CELEX: 62015CC0596
Language: en
Date: 2017-04-25 00:00:00
Title: Opinion of Advocate General Bobek delivered on 25 April 2017.#Bionorica SE and Diapharm GmbH & Co. KG v European Commission.#Appeal — Public health — Consumer protection — Regulation (EC) No 1924/2006 — Health claims on foods — Article 13(3) — List of permitted health claims on foods — Botanical substances — Claims on hold — Action for failure to act — Article 265 TFEU — Defined position of the European Commission — Interest in bringing proceedings — Locus standi.#Joined Cases C-596/15 P and C-597/15 P.

OPINION OF ADVOCATE GENERAL
      BOBEK
      delivered on 25 April 2017 (
            1
         )
      
         Joined Cases C‑596/15 P and C‑597/15 P
      
      
         Bionorica SE (C‑596/15 P)
      
      
         Diapharm GmbH & Co. KG (C‑597/15 P)
      
      
         v
      
      
         European Commission
      
      (Appeal — Public health — Health claims on botanical substances — Failure of Commission to instruct the European Food Safety Authority to conduct evaluations of health claims on botanical substances)
      
         I. Introduction
      
               1.
            
            
               Under Regulation (EC) No 1924/2006 (
                     2
                  ) (‘the Regulation’), the European Commission was to consult the European Food Safety Authority (‘EFSA’) and to adopt, before 31 January 2010, a list of health claims authorised for use on foods. However, in September 2010 it suspended evaluations by EFSA of claims relating to plant-based foods (‘botanicals’). That suspension remains in place to date.
            
         
               2.
            
            
               Bionorica SE (‘Bionorica’) and Diapharm GmbH (‘Diapharm’) (together ‘the Appellants’) are appealing against the General Court’s orders in Cases T‑619/14 and T‑620/14 (‘the contested orders’). (
                     3
                  ) The contested orders dismissed as inadmissible the actions the Appellants had brought against the Commission for failure to act. The Commission’s alleged failure consisted in not instructing EFSA to evaluate health claims for use on botanicals, with a view to adopting a list of health claims that can be used on such foods (‘botanicals claims list’).
            
         
               3.
            
            
               The General Court held the actions to be inadmissible on the grounds that the Commission had brought an end to any failure to act by responding to the Appellants’ invitation to act, thus ‘defining its position’. Moreover, the General Court held that neither Bionorica nor Diapharm had an interest in bringing the actions. Finally, it found that Diapharm also lacked direct concern to bring such an action.
            
         
               4.
            
            
               The present appeals raise a number of important and complex questions in relation to admissibility. To begin with, they require this Court to consider in detail the meaning of ‘interest to act’ and, in particular, to clarify how that concept is to be distinguished from the notions of ‘challengeable act’ and ‘direct concern’. The appeals also require application of the notion of ‘direct concern’ in the context of a failure to act and therefore to the future situation of the Appellants if the sought-after act were to be adopted. Finally, the appeals raise the issue of the continued parallelism, post-Lisbon, between the conditions of admissibility of actions for annulment and failure to act.
            
         
         II. Legal framework
      
         A. EU law
      
         
            1.
          Regulation No 1924/2006
      
               5.
            
            
               Health claims are defined in Article 2(2)(5) of Regulation No 1924/2006 as ‘any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health’.
            
         
               6.
            
            
               Under Article 13, Member States provide the Commission with lists of claims and accompanying conditions. After consulting EFSA, the Commission must have adopted, in accordance with the applicable comitology procedure, a list of permitted claims and related conditions by 31 January 2010. The lists can be modified after that date following the procedures laid down in subsequent provisions of the Regulation.
            
         
               7.
            
            
               The use of claims that are not authorised under the Regulation is prohibited under Article 10.
            
         
               8.
            
            
               Article 17(5) provides that health claims ‘included in the lists provided for in Articles 13 and 14 may be used, in conformity with the conditions applying to them, by any food business operator …’.
            
         
               9.
            
            
               Article 28 (5) and (6) provides for a transitional regime pending adoption of the final list of claims:
               ‘5.   Health claims as referred to in Article 13(1)(a) may be made from the date of entry into force of this Regulation until the adoption of the list referred to in Article 13(3), under the responsibility of food business operators provided that they comply with this Regulation and with existing national provisions applicable to them, and without prejudice to the adoption of safeguard measures as referred to in Article 24.
               6.   Health claims other than those referred to in Article 13(1)(a) and in Article 14(1)(a), which have been used in compliance with national provisions before the date of entry into force of this Regulation, shall be subject to the following:
               
                        (a)
                     
                     
                        health claims which have been the subject of evaluation and authorisation in a Member State shall be authorised as follows:
                        
                                 (i)
                              
                              
                                 Member States shall communicate to the Commission, by 31 January 2008 at the latest, such claims accompanied by a report evaluating the scientific data in support of the claim;
                              
                           
                                 (ii)
                              
                              
                                 after consulting the Authority, the Commission shall, in accordance with the regulatory procedure with scrutiny referred to in Article 25(3), adopt a decision concerning the health claims authorised in this way and designed to amend non-essential elements of this Regulation by supplementing it.
                              
                           Health claims not authorised under this procedure may continue to be used for six months following the adoption of the Decision;
                     
                  
                        (b)
                     
                     
                        health claims which have not been the subject of evaluation and authorisation in a Member State: such claims may continue to be used provided an application is made pursuant to this Regulation before 19 January 2008; health claims not authorised under this procedure may continue to be used for six months after a decision is taken pursuant to Article 17(3).’
                     
                  
         
         III. Facts and Procedure
      
               10.
            
            
               According to the facts as presented in the contested orders, Bionorica is a company that produces and sells pharmaceutical products and food supplements in Europe. It includes certain health claims in its labelling and advertisement of the products. Diapharm provides a range of services internationally including providing advice in relation to the use of health claims on food, and in particular on food supplements. (
                     4
                  )
            
         
               11.
            
            
               Article 13(3) of the Regulation provides that the Commission shall adopt a list of authorised health claims that could be used on foods by 31 January 2010. In order to do this, the Commission first had to gather proposed claims from the Member States and instruct EFSA to evaluate them. The Commission instructed EFSA to conduct the necessary evaluations. However, the Commission subsequently suspended work on claims relating to botanicals in September 2010, but went on to adopt a list of authorised claims in relation to other foods pursuant to Regulation (EU) No 432/2012. (
                     5
                  )
            
         
               12.
            
            
               On 22 April 2014, Bionorica and Diapharm wrote to the Commission inviting it to instruct EFSA to proceed immediately to the evaluation of the health claims that had been suspended, with a view to adopting the list foreseen under Article 13(3) of the Regulation. On 19 June 2014, the Commission replied to the Appellants in the following terms (‘the Letter’):
               ‘As you are aware, the Commission initiated a reflection of health claims on so-called “botanicals” after concerns were raised by a number of Member States and stakeholders with regard to the differentiated treatment of products containing such substances under the legislation on health claims and that on the Traditional Herbal Medicinal Products.
               Pending the outcome of this reflection, the Commission has asked the European Food Safety Authority (EFSA) to discontinue its scientific assessment of health claims on botanicals. The Commission recognises the importance of this complex issue both for consumers and business operators. However, to identify the best course of action needed the Commission should be allowed the time and context necessary for that purpose.’
            
         
         IV. The proceedings before the General Court and the contested orders
      
               13.
            
            
               On 19 August 2014, Bionorica and Diapharm brought actions against the Commission before the General Court for failure to act (Cases T‑619/14 and T‑620/14 respectively).
            
         
               14.
            
            
               On 20 November 2014 the Commission raised an objection of inadmissibility against the actions, to which the Appellants responded on 19 December 2014.
            
         
               15.
            
            
               By orders dated 16 September 2015, the General Court dismissed the actions as inadmissible.
            
         
               16.
            
            
               The General Court held that the Letter constituted a definition of the Commission’s position, which brought an end to any failure to act.
            
         
               17.
            
            
               The General Court also held, as a secondary point, that neither Appellant had an interest to act. In that regard, it made four points.
            
         
               18.
            
            
               First, until such time as the Commission has adopted a list of claims under Article 13(3) of the Regulation, the transitional regime provided for in Article 28(5) and (6) applies. That means that claims can be used as long as the Regulation and applicable national law are respected. (
                     6
                  ) As a result, were the list to be adopted, the most that the Appellants could hope for would be the continued right to use the relevant claims. In fact, the situation may actually be worse if the list was adopted, as the claims might not be authorised. (
                     7
                  )
            
         
               19.
            
            
               Second, failure to adopt the list in no way creates unequal conditions of competition. The transitional regime allows the continued use of claims. Any inequalities resulting from a failure to adopt the list would negatively affect only the interests of those operators whose claims had already been evaluated and rejected. The Appellants could not therefore claim to have any interest in adoption of the list. Moreover, Diapharm is not actually a producer of foodstuffs covered by the relevant claims. (
                     8
                  )
            
         
               20.
            
            
               Third, there was no legal uncertainty (which the Appellants argued meant that they had an interest) resulting from the failure to adopt the list, because it was clear which rules applied during the transitional regime. Moreover, as with Regulation No 432/2012, the Commission is able to set out further transitional provisions even in the final list it adopts. (
                     9
                  )
            
         
               21.
            
