(Action for failure to act and for annulment— Consumer protection— Health claims relating to food— Regulation (EC) No1924/2006

ORDER OF THE GENERAL COURT (Eighth Chamber)

16 September 2015 (*)

(Action for failure to act and for annulment— Consumer protection— Health claims relating to food— Regulation (EC) No1924/2006— Botanical substances— Time-limit for bringing proceedings— No interest in bringing proceedings— Non-actionable measure— Inadmissibility)

In Case T‑578/14,

VSM Geneesmiddelen BV, established in Alkmaar (Netherlands), represented by U.H.Grundmann, lawyer,

applicant,

v

European Commission, represented initially by J.Enegren and, subsequently, by M.Wilderspin and S.Grünheid, acting as Agents,

defendant,

APPLICATION for 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 as a precondition for the adoption of the definitive list of permitted claims in accordance with Article13(3) of Regulation (EC) No1924/2006 of the European Parliament and of the Council of 20December 2006 on nutrition and health claims made on foods (OJ 2006 L404, p.9) and, in the alternative, an application for annulment of the decision purportedly contained in the Commission’s letter of 19June 2014 refusing to instruct the EFSA to assess those claims,

THE GENERAL COURT (Eighth Chamber),

composed of M.Kancheva (Rapporteur), acting as President, C.Wetter and E.Bieliūnas, Judges,

Registrar: E.Coulon,

makes the following

Order

Background to the case

1The applicant, VSM Geneesmiddelen BV, is an undertaking producing and marketing pharmaceutical products and food supplements on the European market. It makes health claims on its product labels and in its advertising on a daily basis.

2Following the adoption of Regulation (EC) No1924/2006 of the European Parliament and of the Council of 20December 2006 on nutrition and health claims made on foods (OJ 2006 L404, p.9), the applicant submitted lists of health claims to the Netherlands authorities for the purposes of the authorisation procedure under Article13(1) to (3) of that regulation. The Commission of the European Communities subsequently received approximately 44000 health claims from the Member States under Article13(2) of that regulation. On the basis of those health claims, the Commission compiled a consolidated list in order to avoid duplications and repetitions, as well as a codification system, published on the iznternet, with a view to ensuring, according to the Commission, that national lists were treated consistently and that claims could be identified by the use of ‘ID’ numbers.

3On 24July 2008, the Commission formally submitted to the European Food Safety Authority (EFSA) a request for a scientific opinion pursuant to Article13(3) of Regulation No1924/2006. On that occasion, the Commission sent to the EFSA a first part of the consolidated list. The remaining parts of that list were provided, after the Member States had been consulted, in November and December 2008, and by means of an addendum in March 2010, making the final number of health claims to be examined 4637. Between October 2009 and July 2011, the EFSA carried out the scientific assessment of the health claims submitted by the Commission.

4On 27September 2010, the Commission issued a press release on its webpage in which it stated that it had requested the EFSA to suspend temporarily its assessment of the health claims relating to botanical substances and to concentrate, instead, on the assessment of the other claims with a view to completing the examination of those claims as soon as possible. According to the Commission, the change in priorities in the procedure for the adoption of the list of permitted claims was explained by the need to speed up the procedure aimed at establishing that list and at the same time to provide the opportunity to examine and assess carefully the specific features of the claims relating to botanical substances and, in particular, the potential tensions between Regulation No1924/2006 and Directive 2004/24/EC of the European Parliament and of the Council of 31March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ 2004 L136, 85). 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.

5On 16May 2012, the Commission adopted Regulation (EU) No432/2012 of 16May 2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health (OJ 2012 L136, p.1). In that regulation, the Commission authorised a partial list of 222 health claims, corresponding to 497 entries included in the consolidated list for which the EFSA had essentially concluded that a cause and effect relationship had been established between a food category, a food or one of its constituents and the claimed effect. Those claims, as well as other claims which were rejected, were also entered in the Union Register of nutrition and health claims made on foods, established by the Commission, pursuant to Article20(2)(c) and (d) of Regulation No1924/2006. Moreover, the Commission stipulated that Regulation No432/2012 would be applicable six months after its entry into force, namely from 14December 2012, in order to enable food business operators to adapt to its provisions, in particular the marketing prohibition laid down in Article10(1) of Regulation No1924/2006 in respect of those health claims whose evaluation by the EFSA and whose consideration by the Commission had been completed.

