Dow AgroSciences Ltd, v European Commission [2013] EUECJ C-584/11 (07 May 2013)

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(Appeal – Plant protection products – Active substance trifluralin – Non-inclusion in Annex I to Directive 91/414/EEC – Decision 1999/468/EC – Article 5)

European Commission, represented by G. von Rintelen and P. Ondrůšek, acting as Agents, and by J. Stuyck, advocaat, with an address for service in Luxembourg,

having decided, after hearing the Advocate General, to rule by order, pursuant to Article 181 of the Rules of Procedure of the Court of Justice,

1 By their appeal, Dow AgroSciences Ltd, Dow AgroSciences LLC, Dow AgroSciences SAS, Dow AgroSciences Export SAS, Dow AgroSciences BV, Dow AgroSciences Hungary kft, Dow AgroSciences Italia Srl, Dow AgroSciences Polska sp. z o.o., Dow AgroSciences Iberica SA, Dow AgroSciences s.r.o., Dow AgroSciences Danmark A/S and Dow AgroSciences GmbH request the Court of Justice to set aside the judgment of the General Court in Case T-475/07 Dow AgroSciences and Others v Commission [2011] ECR I-0000 (‘the judgment under appeal’) by which the General Court dismissed their action for annulment of Commission Decision 2007/629/EC of 20 September 2007 concerning the non-inclusion of trifluralin in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (OJ 2007 L 255, p. 42) (‘the decision at issue’).

2 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1), as amended by Council Regulation (EC) No 806/2003 of 14 April 2003 (OJ 2003 L 122, p. 1; ‘Directive 91/414’), lays down the Community rules applicable to the granting of authorisation to place plant protection products – such as pesticides and weedkillers – on the market and to the withdrawal of such authorisation. The directive requires that the Member States authorise the placing of those products on the market only if the active substance contained in those products is listed in Annex I to that directive.

3 Under Article 4(1) of Directive 91/414, the Member States must ensure that the placing on the market of a plant protection product is not authorised unless it complies with certain criteria relating in particular to the environment and to human health. It is provided that the use of the active substance, that is to say, the ingredient which makes the product effective, must have been authorised at European Union level. Such authorisation cannot be granted until after the active substance has been included in Annex I to that directive.

4 Article 5 of Directive 91/414 lays down the conditions required in order for a plant protection product to be eligible for inclusion in Annex I to that directive. That article provides that inclusion may be envisaged only for an initial period not exceeding 10 years and, moreover, if it may be expected, in the light of current scientific and technical knowledge, that the plant protection products containing the active substance in question will fulfil certain conditions as to harmlessness.

5 Articles 6 and 19 of that directive govern the procedure for including active substances in Annex I.

6 Article 19 of that directive states that the European Commission is to be assisted by the Standing Committee on the Food Chain and Animal Health (‘the Standing Committee’).

7 Trifluralin is an active substance that is covered by the second stage of the work programme referred to in Article 8(2) of Directive 91/414. It belongs to the list of substances which are subject to the procedures put in place by Commission Regulation (EC) No 451/2000 of 28 February 2000 laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Council Directive 91/414 (OJ 2000 L 55, p. 25), as amended by Commission Regulation (EC) No 1490/2002 of 14 August 2002 (OJ 2002 L 224, p. 23) (‘Regulation No 451/2000’).

8 Under the provisions of Directive 91/414 and Regulation No 451/2000, the evaluation procedure operates in several stages. The Commission, having been requested by a producer to include a substance in Annex I to that directive, must designate, after an initial examination of the request, a rapporteur Member State (‘the RMS’) for the active substance that is the subject of the evaluation. Following that designation, there is a complex evaluation procedure involving the authorities of the RMS, the Commission, the European Food Safety Authority (EFSA), the Standing Committee on Plant Health (to which the matter is referred under the ‘comitology’ procedure) and possibly experts from the Member States (peer review). The Commission cannot adopt a final decision on whether or not to include the active substance in Annex I to Directive 91/414 until that procedure has been concluded.

9 Article 6 of Regulation No 451/2000 specifies the documents that must always be included in the complete dossier and in the summary dossier which producers are required to submit to the RMS.

10 Under the third indent of Article 6(2)(c) of that regulation, the submission of an additional study is possible only in so far as the study was already ongoing at the time of submission of the complete dossier, the communication of that study was announced when that dossier was submitted, and the study was submitted at the latest within the 12 months following that submission.

‘The EFSA shall circulate the rapporteur’s draft assessment report to the Member States and may organise a consultation of experts including the [RMS]. The EFSA may consult some or all of the notifiers of active substances specified in Annex I on the report or parts of the report on the relevant active substance.

Without prejudice to Article 7 of [Directive 91/414], submission of new studies shall not be accepted. The [RMS], with the agreement of the EFSA, may request the notifiers to submit within specified periods further data considered by the [RMS] [or] the EFSA necessary to clarify the dossier.’

12 Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC (OJ 2004 L 158, p. 7) is the legal basis for the assessment of chemicals in the light of the persistent organic pollutants (‘POP’) criteria applying the Stockholm Convention on persistent organic pollutants, signed on 22 May 2001 (‘the Stockholm Convention’).

‘Member States and the Commission shall, within the assessment and authorisation schemes for existing and new chemicals and pesticides under the relevant Community legislation, take into consideration the criteria set out in paragraph 1 of Annex D to the [Stockholm] Convention and take appropriate measures to control existing chemicals and pesticides and prevent the production, placing on the market and use of new chemicals and pesticides, which exhibit characteristics of [POP].’

14 A Commission working group concluded that trifluralin met the POP selection criteria referred to in Article 3(3) of Regulation No 850/2004, and therefore that that substance was caught by the legal obligations therein defined.

15 Article 5 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (OJ 1999 L 184, p. 23) (‘the comitology decision’), entitled ‘Regulatory procedure’, provides:

‘1. The Commission shall be assisted by a regulatory committee composed of the representatives of the Member States and chaired by the representative of the Commission.

