# 62012TJ0296

JUDGMENT OF THE GENERAL COURT (Eighth Chamber)

12 June 2015 (
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‛Consumer protection — Regulation (EU) No 432/2012 — Health claims made on foods — Actions for annulment — Regulatory act not entailing implementing measures — Whether directly concerned — Admissibility — Infringement of Articles 13 and 28 of Regulation (EC) No 1924/2006 — Principle of good administration — Non-discrimination — Incorrect assessment criteria — Regulation No 1924/2006 — Plea of illegality — Right to be heard — Legal certainty — Unreasonable transition period — List of claims on hold’

In Case T‐296/12,

The Health Food Manufacturers’ Association, established in East Molesey (United Kingdom),

The Health Food Manufacturers’ Association

Quest Vitamins Ltd, established in Birmingham (United Kingdom),

Quest Vitamins Ltd

Natures Aid Ltd, established in Kirkham (United Kingdom),

Natures Aid Ltd

Natuur-& gezondheidsProducten Nederland, established in Ermelo (Netherlands),

Natuur-& gezondheidsProducten Nederland

New Care Supplements BV, established in Oisterwijk (Netherlands),

New Care Supplements BV

represented by B. Kelly and G. Castle, Solicitors, and P. Bogaert, lawyer,

applicants,

supported by

FederSalus, established in Rome (Italy),

FederSalus

Medestea biotech SpA, established in Turin (Italy),

Medestea biotech SpA

and

Naturando Srl, established in Osio Sotto (Italy),

Naturando Srl

represented by E. Valenti and D. Letizia, lawyers,

interveners,

v

European Commission, represented by L. Flynn and S. Grünheid, acting as Agents,

European Commission

defendant,

supported by

French Republic, represented initially by D. Colas and S. Menez, and subsequently by D. Colas and S. Ghiandoni, acting as Agents,

French Republic

by

European Parliament, represented by J. Rodrigues and L. Visaggio, acting as Agents,

European Parliament

by

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

Council of the European Union

and by

Bureau européen des unions de consommateurs (BEUC), established in Brussels (Belgium), represented by S. Pappas, lawyer,

Bureau européen des unions de consommateurs (BEUC)

interveners,

ACTION for annulment 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 the alleged decision of the Commission adopting a list of ‘on-hold’ health claims,

THE GENERAL COURT (Eighth Chamber),

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

Registrar: S. Spyropoulos, Administrator,

having regard to the written procedure and further to the hearing on 22 October 2014,

gives the following

Judgment

Judgment

Background to the dispute

Background to the dispute

| 1 | The applicants, The Health Food Manufacturers’ Association, Quest Vitamins Ltd, Natures Aid Ltd, Natuur-& gezondheidsProducten Nederland and New Care Supplements BV, are established in the United Kingdom and in the Netherlands and are, on the one hand, undertakings which produce and market food supplements and health foods on the European market and, on the other, professional associations which represent the interests of undertakings involved in such activities. They make health claims about their products on the product labelling and in advertisements for those products on a daily basis. |
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1

The applicants, The Health Food Manufacturers’ Association, Quest Vitamins Ltd, Natures Aid Ltd, Natuur-& gezondheidsProducten Nederland and New Care Supplements BV, are established in the United Kingdom and in the Netherlands and are, on the one hand, undertakings which produce and market food supplements and health foods on the European market and, on the other, professional associations which represent the interests of undertakings involved in such activities. They make health claims about their products on the product labelling and in advertisements for those products 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 of their respective Member States for the purposes of the procedure provided for under Article 13(1) to (3) of that regulation. The Commission of the European Communities then received a total of approximately 44000 health claims from the Member States, pursuant to Article 13(2) of that regulation. On the basis of those health claims the Commission compiled a consolidated list with a view to avoiding duplication and repetitions, and established a coding system, which it published on the internet, in order to ensure, it states, a consistent handling of the national lists and the identification of those claims by means of ‘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 of their respective Member States for the purposes of the procedure provided for under Article 13(1) to (3) of that regulation. The Commission of the European Communities then received a total of approximately 44000 health claims from the Member States, pursuant to Article 13(2) of that regulation. On the basis of those health claims the Commission compiled a consolidated list with a view to avoiding duplication and repetitions, and established a coding system, which it published on the internet, in order to ensure, it states, a consistent handling of the national lists and the identification of those claims by means of ‘ID’ numbers.

| 3 | On 24 July 2008, the Commission formally transmitted to the European Food Safety Authority (‘the EFSA’) a request for a scientific opinion pursuant to Article 13(3) of Regulation No 1924/2006 (‘the request for a scientific opinion’), together with the first part of the consolidated list. The remaining parts of that list were transmitted in November and December 2008 after consultation of the Member States, then, by way of an addendum, in March 2010 which increased the final number of health claims to be examined to 4 637. |
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3

On 24 July 2008, the Commission formally transmitted to the European Food Safety Authority (‘the EFSA’) a request for a scientific opinion pursuant to Article 13(3) of Regulation No 1924/2006 (‘the request for a scientific opinion’), together with the first part of the consolidated list. The remaining parts of that list were transmitted in November and December 2008 after consultation of the Member States, then, by way of an addendum, in March 2010 which increased the final number of health claims to be examined to 4 637.

| 4 | Between October 2009 and July 2011, the EFSA proceeded with the scientific evaluation of the health claims transmitted by the Commission. |
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4

Between October 2009 and July 2011, the EFSA proceeded with the scientific evaluation of the health claims transmitted 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, it 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 (‘the list of permitted claims’). 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 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 its entry into force, namely from 14 December 2012, in order to enable food business operators to adapt to its provisions, in particular the marketing prohibition laid down in Article 10(1) of Regulation No 1924/2006, those health claims whose evaluation by the EFSA and whose consideration by the Commission had been completed. |
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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, it 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 (‘the list of permitted claims’). 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 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 its entry into force, namely from 14 December 2012, in order to enable food business operators to adapt to its provisions, in particular the marketing prohibition laid down in Article 10(1) of Regulation No 1924/2006, those health claims whose evaluation by the EFSA and whose consideration by the Commission had been completed.

| 6 | On 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 (‘the list of health claims on hold’). According to the Commission, those health claims, which concerned, inter alia, the effects of plant or herbal substances, commonly known as ‘botanical substances’, remained on hold and therefore could continue to be used in accordance with the transitional scheme provided for in Article 28(5) and (6) of Regulation No 1924/2006. |
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6

On 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 (‘the list of health claims on hold’). According to the Commission, those health claims, which concerned, inter alia, the effects of plant or herbal substances, commonly known as ‘botanical substances’, remained on hold and therefore could continue to be used in accordance with the transitional scheme provided for in Article 28(5) and (6) of Regulation No 1924/2006.

Procedure and forms of order sought by the parties

Procedure and forms of order sought by the parties

| 7 | By application lodged at the Court Registry on 2 July 2012, the applicants brought the present action. |
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7

By application lodged at the Court Registry on 2 July 2012, the applicants brought the present action.

| 8 | By document lodged at the Court Registry on 25 September 2012, the Czech Republic sought leave to intervene in support of the Commission. |
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8

By document lodged at the Court Registry on 25 September 2012, the Czech Republic sought leave to intervene in support of the Commission.

| 9 | By document lodged at the Court Registry on 26 September 2012, the Council of the European Union sought leave to intervene in support of the Commission. |
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9

By document lodged at the Court Registry on 26 September 2012, the Council of the European Union sought leave to intervene in support of the Commission.

| 10 | By document lodged at the Court Registry on 28 September 2012, the Bureau européen des unions de consommateurs (‘the BEUC’) sought leave to intervene in support of the Commission. |
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10

By document lodged at the Court Registry on 28 September 2012, the Bureau européen des unions de consommateurs (‘the BEUC’) sought leave to intervene in support of the Commission.

| 11 | By document lodged at the Court Registry on 28 September 2012, FederSalus, Medestea biotech SpA and Naturando Srl sought leave to intervene in support of the applicants. |
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11

By document lodged at the Court Registry on 28 September 2012, FederSalus, Medestea biotech SpA and Naturando Srl sought leave to intervene in support of the applicants.

| 12 | By document lodged at the Court Registry on 2 October 2012, the European Parliament sought leave to intervene in support of the Commission. |
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12

By document lodged at the Court Registry on 2 October 2012, the European Parliament sought leave to intervene in support of the Commission.

| 13 | By document lodged at the Court Registry on 3 October 2012, the French Republic sought leave to intervene in support of the Commission. |
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13

By document lodged at the Court Registry on 3 October 2012, the French Republic sought leave to intervene in support of the Commission.

| 14 | By letters received at the Court Registry on 24 October 2012, the applicants requested, pursuant to Article 116(2) of the Rules of Procedure of the General Court, that certain confidential information in the annexes to the application should not be disclosed to the interveners, in the event that they were granted leave to intervene in the proceedings. The applicants produced, for the purpose of disclosure to the interveners, a non-confidential version of the procedural documents in question. |
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14

By letters received at the Court Registry on 24 October 2012, the applicants requested, pursuant to Article 116(2) of the Rules of Procedure of the General Court, that certain confidential information in the annexes to the application should not be disclosed to the interveners, in the event that they were granted leave to intervene in the proceedings. The applicants produced, for the purpose of disclosure to the interveners, a non-confidential version of the procedural documents in question.

| 15 | By order of 16 January 2013, the President of the First Chamber of the General Court granted leave to the Czech Republic, the Council, the Parliament, the French Republic and the BEUC to intervene in support of the Commission and to FederSalus, Medestea biotech and Naturando to intervene in support of the applicants. Furthermore, the President of the First Chamber of the General Court reserved the decision as to whether the application for confidential treatment was well founded and, as a provisional measure, restricted the provision of procedural documents to those parties to a non-confidential version, pending the submission of any observations on the application for confidential treatment. |
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15

By order of 16 January 2013, the President of the First Chamber of the General Court granted leave to the Czech Republic, the Council, the Parliament, the French Republic and the BEUC to intervene in support of the Commission and to FederSalus, Medestea biotech and Naturando to intervene in support of the applicants. Furthermore, the President of the First Chamber of the General Court reserved the decision as to whether the application for confidential treatment was well founded and, as a provisional measure, restricted the provision of procedural documents to those parties to a non-confidential version, pending the submission of any observations on the application for confidential treatment.

| 16 | By letter lodged at the Court Registry on 7 February 2013, the BEUC raised objections to the applicants’ request for confidential treatment. |
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16

By letter lodged at the Court Registry on 7 February 2013, the BEUC raised objections to the applicants’ request for confidential treatment.

| 17 | By document lodged at the Court Registry on 3 April 2013, the Czech Republic informed the General Court that it no longer wished to intervene in support of the Commission. |
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17

By document lodged at the Court Registry on 3 April 2013, the Czech Republic informed the General Court that it no longer wished to intervene in support of the Commission.

| 18 | By order of 5 July 2013, the Czech Republic was removed from the register as an intervener in the present case. |
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18

By order of 5 July 2013, the Czech Republic was removed from the register as an intervener in the present case.

| 19 | After a change in the composition of the Chambers of the General Court, the Judge-Rapporteur was assigned to the Eighth Chamber, to which the present case was, accordingly, assigned. |
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19

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

| 20 | As 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 Article 6 of the Rules of Procedure, 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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20

As 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 Article 6 of the Rules of Procedure, 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.

| 21 | On 22 April 2014, the applicants lodged at the Court Registry, by way of new evidence in support of their arguments, a bulletin of the Department of Health of the United Kingdom dated 16 April 2014. |
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21

On 22 April 2014, the applicants lodged at the Court Registry, by way of new evidence in support of their arguments, a bulletin of the Department of Health of the United Kingdom dated 16 April 2014.

| 22 | By decision of the President of the Eighth Chamber of the General Court of 5 May 2014, the bulletin in question was added to the file and the other parties were given a time limit within which to submit their observations in that respect. Those parties submitted their observations within the period prescribed. |
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22

By decision of the President of the Eighth Chamber of the General Court of 5 May 2014, the bulletin in question was added to the file and the other parties were given a time limit within which to submit their observations in that respect. Those parties submitted their observations within the period prescribed.

| 23 | By order of 4 September 2014, the President of the Eighth Chamber of the General Court granted the application made by the applicants for confidential treatment and reserved the costs. |
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23

By order of 4 September 2014, the President of the Eighth Chamber of the General Court granted the application made by the applicants for confidential treatment and reserved the costs.

| 24 | Acting upon a report of the Judge-Rapporteur, the Court (Eighth Chamber) decided to open the oral procedure and, in the context of the measures of organisation of procedure provided for in Article 64 of the Rules of Procedure, firstly, invited the applicants to provide it with the list of health claims relevant to them and to specify the status of those claims, namely whether they had been authorised, rejected or placed on hold following the adoption of Regulation No 432/2012. Secondly, the Court invited the parties to specify whether Regulation No 432/2012 constituted, in their view, a regulatory act which was of direct concern to the applicants and which did not entail implementing measures, within the meaning of the third limb of the fourth paragraph of Article 263 TFEU. The parties complied with that request within the time allowed. |
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24

Acting upon a report of the Judge-Rapporteur, the Court (Eighth Chamber) decided to open the oral procedure and, in the context of the measures of organisation of procedure provided for in Article 64 of the Rules of Procedure, firstly, invited the applicants to provide it with the list of health claims relevant to them and to specify the status of those claims, namely whether they had been authorised, rejected or placed on hold following the adoption of Regulation No 432/2012. Secondly, the Court invited the parties to specify whether Regulation No 432/2012 constituted, in their view, a regulatory act which was of direct concern to the applicants and which did not entail implementing measures, within the meaning of the third limb of the fourth paragraph of Article 263 TFEU. The parties complied with that request within the time allowed.

| 25 | The parties presented oral argument and answered the questions put to them by the Court at the hearing on 22 October 2014. |
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25

The parties presented oral argument and answered the questions put to them by the Court at the hearing on 22 October 2014.

| 26 | The applicants, supported by FederSalus, Medestea biotech and Naturando, claim that the Court should:





  — | annul Regulation No 432/2012; |
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26

The applicants, supported by FederSalus, Medestea biotech and Naturando, claim that the Court should:

—

annul Regulation No 432/2012;

| — | annul the Commission’s decision adopting the list of claims on hold; |
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—

annul the Commission’s decision adopting the list of claims on hold;

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

order the Commission to pay the costs.

| 27 | The Commission, supported by the Council, the Parliament, the French Republic and the BEUC, contends that the Court should:





  — | dismiss the action; |
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27

The Commission, supported by the Council, the Parliament, the French Republic and the BEUC, contends that the Court should:

—

dismiss the action;

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

order the applicants to pay the costs.

Law

Law

| 28 | It should be pointed out, at the outset, that, although by their first head of claim the applicants request the Court to annul Regulation No 432/2012, it is apparent from the application that that application for annulment is based, in part, on the unlawful nature of the act on which that regulation was based. Accordingly, it must be considered that the application also seeks, in support of its claims for annulment, a declaration, indirectly and on the basis of Article 277 TFEU, that Regulation No 1924/2006 is inapplicable. Moreover, the applicants seek the annulment of the alleged decision of the Commission adopting the list of claims on hold. Those three applications must be examined individually. |
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28

It should be pointed out, at the outset, that, although by their first head of claim the applicants request the Court to annul Regulation No 432/2012, it is apparent from the application that that application for annulment is based, in part, on the unlawful nature of the act on which that regulation was based. Accordingly, it must be considered that the application also seeks, in support of its claims for annulment, a declaration, indirectly and on the basis of Article 277 TFEU, that Regulation No 1924/2006 is inapplicable. Moreover, the applicants seek the annulment of the alleged decision of the Commission adopting the list of claims on hold. Those three applications must be examined individually.

1. The application for annulment of Regulation No 432/2012

The application for annulment of Regulation No 432/2012

Admissibility

Admissibility

| 29 | Without formally raising a plea of inadmissibility in accordance with Article 114 of the Rules of Procedure, the Commission, supported by the Council, the Parliament, the French Republic and the BEUC, submits that the application for annulment of Regulation No 432/2012 is inadmissible. In particular, it argues that, even if Regulation No 432/2012 were to be regarded as a regulatory act which does not entail implementing measures, within the meaning of the fourth paragraph of Article 263 TFEU, the applicants have not shown that the regulation was of direct concern to them. |
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29

Without formally raising a plea of inadmissibility in accordance with Article 114 of the Rules of Procedure, the Commission, supported by the Council, the Parliament, the French Republic and the BEUC, submits that the application for annulment of Regulation No 432/2012 is inadmissible. In particular, it argues that, even if Regulation No 432/2012 were to be regarded as a regulatory act which does not entail implementing measures, within the meaning of the fourth paragraph of Article 263 TFEU, the applicants have not shown that the regulation was of direct concern to them.

| 30 | The applicants contest the Commission’s arguments regarding the inadmissibility of the action. First, they argue 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. Next, they submit that, in accordance with the case-law, the regulation is of direct concern to them since it directly affects their legal situation and leaves no discretion to its addressees, who are entrusted with the task of implementing it. |
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30

The applicants contest the Commission’s arguments regarding the inadmissibility of the action. First, they argue 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. Next, they submit that, in accordance with the case-law, the regulation is of direct concern to them since it directly affects their legal situation and leaves no discretion to its addressees, who are entrusted with the task of implementing it.

| 31 | 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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31

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.

| 32 | In the present case, it is common ground that Regulation No 432/2012 was not addressed to the applicants, which are thus not addressees of that act. Accordingly, under the fourth paragraph of Article 263 TFEU, the applicants may bring an action for annulment against that act only if it is either a regulatory act which is of direct concern to them and does not require implementing measures, or an act of direct and individual concern to them. |
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32

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

| 33 | Thus, in the first place, it needs to be assessed whether Regulation No 432/2012 constitutes a regulatory act within the meaning of the third limb of the fourth paragraph of Article 263 TFEU. |
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33

Thus, in the first place, it needs to be assessed whether Regulation No 432/2012 constitutes a regulatory act within the meaning of the third limb of the fourth paragraph of Article 263 TFEU.

| 34 | According to the case-law, ‘regulatory act’ must be understood as covering all acts of general application apart from 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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34

According to the case-law, ‘regulatory act’ must be understood as covering all acts of general application apart from 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

| 35 | In the present case, first, Regulation No 432/2012 has Article 13(3) of Regulation No 1924/2006 as its legal basis, which empowers the Commission to adopt, in accordance with the procedure set out in Article 25(3) of the same 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, for its part, makes reference 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 in accordance with the codecision procedure. The result is that Regulation No 432/2012 was adopted by the Commission exercising its implementing powers, under the regulatory procedure with scrutiny, and, consequently, does not constitute a legislative act within the meaning of the case-law stemming from the judgment in Inuit Tapiriit Kanatami and Others v Parliament and Council (EU:C:2013:625, paragraph 34 above). |
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35

In the present case, first, Regulation No 432/2012 has Article 13(3) of Regulation No 1924/2006 as its legal basis, which empowers the Commission to adopt, in accordance with the procedure set out in Article 25(3) of the same 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, for its part, makes reference 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 in accordance with the codecision procedure. The result is that Regulation No 432/2012 was adopted by the Commission exercising its implementing powers, under the regulatory procedure with scrutiny, and, consequently, does not constitute a legislative act within the meaning of the case-law stemming from the judgment in Inuit Tapiriit Kanatami and Others v Parliament and Council (EU:C:2013:625, paragraph 34 above).

