CELEX: 62009CC0077
Language: en
Date: 2010-07-15
Title: Opinion of Mr Advocate General Jääskinen delivered on 15 July 2010. # Gowan Comércio Internacional e Serviços Lda v Ministero della Salute. # Reference for a preliminary ruling: Tribunale amministrativo regionale del Lazio - Italy. # Plant protection products - Directive 2006/134/EC - Validity - Restrictions on the use of fenarimol as an active substance. # Case C-77/09.

OPINION OF ADVOCATE GENERAL
      JÄÄSKINEN
      delivered on 15 July 2010 (1)
      
      Case C‑77/09
      Gowan Comércio Internacional e Serviços Lda
      v
      Ministero della Salute
      Reference for a preliminary ruling from the Tribunale amministrativo regionale del Lazio (Italy)
      (Plant protection products – Active substance fenarimol – Directive 91/414/EEC – Inclusion in Annex I – Conditions and limitations – Directive 2006/134/EEC – Validity)
      I –  Introduction
      1.        In the present case the Tribunale amministrativo regionale del Lazio (Regional Administrative Court for Lazio, Italy) asks
         the Court to rule on the validity of Directive 2006/134/EC. (2)
      
      2.        Directive 2006/134 amended Directive 91/414/EEC, (3) which requires the Member States to ensure that plant protection products (in particular, herbicides, pesticides and fungicides
         intended for the treatment of plants) are not placed on the market and used in their territory unless they have authorised
         the product in question in accordance with the provisions of that Directive. A plant protection product may be authorised
         only if its active substances are listed in Annex I to Directive 91/414.  
      
      3.        Directive 2006/134 added fenarimol to Annex I to Directive 91/414, subject to certain conditions.  
      
      4.        In essence, the referring court is uncertain as to whether the validity of Directive 2006/134 may be affected by any difference
         between the Directive and a preparatory document relating to it, in the present case a report drawn up by the Member State
         which was designated to assess the effects of the active substance in question. 
      
      II –  The legal context 
      A –     Directive 91/414
      5.        Directive 91/414 lays down the Community scheme for the authorisation and withdrawal of authorisation to place plant protection
         products on the market.
      
      6.        Article 4 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’.
      
      7.        Article 5(1) and (2) of Directive 91/414 lays down the conditions  for the inclusion of an active substance in Annex I in
         the following terms: 
      
      ‘1. In the light of current scientific and technical knowledge, an active substance shall be included in Annex I for an initial
         period not exceeding 10 years, if it may be expected that plant protection products containing the active substance will fulfil
         the following conditions:
      
      (a)      their residues, consequent on application consistent with good plant protection practice, do not have any harmful effects
         on human or animal health or on groundwater or any unacceptable influence on the environment, and the said residues, in so
         far as they are of toxicological or environmental significance, can be measured by methods in general use; 
      
      (b)      their use, consequent on application consistent with good plant protection practice, does not have any harmful effects on
         human or animal health or any unacceptable influence on the environment as provided for in Article 4(1)(b)(iv) and (v). 
      
      2. For inclusion of an active substance in Annex I, the following shall be taken into particular account: 
      (a)      where relevant, an acceptable daily intake (ADI) for man; 
      (b)      an acceptable operator exposure level if necessary; 
      (c)      where relevant, an estimate of its fate and distribution in the environment as well as its impact on non-target species.’
      8.        Article 5(4) of  Directive 91/414 provides:
      
      ‘Inclusion of an active substance in Annex I may be subject to requirements such as: 
      …
      –        restrictions arising from evaluation of the information referred to in Article 6, taking account of the agricultural, plant
         health and environmental (including climatic) conditions in question, 
      
      …
      –                 manner of use.’
      9.        Article 6 of Directive 91/414 is worded as follows:  
      
      ‘1. Inclusion of an active substance in Annex I shall be decided in accordance with the procedure laid down in Article 19.
      ...’
      10.      Article 8 of Directive 91/414 relates to transitional measures and derogations. The second and fourth subparagraphs of paragraph
         2 provide as follows: 
      
      ‘After the adoption of this Directive, the Commission shall commence a programme of work for the gradual examination of these
         active substances … . 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. 
      
      …
      … 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.’
      
      11.      Article 19 of Directive 91/414 (4) provides that the Commission is to be assisted by a regulatory committee, the Standing Committee on the Food Chain and Animal
         Health (‘the Committee’).
      
