Case T‑17/12

Moritz Hagenmeyer

and

Andreas Hahn

v

European Commission

(Consumer protection — Regulation (EC) No 1924/2006 — Food health claims — Refusal to authorise a reduction of disease risk claim — Designation of a risk factor — Lawfulness of the procedure for the authorisation of reduction of disease risk claims — Action for annulment — Interest in bringing proceedings — Direct and individual concern — Admissibility — Proportionality — Obligation to state reasons)

Summary — Judgment of the General Court (Fifth Chamber), 30 April 2014

1.      Actions for annulment — Interest in bringing proceedings — Need for an actual and current interest — Action for annulment of a decision rejecting an individual application for authorisation of a claim relating to reduction of a disease risk — Admissibility

(Art. 263 TFEU; European Parliament and Council Regulation No 1924/2006, Arts 14(1)(a), and 15; Commission Regulation No 1170/2011, annex)

2.      Actions for annulment — Natural or legal persons — Measures of direct and individual concern to them — Commission regulation rejecting an individual application for authorisation submitted in accordance with the procedure laid down for a reduction of disease risk claim — Action brought by the applicant for that authorisation — Admissibility

(Art. 263, fourth para., TFEU; European Parliament and Council Regulation No 1924/2006, Art. 15; Commission Regulation No 1170/2011, annex)

3.      Approximation of laws — Nutritional and health claims concerning foodstuffs — Regulation No 1924/2006 — Disease risk reduction claim — Application for authorisation of a claim — Obligation of the applicant to designate a risk factor in the development of a disease

(European Parliament and Council Directive No 1924/2006, Arts 2(2), point 6, and 14(1)(a), and (2))

4.      Procedure — Application initiating proceedings — Formal requirements — Brief summary of the pleas in law on which the application is based

(Statute of the Court of Justice, Arts 21, first para., and 53, first para.; Rules of Procedure of the General Court, Art. 44(1)(c))

5.      Approximation of laws — Nutritional and health claims concerning foodstuffs — Regulation No 1924/2006 — Disease risk reduction claim — Authorisation procedure — Breach of principle of proportionality — None

(European Parliament and Council Regulation No 1924/2006, Arts 10(1), 14(1)(a), and 17(1))

6.      Approximation of laws — Nutritional and health claims concerning foodstuffs — Regulation No 1924/2006 — Disease risk reduction claim — Application for authorisation of a claim — Individual nature and general nature — Legal form of the decision left to the discretion of the Commission

(European Parliament and Council Regulation No 1924/2006, Art. 17(1) to (4))

7.      Approximation of laws — Nutritional and health claims concerning foodstuffs — Regulation No 1924/2006 — Disease risk reduction claim — Authorisation procedure — Allocation of competences between the EU authorities and the competent national authority

(European Parliament and Council Regulation No 1924/2006, Art. 16(1), second sentence)

8.      Approximation of laws — Nutritional and health claims concerning foodstuffs — Regulation No 1924/2006 — Disease risk reduction claim — Authorisation procedure — Time limit exceeded — Bearing on the lawfulness of the decision — Conditions

(European Parliament and Council Regulation No 1924/2006, Arts 15(2)(a)(i), 16(1), and 17(1))

9.      Approximation of laws — Nutritional and health claims concerning foodstuffs — Regulation No 1924/2006 — Disease risk reduction claim — Authorisation procedure — Right of the applicant to submit observations to the institution responsible for issuing the authorisation — Scope

(European Parliament and Council Regulation No 1924/2006, Art. 16(6), second para.)

10.    Acts of the institutions — Statement of reasons — Obligation — Scope — Commission decision rejecting an application for authorisation concerning the use of a health claim

(Art. 296, second para., TFEU; Commission Regulation No 1170/2011)

1.      Inasmuch as a party bringing an annulment action must show an actual and current interest in the annulment of the measure in question and may not rely in that respect on future and uncertain situations, a person who, in compliance with the applicable rules and merely referring in general terms to applicants, has applied for authorisation of a reduction of disease risk claim clearly has an interest in seeking annulment of a decision refusing the corresponding authorisation.

