# 62012TJ0334

JUDGMENT OF THE GENERAL COURT (Eighth Chamber)

12 June 2015 (
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  )

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‛Consumer protection — Health claims made on foods — Regulation (EU) No 432/2012 — Action for annulment — Regulatory act not entailing implementing measures — Direct concern — Admissibility — Regulation (EC) No 1924/2006 — Plea of illegality — Register of health claims’

In Case T‐334/12,

Plantavis GmbH, established in Berlin (Germany),

Plantavis GmbH

NEM, Verband mittelständischer europäischer Hersteller und Distributoren von Nahrungsergänzungsmitteln & Gesundheitsprodukten eV, established in Laudert (Germany),

NEM, Verband mittelständischer europäischer Hersteller und Distributoren von Nahrungsergänzungsmitteln & Gesundheitsprodukten eV

represented by T. Büttner, lawyer,

applicants,

v

European Commission, represented by L. Pignataro-Nolin and S. Grünheid, acting as Agents,

European Commission

and

European Food Safety Authority (EFSA), represented by D. Detken, acting as Agent, and by R. Van der Hout and A. Köhler, lawyers,

European Food Safety Authority (EFSA)

defendants,

supported by

European Parliament, represented by J. Rodrigues and P. Schonard, acting as Agents,

European Parliament

intervener in support of the Commission,

and by

Council of the European Union, represented by M. Simm and I. Šulce, acting as Agents,

Council of the European Union

intervener in support of the Commission and EFSA,

APPLICATION for annulment, first, 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, secondly, of 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 2012 L 136, p. 1), and of the Register of nutrition and health claims made on food, published on the website of the Commission.

THE GENERAL COURT (Eighth Chamber),

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

Registrar: J. Weychert, Administrator,

having regard to the written procedure and further to the hearing on 23 October 2014,

gives the following

Judgment

Judgment

Background to the dispute

Background to the dispute

| 1 | The applicants, Plantavis GmbH and NEM, Verband mittelständischer europäischer Hersteller und Distributoren von Nahrungsergänzungsmitteln & Gesundheitsprodukten eV, are established in Germany and are, respectively, a company that produces and markets food supplements and dietetic foods on the European market and a professional association representing the interests of companies engaged in this type of activity. Such companies make health claims on their product labels and in their advertising on a daily basis. |
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1

The applicants, Plantavis GmbH and NEM, Verband mittelständischer europäischer Hersteller und Distributoren von Nahrungsergänzungsmitteln & Gesundheitsprodukten eV, are established in Germany and are, respectively, a company that produces and markets food supplements and dietetic foods on the European market and a professional association representing the interests of companies engaged in this type of activity. Such companies make health claims on their product labels and in their advertising on a daily basis.

| 2 | Following the adoption 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), the applicants submitted health claims to the authorities in their Member State for the purposes of the authorisation procedure provided for in Article 13(1) to (3) of that regulation. The Commission of the European Communities subsequently received approximately 44000 health claims from Member States under Article 13(2) of Regulation No 1924/2006. In that context, a consolidated list, intended to contain all health claims submitted by Member States, was compiled in order to avoid duplication and repetitions. A codification system was also established to ensure, according to the Commission, consistent treatment of national lists and identification of the abovementioned health claims using ID numbers. |
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2

Following the adoption 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), the applicants submitted health claims to the authorities in their Member State for the purposes of the authorisation procedure provided for in Article 13(1) to (3) of that regulation. The Commission of the European Communities subsequently received approximately 44000 health claims from Member States under Article 13(2) of Regulation No 1924/2006. In that context, a consolidated list, intended to contain all health claims submitted by Member States, was compiled in order to avoid duplication and repetitions. A codification system was also established to ensure, according to the Commission, consistent treatment of national lists and identification of the abovementioned health claims using ID numbers.

| 3 | On 24 July 2008, the Commission sent a formal request for a scientific opinion to the European Food Safety Authority (‘EFSA’) under Article 13(3) of Regulation No 1924/2006. On that occasion, the Commission sent an initial part of the consolidated list to EFSA. The remaining parts of the list were sent in November and December 2008 following consultation with the Member States, with an addendum being sent in March 2010, bringing the final number of health claims for consideration to 4 637. |
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3

On 24 July 2008, the Commission sent a formal request for a scientific opinion to the European Food Safety Authority (‘EFSA’) under Article 13(3) of Regulation No 1924/2006. On that occasion, the Commission sent an initial part of the consolidated list to EFSA. The remaining parts of the list were sent in November and December 2008 following consultation with the Member States, with an addendum being sent in March 2010, bringing the final number of health claims for consideration to 4 637.

| 4 | Between October 2009 and July 2011, EFSA carried out scientific evaluations of the health claims sent by the Commission. |
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4

Between October 2009 and July 2011, EFSA carried out scientific evaluations of the health claims sent by the Commission.

| 5 | On 16 May 2012, pursuant to Article 13(3) of Regulation No 1924/2006, the Commission adopted Regulation (EU) No 432/2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health (OJ 2012 L 136, p. 1). In that regulation the Commission authorised a partial list of 222 health claims, corresponding to 497 entries in the consolidated list, with regard to which 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 (‘the list of permitted claims’). Those claims and other claims which had been rejected were also included in the European Union Register of nutrition and health claims made on foods, drawn up by the Commission in accordance with Article 20(2)(c) and (d) of Regulation No 1924/2006. Moreover, the Commission stipulated that Regulation No 432/2012 would be applicable six months after the date of its entry into force, that is to say, from 14 December 2012, in order to enable food business operators using unauthorised claims to adapt to its provisions, in particular the marketing prohibition provided for in Article 10(1) of Regulation No 1924/2006. |
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5

On 16 May 2012, pursuant to Article 13(3) of Regulation No 1924/2006, the Commission adopted Regulation (EU) No 432/2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health (OJ 2012 L 136, p. 1). In that regulation the Commission authorised a partial list of 222 health claims, corresponding to 497 entries in the consolidated list, with regard to which 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 (‘the list of permitted claims’). Those claims and other claims which had been rejected were also included in the European Union Register of nutrition and health claims made on foods, drawn up by the Commission in accordance with Article 20(2)(c) and (d) of Regulation No 1924/2006. Moreover, the Commission stipulated that Regulation No 432/2012 would be applicable six months after the date of its entry into force, that is to say, from 14 December 2012, in order to enable food business operators using unauthorised claims to adapt to its provisions, in particular the marketing prohibition provided for in Article 10(1) of Regulation No 1924/2006.

| 6 | On the same date, the Commission drew up a list of more than 2000 claims in respect of which 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 plant or herbal substances, commonly known as ‘botanical substances’, were on hold and could, therefore, continue to be used under the transitional measures provided for in Article 28(5) and (6) of Regulation No 1924/2006. |
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6

On the same date, the Commission drew up a list of more than 2000 claims in respect of which 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 plant or herbal substances, commonly known as ‘botanical substances’, were on hold and could, therefore, continue to be used under the transitional measures provided for in Article 28(5) and (6) of Regulation No 1924/2006.

