ORDER OF THE PRESIDENT OF THE GENERAL COURT
13 February 2019 (*)
(Application for interim measures — Public health — Implementing Regulation (EU) 2018/700 — Amendment of the lists of third-country establishments from which imports of specified products of animal origin are permitted, regarding certain establishments in Brazil — No urgency — Weighing-up of competing interests)
In Case T‑429/18 R,
BRF SA, established in Itajaí (Brazil),
SHB Comercio e Industria de Alimentos SA, established in Itajaí,
represented by D. Arts and G. van Thuyne, lawyers,
applicants,
v
European Commission, represented by X. Lewis, B. Eggers and B. Hofstötter, acting as Agents,
defendant,
APPLICATION under Articles 278 and 279 TFEU seeking, principally, suspension of the application of Commission Implementing Regulation (EU) 2018/700 of 8 May 2018 amending the lists of third-country establishments from which imports of specified products of animal origin are permitted, regarding certain establishments from Brazil (OJ 2018 L 118, p. 1), either until a definitive ruling has been given on the action brought by the applicants under Article 263 TFEU, or until such date as determined by the President of the General Court, and, in the alternative, suspension of the application of that regulation in so far as it concerns the applicants’ establishments included in (i) the list of establishments authorised to import meat from poultry and lagomorphs from Brazil (Section II), (ii) the list of establishments authorised to import minced meat, meat preparations and mechanically separated meat from Brazil (Section V) which have generated no more than two notifications via the rapid alert system for food and feed between 1 March 2017 and 19 April 2018 or (iii) the list of establishments authorised to import meat products from Brazil (Section VI), or an order for any other or additional measure which the President of the Court may consider necessary or appropriate,
THE PRESIDENT OF THE GENERAL COURT
makes the following
Order
Background to the dispute, procedure and forms of order sought by the parties
1        The applicants, BRF SA and SHB Comercio e Industria de Alimentos SA, belong to the BRF capital group (‘the BRF Group’), a group of companies active in over 150 countries. The BRF Group has 58 production plants throughout the world and maintains a global network of approximately 13 000 integrated farms.
2        The BRF Group, acting through the applicants, is active in Brazil, a country which is the largest exporter of poultrymeat and poultrymeat preparations to the European Union.
3        In March 2017, the European Commission became aware that the Brazilian federal police were investigating, under Operation ‘Carne Franca’, fraud that had taken place in Brazil affecting meat and as part of which civil servants of the Brazilian Ministry of Agriculture were suspected of corruption in respect of their dealings with 21 establishments, including one belonging to the BRF Group.
4        In May 2017, the Commission’s Directorate-General (DG) for Health and Food Safety (‘DG Health’) carried out an audit in which serious concerns were expressed that steps had not been taken in response to recommendations that shortcomings established in previous audits be remedied.
5        DG Health carried out a subsequent audit from 22 January 2018 to 5 February 2018. In that audit, published on 25 June 2018 (‘the 2018 Audit Report’), it is apparent that measures had been taken and improvements had been made.
6        However, Operation ‘Trapaça’, a part of Operation ‘Carne Franca’, became known on 5 March 2018. This time, the fraud investigations were centred on establishments belonging to the BRF Group and involved meat intended for export to countries requiring salmonella tests, such as the EU Member States. More specifically, the investigations focused on laboratory tests for salmonella that had been falsified in order to circumvent the controls carried out by the competent authorities.
7        In the light of those revelations, the Commission called on the Brazilian authorities to suspend immediately the certification of all products from the implicated establishments, to recall those consignments not yet presented for import at EU border inspection points and to prohibit export to the European Union of all consignments certified by the implicated laboratories. The Brazilian authorities complied with the Commission’s requests.
8        At the request of the Brazilian authorities, two meetings were held on 23 March and 11 April 2018. At those meetings the Commission stated to the Brazilian authorities that fraud regarding laboratory certificates was an unacceptable criminal practice and that the establishments involved had to be excluded from the EU market.
9        On 17 April 2018, the Brazilian Minister for Agriculture waived the suspension in respect of the establishments of the BRF Group, and the Brazilian authorities resumed certifying products from those establishments for export.
