Joined Cases C-211/03, C-299/03, C-316/03, C-317/03 and C-318/03

Joined Cases C-211/03, C-299/03, C-316/03, C-317/03 and C-318/03

HLH Warenvertriebs GmbH and Orthica BV

v

Bundesrepublik Deutschland

(Reference for a preliminary ruling from the Oberverwaltungsgericht für das Land Nordrhein-Westfalen)

(Free movement of goods – Distinction between medicinal products and food additives – Product marketed as a food additive in the Member State of origin but treated as a medicinal product in the Member State of import – Marketing authorisation)

Summary of the Judgment

1.Approximation of laws — Medicinal products for human use — Directive 2001/83 — General principles and requirements of food law — Regulation No178/2002 — Classification of a product as a medicinal product or as a foodstuff — Criteria — Taking into account of all the characteristics of the product in its initial and its mixed stage

(European Parliament and Council Regulation No178/2002; European Parliament and Council Directive 2001/83)

2.Approximation of laws — General principles and requirements of food law — Regulation No178/2002 — Food supplements — Directive 2002/46 — Supplementary application of Regulation No178/2002 in relation to Directive 2002/46

(European Parliament and Council Regulation No178/2002, Art. 14; European Parliament and Council Directive 2002/46)

3.Approximation of laws — Medicinal products for human use — Directive 2001/83 —Product meeting the definition of medicinal product laid down in that directive and also the definition of food laid down in Regulation No178/2002 laying down the general principles and requirements of food law — Exclusive application of the Community provisions specific to medicinal products

(European Parliament and Council Regulation No178/2002, Art. 2, first subpara.; European Parliament and Council Directive 2001/83, as amended by Directive 2004/27, Art. 2(2))

4.Approximation of laws — Medicinal products for human use — Directive 2001/83 — Classification of a product as a medicinal product by function — Criteria — Taking into account of the pharmacological properties of the product and of the risk to health entailed by its use

(European Parliament and Council Directive 2001/83, Art. 1(2), second subpara.)

5.Approximation of laws — Medicinal products for human use — Directive 2001/83 — Importation into a Member State of a product constituting a medicinal product — Need to obtain marketing authorisation —Lawful marketing of the product in another Member State as a foodstuff — No effect

(European Parliament and Council Directive 2001/83, Art. 6(1))

6.Approximation of laws — Food supplements — Directive 2002/46 — Distinction between medicinal products and foodstuffs — Concept of ‘upper safe levels’ — Irrelevant criterion

(European Parliament and Council Directive 2002/46, Art. 5(1)(a))

7.Free movement of goods — Quantitative restrictions — Measures having equivalent effect — Prohibition on the marketing of foodstuffs or food supplements lawfully marketed in another Member State — Justification by the absence of a ‘nutritional need’ of the population — Criteria of permissibility —Administrative decision finding the absence of a nutritional need — Limited judicial review — Whether permissible — Conditions

(Art. 30 EC; European Parliament and Council Directive 2002/46, Art. 12)

8.Approximation of laws — New foodstuffs and new food ingredients — Regulation No258/97 —Negligible nature of human consumption of a foodstuff or a food ingredient — Concept — Reference date

(European Parliament and Council Regulation No258/97, Art. 1(2))

9.Approximation of laws — General principles and requirements of food law — Regulation No178/2002 — European Food Safety Authority — Possibility for the national courts to refer questions on the classification of products to the Authority — None — Opinions delivered by the authority — Scope

(European Parliament and Council Regulation No178/2002, Arts 22 and 23)

10.Preliminary rulings — Jurisdiction of the Court — Limits — Jurisdiction of the national court — Establishment and assessment of the facts of the case — Application of the provisions interpreted by the Court

(Art. 234 EC)

1.The classification of a product as a medicinal product or as a foodstuff for the purposes of the Community legislation, more particularly Directive 2001/83 on the Community code relating to medicinal products for human use and Regulation No178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, must take account of all the characteristics of the product, established both in the initial stage of the product and where it is mixed, in accordance with the method by which it is used, with water or with yoghurt.

