Case T-75/06

Bayer CropScience AG and Others

v

Commission of the European Communities

(Directive 91/414/EEC – Plant protection products – Endosulfan as an active substance – Withdrawal of marketing authorisations – Evaluation procedure – Time-limits – Rights of the defence – Principle of proportionality)

Summary of the Judgment

1. Actions for annulment – Interest in bringing proceedings – Action against a Commission Decision concerning the non-inclusion of a substance in Annex I to Directive 91/414

(Arts 230 EC and 233, first para., EC; Council Directive 91/414, Arts 6 and 8(2))

2. Agriculture – Approximation of laws – Placing of plant protection products on the market – Directive 91/414

(Council Directive 91/414, Art. 8(2) and Annex I)

3. Agriculture – Approximation of laws – Placing of plant protection products on the market – Directive 91/414

(Council Directive 91/414, Art. 8(2) and Annex I)

4. Community law – Principles – Rights of the defence – Scope

5. Agriculture – Common agricultural policy – Discretion of the Community institutions – Scope – Judicial review – Limits

6. Agriculture – Approximation of laws – Placing of plant protection products on the market – Directive 91/414

(Council Directive 91/414, Art. 5(1))

1. In an action for annulment of a decision concerning the non-inclusion of a substance in Annex I to Directive 91/414 and the withdrawal of authorisations for plant protection products containing that substance, the applicants’ interest in bringing proceedings is not diminished by the impossibility for the Commission to take a new decision on the basis of Article 8(2) of Directive 91/414 concerning the placing of plant protection products on the market in order to comply with an annulling judgment. Under the first paragraph of Article 233 EC, the Commission is required to take the necessary measures to comply with an annulling judgment. In the event of an annulment, with its attendant retroactive effects, the Commission would have to take a fresh decision on the basis of the notified dossier concerned by that annulment and adjudicate by reference to the date of notification. The fact that, since the adoption of the contested decision, there has been a change in the legislation on which it was based has no bearing, therefore, on the question whether it is appropriate for the applicants to challenge the procedure followed and the outcome obtained under the rules in force at the material time.

(see para. 63)

2. As is clear from recitals 5, 6 and 9 in the preamble thereto, Directive 91/414 concerning the placing of plant protection products on the market aims to remove barriers to intra-Community trade in those products, while maintaining a high level of protection of the environment and of human and animal health. In that context, 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. The power to postpone deadlines is akin to a discretion, which depends on the circumstances of the case.

However, the exercise of that discretion is not excluded from judicial review. According to settled case-law, in the context of such a review the Community judicature must verify whether the relevant procedural rules have been complied with, whether the facts admitted by the Commission have been accurately stated and whether there has been a manifest error of assessment or a misuse of powers.

In particular, where a party claims that the institution competent in the matter has made a manifest error of assessment, the Community judicature must examine whether that institution has examined, carefully and impartially, all the relevant facts of the individual case which support the conclusions reached.

(see paras 81-84)

3. In connection with a decision relating to the inclusion in Annex I to Directive 91/414 concerning the placing of plant protection products on the market of a substance covered by the procedure set out in Article 8(2) of that directive, the deferral must be granted if it is not impossible to derogate from the procedural time-limits laid down in the rules in question, and if the parties who notified the active substance were in a situation of force majeure which prevented them from complying with the procedural time-limits, a situation which might obtain if the impossibility of complying with those time-limits was attributable, at least in part, to contradictory behaviour on the part of the competent authorities. Political or practical considerations do not constitute a sufficient reason for refusing to postpone deadlines in a specific case, if such an extension is necessary to ensure a fair and equitable evaluation procedure.

(see paras 89, 91)

4. Respect for the rights of the defence is, in all proceedings initiated against a person which are liable to culminate in a measure adversely affecting that person, a fundamental principle of Community law which must be guaranteed even in the absence of any rules governing the proceedings in question. That principle requires that the addressees of decisions which significantly affect their interests be placed in a position in which they may effectively make known their views. An irregularity can, however, bring about the annulment of a decision only to the extent that it is such as to actually affect the rights of defence and therefore the content of the decision. The existence of a disagreement on substance as regards the inferences to be drawn from a particular study does not amount to evidence of a lack of opportunity to make their views known and cannot be classed as an infringement of the rights of defence.

(see paras 130-132, 203)

5. In matters concerning the common agricultural policy the Community institutions enjoy a broad discretion as regards the definition of the objectives to be pursued and the choice of the appropriate means of action. Accordingly, review by the Community judicature of the substance must be confined to determining whether the exercise of such discretion is vitiated by manifest error or by misuse of powers, or whether the Community institutions clearly exceeded the bounds of their discretion. Where a Community authority is required to make complex assessments in the performance of its duties, its discretion also applies, to some extent, to the establishment of the factual basis of its action. It follows that where the Community institutions are required to undertake a scientific risk assessment and to evaluate highly complex scientific and technical facts, judicial review of the way in which they do so must be limited. In such cases, the Community judicature is not entitled to substitute its assessment of the facts for that of the Community institutions, on which the Treaty confers sole responsibility for that duty. Instead, it must confine itself to ascertaining whether the exercise by the Community institutions of their discretion in that regard is vitiated by manifest error or by misuse of powers, or whether the Community institutions clearly exceeded the bounds of their discretion.

(see para. 141)

6. Within the context of judicial review of the application of the principle of proportionality, in view of the broad discretion which the Commission enjoys in adopting decisions relating to the inclusion of active substances in Annex I to Directive 91/414 concerning the placing of plant protection products on the market, the lawfulness of a measure can be affected only if the measure is manifestly inappropriate in relation to the objective which it is intended to attain

As the aims of Directive 91/414 are, first, to remove barriers to intra-Community trade in plant protection products and to improve plant production and, second, to protect human and animal health and the environment, the decision not to include a substance in Annex I to Directive 91/414 is not disproportionate when it is based on the absence of sufficient information to show that there were no risks, such as those referred to in Article 5(1) of that directive. The objectives of protecting human and animal health and the environment militate against a deferral of the decision to include or not to include the active substance at issue in Annex I to Directive 91/414 being left to the discretion of the producers of that substance, and, in any event, it is possible for those producers to have the active substance re-examined by means of the procedure provided for in Article 6(2) of that directive.

(see paras 224-225, 228)

JUDGMENT OF THE COURT OF FIRST INSTANCE (Fourth Chamber)

9 September 2008 ( )

(Directive 91/414/EEC – Plant protection products – Endosulfan as an active substance – Withdrawal of marketing authorisations – Evaluation procedure – Time-limits – Rights of the defence – Principle of proportionality)

In Case T‑75/06,

Bayer CropScience AG, established in Monheim am Rhein (Germany),

Makhteshim-Agan Holding BV, established in Rotterdam (Netherlands),

Alfa Georgika Efodia AEVE, established in Athens (Greece),

Aragonesas Agro, SA, established in Madrid (Spain),

represented by C. Mereu and K. Van Maldegem, lawyers,

applicants,

supported by

European Crop Protection Association (ECPA), established in Brussels (Belgium), represented by D. Waelbroeck and N. Rampal, lawyers,

intervener,

v

Commission of the European Communities, represented by B. Doherty and L. Parpala, acting as Agents,

defendant,

supported by

Kingdom of Spain, represented by J. Rodríguez Cárcamo, abogado del Estado,

intervener,

APPLICATION for the annulment of Commission Decision 2005/864/EC of 2 December 2005 concerning the non-inclusion of Endosulfan in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that active substance (OJ 2005 L 317, p. 25),

THE COURT OF FIRST INSTANCE OF THE EUROPEAN COMMUNITIES (Fourth Chamber),

composed of O. Czúcz (Rapporteur), President, J.D. Cooke and I. Labucka, Judges,

Registrar: C. Kristensen, Administrator,

having regard to the written procedure and further to the hearing on 12 February 2008,

gives the following

Judgment

Legal context

Treaty provisions

1 Article 95(3) EC provides that, in its proposals to the Council for measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market and which concern health, safety, environmental protection and consumer protection, the Commission is to take as a base a high level of protection, taking account in particular of any new development based on scientific facts.

2 Article 152(1) EC states that a high level of human health protection is to be ensured in the definition and implementation of all Community policies and activities.

Directive 91/414/EEC

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) lays down the Community rules applicable to the granting of authorisation to place plant protection products on the market and to the withdrawal of such authorisation.

4 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 …’.

5 The conditions for the inclusion of active substances in Annex I are specified in Article 5 of Directive 91/414:

‘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.

…’

6 Article 6 of Directive 91/414 provides:

‘1. Inclusion of an active substance in Annex I shall be decided in accordance with the procedure laid down in Article 19.

…

2. A Member State receiving an application for the inclusion of an active substance in Annex I shall without undue delay ensure that a dossier which is believed to satisfy the requirements of Annex II is forwarded by the applicant to the other Member States and to the Commission together with a dossier complying with Annex III on at least one preparation containing that active substance. The Commission shall refer the dossier to the Standing Committee on Plant Health referred to in Article 19 for examination.

3. Without prejudice to the provisions of paragraph 4, at the request of a Member State, and within three to six months after the date of referral to the committee mentioned in Article 19, it shall be established by the procedure laid down in Article 20 whether the dossier has been submitted in accordance with the requirements of Annexes II and III.