Procedure and forms of order sought

Procedure and forms of order sought

| 7 | By application lodged at the Registry of the Court on 25 July 2012, the applicants brought the present action. |
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7

By application lodged at the Registry of the Court on 25 July 2012, the applicants brought the present action.

| 8 | By document lodged at the Registry of the Court on 25 October 2012, the Council of the European Union sought leave to intervene in support of the form of order sought by the Commission and EFSA. |
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8

By document lodged at the Registry of the Court on 25 October 2012, the Council of the European Union sought leave to intervene in support of the form of order sought by the Commission and EFSA.

| 9 | By document lodged at the Registry of the Court on 16 November 2012, the European Parliament applied for leave to intervene in support of the form of order sought by the Commission. |
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9

By document lodged at the Registry of the Court on 16 November 2012, the European Parliament applied for leave to intervene in support of the form of order sought by the Commission.

| 10 | By order of 15 January 2013, the President of the First Chamber of the Court granted those applications. |
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10

By order of 15 January 2013, the President of the First Chamber of the Court granted those applications.

| 11 | Following a change in the composition of the Chambers of the Court, the Judge-Rapporteur was assigned to the Eighth Chamber, to which the present case was consequently assigned. |
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11

Following a change in the composition of the Chambers of the Court, the Judge-Rapporteur was assigned to the Eighth Chamber, to which the present case was consequently assigned.

| 12 | As the President of the Eighth Chamber was prevented from sitting, the President of the General Court designated, in accordance with the order of precedence laid down in Article 6 of the Rules of Procedure of the General Court, a first judge to replace the President of the Chamber and, pursuant to Article 32(3) of the Rules of Procedure, a second judge to complete the Chamber. |
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12

As the President of the Eighth Chamber was prevented from sitting, the President of the General Court designated, in accordance with the order of precedence laid down in Article 6 of the Rules of Procedure of the General Court, a first judge to replace the President of the Chamber and, pursuant to Article 32(3) of the Rules of Procedure, a second judge to complete the Chamber.

| 13 | Upon hearing the Judge-Rapporteur, the Court (Eighth Chamber) decided to open the oral procedure and, by way of the measures of organisation of procedure provided for in Article 64 of the Rules of Procedure, first, requested that the applicants: (i) provide it with the list of health claims which concerned them and indicate precisely the status of those claims, namely whether they had been authorised, rejected or placed on hold following the adoption of Regulation No 432/2012; (ii) specify the particular acts referred to in their application and the provisions of those acts relating to their action for annulment; and (iii) specify which requests in their application were primary and which secondary. Secondly, the Court requested that the parties state whether they considered Regulation No 432/2012 to be a regulatory act of direct concern to the applicants and not entailing implementing measures, in accordance with the third variant referred to in the fourth paragraph of Article 263 TFEU. The parties complied with those requests within the period prescribed. |
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13

Upon hearing the Judge-Rapporteur, the Court (Eighth Chamber) decided to open the oral procedure and, by way of the measures of organisation of procedure provided for in Article 64 of the Rules of Procedure, first, requested that the applicants: (i) provide it with the list of health claims which concerned them and indicate precisely the status of those claims, namely whether they had been authorised, rejected or placed on hold following the adoption of Regulation No 432/2012; (ii) specify the particular acts referred to in their application and the provisions of those acts relating to their action for annulment; and (iii) specify which requests in their application were primary and which secondary. Secondly, the Court requested that the parties state whether they considered Regulation No 432/2012 to be a regulatory act of direct concern to the applicants and not entailing implementing measures, in accordance with the third variant referred to in the fourth paragraph of Article 263 TFEU. The parties complied with those requests within the period prescribed.

| 14 | The parties presented oral argument and answered the questions put to them by the Court at the hearing on 23 October 2014. |
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14

The parties presented oral argument and answered the questions put to them by the Court at the hearing on 23 October 2014.

| 15 | The applicants claim that the Court should annul the prohibitions provided for in Regulation No 1924/2006, read in conjunction with Regulation No 432/2012 and the Register of nutrition and health claims made on food published on the website of the Commission (‘the Register of permitted health claims’), and EFSA’s evaluations of nutritional and health claims on which the Commission relies. |
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15

The applicants claim that the Court should annul the prohibitions provided for in Regulation No 1924/2006, read in conjunction with Regulation No 432/2012 and the Register of nutrition and health claims made on food published on the website of the Commission (‘the Register of permitted health claims’), and EFSA’s evaluations of nutritional and health claims on which the Commission relies.

| 16 | The Commission and EFSA contend that the Court should:





  — | dismiss the action as inadmissible or, in the alternative, as unfounded; |
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16

The Commission and EFSA contend that the Court should:

—

dismiss the action as inadmissible or, in the alternative, as unfounded;

| — | order the applicants to pay the costs. |
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—

order the applicants to pay the costs.

Law

Law

| 17 | As a preliminary point, it should be noted that, in reply to one of the questions addressed to them in the context of the measures of organisation of procedure, the applicants explained to the Court, first, that their application for annulment was directed, principally and on the basis of Article 263 TFEU, against Regulation No 432/2012. Secondly, they stated that their application, incidentally and on the basis of Article 277 TFEU, sought a declaration that Regulation No 1924/2006 was inapplicable, in support of the claim for annulment. In addition, in their pleadings, the applicants seek annulment of the Register of permitted health claims and of the evaluations of nutritional and health claims made by EFSA, on which the Commission relies. These three applications must therefore be considered separately. |
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17

As a preliminary point, it should be noted that, in reply to one of the questions addressed to them in the context of the measures of organisation of procedure, the applicants explained to the Court, first, that their application for annulment was directed, principally and on the basis of Article 263 TFEU, against Regulation No 432/2012. Secondly, they stated that their application, incidentally and on the basis of Article 277 TFEU, sought a declaration that Regulation No 1924/2006 was inapplicable, in support of the claim for annulment. In addition, in their pleadings, the applicants seek annulment of the Register of permitted health claims and of the evaluations of nutritional and health claims made by EFSA, on which the Commission relies. These three applications must therefore be considered separately.

The application for annulment of Regulation No 432/2012

The application for annulment of Regulation No 432/2012

| 18 | Without formally raising an objection of inadmissibility under Article 114 of the Rules of Procedure, the Commission and EFSA, supported by the Council and the Parliament, maintain that the application for annulment of Regulation No 432/2012 is inadmissible. In particular, they argue that, even if Regulation No 432/2012 is considered to be a regulatory act not entailing implementing measures, in accordance with the fourth paragraph of Article 263 TFEU, the applicants have not demonstrated that the regulation in question directly concerned them. Furthermore, EFSA adds, in any event, that that application for annulment must be rejected in so far as it is directed against EFSA inasmuch as Regulation (EU) No 432/2012 was adopted by the Commission alone. |
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18

Without formally raising an objection of inadmissibility under Article 114 of the Rules of Procedure, the Commission and EFSA, supported by the Council and the Parliament, maintain that the application for annulment of Regulation No 432/2012 is inadmissible. In particular, they argue that, even if Regulation No 432/2012 is considered to be a regulatory act not entailing implementing measures, in accordance with the fourth paragraph of Article 263 TFEU, the applicants have not demonstrated that the regulation in question directly concerned them. Furthermore, EFSA adds, in any event, that that application for annulment must be rejected in so far as it is directed against EFSA inasmuch as Regulation (EU) No 432/2012 was adopted by the Commission alone.

| 19 | The applicants dispute the arguments of the Commission and EFSA regarding the inadmissibility of the action. First, they maintain that Regulation No 432/2012 is a regulatory act, within the meaning of the fourth paragraph of Article 263 TFEU, which does not entail implementing measures. They then state that, in accordance with the case-law, that regulation is of direct concern to them since, first, it directly affects their legal position and, secondly, it leaves no discretion to those to whom it is addressed and who are entrusted with the task of implementing it. |
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19

