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Corte di giustizia UEsentenza

Corte di giustizia UE n. 1924/2016

ECLI:EU:C:2016:812
Testo integrale del provvedimento

Testo integrale del provvedimento

[OSCURATO:PERSONA] ([OSCURATO:PERSONA])

25 [OSCURATO:PERSONA] 2016 (

* ) (Appeal — [OSCURATO:PERSONA] 181 of the [OSCURATO:PERSONA] of Procedure of the [OSCURATO:PERSONA] of Justice — Public health — Consumer protection — [OSCURATO:PERSONA] (EC) No 1924/2006 — [OSCURATO:PERSONA] claims on foods — [OSCURATO:PERSONA] 13(3) — Community list of permitted health claims on foods — Botanical substances — [OSCURATO:PERSONA] on hold — Action for failure to act and for annulment — Definition of position by the [OSCURATO:PERSONA] — Challengeable act)

[OSCURATO:PERSONA] C‑637/15 P,

APPEAL under [OSCURATO:PERSONA] 56 of the Statute of the [OSCURATO:PERSONA] of Justice of the [OSCURATO:PERSONA], brought on 1 December 2015, VSM Geneesmiddelen BV, established in Alkmaar (Netherlands), represented by U. Grundmann, Rechtsanwalt, appellant, the other party to the proceedings being:

[OSCURATO:PERSONA],

represented by M. Wilderspin and S. Grünheid, acting as Agents, defendant at first instance,

[OSCURATO:PERSONA] ([OSCURATO:PERSONA]),

composed of M. Vilaras, President of the [OSCURATO:PERSONA], M. Safjan (Rapporteur) and D. Šváby, [OSCURATO:PERSONA], [OSCURATO:PERSONA]: Y. Bot, Registrar: A. [OSCURATO:PERSONA], having decided, after hearing the [OSCURATO:PERSONA], to give a decision by reasoned order, in accordance with [OSCURATO:PERSONA] 181 of the [OSCURATO:PERSONA] of Procedure of the [OSCURATO:PERSONA], makes the following

[OSCURATO:PERSONA]

1 By its appeal, VSM Geneesmiddelen BV (‘VSM’) seeks annulment of the order of 16 September 2015 of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA], VSM Geneesmiddelen v

[OSCURATO:PERSONA]

(T‑578/14, not published, EU:T:2015:715) (‘the order under appeal’), by which it dismissed its action, seeking, by way of principal claim, a declaration that the [OSCURATO:PERSONA] failed to act in that it unlawfully failed to instruct the [OSCURATO:PERSONA] (EFSA) to assess health claims relating to botanical substances for the adoption of the definitive list of permitted claims in accordance with [OSCURATO:PERSONA] 13(3) of [OSCURATO:PERSONA] (EC) No 1924/2006 of the [OSCURATO:PERSONA] and of the Council of 20 December 2006 on nutrition and health claims made on foods (OJ 2006 L 404, p. 9 and corrigendum OJ 2007, L 12, p. 3), as amended by [OSCURATO:PERSONA] (EC) No 109/2008 of the [OSCURATO:PERSONA] and of the Council of 15 January 2008 (OJ 2008, L 39, p. 14) (‘[OSCURATO:PERSONA] 1924/2006’) and, in the alternative, annulment of the decision purportedly contained in the [OSCURATO:PERSONA]’s letter of 19 June 2014 refusing to instruct the EFSA to assess those claims.

Legal context 2 [OSCURATO:PERSONA] 2 of [OSCURATO:PERSONA] 1924/2006 is entitled ‘Definitions’; [OSCURATO:PERSONA] 2(2)(5) defines a ‘health claim’ 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’. 3 [OSCURATO:PERSONA] 13 of [OSCURATO:PERSONA] 1924/2006, entitled ‘[OSCURATO:PERSONA] claims other than those referring to the reduction of disease risk and to children’s development and health’, provides: ‘1. [OSCURATO:PERSONA] claims describing or referring to: (a) the role of a nutrient or other substance in growth, development and the functions of the body; (b) psychological and behavioural functions; or (c) without prejudice to [[OSCURATO:PERSONA]] Directive 96/8/EC [of 26 February 1996 on foods intended for use in energy-restricted diets for weight reduction (OJ 1996 L 55, p. 22)], slimming or weight-control or a reduction in the sense of hunger or an increase in the sense of satiety or to the reduction of the available energy from the diet, which are indicated in the list provided for in paragraph 3 may be made without undergoing the procedures laid down in Articles 15 to 19, if they are: (i) based on generally accepted scientific evidence; and (ii) well understood by the average consumer.

2. [OSCURATO:PERSONA] shall provide the [OSCURATO:PERSONA] with lists of claims as referred to in paragraph 1 by 31 January 2008 at the latest accompanied by the conditions applying to them and by references to the relevant scientific justification.

3. After consulting the [[OSCURATO:PERSONA]] [OSCURATO:PERSONA] [EFSA], the [OSCURATO:PERSONA] shall adopt, … a Community list designed to amend non-essential elements of the [OSCURATO:PERSONA] by supplementing it, of permitted claims as referred to in paragraph 1, and all necessary conditions for the use of these claims by 31 January 2010 at the latest.

4. Any changes to the list referred to in paragraph 3, based on generally accepted scientific evidence and designed to amend non-essential elements of this [OSCURATO:PERSONA] by supplementing it, shall be adopted …, after consulting [the EFSA], on the [OSCURATO:PERSONA]’s own initiative or following a request by a [OSCURATO:PERSONA].

5. Any additions of claims to the list referred to in paragraph 3 based on newly developed scientific evidence … shall be adopted following the procedure laid down in [OSCURATO:PERSONA] 18, except claims referring to children's development and health ...’ 4 [OSCURATO:PERSONA] 28 of the regulation, entitled ‘Transitional measures’, provides in paragraphs 5 and 6: ‘5. [OSCURATO:PERSONA] claims as referred to in [OSCURATO:PERSONA] 13(1)(a) may be made from the date of entry into force of this [OSCURATO:PERSONA] until the adoption of the list referred to in [OSCURATO:PERSONA] 13(3), under the responsibility of food business operators provided that they comply with this [OSCURATO:PERSONA] and with existing national provisions applicable to them, and without prejudice to the adoption of safeguard measures as referred to in [OSCURATO:PERSONA] 24.

6. [OSCURATO:PERSONA] claims other than those referred to in [OSCURATO:PERSONA] 13(1)(a) and in [OSCURATO:PERSONA] 14(1)(a), which have been used in compliance with national provisions before the date of entry into force of this [OSCURATO:PERSONA], shall be subject to the following: (a) health claims which have been the subject of evaluation and authorisation in a [OSCURATO:PERSONA] shall be authorised as follows: (i) [OSCURATO:PERSONA] shall communicate to the [OSCURATO:PERSONA], 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 EFSA], the [OSCURATO:PERSONA] shall … adopt a decision concerning the health claims authorised in this way and designed to amend non-essential elements of this [OSCURATO:PERSONA] by supplementing it. [OSCURATO:PERSONA] 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 [OSCURATO:PERSONA]: such claims may continue to be used provided an application is made pursuant to this [OSCURATO:PERSONA] 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 [OSCURATO:PERSONA] 17(3).’ Background to the dispute 5 The relevant background to the dispute, as set out in the order under appeal, may be summarised as follows. 6 Following the adoption of [OSCURATO:PERSONA] 1924/2006, VSM, an undertaking producing and marketing pharmaceutical products and food supplements on the [OSCURATO:PERSONA] market and which, in that capacity, makes health claims on its product labels and in its advertising, submitted lists of health claims to the Netherlands authorities for the purposes of the authorisation procedure under [OSCURATO:PERSONA] 13(1) to (3) of that regulation. 7 By 31 January 2008, the [OSCURATO:PERSONA] had received approximately 44 000 health claims from the [OSCURATO:PERSONA] under [OSCURATO:PERSONA] 13(2) of that regulation.

On the basis of those national lists of claims, the [OSCURATO:PERSONA] compiled a consolidated list thereof. 8 On 24 July 2008, the [OSCURATO:PERSONA] formally submitted to the EFSA a request for a scientific opinion pursuant to [OSCURATO:PERSONA] 13(3) of [OSCURATO:PERSONA] 1924/2006.

On that occasion, the [OSCURATO:PERSONA] sent to the EFSA the first part of the consolidated list.

The remaining parts of that list were provided in November and December 2008, and by means of an addendum in March 2010, making the final number of health claims to be examined 4

637. [OSCURATO:PERSONA] 2009 and July 2011, the EFSA carried out the scientific assessment of the health claims submitted by the [OSCURATO:PERSONA]. 9 On 27 September 2010, the [OSCURATO:PERSONA] issued a press release on its webpage in which it stated that, given the large number of health claims and the delays in processing them, it was in favour of establishing a process allowing for gradual adoption of the list of claims permitted in the [OSCURATO:PERSONA].

According to the [OSCURATO:PERSONA], that change of priorities in the procedure for the adoption of that list was explained inter alia by tensions reported about the treatment of plant ingredients under the legislation on health claims and under legislation governing traditional herbal medicinal products, and by the need to continue the reflection on the treatment of those ingredients.

Consequently, it requested the EFSA to suspend temporarily its assessment of the health claims relating to botanical substances and to concentrate instead on all the other claims submitted with a view to completing the examination of those claims as soon as possible.

In that context, the [OSCURATO:PERSONA] explained that the health claims concerning substances other than botanical substances would be examined in a first stage, whereas claims relating to botanical substances would be examined in a second stage. 10 On 16 May 2012, the [OSCURATO:PERSONA] adopted [OSCURATO:PERSONA] (EU) No 432/2012 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 L 136, p. 1).

In that regulation the [OSCURATO:PERSONA] authorised a partial list of 222 health claims, corresponding to 497 entries in the consolidated list, for which the EFSA had essentially concluded that the information submitted was sufficient to establish a cause-and-effect relationship between a food category, a food or one of its constituents and the claimed effect. 11 On the same date, the [OSCURATO:PERSONA] drew up a list of more than 2 000 claims in respect of which the EFSA had not completed its evaluation or the [OSCURATO:PERSONA] itself had not yet taken a decision, and published that list on its website.

According to the [OSCURATO:PERSONA], those health claims, which concerned, inter alia, the effects of botanical substances, remained on hold and therefore could continue to be used in accordance with the transitional scheme provided for in [OSCURATO:PERSONA] 28(5) and (6) of [OSCURATO:PERSONA] 1924/2006.

Whereas the partial list of permitted claims was subsequently updated by the [OSCURATO:PERSONA], the health claims relating to botanical substances remain on hold. 12 By letter of 23 April 2014, VSM requested the [OSCURATO:PERSONA] to resume the assessment of the claims relating to botanical substances and in particular, instruct the EFSA to proceed with that assessment so that the definitive list of permitted claims could be adopted, as required under [OSCURATO:PERSONA] 13(3) of [OSCURATO:PERSONA] 1924/2006.

