The Queen, on the application of Alliance for Natural Health and Nutri-Link Ltd v Secretary of State for Health (C-154/04) and The Queen, on the application of National Association of Health Stores and Health Food Manufacturers Ltd v Secretary of State for Health and National Assembly for Wales (C-155/04).
Date: 2005-07-12
28. By virtue of the Court’s case-law, while a mere finding of disparities between national rules is not sufficient to justify having recourse to Article 95 EC (see, to that effect, Case C‑376/98 Germany  v Parliament and Council  [2000] ECR  I‑8419, paragraph 84), it is, however, otherwise where there are differences between the laws, regulations or administrative provisions of the Member States which are such as to obstruct the fundamental freedoms and thus have a direct effect on the functioning of the internal market (Case C‑434/02 Arnold André  [2004] ECR I‑0000, paragraph 30, and Case C‑210/03 Swedish Match  [2004] ECR I‑0000, paragraph 29; see also, to that effect, Germany v Parliament and Council , paragraph 95, and Case C‑491/01 British American Tobacco (Investments) and Imperial Tobacco [2002] ECR I‑11453, paragraph 60).
29. It also follows from the Court’s case-law that, although recourse to Article 95 EC as a legal basis is possible if the aim is to prevent the emergence of future obstacles to trade resulting from multifarious development of national laws, the emergence of such obstacles must be likely and the measure in question must be designed to prevent them ( Arnold André , paragraph 31, and Swedish Match , paragraph 30; see also, to that effect, Case C‑350/92 Spain  v Council  [1995] ECR I‑1985, paragraph 35, Germany  v Parliament and Council , paragraph 86, Case C‑377/98 Netherlands v Parliament and Council [2001] ECR I‑7079, paragraph 15, and British American Tobacco (Investments) and Imperial Tobacco , paragraph 61).
30. The Court has also held that, provided that the conditions for recourse to Article 95 EC as a legal basis are fulfilled, the Community legislature cannot be prevented from relying on that legal basis on the ground that public health protection is a decisive factor in the choices to be made ( British American Tobacco (Investments) and Imperial Tobacco , paragraph 62, Arnold André , paragraph 32, and Swedish Match , paragraph 31).
31. It must be noted in that regard that the first subparagraph of Article 152(1) EC provides that a high level of human health protection is to be ensured in the definition and implementation of all Community policies and activities, and that Article 95(3) EC explicitly requires that, in achieving harmonisation, a high level of protection of human health should be guaranteed ( British American Tobacco (Investments) and Imperial Tobacco , paragraph 62, Arnold André , paragraph 33, and Swedish Match , paragraph 32).
32. It follows from the foregoing that when there are obstacles to trade, or it is likely that such obstacles will emerge in the future, because the Member States have taken, or are about to take, divergent measures with respect to a product or a class of products, which bring about different levels of protection and thereby prevent the product or products concerned from moving freely within the Community, Article 95 EC authorises the Community legislature to intervene by adopting appropriate measures, in compliance with Article 95(3) EC and with the legal principles mentioned in the Treaty or identified in the case-law, in particular the principle of proportionality ( Arnold André , paragraph 34, and Swedish Match , paragraph 33).
33. Depending on the circumstances, those appropriate measures may consist in requiring all the Member States to authorise the marketing of the product or products concerned, subjecting such an obligation of authorisation to certain conditions, or even provisionally or definitively prohibiting the marketing of a product or products ( Arnold André , paragraph 35, and Swedish Match , paragraph 34).
41. As regards the argument of the claimants in Case C‑155/04 that Articles 3, 4(1) and 15(b) of Directive 2002/46 should be based on Article 133 EC, it must be stated that the fact that those provisions may incidentally affect international trade in food supplements does not make it possible validly to challenge the fact that the primary objective of those provisions is to further the removal of differences between national rules which may affect the functioning of the internal market in that area (see, to that effect, British American Tobacco (Investments) and Imperial Tobacco , paragraph 96).