The applicants dispute the arguments of the Commission and EFSA regarding the inadmissibility of the action. First, they maintain that Regulation No 432/2012 is a regulatory act, within the meaning of the fourth paragraph of Article 263 TFEU, which does not entail implementing measures. They then state that, in accordance with the case-law, that regulation is of direct concern to them since, first, it directly affects their legal position and, secondly, it leaves no discretion to those to whom it is addressed and who are entrusted with the task of implementing it.

| 20 | As a preliminary point, the Court notes that, as EFSA has rightly pointed out, the application for annulment of Regulation No 432/2012 must be declared inadmissible in so far as it concerns that authority inasmuch as the latter is not the author of the contested act. In that regard, suffice it to hold that the list of permitted claims was adopted by the Commission, following consultation with EFSA, in accordance with the procedure set out in Article 13(3) of Regulation No 1924/2006 and all necessary conditions for the use of those claims. Under those circumstances, the present application for annulment must be regarded as being directed solely against the Commission. |
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20

As a preliminary point, the Court notes that, as EFSA has rightly pointed out, the application for annulment of Regulation No 432/2012 must be declared inadmissible in so far as it concerns that authority inasmuch as the latter is not the author of the contested act. In that regard, suffice it to hold that the list of permitted claims was adopted by the Commission, following consultation with EFSA, in accordance with the procedure set out in Article 13(3) of Regulation No 1924/2006 and all necessary conditions for the use of those claims. Under those circumstances, the present application for annulment must be regarded as being directed solely against the Commission.

| 21 | Under the fourth paragraph of Article 263 TFEU, any natural or legal person may, under the conditions laid down in the first and second paragraphs, institute proceedings against an act addressed to that person or which is of direct and individual concern to them, and against a regulatory act which is of direct concern to them and does not entail implementing measures. |
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21

Under the fourth paragraph of Article 263 TFEU, any natural or legal person may, under the conditions laid down in the first and second paragraphs, institute proceedings against an act addressed to that person or which is of direct and individual concern to them, and against a regulatory act which is of direct concern to them and does not entail implementing measures.

| 22 | In the present case, it is common ground that the applicants are not addressees of Regulation No 432/2012. Consequently, under the fourth paragraph of Article 263 TFEU, the applicants may bring an action for annulment of that act only if it is either a regulatory act of direct concern to them and not entailing implementing measures or a decision of direct and individual concern to them. |
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22

In the present case, it is common ground that the applicants are not addressees of Regulation No 432/2012. Consequently, under the fourth paragraph of Article 263 TFEU, the applicants may bring an action for annulment of that act only if it is either a regulatory act of direct concern to them and not entailing implementing measures or a decision of direct and individual concern to them.

| 23 | In the first place, therefore, it is necessary to establish whether the contested regulation is a regulatory act within the meaning of the third possibility set out in the fourth paragraph of Article 263 TFEU. |
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23

In the first place, therefore, it is necessary to establish whether the contested regulation is a regulatory act within the meaning of the third possibility set out in the fourth paragraph of Article 263 TFEU.

| 24 | According to the case-law, the meaning of ‘regulatory act’ must be understood as covering acts of general application other than legislative acts (judgment of 3 October 2013 in Inuit Tapiriit Kanatami and Others v Parliament and Council, C‐583/11 P, ECR, EU:C:2013:625, paragraph 60). |
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24

According to the case-law, the meaning of ‘regulatory act’ must be understood as covering acts of general application other than legislative acts (judgment of 3 October 2013 in Inuit Tapiriit Kanatami and Others v Parliament and Council, C‐583/11 P, ECR, EU:C:2013:625, paragraph 60).

Inuit Tapiriit Kanatami and Others

Parliament and Council

| 25 | In the present case, the legal basis of Regulation No 432/2012 is Article 13(3) of Regulation No 1924/2006, which confers on the Commission a mandate to adopt, in accordance with the procedure referred to in Article 25(3) of that regulation, 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. Article 25(3) of Regulation No 1924/2006 itself refers to Article 5a of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (OJ 1999 L 184, p. 23), which is reserved for the adoption of measures designed to amend non-essential elements of a basic instrument adopted under the co-decision procedure. It follows that Regulation No 432/2012 was adopted by the Commission in the exercise of implementing powers in the context of the regulatory procedure with scrutiny and, consequently, does not constitute a legislative act within the meaning of the case-law arising from Inuit Tapiriit Kanatami and Others v Parliament and Council (EU:C:2013:625, cited in paragraph 24 above). |
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25

In the present case, the legal basis of Regulation No 432/2012 is Article 13(3) of Regulation No 1924/2006, which confers on the Commission a mandate to adopt, in accordance with the procedure referred to in Article 25(3) of that regulation, 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. Article 25(3) of Regulation No 1924/2006 itself refers to Article 5a of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (OJ 1999 L 184, p. 23), which is reserved for the adoption of measures designed to amend non-essential elements of a basic instrument adopted under the co-decision procedure. It follows that Regulation No 432/2012 was adopted by the Commission in the exercise of implementing powers in the context of the regulatory procedure with scrutiny and, consequently, does not constitute a legislative act within the meaning of the case-law arising from Inuit Tapiriit Kanatami and Others v Parliament and Council (EU:C:2013:625, cited in paragraph 24 above).

Inuit Tapiriit Kanatami and Others

Parliament and Council

| 26 | Moreover, since Regulation No 432/2012, read in conjunction with Article 1(2) of Regulation No 1924/2006, applies to all food business operators using health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health, it must be concluded that that regulation is of general application, in that it applies to objectively determined situations and produces legal effects with respect to categories of persons envisaged in general and in the abstract (see, to that effect, judgment of 25 October 2011 in Microban International and Microban (Europe) v Commission, T‐262/10, ECR, EU:T:2011:623, paragraph 23). |
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26

Moreover, since Regulation No 432/2012, read in conjunction with Article 1(2) of Regulation No 1924/2006, applies to all food business operators using health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health, it must be concluded that that regulation is of general application, in that it applies to objectively determined situations and produces legal effects with respect to categories of persons envisaged in general and in the abstract (see, to that effect, judgment of 25 October 2011 in Microban International and Microban (Europe) v Commission, T‐262/10, ECR, EU:T:2011:623, paragraph 23).

Microban International and Microban (Europe)

Commission

| 27 | It follows that Regulation No 432/2012 is a regulatory act within the meaning of the fourth paragraph, in fine, of Article 263 TFEU. |
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27

It follows that Regulation No 432/2012 is a regulatory act within the meaning of the fourth paragraph, in fine, of Article 263 TFEU.

in fine

| 28 | In the second place, with regard to the concept of direct concern, it has been held that that condition requires, first, that the contested measure directly affect the legal situation of the applicant and, secondly, leave no discretion to its addressees entrusted with the task of implementing it, such implementation being purely automatic and resulting from the rules under challenge without the application of other intermediate rules (judgments of 5 May 1998 in Dreyfus v Commission, C‐386/96 P, ECR, EU:C:1998:193, paragraph 43, and 10 September 2009 in Commission v Ente per le Ville Vesuviane and Ente per le Ville Vesuviane v Commission, C‐445/07 P and C‐455/07 P, ECR, EU:C:2009:529, paragraph 45). |
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28

In the second place, with regard to the concept of direct concern, it has been held that that condition requires, first, that the contested measure directly affect the legal situation of the applicant and, secondly, leave no discretion to its addressees entrusted with the task of implementing it, such implementation being purely automatic and resulting from the rules under challenge without the application of other intermediate rules (judgments of 5 May 1998 in Dreyfus v Commission, C‐386/96 P, ECR, EU:C:1998:193, paragraph 43, and 10 September 2009 in Commission v Ente per le Ville Vesuviane and Ente per le Ville Vesuviane v Commission, C‐445/07 P and C‐455/07 P, ECR, EU:C:2009:529, paragraph 45).