4. If the assessment of the dossier referred to in paragraph 2 shows that further information is necessary, the Commission may ask the applicant to submit such information. The applicant or his authorised representative may be asked by the Commission to submit his remarks to it, in particular whenever an unfavourable decision is envisaged.

…’

7 Active substances which are not listed in Annex I to Directive 91/414 may, in certain circumstances, benefit from transitional arrangements permitting derogation. Thus, Article 8(2) of Directive 91/414 provides that ‘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’. That 12-year period, which expired on 26 July 2003, was extended for certain substances by Commission Regulation (EC) No 2076/2002 of 20 November 2002 extending the time period referred to in Article 8(2) of Directive 91/414 and concerning the non-inclusion of certain active substances in Annex I to the directive and the withdrawal of authorisations for plant protection products containing these substances (OJ 2002 L 319, p. 3), as amended by Commission Regulation (EC) No 1335/2005 of 12 August 2005 which also amended Decisions 2002/928/EC, 2004/129/EC, 2004/140/EC, 2004/247/EC and 2005/303/EC as regards the time period referred to in Article 8(2) of Council Directive 91/414 and the continued use of certain substances not included in its Annex I (OJ 2005 L 211, p. 6). Under Regulation No 1335/2005, the 12-year period was extended until 31 December 2006, ‘unless a decision has been taken or is taken before the relevant date to include or not include the active substance concerned in Annex I to Directive 91/414/EEC’.

8 Article 8(2) of Directive 91/414 provides that, during that transitional period, each active substance concerned must undergo a programme for its examination (or ‘review’), on conclusion of which it may be decided that the substance can be included in Annex I, or, if the substance does not satisfy the safety requirements laid down in Article 5 of Directive 91/414 or if the requisite information and data have not been submitted within the prescribed period, that the active substance will not be included. It is also stated that the examination of the active substance is to be carried out in accordance with the procedure referred to in Article 19 of Directive 91/414. That article, as amended by Council Regulation (EC) No 806/2003 of 14 April 2003 adapting to Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its implementing powers laid down in Council instruments adopted in accordance with the consultation procedure (qualified majority) (OJ 2003 L 122, p. 1), provides that the Commission is to be assisted by a regulatory committee, the Standing Committee on the Food Chain and Animal Health (‘the Committee’).

Regulation (EEC) No 3600/92

9 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 92/414 (OJ 1992 L 366, p. 10) regulates the procedure for the assessment of a number of substances with a view to their possible inclusion in Annex I to Directive 91/414. One of those substances is endosulfan.

10 The procedure established by Regulation No 3600/92 begins with a notification of interest, as provided for in Article 4(1) of that regulation, under which ‘[a]ny producer wishing to secure the inclusion of an active substance referred to in Annex I hereto, or any salts, esters or amines thereof, 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’.

11 Article 5(2)(b) of Regulation No 3600/92 provides that, following the examination of the notifications of interest, a rapporteur Member State is to be designated for the assessment of each of the active substances concerned.

12 Once the rapporteur Member State has been designated, it is the responsibility of each notifier to send to that Member State, in accordance with Article 6(1) of Regulation No 3600/92, a ‘summary dossier’ and a ‘complete dossier’, as defined in paragraphs 2 and 3, respectively, of Article 6 of that regulation. The summary dossier must include, in particular, a copy of the notification; the recommended conditions for the use of the active substance; and summaries and results of trials for each point of Annex III to Directive 91/414 relevant to the assessment of the criteria referred to in Article 5 of that directive. That information must relate to one or more preparations which are representative for the recommended conditions of use in relation to the inclusion of the active substance in Annex I to the directive. The complete dossier must contain the protocols and the complete study reports concerning all that information. Under Article 6(2)(b) of Regulation No 3600/92, as supplemented by Regulation (EC) No 2266/2000 of 12 October 2000 (OJ 2000 L 259, p. 27), ‘it has to be demonstrated by the notifier that, on the basis of the information submitted for one or more preparations for a limited range of representative uses, the requirements of [Directive 91/414] in relation to the criteria referred to in Article 5 thereof can be met’.

13 The summary dossier and the complete dossier are to be sent by notifiers to the rapporteur Member State by a deadline to be set by the Commission. In the case of endosulfan, the deadline for lodging those dossiers was set as 30 April 1995 by 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 Regulation No 3600/92 (OJ 1994 L 107, p.8), and subsequently deferred until 31 October 1995 by Commission Regulation (EC) No 2230/95 of 21 September 1995 amending Regulation No 933/94 (OJ 1995 L 225, p. 1). It is also the responsibility of notifiers, under Article 6(1) of Regulation No 3600/92, to send the summary dossier and the complete dossier to the experts from other Member States who have been approved by the Commission, with a view to possible later consultation.

14 The rapporteur Member State is then required to examine the summary dossier and the complete dossier and, pursuant to Article 7(1)(b) of Regulation No 3600/92, must ‘immediately after examining a dossier, ensure that notifiers submit the updated summary dossier to the other Member States and to the Commission’. Article 7(2) of Regulation No 3600/92, as amended by Commission Regulation (EC) No 1199/97 of 27 June 1997 (OJ 1997 L 170, p. 19) provides that, from the start of its examination, ‘the rapporteur Member State may request the notifiers to improve their dossiers, or add to them’ and that it ‘may consult with experts from other Member States, and may request additional technical or scientific information from other Member States in order to assist the evaluation’.

15 A report of its assessment of the dossiers lodged is then to be drawn up and forwarded to the Commission by the rapporteur Member State, at the latest 12 months after receipt of the dossiers, in accordance with Article 7(1)(c) of Regulation No 3600/92. The report must contain, inter alia, a recommendation as to whether it is appropriate to include the active substance concerned in Annex I to Directive 91/414.

16 Article 7(3) of Regulation No 3600/92, as amended by Regulation No 1199/97, provides that, after receiving the summary dossier and the report referred to in Article 7(1), the Commission is to refer the dossier and the report to the Committee for examination. Before referring the dossier and the report to the Committee, the Commission is required to circulate the report of the rapporteur Member State to the other Member States for information. Moreover, before the dossier and the report are referred to the Committee, a consultation of experts of the Member States may be arranged and the Commission may also consult some or all of the notifiers concerned regarding the report or certain parts of the report on the relevant active substance.

17 Paragraph 3A of Article 7 of Regulation No 3600/92, as inserted by Regulation No 1199/97, provides that after the examination by the Committee, the Commission is to present to the Committee: (i) a draft directive to include the active substance in Annex I to Directive 91/414; or (ii) a draft decision addressed to the Member States to withdraw the authorisations of plant protection products containing the active substance; or (iii) a draft decision addressed to the Member States to suspend such products from the market, with the option of reconsidering the inclusion of the active substance in Annex I to the directive after submission of the results of additional trials or additional information; or (iv) a draft decision to postpone inclusion of the active substance in Annex I to that directive pending the submission of the results of additional trials or information.

18 However, under the first indent of the first subparagraph of Article 7(4) of Regulation No 3600/92, as supplemented by Regulation No 2266/2000, where it appears, following the Committee’s examination, that the submission of the results of certain additional trials or of additional information is required, the Commission is to determine the time-limit within which the results or information concerned must be submitted. That provision states:

‘[T]his time-limit will be 25 May 2002 unless an earlier time-limit is established by the Commission for a particular active substance except for the results of long-term studies, identified as being necessary by the rapporteur Member State and the Commission during the examination of the dossier and which are not expected to be fully completed by the deadline established, provided that the information submitted contains evidence that such studies have been commissioned and that their results will be submitted at the latest on 25 May 2003. In exceptional cases, where it has not been possible for the rapporteur Member State and the Commission to identify such studies by 25 May 2001, an alternative date may be established for the completion of such studies, provided the notifier supplies the rapporteur Member State with evidence that such studies have been commissioned within three months of the request to undertake the studies, and with a protocol and progress report of the study by 25 May 2002.’

19 Article 7(4) of Regulation No 3600/92, as supplemented by Regulation No 2266/2000, also provides:

‘[…S]ubmission of new studies will not be accepted. The rapporteur Member State, with the agreement of the Commission, may request the notifiers to submit further data necessary to clarify the dossier.

For active substances for which the results or information referred to in the first indent have not been submitted within the established time-limit the rapporteur Member State shall immediately inform the Commission. The Commission shall decide, as provided for in Article 8(2), last subparagraph, of [Directive 91/414], not to include in Annex I to … [Directive 91/414] such active substances mentioning the reasons for the non-inclusion.’

20 Under Article 7(5) of Regulation No 3600/92, ‘the Commission shall submit to the Committee a draft decision for non-inclusion in Annex I to [Directive 91/414], in accordance with the final subparagraph of Article 8(2) thereof, where … the rapporteur Member State has informed the Commission that the results referred to in the first indent of paragraph 4 have not been submitted within the time-limit laid down’.

21 Article 8 of Regulation No 3600/92, as amended by Regulation No 2266/2000, provides that, after receiving the results of additional trials or additional information, the rapporteur Member State must: (i) examine them; (ii) ensure that the results or additional information are sent by the notifier to the other Member States and to the Commission; and (iii) communicate to the Commission, within six months at the latest following receipt of the results or information, its assessment of the dossier (as an addendum to the assessment report already submitted to the Commission), together with a recommendation for the inclusion or the non-inclusion of the active substance in Annex I to Directive 91/414.

