C-174/82

composed of: J. Mertens de Wilmars, President, U. Everling (President of Chamber), Lord Mackenzie Stuart, O. Due and Y. Galmot, Judges,

Advocate General: G. F. Mancini Registrar: H.;A. Rühi, Principal.Administrator

gives the following

JUDGMENT

Facts and Issues

The facts of the case, the course of to appear before the Economische the procedure and the observations Politierechter [Magistrate dealing with submitted under Article 20 of the commercial offences] for the Arron- Protocol on the Statute of the Court of dissementsrechtbank, 's-Hertogenbosch, Justice of the EEC may be summarized charged with having sold and delivered as follows : in two places in the Netherlands for commercial purposes and human I — Facts and written procedure consumption and without an author- ization from the responsible Minister, 1. By summons of 16 March 1982 food and beverages to which vitamins Sandoz BV, Uden, was summoned had been added.

In the present case Sandoz BV sold (a) food or beverages, or both, to muesli bars, "Powerback." and analeptic which vitamins have been added, beverages imported either from Switzer- have been marketed in one or land or from the Federal Republic of more Member States lawfully, Germany to which a number of vitamins that is to say in accordance with and in particular Vitamins A and D had the legislation in force locally, been added. All the products in question and are lawfully marketed in the Federal Republic of Germany and Belgium. (b) an importer of food or bev- erages, or both, established in It appears from the file on the case that another Member State imports before marketing the said products in lawfully marketed food or the Netherlands the defendant had beverages, or both, to which sought an authorization for that purpose vitamins have been added, from pursuant to Article 10 (a) (1) of the one of the Member States aforesaid Algemeen Besluit. By letter referred to under (a) above into dated 12 July 1979 the Inspecteur van the Member State in which he is de Volksgezondheid [Public Health established, Inspector] replied that an authorization "is granted only if it is shown that there do the provisions derogating from is a demand for the products to which the rules concerning the free move- vitamins . . . have been added". By ment of goods within the Com- decision dated 26 August 1981 the munity, in particular Article 36 of Minister van Volksgezondheid en the EEC Treaty in so far as it relates Milieuhygiëne [Minister for Public to the protection of the health of Health and the Environment] rejected humans, justify the government of the application for an authorization on the Member State of importation in the ground that the Vitamins A and D in prohibiting the marketing of such the products in question represented a food or beverages, or both, in that danger to public health, particularly as State without ministerial authoriz- the labelling did not display instructions ation? as to usage which would make it possible to adapt the intake of vitamins to individual needs. 2. Must the previous question be answered differently if the general prohibition on the sale of food and Sandoz BV contended in its defence beverages to which vitamins have before the Arrondissementsrechtbank been added, unless authorized by a that Article 10 (a) of the Algemeen ministerial decision, has the result

Written observations pursuant to Article The question raised in the present case is 20 of the Protocol on the Statute of the whether recourse to enriched sports Court of Justice of the EEC were nutrition constitutes a danger to health. submitted by Sandoz BV, represented by Although it is generally recognized that Blackstone, Rueb and Van Boeschoten, excessive consumption of certain vit- Advocates at The Hague and amins may have deleterious conse- Amsterdam, and by J. C. Schultsz and quences and undesirable side-effects B. J. H. Grans, Advocates, Amsterdam, scientific research has enabled objective the Netherlands Government, rep- and internationally recognized criteria to resented by F. Italianer, acting for the be established as regards the level of Minister for Foreign Affairs, the Danish toxicity for the various vitamins. If those Government, represented by its Legal criteria are applied to the Sandoz Adviser, Per Lachmann, the Italian products it becomes apparent that it is in Government, represented by Ivo M. practice impossible to reach a toxic level Braguglia, Avvocato dello Stato, and by consuming them in view of the fact the Commission of the European that the amounts which would have to be

JUDGMENT OF 14. 7. 1983 — CASE 174/82

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JUDGMENT OF 14. 7. 1983 — CASE 174/82

been added, which means that the additive. On that basis the administration competent authority of a Member may authorize the use of an additive and State prohibits the sale of foodstuffs restrict it if necessary to certain and beverages to which vitamins foodstuffs and to a given maximum have been added and which are dosage. lawfully produced and marketed in another Member State unless the producer or importer or seller shows not only that the goods constitute no danger to public health but also that The Warenwet provides both for general their marketing is useful and that the derogations from the criteria established addition of vitamins meets a and for systems of case-by-case approval. demand, is incompatible with All the instruments of authorization are Community law and finds no jus- based on the rules that what has not tification in the derogations from the been authorized may not be added. The rules governing the free movement system has been adopted in order to of goods." ensure in the best possible way the protection of public health in view of the rapid developments which are taking place in the sphere of additives.