2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time-limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 205(2) and (4) of the Treaty in the case of decisions which the Council [of the European Union] is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.

3. The Commission shall, without prejudice to Article 8, adopt the measures envisaged if they are in accordance with the opinion of the committee.

4. If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken and shall inform the European Parliament.

5. If the European Parliament considers that a proposal submitted by the Commission pursuant to a basic instrument adopted in accordance with the procedure laid down in Article 251 of the Treaty exceeds the implementing powers provided for in that basic instrument, it shall inform the Council of its position.

6. The Council may, where appropriate in view of any such position, act by qualified majority on the proposal, within a period to be laid down in each basic instrument but which shall in no case exceed three months from the date of referral to the Council.

If within that period the Council has indicated by qualified majority that it opposes the proposal, the Commission shall re-examine it. It may submit an amended proposal to the Council, re-submit its proposal or present a legislative proposal on the basis of the Treaty.

If on the expiry of that period the Council has neither adopted the proposed implementing act nor indicated its opposition to the proposal for implementing measures, the proposed implementing act shall be adopted by the Commission.’

16 Trifluralin is an active substance used as a selective broad spectrum herbicide which belongs to the class of dinitroaniline-type herbicides and which can be used to control grass and broad-leaved weeds. It is absorbed by the roots and shoots and inhibits cell division. In most cases, trifluralin is incorporated in the soil in order to protect it against degradation by sunlight.

17 The representative formulated product for the evaluation required to be carried out under Directive 91/414 is ‘EF 1521’ (known as ‘Treflan’), that is to say, an emulsifiable concentrate registered under different trade names in Europe.

18 In August 2000 the appellants and the other applicants at first instance, that is Makhteshim-Agan Holding BV, Makhteshim Agan International Coordination Center, Dintec Agroquímica – Produtos Químicos L^daand Finchimica SpA, all of which produce or manufacture trifluralin or trifluralin-based plant protection products or hold national authorisations to market and sell those products in one or more Member States of the European Union, notified the Commission of their wish to secure the inclusion of that substance in Annex I to Directive 91/414. They did so within the period laid down in Article 4(1) of Regulation No 451/2000.

19 That notification gave rise to a large number of scientific assessments involving the experts of the Commission’s Directorate-General for the Environment, the EFSA, the Standing Committee, the Member States, the European Union’s trifluralin working group and the European Pesticides Co-ordination (‘EPCO’).

20 The applicants at first instance submitted their dossiers on 24 April 2002 to the Hellenic Republic, the Member State designated by the Commission as RMS for the trifluralin evaluation procedure.

21 In its draft assessment report presented on 11 July 2003, the RMS recommended that trifluralin be included in Annex I to Directive 91/414 subject to two conditions, relating (1) to the minimum purity of the substance, and (2) to the adoption by Member States, when granting authorisations, of risk mitigation measures for the protection of aquatic organisms.

22 In regard to that last point, the draft assessment report stated that the applicants at first instance could ‘consider conducting new experimental tests to address specific concerns at [Member State] level’, while nevertheless pointing out that such studies were ‘not a requirement for the inclusion of trifluralin in Annex I [to Directive 91/414]’.

23 Following the EFSA’s transmission of that draft report to the Member States and the notifying parties on 24 July 2003 in order to initiate the peer review provided for in Article 8(5) of Regulation No 451/2000 (‘the peer review’), two Member States expressed their concerns regarding the persistence, bioaccumulation and high volatility of trifluralin, and the view that that active substance should not be authorised to be placed on the market.

24 At the first meeting of the EFSA ‘Evaluation’ working group, which took place on 15 January 2004 and was attended by representatives of the applicants at first instance and the European Crop Protection Association, it was decided that various further data would be necessary in regard to, inter alia, the storage stability of the substance; its shelf life; analytical methods for the determination of impurities; mammalian toxicology; a metabolism study in oilseeds; and a number of studies on the environmental behaviour and fate of the substance.

25 On 3 March 2004 the applicants at first instance sent an email to the EFSA requesting clarification regarding the deadline set for a new lengthy study of plant metabolites TR-22 and TR-28 of trifluralin.

26 By email of 5 March 2004 the EFSA replied that it was for the applicants at first instance to address the data requirements by either submitting the requested information or providing confirmation that it would be submitted, and that the peer review of trifluralin would continue to stay in line with the deadlines given in Commission Regulation (EC) No 1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414 and amending Regulation (EC) No 451/2000 (OJ 2002 L 224, p. 23). In addition, any outstanding data would be referenced in the EFSA’s conclusion on the risk assessment.

27 Owing to the disagreement of certain Member States with the report of the RMS, the matter was referred to the sittings of EPCO, that is to say, the operational secretariat – composed of officials of the German Federal Ministry for Consumer Protection and Food Safety and the United Kingdom Pesticides Safety Directorate – which is responsible, within the EFSA, for the practical organisation of the rounds of experts responsible for peer review.

28 The conclusions of the EPCO meeting were lodged on 22 June 2004, at the end of the assessment carried out by the Member States’ technical experts between April and June 2004 with the aim of re-examining the draft assessment report. Those conclusions resulted in new requirements, expressed in the following terms:

‘… [t]he initial [predicted environmental concentrations] together with the [no observed effect concentration] of 0.3µg/l should be used for a new risk assessment. If the [applicants at first instance disagree] on this, additional studies with different exposure regimes to identify the most critical exposure period should be conducted. [The applicants at first instance are] to submit exposure studies with different exposure times using the fathead minnow [(pimephales promelas)] as the most sensitive fish species.’