10      On 19 April 2018, the Commission submitted a draft implementing regulation advocating the delisting of all of the applicants’ Brazilian establishments.
11      On 8 May 2018, the Commission adopted Implementing Regulation (EU) 2018/700 amending the lists of third-country establishments from which imports of specified products of animal origin are permitted, regarding certain establishments from Brazil (OJ 2018 L 118, p. 1) (‘the contested regulation’). The applicants’ establishments were removed from the list.
12      By application lodged at the Registry of the General Court on 13 July 2018, the applicants brought an action for annulment of the contested regulation.
13      By a separate document, lodged at the Court Registry on the same date, the applicants brought the present application for interim measures, in which they claim, in essence, that the President of the Court should:
–        principally, suspend application of the contested regulation, either until a definitive ruling has been given on the action brought under Article 263 TFEU, or until such date as determined by the President of the Court;
–        in the alternative, suspend application of the contested regulation in so far as it concerns their establishments included in (i) the list of establishments authorised to import meat from poultry and lagomorphs from Brazil (Section II), (ii) the list of establishments authorised to import minced meat, meat preparations and mechanically separated meat from Brazil (Section V) which have generated no more than two notifications via the rapid alert system for food and feed (‘RASFF’) between 1 March 2017 and 19 April 2018 (that is to say, the establishments with approval numbers 1, 18, 103, 292, 716, 928, 1001 and 4567) and (iii) the list of establishments authorised to import meat products from Brazil (Section VI);
–        order any other or additional measure which the President of the Court may consider necessary or appropriate; and
–        order the Commission to pay the costs.
14      In its observations on the application for interim measures, lodged on 1 August 2018, the Commission claims that the President of the Court should dismiss the application for interim measures and reserve the costs.
Law
General considerations
15      It is apparent from a reading of 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 a judge hearing an application for interim measures may order suspension of the application of an act contested before the General Court or prescribe interim measures (order of 19 July 2016, Belgium v Commission, T‑131/16 R, EU:T:2016:427, paragraph 12).
16      Article 156(4) of the Rules of Procedure requires applications for interim measures 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 measures applied for.
17      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 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).
18      In the context of that overall examination, the judge hearing the application for interim measures enjoys a broad discretion and is free to determine, having regard to the 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).
19      Having regard to the documents 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 measures without there being any need first to hear oral argument from the parties.
20      In the circumstances of the present case, it is appropriate to examine first whether the condition relating to urgency is satisfied.
Urgency
21      As a preliminary point, the applicants claim that the contested regulation causes them serious and irreparable harm by irredeemably affecting their position on the market in the European Union. In that regard, the applicants note, first, that in paragraph 54 of the order of 7 March 2013, EDF v Commission (C‑551/12 P(R), EU:C:2013:157), it was held that, where the harm referred to is of a financial nature, the interim measures sought are justified where, in the absence of those measures the market share of the party seeking those measures would be substantially affected and, second, that harm of a financial nature is considered to be irreparable if it cannot be quantified.
22      The applicants go on to claim that, in the first place, in 2017, the BRF Group’s European sales — in both EU Member States and non-EU countries — generated worldwide turnover of approximately 3 533 million Brazilian real (BRL) (approximately EUR 815 million), with this amount also including turnover of around BRL 1 252 million (around EUR 289 million) generated from sales within the European Union by establishments delisted by the contested regulation. In that regard, the applicants submit that, if they were able to continue to export to the European Union products from the delisted establishments, they would generate annual turnover of approximately BRL 1 252 million, the same as that generated in 2017.
23      In that regard, the applicants claim that those significant sales will largely be lost as long as the contested regulation remains in place, and that they might even ultimately remain lost notwithstanding the annulment of that regulation. The applicants argue that poultrymeat can be profitably exported to the European Union from establishments in Brazil only in so far as its importation benefits from the preferential custom duties provided for in Commission Regulation (EC) No 616/2007 of 4 June 2007 opening and providing for the administration of Community tariff quotas in the sector of poultrymeat originating in Brazil, Thailand and other third countries (OJ 2007 L 142, p. 3).