22 Under Article 8(3) of Regulation No 3600/92, as amended by Regulation No 2266/2000, once the Commission has received the report drawn up by the rapporteur Member State, it must refer it to the Committee for examination, and that ‘[b]efore referring the dossier and report to the Committee, the Commission shall circulate the rapporteur’s report to the Member States for information and may organise a consultation of experts from one or several Member States’. In addition, ‘[t]he Commission may consult some or all of the notifiers of active substances on the report or parts of the report on the relevant active substance’, and ‘[t]he rapporteur Member State shall provide the necessary technical and scientific assistance during these consultations’. On completion of the examination by the Committee, the Commission is to present a draft directive to the Committee for the inclusion of the substance in Annex I to Directive 91//414, or a draft decision for its non-inclusion.

Background to the dispute

The evaluation procedure

23 Endosulfan is an active substance used inter alia in the manufacture of pesticides. It acts as a contact poison on a wide variety of insects and mites on many crops, including cotton and many varieties of fruit and vegetables.

24 The applicants – Bayer CropScience AG, Makhteshim-Agan Holding BV, Alfa Georgika Efodia AEVE and Aragonesas Agro, SA – are companies whose business includes the production and marketing of endosulfan and endosulfan-based plant protection products.

25 Pursuant to Regulation No 933/94, the Kingdom of Spain was designated as the rapporteur Member State responsible for examination of endosulfan. As stated in Annex III to that regulation, the Kingdom of Spain designated as the competent authority for that task, in accordance with Article 3 of Regulation No 3660/92, the Spanish Ministry of Agriculture, Fisheries and Food (‘MAPA’). MAPA assigned to the Instituto Nacional de Investigacíon y Tecnologia Agraria y Alimentaria (National Institute for Agricultural and Food Research and Technology) (‘INIA’) the task of drawing up assessment reports for active substances with a view to their inclusion in Annex I to Directive 91/414. Consequently, INIA was responsible for drawing up the draft assessment report for endosulfan and took part in the discussions between experts organised by the Commission.

26 By the submission deadline of 31 October 1995, only Makhteshim Agan International Coordination Center and AgrEvo GmbH (now called Bayer CropScience AG) had submitted to the Kingdom of Spain dossiers, within the meaning of Article 6 of Regulation No 3600/92, on endosulfan. They combined their efforts within a group called the ‘Endosulfan task force’ (‘the task force’).

27 During February 2000, the Kingdom of Spain sent the Commission a draft assessment report on endosulfan, which was then sent by the Commission to the Member States and to AgrEvo, as representative of the task force. The task force had been sent a preliminary draft of that report several months earlier. In the draft assessment report, the Kingdom of Spain concluded that the decision on the inclusion of endosulfan in Annex I to Directive 91/414 should be deferred pending receipt and examination of the additional information specified in that report.

28 From January to July 2001, a number of meetings were held between experts from several Member States to examine the draft assessment report and the comments to which it gave rise. Those meetings took place as part of the process of consulting experts from other Member States, as provided for in Article 7(2) of Regulation No 3600/92, pursuant to which the Commission, acting in cooperation with the competent national authorities, had established a framework for dialogue within which that kind of evaluation could be carried out, called European Commission Coordination (ECCO). The members of the task force took part in that dialogue.

29 On 27 June 2001, the report drawn up following that examination was circulated to the Member States and, on 25 August 2001, to the task force with a view to obtaining comments and additional clarifications.

30 On finding that certain additional information was needed for the examination of endosulfan, the Commission adopted – on 21 November 2001 – Decision 2001/810/EC concerning the decision on the possible inclusion of certain active substances into Annex I to Directive 91/414 (OJ 2001 L 305, p. 32), postponing to 25 May 2002 the deadline for submission of new data concerning endosulfan, and to 31 May 2003 the deadline for certain long-term studies. The deadlines coincided with those laid down in Article 7(4) of Regulation No 3600/92.

31 In May 2002, the task force produced new data in accordance with the timetable set by Decision 2001/810. In July 2002, the task force entered into discussions with the Kingdom of Spain concerning the possibility of notifying studies relating to a different formulation of endosulfan. The formulation originally notified was that of wettable powder (‘WP’) or emulsifiable concentrate (‘EC’), whereas the new product took the form of a capsule suspension (‘CS’). According to the task force, that new formulation could dispel some of the doubts already expressed by the Kingdom of Spain. At a meeting on 17 July 2002, the representatives of the Kingdom of Spain stated that they could not accept the new dossier, but suggested that the applicants try to obtain informal approval from the Commission on that matter. The applicants did not obtain such approval.

32 In May 2003, the applicants submitted the long-term studies referred to in Decision 2001/810, to which they had added certain new data, that is to say, they submitted a new dossier which was in conformity with Annex III to Directive 91/414 (see paragraph 6 above) concerning the CS formulation (‘the CS dossier’).

33 On 22 January 2004, a meeting took place between the task force and the Spanish authorities at which an expert in environmental matters and ecotoxicology expressed certain misgivings concerning endosulfan.

34 On 26 January 2004, the task force received from the Kingdom of Spain, by way of an addendum to the assessment report, the report on the evaluation of the data submitted by the task force in May 2002 and May 2003, together with an updated version of the evaluation tables.

35 On 17 May 2004, a tripartite meeting was held between the Commission, the Kingdom of Spain and the task force, pursuant to Article 6(4) of Directive 91/414. At that meeting, the Commission explained the problems raised by endosulfan and stated that it planned to propose to the Committee that endosulfan should not be included in Annex I to Directive 91/414. It also invited the task force to submit its comments before 21 June 2004, while making it clear that no new studies in support of the task force’s arguments could be accepted, since the deadline of 31 May 2003 had already passed.

36 On 25 June 2004, the representatives of the task force sent a letter to the Commission objecting to the way in which the evaluation of endosulfan had been conducted and seeking authorisation to produce a number of additional technical explanations. With that letter, they submitted not only additional arguments, but also new studies.

37 By letter of 12 July 2004, the Commission asked the rapporteur Member State not to take into account the new studies submitted by the task force. A copy of that letter was sent to the task force.

38 On 24 September 2004, the task force wrote to the Commission asking it, in essence, to refer the examination of endosulfan back to the rapporteur Member State with instructions to examine all the relevant data, and giving the Commission formal notice to define its position within 60 days.

39 By letter of 26 November 2004, the Commission replied that it was preparing a draft decision for the non-inclusion of endosulfan in Annex I to Directive 91/414 and that it intended to present that draft to the Committee at its first meeting in 2005. The Commission also indicated that, in its letter of 12 July 2004, it had included a reminder of the procedure provided for under Regulation No 3600/92 and the deadlines for completing the examination of the substances covered by that regulation.

40 By application received at the Registry of the Court of First Instance on 31 January 2005, the applicants brought an action for failure to act (Case T-34/05 Bayer CropScience and Others v Commission).

41 By separate document, lodged at the Registry of the Court of First Instance on 31 January 2005, Makhteshim-Agan Holding, Aragonesas Agro and Alfa Georgika Efodia applied for certain interim measures concerning the evaluation of endosulfan with a view to its possible inclusion in Annex I to Directive 91/414.

42 By order of 27 April 2005, the President of the Court of First Instance dismissed the application for interim measures.

43 By order of 6 September 2006, the Third Chamber of the Court of First Instance decided that there was no need to give a decision on the application for failure to act, in view of the adoption by the Commission of Decision 2005/864/EC of 2 December 2005 concerning the non-inclusion of endosulfan in Annex I to Directive 91/414 and the withdrawal of authorisations for plant protection products containing this active substance (OJ 2005 L 317, p. 25; ‘the contested decision’).

The contested decision

44 In the contested decision the Commission concludes that the criteria for inclusion of endosulfan in Annex I to Directive 91/414 are not satisfied. Accordingly, it states in Article 1 of that decision that endosulfan is not to be included as an active substance in Annex I to Directive 91/414. In recital 8 of the contested decision, the Commission summarises the reasons for non-inclusion:

‘During the evaluation of this active substance, a number of areas of concern have been identified. This was in particular the case concerning its environmental fate and behaviour as the route of degradation of the active substance is not completely clear and unknown metabolites were found in soil degradation, water/sediment degradation and mesocosm studies. In ecotoxicology many concerns remain since the long term risk, in particular, due to the presence of the abovementioned metabolites, cannot be sufficiently addressed with the available information. In addition exposure of operators under indoor conditions has not been considered to be sufficiently addressed with the available information. Moreover endosulfan is volatile, its main metabolite is persistent and it has been found in monitoring results of regions where the substance was not used. Consequently, as these concerns remain unsolved, assessments made on the basis of the information submitted have not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing endosulfan satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414…’

45 Article 2 of the contested decision states that the Member States are to ensure that authorisations for plant protection products containing endosulfan are withdrawn by 2 June 2006 and that, from 3 December 2005, no authorisations for plant protection products containing endosulfan are granted or renewed. It also lays down the conditions subject to which certain Member States may, for certain specific uses, maintain in force authorisations for plant protection products containing endosulfan until 30 June 2007.

