Provisional text

23 July 2025 (*)

( Interim relief – Appeal – Articles 278 and 279 TFEU – Application for suspension of operation of a measure – Application for suspension of the effects of provisions of a regulation that have been annulled by the General Court of the European Union – Regulation (EC) No 1925/2006 – Prohibition and placing under scrutiny of certain substances and preparations containing hydroxyanthracene derivatives – Regulation (EU) 2021/468 – First and second entries in point 1 and first and second entries in point 2 of Article 1 – Urgency )

In Case C‑54/25 P-R,

APPLICATION for suspension of operation under Articles 278 and 279 TFEU, brought on 26 February 2025,

European Commission,

represented by S. Delaude, I. Galindo Martín, B. Rous Demiri and F. van Schaik, acting as Agents,

appellant,

the other party to the proceedings being:

Ortis SA,

established in Bütgenbach (Belgium), represented by A. de Brosses, avocat,

applicant at first instance and in the present proceedings,

THE VICE PRESIDENT OF THE COURT,

after hearing the Advocate General, M. Szpunar,

makes the following

By its application for interim measures, Ortis SA asks the Court to order the suspension of the effects of the first and second entries in point 1 and the first and second entries in point 2 of Article 1 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) (‘the provisions of Regulation 2021/468 at issue’).

That application was made in parallel with the appeal brought on 27 January 2025 by the European Commission, pursuant to Article 56 of the Statute of the Court of Justice of the European Union, against the judgment of the General Court of the European Union of 13 November 2024, Ortis v Commission (T‑271/21, ‘the judgment under appeal’, EU:T:2024:804), which annulled the provisions of Regulation 2021/468 at issue.

Legal context

Regulation No 1925/2006

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), as amended by Commission Regulation (EU) 2017/1203 of 5 July 2017 (OJ 2017 L 173, p. 9) (‘Regulation No 1925/2006’), entitled ‘Substances prohibited, restricted or under Community scrutiny’, provides, in paragraph 2 thereof:

‘On its own initiative or on the basis of information provided by Member States, the Commission may take a decision designed to amend non-essential elements of this Regulation, following in each case an assessment of available information by [the European Food Safety Authority (EFSA)], in accordance with the regulatory procedure with scrutiny referred to in Article 14(3), to include, if necessary, the substance or ingredient in Annex III. In particular:

(a)if a harmful effect on health has been identified, the substance and/or the ingredient containing the substance shall:

(i)be placed in Annex III, Part A, and its addition to foods or its use in the manufacture of foods shall be prohibited; or

(ii)be placed in Annex III, Part B, and its addition to foods or its use in the manufacture of foods shall only be allowed under the conditions specified therein;

(b)if the possibility of harmful effects on health is identified but scientific uncertainty persists, the substance shall be placed in Annex III, Part C.

On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 14(4) in order to include the substance or the ingredient in Annex III, Part A or B.’

Annex III to Regulation No 1925/2006, entitled ‘Substances whose use in foods is prohibited, restricted or under Community scrutiny’, provides:

‘Part A – Prohibited substances

…

Part B – Restricted substances

Part C – Substances under Community scrutiny

…’

Regulation 2021/468

Recitals 8 to 11 of Regulation 2021/468 state:

(8)‘(8) Given that aloe-emodin and emodin may be present in the extracts, [EFSA] concluded that hydroxyanthracene derivatives [(“HADs”)] should be regarded as genotoxic and carcinogenic unless there are specific data to the contrary and that there is a safety concern for extracts containing [HADs] although uncertainty persists. [EFSA] was unable to provide advice on a daily intake of [HADs] that does not give rise to concerns for human health.

(9)Considering the severe harmful effects on health associated with the use of aloe-emodin [and] emodin … in food, and that no daily intake of [HADs] that does not give rise to concerns for human health could be set, such substances should be prohibited. Therefore, aloe-emodin [and] emodin … should be included in Annex III, Part A of [Regulation No 1925/2006].

(10)During manufacture, [HADs] can be removed from the botanical preparations through a series of filtering processes resulting in products that contain those substances only at trace levels as impurities.

