Criminal proceedings against John Greenham and Léonard Abel.
Date: 2004-02-05
32. The prohibition set out in Article 28 EC on measures having an effect equivalent to restrictions 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, and Case C-192/01  Commission  v  Denmark  [2003] ECR I-0000, paragraph 39).
33. The file of the main proceedings seems to indicate that they concern foodstuffs imported from another Member State where they are lawfully manufactured and/or marketed.  It is, however, for the national court, which alone has jurisdiction to determine and evaluate the facts in the proceedings before it, to check that such is the case and that the rules and principles flowing from the free movement of goods are indeed to be applied to those proceedings (see, to that effect, Case C-107/97  Rombi and Arkopharma  [2000] ECR I-3367, paragraph 72).
34. National rules such as those at issue in the main proceedings, which prohibit the marketing of foodstuffs to which nutrients have been added, such foodstuffs being lawfully manufactured and/or marketed in the exporting Member State but prohibited in the importing Member State, or which require that such substances have been previously included on a national list provided for for that purpose in order that the marketing of the foodstuffs to which they have been added may be authorised, can be justified, as a measure having equivalent effect to a quantitative restriction within the meaning of Article 28 EC, in so far as they comply with the requirements of Article 30 EC, as interpreted by the Court.
35. First, such rules must make provision for a procedure enabling economic operators to have a nutrient included on the national list of authorised substances.  The procedure must be one which is readily accessible and can be completed within a reasonable time, and, if it leads to a refusal, the decision of refusal must be open to challenge before the courts (see to that effect Case C-344/90  Commission  v  France  [1992] ECR I-4719, paragraph 9, and today ' s judgment in Case C-24/00  Commission  v  France  [2004] ECR I-0000, paragraph 26).
36. Secondly, an application to obtain the inclusion of a nutrient on the national list of authorised substances may be refused by the competent national authorities only if such substance poses a genuine risk to public health (see  Commission  v  Denmark , cited above, paragraph 46).
37. It is of course for the Member States, in the absence of harmonisation and to the extent that there is still uncertainty in the current state of scientific research, to decide on the level of protection of human health and life they wish to ensure and whether to require prior authorisation for the marketing of foodstuffs, taking into account the requirements of the free movement of goods within the Community (see  Commission  v  Denmark , cited above, paragraph 42).
38. 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 nutrients, 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 (see Case 174/82  Sandoz  [1983] ECR 2445, paragraph 17, and  Commission  v  Denmark , cited above, paragraph 43).
39. 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 proportionate to the objective thus pursued, which could not have been attained by measures less restrictive of intra-Community trade (see  Sandoz , paragraph 18, and  Commission  v  Denmark , paragraph 45).
40. 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  Sandoz , paragraph 22, Case 227/82  Van Bennekom  [1983] ECR 3883, paragraph 40, and  Commission  v  Denmark , paragraph 46).
41. 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  Commission  v  Denmark , paragraph 47).
42. A decision to prohibit the marketing of a fortified foodstuff, which is in fact the most restrictive obstacle to trade in products lawfully manufactured and marketed in other Member States, can be adopted only if the alleged real risk for public health appears to be 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).
43. 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 existence and gravity 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 Case C-236/01  Monsanto Agricoltura Italia and Others  [2003] I-0000, paragraph 106, and  Commission  v  Denmark , paragraph 49).
46. While it is true that the Court has observed that, in a context of scientific uncertainty, 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, the absence of such a need cannot, by itself, justify a total prohibition, on the basis of Article 30 EC, on marketing foodstuffs lawfully manufactured and/or marketed in other Member States (see  Commission  v  Denmark , paragraph 54).
47. Moreover, as noted in paragraphs 41 to 43 of this judgment, a prohibition on marketing foodstuffs to which nutrients have been added must be based on a detailed assessment of the real risk to public health alleged by the national authorities invoking Article 30 EC, established on the basis of the most reliable scientific data available and the most recent results of international research (see  Commission  v  Denmark , paragraph 51).
48. 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 , paragraph 52).
50. Having regard to all those considerations, the reply to the question referred must be that Articles 28 EC and 30 EC must be interpreted as meaning that they do not preclude a Member State from prohibiting the marketing without prior authorisation of foodstuffs lawfully manufactured and marketed in another Member State, where nutrients such as vitamins or minerals have been added thereto other than those whose use has been declared lawful in the first Member State, provided that certain conditions are satisfied.
First, the prior authorisation procedure must be readily accessible and capable of being completed within a reasonable time and, if it leads to a refusal, the decision of refusal must be open to challenge before the courts.  Secondly, refusal to authorise marketing must be based on a detailed assessment of the risk to public health, based on the most reliable scientific data available and the most recent results of international research.