            
               Fourth, neither Bionorica nor Diapharm had proven that the Commission’s inaction caused them any financial harm, or how adoption of the botanical claims list would put an end to such harm. (
                     10
                  )
            
         
               22.
            
            
               Additionally, the General Court held that as well as not having an interest to act, Diapharm lacked direct concern, as it neither produces nor sells foodstuffs on the European market. (
                     11
                  )
            
         
         V. Proceedings before the Court
      
               23.
            
            
               By their appeal, the Appellants ask the Court to set aside the General Court’s orders in Cases T‑619/14 and T‑620/14 and to order the Commission to pay its costs.
            
         
               24.
            
            
               Bionorica raises two grounds in support of its appeal. First, the General Court erred in law in holding that the Commission had defined its position. Second, the General Court erred in law in concluding that it did not have interest to act. Diapharm also raises these two grounds and a third: that the General Court erred in holding that it did not meet the criterion of direct concern. (
                     12
                  )
            
         
               25.
            
            
               The Commission rejects these arguments. It claims that it did define its position and that, in any event, neither Appellant has any interest to act. The Commission also pleads that Diapharm lacks direct concern. Finally, the Commission rejects any parallel between the actions for annulment and failure to act as regards failure to adopt a ‘regulatory act’ that ‘does not entail implementing measures’ within the meaning of the fourth paragraph of Article 263 TFEU.
            
         
               26.
            
            
               The Appellants and the Commission submitted written pleadings and presented their arguments at the hearing held on 19 January 2017.
            
         
         VI. Assessment
      
         A. Introduction
      
               27.
            
            
               In both cases under appeal, the General Court concluded that the actions were inadmissible due to the fact (a) that the Commission had defined its position, and (b) that neither Bionorica nor Diapharm had an interest to act. In relation to Diapharm, the General Court also held that the action was inadmissible due to lack of direct concern.
            
         
               28.
            
            
               For the reasons set out below, I consider that on the first two points — definition of position and interest to act — both the General Court’s orders are vitiated by errors of law.
            
         
               29.
            
            
               This should, in my view, result in the General Court’s order in relation to Bionorica being set aside. I further propose that the Court rule on the question of admissibility of Bionorica’s application generally, and in the event the Court agrees that the action is admissible, refer the case back to the General Court for a decision on the substance.
            
         
               30.
            
            
               Although the General Court’s order with respect to Diapharm is also vitiated by errors of law as identified in Diapharm’s first two grounds of appeal, Diapharm’s action must ultimately be dismissed as inadmissible for lack of interest to act, albeit for different reasons, without needing to consider the third ground relating to lack of direct concern.
            
         
         B. First ground of appeal: violation of Article 265 TFEU
      
               31.
            
            
               By their first ground of appeal the Appellants argue that the General Court erred in holding that the Letter constituted a definition of the Commission’s position.
            
         
               32.
            
            
               I agree.
            
         
               33.
            
            
               As can be seen from point 12 above, the first paragraph of the Commission’s Letter simply describes the status quo. The first sentence of the second paragraph indicates that the Commission asked EFSA to suspend its work pending the outcome of Commission’s reflections. The second sentence of the second paragraph acknowledges that the situation is complicated. In the third sentence the Commission simply states that it requires time and context in order to decide what to do.
            
         
               34.
            
            
               Taken together, the meaning of the second paragraph is that examination of this complex question is ongoing and that the Commission is not in a position to act immediately. In other words, it puts the Appellants on hold. The Commission certainly does not say ‘I refuse to act’.
            
         
               35.
            
            
               The case-law makes it clear that asking an operator to be patient or to wait while the institution works on the matter does not constitute a definition of position. (
                     13
                  ) The Letter falls squarely into that type of holding reply. Therefore it is not a definition of its position.
            
         
               36.
            
            
               The Commission argues that, given the context, it was clear that the Commission’s position was to refuse the Appellants’ request for it to act.
            
         
               37.
            
            
               I disagree. The Letter is at best ambiguous. Ambiguities as to the existence of a definition of position arising from Commission’s drafting should be resolved in an applicant’s favour. The applicant cannot be required to contextually second-guess the content of the Commission’s communication and effectively interpret it to her own detriment. Certainly, the clarity of Commission’s communication is by the very nature of its function unlikely to ever reach the Biblical ideal of ‘let your communication be, Yea, yea; Nay, nay’. (
                     14
                  ) But the Commission should certainly be more direct and unequivocal in its correspondence, if indeed what it wished to communicate was a ‘clear’ institutional position.
            
         
               38.
            
            
               In the light of the foregoing, I consider that the Appellants’ first ground is well founded.
            
         
         C. Second ground: interest to act
      
               39.
            
            
               By their second ground the Appellants argue that the General Court erred in holding that they lacked sufficient interest to bring the action (interest to act). In that regard they challenge the conclusions reached by the General Court concerning (a) the comparability of the situation of authorised claims to those subject to the transitional regime; (b) the absence of any competitive disadvantage; and (c) the finding that there was no legal uncertainty. (
                     15
                  )
            
         
               40.
            
            
               In addition, Bionorica argues that the General Court committed an error of fact when asserting that it was a producer of food supplements. Bionorica argues that that error contributed to the General Court’s failure to recognise that Bionorica had an interest to act. (
                     16
                  )
            
         
               41.
            
            
               I will first address the factual inaccuracy alleged by Bionorica (1); then consider generally the case-law on interest to act and the substantive conditions (2); and finally apply this to the present appeals (3).
            
         
         (1) Alleged factual error
      
               42.
            
            
               The General Court alone has jurisdiction to find the facts. The Court will only exercise its review to the extent a substantive inaccuracy of its findings is apparent from the documents submitted to it or that evidence has been distorted. (
                     17
                  )
            
         
               43.
            
            
               In its order in Case T‑619/14, the General Court states that Bionorica is an undertaking that produces and markets pharmaceutical products and food supplements on the European market, and is a ‘food producer’. (
                     18
                  ) It is clear, however, from the General Court’s file that Bionorica is an undertaking that produces and markets pharmaceutical products, not food supplements or food more generally. That has also been confirmed by Bionorica in its written and oral pleadings before this Court.
            
         
               44.
            
            
               There is therefore, in that regard, clearly a substantive inaccuracy in the General Court’s order in Case T‑619/14.
            
         
               45.
            
            
               However, whether that brings into question the General Court’s conclusion in relation to interest to act is another matter. Indeed, as the Commission rightly points out, it would probably have been easier for Bionorica to establish standing in this case had Bionorica actually been active on the market for food supplements.
            
         
               46.
            
            
               Before considering the question of interest to act in this specific case, I will briefly recall the main features of the case-law on the topic.
            
         
         (2) Interest to act
      
               47.
            
            
               Interest to act is an essential condition for bringing any direct action before the Court. (
                     19
                  ) The general purpose of the condition is to ensure that the Court is not seized with actions seeking legal opinions on general or hypothetical questions. (
                     20
                  ) Adoption (or annulment) of the act must procure an advantage for or be of benefit to the applicant. (
                     21
                  ) That ‘advantage’ or ‘benefit’, must also be personal. In other words, an applicant cannot commence a claim in the interests of a third party or in the general interest (that is, actio popularis). (
                     22
                  )
            
         
               48.
            
            
               ‘Interest’ therefore requires that some benefit will accrue to the applicant in case their action is successful. If the outcome of a case would in fact be redundant or negative for the applicant, there is no interest to act. (
                     23
                  )
            
         
               49.
            
            
               Can that personal benefit be factual or must it be legal (in terms of positive repercussions on the legal rights and obligations of the applicant) in order to prove that there is an interest to act? In my view, it may be one, or the other, or both. In any case, one of the two is clearly enough. For example, an improvement in the applicant’s competitive position resulting from an annulment can give rise to an interest to act.
            
         
               50.
            
            
               Looking at past case-law, it would nonetheless be useful for the Court to confirm this explicitly. That is because there are a number of judgments which, at first sight, do appear to require repercussions on the applicant’s legal position in order to show that there is an interest to act. (
                     24
                  ) Some orders even seem to present the notion of benefit and legal consequences as alternative ways of expressing the same requirement. (
                     25
                  )
            
         
               51.
            
            
               However, a closer inspection of these judgments generally reveals that the Court is simply presenting the conditions of the existence of a ‘challengeable act’ and ‘interest to act’ together in a single sentence or paragraph. (
                     26
                  ) Of course, an act must have binding legal effects in order to form the subject matter of an action for annulment or failure to act. (
                     27
                  ) The outcome of the case, as a result, must be capable of leading to legal ramifications in the sense of the act being removed from or inserted into the EU legal order. But that is not the same as interest to act. (
                     28
                  )
            
         
               52.
            
            
               That conclusion is, moreover, confirmed by case-law that accepts as admissible actions by applicants where it is clear that, if the action is ruled in the applicant’s favour, their legal position will be unaffected. Obvious examples include the fact that actions for annulment by competitors against Commission decisions authorising mergers are admissible. (
                     29
                  )
            
         
               53.
            
