danthron, have shown to be genotoxic in vitro. Aloe extracts have also shown to be genotoxic in vitro, most likely due to the presence of HADs in the extracts. Furthermore, aloe-emodin was shown to be genotoxic in vivo. The whole leaf Aloe extract and structural analogue danthron were shown to be carcinogenic.
6        Having regard to the severe harmful effects on health associated with the use of those substances in food and the fact that no daily intake that did not give rise to concerns as to possible harmful effects for human health could be set, the Commission considered that those substances should be prohibited.
7        To that end, in 2018, the Commission began discussions within the group of experts on food supplements and fortified foods. In its draft regulation submitted to that group of experts, the Commission provided for a prohibition of the use of the Aloe leaf in food supplements for laxative purposes, in accordance with Article 8(2)(a)(i) of and Annex III, Part A, to Regulation No 1925/2006.
8        On 25 February 2020, the Member of the Commission with responsibility for the relevant sector, in a letter sent to five Members of the European Parliament, stated that any risk management measure to be taken by the Commission in that regard would cover only products to which HADs or HAD-containing extracts had been intentionally added.
9        On 4 March 2020, the draft regulation became subject to a seven-week public consultation until 23 April 2020 to give all interested parties the possibility of providing feedback.
10      On 22 April 2020, the applicant and its sister companies in the European Union submitted their observations.
11      On 5 November 2020, the ‘General Food Law’ section of the Standing Committee on Plants, Animals, Food and Feed was consulted by written procedure in order to deliver an opinion on the draft regulation.
12      On 12 November 2020, the Standing Committee on Plants, Animals, Food and Feed delivered a favourable opinion.
13      Following the favourable opinion from the Standing Committee on Plants, Animals, Food and Feed, the proposed regulation was scrutinised by the Parliament and the Council of the European Union.
14      On 18 March 2021, the Commission adopted Regulation (EU) 2021/468 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards botanical species containing hydroxyanthracene derivatives (OJ 2021 L 96, p. 6) (‘the contested regulation’), which added aloe-emodin, emodin, danthron and preparations from the leaf of Aloe species containing HADs to Annex III, Part A, to Regulation No 1925/2006.
Procedure and forms of order sought
15      By application lodged at the Court Registry on 10 April 2021, the applicant brought an action for annulment of the contested regulation.
16      By a separate document lodged at the Court Registry on 11 April 2021, the applicant brought the present application for interim measures in which it claims that the President of the General Court should:
–        suspend the operation of the contested regulation for a period of nine months from the date of the present order;
–        order the Commission to pay the costs.
17      In its observations on the application for interim measures, which were lodged at the Court Registry on 3 May 2021, the Commission contends that the President of the General Court should:
–        dismiss the application for interim measures;
–        reserve costs until judgment is delivered in the main proceedings.
18      On 20 May 2021, the applicant lodged its observations on the Commission’s observations.
19      On 3 June 2021, the Commission lodged its observations on the applicant’s observations.
Law
20      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 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 measures may order the suspension of operation of an act challenged before the General Court or prescribe any interim measures (order of 19 July 2016, Belgium v Commission, T‑131/16 R, EU:T:2016:427, paragraph 12).
21      The first sentence of Article 156(4) of the Rules of Procedure provides that applications for interim measures must state ‘the subject matter of the proceedings, the circumstances giving rise to urgency and the pleas of fact and law establishing a prima facie case for the interim measure applied for’.
22      Thus, the judge hearing an application for interim measures 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 measures is also 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).
23      In the context of that overall examination, the judge hearing an application for interim measures enjoys a broad discretion and is free to determine, having regard to the particular 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).
24      Having regard to the material in the file, the President of the Court considers that he has all the information needed to rule on the present application for interim measures without the need first to hear oral argument from the parties.
25      In the circumstances of the present case, it is appropriate to examine, first, whether the condition relating to urgency is satisfied.
26      In order to determine whether the interim measures sought are urgent, it should be borne in mind that the purpose of the procedure for interim relief is to guarantee the full effectiveness of the future final decision, in order to prevent a lacuna in the legal protection afforded by the EU judicature. 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).
27      It is in the light of those criteria that it is necessary to examine whether the applicant has succeeded in demonstrating urgency.
