CJEC, 5th chamber, July 14, 1983, No 174-82

The court (fifth chamber)

1 By judgment of 3 may 1982, received at the court on 28 june 1982, the economische politierechter (magistrate dealing with commercial offences) for the arrondissementsrechtbank (district court), ' s-hertogenbosch, referred to the court under article 177 of the eec treaty for a preliminary ruling three questions on the interpretation of provisions of the eec treaty in relation to free movement of goods within the community and in particular article 36 thereof.

2 The questions were raised in criminal proceedings brought against Sandoz BV, uden, for having sold and delivered in the netherlands for commercial purposes and for human consumption, without an authorization from the responsible minister, food and beverages to which vitamins had been added.

3 According to article 10 (a) (1) of the algemeen besluit (general decree) of 11 july 1949 adopted in implementation of articles 14 and 15 of the warenwet (food and drugs law) of 1935 ' ' no vitamins... May be added to food and beverages without an authorization granted by the minister responsible for implementing this decree ' '.

4 In the present case Sandoz BV (hereinafter referred to as ' ' sandoz ' ') sold in the netherlands muesli bars, ' ' powerback ' ' and analeptic beverages to which certain vitamins, in particular vitamins a and d, had been added. It appears from the file that all the products in question are lawfully marketed in the federal republic of germany or in belgium. Before marketing them in the netherlands sandoz applied for authorization pursuant to the aforesaid legislation. The responsible netherlands authority replied first that authorization would be granted only if there was a market demand for the products in question. The application for authorization was subsequently rejected on the ground that the vitamins a and d in the products in question represented a danger to public health.

5 The economische politierechter took the view that his decision on the matter depended on whether the aforesaid netherlands legislation was compatible with article 30 et seq. Of the treaty and therefore an interpretation of those provisions was necessary for him to give judgment; the proceedings were thereupon stayed and the following questions referred to the court for a preliminary ruling:

' ' 1. Where:

(a) Food or beverages, or both, to which vitamins have been added, have been marketed in one or more member states lawfully, that is to say in accordance with the legislation in force locally, and

(b) An importer of food or beverages, or both, established in another member state imports lawfully marketed food or beverages, or both, to which vitamins have been added, from one of the member states referred to under (a) above into the member state in which he is established,

Do the provisions derogating from the rules concerning the free movement of goods within the community, in particular article 36 of the eec treaty in so far as it relates to the protection of the health of humans, justify the government of the member state of importation in prohibiting the marketing of such food or beverages, or both, in that state without ministerial authorization?

2. Must the previous question be answered differently if the general prohibition on the sale of food and beverages to which vitamins have been added, unless authorized by a ministerial decision, has the result that the importer referred to under 1 (b) above bears the onus of proving that the food and beverages concerned are not a danger to public health and must therefore be authorized?

3. Must the question be answered differently if the application of the general prohibition of the sale of food and beverages to which vitamins have been added, unless authorized by a ministerial decision, has the result that the national authorities of a member state prohibit the sale of such food and beverages which have been lawfully produced and marketed in another member state, unless the producer or seller shows not only that such products are not a danger to health but also that it is desirable to market them and that there is a need for vitamins to be added?

' '.

First question

6 In the first question the national court seeks in essence to know whether, and if so in what circumstances, the provisions of the treaty on free movement of goods preclude national rules prohibiting without prior administrative authorization the marketing of food to which vitamins have been added and which are lawfully marketed in another member state.

7 Article 30 of the treaty prohibits in trade between member states quantitative restrictions on imports and all measures having equivalent effect. According to established case-law of the court all commercial rules of the member states likely to impede directly or indirectly, actually or potentially intra-community trade are to be regarded as measures having an effect equivalent to quantitative restrictions. Nevertheless, according to article 36 of the treaty the provision in article 30 does not preclude prohibitions or restrictions on imports justified on grounds inter alia of the protection of human health provided that such prohibitions or restrictions do not constitute a means of arbitrary discrimination or a disguised restriction on trade between member states.