46 Under Article 3 of the contested decision, any period of grace granted by a Member State to the holder of an authorisation must expire no later than 2 June 2007 in the case of uses for which authorisation is to be withdrawn on 2 June 2006, and no later than 31 December 2007 in the case of uses for which authorisation is to be withdrawn by 30 June 2007.

47 Recital 14 of the contested decision states that the decision does not prejudice ‘the submission of an application for endosulfan according to the provisions of Article 6(2) of Directive 91/414… in view of a possible inclusion in its Annex I’.

48 Article 4 of the contested decision states that the decision is addressed to the Member States.

Procedure and forms of order sought

49 By application lodged at the Registry of the Court of First Instance on 27 February 2006, the applicants brought the present action.

50 By document lodged at the Registry of the Court of First Instance on 18 May 2006, the Kingdom of Spain sought leave to intervene in the present proceedings in support of the form of order sought by the Commission. By order of 30 June 2006, the President of the Third Chamber of the Court of First Instance granted leave to intervene.

51 By document lodged at the Registry on 12 June 2006, the European Crop Protection Association (ECPA) sought leave to intervene in the present proceedings in support of the form of order sought by the applicants. That application was allowed by order of 19 October 2006 of the President of the Third Chamber of the Court of First Instance. ECPA lodged its statement in intervention and the other parties lodged their observations on that statement within the period prescribed.

52 On 14 June 2006, the applicants applied for measures of organisation of procedure relating, in essence, to the appearance before the Court and oral testimony of certain persons who had been involved in the evaluation procedure on behalf of the rapporteur Member State and to the appointment of an expert to answer certain questions which the applicants had set out. The other parties lodged their observations on that application within the prescribed time-limits.

53 Upon hearing the report of the Judge-Rapporteur, the Court decided to open the oral procedure. By way of measures of organisation of procedure, the Court requested, on 24 October 2007, that the applicants, the Commission and the Kingdom of Spain answer written questions, which they did within the prescribed time-limit.

54 The parties presented oral argument at the hearing on 12 February 2008.

55 The applicants, supported by ECPA, claim that the Court of First Instance should:

– declare the application admissible and well founded or, in the alternative, reserve its decision on admissibility until the judgment in the main proceedings;

– annul the contested decision;

– order the Commission to pay the costs.

56 The Commission, supported by the Kingdom of Spain, contends that the Court of First Instance should:

– dismiss the application as inadmissible or unfounded;

– order the applicants to pay the costs.

Admissibility

57 Without raising an objection of inadmissibility, the Commission, supported by the Kingdom of Spain, expresses doubts as to the applicants’ interest in bringing proceedings and also contests the locus standi of certain applicants.

Interest in bringing proceedings

Arguments of the parties

58 According to the Commission, annulment of the contested decision would not necessarily place the applicants in a more favourable position. The marketing authorisation for endosulfan had been maintained, under the transitional provisions laid down in Article 8(2) of Directive 91/414, pending its examination. That review period expired on 31 December 2006. In the event that the contested decision is annulled, the judgment will be delivered after that date. The Commission would have to take steps to comply with the judgment, in accordance with Article 233 EC, but the expiry of the transitional period means that there would be no obvious legal basis for allowing endosulfan to remain on the market pending a new assessment. The applicants’ dossier would then have to be assessed under Article 6 of Directive 91/414 rather than under the review programme. Given that the applicants are free to notify endosulfan under Article 6 even while the present case is pending, the Commission maintains that annulment of the contested decision would not improve their situation except in so far as the judgment might provide guidance on the procedures and criteria for assessment.

59 The applicants dispute the Commission’s arguments.

Findings of the Court

60 The Commission calls into question the applicants’ interest in bringing proceedings. At the very least, it appears to be contending that the applicants’ interest in bringing proceedings was lost in the course of the proceedings, specifically as of 31 December 2006, the date marking the end of the transitional period provided for under Article 8(2) of Directive 91/414, as amended. The Commission appears to be contending first that since that date, the applicants’ products have no longer been covered by a marketing authorisation, although the applicants are free to notify their active substances on the basis of Article 6 of Directive 91/414, which lays down the procedure for the notification and inclusion of active substances not covered by the transitional arrangements under Article 8(2) of the directive for active substances contained in plant protection products which were already on the market two years after the date of notification of the directive. Secondly, it contends that there is no longer any obvious legal basis, other than Article 6, for assessing endosulfan because the review period under those transitional arrangements has expired. It is thus possible for the applicants to achieve the same final outcome – the examination of their additional data – both on the basis of Article 6 of Directive 91/414 and by means of their action for annulment.

61 The Court finds that, by providing that endosulfan is not to be included in Annex I to Directive 91/414 and by requiring the Member States to withdraw authorisations for plant protection products containing endosulfan, the contested decision is an act with adverse effects, the annulment of which would be to the advantage of the applicants, as well as to the producers and vendors of endosulfan-based plant protection products. The applicants’ interest in bringing proceedings at the time when the action was brought was therefore vested and present.

62 Furthermore, contrary to what the Commission appears to be arguing, neither the expiry of the transitional review period nor the availability of the notification procedure provided for in Article 6 of Directive 91/414 affects the continued existence of that interest in bringing proceedings.

63 The applicants’ interest in bringing proceedings is not diminished by the alleged impossibility for the Commission to take a new decision on the basis of Article 8(2) of Directive 91/414 in order to comply with a judgment annulling the contested decision. Under the first paragraph of Article 233 EC, the Commission is required to take the necessary measures to comply with an annulling judgment. In the event of an annulment, with its attendant retroactive effects, the Commission would have to take a fresh decision on the basis of the notified dossier concerned by that annulment and adjudicate by reference to the date of notification (see, to that effect and by analogy, Case T-328/03 O2 (Germany) v Commission [2006] ECR II-1231, paragraph 48). The fact that, since the adoption of the contested decision, there has been a change in the legislation on which it was based has no bearing, therefore, on the question whether it is appropriate for the applicants to challenge the procedure followed and the outcome obtained under the rules in force at the material time.

64 Consequently, the argument that, in the wake of a judgment of annulment, the Commission would have to evaluate endosulfan in accordance with the procedure under Article 6 of Directive 91/414 has no force. In any event, it cannot be denied that, for the applicants, the prospect of notifying endosulfan again on the basis of Article 6 of Directive 91/414 – a possibility to which the contested decision expressly refers in recital 14 – would be a less favourable outcome than the resumption, at the point where illegality possibly arose, of the evaluation procedure already underway. Thus, the fact that the applicants could have endosulfan examined under a new procedure on another legal basis does not undermine their interest in obtaining a decision from the Court on the lawfulness of the procedure initially followed.

65 The applicants have an interest, therefore, in obtaining a decision from the Court on the pleas in law put forward against the contested decision.

Locus standi

Arguments of the parties

66 The Commission acknowledges that Bayer CropScience is individually concerned by the contested decision, since it took part in the administrative procedure. However, it does not accept that the other applicants took part in that procedure and, consequently, denies that they may be regarded as individually concerned by the contested decision.

67 The applicants maintain that they are each individually concerned by the contested decision.

Findings of the Court

68 It should be borne in mind that, according to settled case-law, where admissibility must be established for one and the same application lodged by a number of applicants and the application is admissible in respect of one of them, there is no need to consider whether the other applicants are entitled to bring proceedings (see, to that effect, Case C‑313/90 CIRFS and Others v Commission [1993] ECR I-1125, paragraph 31; Joined Cases T-127/99, T-129/99 and T-148/99 Diputación Foral de Álava and Others v Commission [2002] ECR II‑1275, paragraph 52; and Case T-374/00 Verband der freien Rohrwerke and Others v Commission [2003] ECR II-2275, paragraph 57).

69 In view of the fact that the first applicant, Bayer CropScience, is – as the Commission itself concedes – directly and individually concerned by the contested decision, there is therefore no need to examine the locus standi of the other applicants in order to decide on the admissibility of the action.

70 It follows from all of the above that the action is admissible.

Substance

71 In support of their action, the applicants put forward three pleas in law. The first plea alleges procedural flaws, unfairness of the evaluation procedure and breach of the principle of the protection of legitimate expectations. The second plea alleges in a first branch infringement of Article 95(3) EC and in a second branch infringement of Article 5(1) of Directive 91/414. The third plea alleges breach of certain general principles of Community law. The Court considers it appropriate to examine together the first plea and the second branch of the second plea.

The first plea, alleging procedural flaws, unfairness of the evaluation procedure and breach of the principle of the protection of legitimate expectations, and the second branch of the second plea, alleging infringement of Article 5(1) of Directive 91/414

72 Under the first plea, the applicants put forward a number of objections concerning, inter alia: the fact that the contested decision is based on criteria other than those specified in Directive 91/414; the fact that the assessment of endosulfan is incomplete and based on selective use of the data submitted by the applicants; the retroactive application of new guidelines and new criteria, established by the Commission after the notification and submission of the data; the refusal by the Commission to advise and consult with the applicants in relation to the change in the evaluation criteria and policy; and the Commission’s refusal, at the end of the evaluation procedure, to examine new data provided in direct response to its application of new evaluation criteria and/or guidelines.