29 On 6 October 2004 the RMS, in an email to which the text of the minutes of the EPCO experts’ meeting referred to in paragraph 28 of the present order was attached, stated the following to the applicants at first instance:

‘Please find attached the data requirements for ecotoxicology and residues as presented in the evaluation table for trifluralin that was produced following the EPCO meetings. The sections of fate and behaviour and toxicology have no data requirements and the section of phys-chem and methods of analysis has not prepared its part since a clarification by EPCO for some point is still missing.’

30 On 22 February 2005 the RMS informed the applicants at first instance by email that the draft EFSA conclusions on trifluralin had become final. It is apparent from those conclusions that, although there had been no evaluation either by the EFSA or by the RMS on the POP properties of trifluralin, the meeting of the ‘Evaluation’ working group considered that a paragraph should be included in the EFSA’s conclusions, so as to draw attention to the POP issue. It was also pointed out that, although the POP issue is not a criterion for non-inclusion of any active substance in Annex I to Directive 91/414, a substance that has been classified as POP should be withdrawn from the European Union market.

31 On 14 March 2005 the EFSA delivered its opinion which included a list of eight studies which were to be carried out or were ongoing with, for each of those studies, information on a possible submission date given by the applicants at first instance, going from July 2005 to March 2006, or the information that no valid date had been proposed. The study on chronic toxicity to fish was included among those studies.

32 In that opinion, the EFSA stated that it was unable to take Regulation No 850/2004 into account because it had entered into force when the peer review was at an advanced stage, but that the available information assessed during the peer review should allow the Commission and the Member States to assess trifluralin in the light of the provisions of that regulation as well.

33 In addition, the EFSA stated that various studies remained necessary with regard to the high toxicity of trifluralin for aquatic organisms, in particular fish, the high risk of bioaccumulation, high persistence in soil and the risk of propagation over great distance by air by reason of the high volatility of that active substance. As regards high toxicity for aquatic organisms, the EFSA took the view that further data were needed and that risk assessment in that regard could be concluded only when those data had been evaluated. It further considered that appropriate risk mitigation measures were required with respect to the high risk for aquatic organisms.

34 By letter of 2 May 2005 the Commission invited the applicants at first instance to submit their comments on the conclusions of the EFSA’s final report within four weeks of receipt of that letter, stating that no further studies or modifications to the uses notified would be accepted.

35 Furthermore, in a letter of 23 June 2005, the Commission stated that it refused to respond to the technical issues raised by the applicants at first instance or to give indications as to the positions of the Member States in that regard.

36 The RMS informed the applicants at first instance by email that a draft directive for the inclusion of trifluralin in Annex I to Directive 91/414 had been included on the agenda for the meeting of the Standing Committee of 14 and 15 July 2005. The agenda for the next meeting of the Standing Committee, which was held on 22 and 23 September 2005, again referred to a draft directive for the inclusion of trifluralin.

37 In a note of 21 October 2005 the Commission’s Directorate-General for the Environment expressed the view that it was necessary that trifluralin be examined by the ‘Technical Committee on New and Existing Substances’ sub-group (‘the TC-NES sub-group’) against the POP criteria. It proposed, in view of the time constraints under Directive 91/414, that trifluralin should be submitted to a group of experts as soon as possible, despite the absence of a formal decision on this procedure. The Commission took the view that such an opinion would be very helpful for the Standing Committee and for the Commission itself in the procedure carried out in the context of Directive 91/414. In that note, the Directorate-General for the Environment also expressed the wish that the TC-NES sub-group should discuss that point at its meeting on 25 and 26 October 2005.

38 In a letter of 6 January 2006 the European Union’s trifluralin working group took note of the examination undertaken on the basis of the POP criteria and submitted its comments on the POP evaluation to the TC-NES sub-group.

39 On 19 January 2006, in a letter sent to the Commission, the applicants at first instance challenged the legality, in the context of the evaluation required under Directive 91/414, of the evaluation of trifluralin against the POP criteria.

40 In a working document dated 3 February 2006, the Directorate-General for the Environment stated that trifluralin was an example of an existing active substance used in plant protection products exhibiting POP characteristics, and that, therefore, Article 3(3) of Regulation No 850/2004 had to be applied when considering inclusion of that substance in Annex I to Directive 91/414 and when granting a national authorisation for a plant protection product containing trifluralin. The Directorate-General for the Environment stated that the wording of that provision left a lot to the discretion of authorities involved in the assessment and authorisation schemes, and that, in the case of a plant protection product which is intentionally applied to field crops and therefore also spread into the environment, exposure could be fully eliminated only by prohibiting the use of that product. It added that it could not, however, be directly deduced from the regulation or the Stockholm Convention that there was an obligation to eliminate all exposure, with the result that the decision on what can be regarded as ‘an appropriate measure to control’ a POP-like substance was left to be made, case by case, by the authorities working within the particular assessment and authorisation scheme. The Directorate-General for the Environment therefore requested the POP competent authorities to discuss the issue with their counterparts under Directive 91/414, and, if possible, to agree on an opinion/advice concerning the interpretation of Article 3(3) of Regulation No 850/2004 that could be forwarded to the competent authorities under Directive 91/414.

41 By letter of 14 March 2006, in reply to the letter from the applicants at first instance of 19 January 2006, the Commission reminded them of the functional separation between the EFSA and the Commission and stated that the EFSA assumed sole responsibility for the content of its report.

42 On 17 May 2006 the applicants at first instance submitted to the RMS a study on chronic toxicity to fish undertaken in March 2005 by an independent laboratory, together with an updated chronic risk assessment. That study was also submitted on 12 June 2006 to the Commission, which communicated it to the Member States. The Commission, however, took the view that that study was out of time and that there was thus no need to take it into consideration.

43 The non-inclusion of trifluralin was subsequently included on the agenda of the meetings of the Standing Committee of 22 and 23 May 2006, 13 and 14 July 2006, 28 and 29 September 2006, 23 and 24 November 2006 and 22 and 23 January 2007, without a vote being taken at the end of those meetings.