8 It is apparent that national rules of the kind referred to by the national court prohibiting without prior administrative authorization the marketing of food to which vitamins have been added are likely to impede trade between member states and must therefore be regarded as a measure having an effect equivalent to quantitative restrictions within the meaning of article 30 of the treaty. The answer to the question therefore depends on the applicability of article 36 to such rules.

9 In that respect and in the opinion of sandoz and the commission, it is only in the event of excessive consumption, which is excluded however in the case of products of the kind in question, that vitamins and in particular vitamins soluble in fat, such as vitamins a and d, may have harmful effects. A general prohibition on the marketing of food to which vitamins of any kind have been added is therefore not justified within the meaning of article 36 of the treaty on grounds of the protection of health and is in any event excessive within the meaning of the last sentence of that article.

10 On the other hand the netherlands and danish governments contend that such rules are necessary owing to the very nature of the substances added since the absorption of any vitamins in high doses or for a prolonged period may entail risks to health or at least undesirable side-effects such as malnutrition. In view on the one hand of scientific uncertainties and on the other of the fact that the harmfulness of vitamins depends on the quantity absorbed with the whole nutrition of a person it is not possible to say with certainty whether any food to which vitamins have been added is harmful or not.

11 It appears from the file that vitamins are not in themselves harmful substances but on the contrary are recognized by modern science as necessary for the human organism. Nevertheless excessive consumption of them over a prolonged period may have harmful effects, the extent of which varies according to the type of vitamin: there is generally a greater risk with vitamins soluble in fat than with those soluble in water. According to the observations submitted to the court, however, scientific research does not appear to be sufficiently advanced to be able to determine with certainty the critical quantities and the precise effects.

12 It is not disputed by the parties who have submitted observations that the concentration of vitamins contained in the foodstuffs of the kind in issue is far from attaining the critical threshold of harmfulness so that even excessive consumption thereof cannot in itself involve a risk to public health. Nevertheless such a risk cannot be excluded in so far as the consumer absorbs with other foods further quantities of vitamins which it is impossible to monitor or foresee.

13 The addition of vitamins is thus subject to the general policy in relation to food additives, which are already to a limited extent the subject of community harmonization. Thus in particular the council directive of 23 october 1962 on the approximation of the rules of the member states concerning the colouring matters authorized for use in foodstuffs intended for human consumption (official journal, english special edition 1959-62, p. 279) and council directive n°64-54-eec of 5 november 1963 on the approximation of the laws of the member states concerning the preservatives authorized for use in foodstuffs intended for human consumption (official journal, english special edition 1963-64, p. 99), as amended, require the member states to authorize only the colouring matters and preservatives set out in the list annexed but leave the member states free to restrict, in certain circumstances, the use even of the substances listed.

14 As regards foodstuffs intended for particular nutritional uses there has been some degree of harmonization in council directive n°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 1977, l 26, p. 55). Article 7 thereof requires the member states to adopt all the measures necessary to ensure that trade in the said products cannot be impeded by the application of non-harmonized national provisions governing the composition, manufacturing specifications, packaging or labelling of foodstuffs, subject nevertheless to provisions justified on grounds, inter alia, of protection of public health.

15 The abovementioned community measures clearly show that the community legislature accepts the principle that it is necessary to restrict the use of food additives to the substances specified, whilst leaving the member states a certain discretion to adopt stricter rules. The measures thus testify to great prudence regarding the potential harmfulness of additives, the extent of which is still uncertain in respect of each of the various substances, and leave a wide discretion to the member states in relation to such additives.

16 As the court found in its judgment of 17 december 1981 in case 272-80 (frans-nederlandse maatschappij voor biologische producten (1981) ecr 3277), in so far as there are uncertainties at the present state of scientific research it is for the member states, in the absence of harmonization, to decide what degree of protection of the health and life of humans they intend to assure, having regard however for the requirements of the free movement of goods within the community.

17 Those principles also apply to 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 nutrition, the composition of which is unforeseeable and cannot be monitored. In view of the uncertainties inherent in the scientific assessment, national rules prohibiting, without prior authorization, the marketing of foodstuffs to which vitamins have been added are justified on principle within the meaning of article 36 of the treaty on grounds of the protection of human health.