6On the same date, the Commission identified a list of more than 2000 claims in respect of which the EFSA had not completed its evaluation or the Commission itself had not yet completed its consideration, and published that list on its webpage. 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 Article28(5) and (6) of Regulation No1924/2006. Whereas the partial list of permitted claims was subsequently updated by the Commission, the health claims relating to botanical substances remain on hold.

7On 23April 2014, the applicant sent a letter to MrB., Commission member responsible for health matters, requesting that the Commission instruct the EFSA to proceed without delay with the scientific assessment of the claims on hold as a precondition for the adoption of the definitive list of permitted claims under Article13(3) of Regulation No1924/2006. That applicant also indicated that if the Commission refused to act, it intended to bring proceedings before the General Court.

8On 19June 2014, the Commission replied to the applicant’s letter 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.’

9On 8July 2014, the applicant sent further letters to MrB.and to the President of the Commission in which, essentially, it once again requested that the EFSA be instructed to assess the health claims relating to botanical substances by 31July 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 and forms of order sought by the parties

10By application lodged at the Court Registry on 1August 2014, the applicant brought the present action.

11By separate document lodged at the Court Registry on the same date, the applicant requested that the case be dealt with under the expedited procedure provided for by Article76a of the Rules of Procedure of the General Court of 2May 1991.

12On 21August 2014, the Commission submitted its observations to the effect that that request should be rejected.

13By decision of 11September 2014, the General Court (Eighth Chamber) rejected the application for an expedited procedure.

14By separate document lodged at the Court Registry on 28October 2014, the Commission raised an objection of inadmissibility under Article114(1) of the Rules of Procedure of 2May 1991.

15As the President of the Eighth Chamber was prevented from attending, the President of the General court designated, in accordance with the order of precedence laid down in Article6 of the Rules of Procedure of 2May 1991, a first judge to replace the President of the Chamber and, pursuant to Article32(3) of those rules, a second judge to complete the Chamber. On 12December 2014, the applicant lodged its observations on the objection of inadmissibility.

16On 12December 2014, the applicant lodged its observations on the objection of inadmissibility.

17In its application, the applicant claims that the Court should declare that the Commission has unlawfully failed to initiate the assessment of health claims relating to botanical substances by the EFSA in accordance with the procedure laid down in Article13(3) of Regulation No1924/2006 and, in the alternative, annul the decision contained in the Commission’s letter of 19June 2014 not to initiate the assessment of those claims before 1August 2014.

18In its objection of inadmissibility, the Commission contends that the Court should:

–dismiss the action as inadmissible;

–order the applicant to pay the costs.

19In its observations on the objection of inadmissibility, the applicant claims that the Court should reject the objection and give a ruling on the substance.

Law

20In accordance with Article130(1) of the Rules of Procedure of the General Court, if the defendant so requests, the Court may give a decision on inadmissibility or lack of competence without going to the substance of the case. In the present case, the Court considers that it has sufficient information before it and has decided to give a decision on the action without taking further steps in the proceedings.

21The applicant has asked the Court, in essence, to declare that the Commission failed to act, in that it unlawfully failed to instruct the EFSA to proceed with the assessment of the health claims relating to botanical substances for the purpose of the adoption of the definitive list of permitted health claims, in accordance with the procedure laid down in Article13(3) of Regulation No1924/2006. In the alternative, the applicant seeks the annulment of the decision purportedly contained in the Commission’s letter of 19July 2014 refusing to instruct the EFSA to assess those claims.

22It is necessary to examine the admissibility of those two claims separately.

Application for a declaration of failure to act

23The Commission puts forward, in essence, four pleas of inadmissibility, alleging: (i) that the applicant failed to comply with the requirements laid down in Article265 TFEU; (ii) that the applicant has no legal interest in bringing proceeding and (iii) no standing to bring proceedings; and (iv) that the Commission did in fact act.

The first plea of inadmissibility, alleging failure to comply with the requirement laid down in Article265 TFEU

24The Commission submits that the application for a declaration of failure to act is premature, given that it was lodged on 4August 2014. It maintains in that regard that the applicant called upon it to act most recently on 8July 2014 and that, in those circumstances, the applicant should have waited until 8September 2014 before bringing its action in accordance with Article265 TFEU.The Commission also points out that, while the applicant initially called upon it to act on 23April 2014, it replied to that request by letter of 19June 2014.