Inuit Tapiriit Kanatami and Others

Parliament and Council

| 36 | Secondly, since Regulation No 432/2012, read in conjunction Article 1(2) of Regulation No 1924/2006, applies to all food business operators which make health claims on foods, other than those referring to the reduction of disease risk and to children’s development and health, the regulation is of general application in that it covers situations which are determined objectively and entails legal effects for a class of persons envisaged in a general and abstract manner (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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36

Secondly, since Regulation No 432/2012, read in conjunction Article 1(2) of Regulation No 1924/2006, applies to all food business operators which make health claims on foods, other than those referring to the reduction of disease risk and to children’s development and health, the regulation is of general application in that it covers situations which are determined objectively and entails legal effects for a class of persons envisaged in a general and abstract manner (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

| 37 | Consequently, Regulation No 432/2012 constitutes a regulatory act within the meaning of the fourth paragraph of Article 263 TFEU. |
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37

Consequently, Regulation No 432/2012 constitutes a regulatory act within the meaning of the fourth paragraph of Article 263 TFEU.

| 38 | In the second place, so far as concerns the condition of direct concern, it has been held that that condition requires that, first, the contested measure must directly affect the legal situation of the applicant and, secondly, it must leave no discretion to its addressees, which are entrusted with the task of implementing it, such implementation being purely automatic and resulting from the contested legislation itself 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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38

In the second place, so far as concerns the condition of direct concern, it has been held that that condition requires that, first, the contested measure must directly affect the legal situation of the applicant and, secondly, it must leave no discretion to its addressees, which are entrusted with the task of implementing it, such implementation being purely automatic and resulting from the contested legislation itself 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 and Ente per le Ville Vesuviane

Commission

| 39 | In the present case, the Court points out, first of all, that the effects deriving from Regulation No 432/2012 consist in authorising, by virtue of Article 1 thereof, 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. Moreover, as is set out in recitals 12 and 13 in the preamble thereto, Regulation No 432/2012, in conjunction with Article 10(1) of Regulation No 1924/2006, prohibits a certain number of such claims in relation to which evaluation and consideration under Article 13(3) of that regulation have been completed by the EFSA and the Commission, respectively, by concluding, in essence, that they were either not substantiated scientifically or that the general or specific requirements provided for in that regulation have not been satisfied. |
| --- | --- |

39

In the present case, the Court points out, first of all, that the effects deriving from Regulation No 432/2012 consist in authorising, by virtue of Article 1 thereof, 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. Moreover, as is set out in recitals 12 and 13 in the preamble thereto, Regulation No 432/2012, in conjunction with Article 10(1) of Regulation No 1924/2006, prohibits a certain number of such claims in relation to which evaluation and consideration under Article 13(3) of that regulation have been completed by the EFSA and the Commission, respectively, by concluding, in essence, that they were either not substantiated scientifically or that the general or specific requirements provided for in that regulation have not been satisfied.

| 40 | Consequently, since the applicants contest the legality of Regulation No 432/2012, they are required to identify, in order to demonstrate that they are directly affected for the purposes of the fourth paragraph of Article 263 TFEU, the relevant claims in the regulation which have an adverse effect on their legal situation. More specifically, to the extent that, as is apparent in essence from their written pleadings, the permitted health claims are not at issue in their action, on the ground that their annulment is of no interest to the applicants, they are required to demonstrate that, at the time of bringing their action before the Court, they used, in commercial communications relating to their products, claims which have been prohibited following the adoption of Regulation No 432/2012. |
| --- | --- |

40

Consequently, since the applicants contest the legality of Regulation No 432/2012, they are required to identify, in order to demonstrate that they are directly affected for the purposes of the fourth paragraph of Article 263 TFEU, the relevant claims in the regulation which have an adverse effect on their legal situation. More specifically, to the extent that, as is apparent in essence from their written pleadings, the permitted health claims are not at issue in their action, on the ground that their annulment is of no interest to the applicants, they are required to demonstrate that, at the time of bringing their action before the Court, they used, in commercial communications relating to their products, claims which have been prohibited following the adoption of Regulation No 432/2012.

| 41 | In the present case, in response to the request made by way of a measure of organisation of procedure, the applicants, particularly the second, third and fifth applicants, as food producers, provided the Court with a list of health claims relevant to them, giving precise details of the status of those claims, in particular whether they were rejected following the adoption of Regulation No 432/2012. Moreover, they produced a declaration signed by their respective directors confirming, inter alia, that those claims were in use on the date the action was brought, namely on 2 July 2014. In so far as those documents certify that the applicants were using, in the marketing of their products, health claims rejected by Regulation No 432/2012, it must be found that that regulation is capable of affecting their legal situation. |
| --- | --- |

41

In the present case, in response to the request made by way of a measure of organisation of procedure, the applicants, particularly the second, third and fifth applicants, as food producers, provided the Court with a list of health claims relevant to them, giving precise details of the status of those claims, in particular whether they were rejected following the adoption of Regulation No 432/2012. Moreover, they produced a declaration signed by their respective directors confirming, inter alia, that those claims were in use on the date the action was brought, namely on 2 July 2014. In so far as those documents certify that the applicants were using, in the marketing of their products, health claims rejected by Regulation No 432/2012, it must be found that that regulation is capable of affecting their legal situation.

| 42 | Next, the Court must reject the Commission’s claim, made both in its responses to the measures of organisation of procedure and at the hearing, that the documents produced by the applicants lack probative value. The Court points out, in that regard, that, pursuant to settled case-law, the activity of the Court of Justice and of the General Court is governed by the principle of the unfettered evaluation of evidence, and that it is only the reliability of the evidence furnished which is decisive when it comes to the assessment of its value. Moreover, in order to assess the probative value of a document, regard should be had to the credibility of the account it contains. Regard should also be had, in particular, to the person from whom the document originates, the circumstances in which it came into being, the person to whom it was addressed and whether, on its face, the document appears to be sound and reliable (see, to that effect, judgment of 27 September 2012 in Shell Petroleum and Others v Commission, T‐343/06, ECR, EU:T:2012:478, paragraph 161 and the case-law cited). In the present case, first, the documents produced by the applicants are declarations signed by the directors of the applicants, who are deemed to be in a position to be able to provide precise details in response to the information requested, secondly, the documents were requested specifically by the Court and, thirdly, they were submitted via the lawyer representing the applicants in their action, who, as a collaborator in the administration of justice and as a result of the ethical requirements to which he is subject, is required to ensure the authenticity and veracity of those documents. Accordingly, the Court considers that the credibility of those documents is sufficiently established. Moreover, even though the Commission challenges the veracity of those documents as a whole, it has not furnished any evidence to suggest that the detailed information on the list produced by the applicants, in the context of measures of organisation of procedure, is false. |
| --- | --- |

42

Next, the Court must reject the Commission’s claim, made both in its responses to the measures of organisation of procedure and at the hearing, that the documents produced by the applicants lack probative value. The Court points out, in that regard, that, pursuant to settled case-law, the activity of the Court of Justice and of the General Court is governed by the principle of the unfettered evaluation of evidence, and that it is only the reliability of the evidence furnished which is decisive when it comes to the assessment of its value. Moreover, in order to assess the probative value of a document, regard should be had to the credibility of the account it contains. Regard should also be had, in particular, to the person from whom the document originates, the circumstances in which it came into being, the person to whom it was addressed and whether, on its face, the document appears to be sound and reliable (see, to that effect, judgment of 27 September 2012 in Shell Petroleum and Others v Commission, T‐343/06, ECR, EU:T:2012:478, paragraph 161 and the case-law cited). In the present case, first, the documents produced by the applicants are declarations signed by the directors of the applicants, who are deemed to be in a position to be able to provide precise details in response to the information requested, secondly, the documents were requested specifically by the Court and, thirdly, they were submitted via the lawyer representing the applicants in their action, who, as a collaborator in the administration of justice and as a result of the ethical requirements to which he is subject, is required to ensure the authenticity and veracity of those documents. Accordingly, the Court considers that the credibility of those documents is sufficiently established. Moreover, even though the Commission challenges the veracity of those documents as a whole, it has not furnished any evidence to suggest that the detailed information on the list produced by the applicants, in the context of measures of organisation of procedure, is false.

Shell Petroleum and Others

Commission

| 43 | Furthermore, as regards the first and fourth applicants, which, as associations of food producers, do not, in the Commission’s view, have locus standi in the present case, suffice it to note that, in so far as the applicants have brought a single action the admissibility of which is not in doubt in relation to the second, third and fifth applicants it is not necessary, for reasons of procedural economy, to examine the admissibility of the action as regards the first and fourth applicants (see, to that effect, judgment of 29 November 2012 in Thesing and Bloomberg Finance v ECB, T‐590/10, EU:T:2012:635, paragraph 19 and the case-law cited). |
| --- | --- |

43

Furthermore, as regards the first and fourth applicants, which, as associations of food producers, do not, in the Commission’s view, have locus standi in the present case, suffice it to note that, in so far as the applicants have brought a single action the admissibility of which is not in doubt in relation to the second, third and fifth applicants it is not necessary, for reasons of procedural economy, to examine the admissibility of the action as regards the first and fourth applicants (see, to that effect, judgment of 29 November 2012 in Thesing and Bloomberg Finance v ECB, T‐590/10, EU:T:2012:635, paragraph 19 and the case-law cited).

locus standi

Thesing and Bloomberg Finance

ECB

| 44 | Finally, it should be noted that Regulation No 432/2012 does not leave any discretion to its addressees, within the meaning of the case-law cited in paragraph 38 above, since its implementation is clearly purely automatic and results from the contested regulation itself without the application of other intermediate rules. In that regard, suffice it to note that, pursuant to Article 2 of Regulation No 432/2012, the regulation is binding in its entirety and directly applicable in all Member States. |
| --- | --- |

44

Finally, it should be noted that Regulation No 432/2012 does not leave any discretion to its addressees, within the meaning of the case-law cited in paragraph 38 above, since its implementation is clearly purely automatic and results from the contested regulation itself without the application of other intermediate rules. In that regard, suffice it to note that, pursuant to Article 2 of Regulation No 432/2012, the regulation is binding in its entirety and directly applicable in all Member States.

| 45 | It follows that Regulation No 432/2012 must be regarded as being of direct concern to the applicants. |
| --- | --- |

45

It follows that Regulation No 432/2012 must be regarded as being of direct concern to the applicants.

| 46 | In the third place, as regards the question whether Regulation No 432/2012 entails implementing measures, within the meaning of the fourth paragraph of Article 263 TFEU, the Court notes, first, that in accordance with the case-law, the concept of a ‘regulatory act which ... does not entail implementing measures’ is to be interpreted in the light of that provision’s objective, which, as is clear from its origin, consists in preventing an individual from being obliged to infringe the law in order to have access to a court (judgment of 19 December 2013 in Telefónica v Commission, C‐274/12 P, ECR, EU:C:2013:852, paragraph 27). |
| --- | --- |

46

In the third place, as regards the question whether Regulation No 432/2012 entails implementing measures, within the meaning of the fourth paragraph of Article 263 TFEU, the Court notes, first, that in accordance with the case-law, the concept of a ‘regulatory act which ... does not entail implementing measures’ is to be interpreted in the light of that provision’s objective, which, as is clear from its origin, consists in preventing an individual from being obliged to infringe the law in order to have access to a court (judgment of 19 December 2013 in Telefónica v Commission, C‐274/12 P, ECR, EU:C:2013:852, paragraph 27).

Telefónica

Commission

| 47 | The question whether a regulatory act entails implementing measures should be assessed by reference to the position of the person pleading the right to bring proceedings under the third limb of the fourth paragraph of Article 263 TFEU. It is therefore irrelevant whether the act in question entails implementing measures with regard to other persons (judgment in Telefónica v Commission, paragraph 46 above, EU:C:2013:852, paragraph 30). |
| --- | --- |

47

The question whether a regulatory act entails implementing measures should be assessed by reference to the position of the person pleading the right to bring proceedings under the third limb of the fourth paragraph of Article 263 TFEU. It is therefore irrelevant whether the act in question entails implementing measures with regard to other persons (judgment in Telefónica v Commission, paragraph 46 above, EU:C:2013:852, paragraph 30).

Telefónica

Commission

| 48 | In order to determine whether the measure being challenged entails implementing measures, reference should be made exclusively to the subject-matter of the action and, where an applicant seeks only the partial annulment of an act, it is solely any implementing measures which that part of the act may entail that must, as the case may be, be taken into consideration (judgment in Telefonica v Commission, paragraph 46 above, EU:C:2013:852, paragraph 31). |
| --- | --- |

48

In order to determine whether the measure being challenged entails implementing measures, reference should be made exclusively to the subject-matter of the action and, where an applicant seeks only the partial annulment of an act, it is solely any implementing measures which that part of the act may entail that must, as the case may be, be taken into consideration (judgment in Telefonica v Commission, paragraph 46 above, EU:C:2013:852, paragraph 31).

Telefonica

Commission

| 49 | In the present case, suffice it to note that Regulation No 432/2012 applies, by definition, automatically to the applicants and that its application does not require any measures on the part of national or European public authorities. |
| --- | --- |

49

In the present case, suffice it to note that Regulation No 432/2012 applies, by definition, automatically to the applicants and that its application does not require any measures on the part of national or European public authorities.

| 50 | It follows that Regulation No 432/2012 does not entail implementing measures within the meaning of the fourth paragraph of Article 263 TFEU. |
| --- | --- |

50

It follows that Regulation No 432/2012 does not entail implementing measures within the meaning of the fourth paragraph of Article 263 TFEU.

| 51 | Consequently, in so far as Regulation No 432/2012 constitutes a regulatory act which is of direct concern to the applicants and which does not entail implementing measures, within the meaning of the fourth paragraph of Article 263 TFEU, the plea of inadmissibility raised by the Commission must be rejected, without it being necessary to examine whether the regulation is of individual concern to the applicants. |
| --- | --- |

51

Consequently, in so far as Regulation No 432/2012 constitutes a regulatory act which is of direct concern to the applicants and which does not entail implementing measures, within the meaning of the fourth paragraph of Article 263 TFEU, the plea of inadmissibility raised by the Commission must be rejected, without it being necessary to examine whether the regulation is of individual concern to the applicants.

Substance

Substance

| 52 | In support of their application for the annulment of Regulation No 432/2012, the applicants put forward two pleas in law. The first concerns the lack of a legal basis and an infringement of the principles of legal certainty, good administration and non-discrimination when adopting the decision to split the authorisation procedure for health claims into several stages. The second concerns an infringement of the principle of good administration, the principle of legal certainty and the duty of collaboration with national food authorities, as well as the obligation to state reasons when not including a large number of health claims in the list of permitted claims. |
| --- | --- |

52

In support of their application for the annulment of Regulation No 432/2012, the applicants put forward two pleas in law. The first concerns the lack of a legal basis and an infringement of the principles of legal certainty, good administration and non-discrimination when adopting the decision to split the authorisation procedure for health claims into several stages. The second concerns an infringement of the principle of good administration, the principle of legal certainty and the duty of collaboration with national food authorities, as well as the obligation to state reasons when not including a large number of health claims in the list of permitted claims.

The first plea, alleging the lack of a legal basis and an infringement of the principles of legal certainty, good administration and non-discrimination when adopting the decision to split the authorisation procedure for health claims into several stages

| 53 | The first plea is divided into two parts. |
| --- | --- |

53

The first plea is divided into two parts.

– The first part, alleging the lack of a legal basis and an infringement of the principle of legal certainty

| 54 | The first part of the applicants’ first plea consists of three complaints. |
| --- | --- |

54

The first part of the applicants’ first plea consists of three complaints.

| 55 | By their first complaint, the applicants submit that the measure provided for by Regulation No 432/2012, namely the splitting of the authorisation procedure for health claims into several stages, lacks a legal basis, given that Article 13 of Regulation No 1924/2006 envisages the adoption of only a single definitive list of permitted claims for all of the health claims referred to in paragraphs 1 to 3 thereof, with the result that it is not permissible to establish, as the Commission has done, that list in a partial and gradual manner. The applicants further submit that the Commission failed to comply with the deadline laid down in Regulation No 1924/2006 for the adoption of the list of permitted claims. |
| --- | --- |

55

By their first complaint, the applicants submit that the measure provided for by Regulation No 432/2012, namely the splitting of the authorisation procedure for health claims into several stages, lacks a legal basis, given that Article 13 of Regulation No 1924/2006 envisages the adoption of only a single definitive list of permitted claims for all of the health claims referred to in paragraphs 1 to 3 thereof, with the result that it is not permissible to establish, as the Commission has done, that list in a partial and gradual manner. The applicants further submit that the Commission failed to comply with the deadline laid down in Regulation No 1924/2006 for the adoption of the list of permitted claims.

| 56 | By their second complaint the applicants allege that Article 28(5) and (6) of Regulation No 1924/2006 does not give the Commission the necessary power to provide for additional transitional measures for the claims which that institution decided to place on hold. |
| --- | --- |

56

By their second complaint the applicants allege that Article 28(5) and (6) of Regulation No 1924/2006 does not give the Commission the necessary power to provide for additional transitional measures for the claims which that institution decided to place on hold.

| 57 | By their third complaint the applicants invoke an infringement of the principle of legal certainty in that it is not possible to identify, with clarity and precision, in particular the claims which, according to the Commission, remain on hold from those which have been rejected. |
| --- | --- |

57

By their third complaint the applicants invoke an infringement of the principle of legal certainty in that it is not possible to identify, with clarity and precision, in particular the claims which, according to the Commission, remain on hold from those which have been rejected.

| 58 | The Commission, supported in particular by the French Republic and the BEUC, contests the applicants’ arguments, which, in its view, are based on an erroneous interpretation of the provisions at issue. It further adds that the decision to split the authorisation procedure into several stages was justified by the circumstances of the present case. |
| --- | --- |

58

The Commission, supported in particular by the French Republic and the BEUC, contests the applicants’ arguments, which, in its view, are based on an erroneous interpretation of the provisions at issue. It further adds that the decision to split the authorisation procedure into several stages was justified by the circumstances of the present case.

| 59 | In the first place, as regards the complaint by which it is alleged that there was no legal basis authorising the splitting of the authorisation procedure for health claims into several stages, the Court points out, as a preliminary point, that the EU legislature conferred on the Commission, by means of Article 13 of Regulation No 1924/2006, the task of establishing, at EU level, a harmonised list of authorised health claims, other than those referring to the reduction of disease risk and to children’s development and health. In particular, pursuant to that article, the list was to contain health claims which, in addition to belonging to one of the three categories listed in Article 13(1), were based on generally accepted scientific data and were well understood by the average consumer. Moreover, it is apparent, in essence, from Article 13(2) and (3) of Regulation No 1924/2006 that the Commission was required to adopt the list of authorised health claims, in accordance with the procedure laid down in Article 25(3) of that regulation, after receiving from the Member States the lists of health claims used in their respective markets and after consultation of the EFSA, by 31 January 2010 at the latest. |
| --- | --- |

59

In the first place, as regards the complaint by which it is alleged that there was no legal basis authorising the splitting of the authorisation procedure for health claims into several stages, the Court points out, as a preliminary point, that the EU legislature conferred on the Commission, by means of Article 13 of Regulation No 1924/2006, the task of establishing, at EU level, a harmonised list of authorised health claims, other than those referring to the reduction of disease risk and to children’s development and health. In particular, pursuant to that article, the list was to contain health claims which, in addition to belonging to one of the three categories listed in Article 13(1), were based on generally accepted scientific data and were well understood by the average consumer. Moreover, it is apparent, in essence, from Article 13(2) and (3) of Regulation No 1924/2006 that the Commission was required to adopt the list of authorised health claims, in accordance with the procedure laid down in Article 25(3) of that regulation, after receiving from the Member States the lists of health claims used in their respective markets and after consultation of the EFSA, by 31 January 2010 at the latest.

| 60 | However, the wording of Article 13 of Regulation No 1924/2006 does not specify whether the lists of authorised health claims had to be adopted all at once, as claimed by the applicants, or whether, by contrast, that list could be adopted in several stages, thereby permitting the Commission to postpone the authorisation of the health claims whose evaluation, either by the EFSA or itself, was still ongoing. It thus needs to be examined whether the Commission erred in considering that that provision enabled it to adopt the list of authorised health claims on a gradual basis. |
| --- | --- |

60

However, the wording of Article 13 of Regulation No 1924/2006 does not specify whether the lists of authorised health claims had to be adopted all at once, as claimed by the applicants, or whether, by contrast, that list could be adopted in several stages, thereby permitting the Commission to postpone the authorisation of the health claims whose evaluation, either by the EFSA or itself, was still ongoing. It thus needs to be examined whether the Commission erred in considering that that provision enabled it to adopt the list of authorised health claims on a gradual basis.

| 61 | The Court points out that, according to settled case-law, in interpreting a provision of EU law, it is necessary to consider not only its wording but also the context in which it occurs and the objectives of the rules of which it is part (see judgment of 7 June 2005 in VEMW and Others, C‐17/03, ECR, EU:C:2005:362, paragraph 41 and the case-law cited). |
| --- | --- |

61

The Court points out that, according to settled case-law, in interpreting a provision of EU law, it is necessary to consider not only its wording but also the context in which it occurs and the objectives of the rules of which it is part (see judgment of 7 June 2005 in VEMW and Others, C‐17/03, ECR, EU:C:2005:362, paragraph 41 and the case-law cited).