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Moreover Ariele 10 (a) (1) of the vitamins to foodstuffs and beverages Algemeen Besluit does not prohibit the ' produced in the country or imported." importation and marketing of vitamin preparations in every case. A certain number of these products are approved on the basis of the Wet op de Geneesmiddelenvoorziening [Law on the 3. The Danish Government, dealing Supply of Medicinal Preparations] after only with the first question, states that a preliminary examination to ensure that the Danish legislation on the addition of the medicinal preparation is harmless. vitamins to food products (Law N o 310 of 6 June 1973 on food and other products; Decree.No 65 of 20 February 1981 on additives to food products) is in certain respects comparable to that According to established case-law of the applicable in the Netherlands. Court the national legislature is free, in the absence of Community rules in the matter, to adopt national rules, especially as regards the production, marketing and By virtue of that legislation the addition consumption of the products in question, of nutrients, including vitamins, is with due regard nevertheless to Article allowed only subject to four conditions: 30 et seq. of the Treaty. The prohibition of the addition of vitamins, qualified by a system of individual authorizations enabling needs to be met in a flexible The addition must be presumed to make manner, is justified by the requirements good or prevent an assumed lack of a of the protection of public health certain nutrient in a large part of the referred to in Article 36 of the Treaty, population; since it cannot be established beyond all doubt that such additives are not harmful and since relative harmfulness depends on the food habits of the consumer. The addition must be intended to replace the loss of nutritive value resulting from industrial treatment of the food product;

The system described above is based on The Court has recognized that obstacles the considerations that correct nutrition to intra-Community trade based on is of fundamental importance for human differences in national laws on the health and that a healthy diet depends on marketing of products must be accepted varied food. Danish policy is therefore in so far as such provisions apply without aimed at avoiding "adorning" the distinction to domestic and imported natural qualities of a food product in products and are absolutely necessary for order to prevent the addition of food purposes inter alia of the protection of substances to products with which they public health, the fairness of commercial are not normally associated. In that transactions and the protection of the respect it takes account of the fact that consumer. In that respect the judgment the addition of such substances, even if of 5 February 1981 in Case 53/80 Eyssen they are not harmful in themselves, [1981] ECR 409 confirmed that "the constitutes a means of persuasion for the issue of the addition of preservatives to producer at the expense of the consumer. foodstuffs is embraced by the more general issue of health protection which calls for the adoption of national measures designed to regulate the use of such additives in the interests of the protection of human health." Moreover the Court held in' the judgment of 17 December 1981 in Case 272/80 It follows that it is not sufficient to Biologische Producten [1981] ECR 3277 contemplate labelling which shows the that in the absence of harmonization it content of additives since such labelling was for the Member States, to decide is precisely the factor which leads the what degree of protection of the health consumer to believe that the product in and life of humans they intended to question is a healthy one. ensure and in particular how strict the checks to be carried out were to be.

4. The Italian Government points out in Case 272/80 Biologische Producten that contrary to what the national court [1981] ECR 3277). states dietary products have already been made the subject of preliminary harmon- ization by Council Directive No 77/94 of 21 December 1976 on the approxi- mation of the laws of the Member States relating to foodstuffs for particular The affirmative answer to be given to the nutritional uses. first question deprives the other two questions of their purpose. The Italian Government nevertheless adds by way of a secondary observation that the terms of the procedure leading to an administrative authorization to produce or market such products lie, in the Article 2 of the directive provides that absence of harmonization, within the "the nature or composition of the exclusive jurisdiction of the importing products . . . must be such that the Member State provided that such terms products are appropriate for the are the same for domestic and imported particular nutritional use intended". products. Article 3 allows, in the absence of specific directives, national provisions to regulate changes made to products in order to make them appropriate for a particular nutritional use. Those provisions clearly show the need, for the purposes of protecting public health, 5. The Commission of the European of controls on the production and Communities states that there is as yet no marketing of the products in question. A provision of Community law in force on check on labelling does not suffice to the addition of vitamins to foodstuffs prevent consumers from being misled as and maintains that the prohibition in to the properties of the product. It is also Article 10 (a) of the Algemeen Besluit necessary to check the composition of constitutes a measure having an effect the product itself which must meet the equivalent to a quantitative restriction on requirements which it is intended to imports within the meaning of Article 30 satisfy and must not be harmful. of the Treaty since it is capable of constituting an obstacle to the marketing in the Netherlands of products from other Member States where the market- ing of products with added vitamins is permitted. That prohibition is compatible Accordingly national provisions which with Community law only if it can be give the national authorities the right to justified under Article 36 of the Treaty. check the composition of such products and to prohibit their marketing in the absence of authorization do not constitute unjustified obstacles to the free movement of goods for the purposes As to the first question it is necessary to of Article 36 of the Treaty or the said determine whether the prohibition is directive in so far as such products have required for the effective protection of not already been subject to appropriate the health of humans. That is not so if analysis in the exporting Member State such protection can be ensured as (cf. the judgment of 17 December 1981 effectively by measures which restrict