44 On 16 March 2007 the Standing Committee delivered an opinion in favour of the non-inclusion of trifluralin in Annex I to Directive 91/414. It is evident from the summary report of that meeting that a number of Member States commented on that occasion, including the RMS, which declared that it was in a position to vote in favour of the proposal for the non-inclusion of trifluralin, in order to allow the applicants at first instance to take advantage of the subsequent 18-month period formally to submit the study on chronic toxicity to fish and to allow it, as RMS, formally to evaluate that study.

45 On 20 September 2007 the Commission adopted the decision at issue, concluding that trifluralin should not be included in Annex I to the directive and that authorisations for plant protection products containing that substance should be withdrawn.

46 According to recital 5 in the preamble to the decision at issue, a number of concerns remained unresolved according to the information available, owing, first of all, to trifluralin’s high toxicity to aquatic organisms, in particular to fish; next, to the fact that trifluralin is highly persistent in soil and its potential for accumulation; and, lastly, to the presence of trifluralin in places distant from application (findings on POP properties).

47 On 11 April 2008 the applicants at first instance informed the Commission of their intention to submit a fresh request for the inclusion of trifluralin in Annex I to Directive 91/414, pursuant to Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Directive 91/414 as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that directive but have not been included in its Annex I (OJ 2008 L 15, p. 5).

48 The decision at issue was repealed by Article 2 of Commission Decision 2010/355/EU of 25 June 2010 concerning the non-inclusion of trifluralin in Annex I to Directive 91/414 (OJ 2010 L 160, p. 30).

49 By application lodged at the General Court Registry on 21 December 2007, the appellants brought an action under the fourth paragraph of Article 230 EC for annulment of the decision at issue and for a declaration that Article 3(3) of Regulation No 850/2004 is illegal.

50 In support of their action before the General Court, the appellants put forward six pleas for annulment and a plea of illegality relating to Article 3(3) of Regulation No 850/2004.

51 The first plea alleged that the decision at issue was not based on the EFSA report provided for in Article 8(8) of Regulation No 451/2000 and that it was therefore adopted in breach of the applicable procedural rules. In support of their second plea, the appellants claimed that the Commission had made a certain number of manifest errors of assessment. The third plea alleged that the decision at issue did not comply with the applicable legislative procedure and breached Articles 5 EC and 7 EC, Article 8(8) of Regulation No 451/2000 and Article 5 of the comitology decision. The fourth plea alleged failure to observe the procedural deadlines provided for in Article 8(7) and (8) of Regulation No 451/2000. In support of the fifth plea, the appellants claimed that the decision at issue was inadequately reasoned. Lastly, the sixth plea alleged breach of the principles of legal certainty, protection of legitimate expectations and proportionality, and also infringement of the rights of the defence and of the right to a fair hearing.

52 The General Court dismissed the action, holding, in essence, that the Commission was not required to follow the EFSA’s opinion and that the appellants had not proved any manifest error of assessment, abuse of powers, procedural error or failure to state reasons on the part of the Commission. Moreover, the General Court was unable to establish any breach of the principles of legal certainty, of the rights of the defence or of the appellants’ legitimate expectations.

54 The Commission contends that the Court should dismiss the appeal and order the appellants to pay the costs.

55 Under Article 181 of its Rules of Procedure, where an appeal is, in whole or in part, manifestly inadmissible or manifestly unfounded, the Court may at any time, acting on a proposal from the Judge-Rapporteur and after hearing the Advocate General, dismiss that appeal in whole or in part by reasoned order, without opening the oral procedure. It is appropriate to apply that provision in the present case.

56 The appellants submit that the General Court made a number of errors in interpreting the legal framework applicable in the present case and in interpreting the facts and evidence put forward for its consideration. Those errors of interpretation resulted in the General Court making a number of errors of law. In support of their appeal the appellants, recalling the jurisdiction of the Court of Justice to review a judgment of the General Court where the evidence has been distorted or where the substantive inaccuracy of its findings is apparent from the documents submitted to the General Court, put forward three pleas in law.

57 By the first of those pleas, the appellants submit that, by considering that none of the conditions laid down by Article 8(5) of Regulation No 451/2000 was satisfied and that no request for a further study had been made to the applicants at first instance, the General Court misinterpreted that provision, distorted the evidence brought before it and accordingly made an error of law. By their second plea, they claim that the General Court made a manifest error of assessment in maintaining that the Commission’s decision to postpone the vote on its draft decision for trifluralin’s inclusion in Annex I to Directive 91/414 and on the modification of the proposals for inclusion did not infringe Article 5 of the comitology decision. As regards the third plea, the appellants submit, inter alia, that the General Court made an error of assessment in holding that the contested decision was not based on POP criteria – for which there was no basis in the relevant legal framework – whereas evidence on record clearly showed that the Commission did apply those criteria.

58 The Commission contends, in essence, that, although the appellants largely rely, formally, on a distortion of the evidence, they are in actual fact seeking to challenge the General Court’s assessment of the facts. The pleas regarding the alleged distortion of the evidence should therefore be rejected as inadmissible. However, the Commission also states its views on the substance of the case and challenges the appellants’ claims in their entirety.

59 In support of the first plea, the appellants essentially rely on two complaints. By the first complaint, they criticise the General Court for concluding that no request was ever made to them, even informally, for submission of a further study. The second complaint is that the General Court infringed the procedural rules relating to submission of a request for a further study. In that regard the appellants criticise the General Court for having found, first, that there was no indication in the dossier that the EFSA had given its agreement to such a request; secondly, that it could be concluded from the fact that no deadline was set by the RMS that no request had been made; and, thirdly, that the new aquatic study had not provided an answer with regard to the other risks.

60 The appellants criticise the General Court for having concluded that a reference to additional studies could not be regarded as a request for further data necessary to clarify the dossier, and maintain that, in doing so, it misinterpreted Article 8(5) of Regulation No 451/2000. In that regard they submit, in particular, that Article 8(5) does not specify which type of data are to be considered to constitute further data ‘necessary to clarify the dossier’.

