Acino AG v European Commission.
Date: 2014-04-10
33. It must be borne in mind that, under Article 256 TFEU and the first paragraph of Article 58 of the Statute of the Court of Justice of the European Union, an appeal is limited to points of law and may lie only on grounds of lack of competence of the General Court, a breach of procedure before it which adversely affects the interests of the appellant or infringement of EU law by the General Court (see, to that effect, Case C‑136/92 P Commission  v Brazzelli Lualdi and Others  [1994] ECR I‑1981, paragraph 47).
34. Therefore, the General Court has exclusive jurisdiction to establish the facts, except where the substantive accuracy of its findings is apparent from the documents submitted to it, and to assess the evidence relied on. The establishment of those facts and the assessment of that evidence do not therefore, save where they are distorted, constitute a point of law which is subject as such to review by the Court of Justice (see, to that effect, inter alia, Case C‑449/99 P EIB  v Hautem  [2001] ECR I‑6733, paragraph 44, and Case C‑105/04 P Nederlandse Federatieve Vereniging voor de Groothandel op Elektrotechnisch Gebied  v Commission  [2006] ECR I‑8725, paragraphs 69 and 70).
35. Furthermore, it follows from Article 256 TFEU and the first paragraph of Article 58 of the Statute of the Court of Justice and also from Articles 168(1)(d) and 169(2) of the Rules of Procedure of the Court of Justice that an appeal must indicate precisely the contested elements of the judgment which the appellant seeks to have set aside as well as the legal arguments specifically advanced in support of the appeal (see, inter alia, Case C‑352/98 P Bergaderm and Goupil  v Commission  [2000] ECR I‑5291, paragraph 34; Case C‑41/00 P Interporc  v Commission  [2003] ECR I‑2125, paragraph 15; and Case C‑131/03 P Reynolds Tobacco and Others v Commission  [2006] ECR I‑7795, paragraph 49).
36. Thus, where an appeal merely repeats or reproduces verbatim the pleas in law and arguments submitted to the General Court, including those based on facts expressly rejected by that Court, it fails to satisfy the requirement to state reasons under those provisions (see, inter alia, Interporc  v Commission , paragraph 16). Such an appeal amounts in reality to no more than a request for re-examination of the application submitted to the General Court, which the Court of Justice does not have jurisdiction to undertake (see, inter alia, Reynolds Tobacco and Others v Commission , paragraph 50).
37. However, provided that an appellant challenges the General Court’s interpretation or application of EU law, the points of law examined at first instance may be discussed again in the context of an appeal (Case C‑210/98 P Salzgitter  v Commission  [2000] ECR I‑5843, paragraph 43). Indeed, if an appellant could not thus base his appeal on pleas in law and arguments already relied on before the General Court, an appeal would be deprived of part of its purpose ( Interporc  v Commission , paragraph 17).
57. Next, as regards the complaint concerning the General Court’s alleged disregard for the precautionary principle, it should be noted that, in accordance with that principle, as interpreted by the Court’s case-law, where there is uncertainty as to the existence or extent of risks to human health, protective measures may be taken without having to wait until the reality and seriousness of those risks become fully apparent (see Case C‑236/01 Monsanto Agricoltura Italia and Others  [2003] ECR I‑8105, paragraph 111; to that effect, Case C‑132/03 Codacons and Federconsumatori [2005] ECR I‑4167, paragraph 61; and Case C‑504/04 Agrarproduktion Staebelow  [2006] ECR I‑679, paragraph 39).
58. Although the Court has admittedly already held, inter alia in Case C‑192/01 Commission  v Denmark  [2003] ECR I‑9693, paragraph 49, relied on by Acino, that the risk assessment cannot be based on purely hypothetical considerations, it has, however, also added that where it proves to be impossible to determine with certainty the existence or extent of the alleged risk because of the insufficiency, inconclusiveness or imprecision of the results of studies conducted, but the likelihood of real harm to public health persists should the risk materialise, the precautionary principle justifies the adoption of restrictive measures ( Commission  v Denmark , paragraph 52, and Case C‑333/08 Commission  v France  [2010] ECR I‑757, paragraph 93).
59. The General Court therefore correctly applied the precautionary principle, as interpreted by the Court of Justice, when it stated, in paragraph 63 of the judgment under appeal, that while it is true that all the grounds set out in the first paragraph of Article 116 of Directive 2001/83 aim to prevent certain risks to health, the fact remains that those risks need not be specific, but only potential.
60. The General Court was also correct to state, in paragraph 66 of that judgment, that, subject to compliance with the standard of proof and the limits on the Commission’s powers of discretion, which were examined in the context of other pleas in law raised by Acino, that institution was entitled to restrict itself to supplying solid and persuasive evidence which could give rise to reasonable doubt as to their qualitative and quantitative composition, as declared, of the medicinal products at issue.
120. With regard to the fifth and last ground of appeal, it should be noted that, in paragraph 124 of the judgment under appeal, the General Court referred to settled case-law in accordance with which the statement of reasons required by the second subparagraph of Article 296 TFEU must be appropriate to the measure at issue and must disclose in a clear and unequivocal fashion the reasoning followed by the institution which adopted the measure in such a way as to enable the persons concerned to ascertain the reasons for it and to enable the competent court to exercise its power of review. The requirements to be satisfied by the statement of reasons depend on the circumstances of each case, in particular, the content of the measure in question, the nature of the reasons given and the interest which the addressees of the measure, or other parties to whom it is of direct and individual concern, may have in obtaining explanations. 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 TFEU must be assessed with regard not only to its wording but also to its context and to all the legal rules governing the matter in question (Joined Cases C‑341/06 P and C‑342/06 P Chronopost and La Poste  v UFEX and Others  [2008] ECR I‑4777, paragraph 88 and the case-law cited).