ORDER OF THE COURT (Eighth Chamber)

25 October 2016 ([\*](#Footnote*))

(Appeal — Article 181 of the Rules of Procedure of the Court of Justice — Public health — Consumer protection — Regulation (EC) No 1924/2006 — Health claims on foods — Article 13(3) — Community list of permitted health claims on foods — Botanical substances — Claims on hold — Action for failure to act and for annulment — Definition of position by the European Commission — Challengeable act)

In Case C‐637/15 P,

APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, 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:

**European Commission,** represented by M. Wilderspin and S. Grünheid, acting as Agents,

defendant at first instance,

THE COURT (Eighth Chamber),

composed of M. Vilaras, President of the Chamber, M. Safjan (Rapporteur) and D. Šváby, Judges,

Advocate General: Y. Bot,

Registrar: A. Calot Escobar,

having decided, after hearing the Advocate General, to give a decision by reasoned order, in accordance with Article 181 of the Rules of Procedure of the Court,

makes the following

**Order**

1        By its appeal, VSM Geneesmiddelen BV (‘VSM’) seeks annulment of the order of 16 September 2015 of the General Court of the European Union, *VSM Geneesmiddelen* v *Commission* (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 Commission failed to act in that it unlawfully failed to instruct the European Food Safety Authority (EFSA) to assess health claims relating to botanical substances for the adoption of the definitive list of permitted claims in accordance with Article 13(3) of Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (OJ 2006 L 404, p. 9 and corrigendum OJ 2007, L 12, p. 3), as amended by Regulation (EC) No 109/2008 of the European Parliament and of the Council of 15 January 2008 (OJ 2008, L 39, p. 14) (‘Regulation No 1924/2006’) and, in the alternative, annulment of the decision purportedly contained in the Commission’s letter of 19 June 2014 refusing to instruct the EFSA to assess those claims.

**Legal context**

2        Article 2 of Regulation No 1924/2006 is entitled ‘Definitions’; Article 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        Article 13 of Regulation No 1924/2006, entitled ‘Health claims other than those referring to the reduction of disease risk and to children’s development and health’, provides:

‘1.      Health 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 [Commission] 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.      Member States shall provide the Commission 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 [European Food Safety] Authority [EFSA], the Commission shall adopt, ... a Community list designed to amend non-essential elements of the Regulation 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 Regulation by supplementing it, shall be adopted ..., after consulting [the EFSA], on the Commission’s own initiative or following a request by a Member State.

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 Article 18, except claims referring to children's development and health ...’

4        Article 28 of the regulation, entitled ‘Transitional measures’, provides in paragraphs 5 and 6:

‘5.      Health claims as referred to in Article 13(1)(a) may be made from the date of entry into force of this Regulation until the adoption of the list referred to in Article 13(3), under the responsibility of food business operators provided that they comply with this Regulation and with existing national provisions applicable to them, and without prejudice to the adoption of safeguard measures as referred to in Article 24.

6.      Health claims other than those referred to in Article 13(1)(a) and in Article 14(1)(a), which have been used in compliance with national provisions before the date of entry into force of this Regulation, shall be subject to the following:

(a)      health claims which have been the subject of evaluation and authorisation in a Member State shall be authorised as follows:

(i)      Member States shall communicate to the Commission, by 31 January 2008 at the latest, such claims accompanied by a report evaluating the scientific data in support of the claim;

(ii)      after consulting [the EFSA], the Commission shall ... adopt a decision concerning the health claims authorised in this way and designed to amend non-essential elements of this Regulation by supplementing it.

Health claims not authorised under this procedure may continue to be used for six months following the adoption of the Decision;

(b)      health claims which have not been the subject of evaluation and authorisation in a Member State: such claims may continue to be used provided an application is made pursuant to this Regulation before 19 January 2008; health claims not authorised under this procedure may continue to be used for six months after a decision is taken pursuant to Article 17(3).’

**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 Regulation No 1924/2006, VSM, an undertaking producing and marketing pharmaceutical products and food supplements on the European 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 Article 13(1) to (3) of that regulation.

