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

JUDGMENT OF THE GENERAL COURT (Seventh Chamber)

9 February 2021 (*)

(Plant protection products – Active substance ethoprophos – Non-renewal of approval – Regulation No 1107/2009 and Implementing Regulation No 844/2012 – Rights of the defence – Manifest error of assessment – Legal certainty – Proportionality – Precautionary principle)

In Case T‑317/19,

AMVAC Netherlands BV, established in Amsterdam (Netherlands), represented by C. Mereu, M. Grunchard and S. Englebert, lawyers,

applicant,

v

European Commission, represented by F. Castilla Contreras and A. Dawes, acting as Agents,

defendant,

APPLICATION under Article 263 TFEU for annulment of Commission Implementing Regulation (EU) 2019/344 of 28 February 2019 concerning the non-renewal of approval of the active substance ethoprophos, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ 2019 L 62, p. 7),

THE GENERAL COURT (Seventh Chamber),

composed of R. da Silva Passos, President, V. Valančius and I. Reine (Rapporteur), Judges,

Registrar: P. Cullen, Administrator,

having regard to the written part of the procedure and further to the hearing on 19 November 2020,

gives the following

Judgment

I.      Legal framework

A.      Directive 91/414/EEC

1        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), establishes the EU regime for the authorisation of the placing on the market of those products. It contains provisions applicable to plant protection products and the active substances contained in them.

2        According to Article 4 of Directive 91/414, governing the granting, review and withdrawal of authorisations of plant protection products, a plant protection product must meet certain criteria in order to be approved. In particular, such a product is authorised if its active substances are included in Annex I to that directive and if the conditions set out in that annex are met. Articles 5 and 6 of that directive lay down the procedure for the inclusion of an active substance in Annex I.

3        Directive 91/414 was repealed by Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ 2009 L 309, p. 1), with effect from 14 June 2011.

B.      Regulation No 1107/2009

4        Pursuant to Article 1(3), Regulation No 1107/2009 aims to ensure a high level of protection of human and animal health and the environment and to improve the functioning of the internal market by harmonising the rules concerning the placing of plant protection products on the market, while improving agricultural production.

5        Article 4 of Regulation No 1107/2009 provides criteria for the approval of active substances of plant protection products.

6        In accordance with Article 5 of Regulation No 1107/2009, the first approval of an active substance is valid for a period not exceeding 10 years.

7        Articles 14 to 20 of Regulation No 1107/2009 deal with the renewal of the approval of active substances. The approval of an active substance is renewed on application by a producer of the active substance to a Member State no later than three years before the expiry of the approval where it is established that the approval criteria provided for in Article 4 of that regulation are satisfied (Articles 14(1) and 15(1)). When applying for renewal of approval, the applicant must identify new data he or she intends to submit and demonstrate that they are necessary, because of data requirements or criteria which were not applicable at the time of the last approval of the active substance or because his or her request is for an amended approval (Article 15(2)). At the same time the applicant must submit a timetable of any new and ongoing studies (Article 15(2)). A regulation is to be adopted in accordance with the regulatory procedure referred to in Article 79(3) of Regulation No 1107/2009, providing that the approval of an active substance is renewed, subject to conditions and restrictions where appropriate, or that the approval of an active substance is not renewed (Article 20(1)).

C.      Implementing Regulation No 844/2012

8        Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation No 1107/2009 (OJ 2012 L 252, p. 26), establishes, in particular, the rules concerning the different steps of the renewal procedure.

9        Articles 1 to 8 of Implementing Regulation No 844/2012 provide for the rules concerning the admissibility of the application submitted by a producer of the active substance to a Member State. In accordance with Article 3 of that implementing regulation, that application is first checked by the rapporteur Member State (‘the RMS’) to ensure that it has been submitted within the time limit provided for in the first subparagraph of Article 1(1) of that implementing regulation and that it contains all the elements provided for in Article 2 of that implementing regulation. In particular, in accordance with Article 2(2) of that implementing regulation, the renewal application must contain the list of new information that the applicant intends to submit and that is necessary in accordance with the first subparagraph of Article 15(2) of Regulation No 1107/2009 (see paragraph 7 above). Next, in accordance with Article 6 of that implementing regulation, after receiving the affirmative answer from the RMS on that verification, the applicant submits the supplementary dossiers to the RMS, the co-rapporteur Member State, the European Commission and the European Food Safety Authority (EFSA). Finally, in accordance with Article 8 of the implementing regulation concerned, where the supplementary dossiers have been submitted within the deadline and contain all the elements foreseen, the RMS informs the applicant, the co-rapporteur Member State, the Commission and EFSA of the date of receipt of the supplementary dossiers and the admissibility of the application.

10      Articles 11 to 14 of Implementing Regulation No 844/2012 set out the procedure for the evaluation of the application for renewal of the approval of an active substance. First of all, the RMS, after consulting the co-rapporteur Member State, is to prepare and submit to the Commission, with a copy to EFSA, a report assessing whether the active substance can be expected to meet the criteria for approval in accordance with Article 4 of Regulation No 1107/2009 (Article 11 of that implementing regulation). After receiving the draft assessment report from the RMS, EFSA is to communicate it to the applicant and the other Member States (Article 12 of that implementing regulation). Following the expiry of the period for submission of written comments, EFSA adopts, taking into account the state of scientific and technical knowledge and using the guidance documents in force at the date of submission of the supplementary dossiers, conclusions on whether the active substance can be expected to meet the approval criteria set out in Article 4 of that regulation. Where appropriate, EFSA organises a consultation of experts, including experts from the RMS and the co-rapporteur Member State. It is to communicate its conclusions to the applicant, the Member States and the Commission and to make them publicly available (Article 13 of that implementing regulation). Finally, following receipt of the EFSA conclusions and taking into account the draft assessment report prepared by the RMS, the comments of the applicant and the other Member States and the conclusions adopted by EFSA, the Commission is to submit a report, referred to as the ‘renewal report’, and a draft regulation to the Standing Committee on the Food Chain and Animal Health (‘the Standing Committee’). The applicant is given the opportunity to comment on the renewal report (Article 14(1) of the implementing regulation in question). On the basis of the renewal report and taking into account the comments submitted by the applicant, the Commission is to adopt a regulation in accordance with Article 20(1) of Regulation No 1107/2009 (Article 14(2) of the implementing regulation concerned).

II.    Background to the dispute

11      The applicant, AMVAC Netherlands BV, is a company which markets the active substance ‘ethoprophos’ (‘ethoprophos’) and ethoprophos-based plant protection products throughout the European Union for nematicidal and soil insecticidal purposes.

A.      First approval of ethoprophos at EU level

12      Ethoprophos was first approved on 1 October 2007 for a period of 10 years by Commission Directive 2007/52/EC of 16 August 2007 amending Council Directive 91/414/EEC to include ethoprophos, pirimiphos-methyl and fipronil as active substances (OJ 2007 L 214, p. 3), following its first evaluation at EU level under Directive 91/414. The inclusion was conditional on the provision of further studies on the risk to birds and earthworm-eating mammals.

13      On 20 November 2013, the Commission adopted Implementing Regulation (EU) No 1178/2013 amending Implementing Regulation (EU) No 540/2011 as regards the conditions for approval of the active substance ethoprophos (OJ 2013 L 312, p. 33). In the light of the additional information provided, confirming that a high risk to birds and earthworm-eating mammals could not be excluded, it restricted the use of ethoprophos to one application per season at a dose not exceeding 6 kg of active substance per hectare.

B.      Renewal of the approval of ethoprophos at EU level

14      The approval of ethoprophos was subject to the standard regulatory procedure for renewals of approval provided for in Article 14 et seq. of Regulation No 1107/2009 (see paragraph 7 above). On 30 September 2014, the applicant submitted an application for renewal in that respect, in accordance with Article 1 of Implementing Regulation No 844/2012 (see paragraph 9 above). It requested renewal subject to the same restrictions as those provided for in Implementing Regulation No 1178/2013 (see paragraph 13 above).

15      On 31 January 2016, the applicant submitted the supplementary dossiers pursuant to Article 6 of Implementing Regulation No 844/2012 (see paragraph 9 above).

16      In accordance with Commission Implementing Regulation (EC) No 686/2012 of 26 July 2012 allocating to Member States, for the purposes of the renewal procedure, the evaluation of active substances whose approval expires by 31 December 2018 at the latest (OJ 2012 L 200, p. 5), the Italian Republic was designated as the RMS for the renewal of ethoprophos, the co-rapporteur Member State being Ireland.

17      According to the procedure established by Implementing Regulation No 844/2012, the RMS confirmed the admissibility of the application for renewal of the approval of ethoprophos and provided, in January 2017, its draft renewal assessment report (‘the draft RAR’) to EFSA. In that draft, the RMS proposed to renew the approval of ethoprophos for the specific [or ‘reference’] uses identified in the renewal application, namely as a nematicide and soil insecticide.

18      On 19 July 2017, EFSA circulated the draft RAR to the Member States and the applicant for comments, pursuant to Article 12 of Implementing Regulation No 844/2012. The applicant submitted its comments on 15 September 2017. EFSA forwarded all the comments to the Commission on 19 September 2017, which were simultaneously forwarded to the RMS in the form of a reporting table.

19      On 20 September 2017, the applicant was invited to respond, in column 3 of the reporting table, to the observations referred to in paragraph 18 above, by 4 October 2017 at the latest, which it did.

20      It appears from the EFSA conclusions that, during a conference call held on 31 October 2017, the RMS and EFSA discussed the need to use experts and to request additional information from the applicant, in accordance with Article 13(3) of Implementing Regulation No 844/2012.

21      On 6 November 2017, EFSA sent a request for additional information to the applicant and set a deadline of one month to provide that information, pursuant to Article 13(3) of Implementing Regulation No 844/2012. Amongst that information, EFSA requested the applicant to produce:

–        an Ames test performed with the technical material of ethoprophos, in accordance with Good Laboratory Practice (‘GLP’) and the guidelines of the Organisation for Economic Co-operation and Development (OECD) (‘the new Ames test’);

–        an in vitro micronucleus test with the ethoprophos technical material, in compliance with GLP and OECD guidelines; and

–        an in vitro study of the potential in vitro genotoxic mode of action, including its clastogenic potential and in vivo relevance.

22      On 5 December 2017, in response to EFSA’s request to provide the tests referred to in paragraph 21 above, the applicant provided an Ames study which it had available, together with an expert opinion.

23      On 17 May 2018, EFSA adopted its conclusions on whether ethoprophos was likely to meet the approval criteria laid down in Article 4 of Regulation No 1107/2009 (‘the EFSA conclusions’). In those conclusions, it expressed several concerns and in particular a critical concern related to the impossibility of excluding a genotoxic and clastogenic potential.

24      On 18 May 2018, EFSA communicated its conclusions to the Commission. On the same day, the applicant received four documents from EFSA: the overall report containing the EFSA conclusions, the list of reference values, the peer review report, containing inter alia the reporting table and the evaluation table, and the renewal assessment report (‘the RAR’).

25      The Commission subsequently invited the applicant to comment on the EFSA conclusions. The applicant replied on 8 June 2018.

26      On 28 June 2018, the Commission and the applicant met, at the applicant’s request, to discuss the EFSA conclusions.

27      On 17 July 2018, the Commission sent the applicants its draft renewal report in which it proposed not to renew the approval of ethoprophos. Furthermore, in accordance with the third subparagraph of Article 14(1) of Implementing Regulation No 844/2012, it invited the applicant to submit its comments on that draft by 31 July 2018. At the request of the applicant, the deadline was extended to 17 August 2018.