            
               Case-law also confirms that the interest must be vested and present. (
                     30
                  ) A hypothetical interest is therefore insufficient. (
                     31
                  ) The interest must exist at the stage of issuing the action and must persist until the final decision has been handed down. (
                     32
                  ) If the interest which an applicant claims concerns a future legal situation, she must demonstrate that the prejudice to that situation is already certain. (
                     33
                  )
            
         
               54.
            
            
               For the sake of clarity, these precedents do not imply that for an interest to be established, all relevant future events must be certain. In particular, it is possible that an action that is successful for the applicant will be of benefit to the applicant mainly by creating a chance or opportunity. The existence of the chance is certain, but the outcome is not. With a spin of a roulette wheel there is a small chance of winning big, but no guarantee.
            
         
               55.
            
            
               Obvious examples here can be found in the field of public procurement. An applicant who challenges the award of a contract to a competitor has no guarantee that, if she is successful, she will be awarded the contract. However, she will often have a chance of doing so and hence has an interest in annulment of the award. In those cases where, for some reason, she has no chance, then indeed there may well be no interest. (
                     34
                  )
            
         
               56.
            
            
               The Court’s judgments in Flaherty (
                     35
                  ) and Gordon (
                     36
                  ) provide further examples of this kind of ‘benefit of chance’ or ‘keeping the door open’ interest. In Flaherty the appellants had requested the possibility to increase the capacity of their fishing fleet. The Commission had argued that one group of appellants lacked interest to act, as they had not yet started building the vessels, in contrast to a second group that had. The Court held that both groups had an interest, even if the second group’s interest was more urgent. (
                     37
                  ) In Gordon the appellant contested his career development report. Although he had retired due to permanent invalidity, re-employment was still possible and he therefore had an interest in challenging the report. (
                     38
                  )
            
         
               57.
            
            
               To summarise, an interest to act will exist where adoption of the contested act brings a legal or factual benefit to the applicant, which is personal to her. In general, that benefit should be vested and present, or there should be at least a clear chance or opportunity of obtaining such a benefit. By contrast, exclusion of interest to act because the benefit is only ‘factual’ or because there is merely a ‘chance of benefit’ as opposed to an absolute certainty, regardless of future events, would simply not reflect this Court’s case-law.
            
         
         (3) Application to the present case
      
               58.
            
            
               Applying the above notion of ‘interest to act’ as set down in the case-law, I will explain below why I consider that Bionorica actually does have an interest to act. In that respect the General Court’s order in Case T‑619/14 is vitiated by an error of law. Upstream operator Diapharm, however, does not have an interest to act and the General Court’s order in Case T‑620/14 should be upheld.
            
         
               59.
            
            
               There are various aspects to this question that merit detailed discussion. A general comparison between the transitional regime provided for in Article 28 of the Regulation and the permanent regime (namely adoption of the botanical claims list) is key to the General Court’s reasoning. I will therefore begin by considering what ‘advantage’ or ‘benefit’ might generally be derived from moving from the transitional regime to the ‘permanent’ regime, namely, adoption of the botanicals claims list (i). I will go on to consider the question of legal certainty as a basis for interest to act (ii). Finally, I will consider the specific situations of Bionorica (iii) and Diapharm (iv).
            
         
         (i) Benefit of the permanent regime over the transitional regime
      
               60.
            
            
               The General Court held in paragraph 39 of the contested orders that the Appellants could not derive any benefit from the adoption of the botanicals claims list. In substance, the General Court found that that is because, pending adoption of a list, the transitional regime applies. The situation for a given claim under the transitional regime is in practice as good as it would be if the claim were to be authorised. Indeed, in the event the claim were not authorised, the situation under the transitional regime would be more advantageous.
            
         
               61.
            
            
               I disagree.
            
         
               62.
            
            
               Legally speaking, the transitional regime and authorisation are not equivalent. As pointed out by the Appellants, the situation under the transitional regime is objectively less favourable than authorisation, most obviously because continued use of claims under the transitional regime is subject to conditions set out by national law, (
                     39
                  ) thus subject to 28 potentially differentiated regimes. That is not so for claims specifically authorised by EU rules. (
                     40
                  ) In that sense, as a matter of principle, there would be a clear benefit from authorisation as compared with the transitional regime. (
                     41
                  )
            
         
               63.
            
            
               The General Court stated that the transitional regime could arguably be better than the refusal of a claim. However, I do not consider that the possibility of refusal is in itself sufficient to deprive the Appellants of their interest to act.
            
         
               64.
            
            
               First, I refer in that regard to the public procurement example cited above. In such cases, the applicants seek not a guarantee of benefit, but only a chance of one. Such a potential benefit certainly also exists in this case. (
                     42
                  )
            
         
               65.
            
            
               Second, and more importantly perhaps, the present case is a little different. In public procurement, the possible outcomes are on the face of it either positive (decision annulled, applicant goes on to win the contract) or neutral (decision annulled, applicant loses the contract again). In the present case, the possible outcomes are on the face of it either positive (adoption of list, authorisation of claim) or negative (adoption of list, refusal of claim). However, in both cases it is the clear chance of a benefit that constitutes the interest.
            
         
               66.
            
            
               Third, I also consider that the ‘refusal is negative’ view is an oversimplification. A refusal of a claim also can have clear benefits. For example, as Bionorica pleaded, it may translate into an increased legal certainty for the operator: a particular health claim might not have been authorised, but that also means that that operator can adapt her business strategy for the future. Or, perhaps a little more cynically, a refusal can make life more difficult for competitors wishing to use those claims. In all these cases, there is a factual benefit, personal to the operator.
            
         
               67.
            
            
               More fundamentally, I see some serious problems in the General Court’s approach if taken to its full logical conclusion. Applying that approach, the possibility of a claim being rejected, and thus putting the applicant potentially in a worse position than under the transitional regime, is enough to negate that applicant’s interest. It seems to me that, if such an approach were embraced, an applicant would only ever have an interest in bringing an action for failure to act if the worst possible outcome of that action would be better than the status quo.
            
         
               68.
            
            
               I find that proposition questionable on a number of levels. Two practical implications are particularly troubling.
            
         
               69.
            
            
               First, it is not only Bionorica, but no operator at all that could in practice ever establish that following the adoption of the final list, it would always be better off. Thus, following this line of reasoning to its logical conclusion, no operator could ever bring an action for failure to act.
            
         
               70.
            
            
               Second, such an approach would in many cases allow the Commission to block the adoption of final acts indefinitely, where there is some discretion as to the outcome. (
                     43
                  ) As pointed out by the Appellants in their original action before the General Court, that would adversely affect the applicant in a case of failure to act because it would be unable to bring any form of action. (
                     44
                  )
            
         
               71.
            
            
               I also consider it to be an excessively narrow reading of the notion of interest to act, which is above all a tool to weed out frivolous or spurious actions or those taken in the general interest. At its most basic level, having an interest means having a stake. It means having a dog in the fight, with something to win or lose based on the outcome of the case. It is clear why this Court’s case-law requires the action to be capable of benefiting the claimant. If the outcome can only be harmful, there is no interest.
            
         
               72.
            
            
               However, the requirement of benefit should not be turned on its head to create a condition requiring benefit on the basis of every conceivable outcome. Such an approach could only serve to emasculate the action for failure to act under Article 265 TFEU.
            
         
               73.
            
            
               Finally, there is little case-law on failure to act and far less on failure to adopt preparatory acts. (
                     45
                  ) To my knowledge, there is no judgment of this Court that looks in detail at the notion of interest to act in the context of such actions. It can be legitimately questioned whether the ‘interest to act’ relates to the final regulatory measure (in this case, the botanicals claims list) or the preparatory stages (in this case, instruction to EFSA to evaluate the claims). (
                     46
                  )
            
         
               74.
            
            
               The reasoning adopted in this section looks at interest in the adoption of the final measure. It is acknowledged that, in this case, the final list could be beneficial (authorisation), or it might not be (refusal). (
                     47
                  )
            
         
               75.
            
            
               However, in failure to act actions aiming at the adoption of preparatory acts, where the final act can be positive or negative, there obviously needs to be a preparatory act in order to have any chance at all of a final beneficial act being adopted. In that sense, the immediate ‘interest to act’ in such cases is having the regulatory process move forward. An alternative, and in my point of view also a legitimate way would therefore be to consider the issue of interest to act in the context of actions for failure to adopt a preparatory act. That would also fit well with the reasoning adopted by the Court in the few existing failure to act cases like Pioneer Hi-Bred, where the outcome of the decisional process was uncertain but the General Court nonetheless concluded that there was standing to bring an action for failure to adopt a preparatory act, and thus move things forward. (
                     48
                  )
            
         
         (ii) Legal certainty
      
               76.
            
            
               The Appellants repeatedly submitted to the General Court and this Court that the increased legal certainty would flow from adoption of the botanicals claims list. In that regard, they referred to, for example, the proliferation of different national approaches and summary litigation in national courts with uncertain outcomes that is basically aimed at torpedoing operators’ use of claims.
            
         
               77.
            
            
               In my view, general appeals to the beneficial effects of legal certainty cannot in themselves form a valid basis for interest to act. As explained above in point 47, interest to act must be personal. That in principle excludes interest to act being based on a general concern for the rule of law, hypothetical disputes, academic zeal or plain curiosity.
            
         
               78.
            