Dreyfus

Commission

Commission

Ente per le Ville Vesuviane

Ente per le Ville Vesuviane

Commission

| 29 | First of all, in the present case, it must be noted that the effects of Regulation No 432/2012 include, by virtue of Article 1 thereof, authorisation of a total of 222 health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health. In addition, as stated in recitals 12 and 13 in the preamble to Regulation No 432/2012, by virtue of the application of that regulation, in conjunction with Article 10(1) of Regulation No 1924/2006, Regulation No 432/2012 has the effect of prohibiting a number of claims of the same type, the evaluation and verification of which under Article 13(3) of that regulation were completed by EFSA and the Commission respectively, with the conclusion, in essence, that either they were not scientifically based or did not comply with the general or specific requirements of that regulation. |
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29

First of all, in the present case, it must be noted that the effects of Regulation No 432/2012 include, by virtue of Article 1 thereof, authorisation of a total of 222 health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health. In addition, as stated in recitals 12 and 13 in the preamble to Regulation No 432/2012, by virtue of the application of that regulation, in conjunction with Article 10(1) of Regulation No 1924/2006, Regulation No 432/2012 has the effect of prohibiting a number of claims of the same type, the evaluation and verification of which under Article 13(3) of that regulation were completed by EFSA and the Commission respectively, with the conclusion, in essence, that either they were not scientifically based or did not comply with the general or specific requirements of that regulation.

| 30 | It follows that, since the applicants, as food business operators, dispute the legality of Regulation No 432/2012, they are required to identify the claims concerned by that regulation that affect their legal situation in order to demonstrate that it concerns them directly, within the meaning of the fourth paragraph of Article 263 TFEU. In particular, as is essentially apparent from their pleadings, if permitted health claims are not the subject of their application on the ground that the applicants cannot rely on any interest deriving from their possible annulment, they must show that they were using claims prohibited following the adoption of Regulation No 432/2012 in commercial communications relating to their products when the action was brought before the Court. |
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30

It follows that, since the applicants, as food business operators, dispute the legality of Regulation No 432/2012, they are required to identify the claims concerned by that regulation that affect their legal situation in order to demonstrate that it concerns them directly, within the meaning of the fourth paragraph of Article 263 TFEU. In particular, as is essentially apparent from their pleadings, if permitted health claims are not the subject of their application on the ground that the applicants cannot rely on any interest deriving from their possible annulment, they must show that they were using claims prohibited following the adoption of Regulation No 432/2012 in commercial communications relating to their products when the action was brought before the Court.

| 31 | In the present case, in reply to the Court’s request, made in the context of measures of organisation of procedure, that the applicants provide the list of health claims in Regulation No 432/2012 that concerned them and that they specify the precise status of those claims, the applicants merely stated that the claims which they used in their business activity were those contained in Annex A.1 to their application. |
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31

In the present case, in reply to the Court’s request, made in the context of measures of organisation of procedure, that the applicants provide the list of health claims in Regulation No 432/2012 that concerned them and that they specify the precise status of those claims, the applicants merely stated that the claims which they used in their business activity were those contained in Annex A.1 to their application.

| 32 | However, it must be noted that the annex in question relates only to the list of health claims that the applicants sent to the German authorities for the purposes of drawing up the national lists referred to in Article 13(2) of Regulation No 1924/2006 and contains no information as to whether each of those claims had been permitted or rejected under Regulation No 432/2012. In this respect, even if it is true that this information could be obtained by consulting the annex to the regulation or the register published by the Commission on its website, the link to which was brought to the Court’s attention in the file, it is not for the Court to seek and identify claims that might, as the case may be, constitute the basis for the admissibility of the applicants’ action, in particular, where, as in the present case, approximately 2000 health claims are concerned, 222 of which have been permitted, corresponding to 497 entries in the consolidated list, and 1 719 of which have been rejected (see, to that effect, order of 8 July 2010 in Strålfors v OHIM (ID SOLUTIONS), T‐211/10, EU:T:2010:301, paragraph 7 and the case-law cited). |
| --- | --- |

32

However, it must be noted that the annex in question relates only to the list of health claims that the applicants sent to the German authorities for the purposes of drawing up the national lists referred to in Article 13(2) of Regulation No 1924/2006 and contains no information as to whether each of those claims had been permitted or rejected under Regulation No 432/2012. In this respect, even if it is true that this information could be obtained by consulting the annex to the regulation or the register published by the Commission on its website, the link to which was brought to the Court’s attention in the file, it is not for the Court to seek and identify claims that might, as the case may be, constitute the basis for the admissibility of the applicants’ action, in particular, where, as in the present case, approximately 2000 health claims are concerned, 222 of which have been permitted, corresponding to 497 entries in the consolidated list, and 1 719 of which have been rejected (see, to that effect, order of 8 July 2010 in Strålfors v OHIM (ID SOLUTIONS), T‐211/10, EU:T:2010:301, paragraph 7 and the case-law cited).

Strålfors

OHIM (ID SOLUTIONS)

| 33 | It follows that the applicants have failed to identify the health claims concerned by Regulation No 432/2012, the prohibition of which allegedly affects their legal situation. |
| --- | --- |

33

It follows that the applicants have failed to identify the health claims concerned by Regulation No 432/2012, the prohibition of which allegedly affects their legal situation.

| 34 | The foregoing finding cannot be called into question by the applicants’ other arguments in reply to the questions put by the Court, both by way of measures of organisation of procedure and during the hearing. |
| --- | --- |

34

The foregoing finding cannot be called into question by the applicants’ other arguments in reply to the questions put by the Court, both by way of measures of organisation of procedure and during the hearing.

| 35 | Firstly, the applicants maintain that they are directly concerned by Regulation No 432/2012 on the ground that, following its entry into force, health claims which, like theirs, were not authorised by the Commission were automatically prohibited on the basis of Article 10(1) of Regulation No 1924/2006. |
| --- | --- |

35

Firstly, the applicants maintain that they are directly concerned by Regulation No 432/2012 on the ground that, following its entry into force, health claims which, like theirs, were not authorised by the Commission were automatically prohibited on the basis of Article 10(1) of Regulation No 1924/2006.

| 36 | However, even if, as maintained by the applicants, the claims which concern them were not authorised by Regulation No 432/2012, that assertion is not sufficient to identify with precision the non-authorised claims capable of establishing that the applicants are directly concerned. It must be noted that, as is clear from recitals 10 and 11 in the preamble to Regulation No 432/2012, more than 2000 health claims referred to in Article 13(1) to (3) of Regulation No 1924/2006 are pending evaluation and can therefore be used in accordance with the transitional measures provided for in Article 28(5) and (6) of that regulation. In this context, it cannot be ruled out that the health claims which concern the applicants are on the list of claims on hold. Moreover, it should be stressed in this respect that, in so far as claims on hold are still under evaluation and in so far as the Commission has not issued any definitive authorisation or prohibition in regard to those claims, they are not capable of giving rise to an action for annulment. On-hold claims continue to be treated under the legal rules which applied to them prior to the adoption of Regulation No 432/2012. Consequently, companies concerned by those claims can continue to use them in their food business activities in accordance with Article 28(5) and (6) of Regulation No 1924/2006. |
| --- | --- |