25The applicant disputes the Commission’s arguments and claims, in essence, that the action was lodged within the time-limits laid down in Article265 TFEU.In particular, the applicant submits that the Commission’s letter of 19June 2014 cannot be regarded as defining the Commission’s position within the meaning of that provision and that, as the applicant’s initial request to act was made on 23April 2014, the action was brought in good time.

26The second paragraph of Article265 TFEU provides that ‘[a]n action [for failure to act] is admissible only if the institution, body, office or agency concerned has first been called upon to act’ and that ‘[i]f, within two months of being so called upon, the institution, body, office or agency concerned has not defined its position, the action may be brought within a further period of two months’.

27It is established case-law that the requirements laid down in Article265 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 (see, to that effect, judgments of 7October 2009 in Vischim v Commission, T‑420/05, ECR, EU:T:2009:391, paragraphs254 and 256, and 4July 2012 in Laboratoires CTRS v Commission, T‑12/12, EU:T:2012:343, paragraph46).

28Moreover, it is clear from Article265 TFEU that an action for failure to act may be brought only after a period of two months has elapsed following the expiry of the initial two-month period running from the date on which the institution concerned was called upon to act. Giving the institution formal notice is an essential procedural requirement, the effects of which are, first, to cause the period within which the institution is required to define its position to begin to run and, second, to delimit any action that might be brought should the institution fail to define its position (see judgment in Laboratoires CTRS v Commission, cited in paragraph27 above, EU:T:2012:343, paragraph38 and the case-law cited). As it is premature, an action for failure to act brought before the expiry of the period that begins to run when the institution is called upon to act is inadmissible (see, to that effect, order of 30June 2011 in Tecnoprocess v Commission, T‑367/09, EU:T:2011:320, paragraph53 and the case-law cited).

29In the present case, the parties do not dispute that both the letter of 23April 2014 and that of 8July 2014 from the applicant to the Commission constitute an invitation to act for the purpose of Article265 TFEU.However, the parties disagree as to whether, first, the Commission’s letter of 19June 2014 may be regarded as bringing the Commission’s failure to act to an end and, second, whether, by lodging its action on 4August 2014, the applicant complied with the initial two-month time-limit laid down in Article265 TFEU.

30As regards the first question, it should be noted that, on 23April 2014, the applicant wrote to MrB., requesting that the Commission instruct the EFSA to proceed with the scientific assessment of the health claims relating to botanical substances so that a definitive list of permitted health claims could be adopted in accordance with Article13(3) of Regulation No1924/2006.

31It is apparent from the documents before the Court that MrB.in fact replied to that request by letter of 19June 2014. In that letter, he explained why it had been agreed that the procedure for the assessment of those claims should be suspended and went on to inform the applicant that, in order to examine that issue, the Commission needed more time and a more precise context (see paragraph8 above). In the light of the content of MrB.’s letter, it must be concluded that, as the applicant itself acknowledges in its application, that letter, considered as a whole, was sufficiently clear and precise to enable the applicant to be apprised of the Commission’s position on its request, in particular the fact that the Commission would not be instructing the EFSA to initiate the assessment requested, as well as the reasons for the Commission’s position.

32As a consequence, the letter of 19June 2014 must be regarded as defining the Commission’s position within the meaning of the second paragraph of Article265 TFEU, thus bringing the Commission’s failure to act to an end.

33In that regard, it should be recalled that, according to well established case-law, the fact that the Commission’s reply does not satisfy the applicant is immaterial. Article265 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 (see judgment in Vischim v Commission, cited in paragraph27 above, EU:T:2009:391, paragraph255 and the case-law cited).

34It follows that, in line with the case-law cited in paragraph27 above, the application for a declaration that the Commission failed to act is inadmissible, in so far as it is based on the invitation to act of 23April 2014.

35As regards the second question, it should be noted that, on 8July 2014, the applicant wrote to both MrB.and to the President of the Commission, requesting once again that the EFSA be instructed to assess the health claims relating to botanical substances. Even though the Commission did not reply to the applicant’s request on that occasion, the action for failure to act is premature, since it was brought before the expiry of the initial two-month time-limit within which the institution concerned is required under Article265 TFEU to provide a response to the request submitted to it. As the letter calling upon the Commission to act was sent on 8July 2014, an application for failure to act could not be brought until after 8September 2014. As the applicant’s action for failure to act was lodged on 4August 2014, it was clearly brought more than one month before that period expired.