7        By 31 January 2008, the Commission had received approximately 44 000 health claims from the Member States under Article 13(2) of that regulation. On the basis of those national lists of claims, the Commission compiled a consolidated list thereof.

8        On 24 July 2008, the Commission formally submitted to the EFSA a request for a scientific opinion pursuant to Article 13(3) of Regulation No 1924/2006. On that occasion, the Commission 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. Between October 2009 and July 2011, the EFSA carried out the scientific assessment of the health claims submitted by the Commission.

9        On 27 September 2010, the Commission 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 European Union. According to the Commission, 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 Commission 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 Commission adopted Commission Regulation (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 Commission 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 Commission drew up a list of more than 2 000 claims in respect of which the EFSA had not completed its evaluation or the Commission itself had not yet taken a decision, and published that list on its website. According to the Commission, 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 Article 28(5) and (6) of Regulation No 1924/2006. Whereas the partial list of permitted claims was subsequently updated by the Commission, the health claims relating to botanical substances remain on hold.

12      By letter of 23 April 2014, VSM requested the Commission 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 Article 13(3) of Regulation No 1924/2006. VSM also indicated that if the Commission refused to act, it intended to bring proceedings before the General Court.

13      By letter of 19 June 2014 (‘the letter of 19 June 2014’), the Commission replied to VSM’s request to act, stating, inter alia, as follows:

‘As you are aware, the Commission initiated a reflection on health claims on so called “botanicals” after concerns were raised by a number of Member States and stakeholders with regard to the differentiated treatment of products containing such substances under the legislation on health claims and that on the Traditional Herbal Medicinal Products.

Pending the outcome of this reflection, the Commission has asked the [EFSA] to discontinue its scientific assessment of health claims on botanicals. The Commission recognises the importance of this complex issue both for consumers and business operators. However, to identify the best course of action needed, the Commission should be allowed the time and context necessary for that purpose.’

14      In response to that letter, VSM, by letter of 8 July 2014, once again requested the Commission to instruct the EFSA to assess the health claims relating to botanical substances by 31 July 2014 at the latest. It also informed the Commission that, as a result of the Commission’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 General Court and the order under appeal**

15      By application lodged at the Registry of the General Court on 1 August 2014, VSM requested the General Court, by way of principal claim, to declare that the Commission 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 Article 13(3) of Regulation No 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 General Court Registry on 28 October 2014, the Commission raised an objection of inadmissibility, on which VSM submitted its observations on 12 December 2014, asking the General Court to dismiss the objection and give a ruling on the merits of the case.

17      By the order under appeal, the General Court dismissed VSM’s action as inadmissible and ordered it to pay the costs.

18      The General Court examined first of all the Commission’s plea of inadmissibility alleging failure to comply with the conditions laid down in Article 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 Article 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 General Court 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 Commission’s position on its request, namely that the Commission 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 Commission’s position within the meaning of the second paragraph of Article 265 TFEU, thus bringing the Commission’s failure to act to an end.

20      The General Court then observed, in paragraph 33 of that order, that the fact that the Commission’s reply did not satisfy VSM was immaterial. Article 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      The General Court 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 General Court 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 Article 265 TFEU to provide a response to the request submitted to it. The General Court 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 General Court examined the Commission’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      The General Court 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      The General Court held, in paragraphs 50, 53 and 54 of the order under appeal, that it follows from the wording of Article 28(5) and (6) of Regulation No 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 Commission 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 Article 28(5) and (6) of that regulation.

26      Consequently, according to the General Court, Article 17(5) of Regulation No 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      The General Court further held, in paragraphs 55 and 56 of the order under appeal, that, in any event, even if it could be established that Article 17(5) of Regulation No 1924/2006 had consequences for VSM’s legal situation by comparison, inter alia, with its situation under the transitional provisions provided for in Article 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 Commission’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. The General Court pointed out in that regard that, under Regulation No 432/2012, which established a partial list of permitted health claims, the Commission had authorised only 222 claims out of a total of more than 2 000 claims examined.

28      Lastly, the General Court 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 Commission 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 General Court 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 Article 263 TFEU and accordingly held that request to be inadmissible.

30      In paragraphs 71 and 72 of the order under appeal, the General Court 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 Article 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 General Court 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 Commission 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 Commission needed more time and a more precise context to identify the best course of action.