47. It must be observed that by virtue of settled case-law the prohibition of quantitative restrictions and of all measures having equivalent effect, laid down in Article 28 EC, applies not only to national measures but also to measures adopted by the Community institutions (see Case 15/83 Denkavit Nederland [1984] ECR 2171, paragraph 15, Meyhui, paragraph 11, Case C‑114/96 Kieffer and Thill  [1997] ECR I‑3629, paragraph 27, and Arnold André , paragraph 57).
48. Nevertheless, as Article 30 EC provides, Article 28 EC does not preclude prohibitions or restrictions justified, inter alia, on grounds of protection of the health and life of humans (see Arnold André , paragraph 58, and Swedish Match , paragraph 60).
51. It remains necessary to ascertain whether the measure is necessary and proportionate in relation to the objective of protecting human health.
52. With regard to judicial review of those conditions, the Community legislature must be allowed a broad discretion in an area such as that involved in the present case, which entails political, economic and social choices on its part, and in which it is called upon to undertake complex assessments. Consequently, the legality of a measure adopted in that area can be affected only if the measure is manifestly inappropriate having regard to the objective which the competent institution is seeking to pursue (see British American Tobacco (Investments) and Imperial Tobacco , paragraph 123).
68. In those circumstances and in view of the need for the Community legislature to take account of the precautionary principle when it adopts, in the context of the policy on the internal market, measures intended to protect human health (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, and Case C‑41/02 Commission v Netherlands [2004] ECR I‑0000, paragraph 45), the authors of Directive 2002/46 could reasonably take the view that an appropriate way of reconciling the objective of the internal market, on the one hand, with that relating to the protection of human health, on the other, was for entitlement to free movement to be reserved for food supplements containing substances about which, at the time when the directive was adopted, the competent European scientific authorities had available adequate and appropriate scientific data capable of providing them with the basis for a favourable opinion, whilst giving scope, in Article 4(5) of the directive, for obtaining a modification of the positive lists by reference to scientific and technological developments.
70. Contrary to the contention of the claimants in Case C‑154/04, a negative list system, which entails limiting the prohibition  to only the substances included on that list, might not suffice to achieve the objective of protecting human health. Reliance in this instance on such a system would mean that, as long as a substance is not included on the list, it can be freely used in the manufacture of food supplements, even though, by reason of its novelty for example, it has not been subject to any scientific assessment apt to guarantee that it entails no risk to human health.
73. Such a procedure must be accessible in the sense that it must be expressly mentioned in a measure of general application which is binding on the authorities concerned. It must be capable of being completed within a reasonable time. An application to have a substance included on a list of authorised substances may be refused by the competent authorities only on the basis of a full assessment of the risk posed to public health by the substance, established on the basis of the most reliable scientific data available and the most recent results of international research. If the procedure results in a refusal, the refusal must be open to challenge before the courts (see, by analogy, Case C‑24/00 Commission v France [2004] ECR I‑1277, paragraphs 26, 27 and 36, and Case C‑95/01 Greenham and Abel  [2004] ECR I‑1333, paragraphs 35, 36 and 50).
90. Finally, it should be noted that, when the Community legislature wishes to delegate its power to amend aspects of the legislative act at issue, it must ensure that that power is clearly defined and that the exercise of the power is subject to strict review in the light of objective criteria (see, to that effect, Case 9/56  Meroni v High Authority [1958] ECR 133, at p. 152) because otherwise it may confer on the delegate a discretion which, in the case of legislation concerning the functioning of the internal market in goods, would be capable of impeding, excessively and without transparency, the free movement of the goods in question.
92. Those statements, which are closely related to the concrete expression of those criteria through the positive lists in the body of Directive 2002/46 and which should ideally have been included in the actual provisions of the directive (see, to that effect the Inter-Institutional Agreement of the European Parliament, of the Council and of the Commission of 22 December 1998 on common guidelines for the quality of drafting of Community legislation (OJ 1999 C 73, p. 1)), limit the Commission’s power to modify the lists through their reference to objective criteria connected exclusively with public health. They show that in this instance the Community legislature laid down the essential criteria to be applied in the matter when the powers thus delegated are exercised (see, to that effect, Case 25/70 Köster [1970] ECR 1161, paragraph 6).