24      The applicants argue that Article 8(1) of Regulation No 616/2007 provides that the release for free circulation in the European Union within the quotas referred to in Article 1 of that regulation ‘shall be subject to the presentation of a certificate of origin issued by the competent authorities of Brazil’.
25      The applicants add that the certificates of origin required are issued in accordance with Brazilian law, which provides that the annual quantity of certificates of origin available for each product category — which mirrors the annual quantity of tariff quotas provided for in Regulation No 616/2007 — is allocated on a quarterly basis to individual companies by reference to the volume exported by the company concerned over the course of the previous three years. In particular, 60% of the tariff quota is distributed proportionately to the export volumes, in tonnes, in the last 36 months separately for each category of products, 30% of the tariff quota is distributed according to the order of registration of exports in the customs system — in principle equally among the interested exporters — and 10% of the tariff quota is made available to new exporters.
26      The applicants note that, following the entry into force of the contested regulation, they are no longer able to export poultrymeat, poultrymeat preparations and poultrymeat products to the European Union. They maintain that if that situation, pending the main proceedings, persists for too long, it is highly likely that they will no longer be able to obtain any certificate of origin allowing them to resume their export activity to the European Union following an annulment of the contested regulation. If the current situation were to last for three years, the applicants claim that they would lose any entitlement to a certificate of origin under the general allocation rules provided for in Brazilian law, and that, after three years, assuming that the main proceedings lead to the annulment of the contested regulation and that the applicants wish to resume their exports to the European Union, they would have to apply for part of the 10% of the tariff quota made available to new exporters. For that reason, the applicants submit that they will never be able to recover either their current market position in the European Union or re-establish their commercial relations with their customers in the European Union.
27      In the second place, the applicants claim that, even though the BRF Group operates establishments for producing meat, meat preparations and meat products in other countries, it is impossible to replace the Brazilian establishments by any alternative source of supply. In that respect, they argue that the BRF Group operates two establishments in Thailand and one establishment in Argentina that are authorised to export poultrymeat, poultrymeat preparations and poultrymeat products to the European Union. They maintain that those three establishments are clearly not able to compensate for the loss of the production capacity of the delisted Brazilian establishments. With regard to the Thai establishments, even if it were technically possible to increase the exports by a small additional volume, it would not be commercially viable because of regulatory constraints and the related increase in production costs.
28      Ultimately, by this argument, the applicants submit that the loss of the EU market could not be avoided by switching production to other BRF Group establishments. They add, in this regard, that it would not be possible for their European clients, which are extremely demanding in terms of quality and sanitary standards, to be supplied by non-accredited establishments.
29      In the third place, the applicants claim that continued application of the contested regulation would cause irreparable harm to the applicants’ reputation both within the European Union and worldwide.
30      The Commission disputes the applicants’ arguments.
31      As a preliminary point, 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 prevent a lacuna in the legal protection afforded by the EU Courts. In order to attain that objective, urgency must be assessed in the light of the need for an interlocutory order to avoid serious and irreparable damage to the party requesting the interim protection. 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).
32      Furthermore, according to well-established case-law, there is urgency only if the serious and irreparable harm feared by the party requesting the interim measures is so imminent that its occurrence can be foreseen with a sufficient degree of probability. That party remains, in any event, under an obligation to prove the facts that form the basis of its claim that such damage is likely, it being clear that purely hypothetical damage, based on future and uncertain events, cannot justify the granting of interim measures (see order of 16 February 2017, Gollnisch v Parliament, T‑624/16 R, not published, EU:T:2017:94, paragraph 25 and the case-law cited).
33      In addition, in accordance with the second sentence of Article 156(4) of the Rules of Procedure, applications for interim measures ‘shall contain all the evidence and offers of evidence available to justify the grant of interim measures’. Thus, an application for interim measures must, of itself, enable the defendant to prepare its observations and the judge hearing the application to rule on it, if necessary without any other supporting information, since the essential elements of fact and law on which the application is based must be found in the actual text of that application (see order of 6 September 2016, Inclusion Alliance for Europe v Commission, C‑378/16 P-R, not published, EU:C:2016:668, paragraph 17 and the case-law cited).
