Commission of the European Communities v Kingdom of Denmark.
Date: 2003-09-23
23. The Commission submits that the interpretation by the Danish authorities of the judgment in  Sandoz  is based on an erroneous  a contrario  deduction from paragraph 20 thereof.  It maintains that that paragraph establishes only that a prohibition on marketing of foodstuffs to which vitamins have been added is contrary to the principle of proportionality when the addition meets a nutritional need.  Conversely, that judgment cannot be validly relied upon to support the argument that, in all cases where there is no nutritional need in the relevant population, the addition of vitamins to foodstuffs poses a risk to public health.
38. The free movement of goods between Member States is a fundamental principle of the EC Treaty which finds its expression in the prohibition, set out in Article 28 EC, of quantitative restrictions on imports between Member States and all measures having equivalent effect.
39. The prohibition on measures having an effect equivalent to restrictions set out in Article 28 EC covers all commercial rules enacted by the Member States which are capable of hindering, directly or indirectly, actually or potentially, intra-Community trade (see, in particular, Case 8/74  Dassonville  [1974] ECR 837, paragraph 5; Case 178/84  Commission  v  Germany  [1987) ECR 1227 ( " Beer purity law " ), paragraph 27; and Case C-12/00  Commission  v  Spain  [2003] ECR I-459, paragraph 71).
41. Indeed, that practice, which requires that the marketing of foodstuffs enriched with vitamins and minerals coming from other Member States where they are lawfully manufactured or marketed be made subject to proof of a nutritional need in the Danish population, makes the marketing of such foodstuffs more difficult, if not impossible, and, consequently, hinders trade between the Member States.
42. As regards the question whether that administrative practice may none the less be justified on the basis of Article 30 EC, it is for the Member States, in default 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 Community (see  Sandoz , paragraph 16; Case C-42/90  Bellon  [1990] ECR I-4863, paragraph 11; and Case C-400/96  Harpegnies  [1998] ECR I-5121, paragraph 33).
43. That discretion relating to the protection of public health is particularly wide where it is shown that uncertainties continue to exist 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 nutrition, the composition of which cannot be foreseen or monitored (see  Sandoz , paragraph 17).
44. Community law does not therefore, in principle, preclude a Member State from prohibiting, save for prior authorisation, the marketing of foodstuffs incorporating nutrients, such as vitamins or minerals other than those whose use is lawful under Community legislation.
45. However, 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;  they must be proportional to the objective thus pursued, which could not have been attained by measures which are less restrictive of intra-Community trade (see  Sandoz , paragraph 18;  Bellon , paragraph 14; and  Harpegnies , paragraph 34).
46. Furthermore, since Article 30 EC provides for an exception, to be interpreted strictly, to the rule of free movement of goods within the Community, it is for the national authorities which invoke it 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 that provision and, in particular, that the marketing of the products in question poses a real risk to public health (see, to that effect,  Sand oz , paragraph 22; Case 227/82  Van Bennekom  [1983] ECR 3883, paragraph 40;  Beer purity law , cited above, paragraph 46; and Case C-228/91  Commission  v  Italy  [1993] ECR I-2701, paragraph 27).
47. A prohibition on the marketing of foodstuffs to which nutrients have been added must therefore be based on a detailed assessment of the risk alleged by the Member State invoking Article 30 EC (see, to that effect,  EFTA Surveillance Authority  v  Norway , cited above, paragraph 30).
48. A decision to prohibit marketing, which indeed constitutes the most restrictive obstacle to trade in products lawfully manufactured and marketed in other Member States, can only be adopted if the real risk alleged for public health appears sufficiently established on the basis of the latest scientific data available at the date of the adoption of such decision.  In such a context, the object of the risk assessment to be carried out by the Member State is to appraise the degree of probability of harmful effects on human health from the addition of certain nutrients to foodstuffs and the seriousness of those potential effects.
49. It is clear that such an assessment of the risk 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 (see, to that effect, Case C-157/96  National Farmers ' Union and Others  [1998] ECR I-2211, paragraph 63).  However, the risk assessment cannot be based on purely hypothetical considerations (see, to that effect,  EFTA Surveillance Authority  v  Norway , paragraph 29, and Case C-236/01  Monsanto Agricoltura Italia and Others  [2003] ECR I-8105, paragraph 106).
50. 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  EFTA Surveillance Authority  v  Norway , paragraph 29).
51. 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 presupposes, 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 to health based on the most reliable scientific data available and the most recent results of international research (see, to that effect,  EFTA Surveillance Authority  v  Norway , paragraph 30, and  Monsanto Agricoltura Italia and Others , paragraph 113).
52. 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 (see, to that effect,  EFTA Surveillance Authority  v  Norway , paragraph 31).
53. Such measures must not be allowed unless they are non-discriminatory and objective (see, to that effect,  EFTA Surveillance Authority  v  Norway , paragraph 32).
54. It must be added that, in such a context, the criterion of the nutritional need of the population of a Member State can play a role in its detailed assessment of the risk which the addition of nutrients to foodstuffs may pose for public health.  However, contrary to the interpretation of the  Sandoz  judgment suggested by the Danish Government, 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.
56. Indeed, the systematic prohibition under the Danish administrative practice on the marketing of enriched products which do not meet a nutritional need of the population does not enable Community law to be observed in regard to the identification and assessment of a real risk to public health, which requires a detailed assessment, case-by-case, of the effects which the addition of the minerals and vitamins in question could entail.