CELEX: C2003/275/43
Language: en
Date: 2003-11-15 00:00:00
Title: Case C-317/03: Reference for a preliminary ruling by the Oberverwaltungsgericht für das Land Nordrhein-Westfalen by order of that Court of 7 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

15.11.2003            EN                         Official Journal of the European Union                                           C 275/27
           products analogously? If not, can the German State,                2.    If the Court of Justice concludes that the product in
           without thereby infringing Community law, evade                          question is medicinal, but that in those Member
           an obligation which a German court intends to                            States where it has hitherto been regarded as a
           impose on it to adopt a decision of general appli-                       foodstuff it should continue to be a foodstuff, that
           cation under Paragraph 47a of the LMBG (applied                          raises problems for the referring Chamber such as
           analogously) if it, or the authority responsible for                     those underlying the questions in B VI, in conjunc-
           food but not medicines, objects that because in                          tion with those in B III. Reference is made to those
           the German classification system the product is                          questions and the observations thereon and an
           medicinal no decision of general application under                       answer is requested.
           Paragraph 47a of the LMBG (analogously) may be
           adopted,                                                      B.   In the event that — as has been the case hitherto — the
                                                                              questions posed in section A above are to be answered
           a)    because the body competent to adopt decisions                not by the Court of Justice but by the national courts, the
                 of general application under Paragraph 47a of                replies are, in this Chamber’s view, needed to the
                 the LMBG is not competent for medicines also,                following questions:
           b)    because the product is not authorised as a                   I.    a)    Is the contested product to be classified accord-
                 medicine?                                                                ing to the first and second paragraphs of
                                                                                          Article 2, in conjunction with point (d) of the
      VII. If the Court declines itself to reply to the questions                         third paragraph of Article 2 of Regulation (EC)
           posed in section A, may the national court then                                No 178/2002 of the European Parliament and
           direct questions on the classification of products or                          of the Council of 28 January 2002 laying down
           indeed scientific or methodological questions to the                           the general principles and requirements of food
           European Food Authority and to what extent are                                 law, establishing the European Food Safety
           any guidelines provided by that authority binding                              Authority and laying down procedures in mat-
           on the national court?                                                         ters of food safety (OJ 2002 L 31, p. 1, ‘the
                                                                                          Basic Regulation’), or — once the period for
                                                                                          transposition expires on 31 July 2003 —
                                                                                          according to Directive 2002/46/EC of the
                                                                                          European Parliament and of the Council of
                                                                                          10 June 2002 on the approximation of the
Reference for a preliminary ruling by the Oberverwal-                                     laws of the Member States relating to food
tungsgericht für das Land Nordrhein-Westfalen by order                                    supplements (OJ 2002 L 183, p. 51, ‘the Food
of that Court of 7 July 2003 in the administrative                                        Supplements Directive’), and if so according to
proceedings between Orthica BV against Bundesrepublik                                     which parts of the directive?
Deutschland, represented by the Federal Ministry of
Consumer Protection, Nutrition and Agriculture; Inter-                              b)    If the first and second paragraphs of Article 2,
vener: the representative of the public interest at the                                   in conjunction with point (d) of the third
Oberverwaltungsgericht für das Land Nordrhein-                                            paragraph of Article 2 of the Basic Regulation
                           Westfalen                                                      applies, the following question arises: is it the
                                                                                          case that it is no longer the product’s main
                        (Case C-317/03)                                                   (objective) purpose that is the decisive factor,
                                                                                          but rather that a product which meets the
                        (2003/C 275/43)                                                   criteria for both a food and a medicine is,
                                                                                          legally speaking, always — and only — a
                                                                                          medicinal product? How material for these
Reference has been made to the Court of Justice of the                                    purposes is the type of product and how
European Communities by order of the Oberverwaltungsge-                                   material the individual product?
richt für das Land Nordrhein-Westfalen (Higher Administrative
Court for the Land of Nordrhein-Westfalen) of 7 July 2003,                    II.   a)    How is the term ‘pharmacological effect’, which
received at the Court Registry on 24 July 2003, for a                                     is critical for the purposes of classification,
preliminary ruling in the administrative proceedings between                              inter alia, under the first and second paragraphs
Orthica BV against Bundesrepublik Deutschland, represented                                of Article 2, in conjunction with point (d) of
by the Federal Ministry of Consumer Protection, Nutrition and                             the third paragraph of Article 2 of the Basic
Agriculture; Intervener: the representative of the public interest                        Regulation, to be defined for the purposes
at the Oberverwaltungsgericht für das Land Nordrhein-                                     of Community law? In particular, does the
Westfalen on the following questions:                                                     definition include a requirement that there be a
                                                                                          health risk?