28      In the present case, to demonstrate the seriousness of the damage, the applicant claims that the total prohibition, by the contested regulation, of Aloe preparations containing HADs will lead to the loss of at least 80% of its turnover and force it to discontinue operations almost immediately because it does not have the necessary financial reserves to continue operations without the constant revenue stream from Aloe vera gel. In that regard, it states that, if operation of the contested regulation is not suspended, it will be forced to declare bankruptcy, liquidate its assets and make its employees redundant.
29      To demonstrate the irreparable nature of the damage, the applicant argues that, by the time of the ruling in the main proceedings, it will have been out of business for at least a year and will have made most of its employees redundant. It submits that adoption of the contested regulation would lead to (i) the unemployment of 300 people in the Netherlands, which would affect its sister companies; (ii) the unemployment of 500 people in its sister companies established in other EU Member States; and (iii) significant repercussions on income for some 100 000 independent distributors across the European Union. The loss of almost the entirety of its workforce will create a significant structural barrier to the restarting of its activities should the contested regulation be annulled. Furthermore, the applicant states that it could not have avoided that damage by the time of entry into force of the contested regulation. It adds that it started research over one year ago to develop a method to eliminate HADs and that it hopes to have finished that research by April 2022. That means that it will need only some additional months to meet the legal requirements laid down by the contested regulation. Lastly, it claims that the financial strength of the global group to which it belongs is immaterial in the present case. Since the contested regulation entails a total ban on Aloe vera drinks, its sole raison d’être ceases to exist. Hence, there would be no point in it relying on the financial strength of the group to which it belongs to avoid insolvency.
30      In the first place, as regards the applicant’s argument that the total prohibition, by the contested regulation, of Aloe preparations containing HADs will lead to the loss of at least 80% of its turnover and force it to discontinue its operations, it should be noted at the outset that the damage alleged in this respect is financial in nature.
31      Regarding the seriousness of the financial damage alleged, it is settled case-law that the interim measure sought will be justified only if it is apparent that, without such a measure, the party seeking it would be in a position that could imperil its existence before the final decision in the main action. In that regard, it is settled case-law that the assessment of the serious nature of such damage is to be carried out in the light of, inter alia, the size and turnover of the undertaking and the characteristics of the group to which it belongs (see order of 21 January 2019, Agrochem-Maks v Commission, T‑574/18 R, EU:T:2019:25, paragraphs 33 and 34 and the case-law cited). The fact that the judge hearing an application for interim measures takes into consideration the resources available, as a whole, to the group to which the company seeking interim measures belongs may lead to the conclusion that the condition of urgency is not satisfied despite the fact that that company, taken individually, may become insolvent (see order of 5 March 2020, HB v Commission, T‑796/19 R, not published, EU:T:2020:82, paragraph 58).
32      In order to determine whether those conditions are satisfied, the judge hearing the application for interim measures 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 (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). It follows that that party must provide essential evidence enabling the judge hearing the application for interim measures to establish a true overall picture of its financial situation and that of the shareholders controlling it (see, to that effect, order of 20 April 2012, Fapricela v Commission, C‑507/11 P(R), not published, EU:C:2012:231, paragraph 35 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 measures must contain all the evidence and offers of evidence available to justify the grant of the interim measures sought.
33      Moreover, as regards a loss corresponding to less than 10% of turnover of undertakings active in highly regulated markets, it is clear from settled case-law that the financial difficulties which those undertakings risked suffering do not appear to be such as to threaten their very existence (order of 15 November 2011, Xeda International v Commission, T‑269/11 R, not published, EU:T:2011:665, paragraph 21; see also, to that effect, order of 11 April 2001, Commission v Bruno Farmaceutici and Others, C‑474/00 P(R), EU:C:2001:219, paragraph 106). As regards a loss representing almost two thirds of the turnover of those undertakings, while acknowledging that the financial difficulties they underwent could have been such as to threaten their existence, case-law has emphasised that, in a highly regulated sector where major investment is often required and the competent authorities may be led to intervene when public health risks become apparent, for reasons which cannot always be foreseen by the undertakings concerned, it was for those undertakings, if they were not to bear themselves the loss resulting from such intervention, to protect themselves against its consequences by adopting an appropriate policy (see orders of 16 June 2016, ICA Laboratories and Others v Commission, C‑170/16 P(R), not published, EU:C:2016:462, paragraph 29 and the case-law cited, and of 8 June 2020, Ascenza Agro v Commission, T‑77/20 R, not published, EU:T:2020:246, paragraph 56 and the case-law cited).