      B –    Regulation (EEC) No 3600/92
      12.      The procedure to be followed under Article 8(2) of Directive 91/414 for the inclusion in Annex I to Directive 91/414 of certain
         active substances contained in plant protection products, is laid down by Regulation (EEC) No 3600/92. (5) The procedure begins with notification to the Commission which the producer must give pursuant to Article 4 of that Regulation.
      
      13.      It is clear from the preamble to Regulation No 3600/92 that the work of assessing active substances must be distributed among
         the competent authorities of the Member State and that a rapporteur Member State must be designated for each active substance.
      
      14.      In the present case, the producer of fenarimol, DowElanco Europe, notified the Commission, following which the latter adopted
         Regulation (EC) No 933/1994, pursuant to Article 5(2) of Regulation No 3600/92. (6) It appears from Regulation No 933/1994 that the Member State which was designated as rapporteur Member State is the United
         Kingdom of Great Britain and Northern Ireland. 
      
      15.      Article 7 of Regulation No 3600/92 sets out in detail the obligations of the rapporteur Member State and the Commission respectively
         and the procedure to be followed. The rapporteur Member State must send the Commission a report on its assessment and a recommendation
         (paragraph 1). The Commission, for its part, must refer the dossier and the report to the committee for examination (paragraph
         3) and then, where appropriate, submit a draft directive or a draft decision to the committee (second subparagraph of paragraph
         3). 
      
      16.      Furthermore, if additional trials or additional information are required, Article 8 of Regulation No 3600/92 lays down the
         obligations of the rapporteur Member State and the Commission respectively and the procedure to be followed. 
      
      C –    Directive 2006/134
      17.      Directive 2006/134 included fenarimol in Annex I to Directive 91/414 for the period from 1 January 2007 to 30 June 2008 and
         laid down the restrictions on the use of that active substance. (7)
      
      18.      Recitals 2 to 8 of the preamble to Directive 2006/134 summarise the circumstances leading to its adoption and state the reasons
         for certain key decisions made by the Directive, particularly with regard to the restrictions on permitted uses (recitals
         5 and 6), reduction of the period of inclusion (recital 8) and the need to obtain additional information (recital 10).  
      
      19.      With regard to fenarimol, the Annex to Directive 2006/134 provides that its use as a fungicide is authorised only on certain
         crops (tomatoes, peppers in greenhouses, aubergines, cucumbers in greenhouses, melons, ornamentals, nursery trees and perennial
         plants). The annex also specifies the maximum rates for each crop. In addition, the annex prohibits certain uses of fenarimol
         (air application, knapsack and hand-held applications by amateur users, home gardening). Finally, the Member States must ensure
         that all appropriate measures are taken to mitigate risks and that particular attention is paid to the protection of aquatic
         organisms, earthworms, birds and mammals and to the protection of operators and workers.
      
      III –  The main proceedings and the question referred 
      20.      On 28 July 1993 DowElanco Europe notified the Commission of its interest in having fenarimol included in Annex I to Directive
         91/414.  After taking over the business of DowElanco Europe, the Portuguese-law company Gowan Comércio International e Serviços
         Lda (‘Gowan’) continued the procedure for the inclusion of fenarimol in its own name.
      
      21.      Following the adoption of Directive 2006/134, Italy withdrew, by ministerial decision of 8 June 2007, the authorisations issued
         to Gowan for marketing plant protection products containing fenarimol.
      
      22.      By ministerial decision of 17 October 2007, fenarimol was placed on the list of active substances authorised in Italy, shown
         in Annex I to legislative decree no 194 of 17 March 1995. 
      
      23.      The referring court observes that the decision of 8 June 2007 was partly revoked by a decision, the date of which is not given,
         in order to reinstate provisionally certain fenarimol-based products among those authorised in Italy, in accordance with legislative
         decree no 194, as amended on 17 October 2007 in the light of Directive 2006/134. 
      
      24.      Gowan challenged the last two decisions by bringing an action for annulment before the Tribunale amministrativo regionale
         del Lazio.
      
      25.      In that action, Gowan claims that Directive 2006/134 was unlawful. In essence, it submits that the severe restrictions on
         the use of fenarimol are not justified by the scientific studies carried out in the course of the assessment procedure. 
      
