CELEX: 62006CJ0361
Language: en
Date: 2008-05-22
Title: Judgment of the Court (Third Chamber) of 22 May 2008.#Feinchemie Schwebda GmbH and Bayer CropScience AG v College voor de toelating van bestrijdingsmiddelen.#Reference for a preliminary ruling: College van Beroep voor het bedrijfsleven - Netherlands.#Plant protection products - Authorisation to place on the market - Ethofumesate - Directives 91/414/EEC and 2002/37/EC - Regulation (EEC) No 3600/92 - Application for reopening of the oral procedure.#Case C-361/06.

Case C-361/06
      Feinchemie Schwebda GmbH and Bayer CropScience AG
      v
      College voor de toelating van bestrijdingsmiddelen
      (Reference for a preliminary ruling from the
      College van Beroep voor het bedrijfsleven)
      (Plant protection products – Authorisation to place on the market – Ethofumesate – Directives 91/414/EEC and 2002/37/EC – Regulation (EEC) No 3600/92 – Application for reopening of the oral procedure)
      Summary of the Judgment
      1.        Procedure – Oral procedure – Reopening
      (Art. 222, second para., EC; Rules of Procedure of the Court, Art. 61)
      2.        Agriculture – Approximation of laws – Placing of plant protection products on the market – Directive 2002/37
      (Council Directive 91/414, Annexes I and II; Commission Directive 2002/37, Art. 4(1))
      1.        The Court may of its own motion, on a proposal from the Advocate General or at the request of the parties, reopen the oral
         procedure, in accordance with Article 61 of its Rules of Procedure, if it considers that it lacks sufficient information,
         or that the case must be dealt with on the basis of an argument which has not been debated between the parties. However, it
         is not necessary to reopen the oral procedure pursuant to that provision every time the Advocate General raises a point of
         law that has not been debated by the parties. Although, pursuant to the second paragraph of Article 222 EC, it is the duty
         of the Advocate General, acting with complete impartiality and independence, to make, in open court, reasoned submissions
         on cases which, in accordance with the Statute of the Court of Justice, require the Advocate General’s involvement and although,
         in carrying out that task, the Advocate General may, where appropriate, analyse a reference for a preliminary ruling by placing
         it in a context broader than that strictly defined by the national court or the parties to the main proceedings, the Court
         is not bound either by the Advocate General’s Opinion or by the reasoning which led to that view to be formed.
      
      (see paras 33-34)
      2.        Article 4(1) of Directive 2002/37 amending Directive 91/414 to include ethofumesate as an active substance must be interpreted
         as not requiring Member States to terminate, before 1 September 2003, the authorisation of a plant protection product containing
         ethofumesate on the ground that the holder of that authorisation does not hold, or have access to, a dossier satisfying the
         requirements set out in Annex II to Directive 91/414 concerning the placing of plant protection products on the market.
      
      Although that provision requires Member States, first, to review authorisations previously granted for each plant protection
         product containing ethofumesate, in order to ensure that the conditions relating to that active substance, as set out in Annex
         I to Directive 91/414, are complied with and, second, to amend or, if necessary, to withdraw those authorisations, in accordance
         with that directive, before 1 September 2003, there is nothing in its wording to suggest that the holders of existing authorisations
         must, for the purposes of the review of those authorisations, hold, or have access to, a dossier satisfying the requirements
         set out in Annex II. That is the only interpretation that is compatible with the principle of legal certainty, in accordance
         with which Community legislation must enable those concerned to acquaint themselves with the precise extent of the obligations
         it imposes upon them.
      
      (see paras 44-45, 50, 55, operative part)
JUDGMENT OF THE COURT (Third Chamber)
      22 May 2008 (*)
      
      (Plant protection products – Authorisation to place on the market – Ethofumesate – Directives 91/414/EEC and 2002/37/EC – Regulation (EEC) No 3600/92 – Application for reopening of the oral procedure)
      In Case C‑361/06,
      REFERENCE for a preliminary ruling under Article 234 EC, by the College van Beroep voor het bedrijfsleven (Administrative
         Court for Trade and Industry, Netherlands), made by decision of 1 September 2006, received at the Court on 4 September 2006,
         in the proceedings
      
      Feinchemie Schwebda GmbH,
      Bayer CropScience AG
      v
      College voor de toelating van bestrijdingsmiddelen,
      Third party:
      