(11)As there is a possibility of harmful effects on health associated with the use of Rheum, Cassia and Rhamnus and their preparations in food, but scientific uncertainty persists about whether such preparations contain the substances listed in Annex III, Part A of [Regulation No 1925/2006], such substances should be placed under [EU] scrutiny and therefore, should be included in Part C of Annex III to [Regulation No 1925/2006].’

Article 1 of Regulation 2021/468 provides:

‘Annex III to [Regulation No 1925/2006] is amended as follows:

(1)in Part A, the following entries are added in alphabetical order:

“aloe-emodin and all preparations in which this substance is present”;

“emodin and all preparations in which this substance is present”;

…

(2)in Part C, the following entries are added in alphabetical order:

“preparations from the root or rhizome of Rheum palmatum L., Rheum officinale Baillon and their hybrids containing [HADs]”;

“preparations from the leaf or fruit of Cassia senna L. containing [HADs]”;

…’

Background to the dispute

The background to the dispute is set out in paragraphs 2 to 17 of the judgment under appeal and may, for the purposes of the present proceedings, be summarised as follows.

The applicant for interim measures is a company established in Belgium which manufactures and markets food supplements made of senna (Cassia angustifolia Vahl) and rhubarb (Rheum palmatum L. or Rheum officinale Baillon).

On 29 June 2016, the Commission asked EFSA to evaluate the available information on the safety in use of HADs from all food sources. It also asked EFSA to recommend a daily intake of HADs that does not give rise to concerns about possible harmful effects on health for the general population and, as appropriate, for vulnerable sub-groups of the population. HADs are a class of chemical substances with different and heterogeneous structures and occur naturally in different botanical species, such as certain Aloe species, as well as in certain fruits and vegetables. They are widely used in food supplements and herbal medicinal products for their laxative effect.

On 22 November 2017, EFSA adopted a scientific opinion, entitled ‘Safety of hydroxyanthracene derivates for use in food’, the conclusions of which are set out in paragraph 6 of the judgment under appeal as follows:

‘“the hydroxyanthracenes, emodin, aloe-emodin and the structurally related substance danthron, have been shown to be genotoxic in vitro. Aloe extracts have also been shown to be genotoxic in vitro and the Panel concluded this was most likely due – at least in part – to [HADs] present in the extract. However, the Panel further noted that Aloe extracts depleted of hydroxyanthracenes, contained an additional genotoxic component(s).

Furthermore, aloe-emodin was shown to be genotoxic in mice, the whole leaf aloe extract was carcinogenic to rats and there was evidence of carcinogenicity of the structural analogue danthron in both rodent species. Given that aloe-emodin and emodin may be present in the extracts, the Panel concluded that [HADs] should be regarded as genotoxic and carcinogenic unless there are specific data to the contrary, such as for rhein, and that there is a safety concern for extracts containing [HADs] although uncertainty persists. The Panel was unable to provide advice on a daily intake of [HADs] that does not give rise to concerns about harmful effects to health, for the general population, and as appropriate, for vulnerable subgroups of the population.”’

On 22 June 2018, on the basis of those conclusions, the Commission presented, for discussion with a group of experts on food supplements and fortified foods, an initial proposal for a regulation.

On 4 March 2020, a draft regulation was submitted for public consultation in order to give all interested parties the opportunity to express their views. It contemplated, first, prohibiting the addition to foods or the use in the manufacture of foods of, inter alia, ‘aloe-emodin and all extracts in which this substance is present’ and ‘emodin and all extracts in which this substance is present’, as well as, second, placing under EU scrutiny, inter alia, ‘extracts from the root, rhizome of Rheum palmatum L., Rheum officinale Baillon and their hybrids containing [HADs]’.

On 18 March 2021, the Commission adopted Regulation 2021/468, by which, in the first and second entries in point 1 of Article 1 of that regulation, it added aloe‑emodin, emodin and all preparations in which those substances are present to Part A of Annex III to Regulation No 1925/2006. In addition, in the first and second entries in point 2 of Article 1 of Regulation 2021/468, the Commission added preparations from the roots or rhizome of Rheum palmatum L., Rheum officinale Baillon and their hybrids containing HADs and preparations from the leaf or fruit of Cassia senna L. containing HADs to Part C of Annex III to Regulation No 1925/2006.

