CELEX: C2003/275/41
Language: en
Date: 2003-11-15 00:00:00
Title: Case C-299/03: Reference for a preliminary ruling by the Oberverwaltungsgericht für das Land Nordrhein-Westfalen by order of that Court of 4 July 2003 in the administrative proceedings between Orthica BV against Bundesrepublik Deutschland, represented by the Federal Ministry of Consumer Protection, Nutrition and Agriculture; Intervener: the representative of the public interest at the Oberverwaltungsgericht für das Land Nordrhein-Westfalen

C 275/24                EN                        Official Journal of the European Union                                       15.11.2003
Reference for a preliminary ruling by the Oberverwal-                                    No 178/2002 of the European Parliament and
tungsgericht für das Land Nordrhein-Westfalen by order                                   of the Council of 28 January 2002 laying down
of that Court of 4 July 2003 in the administrative                                       the general principles and requirements of food
proceedings between Orthica BV against Bundesrepublik                                    law, establishing the European Food Safety
Deutschland, represented by the Federal Ministry of                                      Authority and laying down procedures in mat-
Consumer Protection, Nutrition and Agriculture; Inter-                                   ters of food safety (OJ 2002 L 31, p. 1, ‘the
vener: the representative of the public interest at the                                  Basic Regulation’), or — once the period for
Oberverwaltungsgericht für das Land Nordrhein-                                           transposition expires on 31 July 2003 —
                             Westfalen                                                   according to Directive 2002/46/EC of the
                                                                                         European Parliament and of the Council of
                                                                                         10 June 2002 on the approximation of the
                          (Case C-299/03)                                                laws of the Member States relating to food
                                                                                         supplements (OJ 2002 L 183, p. 51, ‘the Food
                                                                                         Supplements Directive’), and if so according to
                          (2003/C 275/41)                                                which parts of the directive?
                                                                                    b)   If the first and second paragraphs of Article 2,
                                                                                         in conjunction with point (d) of the third
                                                                                         paragraph of Article 2 of the Basic Regulation
Reference has been made to the Court of Justice of the                                   applies, the following question arises: is it the
European Communities by order of the Oberverwaltungsge-                                  case that it is no longer the product’s main
richt für das Land Nordrhein-Westfalen (Higher Administrative                            (objective) purpose that is the decisive factor,
Court for the Land of Nordrhein-Westfalen) of 4 July 2003,                               but rather that a product which meets the
received at the Court Registry on 11 July 2003, for a                                    criteria for both a food and a medicine is,
preliminary ruling in the administrative proceedings between                             legally speaking, always — and only — a
Orthica BV against Bundesrepublik Deutschland, represented                               medicinal product? How material for these
by the Federal Ministry of Consumer Protection, Nutrition and                            purposes is the type of product and how
Agriculture; Intervener: the representative of the public interest                       material the individual product?
at the Oberverwaltungsgericht für das Land Nordrhein-
Westfalen on the following questions:
                                                                               II.  a)   How is the term ‘pharmacological effect’, which
                                                                                         is critical for the purposes of classification,
A.    1.    Is the contested product                                                     inter alia, under the first and second paragraphs
                                                                                         of Article 2, in conjunction with point (d) of
                                                                                         the third paragraph of Article 2 of the Basic
            ‘C 1000 (1 000 mg Vitamin C with bioflavonoid                                Regulation, to be defined for the purposes
            complex)’                                                                    of Community law? In particular, does the
                                                                                         definition include a requirement that there be a
            a foodstuff (perhaps in the form of a food sup-                              health risk?
            plement) or a medicinal product? Is this finding
            binding on all the Member States?                                       b)   Now that Directive 2001/83/EC of the Euro-
                                                                                         pean Parliament and of the Council of 6 Nov-
      2.    If the Court of Justice concludes that the product in                        ember 2001 on the Community code relating
            question is medicinal, but that in those Member                              to medicinal products for human use has,
            States where it has hitherto been regarded as a                              by the second sentence of Article 1(2) (on
            foodstuff it should continue to be a foodstuff, that                         ‘functional’ medicinal products), introduced the
            raises problems for the referring Chamber such as                            term ‘physiological functions’, the further ques-
            those underlying the questions in B VI, in conjunc-                          tion arises as to the meaning of that term and
            tion with those in B III. Reference is made to those                         its relation to the term ‘pharmacological effect’.
            questions and the observations thereon and an
            answer is requested.                                               III. Does the view expressed by the Court of Justice in
                                                                                    Case 227/82 van Bennekom [1983] ECR 3883,
B.    In the event that — as has been the case hitherto — the                       paragraph 39 on the general classification of vitamin
      questions posed in section A above are to be answered                         preparations, in which it said that it must be possible
      not by the Court of Justice but by the national courts, the                   to import a product that may be marketed as a food
      replies are, in this Chamber’s view, needed to the                            in the Member State in which it was manufactured
      following questions:                                                          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 com-
      I.    a)    Is the contested product to be classified accord-                 patible with the requirements of health protection,
                  ing to the first and second paragraphs of                         also apply to the product at issue here, and does the
                  Article 2, in conjunction with point (d) of the                   Court of Justice adhere to its view in the light of
                  third paragraph of Article 2 of Regulation (EC)                   subsequent Community law?