36It follows that, in line with the case-law cited in paragraph28 above, the application for a declaration of failure to act is inadmissible in so far as it is based on the invitation to act of 8July 2014.

37The applicant contends, contrary to the above finding, that the letter of 8July 2014 should not be regarded in isolation as a fresh invitation to act, but rather as a request for additional information supplementing the invitation of 23April 2014. However, the Court finds that that argument is, in any event, ineffective since, as concluded in paragraph32 above, the application for failure to act based on the first invitation to act has been dismissed as inadmissible.

38As a consequence, the application for failure to act must be dismissed as inadmissible.

39It is therefore merely for the sake of completeness that the Commission’s plea of inadmissibility alleging that the applicant has no interest in bringing proceedings will be examined.

The second plea of inadmissibility, alleging that the applicant has no interest in bringing proceedings

40The Commission contends that the applicant has failed to show that it has any interest in it being established that the Commission unlawfully failed to instruct the EFSA to assess the health claims relating to botanical substances. In essence, the Commission explains that, as stated in Regulation No432/2012, the health claims on hold are not prohibited and may be used in accordance with the transitional scheme provided for in Article28(5) and (6) of Regulation No1924/2006.

41The applicant contests the Commission’s arguments and maintains, in particular, that the adoption of a definitive decision by the Commission, in so far as regards authorisation of the health claims of concern to the applicant, would enable it to take advantage of the benefits referred to in Article17(5) of Regulation No1924/2006.

42It is settled case-law that an interest in bringing proceedings is an essential and fundamental prerequisite for any legal proceedings (judgment of 5September 2014 in Éditions Odile Jacob v Commission, T‑471/11, ECR, EU:T:2014:739, paragraph39).

43Any applicant must therefore demonstrate, in the light of the purpose of his action, that he has an interest in bringing proceedings, which must exist at the stage of lodging the action, failing which it will be inadmissible (see, to that effect, judgment of 7June 2007 in Wunenburger v Commission, C‑362/05P, ECR, EU:C:2007:322, paragraph42).

44An interest in bringing proceedings presupposes that the action is capable, as a result of its outcome, of procuring a benefit for the person bringing the action (see, to that effect, judgment of 19June 2009 in Socratec v Commission, T‑269/03, EU:T:2009:211, paragraph36 and the case-law cited).

45Lastly, it is the applicant that must prove that it has an interest in bringing proceedings, which must be vested and present. If the interest pleaded by an applicant concerns a future legal situation, it must demonstrate that the prejudice to that situation is already certain (see, to that effect, judgment of 30April 2014 in Hagenmeyer and Hahn v Commission, T‑17/12, ECR, EU:T:2014:234, paragraph39 and the case-law cited).

46In the present case, the Court would point out at the outset that, as observed by the Commission, it is apparent from recitals 10 and 11 in the preamble to Regulation No432/2012 that the health claims that remain on hold, due, inter alia, to the fact that the EFSA has not completed its scientific assessment of them, may still be used in accordance with the transitional measures provided for in Article28(5) and (6) of Regulation No1924/2006.

47It should be noted in that regard that the Court of Justice stated in its judgment of 10April 2014 in Ehrmann (C‑609/12, ECR, EU:C:2014:252) that Article28 of Regulation No1924/2006 introduces transitional measures the objective of which, as is apparent from recital 35 in the preamble to the regulation, is to enable food business operators to adapt to the requirements established by the regulation. The transitional measures for health claims are set out in Article28(5) and (6) of the regulation (judgment in Ehrmann, cited above, EU:C:2014:252, paragraph31).

48Accordingly, first, under Article28(5) of Regulation No1924/2006, the health claims referred to in Article13(1)(a)— that is, claims describing or referring to the role of a nutrient or other substance in growth, development and the functions of the body— can be made from the date of entry into force of that regulation until the adoption of the list referred to in Article13(3), under the responsibility of food business operators, provided that they comply with the regulation and with existing national provisions applicable to them, and without prejudice to the adoption of the safeguard measures set out in Article24. Thus it follows from the wording of Article28(5) of Regulation No1924/2006 that a food business operator may, under its own responsibility and in accordance with the conditions laid down, make health claims during the period between the entry into force of that regulation and the adoption of the list referred to in Article13 (judgment in Ehrmann, cited in paragraph47 above, EU:C:2014:252, paragraphs32 and 33).

