(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)
- 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).
- 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 By those decisions, the CTB had withdrawn the authorisations held by Agrichem for the placing on the market of plant protection products containing ethofumesate as an active substance.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
- 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'.
- 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.
- 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).
- 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.
- 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.
- 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.'
- 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
- 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.
- 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.
...'.
- 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
- 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]'.
- 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
- 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
- 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.
- 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.
- Agrichem did not act with the applicants, either as notifier of the active substance ethofumesate or as co-notifier.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 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
- 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.
- 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.
- 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.
- 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.
- 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).
- 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 leading 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.
- 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
- 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
- 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.
- 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.
- 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 5 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.
- 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.
- 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 eleventh 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...'.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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).
- 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.
- 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.
- 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 eleventh 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.
- In any event, it must be pointed out that the eleventh 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.
- 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
- 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.