34      In the present case, it is apparent from the file that the applicant forms part of the group controlled by Aloe Vera of America, Inc. It is a wholly owned subsidiary of Aloe Vera of Europe LLC, which is a wholly owned subsidiary of Aloe Vera of America.
35      In that regard, the applicant states that the financial impact of the contested regulation is significant for the entire group to which it belongs, with the result that that group would not be in a position to support the applicant financially pending a decision in the main proceedings.
36      However, it should be noted that, in accordance with the case-law referred to in paragraphs 31 and 32 above, to demonstrate a risk to its financial viability, the applicant should have produced, with supporting documentation, a true overall picture of its financial situation and that of the shareholders controlling it.
37      Since the applicant has provided no additional information or certified evidence concerning the financial situation of the shareholders controlling it or the characteristics of the group to which it belongs, it must be stated that the applicant has merely made assertions which are not supported by evidence.
38      Furthermore, as regards the applicant’s argument that there is no point in it relying on the financial strength of the group to which it belongs to avoid insolvency since, given that the contested regulation entails a total ban on Aloe vera drinks, its sole raison d’être ceases to exist, it should be pointed out, first, that the contested regulation does not entail a total ban on Aloe vera drinks but only on preparations from the leaf of Aloe species containing HADs.
39      Secondly, it should be noted that, in so far as the applicant has to be able to be in a position to finish its research aimed at developing a method of eliminating HADs by April 2022 in order to meet the legal requirements of the contested regulation, it does have an objective reason to rely on the financial strength of the group to which it belongs in order to avoid insolvency.
40      In the second place, it should be pointed out that the applicant is operating in a highly regulated market. As noted in paragraph 33 above, it was therefore incumbent on the applicant to behave in such a way as to take into account the increased risk of a ban on the marketing of its product, in order not to have to bear itself the loss arising from such a ban. Consequently, the Court should, in its analysis of the seriousness of the alleged damage, take into account the business strategy that the applicant has adopted (see, to that effect, order of 21 January 2019, Agrochem-Maks v Commission, T‑574/18 R, EU:T:2019:25, paragraph 46).
41      In the present case, the applicant states that it could not have avoided the damage arising from the prohibition before the entry into force of the contested regulation and that, for over a year, it has also been developing an environmentally friendly method to eliminate HADs, which it hopes to have finalised by April 2022.
42      In that regard, while it is true that, for over a year, the applicant has been developing a compliance process aimed at meeting the requirements of the contested regulation, it could have started the research and development process for the new method to eliminate HADs earlier, as the Commission rightly argues.
43      As is apparent from its pleadings, since the applicant was closely following the travaux préparatoires for the contested regulation, it could have anticipated that, following publication of EFSA’s scientific opinion on 23 January 2018, the Commission would in all likelihood take the decision to prohibit the dangerous substances.
44      In particular, since that scientific opinion clearly identified the severe harmful effects on health associated with, inter alia, the use of Aloe extracts containing HADs in food and stated that no daily intake that did not give rise to concerns as to possible harmful effects for human health could be set, the applicant could have expected the Commission to include that substance, in accordance with Article 8(2)(a)(i) or (ii) of Regulation No 1925/2006, either in Annex III, Part A, or possibly in Annex III, Part B.
45      The foregoing considerations cannot be called into question by the applicant’s argument that, in response to EFSA’s opinion, the Commission’s regulatory action was initially focused on food supplements to which HADs had been deliberately added for their laxative effect.
46      It should be noted that, in this context, the Commission performs a risk management task, for the purpose of Article 6(3) of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ 2002 L 31, p. 1). Thus, in the present case, the Commission, in accordance with that provision, took into account the scientific evidence submitted by the risk assessor, namely EFSA, which highlighted the harmful effects on human health of Aloe extracts containing HADs.
47      Prima facie, the amendments made subsequently to the draft of the contested regulation cannot be regarded as arbitrary and lacking any scientific basis. As the Commission explains in its pleadings, during the travaux préparatoires the reference to ‘food supplements’ was removed in order to comply with EFSA’s opinion, which concluded that certain HADs are carcinogenic and genotoxic, regardless of whether they are contained in foods marketed as food supplements or as general foods. In addition, the reference to ‘laxative purposes’ was removed because the risk assessment was performed to address questions on specific concerns about the potential genotoxicity and carcinogenicity of those compounds and not their laxative effect. Lastly, the term ‘extracts’ was replaced by the term ‘preparations’ because no definition had been provided for ‘extracts’ in EFSA’s scientific opinion.
