Joined Cases C‑596/15 P and C‑597/15 P

Bionorica SE
and
Diapharm GmbH & Co. KG

v

European Commission

(Appeal — Public health — Consumer protection — Regulation (EC) No 1924/2006 — Health claims on foods — Article 13(3) — List of permitted health claims on foods — Botanical substances — Claims on hold — Action for failure to act — Article 265 TFEU — Defined position of the European Commission — Interest in bringing proceedings — Locus standi)

Summary — Judgment of the Court (Third Chamber), 23 November 2017

1.        Actions for failure to act — Failure to act — Definition — Failure to adopt a preparatory act — Included — Condition

(Art. 265 TFEU)

2.        Actions for failure to act — Institution called upon to act — Conditions — Clear and express request

(Art. 265 TFEU)

3.        Appeal — Grounds of appeal — Ground regarding the classification of a letter sent by an institution in response to a request to act — Question of law

(Art. 265 TFEU)

4.        Actions for failure to act — Natural or legal persons — Interest in bringing proceedings — Need for an actual and current interest — Assessment at the time when the action was lodged — Action incapable of securing a benefit for the applicant — Inadmissibility

(Art. 265 TFEU)

5.        Approximation of laws — Nutritional and health claims concerning foodstuffs — Regulation No 1924/2006 — Health claims — Distinction between permitted health claims and health claims on hold

(European Parliament and Council Regulation No 1924/2006, Arts 3, second para., (a), 6(1), 17(5) and 28(5) and (6))

6.        Actions for failure to act — Natural or legal persons — Interest in bringing proceedings — Action challenging the failure of the Commission to request the evaluation of certain health claims on hold and subject to the transitional regime — Continued application of transitory regime more advantageous than a rejection of the health claim after evaluation — Irrelevant — Interest in bringing proceedings retained

(Art. 265 TFEU; European Parliament and Council Regulation No 1924/2006, Art. 28(5) and (6))

7.        Actions for failure to act — Natural or legal persons — Admissibility criteria — Interest in bringing proceedings — Locus standi — Conditions cumulative in nature — Inadmissibility of the action where just one of those conditions not met

(Art. 265, third para., TFEU)

8.        Actions for failure to act — Natural or legal persons — Interest in bringing proceedings — Application regarding the failure of the Commission to request the evaluation of certain health claims subject to the transitional regime applicable to claims not yet evaluated — Application brought by a company not active on the market covered by the claims at issue — Inadmissibility — Intention of the company to enter the market if the claims are authorised — Irrelevant

(Art. 265 TFEU; European Parliament and Council Regulation No 1924/2006, Art. 28(5) and (6))

1.      Article 265 TFEU covers a failure to take a decision or to define a position. In that regard, an action for failure to act may be brought not only against a failure to adopt a measure that is legally binding on, and capable of affecting the interests of the applicant by bringing about a distinct change in its legal position, but also against the failure to adopt a preparatory act, if it is a necessary preliminary act in a procedure leading to an act that has binding legal effects.

(see paras 52, 53)

2.      See the text of the decision.

(see para. 54)

3.      The classification for legal purposes of an act or a measure, such as a letter, by the General Court is a question of law which may be raised in an appeal. Hence, the question of whether a letter sent by an institution in response to a request to act brings an end, or not, to the failure to act alleged against that institution is a question of law which is capable of being examined on appeal.

(see para. 55)

4.      See the text of the decision.

(see paras 83-85)

5.      While the permitted health claims and the health claims on hold could, in principle, be used in the marketing of food, it remains the case that the two categories of claims are subject to different requirements and do not benefit from the same conditions.

Whereas Article 17(5) of Regulation No 1924/2006 on nutrition and health claims made on foods authorises, in principle, any food business operator to use the permitted health claims, included in the single definitive list for the European Union, the health claims on hold which are subject to the transitional regime must, inter alia, pursuant to Article 28(5) and (6) of that regulation, comply with that regulation and also the applicable national provisions.

That means, in particular, first, that in accordance with the second paragraph of Article 3, point (a), and Article 6(1) of Regulation No 1924/2006, all health claims must not be false, ambiguous or misleading and must be based on generally accepted scientific evidence. Second, the health claims on hold must also meet, in each Member State, the requirements of its own national regime. Consequently, their examination on a case by case basis entails a risk of giving rise to diverging outcomes at the end of national administrative and judicial proceedings for the authorisation of such claims, not only as between one Member State and another, but also within the same Member State.

(see paras 87-89)

6.      An interest in bringing proceedings is only lacking where the favourable outcome of an action could not, in any event, give the applicant satisfaction.

As regards an action seeking a finding that the Commission failed to ask the European Food Safety Authority to evaluate certain health claims subject to the transitional regime laid down in Article 28(5) and (6) of Regulation No 1924/2006 on nutrition and health claims made on foods, it cannot successfully be argued that the fact that the transitional regime could be more advantageous than the definitive rejection of a health claim weighs against recognising an interest in bringing proceedings. In that regard, even the rejection of a health claim could procure a benefit, in terms of legal certainty, for an economic operator that is planning its entry into the market for food or food supplements. An unequivocal determination of the legal status of health claims on hold until now would thus allow such an operator to adapt its commercial strategy.

(see paras 93, 95, 96)

7.      See the text of the decision.

(see para. 106)

8.      See the text of the decision.

(see para. 115)