61 The Commission challenges the substance of that argument, contending that it is clear beyond any doubt from the first sentence of the second subparagraph of Article 8(5) of Regulation No 451/2000 that the submission of a new study is not accepted in any case. Accordingly, new studies can never be considered to be such further data.

62 In the first place, it must be recalled that Article 8 of Regulation No 451/2000 expressly provides, twice, in paragraphs 2 and 5, that, without prejudice to Article 7 of Directive 91/414, submission of ‘new studies’ is not allowed after notification of the dossier by the notifier.

63 The only exception in that regard concerns the studies referred to in the third indent of Article 6(2)(c) of Regulation No 451/2000. According to that provision, the submission of an additional study is possible only in so far as the study was already ongoing at the time of submission of the complete dossier, the communication of that study was announced when that dossier was submitted, and the study was submitted at the latest within the 12 months following that submission. However, it must be noted that the appellants did not plead the foregoing, either before the General Court or in the present appeal.

64 Even though, according to Article 8 of Regulation No 451/2000, the RMS – in some circumstances with the agreement of the EFSA where the draft assessment report has already been sent to the EFSA – can request the notifier to submit, within the time-limits specified in that provision, further data which the RMS or, where appropriate, the EFSA, judge necessary to clarify the dossier, Article 8 makes no provision for any such exception in respect of the submission of new studies.

65 Accordingly, further data can be communicated solely for the purpose of clarifying the information already included in the complete dossier. It should be noted in that regard that it is incumbent on the notifier to ensure that all the studies and data relevant for the purposes of the evaluation of the active substance sought to be included in Annex I to Directive 91/414 are already in the notified dossier.

66 A literal interpretation of Article 8(2) and (5) of Regulation No 451/2000 thus supports the unequivocal conclusion that a request from the RMS, within the meaning of those provisions, can relate only to ‘further data’ and not to ‘new studies’, and that therefore those further data can never give rise to the submission of new studies.

67 The General Court did not, therefore, err in law when it stated, in paragraphs 108 to 112 of the judgment under appeal, that the submission of new studies cannot be equated with the communication of further data.

68 Consequently, the appellants’ complaint concerning a misinterpretation of Article 8(5) of Regulation No 451/2000 is manifestly unfounded.

69 First, the appellants claim that the General Court distorted the evidence that was put before it by deciding that no request for a further study, as referred to in Article 8(5) of Regulation No 451/2000, had been sent to them. The appellants maintain in that regard that the email from the RMS of 6 October 2004, the EFSA’s table of 22 June 2004 and the EFSA report of 14 March 2005 can be regarded as such a request, inasmuch as that provision does not impose specific formalities on that type of request, unlike other articles in the same regulation. Secondly, the appellants claim that the General Court wrongly found in paragraph 120 of the judgment under appeal that the dossier that was submitted to it did not contain any indication that the EFSA had agreed that the appellants should supply such a further study. Thirdly, the appellants challenge the General Court’s finding that, since no deadline was specified by the RMS in its correspondence with them, the documents relied on in that respect cannot legitimately be described as a request for further data to be supplied, given that the lack of a deadline does not nullify the legitimacy of that request, particularly as the fact that no deadline was set cannot be attributed to the appellants. Fourthly, the appellants criticise the General Court’s finding that the new aquatic study did not provide an answer with regard to the other risks identified by the EFSA, since those other risks were not identified by the EFSA as critical areas of concern, which means that they did not in themselves prevent a decision to include trifluralin in Annex I to Directive 91/414.

70 The Commission challenges the admissibility as well as the substance of those complaints, contending in particular that there was neither a request from the RMS for a further study nor any agreement by the EFSA in that respect, and that the nature of the documents to which the appellants refer means that those documents cannot be regarded as requests meeting the requirement in Regulation No 451/2000. Furthermore, the absence of any deadline in those documents shows that no such request was ever made. As to the General Court’s finding that the new aquatic study did not provide an answer with regard to the other risks identified by the EFSA, the Commission notes that that conclusion is formally correct, given that the study in question could not address such risks, as it had a different purpose.

71 It must be observed that, in paragraphs 16 to 22 of their appeal, the appellants criticise, in particular, the General Court’s assessment of the facts.

72 It is clear from Article 256 TFEU and the first paragraph of Article 58 of the Statute of the Court of Justice of the European Union that the General Court has exclusive jurisdiction, first, to find the facts, except where the substantive inaccuracy of its findings is apparent from the documents submitted to it, and, secondly, to assess those facts. When the General Court has found or assessed the facts, the Court of Justice has jurisdiction under Article 256 TFEU to review the legal characterisation of those facts by the General Court and to review the legal conclusions which it has drawn from them (Joined Cases C-628/10 P and C-14/11 P Alliance One International and Standard Commercial Tobacco v Commission and Commission v Alliance One International and Others [2012] ECR I-0000, paragraph 84 and the case-law cited).

73 The Court of Justice thus has no jurisdiction to establish the facts or, in principle, to examine the evidence which the General Court has accepted in support of those facts. Provided that the evidence has been properly obtained and the general principles of law and the rules of procedure in relation to the burden of proof and the taking of evidence have been observed, it is for the General Court alone to assess the value which should be attached to the evidence produced to it. Save where the clear sense of that evidence is distorted, that appraisal does not therefore constitute a question of law which is subject, as such, to review by the Court of Justice (Case C-105/04 P Nederlandse Federatieve Vereniging voor de Groothandel op Elektrotechnisch Gebied v Commission [2006] ECR I-8725, paragraph 70, and Alliance One International and Standard Commercial Tobacco v Commission and Commission v Alliance One International and Others, paragraph 85 and the case-law cited).

