Opinion of Mr Advocate General Mancini

Mr President,

Members of the Court,

1. This reference to the Court for a preliminary ruling concerns the free movement of goods and in particular a principle contained in the first part of Article 36 of the EEC Treaty which authorizes prohibitions or restrictions on imports... on grounds of... the protection of health and life of humans. The Court must establish whether that principle applies to national rules generally prohibiting (but enabling the administration to authorize in any particular case) the marketing of products containing added vitamins and imported from other Member States where their marketing is lawful.

2. To understand the case fully it is necessary to supply certain information on the rules which in the Netherlands govern the marketing of food with added vitamins. That should not be necessary as a rule, but although the questions put by the court making the reference are framed in appropriate terms and refer to Article 36 of the EEC Treaty, they obviously seek to establish whether the particular national provisions which that court must apply are compatible with Community law. Let me spare the Court fresh complaint about this phenomenon caused, in my opinion, by the inadequate use the Commission makes of the procedure based on Article 169 of the Treaty. I shall confine myself to the observation that, as the present case shows, the practice is spreading and, as it does so, the risk of institutional imbalance to which I have several times drawn the attention of the Court increases (see my Opinion in Case 94/82 Officier van Justitie v De Kikvorsch and Case 59/82 Schutzverband gegen Unwesen in der Wirtschaft v Weinvertriebs GmbH).

3. I do not think there can be any doubt that rules such as those I have just described are likely to impede, be it only indirectly, international trade. The general prohibition (unless there is express authorization) on adding vitamins to food and drinks means that it is impossible to import and market such products. The court concerned with this case recognizes it in the wording of the questions, and in that respect neither the Commission, Sandoz B.V. nor the three intervening Member States (the Netherlands, Italy and Denmark) has expressed a different view. However, once we have established that premise and concluded that rules such as those in Article 10 (a) (1) of the Algemeen Besluit constitute measures having an effect equivalent to a quantitative restriction it is a question of establishing whether and how far the Member States may introduce or retain such rules in their legal systems.

4. The lawfulness, however, of these checks may also be based on Directive No 77/94/EEC to which I have already referred. As we know, its aim is to approximate the national laws relating to foodstuffs for particular nutritional uses and to abolish, if only gradually, the differences between laws which impede their free movement, may create unequal conditions of competition and thus have a direct impact on the establishment and functioning of the common market (see the first recital). In the preamble it is explained that the said approximation requires, in the initial stage, the determination of measures enabling the consumer to be protected and in a subsequent stage the definition of the particular characteristics applicable to certain groups of these products (see the third and fourth recitals).

5. The first question from the Netherlands court does not only raise the question of whether a national rule prohibiting, unless authorized by the administration, the marketing of products to which vitamins have been added complies with Community law. It is in fact more specific: it concerns the case where the products have already circulated in one or more Member States in accordance with their respective laws. In brief, the Netherlands court wishes to know whether preventive inspection, such as that on which the said authorization depends, may be imposed even when similar checking has been carried out by the authorities of the State of origin.

6. The second and third questions from the national court consider the hypothetical (but which obviously has reference to the practice of the Netherlands authorities) case of national rules which specify (a) the conditions which the product in question must meet before it may be marketed and (b) the onus of proof regarding those conditions. The two questions appear to me proper and important. Accepting that the control of the products in question is lawful for the protection of health the crux of the case lies in the aim of the controls and the means employed: that means precisely the conditions required for marketing the products and the formalities for authorization.

7. The third question has a double aspect: on the one hand it considers other conditions laid down for the marketing of food to which vitamins have been added and on the other hand it refers once again to the burden öf proof. Under the first aspect the Netherlands court presupposes that a national law makes it a condition for the marketing of such food that it is useful and meets a demand. Consequently it must not only not be harmful but must be useful and meet actual needs: briefly, it must satisfy positive conditions.

8. For all the reasons put forward above I propose that the questions put by the Economische Politierechter of the Arrondissementsrechtbank 's-Hertogenbosch by order of 3 May 1982 in the criminal proceedings against Sandoz BV, the registered office of which is at Uden in the Netherlands, should be answered as follows :

1 Translated from the Italian.