28      On 17 August 2018, the applicant submitted its observations.

29      On 22 October 2018, the applicant provided the Commission with additional data.

30      On 21 January 2019, the applicant sent a letter to the Commission expressing its concerns about the decision-making process relating to ethoprophos. In that letter, the applicant pointed out that it had not been notified of the Commission’s draft implementing regulation concerning the non-renewal of the approval of ethoprophos for comment. It also noted that it had presented strong evidence that ethoprophos was not a genotoxic substance and asked the Commission to confirm that the additional data submitted on 22 October 2018 had been duly taken into account in the evaluation of ethoprophos. Finally, it asked the Commission to carry out a market analysis before proceeding with any vote on that substance.

31      In response, on 23 January 2019, the Commission informed the applicant that the approval of ethoprophos could not be renewed on the grounds that the genotoxicity assessment could not be finalised, as the equivocal gene mutations and positive clastogenic effects observed in vitro had been followed by in vivo studies of limited reliability, but with equally equivocal and positive results. Furthermore, it stated that no tests to exclude aneugenic potential had been provided and that new data could not be considered at that stage.

32      On 24 January 2019, the applicant replied to the Commission requesting the suspension of the renewal procedure for ethoprophos until the relevant data showing the absence of genotoxicity of that substance have been duly assessed.

33      On 25 January 2019, the Commission adopted its final renewal report. On the same day, Member States voted unanimously in the Standing Committee to give a favourable opinion on the draft Commission implementing regulation on the non-renewal of the approval of ethoprophos.

34      On 28 February 2019, the Commission adopted Implementing Regulation (EU) 2019/344 concerning the non-renewal of approval of the active substance ethoprophos, in accordance with Regulation No 1107/2009, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ 2019 L 62, p. 7) (‘the contested implementing regulation’).

35      Recitals 8 to 12 of the contested implementing regulation set out the reasons for the non-renewal as follows:

‘(8)      On 18 May 2018 [EFSA] communicated to the Commission its conclusion on whether ethoprophos can be expected to meet the approval criteria provided for in Article 4 of [Regulation No 1107/2009].

(9)      [EFSA] identified specific concerns. In particular, it was not possible to conclude on the genotoxic potential of ethoprophos and therefore health-based reference values could not be established. Consequently, the consumer and non-dietary risk assessments could not be conducted. Furthermore, a high acute risk to birds and a high risk to soil dwelling non-target arthropods and soil organisms from the use of ethoprophos were identified. In addition, [EFSA] concluded that several areas of the risk assessment could not be finalised including the consumer assessment with respect to residues in food of plant and animal origin, the assessment of developmental neurotoxicity, the groundwater exposure assessment, the long-term risk to birds, the assessment of secondary poisoning for birds and mammals, the risk to soil organisms from exposure to metabolites of ethoprophos and the risk to earthworms. Finally, [EFSA] concluded that assessment of the endocrine disrupting potential of ethoprophos could not be concluded.

(10)      The Commission invited the applicant to submit its comments on the conclusion of [EFSA] and, in accordance with the third subparagraph of Article 14(1) of [Implementing Regulation No 844/2012], on the draft renewal report. The applicant submitted its comments, which have been carefully examined.

(11)      However, despite the arguments put forward by the applicant, the concerns regarding the active substance could not be eliminated.

(12)      Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product containing ethoprophos that the approval criteria provided for in Article 4 of [Regulation No 1107/2009] are satisfied. It is therefore appropriate not to renew the approval of the active substance ethoprophos in accordance with Article 20(1)(b) of that Regulation.’

III. Procedure and forms of order sought

36      By application lodged on 23 May 2019, the applicant brought the present action.

37      By separate document lodged on 24 May 2019, the applicant lodged an application for interim measures seeking a stay of execution of the contested implementing regulation.

38      By order of 7 November 2019, AMVAC Netherlands v Commission (T‑317/19 R, not published, EU:T:2019:833), the President of the General Court dismissed the application for a stay of execution of the contested implementing regulation and reserved the costs.

39      Since the composition of the Chambers of the General Court has been changed, pursuant to Article 27(5) of the Rules of Procedure of the General Court, the Judge-Rapporteur has been assigned to the Seventh Chamber, to which the present case has consequently been assigned.

40      On 8 September 2020, the Chamber decided to open the oral phase of the proceedings and to invite the parties, as part of the measures of organisation of procedure provided for in Article 89 of the Rules of Procedure, to reply to certain questions, for written answer before the hearing and for oral answer at the hearing. The parties replied within the time limit set.

41      The parties were heard in their pleadings and in their replies to oral questions put by the Court at the hearing on 19 November 2020.

42      The applicant claims that the Court should:

–        annul the contested implementing regulation;

–        order the Commission to pay the costs.

43      The Commission contends that the Court should:

–        dismiss the action;

–        order the applicant to pay the costs.

IV.    Law

44      In support of the action, the applicant relies on five pleas in law, the first alleging manifest errors of assessment, the second alleging failure to respect its rights of the defence, the third alleging breach of the principle of legal certainty, the fourth alleging breach of the principle of proportionality and the fifth alleging breach of the precautionary principle.

A.      Preliminary observations

1.      The scope of the Court’s review

45      According to the case-law, in order to be able to pursue effectively the objectives assigned to it by Regulation No 1107/2009, and in view of the complex technical assessments which it must carry out, the Commission must be granted a broad discretion (see, to that effect, judgments of 18 July 2007, Industrias Químicas del Vallés v Commission, C‑326/05 P, EU:C:2007:443, paragraphs 74 and 75, and of 6 September 2013, Sepro Europe v Commission, T‑483/11, not published, EU:T:2013:407, paragraph 38). That applies, in particular, to the risk management decisions which it has to take pursuant to that regulation.

46      The exercise of that power is not, however, exempt from judicial review. In that regard, it is settled case-law that, in the context of that review, the EU Courts must verify compliance with the procedural rules, the substantive accuracy of the facts adopted by the Commission, the absence of a manifest error in the assessment of those facts or the absence of misuse of powers (judgments of 25 January 1979, Racke, 98/78, EU:C:1979:14, paragraph 5; of 22 October 1991, Nölle, C‑16/90, EU:C:1991:402, paragraph 12; and of 9 September 2008, Bayer CropScience and Others v Commission, T‑75/06, EU:T:2008:317, paragraph 83).

47      As regards the assessment by the EU Courts of the existence of a manifest error of assessment, it should be made clear that, in order to establish that the Commission committed a manifest error in the assessment of complex facts such as to justify the annulment of the contested measure, the evidence adduced by the applicant must be sufficient to render the assessments of the facts contained in the measure implausible (see, to that effect, judgment of 12 December 1996, AIUFFASS and AKT v Commission, T‑380/94, EU:T:1996:195, paragraph 59). Subject to that examination of plausibility, it is not for the Court to substitute its assessment of complex facts for that of the author of the act (judgment of 9 September 2011, Dow AgroSciences and Others v Commission, T‑475/07, EU:T:2011:445, paragraph 152; see also, to that effect, judgment of 15 October 2009, Enviro Tech (Europe), C‑425/08, EU:C:2009:635, paragraph 47).

48      In addition, it should be noted that, in cases where an institution has a wide discretion, it is of fundamental importance to monitor compliance with the guarantees conferred by the EU legal order in administrative procedures. The Court has had occasion to state that those guarantees include the obligation of the competent institution to examine carefully and impartially all the relevant factors of the case and to give adequate reasons for its decision (judgments of 21 November 1991, Technische Universität München, C‑269/90, EU:C:1991:438, paragraph 14; of 7 May 1992, Pesquerias De Bermeo and Naviera Laida v Commission, C‑258/90 and C‑259/90, EU:C:1992:199, paragraph 26; and of 6 November 2008, Netherlands v Commission, C‑405/07 P, EU:C:2008:613, paragraph 56).

49      Thus, it has been held that a scientific risk assessment carried out as thoroughly as possible on the basis of scientific advice founded on the principles of excellence, transparency and independence is an important procedural guarantee whose purpose is to ensure the scientific objectivity of the measures adopted and preclude any arbitrary measures (judgment of 11 September 2002, Pfizer Animal Health v Council, T‑13/99, EU:T:2002:209, paragraph 172).

2.      The burden of proof

50      Article 4(1) of Regulation No 1107/2009, which sets out the conditions for the approval of active substances, requires that it must be ‘expected’ that plant protection products containing an active substance comply with the conditions set out in paragraphs 2 and 3 of that article. The latter paragraphs, in turn, require that such products and their residues comply with the conditions set out thereafter (namely, that they have no harmful effects on human or animal health or unacceptable effects on the environment). In accordance with the principle that it is for the party relying on a legal provision to prove that the conditions for its application are met, it follows from those formulations that it is the applicant who must prove that the conditions for approval are met, in order to obtain approval, and not the Commission which must prove that the conditions for approval are not met in order to be able to refuse it (judgment of 17 May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph 88).

51      The principles set out in paragraph 50 above are applicable in the context of the procedure for the renewal of the approval of an active substance.

52      It is in the light of those considerations that it is appropriate to examine the pleas in law referred to in paragraph 44 above, looking successively at the second plea in law, alleging failure to observe the rights of the defence, the third plea in law, alleging breach of the principle of legal certainty, the first plea in law, alleging manifest errors of assessment, the fourth plea in law, alleging breach of the principle of proportionality, and the fifth plea in law, alleging breach of the principle of precaution.

B.      The second plea in law, alleging failure to respect the rights of the defence

53      The applicant submits at the outset that the second plea in law must be examined in the light of the principle which requires that any person against whom a decision adversely affecting him or her may be taken must be given the opportunity to make his or her views known in a meaningful way concerning the factors on which the Commission relied as a basis for the contested decision. It is of the opinion that the procedure for renewing the approval of an active substance such as ethoprophos necessarily affects the interests of the parties concerned and thus, in the present case, its own. Consequently, it is clearly not one that is only legislative and in which there would, admittedly, be limited, if any, rights of the defence.

54      The applicant considers, in essence, that, in the context of the procedure for the renewal of the approval of ethoprophos, the Commission breached its rights of the defence with regard, firstly, to the possible bias of the Commission at the meeting of 26 June 2018, secondly, to the assessment of the genotoxicity of ethoprophos, thirdly, to the alleged failure to take into account expert opinions and reports on incidents involving wild animals and, fourthly, to its arguments which were allegedly rejected by the Commission’s letter of 23 January 2019.

55      The Commission contests the applicant’s arguments.

56      It should be noted that respect for the rights of the defence in any procedure initiated against a person and likely to result in a measure adversely affecting him or her constitutes a fundamental principle of EU law which must be ensured even in the absence of any rules concerning the procedure. That principle requires that the addressees of decisions which significantly affect their interests be given the opportunity to make their views known in a meaningful way (see, to that effect, judgment of 15 June 2006, Dokter and Others, C‑28/05, EU:C:2006:408, paragraph 74 and the case-law cited).

57      By contrast, in the case of acts of general application, neither the process of their preparation nor the acts themselves require, under the general principles of EU law, such as the right to be heard, consulted or informed, the participation of the persons affected. That is not the case if an express provision of the legal framework governing the adoption of that act confers such a procedural right on an affected person (see judgment of 19 December 2019, Probelte v Commission, T‑67/18, EU:T:2019:873, paragraph 87 and the case-law cited).