95. The objective of the regulation is to liberalise imports of products originating in non-member States. However, it does not aim to liberalise the placing on the market of those products, which takes place after import (see Case C‑296/00 Expo Casa Manta [2002] ECR I‑4657, paragraphs 30 and 31).
103. As the Court has already held, the principle of subsidiarity applies where the Community legislature makes use of Article 95 EC, inasmuch as that provision does not give it exclusive competence to regulate economic activity on the internal market, but only a certain competence for the purpose of improving the conditions for its establishment and functioning by eliminating barriers to the free movement of goods and the freedom to provide services or by removing distortions of competition ( British American Tobacco (Investments) and Imperial Tobacco , paragraph 179).
105. In that regard, it must be stated that the prohibition, under those provisions, on marketing food supplements which do not comply with Directive 2002/46, supplemented by the obligation of the Member States under Article 15(a) of the directive to permit trade in food supplements complying with the directive (see, by analogy, British American Tobacco (Investments) and Imperial Tobacco , paragraph 126), has the objective of removing barriers resulting from differences between the national rules on vitamins, minerals and vitamin or mineral substances authorised or prohibited in the manufacture of food supplements, whilst ensuring, in accordance with Article 95(3) EC, a high level of human-health protection.
115. In that regard, it is appropriate to bear in mind that, by virtue of settled case-law, the principle of equal treatment requires that comparable situations must not be treated differently and that different situations must not be treated in the same way unless such treatment is objectively justified (see Joined Cases C‑184/02 and C‑223/02 Spain and Finland v Parliament and Council [2004] ECR I‑7789, paragraph 64; Arnold André , paragraph 68, and Swedish Match , paragraph 70).
126. It is clear from settled case-law that the right to property, with which the provisions reproduced in the preceding paragraph are concerned, and likewise the freedom to pursue an economic activity, form part of the general principles of Community law. However, those principles are not absolute but must be viewed in relation to their social function. Consequently, the exercise of the right to property and the freedom to pursue an economic activity may be restricted, provided that any restrictions in fact correspond to objectives of general interest pursued by the Community and do not constitute in relation to the aim pursued a disproportionate and intolerable interference, impairing the very substance of the rights guaranteed (see, inter alia, Case 265/87 Schräder  [1989] ECR 2237, paragraph 15, and Case C‑200/96 Metronome Musik  [1998] ECR I‑1953, paragraph 21).
128. Nevertheless, their right to property is not called into question by the introduction of such a measure. No economic operator can claim a right to property in a market share, even if he held it at a time before the introduction of a measure affecting the market, since such a market share constitutes only a momentary economic position exposed to the risks of changing circumstances (Case C‑280/93 Germany  v Council [1994] ECR I‑4973, paragraph 79, and Swedish Match , paragraph 73). Nor can an economic operator claim an acquired right or even a legitimate expectation that an existing situation which is capable of being altered by measure taken by the Community institutions within the limits of their discretion will be maintained (Case 52/81 Faust v Commission [1982] ECR 3745, paragraph 27, and Swedish Match , paragraph 73).
133. In that regard, it should be observed that, although the reasoning required by Article 253 EC must show clearly and unequivocally the reasoning of the Community authority which adopted the contested measure so as to enable the persons concerned to ascertain the reasons for the measure and to enable the Court to exercise its power of review, it is not required to go into every relevant point of fact and law (Case C‑122/94 Commission v Council [1996] ECR I‑881, paragraph 29).
134. Furthermore, the question whether a statement of reasons satisfies the requirements must be assessed with reference not only to the wording of the measure but also to its context and to the whole body of legal rules governing the matter in question. If the contested measure clearly discloses the essential objective pursued by the institution, it would be excessive to require a specific statement of reasons for each of the technical choices made by the institution (see, inter alia, Case C‑100/99 Italy v Council and Commission [2001] ECR I-5217, paragraph 64).