      Agrichem BV,
      THE COURT (Third Chamber),
      composed of A. Rosas, President of the Chamber, U. Lõhmus, J. Klučka (Rapporteur), P. Lindh and A. Arabadjiev, Judges,
      Advocate General: E. Sharpston,
      Registrar: C. Strömholm, Administrator,
      having regard to the written procedure and further to the hearing on 19 September 2007,
      after considering the observations submitted on behalf of:
      –        Feinchemie Schwebda GmbH and Bayer CropScience AG, by A. Vroninks, and D. Waelbroeck, advocaten, and A. Freriks, advocaat,
      –        Agrichem BV, by W. Hoyng and J.P.L. van Marissing, advocaten,
      –        the Netherlands Government, by H.G. Sevenster and C.A.H.M. ten Dam, acting as Agents,
      –        the Belgian Government, by A. Hubert, acting as Agent,
      –        the Commission of the European Communities, by B. Doherty and M. van Heezik, acting as Agents,
      after hearing the Opinion of the Advocate General at the sitting on 29 November 2007,
      gives the following
      Judgment
      1        This reference for a preliminary ruling concerns the interpretation of Council Directive 91/414/EEC of 15 July 1991 concerning
         the placing of plant protection products on the market (OJ 1991 L 230, p. 1, and Corrigendum, OJ 1992 L 170, p. 40), Commission
         Directive 2002/37/EC of 3 May 2002 amending Directive 91/414 to include ethofumesate as an active substance (OJ 2002 L 117,
         p. 10) and Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation
         of the first stage of the programme of work referred to in Article 8(2) of Directive 91/414 (OJ 1992 L 366, p. 10).
      
      2        The reference has been made in the context of an action brought by Feinchemie Schwebda GmbH (‘Feinchemie’) and Bayer CropScience
         AG (‘Bayer’) against the College voor de toelating van bestrijdingsmiddelen (Netherlands Board for the authorisation of pesticides,
         ‘the CTB’) in respect of the CTB’s decision of 19 November 2004, by which it upheld the complaint brought by Agrichem BV (‘Agrichem’)
         against the seven decisions the CTB had taken on 23 January 2004. By those decisions, the CTB had withdrawn the authorisations
         held by Agrichem for the placing on the market of plant protection products containing ethofumesate as an active substance.
      
       Legal context
       Community law
       Directive 91/414
      3        Under Article 2(1) of Directive 91/414, ‘plant protection products’ are ‘active substances and preparations containing one
         or more active substances, put up in the form in which they are supplied to the user’ which are intended, inter alia, to protect
         plants or plant products against all harmful organisms. In Article 2(4) of that directive, active substances are defined as
         ‘substances or micro-organisms including viruses, having general or specific action … against harmful organisms; or … on plants,
         parts of plants or plant products’.
      
      4        Article 3(1) of Directive 91/414 provides that a plant protection product may not, as a rule, be placed on the market and
         used in the territory of a Member State unless the competent authorities of that Member State have authorised the product
         in accordance with the provisions of that directive.
      
      5        Article 4(1)(a) of Directive 91/414 provides that ‘Member States shall ensure that a plant protection product is not authorised
         unless … its active substances are listed in Annex I and any conditions laid down therein are fulfilled’, as well as the conditions
         set out in Article 4(1)(b) to (f).
      
      6        The conditions for including an active substance in Annex I to Directive 91/414 are set out in Article 5 of that directive.
         By way of a particular requirement, it must be expected, in the light of current scientific and technical knowledge, that the residues of plant protection products containing the active substance in question, consequent on application consistent
         with good plant protection practice, will not have any harmful effects on human or animal health or on groundwater and that
         they will not have any unacceptable influence on the environment.
      
      7        The procedure for inclusion of an active substance in Annex I to Directive 91/414 is governed by Article 6 of that directive.
         Pursuant to Article 6(1) of Directive 91/414, the Commission of the European Communities, assisted by the Standing Committee
         on the Food Chain and Animal Health, has the power to include an active substance in Annex I. According to Article 6(2) of
         Directive 91/414, the application for the inclusion of an active substance in Annex I thereto must be accompanied by a dossier
         satisfying the conditions set out in Annex II thereto (‘Annex II dossier’) and a dossier complying with Annex III thereto
         (‘Annex III dossier’) on at least one preparation containing that active substance.
      
      8        Article 8 of Directive 91/414 concerns transitional measures and derogations. According to Article 8(2):
      
      ‘By way of derogation from Article 4 and without prejudice to paragraph 3 or to Directive 79/117/EEC, a Member State may,
         during a period of 12 years following the notification of this Directive, authorise the placing on the market in its territory
         of plant protection products containing active substances not listed in Annex I that are already on the market two years after
         the date of notification of this Directive.
      