Forms of order sought

Ortis claims that the Court should:

–suspend the effects of the provisions of Regulation 2021/468 at issue until the Court has ruled on the appeal; and

–order the Commission to pay the costs.

The Commission contends that the Court should:

–dismiss the application for interim measures; and

–reserve the costs.

The application for interim measures

As a preliminary point, under the first paragraph of Article 60 of the Statute of the Court of Justice of the European Union, an appeal against a judgment of the General Court does not, in principle, have suspensory effect. However, the second paragraph of Article 60 of that statute provides that, by way of derogation from Article 280 TFEU, decisions of the General Court declaring a regulation to be void are to take effect only as from the date of expiry of the time limit for bringing an appeal referred to in the first paragraph of Article 56 of that statute or, if an appeal has been brought within that period, as from the date of dismissal of the appeal, without prejudice, however, to the right of a party to apply to the Court of Justice, pursuant to Articles 278 TFEU and 279 TFEU, for the suspension of the effects of the regulation which has been declared void or for the prescription of any other interim measure (order of the Vice-President of the Court of 7 July 2016, Commission v Bilbaína de Alquitranes and Others, C‑691/15 P-R, EU:C:2016:597, paragraph 16).

In accordance with Article 160(3) of the Rules of Procedure of the Court of Justice, 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. Thus, the judge hearing an application for interim measures may order interim relief only if it is established that such an order is justified, prime facie, in fact and in law (fumus boni juris) and that it is urgent in so far as, in order to avoid serious and irreparable damage to the interests of the party making the application, it must be made and produce its effects before a decision is reached in the main action. The judge hearing an application for interim measures must also, where appropriate, weigh up the interests involved. Those conditions are cumulative, so that an application for interim measures must be dismissed if any one of them is not satisfied (see, to that effect, order of the Vice-President of the Court of 11 April 2024, Vivendi v Commission, C‑90/24 P(R), EU:C:2024:318, paragraph 56).

In the present case, it is appropriate to begin by examining the condition relating to urgency.

Arguments

As regards the condition relating to urgency, Ortis submits that, if the provisions of Regulation 2021/468 at issue were not suspended until the Court rules on the appeal, it would suffer serious and irreparable damage consisting of an adverse effect on its image and of a loss of income of such a kind as to result in its ceasing operations.

In that regard, Ortis submits that the prohibition flowing from those provisions with regard to the use of aloe-emodin and emodin in foods requires it to cease marketing the food supplements in its ‘Fruits & Fibres’ range. According to Ortis, it is impossible to show that there is no aloe-emodin and emodin present in those food supplements, because those substances may occur naturally in the rhubarb roots from which they are manufactured. Moreover, the analysis methods used to verify whether those substances are present do not give stable results.

Ortis states that the sale of those food supplements generates, depending on the year, between 60 and 68% of its turnover and its gross margin on sales. Furthermore, ceasing the marketing of those food supplements would affect almost all of its customers, more than 96% of whom are supplied from that range of products.

Ortis submits that such a situation would rapidly lead it to insolvency. As a family business, it does not have the financial support of a group and its financial situation is already precarious. Moreover, it does not have a significant cash flow, the credit lines available to it would cover only 28 days of operating losses and it would have no recourse to new loans. The expected revenues from supplies already made of products in the ‘Fruits & Fibres’ range, as well as from the other ranges of products, would also not be sufficient to cover its costs.

Ortis adds that it would also be unable to meet its financial commitments by developing substitute products. In that regard, it submits that the prohibition on ‘Fruits & Fibres’ products was not foreseeable until the summer of 2023, when national food safety authorities identified the presence of HADs, and that the development and placing on the market of a new range of products involves a slow, costly process with an uncertain outcome.

The Commission submits that the condition relating to urgency is not satisfied.

In particular, the Commission contends that it is not clear from Ortis’ website that its best-selling products are the five products in the ‘Fruits & Fibres Regular’ range, since they are not included in the ‘best sellers’ list shown on that website.

26In addition, according to the Commission, it is apparent from the application for interim measures that Ortis had difficulties in generating profit even before the product recalls and product withdrawals ordered by the national supervisory authorities in 2023 and 2024. As regards the financial projections, set out in paragraphs 38 to 41 of the application for interim measures, the Commission submits that they were drawn up in relation to a distinct situation of operating losses resulting from material damage or from the loss of the assets of the undertaking concerned.