32      The General Court further noted in paragraph 74 of the order under appeal that, in so far as Article 13(1) to (3) of Regulation No 1924/2006 does not set out the detailed rules in accordance with which the Commission 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 Regulation No 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 General Court noted the settled case-law, according to which if the Commission 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 Court should:

–        set aside the order under appeal in its entirety;

–        annul in its entirety the decision of the President of the General Court not to include in the case file the letters lodged on 22 and 24 July 2015 in Case T‐578/14;

–        by way of principal claim, declare that the Commission 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 Article 13(3) of Regulation No 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 Article 13 of Regulation No 1924/2006 before 1 August 2014, and

–        order the Commission to pay the costs.

34      The Commission contends that the appeal should be dismissed and VSM ordered to bear its own costs and to pay those incurred by the Commission at first instance and on appeal.

**The appeal**

35      Under Article 181 of its Rules of Procedure, where an appeal is, in whole or in part, clearly inadmissible or clearly unfounded, the Court may at any time, acting on a report from the Judge-Rapporteur and after hearing the Advocate General, 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 General Court in the assessment of: (i) compliance by VSM with the time-limits for actions for failure to act under Article 265 TFEU; (ii) its interest in bringing proceedings in the procedure before the General Court; (iii) the insufficient protection given to VSM and other food business operators by the transitional measures provided for in Article 28 of Regulation No 1924/2006; and (iv) the Commission’s broad discretion under Article 13(3) of that regulation. The fifth ground alleges that the Commission, in failing to act, infringed its obligations under that regulation, Article 41 of the Charter of Fundamental Rights of the European Union (‘the Charter’), Article 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 General Court 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      The Commission 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. The Commission submits in that regard that, contrary to what is provided for in Article 169(2) of the Rules of Procedure of the Court 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 Article 256(1) TFEU, the first paragraph of Article 58 of the Statute of the Court of Justice and Articles 168(1)(d) and 169(2) of the Court’s Rules 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, *Inuit Tapiriit Kanatami and Others* v *Commission*, C‐398/13 P, EU:C:2015:535, paragraph 53, and order of 15 October 2015, *Banco Privado Português and Massa Insolvente do Banco Privado Português* v *Commission*, 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 Court 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 *Commission*, C‐295/12 P, EU:C:2014:2062, paragraph 30 and the case-law cited). The Court 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 *Commission*, 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 *Commission*, 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 Commission. Accordingly, the Commission’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 General Court 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 Article 265 TFEU.

45      The Commission 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 General Court’s reasoning concerning the issue of compliance with those time-limits, merely stating that ‘[t]he General Court 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 Commission’s conduct and, as correctly pointed out by the Commission in its response, is a pure and simple repetition of the observations on the objection of inadmissibility put forward by VSM before the General Court.

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 General Court. A ground of appeal such as that is, in reality, an attempt to have reconsidered an argument put forward before the General Court, which falls outside the jurisdiction of the Court of Justice (see, to that effect, order of 15 October 2015, *Banco Privado Português and Massa Insolvente do Banco Privado Português* v *Commission*, 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 Court of Justice of the European Union and by the Court’s Rules of Procedure (see, to that effect, order of 15 October 2015, *Banco Privado Português and Massa Insolvente do Banco Privado Português* v *Commission*, 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 General Court 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 Commission’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 General Court 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 Court’s settled case-law, arguments directed against grounds included in a decision of the General Court 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, *Commission* v *Deutsche Post*, C‐399/08 P, EU:C:2010:481, paragraph 75).