74 In that regard it must be noted that, in this instance – as the Commission, moreover, correctly observes in its submissions –, even though the appellants formally invoke such distortion by the General Court, particularly with regard to the form of the request for further data within the meaning of Article 8(5) of Regulation No 451/2000, in reality the appellants are trying to obtain a new assessment of the facts and of the evidence.

75 In that context, it must also be observed that distortion of the facts must be obvious from the documents on the Court’s file, without there being any need to carry out a new assessment of the facts and the evidence (Case C-551/03 P General Motors v Commission [2006] ECR I-3173, paragraph 54; Case C-254/09 P Calvin Klein Trademark Trust v OHIM [2010] ECR I-7989, paragraph 50; and judgment of 19 July 2012 in Case C-264/11 P Kaimer and Others v Commission, paragraph 24).

76 With regard to the alleged distortion in relation to the nature of the documents referred to by the appellants (an EFSA report, the reporting tables of a meeting of the EFSA, the conclusions of that organisation and an email from the RMS), the absence of the EFSA’s agreement to the alleged request to the appellants to provide further data and the fact that there was no deadline for the submission of such data, it must be noted that, in paragraphs 116 to 124 of the judgment under appeal, the General Court analysed the documents on which the appellants relied in support of their view. It deduced that the appellants were maintaining that the documents communicated by the applicants in the main proceedings on 17 May 2006 constituted not further data but an additional study, and, moreover, that the absence both of any indication that the EFSA gave its agreement in relation to the submission of further data, and of any deadline in that respect, supported the conclusion that no such request for further data had ever been made. It is on that basis that the General Court was able to decide, without distorting either the facts or the evidence put forward for its appraisal, that no request for further data in accordance with the relevant provisions had been made to the appellants.

77 That part of the appeal amounts in reality to no more than a request for re-examination of the application submitted to the General Court, which the Court of Justice does not have jurisdiction to undertake (see order of 6 October 2011 in Joined Cases C-448/10 P to C-450/10 P ThyssenKrupp Acciai Speciali Terni and Others v Commission, paragraph 62 and the case-law cited).

78 It must therefore be concluded that the arguments regarding distortion of the facts and evidence put forward by the appellants in the second complaint of the first plea in law are manifestly inadmissible and, in any event, unfounded.

79 As regards the complaint concerning the General Court’s conclusion, in paragraph 163 of the judgment under appeal, that the new aquatic study did not provide an answer with regard to the other risks, in so far as that complaint seeks to challenge the second part of paragraph 163 of the judgment under appeal, it must be noted that, according to settled case-law, complaints directed against grounds included in a General Court decision purely for the sake of completeness cannot lead to that decision being set aside and are therefore ineffective (Joined Cases C-189/02 P, C-202/02 P, C-205/02 P to C-208/02 P and C-213/02 P Dansk Rørindustri and Others v Commission [2005] ECR I-5425, paragraph 148, and order of 23 February 2006 in Case C-171/05 P Piau v Commission, paragraph 86).

80 In view of the fact that the General Court found, in the first part of paragraph 163, that communication of the study in question was late, a finding which was not contested by the appellants, it follows that that argument of the appellants is directed against a ground included in the judgment under appeal for the sake of completeness and, therefore, even if well-founded, it cannot lead to the setting aside of that judgment, for which there are other grounds. Consequently, that argument must be rejected as ineffective (see, to that effect, Case C-288/11 P Mitteldeutsche Flughafen and Flughafen Leipzig v Commission [2012] ECR I-0000, paragraph 68).

81 That part of the second complaint of the first plea in law must therefore be rejected as ineffective.

82 In those circumstances, the first ground of appeal must be dismissed as being in part manifestly inadmissible, if not, and in any event, manifestly unfounded, and in part ineffective.

83 In support of their second plea, which is presented in a relatively confused manner, the appellants maintain, in essence, that the General Court infringed Article 5(2) of the comitology decision by deciding that that provision does not prohibit the submission of a proposal without a vote taking place, or the withdrawal and resubmission of a proposal after its amendment. Article 5(2) of the comitology decision should be interpreted as authorising neither the submission of a proposal to the Standing Committee without that committee’s proceeding to a vote nor the possibility of withdrawal and modification of such a proposal before its resubmission, on more than one occasion, to the Standing Committee. Consequently, the appellants maintain that the proposals which were presented to the Standing Committee before March 2007 should have been put to a vote, and that it was for the General Court to decide that question of law. However, instead of doing so, the General Court ruled on the length of time that had passed before the vote and, to that end, based its assessment on case-law that was not relevant. The appellants also complain that the General Court erred in holding that a proposal is liable to change in the course of discussion within the Standing Committee, whereas the comitology decision does not allow for a proposal to be amended by the Commission once it has been submitted to that committee. In addition, the appellants claim that the General Court did not directly address their argument that a proposal had been submitted by the Commission prior to March 2007 and that that proposal should have been put to a vote.

84 The Commission contests the appellants’ interpretation of Article 5(2) of the comitology decision and states in particular that the Commission’s decision to postpone the vote on its draft decision to include trifluralin in Annex I to Directive 91/414 and on the modification of the proposals did not infringe Article 5 of the comitology decision. The Commission also challenges the admissibility and the substance of the other complaints relied on by the appellants in the context of that plea.

85 As a preliminary point, it must be observed that the appellants seem to be proceeding on the assumption that any document submitted to the Standing Committee and to the working groups within it should be treated like a draft measure that must be put to a vote as soon as possible.

86 It is true that Article 5(2) of the comitology decision does not expressly provide for the possibility of a proposal being submitted to the Standing Committee without then being subject to a vote, or for the withdrawal of such a proposal and its amendment prior to its resubmission to that committee. However, that article does not explicitly exclude that possibility either.

87 By maintaining that once a proposal is submitted to the Standing Committee, the procedure under Article 5(2) of the comitology decision must be followed, and therefore that the Commission can no longer amend its proposal where that proposal is not supported by the Standing Committee, the appellants clearly misconstrue the effect of that provision.