27The Commission also refers to the order of the Vice-President of the Court of 16 June 2016, ICA Laboratories and Others v Commission (C‑170/16 P(R), EU:C:2016:462), in order to argue that, in the context of a highly regulated market in which the competent authorities may intervene rapidly when public health risks become apparent, it is for the undertakings concerned to protect themselves against the consequences of such intervention by adopting an appropriate policy.

Findings

28According to settled case-law, the purpose of interlocutory proceedings is to guarantee the full effectiveness of the future final decision, in order to ensure that there is no lacuna in the legal protection afforded by the Court. For the purpose of attaining that objective, urgency must be assessed in the light of the need for an interlocutory order in order to avoid serious and irreparable damage to the party seeking the interim protection. It is for that party to prove that it cannot wait for the outcome of the main proceedings without suffering damage of that nature. In order to establish the existence of such serious and irreparable damage, it is not necessary for the occurrence of the damage to be demonstrated with absolute certainty. It is sufficient to show that damage is foreseeable with a sufficient degree of probability (order of 17 December 2018, Commission v Poland, C‑619/18 R, EU:C:2018:1021, paragraph 60 and the case-law cited).

29In addition, the judge hearing an application for interim measures must postulate, solely for the purpose of assessing urgency, without this involving it taking any position as regards the merits of the complaints put forward in the main action by the applicant for interim relief, that those complaints might be upheld. The serious and irreparable damage whose likely occurrence must be established is that which would result, where relevant, from a refusal to grant the interim measures sought in the event that the action in the main proceedings was subsequently successful (order of 17 December 2018, Commission v Poland, C‑619/18 R, EU:C:2018:1021, paragraph 61 and the case-law cited).

30While it is true that, in order to establish the existence of serious and irreparable damage, it is not necessary for the occurrence and imminence of the damage to be demonstrated with absolute certainty, it being sufficient to show that damage is foreseeable with a sufficient degree of probability, the party seeking interim measures is nevertheless required to prove the facts forming the basis of its claim that serious and irreparable damage is likely (see, to that effect, order of the Vice‑President of the Court of 29 April 2025, Advanz Pharma v Commission, C‑859/24 P(R), EU:C:2025:315, paragraph 44 and the case-law cited).

31In that regard, it must be stated at the outset that Ortis has not complied with that requirement as regards the damage consisting in the adverse effect on its image, alleged in paragraph 34 of the application for interim measures. It does not provide in that application any information capable of demonstrating the probability of that damage.

32As regards the damage consisting in its financial viability being imperilled, which is also alleged by Ortis and which would result from the loss of income caused by it ceasing to market its products in the ‘Fruits & Fibres’ range, it should be noted, in the first place, that the first and second entries in point 2 of Article 1 of Regulation 2021/468, which amended Part C of Annex III to Regulation No 1925/2006, relating to substances under scrutiny, do not have the effect of prohibiting the marketing of products containing such substances. Accordingly, the first and second entries in point 2 of Article 1 of Regulation 2021/468 cannot give rise to that damage.

33It follows that the condition relating to urgency is not satisfied with regard to the application for suspension of that provision.

34As regards the first and second entries in point 1 of Article 1 of Regulation 2021/468, which added aloe-emodin, emodin and all preparations in which those substances are present in Part A of Annex III to Regulation No 1925/2006, the immediate implementation thereof has the effect of prohibiting the use of those substances and preparations in foods.

35In paragraphs 15 and 16 of the application for interim measures, Ortis submits, inter alia, without being challenged on that point by the Commission, that the food supplements in its ‘Fruits & Fibres’ range contain such substances because they are naturally present in the rhubarb roots Rheum palmatum L. and Rheum officinale Baillon from which those products are manufactured, the physiological function of which is to improve intestinal transit. In that paragraph 16, Ortis adds that that statement is confirmed by ‘various analyses’ and refers, in particular, to the test report of 18 May 2021, which it had carried out for the product ‘Frutta & Fibre Classico’, set out in Annex A.5.9 to its written pleadings in the proceedings before the General Court that gave rise to the judgment under appeal.