      After the adoption of this Directive, the Commission shall commence a programme of work for the gradual examination of these
         active substances within the 12-year period referred to in the foregoing subparagraph. This programme may require interested
         parties to submit all requisite data to the Commission and the Member States within a period provided for in the programme.
         A Regulation, adopted according to the procedure laid down in Article 19, will set out all the provisions necessary for the
         implementation of the programme.
      
      …
      During the 12-year period referred to in the first subparagraph it may, following examination by the Committee referred to
         in Article 19 of such active substance, be decided by the procedure laid down in that Article that the substance can be included
         in Annex I and under which conditions, or, in cases where the requirements of Article 5 are not satisfied or the requisite
         information and data have not been submitted within the prescribed period, that such active substance will not be included
         in Annex I. The Member States shall ensure that the relevant authorisations are granted, withdrawn or varied, as appropriate,
         within a prescribed period.’
      
      9        Article 13 of Directive 91/414 provides:
      
      ‘1. … Member States shall require that applicants for authorisation of a plant protection product submit with their application:
      (a)      a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex III; and
      (b)      for each active substance in the plant protection product, a dossier satisfying, in the light of current scientific and technical
         knowledge, the requirements set out in Annex II. 
      
      ...
      3.      In granting authorisations, Member States shall not make use of the information referred to in Annex II for the benefit of
         other applicants:
      
      …
      (d)      for a period of five years from the date of a decision, following receipt of further information necessary for first inclusion
         in Annex I, which has been taken either to vary the conditions for, or to maintain, the inclusion of an active substance in
         Annex I, unless the five-year period expires before the period provided for in paragraphs 3(b) and (c), in which case the
         period of five years shall be extended so as to expire on the same date as those periods. 
      
      ...
      6.      By way of derogation from paragraph 1, for active substances already on the market two years after notification of this Directive,
         Member States may, with due regard for the provisions of the Treaty, continue to apply previous national rules concerning
         data requirements as long as such substances are not included in Annex I.
      
      …’.
       Regulation No 3600/92
      10      According to Article 1(1) thereof, Regulation No 3600/92 ‘lays down detailed rules for the implementation of the first stage
         of the programme of work referred to in Article 8(2) of Directive [91/414] …. [That] first stage involves an assessment of
         the substances listed in Annex I to Regulation [3600/92] with a view to their possible inclusion in Annex I to Directive [91/414].’
         One of the substances listed in Annex I to Regulation No 3600/92 lists is ethofumesate.
      
      11      Article 4 of Regulation No 3600/92 provides:
      
      ‘1. Any producer wishing to secure the inclusion of an active substance referred to in Annex I hereto … in Annex I to Directive
         [91/414] shall so notify the Commission within six months of the date of entry into force of this Regulation.
      
      …
      2. Notification must be made to the Commission … in accordance with the notification as shown in Annex II hereto, completed
         and containing the undertaking referred to in part 5 of the specimen notification.
      
      3. Any producer who has not notified in time any given active substance referred to in paragraph 1 will be permitted to participate
         in the programme referred to in Article 1 only collectively with other notifiers of that active substance or, in the case
         referred to in paragraph 4 hereof, in assisting the notifying Member State, with the agreement of the original notifiers.
      
      ...’.
      12      Article 6 of Regulation No 3600/92 provides:
      
      ‘1. Within the time-limit referred to in the third indent of Article 5(4), the notifiers specified in the regulation referred
         to in that Article must, individually or collectively, send to the designated authority of the rapporteur Member State, for
         any given active substance:
      
      (a)      the summary dossier referred to in paragraph 2 hereof; and
      (b)      the complete dossier referred to in paragraph 3 hereof.
      …
      2. The summary dossier shall include the following:
      …
      (c)       for each point of Annex II to Directive [91/414], the available summaries and results of trials, the name of the person or
         institute that has carried out the trials; the same information for each point of Annex III to the Directive relevant to the
         assessment of the criteria referred to in Article 5 of the Directive and for one or more preparations which are representative
         for the conditions of use referred to in [point] (b);
      
      …
      3. The complete dossier shall contain the protocols and the complete study reports concerning all the information referred
         to in paragraph 2(c).
      