34      It is also settled case-law that, in order to determine whether all the conditions referred to in paragraphs 31, 32 and 33 above are fulfilled, the judge hearing the application for interim measures must have specific and precise information, supported by detailed, certified documentary evidence, which shows the situation in which the party seeking the interim measures finds itself and enables the probable consequences, should the measures sought not be granted, to be assessed. It follows that that party, in particular when it relies on the occurrence of financial damage, must produce, with supporting documentation, an accurate overall picture of its financial situation (see order of 29 February 2016, ICA Laboratories and Others v Commission, T‑732/15 R, not published, EU:T:2016:129, paragraph 39 and the case-law cited).
35      Lastly, whilst the application for interim measures may be supplemented on specific points by references to documents annexed to it, those documents cannot make up for the absence of essential elements in that application. It is not for the judge hearing the application for interim measures to seek, in place of the party concerned, those matters contained in the annexes to the application for interim measures, in the main application or in the annexes to the main application which are liable to support the application for interim measures. The imposition of such an obligation on the judge hearing the application for interim measures would, moreover, render ineffective Article 156(5) of the Rules of Procedure, which requires that the application for interim measures be made by a separate document (see order of 20 June 2014, Wilders v Parliament and Council, T‑410/14 R, not published, EU:T:2014:564, paragraph 16 and the case-law cited).
36      It is in the light of those criteria that it is appropriate to examine whether the applicants have succeeded in establishing that the condition of urgency has been satisfied.
37      In that regard, it is necessary to examine together the applicants’ two arguments in which they claim, in essence, that application of the contested regulation would cause them serious and irreparable harm in so far as they would immediately lose, and would subsequently be unable to regain, their European market share, while taking into account the fact that, by relying, in paragraph 116 of their application for interim measures, on the case-law relating to financial harm, the applicants themselves acknowledge that their harm is financial in nature.
38      With regard to the irreparable nature of the alleged harm, it should, admittedly, be noted, as the applicants point out, that in paragraph 54 of the order of 7 March 2013, EDF v Commission (C‑551/12 P(R), EU:C:2013:157), it was indeed held that, where the harm referred to is of a financial nature, the interim measures sought are justified where, in the absence of those measures, the market share of the party requesting those measures would be significantly affected. However, also in paragraph 54 of the order cited by the applicants, the Vice-President of the Court of Justice stated that that significant effect on market shares must be examined in the light of, inter alia, the size and turnover of the party requesting the interim measures and the characteristics of the group to which it belongs.
39      In that regard, it must be stated that the applicants claim that, in 2017, the BRF Group’s European sales — in both EU Member States and non-EU countries — generated worldwide turnover of BRL 3 535 million and that the delisting of their Brazilian establishments would cause a loss of around BRL 1 252 million in 2018. However, that alleged immediate financial loss which, the applicants claim, is likely to involve the future loss of their market share, relates only to the market within the EU Member States. Accordingly, it should be noted that, in their pleadings, the applicants are unable to substantiate the worldwide turnover of the BRF Group on markets other than the European market. Consequently, even if it were true that the loss of turnover that, prima facie, could be associated with the entry into force of the contested regulation represented around a third of the European market, the judge hearing the application for interim measures is not in a position to establish that the harm to the worldwide turnover of the BRF Group — a group which the applicants themselves present as being active on the worldwide market and which does not, therefore, market its products solely on the European market — is irreparable.
40      Further, it must also be noted that the delisting of the applicants’ establishments is limited to the markets of the EU Member States, which means that those establishments can continue to market their products outside of the European Union. In that respect, the applicants themselves refer to the highly integrated nature of the BRF Group on a worldwide scale and its presence in more than 150 countries.
41      In the light of those considerations, the applicants’ argument that it would be impossible for the BRF Group’s establishments in Thailand to replace the delisted establishments on the European market must also be rejected. The assertion that it is impossible for the BRF Group to guarantee supply to the EU market through its establishments in Thailand, even if it were to be proved, is not capable of calling into question the fact that the judge hearing the application for interim measures is not in a position to establish that the alleged harm is irreparable, given that there is no accurate statement on the total worldwide turnover of the BRF Group and, in particular, its turnover on all the other markets on which its products are sold.