58      Furthermore, it has been held that measures approving, extending or renewing the approval of active substances adopted on the basis of Regulation No 1107/2009 are of general application (see, to that effect, judgment of 27 September 2018, Mellifera v Commission, T‑12/17, EU:T:2018:616, paragraph 71).

59      In the present case, the contested implementing regulation relates to the non-renewal of the approval of ethoprophos, in accordance with Regulation No 1107/2009, and that implementing regulation is not addressed to the applicant. Therefore, that implementing regulation must be considered to be an act of general application.

60      In that context, the procedural rights enjoyed by the applicant in the context of the procedure for renewal of the approval of ethoprophos are those explicitly provided for by Regulation No 1107/2009 laying down general provisions relating, in particular, to the procedure for renewal of the approval of an active substance, and by Implementing Regulation No 844/2012 laying down specific provisions relating to the implementation of the procedure for renewal of the approval of an active substance.

61      In particular, as regards the applicant’s rights to be heard during the evaluation of the renewal of the approval of an active substance, it follows from Implementing Regulation No 844/2012 that the applicant may submit comments, first, on the draft RAR (Article 12(3)) and, second, on the Commission’s renewal report (third subparagraph of Article 14(1)).

62      It follows from Article 12(1) and (3) of Implementing Regulation No 844/2012 that EFSA is to communicate to the applicant and to the other Member States, no later than 30 days after receiving it, the draft RAR forwarded to it by the RMS and to allow written comments to be submitted for a period of 60 days from the date on which the report is made available to the public. In the present case, it is common ground that the applicant was given the opportunity to submit its comments on the draft RAR in accordance with Article 12(3) of that implementing regulation (see paragraph 18 above).

63      According to the third subparagraph of Article 14(1) of Implementing Regulation No 844/2012, the applicant is given the opportunity to submit comments on the renewal report within 14 days. The applicant was given that opportunity and made use of it, as is apparent from paragraphs 27 and 28 above.

64      In accordance with Articles 11(5) and 13(3) of Implementing Regulation No 844/2012, the applicant may also be requested to submit additional information if the RMS or EFSA considers it necessary. As indicated in paragraphs 21 and 22 above, the applicant, on 5 December 2017, submitted such information in response to EFSA’s invitation of 6 November 2017.

65      In addition, as indicated in paragraphs 19, 25 and 26 above, the applicant was given the opportunity, firstly, to react to the comments received on the draft RAR, secondly, to comment on the EFSA conclusions and, thirdly, to participate in a meeting with the Commission to discuss those conclusions.

66      Firstly, as regards the possible bias of the Commission at the meeting of 26 June 2018, it must be noted that that meeting took place at the request of the applicant in order to discuss the EFSA conclusions, on which it had previously had the opportunity to comment on 8 June 2018 (see paragraph 25 above). However, as is clear from the Court’s observations in paragraphs 56 to 64 above, in the context of the procedure for the renewal of the approval of ethoprophos, the Commission is not required, under the rules applicable in the present case, either to hear the applicant on the EFSA conclusions or to organise a meeting to discuss them. Consequently, the applicant’s argument that the Commission was biased at the meeting of 26 June 2018 is inoperative.

67      Secondly, the applicant considers that it was not given sufficient opportunity to defend its position since the genotoxicity concern was only raised in relation to ethoprophos at the end of the peer review procedure. It alleged that EFSA had given it insufficient time to carry out a new Ames test and that the Commission had failed to take into account the results of that new test, which were communicated to the Commission on 17 August 2018 in provisional form and on 22 October 2018 in final form.

68      First of all, it appears from the Ethoprophos Peer Review Report of May 2018 and, more specifically, from the reporting table dated 31 October 2017 (see paragraphs 18 and 19), that during the peer review procedure, Member States disagreed with the RMS’s opinion that the studies submitted by the applicant in the framework of its renewal dossier were sufficient to exclude the genotoxic potential of ethoprophos. Furthermore, EFSA questioned the quality and completeness of the data provided by the applicant on genotoxicity and strongly recommended the applicant to perform a new GLP-compliant Ames test. In response to those observations, the applicant commented on the genotoxicity of ethoprophos. It can be seen from column 3 of the reporting table that the applicant was given the opportunity in its comments to defend its position that, first, the studies it had already produced contained convincing data showing that ethoprophos had no genotoxic properties and, second, that no new tests were necessary.

69      Next, it is common ground that EFSA addressed a request for additional information to the applicant and set a deadline of one month to provide that information, pursuant to Article 13(3) of Implementing Regulation No 844/2012, in particular in relation to the genotoxicity of ethoprophos (see paragraph 21 above). In response, the applicant provided the report of the ‘Regulatory Science Associates’ (‘the RSA’), dated 25 November 2017, concerning additional information on mutagenicity, together with a second Ames test performed in 1985 (‘the second Ames test’). In its conclusions, EFSA stated that it was not in a position to draw conclusions as to the genotoxic potential of ethoprophos and thus to establish reference values based on health protection, in particular due to the incompleteness of the Ames tests provided by the applicant (see paragraph 23 above).

70      Furthermore, in its comments of 8 June 2018 on the EFSA conclusions, the applicant expressed surprise at the conclusion concerning the genotoxicity of ethoprophos, on the ground that the genotoxic potential of that active substance had already been assessed in the context of its first approval and that it had been concluded that that hazard was acceptable and did not give rise to concern. In addition, it noted that the genotoxicity of ethoprophos was examined during the renewal procedure in the light of the updated opinion of the EFSA Scientific Committee of 13 September 2011 on the genotoxicity testing strategies applicable to the Food and Feed Safety Agreement, of 16 November 2017, which was dated after the date of submission of the renewal application.

71      In addition, as can be seen from the minutes of the meeting with the Commission on 28 June 2018, at that meeting, the applicant indicated that the RMS had not raised any concerns in that regard in the draft RAR.

72      Finally, it should be noted that, on 17 July 2018, the Commission invited the applicant to submit its comments on the draft renewal report. In response to that invitation, as regards the subject of the genotoxicity of ethoprophos, the applicant, on 17 August 2018, reiterated the procedural comments it had made both in its observations of 8 June 2018 and at the meeting with the Commission on 28 June 2018. In addition, it referred to the availability, in provisional form, of the results of a new Ames test which would be finalised before the end of September 2018 and which already confirmed the absence of concerns regarding the genotoxicity of ethoprophos in vitro.

73      Consequently, the applicant had the opportunity to make meaningful submissions regarding the genotoxicity of ethoprophos at each stage of the procedure triggered by its renewal application, in accordance with Articles 12 and 14 of Implementing Regulation No 844/2012. The fact that the genotoxicity concern had not been raised in relation to ethoprophos in the draft RAR cannot be interpreted as meaning that the applicant’s right to be heard was infringed.

74      As regards the allegedly insufficient time allowed to the applicant to carry out a new Ames test, it should be observed that the additional information, including a new Ames test, was requested by EFSA from the applicant in accordance with Article 13(3) of Implementing Regulation No 844/2012, which provides for a maximum period of one month for the provision of such information. In addition, that provision does not provide for any possibility of extending or suspending that period in the circumstances of the present case. Moreover, contrary to what the applicant suggests, that request for information is in no way linked to the possible intervention of the Commission to request another opinion from EFSA, which would start a new one-month period.

75      It should be added that, as is apparent from paragraphs 68 and 69 above, Member States and EFSA had, in their observations sent to the applicant as early as September 2017, expressed disagreement or doubts about the relevance of the Ames test which the applicant had produced in the context of its renewal application and, more generally, about the data on genotoxicity provided by the applicant. Furthermore, it does not appear from the file, which was in essence also confirmed by the applicant at the hearing, that, in its response to EFSA’s request of 6 November 2017, the applicant, first, drew EFSA’s attention to the inadequacy of the period of one month which it had been given to carry out the requested new Ames test and, second, gave reasons why it would have needed more time in that regard. Finally, it was only after the adoption of the EFSA conclusions, namely in its observations of 8 June 2018, that the applicant indicated for the first time that it had planned to initiate a new Ames test.

76      It follows that, in the context of the analysis of the alleged infringement of the rights of the defence, the applicant’s argument concerning the allegedly insufficient time allowed to carry out a new Ames test must be rejected. As for the applicant’s argument that, in its renewal dossier, it did not have to focus on the question of genotoxicity on the ground that that question had already been dealt with and finalised at the time of the first approval of ethoprophos, it is inoperative in so far as it is formally raised in support of the second plea in law, but will be addressed in the context of the examination of the third plea in law, which alleges infringement of the principle of legal certainty, to which it is in fact linked (see paragraphs 82 to 92 below).

77      As regards the alleged failure to take into account the provisional and final results of the new test, referred to in paragraph 67 above, it is important to note that, on the dates on which the applicant communicated those studies to the Commission, namely 17 August and 22 October 2018, no possibility of submitting new data or additional elements on EFSA’s scientific assessment was open pursuant to Articles 12 and 14 of Implementing Regulation No 844/2012 (see paragraphs 60 to 63 above).

78      Thirdly, as regards the alleged failure of EFSA, and subsequently the Commission, to take into account expert opinions and reports on incidents involving wild animals which would address any concerns about the risk to birds, the risk to non-target soil-dwelling arthropods and soil organisms, as well as the lack of data referred to in the contested implementing regulation, that complaint is inoperative in so far as it is formally raised in support of the second plea in law, but will be dealt with in the context of the examination of the first plea in law, alleging manifest errors of assessment, to which it is in fact related (see, in that regard, paragraphs 121 to 126, 137, 142, 143, 148, 152 to 153, 160 and 167 to 169 below).

79      Finally, fourthly, with regard to the alleged infringement of the rights of the defence by the Commission’s letter of 23 January 2019, the applicant alleges that the Commission indicated that it had taken its observations into account without, however, justifying how it had done so. In the reply, the applicant states on that point that the Commission did not reply to observations concerning, inter alia, the non-genotoxicity of ethoprophos which it had made on several occasions over a period of six months. In that regard, in the light of the finding in paragraph 73 above, the complaint must be rejected in so far as it alleges failure to respect the applicant’s rights of the defence.

80      It follows from the considerations set out in paragraphs 68 to 79 above that the procedure for renewal of the approval of ethoprophos is not vitiated by any irregularity capable of constituting a breach of the applicant’s right to be heard.

81      It follows that the second plea in law must be rejected.

C.      The third plea in law, alleging breach of the principle of legal certainty

82      The applicant claims that the issue of genotoxicity was only raised in respect of ethoprophos at the end of the EFSA peer review procedure, so that in its renewal dossier it did not have to focus on that issue on the ground that it had already been addressed and finalised at the time of the first approval of ethoprophos. It also argues that its arguments on genotoxicity were judged against a guidance document that is later than 2016, the date on which it submitted its data. According to the applicant, the Commission unlawfully allowed EFSA to apply retroactively the updated version of the guidance document on how EFSA assesses genotoxicity. It states that, as that version was published (in 2017) after the submission of the applicant’s dossier (in January 2016), it was not in a position to foresee that change in the approach to the evaluation of ethoprophos.

83      The Commission contests the applicant’s arguments.

84      According to settled case-law, the principle of legal certainty requires that the rules of law be clear, precise and foreseeable in their effects, so that those concerned can find their way in legal situations and relationships falling within the legal order of the European Union (see judgment of 8 December 2011, France Télécom v Commission, C‑81/10 P, EU:C:2011:811, paragraph 100 and the case-law cited; judgment of 31 January 2013, LVK, C‑643/11, EU:C:2013:55, paragraph 51). However, notifiers do not have a general right, arising from that principle, to expect the risk assessment and risk management criteria in respect of an active substance to remain fixed, in the event of a review or renewal, as at the date of the request for approval (see, to that effect, judgment of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 288).