54      In the present case, after upholding the Commission’s plea of inadmissibility put forward on the basis of non-compliance with the time-limits laid down in Article 265 TFEU and, consequently, dismissing the action for failure to act as inadmissible, the General Court found, in paragraph 39 of the order under appeal, that ‘[i]t [was] therefore merely for the sake of completeness that the Commission’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 Commission’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, *Commission* v *Deutsche Post*, 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 General Court 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 General Court 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 General Court analysed the categorisation of the letter of 19 June 2014 as a challengeable act under Article 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 General Court examined the scope of the Commission’s obligations under Article 13(3) of Regulation No 1924/2006 and held, in particular, that the Commission was free to establish the list of permitted claims on a gradual basis. Lastly, in paragraphs 77 to 80 of its order, the General Court 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 Article 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 General Court for having infringed Regulation No 1924/2006 and the Charter in having held, in paragraphs 46 to 50 of the order under appeal, that the transitional measures laid down in Article 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      The Commission 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 General Court for having infringed Article 13(3) of Regulation No 1924/2006 and the Charter, by having held, in paragraphs 73 to 75 of the order under appeal, that the Commission 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 General Court erred in law in holding that the Commission 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 Commission before taking any decision on specific Health Claims, stopping this consulting procedure is a clear violation of the law. ... [T]here is no discretion for the Commission [as to] how to proceed. The Commission must consult with EFSA before taking any decision. For this reason the General Court failed with the argument that the Commission has a broad discretion in the question how to act.’

68      Yet according to the Court’s 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 Court 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 Article 13(3) of Regulation No 1924/2006, the conduct in respect of which the Commission is specifically criticised and the error of law allegedly made by the General Court. 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 General Court in paragraphs 73 to 75 of that order, which does not enable the Court 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 General Court erred in law in holding that the Commission enjoys broad discretion as to when to act in adopting the definitive list of permitted health claims.

72      The Commission contends in that regard that it follows from the General Court’s judgment of 12 June 2015, *Health Food Manufacturers’ Association and Others* v *Commission* (T‐296/12, EU:T:2015:375) that it has broad discretion as to the pace leading to the adoption of that list. The Commission refers in particular in paragraphs 65 to 69 of that judgment, where the General Court held that it could not be inferred from the wording of Regulation No 1924/2006 that the EU legislature intended to prohibit the Commission from adopting the list of permitted claims in several stages.

73      It is common ground in that regard that, under Article 13(3) of Regulation No 1924/2006, the Commission 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 Regulation No 432/2012.

74      Concerning that question, in paragraph 74 of the order under appeal, the General Court held that, in so far as Article 13(1) to (3) of Regulation No 1924/2006 does not set out the detailed rules in accordance with which the Commission is required to fulfil its task, in particular whether the Commission 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 Regulation No 1924/2006 and in EU law, the speed at which the list of permitted claims is to be adopted. The General Court went on to state that the Commission 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 Article 13 thereof must be interpreted as imposing on the Commission 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 Member States.

75      Yet under the second part of the fourth ground of appeal, VSM submits that, under Regulation No 1924/2006, all decisions on health claims had to be taken by the Commission no later than 31 January 2010 and that after that date it had no discretion to take a decision on those claims.

76      The General Court was correct in holding, in paragraph 74 of the order under appeal, that, in so far as Article 13(1) to (3) of Regulation No 1924/2006 does not set out the detailed rules in accordance with which the Commission 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 Article 13(4) and (5) of Regulation No 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 Commission due to its inaction, contrary to its obligations under Regulation No 1924/2006, Article 41 of the Charter, Article 168 TFEU, the principle of effectiveness of Regulation No 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 Commission’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 General Court but at an act of an institution, does not satisfy the requirements of the first paragraph of Article 56 of the Statute of the Court of Justice of the European Union and Article 169 of the Rules of Procedure of the Court 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 General Court 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 Article 169 of the Rules of Procedure of the Court of Justice, but rather concerns a separate decision of the President of the Eighth Chamber of the General Court 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 European Confederation of Pharmaceutical Entrepreneurs (EUCOPE).

**Costs**

87      Under Article 138(1) of the Rules of Procedure of the Court of Justice, applicable to appeal proceedings by virtue of Article 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 Commission 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 Article 142 of the Rules of Procedure of the Court 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 Court.

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 Court (Eighth Chamber) hereby orders:

1.      **The appeal is dismissed.**

2.      **There is no need to rule on the application for leave to intervene lodged by the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE).**

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

4.      **VSM Geneesmiddelen BV and the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) shall bear their own costs relating to EUCOPE’s application for leave to intervene.**

[Signatures]

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[\*](#Footref*) Language of the case: English.