36It is also apparent from the file submitted to the Court, and in particular from paragraphs 6 to 9 of the application for interim measures and from paragraphs 16 to 22 of the Commission’s observations, that the Belgian, French and Luxembourg authorities, which are competent to carry out official controls on food pursuant to Articles 137 and 138 of Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (OJ 2017 L 95, p. 1), relied on the prohibition flowing from Regulation 2021/468 with regard to the use of aloe‑emodin and emodin in foods in order to adopt, in 2023 and 2024, decisions to recall and withdraw products from Ortis’ ‘Fruits & Fibres’ range. In paragraph 20 of its observations, the Commission also refers to a decision of the Belgian food safety authority of 16 May 2024, by which that authority also asked Ortis to put in place an ‘action plan’ to demonstrate that all of its lots and food supplements containing an extract of Rheum palmatum L. and/or Rheum officinale Baillon rhubarb, as well as hybrids thereof, complied with Regulation No 1925/2006.

37In the light of the foregoing, it therefore seems likely that, as Ortis claims, the first and second entries in point 1 of Article 1 of Regulation 2021/468 prohibit Ortis from marketing its range of ‘Fruits & Fibres’ products.

38In the second place, it must be noted that the damage referred to in paragraph 32 of the present order constitutes purely financial damage.

39In that regard, it should be borne in mind that the judge hearing an application for interim measures must have specific and precise information, supported by detailed documents showing the situation of the party seeking the interim measures and enabling an assessment to be made of the likely consequences if the measures sought are not granted. That party is therefore required to provide, with supporting documents, evidence and information allowing an accurate overall picture of its financial situation to be established (see, to that effect, order of the Vice-President of the Court of 29 April 2025, Advanz Pharma v Commission, C‑859/24 P(R), EU:C:2025:315, paragraph 45 and the case-law cited).

40Those requirements apply in particular to damage of a financial nature which cannot, other 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 prevailed before he or she suffered the damage. Any such damage could be remedied by the applicant’s bringing an action for compensation on the basis of Articles 268 and 340 TFEU (see, to that effect, order of the Vice-President of the Court of 29 April 2025, Advanz Pharma v Commission, C‑859/24 P(R), EU:C:2025:315, paragraph 46 and the case-law cited).

41Accordingly, where the damage alleged 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 (order of the Vice-President of the Court of 29 April 2025, Advanz Pharma v Commission, C‑859/24 P(R), EU:C:2025:315, paragraph 47 and the case-law cited).

42It should be added that, in that assessment, the judge hearing the application for interim measures must be able to take into account the financial situation of the shareholders of the undertaking, on the basis of supporting documents enabling an assessment to be made of that situation, in order to ascertain whether it is likely that the opening of insolvency proceedings cannot be avoided through the intervention of those shareholders (see, to that effect, order of the Vice-President of the Court of 30 November 2021, Land Rheinland-Pfalz v Deutsche Lufthansa, C‑466/21 P-R, EU:C:2021:972, paragraph 55).

43The objective interests of the undertaking concerned are not wholly distinct from those of the natural or legal persons which control it or are members of the same group. In particular, given that the interests at stake overlap, the undertaking’s interest in its own survival must not be viewed in isolation from the interest of those controlling it in its continued existence (see, to that effect, order of the President of the Court of 20 April 2012, Fapricela v Commission, C‑507/11 P(R), EU:C:2012:231, paragraph 34 and the case-law cited).

44It is therefore for the party relying on the likelihood of its financial viability being imperilled to provide evidence enabling the judge hearing the application for interim measures to establish an accurate overall picture of its financial situation and that of the shareholders controlling it (see, to that effect, order of the Vice-President of the Court of 17 March 2023, LE v Commission, C‑781/22 P-R, EU:C:2023:226, paragraphs 27 and 28 and the case-law cited). That information must be specific and precise and supported by detailed and certified documentary evidence (see, to that effect, order of the President of the Court of 20 April 2012, Fapricela v Commission, C‑507/11 P(R), EU:C:2012:231, paragraph 35 and the case-law cited).

45In the present case, Ortis states, in particular, that the sales of products concerned in the ‘Fruits & Fibres’ range represent almost two thirds of its turnover and that such a loss of revenue would leave it unable to cover its costs, which would rapidly lead it to insolvency.