85      It should be observed that, according to Article 114(3) TFEU, on which Regulation No 1107/2009 is based, the Commission, in its proposals in the fields of health, safety, environmental protection and consumer protection made in the context of the approximation of laws having as their object the establishment and functioning of the internal market, takes as a base a high level of protection, taking into account, in particular, any new developments based on scientific facts. Moreover, it has been held that that protection, in particular of public health and the environment, is of overriding importance in relation to economic considerations, so that it is such as to justify negative economic consequences, even considerable ones, for certain operators (see, to that effect, judgments of 9 September 2011, Dow AgroSciences and Others v Commission, T‑475/07, EU:T:2011:445, paragraph 143; of 6 September 2013, Sepro Europe v Commission, T‑483/11, not published, EU:T:2013:407, paragraph 85; and of 12 December 2014, Xeda International v Commission, T‑269/11, not published, EU:T:2014:1069, paragraph 138). It follows from those principles, which form the basis of the general objective of protection of that regulation (see paragraph 4 above), that, unless otherwise indicated, the decisions which the Commission is called upon to take under that regulation must always take account of the most recent scientific and technical knowledge (see, to that effect, judgment of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 289).

86      More specifically, as regards the procedure for renewing the approval of an active substance, those considerations of principle are expressed, first, in Article 2(2) of Implementing Regulation No 844/2012. As noted in paragraph 4 above, that provision provides that the application for renewal must contain the list of new information that the applicant intends to submit and that is necessary, in accordance with the first subparagraph of Article 15(2) of Regulation No 1107/2009. It follows from the latter provision that the need for the new information is demonstrated, in particular with regard to data requirements or criteria which did not apply at the time of the last approval of the active substance.

87      Second, as regards the supplementary dossiers submitted for renewal, recital 8 of Implementing Regulation No 844/2012 provides that such dossiers must include, inter alia, new data requirements and new risk assessments. In that respect, it follows from Article 7 of that implementing regulation, which provides for the content of the supplementary dossiers, that the dossier should take into account, inter alia, changes in legal requirements since the approval or last renewal of the approval of the active substance concerned as well as changes in scientific and technical knowledge since the approval.

88      In the present case, firstly, it should be noted that, in the rejoinder, the Commission explained, with regard to genotoxicity, without being contradicted by the applicant, that the latter did not submit any new studies when it applied for renewal, but merely relied on the studies submitted with the dossier which had been submitted in order to obtain the initial approval. In that regard, the introduction to the part of the RAR dealing with genotoxicity is worded as follows:

‘Please refer to original EU dossier for summaries of studies carried out as part of the submission for Annex 1 inclusion in 2002. The critical information obtained from those studies is taken from the [draft assessment report] (2004) and the EFSA conclusions (2006) and summarised in the table below. No further studies, data or assessments are provided to address genotoxicity’.

89      Secondly, it should be noted that, in 2011, that is to say before the applicant submitted its renewal dossier in January 2016, the EFSA Scientific Committee had adopted an opinion on genotoxicity testing strategies applicable to food and feed safety assessments. In that opinion, that scientific committee reviewed the current state of science on genotoxicity testing and provided commentary and recommendations on genotoxicity testing strategies. In particular, it indicated that a stepwise approach was recommended for the generation and evaluation of data on genotoxic potential, starting with a core battery of in vitro tests, including a bacterial reverse mutation assay and an in vitro micronucleus test.

90      Thirdly, the EFSA Scientific Committee opinion of 2011 referred to the relevant OECD guidelines which provided for the inclusion of TA 102 or E. coli strains in the Ames test in order to better detect cross-linking and oxidising agents. It is apparent from the evidence in the file that the first Ames test, carried out in 1985, did not take into account the 1997 update of the OECD guidelines, in particular to include TA 102 or E. coli strains to better detect cross-linking and oxidising agents.

91      It is against that legal and factual background, firstly, that Member States and EFSA, in their submissions to the applicant in September 2017, disagreed with or expressed doubts about the adequacy of the first Ames test and the genotoxicity data on which the applicant relied in its renewal application, secondly, that EFSA requested a new Ames test from the applicant and, thirdly, that EFSA considered that it was not possible to draw conclusions on the genotoxic potential of ethoprophos.

92      Thus, it must be considered that the applicant could reasonably expect that it would have to focus specifically, in its renewal dossier, on the genotoxicity of ethoprophos, in accordance with Article 2(2) of Implementing Regulation No 844/2012 and, in particular, that it would have to provide a new Ames test.

93      Admittedly, in its conclusions, EFSA refers to the document of its Scientific Committee entitled ‘Scientific Opinion on the clarification of some aspects related to genotoxicity’, which was published in 2017, namely, after the submission of the applicant’s dossier in January 2016.

94      However, firstly, it is not disputed that the document in question did not introduce any new test elements and therefore had no influence on the finding that it had not been possible to draw any conclusions as to the genotoxic potential of ethoprophos on the basis of the information which had been provided by the applicant in its renewal application dossier. It appears from the dossier that it is the opinion of the EFSA Scientific Committee of 2011 and not that of 2017 that required a new Ames test and, more generally, new data on the genotoxicity of ethoprophos.

95      Secondly, the applicant does not specify what new elements were introduced in the updated version in 2017, as compared to the document published in 2011, which it could not have foreseen before submitting its application for renewal concerning the genotoxicity of ethoprophos.

96      Thirdly, the Commission demonstrated that the only additional guidance contained in that document which was relevant in the case of ethoprophos, namely that reference values should not be established if genotoxic potential could not be excluded, merely confirmed EFSA’s previous practice. In that respect, it explained, inter alia, that more than a year before the applicant submitted its application for renewal of the approval of ethoprophos, EFSA had already, in the context of the examination of an application submitted by the applicant for another substance, considered that no reference value could be determined in view of the limited data set and the existence of positive results for genotoxicity.

97      The third plea in law must therefore be rejected.

D.      The first plea in law, alleging manifest errors of assessment

98      First, the applicant considers that the Commission committed a manifest error of assessment by reporting three specific concerns, namely the genotoxicity concern, the high acute risk to birds and the high risk to non-target soil-dwelling arthropods and soil organisms.

99      Second, the applicant considers that the Commission committed a manifest error of assessment in concluding that the assessment of certain specific issues could not be finalised in the context of the evaluation of ethoprophos. It submits that there were no data gaps with regard to the consumer risk assessment, the developmental neurotoxicity assessment, the groundwater exposure assessment, the long-term risk to birds, the assessment of secondary poisoning of birds and mammals and the risk to soil organisms resulting from exposure to ethoprophos metabolites, the risk to earthworms and the endocrine disrupting potential.

100    The Commission contests the applicant’s arguments.

1.      The specific concerns reported

(a)    The genotoxicity concern

101    The applicant states that, by concluding, in recital 9 of the contested implementing regulation, that it was not possible to draw conclusions as to the genotoxic potential of ethoprophos and, therefore, to establish reference values based on health protection, the Commission did not take into account, first, the comments it had submitted to EFSA on 5 December 2017 and to the Commission itself on 8 June 2018, which were based on an expert opinion that the genotoxic potential of ethoprophos could be excluded. Second, the Commission did not take into account the results of the new Ames test and the in vitro micronucleus study carried out by the applicant, both in their provisional form, submitted to the Commission in August 2018, and in their final form, submitted in October 2018. In support of those allegations, the applicant invokes the Commission’s letter of 23 January 2019, in which the Commission merely states that ‘the studies provided do not address the EFSA conclusions which states that robust in vivo follow-up is also necessary’.

102    In the reply, the applicant adds, in essence, that the final peer review report does not contain any reference to the review that had been carried out by its experts and provided to EFSA in December 2017. In addition, the Commission makes no reference to two studies submitted by the applicant, one to EFSA on 4 December 2017 and the other together with its comments on the draft renewal report on 17 August 2018.

103    The Commission contests the applicant’s arguments.

(1)    The alleged failure of the Commission to take into account the comments submitted by the applicant to EFSA on 5 December 2017

104    It appears from the applicant’s observations of 5 December 2017 that it provided EFSA with the RSA report of 25 November 2017 concerning additional information on mutagenicity. That report was submitted by the applicant in response to point 4 of EFSA’s request of 6 November 2017 to produce certain tests regarding the genotoxic potential of ethoprophos. According to the dossier, that report was produced in conjunction with the second Ames test.

105    As stated by the Commission, it appears from the peer review report on ethoprophos and, more specifically, from the evaluation table, dated 17 May 2018, that the additional information provided by the applicant was taken into account during the expert consultation and that data gaps and a critical concern were identified.

106    As regards the second Ames test produced by the applicant in December 2017, it should be noted that, as the Commission states, it is apparent from the minutes of a peer review meeting held from 19 to 22 February 2018 that that test was flawed in the same way as the one already included in the dossier.

107    Furthermore, as the Commission notes, EFSA explained in its conclusions that:

–        the genotoxic potential of ethoprophos could not be concluded based on incomplete investigations in bacterial cells (strains sensitive to cross-linking and oxidising mutagens, TA 102 and Escherichia coli WP2 strain were not investigated);

–        equivocal in vitro results in gene mutation in mammalian cells and positive clastogenic effects in vitro could not be ruled out with robust in vivo assays;

–        one of the in vivo studies (presenting shortcomings such as a low number of cells investigated) presented an increased chromosomal exchange which reflects the results observed in vitro;

–        one of the two tests in germ cells (of limited reliability) produced positive results (in relation to clastogenic effects);

–        on top of the clastogenic potential identified, the aneugenic potential has not been investigated (data gap).

108    The evidence put forward by the applicant does not allow it to be considered that the Commission committed a manifest error of assessment in concluding, after examining the second Ames test and the RSA report provided in conjunction with that test, that it was not possible to draw any conclusions as to the genotoxic potential of ethoprophos and, consequently, to establish reference values based on the protection of health (see recital 9 of the contested implementing regulation).

109    That conclusion cannot be called into question by the applicant’s claim that the RSA report was prepared by two independent experts explaining why a new Ames test requested by EFSA in its request for additional information was not necessary.

110    The mention of the existence of the RSA report, its authors, and its conclusions, without further clarification or explanation, is insufficient to deprive the Commission’s assessment, based on the EFSA conclusions, of plausibility.

111    In the light of the foregoing, the applicant’s argument that the Commission failed to take account of its observations submitted in response to EFSA’s request for additional information of 6 November 2017 cannot succeed.

(2)    The alleged failure of the Commission to take into account, first, the observations submitted by the applicant on 8 June 2018 and, second, the results of the Ames study and the in vitro micronucleus study, both in their provisional form, submitted in August 2018, and in their final form of October 2018

112    In the first place, with regard to the comments of 8 June 2018 on the EFSA conclusions, the applicant stated, in relation to the concern relating to the genotoxicity of ethoprophos, that, in accordance with those conclusions, it would carry out, as from June 2018, a new Ames test and a new in vitro gene mutation study. It added that their provisional results would be available in the middle of August 2018. It did not refer to any other expert opinion or recent studies regarding the genotoxicity concern of ethoprophos. By contrast, it invoked an infringement of the principle of legal certainty (see paragraphs 82 to 97 above).