42      It must also be noted that, in any event, the applicants’ argument in which they claim that the loss of their European market share caused by the entry into force of the contested regulation is not capable of being recovered is based on a hypothetical premiss and, therefore, cannot succeed. The applicants submit, first, that, if the contested regulation had to remain in force for three years, they would lose any entitlement to a certificate of origin under the general allocation rules provided for in Brazilian law, and, second, that, after that period, assuming that the main proceedings lead to the annulment of the contested regulation and that the applicants wish to resume their exports to the European Union, they would have to apply for part of the 10% of the tariff quota made available to new exporters.
43      Without it being necessary to adjudicate on the question of whether, as is claimed by the Commission, the harm associated with the loss of the European market share is caused by Brazilian law and is therefore not a direct consequence of EU law, it is sufficient to find that — contrary to what is argued by the applicants, namely that the harm can not only be foreseen with a sufficient degree of probability, but that it is actually certain — in view of the average length of proceedings before the General Court the judgment in the main proceedings will most likely be delivered within two years from the date on which the application in the main proceedings was lodged, that is to say, in the course of 2020. That means that the actual duration of the proceedings before the General Court will be shorter than the duration on which the applicants base their argument. In the event that the contested regulation were annulled at the end of proceedings lasting less than three years, the alleged loss of market share would be limited and would not, consequently, be on the same scale as that claimed by the applicants. Therefore, the harm alleged by the applicants cannot be considered to be foreseeable, much less certain.
44      Finally, with regard to the applicants’ argument that the alleged harm is impossible to quantify and is, therefore, irreparable, it is sufficient to note that the applicants merely refer to the case-law stating that harm that is impossible to quantify is to be regarded as irreparable. However, it is for the applicants to present precise and convincing arguments and evidence in that regard if they wish to rely on that case-law (see, to that effect, order of 7 March 2013, EDF v Commission, C‑551/12 P(R), EU:C:2013:157, paragraph 61), something which they have failed to do in the present case. In the part of their application for interim measures dealing with urgency, the applicants are unable to explain why the alleged loss of market share is unquantifiable and even go on to quantify it at BRL 1 252 million.
45      Consequently, it must be concluded that the applicants are unable to provide evidence allowing the judge hearing the application for interim measures to examine whether the harm allegedly caused by the loss of the European market share is irreparable in nature.
46      With regard to the argument concerning the allegedly irreparable nature of the harm caused to the applicants’ reputation, it must be stated that, in accordance with settled case-law, if it were assumed to be established, the harm would already have been caused by the contested regulation, with the result that the harm has already occurred. The purpose of interim proceedings, however, is not to secure reparation of harm already suffered (see, to that effect, order of 10 December 2015, GGP Italy v Commission, T‑474/15 R, not published, EU:T:2015:958, paragraph 35 and the case-law cited). In addition, the applicants cannot reasonably claim, in order to establish that they have suffered serious and irreparable damage, that only suspension of the application of the contested regulation would be sufficient in order to avoid harm to their reputation. Annulment of the contested regulation at the end of the main proceedings would be sufficient compensation for the alleged non-material harm (see, to that effect, orders of 25 March 1999, Willeme v Commission, C‑65/99 P(R), EU:C:1999:176, paragraph 14; of 22 July 2010, H v Council and Others, T‑271/10 R, not published, EU:T:2010:315, paragraph 36; and of 18 November 2011, EMA v Commission, T‑116/11 R, not published, EU:T:2011:681, paragraph 21).
47      In those circumstances, it must be concluded that the present application for interim measures does not satisfy the condition of urgency.
Weighing-up of interests
48      Furthermore, it must be emphasised that, for the rest, the balance of interests does not tip in favour of suspension of the contested regulation.
49      According to the case-law, the risks associated with each of the possible disposals of the case must be weighed in the proceedings for interim measures. In practical terms, this means examining whether or not the interest of the party seeking interim measures in obtaining suspension of the operation of the contested act outweighs the interest in that act’s immediate implementation. In that examination, it is necessary to determine whether the possible annulment of that act by the judgment on the substance would make it possible to reverse the situation that would have been brought about by its immediate implementation and, conversely, whether suspension of its operation would be such as to impede the objectives pursued by the contested act in the event of the main action being dismissed (order of 1 March 2017, EMA v MSD Animal Health Innovation and Intervet international, C‑512/16 P(R), not published, EU:C:2017:149, paragraph 127).
