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. The provisions to be considered from that point of view, which is really the main issue in the case, are Article 36 of the Treaty and, in certain respects, Council Directive No 77/94/EEC of 21 December 1976 on the approximation of the laws of the Member States relating to foodstuffs for particular nutritional uses (Official Journal, L 26, p. 55 of 31 January 1977). Let us start with Article 36. As is known, that article derogates from Article 30 (and from the following Articles 31 to 34) by authorizing prohibitions and restrictions on imports justified, inter alia, on grounds of “the protection of health and life of humans”. According to the Netherlands Government Article 10 (a) (1) of the Algemeen Besluit complies with the Treaty because it answers the need to prevent the excessive consumption of certain vitamins, in particular Vitamins A and D, from harming the health of the consumer. In a general way at least, that argument is valid. Indeed, we all know, and the parties basically agree, that vitamins may be harmful to the health of the person who consumes an excessive quantity of them. At least vitamins soluble in fat are dangerous, whereas the risk is less or nonexistent in the case of vitamins soluble in water because the human body eliminates them even if they are consumed in excessive quantities. However that may be, I do not think the Court need go further into those problems of the pathology of metabolism. Once it is established that there is uncertainty with regard to the quantity of vitamins which may be consumed without harm it is not possible not to allow the States the right to introduce restrictions on their marketing at least so long as the national legal systems have not been harmonized in relation to food additives (see on that issue the judgment of 5 February 1981 in Case 53/80 Officier van Justitie v Koninklijke Kaasfahriek Eyssen BV [1981] ECR 409). Naturally that power must be exercised within the limits established by Title I of the Treaty. However, since the aims which those limits leave untouched include the protection of health and life, the Member States may assume responsibility therefor and, in particular, “decide... how strict the checks to be carried out [are] to be” for that purpose (see the judgments of 20 May 1976 in Case 104/75 De Peijper [1976] ECR 613 at p. 635 and 17 December 1981 in Case 272/80 Frans-Nederlandse Maatschappij voor Biologische Produkten [1981] ECR 3277, paragraph 12 at p. 3290). As regards the present case, I would say therefore that the preventive checks provided for by national law to ascertain the addition of vitamins to food fall within the terms of Article 36 inasmuch as they satisfy a condition specified therein. Moreover, Sandoz itself admits their expediency.