Gowan Comércio Internacional e Serviços Lda v Ministero della Salute.
Date: 2010-12-22
24. When a question on the validity of a measure adopted by the Community institutions is raised before a national court, it is for that court to decide whether a decision on the matter is necessary to enable it to give judgment and consequently whether it should request the Court to rule on that question. Accordingly, where the national court’s questions relate to the validity of a provision of Community law, the Court is obliged in principle to give a ruling (Case C‑491/01 British American Tobacco (Investments) and Imperial Tobacco  [2002] ECR I‑11453, paragraph 34, and Case C‑308/06 Intertanko and Others  [2008] ECR I‑4057, paragraph 31).
25. The Court is unable to rule on a question referred by a national court only where it is manifest that the interpretation or the assessment of the validity of Community law sought by that court bears no relation to the true nature of the main action or its purpose, or where the problem is hypothetical and the Court does not have before it the factual or legal material necessary to give a useful answer to the questions submitted to it (see, in particular, Case C-415/93 Bosman and Others  [1995] ECR I-4921, paragraph 61, and C‑45/09 Rosenbladt  [2010] ECR I-0000, paragraph 33).
27. In its order for reference, the national court explained that it had doubts regarding the validity of Directive 2006/134, essentially because of the inconsistency between the restrictions on the use of fenarimol laid down by that directive and the technical and scientific assessments of the substance which were, overall, positive. Although the order for reference does not contain an exhaustive account of the heads of claim in the main proceedings, it must be observed that that order and the written and oral observations have given the Court sufficient information to enable it to examine the validity of Directive 2006/134 in relation to the situation which is the subject of the main proceedings (see, inter alia, to that effect, Joined Cases C‑295/04 to C‑298/04 Manfredi and Others  [2006] ECR I‑6619, paragraph 29, and the case-law cited).
47. According to settled case-law, the general principle of legal certainty, which is a fundamental principle of Community law, requires, in particular, that rules should be clear and precise, so that individuals may be able to ascertain unequivocally what their rights and obligations are and may take steps accordingly (see Case 169/80 Gondrand and Garancini  [1981] ECR 1931, paragraph 17; Case C‑110/03 Belgium  v Commission  [2005] ECR I‑2801, paragraph 30; Case C‑344/04 IATA and ELFAA  [2006] ECR I‑403, paragraph 68; and Intertanko and Others , paragraph 69).
54. In that regard, it should be noted that, as is clear from recitals 5, 6 and 9 in the preamble thereto, Directive 91/414 aims to remove barriers to intra-Community trade in plant protection products, while maintaining a high level of protection of the environment and of human and animal health (Case C-326/05 P Industrias Químicas del Vallés  v Commission  [2007] ECR I-6557, paragraph 74).
56. The exercise of that discretion is not, however, excluded from review by the Court. The Court has consistently held that in the context of such a review the courts of the European Union must verify whether the relevant procedural rules have been complied with, whether the facts admitted by the Commission have been accurately stated and whether there has been a manifest error of appraisal or a misuse of powers (Case 98/78 Racke  [1979] ECR 69, paragraph 5, and Case C 16/90 Nölle  [1991] ECR 1-5163, paragraph 12).
57. In particular, where a party claims that the institution competent in the matter has committed a manifest error of appraisal, the the courts of the European Union must verify whether that institution has examined, carefully and impartially, all the relevant facts of the individual case, facts which support the conclusions reached (see, inter alia, Case C-269/90 Technische Universität München  [1991] ECR 1-5469, paragraph 14).
71. It should be borne in mind that, according to Article 191(1) and (2) TFEU, Community policy on the environment is to pursue the objective inter alia of protecting human health. That policy, which seeks a high level of protection, is based, inter alia, on the precautionary principle. The requirements of that policy must be included in the definition and implementation of the other policies of the Union. Moreover, as provided in Article 168 TFEU, requirements relating to the protection of human health are a part of all the policies and actions of the Union and must therefore be taken into account in the implementation of the common agricultural policy by the institutions of the Union.
72. The precautionary principle applies where the institutions of the Union take measures to protect human health under the common agricultural policy (see, to that effect, Case C-157/96 National Farmers’ Union and Others  [1998] ECR I‑2211, paragraph 64, and Case C-180/96 United Kingdom  v Commission  [1998] ECR I-2265, paragraph 100).
73. It follows from the precautionary principle that, where there is uncertainty as to the existence or extent of risks to the health of consumers, the institutions may take protective measures without having to wait until the reality and the seriousness of those risks become fully apparent ( National Farmers’ Union and Others , paragraph 63, United Kingdom  v Commission , paragraph 99, and Case C‑236/01 Monsanto Agricoltura Italia and Others  [2003] ECR I‑8105, paragraph 111). .
75. A correct application of the precautionary principle presupposes, first, identification of the potentially negative consequences for health of the proposed use of the substance at issue, and, secondly, a comprehensive assessment of the risk to health based on the most reliable scientific data available and the most recent results of international research (see Case C‑333/08 Commission  v France  [2010] ECR I‑0000, paragraph 92, and the case-law cited therein).
76. 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, provided they are non-discriminatory and objective (see Commission  v France , paragraph 93 and the case-law cited therein).
81. It is settled case-law that the principle of proportionality, which is one of the general principles of European Union law, requires that measures implemented by acts of the European Union are appropriate for attaining the objective pursued and do not go beyond what is necessary to achieve it (Case C‑58/08 Vodafone and Others  [2010] ECR I‑0000, paragraph 51, and the case-law cited).
82. As regards the judicial review of the conditions mentioned in the preceding paragraph, it must be acknowledged that the Commission has a wide discretion when it adopts risk management measures under the procedure for the inclusion of a substance in Annex I to Directive 91/414. That procedure entails political choices on its part and complex assessments. The legality of a measure adopted in that area can be affected only if the measure is manifestly inappropriate (see by analogy, Joined Cases C-154/04 and C‑155/04 Alliance for Natural Health and Others  [2005] ECR I‑6451, paragraph 52, and Case C‑558/07 S.P.C.M. and Others  [2009] ECR I‑5783, paragraph 42 and the case-law cited ).