VEMW and Others

| 62 | Where the textual and historical interpretations of a regulation, and in particular of one of its provisions, do not permit its precise scope to be assessed, the legislation in question must be interpreted by reference to its purpose and general structure (see judgment of 10 October 2012 in Gem-Year and Jinn-Well Auto-Parts (Zhejiang) v Council, T‐172/09, EU:T:2012:532, paragraph 106 and the case-law cited). |
| --- | --- |

62

Where the textual and historical interpretations of a regulation, and in particular of one of its provisions, do not permit its precise scope to be assessed, the legislation in question must be interpreted by reference to its purpose and general structure (see judgment of 10 October 2012 in Gem-Year and Jinn-Well Auto-Parts (Zhejiang) v Council, T‐172/09, EU:T:2012:532, paragraph 106 and the case-law cited).

Gem-Year and Jinn-Well Auto-Parts (Zhejiang)

Council

| 63 | Moreover, the operative part of an act is indissociably linked to the statement of reasons for it, so that, when it has to be interpreted, account must be taken of the reasons which led to its adoption (see judgment of 11 September 2014 in Gold East Paper and Gold Huasheng Paper v Council, T‐443/11, ECR, EU:T:2014:774, paragraph 118 and the case-law cited). |
| --- | --- |

63

Moreover, the operative part of an act is indissociably linked to the statement of reasons for it, so that, when it has to be interpreted, account must be taken of the reasons which led to its adoption (see judgment of 11 September 2014 in Gold East Paper and Gold Huasheng Paper v Council, T‐443/11, ECR, EU:T:2014:774, paragraph 118 and the case-law cited).

Gold East Paper and Gold Huasheng Paper

Council

| 64 | In the present case, it should be pointed out that, as is apparent from recitals 1 and 2 in the preamble to, and Article 1 of, Regulation No 1924/2006, the regulation seeks to eliminate barriers to trade in the Union resulting from differences between national provisions relating to commercial communications of claims used in the labelling and advertising of foods, while ensuring a high level of protection for consumers and facilitating their choice by ensuring that products put on the market are safe and adequately labelled. More specifically, according to recital 14 in the preamble to Regulation No 1924/2006, it is necessary to ensure that the substances for which a claim is made have been shown to have a beneficial nutritional or physiological effect. Moreover, recital 23 in the preamble to Regulation No 1924/2006 states that health claims should only be authorised for use in the Union after a scientific assessment of the highest possible standard and which should be carried out by the EFSA. |
| --- | --- |

64

In the present case, it should be pointed out that, as is apparent from recitals 1 and 2 in the preamble to, and Article 1 of, Regulation No 1924/2006, the regulation seeks to eliminate barriers to trade in the Union resulting from differences between national provisions relating to commercial communications of claims used in the labelling and advertising of foods, while ensuring a high level of protection for consumers and facilitating their choice by ensuring that products put on the market are safe and adequately labelled. More specifically, according to recital 14 in the preamble to Regulation No 1924/2006, it is necessary to ensure that the substances for which a claim is made have been shown to have a beneficial nutritional or physiological effect. Moreover, recital 23 in the preamble to Regulation No 1924/2006 states that health claims should only be authorised for use in the Union after a scientific assessment of the highest possible standard and which should be carried out by the EFSA.

| 65 | In the light of the objectives referred to in paragraph 64 above, it is first of all necessary to interpret Article 13(1) to (3) of Regulation No 1924/2006 as containing an obligation for the Commission only to attain a result, 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 No 1924/2006, 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 Article 13(1) to (3) of Regulation No 1924/2006 does not set out the detailed rules in accordance with which the Commission is required to fulfil its task, that provision leaves it to the discretion of that institution to define, in accordance with the principles laid down in Regulation No 1924/2006 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 9 September 2008 in Bayer CropScience and Others v Commission, T‐75/06, ECR, EU:T:2008:317, paragraphs 81 and 82, and 19 January 2012 in Xeda International and Pace International v Commission, T‐71/10, EU:T:2012:18, paragraph 69). |
| --- | --- |

65

In the light of the objectives referred to in paragraph 64 above, it is first of all necessary to interpret Article 13(1) to (3) of Regulation No 1924/2006 as containing an obligation for the Commission only to attain a result, 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 No 1924/2006, 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 Article 13(1) to (3) of Regulation No 1924/2006 does not set out the detailed rules in accordance with which the Commission is required to fulfil its task, that provision leaves it to the discretion of that institution to define, in accordance with the principles laid down in Regulation No 1924/2006 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 9 September 2008 in Bayer CropScience and Others v Commission, T‐75/06, ECR, EU:T:2008:317, paragraphs 81 and 82, and 19 January 2012 in Xeda International and Pace International v Commission, T‐71/10, EU:T:2012:18, paragraph 69).

Bayer CropScience and Others

Commission

Xeda International and Pace International

Commission

| 66 | Next, the foregoing interpretation is also corroborated, as submitted by the French Republic inter alia, by the fact that, as is apparent from Article 13(4) and (5) of Regulation No 1924/2006, the legislature provided for the possibility for changes to be made to the list of permitted claims either on the basis of generally established scientific data or newly developed scientific data. It must therefore be considered that the legislature was not opposed to that list being added to on a gradual basis, in the light of the scientific data available, and, consequently, to the fact that it was of a progressive nature. |
| --- | --- |

66

Next, the foregoing interpretation is also corroborated, as submitted by the French Republic inter alia, by the fact that, as is apparent from Article 13(4) and (5) of Regulation No 1924/2006, the legislature provided for the possibility for changes to be made to the list of permitted claims either on the basis of generally established scientific data or newly developed scientific data. It must therefore be considered that the legislature was not opposed to that list being added to on a gradual basis, in the light of the scientific data available, and, consequently, to the fact that it was of a progressive nature.

| 67 | Lastly, although the applicants submit that recital 26 in the preamble to Regulation No 1924/2006 refers to ‘a’ list of authorised health claims and that Article 28(5) of that regulation also refers to ‘the’ list of authorised health claims, the Court finds that that fact has no bearing on the possibility of adopting that list on a gradual basis. As the Commission has pointed out, the approach based on the adoption of the list of authorised health claims in several stages does not result in the adoption of several lists, as claimed by the applicants, but rather in the adoption of a single list which is added to gradually. |
| --- | --- |

67

Lastly, although the applicants submit that recital 26 in the preamble to Regulation No 1924/2006 refers to ‘a’ list of authorised health claims and that Article 28(5) of that regulation also refers to ‘the’ list of authorised health claims, the Court finds that that fact has no bearing on the possibility of adopting that list on a gradual basis. As the Commission has pointed out, the approach based on the adoption of the list of authorised health claims in several stages does not result in the adoption of several lists, as claimed by the applicants, but rather in the adoption of a single list which is added to gradually.

| 68 | It follows that the wording of Regulation No 1924/2006, in particular Article 13(1) to (3) thereof, cannot be interpreted as prohibiting the Commission from adopting the list of permitted claims in several stages. |
| --- | --- |

68

It follows that the wording of Regulation No 1924/2006, in particular Article 13(1) to (3) thereof, cannot be interpreted as prohibiting the Commission from adopting the list of permitted claims in several stages.

| 69 | Consequently, it must be concluded that the Commission did not err in considering that that provision enabled it to adopt the list of authorised health claims on a gradual basis. |
| --- | --- |

69

Consequently, it must be concluded that the Commission did not err in considering that that provision enabled it to adopt the list of authorised health claims on a gradual basis.

| 70 | The foregoing conclusion cannot be called into question by the other arguments raised by the applicants in the context of their first complaint. |
| --- | --- |

70

The foregoing conclusion cannot be called into question by the other arguments raised by the applicants in the context of their first complaint.

| 71 | First, although it is true, as noted by the applicants, that, under Article 13(3) of Regulation No 1924/2006, the Commission was required to adopt the complete list of permitted claims by 31 January 2010 at the latest and that that list was adopted only in part by Regulation No 432/2012 on 16 May 2012, it is appropriate to have regard to the case-law according to which, in the absence of a provision setting out either expressly or implicitly the consequences of failure to comply with procedural time limits such as those in the present case, such a failure can entail the annulment, in whole or in part, of the measure to be adopted within the period in question only if it is shown that, had it not been for such an irregularity, the content of the measure might have been substantively different (see judgment of 30 April 2014 in Hagenmeyer and Hahn v Commission, T‐17/12, ECR, EU:T:2014:234, paragraph 160 and the case-law cited). |
| --- | --- |

71

First, although it is true, as noted by the applicants, that, under Article 13(3) of Regulation No 1924/2006, the Commission was required to adopt the complete list of permitted claims by 31 January 2010 at the latest and that that list was adopted only in part by Regulation No 432/2012 on 16 May 2012, it is appropriate to have regard to the case-law according to which, in the absence of a provision setting out either expressly or implicitly the consequences of failure to comply with procedural time limits such as those in the present case, such a failure can entail the annulment, in whole or in part, of the measure to be adopted within the period in question only if it is shown that, had it not been for such an irregularity, the content of the measure might have been substantively different (see judgment of 30 April 2014 in Hagenmeyer and Hahn v Commission, T‐17/12, ECR, EU:T:2014:234, paragraph 160 and the case-law cited).

Hagenmeyer and Hahn

Commission

| 72 | In the present case, other than the finding that the Commission failed to comply with the time limit referred to above, the applicants do not raise any argument, in the context of the complaint under examination, seeking a declaration that the content of Regulation No 432/2012 would have been different if it had been adopted before 31 January 2010. Consequently, Regulation No 432/2012 cannot be annulled on the sole ground that it was not adopted within the time limit established in Article 13(3) of Regulation No 1924/2006. |
| --- | --- |

72

In the present case, other than the finding that the Commission failed to comply with the time limit referred to above, the applicants do not raise any argument, in the context of the complaint under examination, seeking a declaration that the content of Regulation No 432/2012 would have been different if it had been adopted before 31 January 2010. Consequently, Regulation No 432/2012 cannot be annulled on the sole ground that it was not adopted within the time limit established in Article 13(3) of Regulation No 1924/2006.

| 73 | Second, in so far as the applicants’ complaint must be understood as seeking a declaration that the decision to split the authorisation procedure was not justified in any event, it should be pointed out, at the outset, that in the light of the broad powers of discretion entrusted in the Commission, pursuant to the case-law cited in paragraph 65 above, in a sphere in which the EU legislature is called on to undertake complex assessments, judicial review of the exercise of its powers must be limited to examining whether it is vitiated by a manifest error of assessment or a misuse of powers or whether the legislature has manifestly exceeded the limits of its discretion (judgments of 9 September 2003 in Monsanto Agricoltura Italia and Others, C‐236/01, ECR, EU:C:2003:431, paragraph 135, and 15 October 2009 in Enviro Tech (Europe), C‐425/08, ECR, EU:C:2009:635, paragraph 47). |
| --- | --- |

73

Second, in so far as the applicants’ complaint must be understood as seeking a declaration that the decision to split the authorisation procedure was not justified in any event, it should be pointed out, at the outset, that in the light of the broad powers of discretion entrusted in the Commission, pursuant to the case-law cited in paragraph 65 above, in a sphere in which the EU legislature is called on to undertake complex assessments, judicial review of the exercise of its powers must be limited to examining whether it is vitiated by a manifest error of assessment or a misuse of powers or whether the legislature has manifestly exceeded the limits of its discretion (judgments of 9 September 2003 in Monsanto Agricoltura Italia and Others, C‐236/01, ECR, EU:C:2003:431, paragraph 135, and 15 October 2009 in Enviro Tech (Europe), C‐425/08, ECR, EU:C:2009:635, paragraph 47).

Monsanto Agricoltura Italia and Others

Enviro Tech (Europe)

| 74 | In the present case, it must be found that the Commission was legitimately able to consider that the decision to split the authorisation procedure for health claims and to postpone the evaluation of some of those claims was necessary so as better to attain the various objectives of Regulation No 1924/2006, in the light, inter alia, of the particular difficulties which arose during that procedure and even though that constituted, as submitted by the applicants, a deviation from the initial approach. |
| --- | --- |

74

In the present case, it must be found that the Commission was legitimately able to consider that the decision to split the authorisation procedure for health claims and to postpone the evaluation of some of those claims was necessary so as better to attain the various objectives of Regulation No 1924/2006, in the light, inter alia, of the particular difficulties which arose during that procedure and even though that constituted, as submitted by the applicants, a deviation from the initial approach.

| 75 | Various circumstances, in particular the number, in excess of 44000, of health claims on the national lists provided by the Member States pursuant to Article 13(2) of Regulation No 1924/2006, the lack of accurate information in the documents provided by certain Member States and the need to establish a consolidated list and a codification system so as to be able to ensure the identification of the claims to be examined, meant that the Commission was forced to adopt an alternative approach, intended, in particular, to strike a balance between the objectives of providing clarity on the market and the protection of consumers. In that regard, the Court points out, as the Commission has argued, that a decision to wait for the completion of the assessment of all health claims provided by the Member States before adopting the list of permitted claims would have created an even longer delay in the attainment of the objectives of Regulation No 1924/2006. |
| --- | --- |

75

Various circumstances, in particular the number, in excess of 44000, of health claims on the national lists provided by the Member States pursuant to Article 13(2) of Regulation No 1924/2006, the lack of accurate information in the documents provided by certain Member States and the need to establish a consolidated list and a codification system so as to be able to ensure the identification of the claims to be examined, meant that the Commission was forced to adopt an alternative approach, intended, in particular, to strike a balance between the objectives of providing clarity on the market and the protection of consumers. In that regard, the Court points out, as the Commission has argued, that a decision to wait for the completion of the assessment of all health claims provided by the Member States before adopting the list of permitted claims would have created an even longer delay in the attainment of the objectives of Regulation No 1924/2006.

| 76 | Moreover, as regards the applicants’ argument that there was no urgency in this matter, especially in the light of the general provisions which exist in relation to labelling, in particular those of Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (OJ 2000 L 109, p. 29), the Court points out that that directive seeks only to prohibit, in a general manner, the use of information that would mislead the purchaser or attribute medicinal properties to foods. By contrast, as is apparent from recital 3 in the preamble to Regulation No 1924/2006, that regulation and, as a consequence, Regulation No 432/2012 seek to complement the general principles in Directive 2000/13 and lay down specific provisions concerning the use of nutrition and health claims concerning foods to be delivered as such to the consumer. |
| --- | --- |

76

Moreover, as regards the applicants’ argument that there was no urgency in this matter, especially in the light of the general provisions which exist in relation to labelling, in particular those of Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (OJ 2000 L 109, p. 29), the Court points out that that directive seeks only to prohibit, in a general manner, the use of information that would mislead the purchaser or attribute medicinal properties to foods. By contrast, as is apparent from recital 3 in the preamble to Regulation No 1924/2006, that regulation and, as a consequence, Regulation No 432/2012 seek to complement the general principles in Directive 2000/13 and lay down specific provisions concerning the use of nutrition and health claims concerning foods to be delivered as such to the consumer.

| 77 | It follows that the Commission cannot be accused of having committed a manifest error of assessment in deciding to split the authorisation procedure for health claims into several stages. |
| --- | --- |

77

It follows that the Commission cannot be accused of having committed a manifest error of assessment in deciding to split the authorisation procedure for health claims into several stages.

| 78 | The first complaint must therefore be rejected. |
| --- | --- |

78

The first complaint must therefore be rejected.

| 79 | In the second place, as regards the complaint by which an infringement is alleged of the transitional scheme provided for in Article 28(5) and (6) of Regulation No 1924/2006, it should be pointed out, at the outset, that, as is apparent from recitals 10 and 11 in the preamble to Regulation No 432/2012, the Commission actually explained that the claims which were placed on hold, because the EFSA had yet to complete a scientific evaluation or in relation to which there were other legitimate factors preventing the Commission from authorising those claims at that time, could continue to be used in accordance with the transitional scheme provided for in the articles referred to above. |
| --- | --- |

79

In the second place, as regards the complaint by which an infringement is alleged of the transitional scheme provided for in Article 28(5) and (6) of Regulation No 1924/2006, it should be pointed out, at the outset, that, as is apparent from recitals 10 and 11 in the preamble to Regulation No 432/2012, the Commission actually explained that the claims which were placed on hold, because the EFSA had yet to complete a scientific evaluation or in relation to which there were other legitimate factors preventing the Commission from authorising those claims at that time, could continue to be used in accordance with the transitional scheme provided for in the articles referred to above.

| 80 | The Court held, in that regard, in its judgment of 10 April 2014 in Ehrmann (C‐609/12, ECR, EU:C:2014:252), that Article 28 of Regulation No 1924/2006 lays down measures the objective of which, as is stated in recital 35 in the preamble to that regulation, is to enable food business operators to adapt to the requirements of that regulation. In relation to health claims, the relevant transitional measures are set out in Article 28(5) and (6) of that regulation (judgment in Ehrmann, EU:C:2014:252, paragraph 31). |
| --- | --- |

80

The Court held, in that regard, in its judgment of 10 April 2014 in Ehrmann (C‐609/12, ECR, EU:C:2014:252), that Article 28 of Regulation No 1924/2006 lays down measures the objective of which, as is stated in recital 35 in the preamble to that regulation, is to enable food business operators to adapt to the requirements of that regulation. In relation to health claims, the relevant transitional measures are set out in Article 28(5) and (6) of that regulation (judgment in Ehrmann, EU:C:2014:252, paragraph 31).

Ehrmann

Ehrmann

| 81 | Thus, firstly, under Article 28(5) of Regulation No 1924/2006, the health claims referred to in Article 13(1)(a) could be made from the date of entry into force of that regulation until the adoption of the list referred to in Article 13(3), under the responsibility of food business operators, provided that they comply with Regulation No 1924/2006 and with existing national provisions applicable to them, and without prejudice to the adoption of the safeguard measures referred to in Article 24. Thus it follows from the wording of Article 28(5) of Regulation No 1924/2006 that a food business operator could, 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 Article 13 (judgment in Ehrmann, paragraph 80 above, EU:C:2014:252, paragraphs 32 and 33). |
| --- | --- |

81

Thus, firstly, under Article 28(5) of Regulation No 1924/2006, the health claims referred to in Article 13(1)(a) could be made from the date of entry into force of that regulation until the adoption of the list referred to in Article 13(3), under the responsibility of food business operators, provided that they comply with Regulation No 1924/2006 and with existing national provisions applicable to them, and without prejudice to the adoption of the safeguard measures referred to in Article 24. Thus it follows from the wording of Article 28(5) of Regulation No 1924/2006 that a food business operator could, 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 Article 13 (judgment in Ehrmann, paragraph 80 above, EU:C:2014:252, paragraphs 32 and 33).

