CELEX: C2003/200/14
Language: en
Date: 2003-08-23 00:00:00
Title: Case C-211/03: Reference for a preliminary ruling by the Oberverwaltungsgericht für das Land Nordrhein-Westfalen by order of that Court of 7 May 2003 in the administrative proceedings between HLH Warenvertriebs GmbH and Bundesrepublik Deutschland; Intervener: The representative of the public interest at the Oberverwaltungsgericht für das Land Nordrhein-Westfalen

C 200/8               EN                        Official Journal of the European Union                                           23.8.2003
     The Commission's analysis ignored its obligation, before                    condition in which it is imported the determining
     claiming overpayment or overfinancing had occurred, to                      factor?
     take into account the actual costs of the eligible projects
     and the actual matching co-funding and the correct
     exchange calculations from the Irish authorities before                3.   If the Court of Justice concludes that the product in
     determining whether Ireland breached the 75 % ESF                           question is medicinal, but that in those Member
     funding limit.                                                              States where it has hitherto been regarded as a
                                                                                 foodstuff it should continue to be a foodstuff, that
2.   It is submitted that the failure of the Commission to                       raises problems for the referring Chamber such as
     accept the Applicant's explanations in this case amounts                    those underlying the questions in B VI, in conjunc-
     to a breach of a fundamental rule of law relating to the                    tion with those in B III. Reference is made to those
     operation of the structural funds and the principles iden-                  questions and the observations thereon and an
     tified by the Commission in the context of the Decision.                    answer is requested.
3.   It is submitted that the approach adopted by the Commis-
     sion is out of all proportion to the result intended to be             4.   If ‘Lactobact omni FOS’ is a foodstuff (food supple-
     achieved having regard to the ongoing efficacy of the                       ment), is it then a novel food within the meaning of
     projects in issue and the nature of the project beneficiary.                Regulation (EC) No 258/97 of the European Parlia-
     Such an approach effectively amounts to the imposition                      ment and of the Council of 27 January 1997
     of a penalty in circumstances where the beneficiary is                      concerning novel foods and novel food ingredients
     innocent of any wrongdoing.                                                 (OJ 1997 L43, p. 1, ‘the Novel Foods Regulation’)?
                                                                                 What is the relationship between the various legal
4.   Finally, it is submitted that the Commission's approach                     bases?
     fails to respect the principles of legal certainty and
     legitimate expectations.
                                                                        B   In the event that — as has been the case hitherto — the
                                                                            questions (as to classification) posed in section A above
                                                                            are 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 the questions in A 2 from a Commu-
                                                                            nity law standpoint, in so far as Community law is
                                                                            applicable.
Reference for a preliminary ruling by the Oberverwal-
tungsgericht für das Land Nordrhein-Westfalen by order
of that Court of 7 May 2003 in the administrative                           In addition the following questions arise:
proceedings between HLH Warenvertriebs GmbH and
Bundesrepublik Deutschland; Intervener: The representa-
tive of the public interest at the Oberverwaltungsgericht                   I    a)    Is the contested product to be classified
               für das Land Nordrhein-Westfalen                                        according to Article 2, subparagraphs (1) and
                                                                                       (2),   in    conjunction       with     Article   2,
                         (Case C-211/03)                                               subparagraph (3)(d), of Regulation (EC)
                                                                                       No 178/2002 of the European Parliament and
                         (2003/C 200/14)                                               of the Council of 28 January 2002 laying down
                                                                                       the general principles and requirements of food
                                                                                       law, establishing the European Food Safety
                                                                                       Authority and laying down procedures in
Reference has been made to the Court of Justice of the                                 matters of food safety (OJ 2002 L31, p. 1, ‘the
European Communities by order of the Oberverwaltungsge-                                Basic Regulation’), or — once the period for
richt für das Land Nordrhein-Westfalen (Higher Administrative                          transposition expires on 31 July 2003 —
Court for the Land of Nordrhein-Westfalen) of 7 May 2003,                              according to Directive 2002/46/EC of the
received at the Court Registry on 15 May 2003, for a preli-                            European Parliament and of the Council of
minary ruling in the administrative proceedings between HLH                            10 June 2002 on the approximation of the
Warenvertriebs GmbH and Bundesrepublik Deutschland; Inter-                             laws of the Member States relating to food
vener: The representative of the public interest at the Oberver-                       supplements (OJ 2002 L 183, p. 51, ‘the Food
waltungsgericht für das Land Nordrhein-Westfalen (Higher                               Supplements Directive’), and if so according to
Administrative Court for the Land of Nordrhein-Westfalen) on                           which parts of the directive?
the following questions:
A.   1.    Is the contested product                                              b)    If Article 2, subparagraphs (1) and (2), in
                                                                                       conjunction with Article 2, subparagraph (3)(d),
           ‘Lactobact omni FOS’                                                        of the Basic Regulation applies, the following
                                                                                       question arises: is it the case that it is no longer
           a foodstuff (perhaps in the form of a food supple-                          the product's main (objective) purpose that is
           ment) or a medicinal product? Is this finding binding                       the decisive factor, but rather that a product
           on all the Member States?                                                   which meets the criteria for both a food and a
                                                                                       medicine is, legally speaking, always — and
     2.    Is it relevant when classifying the product that,                           only — a medicinal product? How material for
           according to the directions for use, it is intended to                      these purposes is the type of product and how
           be dissolved in water or in yoghurt? Or is the                              material the individual product?
 ---pagebreak--- 23.8.2003             EN                        Official Journal of the European Union                                          C 200/9
     II  How is the term ‘pharmacological effect’, which is                      medicinal, whereas it can be marketed as a foodstuff
         critical for the purposes of classification, inter alia,                in the Member State where it was manufactured? Is
         under Article 2, subparagraphs (1) and (2), in                          it compatible with Community law, and in particular
         conjunction with Article 2, subparagraph (3)(d) of                      Articles 28 and 30 EC, not to apply the rule in
         the Basic Regulation, to be defined for the purposes                    Paragraph 47a of the LMBG to such medicinal
         of Community law?                                                       products analogously? If not, can the German State
                                                                                 evade an obligation to act intended by a German
                                                                                 court to adopt a decision of general application
         In particular, does the definition include a require-                   under Paragraph 47a of the LMBG (applied analo-
         ment that there be a health risk?                                       gously) without there being any infringement of
                                                                                 Community law if it, or the authority responsible
     III Does the view expressed by the Court of Justice in                      for food but not medicines, objects that no decision
         Case C-227/82 van Bennekom [1983] ECR 3883,                             of general application under Paragraph 47a of the
         paragraph 39 on the general classification of vitamin                   LMBG (analogously) may be adopted because in the
         preparations, in which it said that it must be possible                 German classification system a product is medicinal,
         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
                                                                                 a)    on the ground that the body competent to
         though it is regarded as a medicine in the Member
                                                                                       adopt decisions of general application under
         State of import, a marketing authorisation is compa-
                                                                                       Paragraph 47a of the LMBG is not competent
         tible with the requirements of health protection, also
                                                                                       for medicines also,
         apply to probiotic products of the kind at issue here,
         and does the Court of Justice adhere to its view in
         the light of subsequent Community law?
                                                                                 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
               and 30 EC: Is the relevant threshold the ‘upper              VII If as a result of the Court's replies it transpires that
               safe level’ or should it be reduced, say, because                 the product in question is a foodstuff (including,
               the substances in question are also ingested                      possibly, a food supplement) but is in any event not
               with food and/or because — at least where                         a medicine, questions will arise for the Chamber on
               they are taken long-term — regard may have                        the on the applicability of the Novel Foods Regula-
               to be had to the various consumer groups and                      tion, which takes precedence over Paragraph 47a of
               their different sensitivities?                                    the LMBG, and the effect of which may be to
                                                                                 remove any interest in legal protection in this case.
                                                                                 The Chamber therefore asks:
         b)    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, subject                   How is the phrase ‘which have not hitherto been
               only to review by the courts?                                     used for human consumption to a significant degree’
                                                                                 in Article 1(2) of the Novel Foods Regulation to be
                                                                                 interpreted? Is it sufficient that the Netherlands Offi-
     V   a)    If a product may be marketed in at least one                      cial Gazette of 16 February 1995 declared trading in
               other Member State as a foodstuff, is the fact                    a probiotic similar to the contested product called
               that the competent German authority essentially                   Ecologic 316 to be permissible and that, according to
               says that in Germany that there is no ‘nutri-                     the invoice of 20 May 1996 a delivery of Ecologic
               tional need’ for that product significant in terms                326 was made to the applicant, or alternatively what
               of the freedom to market the product as a                         are the minimum requirements that must be met in
               foodstuff (food supplement) in Germany?                           order for there to have been use to a significant
                                                                                 degree hitherto for the purposes of Article 1(2) of
                                                                                 the Novel Foods Regulation? What is the starting
         b)    If so, is it compatible with Community law for                    point for interpreting the words ‘not hitherto’?
               the authority to have a discretion under
               national law that is subject only to limited
               review by the courts?
                                                                            VIII If the Court declines itself to reply to the questions
                                                                                 posed in section A, may the national court then
     VI  If in regard to the questions posed in section III the                  direct questions on the classification of products or
         Court confirms the judgment in van Bennekom and                         indeed scientific or methodological questions to the
         there is no incompatibility in this case with the                       European Food Authority and to what extent are any
         requirements of health protection, how can the                          guidelines provided by that authority binding on the
         request for marketing authorisation be successfully                     national court? Can (or must) such guidelines be
         pursued? Can a decision of general application under                    reviewed by the Community judicature alone or by
         Paragraph 47a of the LMBG be refused, without                           the referring national court also?
         Community law being infringed, on the basis that
         in the German classification system a product is