      ….’.
       Directive 2002/37
      13      The fifth and eighth recitals in the preamble to Directive 2002/37 are worded as follows:
      
      ‘(5)  It has appeared from the various examinations made that plant protection products containing ethofumesate may be expected
         to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive [91/414], in particular with regard
         to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include ethofumesate
         in Annex I to Directive [91/414], in order to ensure that in all Member States authorisations of plant protection products
         containing ethofumesate can be granted in accordance with the provisions of Directive [91/414].
      
      …
      (8)       After inclusion, Member States should be allowed a reasonable period within which to implement the provisions of Directive
         [91/414] as regards plant protection products containing ethofumesate, and in particular, to review existing authorisations
         in accordance with the provisions of Directive [91/414] to ensure that the conditions regarding ethofumesate set out in Annex
         I to Directive [91/414] are satisfied. A longer period should be provided within which a complete dossier for each such plant
         protection product, satisfying the requirements of Annexes II and III to Directive [91/414] should be submitted and that product
         re-evaluated in accordance with the uniform principles laid down in Directive [91/414]’.
      
      14      Article 4 of Directive 2002/37 provides:
      
      ‘1. Member States shall review the authorisation for each plant protection product containing ethofumesate to ensure that
         the conditions relating to ethofumesate set out in Annex I to Directive [91/414] are complied with. Where necessary, they
         shall amend or withdraw the authorisation in accordance with Directive [91/414] before 1 September 2003.
      
      2. Member States shall, for each authorised plant protection product containing ethofumesate as either the only active substance
         or as one of several active substances all of which were listed in Annex I to Directive [91/414] by 1 March 2003, re-evaluate
         the product in accordance with the uniform principles provided for in Annex VI to Directive [91/414], on the basis of a dossier
         satisfying the requirements of Annex III thereto. On the basis of that evaluation, they shall determine whether the product
         satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive [91/414]. Where necessary and by 28 February
         2007 at the latest, they shall amend or withdraw the authorisation for each such plant protection product.’
      
       National law
      15      According to Article 7(1)(c) of the Law on Pesticides of 12 July 1962 (Bestrijdingsmiddelenwet, Stb. 1962, No 288, ‘the Bmw’),
         the CTB is to withdraw the authorisation or registration referred to in Article 4 of that law if that is necessary for the
         implementation of a Community measure.
      
       The main proceedings and the question referred for a preliminary ruling
      16      Ethofumesate is an active substance which was already on the market two years after notification of Directive 91/414. Consequently,
         it comes under the transitional measures provided for in Articles 8(2) and 13(6) of that directive. It was by operation of
         those transitional measures that Agrichem was granted authorisations to place on the market a certain number of plant protection
         products containing ethofumesate as an active substance.
      
      17      As notifiers for the purposes of Article 4 of Regulation No 3600/92, Feinchemie and Bayer followed the procedure provided
         for in that regulation, with the result that ethofumesate was included in Annex I to Directive 91/414. In accordance with
         Article 6(2) of Directive 91/414, those undertakings submitted an Annex II dossier to the Commission.
      
      18      Agrichem did not act with the applicants, either as notifier of the active substance ethofumesate or as co-notifier.
      
      19      Following the inclusion of ethofumesate in Annex I to Directive 91/414, the CTB, by seven decisions taken on 23 January 2004
         pursuant to the Bmw, withdrew the authorisations held by Agrichem to place on the market plant protection products containing
         ethofumesate as an active substance, on the grounds that no deadline had been set for the use of those products and that Agrichem
         did not hold, or have access to, a complete Annex II dossier.
      
      20      On 28 January 2004, Agrichem brought a complaint before the CTB against those decisions, submitting that it did not have to
         provide an Annex II dossier or show that it had access to such a dossier, given that, in particular, Article 4(1) of Directive
         2002/37 merely required it to comply with the conditions set out in Annex I to Directive 91/414, as amended by Directive 2002/37.
         By decision of 30 January 2004, the CTB amended one of its decisions of 23 January 2004, to the effect that the withdrawal
         of one of the authorisations at issue was to take effect on 30 January 2004.
      
      21      On 28 January 2004, Agrichem also brought an action for interim measures before the President of the College van Beroep voor
         het bedrijfsleven. By decision of 20 February 2004, the latter granted interim relief and suspended the decisions of the CTB
         of 23 January 2004 for six weeks.
      
