Commission of the European Communities v Kingdom of the Netherlands.
Date: 2004-12-02
29. Vitamins and minerals are not as a general rule harmful in themselves but may have special harmful effects if taken to excess as part of the general nutrition, the composition of which cannot be foreseen or monitored (see, with respect to vitamins, Case 174/82 Sandoz  [1983] ECR 2445, paragraph 17; Case C-192/01 Commission  v Denmark  [2003] ECR I‑9693, paragraph 43; and Case C‑24/00 Commission  v France  [2004] ECR II‑0000, paragraph 50).
38. The free movement of goods between Member States is a fundamental principle of the Treaty, expressed in the prohibition laid down in Article 30 of the Treaty on quantitative restrictions on imports between Member States and all measures having equivalent effect.
39. The prohibition on measures having equivalent effect to restrictions set out in Article 30 of the Treaty 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; Commission  v Denmark , paragraph 39; and Commission  v France , paragraph 22).
41. Indeed, that practice, which requires that the marketing of foodstuffs fortified with vitamins and minerals and coming from other Member States where they are lawfully manufactured or marketed be subject to proof of a nutritional need in the Netherlands population, makes the marketing of such foodstuffs more difficult, if not impossible, and consequently hinders trade between the Member States (see, to that effect, Commission  v Denmark , paragraph 41).
The justification based on the protection of public health
42. As regards the question whether the Netherlands administrative practice may be justified on the basis of Article 36 of the Treaty, 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 Community (see Sandoz , paragraph 16; Commission  v Denmark , paragraph 42; and Commission  v France , paragraph 49).
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, as observed in paragraph 29 of this judgment, are not as a general rule harmful in themselves but may have special harmful effects if taken to excess as part of the general nutrition, the composition of which cannot be foreseen or monitored (see Sandoz , paragraph 17; Commission  v Denmark , paragraph 43; and Commission  v France , paragraph 50).
44. Community law does not therefore preclude legislation of a Member State prohibiting in accordance with the precautionary principle, save for prior authorisation, the marketing of foodstuffs when nutrients other than those whose addition is lawful under that legislation have been added thereto (see, to that effect, Commission  v Denmark , paragraph 44; and Commission  v France , paragraph 51).
45. It is clear from Article 130r of the EC Treaty (now, after amendment, Article 174 EC) that the protection of human health is one of the objectives of the Community policy on the environment, that that policy aims at a high level of protection and is to be based inter alia on the precautionary principle, and that the requirements of that policy must be integrated into the definition and implementation of other Community policies. In addition, it follows from the case-law of the Court that the precautionary principle may also apply in policy on the protection of human health which, according to Article 129 of the EC Treaty (now, after amendment, Article 152 EC) likewise aims at a high level of protection (see, to that effect, Case C-157/96 National Farmers’ Union and Others  [1998] ECR I-2211, paragraphs 63 and 64; Case C-236/01 Monsanto Agricoltura Italia and Others  [2003] ECR I-8105, paragraphs 128 and 133; Commission  v Denmark , paragraph 49; and Commission  v France , paragraph 56; see also, to that effect, Case T-13/99 Pfizer Animal Health  v Council  [2002] ECR II-3305, paragraphs 139 and 140; Case T-70/99 Alpharma  v Council  [2002] ECR II-3495, paragraphs 152 and 153; and Case T-177/02 Malagutti-Vezinhet  v Commission [2004] ECR II‑0000, paragraph 54).
46. 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; Commission  v Denmark , paragraph 45; and Commission  v France , paragraph 52).
47. Furthermore, since Article 36 of the Treaty 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 for public health (see Commission  v Denmark , paragraph 46; and Commission  v France , paragraph 53).
48. 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 36 of the Treaty (see Commission  v Denmark , paragraph 47; and Commission  v France , paragraph 54).
49. A decision to prohibit the marketing of a fortified foodstuff, which indeed constitutes the most restrictive obstacle to trade in products lawfully manufactured and marketed in other Member States, can be adopted only if the real risk for public health alleged 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 (see Commission  v Denmark , paragraph 48; and Commission  v France , paragraph 55).
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 Commission  v Denmark , paragraph 50).
51. In a number of cases, the assessment of those factors will demonstrate that there is much uncertainty, in science and in practice, in that regard. Such uncertainty, which is inseparable from the precautionary principle, affects the scope of the Member State’s discretion and thus also the manner in which the precautionary principle is applied.
52. It must therefore be accepted that a Member State may, in accordance with the precautionary principle, take protective measures without having to wait until the existence and gravity of those risks become fully apparent (see, to that effect, National Farmers’ Union , paragraph 63). However, the risk assessment cannot be based on purely hypothetical considerations (see Monsanto Agricoltura Italia , paragraph 106; Commission  v Denmark , paragraph 49; and Commission  v France , paragraph 56).
53. 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).
54. 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 Commission  v Denmark , paragraphs 52 and 53).
63. In those circumstances, the systematic prohibition on the marketing of fortified foodstuffs, as it results from the administrative practice in the Netherlands, does not enable Community law to be observed in regard to the identification and assessment of a real risk for 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 (see, to that effect, Commission  v Denmark , paragraph 56).
69. Although the criterion of 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, the absence of such a need cannot, by itself, justify a total prohibition, on the basis of Article 36 of the Treaty, of the marketing of foodstuffs lawfully manufactured and/or marketed in other Member States (see Commission  v Denmark , paragraph 54; and Commission  v France , paragraphs 59 and 60).