CELEX: C2003/275/42
Language: en
Date: 2003-11-15 00:00:00
Title: Case C-316/03: Reference for a preliminary ruling by the Oberverwaltungsgericht für das Land Nordrhein-Westfalen by order of that Court of 3 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 275/25
    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.
 ---pagebreak--- C 275/26              EN                          Official Journal of the European Union                                       15.11.2003
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                          b)    Is it an infringement of Community law for the
               paragraph of Article 2 of the Basic Regulation                            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                              safe levels and any (individual) reductions that
               (objective) purpose that is the decisive factor,                          is subject to only limited review by the courts?
               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                       V.  a)    If a product may be marketed in at least one
               purposes is the type of product and how                                   other Member State as a foodstuff, is the fact
               material the individual product?                                          that there is no ‘nutritional need’ for that
                                                                                         product in Germany significant in terms of the
    II.   a)   How is the term ‘pharmacological effect’, which                           freedom to market the product in Germany?
               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 the Basic                       b)    If so, is it compatible with Community law
               Regulation, to be defined for the purposes                                for the authority to have a discretion under
               of Community law? In particular, does the                                 national law that is subject to only limited
               definition include a requirement that there be a                          review by the courts?
               health risk?
          b)   Now that Directive 2001/83/EC of the Euro-
               pean Parliament and of the Council of 6 Nov-                    VI. If in regard to the questions posed in section III the
               ember 2001 on the Community code relating                           Court confirms the judgment in van Bennekom and
               to medicinal products for human use has,                            there is no incompatibility in this case with the
               by the second sentence of Article 1(2) (on                          requirements of health protection, how can the
               ‘functional’ medicinal products), introduced the                    request for marketing authorisation be successfully
               term ‘physiological functions’, the further ques-                   pursued? Can a decision of general application under
               tion arises as to the meaning of that term and                      Paragraph 47a of the LMBG be refused, without
               its relation to the term ‘pharmacological effect’.                  Community law being infringed, on the basis that
                                                                                   in the German classification system a product is
    III. Does the view expressed by the Court of Justice in                        medicinal, whereas it can be marketed as a foodstuff
          Case 227/82 van Bennekom [1983] ECR 3883,                                in the Member State where it was manufactured? Is
          paragraph 39 on the general classification of vitamin                    it compatible with Community law, and in particular
          preparations, in which it said that it must be possible                  Articles 28 and 30 EC, not to apply the rule in
          to import a product that may be marketed as a food                       Paragraph 47a of the LMBG to such medicinal
 ---pagebreak--- 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