Ehrmann

| 82 | Secondly, as regards health claims referred to in Articles 13(1)(b) and (c) of Regulation No 1924/2006, such claims are subject to the transitional measures referred to in Article 28(6) of that regulation. That provision refers to health claims made in accordance with national provisions before the date of entry into force of Regulation No 1924/2006, that is to say, before 19 January 2007 (see, to that effect, judgment in Ehrmann, paragraph 80 above, EU:C:2014:252, paragraphs 34 and 35) and permits the use of those claims, where applicable, for six months following the adoption of a decision in accordance with the procedures laid down in that provision. |
| --- | --- |

82

Secondly, as regards health claims referred to in Articles 13(1)(b) and (c) of Regulation No 1924/2006, such claims are subject to the transitional measures referred to in Article 28(6) of that regulation. That provision refers to health claims made in accordance with national provisions before the date of entry into force of Regulation No 1924/2006, that is to say, before 19 January 2007 (see, to that effect, judgment in Ehrmann, paragraph 80 above, EU:C:2014:252, paragraphs 34 and 35) and permits the use of those claims, where applicable, for six months following the adoption of a decision in accordance with the procedures laid down in that provision.

Ehrmann

| 83 | It is apparent from the wording of Article 28(5) and (6) of Regulation No 1924/2006 that the application of transitional measures is provided for in respect of health claims which are in the evaluation process and in respect of which a decision is yet to be adopted by the Commission. Accordingly, irrespective of their classification within the three categories provided for in Article 13(1) of that regulation, there is nothing preventing claims which are on hold, waiting to be evaluated by the EFSA or to be examined by the Commission, from benefiting from the transitional scheme provided for in that regulation. |
| --- | --- |

83

It is apparent from the wording of Article 28(5) and (6) of Regulation No 1924/2006 that the application of transitional measures is provided for in respect of health claims which are in the evaluation process and in respect of which a decision is yet to be adopted by the Commission. Accordingly, irrespective of their classification within the three categories provided for in Article 13(1) of that regulation, there is nothing preventing claims which are on hold, waiting to be evaluated by the EFSA or to be examined by the Commission, from benefiting from the transitional scheme provided for in that regulation.

| 84 | It follows that, contrary to what the applicants claim, the Commission did not establish additional transitional measures to those provided for in Article 28(5) and (6) of Regulation No 1924/2006, nor did it infringe that article by stating that the health claims which were on hold could still be used. |
| --- | --- |

84

It follows that, contrary to what the applicants claim, the Commission did not establish additional transitional measures to those provided for in Article 28(5) and (6) of Regulation No 1924/2006, nor did it infringe that article by stating that the health claims which were on hold could still be used.

| 85 | The second complaint must therefore be rejected. |
| --- | --- |

85

The second complaint must therefore be rejected.

| 86 | In the third place, as regards the complaint by which an infringement of the principle of legal certainty is alleged, the Court points out, as a preliminary point, that the case-law requires that legal rules be clear and precise, and that their consequences be foreseeable (see judgment of 15 September 2005 in Ireland v Commission, C‐199/03, ECR, EU:C:2005:548, paragraph 69 and the case-law cited). |
| --- | --- |

86

In the third place, as regards the complaint by which an infringement of the principle of legal certainty is alleged, the Court points out, as a preliminary point, that the case-law requires that legal rules be clear and precise, and that their consequences be foreseeable (see judgment of 15 September 2005 in Ireland v Commission, C‐199/03, ECR, EU:C:2005:548, paragraph 69 and the case-law cited).

Ireland

Commission

| 87 | In the present case, although the applicants argue that the claims placed on hold cannot easily be identified by market operators, which are thus uncertain as to which claims may still be used in accordance with Article 28(5) and (6) of Regulation No 1924/2006 and which may not, it must be found that recitals 4 and 11 in the preamble to Regulation No 432/2012 refer to the websites of the EFSA and the Commission, which make available to the public, (i) the consolidated list of all ID codes of the health claims which have be submitted by the Member States pursuant to Article 13(2) of Regulation No 1924/2006 and, (ii) the list setting out the ID codes of those claims which have been placed on hold, as well as the ID codes of the health claims which have been rejected. Against that background, the Court points out that the health claims which are under evaluation and remain on hold can be identified by consulting the consolidated list on the basis of the ID codes provided by the Commission. Although it would have been desirable for the Commission to adopt, for both the on-hold claims and the rejected claims, a list bearing a similar format to the list of permitted claims, annexed to Regulation No 432/2012, in order to make the task of identification easier for interested parties, the fact that, in this instance, the Commission adopted a different approach cannot suffice to support the applicants’ complaint of a lack of clarity or precision in that regard. |
| --- | --- |

87

In the present case, although the applicants argue that the claims placed on hold cannot easily be identified by market operators, which are thus uncertain as to which claims may still be used in accordance with Article 28(5) and (6) of Regulation No 1924/2006 and which may not, it must be found that recitals 4 and 11 in the preamble to Regulation No 432/2012 refer to the websites of the EFSA and the Commission, which make available to the public, (i) the consolidated list of all ID codes of the health claims which have be submitted by the Member States pursuant to Article 13(2) of Regulation No 1924/2006 and, (ii) the list setting out the ID codes of those claims which have been placed on hold, as well as the ID codes of the health claims which have been rejected. Against that background, the Court points out that the health claims which are under evaluation and remain on hold can be identified by consulting the consolidated list on the basis of the ID codes provided by the Commission. Although it would have been desirable for the Commission to adopt, for both the on-hold claims and the rejected claims, a list bearing a similar format to the list of permitted claims, annexed to Regulation No 432/2012, in order to make the task of identification easier for interested parties, the fact that, in this instance, the Commission adopted a different approach cannot suffice to support the applicants’ complaint of a lack of clarity or precision in that regard.

| 88 | The applicants also communicated to the Court, by way of a new submission of evidence in support of their argument that the list of health claims on hold lacks clarity, a bulletin of the Department of Health of the United Kingdom dated 16 April 2014, which draws attention to the fact that the authorities of that Member State considered it a ‘difficult task’ to determine which claims were on hold and which were not. |
| --- | --- |

88

The applicants also communicated to the Court, by way of a new submission of evidence in support of their argument that the list of health claims on hold lacks clarity, a bulletin of the Department of Health of the United Kingdom dated 16 April 2014, which draws attention to the fact that the authorities of that Member State considered it a ‘difficult task’ to determine which claims were on hold and which were not.

| 89 | However, in that regard, it is sufficient to point out, first, that the fact that the United Kingdom authorities considered it somewhat difficult to research which health claims were on hold is not, in itself, sufficient to accuse the Commission of a lack of precision or clarity, in so far as, as is apparent from paragraph 87 above, the claims placed on hold can be found by consulting the documents made publicly available by the Commission and the EFSA. Next, although the bulletin of the Department of Health of the United Kingdom dated 16 April 2014 also directs readers to a table of claims on hold, drawn up by that ministry, which offers a simplified version of the list of those claims, the decision of the national authorities to provide a tool to food producers cannot be regarded as revealing the defective nature of Regulation No 432/2012, so as to bring about its annulment, but rather as a support mechanism put in place by those authorities, of their own volition, in exercising their powers. Finally, although the applicants submit, in the light of that bulletin, that the lack of clarity of the list of claims on hold can also be inferred from the lack of detailed information as to the type of language which may be used for such claims, it must be found, as submitted by the Commission, that such an argument was not raised by the applicants in their written pleadings, but in the context of the new submission of evidence, with the result that it must be rejected as being time-barred and thereby inadmissible. |
| --- | --- |

89

However, in that regard, it is sufficient to point out, first, that the fact that the United Kingdom authorities considered it somewhat difficult to research which health claims were on hold is not, in itself, sufficient to accuse the Commission of a lack of precision or clarity, in so far as, as is apparent from paragraph 87 above, the claims placed on hold can be found by consulting the documents made publicly available by the Commission and the EFSA. Next, although the bulletin of the Department of Health of the United Kingdom dated 16 April 2014 also directs readers to a table of claims on hold, drawn up by that ministry, which offers a simplified version of the list of those claims, the decision of the national authorities to provide a tool to food producers cannot be regarded as revealing the defective nature of Regulation No 432/2012, so as to bring about its annulment, but rather as a support mechanism put in place by those authorities, of their own volition, in exercising their powers. Finally, although the applicants submit, in the light of that bulletin, that the lack of clarity of the list of claims on hold can also be inferred from the lack of detailed information as to the type of language which may be used for such claims, it must be found, as submitted by the Commission, that such an argument was not raised by the applicants in their written pleadings, but in the context of the new submission of evidence, with the result that it must be rejected as being time-barred and thereby inadmissible.

| 90 | It follows that the applicants have not succeeded in demonstrating that the Commission infringed the principle of legal certainty in relation to the identification of the claims on hold. |
| --- | --- |

90

It follows that the applicants have not succeeded in demonstrating that the Commission infringed the principle of legal certainty in relation to the identification of the claims on hold.

| 91 | The third complaint must therefore be rejected. |
| --- | --- |

91

The third complaint must therefore be rejected.

| 92 | In view of the foregoing, the first part of the first plea in law must be rejected. |
| --- | --- |

92

In view of the foregoing, the first part of the first plea in law must be rejected.

– The second part, alleging an infringement of the principles of good administration and non-discrimination

| 93 | By the second part of their first plea, the applicants invoke two complaints. |
| --- | --- |

93

By the second part of their first plea, the applicants invoke two complaints.

| 94 | By their first complaint it is alleged that the decision to split the authorisation procedure into several stages infringes the principle of good administration, as embedded in Article 41 of the Charter of Fundamental Rights of the European Union. In particular, the applicants accuse the Commission of having failed to inform the various interested parties of that decision and to consult them thereon, and of not providing sufficient grounds for that decision. |
| --- | --- |

94

By their first complaint it is alleged that the decision to split the authorisation procedure into several stages infringes the principle of good administration, as embedded in Article 41 of the Charter of Fundamental Rights of the European Union. In particular, the applicants accuse the Commission of having failed to inform the various interested parties of that decision and to consult them thereon, and of not providing sufficient grounds for that decision.

| 95 | The second complaint alleges an infringement of the principle of equal treatment and non-discrimination by the fact that certain food business operators will be able, during the transitional period granted to the health claims placed on hold, to pursue discussions with the Member States and, therefore, benefit from additional opportunities to have claims of interest to them approved. |
| --- | --- |

95

The second complaint alleges an infringement of the principle of equal treatment and non-discrimination by the fact that certain food business operators will be able, during the transitional period granted to the health claims placed on hold, to pursue discussions with the Member States and, therefore, benefit from additional opportunities to have claims of interest to them approved.

| 96 | The Commission, supported by the French Republic and the BEUC, contests the applicants’ arguments. |
| --- | --- |

96

The Commission, supported by the French Republic and the BEUC, contests the applicants’ arguments.

| 97 | In the first place, in so far as concerns the complaint relating to an infringement of the principle of good administration, the Court points out that, pursuant to Article 41(2)(a) of the Charter of Fundamental Rights, the right to good administration includes, inter alia, the right of every person to be heard, before any individual measure which would affect him or her adversely is taken. |
| --- | --- |

97

In the first place, in so far as concerns the complaint relating to an infringement of the principle of good administration, the Court points out that, pursuant to Article 41(2)(a) of the Charter of Fundamental Rights, the right to good administration includes, inter alia, the right of every person to be heard, before any individual measure which would affect him or her adversely is taken.

| 98 | In that regard, the Court has pointed out that the right to good administration, as it results from that provision, does not cover the process of enacting measures of general application (judgment of 17 March 2011 in AJD Tuna, C‐221/09, ECR, EU:C:2011:153, paragraph 49). The right to be heard in an administrative procedure affecting a specific person cannot be transposed to the context of a legislative process leading to the adoption of general laws (see, to that effect and by analogy, judgment of 11 December 1996 in Atlanta and Others v European Community, T‐521/93, ECR, EU:T:1996:184, paragraphs 70 and 71, upheld on appeal by judgment of 14 October 1999 in Atlanta v European Community, C‐104/97 P, ECR, EU:C:1999:498, paragraphs 31 to 40). |
| --- | --- |

98

In that regard, the Court has pointed out that the right to good administration, as it results from that provision, does not cover the process of enacting measures of general application (judgment of 17 March 2011 in AJD Tuna, C‐221/09, ECR, EU:C:2011:153, paragraph 49). The right to be heard in an administrative procedure affecting a specific person cannot be transposed to the context of a legislative process leading to the adoption of general laws (see, to that effect and by analogy, judgment of 11 December 1996 in Atlanta and Others v European Community, T‐521/93, ECR, EU:T:1996:184, paragraphs 70 and 71, upheld on appeal by judgment of 14 October 1999 in Atlanta v European Community, C‐104/97 P, ECR, EU:C:1999:498, paragraphs 31 to 40).

AJD Tuna

Atlanta and Others

European Community

Atlanta

European Community

| 99 | In the present case, in so far as the Court has held, in paragraph 36 above, that Regulation No 432/2012 constituted an act of general application, it is sufficient to point out that Article 41 of the Charter of Fundamental Rights is not applicable. |
| --- | --- |

99

In the present case, in so far as the Court has held, in paragraph 36 above, that Regulation No 432/2012 constituted an act of general application, it is sufficient to point out that Article 41 of the Charter of Fundamental Rights is not applicable.

| 100 | Moreover, and in any event, Article 13(1) to (3) of Regulation No 1924/2006, as a legal basis for the adoption of Regulation No 432/2012, does not provide that the Commission is required to consult food business operators and other interested parties in the adoption procedure for the list of permitted claims. It is apparent from Article 13(2) of that regulation that only the Member States were empowered to provide the Commission with national lists of health claims intended to form the basis of the list of permitted claims. Accordingly, the applicants cannot invoke an infringement by the Commission of any right, on their part, to be consulted, based on Article 13(1) to (3) of Regulation No 1924/2006, in relation to the decision to adopt the list of permitted claims in several stages. |
| --- | --- |

100

Moreover, and in any event, Article 13(1) to (3) of Regulation No 1924/2006, as a legal basis for the adoption of Regulation No 432/2012, does not provide that the Commission is required to consult food business operators and other interested parties in the adoption procedure for the list of permitted claims. It is apparent from Article 13(2) of that regulation that only the Member States were empowered to provide the Commission with national lists of health claims intended to form the basis of the list of permitted claims. Accordingly, the applicants cannot invoke an infringement by the Commission of any right, on their part, to be consulted, based on Article 13(1) to (3) of Regulation No 1924/2006, in relation to the decision to adopt the list of permitted claims in several stages.

| 101 | Next, in so far as the applicants’ line of argument should be understood as seeking to allege that there was a lack of transparency on the part of the Commission, it must be found that such an allegation is not supported by the facts of the case. |
| --- | --- |

101

Next, in so far as the applicants’ line of argument should be understood as seeking to allege that there was a lack of transparency on the part of the Commission, it must be found that such an allegation is not supported by the facts of the case.

| 102 | First, by press release published on 14 July 2009, the Commission informed the interested parties, including the food business operators, that, in the light of the difficulties and the circumstances described in paragraph 75 above, it planned on adopting the list of permitted claims on a gradual basis. Second, in response to a letter in which certain associations of manufacturers of dietary and botanical products in the Union, of which the applicants are members, requested a reevaluation of that form of action, the Commission reiterated, by letter of 11 November 2009, its intention to establish the list of permitted claims in a progressive fashion. Third, on 27 September 2010 and 28 July 2011, the Commission announced, by means of two press releases, that it was restructuring the process of adoption of the list of permitted claims in accordance with Article 13(3) of Regulation No 1924/2006, explaining that the health claims concerning substances other than so-called ‘botanicals’ would be examined in a first stage, whereas claims relating to botanical substances would be examined in a second stage. |
| --- | --- |

102

First, by press release published on 14 July 2009, the Commission informed the interested parties, including the food business operators, that, in the light of the difficulties and the circumstances described in paragraph 75 above, it planned on adopting the list of permitted claims on a gradual basis. Second, in response to a letter in which certain associations of manufacturers of dietary and botanical products in the Union, of which the applicants are members, requested a reevaluation of that form of action, the Commission reiterated, by letter of 11 November 2009, its intention to establish the list of permitted claims in a progressive fashion. Third, on 27 September 2010 and 28 July 2011, the Commission announced, by means of two press releases, that it was restructuring the process of adoption of the list of permitted claims in accordance with Article 13(3) of Regulation No 1924/2006, explaining that the health claims concerning substances other than so-called ‘botanicals’ would be examined in a first stage, whereas claims relating to botanical substances would be examined in a second stage.

| 103 | Consequently, the decision to adopt the list of permitted claims in several stages was taken by the Commission in a transparent manner, in particular as towards producers in the sector. |
| --- | --- |

103

Consequently, the decision to adopt the list of permitted claims in several stages was taken by the Commission in a transparent manner, in particular as towards producers in the sector.

| 104 | Finally, as regards the applicants’ criticism relating to an infringement of the obligation to state reasons, the Court points out that, in accordance with Article 296(2) TFEU, legal acts adopted by the EU institutions are to state the reasons on which they are based. |
| --- | --- |

104

Finally, as regards the applicants’ criticism relating to an infringement of the obligation to state reasons, the Court points out that, in accordance with Article 296(2) TFEU, legal acts adopted by the EU institutions are to state the reasons on which they are based.

| 105 | In accordance with settled case-law, the statement of reasons required by Article 296(2) TFEU must be appropriate to the act at issue and must disclose in a clear and unequivocal fashion the reasoning followed by the institution which adopted the measure in question in such a way as to enable the persons concerned to ascertain the reasons for the measure. It is not necessary for the reasoning to go into all the relevant facts and points of law, since the question whether the statement of reasons meets the requirements of Article 296(2) TFEU must be assessed with regard not only to the wording of the measure, but also to its context (see, to that effect, judgment of 5 March 2009 in France v Council, C‐479/07, EU:C:2009:131, paragraph 49 and the case-law cited). |
| --- | --- |

105

In accordance with settled case-law, the statement of reasons required by Article 296(2) TFEU must be appropriate to the act at issue and must disclose in a clear and unequivocal fashion the reasoning followed by the institution which adopted the measure in question in such a way as to enable the persons concerned to ascertain the reasons for the measure. It is not necessary for the reasoning to go into all the relevant facts and points of law, since the question whether the statement of reasons meets the requirements of Article 296(2) TFEU must be assessed with regard not only to the wording of the measure, but also to its context (see, to that effect, judgment of 5 March 2009 in France v Council, C‐479/07, EU:C:2009:131, paragraph 49 and the case-law cited).