            
               However, there is an obvious difference between such general concerns and situations where long-term, indefinite application of a transitional regime creates legal uncertainty that impacts on a party’s own competitive position and its own commercial and investment strategies. Such cases simply cannot simply be dismissed as an instance of an ‘actio popularis’. They can involve personal interest. Whether such interests amount to an interest to act in the present appeals is addressed in the immediately following sections with regard to each of the applicants in turn.
            
         
         (iii) Case C‑596/15 P Bionorica
      
               79.
            
            
               Bionorica produces and markets pharmaceutical products in the EU. As explained above in point 43, contrary to what is stated in the contested order, Bionorica is not currently active on the market for food supplements in the EU. Within such a constellation, Bionorica’s interest would then relate to its potential entry onto the market for plant-based food supplements, which bear health claims.
            
         
               80.
            
            
               However, Bionorica is also active in the neighbouring market for plant-based pharmaceuticals, which it claims are in a competitive relationship with food supplements. In particular, Bionorica listed in its application before the General Court a number of pharmaceutical products that it markets containing active substances (a) which are also used in food supplements, and (b) which are the same as the active substances in relation to which authorisation of health claims have been sought under the Regulation.
            
         
               81.
            
            
               In essence, Bionorica argues that, whatever the outcome of the regulatory process — whether authorisation or rejection of claims — Bionorica stands to benefit.
            
         
               82.
            
            
               In case of authorisation, Bionorica asserts that it would be able to enter the market for food supplements containing the relevant substances and bearing related authorised claims. In doing so, it would be marketing products directly competing with the kind of pharmaceutical products it currently sells, but without many of the related costs in terms of, for example, clinical testing and pharmacovigilance. If, on the other hand, the claims are rejected, it would at least have legal certainty in that regard. It could adapt accordingly. In addition, there is also the very clear implication in Bionorica’s pleadings that, in case claims were rejected, it would also benefit from the fact that its current competitors selling food supplements would no longer be able to use those claims to promote their products.
            
         
               83.
            
            
               In its finding that Bionorica does not have interest to act, the General Court focuses on the general proposition that as a matter of principle the transitional regime is at least as permissive as having a list of authorised claims. As a result, no benefit can be derived, by Bionorica or anyone else, (
                     49
                  ) from the adoption of a botanicals claims list.
            
         
               84.
            
            
               I consider that aspect of the General Court’s reasoning to be flawed. Concerning the impact on competition, the General Court notes that any disadvantage would be suffered by operators whose request for authorisation of claims have been rejected and could not be used. By contrast operators whose requests have been suspended and can be still be used under the transitory regime suffer no disadvantage. However, that reasoning relies again on a misconceived comparison of the advantages and disadvantages of the transitional and permanent regimes.
            
         
               85.
            
            
               For the reasons set out above, I consider that the notion of interest to act must be understood to encompass situations where an applicant personally stands to derive a benefit in fact or in law from the annulment or adoption of the relevant act.
            
         
               86.
            
            
               In my view, contrary to the General Court’s finding, Bionorica has provided sufficient elements to establish such a personal benefit and interest to act.
            
         
               87.
            
            
               First, Bionorica argues that its pharmaceutical products compete with food supplements, some of which contain the same substances as its own products, and that the evaluations of claims in relation to those substances have been suspended. That competitive relationship has not been contested. (
                     50
                  )
            
         
               88.
            
            
               Second, Bionorica alleges that given its presence on the market for pharmaceuticals containing those substances, it is poised to enter the market for food supplements in the event relevant claims are authorised. That potential entry has not been contested. (
                     51
                  )
            
         
               89.
            
            
               Third, Bionorica has established that the transitional regime is less certain than the permanent regime, and has argued that that relative uncertainty inhibits its own entry into the market. In other words, lack of legal certainty impacts on its own competitive and investment decisions.
            
         
               90.
            
            
               Taken together, I consider that these factors — and in particular Bionorica’s presence on neighbouring markets for products using identical substances — establish that Bionorica stands to derive a personal benefit and thus has an interest to act in this case. Moreover, no doubt is cast on that conclusion by the General Court’s finding of fact that Bionorica did not establish the existence of financial harm. Although establishing such harm would help support a finding of interest, there is clearly no obligation to do so. (
                     52
                  )
            
         
               91.
            
            
               The General Court therefore erred in law in concluding that Bionorica lacked interest to act. Bionorica’s second ground of appeal is well founded.
            
         
         (iv) Case C‑597/15 P Diapharm
      
               92.
            
            
               Diapharm’s activities include advising companies on health claims, including in relation to foodstuffs, and in particular food supplements. It is not itself active on the market for foodstuffs or neighbouring markets. Rather, it is present upstream.
            
         
               93.
            
            
               Diapharm argues in substance that the Commission’s failure to adopt the botanicals claims list negatively affects it by reducing demand for its services, resulting in significant loss of revenue. In that respect, reduced legal certainty as regards the use of health claims, it argues, makes the market for plant-based medicinal products less attractive. That is because entry into that market is expensive and companies can enter the market for food supplements, and benefit from the transitional regime, to use claims at a lower cost, thus avoiding costs associated with marketing medicinal products.
            
         
               94.
            
            
               Diapharm also argued before the General Court that it was closely associated with the process led by an industry association that culminated in the submission to the German authorities of a list of health claims for authorisation, later passed on to the Commission for authorisation under the Regulation. In that regard, Diapharm included in its application before the General Court a list of substances in relation to which, it asserts, it proposed health claims to the industry association, which were then passed on to the Commission via the German authorities.
            
         
               95.
            
            
               In holding that Diapharm did not have interest to act, the General Court adopts reasoning almost identical to that used in relation to Bionorica. For the same reasons as set out above under section (i), I consider that reasoning to be flawed.
            
         
               96.
            
            
               Nonetheless, I agree with the General Court’s ultimate conclusion that Diapharm has not shown sufficient elements to establish an interest to act in this case, but for a different reason. Diapharm’s interest is simply too remote, thus not fulfilling the conditions of there being a personal benefit for the applicant.
            
         
               97.
            
            
               ‘Interest to act’ requires personal benefit. It is correct that Diapharm was closely involved in the procedure leading to the list of proposed claims submitted to the Commission. That is in my view an important element, but cannot serve to establish a personal interest in terms of a benefit that would be derived by Diapharm itself from the adoption of the botanicals claims list. Irrespective of its degree of involvement, Diapharm only participated indirectly in the submission of the claims list to the German authorities. It will not use (or compete with operators using) relevant claims. Diapharm’s arguments relating to increased legal certainty, which would in principle mainly benefit companies active on the relevant or competing markets, is also too weak and indirect to make a difference here.
            
         
               98.
            
            
               In coming to that conclusion, I take note of the finding of the General Court that Diapharm has failed to adduce sufficient evidence to establish financial harm resulting from the Commission’s failure to act. (
                     53
                  ) That finding of fact, which cannot be reopened by this Court, is in my view relevant, because financial harm in terms of loss of revenue was so central to Diapharm’s arguments. I stress that Diapharm was not required to establish financial harm in order to demonstrate a benefit in fact deriving from adoption of the act and hence interest to act. However, in this case doing so might well have helped it over the finishing line as regards interest to act.
            
         
               99.
            
            
               One rather practical element ought to be mentioned in lieu of a conclusion here. According to this Court’s case-law, it is for the applicant to establish interest to act. (
                     54
                  ) In that regard, I think it is worth recalling the need to be practical and proportionate about the amount of supporting evidence the applicant is expected to proactively present in that regard. Thus, expecting, at the stage of the application, exhaustive demonstration of commercial impact through, for example, lengthy economic or financial reports, is in my view neither realistic from the applicant’s perspective (particularly in terms of cost and also limits on number of pages allowed) nor in the interests of procedural efficiency of the Court. Should it be necessary, however, further evidence might be presented at the stage of the reply or, if indeed central to the reasoning of the General Court, ought to be elicited by the General Court through measures of instruction.
            
         
               100.
            
            
               In the light of the foregoing, despite shortcomings in the General Court’s reasoning, I consider that it did not err in law when it concluded that Diapharm lacked interest to act. The second ground advanced by Diapharm should therefore be held to be inoperative and the General Court’s judgment upheld as regards lack of interest to act.
            
         
               101.
            
            
               There is, as a result, no need to consider the General Court’s finding that Diapharm’s action is also inadmissible for lack of direct concern.
            
         
         D. Other conditions of admissibility
      
               102.
            
            
               Since both grounds of inadmissibility in the General Court’s order in relation to Bionorica are vitiated by errors of law, the Court could decide to set aside that order and refer the case back to the General Court for a final decision. Bionorica would then need to establish before the General Court that the other conditions of admissibility are fulfilled and, if successful in that regard, only then argue its case on the merits. (
                     55
                  )
            
         
               103.
            
            
               In accordance with the first paragraph of Article 61 of the Statute of the Court of Justice of the European Union, the Court may also, after quashing the decision of the General Court, itself give judgment in the matter, where the state of the proceedings so permits.
            
         
               104.
            
            
               In the present case, the Court is not in a position, at this stage of the proceedings, to give judgment on the substance of the action brought before the General Court. The Commission made no arguments on the merits.
            
         
               105.
            