intra-Community trade to a lesser degree out in Article 36 to show that the (judgment of 20 May 1976 in Case measures it imposes are indispensable. It 104/75 DePeijper[l976] ECR613). follows that it is for the national auth- orities to show that a specific product is harmful to public health although it is lawfully marketed in another Member In view of those criteria the Commission State. contends that vitamins are not harmful in themselves. According to scientific literature it is necessary to distinguish between vitamins soluble in water, such The third question asks whether the fact as Vitamin B2, which are harmless, and that there is or is not a demand for vitamins soluble in fat which may have imported products to which vitamins harmful effects if absorbed in excessive have been added may be taken as a quantities. criterion for the grant of an authoriz- ation to market the product in question. The answer is in the negative since none of the grounds which are exhaustively That conclusion is confirmed by the stated in Article 36 and which justify a "International rules Recommended for restriction on imports can be interpreted Food for Babies and Young Children" in such a way as to cover a requirement adopted by the Commission of the of a demand for a specific product. Codex Alimentarius of the Food and Agriculture Organization and the World Health Organization and by the German legislation on the subject. The inter- In conclusion the Commission proposes national rules do not lay down maximum that the questions referred to the Court quantities except for Vitamins A and D. for a preliminary ruling should be Unless derogation is granted by the answered as follows: competent federal Minister, German legislation prohibits the addition of Vitamins A and D but allows the " 1 . Article 36 of the EEC Treaty must addition of other vitamins to foodstuffs be interpreted as meaning that a provided that the product states the general prohibition of the marketing amount of vitamins it contains and the of products to which vitamins have health authorities are informed. been added and which are lawfully marketed in another Member State is not justified on grounds of the protection of public health. The Commission is therefore of the view that a general prohibition of the mar- keting of imported products to which vitamins are added goes beyond what is 2. It is for the national authorities to required for the effective protection of show that a product is harmful to the health of humans. public health.

1. Sandoz states that toxic levels have 3. The Danish Government considers been found for vitamins soluble in water, that the absorption of Vitamins A, B, C namely Bl, B6, C, niacin, calcium-pan - and D in abnormal quantities or over a tothenate and folic acid and for Vitamins prolonged period may give rise to A, D3 and E, which are soluble in fat. symptoms of intoxication. On the other On the other hand, no harmful side- hand Bl, B2, B6, B12, niacin, effect has been recorded in the case of pantothenic acid, biotin and Vitamins E Vitamins B2, B12 and biotin which are and K do not really provide any cause soluble in water. No toxic level has been for concern in the matter of health even established for Vitamin Kl which is if consumed in abnormal quantities. The soluble in fat. Danish Government nevertheless states that the greatest risk to health in relation to nutrition is not the danger of intoxication but on the contrary the lack of certain nutrients as the result of Sandoz adds that the addition of all incorrect diet. vitamins may be calculated in such a way that their consumption can involve no risk for human health since it would be necessary to consume excessive quantities of products, which the organism would 4. The Commission of the European be incapable of assimilating, to reach the Communities confirms that vitamins are toxic level. not in themselves harmful substances or a danger to human health. Only vitamins soluble in fat and more particularly Vitamins A and D may have harmful effects if absorbed in excessive doses 2. The Netherlands Government states over a certain period. The position is that the absorption of any vitamins in different as regards vitamins soluble in high dosages or over a prolonged period water such as Vitamins Bl, B2, B6, B12,

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

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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 authoriz- ation 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

First q u e s t i o n

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.

s 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

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Treaty. The answer to the question therefore depends on the applicability of Article 36 to such rules.

i2 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

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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.

is 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

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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.

i6 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.

i7 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.

Second question

2i 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 Inasmuch 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.

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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.

JUDGMENT OF 14. 7. 1983 — CASE 174/82

On those grounds,

T H E C O U R T (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 auth- orization 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 authoriz- ation 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.