113    In the second place, with regard to the results of the Ames study and the in vitro micronucleus study both in their provisional form, presented in August 2018, and in their final form of October 2018, the following findings should be made.

114    First, it should be noted that, on the dates on which the applicant communicated those studies to the Commission, namely 17 August and 22 October 2018, no possibility of submitting new data or additional elements on EFSA’s scientific assessment was open under Articles 12 and 14 of Implementing Regulation No 844/2012 (see paragraph 77 above).

115    Second, it should be noted that, on 23 January 2019, the Commission informed the applicant that, even if the new data produced by the latter were taken into account, the approval of ethoprophos could not be renewed on the ground that the assessment of genotoxicity could not be finalised, since the equivocal gene mutations and positive clastogenic effects observed in vitro had been followed by in vivo studies which were of limited reliability, but whose results were also equivocal and positive. In addition, the Commission indicated that no tests to exclude aneugenic potential had been provided (see paragraph 31 above).

116    Thus, the Commission was under no obligation to take into consideration the new data produced by the applicant on 17 August and 22 October 2018. In any event, it took into consideration the new data produced by the applicant. It considered, in essence, that they were not sufficient to dispel the concerns expressed by EFSA. In the light of the evidence in the dossier, that assessment does not appear to be manifestly erroneous.

(3)    Conclusion

117    In the light of the foregoing, the applicant has not adduced sufficient evidence to render implausible the assessment that it was not possible to draw conclusions as to the genotoxic potential of ethoprophos and thus to establish reference values based on health protection.

(b)    The high acute risk to birds

118    The applicant considers that the Commission failed to examine exposure to ethoprophos in the real context of the use of that substance, having regard to the scientifically available and valid ecotoxicological data presented to it.

119    According to the applicant, the Commission also failed to take into account relevant information and data. In that regard, it relies, first, on detailed higher-level bird monitoring studies carried out in Italy and the United Kingdom, which showed no effect on birds, and, second, a new study on the reproduction of bobwhite quail, submitted during the approval procedure for ethoprophos under Directive 91/414, which led to the first approval of the substance in 2007. It also states that the acceptable risk to birds is confirmed both by the long history of ethoprophos without any reported incidents and by the lack of changes in the guidelines for the conduct of the studies and in the guidance document for the risk assessment of birds since the previous evaluation of ethoprophos.

120    The Commission contests the applicant’s arguments.

121    In the first place, it is necessary to consider whether, in the present case, the Commission has taken into account the higher-level bird monitoring studies carried out in the United Kingdom and Italy, which were communicated to it on 17 August 2018.

122    It should be noted that the applicant refers in that regard to the following three studies: first, the study by Nikolakis, A. and Deutsch, M., of 2005, ‘Avian field study on freshly planted, Mocap 10G and Non-Mocap treated potato fields in Great Britain’, Bayer CropScience AG, Laboratory No NAX/AF 01-2005 (‘the Nikolakis study’); secondly, the study by Sotti, F. and Elipe, R.S., of 2014, ‘Monitoring of birds on potato fields treated with Mocap 10G in Italy’, Tier 3 Solutions GmbH, Laboratory No B13072 (‘the Sotti study’), and, thirdly, the study by Benito, M.M. and Elipe, R.S., of 2015, ‘Monitoring of birds on potato fields treated with Mocap 15G in UK’, Tier 3 Solutions GmbH, Laboratory No B14054 (‘the Benito study’).

123    It appears from the file that the Nikolakis, Sotti and Benito studies were considered in the context of the ethoprophos renewal. First, as stated by the Commission, it appears from the reporting table in the EFSA peer review report that the experts discussed the implications of those studies on the risk assessment for birds. Second, regarding the Benito study, as also indicated by the Commission, it appears from the RAR that the experts agreed that ‘the available data were not sufficient to address the identification of a proper focal species for southern Europe’.

124    The applicant also alleges that the discussion during the expert consultation on the three studies at issue focused exclusively on the choice of focal species for southern Europe, so that the experts did not take into account qualitative arguments, such as, for example, the time of application at a bare field which is not attractive to birds.

125    However, even if it were the case that the experts did not take into account the time of application of ethoprophos at a bare field which is not attractive to birds, the applicant does not provide any explanation which would make it possible to identify the manifest error committed by the Commission in that respect. As was pointed out in paragraph 47 above, subject to an examination of the sufficiency of the evidence adduced by the applicant to render the assessments of the facts contained in the measure implausible, it is not for the Court to substitute its assessment of complex facts for that of the author of the measure (see paragraph 47 above).

126    In the light of the foregoing, the applicant’s complaint that the studies referred to in paragraph 122 above were not taken into consideration must be rejected.

127    In the second place, it has to be examined whether the Commission committed a manifest error of assessment when it came to a different conclusion than in the first approval of ethoprophos in the European Union with regard to the evaluation of the bobwhite quail study (Temple, D., Frey, L.T., Martin, K.H., Beavers, J.B. and Jaber, M., Ethoprophos: A Reproduction Study with the Northern Bobwhite using a Shortened Exposure Period, Wildlife International Ltd., 2006, Report No M-257246-01-1, project No 149-205; ‘the bobwhite quail study’).

128    It is common ground that the bobwhite quail study was carried out in 2006 under the OECD Guidelines for Testing of Chemicals (1984), Test No 206: Birds, Breeding Test (‘the 1984 OECD Guidelines’). As the applicant states, in the context of the assessment of the confirmatory information requested in 2007 concerning ethoprophos, EFSA, in 2013, found that that study had been carried out on the basis of a modified test design, according to which the birds had been exposed for a shorter period (seven weeks) than that recommended in the 1984 OECD Guidelines (10 weeks). It follows, as the Commission rightly pointed out at the hearing, that that study was not consistent in that respect with the guidelines at issue. Therefore, even if EFSA had considered in 2013 that the bobwhite quail study was ‘suitable for regulatory risk assessment’ and even if ethoprophos had been approved in 2013, the applicant knew that, at the time of the latter approval, the study in question had been found to be non-compliant. In those circumstances, it could reasonably foresee that the bobwhite quail study might be subject to a new assessment in the context of the procedure for the renewal of the ethoprophos, so that, by submitting a new application, the applicant had to submit a new study which complied with the regulations in force. Consequently, the Commission cannot be criticised for having reached a different conclusion with regard to the assessment of the bobwhite quail study in the context of the procedure for the renewal of the approval of ethoprophos from that reached in its first approval in the European Union.

129    In any event, it does not appear from the dossier that the bobwhite quail study was the sole basis on which ethoprophos was not renewed because of the existence of the high acute risk to birds. In so far as the applicant’s claim that certain relevant information and data examined were not taken into account was rejected (see paragraph 126 above), a possible error by the Commission in the assessment of the bobwhite quail study does not allow a finding that the Commission committed a manifest error of assessment when it relied on a high acute risk to birds resulting from the use of ethoprophos.

130    In the light of the foregoing, the applicant has not adduced sufficient evidence to render implausible the assessment that there was a high acute risk to birds resulting from the use of ethoprophos.

(c)    High risk to non-target soil-dwelling arthropods and soil organisms

131    The applicant complains that the Commission did not consider sufficient the studies on aged residues concerning two soil organisms and a field study, which were nevertheless considered admissible in the first approval procedure for ethoprophos. It pointed out that the applicable guidance document on terrestrial ecotoxicology had not changed since 2002. Furthermore, there are no other higher-level studies available to assess the risk to non-target soil-dwelling arthropods.

132    The applicant also states that the 2002 guidance document on terrestrial ecotoxicology recommends that a study be carried out on the contents of a litter bag in order to assess the effects of a substance from a biological point of view under real conditions. It added that the study carried out in 2006 and submitted for evaluation in the framework of the renewal of ethoprophos showed acceptable risks to soil organisms, which were recognised by an independent expert opinion and scientific argumentation, communicated by it to the Commission on 17 August 2018.

133    The Commission contests the applicant’s arguments.

134    In the present case, it is common ground that, at the time of the first approval of ethoprophos in 2007, the Commission did not consider that there was a risk to non-target soil-dwelling arthropods and soil organisms, whereas, in the context of the renewal procedure for ethoprophos, EFSA and the Commission, in 2018 and 2019 respectively, concluded that such risks existed. The parties do not dispute that the same guidance document on terrestrial ecotoxicology (SANCO/10329/2002 final), was applicable in the initial approval procedure and in the renewal procedure of that active substance to assess the risks to non-target soil-dwelling arthropods and soil organisms.

135    However, at the hearing, the applicant argued, in essence, that, at the time of the first approval in 2007, the study on the contents of a litter bag, carried out in 2006, had not initially been examined by the RMS for that procedure, namely, the United Kingdom of Great Britain and Northern Ireland. It states that that study was subsequently referred to in the EFSA conclusions of 2006 which noted that, since that study had not been evaluated, no definitive conclusions could be drawn. In addition, it states that the guidance document on terrestrial ecotoxicology of 2002, referred to in paragraph 134 above, recommends that a litter bag study be conducted to demonstrate that there is no effect on soil organisms.

136    In so far as, first, the performance of a study on the contents of a litter bag had been recommended in the applicable guidance document in order to demonstrate that there was no effect on organisms living in the soil and, second, such a study had not been evaluated at the time of the first approval of ethoprophos in 2007, the applicant cannot rely on the absence of valid scientific grounds justifying a different conclusion in 2018 from that reached in 2007.

137    As regards the assessment of the study on the contents of a litter bag, carried out in 2006 and examined in the context of the procedure for the renewal of ethoprophos, the Commission states, without being challenged by the applicant, that the RMS and the experts agreed that that study could not be used to refine the assessment of soil organisms. The opinions of other experts referred to by the applicant for the purpose of demonstrating the appropriateness of the study in question with a view to concluding that there is an acceptable risk to non-target soil-dwelling arthropods and soil organisms do not allow the Commission to be held to have committed a manifest error of assessment in that regard.

138    In the light of the foregoing, the applicant has not adduced sufficient evidence to render implausible the assessment that there was a high risk to non-target soil-dwelling arthropods and soil organisms from the use of ethoprophos.

2.      The lack of data

(a)    Consumer risk assessment

139    In the context of the consumer risk assessment, the applicant complains that EFSA and the Commission did not take into account, first, a report by ‘ENVIGO’ which it submitted in response to points 23 and 24 of EFSA’s request for additional information of 6 November 2017, which related to ethoprophos residues, and, second, a statement by ‘Freedlander (2018). Ethoprophos – Response to draft renewal report, Ecological Position Statements. Ref. RAD-2018-062, AMVAC Chemical Corporation, USA’, submitted to the Commission together with comments on the draft renewal report concerning ethoprophos.

140    The Commission contests the applicant’s arguments.

141    First, it should be noted that, as is apparent from recital 9 of the contested implementing regulation, EFSA reported that it had not been possible to draw conclusions as to the genotoxic potential of ethoprophos and thus to establish reference values based on health protection. Consequently, the consumer risk assessment and the non-food risk assessment could not be carried out. However, the applicant has not provided sufficient evidence to render implausible the assessment that it was not possible to draw conclusions as to the genotoxic potential of ethoprophos and thus to establish reference values based on health protection (see paragraph 117 above).

142    Next, as the Commission indicated at the hearing, it appears from the EFSA peer review report on ethoprophos that the ‘ENVIGO’ report, submitted by the applicant in December 2017, was evaluated by the RMS. According to the information submitted by the RMS (column B) after the comments submitted on the draft RAR pursuant to Article 12 of Implementing Regulation No 844/2012 (column A), the latter report had been included in Volume 3 of the RAR. Furthermore, according to that EFSA peer review report, EFSA concluded that there was a lack of data (column E).