France

Council

| 106 | In the present case, the Court notes, first, that it is apparent from the press release of 27 September 2010, referred to in paragraph 102 above, that the Commission explained that it had invited the EFSA provisionally to suspend the evaluation of the health claims relating to botanical substances and to focus, by contrast, on the evaluation of all of the other claims for the purposes of Article 13(1) of Regulation No 1924/2006 in order to be able to complete the evaluation of those claims as soon as possible. The Commission also stated that it thereby sought to accelerate the procedure aimed at establishing the list of permitted claims, while having the opportunity to examine and assess carefully the specific features of the claims related to botanical substances and, in particular, the potential tensions between Regulation No 1924/2006 and Directive 2004/24/EC of the European Parliament and of the Council of 31 March 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 L 136, 85). |
| --- | --- |

106

In the present case, the Court notes, first, that it is apparent from the press release of 27 September 2010, referred to in paragraph 102 above, that the Commission explained that it had invited the EFSA provisionally to suspend the evaluation of the health claims relating to botanical substances and to focus, by contrast, on the evaluation of all of the other claims for the purposes of Article 13(1) of Regulation No 1924/2006 in order to be able to complete the evaluation of those claims as soon as possible. The Commission also stated that it thereby sought to accelerate the procedure aimed at establishing the list of permitted claims, while having the opportunity to examine and assess carefully the specific features of the claims related to botanical substances and, in particular, the potential tensions between Regulation No 1924/2006 and Directive 2004/24/EC of the European Parliament and of the Council of 31 March 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 L 136, 85).

| 107 | Secondly, in recital 10 in the preamble to Regulation No 432/2012, the Commission reaffirmed that, during the authorisation procedure provided for in Article 13(3) of Regulation No 1924/2006, the EFSA had yet to complete a scientific evaluation in relation to a number of claims submitted for evaluation, which referred to effects of plant or herbal substances. In addition, according to that same recital, for a number of health claims a further evaluation was required before the Commission itself was able to decide on their inclusion in the list of permitted claims, whereas for other claims the evaluation had been completed, but due to other legitimate factors consideration could not be completed by the Commission at that time. |
| --- | --- |

107

Secondly, in recital 10 in the preamble to Regulation No 432/2012, the Commission reaffirmed that, during the authorisation procedure provided for in Article 13(3) of Regulation No 1924/2006, the EFSA had yet to complete a scientific evaluation in relation to a number of claims submitted for evaluation, which referred to effects of plant or herbal substances. In addition, according to that same recital, for a number of health claims a further evaluation was required before the Commission itself was able to decide on their inclusion in the list of permitted claims, whereas for other claims the evaluation had been completed, but due to other legitimate factors consideration could not be completed by the Commission at that time.

| 108 | Thirdly, in recital 11 in the preamble to Regulation No 432/2012, the Commission stated, as has been examined in paragraphs 79 to 84 above, that the health claims placed on hold could still be used pursuant to Article 28(5) and (6) of Regulation No 1924/2006 and that, consequently, for claims yet to be evaluated, the transitional scheme provided for in that regulation remained applicable. |
| --- | --- |

108

Thirdly, in recital 11 in the preamble to Regulation No 432/2012, the Commission stated, as has been examined in paragraphs 79 to 84 above, that the health claims placed on hold could still be used pursuant to Article 28(5) and (6) of Regulation No 1924/2006 and that, consequently, for claims yet to be evaluated, the transitional scheme provided for in that regulation remained applicable.

| 109 | It follows that the Commission set out in a clear manner the reasoning behind its decision to adopt the list of permitted claims in stages, thereby enabling interested parties to understand the justification for that decision and the consequences thereof. |
| --- | --- |

109

It follows that the Commission set out in a clear manner the reasoning behind its decision to adopt the list of permitted claims in stages, thereby enabling interested parties to understand the justification for that decision and the consequences thereof.

| 110 | Moreover, although the applicants essentially accuse the Commission of having failed to state, in an even more detailed manner, the reasons justifying the decision to postpone the evaluation of the claims placed on hold, in particular the evaluation of the claims relating to botanical substances, suffice it to note that the scope of the duty to state reasons depends upon the nature of the measure at issue. In particular, in the case of measures of general application, such as Regulation No 432/2012, the statement of reasons may be confined to indicating the general situation which led to its adoption, on the one hand, and the general objectives which it is intended to achieve, on the other. In that regard, the Court has repeatedly ruled that if the contested measure clearly discloses the essential objective pursued by the institution, it would be excessive to require a specific statement of reasons for the various technical choices made (judgments of 22 November 2001 in Netherlands v Council, C‐301/97, ECR, EU:C:2001:621, paragraph 188, and 21 July 2011 in Etimine, C‐15/10, ECR, EU:C:2011:504, paragraph 115). |
| --- | --- |

110

Moreover, although the applicants essentially accuse the Commission of having failed to state, in an even more detailed manner, the reasons justifying the decision to postpone the evaluation of the claims placed on hold, in particular the evaluation of the claims relating to botanical substances, suffice it to note that the scope of the duty to state reasons depends upon the nature of the measure at issue. In particular, in the case of measures of general application, such as Regulation No 432/2012, the statement of reasons may be confined to indicating the general situation which led to its adoption, on the one hand, and the general objectives which it is intended to achieve, on the other. In that regard, the Court has repeatedly ruled that if the contested measure clearly discloses the essential objective pursued by the institution, it would be excessive to require a specific statement of reasons for the various technical choices made (judgments of 22 November 2001 in Netherlands v Council, C‐301/97, ECR, EU:C:2001:621, paragraph 188, and 21 July 2011 in Etimine, C‐15/10, ECR, EU:C:2011:504, paragraph 115).

Netherlands

Council

Etimine

| 111 | Consequently, the Commission complied with the obligation to state reasons incumbent on it by virtue of Article 296(2) TFEU. |
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111

Consequently, the Commission complied with the obligation to state reasons incumbent on it by virtue of Article 296(2) TFEU.

| 112 | The first complaint must therefore be rejected. |
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112

The first complaint must therefore be rejected.

| 113 | In the second place, regarding the complaint by which an infringement of the principle of equal treatment is alleged, it should be borne in mind that, in accordance with settled case-law, that principle requires that comparable situations must not be treated differently and that different situations must not be treated in the same way unless such treatment is objectively justified (see judgment of 16 December 2008 in Arcelor Atlantique et Lorraine and Others, C‐127/07, ECR, EU:C:2008:728, paragraph 23 and the case-law cited). |
| --- | --- |

113

In the second place, regarding the complaint by which an infringement of the principle of equal treatment is alleged, it should be borne in mind that, in accordance with settled case-law, that principle requires that comparable situations must not be treated differently and that different situations must not be treated in the same way unless such treatment is objectively justified (see judgment of 16 December 2008 in Arcelor Atlantique et Lorraine and Others, C‐127/07, ECR, EU:C:2008:728, paragraph 23 and the case-law cited).

Arcelor Atlantique et Lorraine and Others

| 114 | The applicants submit, in essence, that certain food business operators will be able, during the transitional period granted to the health claims placed on hold, to pursue additional discussions with the Member States and the Commission and thereby benefit from additional opportunities to have those claims approved. |
| --- | --- |

114

The applicants submit, in essence, that certain food business operators will be able, during the transitional period granted to the health claims placed on hold, to pursue additional discussions with the Member States and the Commission and thereby benefit from additional opportunities to have those claims approved.

| 115 | That argument cannot prevail, however. Not only is it an argument of a general nature, but it also infers, in essence, that the Commission could provide preferential treatment to the operators concerned by claims placed on hold. |
| --- | --- |

115

That argument cannot prevail, however. Not only is it an argument of a general nature, but it also infers, in essence, that the Commission could provide preferential treatment to the operators concerned by claims placed on hold.

| 116 | Next, the applicants do not explain the extent to which the producers concerned by claims placed on hold could benefit from a more favourable decision on the part of the Commission as a result of Member State intervention. |
| --- | --- |

116

Next, the applicants do not explain the extent to which the producers concerned by claims placed on hold could benefit from a more favourable decision on the part of the Commission as a result of Member State intervention.

| 117 | Furthermore, as has been pointed out in paragraph 100 above, the Commission is not required to consult producers in the sector and other interested parties in the adoption procedure for the list of permitted claims, with the result that preferential treatment on the part of the Commission cannot, in any event, be verified. |
| --- | --- |

117

Furthermore, as has been pointed out in paragraph 100 above, the Commission is not required to consult producers in the sector and other interested parties in the adoption procedure for the list of permitted claims, with the result that preferential treatment on the part of the Commission cannot, in any event, be verified.

| 118 | The second complaint must therefore be rejected. |
| --- | --- |

118

The second complaint must therefore be rejected.

| 119 | In the light of the foregoing, the second part of the first plea must be rejected, as must the first plea in its entirety. |
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119

In the light of the foregoing, the second part of the first plea must be rejected, as must the first plea in its entirety.

The second plea: infringement of the principle of good administration, the principle of legal certainty and the duty of collaboration with national food authorities, as well as the obligation to state reasons when not including a large number of claims in the list of permitted claims

| 120 | The second plea is divided into three parts. |
| --- | --- |

120

The second plea is divided into three parts.

– The first part, alleging the application of erroneous criteria in the establishment of the list of permitted claims

| 121 | The applicants invoke two complaints in support of the first part of the second plea. |
| --- | --- |

121

The applicants invoke two complaints in support of the first part of the second plea.

| 122 | By the first complaint it is alleged that the request for a scientific opinion, made by the Commission to the EFSA for the evaluation of the health claims referred to in Article 13(1) to (3) of Regulation No 1924/2006, was inappropriately formulated as a result of its excessive demands. In particular, the applicants consider that Article 13(3) of that regulation did not require the EFSA to provide exhaustive and conclusive scientific opinions, but mere consultation. Moreover, they submit that that provision required a different type of evaluation from the specific and more binding procedures aimed at approving health claims under Article 13(5) and Article 14 of the same regulation. |
| --- | --- |

122

By the first complaint it is alleged that the request for a scientific opinion, made by the Commission to the EFSA for the evaluation of the health claims referred to in Article 13(1) to (3) of Regulation No 1924/2006, was inappropriately formulated as a result of its excessive demands. In particular, the applicants consider that Article 13(3) of that regulation did not require the EFSA to provide exhaustive and conclusive scientific opinions, but mere consultation. Moreover, they submit that that provision required a different type of evaluation from the specific and more binding procedures aimed at approving health claims under Article 13(5) and Article 14 of the same regulation.

| 123 | By the second complaint it is alleged that, even supposing that the examination carried out under Article 13(1) of Regulation No 1924/2006 could be a full review, based on generally accepted scientific evidence, the criteria applied to the scientific evidence by the Commission and the EFSA were erroneous. |
| --- | --- |

123

By the second complaint it is alleged that, even supposing that the examination carried out under Article 13(1) of Regulation No 1924/2006 could be a full review, based on generally accepted scientific evidence, the criteria applied to the scientific evidence by the Commission and the EFSA were erroneous.

| 124 | The Commission, supported by the French Republic and the BEUC, contests the applicants’ arguments. |
| --- | --- |

124

The Commission, supported by the French Republic and the BEUC, contests the applicants’ arguments.

| 125 | In relation to the first complaint, it should be pointed out, as a preliminary point, that, as submitted by the French Republic, the applicants’ arguments seek to establish that the required level of scientific substantiation in order to authorise health claims, under Article 13(1) of Regulation No 1924/2006, should have been less stringent than that required by the Commission in the request for a scientific opinion and, in particular, less rigorous than that applicable to the authorisation of the health claims referred to in Article 13(5) and Article 14 of that regulation. |
| --- | --- |

125

In relation to the first complaint, it should be pointed out, as a preliminary point, that, as submitted by the French Republic, the applicants’ arguments seek to establish that the required level of scientific substantiation in order to authorise health claims, under Article 13(1) of Regulation No 1924/2006, should have been less stringent than that required by the Commission in the request for a scientific opinion and, in particular, less rigorous than that applicable to the authorisation of the health claims referred to in Article 13(5) and Article 14 of that regulation.

| 126 | In that regard, the Court notes, first of all, that, according to recital 17 in the preamble to Regulation No 1924/2006, scientific substantiation should be the main aspect to be taken into account for the use of nutrition and health claims and the food business operators using claims should justify them. A claim should be scientifically substantiated by taking into account the totality of the available scientific data, and by weighing the evidence. Moreover, recital 23 in the preamble to Regulation No 1924/2006 provides that health claims should be authorised for use in the European Union only after a scientific assessment of the highest possible standard and that, in order to ensure harmonised scientific assessment of those claims, the EFSA should carry out such assessments. |
| --- | --- |

126

In that regard, the Court notes, first of all, that, according to recital 17 in the preamble to Regulation No 1924/2006, scientific substantiation should be the main aspect to be taken into account for the use of nutrition and health claims and the food business operators using claims should justify them. A claim should be scientifically substantiated by taking into account the totality of the available scientific data, and by weighing the evidence. Moreover, recital 23 in the preamble to Regulation No 1924/2006 provides that health claims should be authorised for use in the European Union only after a scientific assessment of the highest possible standard and that, in order to ensure harmonised scientific assessment of those claims, the EFSA should carry out such assessments.

| 127 | Next, Article 5 of Regulation No 1924/2006, entitled ‘General conditions’, provides, in essence, that the use of health claims is permitted only if, among other conditions, it is established, by means of generally accepted scientific evidence, (i) that the substance in respect of which the claim is made has been shown to have the claimed beneficial effect, (ii) that the substance for which the claim is made is contained in the final product in a quantity that will produce the beneficial effect claimed or is not present, and (iii) that the quantity of the product that can reasonably be expected to be consumed provides a significant quantity of the substance to which the claim relates that will produce the effect claimed. |
| --- | --- |

127

Next, Article 5 of Regulation No 1924/2006, entitled ‘General conditions’, provides, in essence, that the use of health claims is permitted only if, among other conditions, it is established, by means of generally accepted scientific evidence, (i) that the substance in respect of which the claim is made has been shown to have the claimed beneficial effect, (ii) that the substance for which the claim is made is contained in the final product in a quantity that will produce the beneficial effect claimed or is not present, and (iii) that the quantity of the product that can reasonably be expected to be consumed provides a significant quantity of the substance to which the claim relates that will produce the effect claimed.

| 128 | Finally, pursuant to Article 6 of Regulation No 1924/2006, entitled ‘Scientific substantiation for claims’, health claims are to be based on and substantiated by generally accepted scientific evidence. Moreover, a food business operator making a health claim is required to justify the use of that claim. |
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128

Finally, pursuant to Article 6 of Regulation No 1924/2006, entitled ‘Scientific substantiation for claims’, health claims are to be based on and substantiated by generally accepted scientific evidence. Moreover, a food business operator making a health claim is required to justify the use of that claim.

| 129 | It is apparent from the provisions referred to above, taken together, that Regulation No 1924/2006 requires, first, that only health claims which have been scientifically proven may be used in the European Union and, second, that those claims are to be permitted only after a harmonised scientific evaluation by the EFSA meeting the highest possible standards. That consideration is also applicable, contrary to what the applicants submit, to the authorisation procedure referred to in Article 13(1) to (3) of Regulation No 1924/2006, in the context of which the Commission cannot request from the EFSA a less stringent scientific evaluation in relation to claims coming under Article 13(5) of that regulation or Article 14 thereof. In that regard, the Court concurs with the Commission in finding that none of the provisions referred to above introduces different conditions, as regards the scientific evaluation to be carried out, for health claims depending on the provision which is applicable to them. |
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129

It is apparent from the provisions referred to above, taken together, that Regulation No 1924/2006 requires, first, that only health claims which have been scientifically proven may be used in the European Union and, second, that those claims are to be permitted only after a harmonised scientific evaluation by the EFSA meeting the highest possible standards. That consideration is also applicable, contrary to what the applicants submit, to the authorisation procedure referred to in Article 13(1) to (3) of Regulation No 1924/2006, in the context of which the Commission cannot request from the EFSA a less stringent scientific evaluation in relation to claims coming under Article 13(5) of that regulation or Article 14 thereof. In that regard, the Court concurs with the Commission in finding that none of the provisions referred to above introduces different conditions, as regards the scientific evaluation to be carried out, for health claims depending on the provision which is applicable to them.

| 130 | Moreover, in accordance with the case-law, a scientific risk assessment carried out as thoroughly as possible on the basis of scientific advice founded on the principles of excellence, transparency and independence is an important procedural guarantee whose purpose is to ensure the scientific objectivity of the measures adopted and preclude any arbitrary measures (see, to that effect, judgments of 11 September 2002 in Pfizer Animal Health v Council, T‐13/99, ECR, EU:T:2002:209, paragraph 172, and 9 September 2011 in France v Commission, T‐257/07, ECR, EU:T:2011:444, paragraph 89). |
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130

Moreover, in accordance with the case-law, a scientific risk assessment carried out as thoroughly as possible on the basis of scientific advice founded on the principles of excellence, transparency and independence is an important procedural guarantee whose purpose is to ensure the scientific objectivity of the measures adopted and preclude any arbitrary measures (see, to that effect, judgments of 11 September 2002 in Pfizer Animal Health v Council, T‐13/99, ECR, EU:T:2002:209, paragraph 172, and 9 September 2011 in France v Commission, T‐257/07, ECR, EU:T:2011:444, paragraph 89).

Pfizer Animal Health

Council

France

Commission

| 131 | Finally, the Court must reject the applicants’ arguments that Article 13(1) of Regulation No 1924/2006 should be interpreted as providing for the application of a general presumption in favour of health claims already on the market, which should be regarded as being based on generally accepted scientific evidence. The Court concurs with the French Republic in considering that the application of a general presumption in the manner proposed by the applicants would be contrary to Article 6 of Regulation No 1924/2006, which is based on the finding, noted in recital 14 in the preamble to that regulation, that there is a wide variety of claims on the market that have not been substantiated from a scientific point of view. |
| --- | --- |

131

Finally, the Court must reject the applicants’ arguments that Article 13(1) of Regulation No 1924/2006 should be interpreted as providing for the application of a general presumption in favour of health claims already on the market, which should be regarded as being based on generally accepted scientific evidence. The Court concurs with the French Republic in considering that the application of a general presumption in the manner proposed by the applicants would be contrary to Article 6 of Regulation No 1924/2006, which is based on the finding, noted in recital 14 in the preamble to that regulation, that there is a wide variety of claims on the market that have not been substantiated from a scientific point of view.

| 132 | It follows that the Commission did not infringe Article 13 of Regulation No 1924/2006 in formulating its request for a scientific opinion to the EFSA for the evaluation of the health claims. |
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132

It follows that the Commission did not infringe Article 13 of Regulation No 1924/2006 in formulating its request for a scientific opinion to the EFSA for the evaluation of the health claims.

| 133 | The first complaint must therefore be rejected. |
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133

The first complaint must therefore be rejected.

| 134 | As regards the second complaint, the applicants submit, in essence, that the evaluation criteria applied by the Commission and the EFSA to the scientific evidence, as is apparent inter alia from the request for a scientific opinion, were erroneous. |
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134

As regards the second complaint, the applicants submit, in essence, that the evaluation criteria applied by the Commission and the EFSA to the scientific evidence, as is apparent inter alia from the request for a scientific opinion, were erroneous.

| 135 | Thus, in the first place, they submit that the requirement that the beneficial effect of the dietary intake of the foods to which those health claims relate had to be ‘significant’ went beyond the general criterion in Article 5 of Regulation No 1924/2006, namely that ‘a’ beneficial physiological effect is sufficient. |
| --- | --- |

135

Thus, in the first place, they submit that the requirement that the beneficial effect of the dietary intake of the foods to which those health claims relate had to be ‘significant’ went beyond the general criterion in Article 5 of Regulation No 1924/2006, namely that ‘a’ beneficial physiological effect is sufficient.

| 136 | In that regard, the Court points out, at the outset, that, even if, as submitted by the applicants, the Commission established, in the context of the request for an opinion, that the alleged beneficial effect had to be significant, it nonetheless defined that requirement as requiring it to be demonstrated in a satisfactory manner that that effect beneficially affected identified functions of the body in a way which was relevant to health. Such a requirement constitutes a condition which may be inferred from Article 5(1)(b) and (d) of Regulation No 1924/2006. As has been pointed out in paragraph 127 above, that provision establishes as conditions for the authorisation of health claims that, (i) the substance for which the claim is made is contained in the final product in a quantity that will produce the beneficial effect claimed or is not present, and, (ii) that the quantity of the product that can reasonably be expected to be consumed provides a significant quantity of the substance to which the claim relates that will produce the effect claimed. The requirement of a significant beneficial effect, as referred to in the request for a scientific opinion, thus exists to ensure that consumers are not misled when purchasing foods in relation to which it is claimed that they contain substances which produce such an effect. Accordingly, the request for a scientific opinion cannot be regarded as going beyond the general conditions of use of claims laid down in Regulation No 1924/2006. |
| --- | --- |

