Case T‑334/12

Plantavis GmbH

and

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

v

European Commission

and

European Food Safety Authority (EFSA)

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

Summary — Judgment of the General Court (Eighth Chamber), 12 June 2015

Actions for annulment — Natural or legal persons — Measures of direct and individual concern to them — Whether directly concerned — Criteria — Commission regulation establishing a list of authorised health claims concerning foodstuffs — No precise indication by the applicant as to the claims capable of affecting its legal position — No direct concern — Inadmissibility

See the text of the decision. (see para. 20)

The meaning of ‘regulatory act’ for the purposes of the fourth paragraph of Article 263 TFEU must be understood as covering all acts of general application apart from legislative acts. The legal basis of Regulation No 432/2012 is Article 13(3) of Regulation No 1924/2006, which confers on the Commission a mandate to adopt, in accordance with the procedure referred to in Article 25(3) of that regulation, a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health. The said regulation was adopted by the Commission in the exercise of implementing powers in the context of the regulatory procedure with scrutiny and, consequently, does not constitute a legislative act. Moreover, Regulation No 432/2012 is of general application, in that it applies to objectively determined situations and produces legal effects with respect to categories of persons envisaged in general and in the abstract. (see paras 24-27)

The condition of direct concern within the meaning of the fourth paragraph of Article 263 TFEU requires, first, that the contested measure directly affect the legal situation of the applicant and, secondly, leave no discretion to its addressees entrusted with the task of implementing it, such implementation being purely automatic and resulting from the rules under challenge without the application of other intermediate rules. In the case of an action brought against Regulation 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, it is for the applicant to identify the claims concerned by that regulation that affect its legal situation in order to demonstrate that is directly concerned, within the meaning of the fourth paragraph of Article 263 TFEU. In particular, the applicant is required to demonstrate that it was using claims prohibited following the adoption of Regulation No 432/2012 in commercial communications relating to its products when the action was brought before the Court. It is not for the Court to seek and identify claims that might, as the case may be, constitute the basis for the admissibility of the applicant’s action, in particular where approximately 2000 health claims are concerned, 222 of which have been permitted and 1 719 of which have been prohibited. Even if the claims concerning the applicant form part of the list of claims on hold, in that they are still under evaluation and the Commission has not issued any definitive authorisation or prohibition in their regard, they are not capable of giving rise to an action for annulment. On-hold claims continue to be treated under the legal rules which applied to them prior to the adoption of Regulation No 432/2012. Consequently, undertakings concerned by those claims can continue to use them in their food business activities in accordance with Article 28(5) and (6) of Regulation No 1924/2006 on nutrition and health claims made on foods. (see paras 28, 30, 32, 36)

See the text of the decision. (see paras 50, 51)

Any measure the legal effects of which are binding on and capable of affecting the interests of applicants by bringing about a distinct change in their legal position is an act or a decision which may be the subject of an action for annulment under Article 263 TFEU. In order to determine whether an act or decision produces such effects, it is necessary to look to its substance. The register of permitted health claims established by the Commission in accordance with Article 20 of Regulation No 1924/2006 on nutrition and health claims made on foods does not, as such, constitute a legal act. As follows from recital 31 in the preamble to Regulation No 1924/2006, the register of permitted health claims is a means of communication for the purposes of transparency and information in order to avoid requests concerning claims that have already been evaluated. Although that register provides information on legal acts adopted in the field of nutritional and health claims, the fact remains that it is not intended to produce legal effects in respect of third parties. (see paras 56, 58, 59)