VSM also indicated that if the [OSCURATO:PERSONA] refused to act, it intended to bring proceedings before the [OSCURATO:PERSONA]. 13 By letter of 19 June 2014 (‘the letter of 19 June 2014’), the [OSCURATO:PERSONA] replied to VSM’s request to act, stating, inter alia, as follows: ‘As you are aware, the [OSCURATO:PERSONA] initiated a reflection on health claims on so called “botanicals” after concerns were raised by a number of [OSCURATO:PERSONA] and stakeholders with regard to the differentiated treatment of products containing such substances under the legislation on health claims and that on the [OSCURATO:PERSONA].

Pending the outcome of this reflection, the [OSCURATO:PERSONA] has asked the [EFSA] to discontinue its scientific assessment of health claims on botanicals. [OSCURATO:PERSONA] recognises the importance of this complex issue both for consumers and business operators.

However, to identify the best course of action needed, the [OSCURATO:PERSONA] should be allowed the time and context necessary for that purpose.’ 14 In response to that letter, VSM, by letter of 8 July 2014, once again requested the [OSCURATO:PERSONA] to instruct the EFSA to assess the health claims relating to botanical substances by 31 July 2014 at the latest.

It also informed the [OSCURATO:PERSONA] that, as a result of the [OSCURATO:PERSONA]’s failure to act, it had suffered damage and that, in the event of continued failure to act, it would instigate the legal proceedings necessary.

Procedure before the [OSCURATO:PERSONA] and the order under appeal 15 By application lodged at the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] on 1 August 2014, VSM requested the [OSCURATO:PERSONA], by way of principal claim, to declare that the [OSCURATO:PERSONA] had, since 1 August 2014, unlawfully failed to instruct the EFSA to assess health claims relating to botanical substances in accordance with the procedure laid down in [OSCURATO:PERSONA] 13(3) of [OSCURATO:PERSONA] 1924/2006 and, in the alternative, to annul the decision contained in the letter of 19 June 2014 not to initiate the assessment of those claims before 1 August 2014. 16 By separate document, lodged at the [OSCURATO:PERSONA] on 28 [OSCURATO:PERSONA] 2014, the [OSCURATO:PERSONA] raised an objection of inadmissibility, on which VSM submitted its observations on 12 December 2014, asking the [OSCURATO:PERSONA] to dismiss the objection and give a ruling on the merits of the case. 17 By the order under appeal, the [OSCURATO:PERSONA] dismissed VSM’s action as inadmissible and ordered it to pay the costs. 18 [OSCURATO:PERSONA] examined first of all the [OSCURATO:PERSONA]’s plea of inadmissibility alleging failure to comply with the conditions laid down in [OSCURATO:PERSONA] 265 TFEU and, in paragraph 38 of the order under appeal, held that the action for failure to act was inadmissible. 19 After observing, in paragraphs 26 and 27 of the order under appeal, that the requirements laid down in [OSCURATO:PERSONA] 265 TFEU for the admissibility of an action for failure to act are not met where the institution called upon to act has defined its position on that request before proceedings are brought, the [OSCURATO:PERSONA] concluded, in paragraphs 31 and 32 of that order, that the letter of 19 June 2014 was sufficiently clear and precise to enable VSM to be apprised of the [OSCURATO:PERSONA]’s position on its request, namely that the [OSCURATO:PERSONA] would not be instructing the EFSA to initiate the assessment requested, and that, as a consequence, the letter of 19 June 2014 had to be regarded as defining the [OSCURATO:PERSONA]’s position within the meaning of the second paragraph of [OSCURATO:PERSONA] 265 TFEU, thus bringing the [OSCURATO:PERSONA]’s failure to act to an end. 20 [OSCURATO:PERSONA] then observed, in paragraph 33 of that order, that the fact that the [OSCURATO:PERSONA]’s reply did not satisfy VSM was immaterial. [OSCURATO:PERSONA] 265 TFEU refers to failure to act in the sense of failure to take a decision or to define a position, not the fact that a measure different from that desired by the persons concerned has been adopted. 21 [OSCURATO:PERSONA] went on to hold, in paragraph 34 of the order under appeal, that the action for failure to act was inadmissible in so far as it was based on the invitation to act of 23 April 2014. 22 Furthermore, as regards the invitation to act contained in the letter of 8 July 2014, the [OSCURATO:PERSONA] held, in paragraphs 35 and 36 of that order, that the action for failure to act was premature, as it was lodged on 4 August 2014, more than a month before the expiry, on 8 September 2014, of the two-month time-limit within which the institution concerned is required under [OSCURATO:PERSONA] 265 TFEU to provide a response to the request submitted to it. [OSCURATO:PERSONA] accordingly declared the action for failure to act inadmissible in so far as it was based on that invitation to act. 23 Secondly, for the sake of completeness, the [OSCURATO:PERSONA] examined the [OSCURATO:PERSONA]’s plea of inadmissibility alleging that VSM had no interest in bringing proceedings and held, in paragraph 68 of the order under appeal, that the action for failure to act was also inadmissible on grounds of VSM’s having no interest in bringing proceedings. 24 [OSCURATO:PERSONA] concluded in that regard that VSM had not adduced evidence establishing sufficiently how the EFSA’s resumption of assessments of the health claims relating to botanical substances and the adoption of the definitive list of permitted health claims was liable to procure a definite advantage for it. 25 [OSCURATO:PERSONA] held, in paragraphs 50, 53 and 54 of the order under appeal, that it follows from the wording of [OSCURATO:PERSONA] 28(5) and (6) of [OSCURATO:PERSONA] 1924/2006 that provision is made for the application of transitional measures, following the adoption of that regulation, for health claims which are still being assessed and for which the [OSCURATO:PERSONA] is yet to adopt a decision.

In those circumstances, undertakings affected by claims on hold may continue to make those claims, provided they comply with [OSCURATO:PERSONA] 28(5) and (6) of that regulation. 26 Consequently, according to the [OSCURATO:PERSONA], [OSCURATO:PERSONA] 17(5) of [OSCURATO:PERSONA] 1924/2006, which allows, in principle, any food business operator to make permitted health claims included in the definitive list, places permitted health claims in the same situation as health claims on hold, that is to say, in a situation in which they may be used for the marketing of food. 27 [OSCURATO:PERSONA] further held, in paragraphs 55 and 56 of the order under appeal, that, in any event, even if it could be established that [OSCURATO:PERSONA] 17(5) of [OSCURATO:PERSONA] 1924/2006 had consequences for VSM’s legal situation by comparison, inter alia, with its situation under the transitional provisions provided for in [OSCURATO:PERSONA] 28(5) and (6) of the regulation, it was clear that there would be an advantage for VSM, by definition, only if its claims on hold were authorised at the conclusion of the EFSA’s assessment and in the [OSCURATO:PERSONA]’s final decision.

That premiss remained, for the time being, a premiss and, for that reason, could not satisfy the requirements of the case-law, which established that, if the interest pleaded by an applicant concerns a future legal situation, it must demonstrate that the prejudice to that situation is already certain. [OSCURATO:PERSONA] pointed out in that regard that, under [OSCURATO:PERSONA] 432/2012, which established a partial list of permitted health claims, the [OSCURATO:PERSONA] had authorised only 222 claims out of a total of more than 2 000 claims examined. 28 Lastly, the [OSCURATO:PERSONA] in paragraphs 60, 62 and 66 of the order under appeal respectively, rejected VSM’s arguments to the effect that the lack of a complete, definitive [OSCURATO:PERSONA] decision had given rise to unequal conditions of competition and legal uncertainty on the market, as well as to financial loss for VSM. 29 Thirdly, the [OSCURATO:PERSONA] examined the request for annulment of the letter of 19 June 2014 and concluded, in paragraphs 81 and 82 of the order under appeal, that that letter could not be regarded as a challengeable act for the purposes of [OSCURATO:PERSONA] 263 TFEU and accordingly held that request to be inadmissible. 30 In paragraphs 71 and 72 of the order under appeal, the [OSCURATO:PERSONA] referred to the case-law according to which only measures the legal effects of which are binding on and capable of affecting the interests of the applicant by bringing about a distinct change in his legal position are acts or decisions which may be the subject of an action for annulment for the purpose of [OSCURATO:PERSONA] 263 TFEU, adding that, in order to ascertain whether or not a measure which has been challenged produces such effects, it is necessary to look to its substance, with the form in which such acts or decisions are cast being, in principle, immaterial as regards the question whether they can be challenged through an action for annulment. 31 In paragraph 73 of the order under appeal, the [OSCURATO:PERSONA] took the view that, in the light of its content, the letter of 19 June 2014 could not be regarded as a challengeable act since, in that letter, the [OSCURATO:PERSONA] had simply set out the reason why it had initially been agreed that the procedure for the scientific assessment of the health claims relating to botanical substances should be suspended and went on to inform VSM that the [OSCURATO:PERSONA] needed more time and a more precise context to identify the best course of action. 32 [OSCURATO:PERSONA] further noted in paragraph 74 of the order under appeal that, in so far as [OSCURATO:PERSONA] 13(1) to (3) of [OSCURATO:PERSONA] 1924/2006 does not set out the detailed rules in accordance with which the [OSCURATO:PERSONA] is required to fulfil its task consisting in adopting the list of permitted claims, that provision leaves it to the discretion of that institution to define, in accordance with the principles laid down in [OSCURATO:PERSONA] 1924/2006 and in EU law, the speed at which the list of permitted claims is to be adopted, imposing on it only an obligation as to the result to be attained.

In that same paragraph of the order, the [OSCURATO:PERSONA] noted the settled case-law, according to which if the [OSCURATO:PERSONA] is to be able to pursue effectively the objective assigned to it, account being taken of the complex technical assessments which it must undertake, it must be recognised as enjoying a broad discretion.

Forms of order sought 33 By its appeal, VSM claims that the [OSCURATO:PERSONA] should: – set aside the order under appeal in its entirety; – annul in its entirety the decision of the President of the [OSCURATO:PERSONA] not to include in the case file the letters lodged on 22 and 24 July 2015 in [OSCURATO:PERSONA] T‑578/14; – by way of principal claim, declare that the [OSCURATO:PERSONA] has, since 1 August 2014, unlawfully failed to instruct the EFSA to assess health claims relating to botanical substances in accordance with the procedure laid down in [OSCURATO:PERSONA] 13(3) of [OSCURATO:PERSONA] 1924/2006 and, in the alternative, annul the decision contained in the letter of 19 June 2014 not to instruct the EFSA to assess those claims in accordance with the procedure laid down in [OSCURATO:PERSONA] 13 of [OSCURATO:PERSONA] 1924/2006 before 1 August 2014, and – order the [OSCURATO:PERSONA] to pay the costs. 34 [OSCURATO:PERSONA] contends that the appeal should be dismissed and VSM ordered to bear its own costs and to pay those incurred by the [OSCURATO:PERSONA] at first instance and on appeal.

The appeal 35 [OSCURATO:PERSONA] 181 of its [OSCURATO:PERSONA] of Procedure, where an appeal is, in whole or in part, clearly inadmissible or clearly unfounded, the [OSCURATO:PERSONA] may at any time, acting on a report from the Judge-Rapporteur and after hearing the [OSCURATO:PERSONA], by reasoned order decide to dismiss the appeal in whole or in part, without opening the oral procedure. 36 That provision should be applied in the present case. 37 VSM puts forward six grounds in support of its appeal.