36

However, even if, as maintained by the applicants, the claims which concern them were not authorised by Regulation No 432/2012, that assertion is not sufficient to identify with precision the non-authorised claims capable of establishing that the applicants are directly concerned. It must be noted that, as is clear from recitals 10 and 11 in the preamble to Regulation No 432/2012, more than 2000 health claims referred to in Article 13(1) to (3) of Regulation No 1924/2006 are pending evaluation and can therefore be used in accordance with the transitional measures provided for in Article 28(5) and (6) of that regulation. In this context, it cannot be ruled out that the health claims which concern the applicants are on the list of claims on hold. Moreover, it should be stressed in this respect that, in so far as claims on hold are still under evaluation and in so far as the Commission has not issued any definitive authorisation or prohibition in regard to those claims, they are not capable of giving rise to an action for annulment. On-hold claims continue to be treated under the legal rules which applied to them prior to the adoption of Regulation No 432/2012. Consequently, companies concerned by those claims can continue to use them in their food business activities in accordance with Article 28(5) and (6) of Regulation No 1924/2006.

| 37 | Secondly, the applicants maintain that rejected claims cannot be easily identified by market operators, which will therefore not know which claims have been rejected and which may still be used in accordance with Article 28(5) and (6) of Regulation No 1924/2006. |
| --- | --- |

37

Secondly, the applicants maintain that rejected claims cannot be easily identified by market operators, which will therefore not know which claims have been rejected and which may still be used in accordance with Article 28(5) and (6) of Regulation No 1924/2006.

| 38 | However, in this respect, the Court notes that recitals 4 and 11 in the preamble to Regulation No 432/2012 contain a reference to the respective websites of EFSA and the Commission, on which, first, the consolidated list of all ID codes of health claims submitted by the Member States under Article 13(2) of Regulation No 1924/2006 and, secondly, the lists of ID codes relating to health claims under evaluation and rejected health claims are available to the public. Under those circumstances, it must be noted that non-authorised health claims and on-hold health claims can be identified by consulting the consolidated list using the ID codes supplied by the Commission, with the result that the applicants’ complaint concerning lack of clarity or accuracy in this matter must be rejected. |
| --- | --- |

38

However, in this respect, the Court notes that recitals 4 and 11 in the preamble to Regulation No 432/2012 contain a reference to the respective websites of EFSA and the Commission, on which, first, the consolidated list of all ID codes of health claims submitted by the Member States under Article 13(2) of Regulation No 1924/2006 and, secondly, the lists of ID codes relating to health claims under evaluation and rejected health claims are available to the public. Under those circumstances, it must be noted that non-authorised health claims and on-hold health claims can be identified by consulting the consolidated list using the ID codes supplied by the Commission, with the result that the applicants’ complaint concerning lack of clarity or accuracy in this matter must be rejected.

| 39 | Thirdly, while the applicants seek, in the present case, application of the judgment of 30 April 2014 in Hagenmeyer and Hahn v Commission (T‐17/12, ECR, EU:T:2014:234), in which the Court accepted that two applicants were directly concerned on the sole ground that they had submitted a request for authorisation of a health claim to the national authorities, it must be noted, in the first place, that that judgment relates to the authorisation procedure referred to in Articles 14 to 18 of Regulation No 1924/2006 concerning health claims relating to a reduction of disease risk and to children’s development and health, which differs from the authorisation procedure relevant to the present case, namely the procedure referred to in Article 13(1) to (3) of Regulation No 1924/2006, concerning health claims other than those referring to the reduction of disease risk and children’s development and health. Indeed, it should be pointed out that, while, as the Court noted in paragraph 42 of the judgment in Hagenmeyer and Hahn v Commission (EU:T:2014:234), the procedure referred to in Articles 14 to 18 of Regulation No 1924/2006 is initiated when an authorisation request is made by individuals, who can then submit comments on EFSA’s opinions and obtain an individual decision, the procedure referred to in Article 13(1) to (3) of that regulation is based on the lists of claims submitted by Member States, individuals being unable to submit authorisation requests on an individual basis. In the second place, it must be noted that, unlike the position in the present case, in the judgment in Hagenmeyer and Hahn v Commission (EU:T:2014:234), the Court held that the applicants were directly concerned in so far as the final decision refusing their authorisation request appeared in the contested regulation. In the present case, however, and in line with the conclusion drawn in paragraph 33 above, the applicants have failed to show that a final decision rejecting the claims that concern them resulted from the adoption of Regulation No 432/2012. Accordingly, the solution upheld in the judgment in Hagenmeyer and Hahn v Commission (EU:T:2014:234) cannot be applied to the present case. |
| --- | --- |

39

Thirdly, while the applicants seek, in the present case, application of the judgment of 30 April 2014 in Hagenmeyer and Hahn v Commission (T‐17/12, ECR, EU:T:2014:234), in which the Court accepted that two applicants were directly concerned on the sole ground that they had submitted a request for authorisation of a health claim to the national authorities, it must be noted, in the first place, that that judgment relates to the authorisation procedure referred to in Articles 14 to 18 of Regulation No 1924/2006 concerning health claims relating to a reduction of disease risk and to children’s development and health, which differs from the authorisation procedure relevant to the present case, namely the procedure referred to in Article 13(1) to (3) of Regulation No 1924/2006, concerning health claims other than those referring to the reduction of disease risk and children’s development and health. Indeed, it should be pointed out that, while, as the Court noted in paragraph 42 of the judgment in Hagenmeyer and Hahn v Commission (EU:T:2014:234), the procedure referred to in Articles 14 to 18 of Regulation No 1924/2006 is initiated when an authorisation request is made by individuals, who can then submit comments on EFSA’s opinions and obtain an individual decision, the procedure referred to in Article 13(1) to (3) of that regulation is based on the lists of claims submitted by Member States, individuals being unable to submit authorisation requests on an individual basis. In the second place, it must be noted that, unlike the position in the present case, in the judgment in Hagenmeyer and Hahn v Commission (EU:T:2014:234), the Court held that the applicants were directly concerned in so far as the final decision refusing their authorisation request appeared in the contested regulation. In the present case, however, and in line with the conclusion drawn in paragraph 33 above, the applicants have failed to show that a final decision rejecting the claims that concern them resulted from the adoption of Regulation No 432/2012. Accordingly, the solution upheld in the judgment in Hagenmeyer and Hahn v Commission (EU:T:2014:234) cannot be applied to the present case.