            
               I consider, however, that the Court has all the necessary material before it to be able to give a ruling rejecting the preliminary plea of inadmissibility raised by the Commission at first instance. In the interests of efficiency and economy of procedure, and in order to ensure that Bionorica receives a timely answer on the question of whether its case will be heard on the substance, I propose that the Court take that route.
            
         
         (1) Conditions of admissibility of actions for failure to act
      
               106.
            
            
               Bionorica’s appeal ultimately seeks the adoption of a regulation containing a list of authorised claims.
            
         
               107.
            
            
               According to existing case-law, an applicant can bring an action for failure to adopt an act that would be addressed to them or concern them directly and individually. (
                     56
                  )
            
         
               108.
            
            
               Bionorica does not argue that the botanical claims list would be addressed to it. It must therefore establish that such a regulation would be of direct and individual concern to it.
            
         
               109.
            
            
               The latter, alternative basis of admissibility is not provided for explicitly in the text of Article 265 TFEU. Instead, it derives from a case-law based parallelism with Article 263 TFEU, which does allow non-privileged applicants to challenge acts directly and individually concerning them. In confirming that parallelism of conditions under both provisions of the Treaty, the Court concluded in T. Port that ‘the possibility for individuals to assert their rights should not depend upon whether the institution concerned has acted or failed to act’. (
                     57
                  )
            
         
               110.
            
            
               In the present case, the question was raised whether that parallelism is affected by the change in the wording of Article 263 TFEU brought about by the Treaty of Lisbon. Indeed, since the Treaty of Lisbon, Article 263, fourth paragraph, TFEU provides that applicants may bring an action for annulment also against any ‘regulatory act, which is of direct concern to them and does not entail any implementing measures’.
            
         
               111.
            
            
               Does that modification, when combined with the T. Port line of case law mentioned above, also imply that actions may now be brought by applicants for failure to adopt a ‘regulatory act, which is of direct concern to them and does not entail implementing measures’?
            
         
               112.
            
            
               At the hearing, the Commission stated that the answer to that question should be ‘no’. It maintained that the aim of the Treaty of Lisbon was to close a concrete and specific gap in legal protection arising under the former Article 230, fourth paragraph, TEC. However, in full knowledge of the parallelism case-law of the Court, the modification was carried out only with regard to the then Article 230, fourth paragraph, TEC (today the fourth paragraph of Article 263 TFEU), while leaving the text of former Article 232 TEC (today Article 265 TFEU) unchanged.
            
         
               113.
            
            
               I disagree. In my opinion, the answer should be ‘yes’, in particular for the following three reasons.
            
         
               114.
            
            
               First, the pre-Lisbon parallelism between the conditions of Articles 263 and 265 TFEU derives from a concern for coherency in the system of remedies, not from the wording of Article 265 TFEU. Thus, the Commission’s argument relating to the unchanged wording of Article 265 TFEU is not the strongest one, as even pre-Lisbon, the main argument for parallelism was different. At the same time, that main argument and concerns, which led the Court to depart from the strict wording of Article 265 TFEU, continue to exist in the same manner post-Lisbon.
            
         
               115.
            
            
               Second, the changes to the fourth paragraph of Article 263 TFEU made by the Treaty of Lisbon were aimed at broadening access to the Union courts for certain types of act, (
                     58
                  ) in particular in response to the Jégo-Quéré (
                     59
                  ) and UPA (
                     60
                  ) case-law. Limiting access under Article 265 TFEU now by denying a parallel between the two actions would in my view clearly go against the main aim and spirit of those Treaty amendments.
            
         
               116.
            
            
               Third, fundamentally the aim of the action for failure to act is relatively modest: to combat institutional sclerosis. In contrast to the action for annulment, it does not suggest that the job was done badly, but rather simply that the job has not been done at all. The aim of the failure to act action is not to slow down the process, but rather to speed it up in line with the obligations that the Union institutions took upon themselves. As such, if the Commission’s argument were to be embraced, it would be quite paradoxical to have narrower conditions of standing under Article 265 TFEU than under Article 263 TFEU. Indeed, if ever the parallelism between these two provisions were to be abandoned, it ought to happen, in my opinion, in exactly the opposite direction: to have a more permissive standing for actions for failure to act than for actions for annulment.
            
         
               117.
            
            
               For those reasons, in my view, the parallelism established by this Court between Articles 263 and 265 TFEU ought to be maintained. As such, actions for failure to act by non-privileged applicants should be admissible in three situations, namely where the act ultimately sought:
               
                        –
                     
                     
                        would be addressed to the applicant; or
                     
                  
                        –
                     
                     
                        would be of direct and individual concern to the applicant; or
                     
                  
                        –
                     
                     
                        would be a regulatory act of direct concern to the applicant and which does not entail implementing measures.
                     
                  
         
         (2) Individual concern and regulatory act not entailing implementing measures
      
               118.
            
            
               It is rather clear that Bionorica would not be individually concerned by the act whose adoption is sought, in the sense of the Court’s case-law. Nothing distinguishes it from any other operator that could potentially be affected by such an act. (
                     61
                  ) In particular, there is no allegation that Bionorica specifically requested authorisation for any of the claims whose evaluation has been suspended. (
                     62
                  )
            
         
               119.
            
            
               Assuming the Court does uphold its case-law based parallel with Article 263 TFEU, does adoption of the sought-after act nonetheless qualify as a ‘regulatory act’ which ‘does not entail implementing measures’?
            
         
               120.
            
            
               In my view it does. The act in question would not be a legislative act but an act adopted by the Commission following a comitology procedure. (
                     63
                  ) As such, it would clearly be a ‘regulatory act’ within the meaning of existing case-law. (
                     64
                  )
            
         
               121.
            
            
               Concerning the absence of implementing measures, I simply note that the act whose adoption is sought results in the creation of an immediate right to use authorised claims on food stuffs, subject to any specified conditions attached to their use, or, in case of refusal to authorise, an automatic prohibition on their use. No action on the part of the Member States or institutions is required to validate those rights or trigger the prohibitions. A similar conclusion had indeed already been reached by the General Court when it held that Regulation No 432/2012 did not entail any implementing measures. (
                     65
                  )
            
         
               122.
            
            
               Thus, the act whose adoption is sought qualifies as a regulatory act which does not entail implementing measures. The remaining issue is therefore whether such a regulatory act would be of direct concern to Bionorica.
            
         
         (3) Direct concern
      
               123.
            
            
               For an action for failure to act to be admissible, the applicant must also demonstrate direct concern. According to the formula often used in the case-law, (
                     66
                  )‘direct concern’ means that act must affect directly the legal situation of the individual and leave no discretion to its addressees, who are entrusted with the task of implementing it, such implementation being purely automatic and resulting from Union rules without the application of other intermediate rules. (
                     67
                  )
            
         
               124.
            
            
               As regards the second limb of that test — automaticity or absence of discretion — the present case does not raise any particular difficulties. Similarly to the General Court’s findings in relation to Regulation No 432/2012, (
                     68
                  ) I consider it clear that in this case implementation would indeed be automatic and leave no room for discretion on the part of the Member States.
            
         
               125.
            
            
               In relation to the first limb — on directly affecting the applicant’s legal situation — Bionorica argues in substance that its legal situation would be directly affected in particular because the act sought would either grant it the legal right to use certain claims on food supplements or prevent it, and its competitors, from doing so.
            
         
               126.
            
            
               Preventing competitors from using claims might amount to a direct affecting of the legal situation of those competitors but not that of Bionorica.
            
         
               127.
            
            
               The remainder of the claim is more complex. It seems to me difficult to argue that Bionorica would not, as a result of the sought-after act, obtain a right to use authorised claims (
                     69
                  ) or at least be prevented from using others. Such a legal right could be exercised directly by Bionorica. Such a prohibition would be immediately effective in its regard. There would be direct changes to its legal situation.
            
         
               128.
            
            
               One objection that might be raised in response to that reasoning is that Bionorica is not currently active on the market for food stuffs, or at least was not at the time the action was launched.
            
         
               129.
            
            
               A requirement for actual presence on the market concerned is mentioned in precedents in relation to direct concern. (
                     70
                  ) However, this is not systematic. Direct concern has been found to exist, for example, in case of potential (arguably theoretical) entry (
                     71
                  ) and presence on an upstream market. (
                     72
                  )
            
         
               130.
            
            
               More fundamentally, however, I consider that such a requirement does not follow from the notion of direct concern itself. To read such a requirement into the notion is indeed questionable on at least two accounts: practical and systemic.
            
         
               131.
            
            
               First, on the practical side, it is eminently unclear what currently being on the market actually implies in a case like the present one. Would it imply actual use of the relevant claims on foodstuffs being marketed at the moment the action for failure to act (or annulment) is brought? But what if those claims cannot be used in practice as a result of the application of national law (as is possible under the transitional regime)? Or would it imply some form of presence on the market for foodstuffs using the ingredients or substances in relation to which the claims relate, without actual use of the claims being necessary? What if there are sales of products (using the claims) but the activity is sporadic or has not been conducted for some time? What if entry onto the market is imminent but not actual? What if entry onto the market and use of claims only makes sense once the legal situation is clarified and the claims authorised so that necessary investments can be justified (in substance one of the arguments made by Bionorica)?
            