The first four grounds allege errors of law committed by the [OSCURATO:PERSONA] in the assessment of: (i) compliance by VSM with the time-limits for actions for failure to act under [OSCURATO:PERSONA] 265 TFEU; (ii) its interest in bringing proceedings in the procedure before the [OSCURATO:PERSONA]; (iii) the insufficient protection given to VSM and other food business operators by the transitional measures provided for in [OSCURATO:PERSONA] 28 of [OSCURATO:PERSONA] 1924/2006; and (iv) the [OSCURATO:PERSONA]’s broad discretion under [OSCURATO:PERSONA] 13(3) of that regulation.

The fifth ground alleges that the [OSCURATO:PERSONA], in failing to act, infringed its obligations under that regulation, [OSCURATO:PERSONA] 41 of the [OSCURATO:PERSONA] of [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] (‘the [OSCURATO:PERSONA]’), [OSCURATO:PERSONA] 168 TFEU, the principle of effectiveness of that same regulation and the principle venire contra factum proprium .

Lastly, by its sixth ground of appeal, VSM criticises the [OSCURATO:PERSONA] for having infringed its own procedural rules in deciding not to include its letters of 22 and 24 July 2015 in the case file.

Admissibility of the appeal as a whole 38 [OSCURATO:PERSONA] disputes the admissibility of the appeal in its entirety. 39 It submits that VSM puts forward, in a very confusing order, a number of general criticisms, instead of challenging in sequence the grounds on which the order under appeal is based. [OSCURATO:PERSONA] submits in that regard that, contrary to what is provided for in [OSCURATO:PERSONA] 169(2) of the [OSCURATO:PERSONA] of Procedure of the [OSCURATO:PERSONA] of Justice, neither the legal grounds of appeal nor the arguments put forward by VSM identify precisely which paragraphs of the reasons in that order are being challenged. 40 It should be borne in mind in that regard that it is apparent from the second subparagraph of [OSCURATO:PERSONA] 256(1) TFEU, the first paragraph of [OSCURATO:PERSONA] 58 of the Statute of the [OSCURATO:PERSONA] of Justice and Articles 168(1)(d) and 169(2) of the [OSCURATO:PERSONA] of Procedure that an appeal must identify precisely the contested points in the grounds of the judgment which the appellant seeks to have set aside and indicate precisely the legal arguments specifically advanced in support of the appeal, failing which the appeal or ground of appeal concerned is inadmissible (judgment of 3 September 2015, [OSCURATO:PERSONA] and Others v

[OSCURATO:PERSONA]

, C‑398/13 P, EU:C:2015:535, paragraph 53, and order of 15 [OSCURATO:PERSONA] 2015, [OSCURATO:PERSONA] and [OSCURATO:PERSONA] do [OSCURATO:PERSONA] v

[OSCURATO:PERSONA]

, C‑93/15 P, not published, EU:C:2015:703, paragraph 21). 41 Accordingly, a ground of appeal supported by an argument that is not sufficiently clear and precise to enable the [OSCURATO:PERSONA] to exercise its powers of judicial review, in particular because essential elements on which the ground of appeal is based are not indicated sufficiently coherently and intelligibly in the text of the appeal, which is worded in a vague and ambiguous manner in that regard, does not satisfy those requirements and must be dismissed as inadmissible (judgment of 10 July 2014, Telefónica and Telefónica de España v

[OSCURATO:PERSONA]

, C‑295/12 P, EU:C:2014:2062, paragraph 30 and the case-law cited). [OSCURATO:PERSONA] has also held that an appeal lacking any coherent structure which simply makes general statements and contains no specific indications as to the points of the order under appeal which may be vitiated by an error of law must be dismissed as clearly inadmissible (judgment of 10 July 2014, Telefónica and Telefónica de España v

[OSCURATO:PERSONA]

, C‑295/12 P, EU:C:2014:2062, paragraph 30 and the case-law cited). 42 In the present case, although it is true in respect of the first four grounds of appeal that the structure of the appeal and VSM’s formulation and presentation of the grounds of appeal may lack rigour, it is nevertheless possible to identify the elements of the order under appeal that are being challenged, as VSM has set out the relevant passages of that order in paragraph 16 of the appeal (see, by analogy, judgment of 24 mars 2011, ISD Polska and Others v

[OSCURATO:PERSONA]

, C‑369/09 P, EU:C:2011:175, paragraph 67). 43 Consequently, the present appeal is not inadmissible in its entirety for the reasons put forward by the [OSCURATO:PERSONA].

Accordingly, the [OSCURATO:PERSONA]’s objection of inadmissibility directed at the appeal as a whole must be rejected and it is appropriate to consider in turn each ground of appeal put forward in support thereof.

Consideration of the grounds of appeal The first ground of appeal 44 By its first ground of appeal, VSM criticises the [OSCURATO:PERSONA] for having erred in law by holding, in paragraphs 23 to 38 of the order under appeal, that VSM had not complied with the time-limits laid down in the second paragraph of [OSCURATO:PERSONA] 265 TFEU. 45 [OSCURATO:PERSONA] contends, as its principal argument, that this ground of appeal is inadmissible or, in the alternative, clearly unfounded. 46 It should be observed that, in its first ground of appeal, VSM has not put forward any legal line of argument substantiating specifically the request for annulment of the order under appeal.

In particular, VSM does not challenge the [OSCURATO:PERSONA] reasoning concerning the issue of compliance with those time-limits, merely stating that ‘[t]he [OSCURATO:PERSONA] argues that [VSM] did not meet the time lines for the complaint [thereby violating] EU law’.

On the contrary, VSM’s arguments are directed solely at the [OSCURATO:PERSONA]’s conduct and, as correctly pointed out by the [OSCURATO:PERSONA] in its response, is a pure and simple repetition of the observations on the objection of inadmissibility put forward by VSM before the [OSCURATO:PERSONA]. 47 However, the requirements referred to in paragraph 40 above cannot be satisfied by a ground of appeal which, without even including arguments aimed specifically at identifying the error of law allegedly vitiating the order under appeal, merely reproduces arguments already put forward before the [OSCURATO:PERSONA].

A ground of appeal such as that is, in reality, an attempt to have reconsidered an argument put forward before the [OSCURATO:PERSONA], which falls outside the jurisdiction of the [OSCURATO:PERSONA] of Justice (see, to that effect, order of 15 [OSCURATO:PERSONA] 2015, [OSCURATO:PERSONA] and [OSCURATO:PERSONA] do [OSCURATO:PERSONA] v

[OSCURATO:PERSONA]

, C‑93/15 P, not published, EU:C:2015:703, paragraph 22). 48 It follows that, in the light of the case-law cited in the foregoing paragraph, the first ground of appeal put forward by VSM does not satisfy the requirements of precision and clarity for a ground of appeal and, moreover, is merely a request to have reconsidered arguments that were put forward at first instance, contrary to the requirements imposed by both the Statute of the [OSCURATO:PERSONA] of Justice of the [OSCURATO:PERSONA] and by the [OSCURATO:PERSONA] of Procedure (see, to that effect, order of 15 [OSCURATO:PERSONA] 2015, [OSCURATO:PERSONA] and [OSCURATO:PERSONA] do [OSCURATO:PERSONA] v

[OSCURATO:PERSONA]

, C‑93/15 P, not published, EU:C:2015:703, paragraph 28). 49 Consequently, this ground of appeal must be rejected as clearly inadmissible.

The second ground of appeal 50 By its second ground of appeal, which comprises two parts, VSM criticises the [OSCURATO:PERSONA] for having held that its action for failure to act and for annulment was inadmissible on the ground that it had no interest in bringing proceedings, and maintains that, on the contrary, its interests were significantly affected. 51 In the [OSCURATO:PERSONA]’s submission, this ground of appeal is, in the main, inadmissible and, in the alternative, clearly unfounded. 52 By the first part of its second ground of appeal, VSM submits that, in paragraphs 39 to 68 of the order under appeal, the [OSCURATO:PERSONA] held, incorrectly, that its action for failure to act was inadmissible on grounds of its having no interest in bringing proceedings. 53 In that regard, it should be borne in mind that, according to the [OSCURATO:PERSONA] settled case-law, arguments directed against grounds included in a decision of the [OSCURATO:PERSONA] purely for the sake of completeness cannot lead to the decision being set aside and are therefore ineffective ab initio (judgment of 2 September 2010,

[OSCURATO:PERSONA]

v

[OSCURATO:PERSONA]

, C‑399/08 P, EU:C:2010:481, paragraph 75). 54 In the present case, after upholding the [OSCURATO:PERSONA]’s plea of inadmissibility put forward on the basis of non-compliance with the time-limits laid down in [OSCURATO:PERSONA] 265 TFEU and, consequently, dismissing the action for failure to act as inadmissible, the [OSCURATO:PERSONA] found, in paragraph 39 of the order under appeal, that ‘[i]t [was] therefore merely for the sake of completeness that the [OSCURATO:PERSONA]’s plea of inadmissibility alleging that the applicant [had] no interest in bringing proceedings [would] be examined’. 55 Consequently, even assuming that the reasoning contained in paragraphs 40 to 68 of the order under appeal, concerning the assessment of the [OSCURATO:PERSONA]’s plea of inadmissibility alleging a lack of interest in bringing proceedings, were wrong in law, that finding would not affect the outcome of the appeal (see, to that effect, judgment of 2 September 2010,

[OSCURATO:PERSONA]

v

[OSCURATO:PERSONA]

, C‑399/08 P, EU:C:2010:481, paragraph 77). 56 In those circumstances, the first part of the second ground of appeal is ineffective ab initio and must be rejected as inadmissible. 57 By the second part of its second ground of appeal, VSM submits that the [OSCURATO:PERSONA] erred in paragraphs 69 to 82 of the order under appeal in holding its request for annulment to be inadmissible on the ground that it had no interest in bringing proceedings. 58 It should be noted in that regard that, in its reasoning set out in paragraphs 69 to 82 of the order under appeal, the [OSCURATO:PERSONA] did not examine directly VSM’s interest in bringing proceedings. 59 First of all, in paragraphs 71 to 73 and 76 of the order under appeal, the [OSCURATO:PERSONA] analysed the categorisation of the letter of 19 June 2014 as a challengeable act under [OSCURATO:PERSONA] 263 TFEU and concluded that that letter, which was purely informative in nature, was not a measure producing binding legal effects and capable of affecting VSM’s interests by bringing about a distinct change in its legal position.

Next, in paragraphs 74 and 75 of its order, the [OSCURATO:PERSONA] examined the scope of the [OSCURATO:PERSONA]’s obligations under [OSCURATO:PERSONA] 13(3) of [OSCURATO:PERSONA] 1924/2006 and held, in particular, that the [OSCURATO:PERSONA] was free to establish the list of permitted claims on a gradual basis.