Hagenmeyer and Hahn

Commission

Hagenmeyer and Hahn

Commission

Hagenmeyer and Hahn

Commission

Hagenmeyer and Hahn

Commission

| 40 | Fourthly, at the hearing, the applicants even asserted that the claims which they had sent to the German authorities had never been forwarded to the Commission in accordance with Article 13(2) of Regulation No 1924/2006 and that they did not know the reasons for that omission. |
| --- | --- |

40

Fourthly, at the hearing, the applicants even asserted that the claims which they had sent to the German authorities had never been forwarded to the Commission in accordance with Article 13(2) of Regulation No 1924/2006 and that they did not know the reasons for that omission.

| 41 | In this respect, it should be noted at the outset that, in accordance with Article 13(2) of Regulation No 1924/2006, national authorities of Member States were required to provide the Commission with the list of health claims subsequently to be subjected to scientific evaluation by EFSA and verification of the other conditions provided for in Regulation No 1924/2006 by the Commission. It follows that, if, as the applicants claim, the German authorities did not forward the list of claims sent to them by the applicants, any complaint relating to that alleged failure could be examined only by the competent national authorities. |
| --- | --- |

41

In this respect, it should be noted at the outset that, in accordance with Article 13(2) of Regulation No 1924/2006, national authorities of Member States were required to provide the Commission with the list of health claims subsequently to be subjected to scientific evaluation by EFSA and verification of the other conditions provided for in Regulation No 1924/2006 by the Commission. It follows that, if, as the applicants claim, the German authorities did not forward the list of claims sent to them by the applicants, any complaint relating to that alleged failure could be examined only by the competent national authorities.

| 42 | Next, it should be noted that, as is essentially apparent from a joint reading of recitals 13 and 15 in the preamble to Regulation No 432/2012, that regulation covers only claims sent to the Commission, and not subsequently withdrawn by the Member States, and which have then been examined by EFSA and are subject to a final authorisation or rejection decision by the Commission. However, if claims sent by the applicants to the German authorities were not forwarded to the Commission, or were even withdrawn by those authorities, it would then necessarily be the case that those claims could not have been examined by EFSA or the Commission and that, accordingly, they could not be covered by Regulation No 432/2012. |
| --- | --- |

42

Next, it should be noted that, as is essentially apparent from a joint reading of recitals 13 and 15 in the preamble to Regulation No 432/2012, that regulation covers only claims sent to the Commission, and not subsequently withdrawn by the Member States, and which have then been examined by EFSA and are subject to a final authorisation or rejection decision by the Commission. However, if claims sent by the applicants to the German authorities were not forwarded to the Commission, or were even withdrawn by those authorities, it would then necessarily be the case that those claims could not have been examined by EFSA or the Commission and that, accordingly, they could not be covered by Regulation No 432/2012.

| 43 | Furthermore, as the Commission maintained at the hearing, it is possible that those claims were forwarded by the authorities of other Member States and were accordingly rejected or placed on hold. In that case, it would be possible to establish that the applicants were directly concerned, in accordance with the argument set out in paragraph 30 above, only if they were to specify accurately the status of each of those claims. |
| --- | --- |

43

Furthermore, as the Commission maintained at the hearing, it is possible that those claims were forwarded by the authorities of other Member States and were accordingly rejected or placed on hold. In that case, it would be possible to establish that the applicants were directly concerned, in accordance with the argument set out in paragraph 30 above, only if they were to specify accurately the status of each of those claims.

| 44 | Finally, while the applicants claim that, in this context, they are deprived of all possibility of obtaining authorisation for the claims which they use on a daily basis in marketing their products and that an action against Regulation No 432/2012 is the only way to achieve this, that argument cannot be accepted. If it is the case that the national authorities did not submit the abovementioned claims to the Commission, with the result that they were not included in the authorisation procedure at issue, the applicants would remain entitled to refer the matter to those authorities, which have the power to ask the Commission to amend the list of permitted health claims in accordance with Article 13(4) of Regulation No 1924/2006, following consultation with EFSA. |
| --- | --- |

44

Finally, while the applicants claim that, in this context, they are deprived of all possibility of obtaining authorisation for the claims which they use on a daily basis in marketing their products and that an action against Regulation No 432/2012 is the only way to achieve this, that argument cannot be accepted. If it is the case that the national authorities did not submit the abovementioned claims to the Commission, with the result that they were not included in the authorisation procedure at issue, the applicants would remain entitled to refer the matter to those authorities, which have the power to ask the Commission to amend the list of permitted health claims in accordance with Article 13(4) of Regulation No 1924/2006, following consultation with EFSA.

| 45 | In the light of the foregoing, the applicants have failed to show that they were directly concerned by Regulation No 432/2012. |
| --- | --- |

45

In the light of the foregoing, the applicants have failed to show that they were directly concerned by Regulation No 432/2012.

| 46 | Under these circumstances, their application for annulment of Regulation No 432/2012 must be rejected as being inadmissible, without there being any need to examine the other conditions stipulated in the fourth paragraph of Article 263 TFEU. |
| --- | --- |

46

Under these circumstances, their application for annulment of Regulation No 432/2012 must be rejected as being inadmissible, without there being any need to examine the other conditions stipulated in the fourth paragraph of Article 263 TFEU.

Application seeking to establish the inapplicability of Regulation No 1924/2006

Application seeking to establish the inapplicability of Regulation No 1924/2006

| 47 | The Commission and EFSA, supported by the Council and the Parliament, maintain that the application for annulment of Regulation No 1924/2006 is inadmissible on the ground that it fails to meet the requirements laid down in Article 277 TFEU for consideration as a plea of illegality. |
| --- | --- |

47

The Commission and EFSA, supported by the Council and the Parliament, maintain that the application for annulment of Regulation No 1924/2006 is inadmissible on the ground that it fails to meet the requirements laid down in Article 277 TFEU for consideration as a plea of illegality.

| 48 | The applicants dispute those arguments. |
| --- | --- |

48

The applicants dispute those arguments.

| 49 | Article 277 TFEU provides that, ‘[n]otwithstanding the expiry of the period laid down in Article 263, sixth paragraph, [TFEU], any party may, in proceedings in which an act of general application adopted by an institution, body, office or agency of the Union is at issue, plead the grounds specified in Article 263, second paragraph, [TFEU], in order to invoke before the Court of Justice of the European Union the inapplicability of that act’. |
| --- | --- |

49

Article 277 TFEU provides that, ‘[n]otwithstanding the expiry of the period laid down in Article 263, sixth paragraph, [TFEU], any party may, in proceedings in which an act of general application adopted by an institution, body, office or agency of the Union is at issue, plead the grounds specified in Article 263, second paragraph, [TFEU], in order to invoke before the Court of Justice of the European Union the inapplicability of that act’.

| 50 | According to settled case‐law, the possibility offered by Article 277 TFEU of invoking the illegality of an act of general application does not constitute an independent right of action and may be exercised only incidentally, with the result that, if the main action is inadmissible, so too is the plea of illegality (see, to that effect, judgment of 16 July 1981 in Albini v Council and Commission, 33/80, ECR, EU:C:1981:186, paragraph 17, and order of 16 November 2000 in Schiocchet v Commission, C‐289/99 P, ECR, EU:C:2000:641, paragraphs 11 and 25). |
| --- | --- |

50

According to settled case‐law, the possibility offered by Article 277 TFEU of invoking the illegality of an act of general application does not constitute an independent right of action and may be exercised only incidentally, with the result that, if the main action is inadmissible, so too is the plea of illegality (see, to that effect, judgment of 16 July 1981 in Albini v Council and Commission, 33/80, ECR, EU:C:1981:186, paragraph 17, and order of 16 November 2000 in Schiocchet v Commission, C‐289/99 P, ECR, EU:C:2000:641, paragraphs 11 and 25).