136

In that regard, the Court points out, at the outset, that, even if, as submitted by the applicants, the Commission established, in the context of the request for an opinion, that the alleged beneficial effect had to be significant, it nonetheless defined that requirement as requiring it to be demonstrated in a satisfactory manner that that effect beneficially affected identified functions of the body in a way which was relevant to health. Such a requirement constitutes a condition which may be inferred from Article 5(1)(b) and (d) of Regulation No 1924/2006. As has been pointed out in paragraph 127 above, that provision establishes as conditions for the authorisation of health claims that, (i) the substance for which the claim is made is contained in the final product in a quantity that will produce the beneficial effect claimed or is not present, and, (ii) that the quantity of the product that can reasonably be expected to be consumed provides a significant quantity of the substance to which the claim relates that will produce the effect claimed. The requirement of a significant beneficial effect, as referred to in the request for a scientific opinion, thus exists to ensure that consumers are not misled when purchasing foods in relation to which it is claimed that they contain substances which produce such an effect. Accordingly, the request for a scientific opinion cannot be regarded as going beyond the general conditions of use of claims laid down in Regulation No 1924/2006.

| 137 | In the second place, the applicants criticise the request for a scientific opinion made by the Commission to the EFSA for having overemphasised the role of the cause and effect relationship. |
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137

In the second place, the applicants criticise the request for a scientific opinion made by the Commission to the EFSA for having overemphasised the role of the cause and effect relationship.

| 138 | However, that criticism cannot be upheld. The obligation to show the existence of a cause and effect relationship between the food to which the claim relates and the alleged effect results from Regulation No 1924/2006 itself. Thus, suffice it to note that Article 2(2)(5) of Regulation No 1924/2006 defines a health claim as any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health. Therefore, it must be found that, in order to establish whether a health claim was justified in accordance with that regulation, it was necessary to determine the existence of a cause and effect relationship between the food and the specific functions referred to. |
| --- | --- |

138

However, that criticism cannot be upheld. The obligation to show the existence of a cause and effect relationship between the food to which the claim relates and the alleged effect results from Regulation No 1924/2006 itself. Thus, suffice it to note that Article 2(2)(5) of Regulation No 1924/2006 defines a health claim as any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health. Therefore, it must be found that, in order to establish whether a health claim was justified in accordance with that regulation, it was necessary to determine the existence of a cause and effect relationship between the food and the specific functions referred to.

| 139 | In the third place, the applicants submit that the mandate places too much emphasis on food characterisation. |
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139

In the third place, the applicants submit that the mandate places too much emphasis on food characterisation.

| 140 | However, as the Commission asserts, the characterisation of the food to which the claim relates is an essential component of the evaluation. In that regard, it is only in the light of the precise characterisation of the food or of a component thereof to which a claim relates that the EFSA may determine whether the scientific substantiation for the claim is relevant. That being so, the characterisation of the food to which the claim relates ensures that that claim is used only on foods in relation to which the influence on a specific function of the body has been demonstrated. |
| --- | --- |

140

However, as the Commission asserts, the characterisation of the food to which the claim relates is an essential component of the evaluation. In that regard, it is only in the light of the precise characterisation of the food or of a component thereof to which a claim relates that the EFSA may determine whether the scientific substantiation for the claim is relevant. That being so, the characterisation of the food to which the claim relates ensures that that claim is used only on foods in relation to which the influence on a specific function of the body has been demonstrated.

| 141 | In the fourth place, the applicants assert that the requirement laid down in Article 13(1)(ii) of Regulation No 1924/2006, pursuant to which health claims must be ‘well understood by the average consumer’, was not correctly reviewed by the Commission, in so far as it permitted claims worded in complex scientific language. However, suffice it to note in that regard that that criticism concerns only the list of permitted claims, which is excluded, as the applicants have stated on numerous occasions in their pleadings, from the scope of their application for annulment of Regulation No 432/2012. Accordingly, their argument must be rejected as being of no effect. |
| --- | --- |

141

In the fourth place, the applicants assert that the requirement laid down in Article 13(1)(ii) of Regulation No 1924/2006, pursuant to which health claims must be ‘well understood by the average consumer’, was not correctly reviewed by the Commission, in so far as it permitted claims worded in complex scientific language. However, suffice it to note in that regard that that criticism concerns only the list of permitted claims, which is excluded, as the applicants have stated on numerous occasions in their pleadings, from the scope of their application for annulment of Regulation No 432/2012. Accordingly, their argument must be rejected as being of no effect.

| 142 | It follows that the applicants have not succeeded in demonstrating that the evaluation criteria applied by the Commission and the EFSA during the evaluation of the health claims were erroneous. |
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142

It follows that the applicants have not succeeded in demonstrating that the evaluation criteria applied by the Commission and the EFSA during the evaluation of the health claims were erroneous.

| 143 | In the light of the foregoing, the applicants’ second complaint must be rejected, as must the first part of the second plea. |
| --- | --- |

143

In the light of the foregoing, the applicants’ second complaint must be rejected, as must the first part of the second plea.

– The second part, alleging an infringement of the principles of good administration and legal certainty

| 144 | The applicants invoke two complaints in the context of the second part of their second plea. |
| --- | --- |

144

The applicants invoke two complaints in the context of the second part of their second plea.

| 145 | By their first complaint the applicants allege that the review of the health claims carried out by the EFSA infringed the principle of legal certainty since, first, the criteria to be applied during that review were not specified in detail in the guidelines when the national lists of health claims were being drawn up in accordance with Article 13(2) of Regulation No 1924/2006, but once the review procedure had already commenced and, second, the EFSA adopted incoherent and contradictory scientific opinions. |
| --- | --- |

145

By their first complaint the applicants allege that the review of the health claims carried out by the EFSA infringed the principle of legal certainty since, first, the criteria to be applied during that review were not specified in detail in the guidelines when the national lists of health claims were being drawn up in accordance with Article 13(2) of Regulation No 1924/2006, but once the review procedure had already commenced and, second, the EFSA adopted incoherent and contradictory scientific opinions.

| 146 | By their second complaint the applicants allege an infringement of the principle of good administration, in that the review procedure did not guarantee, in their view, that all the information provided by the interested parties was examined by the EFSA and that, moreover, the opinions of the EFSA were made public without the interested parties having been granted the opportunity to submit comments. |
| --- | --- |

146

By their second complaint the applicants allege an infringement of the principle of good administration, in that the review procedure did not guarantee, in their view, that all the information provided by the interested parties was examined by the EFSA and that, moreover, the opinions of the EFSA were made public without the interested parties having been granted the opportunity to submit comments.

| 147 | The Commission, supported by the French Republic and the BEUC, contests the applicants’ arguments. |
| --- | --- |

147

The Commission, supported by the French Republic and the BEUC, contests the applicants’ arguments.

| 148 | In the first place, as regards the complaint by which an infringement of the principle of legal certainty is alleged and, in particular, the applicants’ argument that the authorisation procedure at issue was not appropriate given that specific provisions regarding the scientific review carried out by the EFSA were lacking, the Court points out, at the outset, that Chapter III of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the EFSA and laying down procedures in matters of food safety (OJ 2002 L 31, p. 1) sets out in detail the working method and means of operation of the EFSA. |
| --- | --- |

148

In the first place, as regards the complaint by which an infringement of the principle of legal certainty is alleged and, in particular, the applicants’ argument that the authorisation procedure at issue was not appropriate given that specific provisions regarding the scientific review carried out by the EFSA were lacking, the Court points out, at the outset, that Chapter III of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the EFSA and laying down procedures in matters of food safety (OJ 2002 L 31, p. 1) sets out in detail the working method and means of operation of the EFSA.

| 149 | Next, contrary to what the applicants claim, neither Regulation No 1924/2006 nor Regulation No 178/2002 contains any obligation for the Commission or the EFSA to provide, before commencing the review procedure under Article 13(3) of Regulation No 1924/2006, specific scientific guidelines concerning how the EFSA plans to review applications for approval of claims. The fact that, as submitted by the applicants, the EFSA subsequently adopted such guidelines on 11 November 2009 and on 25 March 2011, in the light of the experience which it gained during the first reviews it carried out, is not such as to demonstrate an infringement of the principle of legal certainty. On the contrary, as the Commission maintains, the adoption of those guidelines adds to legal certainty as regards interested parties, inter alia. |
| --- | --- |

149

Next, contrary to what the applicants claim, neither Regulation No 1924/2006 nor Regulation No 178/2002 contains any obligation for the Commission or the EFSA to provide, before commencing the review procedure under Article 13(3) of Regulation No 1924/2006, specific scientific guidelines concerning how the EFSA plans to review applications for approval of claims. The fact that, as submitted by the applicants, the EFSA subsequently adopted such guidelines on 11 November 2009 and on 25 March 2011, in the light of the experience which it gained during the first reviews it carried out, is not such as to demonstrate an infringement of the principle of legal certainty. On the contrary, as the Commission maintains, the adoption of those guidelines adds to legal certainty as regards interested parties, inter alia.

| 150 | Finally, although the applicants accuse the Commission of having failed to specify, when the national lists of health claims were been drawn up, that those lists would be subject to the same level of scientific substantiation as required for the claims referred to in Article 13(5) and Article 14 of Regulation No 1924/2006, as is apparent from the guidelines subsequently adopted by the EFSA, it must be found that that complaint is not substantiated by the facts of this case. |
| --- | --- |

150

Finally, although the applicants accuse the Commission of having failed to specify, when the national lists of health claims were been drawn up, that those lists would be subject to the same level of scientific substantiation as required for the claims referred to in Article 13(5) and Article 14 of Regulation No 1924/2006, as is apparent from the guidelines subsequently adopted by the EFSA, it must be found that that complaint is not substantiated by the facts of this case.

| 151 | The Court joins the Commission in pointing out that the issue concerning scientific evidence supporting claims covered by Articles 13 and 14 of Regulation No 1924/2006 was addressed in the document adopted by the Commission on 14 December 2007, accessible on its website, entitled ‘Guidance on the implementation of Regulation No 1924/2006 on nutrition and health claims made on foods — Conclusions of the standing committee on the food chain and animal health’. In particular, it is stated expressly in Point III.2.3 of that document, entitled ‘Impact of classification between Article 13 and 14’, that the classification of claims under those provisions had no impact on the level of scientific substantiation needed for their authorisation. |
| --- | --- |

151

The Court joins the Commission in pointing out that the issue concerning scientific evidence supporting claims covered by Articles 13 and 14 of Regulation No 1924/2006 was addressed in the document adopted by the Commission on 14 December 2007, accessible on its website, entitled ‘Guidance on the implementation of Regulation No 1924/2006 on nutrition and health claims made on foods — Conclusions of the standing committee on the food chain and animal health’. In particular, it is stated expressly in Point III.2.3 of that document, entitled ‘Impact of classification between Article 13 and 14’, that the classification of claims under those provisions had no impact on the level of scientific substantiation needed for their authorisation.

| 152 | It follows that the applicants have not succeeded in showing that the procedure before the EFSA infringed the principle of legal certainty in so far as concerned the scientific assessment criteria. |
| --- | --- |

152

It follows that the applicants have not succeeded in showing that the procedure before the EFSA infringed the principle of legal certainty in so far as concerned the scientific assessment criteria.

| 153 | The first complaint must therefore be rejected. |
| --- | --- |

153

The first complaint must therefore be rejected.

| 154 | In the second place, as regards the complaint by which an infringement of the principle of good administration is alleged, in so far as that principle encompasses the right to be heard, the Court points out that, in accordance with the wording of Article 41(2)(a) of the Charter of Fundamental Rights and the Court’s case-law cited in paragraph 98 above, such a principle does not apply to the adoption of measures of general application. |
| --- | --- |

154

In the second place, as regards the complaint by which an infringement of the principle of good administration is alleged, in so far as that principle encompasses the right to be heard, the Court points out that, in accordance with the wording of Article 41(2)(a) of the Charter of Fundamental Rights and the Court’s case-law cited in paragraph 98 above, such a principle does not apply to the adoption of measures of general application.

| 155 | In the present case, suffice it to note, once again, that since, in paragraph 36 above, the Court has found that Regulation No 432/2012 constituted a measure of general application, Article 41 of the Charter of Fundamental Rights cannot apply. |
| --- | --- |

155

In the present case, suffice it to note, once again, that since, in paragraph 36 above, the Court has found that Regulation No 432/2012 constituted a measure of general application, Article 41 of the Charter of Fundamental Rights cannot apply.

| 156 | In the light of the foregoing, the applicants’ second complaint must be rejected, as must the second part of the second plea. |
| --- | --- |

156

In the light of the foregoing, the applicants’ second complaint must be rejected, as must the second part of the second plea.

– The third part, alleging an infringement of the duty of collaboration with national food authorities and of the obligation to state reasons

| 157 | By the third part the applicants submit, first, that the duty of collaboration with national food authorities, as prescribed in Article 30(4) of Regulation No 178/2002, has been infringed in so far as the EFSA did not carry out a detailed analysis of the examinations carried out earlier by national bodies concerning health claims on the lists established in accordance with Article 13(2) of Regulation No 1924/2006. Second, they claim that, even supposing that discussions with the national authorities took place, the obligation to state reasons was also not complied with in the present case, since the content and scope of those discussions were not reproduced in the recitals in the preamble to Regulation No 432/2012. |
| --- | --- |

157

By the third part the applicants submit, first, that the duty of collaboration with national food authorities, as prescribed in Article 30(4) of Regulation No 178/2002, has been infringed in so far as the EFSA did not carry out a detailed analysis of the examinations carried out earlier by national bodies concerning health claims on the lists established in accordance with Article 13(2) of Regulation No 1924/2006. Second, they claim that, even supposing that discussions with the national authorities took place, the obligation to state reasons was also not complied with in the present case, since the content and scope of those discussions were not reproduced in the recitals in the preamble to Regulation No 432/2012.

| 158 | The Commission, supported by the French Republic, inter alia, contests the applicants’ arguments. |
| --- | --- |

158

The Commission, supported by the French Republic, inter alia, contests the applicants’ arguments.

| 159 | As a preliminary point, the Court points out that Article 30(1) to (3) of Regulation No 178/2002, entitled ‘Diverging scientific opinions’, states, in essence, that the EFSA is required to exercise vigilance in order to identify at an early stage any potential source of divergence between its scientific opinions and the scientific opinions issued by other bodies carrying out similar tasks. Moreover, Article 30(4) of that regulation provides that, where a substantive divergence over scientific issues has been identified and the body in question is a Member State body, the EFSA and the national body shall be obliged to cooperate with a view to either resolving the divergence or preparing a joint document clarifying the contentious scientific issues and identifying the relevant uncertainties in the data. This document shall be made public. |
| --- | --- |

159

As a preliminary point, the Court points out that Article 30(1) to (3) of Regulation No 178/2002, entitled ‘Diverging scientific opinions’, states, in essence, that the EFSA is required to exercise vigilance in order to identify at an early stage any potential source of divergence between its scientific opinions and the scientific opinions issued by other bodies carrying out similar tasks. Moreover, Article 30(4) of that regulation provides that, where a substantive divergence over scientific issues has been identified and the body in question is a Member State body, the EFSA and the national body shall be obliged to cooperate with a view to either resolving the divergence or preparing a joint document clarifying the contentious scientific issues and identifying the relevant uncertainties in the data. This document shall be made public.

| 160 | It follows from the system established by Regulation No 178/2002, in particular by Article 30 thereof, that, so far as concerns the requirements governing the procedure for adopting scientific opinions, that regulation constitutes an additional set of rules in relation to Regulation No 1924/2006, the application of which is precluded to the extent to which an EU rule, such as that regulation, contains specific provisions for the authorisation of health claims (see, by analogy, judgment of 9 June 2005 in HLH Warenvertrieb and Orthica, C‐211/03, C‐299/03 and C‐316/03 to C‐318/03, ECR, EU:C:2005:370, paragraphs 38 and 39). |
| --- | --- |

160

It follows from the system established by Regulation No 178/2002, in particular by Article 30 thereof, that, so far as concerns the requirements governing the procedure for adopting scientific opinions, that regulation constitutes an additional set of rules in relation to Regulation No 1924/2006, the application of which is precluded to the extent to which an EU rule, such as that regulation, contains specific provisions for the authorisation of health claims (see, by analogy, judgment of 9 June 2005 in HLH Warenvertrieb and Orthica, C‐211/03, C‐299/03 and C‐316/03 to C‐318/03, ECR, EU:C:2005:370, paragraphs 38 and 39).

HLH Warenvertrieb and Orthica

| 161 | In the present case, in so far as Article 13(3) of Regulation No 1924/2006 provides expressly that the EFSA is entrusted with the task of performing the harmonised scientific evaluation of the lists of claims submitted by the Member States in accordance with Article 13(2) of that regulation, the Court concurs with the Commission and the French Republic in considering that Article 30(4) of Regulation No 178/2002 is not applicable in the present case, with the result that the EFSA was not required either to enter into negotiations with national authorities or to make public the documents accompanying those discussions in the context of the evaluations carried out. |
| --- | --- |

161

In the present case, in so far as Article 13(3) of Regulation No 1924/2006 provides expressly that the EFSA is entrusted with the task of performing the harmonised scientific evaluation of the lists of claims submitted by the Member States in accordance with Article 13(2) of that regulation, the Court concurs with the Commission and the French Republic in considering that Article 30(4) of Regulation No 178/2002 is not applicable in the present case, with the result that the EFSA was not required either to enter into negotiations with national authorities or to make public the documents accompanying those discussions in the context of the evaluations carried out.

| 162 | Moreover, as regards the applicants’ argument that the existence of diverging opinions between the EFSA and national food agencies in relation to certain health claims is manifest in the light of the opinions annexed to their application, the Court points out that, in accordance with settled case-law, in order to ensure legal certainty and the sound administration of justice, if an action is to be admissible, the essential matters of fact and law on which it is based must be stated, at least in summary form, coherently and intelligibly in the application itself. In that regard, whilst the body of the application may be supported and supplemented on specific points by references to extracts from documents annexed thereto, a general reference to other documents, even those annexed to the application, cannot make up for the absence of the essential arguments in law which, in accordance with the abovementioned provisions, must appear in the application (see, to that effect, judgment of 14 December 2005 in General Electric v Commission, T‐210/01, ECR, EU:T:2005:456, paragraph 592). That argument must therefore be rejected as inadmissible. |
| --- | --- |

162

Moreover, as regards the applicants’ argument that the existence of diverging opinions between the EFSA and national food agencies in relation to certain health claims is manifest in the light of the opinions annexed to their application, the Court points out that, in accordance with settled case-law, in order to ensure legal certainty and the sound administration of justice, if an action is to be admissible, the essential matters of fact and law on which it is based must be stated, at least in summary form, coherently and intelligibly in the application itself. In that regard, whilst the body of the application may be supported and supplemented on specific points by references to extracts from documents annexed thereto, a general reference to other documents, even those annexed to the application, cannot make up for the absence of the essential arguments in law which, in accordance with the abovementioned provisions, must appear in the application (see, to that effect, judgment of 14 December 2005 in General Electric v Commission, T‐210/01, ECR, EU:T:2005:456, paragraph 592). That argument must therefore be rejected as inadmissible.