46As regards that damage, it must be stated, first of all, that the financial projections set out in paragraphs 38 to 41 of the application for interim measures, for the purpose of calculating the amount of the fixed costs that would still have to be covered by Ortis in the event that it ceased to market those products, appear to have been drawn up on the basis of an insurance policy taken out by that company to cover a situation of operating losses linked to material damage to its assets or to the loss of those assets, for example as a result of a fire. The situation covered by that insurance policy is different from that at issue in the present case, in which the marketing of some of the products of the undertaking concerned is likely to be prohibited.

47Next, the mere fact that Ortis would not be in a position to cover its costs if it were to cease to market its products in the ‘Fruits & Fibres’ range, even if it were established, is not sufficient to demonstrate that such a situation would necessarily lead to the opening of insolvency proceedings. It is necessary for that company also to demonstrate that it would not be able, on the basis of its own financial reserves, of loans granted by banking institutions or of financial support from its shareholders, to have the funds necessary to avoid such proceedings (see, to that effect, order of the Vice-President of the Court of 30 November 2021, Land Rheinland-Pfalz v Deutsche Lufthansa, C‑466/21 P-R, EU:C:2021:972, paragraph 54).

48In that regard, it is true that Ortis provided information to the effect that its cash flow, the credit lines available to it, the revenue from the ‘Fruits & Fibres’ products already supplied and the expected revenues from other product lines would not be sufficient to cover its costs.

49However, Ortis did not provide any precise information, substantiated by supporting documents, to confirm its claim, in paragraph 50 of the application for interim measures, that it would have no recourse to new loans in such a context.

50Last, although it is apparent from Annex 14 to the application for interim measures that Ortis’ two main shareholders each hold 43.8880% of its capital, Ortis has not provided information on the financial capacity of those main shareholders that would make it possible to assess whether they could take the financial measures necessary to avoid the opening of insolvency proceedings while the Court is ruling on the appeal. As is clear from the case-law referred to in paragraphs 42 to 44 of the present order, such information is necessary for the judge hearing the application for interim measures to assess the likelihood of insolvency for that undertaking. In the present case, that information appears to be all the more essential since, as is apparent in particular from paragraph 35 of the application for interim measures, Ortis has been owned by the same family for two generations, and therefore it may be presumed that that family is particularly attached to the continued existence of that undertaking.

51Consequently, it follows from the foregoing that Ortis has not sufficiently demonstrated the likelihood that the opening of insolvency proceedings could not be avoided before the Court rules on the appeal and has therefore not established that it cannot wait for the outcome of the main proceedings without suffering serious and irreparable financial damage.

52In the third place, even assuming that it cannot be ruled out that such damage may occur, account should also be taken of the fact that Ortis operates on the food market, which, as the Commission points out, is highly regulated (see, by analogy, order of the President of the Court of 11 April 2001, Commission v Bruno Farmaceutici and Others, C‑474/00 P(R), EU:C:2001:219, paragraph 108).

53The Court has held 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, order of the President of the Court of 11 April 2001, Commission v Bruno Farmaceutici and Others, C‑474/00 P(R), EU:C:2001:219, paragraph 109, and order of the Vice-President of the Court of 16 June 2016, ICA Laboratories and Others v Commission, C‑170/16 P(R), EU:C:2016:462, paragraph 29).

54In the present case, in its scientific opinion of 9 October 2013 on the scientific substantiation of a health claim relating to HADs and improvement of bowel function, EFSA concluded that those substances in food could improve bowel function, but advised against long-term use and consumption at high doses due to potential safety concerns such as the danger of electrolytic imbalance, impaired function of the intestine and dependence on laxatives. In addition, and more importantly, in its scientific opinion of 22 November 2017, which concerned the evaluation of safety of use of those substances in food, that authority found that HADs, including aloe-emodin and emodin, were genotoxic and carcinogenic and was not able to provide advice on a daily intake that did not give rise to concerns for human health.

55In that context, Ortis could reasonably anticipate, at the very least when the latter opinion was published on 23 January 2018, that the Commission would, in all likelihood, take the decision to prohibit the use of those substances in food by including them in Part A of Annex III to Regulation No 1925/2006.