50      It must also be noted that, in any event, even if the party applying for interim measures succeeds in proving the urgency relating to the characteristics of its harm, it is still necessary to assess the evidence in the light of the principle established by settled case-law that the priority which must be given to the mandatory requirements of the protection of public health may justify restrictions which have adverse consequences, and even substantial adverse consequences, for certain economic operators (see, to that effect, judgment of 1 June 2010, Blanco Pérez and Chao Gómez, C‑570/07 and C‑571/07, EU:C:2010:300, paragraph 90 and the case-law cited). In that context, it has even been pointed out that it is important to recognise the precautionary principle that, where there is uncertainty as to the existence or extent of risks to human health, the EU institutions may take protective measures without having to wait until the reality and seriousness of those risks become apparent (see, to that effect, order of 19 December 2013, Commission v Germany, C‑426/13 P(R), EU:C:2013:848, paragraph 54 and the case-law cited).
51      In the present case, the applicants claim that the balance of interests tips in their favour as, first, during the quarter preceding the adoption of the contested regulation, there had been only one notification of non-compliance due to the presence of salmonella in respect of products originating from their establishments and, second, the 2018 Audit Report demonstrates that the Brazilian authorities have taken the measures recommended by the Commission in order to prevent any further risk of serious non-compliance. Consequently, the applicants argue that, in the absence of any clear indications to suggest that food safety is at risk, the protection of such interests cannot outweigh the applicants’ interest in avoiding severe and lasting harm to their business.
52      The applicants add that ‘in any event, the interim measure of suspending the [contested regulation] should at least cover the establishments [with approval numbers 1, 18, 103, 292, 716, 928, 1001 and 4567] for which no significant number of RASFF notifications can be found as they generated no more than two RASFF notifications between 1 March 2017 and 19 April 2018, as well as the establishments [with approval numbers 104, 292, 466, 716, 1001 and 2014] which produce meat products’. With regard to those establishments which produce meat products, the applicants add, first, that no RASFF notification relates to those establishments and, second, that they are not mentioned in the recitals of the contested regulation and that the Commission therefore did not take them into account when determining that the risk to public health related to the other establishments.
53      The Commission submits that, in the circumstances of the present case, the balancing of interests weighs against granting the interim relief sought and that, according to well-established case-law, commercial and social damage, even if serious and difficult to remedy, cannot outweigh the harm to public health liable to be caused by the suspension of the contested regulation and which could not be remedied if the main action were subsequently to be dismissed. In that regard, the Commission argues that, if the application of the contested regulation were to be suspended, consumers could be exposed to salmonella. It claims that such harm could not be remedied if the establishments in question had to be delisted again if the main action were subsequently to be dismissed.
54      In the present case, it should be pointed out that the applicants mention no other interests to be taken into account in the context of the balancing of interests aside from pecuniary interests associated with the risks to their activities. It is, however, settled case-law that, in principle, the requirements of the protection of public health must unquestionably be given precedence over economic considerations (see order of 11 April 2001, Commission v Bruno Farmaceutici and Others, C‑474/00 P(R), EU:C:2001:219, paragraph 112 and the case-law cited, and judgment of 19 April 2012, Artegodan v Commission, C‑221/10 P, EU:C:2012:216, paragraph 99 and the case-law cited).
55      With regard to the applicants’ argument that, in the absence of any clear indications to suggest that food safety is at risk, their interest should outweigh the interest of food security, it is appropriate to find as follows.
56      First, it must be held that it is necessary to put into perspective the applicants’ arguments that, first, there had been only one notification of non-compliance due to the presence of salmonella in respect of products originating from their establishments in the quarter prior to the adoption of the contested regulation and, second, the 2018 Audit Report demonstrates that the Brazilian authorities have taken the measures recommended by the Commission in order to prevent any further risk of serious non-compliance.