Lastly, in paragraphs 77 to 80 of its order, the [OSCURATO:PERSONA] held that it was not possible, on the basis of the principle requiring that access be given to the courts and the principle of effective judicial protection, for an action for annulment not meeting the requirements for admissibility laid down in [OSCURATO:PERSONA] 263 TFU to be deemed admissible. 60 It follows that the second part of the second ground of appeal, which moreover lacks reasons, is based on an incorrect reading of the order under appeal and must be rejected as clearly unfounded. 61 Consequently, VSM’s second ground of appeal must be rejected as partly ineffective ab initio and partly clearly unfounded.

The third ground of appeal 62 By its third ground of appeal, VSM criticises the [OSCURATO:PERSONA] for having infringed [OSCURATO:PERSONA] 1924/2006 and the [OSCURATO:PERSONA] in having held, in paragraphs 46 to 50 of the order under appeal, that the transitional measures laid down in [OSCURATO:PERSONA] 28 of that regulation were insufficient protection for food business operators, who derived no definite advantage from the adoption of the definitive list of permitted health claims. 63 [OSCURATO:PERSONA] contends that this ground of appeal is, in the main, inadmissible and, in the alternative, clearly unfounded. 64 Suffice it to observe in that regard that this ground of appeal also refers to reasons in the order under appeal which were set out for the sake of completeness.

Therefore, for the same reasons as set out in paragraphs 53 to 55 above, the third ground of appeal is ineffective ab initio and must accordingly be rejected.

The fourth ground of appeal 65 By its fourth ground of appeal, which comprises two parts, VSM criticises the [OSCURATO:PERSONA] for having infringed [OSCURATO:PERSONA] 13(3) of [OSCURATO:PERSONA] 1924/2006 and the [OSCURATO:PERSONA], by having held, in paragraphs 73 to 75 of the order under appeal, that the [OSCURATO:PERSONA] has broad discretion in adopting the definitive list of permitted health claims. 66 By the first part of its fourth ground of appeal, VSM submits that the [OSCURATO:PERSONA] erred in law in holding that the [OSCURATO:PERSONA] enjoys broad discretion in its courses of action in the adoption of that list. 67 It should be noted in that regard that VSM merely stated as follows in support of its assertions: ‘Since consulting with EFSA is mandatory for the [OSCURATO:PERSONA] before taking any decision on specific [OSCURATO:PERSONA], stopping this consulting procedure is a clear violation of the law. … [T]here is no discretion for the [OSCURATO:PERSONA] [as to] how to proceed. [OSCURATO:PERSONA] must consult with EFSA before taking any decision.

For this reason the [OSCURATO:PERSONA] failed with the argument that the [OSCURATO:PERSONA] has a broad discretion in the question how to act.’ 68 Yet according to the [OSCURATO:PERSONA] consistent case-law, referred to in paragraphs 40 and 41 above, a ground of appeal supported by an argument that is not sufficiently clear and precise to enable the [OSCURATO:PERSONA] to exercise its powers of judicial review, in particular because essential elements on which the ground of appeal is based are not indicated sufficiently coherently and intelligibly in the text of the appeal, because it is worded in a vague manner or because it does not indicate precisely the legal arguments specifically advanced in support of the application for annulment of a decision. 69 It is clear in that regard that the first part of the fourth ground of appeal lacks coherence, clarity and relevance because it does not show an unequivocal link between the requirements of [OSCURATO:PERSONA] 13(3) of [OSCURATO:PERSONA] 1924/2006, the conduct in respect of which the [OSCURATO:PERSONA] is specifically criticised and the error of law allegedly made by the [OSCURATO:PERSONA].

In particular, VSM’s line of argument, which is supposed to support the request to have the order under appeal set aside, does not refer specifically to the reasoning set out by the [OSCURATO:PERSONA] in paragraphs 73 to 75 of that order, which does not enable the [OSCURATO:PERSONA] to exercise its powers of judicial review. 70 Consequently, the first part of the fourth ground of appeal must be rejected as clearly inadmissible. 71 By the second part of its fourth ground of appeal, VSM submits that the [OSCURATO:PERSONA] erred in law in holding that the [OSCURATO:PERSONA] enjoys broad discretion as to when to act in adopting the definitive list of permitted health claims. 72 [OSCURATO:PERSONA] contends in that regard that it follows from the [OSCURATO:PERSONA] judgment of 12 June 2015, [OSCURATO:PERSONA] and Others v

[OSCURATO:PERSONA]

(T‑296/12, EU:T:2015:375) that it has broad discretion as to the pace leading to the adoption of that list. [OSCURATO:PERSONA] refers in particular in paragraphs 65 to 69 of that judgment, where the [OSCURATO:PERSONA] held that it could not be inferred from the wording of [OSCURATO:PERSONA] 1924/2006 that the EU legislature intended to prohibit the [OSCURATO:PERSONA] from adopting the list of permitted claims in several stages. 73 It is common ground in that regard that, under [OSCURATO:PERSONA] 13(3) of [OSCURATO:PERSONA] 1924/2006, the [OSCURATO:PERSONA] was required to adopt the list of permitted claims by 31 January 2010 at the latest and that, as at 16 May 2012, that list had been adopted only partially by [OSCURATO:PERSONA] 432/2012. 74 Concerning that question, in paragraph 74 of the order under appeal, the [OSCURATO:PERSONA] held that, in so far as [OSCURATO:PERSONA] 13(1) to (3) of [OSCURATO:PERSONA] 1924/2006 does not set out the detailed rules in accordance with which the [OSCURATO:PERSONA] is required to fulfil its task, in particular whether the [OSCURATO:PERSONA] may defer authorisation of health claims for which the EFSA has not completed its assessment, that provision leaves it to the discretion of that institution to define, in accordance with the principles laid down in [OSCURATO:PERSONA] 1924/2006 and in EU law, the speed at which the list of permitted claims is to be adopted. [OSCURATO:PERSONA] went on to state that the [OSCURATO:PERSONA] may complete that list as and when technical evaluations have been completed by the EFSA and verify itself the conditions established in the regulation, explaining that [OSCURATO:PERSONA] 13 thereof must be interpreted as imposing on the [OSCURATO:PERSONA] only an obligation as to the result to be attained, namely that of adopting, after consulting the EFSA, the list of permitted claims on the basis of the national lists provided by the [OSCURATO:PERSONA]. 75 Yet under the second part of the fourth ground of appeal, VSM submits that, under [OSCURATO:PERSONA] 1924/2006, all decisions on health claims had to be taken by the [OSCURATO:PERSONA] no later than 31 January 2010 and that after that date it had no discretion to take a decision on those claims. 76 [OSCURATO:PERSONA] was correct in holding, in paragraph 74 of the order under appeal, that, in so far as [OSCURATO:PERSONA] 13(1) to (3) of [OSCURATO:PERSONA] 1924/2006 does not set out the detailed rules in accordance with which the [OSCURATO:PERSONA] is required to fulfil its task, that provision leaves it to the discretion of that institution to define, in accordance with the principles laid down in that regulation and in EU law, the speed at which the list of permitted claims is to be adopted. 77 It should also be noted that [OSCURATO:PERSONA] 13(4) and (5) of [OSCURATO:PERSONA] 1924/2006 provides for the possibility of changing the list of permitted claims either on the basis of generally accepted scientific evidence, or on the basis of newly established scientific evidence.

It must therefore be considered that that provision does not preclude that list from being added to on a gradual basis, in the light of the scientific data available, and, consequently, to the fact that it is of a progressive nature. 78 It follows that the second part of the fourth ground of appeal must be rejected as being clearly unfounded. 79 In the light of the foregoing considerations, the fourth ground of appeal must be dismissed as being in part clearly inadmissible and in part clearly unfounded.

The fifth ground of appeal 80 VSM’s fifth ground of appeal alleges infringement by the [OSCURATO:PERSONA] due to its inaction, contrary to its obligations under [OSCURATO:PERSONA] 1924/2006, [OSCURATO:PERSONA] 41 of the [OSCURATO:PERSONA], [OSCURATO:PERSONA] 168 TFEU, the principle of effectiveness of [OSCURATO:PERSONA] 1924/2006 and the principle venire contra factum proprium . 81 It should be noted that, in this ground of appeal, VSM merely directs criticisms at the [OSCURATO:PERSONA]’s conduct, without specifying any paragraph of the reasons in the order under appeal that is being challenged or identifying the least error of law vitiating that order.

Therefore, a ground of appeal of this nature, directed not at a decision of the [OSCURATO:PERSONA] but at an act of an institution, does not satisfy the requirements of the first paragraph of [OSCURATO:PERSONA] 56 of the Statute of the [OSCURATO:PERSONA] of Justice of the [OSCURATO:PERSONA] and [OSCURATO:PERSONA] 169 of the [OSCURATO:PERSONA] of Procedure of the [OSCURATO:PERSONA] of Justice. 82 In view of the foregoing, the fifth ground of appeal must be rejected as being clearly inadmissible.

The sixth ground of appeal 83 By its sixth ground of appeal, VSM criticises the [OSCURATO:PERSONA] for having infringed its own procedural rules in deciding not to include its letters of 22 and 24 July 2015 in the case file. 84 Suffice it to observe in that regard that nor is this ground of appeal directed at the order under appeal, contrary to [OSCURATO:PERSONA] 169 of the [OSCURATO:PERSONA] of Procedure of the [OSCURATO:PERSONA] of Justice, but rather concerns a separate decision of the President of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] delivered in judicial proceedings.

It must therefore be dismissed as clearly inadmissible. 85 Since none of the grounds of appeal has been successful, the appeal must be dismissed in its entirety.

The application for leave to intervene 86 In the light of the foregoing, there is no need to rule on the application for leave to intervene in support of the forms of order sought by VSM, lodged on 31 March 2016 by the [OSCURATO:PERSONA] of [OSCURATO:PERSONA] (EUCOPE).

Costs 87 [OSCURATO:PERSONA] 138(1) of the [OSCURATO:PERSONA] of Procedure of the [OSCURATO:PERSONA] of Justice, applicable to appeal proceedings by virtue of [OSCURATO:PERSONA] 184(1) thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. 88 Since the [OSCURATO:PERSONA] has applied for costs and VSM has been unsuccessful in all its grounds of appeal, it must be ordered to pay the costs incurred in the present appeal proceedings. 89 Moreover, under [OSCURATO:PERSONA] 142 of the [OSCURATO:PERSONA] of Procedure of the [OSCURATO:PERSONA] of Justice, where there is no need to rule, including no need to rule on applications for leave to intervene, costs are in the discretion of the [OSCURATO:PERSONA]. 90 In those circumstances, VSM and EUCOPE are to bear their own costs relating to EUCOPE’s application for leave to intervene.

On those grounds, the [OSCURATO:PERSONA] ([OSCURATO:PERSONA]) hereby orders:

1. The appeal is dismissed.

2. There is no need to rule on the application for leave to intervene lodged by the [OSCURATO:PERSONA] of [OSCURATO:PERSONA] (EUCOPE).

3. VSM Geneesmiddelen BV shall pay the costs relating to the appeal proceedings.

4. VSM Geneesmiddelen BV and the [OSCURATO:PERSONA] of [OSCURATO:PERSONA] (EUCOPE) shall bear their own costs relating to EUCOPE’s application for leave to intervene. [Signatures] * Language of the case: English.