General Electric

Commission

| 163 | It follows that neither Article 30(4) of Regulation No 178/2002 nor the obligation to state reasons was infringed during the review of the health claims submitted to the EFSA. |
| --- | --- |

163

It follows that neither Article 30(4) of Regulation No 178/2002 nor the obligation to state reasons was infringed during the review of the health claims submitted to the EFSA.

| 164 | In light of the foregoing, the third part of the second plea must be rejected, as must the second plea in its entirety. |
| --- | --- |

164

In light of the foregoing, the third part of the second plea must be rejected, as must the second plea in its entirety.

| 165 | Consequently, the application for the annulment of Regulation No 432/2012 must be rejected. |
| --- | --- |

165

Consequently, the application for the annulment of Regulation No 432/2012 must be rejected.

2. The application for a declaration that Regulation No 1924/2006 is inapplicable

The application for a declaration that Regulation No 1924/2006 is inapplicable

Admissibility

Admissibility

| 166 | The Commission and the Council consider that the application made in the alternative by the applicants, seeking a declaration, pursuant to Article 277 TFEU, that Regulation No 1924/2006 is inapplicable, since the main action brought against Regulation No 432/2012 is itself inadmissible. Moreover, they submit that, in any event, the scope of a plea of illegality must, in accordance with settled case-law, be limited to what is necessary for the outcome of the proceedings. |
| --- | --- |

166

The Commission and the Council consider that the application made in the alternative by the applicants, seeking a declaration, pursuant to Article 277 TFEU, that Regulation No 1924/2006 is inapplicable, since the main action brought against Regulation No 432/2012 is itself inadmissible. Moreover, they submit that, in any event, the scope of a plea of illegality must, in accordance with settled case-law, be limited to what is necessary for the outcome of the proceedings.

| 167 | The applicants contest those arguments. |
| --- | --- |

167

The applicants contest those arguments.

| 168 | Pursuant to Article 277 TFEU, notwithstanding the expiry of the period laid down in the sixth paragraph of Article 263 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 the second paragraph of that article, in order to invoke before the Court of Justice of the European Union the inapplicability of that act. |
| --- | --- |

168

Pursuant to Article 277 TFEU, notwithstanding the expiry of the period laid down in the sixth paragraph of Article 263 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 the second paragraph of that article, in order to invoke before the Court of Justice of the European Union the inapplicability of that act.

| 169 | According to settled case-law, the possibility provided by Article 277 TFEU of invoking the illegality of a measure of general application does not constitute an independent right of action and may only be sought incidentally, since where the main action is inadmissible the plea of illegality must also be declared inadmissible (see, to that effect, order of 17 June 2008 in Dow AgroSciences v EFSA, T‐397/06, EU:T:2008:208, paragraph 63 and the case-law cited). |
| --- | --- |

169

According to settled case-law, the possibility provided by Article 277 TFEU of invoking the illegality of a measure of general application does not constitute an independent right of action and may only be sought incidentally, since where the main action is inadmissible the plea of illegality must also be declared inadmissible (see, to that effect, order of 17 June 2008 in Dow AgroSciences v EFSA, T‐397/06, EU:T:2008:208, paragraph 63 and the case-law cited).

Dow AgroSciences

EFSA

| 170 | A plea of illegality raised indirectly under Article 277 TFEU, when challenging in the main proceedings the legality of another measure, is admissible only if there is a link between the contested measure and the provision forming the subject-matter of the plea. 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 outcome of the proceedings. It follows that the general measure claimed to be illegal must be applicable, directly or indirectly, to the issue with which the action is concerned (see, to that effect, judgment of 20 November 2007 in Ianniello v Commission, T‐308/04, EU:T:2007:347, paragraph 33 and the case-law cited). |
| --- | --- |

170

A plea of illegality raised indirectly under Article 277 TFEU, when challenging in the main proceedings the legality of another measure, is admissible only if there is a link between the contested measure and the provision forming the subject-matter of the plea. 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 outcome of the proceedings. It follows that the general measure claimed to be illegal must be applicable, directly or indirectly, to the issue with which the action is concerned (see, to that effect, judgment of 20 November 2007 in Ianniello v Commission, T‐308/04, EU:T:2007:347, paragraph 33 and the case-law cited).

Ianniello

Commission

| 171 | In the present case, the Court points out, in the first place, that in so far as the applicants’ action has been brought primarily against Regulation No 432/2012 and, indirectly, against Regulation No 1924/2006, the admissibility of the application brought on the basis of Article 277 TFEU depends, as is apparent from the case-law cited in paragraph 169 above, on the admissibility of the action seeking the annulment of Regulation No 432/2012. In the light of the conclusion reached in paragraph 51 above in relation to the admissibility of the application seeking the annulment of Regulation No 432/2012, the plea of illegality must be declared admissible. |
| --- | --- |

171

In the present case, the Court points out, in the first place, that in so far as the applicants’ action has been brought primarily against Regulation No 432/2012 and, indirectly, against Regulation No 1924/2006, the admissibility of the application brought on the basis of Article 277 TFEU depends, as is apparent from the case-law cited in paragraph 169 above, on the admissibility of the action seeking the annulment of Regulation No 432/2012. In the light of the conclusion reached in paragraph 51 above in relation to the admissibility of the application seeking the annulment of Regulation No 432/2012, the plea of illegality must be declared admissible.

| 172 | In the second place, in so far as Regulation No 1924/2006, in particular Article 13(3) thereof, constitutes the basis on which Regulation No 432/2012 was adopted, a sufficiently close link can be found between the two measures for the purposes of the case-law cited in paragraph 170 above. The existence of such a link may be inferred, inter alia, from the finding that the measure against which the main action has been brought is essentially based on a provision of a measure whose legality is contested (see, to that effect, judgments of 25 October 2006 in Carius v Commission, T‐173/04, ECR-SC, EU:T:2006:333, paragraph 46, and Ianniello v Commission, paragraph 170 above, EU:T:2007:347, paragraph 33; see, to that effect and by analogy, judgment of 4 March 1998 in De Abreu v Court of Justice, T‐146/96, ECR-SC, EU:T:1998:50, paragraphs 25 and 29). |
| --- | --- |

172

In the second place, in so far as Regulation No 1924/2006, in particular Article 13(3) thereof, constitutes the basis on which Regulation No 432/2012 was adopted, a sufficiently close link can be found between the two measures for the purposes of the case-law cited in paragraph 170 above. The existence of such a link may be inferred, inter alia, from the finding that the measure against which the main action has been brought is essentially based on a provision of a measure whose legality is contested (see, to that effect, judgments of 25 October 2006 in Carius v Commission, T‐173/04, ECR-SC, EU:T:2006:333, paragraph 46, and Ianniello v Commission, paragraph 170 above, EU:T:2007:347, paragraph 33; see, to that effect and by analogy, judgment of 4 March 1998 in De Abreu v Court of Justice, T‐146/96, ECR-SC, EU:T:1998:50, paragraphs 25 and 29).

Carius

Commission

Ianniello

Commission

De Abreu

Court of Justice

| 173 | It follows that the arguments of the Commission and the Council seeking that the plea of illegality raised by the applicants in relation to Regulation No 1924/2006 be declared inadmissible must be rejected. |
| --- | --- |

173

It follows that the arguments of the Commission and the Council seeking that the plea of illegality raised by the applicants in relation to Regulation No 1924/2006 be declared inadmissible must be rejected.

| 174 | Moreover, the Court points out that the applicants merely contest the legality of Article 13(1) to (3) of Regulation No 1924/200 and of the transitional schemes established in Article 28(5) and (6) of that regulation. Accordingly, in the light of the case-law cited in paragraph 170 above, only those provisions may be the subject of a plea of illegality under Article 277 TFEU. Consequently, the Court shall restrict its examination in the context of the present application to those provisions. |
| --- | --- |

174

Moreover, the Court points out that the applicants merely contest the legality of Article 13(1) to (3) of Regulation No 1924/200 and of the transitional schemes established in Article 28(5) and (6) of that regulation. Accordingly, in the light of the case-law cited in paragraph 170 above, only those provisions may be the subject of a plea of illegality under Article 277 TFEU. Consequently, the Court shall restrict its examination in the context of the present application to those provisions.

Substance

Substance

| 175 | The applicants rely on two pleas in support of the application for a declaration that Regulation No 1924/2006 is inapplicable, alleging an infringement of the right to be heard and of the principle of legal certainty. |
| --- | --- |

175

The applicants rely on two pleas in support of the application for a declaration that Regulation No 1924/2006 is inapplicable, alleging an infringement of the right to be heard and of the principle of legal certainty.

The first plea in support of the application for a declaration that Regulation No 1924/2006 is inapplicable, alleging an infringement of the right to be heard

The first plea in support of the application for a declaration that Regulation No 1924/2006 is inapplicable, alleging an infringement of the right to be heard

| 176 | The applicants claim that Article 13(3) of Regulation No 1924/2006 infringes their right to be heard, laid down in Article 41 of the Charter of Fundamental Rights. In particular, they consider that, like Article 13(5) and Article 14 of Regulation No 1924/2006, the authorisation procedure for the health claims referred to in Article 13(3) of that regulation should have enabled food business operators to submit comments, particularly before the EFSA, as regards claims of interest to them. The applicants cite the judgment of 17 September 1998 in Primex Produkte Import-Export and Others v Commission (T‐50/96, ECR, EU:T:1998:223, paragraphs 58 to 61), in which it was held, in essence, that the parties directly affected by a public measure must have an opportunity to be heard even in the absence of any specific rules in that regard. |
| --- | --- |

176

The applicants claim that Article 13(3) of Regulation No 1924/2006 infringes their right to be heard, laid down in Article 41 of the Charter of Fundamental Rights. In particular, they consider that, like Article 13(5) and Article 14 of Regulation No 1924/2006, the authorisation procedure for the health claims referred to in Article 13(3) of that regulation should have enabled food business operators to submit comments, particularly before the EFSA, as regards claims of interest to them. The applicants cite the judgment of 17 September 1998 in Primex Produkte Import-Export and Others v Commission (T‐50/96, ECR, EU:T:1998:223, paragraphs 58 to 61), in which it was held, in essence, that the parties directly affected by a public measure must have an opportunity to be heard even in the absence of any specific rules in that regard.

Primex Produkte Import-Export and Others

Commission

| 177 | The Commission, supported by the Council, the BEUC, the Parliament and the French Republic, contests those arguments. |
| --- | --- |

177

The Commission, supported by the Council, the BEUC, the Parliament and the French Republic, contests those arguments.

| 178 | First of all, in so far as concerns the argument alleging an infringement of the right to good administration, suffice it to note that, as is apparent from paragraph 97 above, Article 41(2)(a) of the Charter of Fundamental Rights includes, inter alia, the right of every person to be heard, before any individual measure which would affect him or her adversely is taken. However, in the present case, in so far as Article 13(3) of Regulation No 1924/2006 leads, as has been stated in paragraph 36 above, to the adoption of a measure of general application, the arguments seeking a declaration that there has been an infringement of the right to be heard, as laid down in that provision of the Charter of Fundamental Rights, cannot be upheld. |
| --- | --- |

178

First of all, in so far as concerns the argument alleging an infringement of the right to good administration, suffice it to note that, as is apparent from paragraph 97 above, Article 41(2)(a) of the Charter of Fundamental Rights includes, inter alia, the right of every person to be heard, before any individual measure which would affect him or her adversely is taken. However, in the present case, in so far as Article 13(3) of Regulation No 1924/2006 leads, as has been stated in paragraph 36 above, to the adoption of a measure of general application, the arguments seeking a declaration that there has been an infringement of the right to be heard, as laid down in that provision of the Charter of Fundamental Rights, cannot be upheld.

| 179 | Moreover, as regards the applicants’ argument that Article 13(5) and Article 14 of Regulation No 1924/2006 provide for a procedure under which operators in the sector are to be duly heard, the Court points out, as do the Parliament and the Commission, that the authorisation procedure set out in those two articles is different from that in Article 13(3) of Regulation No 1924/2006 in that it is triggered by the application of individuals, who may then submit comments on EFSA opinions and obtain an individual decision. By contrast, Article 13(1) to (3) of Regulation No 1924/2006 concerns only an authorisation procedure which is triggered by the Member States, in the context of which no right to be heard is thus conferred on individuals. |
| --- | --- |

179

Moreover, as regards the applicants’ argument that Article 13(5) and Article 14 of Regulation No 1924/2006 provide for a procedure under which operators in the sector are to be duly heard, the Court points out, as do the Parliament and the Commission, that the authorisation procedure set out in those two articles is different from that in Article 13(3) of Regulation No 1924/2006 in that it is triggered by the application of individuals, who may then submit comments on EFSA opinions and obtain an individual decision. By contrast, Article 13(1) to (3) of Regulation No 1924/2006 concerns only an authorisation procedure which is triggered by the Member States, in the context of which no right to be heard is thus conferred on individuals.

| 180 | Furthermore, as regards the judgment in Primex Produkte Import-Export and Others v Commission, paragraph 176 above (EU:T:1998:223), invoked by the applicants, it must be found that, unlike in the present case, that judgment concerned individual administrative measures, adopted in the area of duty on imports of meat of bovine animals. It is only in that context that the Court established, as the applicants point out, that respect for the rights of the defence is, in all proceedings initiated against a person which are liable to culminate in a measure adversely affecting that person, a fundamental principle of EU law which must be guaranteed even in the absence of any rules governing the proceedings in question (judgment in Primex Produkte Import-Export and Others v Commission, paragraph 176 above, EU:T:1998:223, paragraph 59). However, in so far as Regulation No 432/2012 constitutes a measure of general application, the reasoning and conclusions in that judgment are not relevant to the present case. |
| --- | --- |

180

Furthermore, as regards the judgment in Primex Produkte Import-Export and Others v Commission, paragraph 176 above (EU:T:1998:223), invoked by the applicants, it must be found that, unlike in the present case, that judgment concerned individual administrative measures, adopted in the area of duty on imports of meat of bovine animals. It is only in that context that the Court established, as the applicants point out, that respect for the rights of the defence is, in all proceedings initiated against a person which are liable to culminate in a measure adversely affecting that person, a fundamental principle of EU law which must be guaranteed even in the absence of any rules governing the proceedings in question (judgment in Primex Produkte Import-Export and Others v Commission, paragraph 176 above, EU:T:1998:223, paragraph 59). However, in so far as Regulation No 432/2012 constitutes a measure of general application, the reasoning and conclusions in that judgment are not relevant to the present case.

Primex Produkte Import-Export and Others

Commission

Primex Produkte Import-Export and Others

Commission

| 181 | In any event, even supposing that the approach adopted in that judgment of the Court relied on by the applicants may be transposed to the present case, it must be considered that, as acknowledged by the applicants in their application, the adoption of Regulation No 432/2012 was preceded by a public consultation stage, during which the interested parties, including the applicants, were given the opportunity to submit comments. The procedure followed by the Commission must, therefore, be regarded as being consistent with the findings of the Court in the judgment in Primex Produkte Import-Export and Others v Commission, paragraph 176 above (EU:T:1998:223). Moreover, as pointed out by the Parliament, in the context of the adoption procedure of the regulation, provided for in Article 25 of Regulation No 1924/2006, food business operators had the opportunity to express their views in the context of the regular contact which the Commission, Parliament, Council and the Member States maintained with interested parties. |
| --- | --- |

181

In any event, even supposing that the approach adopted in that judgment of the Court relied on by the applicants may be transposed to the present case, it must be considered that, as acknowledged by the applicants in their application, the adoption of Regulation No 432/2012 was preceded by a public consultation stage, during which the interested parties, including the applicants, were given the opportunity to submit comments. The procedure followed by the Commission must, therefore, be regarded as being consistent with the findings of the Court in the judgment in Primex Produkte Import-Export and Others v Commission, paragraph 176 above (EU:T:1998:223). Moreover, as pointed out by the Parliament, in the context of the adoption procedure of the regulation, provided for in Article 25 of Regulation No 1924/2006, food business operators had the opportunity to express their views in the context of the regular contact which the Commission, Parliament, Council and the Member States maintained with interested parties.

Primex Produkte Import-Export and Others

Commission

| 182 | The result is that the applicants cannot usefully submit that Regulation No 1924/2006, in particular Article 13(3) thereof, infringes the right to good administration and, in particular, the right to be heard. |
| --- | --- |

182

The result is that the applicants cannot usefully submit that Regulation No 1924/2006, in particular Article 13(3) thereof, infringes the right to good administration and, in particular, the right to be heard.

| 183 | In the light of all of the foregoing, the first plea in support of the application seeking a declaration that Regulation No 1924/2006 is inapplicable must be rejected. |
| --- | --- |

183

In the light of all of the foregoing, the first plea in support of the application seeking a declaration that Regulation No 1924/2006 is inapplicable must be rejected.

The second plea in support of the application for a declaration that Regulation No 1924/2006 is inapplicable, alleging an infringement of the principle of legal certainty

The second plea in support of the application for a declaration that Regulation No 1924/2006 is inapplicable, alleging an infringement of the principle of legal certainty

| 184 | The second plea of the applicants in support of the application for a declaration that Regulation No 1924/2006 is inapplicable comprises two complaints. |
| --- | --- |

184

The second plea of the applicants in support of the application for a declaration that Regulation No 1924/2006 is inapplicable comprises two complaints.

| 185 | By their first complaint the applicants submit that Regulation No 1924/2006 infringes the principle of legal certainty in so far as Article 28 of the regulation does not lay down reasonable transitional periods within which to comply with provisions of the regulation. In essence, they criticise the obligation, after the entry into force of Regulation No 432/2012, to remove from the supply chain foods which had lawfully been placed onto the market prior to 2012. |
| --- | --- |

185

By their first complaint the applicants submit that Regulation No 1924/2006 infringes the principle of legal certainty in so far as Article 28 of the regulation does not lay down reasonable transitional periods within which to comply with provisions of the regulation. In essence, they criticise the obligation, after the entry into force of Regulation No 432/2012, to remove from the supply chain foods which had lawfully been placed onto the market prior to 2012.

| 186 | By their second complaint the applicants submit that the scope of the review required so as to authorise health claims under Article 13(3) of Regulation No 1924/2006 was not clearly defined. |
| --- | --- |

186

By their second complaint the applicants submit that the scope of the review required so as to authorise health claims under Article 13(3) of Regulation No 1924/2006 was not clearly defined.

| 187 | The Commission, supported by the Council, the BEUC, the Parliament and the French Republic, contests those two complaints. |
| --- | --- |

187

The Commission, supported by the Council, the BEUC, the Parliament and the French Republic, contests those two complaints.

| 188 | It should be pointed out, at the outset, that, in accordance with the case-law cited in paragraph 86 above, the principle of legal certainty requires that legal rules be clear and precise, and that their consequences be foreseeable. |
| --- | --- |

188

It should be pointed out, at the outset, that, in accordance with the case-law cited in paragraph 86 above, the principle of legal certainty requires that legal rules be clear and precise, and that their consequences be foreseeable.

| 189 | As regards, in the first place, the complaint by which it is alleged that the transitional period provided for in Regulation No 1924/2006 was unreasonably short, particularly in order to comply with the requirements of Regulation No 432/2012, the Court finds that, although the applicants accuse the Council and the Parliament of having laid down very short transitional adaptation periods, they merely advance vague assertions in that regard and do not state at any point in their written pleadings that those transitional periods led to uncertainty on their part as a result of a possible lack of clarity. |
| --- | --- |

189

As regards, in the first place, the complaint by which it is alleged that the transitional period provided for in Regulation No 1924/2006 was unreasonably short, particularly in order to comply with the requirements of Regulation No 432/2012, the Court finds that, although the applicants accuse the Council and the Parliament of having laid down very short transitional adaptation periods, they merely advance vague assertions in that regard and do not state at any point in their written pleadings that those transitional periods led to uncertainty on their part as a result of a possible lack of clarity.