143    Finally, as regards the expert statement relied on by the applicant and intended to challenge EFSA’s proposal to add ethyl phosphate to the definition of residues, it is not capable of calling into question the finding that the assessment of the risks to consumers arising from residues in foodstuffs of plant and animal origin could not be finalised.

144    Consequently, the applicant has not adduced sufficient evidence to render implausible the finding that the assessment of the risks to consumers arising from residues in foodstuffs of plant and animal origin could not be finalised.

(b)    Assessment of developmental neurotoxicity

145    The applicant claims that EFSA did not request any additional information to assess developmental neurotoxicity and that the existence of data gaps on developmental neurotoxicity was raised after the expert consultations and first appeared in the EFSA conclusions. It also refers to its letter of 8 June 2018 and its comments of 17 August 2018 on the draft renewal report to demonstrate that it reminded the Commission of the existence of available studies to address the question of developmental neurotoxicity, which the Commission did not take into consideration.

146    The Commission contests the applicant’s arguments.

147    In the present case, as the Commission states, it appears from the EFSA peer review report on ethoprophos and, more specifically, from the evaluation table, that developmental neurotoxicity was assessed in expert discussions. Furthermore, the applicant does not contest that it had the opportunity to respond to the comments made in that respect before the adoption of the EFSA conclusions. Nor does it allege that, as such, the issue of developmental neurotoxicity was raised for the first time during EFSA’s assessment of that question.

148    As regards the applicant’s observations of 8 June 2018 and 17 August 2018, it should be noted that, in the application, the applicant confines itself to recalling, without further clarification, that, in those observations, it pointed out that there were studies available and that those studies had not been taken into account. Such imprecise allegations are not capable of calling into question EFSA’s findings, taken up by the Commission, concerning the assessment of developmental neurotoxicity.

149    Consequently, the applicant has not adduced sufficient evidence to render implausible the finding that the risk assessment could not be finalised with regard to developmental neurotoxicity.

(c)    Assessment of groundwater exposure

150    In order to demonstrate that the assessment of groundwater exposure could be finalised, the applicant relies on the field leaching studies and higher-level lysimetric studies which were allegedly provided to the Commission in the context of the renewal procedure, and which show that ethoprophos leaches minimally when applied at doses considerably higher than those proposed in the present case. In its view, the fact that the Commission reached a different conclusion necessarily means that it did not take it into account.

151    The Commission contests the applicant’s arguments.

152    In the present case, it appears from the dossier that EFSA, and subsequently the Commission, took into account the available lysimetric studies and the monitoring data. As stated by the Commission, EFSA, in its conclusions, considered that the two available lysimetric studies and the monitoring data suggested that the respective threshold could occasionally be exceeded in vulnerable situations. As the Commission adds, that finding is also reflected in its final renewal report of 25 January 2019.

153    Furthermore, the mere fact that, in August 2018, the applicant pointed out, through its expert, that there were, without further clarification, higher-level lysimetric studies from which it emerged that ethoprophos was subject to maximum leaching when applied at doses considerably higher than those proposed in the renewal dossier is not such as to call into question the findings made by EFSA and the Commission referred to in paragraph 152 above.

154    Consequently, the applicant has not adduced sufficient evidence to render implausible the finding that the risk assessment could not be finalised with regard to groundwater exposure.

(d)    Long-term risk to birds

155    The applicant refers to its arguments on the absence of a high acute risk to birds, which show that there was no lack of data on the long-term risk to birds.

156    In so far as those arguments overlap with those put forward in the context of the first plea in law, namely the absence of a high acute risk to birds, which were rejected in paragraph 130 above, it must be concluded that the applicant has not adduced sufficient evidence to render implausible the finding that it was not possible to carry out a full risk assessment as regards the long-term risk to birds.

(e)    Assessment of secondary poisoning of birds and mammals and risk to soil organisms from exposure to ethoprophos metabolites

157    The applicant states that, on the basis of the publicly available literature, the nature of the soil metabolites can be sufficiently determined so that the assessments of the long-term secondary risk to birds and mammals and the risk to soil organisms resulting from exposure to the metabolites of ethoprophos can be finalised. In addition, it cites a passage in the RAR from which it appears that the RMS considered that the lack of data on the risk to soil organisms from exposure to metabolites could be addressed by submitting confirmatory data, after the renewal of the approval of ethoprophos. In the reply, it also refers to its arguments regarding concerns about the risk to birds and the risk to soil organisms.

158    The Commission contests the applicant’s arguments.

159    As can be seen from the dossier, both the RMS and EFSA identified a data gap regarding risks to soil organisms. In addition, EFSA identified a data gap regarding secondary poisoning of birds and mammals. In its conclusions, EFSA considered, first, that the secondary poisoning of soil metabolites could not be finalised and, second, that it was necessary to carry out the risk assessment of metabolites to birds and mammals.

160    As regards the ‘publicly available literature’ relied on by the applicant to demonstrate that there are no gaps in the data concerning the risks to soil organisms resulting from exposure to metabolites, it must be noted that the applicant cites only one work dated 1977. In that respect, it is sufficient to note, as the Commission stated at the hearing, that it appears from the EFSA peer review report on ethoprophos that the 1977 study was evaluated in the context of the renewal of that active substance and was considered unacceptable.

161    As for the RMS’s proposal regarding the possible submission of confirmatory data, it had not been accepted by either EFSA or the Commission. In that regard, it is important to emphasise that it follows from the second subparagraph of Article 14(1) of Implementing Regulation No 844/2012 that the Commission is not bound by the conclusions of the RMS, even though it must ‘take them into account’ in the preparation of the renewal report which serves as a basis for the contested implementing regulation, just as, moreover, it must take into account the EFSA conclusions. However, such taking into account cannot be interpreted as an obligation on the part of the Commission to follow the conclusions of the RMS in all respects, even though such conclusions are the starting point of the assessment and therefore carry significant weight in that assessment.

162    As regards the applicant’s arguments relating to concerns about the risk to birds and the risk to soil organisms, it is sufficient to note that those arguments were rejected in paragraphs 130 and 138 above.

163    Consequently, the applicant has not adduced sufficient evidence to render implausible the finding that the risk assessment could not be finalised with regard to secondary poisoning of birds and mammals and the risk to soil organisms resulting from exposure to the metabolites of ethoprophos.

(f)    Risk to earthworms

164    The applicant considers that the risk assessment for earthworms could be finalised for two reasons: firstly, a higher-level field study from 2001 demonstrates the full recovery of the earthworm population within one year and, secondly, there is no evidence that the general ecology of the soil was affected by ethoprophos.

165    In the reply, the applicant points out that the expert statement, presented in its response to EFSA’s request for additional information of 6 November 2017, was not mentioned in the final peer review report, that one field study, presented in the original renewal dossier, was assessed individually only for its representativeness and that another field study, also included in the original renewal dossier, was not assessed at all.

166    The Commission contests the applicant’s arguments.

167    First of all, as stated by the Commission at the hearing, it appears from the EFSA conclusions that the experts agreed that the data from the available field studies were not sufficient to demonstrate a potential for recovery of recolonisation given the low numbers of individuals recorded in the studies presented, and in view of other shortcomings. In addition, further information was needed to address the risk to earthworms.

168    Next, as regards, more specifically, a higher-level field study from 2001, it appears from the EFSA peer review report on ethoprophos that, as the Commission stated at the hearing, the experts questioned its representativeness and compliance with the guidance, and that the lack of data had been noted in the RAR.

169    Finally, as regards the applicant’s arguments set out in the reply, it should be noted that the applicant merely mentions, without any further clarification, ‘two acute studies, one chronic, and two field studies’ which were included in the initial renewal dossier, all of which were carried out with the formulated product (granules), as well as ‘an expert opinion [which was] presented in the reply to EFSA’s request for additional information (December 2017)’. Such argumentation is therefore not such as to call into question the finding that the risk assessment could not be finalised with regard to the risk to earthworms.

170    Consequently, the applicant has not adduced any evidence to render implausible the assessment that the risk assessment could not be finalised with regard to earthworms.

(g)    Assessment of endocrine disrupting potential

171    The applicant considers that the Commission should have referred only to the guidance document on endocrine disrupting properties that was in force in January 2016, when the initial assessment for the renewal of the approval of ethoprophos was carried out, and not to the most recent criteria. According to the criteria in force in January 2016, ethoprophos did not show any endocrine disrupting properties.

172    In any event, the applicant points out that it still had the possibility to submit new data in accordance with, first, Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ 2018 L 101, p. 33), and, second, Commission Implementing Regulation (EU) 2018/1659 of 7 November 2018 amending Implementing Regulation No 844/2012 in view of the scientific criteria for the determination of endocrine disrupting properties introduced by Regulation 2018/605 (OJ 2018 L 278, p. 3).

173    The Commission contests the applicant’s arguments.

174    It should be noted that, as regards the assessment of the endocrine disrupting potential of ethoprophos, the applicant does not challenge EFSA’s conclusion that it was unable to carry out that assessment. By contrast, the applicant contests the Commission’s assessment of that potential after the adoption of the EFSA conclusions.

175    As regards the question whether the Commission could apply in the present case more recent criteria than those in force in January 2016, it must be noted, as the Commission stated at the hearing, that the scientific criteria for the determination of endocrine disrupting properties were amended by Regulation 2018/605 and implemented by Implementing Regulation 2018/1659. In that respect, pursuant to Article 2 of that regulation, as rectified, those new criteria applied from 10 November 2018, with an exception in the case of procedures for which the Standing Committee had voted on a draft regulation by 10 November 2018.

176    In the present case, as the Standing Committee adopted the draft of the contested implementing regulation on 25 January 2019, the Commission cannot be criticised for applying the new criteria in force from 10 November 2018, in accordance with Article 2 of Regulation 2018/605.

177    As regards the possibility to submit new data, pursuant to Regulation 2018/605 and Implementing Regulation 2018/1659, concerning the endocrine disrupting potential of ethoprophos, it should be noted that the procedure for the assessment of the endocrine disrupting potential of an active substance, including the possibility to submit new data, is governed by that implementing regulation. As the Commission noted at the hearing, it follows from Article 1(4) of that implementing regulation that, for substances for which EFSA had finalised its evaluation, but for which there had been no vote in the Standing Committee, as in the present case, on 10 November 2018, the Commission, if it considered that additional information was needed to evaluate an active substance in the light of the new criteria for endocrine disrupting properties, could initiate an evaluation of compliance of an active substance with those criteria, in accordance with that implementing regulation. It followed that it was for the Commission to assess the need for additional information in the individual case.

178    In the present case, the Commission explains that, in view of the many other concerns which justified the non-renewal of the approval of ethoprophos, it was appropriate to finalise the process in the interest of the protection of health and the environment, rather than to reach a definitive conclusion on whether or not to approve that active substance on the basis of possible endocrine disrupting properties under the new criteria.

179    In that regard, it should be recalled, as noted in paragraph 45 above, that the Commission is granted a broad discretion in order to be able to pursue effectively the objectives assigned to it by Regulation No 1107/2009, and in view of the complex technical assessments which it must carry out. Furthermore, the applicant does not put forward any specific argument to challenge the Commission’s choice not to assess the endocrine disrupting potential of ethoprophos under the new criteria.