 ---pagebreak--- 15.11.2003           EN                        Official Journal of the European Union                                          C 275/25
    IV. a)    In so far as the term ‘health risk’ is relevant to                  b)    because the product is not authorised as a
              the questions in sections II or III, or to other                          medicine?
              applicable Community law, such as Articles 28
              and 30 EC: Is the relevant threshold the ‘upper                VII. If the Court declines itself to reply to the questions
              safe level’ or should it be reduced, say, because                   posed in section A, may the national court then
              the substances in question are also ingested                        direct questions on the classification of products or
              with food and/or because — at least where                           indeed scientific or methodological questions to the
              they are taken long-term — regard may have                          European Food Authority and to what extent are
              to be had to the various consumer groups and                        any guidelines provided by that authority binding
              their different sensitivities? How are the words                    on the national court?
              ‘reference intakes for the population’ within the
              meaning of Article 5 of the Food Supplements
              Directive to be defined?
         b)   Is it an infringement of Community law for the
              specialist authorities to have a discretion under
              national law to determine (individual) upper
                                                                       Reference for a preliminary ruling by the Oberverwal-
              safe levels and any (individual) reductions that
                                                                       tungsgericht für das Land Nordrhein-Westfalen by order
              is subject to only limited review by the courts?
                                                                       of that Court of 3 July 2003 in the administrative
                                                                       proceedings between Orthica BV against Bundesrepublik
    V.   a)   If a product may be marketed in at least one             Deutschland, represented by the Federal Ministry of
              other Member State as a foodstuff, is the fact           Consumer Protection, Nutrition and Agriculture; Inter-
              that there is no ‘nutritional need’ for that             vener: the representative of the public interest at the
              product in Germany significant in terms of the           Oberverwaltungsgericht für das Land Nordrhein-
              freedom to market the product in Germany?                                           Westfalen
                                                                                               (Case C-316/03)
         b)   If so, is it compatible with Community law
              for the authority to have a discretion under
              national law that is subject to only limited                                     (2003/C 275/42)
              review by the courts?
    VI. If in regard to the questions posed in section III the         Reference has been made to the Court of Justice of the
         Court confirms the judgment in van Bennekom and               European Communities by order of the Oberverwaltungsge-
         there is no incompatibility in this case with the             richt für das Land Nordrhein-Westfalen (Higher Administrative
         requirements of health protection, how can the                Court for the Land of Nordrhein-Westfalen) of 3 July 2003,
         request for marketing authorisation be successfully           received at the Court Registry on 24 July 2003, for a
         pursued? Can a decision of general application under          preliminary ruling in the administrative proceedings between
         Paragraph 47a of the LMBG be refused, without                 Orthica BV against Bundesrepublik Deutschland, represented
         Community law being infringed, on the basis that              by the Federal Ministry of Consumer Protection, Nutrition and
         in the German classification system a product is              Agriculture; Intervener: the representative of the public interest
         medicinal, whereas it can be marketed as a foodstuff          at the Oberverwaltungsgericht für das Land Nordrhein-
         in the Member State where it was manufactured? Is             Westfalen on the following questions:
         it compatible with Community law, and in particular
         Articles 28 and 30 EC, not to apply the rule in               A.    1.   Is the contested product
         Paragraph 47a of the LMBG to such medicinal
         products analogously? If not, can the German State,
                                                                                  ‘OPC 85’
         without thereby infringing Community law, evade
         an obligation which a German court intends to
         impose on it to adopt a decision of general appli-                       a foodstuff (perhaps in the form of a food sup-
         cation under Paragraph 47a of the LMBG (applied                          plement) or a medicinal product? Is this finding
         analogously) if it, or the authority responsible for                     binding on all the Member States?
         food but not medicines, objects that because in
         the German classification system the product is                     2.   If the Court of Justice concludes that the product in
         medicinal no decision of general application under                       question is medicinal, but that in those Member
         Paragraph 47a of the LMBG (analogously) may be                           States where it has hitherto been regarded as a
         adopted,                                                                 foodstuff it should continue to be a foodstuff, that
                                                                                  raises problems for the referring Chamber such as
                                                                                  those underlying the questions in B VI, in conjunc-
         a)   because the body competent to adopt decisions                       tion with those in B III. Reference is made to those
              of general application under Paragraph 47a of                       questions and the observations thereon and an
              the LMBG is not competent for medicines also,                       answer is requested.