      22      After Agrichem – as well as Feinchemie and Bayer, in their capacity as interested third parties – had been heard by the CTB’s
         Adviescommissie voor de bezwaarschriften (Consultative committee for complaints), the CTB, by decision of 19 November 2004,
         revoked the withdrawal of the seven authorisations at issue, on the ground that neither Directive 2002/37 nor Directive 91/414
         gives it the power to require – for the purposes of the review, in accordance with Article 4(1) of Directive 2002/37, of existing
         authorisations – an Annex II dossier to back up such authorisations.
      
      23      On 23 December 2004, Feinchemie and Bayer appealed against the CTB’s decision of 19 November 2004 to the College van Beroep
         voor het bedrijfsleven. They submit that it is apparent from Article 13(1) and (3) of Directive 91/414 that the holder of
         an authorisation for a plant protection product who is not at the same time a notifier of the active substance included in
         Annex I to that directive which is contained in the product must hold, or have access to, an Annex II dossier and that, for
         a period of five years following the inclusion of ethofumesate in Annex I to that directive, the data submitted by the notifiers
         concerned in the Annex II dossier cannot, without the consent of those notifiers, be used by third parties or for the benefit
         of third parties.
      
      24      According to those undertakings, in so far as, on 1 September 2003, Agrichem did not hold, or have access to, an Annex II
         dossier, the existing authorisations for plant protection products containing the active substance ethofumesate marketed by
         Agrichem had to be withdrawn.
      
      25      In that respect, the national court observes, first, that paragraphs 1 and 2 of Article 4 of Directive 2002/37 provide for
         different levels of review of authorisations to place plant protection products on the market. Second, the national court
         points out that the deadline for the review provided for in Article 4(1) is significantly shorter than the deadline for the
         re-evaluation under Article 4(2). Third, the national court states that the very wording of those provisions shows that it
         is only in the context of the re-evaluation of existing authorisations to place plant protection products on the market that
         the competent authorities must be provided with an Annex II dossier and an Annex III dossier.
      
      26      Finally, as regards the arguments submitted by Feinchemie and Bayer in relation to the confidentiality of information produced
         in the course of the procedure for inclusion of an active substance in Annex I to Directive 91/414, the national court states
         that it has not been shown that the CTB based the contested decision on information contained in the Annex II dossier submitted
         by those undertakings and queries whether the holders of an existing authorisation, issued pursuant to Article 8(2) of Directive
         91/414 and reviewed under Article 4(1) of Directive 2002/37, are to be regarded as applicants for authorisation within the
         meaning of Article 13(3) of Directive 91/414.
      
      27      Consequently, the national court considers it likely that the CTB was not required, in the context of a review of an authorisation
         under Article 4(1) of Directive 2002/37, to check that the holder of the authorisations at issue in the main proceedings was
         indeed in possession of an Annex II dossier, or had access to such a dossier, or, if the holder did not fulfil those conditions,
         to withdraw the authorisations. However, the national court maintains that the interpretation to be given to Article 4(1)
         of Directive 2002/37 is not so obvious as to leave no room for reasonable doubt.
      
      28      It was in those circumstances that the College van Beroep voor het bedrijfsleven decided to stay proceedings and to refer
         the following question to the Court of Justice for a preliminary ruling: 
      
      ‘Must Article 4(1) of Directive 2002/37/EC be interpreted as meaning that that provision does not require Member States to
         terminate the authorisation of a plant protection product containing ethofumesate before 1 September 2003 on the ground that
         the authorisation holder does not have, or have access to, a dossier satisfying the conditions set out in Annex II to Directive
         91/414/EEC?’
      
       The request that the oral procedure be re-opened
      29      By letter of 7 December 2007, Feinchemie and Bayer asked the Court to order the reopening of the oral procedure pursuant to
         Article 61 of the Rules of Procedure, on the ground that the Advocate General’s Opinion was based on facts and arguments which
         were not and could not have been debated between the parties.
      
      30      First, according to points 85 to 88 of the Opinion, the competition rules are essential to the analysis of the question referred
         for a preliminary ruling. However, the parties have never exchanged views on this point. In addition, Feinchemie submits that,
         by proposing that the provisions concerning data protection laid down in Directive 91/414 should not be applied to holders
         of existing authorisations, the Advocate General’s Opinion actually runs counter to the competition rules.
      
      31      Second, in point 95 of her Opinion, the Advocate General takes no account of the difference between data protection and the
         confidentiality of information in a dossier, which constitutes a new position which has also not been debated between the
         parties.
      
