CELEX: C2003/275/44
Language: en
Date: 2003-11-15 00:00:00
Title: Case C-318/03: Reference for a preliminary ruling by the Oberverwaltungsgericht für das Land Nordrhein-Westfalen by order of that Court of 8 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 275/28             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:
 ---pagebreak--- 15.11.2003            EN                           Official Journal of the European Union                                         C 275/29
A.  1.    Is the contested product                                                   b)   Now that Directive 2001/83/EC of the Euro-
                                                                                          pean Parliament and of the Council of 6 Nov-
          ‘E-400’ (natural vitamin E)                                                     ember 2001 on the Community code relating
                                                                                          to medicinal products for human use has,
          a foodstuff (perhaps in the form of a food sup-                                 by the second sentence of Article 1(2) (on
          plement) or a medicinal product? Is this finding                                ‘functional’ medicinal products), introduced the
          binding on all the Member States?                                               term ‘physiological functions’, the further ques-
    2.    If the Court of Justice concludes that the product in                           tion arises as to the meaning of that term and
          question is medicinal, but that in those Member                                 its relation to the term ‘pharmacological effect’.
          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 the questions in B VI, in conjunc-                   III. Does the view expressed by the Court of Justice in
          tion with those in B III. Reference is made to those                       Case 227/82 van Bennekom [1983] ECR 3883,
          questions and the observations thereon and an                              paragraph 39 on the general classification of vitamin
          answer is requested.                                                       preparations, in which it said that it must be possible
                                                                                     to import a product that may be marketed as a food
B.  In the event that — as has been the case hitherto — the                          in the Member State in which it was manufactured
    questions posed in section A above are to be answered                            by the granting of a marketing authorisation if, even
    not by the Court of Justice but by the national courts, the                      though it is regarded as a medicine in the Member
    replies are, in this Chamber’s view, needed to the                               State of import, a marketing authorisation is com-
    following questions:                                                             patible with the requirements of health protection,
                                                                                     also apply to the product at issue here, and does the
    I.    a)    Is the contested product to be classified accord-                    Court of Justice adhere to its view in the light of
                ing to the first and second paragraphs of                            subsequent Community law?
                Article 2, in conjunction with point (d) of the
                third paragraph of Article 2 of Regulation (EC)
                No 178/2002 of the European Parliament and
                of the Council of 28 January 2002 laying down                   IV. a)    In so far as the term ‘health risk’ is relevant to
                the general principles and requirements of food                           the questions in sections II or III, or to other
                law, establishing the European Food Safety                                applicable Community law, such as Articles 28
                Authority and laying down procedures in mat-                              and 30 EC: Is the relevant threshold the ‘upper
                ters of food safety (OJ 2002 L 31, p. 1, ‘the                             safe level’ or should it be reduced, say, because
                Basic Regulation’), or — once the period for                              the substances in question are also ingested
                transposition expires on 31 July 2003 —                                   with food and/or because — at least where
                according to Directive 2002/46/EC of the                                  they are taken long-term — regard may have
                European Parliament and of the Council of                                 to be had to the various consumer groups and
                10 June 2002 on the approximation of the                                  their different sensitivities? How are the words
                laws of the Member States relating to food                                ‘reference intakes for the population’ within the
                supplements (OJ 2002 L 183, p. 51, ‘the Food                              meaning of Article 5 of the Food Supplements
                Supplements Directive’), and if so according to                           Directive to be defined?
                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                       b)   Is it an infringement of Community law for the
                                                                                          specialist authorities to have a discretion under
                applies, the following question arises: is it the
                                                                                          national law to determine (individual) upper
                case that it is no longer the product’s main
                (objective) purpose that is the decisive factor,                          safe levels and any (individual) reductions that
                but rather that a product which meets the                                 is subject to only limited review by the courts?
                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                         V.   a)   If a product may be marketed in at least one
                material the individual product?                                          other Member State as a foodstuff, is the fact
                                                                                          that there is no ‘nutritional need’ for that
    II.   a)    How is the term ‘pharmacological effect’, which                           product in Germany significant in terms of the
                is critical for the purposes of classification,                           freedom to market the product in Germany?