(see para. 32, operative part 1)

2.Regulation No178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety constitutes an additional set of rules in relation to Directive 2002/46 concerning food supplements, the application of which is precluded to the extent to which a Community rule, such as that directive, contains specific provisions for certain categories of foodstuffs.

(see para. 39, operative part 2)

3.Only the provisions of Community law specific to medicinal products apply to a product which satisfies equally well the conditions for classification as a foodstuff for the purposes of Regulation No178/2002 laying down the general principles and requirements of food law, establishing a European Food Safety Authority and laying down procedures in matters of food safety and the conditions for classification as a medicinal product for the purposes of Directive 2001/83 on the Community code relating to medicinal products for human use.

(see para. 45, operative part 3)

4.The pharmacological properties of a product are the factor on the basis of which the authorities of the Member States must ascertain, in the light of the potential capacities of the product, whether it may, for the purposes of the second subparagraph of Article 1(2) of Directive 2001/83 on the Community code relating to medicinal products for human use, be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings (medicinal product ‘by function’). The risk that the use of a product may entail for health is an autonomous factor that must also be taken into consideration by the competent national authorities in the context of the classification of the product as a medicinal product.

(see para. 54, operative part 4)

5.A product which constitutes a medicinal product within the meaning of Directive 2001/83 on the Community code relating to medicinal products for human use may be imported into another Member State only upon acquisition of a marketing authorisation issued in accordance with the provisions of that directive, even where it is lawfully marketed as a foodstuff in another Member State.

(see para. 60, operative part 5)

6.The concept of ‘upper safe levels’ in Article 5(1)(a) of Directive 2002/46 concerning food supplements is of no importance for the purposes of drawing a distinction between medicinal products and foodstuffs.

(see para. 64, operative part 6)

7.In the context of an evaluation by a Member State of the risks that foodstuffs or food supplements may constitute for human health, the criterion of the existence of a nutritional need in the population of the Member State may be taken into consideration. However, the absence of such a need does not in itself suffice to justify, either under Article 30EC or under Article 12 of Directive 2002/46 concerning food supplements, a complete ban on marketing foodstuffs or food supplements lawfully manufactured or placed on the market in another Member State.

In that regard, the fact that the discretion enjoyed by the national authorities as regards the establishment of an absence of nutritional need is subject to only limited review by the courts is compatible with Community law, on condition that the national procedure for judicial review of the decisions in that regard taken by those authorities enables the court or tribunal seised of an application for annulment of such a decision effectively to apply the relevant principles and rules of Community law when reviewing its legality.

(see paras 73, 79, operative part 7-8)

8.Article 1(2) of Regulation No258/97 concerning novel foods and novel food ingredients is to be interpreted as meaning that a food or a food ingredient has not been used for human consumption to a significant degree within the Community if, when all the circumstances of the case are taken into account, it is established that that food or that food ingredient has not been consumed in a significant quantity by humans in any of the Member States before the reference date. 15 May 1997 is the reference date for the purpose of determining the extent of human consumption of that food or food ingredient.

(see para. 88, operative part 9)

9.A national court cannot refer questions on the classification of products to the European Food Safety Authority established by Regulation No178/2002. An opinion delivered by that Authority, possibly in a matter forming the subject-matter of a dispute pending before a national court, may constitute evidence that that court should take into consideration in the context of that dispute.

(see para. 94, operative part 10)

10.In proceedings under Article 234EC, which are based on a clear separation of functions between the national courts and the Court of Justice, any assessment of the facts in the case is a matter for the national court. The Court therefore has no jurisdiction to give a ruling on the facts in the main proceedings or to apply the rules of Community law which it has interpreted to national measures or situations, since those questions are matters for the exclusive jurisdiction of the national court.

(see para. 96)