      32      Third, and lastly, Feinchemie and Bayer submit that point 97 of the Opinion shows that the view put forward by the Advocate
         General is based on a manifestly incorrect interpretation of Directive 91/414.
      
      33      It should be recalled, first, that the Court may of its own motion, on a proposal from the Advocate General or at the request
         of the parties, reopen the oral procedure, in accordance with Article 61 of its Rules of Procedure, if it considers that it
         lacks sufficient information, or that the case must be dealt with on the basis of an argument which has not been debated between
         the parties (see the order of 4 February 2000 in Case C-17/98 Emesa Sugar [2000] ECR I‑665, paragraph 18; Case C-210/03 Swedish Match [2004] ECR I‑11893, paragraph 25; and Case 138/05 Stichting Zuid-Hollandse Milieufederatie [2006] ECR I-8339, paragraph 23).
      
      34      Second, pursuant to the second paragraph of Article 222 EC, it is the duty of the Advocate General, acting with complete impartiality
         and independence, to make, in open court, reasoned submissions on cases which, in accordance with the Statute of the Court
         of Justice, require the Advocate General’s involvement. In carrying out that task, the Advocate General may, where appropriate,
         analyse a reference for a preliminary ruling by placing it in a context broader than that strictly defined by the national
         court or the parties to the main proceedings. Given that the Court is not bound either by the Advocate General’s Opinion or
         by the reasoning which led to that view to be formed, it is not necessary to reopen the oral procedure, pursuant to Article
         61 of the Rules of Procedure, every time the Advocate General raises a point of law that has not been debated by the parties.
      
      35      In the present case, since the Court considers that it has sufficient information for a ruling and the case does not have
         to be dealt with on the basis of arguments which have not been debated between the parties, there is no need to allow the
         request for the reopening of the oral procedure.
      
       The question referred for a preliminary ruling
      36      By its question, the national court asks, essentially, whether Article 4(1) of Directive 2002/37 must be interpreted as not
         requiring Member States to terminate, before 1 September 2003, an existing authorisation of a plant protection product containing
         ethofumesate on the ground that, for the purposes of the review of that authorisation, the holder of the authorisation does
         not hold, or have access to, an Annex II dossier.
      
       Observations submitted to the Court
      37      Feinchemie and Bayer – as well as the Governments of the Netherlands and Belgium, and the Commission – maintain that the question
         referred should be answered in the negative. They submit that the holders of existing previous authorisations must be in possession
         of an Annex II dossier from the moment the active substance is included in Annex I to Directive 91/414. Even though Article 4(1)
         of Directive 2002/37 does not so expressly provide, the obligation imposed on Member States to terminate, before 1 September
         2003, existing previous authorisations for plant protection products containing ethofumesate flows from the purpose, the general
         scheme and the rules of Directive 91/414.
      
      38      The Commission submits moreover that the deadline laid down in Article 4(1) of Directive 2002/37 relates to the submission
         of an Annex II dossier, whereas the deadline laid down in Article 4(2) of that directive relates to the re-evaluation of a
         plant protection product on the basis of an Annex III dossier, in so far as compiling an Annex III dossier requires more time
         than compiling an Annex II dossier. 
      
      39      Since Article 13(3)(d) of Directive 91/414 generally precludes the Member States from using information submitted in support
         of an application for inclusion of an active substance in Annex I to the directive – that is to say, the information referred
         to in Annex II to the directive – for the benefit of other applicants for a period of five years from the date on which the
         decision to include the active substance concerned took effect, those Member States must check that the holders of existing
         authorisations also hold, or have access to, an Annex II dossier. 
      
      40      Accordingly, Article 13(6) of Directive 91/414 authorises the Member States to continue to apply previous national rules concerning
         data requirements so long as the substances concerned are not included in Annex I to that directive. It follows that, as soon
         as an active substance is included in that annex, the transitional measures under that directive cease to be applicable to
         the active substance in question, or to plant protection products containing that active substance, and the rules laid down
         in Article 13(1) then apply. Specifically, applications for authorisation of a plant protection product must be accompanied
         by an Annex II and an Annex III dossier.
      
      41      Feinchemie and Bayer and the Commission submit that their interpretation of Directives 91/414 and 2002/37 is confirmed by
         the wording of subsequent directives concerning the inclusion of an active substance in Annex I to Directive 91/414, such
         as Commission Directive 2005/53/EC of 16 September 2005 amending Council Directive 91/414 (OJ 2005 L 241, p. 51), which states
         in the 11th recital in the preamble thereto:
      
      ‘The experience gained from previous inclusions in Annex I to Directive 91/414 of active substances assessed in the framework
         of Regulation No 3600/92 has shown that difficulties can arise in interpreting the duties of holders of existing authorisations
         in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties
         of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying
         the requirements of Annex II to that Directive…’.
      