Albini

Council and Commission

Schiocchet

Commission

| 51 | Furthermore, a plea of illegality raised incidentally under Article 277 TFEU, in a case where the challenge to the legality of a separate act constitutes the main subject-matter of the action, will be admissible only if there is a link between that act and the provision forming the subject-matter of the plea of illegality. Since the purpose of Article 277 TFEU is not to enable a party to contest the applicability of any measure of general application in support of any action whatsoever, the scope of a plea of illegality must be limited to what is necessary for the resolution of the dispute. It follows that the general act, the illegality of which has been raised, must be applicable, directly or indirectly, to the case which is the subject-matter of the action (see, to that effect, judgment of 26 October 1993 in Reinarz v Commission, T‐6/92 and T‐52/92, ECR, EU:T:1993:89, paragraph 57 and the case-law cited). |
| --- | --- |

51

Furthermore, a plea of illegality raised incidentally under Article 277 TFEU, in a case where the challenge to the legality of a separate act constitutes the main subject-matter of the action, will be admissible only if there is a link between that act and the provision forming the subject-matter of the plea of illegality. Since the purpose of Article 277 TFEU is not to enable a party to contest the applicability of any measure of general application in support of any action whatsoever, the scope of a plea of illegality must be limited to what is necessary for the resolution of the dispute. It follows that the general act, the illegality of which has been raised, must be applicable, directly or indirectly, to the case which is the subject-matter of the action (see, to that effect, judgment of 26 October 1993 in Reinarz v Commission, T‐6/92 and T‐52/92, ECR, EU:T:1993:89, paragraph 57 and the case-law cited).

Reinarz

Commission

| 52 | In the present case, it should be noted that the admissibility of the application made on the basis of Article 277 TFEU depends, as is clear from the case-law cited in paragraph 50 above, on the admissibility of the action seeking to have Regulation No 432/2012 annulled. |
| --- | --- |

52

In the present case, it should be noted that the admissibility of the application made on the basis of Article 277 TFEU depends, as is clear from the case-law cited in paragraph 50 above, on the admissibility of the action seeking to have Regulation No 432/2012 annulled.

| 53 | Since, as noted in paragraph 46 above, the application for annulment of Regulation No 432/2012 has been declared inadmissible, the plea of illegality must also be declared inadmissible. |
| --- | --- |

53

Since, as noted in paragraph 46 above, the application for annulment of Regulation No 432/2012 has been declared inadmissible, the plea of illegality must also be declared inadmissible.

Application for annulment of the Register of permitted health claims and of the evaluations carried out by EFSA

Application for annulment of the Register of permitted health claims and of the evaluations carried out by EFSA

| 54 | The Commission and EFSA maintain that neither the Register of permitted health claims nor the evaluations carried out by EFSA under the procedure set out in Article 13(1) to (3) of Regulation No 1924/2006 can be the subject of an action within the meaning of Article 263 TFEU since they do not constitute acts with binding effect capable of modifying the legal situation of the applicants. |
| --- | --- |

54

The Commission and EFSA maintain that neither the Register of permitted health claims nor the evaluations carried out by EFSA under the procedure set out in Article 13(1) to (3) of Regulation No 1924/2006 can be the subject of an action within the meaning of Article 263 TFEU since they do not constitute acts with binding effect capable of modifying the legal situation of the applicants.

| 55 | The applicants take the view that both the material published by the Commission in the Register of permitted health claims and the material published by EFSA are subject to review by the Courts of the European Union by virtue of Article 263 TFEU. With regard to EFSA, they submit that it in fact performs a key role having direct legal consequences in respect of third parties in the context of the examination of Regulations No 1924/2006 and No 432/2012. |
| --- | --- |

55

The applicants take the view that both the material published by the Commission in the Register of permitted health claims and the material published by EFSA are subject to review by the Courts of the European Union by virtue of Article 263 TFEU. With regard to EFSA, they submit that it in fact performs a key role having direct legal consequences in respect of third parties in the context of the examination of Regulations No 1924/2006 and No 432/2012.

| 56 | According to settled case-law, any measure the legal effects of which are binding on and capable of affecting the interests of applicants by bringing about a distinct change in their legal position is an act or a decision which may be the subject of an action for annulment under Article 263 TFEU (judgments of 11 November 1981 in IBM v Commission, 60/81, ECR, EU:C:1981:264, paragraph 9; 31 March 1998 in France and Others v Commission, C‐68/94 and C‐30/95, ECR, EU:C:1998:148, paragraph 62; and 4 March 1999 in Assicurazioni Generali and Unicredito v Commission, T‐87/96, ECR, EU:T:1999:37, paragraph 37). In order to determine whether an act or decision produces such effects, it is necessary to look to its substance (order of 13 June 1991 in Sunzest v Commission, C‐50/90, ECR, EU:C:1991:253, paragraph 12, and judgment in France and Others v Commission, EU:C:1998:148, paragraph 63). |
| --- | --- |

56

According to settled case-law, any measure the legal effects of which are binding on and capable of affecting the interests of applicants by bringing about a distinct change in their legal position is an act or a decision which may be the subject of an action for annulment under Article 263 TFEU (judgments of 11 November 1981 in IBM v Commission, 60/81, ECR, EU:C:1981:264, paragraph 9; 31 March 1998 in France and Others v Commission, C‐68/94 and C‐30/95, ECR, EU:C:1998:148, paragraph 62; and 4 March 1999 in Assicurazioni Generali and Unicredito v Commission, T‐87/96, ECR, EU:T:1999:37, paragraph 37). In order to determine whether an act or decision produces such effects, it is necessary to look to its substance (order of 13 June 1991 in Sunzest v Commission, C‐50/90, ECR, EU:C:1991:253, paragraph 12, and judgment in France and Others v Commission, EU:C:1998:148, paragraph 63).

IBM

Commission

France and Others

Commission

Assicurazioni Generali and Unicredito

Commission

Sunzest

Commission

France and Others

Commission

| 57 | In the present case, it should be observed that the applicants seek annulment of the ‘Commission publications appearing in the Community Register managed by the Commission, and evaluations of nutritional and health claims carried out by EFSA, on which the Commission relies’. |
| --- | --- |

57

In the present case, it should be observed that the applicants seek annulment of the ‘Commission publications appearing in the Community Register managed by the Commission, and evaluations of nutritional and health claims carried out by EFSA, on which the Commission relies’.

| 58 | As regards, first, the application for annulment of the Register of permitted health claims, it should be observed, in line with the Commission’s view, that that register was established in accordance with Article 20 of Regulation No 1924/2006 and does not, as such, constitute a legal act within the meaning of the case-law cited in paragraph 56 above. As follows from recital 31 in the preamble to Regulation No 1924/2006, the Register of permitted health claims is a means of communication for the purposes of transparency and information in order to avoid requests concerning claims that have already been evaluated. Although that register provides information on legal acts adopted in the field of nutritional and health claims, the fact remains that it is not intended to produce legal effects in respect of third parties. |
| --- | --- |

58

As regards, first, the application for annulment of the Register of permitted health claims, it should be observed, in line with the Commission’s view, that that register was established in accordance with Article 20 of Regulation No 1924/2006 and does not, as such, constitute a legal act within the meaning of the case-law cited in paragraph 56 above. As follows from recital 31 in the preamble to Regulation No 1924/2006, the Register of permitted health claims is a means of communication for the purposes of transparency and information in order to avoid requests concerning claims that have already been evaluated. Although that register provides information on legal acts adopted in the field of nutritional and health claims, the fact remains that it is not intended to produce legal effects in respect of third parties.

| 59 | Consequently, the Register of permitted health claims cannot be the subject of an action under Article 263 TFEU. |
| --- | --- |