18 Nevertheless the principle of proportionality which underlies the last sentence of article 36 of the treaty requires that the power of the member states to prohibit imports of the products in question from other member states should be restricted to what is necessary to attain the legitimate aim of protecting health. Accordingly, national rules providing for such a prohibition are justified only if authorizations to market are granted when they are compatible with the need to protect health.

19 Such an assessment is, however, difficult to make in relation to additives such as vitamins the abovementioned characteristics of which exclude the possibility of foreseeing or monitoring the quantities consumed as part of the general nutrition and the degree of harmfulness of which cannot be determined with sufficient certainty. Nevertheless, although in view of the present stage of harmonization of national laws at the community level a wide discretion must be left to the member states, they must, in order to observe the principle of proportionality, authorize marketing when the addition of vitamins to foodstuffs meets a real need, especially a technical or nutritional one.

20 The first question must therefore be answered to the effect that community law permits national rules prohibiting without prior authorization the marketing of foodstuffs lawfully marketed in another member state to which vitamins have been added, provided that the marketing is authorized when the addition of vitamins meets a real need, especially a technical or nutritional one.

Second question

21 In the second question the national court asks in essence whether community law precludes national rules such as those referred to by the national court where the authorization to market is subject to proof by the importer that the product in question is not harmful to health.

22 In as much as the question arises as to where the onus of proof lies when there is a request for authorization, in view of the answer to the first question, it must be remembered that article 36 of the treaty creates an exception, which must be strictly interpreted, to the rule of free movement of goods within the community which is one of the fundamental principles of the common market. It is therefore for the national authorities who rely on that provision in order to adopt a measure restricting intra-community trade to check in each instance that the measure contemplated satisfies the criteria of that provision.

23 Accordingly, although the national authorities may, in so far as they do not have it themselves, ask the importer to produce the information in his possession relating to the composition of the product and the technical or nutritional reasons for adding vitamins, they must themselves assess, in the light of all the relevant information, whether authorization must be granted pursuant to community law.

24 The second question must therefore be answered to the effect that community law does not permit national rules which subject authorization to market to proof by the importer that the product in question is not harmful to health, without prejudice to the right of the national authorities to ask the importer to submit all the information in his possession needed to assess the facts.

Third question

25 In the third question the national court asks in essence whether community law precludes national rules of the kind referred to by the national court where authorization to market is subject to proof by the importer that the marketing of the product in question meets a market demand.

26 As regards the requirement of a market demand it must be emphasized that the sole fact of imposing such a condition constitutes in itself a measure having an equivalent effect to a quantitative restriction prohibited by article 30 which cannot be covered by the exception in article 36. The objective pursued by the principle of free movement of goods is precisely to ensure for products from the various member states access to markets on which they were not previously represented.

27 The third question must therefore be answered to the effect that community law does not permit national rules which subject authorization to market to proof by the importer that the marketing of the product in question meets a market demand.

Costs

28 The costs incurred by the netherlands, danish and italian governments and by the commission of the european communities, which have submitted observations to the court, are not recoverable. As these proceedings are, in so far as the parties to the main proceedings are concerned, in the nature of a step in the proceedings before the national court, the decision on costs is a matter for that court.

On those grounds,

The court (fifth chamber)

In answer to the questions submitted to it by the economische politierechter for the arrondissementsrechtbank, ' s-hertogenbosch, by judgment of 3 may 1982, hereby rules:

1. Community law permits national rules prohibiting without prior authorization the marketing of foodstuffs lawfully marketed in another member state to which vitamins have been added, provided that the marketing is authorized where the addition of vitamins meets a real need, especially a technical or nutritional one.

2. Community law does not permit national rules which subject authorization to market to proof by the importer that the product in question is not harmful to health, without prejudice to the right of the national authorities to ask the importer to submit all the information in his possession needed to assess the facts.

3. Community law does not permit national rules which subject authorization to market to proof by the importer that the marketing of the product in question meets a market demand.