      42      Agrichem, for its part, contends that the question referred should be answered in the affirmative. The clear provisions of
         Article 4(1) of Directive 2002/37 show that, at the review stage, authorisations of plant protection products containing ethofumesate
         only have to fulfil the conditions for that active substance laid down in Annex I to Directive 91/414. The longer period allowed
         under Article 4(2) of Directive 2002/37 is justified by the time required for the compilation of an Annex III dossier. The
         period allowed under Article 4(1) of Directive 2002/37 cannot therefore be considered to be sufficient for the compilation
         of an Annex II or an Annex III dossier. Agrichem also contends that, if it were necessary to submit such a complete dossier
         already at the stage of the review, in the light of Annex I to Directive 91/414, of authorisations to place on the market
         plant protection products containing ethofumesate as an active substance, there would be no difference between the two types
         of examination provided for, respectively, in paragraphs 1 and 2 of Article 4 of Directive 2002/37. In addition, that interpretation
         of Article 4(1) cannot be called into question by the provisions of Directive 91/414, given that, in relation to Directive
         91/414, Directive 2002/37 is a lex specialis.
      
       Findings of the Court
      43      It should be recalled, first, that, under Article 6 of Directive 91/414, it is the Commission, assisted by the Standing Committee
         on the Food Chain and Animal Health, that has the power to include an active substance in Annex I to that directive. The Commission’s
         decision takes the form of a directive, like Directive 2002/37, Article 1 of which includes the active substance ethofumesate
         in Annex I to Directive 91/414.
      
      44      Having regard to that inclusion, Article 4(1) of Directive 2002/37 requires Member States, first, to review authorisations
         previously granted for each plant protection product containing ethofumesate, in order to ensure that the conditions relating
         to that active substance, as set out in Annex I to Directive 91/414, are complied with and, second, to amend or, if necessary,
         to withdraw those authorisations, in accordance with that directive, before 1 September 2003. Article 4(2) of Directive 2002/37,
         on the other hand, provides that each plant protection product containing ethofumesate – whether as the only active substance
         or as one of several active substances all of which are listed in Annex I to Directive 91/414 by 1 March 2003 – is to be re-evaluated
         by the Member States in accordance with the uniform principles provided for in Annex IV to that directive, on the basis of
         an Annex III dossier. 
      
      45      Thus, there is nothing in the wording of Article 4(1) of Directive 2002/37 to suggest that the holders of existing authorisations
         must, for the purposes of the review of those authorisations, hold, or have access to, an Annex II dossier.
      
      46      That interpretation is supported by the eighth recital in the preamble to Directive 2002/37. According to that recital, following
         the inclusion of ethofumesate in Annex I to Directive 91/414, Member States should be allowed a reasonable period within which
         to implement the provisions of Directive 91/414 as regards plant protection products containing that active substance, and
         in particular, to review existing authorisations in accordance with the provisions of that directive in order to ensure that
         the conditions regarding ethofumesate set out in Annex I to that directive are satisfied. It is also clear from that recital
         that the holders of such authorisations should be allowed a longer period for the submission of an Annex II and an Annex III
         dossier for each plant protection product, and for the re-evaluation of that product in accordance with the uniform principles
         laid down in Annex VI to Directive 91/414.
      
      47      Accordingly, it does not seem that Article 4(1) of Directive 2002/37 must be interpreted as requiring Member States to terminate,
         before 1 September 2003, an existing authorisation of a plant protection product containing ethofumesate on the ground that
         the authorisation holder does not hold, or have access to, an Annex II dossier.
      
      48      In order to respond to the arguments raised by Feinchemie and Bayer, the Governments of the Netherlands and Belgium and the
         Commission – according to which such a literal interpretation conflicts with the provisions concerning data protection laid
         down in Directive 91/414, including Article 13(3) of that directive, and that, therefore, Article 4(1) of Directive 2002/37
         must be read in the light of Directive 91/414 – it must be stated from the outset that Directive 2002/37 pursues three principal
         objectives: (i) to include ethofumesate in Annex I to Directive 91/414; (ii) to ensure that Member States check whether the
         existing authorisations for plant protection products containing that active substance comply with the conditions relating
         to ethofumesate set out in that Annex and, if necessary, amend or withdraw those authorisations before 1 September 2003; and
         (iii) to ensure that Member States re-evaluate those products in accordance with the uniform principles laid down in Annex
         VI to Directive 91/414, on the basis of an Annex III dossier.
      
