Solgar Vitamin's France and Others v Ministre de l'Économie, des Finances et de l'Emploi and Others.
Date: 2010-04-29
22. In that connection, the Court has already held that, according to Article 11(2) of Directive 2002/46, in the absence of specific European Union rules laid down in that directive, national rules may be applied without prejudice to the provisions of the Treaty (see Case C-319/05 Commission  v Germany  [2007] ECR I-9811, paragraph 84).
24. In those circumstances, the answer to the first question is that Directive 2002/46 must be interpreted as meaning that, without prejudice to the Treaty, the Member States remain competent to adopt legislation on the maximum and minimum amounts of vitamins and minerals which may be used in the manufacture of food supplements so long as the Commission has not laid down those amounts in accordance with Article 5(4) of that directive.
Question 2(a)
27. In that connection, it must be recalled that the obligation of a Member State to take all the measures necessary to achieve the result prescribed by a directive is a binding obligation imposed by the third paragraph of Article 249 EC and by the directive itself (Case C-129/96 Inter-Environnement Wallonie  [1997] ECR I-7411, paragraph 40).
32. In those circumstances, the answer to Question 2(a) is that, in addition to the obligation to comply with Articles 28 EC and 30 EC, the Member States must also be guided by the criteria laid down in Article 5(1) and (2) of Directive 2002/46, including the requirement for a risk assessment based on generally accepted scientific data, in setting the maximum amounts of vitamins and minerals which may be used in the manufacture of food supplements, while waiting for the Commission to lay down those amounts pursuant to Article 5(4).
Question 2(b)
35. According to settled case-law, it is for the Member States, in the absence of harmonisation and to the extent that uncertainties continue to exist in the current state of scientific research, to decide on their intended level of protection of human health and life and on whether to require prior authorisation for the marketing of foodstuffs, always taking into account the requirements of the free movement of goods within the European Union (Case C-192/01 Commission  v Denmark  [2003] ECR I-9693, paragraph 42, and Case C-24/00 Commission v France  [2004] ECR I-1277, paragraph 49).
36. That discretion relating to the protection of public health is particularly wide where it is shown that there is still uncertainty in the current state of scientific research as to certain substances, such as vitamins, which are not as a general rule harmful in themselves but may have special harmful effects solely if taken to excess as part of the general diet, the composition of which cannot be foreseen or monitored ( Commission  v Denmark , paragraph 43, and Commission  v France , paragraph 50).
51. On the other hand, it must be recalled that appropriate labelling, informing consumers about the nature, the ingredients and the characteristics of fortified foodstuffs, can enable consumers who are at risk from excessive consumption of a nutrient added to those products to decide for themselves whether to use them ( Commission  v France , paragraph 75), and that that solution is consonant with the protection of public health without imposing serious restrictions on the free movement of goods (see Commission  v Germany , paragraph 95).
54. In exercising their discretion relating to the protection of public health, the Member States must comply with the principle of proportionality. The means which they choose must therefore be confined to what is actually necessary to ensure the safeguarding of public health or to satisfy overriding requirements regarding, for example, consumer protection. They must be proportional to the objective thus pursued, which could not have been attained by measures which are less restrictive of trade within the European Union (see Commission  v Denmark , paragraph 45, Commission  v France , paragraph 52, and Commission  v Germany , paragraph 87).
55. Furthermore, it is for the national authorities to show in each case, in the light of national nutritional habits and in the light of the results of international scientific research, that their rules are necessary to give effective protection to the interests referred to in Article 30 EC and, in particular, that the marketing of the products in question poses a real risk to public health (see, to that effect, Commission  v Denmark , paragraph 46, and Commission  v France , paragraph 53).
60. In that context, it must also be recalled that, although the criterion of the nutritional need of the population of a Member State can play a role in its detailed assessment of the risks which the addition of nutrients to foodstuffs may pose for public health, the absence of such a need cannot, by itself, justify a total prohibition, on the basis of Article 30 EC, of the marketing of foodstuffs lawfully manufactured and/or marketed in other Member States ( Commission  v Denmark , paragraph 54, Commission  v France , paragraphs 59 and 60, and Joined Cases C-211/03, C-299/03, C-316/03 and C-318/03 HLH Warenvertriebs and Orthica  [2005] ECR I-5141, paragraph 69).
63. It must be recalled, as held in paragraph 32 of this judgment, that setting the maximum amounts of vitamins and minerals which may be used in the manufacture of food supplements must be based on the criteria in Article 5(1) and (2) of Directive 2002/46.
64. In that connection, according to Article 5(1)(a) those amounts are set per daily portion of consumption as recommended by the manufacturer, taking into account the upper safe levels of vitamins and minerals established by scientific risk assessment based on generally accepted scientific data, taking into account, as appropriate, the varying degrees of sensitivity of different consumer groups.
65. It is clear that setting those amounts must in particular be based on consideration of the upper safe limits established, for the vitamins and minerals concerned, following a scientific assessment of the risks to human health based on the relevant scientific data and not on purely hypothetical considerations.
66. Setting maximum amounts for vitamins and minerals which may be used in the manufacture of food supplements where, in the absence of a proven risk to human health, upper safe limits have not been established for those nutrients after such a scientific assessment, does not satisfy that requirement.
67. That being the case, although, in the absence of such a risk, such limits have not been established, a scientific risk assessment could reveal that scientific uncertainty persists as regards the existence or extent of real risks to human health. In such circumstances, it must be accepted that a Member State may, in accordance with the precautionary principle, take protective measures without having to wait until the reality and seriousness of those risks are fully demonstrated. However, the risk assessment cannot be based on purely hypothetical considerations (see, Commission  v Denmark , paragraph 49, and Commission v France , paragraph 56).
68. In assessing the risk in question, it is not only the particular effects of the marketing of an individual product containing a definite quantity of nutrients which are relevant. It could be appropriate to take into consideration the cumulative effect of the presence on the market of several sources, natural or artificial, of a particular nutrient and of the possible existence in the future of additional sources which can reasonably be foreseen (see Commission  v Denmark , paragraph 50).
69. In many cases, the assessment of those factors will demonstrate that there is a high degree of scientific and practical uncertainty in that regard. A proper application of the precautionary principle requires, in the first place, the identification of the potentially negative consequences for health of the proposed addition of nutrients, and, secondly, a comprehensive assessment of the risk for health based on the most reliable scientific data available and the most recent results of international research (see, Commission  v Denmark , paragraph 51).
70. 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 that they are non-discriminatory and objective (see, Commission  v Denmark , paragraphs 52 and 53).
71. However, after the upper safe limits have been established the possibility of setting maximum amounts of vitamins and minerals which may be used in the manufacture of food supplements at a level significantly lower than those limits cannot be excluded if the setting of those maximum amounts can be justified by taking into account the criteria in Article 5(1) and (2) of Directive 2002/46 and that it complies with the principle of proportionality.
72. That assessment is a matter for the national court and must be carried out on a case-by-case basis.