      26.      According to Gowan, the conditions for the inclusion of fenarimol in Annex I to Directive 91/414 restrict its use for a period
         of 18 months to certain crops of marginal importance by comparison with those which have hitherto constituted its main market
         (vines, apples, pears, peaches, water melons, courgettes, non-greenhouse peppers and strawberries).
      
      27.      The referring court finds that the scientific assessment procedure led to positive conclusions and that the Commission originally
         proposed to include fenarimol in Annex I of Directive 91/414 without any restriction. 
      
      28.      As the Tribunale amministrativo regionale del Lazio was uncertain as to whether Directive 2006/134 is lawful, it decided to
         stay the proceedings and to refer the following question to the Court for a preliminary ruling:
      
      ‘In view of the fact that the conclusion of the technical and scientific assessment carried out by the rapporteur State appears
         to be that the risk arising from the use of fenarimol is acceptable, is Directive 2006/134, which significantly limited such
         use, valid?’
      
      IV –  Summary of the parties’ observations 
      29.      Written observations have been lodged by the applicant in the main proceedings, the German and Greek Governments and the Commission.
         All, with the exception of the German Government, were represented at the hearing of 29 April 2010.
      
      30.      With the exception of the applicant in the main proceedings, all the parties represented took the view that Directive 2006/134
         is valid. 
      
      V –  Admissibility 
      31.      The German Government and the Commission expressed doubts concerning the admissibility of the reference for a preliminary
         ruling on the ground that it is imprecise and unclear. 
      
      32.      On that point, it has consistently been held that the need to provide an interpretation of Community law which will be of
         use to the national court makes it necessary that the national court should define the factual and legislative context of
         the questions which it is asking or, at the very least, explain the factual circumstances on which those questions are based. (8)
      
      33.      The information provided in orders for reference must not only enable the Court to reply usefully but must also give the governments
         of the Member States and other interested parties the opportunity to submit observations pursuant to Article 23 of the Statute
         of the Court of Justice. It is the Court’s duty to ensure that that opportunity is safeguarded, bearing in mind that under
         that provision only the orders for reference are notified to the interested parties. (9)
      
      34.      In the present case, the order for reference contains sufficient detail to enable the governments of the Member States and
         the other parties to submit observations. It is also clear from the observations submitted by the German and Greek Governments,
         and by the Commission, that those Governments and the Commission have been able to make a useful contribution on the question
         put by the referring court.
      
      35.      For my part, it seems to me that the Court may consider that it has sufficient information in the order for reference and
         in the observations which have been submitted to enable the Court to give a useful reply to the question before it.
      
      36.      However, there is another question relating to the admissibility of the present reference for a preliminary ruling which should
         be examined. That question is whether Gowan is still entitled to claim before the national courts that Directive 2006/134
         is unlawful in view of the fact that Gowan did not bring an action for the annulment of the Directive before the Court of
         First Instance within the time lime prescribed in Article 230 EC, when it may still have had the right to do so. (10)
      
      37.      According to the judgment in TWD Textilwerke Deggendorf, a natural or legal person cannot, in principle, bring an indirect challenge to the validity of an act of a Community institution
         by means of a reference for a preliminary ruling if that person would have been entitled to do so directly on the basis of
         Article 230 EC. (11)
      
      38.      The limitation of the right to challenge a Community act by means of a reference for a preliminary ruling is intended to safeguard
         legal certainty by preventing Community measures which involve legal effects from being called into question indefinitely.
         Otherwise any person would be able to overcome the definitive nature which the decision assumes once the time limit for bringing
         an action under the fourth paragraph of Article 230 EC has expired. (12)
      
      39.      However, it is clear from the settled case-law that a person can be prevented from claiming before a national court that a
         Community  measure is illegal and challenging its validity indirectly on the basis of  Article 234 EC only if his right to
         bring an action for annulment under Article 230 EC is undoubtedly admissible. (13)
      
      40.      Consequently, as the question referred relates to a directive, it is necessary to ascertain whether an action brought by Gowan
         against Directive 2006/134 would undoubtedly have been admissible on the ground that its provisions concerned Gowan directly
         and individually. (14)
      
      41.      In my opinion, that is not the case here.
      
      42.      First of all, it must be observed that, in the TWD Textilwerke Deggendorf case, the undertaking in question was the subject of compliance measures. That case-law was applied to certain regulations
         when the Court stated that, in certain circumstances, a regulation could be a challengeable act, with the result that a reference
         for a preliminary ruling could be inadmissible. (15)
      