      49      It must also be stated that, where an implementing directive requires interpretation, that interpretation must, as far as
         possible, be consistent with the provisions of the basic directive (see, by analogy, Case C-90/92 Dr Tretter [1993] ECR I‑3569, paragraph 11). In addition, a provision must be interpreted, as far as possible, in such a way as not
         to affect its validity (Case C-403/99 Italy v Commission [2001] ECR I‑6883, paragraphs 28 and 37). 
      
      50      However, although, by not expressly requiring Member States to check that the holders of previous authorisations have access
         to an Annex II dossier, Article 4(1) of Directive 2002/37 has the effect of curtailing the period during which data is protected
         pursuant to Article 13(3)(d) of Directive 91/414, that situation arises as a direct result of the way in which Article 4(1)
         of Directive 2002/37 is drafted. Given that the wording of Article 4(1) of Directive 2002/37 is clear and unambiguous, the
         interpretation according to which the holder of an existing authorisation is not required, under that provision, to submit
         an Annex II dossier during the review phase is the only interpretation that is compatible with the principle of legal certainty,
         in accordance with which Community legislation must enable those concerned to acquaint themselves with the precise extent
         of the obligations it imposes upon them (see Case C-161/06 Skoma-Lux [2007] ECR I‑0000, paragraphs 36 and 38).
      
      51      It must also be stated that Article 4(2) of Directive 2002/37 provides that Member States are to check, on the basis of an
         Annex III dossier, whether the plant protection products containing ethofumesate satisfy the conditions set out in Article
         4(1)(b) to (e) of Directive 91/414 and then, if necessary, to amend or withdraw, for each plant protection product concerned,
         the authorisation granted previously. Thus, that provision enables a balance to be struck between, on the one hand, data protection
         in accordance with Article 13(3) of Directive 91/414 and, on the other hand, the rights that holders of previous authorisations
         derive from the clear provisions of Article 4(1) of Directive 2002/37.
      
      52      The interpretation of Article 4(1) of Directive 2002/37 cannot therefore be called into question by an interpretation of Directive
         91/414 according to which the conditions of the review provided for in that provision would be stricter.
      
      53      As regards the argument, submitted by Feinchemie and Bayer and by the Commission, based on the interpretation of Article 4(1)
         of Directive 2002/37 in the light of subsequent directives – such as Directive 2005/53 – relating to the inclusion of various
         active substances in Annex I to Directive 91/414, it must be held, first, that the interpretation of Directive 2002/37 cannot
         depend on the subsequent adoption of similar measures and, second, that the last sentence of the 11th recital in the preamble
         to Directive 2005/53 states specifically that, as compared with the directives already adopted for the purposes of amending
         Annex I to Directive 91/414, Directive 2005/53 does not impose any new obligations on Member States or on the holders of authorisations.
      
      54      In any event, it must be pointed out that the 11th recital in the preamble to Directive 2005/53 also states that ‘experience
         has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access
         to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States,
         especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements
         of Annex II to that Directive.’ That clarification confirms that the choice made in Directive 2005/53 is of relevance to the
         future and that Directive 2005/53 in no way constitutes an interpretative act that can affect the interpretation of Directive
         2002/37. 
      
      55      In those circumstances, the answer to the question referred must be that Article 4(1) of Directive 2002/37 must be interpreted
         as not requiring Member States to terminate, before 1 September 2003, the authorisation of a plant protection product containing
         ethofumesate on the ground that the holder of that authorisation does not hold, or have access to, an Annex II dossier.
      
       Costs
      56      Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court,
         the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs
         of those parties, are not recoverable.
      
      On those grounds, the Court (Third Chamber) hereby rules:
      Article 4(1) of Commission Directive 2002/37/EC of 3 May 2002 amending Council Directive 91/414/EEC to include ethofumesate
            as an active substance must be interpreted as not requiring Member States to terminate, before 1 September 2003, the authorisation
            of a plant protection product containing ethofumesate on the ground that the holder of that authorisation does not hold, or
            have access to, a dossier satisfying the requirements set out in Annex II to Council Directive 91/414/EEC of 15 July 1991
            concerning the placing of plant protection products on the market.
       [Signatures]
      * Language of the case: Dutch.