73 Those objections relate essentially to seven issues: (i) the unknown metabolite; (ii) the CS dossier; (iii) operator exposure under indoor conditions (iv) the revised good agricultural practices (GAP); (v) the classification of endosulfan as a persistent organic pollutant (POP) and a persistent, bioaccumulable and toxic substance (PBT); (vi) glasshouse use; and (vii) the impact of the delay brought about by the rapporteur Member State and the Commission in the progress of the evaluation procedure. Those issues will be examined in paragraphs 96 to 206 below.

74 Some of those issues, as well as the objections put forward under the second branch of the second plea, alleging infringement of Article 5(1) of Directive 91/414, relate to the question whether the Commission was entitled to refuse to examine certain data or studies allegedly submitted out of time. The Court considers that, since it relates to the general framework of assessment for the present case, it is appropriate to examine first the question whether the procedural time-limits for the submission of studies were applicable given that Article 5(1) of Directive 91/414 states that a decision as to the inclusion of an active substance in Annex I to that directive must be made ‘in the light of current scientific and technical knowledge’.

The preliminary question concerning the application of the procedural time-limits and Article 5(1) of Directive 91/414

– Arguments of the parties

75 The applicants, supported by ECPA, complain in essence that the Commission took the decision not to include endosulfan in Annex I to Directive 91/414 because of doubts concerning the safety of that substance which were based on the insufficient information available at a specific point in time before the end of the transitional period. The applicants submit that Article 5(1) of Directive 91/414, under which such decisions must take into account current scientific and technical knowledge, means that all the data they provided up to the end of the evaluation process must be taken into account. Failure to defer the deadlines for the submission of studies in the present case amounts to a manifest error of assessment, having regard to the fact that it was the behaviour of the Commission and the Kingdom of Spain that prevented the applicants from complying with the legislative deadlines. In support of their arguments, the applicants rely on the judgment of the Court of Justice in Case C-326/05 P Industrias Químicas del Vallés v Commission [2007] ECR I-6557 (‘IQV’)

76 The Commission, supported by the Kingdom of Spain, maintains that Article 5(1) of Directive 91/414 must be read in the light of the overall policy objective of placing plant protection products on the market and the system put in place to achieve that. The assessment of plant protection products serves to improve agricultural production but also to protect health and the environment. According to the Commission, the evaluation procedures must enable a very detailed examination to be made, while ensuring that decisions are reached within a reasonable length of time. Finally, those procedures must ensure the equal treatment of undertakings which have notified active substances, while taking account of the specific circumstances of individual substances. The applicants’ extensive interpretation of Article 5(1) of Directive 91/414 would ultimately paralyse the whole system for placing plant protection products on the market, contrary to the objectives of Directive 91/414. Furthermore, IQV, cited in paragraph 75 above, related to a special case and is not relevant to the settlement of the dispute in the present case.

– Findings of the Court

77 The applicants claim that the Commission was under an obligation to take into account certain data and studies submitted out of time, which is tantamount to maintaining that they should have been granted an extension of the procedural time-limits or that new deadlines should have been set for them.

78 It must be borne in mind that specific legislative provision has been made concerning the duration of the general evaluation procedure for active substances and the deadlines for submitting a complete dossier and additional information. Thus, Regulation No 3600/92, as amended by Regulation No 2266/2000, and Decision 2001/810 provided that, in the case of endosulfan, the deadline was 25 May 2002 for the submission of studies and additional data and 31 May 2003 for certain long-term studies. The lawfulness of those provisions has not been disputed in the present case.

79 Moreover, it is clear from Article 7(4) of Regulation No 3600/92 (see paragraph 18 above) that the Commission may postpone the deadline for long-term studies only in exceptional cases, that is to say, only where it has not been possible for the rapporteur Member State and the Commission to identify by 25 May 2001 the long-term studies necessary for the examination of the dossier. Furthermore, the notifier must provide the rapporteur Member State with evidence that such studies have been commissioned within three months of the request that they be undertaken, together with a protocol and progress report of the study by 25 May 2002. However, that was not the position in the present case because the data and studies at issue did not concern long-term studies requested by the evaluators.

80 Notwithstanding that clear legislative framework, it is necessary in the present case to examine the circumstances in which the Commission might have been under an obligation to postpone the deadline, especially in light of the fact that the transitional period for marketing authorisation for endosulfan should in principle have expired in July 2003, but had been extended in 2002 to 31 December 2005 and, finally, in 2005 to 31 December 2006 (see paragraph 7 above), provided that no decision had been taken before that date to include or not to include endosulfan in Annex I to Directive 91/414.

81 In that regard, it should be noted that, as is clear from recitals 5, 6 and 9 in the preamble thereto, Directive 91/414 aims to remove barriers to intra-Community trade in plant protection products, while maintaining a high level of protection of the environment and of human and animal health (Case C-138/05 Stichting Zuid-Hollandse Milieufederatie [2006] ECR I-8339, paragraph 43).

82 In that context, 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 (IQV, cited in paragraph 75 above, paragraph 75). The power to postpone deadlines is akin to a discretion, which depends on the circumstances of the case.

83 However, the exercise of that discretion is not excluded from judicial review. According to settled case-law, in the context of such a review the Community judicature must verify whether the relevant procedural rules have been complied with, whether the facts admitted by the Commission have been accurately stated and whether there has been a manifest error of assessment or a misuse of powers (Case 98/78 Racke [1979] ECR 69, paragraph 5, and Case C-16/90 Nölle [1991] ECR I-5163, paragraph 12).

84 In particular, where a party claims that the institution competent in the matter has made a manifest error of assessment, the Community judicature must examine whether that institution has examined, carefully and impartially, all the relevant facts of the individual case which support the conclusions reached (Case C-269/90 Technische Universität München [1991] ECR I-5469, paragraph 14).

85 It must also be borne in mind that – as is clear from Article 6(2)(b) of Regulation No 3600/92, as supplemented by Regulation No 2266/2000 – it is the notifier who has to demonstrate that, on the basis of the information submitted for one or more preparations for a limited range of representative uses, the requirements of Directive 91/414 in relation to the criteria referred to in Article 5 thereof can be met. The burden of proof as regards the safety of the active substance thus lies with the notifier, something which is not, indeed, disputed by the applicants.

86 Furthermore, it is obvious that an indefinite postponement of the deadline for evaluating an active substance would be contrary to the aim pursued by Directive 91/414 of ensuring a high level of protection of the health of humans and animals.

87 As regards the applicants’ reliance on IQV, cited in paragraph 75 above, it must be pointed out that that case concerned very specific facts, which differ from those in the present case, in so far as the decision refusing to include the active substance at issue in that case in Annex I to Directive 91/414 had been taken because of the total absence of any assessment, since a complete initial dossier had not been submitted. Accordingly, the point at issue in that dispute was the applicable deadline for submission of a complete notification dossier. In the present case, the non-inclusion decision was taken at the end of an evaluation process based, inter alia, on an initial notification accepted as complete, a draft assessment report, consultations with experts from the Member States and possibilities for the task force to submit arguments and additional studies in order to address doubts raised by the rapporteur Member State in the draft assessment report and in the course of those consultations.

88 Although the facts in the case which gave rise to the IQV judgment are very different from those in the present case, it should be noted that, after recognising that the Commission enjoys a broad discretion in the exercise of its powers under Directive 91/414, the Court of Justice held that the Commission had made a manifest error of assessment in refusing to grant Industrias Químicas del Vallés SA (‘IQV’) a deferral of the deadline for submission of a complete initial dossier because, first, the impossibility on the part of IQV of complying with those deadlines was attributable, at least in part, to the contradictory behaviour of the competent authorities and, secondly, it was possible under the rules in question to defer the deadlines at issue (IQV, cited in paragraph 75 above, paragraphs 84 to 88).

89 It may be inferred from the case-law cited above that, in connection with a decision relating to the inclusion in Annex I to Directive 91/414 of a substance covered by the procedure set out in Article 8(2) of that directive, the deferral must be granted if it is not impossible to derogate from the procedural time-limits laid down in the rules in question, and if the parties who notified the active substance were in a situation of force majeure which prevented them from complying with the procedural time-limits, a situation which might obtain if the impossibility of complying with those time-limits was attributable, at least in part, to contradictory behaviour on the part of the competent authorities.

90 As regards the question whether it was impossible for the Commission to derogate from the procedural time-limits at issue in the present case, the Court considers that the Commission has not put forward any convincing arguments in that regard. It refers to practical and political constraints stemming from the fact that in 2001 it undertook to the Council and Parliament to take as many decisions as possible by July 2003, while emphasising that any extension would be limited and exceptional. The Commission also claims that all notifiers must comply with the procedural time-limits and that to allow special treatment for the applicants would raise questions of discrimination, specifically vis-à-vis undertakings which withdrew from the procedure on account of the expiry of the procedural deadlines, which they took to be mandatory. By the same token, according to the Commission, if the applicants were allowed to add new elements to their dossier at all times, resources devoted to endosulfan would have to be found at the expense of other substances, the assessment of which would therefore be delayed.

91 Clearly, political or practical considerations do not constitute a sufficient reason for refusing to postpone deadlines in a specific case, if such an extension is necessary to ensure a fair and equitable evaluation procedure. Furthermore, the Commission’s argument relating to discrimination cannot be accepted where postponement is necessary on account of the specific circumstances of a particular evaluation procedure and its participants. It is settled law that the principle of equal treatment does not preclude all differences in treatment, but prohibits comparable situations from being treated differently, leading to a disadvantage for some operators as compared with others, unless such treatment is objectively justified (see Case T-351/02 Deutsche Bahn v Commission [2006] ECR II-1047, paragraph 137 and the case-law cited).