180    In those circumstances, it was without committing a manifest error of assessment that the Commission was able to consider that it was not necessary to request additional information for the purposes of assessing compliance of ethoprophos with the new criteria established by Regulation 2018/605 and implemented by Implementing Regulation 2018/1659 for the determination of endocrine disrupting properties of an active substance.

181    Consequently, the applicant’s complaints concerning the assessment of the endocrine disrupting potential of ethoprophos must be rejected.

182    In view of the foregoing, the first plea in law must be rejected.

E.      The fourth plea in law, alleging breach of the principle of proportionality

183    The applicant submits that the contested implementing regulation is disproportionate, given that the Commission could choose between several measures and that the adoption of that implementing regulation causes excessive inconvenience in relation to the aims sought. It considers that a reasonable option would have been to wait until it provided the Commission with, inter alia, the requested Ames test and in vitro gene mutation study, given that it had announced to the Commission, in its letter of 17 August 2018, that the finalisation of those studies was imminent.

184    The applicant adds that the Commission could, for example, have proposed the renewal of the approval of ethoprophos subject to certain specific conditions, such as the submission of confirmatory data under Article 6(f) of Regulation No 1107/2009. It mentions, as an example, the data regarding groundwater exposure, which could not be fully assessed due to a data gap regarding the rate and route of degradation in soils. It added that in the RAR, the RMS tended to consider the lack of groundwater exposure data as a minor data gap that could be corrected by confirmatory data. In addition, it criticises the Commission for interpreting that provision literally and for failing to take into account the fact that, at the time the file was submitted in 2016, it could not know the ‘data requirements that would be raised a year later’.

185    Furthermore, the applicant is of the opinion that it would clearly be less burdensome for the Commission and for the interests at stake to suspend the renewal procedure than to require it to submit a new application. It invokes the heavy financial burden of preparing a new file to be submitted, as well as the time required for such preparation.

186    The Commission contests the applicant’s arguments.

187    According to settled case-law, the principle of proportionality, which forms part of the general principles of EU law, requires that acts of the institutions of the European Union do not exceed the limits of what is appropriate and necessary to achieve the legitimate objectives pursued by the legislation in question, it being understood that, where there is a choice between several appropriate measures, recourse must be had to the least restrictive and that the inconvenience caused must not be disproportionate in relation to the aims pursued (see judgment of 9 September 2011, Dow AgroSciences and Others v Commission, T‑475/07, EU:T:2011:445, paragraph 279 and the case-law cited).

188    It should also be recalled that the Commission has a wide discretion for the purposes of adopting risk management measures involving complex policy choices and technical assessments (see paragraphs 45 to 49 above). Consequently, only the manifestly inappropriate nature of a measure adopted in that field, in relation to the objective which the Commission intends to pursue, may affect the legality of such a measure (see, to that effect, judgment of 9 September 2011, Dow AgroSciences and Others v Commission, T‑475/07, EU:T:2011:445, paragraph 280 and the case-law cited).

189    In the present case, firstly, it follows from the examination of the first plea in law (see paragraphs 101 to 182 above) that it has not been established that the Commission committed a manifest error of assessment when, in recital 8 of the contested implementing regulation, it relied on the EFSA conclusions that, first, there were specific concerns relating to genotoxicity, the high acute risk to birds and the high risk to non-target soil-dwelling arthropods and soil organisms, and, second, that the risk assessment could not be finalised for ethoprophos due to data gaps in the consumer risk assessment, the developmental neurotoxicity assessment, the groundwater exposure assessment, the long-term risk to birds, the assessment of secondary poisoning of birds and mammals, the risk to soil organisms from exposure to ethoprophos metabolites, the risk to earthworms and the assessment of endocrine disrupting potential.

190    The applicant’s argument focuses on the possibility of providing confirmatory data with regard to genotoxicity and groundwater exposure.

191    Secondly, it should be noted that Article 6 of Regulation No 1107/2009 lays down the conditions and restrictions to which the approval of an active substance may be subject. It follows from Article 6(f) of that regulation that such approval may be made subject to the ‘submission of further confirmatory information to Member States, the Commission and [EFSA], where new requirements are established during the assessment process or as a result of new scientific and technical knowledge’.

192    As regards the lack of data relating to the assessment of groundwater exposure, the applicant’s claim was rejected in paragraph 161 above.

193    Furthermore, the applicant does not establish that the data which were considered to be missing by EFSA in the context of the groundwater exposure assessment and which were requested by EFSA on 6 November 2017 are data for which, in accordance with Article 6(f) of Regulation No 1107/2009, ‘new requirements [had been] established during the assessment process or as a result of new scientific and technical knowledge’.

194    As regards the possible application of Article 6(f) of Regulation No 1107/2009 to the genotoxicity assessment of ethoprophos, it should be noted, first, that it was found in paragraph 94 above that it was the scientific opinion of the EFSA Scientific Committee of 2011 and not that of 2017 that required a new Ames test and, more generally, new data on the genotoxicity of ethoprophos. Second, in paragraphs 95 and 96 above, the applicant’s argument that the 2017 update was not foreseeable prior to the submission of the renewal dossier, so that it could not have expected that it would have to specifically focus in its dossier on the genotoxicity of ethoprophos, was rejected.

195    In those circumstances, the applicant cannot rely on the existence of an unforeseen and complex situation within the meaning of the judgment of 18 July 2007, Industrias Químicas del Vallés v Commission (C‑326/05 P, EU:C:2007:443, paragraph 80), cited at the hearing, concerning EFSA’s request for additional information, of 6 November 2017, in particular with regard to the genotoxicity of ethoprophos.

196    Thirdly, as regards the option of awaiting the results of the new Ames test and the in vitro gene mutation study before adopting the final decision in the procedure for renewing the approval of ethoprophos, reference should be made to paragraphs 113 to 116 above, concerning the Commission’s alleged failure to take those results into consideration.

197    Fourthly, as regards the applicant’s argument that the submission of a new application for renewal of ethoprophos would entail a heavy financial burden and that suspension of the current renewal procedure would be an alternative in that regard, it is sufficient to recall, as has already been observed in paragraph 85 above, that the protection, in particular, of public health and the environment is of overriding importance compared with economic considerations, so that it is such as to justify negative economic consequences, even considerable ones, for certain operators.

198    In the light of the foregoing, the applicant does not establish that the adoption of the contested implementing regulation is manifestly inappropriate for achieving the objectives of protection of health and the environment pursued by that measure.

199    Consequently, the fourth plea in law must be rejected.

F.      The fifth plea in law, alleging breach of the precautionary principle

200    The applicant submits that the Commission violated the precautionary principle in that it failed to carry out an ‘impact assessment’ in accordance with point 6.3.4 of the Communication from the Commission on the precautionary principle (COM(2000) 1 final) (‘the Communication on the precautionary principle’). It states that it expressly requested such an analysis in its letter of 21 January 2019 and that the Commission’s response was clearly insufficient.

201    In the reply, in response to the Commission’s argument that it was not required to carry out an ‘impact assessment’ in the context of the procedure for the renewal of the approval of an active substance, the applicant states that the Commission misinterprets such an analysis which requires the institutions to take account of the concrete circumstances of the case and to weigh up all the options available to them in order to apply the least burdensome measure before adopting a decision.

202    The Commission contest the applicant’s arguments.

1.      Preliminary remarks on the precautionary principle

203    It should be noted, as a preliminary point, that, while Article 191(2) TFEU provides that environmental policy is to be based, inter alia, on the precautionary principle, that principle is also intended to apply in the context of other EU policies, in particular the policy of protection of public health and when the institutions of the European Union adopt, under the common agricultural policy or the policy of the internal market, measures for the protection of human health (see judgment of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraph 41 and the case-law cited).

204    It is therefore incumbent on the EU legislature, when adopting rules governing the placing of plant protection products on the market, such as those set out in Regulation No 1107/2009, to comply with the precautionary principle, in particular with a view to ensuring, in accordance with Article 35 of the Charter of Fundamental Rights of the European Union and Article 9 and Article 168(1) TFEU, a high level of protection of human health (see judgment of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraph 42 and the case-law cited).

205    The precautionary principle implies that, where there is uncertainty as to the existence or extent of risks to human health, protective measures may be taken without having to wait for the reality and seriousness of those risks to be fully demonstrated (see judgment of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraph 43 and the case-law cited).

206    According to settled case-law, the institutions of the European Union enjoy, in implementing the measures to be taken for the protection of human health, a wide discretion as regards the definition of the objectives pursued and the choice of appropriate means of action (see judgment of 11 February 2015, Spain v Commission, T‑204/11, EU:T:2015:91, paragraph 30 and the case-law cited).

207    The considerations set out in paragraphs 203 to 206 above are applicable, by analogy, in relation to the other interests protected by Article 4 of Regulation No 1107/2009, namely, inter alia, animal health and the environment (see, to that effect, judgment of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 130).

208    Within the process leading to the adoption by an institution of appropriate measures to prevent certain potential risks to public health, safety and the environment by reason of the precautionary principle, three successive stages can be identified: first, identification of the potentially adverse effects arising from a phenomenon; second, assessment of the risks to public health, safety and the environment which are related to that phenomenon; and, third, when the potential risks identified exceed the threshold of what is acceptable for society, risk management by the adoption of appropriate protective measures (judgment of 17 May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph 60).

209    With regard to the third stage concerning risk management, it should be noted that point 6.3.4 of the Communication on the precautionary principle, entitled ‘Examination of the benefits and costs of action or lack of action’, (‘the examination of benefits and costs’) to which the applicant refers, reads as follows:

‘A comparison must be made between the most likely positive or negative consequences of the envisaged action and those of inaction in terms of the overall cost to the [European Union], both in the long and short term. The measures envisaged must produce an overall advantage as regards reducing risks to an acceptable level.

Examination of the pros and cons cannot be reduced to an economic cost‑benefit analysis. It is wider in scope and includes non-economic considerations.

However, examination of the pros and cons should include an economic cost‑benefit analysis where this is appropriate and possible.

Besides, other analysis methods, such as those concerning the efficacy of possible options and their acceptability to the public may also have to be taken into account. A society may be willing to pay a higher cost to protect an interest, such as the environment or health, to which it attaches priority.

The Commission affirms, in accordance with the case-law of the Court that requirements linked to the protection of public health should undoubtedly be given greater weight [than] economic considerations.

The measures adopted presuppose examination of the benefits and costs of action and lack of action. This examination should include an economic cost/benefit analysis when this is appropriate and feasible. However, other analysis methods, such as those concerning efficacy and the socio-economic impact of the various options, may also be relevant. Besides the decision-maker may, in certain circumstances, [be] guided by non-economic considerations such as the protection of health.’

210    It is in the light of the foregoing legal framework and case-law that it must be examined whether, in applying the precautionary principle, the Commission was required, in the present case, to carry out an examination of the benefits and costs within the meaning of point 6.3.4 of the Communication on the precautionary principle and, if so, whether it did so in this case.

2.      The Commission’s obligation to examine the benefits and costs

211    In the first place, it must be ascertained whether, as the Commission maintains, it is not obliged to carry out an examination of the benefits and costs, within the meaning of point 6.3.4 of the Communication on the precautionary principle, in a procedure for the renewal of the approval of an active substance, provided for in Regulation No 1107/2009, and in the context of which it is for the applicant to demonstrate the efficacy and safety of the active substance in question.

212    It follows from recital 8 and Article 1(4) of Regulation No 1107/2009 that the provisions of that regulation are based on the precautionary principle in order to prevent active substances or products placed on the market from causing harm to human and animal health or the environment.