57      The fact that a single decision establishing non-compliance due to the presence of salmonella in respect of products originating from their establishments was taken in the quarter prior to the adoption of the contested regulation can be explained by the fact that, as is apparent from the documents in the case file, the Brazilian authorities suspended a number of the applicants’ establishments during that period, which may have had an effect on the number of decisions establishing non-compliance that might have been adopted.
58      With regard to the fact that the 2018 Audit Report shows that the Brazilian authorities took the measures recommended by the Commission in order to prevent any further risk of serious non-compliance, and even though the Commission itself acknowledges that the 2018 Audit Report referred to an improvement, the Commission nevertheless submits that the claims made in March 2018 regarding Operation ‘Trapaça’, which refer to an ongoing fraud investigation centred on establishments belonging to the BRF Group involving meat intended for export to countries requiring laboratory tests for salmonella, such as the EU Member States, and, more specifically, on laboratory tests for salmonella, which had been falsified in order to circumvent the controls of the competent authorities, constituted a new fact that could be taken into account because of the higher-ranking requirements linked to the protection of public health referred to in paragraph 50 above.
59      Second, in any event, even in the absence of clear indications giving reason to believe that food safety is at risk and even if the applicants had established urgency relating to the characteristics of their harm, it should be noted that, according to the case-law cited in paragraph 50 above, first, it would have been necessary to assess that evidence in the light of the principle that the priority which must be given to the mandatory requirements relating to the protection of public health may justify restrictions which have adverse consequences, and even substantial adverse consequences, for certain economic operators and, second, it is important to recognise the precautionary principle, according to which, where there is uncertainty as to the existence or extent of risks to human health, the EU institutions may take protective measures without having to wait until the reality and seriousness of those risks become apparent.
60      Third, it is apparent from the documents in the case file that, in any event, the number of RASFF notifications was not the only reason for the removal of the applicants’ establishments from the list, as their removal was also linked to Operation ‘Trapaça’.
61      With regard to the argument that the establishments listed by the applicants have not been the subject of a large number of RASFF notifications as they have generated no more than two RASFF notifications between 1 March 2017 and 19 April 2018, suffice it to note the findings made in paragraphs 57 to 60 above, particularly in paragraph 57, and the principle that, where there is uncertainty as to the existence or extent of risks to human health, the EU institutions may take protective measures without having to wait until the reality and seriousness of those risks become apparent.
62      Finally, with regard to the applicants’ argument concerning the establishments producing meat products to the effect that, first, no RASFF notification relates to them and, second, they are not mentioned in the recitals of the contested regulation, suffice it to point out, primarily, that this is factually inaccurate, in so far as recital 6 of the contested regulation states that ‘in March 2018, according to information provided by the Brazilian competent authorities, cases of fraud [had] been found in Brazil concerning laboratory certification for meat and meat products exported to the Union’ and that, consequently, ‘it [was] appropriate to remove them from the list of establishments from which imports into the Union of meat and meat products [were] permitted’.
63      Consequently, it must be concluded, in accordance with the case-law cited in paragraph 49 above, that the balance of interests does not tip in favour of granting the interim measures sought.
64      In the light of the foregoing, and without it being necessary to examine whether the condition that there be a prima facie case is satisfied in the present case, it must be concluded that it is necessary to reject both the principal and alternative heads of claim in the application for interim measures, since the applicants have not succeeded in demonstrating, first, that the condition of urgency is satisfied, as the alleged harm has not been shown to be irreparable, and, second, that the balance of interests tips in their favour.
65      It is also appropriate to reject as inadmissible the head of claim in which the applicants request the grant of any other or additional measure considered necessary or appropriate, in accordance with the settled case-law to the effect that asking the judge hearing the application for interim measures to adopt any other interim relief measures, without specifying in what those measures might consist, amounts to asking the judge himself to draw up the form of order which he is subsequently supposed to assess (see, to that effect, order of 13 December 2004, Sumitomo Chemical v Commission, C‑381/04 P(R), not published, EU:C:2004:796, paragraph 20).
66      In accordance with 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, 13 February 2019.
E. Coulon
M. Jaeger
Registrar
President
*      Language of the case: English.