HLH Warenvertriebs GmbH (C-211/03) and Orthica BV (C-299/03 and C-316/03 to C-318/03) v Bundesrepublik Deutschland.
Date: 2005-06-09
25. It was in those circumstances that the Oberverwaltungsgericht für das Land Nordrhein-Westfalen decided to stay proceedings and to refer the following questions to the Court for a preliminary ruling in Case C-211/03:
‘1. (a) Is the contested product “Lactobact omni FOS” a foodstuff (perhaps in the form of a food supplement) or a medicinal product? Is this classification binding on all the Member States?
(b) Is it relevant when classifying the product that, according to the directions for use, it is intended to be dissolved in water or in yoghurt? Or is the condition in which it is imported the determining factor?
(c) If the Court of Justice concludes that the product in question is medicinal, but that in those Member States where it has hitherto been regarded as a foodstuff it should continue to be a foodstuff, that raises problems for the referring Chamber such as those underlying Question 2(f), in conjunction with question 2(c). Reference is made to those questions and the observations thereon and an answer is requested.
(d) If “Lactobact omni FOS” is a foodstuff (food supplement), is it then a novel food within the meaning of Regulation … No 258/97 …? What is the relationship between the various legal bases?
2. In the event that – as has been the case hitherto – Question 1(a) to (d) is to be answered not by the Court of Justice but by the national courts, guidance is none the less sought on how correctly to resolve Question 1(b) from a Community law standpoint, in so far as Community law is applicable.
In addition, the following questions arise:
(a) (i) Is the contested product to be classified according to the first and second paragraphs of Article 2, in conjunction with point (d) of the third paragraph of Article 2 of Regulation No 178/2002 … or – once the period for transposition expires on 31 July 2003 – according to Directive 2002/46 … , and if so according to which parts of the directive?
(ii) If the first and second paragraphs of Article 2 in conjunction with point (d) of the third paragraph of Article 2 of … Regulation [No 178/2002] apply, the following question arises: is it the case that it is no longer the product’s main (objective) purpose that is the decisive factor, but rather that a product which meets the criteria for both a food and a medicine is, legally speaking, always – and only – a medicinal product? How material for these purposes is the type of product and how material the individual product?
(b) How is the term “pharmacological effect”, which is critical for the purposes of classification, inter alia, under the first and second paragraphs of Article 2, in conjunction with point (d) of the third paragraph of Article 2 of … Regulation [No 178/2002], to be defined for the purposes of Community law?
In particular, does the definition include a requirement that there be a health risk?
(c) Does the view expressed by the Court of Justice at paragraph 39 of its judgment in Case 227/82 Van Bennekom  [1983] ECR 3883 on the general classification of vitamin preparations, in which it said that it must be possible to import a product that may be marketed as a food in the Member State in which it was manufactured by the granting of a marketing authorisation if, even though it is regarded as a medicine in the Member State of import, a marketing authorisation is compatible with the requirements of health protection, also apply to probiotic products of the kind at issue here, and dose the Court of Justice adhere to its view in the light of subsequent Community law?
(d) (i) In so far as the term “health risk” is relevant to Question 2(b) and (c), or to other applicable Community law, such as Articles 28 EC and 30 EC:
Is the relevant threshold the “upper safe level” or should it be reduced, say, because the substances in question are also ingested with food and/or because – at least where they are taken long-term – regard may have to be had to the various consumer groups and their different sensitivities?
(ii) Is it an infringement of Community law for the specialist authorities to have a discretion under national law to determine (individual) upper safe levels and any (individual) reductions that is subject to only limited review by the courts?
(e) (i) If a product may be marketed in at least one other Member State as a foodstuff, is the fact that the competent German authority essentially says that in Germany there is no “nutritional need” for that product significant in terms of the freedom to market the product as a foodstuff (food supplement) in Germany?
(ii) If so, is it compatible with Community law for the authority to have a discretion under national law that is subject to only limited review by the courts?