      43.      However, the situation is different with regard to directives. In the Eurotunnel case the Court made it clear that a directive could not be treated in the same way. (16)
      
      44.      Although it is true that, in the specific context of Directive 91/414, the Court of First Instance recently found that an
         action for annulment brought by a notifying undertaking against a directive adopted on the basis of that notification was
         admissible, (17) that does not mean that the applicant in the main proceedings in the present case undoubtedly has standing to bring such
         an action, and there are three series of reasons for this. First, the abovementioned judgment was given only in 2009, but
         the applicant in the main proceedings ought to have brought its action at the beginning of 2007, that is to say, long before
         the judgment was delivered. In addition, the Court of Justice has not had an opportunity to give a ruling on the General Court’s
         decision. Finally, taking account of the wording of the Treaty and its general system, which make no provision, even indirectly,
         for the possibility of such an action, I think the principle of legal certainty precludes such a restriction of admissibility
         by judge-made law. Therefore Gowan would not undoubtedly have had standing to bring an action against Directive 2006/134.
      
      45.      It follows that the question referred seems to me admissible.  
      
      VI –  Analysis of the merits
      A –    Interpretation of the question referred 
      46.      In the question referred, the referring court states that Directive 2006/134 significantly limited the use of fenarimol. 
         The referring court wishes to know whether the Directive is valid, taking account of the fact that the technical and scientific
         assessment carried out by the rapporteur Member State appears to find that the risk arising from the use of fenarimol is acceptable.
         
      
      47.      First of all, I note that the question, which concerns the validity of a Community measure, is worded in a rather general
         way, without specifying the rule of law or the legal principle which may have been infringed. 
      
      48.      In references for a preliminary ruling concerning validity, the questions and possible grounds of invalidity are often worded
         in a rather precise way by the referring court in the question itself. (18) Where that has not been the case, it has nevertheless been possible to clarify the question in the light of the order for
         reference itself. (19)
      
      49.      However, that is not the case here. The referring court has decided to put the question in rather general terms. To clarify
         the question, it might be possible to seek clues in the reasoning of the order for reference itself, but that is hardly more
         specific.  
      
      50.      I would point out that Article 234 EC establishes the framework for close cooperation between the national courts and the
         Court of Justice, based on the division of jurisdiction between them. In the framework of that cooperation, the right to determine
         the questions to be submitted to the Court of Justice devolves upon the national courts alone and it is not for the parties
         to the proceedings before the Court of Justice to limit or extend the questions. 
      
      51.      With regard to assessing the validity of an act, the situation is to a certain degree parallel with an action for annulment.
         As the Court has observed, requests for preliminary rulings on validity, like actions for annulment, constitute means for
         reviewing the legality of acts of the community institutions. (20) An action for annulment which does not indicate exactly the reasons why the contested act should be annulled is inadmissible.
         In the same way, a reference for a preliminary ruling concerning validity must be ruled inadmissible if the grounds of invalidity
         do not appear from the question or, alternatively, the decision. It is not for the Court to ascertain of its own motion any
         reason which could affect the validity of an act. (21)
      
      52.      With regard to the question concerning the validity of an act and the possibility of rewording the question, the Court should,
         in my opinion, abide by the question and refrain from expanding it. There are two sets of arguments in favour of that approach.
         
      
      53.      First, in an action for annulment it is for the applicant itself to choose and to formulate its complaints in its own way.
         A reference for a preliminary ruling, on the other hand, is a form of cooperation between the national court and the Court
         of Justice, and the parties to the main proceedings do not determine the procedure. The decision to refer a question is a
         matter for the national court alone. That court must also formulate the question and it is not for the Court of Justice, save
         in exceptional cases, to consider whether the decision is well-founded or to reword it, having regard to the rules of cooperation.
         With all the more reason it is not for the parties to expand the question formulated by the referring court.  
      