49Second, the health claims referred to in particular in Article13(1)(b) and (c) of Regulation No1924/2006— that is the claims describing or referring to psychological and behavioural functions or slimming or weight-control or a reduction in the sense of hunger or an increase in the sense of satiety or the reduction of the available energy from the diet— are subject to the transitional measures set out in Article28(6) of the regulation. That provision refers to health claims made in accordance with national provisions before the date of entry into force of Regulation No1924/2006, that is to say, before 19January 2007 (see, to that effect, judgment in Ehrmann, cited in paragraph47 above, EU:C:2014:252, paragraphs34 and 35) and allows such claims to be made, where appropriate, for six months following the adoption of a decision in accordance with the procedures referred to by that provision.

50It therefore follows from the wording of Article28(5) and (6) of Regulation No1924/2006 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 in respect of which the Commission is yet to adopt a decision. In those circumstances, irrespective of how the claims are classified under the three categories set out in Article13(1) of that regulation, undertakings affected by claims on hold may continue to make those claims, provided they comply with the transitional provisions referred to above, which the applicant itself acknowledges.

51As a consequence, the Commission’s argument that the applicant cannot claim that it would procure a definite advantage from the adoption of the definitive list of permitted health claims must be upheld.

52The above conclusion is not affected, first, by the applicant’s argument that a finding that the Commission had failed to act would ultimately lead to the Commission’s adopting the definitive list of permitted health claims, which could secure the applicant the right to make the claims relevant to it in accordance with Article17(5) of Regulation No1924/2006. In particular, the applicant explains that it could manufacture and market products using the health claims that have been given a positive assessment.

53It should be noted in that regard that Article17(5) of Regulation No1924/2006 provides, in essence, that health claims on list of claims authorised in accordance with the procedure laid down in Article13 of the regulation may be made, in conformity with the conditions applicable to such claims, by any food business operator if their use is not restricted in accordance with the provisions laid down in Article21 of the regulation.

54Article17(5) of Regulation No1924/2006 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. Once again, it should be noted that, in those circumstances, there would be no discernible advantage to be procured for the applicant as a result of its request that the EFSA be instructed to proceed with the assessment of the health claims on hold with a view to the adoption of the definitive list of permitted claims.

55Furthermore and in any event, even if it could be established that Article17(5) of Regulation No1924/2006 has consequences for the applicant’s legal situation by comparison, inter alia, with its situation under the transitional provisions provided for in Article28(5) and (6) of the regulation, it is clear that there would be an advantage for the applicant, 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 remains, for the time being, a premiss and, for that reason, cannot satisfy the requirements of the case-law cited in paragraph45 above, which establishes 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.

56The above assessment is all the more justified if account is also taken of the fact that, as pointed out by the Commission, the current regulatory situation, under which the health claims on hold can still be made, may be more advantageous for the applicant than the situation in which its health claims are rejected. In that regard, it must be pointed out that, under Regulation No1924/2006, which has established a partial list of permitted health claims, the Commission has authorised only 222 claims out of a total of more than 2000 claims examined.

57Second, the applicant maintains that, as a result of the Commission’s failure to act, in particular as a result of the fact that some health claims have been assessed and other remain on hold, unequal conditions of competition have been created on the market.

58It should be noted in that connection that, according to the applicant itself, such an unequal situation can affect only the interests of producers whose claims have been rejected following the adoption of Regulation No432/2012, not the interests of producers whose claims are still on hold.

59The applicant contends that producers whose claims have not yet been the subject of a final decision authorising or prohibiting the claims on the part of the Commission currently have a ‘significant competitive advantage’ and a ‘privileged position’ by comparison with producers whose claims have been rejected.

60In that context, in so far as the applicant states that it is a producer of foodstuffs affected by the health claims on hold, its argument alleging unequal conditions of competition cannot justify its claim that it has a legal interest in bringing proceedings in the present case.

61Third, the applicant submits that it is greatly affected by the legal uncertainty prevailing on the market as a result of the lack of a complete, definitive Commission decision on the authorisation of health claims.

62However, the fact that some health claims have been assessed and a final decision taken in their regard by the EFSA and the Commission respectively, whereas other claims are still on hold cannot be regarded as giving rise to a situation creating legal uncertainty for an economic operator such as the applicant.