92 In any event, Decision 2001/810 itself sets different deadlines for the submission of data and studies in respect of certain substances. Thus, for example, the deadline for submission of studies, which is 25 May 2002 for most of the substances covered by that decision, is nevertheless set as 30 November 2002 for chlorotoluron, 31 December 2002 for dinocap and 31 January 2003 for benalaxyl. As regards the deadlines for the submission of long-term studies, the deadline for endosulfan is set as 31 May 2003. For most of the other substances covered by that decision, the deadline is 25 May 2003. However, the deadline for benomyl, chlorotoluron and dinocap is set as 31 December 2003. In Decision 2001/810, the Commission states that those substances are exceptional cases. Clearly, however, Article 7(4) of Regulation No 3600/92, as supplemented by Regulation No 2266/2000, provides for deadlines to be postponed only in ‘exceptional cases’ relating to long-term studies. Decision 2001/810 also grants derogations from the general deadline of 25 May 2002, in respect of which Regulation No 3600/92 allows no possibility of postponement (see paragraph 18 above). It follows that the Commission has failed to show that it would have been impossible to extend the procedural time-limits in the present case.

93 It is also important, however, to note that the reference in Article 5(1) of Directive 91/414 to ‘current scientific and technical knowledge’ cannot support the inference that undertakings which have notified an active substance and which are faced with the likelihood of a decision not to include that substance in Annex I to Directive 91/414 should have the possibility of submitting new data for as long as doubts persist regarding the safety of that active substance. Such an interpretation of that provision would run counter to the objective of a high level of protection of the environment and of human and animal health which underlies Article 5(1) of Directive 91/414, in that it would be tantamount to granting to the notifier – on whom the burden of proof lies as regards the safety of the active substance and who has a better knowledge of that substance – a right of veto over a decision not to include the substance in Annex I to Directive 91/414.

94 Furthermore, the existence of such a right of veto is particularly inconceivable having regard to the fact that, as stated in recital 14 of the contested decision, it is possible to (re)notify the active substance on the basis of Article 6(2) of Directive 91/414, with a view to its inclusion in Annex I to that directive.

95 It is in the light of the above considerations that the claims put forward by the applicants must be examined in order to determine whether, in the present case, they were placed by the contradictory behaviour of the evaluators in a situation of force majeure which prevented them from complying with the legislative deadlines.

(i) the unknown metabolite

– Arguments of the parties

96 In essence, the applicants claim that the conclusion in recital 8 of the contested decision that the route of degradation of the active substance is not completely clear and that unknown metabolites were found in soil degradation, water/sediment degradation and mesocosm studies, and the conclusion that in ecotoxicology many concerns remain – since the long-term risk due, in particular, to the presence of the abovementioned metabolites, cannot be sufficiently addressed with the available information – are based on manifest errors of assessment, that they infringe their rights of defence and frustrate their legitimate expectations, with the result that the evaluation procedure was inequitable.

97 First, the applicants maintain that they were informed belatedly – that is to say, not until January 2004 – of the problem concerning the unknown metabolite and, in particular, of the fact that it was crucial to the outcome of the evaluation procedure, so that it was impossible for them to address that concern on the part of the evaluators before the legislative deadlines. In May 2002, however, the applicants themselves had pointed out the presence of an unknown metabolite in endosulfan’s route of degradation.

98 Secondly, they were confronted with guidelines which were constantly changing and included changing criteria for the relevance of metabolites, which had been retroactively applied. In particular, one of the criteria used by the evaluators – according to which metabolites accounting for less than 10% of the initial active substance are relevant – had been introduced by the 2002 guidelines, which were supposed to apply only to active substances notified during the third phase of the review programme but had been applied retroactively, given that endosulfan came under the first phase.

99 Thirdly, the presence of an unknown metabolite was pointed out in a study concerning the route of degradation rather than the rate of degradation, which the applicants were not even required to carry out because it related to tests based on the metabolite endosulfan sulfate and not on endosulfan itself. The evaluators thus took an inappropriate study into account in order to raise a problem which is not a problem.

100 Fourthly, the taking into account of a 10% threshold as a relevance criterion for ‘metabolites of metabolites’ (that is to say, for metabolites of endosulfan sulfate, itself a metabolite of endosulfan) is contrary to the guidelines, which do not provide for any analysis based on metabolites of active substances but only for studies based on the active substance itself. Furthermore, when assessing the various aspects of the applicants’ active substance and related formulated products, the Commission aimed at ‘zero risk’, which amounts essentially to requiring the applicants to produce a probatio diabolica, which is considered illegal in all the Member States and in the case-law.

101 Fifthly, there was a constant lack of interaction with the rapporteur Member State on the issue of the unknown metabolite because there was no feedback on environmental issues, a problem which was most obvious in the period from 2001 to 2004.

102 Sixthly, the applicants have, in any event, provided scientific evidence that not even the 10% relevance threshold for metabolites of metabolites was met, with the result that the metabolite of endosulfan sulphate was not significant and could pose no risk to the environment. That is clear in particular from an extrapolation from the study of the routes of degradation in soil, which was submitted before the May 2002 deadline. Furthermore, the applicants submitted studies showing that the metabolite of the metabolite found in the soil was not relevant for the assessment of the ecotoxicology and environmental behaviour of endosulfan, because it was less toxic than the active substance itself.

103 Seventhly, the issue of the unknown metabolite could have been resolved by means of the revised GAP, the CS formulation and glasshouse use, all of which were covered by studies and arguments which the Commission refused to take into account because they were submitted out of time.

104 The Commission, supported by the Kingdom of Spain, disputes the applicants’ arguments.

105 First, the Commission contends that it was already clear from the draft assessment report that endosulfan’s route of degradation was problematic, and that the issue had also been raised during a meeting on 20 January 2000.

106 Secondly, the guidelines have no legal effects, so there is no positive rule of law stating that environmental concerns can be ignored below a certain threshold.

107 Thirdly, the rapporteur Member State and the Commission are entitled to base their findings on any type of study submitted by the applicants, irrespective of what type of issue the study in question is addressing.

108 Fourthly, as regards the issue of the relevance threshold for metabolites of metabolites, the Commission questions whether the applicants’ arguments are admissible since they are not clear enough to comply with Article 44(1)( c) of the Rules of Procedure of the Court of First Instance. For the sake of completeness, the Commission nevertheless responds to those arguments by referring to an opinion of 30 November 2000 of the Scientific Committee on Pesticides, which supports the conclusion that a risk of ground water contamination cannot be ruled out where the level of metabolites generated is below the 10% threshold. Furthermore, it is clear from Annex II to Directive 91/414 that data relating to metabolites below the 10% level should also be submitted. In any event, the issue of the relevance threshold for metabolites comes under the broad discretion of the Commission.

109 Fifthly, as regards the alleged lack of interaction, the Commission and the Kingdom of Spain maintain, in essence, that the applicants had numerous opportunities during the evaluation process to make their point of view known and to submit additional data. Furthermore, the applicable legislation does not contain any information as regards the degree of interaction or feedback necessary.

110 Sixthly, the argument that the applicants submitted evidence that the metabolite of the metabolite did not meet the 10% relevance threshold, that it is not persistent and that, in any event, it is less toxic than endosulfan is inadmissible. The applicants did not call into question the scientific findings of the evaluation process until the reply: their application merely criticised the way in which the procedure had been carried out. In any event, the applicants’ argument that the issue of the unknown metabolite can be disregarded is erroneous. For its part, the Kingdom of Spain also disputes the scientific findings of the studies submitted by the applicants in that regard.

111 Seventhly, as regards the question whether an answer to the metabolite problem is to be found in the approaches suggested by the applicants at the end of the procedure – relating, inter alia, to the revised GAP, the CS formulation and glasshouse use – the Commission and the rapporteur Member State were entitled to refuse to take those studies into account because they had been submitted out of time.

– Findings of the Court

112 A preliminary point to note is that the issue of the unknown metabolite relates in essence to the question whether the Commission could legitimately base the refusal to include endosulfan in Annex I to Directive 91/414 on the absence of sufficient data concerning certain substances deriving from the endosulfan degradation process, in particular, the metabolites or residue which appear only at the second stage of degradation, that is to say, the degradation of the primary metabolite, endosulfan sulfate.

113 As regards, first, the question whether the applicants were informed in good time of the problem concerning the unknown metabolite, and the fact that it was crucial to the outcome of the analyses of the environmental risk posed by endosulfan and, in particular, whether they were so informed before the meeting of January 2004, during which – according to the applicants – the problem of the unknown metabolite was raised for the first time, it must be pointed out first of all that it is clear from the documents before the Court that various comments and requests for data made before 2004 refer to the evaluators’ concern with understanding the degradation route of endosulfan and its metabolites, as well as the rate of degradation.

114 It is stated in the draft assessment report of December 1999 that ‘a wider investigation of the degradation routes in soil and water must be done’ and that ‘correct degradation kinetics (route and rates) should be proposed’. It is also stated in that draft report that ‘most of the degradation products of endosulfan are organochlorides that may be persistent and of environmental concern’.