| 190 | In any event, in so far as concerns the argument that food supplements or health foods, which can be preserved for long periods of two to three years, should have benefited from a longer transitional period, the six months granted by Regulation No 432/2012 appear sufficient to adapt the labelling and advertising of those foods, and the applicants have not even stated, for example, what, in their view, the reasonable duration which the Commission should have provided for in the regulation ought to have been. In that regard, the Court points out that Regulation No 432/2012 did not aim to prohibit the marketing of the applicants’ goods as such, but merely to have the health claims which were not consistent with Regulation No 1924/2006 removed from their labelling. |
| --- | --- |

190

In any event, in so far as concerns the argument that food supplements or health foods, which can be preserved for long periods of two to three years, should have benefited from a longer transitional period, the six months granted by Regulation No 432/2012 appear sufficient to adapt the labelling and advertising of those foods, and the applicants have not even stated, for example, what, in their view, the reasonable duration which the Commission should have provided for in the regulation ought to have been. In that regard, the Court points out that Regulation No 432/2012 did not aim to prohibit the marketing of the applicants’ goods as such, but merely to have the health claims which were not consistent with Regulation No 1924/2006 removed from their labelling.

| 191 | The result is that Regulation No 1924/2006 does not infringe the principle of legal certainty in so far as concerns the transitional periods provided for in Article 28 thereof. |
| --- | --- |

191

The result is that Regulation No 1924/2006 does not infringe the principle of legal certainty in so far as concerns the transitional periods provided for in Article 28 thereof.

| 192 | The first complaint cannot therefore be upheld. |
| --- | --- |

192

The first complaint cannot therefore be upheld.

| 193 | As regards, in the second place, the complaint by which it is alleged that Regulation No 1924/2006 lacks clarity, the Court points out that the legal framework applicable to the health claims under that regulation was clear and that its consequences were foreseeable for food business operators and, consequently, that no infringement of the principle of legal certainty can be found within the meaning of the case-law. First, a reading of Article 10(1) of Regulation No 1924/2006 in conjunction with Article 13 thereof makes it clear that the health claims were prohibited unless, (i) they complied with the general and specific requirements laid down in the regulation and, (ii) they were authorised in accordance with the regulation. Second, Article 28(5) and (6) of Regulation No 1924/2006, which concerns transitional provisions, authorised the use of health claims until the adoption of the list of permitted health claims, as explained in paragraphs 80 to 83 above. |
| --- | --- |

193

As regards, in the second place, the complaint by which it is alleged that Regulation No 1924/2006 lacks clarity, the Court points out that the legal framework applicable to the health claims under that regulation was clear and that its consequences were foreseeable for food business operators and, consequently, that no infringement of the principle of legal certainty can be found within the meaning of the case-law. First, a reading of Article 10(1) of Regulation No 1924/2006 in conjunction with Article 13 thereof makes it clear that the health claims were prohibited unless, (i) they complied with the general and specific requirements laid down in the regulation and, (ii) they were authorised in accordance with the regulation. Second, Article 28(5) and (6) of Regulation No 1924/2006, which concerns transitional provisions, authorised the use of health claims until the adoption of the list of permitted health claims, as explained in paragraphs 80 to 83 above.

| 194 | The applicants further submit that the EFSA consultation procedure was not set out in detail in Regulation No 1924/2006 and that, in particular, the scientific criteria which that authority was to apply in its evaluations of health claims was not specified in the regulation. |
| --- | --- |

194

The applicants further submit that the EFSA consultation procedure was not set out in detail in Regulation No 1924/2006 and that, in particular, the scientific criteria which that authority was to apply in its evaluations of health claims was not specified in the regulation.

| 195 | However, it must be found, in that regard, that in the light of the provisions of Regulation No 1924/2006 there was no doubt as to the scientific evaluation criteria to be applied under the regulation. First of all, as has been pointed out in paragraphs 135 and 138 above, Article 2(2)(5) of Regulation No 1924/2006 states that, to establish whether a health claim is justified, it is necessary to determine the existence of a cause and effect relationship between the food at issue and the specific functions referred to. Next, Article 5 of Regulation No 1924/2006 establishes as conditions for the authorisation of health claims that, (i) the substance for which the claim is made is contained in the final product in a quantity that will produce the beneficial effect claimed or is not present, and, (ii) that the quantity of the product that can reasonably be expected to be consumed provides a significant quantity of the substance to which the claim relates that will produce the effect claimed. Finally, pursuant to Article 6 of Regulation No 1924/2006, read in the light of recitals 17 and 23 in the preamble thereto, cited in paragraph 126 above, health claims had to be based on and substantiated by generally accepted scientific evidence. |
| --- | --- |

195

However, it must be found, in that regard, that in the light of the provisions of Regulation No 1924/2006 there was no doubt as to the scientific evaluation criteria to be applied under the regulation. First of all, as has been pointed out in paragraphs 135 and 138 above, Article 2(2)(5) of Regulation No 1924/2006 states that, to establish whether a health claim is justified, it is necessary to determine the existence of a cause and effect relationship between the food at issue and the specific functions referred to. Next, Article 5 of Regulation No 1924/2006 establishes as conditions for the authorisation of health claims that, (i) the substance for which the claim is made is contained in the final product in a quantity that will produce the beneficial effect claimed or is not present, and, (ii) that the quantity of the product that can reasonably be expected to be consumed provides a significant quantity of the substance to which the claim relates that will produce the effect claimed. Finally, pursuant to Article 6 of Regulation No 1924/2006, read in the light of recitals 17 and 23 in the preamble thereto, cited in paragraph 126 above, health claims had to be based on and substantiated by generally accepted scientific evidence.

| 196 | It follows that the applicants’ argument relating to the lack of a more detailed provision in relation to the application by the EFSA of the criteria set out in Article 13(1) of Regulation No 1924/2006, when it is consulted in the context of the procedure provided for in Article 13(3) of that regulation, must be rejected. |
| --- | --- |

196

It follows that the applicants’ argument relating to the lack of a more detailed provision in relation to the application by the EFSA of the criteria set out in Article 13(1) of Regulation No 1924/2006, when it is consulted in the context of the procedure provided for in Article 13(3) of that regulation, must be rejected.

| 197 | The applicants’ second complaint cannot therefore be upheld. |
| --- | --- |

197

The applicants’ second complaint cannot therefore be upheld.

| 198 | In the light of the foregoing, the second plea raised in support of the application for a declaration that Regulation No 1924/2006 is inapplicable must be rejected, as must, consequently, that application in its entirety. |
| --- | --- |

198

In the light of the foregoing, the second plea raised in support of the application for a declaration that Regulation No 1924/2006 is inapplicable must be rejected, as must, consequently, that application in its entirety.

2. The application for annulment of the list of claims on hold

The application for annulment of the list of claims on hold

| 199 | The Commission, supported, inter alia, by the French Republic and the BEUC, submits that the application for annulment of the list of health claims on hold is inadmissible. In its view, an action cannot be brought under Article 263 TFEU against that list, since it is merely an interim measure which does not have any regulatory or decisional content and which is therefore not capable of altering the legal situation of the applicants. Moreover, the Commission asserts that it is not possible to identify from the application the complaints raised by the applicants in support of the substance of their application. |
| --- | --- |

199

The Commission, supported, inter alia, by the French Republic and the BEUC, submits that the application for annulment of the list of health claims on hold is inadmissible. In its view, an action cannot be brought under Article 263 TFEU against that list, since it is merely an interim measure which does not have any regulatory or decisional content and which is therefore not capable of altering the legal situation of the applicants. Moreover, the Commission asserts that it is not possible to identify from the application the complaints raised by the applicants in support of the substance of their application.

| 200 | The applicants contest the plea of inadmissibility raised by the Commission. They consider, in essence, that the list of claims on hold constitutes a challengeable act given that, among other legal effects, it makes the list of claims on hold subject to the transitional provisions laid down in Article 28 of Regulation No 1924/2006. As to the substance, the applicants claim that the list of claims on hold is unlawful and should be annulled ‘as the creation of such a list lacks legal basis and infringes the principles of legal certainty, good administration and non-discrimination’ and ‘[f]or the same grounds as identified in section V of [the] application’. |
| --- | --- |

200

The applicants contest the plea of inadmissibility raised by the Commission. They consider, in essence, that the list of claims on hold constitutes a challengeable act given that, among other legal effects, it makes the list of claims on hold subject to the transitional provisions laid down in Article 28 of Regulation No 1924/2006. As to the substance, the applicants claim that the list of claims on hold is unlawful and should be annulled ‘as the creation of such a list lacks legal basis and infringes the principles of legal certainty, good administration and non-discrimination’ and ‘[f]or the same grounds as identified in section V of [the] application’.

| 201 | According to settled case-law, any measure 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 is an act or a decision which may be the subject of an action under Article 263 TFEU for a declaration that it is void (judgments of 11 November 1981 in IBM v Commission, 60/81, ECR, EU:C:1981:264, paragraph 9; of 31 March 1998 in France and Others v Commission, C‐68/94 and C‐30/95, ECR, EU:C:1998:148, paragraph 62; and of 4 March 1999 in Assicurazioni Generali and Unicredito v Commission, T‐87/96, ECR, EU:T:1999:37, paragraph 37). 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). |
| --- | --- |

201

According to settled case-law, any measure 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 is an act or a decision which may be the subject of an action under Article 263 TFEU for a declaration that it is void (judgments of 11 November 1981 in IBM v Commission, 60/81, ECR, EU:C:1981:264, paragraph 9; of 31 March 1998 in France and Others v Commission, C‐68/94 and C‐30/95, ECR, EU:C:1998:148, paragraph 62; and of 4 March 1999 in Assicurazioni Generali and Unicredito v Commission, T‐87/96, ECR, EU:T:1999:37, paragraph 37). 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

| 202 | Moreover, according to equally settled case-law, in the case of acts or decisions adopted by a procedure involving several stages, in principle an act is 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). |
| --- | --- |

202

Moreover, according to equally settled case-law, in the case of acts or decisions adopted by a procedure involving several stages, in principle an act is 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

| 203 | In the present case, it must be considered that the list of claims on hold does not constitute a challengeable act. The adoption of a list the sole purpose of which is to compile a register of the health claims which are still being evaluated and in respect of which the Commission has not made a final decision constitutes merely an interim measure the purpose of which is to determine which health claims are, and which are not, to be included on the list of permitted claims. It is that latter list which constitutes the final decision. |
| --- | --- |

203

In the present case, it must be considered that the list of claims on hold does not constitute a challengeable act. The adoption of a list the sole purpose of which is to compile a register of the health claims which are still being evaluated and in respect of which the Commission has not made a final decision constitutes merely an interim measure the purpose of which is to determine which health claims are, and which are not, to be included on the list of permitted claims. It is that latter list which constitutes the final decision.

| 204 | Moreover, although, as the applicants submit, the Commission has stated that the claims on hold remained subject to the transitional provisions laid down in Article 28(5) and (6) of Regulation No 1924/2006, that indication lacks any element of decision and merely points out the consequences resulting from the regulation itself for the claims which are still being evaluated. |
| --- | --- |

204

Moreover, although, as the applicants submit, the Commission has stated that the claims on hold remained subject to the transitional provisions laid down in Article 28(5) and (6) of Regulation No 1924/2006, that indication lacks any element of decision and merely points out the consequences resulting from the regulation itself for the claims which are still being evaluated.

| 205 | It follows that the application for annulment of the list of claims on hold must be rejected as inadmissible. |
| --- | --- |

205

It follows that the application for annulment of the list of claims on hold must be rejected as inadmissible.

| 206 | For the sake of completeness, even supposing that the list of claims on hold may be regarded as a challengeable act, in the way put forward by the applicants, suffice it to note that, according to settled case-law, a claim for annulment is not admissible unless the applicant has an interest in seeing the contested act annulled. An applicant’s interest in bringing proceedings presupposes that the annulment of the contested act is capable alone of having legal consequences, that the action is therefore appropriate, by its result, to obtain a benefit for the party which brought it and that that party can show an actual and current interest in the annulment of that act (see judgment of 19 June 2009 in Socratec v Commission, T‐269/03, EU:T:2009:211, paragraph 36 and the case-law cited). |
| --- | --- |

206

For the sake of completeness, even supposing that the list of claims on hold may be regarded as a challengeable act, in the way put forward by the applicants, suffice it to note that, according to settled case-law, a claim for annulment is not admissible unless the applicant has an interest in seeing the contested act annulled. An applicant’s interest in bringing proceedings presupposes that the annulment of the contested act is capable alone of having legal consequences, that the action is therefore appropriate, by its result, to obtain a benefit for the party which brought it and that that party can show an actual and current interest in the annulment of that act (see judgment of 19 June 2009 in Socratec v Commission, T‐269/03, EU:T:2009:211, paragraph 36 and the case-law cited).

Socratec

Commission

| 207 | According to settled case-law, it is the applicant that must prove that it has an interest in bringing proceedings. If the interest pleaded by an applicant concerns a future legal situation, it must demonstrate that the prejudice to that situation is already certain. Accordingly, an applicant cannot rely on future and uncertain situations to justify its interest in applying for annulment of the contested act (see judgment in Hagenmeyer and Hahn v Commission, paragraph 71 above, EU:T:2014:234, paragraph 39 and the case-law cited). |
| --- | --- |

207

According to settled case-law, it is the applicant that must prove that it has an interest in bringing proceedings. If the interest pleaded by an applicant concerns a future legal situation, it must demonstrate that the prejudice to that situation is already certain. Accordingly, an applicant cannot rely on future and uncertain situations to justify its interest in applying for annulment of the contested act (see judgment in Hagenmeyer and Hahn v Commission, paragraph 71 above, EU:T:2014:234, paragraph 39 and the case-law cited).

Hagenmeyer and Hahn

Commission

| 208 | In the present case, the Court observes that, as indicated in recitals 10 and 11 in the preamble to Regulation No 432/2012, the claims which have been placed on hold continue to benefit from the legal rules which were applicable to them prior to the adoption of Regulation No 432/2012. Consequently, the undertakings concerned by those claims may continue to use them for the marketing of their foods in accordance with Article 28(5) and (6) of Regulation No 1924/2006. Accordingly, no benefit can be derived from the annulment of the list of health claims on hold. Moreover, when questioned in that regard by the Court at the hearing, the applicants failed to substantiate such a benefit. |
| --- | --- |

208

In the present case, the Court observes that, as indicated in recitals 10 and 11 in the preamble to Regulation No 432/2012, the claims which have been placed on hold continue to benefit from the legal rules which were applicable to them prior to the adoption of Regulation No 432/2012. Consequently, the undertakings concerned by those claims may continue to use them for the marketing of their foods in accordance with Article 28(5) and (6) of Regulation No 1924/2006. Accordingly, no benefit can be derived from the annulment of the list of health claims on hold. Moreover, when questioned in that regard by the Court at the hearing, the applicants failed to substantiate such a benefit.

| 209 | In any event, it should also be pointed out that, according to settled case-law, under Article 44(1)(c) of the Rules of Procedure, for an application for annulment to be admissible the application initiating proceedings must contain a summary of the pleas in law on which it is based. That summary must be sufficiently clear and precise to enable the defendant to prepare its defence and the Court to rule on the action, if necessary without any other supporting information. The application must accordingly specify the nature of the grounds on which the action is based, so that a mere abstract statement of the grounds does not satisfy the requirements of the Rules of Procedure (see, to that effect, judgment of 27 September 2012 in Nynäs Petroleum and Nynas Belgium v Commission, T‐347/06, ECR, EU:T:2012:480, paragraph 107). |
| --- | --- |

209

In any event, it should also be pointed out that, according to settled case-law, under Article 44(1)(c) of the Rules of Procedure, for an application for annulment to be admissible the application initiating proceedings must contain a summary of the pleas in law on which it is based. That summary must be sufficiently clear and precise to enable the defendant to prepare its defence and the Court to rule on the action, if necessary without any other supporting information. The application must accordingly specify the nature of the grounds on which the action is based, so that a mere abstract statement of the grounds does not satisfy the requirements of the Rules of Procedure (see, to that effect, judgment of 27 September 2012 in Nynäs Petroleum and Nynas Belgium v Commission, T‐347/06, ECR, EU:T:2012:480, paragraph 107).

Nynäs Petroleum and Nynas Belgium

Commission

| 210 | In the present case, the Court considers that the line of argument relied on by the applicants in support of their application for annulment, by which they merely, (i) assert that the list of claims on hold is unlawful and should be annulled since its establishment lacks legal basis and infringes the principles of legal certainty, good administration and non-discrimination and, (ii) make reference to the pleas set out in section V of the application, is manifestly insufficient to enable the complaints made by the applicants against the Commission as the author of that list to be identified in a precise manner. |
| --- | --- |

210

In the present case, the Court considers that the line of argument relied on by the applicants in support of their application for annulment, by which they merely, (i) assert that the list of claims on hold is unlawful and should be annulled since its establishment lacks legal basis and infringes the principles of legal certainty, good administration and non-discrimination and, (ii) make reference to the pleas set out in section V of the application, is manifestly insufficient to enable the complaints made by the applicants against the Commission as the author of that list to be identified in a precise manner.

| 211 | Consequently, the form of order sought by the applicants seeking the annulment of the list of claims on hold must be declared inadmissible. |
| --- | --- |

211

Consequently, the form of order sought by the applicants seeking the annulment of the list of claims on hold must be declared inadmissible.

| 212 | It follows from the foregoing considerations that the action must be dismissed in its entirety. |
| --- | --- |

212

It follows from the foregoing considerations that the action must be dismissed in its entirety.

Costs

Costs

| 213 | 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 have been unsuccessful, they must be ordered to bear their own costs and to pay those of the Commission. |
| --- | --- |

213

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 have been unsuccessful, they must be ordered to bear their own costs and to pay those of the Commission.

| 214 | Under Article 87(4) of the Rules of Procedure, Member States and institutions which intervene in proceedings are to bear their own costs, and the General Court may also order another intervener to bear its own costs. In the present case, the French Republic, the Council, the Parliament, the BEUC, FederSalus, Medestea biotech and Naturando are ordered to bear their own costs. |
| --- | --- |

214

Under Article 87(4) of the Rules of Procedure, Member States and institutions which intervene in proceedings are to bear their own costs, and the General Court may also order another intervener to bear its own costs. In the present case, the French Republic, the Council, the Parliament, the BEUC, FederSalus, Medestea biotech and Naturando are ordered to 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 The Health Food Manufacturers’ Association, Quest Vitamins Ltd, Natures Aid Ltd, Natuur-& gezondheidsProducten Nederland and New Care Supplements BV to bear their own costs and those incurred by the European Commission; |
| --- | --- | --- |

2.

2.

Orders The Health Food Manufacturers’ Association, Quest Vitamins Ltd, Natures Aid Ltd, Natuur-& gezondheidsProducten Nederland and New Care Supplements BV to bear their own costs and those incurred by the European Commission;

Orders The Health Food Manufacturers’ Association, Quest Vitamins Ltd, Natures Aid Ltd, Natuur-& gezondheidsProducten Nederland and New Care Supplements BV to bear their own costs and those incurred by the European Commission;

| | 3. | Orders the French Republic, the European Parliament, the Council of the European Union, the Bureau européen des unions de consommateurs (BEUC), FederSalus, Medestea biotech SpA and Naturando Srl to bear their own costs. |
| --- | --- | --- |

3.

3.

Orders the French Republic, the European Parliament, the Council of the European Union, the Bureau européen des unions de consommateurs (BEUC), FederSalus, Medestea biotech SpA and Naturando Srl to bear their own costs.

Orders the French Republic, the European Parliament, the Council of the European Union, the Bureau européen des unions de consommateurs (BEUC), FederSalus, Medestea biotech SpA and Naturando Srl 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: English

*1