         
               132.
            
            
               More generally, in case of actions for failure to act, how does one cater for the fact that the discussion is actually an entirely hypothetical one about a legal situation that will only potentially come into being many years in the future being directly affected, but is applied to the facts as they stand now?
            
         
               133.
            
            
               The complexities surrounding the notion of market presence (ongoing presence? sporadic presence? minimal presence? imminent presence?) may be relevant, for example, to the issue of interest to act. Indeed, they are in my view decisive as regards the upstream actor Diapharm. They cannot, however, in my view be a formal condition for direct concern.
            
         
               134.
            
            
               Second, I consider that such an approach would be inherently contradictory from a systemic point of view. Either an act produces legal rights or prohibitions that directly apply to an individual, or it does not. Direct concern as presented by the standard case-law formula necessitates an inquiry into what rights or prohibitions apply to an individual, not whether she is actively exercising those rights or enduring the prohibitions at a specific moment in time. Again, the specific factual situation of the applicant at the moment the application is made may be relevant for ascertaining her interest to act, (
                     73
                  ) but not conclusive in the context of direct concern.
            
         
               135.
            
            
               Moreover, another systemic argument is worth highlighting here. It is well established case-law that market presence is considered completely irrelevant by the Court in the assessment of the applicant’s specific situation for the purposes of determining individual concern. In those cases, it has been repeated that anyone can in theory enter any market at any time. It would seem strange to me that exactly the same factor — actual market presence — which is discarded as irrelevant in relation to one element of admissibility should then suddenly become decisive in the ostensibly more objective assessment of the applicant’s legal rights and obligations, for the purposes of determining direct concern.
            
         
               136.
            
            
               In sum, I do not consider that a requirement of market presence can be read into the notion of direct concern.
            
         
               137.
            
            
               Could the requirement of market presence nonetheless stem from the Regulation itself?
            
         
               138.
            
            
               As a general proposition, a regulation can obviously restrict the persons to whom it grants rights or on whom it imposes obligations. In the present case and with regard to this particular Regulation, however, there is no restrictive requirement of market presence in that sense.
            
         
               139.
            
            
               Prohibitions on the use of claims under Article 10 of the Regulation are generally applicable. This means that they are not restricted to any particular group. Any entity selling foodstuffs containing relevant ingredients or contemplating doing so is affected by being directly legally prevented from using specific health claims. Actual presence on the market is not relevant.
            
         
               140.
            
            
               As regards authorisation of claims in Article 17(5) of the Regulation, that provision states that ‘health claims included in the lists provided for in Articles 13 and 14 may be used … by any food business operator …’. (
                     74
                  ) Does this mean that the act sought by the Appellants would confer legal rights to use claims only on a restricted group of persons as defined at a specific moment in time (‘food business operators’)?
            
         
               141.
            
            
               That may indeed be one interpretation of that provision. However, I do not consider it to be the correct one. The term ‘food business operator’ is defined as ‘the natural or legal persons responsible for ensuring that the requirements of food law are met within the food business under their control’. (
                     75
                  ) That is, rather than any clear definition, a description of a vast and highly eclectic group covering anyone from distributors of cauliflowers to energy drink producers to manufacturers of amino acids for use in food supplements. Moreover, the group is open, constantly changing in composition. Thus, as explained above in points 134 and 135, the list of authorised or prohibited health claims will be applicable immediately to anyone engaging in such an activity by the sole virtue of that engagement. (
                     76
                  )
            
         
               142.
            
            
               As a result, it is simply illogical to try to draw a sharp distinction between, on the one hand, a ‘closed’ group directly deriving legal rights as a result of that provision and everyone else, on the other. (
                     77
                  )
            
         
               143.
            
            
               The fact that the reference in Article 17(5) to ‘food business operators’ is not intended to define a closed group benefiting from certain legal rights to the exclusion of all others is further illustrated by contrast with cases where such an approach was adopted. Thus, for example, in T&L Sugars, (
                     78
                  ) the Court rejected an application for the annulment of a regulation in the sugar sector which granted rights to sugar producers — a very clearly defined, closed group delimited by reference to an authorisation process (
                     79
                  ) — on the basis that the applicants were not members of that group and their legal situation was therefore unaffected by the regulation. (
                     80
                  )
            
         
               144.
            
            
               In conclusion, I consider that Bionorica is directly concerned by the act whose adoption is ultimately sought, that is the list of authorised claims in relation to botanicals, in the sense of its legal situation being directly affected by that act.
            
         
         (4) Conclusion
      
               145.
            
            
               In the light of the foregoing, I would propose that the Court conclude that Bionorica’s action for failure to act is admissible.
            
         
               146.
            
            
               Coming to that conclusion does not require any change in interpretation of the existing conditions of admissibility. However, it does invite a confirmatory clarification of the existing conditions and articulation between them. In particular, it requires the reaffirmation of the difference between the notions of interest to act and direct concern which, arguably, might have become somewhat blurred in some cases. (
                     81
                  )
            
         
               147.
            
            
               In line with existing case-law, interest to act requires a personal benefit to the applicant as a result of adoption (or annulment) of the relevant act, or at least a clear chance or opportunity of obtaining such a benefit. (
                     82
                  ) That benefit can be factual or legal.
            
         
               148.
            
            
               Direct concern exists where an act ‘directly affect[s] the legal situation of the individual and leave[s] no discretion to the addressees of that measure who are entrusted with the task of implementing it, such implementation being purely automatic and resulting from Community rules without the application of other intermediate rules’. (
                     83
                  )
            
         
               149.
            
            
               There is clearly a degree of overlap between the conditions for interest to act and direct concern. However, they have different content and different aims and must be distinguished. That is not a mere intellectual exercise. It is of clear practical relevance, in particular to applicants, who are required by the Court’s case law to demonstrate the existence of both those conditions at pain of having their application rejected.
            
         
               150.
            
            
               Interest to act thus aims at the factual or legal situation of the applicant and the impact the outcome of the action would have on that situation. As a condition of admissibility, it seeks to avoid actions in the general interest and actions that can be of no help to the applicant. Hence the need for the existence of a personal benefit. In some ways it can be seen as a ‘first screening’ of actions, arguably with a lower threshold in terms of personal impact than the main conditions of ‘direct concern’ and ‘individual concern’.
            
         
               151.
            
            
               Direct concern, by contrast, focuses primarily on the nature of the challenged legal act and the type of legal right or obligations stemming from it. It takes into account the discretion of the author of the act and the existence of any intervening act that might break the chain between the EU act and the applicant. To the extent that direct concern requires that the applicant’s legal situation is directly affected, (
                     84
                  ) the question is whether the act creates legal rights or obligations that the applicant can rely on or which may limit his or her actions. It is not conclusive in that regard whether on the facts of the case the applicant is actively exercising those rights at the moment she brings the action.
            
         
         VII. Conclusions
      
               152.
            
            
               I propose that the Court:
               
                        (1)
                     
                     
                        As regards Case C–596/15 P
                        
                                 –
                              
                              
                                 set aside the order of the General Court of the European Union in Case T–619/14 and hold admissible the Appellant’s action for failure to act in that case;
                              
                           
                                 –
                              
                              
                                 refer the case back to the General Court for a decision on the merits;
                              
                           
                                 –
                              
                              
                                 order that costs be reserved.
                              
                           
                  
                        (2)
                     
                     
                        As regards Case C–597/15 P
                        
                                 –
                              
                              
                                 dismiss the appeal as unfounded;
                              
                           
                                 –
                              
                              
                                 order the Appellant in that case to pay its own costs and those of the Commission.
                              
                           
                  