115 Furthermore, in the findings of that draft assessment report reference is made to ‘a high persistence of a soil residue constituted by a number of chlorinated metabolites, which may not account individually for more than 10% of applied dose but that all together may represent a high amount of it’. The following is also stated:

‘Based on their chemical structure it may be expected that the physico chemical properties of these compounds will be similar and generally persistent and bioaccumulable. Therefore, a wider investigation of the degradation routes of this compound must be done.’

116 Furthermore, the minutes of a visit to INIA in December 1999, drawn up by the applicants, states that ‘it must be clearly shown that degradation of the chlorinated [ring] takes place with identification of the degradation products’.

117 Reference may also be made to the minutes of a meeting of 25 August 2001, which state as follows:

‘The question on relevance of other metabolites in soil besides the endosulfan sulfate and their ecotoxicological impact was raised and becomes very important, in view of the clear message from Dr T., that the recently submitted ecotoxicological studies for the other metabolites clearly led to the conclusion that they are relevant from the toxicity point of view. Therefore, their relevance has finally to be based on the results of the running environmental chemistry studies in soil and sediment. If they show up only in minor quantities, their relevance will be denied. If opposite, major consequences for the ecotoxicological test program can be expected.’

118 It is apparent from the above examination of the documentary evidence that the applicants cannot deny that they were informed of the need to clarify the degradation routes of endosulfan at an early stage in the procedure, because requests to that effect had been made by the beginning of 2000 at the latest. It is also apparent from that examination that at that time, and by August 2001 at the latest, they had been informed of the evaluators’ concern regarding the persistence of certain metabolites and that, if those metabolites were found to be relevant, the impact on the toxicological analyses would be considerable. Consequently, the applicants had the opportunity to clarify the way in which endosulfan degraded, which was an issue of crucial importance for the environmental risk analysis. Nevertheless, on the basis of the studies submitted before May 2003, it was then found that the route of degradation was not sufficiently clear, a finding which the applicants dispute and with regard to which they have, moreover, been able to submit additional arguments. However, such a disagreement as to substance cannot be confused with the question whether the applicants had a genuine opportunity during the evaluation process to clarify the degradation route of endosulfan, or whether the evaluators disclosed the significance of that issue for the risk analysis.

119 Secondly, as regards the question whether the applicants were confronted during the evaluation process with guidelines which had undergone a number of amendments, making it impossible to comply with the procedural deadlines of May 2002 and May 2003, it must first of all be stated that the Commission is permitted to lay down for itself guidelines for the exercise of its discretionary power in the form of measures not provided for in Article 249 EC, provided that those measures contain directions as to the approach to be followed and do not depart from the rules of the Treaty. The Community judicature determines whether the disputed measure is consistent with those guidelines. However, documents which are no more than drafts cannot entail any self-imposed limitation on the Commission’s discretion (see, to that effect, Case T-70/99 Alpharma v Council [2002] ECR II-3495, paragraphs 140 to 142). Consequently, the lawfulness of the contested decision must be assessed in the light of the provisions of Directive 91/414, not of the abovementioned guidelines (see, to that effect and by analogy, Alpharma v Council, paragraph 146).

120 Furthermore, the examination of that objection, which was framed in very broad terms in the application, must be confined to specific examples – given by the applicants in the application – of cases in which they were confronted by rules deriving from guidelines which had undergone a number of amendments. The need for such precision arises because, under the first paragraph of Article 21 of the Statute of the Court of Justice, which applies to the procedure before the Court of First Instance pursuant to the first paragraph of Article 53 of that Statute, and under Article 44(1)(c) of the Rules of Procedure of the Court of First Instance, the application is required to contain, inter alia, a summary of the pleas in law on which it is based. It must accordingly specify the nature of the grounds on which the action is based and, in consequence, a mere abstract statement of the grounds does not satisfy the requirements of the Statute of the Court of Justice or the Rules of Procedure of the Court of First Instance (Case T-102/92 Viho v Commission [1995] ECR II-17, paragraph 68).

121 The objection that the applicants were confronted with guidelines which had undergone a number of amendments, as specified in the application, relates, first, to a set of draft guidelines on the relevance of metabolites in groundwater of regulated substances, the November 2001 version of which had introduced a new relevance criterion: an upper cut-off value of 10 µg/l in groundwater for all metabolites, regardless of their toxicity. Those guidelines were not completed until February 2003. In that regard, it must be noted that the applicants do not explain why, in November 2001, it was too late to submit further studies in accordance with that criterion. In any event, it should also be noted that, according to the applicants, they submitted studies which took that criterion into account before the May 2003 deadline. Furthermore, as the Commission points out, an opinion of November 2000 of the Scientific Committee on Pesticides, which was accessible via the internet, stated that every effort possible should be made to identify metabolites. In addition, it is stated in Annex II to Directive 91/414, as amended in 1995 by Commission Directive 95/36/EC of 14 July 1995 (OJ 1995 L 172, p. 8), that undertakings notifying an active substance with a view to its inclusion in Annex I to Directive 91/414 must ‘identify where possible … individual components present which account for less than 10% of the amount of active substance’. The applicants cannot therefore claim that that criterion was ‘new’ in 2001 or that it was applied retroactively.

122 Secondly, the objection that the applicants were confronted with guidelines which had undergone a number of amendments relates to guidelines on aquatic and terrestrial ecotoxicology issued in October 2002, which – according to the applicants – required for the first time that a distinction be made between ‘minor’ (<10%) metabolites in soil and ‘major’ (>10%) metabolites in soil, for the purposes of assessing their relevance for the evaluation of the harmful effects of the active substance. However, it is clear from the above that that criterion was not new, as it had appeared in Annex II to Directive 91/414 since 1995.

123 In any event, the evaluators’ approach of taking into account metabolites which did not individually exceed the 10% threshold but could exceed it when taken together with other metabolites had already been pointed out in the conclusions of the draft assessment report (see paragraph 115 above).

124 Lastly, it should also be pointed out that what the applicants are actually disputing is the relevance of that threshold for metabolites of metabolites. The objection contesting that threshold and its application in the present case will be examined below (see paragraph 133 et seq. below).

125 Thirdly, as regards whether the evaluators could legitimately raise the issue of the metabolite of the metabolite and the risk of its persistence in soil, given that that issue emerged from a study carried out by the applicants for a different purpose, it should be pointed out that, manifestly, it is not relevant to know, for the purposes of the inclusion of endosulfan in Annex I to Directive 91/414, in which study a potential problem for the environment was raised provided that it was in a document on which the applicants were able to adopt a position. In the present case, it is clear from the documents before the Court that it was a study by the applicants themselves that confirmed for the evaluators that there was indeed a problem concerning a metabolite of a metabolite. The Court finds that the applicants have failed to submit any cogent argument to substantiate the view that the Commission may not take into account the results of such a study.

126 Fourthly, as regards whether the taking into account of the 10% relevance threshold for metabolites of metabolites is contrary to the guidelines, hence based on a criterion foreign to the applicable regulatory framework, it must be stated that the wording of that objection – according to which ‘there are no EU requirements or guidelines for assessing the metabolite of a metabolite when the starting material is anything but the parent substance’ – is very abstract. That objection is linked to the applicants’ refutation of a statement in the draft assessment report to the effect that the studies concerning the degradation of endosulfan suggest ‘a high persistence of a residue in soil composed of a number of chlorinated metabolites which, while individually they may not exceed the level of 10% of the dose applied, together … may comprise a large quantity of residue’. In order to appraise that objection, it is necessary to determine whether the concepts used in Directive 91/414 and the Annexes thereto have been defined broadly enough to allow the evaluators to take into account the potentially harmful effects of metabolites of metabolites.

127 In the context of that examination, the Court would point out that Article 5(1)(a) of Directive 91/414 provides that an active substance is to be included in Annex I if it may be expected that plant protection products containing that active substance will fulfil, inter alia, the following condition: that ‘their residues … 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’. Article 2(2) of the directive defines the terms ‘residues of plant protection products’ broadly, as ‘one or more substances present in or on plants or products of plant origin, edible animal products or elsewhere in the environment and resulting from the use of a plant protection product, including their metabolites and products resulting from their degradation or reaction’. Furthermore, Annexes II and III to Directive 91/414, concerning the dossiers for evaluation, contain a number of references to requests for data relating to the breakdown products of active substances in the broad sense. It follows that it is Directive 91/414 itself which authorises the evaluators to examine the behaviour of the products derived from the active substance. In those circumstances and in the absence of actual evidence to the contrary, it cannot be accepted that the evaluators made a manifest error of assessment by wanting to clarify the route of degradation of the metabolite of endosulfan sulfate and by applying the relevance threshold at issue to its breakdown products. The claim that such an examination is contrary to the guidelines is thus unfounded. It follows that the applicants have failed to establish that the Commission made a manifest error of assessment or infringed their rights of defence by taking the view, in the present case, that breakdown products of endosulfan which individually represented less than 10% of the active substance endosulfan, but more than 10% of the metabolite endosulfan sulphate, were relevant.