63It should be recalled that, according to settled case-law, the principle of legal certainty requires legal rules to be clear and precise and their consequences to be foreseeable (see, to that effect, judgment of 15September 2005 in Ireland v Commission, C‑199/03, ECR, EU:C:2005:548, paragraph69).

64In the present case, it is clear that the rules applicable to both claims that have been authorised or rejected and to claims on hold fulfil those conditions. In particular, the rules to which claims on hold are subject are expressly set out in Regulation No1924/2006, namely in Article28(5) and (6), which, as examined in paragraphs46 to 50 above, lays down the rules applicable to health claims which had not been assessed and were not the subject of a final decision following the adoption of the regulation.

65Moreover, while the applicant maintains that the fact that a final decision has yet to be made with regard to its claims on hold prevents it from making economic forecasts in its business, the fact nevertheless remains that, as observed by the Commission, all economic spheres may be adversely affected by the adoption of new rules and by having to wait for administrative decisions or indeed judicial decisions. In any event, it is clear that when Regulation No432/2012 was adopted establishing the partial list of authorised health claims, the Commission provided, in Article2 of the regulation, for a transitional period to enable food business operators to adapt to its provisions, in particular the prohibition laid down in Article10(1) of Regulation No1924/2006. In the present case, there is nothing to support the claim that the Commission will not provide for an equivalent measure when the definitive list of authorised health claims is adopted.

66Fourth, while the applicant claims that is has suffered financial loss as a result of the Commission’s failure to act, it has failed to explain either how such loss has come about as a result of the Commission’s failure to act or how the loss might disappear if the Commission were to instruct the EFSA, as requested by the applicant, to proceed with the assessment of the health claims on hold.

67It follows that the applicant has failed to provide in its written pleadings before the Court any evidence demonstrating to the requisite legal standard how the resumption by the EFSA of its assessment of the health claims relating to botanical substances and the adoption of the definitive list of permitted health claims could procure an advantage for it, as required by case-law.

68In the light of the foregoing, the application for failure to act must be dismissed as inadmissible on the ground that the applicant has failed to establish an interest in bringing proceedings, without there being any need to examine the other pleas of inadmissibility raised by the Commission.

The application for annulment of the letter of 19June 2014

69The Commission contends that the application for annulment of the letter of 19June 2014 is inadmissible as that letter does not constitute a challengeable act for the purpose of Article263 TFEU.It observes in that regard that, according to settled case-law, not every letter sent by the Commission in response to a request by a natural person may be classified as a decision in respect of which an action for annulment may be brought.

70The applicant disputes the Commission’s arguments. It submits, in essence, that if the letter of 19June 2014 is to be interpreted as defining the Commission’s position within the meaning of Article265 TFEU, thus bringing the Commission’s failure to act to an end, it must, necessarily, constitute a challengeable act under Article263 TFEU.Otherwise, according to the applicant, it would be denied access to the courts and to effective judicial protection against the Commission’s failure to act.

71According to established case-law, 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 Article263 TFEU (see judgment of 26September 2013 in PPG and SNF v ECHA, C‑626/11P, ECR, EU:C:2013:595, paragraph37 and the case-law cited).

72In order to ascertain whether or not a measure which has been challenged produces such effects, it is necessary to look to its substance. The form in which such acts or decisions are cast is, in principle, immaterial as regards the question whether they are open to challenge by an action for annulment (judgment of 11November 1981 in IBM v Commission, 60/81, ECR, EU:C:1981:264, paragraph9; see also order of 22February 2008 in Base v Commission, T‑295/06, EU:T:2008:48, paragraph56 and the case-law cited).

73In the present case, it should be noted, first, that, in the light of its content, the letter of 19June 2014 cannot be regarded as a challengeable act. As indicated in paragraph31 above, that letter was sent to the applicant for the sole purpose of replying to its request that the EFSA be instructed to proceed with the scientific assessment of the health claims relating to botanical substances in accordance with Article13(3) of Regulation No1924/2006. In that letter, the Commission simply set out the reason why it had initially been agreed that the procedure for the assessment of those claims should be suspended and went on to inform the applicant that the Commission needed more time and a more precise context for that purpose.