         (
            1
         )	Original language: English.
      (
            2
         )	Regulation of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (OJ 2006 L 404, p. 9).
      (
            3
         )	Order of 16 September 2015, Bionorica v Commission (T‑619/14, not published, EU:T:2015:723); order of 16 September 2015, Diapharm v Commission (T‑620/14, not published, EU:T:2015:714).
      (
            4
         )	See paragraph 1 of the contested orders.
      (
            5
         )	Commission Regulation of 16 May 2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health (OJ 2012 L 136, p. 1).
      (
            6
         )	See paragraphs 34 to 38 of the contested orders.
      (
            7
         )	See paragraphs 40 to 45 of the contested order in Case T‑619/14 and paragraphs 40 to 44 of the contested order in Case T‑620/14.
      (
            8
         )	Paragraphs 46 to 48 of the contested order in Case T‑619/14 and paragraphs 45 to 47 of the contested order in Case T‑620/14.
      (
            9
         )	Paragraphs 49 to 53 of the contested order in Case T‑619/14 and paragraphs 48 to 52 of the contested order in Case T‑620/14.
      (
            10
         )	Paragraph 54 of the contested order in Case T‑619/14 and paragraph 53 of the contested order in Case T‑620/14.
      (
            11
         )	Paragraph 56 of the contested order in Case T‑620/14.
      (
            12
         )	The Appellants do not number the grounds in this way. I do so for ease of presentation.
      (
            13
         )	Judgments of 22 May 1985, Parliament v Council (13/83, EU:C:1985:220, paragraph 25); of 15 September 1998, Gestevisión Telecinco v Commission (T‑95/96, EU:T:1998:206, paragraph 88) and of 7 March 2002, Intervet International v Commission (T‑212/99, EU:T:2002:63, paragraph 61).
      (
            14
         )	Matthew 5: 37. King James 2000 version.
      (
            15
         )	See above, points 18 to 20 of this Opinion.
      (
            16
         )	Albeit presented separately from the part on interest to act, under the heading ‘errors of fact’.
      (
            17
         )	Judgments of 1 June 1994, Commission v Brazzelli Lualdi and Others (C‑136/92 P, EU:C:1994:211, paragraph 49), and of 15 June 2000, Dorsch Consult v Council and Commission (C‑237/98 P, EU:C:2000:321, paragraphs 35 and 36).
      (
            18
         )	Contested order in Case T‑619/14 in paragraphs 1 and 48.
      (
            19
         )	Judgment of 4 June 2015, Andechser Molkerei Scheitz v Commission (C‑682/13 P, not published, EU:C:2015:356, paragraph 27); order of 31 July 1989, S. v Commission (206/89 R, EU:C:1989:333, paragraph 8). The case-law generally concerns actions for annulment. However, regarding actions for failure to act, see judgments of 27 June 1995, Guérin automobiles v Commission (T‑186/94, EU:T:1995:114, paragraph 25), and of 7 March 2002, Intervet International v Commission (T‑212/99, EU:T:2002:63, paragraph 53).
      (
            20
         )	Van Raepenbusch, S., ‘L’Intérêt à agir dans le contentieux communautaire’, in Mélanges en hommage à Georges Vandersanden, Brussels, Bruyant, 2008, at p. 381.
      (
            21
         )	Judgment of 7 June 2007, Wunenburger v Commission (C‑362/05 P, EU:C:2007:322, paragraph 42); order of 8 April 2008, Saint-Gobain Glass Deutschland v Commission (C‑503/07 P, EU:C:2008:207, paragraph 48); judgments of 17 April 2008, Flaherty and Others v Commission (C‑373/06 P, C‑379/06 P and C‑382/06 P, EU:C:2008:230, paragraph 25); and of 4 June 2015, Andechser Molkerei Scheitz v Commission (C‑682/13 P, not published, EU:C:2015:356, paragraph 25).
      (
            22
         )	Judgment of 10 July 1986, DEFI v Commission (282/85, EU:C:1986:316, paragraph 18); order of 25 June 2003, Pérez Escolar v Commission (T‑41/01, EU:T:2003:175, paragraphs 35 and 36) — upheld on appeal in the order of 1 October 2004, Pérez Escolar v Commission (C‑379/03 P, not published, EU:C:2004:580). A contrario, see judgment of 4 April 2001, Regione Autonoma Friuli-Venezia Giulia v Commission (T‑288/97, EU:T:2001:115, paragraph 49).
      (
            23
         )	Judgment of 18 December 1997, ATM v Commission, (T‑178/94, EU:T:1997:210, paragraphs 59 to 62), in which it was held that the confirmation or annulment of the decision in no way affected the interests of the applicant and therefore there was no interest to act.
      (
            24
         )	Judgment of 24 June 1986, AKZO Chemie and AKZO Chemie UK v Commission (53/85, EU:C:1986:256, paragraph 16): it ‘is necessary to determine whether … the contested act constitutes a measure producing legal effects of such a kind as to affect the applicant’s interest by clearly altering its legal position’. See also, for example, order of 3 September 2014, Schutzgemeinschaft Milch und Milcherzeugnisse v Commission (T‑112/11, EU:T:2014:752, paragraph 22); and judgments of 19 September 2001, Procter & Gamble v OHIM (Rectangular tablet with inlay) (T‑129/00, EU:T:2001:231, paragraph 12); of 7 March 2002, Intervet International v Commission (T‑212/99, EU:T:2002:63, paragraph 43); and of 3 April 2008, Kongra-Gel and Others v Council (T‑253/04, not published, EU:T:2008:88, paragraphs 82 to 85).
      (
            25
         )	See, for example, order of 15 October 2013, Andechser Molkerei Scheitz v Commission (T‑13/12, not published, EU:T:2013:567, paragraph 31), upheld on appeal, and judgment of 4 June 2015, Andechser Molkerei Scheitz v Commission (C‑682/13 P, not published, EU:C:2015:356, paragraph 25).
      (
            26
         )	Those judgments appear ‘to blur [the interest requirement] with the challengeable act requirement’, see Lenaerts, K., Maselis, I., and Gutman, K., EU Procedural Law, Oxford University Press, Oxford, 2014, p. 356, footnote 528.
      (
            27
         )	In the case of actions for failure to act, it is the act ultimately sought that must be challengeable in the sense of having binding legal effects. However, the specific object of the action may be failure to adopt a preparatory act as an intermediary step. See, for example, judgment of 26 September 2013, Pioneer Hi-Bred International v Commission (T‑164/10, not published, EU:T:2013:503).
      (
            28
         )	Similarly, there are judgments that juxtapose statements in relation to interest to act and direct concern. See, for example, order of 3 September 2014, Schutzgemeinschaft Milch und Milcherzeugnisse v Commission (T‑112/11, EU:T:2014:752, paragraphs 24 to 31). Those remain, however, two separate conditions.
      (
            29
         )	See, for example, judgment of 4 July 2006, easyJet v Commission (T‑177/04, EU:T:2006:187, paragraph 41).
      (
            30
         )	Order of 5 March 2009, Commission v Provincia di Imperia (C‑183/08 P, not published, EU:C:2009:136, paragraph 26).
      (
            31
         )	Judgment of 21 January 1987, Stroghili v Court of Auditors (204/85, EU:C:1987:21, paragraph 11).
      (
            32
         )	Judgments of 7 June 2007, Wunenburger v Commission (C‑362/05 P, EU:C:2007:322, paragraph 42); and of 17 September 2015, Mory and Others v Commission (C‑33/14 P, EU:C:2015:609, paragraph 57).
      (
            33
         )	Judgment of 17 September 1992, NBV and NVB v Commission (T‑138/89, EU:T:1992:95, paragraph 33).
      (
            34
         )	Judgment of 9 June 2011, Evropaïki Dynamiki v ECB (C‑401/09 P, EU:C:2011:370, paragraph 49).
      (
            35
         )	Judgment of 17 April 2008, Flaherty and Others v Commission (C‑373/06 P, C‑379/06 P and C‑382/06 P, EU:C:2008:230).
      (
            36
         )	Judgment of 22 December 2008, Gordon v Commission (C‑198/07 P, EU:C:2008:761).
      (
            37
         )	Judgment of 17 April 2008, Flaherty and Others v Commission (C‑373/06 P, C‑379/06 P and C‑382/06 P, EU:C:2008:230, paragraph 32).
      (
            38
         )	Judgment of 22 December 2008, Gordon v Commission (C‑198/07 P, EU:C:2008:761, paragraphs 41 to 53).
      (
            39
         )	See Article 28(5) and (6) of the Regulation.
      (
            40
         )	See Article 17(5) of the Regulation.
      (
            41
         )	I shall return to the question of whether that benefit would be personal to each Appellant below in points 87 to 90 and 97 of this Opinion.
      (
            42
         )	See above in point 55.
      (
            43
         )	In its orders the General Court points out that exercise of that discretion has meant that, in practice, claims have a very low chance of being authorised. I do not consider that a 10%, 50% or 90% chance of success is relevant to determining interest to act. It would simply be wrong to make the notion of interest to act dependant on general statistics relating to historical choices by the executive in different cases.
      (
            44
         )	See, in that sense, judgment of 26 September 2013, Pioneer Hi-Bred International v Commission (T‑164/10, not published, EU:T:2013:503, paragraph 35). The issue of interest to act was not considered in detail. However, it is worth mentioning here to the extent that the General Court accepted as admissible an action contesting the Commission’s failure to address to the Council a proposal for authorisation of a GMO, even though it was fully recognised that the proposal could be rejected by the Council, but that it could also be accepted.
      (
            45
         )	See judgments of 27 June 1995, Guérin automobiles v Commission (T‑186/94, EU:T:1995:114, paragraph 25); of 7 March 2002, Intervet International v Commission (T‑212/99, EU:T:2002:63, paragraph 61); and of 26 September 2013, Pioneer Hi-Bred International v Commission (T‑164/10, not published, EU:T:2013:503).
      (
            46
         )	The General Court’s judgments in Intervet and Pioneer Hi-Bred (cited in footnote 45) in practice consider the existence of interest to act from the point of view of interest in the final outcome of the legislative process. However, the issue was not specifically discussed in the judgments.
      (
            47