      54.      Second, the preliminary ruling procedure is of the nature of an interlocutory matter in relation to the main proceedings,
         where the parties are able to argue in accordance with the principle that both parties should have the opportunity to state
         their case. In addition, unlike an action for annulment before the General Court, where two successive exchanges of pleadings
         are provided for (application and defence, then reply and rejoinder), a reference for a preliminary ruling from the Court
         of Justice is limited to a single statement of case by each party, lodged simultaneously, and the parties cannot submit written
         observations on the statements of the others. Furthermore, a hearing in an action for annulment is almost automatic before
         the General Court, but it is not for a reference for a preliminary ruling from the Court of Justice. (22)
      
      55.      In those circumstances, it is clear that the wording of the order for reference itself remains the keystone of cooperation.
         It is the document on the basis of which, first, the Member States decide whether or not to submit written observations and,
         second, each party to the procedure before the Court of Justice prepares its submissions. If it were generally accepted that
         the parties presenting written observations could take control of the procedure and thereby reword the questions referred
         to the Court in order to put forward other grounds of invalidity, that would open the way to changing the nature of the reference
         for a preliminary ruling into a covert action for annulment, at the risk of seriously disrupting the procedure before the
         Court. (23)
      
      56.      In view of those considerations, it is necessary to concentrate on the two factors giving rise to the doubts concerning the
         validity of Directive 2006/134 mentioned by the referring court in the order for reference, namely, first, the question of
         the relation between the report of the rapporteur Member State and Directive 2006/134 and, second, the fact that that directive
         makes the use of fenarimol subject to various conditions. 
      
      B –    The relation between the report of the rapporteur Member State and Directive 2006/134
      57.      The referring court indicates that the fact that the report of the rapporteur Member State may not be consistent with the
         directive adopted may be a ground of invalidity.  
      
      58.      In that connection it must be observed that it is clear from Regulation No 3600/92, and in particular Articles 7 and 8, that
         the adoption of any act by the Commission following an assessment (or by the Council, as the case may be) is preceded by a
         series of exchanges between different agencies.   
      
      59.      With regard to the role of the rapporteur Member State in the present case, the applicant in the main proceedings and the
         Commission produced, on request by the Court, the report of the rapporteur Member State of March 1996, together with three
         addenda to the report dated August 2000, February 2001 and October 2003 respectively.
      
      60.      The Commission points out that, in that first report, it was not proposed to include fenarimol in Annex I to Directive 91/414,
         but to defer a decision as certain data were not available concerning its residues and its ecotoxic valency, that is to say,
         the risks to aquatic organisms. 
      
      61.      The Commission also claims that the reports were submitted for evaluation by the other Member States. In the course of that
         examination by national experts, which took place between 1997 and 2004, the other Member States proposed modifications and
         additions to the reports.
      
      62.      According to the Commission, from November 2000 the report was discussed by two working groups. The ‘evaluation’ working group
         examined the substance of the report from a technical and scientific viewpoint with the object, in particular, of determining
         the level of risk on the basis of scientific data (risk assessment). The ‘legislation’ working group is responsible for preparing
         the draft directive on inclusion, taking account, where necessary, of a broader assessment of risk management in the event
         of scientific uncertainty. The ‘legislation’ working group must take into account political and social considerations. It
         establishes the level of scientific uncertainty acceptable to society and evaluates the possibility of managing and containing
         the risk which has been recognised (risk management). 
      
      63.      In the present case, the activities of the working groups continued from 2000 to 2004 in relation to the technical and scientific
         assessment alone. Even before they began, a number of Member States had presented contributions in the form of addenda in
         the course of the joint assessment.
      
      64.      According to the Commission, the first version of the draft directive was not presented until 2004. However, between 27 July
         2004 and 13 September 2006 the Commission prepared no less than eight different versions of the directive, three of which
         were discussed by the ‘legislation’ working group and one was submitted for a vote by the committee.
      
      65.      The applicant in the main proceedings and the Commission have presented somewhat differing accounts of the process of adoption
         of the directive in question. Accordingly the Court has three different versions of events – those of Gowan and the Commission,
         and the version in the preamble to the directive. In the context of a reference for a preliminary ruling, it is certainly
         not necessary to examine those different versions in detail. (24)
      
      66.      So far as the question referred is concerned, the national court does not make it clear how the alleged difference between
         the report and the directive may affect the validity of the latter. Furthermore, the national court does not specify to which
         of the three reports it is referring.
      
      67.      On that point, it must be observed that a direct correlation between a report prepared by the rapporteur Member State and
         the act adopted by the Commission cannot be established.  
      
      68.      The report of the rapporteur Member State and the addenda are used as the starting point for discussions with the Member States’
         experts and when the inclusion of active substances is considered by the ‘evaluation’ and ‘legislation’ working groups. The
         first draft of a directive is drawn up by the Commission only on completion of that complex process.  
      