59

Consequently, the Register of permitted health claims cannot be the subject of an action under Article 263 TFEU.

| 60 | Secondly, as regards EFSA’s scientific opinions published following evaluations carried out in accordance with the procedure provided for in Article 13(3) of Regulation No 1924/2006, it is sufficient to point out that, as indicated in paragraph 20 above, EFSA acts in the capacity of an authority performing scientific and technical tasks with no possibility of adopting acts having legal effects on the legal situation of third parties. |
| --- | --- |

60

Secondly, as regards EFSA’s scientific opinions published following evaluations carried out in accordance with the procedure provided for in Article 13(3) of Regulation No 1924/2006, it is sufficient to point out that, as indicated in paragraph 20 above, EFSA acts in the capacity of an authority performing scientific and technical tasks with no possibility of adopting acts having legal effects on the legal situation of third parties.

| 61 | In this respect, it should be noted that opinions and recommendations of European Union institutions, bodies, offices and agencies are expressly excluded from the scope of Article 263 TFEU and cannot therefore be the subject of an action for annulment (see, to that effect, order of 14 May 2012 in Sepracor Pharmaceuticals (Ireland) v Commission, C‐477/11 P, EU:C:2012:292, paragraph 52 and case-law cited). |
| --- | --- |

61

In this respect, it should be noted that opinions and recommendations of European Union institutions, bodies, offices and agencies are expressly excluded from the scope of Article 263 TFEU and cannot therefore be the subject of an action for annulment (see, to that effect, order of 14 May 2012 in Sepracor Pharmaceuticals (Ireland) v Commission, C‐477/11 P, EU:C:2012:292, paragraph 52 and case-law cited).

Sepracor Pharmaceuticals (Ireland)

Commission

| 62 | In addition, according to settled case-law, in the case of acts or decisions adopted by a procedure involving several stages, an act will in principle be open to review only if it is a measure definitively laying down the position of the institution on the conclusion of that procedure, and not a provisional measure intended to pave the way for the final decision (judgment of 18 December 1992 in Cimenteries CBR and Others v Commission, T‐10/92 to T‐12/92 and T‐15/92, ECR, EU:T:1992:123, paragraph 28). |
| --- | --- |

62

In addition, according to settled case-law, in the case of acts or decisions adopted by a procedure involving several stages, an act will in principle be open to review only if it is a measure definitively laying down the position of the institution on the conclusion of that procedure, and not a provisional measure intended to pave the way for the final decision (judgment of 18 December 1992 in Cimenteries CBR and Others v Commission, T‐10/92 to T‐12/92 and T‐15/92, ECR, EU:T:1992:123, paragraph 28).

Cimenteries CBR and Others

Commission

| 63 | In the present case, the view must be taken that, in accordance with Article 13(3) of Regulation No 1924/2006, EFSA’s scientific opinions are intermediary steps in the procedure which are not capable of affecting the legal situation of third parties. As EFSA notes, it is required to provide opinions where, as in the case here at issue, the relevant legal framework so provides. However, in such cases, since EFSA is not capable of adopting measures producing legal effects, the only challengeable acts are those containing the final decision adopted by the Commission concerning the authorisation or prohibition of the claims examined. |
| --- | --- |

63

In the present case, the view must be taken that, in accordance with Article 13(3) of Regulation No 1924/2006, EFSA’s scientific opinions are intermediary steps in the procedure which are not capable of affecting the legal situation of third parties. As EFSA notes, it is required to provide opinions where, as in the case here at issue, the relevant legal framework so provides. However, in such cases, since EFSA is not capable of adopting measures producing legal effects, the only challengeable acts are those containing the final decision adopted by the Commission concerning the authorisation or prohibition of the claims examined.

| 64 | Consequently, evaluations carried out by EFSA under the procedure set out in Article 13(3) of Regulation No 1924/2006 cannot be the subject of an action under Article 263 TFEU. |
| --- | --- |

64

Consequently, evaluations carried out by EFSA under the procedure set out in Article 13(3) of Regulation No 1924/2006 cannot be the subject of an action under Article 263 TFEU.

| 65 | It follows that, in so far as neither the Register of permitted health claims nor EFSA’s opinions constitute acts capable of being the subject of an action under Article 263 TFEU, the applicants’ third application for annulment must be rejected as inadmissible. |
| --- | --- |

65

It follows that, in so far as neither the Register of permitted health claims nor EFSA’s opinions constitute acts capable of being the subject of an action under Article 263 TFEU, the applicants’ third application for annulment must be rejected as inadmissible.

| 66 | In the light of the foregoing, the action must be dismissed as inadmissible in its entirety. |
| --- | --- |

66

In the light of the foregoing, the action must be dismissed as inadmissible in its entirety.

Costs

Costs

| 67 | Under Article 87(2) 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 applicants in this case have been unsuccessful, they must be ordered to bear their own costs and to pay the costs incurred by the Commission and EFSA, in accordance with the forms of order sought by the latter. |
| --- | --- |

67

Under Article 87(2) 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 applicants in this case have been unsuccessful, they must be ordered to bear their own costs and to pay the costs incurred by the Commission and EFSA, in accordance with the forms of order sought by the latter.

| 68 | Under Article 87(4) of the Rules of Procedure, Member States and institutions which have intervened in the proceedings are to bear their own costs and the Court may order an intervener to bear its own costs. In the present case, the Council and Parliament shall bear their own costs. |
| --- | --- |

68

Under Article 87(4) of the Rules of Procedure, Member States and institutions which have intervened in the proceedings are to bear their own costs and the Court may order an intervener to bear its own costs. In the present case, the Council and Parliament shall bear their own costs.

| | On those grounds,
  THE GENERAL COURT (Eighth Chamber)
  hereby: |
| --- | --- |

On those grounds,

THE GENERAL COURT (Eighth Chamber)

hereby:

| | 1. | Dismisses the action; |
| --- | --- | --- |

1.

1.

Dismisses the action;

Dismisses the action;

| | 2. | Orders Plantavis GmbH and NEM, Verband mittelständischer europäischer Hersteller und Distributoren von Nahrungsergänzungsmitteln & Gesundheitsprodukten eV to bear their own costs and, in addition, to pay the costs incurred by the European Commission and the European Food Safety Authority (EFSA); |
| --- | --- | --- |

2.

2.

Orders Plantavis GmbH and NEM, Verband mittelständischer europäischer Hersteller und Distributoren von Nahrungsergänzungsmitteln & Gesundheitsprodukten eV to bear their own costs and, in addition, to pay the costs incurred by the European Commission and the European Food Safety Authority (EFSA);

Orders Plantavis GmbH and NEM, Verband mittelständischer europäischer Hersteller und Distributoren von Nahrungsergänzungsmitteln & Gesundheitsprodukten eV to bear their own costs and, in addition, to pay the costs incurred by the European Commission and the European Food Safety Authority (EFSA);

| | 3. | Orders the Council of the European Union and the European Parliament to bear their own costs. |
| --- | --- | --- |

3.

3.

Orders the Council of the European Union and the European Parliament to bear their own costs.

Orders the Council of the European Union and the European Parliament to bear their own costs.

| | Kancheva


  Wetter


  Bieliūnas


  Delivered in open court in Luxembourg on 12 June 2015.
  [Signatures] |
| --- | --- |

Kancheva

Wetter

Bieliūnas

Delivered in open court in Luxembourg on 12 June 2015.

[Signatures]

---

(
  *1
  )	Language of the case: German.

*1