213    As recalled in paragraph 209 above, point 6.3.4 of the Communication on the precautionary principle requires the consideration of benefits and costs. It should be noted that that point is included under the heading ‘The general principles of application’. Thus, such an examination is considered to be one of the general principles applicable to the use of the precautionary principle. In that respect, the first paragraph of point 6.3 of that communication specifies that those general principles apply ‘to all risk management measures’.

214    In those circumstances, contrary to what the Commission maintains, it cannot be considered that the examination of the benefits and costs in the context of the application of the precautionary principle applies only to procedures for the review of the approval of an active substance under Article 21 of Regulation No 1107/2009.

215    That conclusion cannot be called into question by the Commission’s arguments.

216    Firstly, the Commission relies on the judgments of 17 May 2018, BASF Agro and Others v Commission (T‑584/13, EU:T:2018:279), and of 17 May 2018, Bayer CropScience and Others v Commission (T‑429/13 and T‑451/13, EU:T:2018:280), in which the Court held that the Commission had to carry out an examination of the benefits and costs in the context of an assessment of the market value of a product under Article 21 of Regulation No 1107/2009. However, those judgments cannot be interpreted a contrario as meaning that the Commission would not be obliged to carry out an examination of the benefits and costs in the context of a renewal procedure.

217    Secondly, the Commission states that the renewal procedure is different from the review procedure provided for in Article 21 of Regulation No 1107/2009 as regards the burden of proof to demonstrate the efficacy and safety of the active substance concerned. In that respect, it is sufficient to recall, as noted in paragraph 209 above, that the consideration of benefits and costs is part of the management of the identified risks. By contrast, the burden of demonstrating the efficacy and safety of the active substance concerned, which falls on the applicant in a renewal procedure, is only relevant in the context of the first two stages referred to in paragraph 208 above, namely the identification of potentially adverse effects arising from a phenomenon and the assessment of the risks to public health, safety and the environment associated with that phenomenon.

218    Thirdly, the Commission alleges that it has no choice or discretion in the case of an application for renewal, in that it would be obliged to act to renew the approval, not to renew it or to renew it subject to certain conditions and restrictions. However, it is precisely the three options indicated that give the Commission a margin of discretion to choose the most appropriate option for an active substance to be renewed, with a view to preventing certain potential risks to public health, safety and the environment under the precautionary principle. Even if the risk assessment identifies animal and human health concerns and if there are various data gaps, the Commission retains two options: either not to renew the active substance in question or to renew it subject to certain conditions and restrictions.

219    Fourthly, in response to a question posed in the context of the measures of organisation of procedure, as well as at the hearing, the Commission referred to paragraph 95 of the judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800). There, the Court held, in the context of a procedure for the initial approval of an active substance under Regulation No 1107/2009, that, should the competent authorities come to the conclusion that, in the light of all the evidence before them, the applicant has not sufficiently established that the conditions governing the approval or authorisation applied for are satisfied, they are obliged to conclude that the application should be rejected, without it being necessary, in order to reach such a conclusion, to undertake a second assessment.

220    In that regard, it is sufficient to note that that passage forms part of the analysis of the question whether the fact that the tests, studies and analyses necessary for the approval procedures for, inter alia, an active substance are provided by the applicant, without an independent counter-analysis, is contrary to the precautionary principle, in so far as it implies that those tests, studies and analyses could be partial. In the present case, in the context of the fifth plea in law, alleging infringement of the precautionary principle, neither the reliability of the studies and analyses provided by the applicant nor the absence of any counter-analysis is disputed. In any event, the examination of the benefits and costs in a procedure for the renewal of the approval of an active substance cannot be regarded as an ‘independent counter-analysis’ for the reason given in paragraph 217 above. As regards the procedure for renewal of the approval of an active substance, it follows from the system established by Regulation No 1107/2009 that the necessary tests, studies and analyses must be provided by the applicant mainly prior to the assessment of the renewal application itself, namely in its renewal application (Article 15(2) of Regulation No 1107/2009; Article 2(2) of Implementing Regulation No 844/2012) and in its supplementary dossiers (Article 7 of that implementing regulation). By contrast, as noted in paragraph 209 above, the examination of benefits and costs is only part of the risk management stage, which follows the evaluation stage.

221    In the light of the foregoing, it must be concluded that the Commission was required to carry out an examination of the benefits and costs within the meaning of point 6.3.4 of the Communication on the precautionary principle. It is still necessary to examine whether the Commission carried out such an examination in the present case.

3.      The conduct of the Commission’s review of benefits and costs

222    It should be recalled that point 6.3.4 of the Communication on the precautionary principle does not specify the format and scope of the examination of benefits and costs. In particular, it does not follow from the provisions of that point that the authority concerned is obliged to initiate a specific assessment procedure leading for example to a formal written assessment report. Furthermore, it follows from that text that the authority applying the precautionary principle has a considerable margin of appreciation as to the methods of analysis. While the communication states that the examination ‘should’ include an economic analysis, the authority concerned must in any case also integrate non-economic considerations. Moreover, it is expressly pointed out that in certain circumstances economic considerations may have to be regarded as less important than other interests recognised as important; expressly mentioned by way of example are interests such as the environment or health (judgment of 17 May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph 162).

223    Furthermore, the requirements of the Communication on the precautionary principle are satisfied where the authority concerned, in this case the Commission, has in fact acquainted itself with the effects, positive and negative, economic and otherwise, to which the proposed action, as well as the failure to act, may lead, and has taken that into account in its decision. By contrast, it is not necessary for those effects to be estimated precisely, if that is not possible or would require disproportionate effort (judgment of 17 May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph 163).

224    In the present case, it should be noted that, in order to demonstrate that it has fulfilled its obligation to carry out an examination of the benefits and costs, the Commission relies on a ‘note to the file of ethoprophos’, dated 18 January 2019, attached to the statement of defence (‘the note to the file of ethoprophos’).

225    Asked in the context of the organisational measures of the procedure to explain why the note to the file of ethoprophos should be considered as an examination of the benefits and costs in this case, the Commission indicated, first, that that note emphasises that the non-renewal of ethoprophos will have certain negative consequences, since ‘plant protection products containing ethoprophos are currently authorised in’ 10 Member States and ‘there are limited alternative substances approved’ for use ‘on potatoes to control nematodes and wireworms’. Second, it recalled that the note emphasised that ‘the risks and problems identified overrule the impact of the loss of the substance and also any possible economic impact, taking into account the alternatives still available’. Furthermore, it was also noted that if Member States consider ‘the use of ethoprophos is indispensable for certain uses’, they ‘may grant emergency authorisations according to Article 53’ of Regulation 1107/2009.

226    Furthermore, the Commission’s observation in the note to the file of ethoprophos that ‘the risks and issues identified … overrule the impact of the loss of the substance and also any economic impact, taking into account that some alternatives are still available’ is also set out in its reply of 23 January 2019 to the applicant’s letter of 21 January 2019. As the applicant itself indicates, in that reply, the Commission explained that, ‘whilst the loss of ethoprophos may present some challenges for control of wireworm in potatoes, the Commission consider[ed] that the risks and issues identified by EFSA overrule[d] the impact of the loss of the substance and also any economic impact, taking into account that some alternatives [were] still available’.

227    It is therefore necessary to take account of the note to the file of ethoprophos in order to verify whether the Commission has carried out an examination of the benefits and costs within the meaning of point 6.3.4 of the Communication on the precautionary principle.

228    In that regard, it should be noted that it is apparent from the note to the file of ethoprophos, as well as from the Commission’s letter of 23 January 2019, which partly repeats what had been written in that note, that the Commission did in fact take cognisance of the effects, both positive and negative, economic and otherwise, which might be induced by the renewal or non-renewal of the approval of ethoprophos, and that it took them into account in adopting its decision.

229    That conclusion cannot be called into question by the applicant’s argument that the examination of the benefits and costs, within the meaning of point 6.3.4 of the Communication on the precautionary principle, should include a thorough assessment of the most likely positive or negative consequences of the proposed non-renewal.

230    First, it is clear from the case-law cited in paragraph 206 above that the institutions of the European Union enjoy, when implementing the measures to be taken for the protection of human health, a wide discretion as regards the definition of the objectives pursued and the choice of appropriate instruments for action. It should, moreover, be made clear that, because of the need to balance several objectives and principles, as well as the complexity of the implementation of the relevant criteria, judicial review must necessarily be limited to the question whether the institutions of the European Union have committed a manifest error of assessment (see, to that effect, judgment of 21 December 2016, Associazione Italia Nostra Onlus, C‑444/15, EU:C:2016:978, paragraph 46). Nevertheless, in the present case, the applicant does not put forward any specific argument as to a possible error on the part of the Commission with regard to the examination of the benefits and costs, within the meaning of point 6.3.4 of the Communication on the precautionary principle.

231    Second, as recalled in paragraph 223 above, it is not necessary that the effects, positive and negative, economic and otherwise, to which the proposed action, as well as the failure to act, may lead, be precisely estimated, if that is not possible or would require disproportionate effort.

232    Consequently, the applicant is wrong to claim that the Commission misapplied the precautionary principle. The fifth plea in law must therefore be rejected.

233    In view of all the above, the application must be dismissed in its entirety.

V.      Costs

234    Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.

235    Since the applicant has been unsuccessful, it must be ordered to pay the costs incurred by the Commission in the present action and in the proceedings for interim measures in accordance with the form of order sought by the latter.

On those grounds,

THE GENERAL COURT (Seventh Chamber)

hereby:

1.      Dismisses the action;

2.      Orders AMVAC Netherlands BV to bear its own costs and to pay those incurred by the European Commission in the present action and in the proceedings for interim measures.

Delivered in open court in Luxembourg on 9 February 2021.

Table of contents

I. Legal framework

A. Directive 91/414/EEC

B. Regulation No 1107/2009

C. Implementing Regulation No 844/2012

II. Background to the dispute

A. First approval of ethoprophos at EU level

B. Renewal of the approval of ethoprophos at EU level

III. Procedure and forms of order sought

IV. Law

A. Preliminary observations

1. The scope of the Court’s review

2. The burden of proof

B. The second plea in law, alleging failure to respect the rights of the defence

C. The third plea in law, alleging breach of the principle of legal certainty

D. The first plea in law, alleging manifest errors of assessment

1. The specific concerns reported

(a) The genotoxicity concern

(1) The alleged failure of the Commission to take into account the comments submitted by the applicant to EFSA on 5 December 2017

(2) The alleged failure of the Commission to take into account, first, the observations submitted by the applicant on 8 June 2018 and, second, the results of the Ames study and the in vitro micronucleus study, both in their provisional form, submitted in August 2018, and in their final form of October 2018

(3) Conclusion

(b) The high acute risk to birds

(c) High risk to non-target soil-dwelling arthropods and soil organisms

2. The lack of data

(a) Consumer risk assessment

(b) Assessment of developmental neurotoxicity

(c) Assessment of groundwater exposure

(d) Long-term risk to birds

(e) Assessment of secondary poisoning of birds and mammals and risk to soil organisms from exposure to ethoprophos metabolites

(f) Risk to earthworms

(g) Assessment of endocrine disrupting potential

E. The fourth plea in law, alleging breach of the principle of proportionality

F. The fifth plea in law, alleging breach of the precautionary principle

1. Preliminary remarks on the precautionary principle

2. The Commission’s obligation to examine the benefits and costs

3. The conduct of the Commission’s review of benefits and costs

V. Costs

*      Language of the case: English.

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