(f) If in regard to Question 2(c) the Court confirms the judgment in Van Bennekom  and there is no incompatibility in this case with the requirements of health protection, how can the request for marketing authorisation be successfully pursued? Can a decision of general application under Paragraph 47a of the LMBG be refused, without Community law being infringed, on the basis that in the German classification system a product is medicinal, whereas it can be marketed as a foodstuff in the Member State where it was manufactured? Is it compatible with Community law, and in particular with Articles 28 EC and 30 EC, not to apply the rule in Paragraph 47a of the LMBG to such medicinal products analogously? If not, can the German State, without thereby infringing Community law, evade an obligation which a German court intends to impose on it to adopt a decision of general application under Paragraph 47a of the LMBG (applied analogously) if it, or the authority responsible for food but not medicines, objects that, because in the German classification system the product is medicinal, no decision of general application under paragraph 47a of the LMBG (analogously) may be adopted:
(i) because the body competent to adopt decisions of general application under Paragraph 47a of the LMBG is not competent for medicines also;
(ii) because the product is not authorised as a medicine?
(g) If as a result of the Court’s replies it transpires that the product in question is a foodstuff (including, possibly, a food supplement) but is in any event not a medicine, questions will arise for the Chamber on the applicability of … Regulation [No 258/97], which takes precedence over Paragraph 47a of the LMBG, and the effect of which may be to remove any interest in legal protection in this case. The Chamber therefore asks:
How is the phrase “which have not hitherto been used for human consumption to a significant degree” in Article 1(2) of … Regulation [No 258/97] to be interpreted? Is it sufficient that the Netherlands Official Gazette of 16 February 1995 declared trading in a probiotic similar to the contested product called “Ecologic 316” to be permissible and that, according to the invoice of 20 May 1996, a delivery of Ecologic 316 was made to the applicant, or alternatively what are the minimum requirements that must be met in order for there to have been use to a significant degree hitherto for the purposes of Article 1(2) of … Regulation [No 258/97]? What is the starting point for interpreting the words “not hitherto”?
(h) If the Court declines itself to reply to Question 1(a) to (d), may the national court then direct questions on the classification of products or indeed scientific or methodological questions to the European Food Safety Authority and to what extent are any guidelines provided by that authority binding on the national court? Can (or must) such guidelines be reviewed by the Community judicature alone or by the referring national court also?’
30. For the purposes of determining whether a product must be classified as a medicinal product or as a foodstuff within the meaning of the Community regulations, the competent national authority must decide on a case-by-case basis, taking account of all the characteristics of the product, in particular its composition, its pharmacological properties, to the extent to which they can be established in the present state of scientific knowledge, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail (see Van Bennekom , cited above, paragraph 29; Case C-369/88 Delattre  [1991] ECR I-1487, paragraphs 26 and 35; Case C-60/89 Monteil and Samanni  [1991] ECR I-1547, paragraph 29; Case C-112/89 Upjohn  (‘ Upjohn I ’) [1991] ECR I-1703, paragraph 23; Case C-290/90 Commission  v Germany  [1992] ECR I-3317, paragraph 17; and Case C-150/00 Commission  v Austria  [2004] ECR I-3891, paragraph 64).
40. By Question 2(a)(ii), the referring court asks essentially whether 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 and the conditions for classification as a medicinal product.
43. It follows that 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 and the conditions for classification as a medicinal product (see, to that effect, Case C-219/91 Ter Voort  [1992] ECR I-5485, paragraphs 19 and 20).
49. Directive 2001/83 thus provides two definitions of medicinal product: one definition ‘by presentation’ and another definition ‘by function’. A product is a medicinal product if it comes within one or other of those two definitions.
51. As stated at paragraph 30 of this judgment, for the purposes of determining whether a product comes within the definition of a medicinal product ‘by function’ within the meaning of Directive 2001/83, the national authorities, acting under the supervision of the courts, must proceed on a case-by-case basis, taking account of all the characteristics of the product, in particular its composition, its pharmacological properties, to the extent to which they can be established in the present state of scientific knowledge, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail.
52. 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, be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings.