Anonimizzato ex art. 52 D.Lgs. 196/2003
[OSCURATO:PERSONA] ([OSCURATO:PERSONA]) 25 [OSCURATO:PERSONA] 2016 ( * ) (Appeal — [OSCURATO:PERSONA] 181 of the [OSCURATO:PERSONA] of Procedure of the [OSCURATO:PERSONA] of Justice — Public health — Consumer protection — [OSCURATO:PERSONA] (EC) No 1924/2006 — [OSCURATO:PERSONA] claims on foods — [OSCURATO:PERSONA] 13(3) — Community list of permitted health claims on foods — Botanical substances — [OSCURATO:PERSONA] on hold — Action for failure to act and for annulment — Definition of position by the [OSCURATO:PERSONA] — Challengeable act) [OSCURATO:PERSONA] C‑637/15 P, APPEAL under [OSCURATO:PERSONA] 56 of the Statute of the [OSCURATO:PERSONA] of Justice of the [OSCURATO:PERSONA], brought on 1 December 2015, VSM Geneesmiddelen BV, established in Alkmaar (Netherlands), represented by U. Grundmann, Rechtsanwalt, appellant, the other party to the proceedings being: [OSCURATO:PERSONA], represented by M. Wilderspin and S. Grünheid, acting as Agents, defendant at first instance, [OSCURATO:PERSONA] ([OSCURATO:PERSONA]), composed of M. Vilaras, President of the [OSCURATO:PERSONA], M. Safjan (Rapporteur) and D. Šváby, [OSCURATO:PERSONA], [OSCURATO:PERSONA]: Y. Bot, Registrar: A. [OSCURATO:PERSONA], having decided, after hearing the [OSCURATO:PERSONA], to give a decision by reasoned order, in accordance with [OSCURATO:PERSONA] 181 of the [OSCURATO:PERSONA] of Procedure of the [OSCURATO:PERSONA], makes the following [OSCURATO:PERSONA] 1 By its appeal, VSM Geneesmiddelen BV (‘VSM’) seeks annulment of the order of 16 September 2015 of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA], VSM Geneesmiddelen v [OSCURATO:PERSONA] (T‑578/14, not published, EU:T:2015:715) (‘the order under appeal’), by which it dismissed its action, seeking, by way of principal claim, a declaration that the [OSCURATO:PERSONA] failed to act in that it unlawfully failed to instruct the [OSCURATO:PERSONA] (EFSA) to assess health claims relating to botanical substances for the adoption of the definitive list of permitted claims in accordance with [OSCURATO:PERSONA] 13(3) of [OSCURATO:PERSONA] (EC) No 1924/2006 of the [OSCURATO:PERSONA] and of the Council of 20 December 2006 on nutrition and health claims made on foods (OJ 2006 L 404, p. 9 and corrigendum OJ 2007, L 12, p. 3), as amended by [OSCURATO:PERSONA] (EC) No 109/2008 of the [OSCURATO:PERSONA] and of the Council of 15 January 2008 (OJ 2008, L 39, p. 14) (‘[OSCURATO:PERSONA] 1924/2006’) and, in the alternative, annulment of the decision purportedly contained in the [OSCURATO:PERSONA]’s letter of 19 June 2014 refusing to instruct the EFSA to assess those claims. Legal context 2 [OSCURATO:PERSONA] 2 of [OSCURATO:PERSONA] 1924/2006 is entitled ‘Definitions’; [OSCURATO:PERSONA] 2(2)(5) defines a ‘health claim’ 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’. 3 [OSCURATO:PERSONA] 13 of [OSCURATO:PERSONA] 1924/2006, entitled ‘[OSCURATO:PERSONA] claims other than those referring to the reduction of disease risk and to children’s development and health’, provides: ‘1.      [OSCURATO:PERSONA] claims describing or referring to: (a)      the role of a nutrient or other substance in growth, development and the functions of the body; (b)      psychological and behavioural functions; or (c)      without prejudice to [[OSCURATO:PERSONA]] Directive 96/8/EC [of 26 February 1996 on foods intended for use in energy-restricted diets for weight reduction (OJ 1996 L 55, p. 22)], slimming or weight-control or a reduction in the sense of hunger or an increase in the sense of satiety or to the reduction of the available energy from the diet, which are indicated in the list provided for in paragraph 3 may be made without undergoing the procedures laid down in Articles 15 to 19, if they are: (i)      based on generally accepted scientific evidence; and (ii)      well understood by the average consumer. 2.      [OSCURATO:PERSONA] shall provide the [OSCURATO:PERSONA] with lists of claims as referred to in paragraph 1 by 31 January 2008 at the latest accompanied by the conditions applying to them and by references to the relevant scientific justification. 3.      After consulting the [[OSCURATO:PERSONA]] [OSCURATO:PERSONA] [EFSA], the [OSCURATO:PERSONA] shall adopt, … a Community list designed to amend non-essential elements of the [OSCURATO:PERSONA] by supplementing it, of permitted claims as referred to in paragraph 1, and all necessary conditions for the use of these claims by 31 January 2010 at the latest. 4.      Any changes to the list referred to in paragraph 3, based on generally accepted scientific evidence and designed to amend non-essential elements of this [OSCURATO:PERSONA] by supplementing it, shall be adopted …, after consulting [the EFSA], on the [OSCURATO:PERSONA]’s own initiative or following a request by a [OSCURATO:PERSONA]. 5.      Any additions of claims to the list referred to in paragraph 3 based on newly developed scientific evidence … shall be adopted following the procedure laid down in [OSCURATO:PERSONA] 18, except claims referring to children's development and health ...’ 4 [OSCURATO:PERSONA] 28 of the regulation, entitled ‘Transitional measures’, provides in paragraphs 5 and 6: ‘5.      [OSCURATO:PERSONA] claims as referred to in [OSCURATO:PERSONA] 13(1)(a) may be made from the date of entry into force of this [OSCURATO:PERSONA] until the adoption of the list referred to in [OSCURATO:PERSONA] 13(3), under the responsibility of food business operators provided that they comply with this [OSCURATO:PERSONA] and with existing national provisions applicable to them, and without prejudice to the adoption of safeguard measures as referred to in [OSCURATO:PERSONA] 24. 6.      [OSCURATO:PERSONA] claims other than those referred to in [OSCURATO:PERSONA] 13(1)(a) and in [OSCURATO:PERSONA] 14(1)(a), which have been used in compliance with national provisions before the date of entry into force of this [OSCURATO:PERSONA], shall be subject to the following: (a)      health claims which have been the subject of evaluation and authorisation in a [OSCURATO:PERSONA] shall be authorised as follows: (i)      [OSCURATO:PERSONA] shall communicate to the [OSCURATO:PERSONA], 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 EFSA], the [OSCURATO:PERSONA] shall … adopt a decision concerning the health claims authorised in this way and designed to amend non-essential elements of this [OSCURATO:PERSONA] by supplementing it. [OSCURATO:PERSONA] 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 [OSCURATO:PERSONA]: such claims may continue to be used provided an application is made pursuant to this [OSCURATO:PERSONA] 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 [OSCURATO:PERSONA] 17(3).’ Background to the dispute 5 The relevant background to the dispute, as set out in the order under appeal, may be summarised as follows. 6 Following the adoption of [OSCURATO:PERSONA] 1924/2006, VSM, an undertaking producing and marketing pharmaceutical products and food supplements on the [OSCURATO:PERSONA] market and which, in that capacity, makes health claims on its product labels and in its advertising, submitted lists of health claims to the Netherlands authorities for the purposes of the authorisation procedure under [OSCURATO:PERSONA] 13(1) to (3) of that regulation. 7 By 31 January 2008, the [OSCURATO:PERSONA] had received approximately 44 000 health claims from the [OSCURATO:PERSONA] under [OSCURATO:PERSONA] 13(2) of that regulation. On the basis of those national lists of claims, the [OSCURATO:PERSONA] compiled a consolidated list thereof. 8 On 24 July 2008, the [OSCURATO:PERSONA] formally submitted to the EFSA a request for a scientific opinion pursuant to [OSCURATO:PERSONA] 13(3) of [OSCURATO:PERSONA] 1924/2006. On that occasion, the [OSCURATO:PERSONA] sent to the EFSA the first part of the consolidated list. The remaining parts of that list were provided in November and December 2008, and by means of an addendum in March 2010, making the final number of health claims to be examined 4 637. [OSCURATO:PERSONA] 2009 and July 2011, the EFSA carried out the scientific assessment of the health claims submitted by the [OSCURATO:PERSONA]. 9 On 27 September 2010, the [OSCURATO:PERSONA] issued a press release on its webpage in which it stated that, given the large number of health claims and the delays in processing them, it was in favour of establishing a process allowing for gradual adoption of the list of claims permitted in the [OSCURATO:PERSONA]. According to the [OSCURATO:PERSONA], that change of priorities in the procedure for the adoption of that list was explained inter alia by tensions reported about the treatment of plant ingredients under the legislation on health claims and under legislation governing traditional herbal medicinal products, and by the need to continue the reflection on the treatment of those ingredients. Consequently, it requested the EFSA to suspend temporarily its assessment of the health claims relating to botanical substances and to concentrate instead on all the other claims submitted with a view to completing the examination of those claims as soon as possible. In that context, the [OSCURATO:PERSONA] explained that the health claims concerning substances other than botanical substances would be examined in a first stage, whereas claims relating to botanical substances would be examined in a second stage. 10 On 16 May 2012, the [OSCURATO:PERSONA] adopted [OSCURATO:PERSONA] (EU) No 432/2012 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 L 136, p. 1). In that regulation the [OSCURATO:PERSONA] authorised a partial list of 222 health claims, corresponding to 497 entries in the consolidated list, for which the EFSA had essentially concluded that the information submitted was sufficient to establish a cause-and-effect relationship between a food category, a food or one of its constituents and the claimed effect. 11 On the same date, the [OSCURATO:PERSONA] drew up a list of more than 2 000 claims in respect of which the EFSA had not completed its evaluation or the [OSCURATO:PERSONA] itself had not yet taken a decision, and published that list on its website. According to the [OSCURATO:PERSONA], those health claims, which concerned, inter alia, the effects of botanical substances, remained on hold and therefore could continue to be used in accordance with the transitional scheme provided for in [OSCURATO:PERSONA] 28(5) and (6) of [OSCURATO:PERSONA] 1924/2006. Whereas the partial list of permitted claims was subsequently updated by the [OSCURATO:PERSONA], the health claims relating to botanical substances remain on hold. 12 By letter of 23 April 2014, VSM requested the [OSCURATO:PERSONA] to resume the assessment of the claims relating to botanical substances and in particular, instruct the EFSA to proceed with that assessment so that the definitive list of permitted claims could be adopted, as required under [OSCURATO:PERSONA] 13(3) of [OSCURATO:PERSONA] 1924/2006. VSM also indicated that if the [OSCURATO:PERSONA] refused to act, it intended to bring proceedings before the [OSCURATO:PERSONA]. 