A.    1.   Is the contested product
                                                                                    b)    Now that Directive 2001/83/EC of the Euro-
           ‘Acid Free C-1000’                                                             pean Parliament and of the Council of 6 Nov-
                                                                                          ember 2001 on the Community code relating
           a foodstuff (perhaps in the form of a food sup-                                to medicinal products for human use has,
           plement) or a medicinal product? Is this finding                               by the second sentence of Article 1(2) (on
           binding on all the Member States?                                              ‘functional’ medicinal products), introduced the
 ---pagebreak--- C 275/28             EN                         Official Journal of the European Union                                        15.11.2003
              term ‘physiological functions’, the further ques-                    Articles 28 and 30 EC, not to apply the rule in
              tion arises as to the meaning of that term and                       Paragraph 47a of the LMBG to such medicinal
              its relation to the term ‘pharmacological effect’.                   products analogously? If not, can the German State,
                                                                                   without thereby infringing Community law, evade
                                                                                   an obligation which a German court intends to
    III. Does the view expressed by the Court of Justice in                        impose on it to adopt a decision of general appli-
         Case 227/82 van Bennekom [1983] ECR 3883,                                 cation under Paragraph 47a of the LMBG (applied
         paragraph 39 on the general classification of vitamin                     analogously) if it, or the authority responsible for
         preparations, in which it said that it must be possible                   food but not medicines, objects that because in
         to import a product that may be marketed as a food                        the German classification system the product is
         in the Member State in which it was manufactured                          medicinal no decision of general application under
         by the granting of a marketing authorisation if, even                     Paragraph 47a of the LMBG (analogously) may be
         though it is regarded as a medicine in the Member                         adopted,
         State of import, a marketing authorisation is com-
         patible with the requirements of health protection,
         also apply to the product at issue here, and does the                     a)    because the body competent to adopt decisions
         Court of Justice adhere to its view in the light of                             of general application under Paragraph 47a of
         subsequent Community law?                                                       the LMBG is not competent for medicines also,
                                                                                   b)    because the product is not authorised as a
    IV. a)    In so far as the term ‘health risk’ is relevant to                         medicine?
              the questions in sections II or III, or to other
              applicable Community law, such as Articles 28                   VII. If the Court declines itself to reply to the questions
              and 30 EC: Is the relevant threshold the ‘upper
                                                                                   posed in section A, may the national court then
              safe level’ or should it be reduced, say, because
                                                                                   direct questions on the classification of products or
              the substances in question are also ingested
                                                                                   indeed scientific or methodological questions to the
              with food and/or because — at least where                            European Food Authority and to what extent are
              they are taken long-term — regard may have
                                                                                   any guidelines provided by that authority binding
              to be had to the various consumer groups and
                                                                                   on the national court?
              their different sensitivities? How are the words
              ‘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 8 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
         b)   If so, is it compatible with Community law                                        (Case C-318/03)
              for the authority to have a discretion under
              national law that is subject to only limited                                      (2003/C 275/44)
              review by the courts?
    VI. If in regard to the questions posed in section III the
         Court confirms the judgment in van Bennekom and                Reference has been made to the Court of Justice of the
         there is no incompatibility in this case with the              European Communities by order of the Oberverwaltungsge-
         requirements of health protection, how can the                 richt für das Land Nordrhein-Westfalen (Higher Administrative
         request for marketing authorisation be successfully            Court for the Land of Nordrhein-Westfalen) of 8 July 2003,
         pursued? Can a decision of general application under           received at the Court Registry on 24 July 2003, for a
         Paragraph 47a of the LMBG be refused, without                  preliminary ruling in the administrative proceedings between
         Community law being infringed, on the basis that               Orthica BV against Bundesrepublik Deutschland, represented
         in the German classification system a product is               by the Federal Ministry of Consumer Protection, Nutrition and
         medicinal, whereas it can be marketed as a foodstuff           Agriculture; Intervener: the representative of the public interest
         in the Member State where it was manufactured? Is              at the Oberverwaltungsgericht für das Land Nordrhein-
         it compatible with Community law, and in particular            Westfalen on the following questions: