CELEX: C2000/335/51
Language: en
Date: 2000-11-25 00:00:00
Title: Case C-321/00: Action brought on 30 August 2000 by the Federal Republic of Germany against the Commission of the European Communities

C 335/28              EN                    Official Journal of the European Communities                                     25.11.2000
Reference for a preliminary ruling by the Nederlandse                  4.b )If so, is Regulation No 259/53, in so far as it permits
Raad van State by order of 8 August 2000 in the case of                      such a prohibition on export solely on the basis of the
N.V.      Sturing      Afvalverwijdering       Noord-Brabant,                principle of self-sufficiency at national level, compatible
N.V. Afvalverbranding Zuid Nederland, UTR Umwelt                             with Article 29 of the Treaty establishing the European
Gmbh and Minister van Volkshuisvesting, Ruimtelijke                          Community?
                   Ordening en Milieubeheer
                                                                       (1) OJ 1975 L 194, p. 39.
                        (Case C-311/00)                                (2) OJ 1993 L 30, p. 1.
                        (2000/C 335/50)
Reference has been made to the Court of Justice of the
European Communities by order of 8 August 2000 by the
Nederlandse Raad van State (Council of State), Netherlands,
which was received at the Court Registry on 16 August
                                                                       Action brought on 30 August 2000 by the Federal Repub-
2000, for a preliminary ruling in the case of N.V. Sturing
                                                                       lic of Germany against the Commission of the European
Afvalverwijdering Noord-Brabant, N.V. Afvalverbranding Zuid
                                                                                                 Communities
Nederland, UTR Umwelt Gmbh and Minister van Volkshuis-
vesting, Ruimtelijke Ordening en Milieubeheer on the follow-
ing questions:                                                                                  (Case C-321/00)
1.a) Must the operation, recycling/reclamation of other inor-                                   (2000/C 335/51)
     ganic materials, referred to under R5 of Annex II B
     to Directive 75/442/EEC (1) on waste (hereinafter: ‘the
     Framework Directive’) be interpreted as also covering ‘re-        An action against the Commission of the European Communi-
     use’ within the meaning of Article 3(b)(i) of the Frame-          ties was brought before the Court of Justice of the European
     work Directive?                                                   Communities on 30 August 2000 by the Federal Republic of
                                                                       Germany, represented by Wolf-Dieter Plessing, Ministerialrat,
1.b) How must R5 be interpreted, in view of the answer to the          Federal Ministry of Finance, Graurheindorfer Strasse 108,
     above question? For the operation referred to therein to          D-53117 Bonn, and Jochim Sedemund, Rechtsanwalt, Charlot-
     exist is it necessary that the substance be submitted to a        tenstrasse 65, D-10117 Berlin, acting as Agents.
     treatment, can be used several times or can be taken
     back?                                                             The applicant claims that the Court should:
2.   If it follows from the answer to the abovementioned               1.    Annul Commission Directive 2000/38/EC of 5 June 2000
     questions that an operation such as the processing of fly               amending Chapter Va (Pharmacovigilance) of Council
     ash does not fall within the scope of R5, are the lists of              Directive 75/319/EEC on the approximation of pro-
     operations in Annexes II A and II B of the Framework                    visions laid down by law, regulation or administrative
     Directive exhaustive or is one of these lists exhaustive,               action relating to medicinal products (OJ 2000 L 139 of
     and if so which one?                                                    10 June 2000, p. 28);
3.a) On the basis of which criteria must it be decided whether         2.    Order the Commission to pay the costs of the proceed-
     an operation must be regarded as disposal or recovery                   ings.
     within the meaning of Article 1 of the Framework
     Directive?
                                                                       Pleas in law and main arguments
3.b) If an operation can be classified both as a disposal
     operation and a recovery operation, must priority be              —     Infringement of the Council’s legislative competence
     given to the list in Annex II A or II B when classifying                through circumvention of the prescribed legislative pro-
     that operation or does neither of the two lists take                    cedure: the contested directive contains a series of amend-
     precedence over the other?                                              ments which do not in any way relate to the adaptation
                                                                             of existing provisions governing pharmacovigilance to
4.a) If the shipment of the fly ash must be regarded as a                    ‘scientific and technical progress’ (Article 29i of Directive
     shipment of waste for disposal, can an objection be                     75/319) but alter specific legal obligations of undertak-
     raised to the shipment pursuant to Article 4(3)(b)(1) of                ings having a duty to notify within the context of
     Regulation (EEC) No 259/93 (2) of 1 February 1993 on                    pharmacovigilance. In addition, the efficacy of hitherto
     the supervision and control of shipments of waste within,               existing national notification procedures is adversely
     into and out of the European Community to the shipment                  affected inasmuch as they have to be replaced by a system
     solely on account of the need to achieve self-sufficiency               based on a European data-processing network which will
     at national level without showing that self-sufficiency at              still not be available for that purpose on 5 December
     national level is necessary to achieve self-sufficiency at              2001, the date by which the contested directive must be
     Community level?                                                        transposed.
 ---pagebreak--- 25.11.2000           EN                     Official Journal of the European Communities                                       C 335/29
    —    The power newly conferred on the Commission to                —     Infringement of the duty to state reasons (Article 253
         draw up ‘guidance on the collection, verification                   EC): the recitals in the preamble give the misleading
         and presentation of adverse reaction reports ...’                   impression that the directive carries out no more than a
         [Article 29g(a)] is in particular of substantive signifi-           merely technical adaptation to international develop-
         cance for the scope of the duty of notification                     ments in pharmacovigilance and the related development
         [Article 29d(4)] and for the examination of pharma-                 of data-processing and therefore provide a false picture
         covigilance data with regard to suspension, with-                   as to the justification of the legal basis claimed by the
         drawal or variation of the authorisation for a                      Commission (Articles 29i and 37a of Directive
         medicinal product (Article 29h). The power of the                   75/319/EEC).
         Commission to adopt rules, the content of which is
         not yet even known, classifiable purely within the
         area of institutional law, clearly does not constitute
         a rule for adapting the directive to ‘scientific and
         technical progress’.
    —    Article 29d(2) and (3) of the new version will in
         future limit the duty of notification devolving on            Action brought on 30 August 2000 by the Commission
         the undertaking concerned to notification of the              of the European Communities against the Kingdom of the
         ‘competent authority of the Member State in whose                                        Netherlands
         territory the incident occurred’, and thus alters its
         substantive content. This amendment would be                                          (Case C-322/00)
         acceptable from a health-policy perspective if the
         data-processing network to be set up by the Agency
                                                                                               (2000/C 335/52)
         under the new version of Article 29f could also
         guarantee the provision of equivalent information,
         in terms of time and quality, to the authorities              An action against the Kingdom of the Netherlands was brought
         of the other Member States; however, this data-               before the Court of Justice of the European Communities
         processing network is not yet in existence, and it is         on 30 August 2000 by the Commission of the European
         not envisaged that it will be set up before or shortly        Communities, represented by Gregorio Valero Jordana and
         after the period for transposition of the contested           Christopher Van Der Hauwaert, of its Legal Service, acting as
         directive has expired.                                        Agents, with an address for service in Luxembourg at the office
                                                                       of Carlos Gómez de la Cruz, of its Legal Service, Wagner
    —    Article 29d(4) of the new version alters the existing         Centre, Kirchberg.
         duty to notify suspected serious adverse reactions
         occurring in the territory of a non-member country,           The Commission of the European Communities claims that
         inasmuch as — at least according to the English-              the Court should:
         and French-language versions — such adverse reac-
         tions will in future be notifiable only if they are           1.    declare that, by failing to adopt the necessary laws,
         unexpected. This means that risks involved in the                   regulations and administrative measures referred to in
         use of medicinal products which must in principle                   Articles 4 and 5(4) and (5) and points 1, 2, 4 and 6 of
         be regarded as being known will no longer be                        part A of Annex II and points 1(2), 1(3) and 2 of Annex III
         covered, in particular the ‘known’ risk of viral                    to Council Directive 91/676/EEC of 12 December 1991
         transmission in the case of medicinal products                      concerning the protection of waters against pollution
         containing biological components. This amendment                    caused by nitrates from agricultural sources (1), the
         likewise does not constitute an adaptation to ‘scien-               Kingdom of the Netherlands has failed to fulfil its
         tific and technical progress’.                                      obligations under that directive;
    —    The option for the marketing authorisation holder             2.    order the Kingdom of the Netherlands to pay the costs.
         to negotiate notification periods, introduced by
         Article 29d(7) of the new version, constitutes a
         substantive amendment having nothing to do with               Pleas in law and main arguments
         adaptation to ‘scientific and technical progress’.
                                                                       —     Absence in the Netherlands action programme of any
    —    Article 29d of the new version defines the person                   provisions relating to the minimum capacity, as pre-
         having the duty to notify as being in future the                    scribed by the directive, of storage vessels for livestock
         ‘marketing authorisation holder’ rather than, as                    manure (Article 5(4)(a) in conjunction with point 1(2) of
         previously, ‘the person responsible for placing the                 Annex III to the directive);
         medicinal product on the market’. As a result, a duty
         to notify will no longer be imposed on potential              —     Absence in the Netherlands action programme of any
         licensees of the marketing authorisation holder or on               mandatory provisions concerning the limitation of the
         parallel importers, who, together with the original                 land application of fertilisers, taking into account the
         vendor of the medicinal product, are regarded in the                climatic conditions, rainfall and irrigation (Article 5(4)(a)
         Member State concerned as being the persons                         in conjunction with point 1(3)(b) of Annex III to the
         responsible for placing the product on the market.                  directive);