56As for the possible presence of such substances in food supplements containing rhubarb (Rheum palmatum L. and Rheum officinale

56Baillon), recital 11 of Regulation 2021/468 refers to the ‘scientific uncertainty’ which persisted in that regard, so that preparations from Rheum palmatum L. and Rheum officinale Baillon were not prohibited but were placed under EU scrutiny by being included in Part C of Annex III to Regulation No 1925/2006. Nevertheless, in the light of that information, Ortis could also reasonably anticipate the risk of aloe-emodin and emodin being present in products manufactured from those preparations.

57In any event, since the test report of 18 May 2021 requested by Ortis in respect of the product ‘Frutta & Fibre Classico’, which is referred to in paragraph 35 of the present order and which revealed the presence of aloe-emodin and emodin, Ortis has been aware of the uncertainty as to whether products in that range comply with Regulation No 1925/2006. It is also apparent from the application for interim measures that that company expressly admits that it was aware of the issue in the management report of Ortis’ managing director for the 2023 financial year, set out in Annex 35 to the application for interim measures, in which that company acknowledges being exposed to an ‘uncertain regulatory environment’ because one of the main ingredients used in the composition of one of the product ranges had been ‘placed under scrutiny by European legislation published in March 2021 and could ultimately see its use restricted or even prohibited’.

58As regards the measures taken by Ortis to anticipate that risk, in paragraph 67 of the application for interim measures, Ortis submits that it has been engaged in a process of researching and developing a substitute product since 2020. However, it refers, in that regard, to an amendment to an agreement relating to a technological innovation partnership that the Walloon Region entered into with universities and undertakings, set out in Annex 48 to the application for interim measures, which does not expressly indicate that Ortis is actively engaged in researching such a product.

59In addition, Ortis submits that the discovery of an extraction process that would make it possible to eliminate the presence of aloe-emodin and emodin in a product manufactured from a rhubarb extract could prove futile in view of a draft amendment to Regulation No 1925/2006 drawn up by the Commission, set out in Annex 51 to the application for interim measures, for the purpose of including the rhubarb Rheum palmatum L., Rheum officinale Baillon and their hybrids containing HADs in Part A of Annex III to Regulation No 1925/2006. However, it must be stated that such a decision, if it were to be taken, would form part of the regulatory developments which, in accordance with the case-law referred to in paragraph 53 of the present order, the undertaking must also anticipate by adopting an appropriate policy. It would, moreover, be regarded as reasonably foreseeable since preparations from the roots or rhizomes of Rheum palmatum L., Rheum officinale Baillon and their hybrids containing HADs were added to Part C of Annex III to Regulation No 1925/2006 by Regulation 2021/468.

60Last, in paragraphs 71 and 72 of the application for interim measures, Ortis refers to the length of the authorisation procedure for a medicinal product for human use and to the fact that such a medicinal product may be sold only in pharmacies, but without explaining why an alternative food supplement which it would market instead of products in the ‘Fruits & Fibres’ range should be classified as such.

61It must therefore be held that Ortis has not demonstrated that it took appropriate measures to protect itself against the risk of a prohibition on the marketing of those products on account of the presence of aloe-emodin and emodin, such as diversifying its range to reduce its alleged economic dependence on those products or actively researching solutions to avoid the risk of those products not complying with EU legislation.

62Consequently, Ortis must bear the damage allegedly suffered on account of the first and second entries in point 1 of Article 1 of Regulation 2021/468, notwithstanding the possibly serious and irreparable nature of that damage (see, to that effect, order of the Vice-President of the Court of 16 June 2016, ICA Laboratories and Others v Commission, C‑170/16 P(R), EU:C:2016:462, paragraph 44).

63Therefore, since the condition relating to urgency is also not satisfied with regard to the first and second entries in point 1 of Article 1 of Regulation 2021/468 and, accordingly, with regard to all of the provisions of that regulation at issue, the application for interim measures must be dismissed, without it being necessary to examine whether there is a prima facie case or, consequently, to weigh up the interests involved.

Costs

64In accordance with Article 137 of the Rules of Procedure, applicable to proceedings on appeal pursuant to Article 184(1) of those rules, a decision as to costs is to be given in the judgment or order which closes the proceedings.

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

1.The application for interim measures is dismissed.

2.The costs are reserved.

[Signatures]

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Language of the case: French.