128 Lastly, it is also necessary to reject the argument that the evaluators wished thus to achieve ‘zero risk’ and required the applicants to produce a probatio diabolica, by basing the decision not to include endosulfan in Annex I to Directive 91/414 on a lack of information rather than on identified risks, because it is clear from the above analysis that the Commission wished to have evidence of a safe use, but that meant that it had to understand the behaviour of the metabolite of endosulfan sulfate. That position has not been shown to be manifestly incorrect. In any event, the applicants claim that they established a safe use and that they demonstrated an acceptable level of persistence and toxicity in respect of that metabolite. Accordingly, it must be held that there is no force in the argument that the Commission required them to submit evidence which was scientifically impossible to establish.

129 Fifthly, as regards the objection alleging lack of interaction with the rapporteur Member State on the issue of the unknown metabolite and, in particular, the alleged absence of feedback on environmental issues during the period from 2001 to 2004, it must be borne in mind that, as pointed out by the Commission and the Kingdom of Spain, the applicable rules do not impose any obligation of communication or feedback in the light of which the numerous meetings and exchanges of information between the rapporteur Member State and the applicants could have been considered insufficient. As for the comment in ECCO report 106, relied on by the applicants – according to which they were requested to ‘work very closely with the rapporteur Spain in order not to run into any misunderstandings on the data to be provided or the deadlines to be observed’ – it is difficult to gauge, by reference to a requirement framed in such general terms, whether the interaction with the rapporteur Member State was sufficient.

130 However, it should be borne in mind that respect for the rights of the defence is, in all proceedings initiated against a person which are liable to culminate in a measure adversely affecting that person, a fundamental principle of Community law which must be guaranteed even in the absence of any rules governing the proceedings in question. That principle requires that the addressees of decisions which significantly affect their interests be placed in a position in which they may effectively make known their views (see, to that effect, Case C-28/05 Dokter and Others [2006] ECR I-5431, paragraph 74 and the case-law cited).

131 As regards whether, in the light of that case-law and with regard to the disputed period from August 2001 to January 2004 during which the applicants did not receive feedback on environmental fate and behaviour or on ecotoxicology and received insufficient feedback from one person in particular – Dr T., a contract expert who was specialised in those areas – those circumstances could have led the applicants’ rights of defence to be infringed, their reasoning is clearly contradictory as they claim to have submitted studies in May 2002 which resolved the problem of the unknown metabolite. It is therefore difficult to understand how more meetings could have led to a different final outcome in the contested decision. An irregularity can bring about the annulment of the contested decision only to the extent that it is such as to actually affect the applicant’s rights of defence and therefore the content of that decision (see, to that effect, Case 30/78 Distillers Company v Commission [1980] ECR 2229, paragraph 26). The objection is therefore of no consequence.

132 In any event, the objection relates, at least in part, to the question already examined above of whether the problem of the unknown metabolite and, in particular, the fact that it was crucial to the analyses of the environmental risk posed by endosulfan, was not raised until the meeting in January 2004. As has been pointed out above, the applicants were informed well before that meeting of the need to identify endosulfan’s route of degradation and of the significance of that issue for the risk analysis. They thus had the opportunity to submit studies clarifying the route of degradation, but disagree with the evaluators as regards the results of those studies, in particular as regards the relevance of the metabolite of endosulfan sulfate, and its persistence and toxicity. The existence of a disagreement on substance as regards the inferences to be drawn from a particular study does not amount to evidence of a lack of opportunity to make their views known and cannot be classed as an infringement of the applicants’ rights of defence.

133 Sixthly, as regards the applicants’ objection that they provided scientific evidence showing, first, that the metabolite of endosulfan sulfate did not meet the more stringent relevance criterion for metabolites of metabolites and, secondly, that that metabolite of the metabolite found in soil was not relevant for the assessment of endosulfan’s ecotoxicology and environmental behaviour because it was not persistent and was less toxic than the active substance itself, it must be pointed out that the applicants claim, in essence, that endosulfan should have been included in Annex I to Directive 91/414 because the evaluators’ findings regarding the relevance of the metabolite of the metabolite of endosulfan were incorrect. However, clearly that objection was put forward for the first time in the reply.

134 It follows from Article 44(1)(c), read in conjunction with Article 48(2) of the Rules of Procedure, that the application initiating proceedings must contain, inter alia, a summary of the pleas in law relied on, and that new pleas in law may not be introduced in the course of proceedings unless they are based on matters of law or of fact which came to light in the course of the procedure. A plea which may be regarded as amplifying a plea put forward previously – whether directly or by implication – in the originating application and which is closely connected therewith, must be held admissible. By contrast, a plea which cannot be regarded as based on matters of law or of fact which came to light in the course of the proceedings has to be held inadmissible. In the circumstances of the present case, there was nothing to prevent the applicants from raising the plea at the stage of the application (see, to that effect, Case C‑430/00 P Dürbeck v Commission [2001] ECR I-8547, paragraphs 17 to 19).

135 In response to a written question from the Court asking them to respond to the Commission’s argument that the challenge to the scientific assessment underpinning the contested decision is a new line of argument which is not found in the application and should therefore be held inadmissible, the applicants submit that the legal grounds set out in the application – inter alia, infringement of Article 95(3) EC, Article 5(1) of Directive 91/414 and breach of the principle of the excellence and independence of scientific advice – clearly include the submission that they regarded the scientific assessment underpinning the contested decision as incorrect, especially because that assessment did not take into account all the available data that they had submitted. Moreover, the applicants maintain that, by addressing the scientific issues at stake in closer detail in the reply, they are merely rebutting the factual arguments put forward by the Commission and are not introducing new legal grounds for annulment.

136 In that respect, it must be pointed out – as regards the reliance in the application on Article 95(3) EC, Article 5(1) of Directive 91/414 and the principle of the excellence and independence of scientific advice – that it is absolutely clear from the arguments put forward in support of the pleas relied on in the application that those pleas concern the question whether the Commission was under an obligation to take into account in its analysis studies submitted by the applicants after a particular deadline, which is a question relating to the way in which the Commission carried out the evaluation procedure but not a challenge directed at the substantive content of its findings, even though the taking into account of the documents which were refused could conceivably have led to a different final decision on the substance. The argument that the applicants’ objection merely seeks to rebut the factual arguments put forward in the course of the proceedings cannot succeed either, because it is clear from the reply that, by that objection, the applicants are maintaining that the Commission’s finding that endosulfan’s route of degradation is not completely clear and that unknown metabolites have been discovered in the course of certain studies (soil degradation, water or sediment degradation and mesocosm studies) is based on a premiss which is factually and scientifically incorrect. However, as was pointed out above, the clear aim of the pleas relied on in the application is to challenge, not the content of the Commission’s findings, but the way in which the Commission had arrived at those findings and, in particular, its refusal to take certain evidence into account.

137 Accordingly, it cannot be accepted that that objection merely amplifies a plea put forward previously. Furthermore, it has not been shown that it was impossible for the applicants to raise that plea at the stage of the application. The objection that the findings in the contested decision concerning the relevance of metabolites of metabolites are incorrect is therefore inadmissible.

138 In any event, there is obvious disagreement between the parties as regards the scientific findings in the applicants’ studies.

139 As regards whether the metabolite of endosulfan sulfate meets the relevance threshold, the applicants submit that the unknown secondary metabolite represents 17% of the primary metabolite endosulfan sulfate, which in turn represents 13.4% of the parent endosulfan, and that the secondary metabolite therefore represents only 2.3% of the parent endosulfan. The Commission and the Kingdom of Spain do not dispute those calculations but maintain that they are entitled, as was explained above, to treat as relevant metabolites below the 10% threshold in relation to the parent substance endosulfan.

140 As regards the persistence of the metabolite of endosulfan sulphate, this is measured mainly by reference to its capacity to change into CO2 (mineralisation) and by establishing the rate of degradation for 50% and for 90%. According to the applicants, it is apparent from a study submitted in May 2002 that endosulfan sulfate degrades up to 35% after the first year, which corresponds to a degradation rate of 9.5% after 100 days. The applicants argue that the relevant Commission guidelines require the mineralisation rate to be above 5% over a period of 100 days and that that criterion has thus clearly been met. The Kingdom of Spain maintains, on the other hand, that it is apparent from the study in question that the mineralisation of endosulfan in soil is probably less than 5%. The average lifespan of endosulfan sulfate (degradation rate of 50%) is in the range of 123 to 391 days and the mineralisation at 120 days ranges between 1.01% and 13.08%. The average mineralisation of endosulfan sulfate is in line with that of endosulfan. It may therefore be concluded that endosulfan breaks down into endosulfan sulfate and that the mineralisation of endosulfan sulfate ranges between 1.01% and 13.08% at 120 days and between 5% and 35% at 365 days, depending on the type of soil. None of the metabolites detected and identified in earlier assays were detected in that study. Nevertheless, there is a metabolite which appeared at levels in excess of 10% of the applied radioactivity. All attempts to identify that metabolite failed but the suspicion is that its structure is similar to that of the metabolites dicarboxylic acid and dihidrodiol. The identification of that metabolite is essential for the purposes of establishing endosulfan’s route of degradation and the residue definition which must be used in the field dissipation studies.

141 As was pointed out above, it is settled case-law that in matters concerning the common agricultural policy the Community institutions enjoy a broad discretion as regards the definition of the objectives to be pursued and the choice of the appropriate means of action. Accordingly, review by the Community judicature of the substance must be confined to determining whether the exercise of such discretion is vitiated by m