(see paras 38, 39, 44, 45)

2.      In accordance with the fourth paragraph of Article 263 TFEU, a natural or legal person may institute proceedings against a decision addressed to another only if the decision is of direct and individual concern to that natural or legal person. In that regard, a Commission regulation published in the Official Journal of the European Union definitively rejecting an application for authorisation under the procedure for reduction of disease risk claims on the basis of Regulation No 1924/2006 on nutrition and health claims made on foods directly affects the applicant since it was the legislature’s intention that any natural or legal person should be able to submit an application for authorisation under Article 15 of Regulation No 1924/2006 and since the definitive decision rejecting the application for authorisation is set out in the contested regulation, which constitutes the final point in the authorisation procedure. The applicant is, moreover, individually affected by that regulation, since he submitted an individual application for authorisation.

(see paras 50, 51, 56, 61)

3.      The authorisation of a reduction of disease risk claim, within the meaning of Article 2(2)(6) of Regulation No 1924/2006 requires, in addition to the designation of a disease, the designation of a risk factor in the development of that disease which, in the applicant’s submission, is significantly reduced. The legislature recognised, in Article 14(2) of Regulation No 1924/2006, that a disease has multiple risk factors. According to that provision, the labelling or, if no such labelling exists, the presentation or advertising is also to bear a statement indicating that the disease to which the claim is referring has multiple risk factors and that altering one of these risk factors may or may not have a beneficial effect. Consequently, without a designation of a disease and a specific risk factor by the applicants, the Commission is not in a position to assess what risk factor in the development of what disease would be significantly reduced by the nutritional conduct forming the subject matter of the claim. It is sufficient for the designation of the risk factor to emerge, at least implicitly, from the proposed wording of the claim in question or from the documents accompanying the application for authorisation.

(see paras 73, 75)

4.      See the text of the decision.

(see paras 99, 122)

5.      Article 10(1), Article 14(1)(a) and Article 17(1) of Regulation No 1924/2006 are not manifestly inappropriate by reference to the objectives that the institutions intend to pursue and, consequently, are not unlawful on account of a breach of the principle of proportionality.

More particularly, it does not appear that measures adopted on the basis of the arrangements provided for in Directive 2000/13 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs which applied until the adoption of Regulation No 1924/2006 in the area of reduction of disease risk claims would, by comparison with the objectives pursued, particularly the protection of health, be just as appropriate as the provisions at issue of Regulation No 1924/2006.

(see paras 113, 121)

6.      It follows from the terms used in Article 17 of Regulation No 1924/2006 that that provision envisages the various stages of the procedure which the Commission must follow in order to deliver a final decision on an application pursuant to Article 14 of that regulation. On the other hand, the regulation is silent as to the legal form of that decision, that choice being left to the discretion of the Commission, which must rule positively or negatively on the application in question.

In that regard, the adoption of a regulation, which is general in scope, is not contrary to the structure of the procedure in question. Whilst it is true that the authorisation procedure in question has as its subject matter an individual application, the fact none the less remains that, in accordance with Article 17(5) of that regulation, the health claims authorised by the Commission may be used by any food business operator. Since that provision produces effects erga omnes, the authorisation procedure in question therefore has a dual nature, namely an individual nature and a general nature.

(see paras 127, 130, 131)

7.      The fact that the competent national authority has given its opinion, during the administrative procedure, on the requirements relating to the validity of the application for authorisation of the claim at issue does not constitute a procedural irregularity. It follows from the first sentence of Article 16(1) of Regulation No 1924/2006 that responsibility for the existence of a valid application, satisfying the formal and substantive requirements laid down by the regulation, and in particular the requirement that a risk factor be designated, is to be borne, at least equally, by the competent national authority.

(see paras 136, 138)

8.      See the text of the decision.

(see para. 160)

9.      See the text of the decision.

(see para. 165)

10.    See the text of the decision.

(see paras 173, 175, 177-179)