         )	As mentioned above in point 66, this is shorthand. I consider a binary conception of authorisation good/refusal bad as a (potentially misleading) oversimplification. As argued by the Appellants, refusal arguably does have benefits in terms of legal certainty. On the other hand, authorisation is not necessarily a carte blanche. It may, for example, come with conditions that are considered as more onerous by operators than those imposed by the transitional regime.
      (
            48
         )	See above at footnote 44. The existence of interest was not even questioned in that case.
      (
            49
         )	The General Court’s reasoning on that point is indeed basically abstracted from the specific situation of either Appellant.
      (
            50
         )	This contrasts with the situation in Andechser (judgment of 4 June 2015, Andechser Molkerei Scheitz v Commission (C‑682/13 P, not published, EU:C:2015:356)). In that case, the applicant argued that it suffered a competitive disadvantage because its products (organic yoghurts) competed with non-organic yoghurts. The contested regulation permitted use of the sugar substitute stéviol as an additive in non-organic yoghurts, but did not explicitly allow stéviol to be used as an ingredient in organic yoghurts. The Court held that the appellant in that case had not established an interest to act because the competitive relationship between the organic and non-organic products was simply alleged and not proven.
      (
            51
         )	Indeed, as discussed above under the first ground, in points 42 to 46, the General Court even states (incorrectly) that it has already happened.
      (
            52
         )	It should be stressed that the issue being addressed here is a procedural one about interest to act, not a substantive one about damages.
      (
            53
         )	Contested order in Case T‑620/14, in paragraph 53.
      (
            54
         )	See, for example, judgment of 4 June 2015, Andechser Molkerei Scheitz v Commission (C‑682/13 P, not published, EU:C:2015:356, paragraph 27).
      (
            55
         )	Judgment of 27 February 2014, Stichting Woonpunt and Others v Commission (C‑132/12 P, EU:C:2014:100, paragraphs 47 and 48).
      (
            56
         )	Judgment of 26 November 1996, T. Port (C‑68/95, EU:C:1996:452, paragraph 59); order of 1 October 2004, Pérez Escolar v Commission (C‑379/03 P, not published, EU:C:2004:580, paragraph 15).
      (
            57
         )	Judgment of 26 November 1996, C‑68/95, EU:C:1996:452, paragraph 59.
      (
            58
         )	Judgment of 3 October 2013, Inuit Tapiriit Kanatami and Others v Parliament and Council (C‑583/11 P, EU:C:2013:625, paragraph 57); Opinion of Advocate General Cruz Villalón in T & L Sugars and Sidul Açúcares v Commission (C‑456/13 P, EU:C:2014:2283, paragraphs 19 and 20).
      (
            59
         )	Judgment of 1 April 2004, Commission v Jégo-Quéré (C‑263/02 P, EU:C:2004:210) annulling the judgment of 3 May 2002, Jégo-Quéré v Commission (T‑177/01, EU:T:2002:112).
      (
            60
         )	Judgment of 25 July 2002, Unión de Pequeños Agricultores v Council (C‑50/00 P, EU:C:2002:462).
      (
            61
         )	Judgment of 15 July 1963, Plaumann v Commission (25/62, EU:C:1963:17, at p. 107).
      (
            62
         )	Contrast judgment of 30 April 2014, Hagenmeyer and Hahn v Commission (T‑17/12, EU:T:2014:234, paragraph 61).
      (
            63
         )	See Article 13(3) and 24(2) of the Regulation.
      (
            64
         )	Judgment of 3 October 2013, Inuit Tapiriit Kanatami and Others v Parliament and Council (C‑583/11 P, EU:C:2013:625). The General Court concluded that Regulation No 432/2012 was a regulatory act in its judgment of 12 June 2015, Health Food Manufacturers’ Association and Others v Commission (T‑296/12, EU:T:2015:375, paragraph 37).
      (
            65
         )	Judgment of 12 June 2015, Health Food Manufacturers’ Association and Others v Commission (T‑296/12, EU:T:2015:375, paragraph 50).
      (
            66
         )	Judgments of 5 May 1998, Glencore Grain v Commission (C‑404/96 P, EU:C:1998:196, paragraph 41); of 13 March 2008, Commission v Infront WM (C‑125/06 P, EU:C:2008:159, paragraph 47); and of 2 July 2009, Bavaria and Bavaria Italia (C‑343/07, EU:C:2009:415, paragraph 43). See also judgments of 5 May 1998, in Dreyfus v Commission (C‑386/96 P, EU:C:1998:193, paragraph 43), and of 10 September 2009, Commission v Ente per le Ville Vesuviane and Ente per le Ville Vesuviane v Commission (C‑445/07 P and C‑455/07 P, EU:C:2009:529, paragraph 45). I note that the Dreyfus case constitutes the Court’s first use of the case law formula referring to acts directly affecting the ‘legal situation’ of an applicant. Although paragraph 43 of that case refers to a number of precedents supporting that specific conclusion, none of those precedents actually sets out such direct impact on the applicant’s legal situation as a condition of direct concern (also, in the Dreyfus case the contested act was ultimately held by the Court to directly affect the applicant’s legal situation, reversing the General Court’s ruling in that regard).
      (
            67
         )	I nonetheless share the doubts already expressed elsewhere as to whether this formula is actually capable of fully reflecting the myriad subtleties of ‘direct concern’ as applied by the Court (See Opinion of Advocate General Kokott in Inuit Tapiriit Kanatami and Others v Parliament and Council (C‑583/11 P, EU:C:2013:21, point 71)). In particular, as regards the first limb of the test, direct concern is often held to exist where the effects of the relevant acts on the applicant are not legal, but merely factual, for example because they are directly affected in their capacity as market participants in competition with other market participants. The case-law on actions against State aid and merger decisions are obvious examples of that phenomenon. In relation to State aid, see judgment of 12 July 1990, Cofaz and Others v Commission (C‑169/84, EU:C:1990:301, paragraph 9), in which admissibility was taken for granted. See also judgment of 22 November 2007, Spain v Lenzing (C‑525/04 P, EU:C:2007:698, paragraphs 31, and 35 to 38). For a more recent example, see judgment of 15 September 2016, Ferracci v Commission (T‑219/13, EU:T:2016:485, paragraph 44). Concerning merger control, see judgments of 3 April 2003, BaByliss v Commission (T‑114/02, EU:T:2003:100, paragraph 89), and of 30 September 2003, ARD v Commission (T‑158/00,EU:T:2003:246, paragraph 60).
      (
            68
         )	Judgment of 12 June 2015, Health Food Manufacturers’ Association and Others v Commission (T‑296/12, EU:T:2015:375, paragraph 50).
      (
            69
         )	However, see points 137 to 139 below.
      (
            70
         )	Judgment of 12 June 2015, Health Food Manufacturers’ Association and Others v Commission (T‑296/12, EU:T:2015:375, paragraphs 40 and 41).
      (
            71
         )	Judgment of 30 April 2014, Hagenmeyer and Hahn v Commission (T‑17/12, EU:T:2014:234). In that case, the applicant was a university professor who had made a request for authorisation of a health claim extolling the virtues of water. His application for annulment of the Commission’s refusal in the form of Regulation (EU) No 1170/2011 (Commission Regulation of 16 November 2011 refusing to authorise certain health claims made on foods and referring to the reduction of disease risk (OJ 2011 L 299, p. 1)) was declared admissible by the General Court.
      (
            72
         )	In the judgment of 25 October 2011, Microban International and Microban (Europe) v Commission (T‑262/10, EU:T:2011:623)), the applicant challenged a prohibition on the use of triclosan in food packaging materials. The applicant was a manufacturer, seller and marketer of additives, and applied for the inclusion of triclosan to the list of additives authorised by Directive 90/128/EEC (Commission Directive of 23 February 1990 relating to plastic materials and articles intended to come into contact with foodstuffs (OJ 1990 L 75, p. 19)). It was clearly going to be affected commercially by the ban (see paragraph 28 of the Microban judgment). However, it was not actually present on the downstream market for food packaging.
      (
            73
         )	See the discussion above in relation to interest to act (Section C).
      (
            74
         )	Emphasis added.
      (
            75
         )	See Article 2(1)(a) of the Regulation and Article 3(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 foodsafety (OJ 2002 L 31, p. 1).
      (
            76
         )	Further issues also arise in relation to sporadic or temporary activities in the food industry as already highlighted above in point 131.
      (
            77
         )	Indeed, to hold otherwise would be to admit that the Appellants in this case could potentially have ‘engineered’ direct concern by engaging temporarily in some marginal and completely unrelated activity in the food industry in order to obtain the status of ‘food business operator’. It would be neither credible nor coherent to attribute such legal consequences to presence on a far flung pixel of the food industry mosaic, while at the same time declaring irrelevant established presence on closely related markets.
      (
            78
         )	Judgment of 28 April 2015, T & L Sugars and Sidul Açúcares v Commission (C‑456/13 P, EU:C:2015:284).
      (
            79
         )	In the judgment of 28 April 2015, T & L Sugarsand Sidul Açúcares v Commission (C‑456/13 P, EU:C:2015:284, paragraph 34) it was held that applications could only be made by ‘… undertakings producing beet and cane sugar or isoglucose, which are approved in accordance with Article 57 of Regulation No 1234/2007 and have been allocated a production quota for that marketing year’.
      (
            80
         )	Judgment of 28 April 2015, T & L Sugarsand Sidul Açúcares v Commission (C‑456/13 P, EU:C:2015:284, paragraph 37).
      (
            81
         )	Above, footnote 26.
      (
            82
         )	See above in point 50 of this Opinion.
      (
            83
         )	Judgment of 5 May 1998, Dreyfus v Commission (C‑386/96 P, EU:C:1998:193, paragraph 43). See other case-law cited above at footnote 66 See also above footnote 71. The issue of ‘factual’ direct concern does not, however, need to be addressed here.
      (
            84
         )	See above footnote 67.