      69.      By virtue of a fundamental rule of the Treaty, the Commission may at any time modify its draft or replace it with a new draft
         taking account of comments, as was the case here. With regard to legislative proposals, Article 293(2) TFEU expresses that
         rule.
      
      70.      In the process of adopting any directive pursuant to Directive 91/414, the Commission has a discretion in at least two respects,
         that is to say, it assesses the risks and carries out a political evaluation of their acceptability.  
      
      71.      Risk assessment is a fairly objective exercise provided that an established and undisputed methodology exists, but where there
         is none (as in the present case for fenarimol) opinions are necessarily expressed in the exercise of a discretion. (25) An assessment of the risks revealed by analysis necessarily entails choices of a political and social nature which are for
         the Commission to make.
      
      72.      In any case, this is a field characterised by complex evaluations and a broad discretion. It is a field in which the Court
         should censure decisions only in the event of a manifest error of fact or of law or a misuse of power. As the General Court
         has observed, if the Commission is to be able to pursue effectively the objective assigned to it, account being taken of the
         complex technical assessments which it must undertake, it must be recognised as enjoying a broad discretion. (26)
      
      73.      In the present case, it is not possible to go into detail in view of the brevity of the question referred on that point. Furthermore,
         there are differences in the accounts of the facts given by the applicant in the main proceedings and the Commission with
         regard to the stages which preceded the adoption of the Directive. The very nature of the preliminary ruling procedure before
         the Court does not seem to me to permit the clarification of factual questions of that kind. In those circumstances, no more
         can be said.
      
      74.      The conclusion that must be drawn from the foregoing is that any document drawn up by the rapporteur Member State in connection
         with Regulation No 3600/92 is a document which is necessary and useful for the preparation of the Commission’s opinion, but
         it is not in itself decisive or determining. It is merely a preparatory document. The act in question could be rendered invalid
         only by flagrant inconsistency between, on the one hand, a report based on an undisputed methodology leaving no room for scientific
         uncertainty and, on the other hand, the Commission’s opinion.
      
      75.      However, the file does not reveal any such inconsistency which would be capable of calling into question the validity of Directive
         2006/134.
      
      C –    Use of fenarimol subject to conditions laid down by Directive 2006/134 
      76.      The referring court is doubtful as to the validity of Directive 2006/134 also on the ground that it significantly limited
         the use of fenarimol. However, the court does not specify which conditions in particular are likely to affect the validity
         of the Directive. Therefore my analysis will be in general terms.
      
      77.      It must be noted that, according to Article 5 of Directive 914/14, various conditions may be imposed when an active substance
         is included in Annex I of the Directive. 
      
      78.      With regard to the conditions laid down by Directive 2006/134 for fenarimol, it must be borne in mind that the general principle
         of proportionality requires that measures adopted by Community institutions do not exceed the limits of what is appropriate
         and necessary in order to attain the legitimate objectives pursued by the legislation in question; when there is a choice
         between several appropriate measures, recourse must be had to the least onerous, and the disadvantages caused must not be
         disproportionate to the aims pursued. (27)
      
      79.      It follows from this that, within the context of judicial review of the application of such a principle, having regard to
         the broad discretion enjoyed by the Commission in adopting Directive 2006/134, the legality of that measure can be affected
         only if the measure is manifestly inappropriate having regard to the objective which the Commission sought to pursue. (28)
      
      80.      With regard to the statement of reasons of Directive 2006/134, reference must be made to the following matters set out in
         its preamble. 
      
      81.      On the basis of the various examinations that were carried out, the Commission considers that plant protection products containing
         fenarimol may be expected to satisfy the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, with regard
         to the uses which were examined and detailed in the Commission review report, provided that adequate risk mitigation measures
         are applied. (29)
      
      82.      The Commission points out, however, that fenarimol is a hazardous substance. Therefore its use should not be authorised without
         restriction. The Commission refers to concerns about its intrinsic toxic effects, including potential endocrine disrupting
         properties and to the fact that there is at present no scientific consensus on the exact extent of the risk. Applying the
         precautionary principle, and taking into account the current state of scientific knowledge, the Commission decided to impose
         risk mitigation measures in order to achieve the high level of protection of human and animal health and the environment chosen
         in the European Community. (30)
      