74Second, it should be noted that, in spite of the lack of precision in the terms in which Article13 of Regulation No1924/2006 is couched as to whether the Commission may defer authorisation of health claims for which the EFSA has not completed its assessment, that provision 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. There is nothing in the wording of that article of Regulation No1924/2006, or in the recitals in the preamble to that regulation, which suggests that the EU legislature sought to deprive the Commission of its discretionary power to establish that list on a gradual basis and, in particular, to add to that list as and when technical evaluations have been completed by the EFSA and verify itself the conditions established in the regulation. On the contrary, in so far as Article13(1) to (3) of Regulation No1924/2006 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 Regulation No1924/2006 and in EU law, the speed at which the list of permitted claims is to be adopted. The Court points out, in that regard, that, according to settled case-law, 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, as is the case in this instance, it must be recognised as enjoying a broad discretion (see, to that effect, judgments of 9September 2008 in Bayer CropScience and Others v Commission, T‑75/06, ECR, EU:T:2008:317, paragraphs81 and 82, and 19January 2012 in Xeda International and Pace International v Commission, T‑71/10, EU:T:2012:18, paragraph69).

75It follows that the Commission is not in fact under any obligation to act without delay, as requested by the applicant, so that its decision not to instruct the EFSA to assess the health claims relating to botanical substances cannot produce binding legal effects capable of affecting the applicant’s interests, as required by the case-law cited in paragraph71 above.

76Third, the applicant’s claim that, if the letter of 19June 2014 were to be regarded as defining the Commission’s position, it would necessarily constitute a challengeable act, must be rejected. It is sufficient to observe in that connection that, according to well-established case-law, even an act which is not challengeable by an action for annulment may constitute a definition of position terminating the failure to act if it forms part of a procedure which has, in principle, to culminate in a legal act which itself will be challengeable by an action for annulment (judgments of 27June 1995 in Guérin automobiles v Commission, T‑186/94, ECR, EU:T:1995:114, paragraph25, and 17February 1998 in Pharos v Commission, T‑105/96, ECR, EU:T:1998:35, paragraph43). In the present case, it is clear that the letter of 19June 2014 forms part of the procedure for the adoption of the list of permitted health claims provided for in Article13(3) of Regulation No1924/2006, which, in turn, will give rise to a challengeable act.

77Fourth, the applicant’s arguments based on the principle requiring that access be given to the courts and the principle of effective judicial protection cannot affect that conclusion.

78As established by case-law, it is not possible on the basis of those principles for an action for annulment which does not meet the requirements for admissibility laid down in Article263 TFU to be deemed admissible.

79First, the principle of access to the courts is one of the elements of a Community governed by the rule of law, upheld in the legal system based on the FEU Treaty in that that Treaty established a complete system of legal remedies and procedures designed to permit the EU judicature to review the legality of measures adopted by the institutions. However, individuals are not deprived of access to the courts by reason of the fact that a measure not producing binding effects capable of affecting their interests by bringing about a significant change in their legal position cannot be the subject of an action for annulment, an action to establish non-contractual liability provided for the second paragraph of Article340 TFEU being available to them if such a measure is capable of causing the European Union to incur liability (order of 30March 2006 in Korkmaz and Others v Commission, T‑2/04, EU:T:2006:97 paragraph55).

80Second, even supposing that the applicant was unable to obtain effective judicial protection, as it alleges, it must be observed that, if the conditions for the availability of a remedy before the EU judicature must be interpreted in the light of the principle of effective judicial protection, such an interpretation cannot lead to the disapplication of a condition expressly provided for by the Treaty, such as the condition regarding the existence of a measure against which an action may be brought under the first paragraph of Article263 TFEU, which is not fulfilled in this case (see, to that effect, order in Korkmaz and Others v Commission, cited in paragraph79 above, EU:T:2006:97, paragraph56).

81It is apparent from the foregoing that the letter of 19June 2014 cannot be regarded as an act open to challenge for the purposes of Article263 TFEU.

82As a consequence, the application for annulment of the letter of 19June 2014 must be dismissed as inadmissible.

83In the light of all the above considerations, the action must be dismissed in its entirety as inadmissible.

Costs

84Under Article134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the applicant has been unsuccessful, it must be ordered to pay the costs, in accordance with form of order sought by the Commission.

On those grounds,

THE GENERAL COURT (Eighth Chamber)

hereby orders:

1.The action is dismissed as inadmissible.

2.VSM Geneesmiddelen BV is ordered to pay the costs.

Luxembourg, 16 September 2015.

* Language of the case: English.