13 By letter of 19 June 2014 (‘the letter of 19 June 2014’), the [OSCURATO:PERSONA] replied to VSM’s request to act, stating, inter alia, as follows: ‘As you are aware, the [OSCURATO:PERSONA] initiated a reflection on health claims on so called “botanicals” after concerns were raised by a number of [OSCURATO:PERSONA] and stakeholders with regard to the differentiated treatment of products containing such substances under the legislation on health claims and that on the [OSCURATO:PERSONA]. Pending the outcome of this reflection, the [OSCURATO:PERSONA] has asked the [EFSA] to discontinue its scientific assessment of health claims on botanicals. [OSCURATO:PERSONA] recognises the importance of this complex issue both for consumers and business operators. However, to identify the best course of action needed, the [OSCURATO:PERSONA] should be allowed the time and context necessary for that purpose.’ 14 In response to that letter, VSM, by letter of 8 July 2014, once again requested the [OSCURATO:PERSONA] to instruct the EFSA to assess the health claims relating to botanical substances by 31 July 2014 at the latest. It also informed the [OSCURATO:PERSONA] that, as a result of the [OSCURATO:PERSONA]’s failure to act, it had suffered damage and that, in the event of continued failure to act, it would instigate the legal proceedings necessary. Procedure before the [OSCURATO:PERSONA] and the order under appeal 15 By application lodged at the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] on 1 August 2014, VSM requested the [OSCURATO:PERSONA], by way of principal claim, to declare that the [OSCURATO:PERSONA] had, since 1 August 2014, unlawfully failed to instruct the EFSA to assess health claims relating to botanical substances in accordance with the procedure laid down in [OSCURATO:PERSONA] 13(3) of [OSCURATO:PERSONA] 1924/2006 and, in the alternative, to annul the decision contained in the letter of 19 June 2014 not to initiate the assessment of those claims before 1 August 2014. 16 By separate document, lodged at the [OSCURATO:PERSONA] on 28 [OSCURATO:PERSONA] 2014, the [OSCURATO:PERSONA] raised an objection of inadmissibility, on which VSM submitted its observations on 12 December 2014, asking the [OSCURATO:PERSONA] to dismiss the objection and give a ruling on the merits of the case. 17 By the order under appeal, the [OSCURATO:PERSONA] dismissed VSM’s action as inadmissible and ordered it to pay the costs. 18 [OSCURATO:PERSONA] examined first of all the [OSCURATO:PERSONA]’s plea of inadmissibility alleging failure to comply with the conditions laid down in [OSCURATO:PERSONA] 265 TFEU and, in paragraph 38 of the order under appeal, held that the action for failure to act was inadmissible. 19 After observing, in paragraphs 26 and 27 of the order under appeal, that the requirements laid down in [OSCURATO:PERSONA] 265 TFEU for the admissibility of an action for failure to act are not met where the institution called upon to act has defined its position on that request before proceedings are brought, the [OSCURATO:PERSONA] concluded, in paragraphs 31 and 32 of that order, that the letter of 19 June 2014 was sufficiently clear and precise to enable VSM to be apprised of the [OSCURATO:PERSONA]’s position on its request, namely that the [OSCURATO:PERSONA] would not be instructing the EFSA to initiate the assessment requested, and that, as a consequence, the letter of 19 June 2014 had to be regarded as defining the [OSCURATO:PERSONA]’s position within the meaning of the second paragraph of [OSCURATO:PERSONA] 265 TFEU, thus bringing the [OSCURATO:PERSONA]’s failure to act to an end. 20 [OSCURATO:PERSONA] then observed, in paragraph 33 of that order, that the fact that the [OSCURATO:PERSONA]’s reply did not satisfy VSM was immaterial. [OSCURATO:PERSONA] 265 TFEU refers to failure to act in the sense of failure to take a decision or to define a position, not the fact that a measure different from that desired by the persons concerned has been adopted. 21 [OSCURATO:PERSONA] went on to hold, in paragraph 34 of the order under appeal, that the action for failure to act was inadmissible in so far as it was based on the invitation to act of 23 April 2014. 22 Furthermore, as regards the invitation to act contained in the letter of 8 July 2014, the [OSCURATO:PERSONA] held, in paragraphs 35 and 36 of that order, that the action for failure to act was premature, as it was lodged on 4 August 2014, more than a month before the expiry, on 8 September 2014, of the two-month time-limit within which the institution concerned is required under [OSCURATO:PERSONA] 265 TFEU to provide a response to the request submitted to it. [OSCURATO:PERSONA] accordingly declared the action for failure to act inadmissible in so far as it was based on that invitation to act. 23 Secondly, for the sake of completeness, the [OSCURATO:PERSONA] examined the [OSCURATO:PERSONA]’s plea of inadmissibility alleging that VSM had no interest in bringing proceedings and held, in paragraph 68 of the order under appeal, that the action for failure to act was also inadmissible on grounds of VSM’s having no interest in bringing proceedings. 24 [OSCURATO:PERSONA] concluded in that regard that VSM had not adduced evidence establishing sufficiently how the EFSA’s resumption of assessments of the health claims relating to botanical substances and the adoption of the definitive list of permitted health claims was liable to procure a definite advantage for it. 25 [OSCURATO:PERSONA] held, in paragraphs 50, 53 and 54 of the order under appeal, that it follows from the wording of [OSCURATO:PERSONA] 28(5) and (6) of [OSCURATO:PERSONA] 1924/2006 that provision is made for the application of transitional measures, following the adoption of that regulation, for health claims which are still being assessed and for which the [OSCURATO:PERSONA] is yet to adopt a decision. In those circumstances, undertakings affected by claims on hold may continue to make those claims, provided they comply with [OSCURATO:PERSONA] 28(5) and (6) of that regulation. 26 Consequently, according to the [OSCURATO:PERSONA], [OSCURATO:PERSONA] 17(5) of [OSCURATO:PERSONA] 1924/2006, which allows, in principle, any food business operator to make permitted health claims included in the definitive list, places permitted health claims in the same situation as health claims on hold, that is to say, in a situation in which they may be used for the marketing of food. 27 [OSCURATO:PERSONA] further held, in paragraphs 55 and 56 of the order under appeal, that, in any event, even if it could be established that [OSCURATO:PERSONA] 17(5) of [OSCURATO:PERSONA] 1924/2006 had consequences for VSM’s legal situation by comparison, inter alia, with its situation under the transitional provisions provided for in [OSCURATO:PERSONA] 28(5) and (6) of the regulation, it was clear that there would be an advantage for VSM, by definition, only if its claims on hold were authorised at the conclusion of the EFSA’s assessment and in the [OSCURATO:PERSONA]’s final decision. That premiss remained, for the time being, a premiss and, for that reason, could not satisfy the requirements of the case-law, which established that, if the interest pleaded by an applicant concerns a future legal situation, it must demonstrate that the prejudice to that situation is already certain. [OSCURATO:PERSONA] pointed out in that regard that, under [OSCURATO:PERSONA] 432/2012, which established a partial list of permitted health claims, the [OSCURATO:PERSONA] had authorised only 222 claims out of a total of more than 2 000 claims examined. 28 Lastly, the [OSCURATO:PERSONA] in paragraphs 60, 62 and 66 of the order under appeal respectively, rejected VSM’s arguments to the effect that the lack of a complete, definitive [OSCURATO:PERSONA] decision had given rise to unequal conditions of competition and legal uncertainty on the market, as well as to financial loss for VSM. 29 Thirdly, the [OSCURATO:PERSONA] examined the request for annulment of the letter of 19 June 2014 and concluded, in paragraphs 81 and 82 of the order under appeal, that that letter could not be regarded as a challengeable act for the purposes of [OSCURATO:PERSONA] 263 TFEU and accordingly held that request to be inadmissible. 30 In paragraphs 71 and 72 of the order under appeal, the [OSCURATO:PERSONA] referred to the case-law according to which only measures the legal effects of which are binding on and capable of affecting the interests of the applicant by bringing about a distinct change in his legal position are acts or decisions which may be the subject of an action for annulment for the purpose of [OSCURATO:PERSONA] 263 TFEU, adding that, in order to ascertain whether or not a measure which has been challenged produces such effects, it is necessary to look to its substance, with the form in which such acts or decisions are cast being, in principle, immaterial as regards the question whether they can be challenged through an action for annulment. 31 In paragraph 73 of the order under appeal, the [OSCURATO:PERSONA] took the view that, in the light of its content, the letter of 19 June 2014 could not be regarded as a challengeable act since, in that letter, the [OSCURATO:PERSONA] had simply set out the reason why it had initially been agreed that the procedure for the scientific assessment of the health claims relating to botanical substances should be suspended and went on to inform VSM that the [OSCURATO:PERSONA] needed more time and a more precise context to identify the best course of action. 32 [OSCURATO:PERSONA] further noted in paragraph 74 of the order under appeal that, in so far as [OSCURATO:PERSONA] 13(1) to (3) of [OSCURATO:PERSONA] 1924/2006 does not set out the detailed rules in accordance with which the [OSCURATO:PERSONA] is required to fulfil its task consisting in adopting the list of permitted claims, that provision leaves it to the discretion of that institution to define, in accordance with the principles laid down in [OSCURATO:PERSONA] 1924/2006 and in EU law, the speed at which the list of permitted claims is to be adopted, imposing on it only an obligation as to the result to be attained. In that same paragraph of the order, the [OSCURATO:PERSONA] noted the settled case-law, according to which if the [OSCURATO:PERSONA] is to be able to pursue effectively the objective assigned to it, account being taken of the complex technical assessments which it must undertake, it must be recognised as enjoying a broad discretion. Forms of order sought 33 By its appeal, VSM claims that the [OSCURATO:PERSONA] should: –        set aside the order under appeal in its entirety; –        annul in its entirety the decision of the President of the [OSCURATO:PERSONA] not to include in the case file the letters lodged on 22 and 24 July 2015 in [OSCURATO:PERSONA] T‑578/14; –        by way of principal claim, declare that the [OSCURATO:PERSONA] has, since 1 August 2014, unlawfully failed to instruct the EFSA to assess health claims relating to botanical substances in accordance with the procedure laid down in [OSCURATO:PERSONA] 13(3) of [OSCURATO:PERSONA] 1924/2006 and, in the alternative, annul the decision contained in the letter of 19 June 2014 not to instruct the EFSA to assess those claims in accordance with the procedure laid down in [OSCURATO:PERSONA] 13 of [OSCURATO:PERSONA] 1924/2006 before 1 August 2014, and –        order the [OSCURATO:PERSONA] to pay the costs. 34 [OSCURATO:PERSONA] contends that the appeal should be dismissed and VSM ordered to bear its own costs and to pay those incurred by the [OSCURATO:PERSONA] at first instance and on appeal. The appeal 35 [OSCURATO:PERSONA] 181 of its [OSCURATO:PERSONA] of Procedure, where an appeal is, in whole or in part, clearly inadmissible or clearly unfounded, the [OSCURATO:PERSONA] may at any time, acting on a report from the Judge-Rapporteur and after hearing the [OSCURATO:PERSONA], by reasoned order decide to dismiss the appeal in whole or in part, without opening the oral procedure. 