Commission of the European Communities v French Republic.
Date: 2004-02-05
9. The orders referred to in Article 3 of Decree No 91-827 are the Order of 20 July 1977 implementing Decree No 75-85 of 24 July 1975 on dietary and diet products and the Order of 4 August 1986 on the use of additives in the manufacture of food intended for particular nutritional uses, both subsequently amended, which were adopted on the basis of the decrees which preceded Decree No 91-827 and were kept in force by the second subparagraph of Article 9 thereof.
Pre-litigation procedure
22. The prohibition set out in Article 30 of the Treaty 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).
23. It is not disputed that the French legislation is a measure having equivalent effect to quantitative restrictions within the meaning of Article 30 of the Treaty. That legislation, which requires for the marketing of foodstuffs fortified with vitamins and minerals prior inclusion of those nutrients on an   " authorised list" , makes the marketing of such foodstuffs more difficult and more expensive, and consequently hinders trade between the Member States.
25. However, the Court has held that national legislation which makes the addition of a nutrient to a foodstuff lawfully manufactured and/or marketed in other Member States subject to prior authorisation is not, in principle, contrary to Community law, provided that certain conditions are satisfied (see to that effect Case C-344/90  Commission  v  France  [1992] ECR I-4719, paragraph 8, and  Commission  v  Denmark , cited above, paragraph 44).
26. First, such legislation must make provision for a procedure enabling economic operators to have that 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 , cited above, paragraph 9).
27. 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 , paragraph 46).
36. As is clear from paragraph 26 of this judgment, a procedure which requires prior authorisation, in the interest of public health, for the addition of a nutrient authorised in another Member State complies with Community law only if it is readily accessible and can be completed within a reasonable time and if, when it is refused, the refusal can be challenged before the courts.
37. As regards first the accessibility of the procedure in question in this case, a Member State ' s obligation to provide for such a procedure in the case of any national rule which on grounds of public health makes the addition of nutrients subject to authorisation cannot be fulfilled if that procedure is not expressly provided for in a measure of general application which is binding on the national authorities (see also to that effect Case 176/84  Commission  v  Greece  [1987] ECR 1193, paragraph 41).
40. Secondly, the examples provided by the Commission in its application reveal that applications for authorisation submitted by economic operators were not dealt with either within a reasonable period or according to a procedure which was sufficiently transparent as regards the possibility of challenging refusal to authorise before the courts.
49. It must be borne in mind, first, that it is 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 Case 174/82  Sandoz  [1983] ECR 2445, paragraph 16, and  Commission  v  Denmark , cited above, paragraph 42).
50. 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 (see  Sandoz , paragraph 17, and  Commission  v  Denmark , paragraph 43).
51. It follows, as is clear from paragraph 25 of this judgment, that Community law does not, in principle, preclude legislation of a Member State which prohibits, save with prior authorisation, possession with a view to sale or the putting on sale of foodstuffs intended for human consumption where nutrients other than those whose addition is lawful under the said legislation have been added thereto.
52. 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 or to satisfy overriding requirements regarding, for example, consumer protection, and they must be proportional 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).
53. Furthermore, since Article 36 of the EC Treaty (now, after amendment, 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  Commission  v  Denmark , paragraph 46).
54. 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).
55. 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 ( Commission  v  Denmark , paragraph 48).
56. 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] ECR I-0000, paragraph 106, and  Commission  v  Denmark , paragraph 49).
59. As regards the French Government ' s argument based on this absence of a nutritional need necessitating the addition of nutrients to the foodstuffs concerned, it must be noted that where there is scientific uncertainty the criterion of nutritional need of the population of a Member State can play a role in the latter ' s detailed assessment of the risk which the addition of nutrients to foodstuffs may pose for public health.
60. However,  the absence of such a need cannot, by itself, justify a total prohibition, on the basis of Article 36 of the Treaty, on marketing foodstuffs lawfully manufactured and/or marketed in other Member States (see  Commission  v  Denmark , paragraph 54).
62. It must therefore be held that, as regards confectionery and drinks to which nutrients have been added, the French authorities have not observed the requirements of Community law as set out in the Court ' s case-law mentioned in paragraphs 52 and 56 of this judgment and, in particular, the requirement for a detailed assessment in each case of the effects which the addition of vitamins and minerals could have on public health in a case such as this (see, to that effect,  Commission  v  Denmark , paragraph 56).
69. It is of course necessary for it to show why the prohibition on marketing energy drinks containing caffeine in excess of a certain limit is necessary and proportionate for public health (see to that effect Case C-420/01  Commission  v  Italy  [2003] ECR I-6445, paragraphs 30 and 31).
72. In those circumstances, it was for the Commission to state explicitly why the French Government ' s argument based on that Opinion cannot suffice to justify the refusal to authorise the marketing of energy drinks to which taurine and glucurunolactone have been added.
74. Secondly, as regards effective consumer protection, to which the French Government also refers, it is naturally legitimate, as follows from paragraphs 63 and 67 of this judgment, to seek to ensure that consumers are properly informed about the products which they consume (see to that effect Case 216/84  Commission  v  France  [1988] ECR 793, paragraph 10, and Case 274/87  Commission  v  Germany  [1989] ECR 229).
75. However, appropriate labelling, informing consumers about the nature, the ingredients and the characteristics of fortified foodstuffs, can enable consumers who risk excessive consumption of a nutrient added to those products to decide for themselves whether to use them (see Case 216/84  Commission  v  France , cited above, paragraph 16).