88 It must be observed in that regard that it is clear from Article 8(8) of Regulation No 451/2000 that, at the latest six months after receipt of the EFSA opinion, the Commission must submit a draft review report. On the basis of the finalised review report the Commission then submits to the Standing Committee either a draft directive to include the active substance concerned in Annex I to Directive 91/414, setting out where appropriate the conditions, including the time-limit, for such inclusion, or, pursuant to the fourth subparagraph of Article 8(2) of the directive, a duly reasoned draft decision addressed to the Member States to withdraw the authorisations of plant protection products containing that active substance, whereby that substance is not included in Annex I to Directive 91/414.

89 In addition, Article 8(9) of Regulation No 451/2000 provides that where the Commission submits a draft directive or a draft decision in accordance with paragraph 8 of that article, it is at the same time to submit the conclusions of the Standing Committee’s examination in the format of a finalised review report which is to be noted in the summary record of the meeting.

90 The General Court stated, quite correctly, in paragraph 194 of the judgment under appeal, that Article 8 of Regulation No 451/2000 thus draws a distinction between two stages in the procedure for the evaluation of dossiers in the context of the procedure for the inclusion of an active substance in Annex I to that regulation: on the one hand, that relating to the submission of a draft review report, which must occur at the latest six months after receipt of the EFSA opinion, and, on the other hand, that relating to the submission of a draft directive or decision on the basis of the finalised review report and which is not subject to compliance with that time-limit.

91 Only the latter draft directive or decision is covered by Article 5 of the comitology decision when it states, in paragraph 2, that ‘[t]he representative of the Commission shall submit to the [Standing Committee] a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time-limit which the chairman may lay down according to the urgency of the matter’. Thereafter the Commission is, without prejudice to Article 8 of that decision, to adopt the measures envisaged if they are in accordance with the opinion of that committee. If that is not the case, the Commission is, without delay, to submit to the Council a proposal relating to the measures to be taken and to inform the European Parliament.

92 Contrary to what is claimed by the appellants, it does not follow from that provision that the Commission is obliged to put to a vote any document it submits to the committee. Article 5(2) of the comitology decision does not refer to any and all working or preparatory documents whatsoever that are distributed by the Commission within the Standing Committee, but only to draft directives or decisions.

93 Furthermore, it is evident from Article 5 of the comitology decision that there is no time-limit for the lodging of a draft with the committee and that the chairman of the Standing Committee – a representative of the Commission – can set a time-limit for delivery of its opinion on the draft, the Commission accordingly having some flexibility in that respect. Article 5, therefore, merely lays down a simple obligation to submit a proposal but does not specify when that proposal must be made, nor does it specify a period within which a vote on it must take place.

94 That interpretation is supported by certain provisions of the rules of procedure of the Standing Committee. Thus, it is apparent from Article 5(2) of those internal rules of procedure that there is a preparatory stage before a draft may be put to a vote. In that context, the internal rules of procedure provide that the agenda of a meeting of a working group must make a distinction between ‘drafts of measures’ and ‘other issues put to the committee for information or a simple exchange of views’, such issues being intended to provide an overview of the different positions of the Member States. Accordingly, those exchanges of views cannot be regarded as a vote on a draft of a measure.

95 In addition, Article 5(2) of those internal rules of procedure provides that even if the agenda of a meeting of the Standing Committee envisages that a point will be put to a vote, that vote does not necessarily have to take place during that session, since the chairman has considerable flexibility in that respect. Indeed, he may, on his own initiative or at the request of a committee member, postpone the vote on a particular agenda point until the end of the meeting or a later meeting if a substantive change is made to the proposal during the meeting, if the text of the proposal has been submitted to the committee during the meeting, or if a new point has been added to the agenda of the meeting, in accordance with Article 3(3) of the internal rules of procedure of the Standing Committee.

96 Furthermore, as regards the alleged prohibition against the Commission’s amendment of a proposal, it must be noted that Article 5(2) of the comitology decision – which, moreover, does not contain any such prohibition – is not, in accordance with a common practice of which the appellants ought to be aware, either applied or interpreted as meaning that the Commission has just one opportunity to propose the adoption of a measure. Such an interpretation would deprive the Commission of the opportunity to amend its proposals under the procedure laid down by the comitology decision.

97 It follows that it is only when the Standing Committee proceeds to a vote that Article 5 of the comitology decision must be applied.

98 The General Court did not, therefore, err in law when it interpreted Article 5(2) of the comitology decision as permitting a proposal to be submitted to the Standing Committee without a vote taking place, and as permitting such a proposal to be withdrawn and resubmitted after being amended.

99 The arguments put forward by the appellants on this point must therefore be rejected.

100 Consequently, the Court must also reject the appellants’ argument that, given that the comitology decision does not allow for a proposal to be amended by the Commission once it has been submitted to the Standing Committee, the General Court erred in law in holding that a proposal is liable to change in the course of discussion within that committee.

101 It also follows from the General Court’s – correct – interpretation of Article 5 of the comitology decision that the General Court cannot have distorted the evidence submitted by the appellants when it concluded that no vote had taken place prior to March 2007.

102 In view of the fact that the proposal for a non-inclusion decision was put to a vote only once, on 16 March 2007, contrary to what is claimed by the appellants, and that, in that vote, the proposal received the qualified majority required for its adoption, it was not necessary for the proposal to be submitted to the Council pursuant to Article 5(4) of the comitology decision.

103 Accordingly, the arguments put forward by the appellants in that regard must be rejected as manifestly unfounded.

104 It follows from all the foregoing considerations that the second ground of appeal must be dismissed as being manifestly unfounded.