53. The risk to health, mentioned by the referring court, 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 ‘by function’ (see, to that effect, Commission  v Austria , cited above, paragraph 65).
56. As Community law stands, it is still possible that differences will continue to exist between Member States in the classification of products as medicinal products or as foodstuffs. Thus, the fact that a product is classified as a foodstuff in another Member State cannot prevent it from being classified as a medicinal product in the Member State of importation, if it displays the characteristics of such a product (see Case C-387/99 Commission  v Germany  [2004] ECR I-3773, paragraphs 52 and 53, and Commission  v Austria , paragraphs 59 and 60).
57. If a product is correctly classified as a medicinal product for the purposes of Directive 2001/83, its marketing is subject to the issue of marketing authorisation pursuant to Article 6(1) of that directive. The procedure governing the issue and the effects of such authorisation are set out in detail in Articles 7 to 39 of that directive.
58. In so far as Directive 2001/83 harmonises the procedures for the production, distribution and use of medicinal products, it is no longer possible for Member States to adopt national measures which restrict the free movement of goods on the basis of Article 30 EC, in particular on grounds of the protection of health of humans (see Case C-1/96 Compassion in World Farming  [1998] ECR I-1251, paragraph 47 and the case-law cited).
68. In default of harmonisation and to the extent that uncertainties continue to exist in the current state of scientific research, Member States may, in certain conditions, restrict on the basis of Article 30 EC the marketing of foodstuffs lawfully marketed in another Member State on grounds of the protection of the health and life of humans (see, to that effect, Case C-192/01 Commission  v Denmark  [2003] ECR I-9693, paragraph 42).
69. In such a context, the criterion of the nutritional need of the population of a Member State can play a role in its detailed assessment of the risks which the addition of nutrients to foodstuffs may pose for public health. However, the absence of such a need cannot, by itself, justify a total prohibition, on the basis of Article 30 EC, of the marketing of foodstuffs lawfully manufactured and/or marketed in other Member States ( Commission  v Denmark , cited above, paragraph 54).
75. At paragraph 34 of its judgment in Case C-120/97 Upjohn  (‘ Upjohn II’ ) [1999] ECR I-223, the Court held that where a Community authority is called upon, in the performance of its duties, to make complex assessments, it enjoys a wide measure of discretion, the exercise of which is subject to limited judicial review in the course of which the Community judicature may not substitute its assessment of the facts for the assessment made by the authority concerned. Thus, in such cases, the Community judicature must restrict itself to examining the accuracy of the findings of fact and law made by the authority concerned and to verifying, in particular, that the action taken by the authority is not vitiated by a manifest error or misuse of powers and that it clearly did not exceed the bounds of its discretion.
76. The Court concluded, at paragraph 35 of the judgment in Upjohn II , that Community law does not require the Member States to establish a procedure for judicial review of national decisions revoking marketing authorisations, taken under Directive 65/65 and in the exercise of complex assessments, which involve a more extensive review than that carried out by the Court in similar cases.
77. The Court none the less observed, at paragraph 36 of the judgment in Upjohn II , that any national procedure for judicial review of decisions of national authorities revoking marketing authorisations must enable 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.
79. It follows that the answer to Question 2(e)(ii) must be that 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.
Question 2(g)
81. Regulation No 258/97 is aimed at the placing on the market of novel foods and novel food ingredients, such as those containing genetically modified organisms.
82. Article 1(2) of that regulation seeks to delimit the scope of the regulation, notably by defining what is to be understood by novel foods and food ingredients. According to that definition, ‘novel’ food and food ingredients are those ‘which have not hitherto been used for human consumption to a significant degree within the Community’.
87. As regards the reference date which must be taken into account in order to determine the extent of the human consumption of the food or food ingredient in question, it must be held that the term ‘hitherto’ in Article 1(2) of Regulation No 258/97 refers to the date on which that regulation entered into force. In accordance with Article 15 of that regulation, that date is 15 May 1997.
96. In proceedings under Article 234 EC, 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 Case C-318/98 Fornasar and Others  [2000] ECR I-4785, paragraphs 31 and 32).