                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
                Regulation, to be defined for the purposes                           b)   If so, is it compatible with Community law
                of Community law? In particular, does the                                 for the authority to have a discretion under
                definition include a requirement that there be a                          national law that is subject to only limited
                health risk?                                                              review by the courts?
 ---pagebreak--- C 275/30              EN                         Official Journal of the European Union                                        15.11.2003
      VI. If in regard to the questions posed in section III the         The applicant claims that the Court should
           Court confirms the judgment in van Bennekom and
           there is no incompatibility in this case with the
           requirements of health protection, how can the                1.    declare that by failing to adopt within the period laid
           request for marketing authorisation be successfully                 down all the laws and administrative provisions required
           pursued? Can a decision of general application under                to transpose Council Directive 91/439/EEC of 29 July
           Paragraph 47a of the LMBG be refused, without                       1991 on driving licences (1) the Federal Republic of
           Community law being infringed, on the basis that                    Germany has failed to fulfil its obligations under the EC
           in the German classification system a product is                    Treaty and that Directive;
           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           2.    Order the defendant to pay the costs.
           Articles 28 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 appli-            Pleas in law and main arguments
           cation under Paragraph 47a of the LMBG (applied
           analogously) if it, or the authority responsible for          The Commission takes the view that German law is inconsist-
           food but not medicines, objects that because in               ent with Directive 91/439/EEC on the following points:
           the German classification system the product is
           medicinal no decision of general application under
           Paragraph 47a of the LMBG (analogously) may be                —     Minimum age for direct access to heavy motor-cycles in
           adopted,                                                            category A
           a)    because the body competent to adopt decisions                 Paragraph 6.2, second sentence, of the regulation on
                 of general application under Paragraph 47a of                 granting persons permission to drive on the road (1998
                 the LMBG is not competent for medicines also,                 regulation on permission to drive, hereinafter ‘the FeV’)
                                                                               provides for a minimum age of 25 for direct access to
           b)    because the product is not authorised as a                    heavy motor-cycles in category A. Article 6(1)(b), first
                 medicine?                                                     indent, last paragraph, of the Directive, however, provides
                                                                               for a minimum age of 21 years for direct access.
      VII. If the Court declines itself to reply to the questions
           posed in section A, may the national court then
           direct questions on the classification of products or         —     Permission to drive motor vehicles in category DE with
           indeed scientific or methodological questions to the                permission to drive vehicles in categories C1E and D
           European Food Authority and to what extent are
           any guidelines provided by that authority binding                   Under paragraph 6.3.6 of the FeV, it is permissible to
           on the national court?                                              drive vehicles in category DE with a driving permit for
                                                                               categories C1E and D, whereas Article 5(2)(b) of the
                                                                               Directive expressly permits only the driving of motor
                                                                               vehicles in category D with a driving permit covering
                                                                               categories CE and D
                                                                         —     Permission to drive motor vehicles in category D for
Action brought on 2 September 2003 by the Commission
                                                                               holders of driving permits in categories C1, C1E, C or CE
of the European Communities against the Federal Repub-
                         lic of Germany                                        in certain cases
                                                                               Paragraph 6.4 of the FeV entitles holders of driving
                        (Case C-372/03)                                        permits in categories C1, C1E, C and CE in their Member
                                                                               State of origin to drive motor vehicles in category D
                        (2003/C 275/45)                                        (motorised omnibuses) without passengers if the journey
                                                                               is made merely for the purposes of examining the
                                                                               technical state of the vehicle or of transfering the vehicle
                                                                               to another location. However the Directive does not draw
An action against the Federal Republic of Germany was                          any distinction between the carriage of passengers and
brought before the Court of Justice of the European Communi-                   driving an empty bus. The Directive does not make
ties on 2 September 2003 by the Commission of the European                     provision for the driving of motor vehicles in category D
Communities, represented by Gerald Braun and Wouter Wils,                      without the corresponding driving licence, although such
members of the Legal Service of the Commission of the                          vehicles may be so driven for the purposes of examining
European Communities, with an address for service in Luxem-                    the technical state of the vehicle after repairs have been
bourg.                                                                         carried out on grounds of practical convenience. A more