36 That provision should be applied in the present case. 37 VSM puts forward six grounds in support of its appeal. The first four grounds allege errors of law committed by the [OSCURATO:PERSONA] in the assessment of: (i) compliance by VSM with the time-limits for actions for failure to act under [OSCURATO:PERSONA] 265 TFEU; (ii) its interest in bringing proceedings in the procedure before the [OSCURATO:PERSONA]; (iii) the insufficient protection given to VSM and other food business operators by the transitional measures provided for in [OSCURATO:PERSONA] 28 of [OSCURATO:PERSONA] 1924/2006; and (iv) the [OSCURATO:PERSONA]’s broad discretion under [OSCURATO:PERSONA] 13(3) of that regulation. The fifth ground alleges that the [OSCURATO:PERSONA], in failing to act, infringed its obligations under that regulation, [OSCURATO:PERSONA] 41 of the [OSCURATO:PERSONA] of [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] (‘the [OSCURATO:PERSONA]’), [OSCURATO:PERSONA] 168 TFEU, the principle of effectiveness of that same regulation and the principle venire contra factum proprium . Lastly, by its sixth ground of appeal, VSM criticises the [OSCURATO:PERSONA] for having infringed its own procedural rules in deciding not to include its letters of 22 and 24 July 2015 in the case file. Admissibility of the appeal as a whole 38 [OSCURATO:PERSONA] disputes the admissibility of the appeal in its entirety. 39 It submits that VSM puts forward, in a very confusing order, a number of general criticisms, instead of challenging in sequence the grounds on which the order under appeal is based. [OSCURATO:PERSONA] submits in that regard that, contrary to what is provided for in [OSCURATO:PERSONA] 169(2) of the [OSCURATO:PERSONA] of Procedure of the [OSCURATO:PERSONA] of Justice, neither the legal grounds of appeal nor the arguments put forward by VSM identify precisely which paragraphs of the reasons in that order are being challenged. 40 It should be borne in mind in that regard that it is apparent from the second subparagraph of [OSCURATO:PERSONA] 256(1) TFEU, the first paragraph of [OSCURATO:PERSONA] 58 of the Statute of the [OSCURATO:PERSONA] of Justice and Articles 168(1)(d) and 169(2) of the [OSCURATO:PERSONA] of Procedure that an appeal must identify precisely the contested points in the grounds of the judgment which the appellant seeks to have set aside and indicate precisely the legal arguments specifically advanced in support of the appeal, failing which the appeal or ground of appeal concerned is inadmissible (judgment of 3 September 2015, [OSCURATO:PERSONA] and Others v [OSCURATO:PERSONA] , C‑398/13 P, EU:C:2015:535, paragraph 53, and order of 15 [OSCURATO:PERSONA] 2015, [OSCURATO:PERSONA] and [OSCURATO:PERSONA] do [OSCURATO:PERSONA] v [OSCURATO:PERSONA] , C‑93/15 P, not published, EU:C:2015:703, paragraph 21). 41 Accordingly, a ground of appeal supported by an argument that is not sufficiently clear and precise to enable the [OSCURATO:PERSONA] to exercise its powers of judicial review, in particular because essential elements on which the ground of appeal is based are not indicated sufficiently coherently and intelligibly in the text of the appeal, which is worded in a vague and ambiguous manner in that regard, does not satisfy those requirements and must be dismissed as inadmissible (judgment of 10 July 2014, Telefónica and Telefónica de España v [OSCURATO:PERSONA] , C‑295/12 P, EU:C:2014:2062, paragraph 30 and the case-law cited). [OSCURATO:PERSONA] has also held that an appeal lacking any coherent structure which simply makes general statements and contains no specific indications as to the points of the order under appeal which may be vitiated by an error of law must be dismissed as clearly inadmissible (judgment of 10 July 2014, Telefónica and Telefónica de España v [OSCURATO:PERSONA] , C‑295/12 P, EU:C:2014:2062, paragraph 30 and the case-law cited). 42 In the present case, although it is true in respect of the first four grounds of appeal that the structure of the appeal and VSM’s formulation and presentation of the grounds of appeal may lack rigour, it is nevertheless possible to identify the elements of the order under appeal that are being challenged, as VSM has set out the relevant passages of that order in paragraph 16 of the appeal (see, by analogy, judgment of 24 mars 2011, ISD Polska and Others v [OSCURATO:PERSONA] , C‑369/09 P, EU:C:2011:175, paragraph 67). 43 Consequently, the present appeal is not inadmissible in its entirety for the reasons put forward by the [OSCURATO:PERSONA]. Accordingly, the [OSCURATO:PERSONA]’s objection of inadmissibility directed at the appeal as a whole must be rejected and it is appropriate to consider in turn each ground of appeal put forward in support thereof. Consideration of the grounds of appeal The first ground of appeal 44 By its first ground of appeal, VSM criticises the [OSCURATO:PERSONA] for having erred in law by holding, in paragraphs 23 to 38 of the order under appeal, that VSM had not complied with the time-limits laid down in the second paragraph of [OSCURATO:PERSONA] 265 TFEU. 45 [OSCURATO:PERSONA] contends, as its principal argument, that this ground of appeal is inadmissible or, in the alternative, clearly unfounded. 46 It should be observed that, in its first ground of appeal, VSM has not put forward any legal line of argument substantiating specifically the request for annulment of the order under appeal. In particular, VSM does not challenge the [OSCURATO:PERSONA] reasoning concerning the issue of compliance with those time-limits, merely stating that ‘[t]he [OSCURATO:PERSONA] argues that [VSM] did not meet the time lines for the complaint [thereby violating] EU law’. On the contrary, VSM’s arguments are directed solely at the [OSCURATO:PERSONA]’s conduct and, as correctly pointed out by the [OSCURATO:PERSONA] in its response, is a pure and simple repetition of the observations on the objection of inadmissibility put forward by VSM before the [OSCURATO:PERSONA]. 47 However, the requirements referred to in paragraph 40 above cannot be satisfied by a ground of appeal which, without even including arguments aimed specifically at identifying the error of law allegedly vitiating the order under appeal, merely reproduces arguments already put forward before the [OSCURATO:PERSONA]. A ground of appeal such as that is, in reality, an attempt to have reconsidered an argument put forward before the [OSCURATO:PERSONA], which falls outside the jurisdiction of the [OSCURATO:PERSONA] of Justice (see, to that effect, order of 15 [OSCURATO:PERSONA] 2015, [OSCURATO:PERSONA] and [OSCURATO:PERSONA] do [OSCURATO:PERSONA] v [OSCURATO:PERSONA] , C‑93/15 P, not published, EU:C:2015:703, paragraph 22). 48 It follows that, in the light of the case-law cited in the foregoing paragraph, the first ground of appeal put forward by VSM does not satisfy the requirements of precision and clarity for a ground of appeal and, moreover, is merely a request to have reconsidered arguments that were put forward at first instance, contrary to the requirements imposed by both the Statute of the [OSCURATO:PERSONA] of Justice of the [OSCURATO:PERSONA] and by the [OSCURATO:PERSONA] of Procedure (see, to that effect, order of 15 [OSCURATO:PERSONA] 2015, [OSCURATO:PERSONA] and [OSCURATO:PERSONA] do [OSCURATO:PERSONA] v [OSCURATO:PERSONA] , C‑93/15 P, not published, EU:C:2015:703, paragraph 28). 49 Consequently, this ground of appeal must be rejected as clearly inadmissible. The second ground of appeal 50 By its second ground of appeal, which comprises two parts, VSM criticises the [OSCURATO:PERSONA] for having held that its action for failure to act and for annulment was inadmissible on the ground that it had no interest in bringing proceedings, and maintains that, on the contrary, its interests were significantly affected. 51 In the [OSCURATO:PERSONA]’s submission, this ground of appeal is, in the main, inadmissible and, in the alternative, clearly unfounded. 52 By the first part of its second ground of appeal, VSM submits that, in paragraphs 39 to 68 of the order under appeal, the [OSCURATO:PERSONA] held, incorrectly, that its action for failure to act was inadmissible on grounds of its having no interest in bringing proceedings. 53 In that regard, it should be borne in mind that, according to the [OSCURATO:PERSONA] settled case-law, arguments directed against grounds included in a decision of the [OSCURATO:PERSONA] purely for the sake of completeness cannot lead to the decision being set aside and are therefore ineffective ab initio (judgment of 2 September 2010, [OSCURATO:PERSONA] v [OSCURATO:PERSONA] , C‑399/08 P, EU:C:2010:481, paragraph 75). 54 In the present case, after upholding the [OSCURATO:PERSONA]’s plea of inadmissibility put forward on the basis of non-compliance with the time-limits laid down in [OSCURATO:PERSONA] 265 TFEU and, consequently, dismissing the action for failure to act as inadmissible, the [OSCURATO:PERSONA] found, in paragraph 39 of the order under appeal, that ‘[i]t [was] therefore merely for the sake of completeness that the [OSCURATO:PERSONA]’s plea of inadmissibility alleging that the applicant [had] no interest in bringing proceedings [would] be examined’. 55 Consequently, even assuming that the reasoning contained in paragraphs 40 to 68 of the order under appeal, concerning the assessment of the [OSCURATO:PERSONA]’s plea of inadmissibility alleging a lack of interest in bringing proceedings, were wrong in law, that finding would not affect the outcome of the appeal (see, to that effect, judgment of 2 September 2010, [OSCURATO:PERSONA] v [OSCURATO:PERSONA] , C‑399/08 P, EU:C:2010:481, paragraph 77). 56 In those circumstances, the first part of the second ground of appeal is ineffective ab initio and must be rejected as inadmissible. 57 By the second part of its second ground of appeal, VSM submits that the [OSCURATO:PERSONA] erred in paragraphs 69 to 82 of the order under appeal in holding its request for annulment to be inadmissible on the ground that it had no interest in bringing proceedings. 58 It should be noted in that regard that, in its reasoning set out in paragraphs 69 to 82 of the order under appeal, the [OSCURATO:PERSONA] did not examine directly VSM’s interest in bringing proceedings. 59 First of all, in paragraphs 71 to 73 and 76 of the order under appeal, the [OSCURATO:PERSONA] analysed the categorisation of the letter of 19 June 2014 as a challengeable act under [OSCURATO:PERSONA] 263 TFEU and concluded that that letter, which was purely informative in nature, was not a measure producing binding legal effects and capable of affecting VSM’s interests by bringing about a distinct change in its legal position. Next, in paragraphs 74 and 75 of its order, the [OSCURATO:PERSONA] examined the scope of the [OSCURATO:PERSONA]’s obligations under [OSCURATO:PERSONA] 13(3) of [OSCURATO:PERSONA] 1924/2006 and held, in particular, that the [OSCURATO:PERSONA] was free to establish the list of permitted claims on a gradual basis. Lastly, in paragraphs 77 to 80 of its order, the [OSCURATO:PERSONA] held that it was not possible, on the basis of the principle requiring that access be given to the courts and the principle of effective judicial protection, for an action for annulment not meeting the requirements for admissibility laid down in [OSCURATO:PERSONA] 263 TFU to be deemed admissible. 