48      Furthermore, as regards the statement by the Member of the Commission, relied on by the applicant, to the effect that any measure to be taken by the Commission in that regard would cover only products to which HADs or HAD-containing extracts had been intentionally added, it should be pointed out that, according to case-law, the expression of an opinion by a Member of the Commission is, in so far as it is strictly personal and without prejudice, attributable to that Member alone and does not predetermine the position that the College of Members will adopt at the end of the procedure. Under Article 250 TFEU, the operation of the Commission is governed by the principle of collegiality. That principle is based on the equal participation of the Members of the Commission in the adoption of decisions, and entails in particular that decisions should be the subject of collective deliberation (see, to that effect, judgment of 8 July 1999, Vlaamse Televisie Maatschappij v Commission, T‑266/97, EU:T:1999:144, paragraph 49 and the case-law cited).
49      Thus, the applicant, as a responsible, informed and diligent trader, should have taken in good time all the measures necessary to reduce its economic dependence on Aloe vera inner leaf gel by diversifying its product range or taking other measures to mitigate the risks of non-compliance.
50      However, it is apparent from its pleadings that, instead, the applicant continued to invest in Aloe vera drinks in 2018, 2019 and 2020.
51      In those circumstances, while it is true that manufacturers in highly regulated sectors may encounter difficulties when attempting to replace a product that may be banned with a similar one, the fact remains that, in the present case, the applicant could have been taking measures as from January 2018 in order to reduce its economic dependence on Aloe vera inner leaf gel.
52      Consequently, in so far as the applicant may not have sufficiently diversified its activities or taken risk mitigation measures in good time, there was a lack of diligence that precludes granting the suspension of operation sought.
53      In the third place, as regards the applicant’s argument that it will suffer an irreparable loss of employees and face significant structural barriers to the restarting of its activities should the contested regulation be annulled, it should be noted that, in accordance with case-law, the fact that an undertaking has to shed jobs and thus lose a trained and operational workforce may cause it direct and personal harm, independently of the separate harm suffered by its employees, to the extent that it will be more difficult subsequently to restart its activities should there be a change in economic conditions (order of 12 June 2014, Commission v Rusal Armenal, C‑21/14 P-R, EU:C:2014:1749, paragraph 52).
54      However, as is apparent from its pleadings, the applicant employed on average only three people in 2017, 2018 and 2019. The risk of 300 people in the Netherlands and 500 people in other EU Member States becoming unemployed, the significant repercussions on income for some 100 000 independent distributors across the European Union and the resulting structural barriers do not therefore concern the applicant itself.
55      In that regard, it should be noted that the serious and irreparable damage alleged, which suspension of operation of the contested regulation is intended to avoid, can be taken into account by the Court hearing the application for interim measures, in its 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. It follows that the damage which the operation of the contested regulation may cause to a party other than the party seeking the interim relief can be taken into consideration by the Court hearing the application for interim measures only when balancing the interests at stake (see, to that effect, order of 30 June 1999, Pfizer Animal Health v Council, T‑13/99 R, EU:T:1999:130, paragraph 136).
56      In those circumstances, the dismissals pleaded by the applicant and the resulting structural barriers on which it relies cannot be taken into account by the President of the Court. Such damage is caused to third parties and must therefore be assessed when weighing up the interests at stake.
57      In the light of the foregoing, the President of the Court can find only that the applicant has not succeeded in establishing that, if suspension of operation of the contested regulation were not granted, it would imminently suffer serious and irreparable damage. The condition relating to urgency is therefore not satisfied.
58      It follows from all of the foregoing that the application for interim measures must be dismissed, as the applicant has failed to establish urgency, without it being necessary to rule on whether there is a prima facie case or to weigh up the competing interests.
59      Pursuant to Article 158(5) of the Rules of Procedure, the costs must be reserved.
On those grounds,
THE PRESIDENT OF THE GENERAL COURT
hereby orders:
1.      The application for interim measures is dismissed.
2.      The costs are reserved.
Luxembourg, 22 July 2021.
E. Coulon
M. Van der Woude
Registrar
President
*      Language of the case: English.