      83.      For that purpose, inclusion in Annex I to Directive 91/414 is limited to the proposed uses of fenarimol that have been actually
         assessed within the Community evaluation and which were considered to comply with the conditions of Directive 91/414. Consequently
         other uses, which were not or only partially covered by this assessment, must first be subject to a complete assessment, before
         their inclusion in Annex I to Directive 91/414 can be considered. (31)
      
      84.      Furthermore, with regard to the period of inclusion, the Commission considers it appropriate to limit the period to 18 months.
         According to the Commission, this further reduces any risk by ensuring a priority re-assessment of the substance. (32)
      
      85.      It seems to me that these passages in the preamble to Directive 2006/134 prove that the Commission carried out an overall
         assessment of the advantages and disadvantages of the system to be put in place and that, in any case, the system was not
         manifestly inappropriate in the light of the objectives pursued. 
      
      86.      In addition, the substantive conditions and the time restrictions imposed in relation to fenarimol do not seem at all exceptional
         by comparison with those adopted on the same day by different directives for certain other active substances such as methamidophos,
         procymidone, flusilazole, carbendazim and dinocap. (33)
      
      87.      Therefore the fact that Directive 2006/134 includes conditions such as those provided for in the present case in accordance
         with Article 5 of Directive 91/414 does not in itself affect its validity.
      
      VII –  Conclusion
      88.      I therefore propose that the Court give the following reply to the Tribunale amministrativo regionale del Lazio:
      
      Examination of the question which has been referred reveals nothing which would justify the conclusion that Commission Directive
         2006/134/EC of 11 December 2006, amending Council Directive 91/414/EEC to include fenarimol as active substance, was not validly
         adopted.
      
      1 –	Original language:  French.
      
      2 –	Commission Directive 2006/134/EC of 11 December 2006 amending Council Directive 91/414/EEC to include fenarimol as active
         substance (OJ 2006 L 349, p. 32).
      
      3 –	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), as amended by Directive 2006/134 (‘Directive 91/414’). 
      
      4 –	As amended by Council Regulation (EC) No 806/2003 of 14 April 2003 (OJ 2003 L 122, p. 1).
      
      5 –	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), as amended by
         Commission Regulation (EC) No 2266/2000 of 12 October 2000 (OJ 2000 L 259, p. 27, ‘Regulation No 3600/92’). 
      
      6 –	Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and
         designating the rapporteur Member States for the implementation of Commission Regulation (EEC) No 3600/92 (OJ 1994 L 107,
         p. 8).
      
      7 –	Directive 2006/134 was adopted on the basis of Article 6(1) of Directive 91/414.
      
      8 –	See, inter alia, Case C‑67/96 Albany [1999] ECR I‑5751, paragraph 39; Joined Cases C‑51/96 and C‑191/97 Deliège [2000] ECR I‑2549, paragraph 30; Case C‑506/04 Wilson [2006] ECR I-8613, paragraph 38, and Case C-126/08 Distillerie Smeets Hasselt and Others  [2009] ECR I‑6809, paragraph 16.
      
      9 –	See, inter alia, Albany, paragraph 40; Case C‑145/03 Keller [2005] ECR I‑2529, paragraph 30; Wilson, paragraph 39, and Distillerie Smeets Hasselt NV, paragraph 17.
      
      10 –	Case C-188/92 TWD Textilwerke Deggendorf [1994] ECR I‑833. See also the Opinions of Advocate General Kokott in Case C-343/09 Afton Chemical [2010] ECR I-0000, points 17 to 20, pending before the Court, and of Advocate General Mazák in Case C-343/07 Bavaria and Bavaria Italia [2009] ECR I-5491, points 34 to 37. 
      
      11 –	TWD Textilwerke Deggendorf, paragraphs 13 to 15, and Case C-239/99 Nachi Europe [2001] ECR I‑1197, paragraph 36.
      
      12 –	TWD Textilwerke Deggendorf,  paragraphs 16 to 18; Nachi Europe, paragraph 37, and Case C‑441/05 Roquette Frères [2007] ECR I‑1993, paragraph 40. 
      
      13 –	See, inter alia, TWD Textilwerke Deggendorf, paragraphs 24 and 25; Nachi Europe, paragraph 37; Roquette Frères, paragraphs 40 and 41, and Case C-241/95 Accrington Beef and Others [1996] ECR I‑6699, paragraph 15.
      
      14 –	Roquette Frères, paragraph 41, and Nachi Europe, paragraph 37.
      