60 It follows that the second part of the second ground of appeal, which moreover lacks reasons, is based on an incorrect reading of the order under appeal and must be rejected as clearly unfounded. 61 Consequently, VSM’s second ground of appeal must be rejected as partly ineffective ab initio and partly clearly unfounded. The third ground of appeal 62 By its third ground of appeal, VSM criticises the [OSCURATO:PERSONA] for having infringed [OSCURATO:PERSONA] 1924/2006 and the [OSCURATO:PERSONA] in having held, in paragraphs 46 to 50 of the order under appeal, that the transitional measures laid down in [OSCURATO:PERSONA] 28 of that regulation were insufficient protection for food business operators, who derived no definite advantage from the adoption of the definitive list of permitted health claims. 63 [OSCURATO:PERSONA] contends that this ground of appeal is, in the main, inadmissible and, in the alternative, clearly unfounded. 64 Suffice it to observe in that regard that this ground of appeal also refers to reasons in the order under appeal which were set out for the sake of completeness. Therefore, for the same reasons as set out in paragraphs 53 to 55 above, the third ground of appeal is ineffective ab initio and must accordingly be rejected. The fourth ground of appeal 65 By its fourth ground of appeal, which comprises two parts, VSM criticises the [OSCURATO:PERSONA] for having infringed [OSCURATO:PERSONA] 13(3) of [OSCURATO:PERSONA] 1924/2006 and the [OSCURATO:PERSONA], by having held, in paragraphs 73 to 75 of the order under appeal, that the [OSCURATO:PERSONA] has broad discretion in adopting the definitive list of permitted health claims. 66 By the first part of its fourth ground of appeal, VSM submits that the [OSCURATO:PERSONA] erred in law in holding that the [OSCURATO:PERSONA] enjoys broad discretion in its courses of action in the adoption of that list. 67 It should be noted in that regard that VSM merely stated as follows in support of its assertions: ‘Since consulting with EFSA is mandatory for the [OSCURATO:PERSONA] before taking any decision on specific [OSCURATO:PERSONA], stopping this consulting procedure is a clear violation of the law. … [T]here is no discretion for the [OSCURATO:PERSONA] [as to] how to proceed. [OSCURATO:PERSONA] must consult with EFSA before taking any decision. For this reason the [OSCURATO:PERSONA] failed with the argument that the [OSCURATO:PERSONA] has a broad discretion in the question how to act.’ 68 Yet according to the [OSCURATO:PERSONA] consistent case-law, referred to in paragraphs 40 and 41 above, a ground of appeal supported by an argument that is not sufficiently clear and precise to enable the [OSCURATO:PERSONA] to exercise its powers of judicial review, in particular because essential elements on which the ground of appeal is based are not indicated sufficiently coherently and intelligibly in the text of the appeal, because it is worded in a vague manner or because it does not indicate precisely the legal arguments specifically advanced in support of the application for annulment of a decision. 69 It is clear in that regard that the first part of the fourth ground of appeal lacks coherence, clarity and relevance because it does not show an unequivocal link between the requirements of [OSCURATO:PERSONA] 13(3) of [OSCURATO:PERSONA] 1924/2006, the conduct in respect of which the [OSCURATO:PERSONA] is specifically criticised and the error of law allegedly made by the [OSCURATO:PERSONA]. In particular, VSM’s line of argument, which is supposed to support the request to have the order under appeal set aside, does not refer specifically to the reasoning set out by the [OSCURATO:PERSONA] in paragraphs 73 to 75 of that order, which does not enable the [OSCURATO:PERSONA] to exercise its powers of judicial review. 70 Consequently, the first part of the fourth ground of appeal must be rejected as clearly inadmissible. 71 By the second part of its fourth ground of appeal, VSM submits that the [OSCURATO:PERSONA] erred in law in holding that the [OSCURATO:PERSONA] enjoys broad discretion as to when to act in adopting the definitive list of permitted health claims. 72 [OSCURATO:PERSONA] contends in that regard that it follows from the [OSCURATO:PERSONA] judgment of 12 June 2015, [OSCURATO:PERSONA] and Others v [OSCURATO:PERSONA] (T‑296/12, EU:T:2015:375) that it has broad discretion as to the pace leading to the adoption of that list. [OSCURATO:PERSONA] refers in particular in paragraphs 65 to 69 of that judgment, where the [OSCURATO:PERSONA] held that it could not be inferred from the wording of [OSCURATO:PERSONA] 1924/2006 that the EU legislature intended to prohibit the [OSCURATO:PERSONA] from adopting the list of permitted claims in several stages. 73 It is common ground in that regard that, under [OSCURATO:PERSONA] 13(3) of [OSCURATO:PERSONA] 1924/2006, the [OSCURATO:PERSONA] was required to adopt the list of permitted claims by 31 January 2010 at the latest and that, as at 16 May 2012, that list had been adopted only partially by [OSCURATO:PERSONA] 432/2012. 74 Concerning that question, in paragraph 74 of the order under appeal, the [OSCURATO:PERSONA] held that, in so far as [OSCURATO:PERSONA] 13(1) to (3) of [OSCURATO:PERSONA] 1924/2006 does not set out the detailed rules in accordance with which the [OSCURATO:PERSONA] is required to fulfil its task, in particular whether the [OSCURATO:PERSONA] may defer authorisation of health claims for which the EFSA has not completed its assessment, that provision leaves it to the discretion of that institution to define, in accordance with the principles laid down in [OSCURATO:PERSONA] 1924/2006 and in EU law, the speed at which the list of permitted claims is to be adopted. [OSCURATO:PERSONA] went on to state that the [OSCURATO:PERSONA] may complete that list as and when technical evaluations have been completed by the EFSA and verify itself the conditions established in the regulation, explaining that [OSCURATO:PERSONA] 13 thereof must be interpreted as imposing on the [OSCURATO:PERSONA] only an obligation as to the result to be attained, namely that of adopting, after consulting the EFSA, the list of permitted claims on the basis of the national lists provided by the [OSCURATO:PERSONA]. 75 Yet under the second part of the fourth ground of appeal, VSM submits that, under [OSCURATO:PERSONA] 1924/2006, all decisions on health claims had to be taken by the [OSCURATO:PERSONA] no later than 31 January 2010 and that after that date it had no discretion to take a decision on those claims. 76 [OSCURATO:PERSONA] was correct in holding, in paragraph 74 of the order under appeal, that, in so far as [OSCURATO:PERSONA] 13(1) to (3) of [OSCURATO:PERSONA] 1924/2006 does not set out the detailed rules in accordance with which the [OSCURATO:PERSONA] is required to fulfil its task, that provision leaves it to the discretion of that institution to define, in accordance with the principles laid down in that regulation and in EU law, the speed at which the list of permitted claims is to be adopted. 77 It should also be noted that [OSCURATO:PERSONA] 13(4) and (5) of [OSCURATO:PERSONA] 1924/2006 provides for the possibility of changing the list of permitted claims either on the basis of generally accepted scientific evidence, or on the basis of newly established scientific evidence. It must therefore be considered that that provision does not preclude that list from being added to on a gradual basis, in the light of the scientific data available, and, consequently, to the fact that it is of a progressive nature. 78 It follows that the second part of the fourth ground of appeal must be rejected as being clearly unfounded. 79 In the light of the foregoing considerations, the fourth ground of appeal must be dismissed as being in part clearly inadmissible and in part clearly unfounded. The fifth ground of appeal 80 VSM’s fifth ground of appeal alleges infringement by the [OSCURATO:PERSONA] due to its inaction, contrary to its obligations under [OSCURATO:PERSONA] 1924/2006, [OSCURATO:PERSONA] 41 of the [OSCURATO:PERSONA], [OSCURATO:PERSONA] 168 TFEU, the principle of effectiveness of [OSCURATO:PERSONA] 1924/2006 and the principle venire contra factum proprium . 81 It should be noted that, in this ground of appeal, VSM merely directs criticisms at the [OSCURATO:PERSONA]’s conduct, without specifying any paragraph of the reasons in the order under appeal that is being challenged or identifying the least error of law vitiating that order. Therefore, a ground of appeal of this nature, directed not at a decision of the [OSCURATO:PERSONA] but at an act of an institution, does not satisfy the requirements of the first paragraph of [OSCURATO:PERSONA] 56 of the Statute of the [OSCURATO:PERSONA] of Justice of the [OSCURATO:PERSONA] and [OSCURATO:PERSONA] 169 of the [OSCURATO:PERSONA] of Procedure of the [OSCURATO:PERSONA] of Justice. 82 In view of the foregoing, the fifth ground of appeal must be rejected as being clearly inadmissible. The sixth ground of appeal 83 By its sixth ground of appeal, VSM criticises the [OSCURATO:PERSONA] for having infringed its own procedural rules in deciding not to include its letters of 22 and 24 July 2015 in the case file. 84 Suffice it to observe in that regard that nor is this ground of appeal directed at the order under appeal, contrary to [OSCURATO:PERSONA] 169 of the [OSCURATO:PERSONA] of Procedure of the [OSCURATO:PERSONA] of Justice, but rather concerns a separate decision of the President of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] delivered in judicial proceedings. It must therefore be dismissed as clearly inadmissible. 85 Since none of the grounds of appeal has been successful, the appeal must be dismissed in its entirety. The application for leave to intervene 86 In the light of the foregoing, there is no need to rule on the application for leave to intervene in support of the forms of order sought by VSM, lodged on 31 March 2016 by the [OSCURATO:PERSONA] of [OSCURATO:PERSONA] (EUCOPE). Costs 87 [OSCURATO:PERSONA] 138(1) of the [OSCURATO:PERSONA] of Procedure of the [OSCURATO:PERSONA] of Justice, applicable to appeal proceedings by virtue of [OSCURATO:PERSONA] 184(1) thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. 88 Since the [OSCURATO:PERSONA] has applied for costs and VSM has been unsuccessful in all its grounds of appeal, it must be ordered to pay the costs incurred in the present appeal proceedings. 89 Moreover, under [OSCURATO:PERSONA] 142 of the [OSCURATO:PERSONA] of Procedure of the [OSCURATO:PERSONA] of Justice, where there is no need to rule, including no need to rule on applications for leave to intervene, costs are in the discretion of the [OSCURATO:PERSONA]. 90 In those circumstances, VSM and EUCOPE are to bear their own costs relating to EUCOPE’s application for leave to intervene. On those grounds, the [OSCURATO:PERSONA] ([OSCURATO:PERSONA]) hereby orders: 1. The appeal is dismissed. 2. There is no need to rule on the application for leave to intervene lodged by the [OSCURATO:PERSONA] of [OSCURATO:PERSONA] (EUCOPE). 3. VSM Geneesmiddelen BV shall pay the costs relating to the appeal proceedings. 4. VSM Geneesmiddelen BV and the [OSCURATO:PERSONA] of [OSCURATO:PERSONA] (EUCOPE) shall bear their own costs relating to EUCOPE’s application for leave to intervene. [Signatures] * Language of the case: English.
Sentenza Corte di giustizia UE n. 1924/2016 — Fons Iuris — Fons Iuris