105 By their third plea in law, the appellants claim that the General Court, first, erred in law when it ruled, in paragraphs 178 to 182 of the judgment under appeal, that the criteria of persistence in soil, biodegradability, bioaccumulation and propagation through air of trifluralin are not only related to the POP criteria but are also included in Directive 91/414 since Article 5(2)(c) of that directive and point 7 of Part A of Annex II thereto refer specifically to the ‘[f]ate and behaviour [of the substance] in the environment’ and deal with its fate and behaviour in soil, water and air, and with the bioaccumulation and biodegradability of that active substance. Furthermore, the appellants take the view that such an interpretation breaches the principle of legal certainty in that it opens the door to ‘indefinite situations’ and to criteria being applied ad hoc to any assessment, rendering the whole assessment under Directive 91/414 entirely uncertain and unpredictable.

106 Secondly, the appellants submit that the General Court distorted the evidence submitted to it in holding that the evaluation of trifluralin was not based on POP criteria, even though the evidence in the dossier clearly demonstrated that the Commission had applied those criteria.

107 The Commission challenges those arguments, referring to the relevant minutes of meetings of the Standing Committee, and contends that the decision at issue is based on Directive 91/414 alone.

108 In the first place, with regard to the complaint of an error of interpretation of the law, it should be borne in mind that Regulation No 850/2004 does indeed introduce an evaluation mechanism separate from that laid down by Directive 91/414.

109 Nevertheless, it cannot be inferred from the fact that the POP criteria were assessed, in terms of Regulation No 850/2004, during the evaluation procedure that in that respect the decision at issue infringes Article 5(1) of Directive 91/414.

110 It must be noted that the criteria set out in that provision are expressed in broad terms and based on an analysis of the risk of harmful effects of the active substance on human or animal health or on groundwater or any unacceptable influence on the environment.

111 In addition, the General Court was fully entitled to find that, under Article 5(2)(c) of Directive 91/414, for inclusion of an active substance in Annex I to that directive, particular account is to be taken of, where relevant, an estimate of its fate and distribution in the environment.

112 Furthermore, point 7 of Part A of Annex II to Directive 91/414 refers specifically to the fate and behaviour of the active substance in the environment and deals with its fate and behaviour in soil, water and air and with its bioaccumulation and biodegradability.

113 It follows that the criteria of persistence in soil, biodegradability, bioaccumulation and transport through air of the active substance, to which reference is made in recital 5 in the preamble to the decision at issue, are not only related to the POP criteria but are also implicitly included in Directive 91/414, and that the assessment of the POP criteria and the possible classification as POP do not preclude that substance from having harmful effects within the meaning of Article 5(1) of Directive 91/414 (see, to that effect, order of 15 April 2010 in Case C-517/08 P Makhteshim-Agan Holding and Others v Commission, paragraph 95).

114 Accordingly, the mere fact that an evaluation of trifluralin was carried out in the light of the POP criteria in an assessment during the evaluation procedure under Directive 91/414 is not a ground for annulment of the decision at issue.

115 The General Court did not, therefore, err in its interpretation of the law in that respect, and the first complaint of the present plea must accordingly be rejected.

116 In the second place, as regards the complaint concerning the distortion of evidence, it must be noted that, as the Commission correctly states in its submissions, even though the appellants formally invoke such distortion by the General Court, they confine themselves to reiterating the arguments they put forward in the General Court, and are thus in reality seeking to challenge the General Court’s assessment of the facts.

117 It has consistently been held that an appeal must specify the alleged flaws in the judgment which the appellant claims should be set aside and the legal arguments which specifically support that claim. That requirement is not satisfied by an appeal which, without even including an argument specifically identifying the error of law allegedly vitiating the judgment under appeal, merely reproduces the pleas in law and arguments previously submitted to the General Court. In reality, such an appeal amounts to no more than a request for re-examination of the application submitted to the General Court, which falls outside the jurisdiction of the Court of Justice (see order in ThyssenKrupp Acciai Speciali Terni and Others v Commission, paragraph 62 and the case-law cited).

118 Moreover, as has already been stated in paragraph 72 of the present order, it has consistently been held that, in accordance with Article 256 TFEU and the first paragraph of Article 58 of the Statute of the Court of Justice, the General Court has exclusive jurisdiction, first, to find the facts, except where the substantive inaccuracy of its findings is apparent from the documents submitted to it, and, secondly, to assess those facts.

119 Consequently, in the absence of arguments demonstrating that there was distortion of evidence by the General Court, the second complaint of the third plea in law must be rejected as inadmissible.

120 It follows from all the foregoing considerations that the present ground of appeal must be dismissed as being, in part, manifestly inadmissible and, in part, manifestly unfounded.

121 Accordingly, in the light of all those considerations, the Court must reject all the pleas put forward in support of the present appeal as being in part manifestly inadmissible, in part ineffective and in part manifestly unfounded.

122 Under Article 138(1) of the Rules of Procedure, which applies to appeal proceedings by virtue of Article 184(1) thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.

123 Since the Commission has applied for the costs to be paid by the appellants, and the latter have been unsuccessful, the appellants must be ordered to pay the costs.

2. Dow AgroSciences Ltd, Dow AgroSciences LLC, Dow AgroSciences SAS, Dow AgroSciences Export SAS, Dow Agrosciences BV, Dow AgroSciences Hungary kft, Dow AgroSciences Italia Srl, Dow AgroSciences Polska sp. z o.o., Dow AgroSciences Iberica SA, Dow AgroSciences s.r.o., Dow AgroSciences Danmark A/S and Dow AgroSciences GmbH shall pay the costs.

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You are here: BAILII >> Databases >> Court of Justice of the European Communities (including Court of First Instance Decisions) >> Dow AgroSciences Ltd, v European Commission [2013] EUECJ C-584/11 (07 May 2013) URL: http://www.bailii.org/eu/cases/EUECJ/2013/C58411_A.html Cite as: [2013] EUECJ C-584/11

Court of Justice of the European Communities (including Court of First Instance Decisions)