      15 –	Nachi Europe, paragraph 37. That possibility follows from the actual wording of the EC Treaty (see the fourth paragraph of Article 230
         EC, which is now, after amendment, the fourth paragraph of Article 263 TFEU. 
      
      16 –	Case C-408/95 Eurotunnel and Others [1997] ECR I‑6315, paragraph 32: ‘… a natural or legal person may challenge before a national court the validity of provisions
         in directives, such as Articles 28 and 28k, even though that person has not brought an action for annulment of those provisions
         pursuant to Article 173 of the Treaty’.
      
      17 –	Case T-380/06 Vischim v Commission [2009] ECR II-3911, paragraphs 57 to 59.
      
      18 –	See, for example, Joined Cases C-453/03, C-11/04, C-12/04 and C-194/04 ABNA and Others [2005] ECR I‑10423, paragraphs 20, 30 and 31.
      
      19 –	See, for example, Case C-174/05 Zuid‑Hollandse Milieufederatie and Natuur en Milieu [2006] ECR I‑2443, paragraphs 10 to 16.
      
      20 –	Case 314/85 Foto-Frost [1987] ECR 4199, paragraph 16.
      
      21 –	It should, however, be added that the Court is entitled to ascertain of its own motion whether the procedural safeguards
         conferred by the European Union’s legal order have been complied with (Case C-291/89 Interhotel v Commission [1991] ECR I-2257, paragraphs 14 and 15, and Case C-160/08 Commission v Germany [2010] ECR I-0000, paragraph 40).
      
      22 –	See Article 104(4) of the Rules of Procedure of the Court of Justice.
      
      23 –	See, to that effect, Joined Cases 50/82 to 58/82 Dorca Marina and Others [1982] ECR 3949, paragraph 13. In its written observations, Gowan disputes the validity of Directive 2006/134 on eleven grounds,
         namely infringement of Article 5 of Directive 91/414, no statement of reasons, non-adherence to the principles of legal certainty
         and the protection of legitimate expectations, misapplication of the precautionary principle, misuse of powers, infringement
         of the right to a fair hearing, erroneous assessment of risk, non-adherence to the principle of scientific excellence, jeopardizing
         the uniform application of Community law and non-adherence to the principle of equal treatment. Those complaints go far beyond
         the two grounds of invalidity referred to by the referring court in the question it has put to the Court of Justice. 
      
      24 –	In view of the constraints arising from the nature of the preliminary ruling procedure, the Court has not been fully informed
         concerning that procedure. On the other hand, it is clear from Case T-75/06 Bayer CropScienceand Others v Commission [2008] ECR II-2081, that all the relevant technical details concerning another modification of Annex I to Directive 91/414
         may be meticulously examined in the context of an application for annulment before the General Court, after two exchanges
         of pleadings and supplementary questions in that particular case. 
      
      25 –	At the hearing, the Commission referred in particular to the fact that there are no OECD guidelines tests for changes in
         the endocrine system.
      
      26 –	Bayer CropScience and Others v Commission, paragraph 82.
      
      27 –	Case 265/87 SchräderHS Kraftfutter [1989] ECR 2237, paragraph 21; Case C‑331/88 Fedesa and Others [1990] ECR I-4023, paragraph 13; Joined Cases C‑133/93, C-300/93 and C-362/93 Crispoltoni and Others [1994] ECR I‑4863, paragraph 41; Case C‑189/01 Jippes and Others [2001] ECR I‑5689, paragraph 81, and Case C-174/05 Zuid‑Hollandse Milieufederatie and Natuur en Milieu [2006] ECR I‑2443, paragraph 28.
      
      28 –	See, to that effect, the cases Schräder HS Kraftfutter, paragraph 22; Fedesa and Others, paragraph 14; Crispoltoni and Others, paragraph 42; Jippes and Others, paragraph 82, and Zuid‑Hollandse Milieufederati and Natuur en Milieu, paragraph 29.
      
      29 –	Recital 5 of the preamble to Directive 2006/134.
      
      30 –	Ibid. 
      
      31 –	Ibid. 
      
      32 –	Recital 8 of the preamble to Directive 2006/134.
      
      33 –	Commission Directives 2006/131/EC, 2006/132/EC, 2006/133/EC, 2006/135/EC and 2006/136/EC of 11 December 2006 amending Directive
         91/414 (OJ 2006 L 349).