JUDGMENT OF THE GENERAL COURT (Seventh Chamber)

15 February 2023 (*) (1)

(Plant protection products – Active substance mancozeb – Non-renewal of approval – Regulation (EC) No 1107/2009 and Implementing Regulation (EU) No 844/2012 – Procedure for assessing the application for renewal of approval of an active substance – Designation of a new rapporteur Member State due to the withdrawal of the previous rapporteur Member State from the European Union – Rights of the defence – Principle of sound administration – Manifest error of assessment – Procedure for harmonised classification and labelling – Regulation (EC) No 1272/2008 – Legitimate expectations)

In Case T‑742/20,

UPL Europe Ltd, established in Warrington (United Kingdom),

Indofil Industries (Netherlands) BV, established in Amsterdam (Netherlands),

represented by C. Mereu and P. Sellar, lawyers,

applicants,

v

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

defendant,

THE GENERAL COURT (Seventh Chamber),

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

Registrar: I. Kurme, Administrator,

having regard to the written part of the procedure,

further to the hearing on 30 June 2022,

gives the following

Judgment

1        By their action under Article 263 TFEU, the applicants, UPL Europe Ltd and Indofil Industries (Netherlands) BV, seek annulment of Commission Implementing Regulation (EU) 2020/2087 of 14 December 2020 concerning the non-renewal of approval of the active substance mancozeb, 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 2020 L 423, p. 50) (‘the contested implementing regulation’).

I.      Background to the dispute

2        The applicants are companies which market plant protection products containing the active substance ‘mancozeb’, including throughout the European Union. Mancozeb is a fungicide used to combat a number of fungal pathogens affecting potato, vine, pome fruit, tree fruit, carrot and onion crops.

A.      Approval of mancozeb at EU level

3        Mancozeb was approved in the European Union for a 10-year period as from 1 July 2006 by Commission Directive 2005/72/EC of 21 October 2005 amending Council Directive 91/414/EEC to include chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb, and metiram as active substances (OJ 2005 L 279, p. 63), which added the active substance mancozeb to Annex I to 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).

4        With the entry into force of 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 (OJ 2009 L 309, p. 1), the active substances included in Annex I to Directive 91/414, including mancozeb, were deemed to have been approved and were listed in the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation No 1107/2009 as regards the list of approved active substances (OJ 2011 L 153, p. 1). Implementing Regulation No 540/2011 was amended on four occasions, by Commission Implementing Regulations (EU) No 762/2013 of 7 August 2013 (OJ 2013 L 213, p. 14), (EU) 2018/84 of 19 January 2018 (OJ 2018 L 165, p. 8), (EU) 2018/1796 of 20 November 2018 (OJ 2018 L 294, p. 15) and (EU) 2019/2094 of 29 November 2019 (OJ 2019 L 317, p. 102). By Implementing Regulation 2019/2094, the Commission extended the approval period of mancozeb until 31 January 2021 in order to allow the renewal procedure to be completed before the expiry of the approval period of that substance.

B.      Renewal of the approval of mancozeb at EU level

5        In June 2013 and November 2014, respectively, separate applications for renewal of the approval of mancozeb were submitted by the ‘EU Mancozeb Task Force’, which was a task force founded by the applicants specifically for the purposes of the procedure for renewal of the approval of mancozeb and by another company.

6        The approval of mancozeb was subject to the standard regulatory procedure for the renewals of approval provided for in Article 14 et seq. of Regulation No 1107/2009 and at the various stages of that procedure provided for in 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).

7        In accordance with Commission Implementing Regulation (EU) No 686/2012 of 26 July 2012 allocating to the Member States, for the purposes of the renewal procedure, the evaluation of active substances whose approval expires on 31 December 2018 at the latest (OJ 2012 L 200, p. 5), the United Kingdom of Great Britain and Northern Ireland was designated as the rapporteur Member State for the evaluation of mancozeb in the context of the renewal procedure for its approval (‘the initial RMS’), the co-rapporteur Member State being the Hellenic Republic.

8        Following the notification, on 29 March 2017, by the United Kingdom of its intention to withdraw from the European Union pursuant to Article 50(2) TEU, the European Union negotiated with that State an agreement setting out the arrangements for such withdrawal, in accordance with that provision. The date of withdrawal was initially fixed at 29 March 2019.

9        On 27 September 2017, the initial RMS submitted its draft renewal assessment report (‘the draft RAR of September 2017’) to the European Food Safety Authority (EFSA), in accordance with Article 11 of Implementing Regulation No 844/2012. In that draft, the initial RMS considered that Article 4 of Regulation No 1107/2009 had been complied with and that mancozeb could be approved. Although the initial RMS identified certain risks relating to safe use of certain products or uses, it acknowledged that those risks could be mitigated at Member State level.

10      In February 2018, EFSA circulated the draft RAR of September 2017 to the Member States and the applicants for comments, pursuant to Article 12 of Implementing Regulation No 844/2012. The applicants submitted their comments on 26 April 2018.

11      On 4 July 2018, EFSA asked the applicants to provide additional information within a period of one month, pursuant to Article 13(3) of Implementing Regulation No 844/2012. That request included 88 points relating, inter alia, to storage stability of mancozeb and the metabolite ethylene thiourea (‘ETU’), the intended use of the substance in cereals, the processing factors for mancozeb and ETU for wheat and potato processed commodities, as well as the criteria for endocrine disruption. On 3 August 2018, the applicants provided some of the information requested. On 19 October 2018, with the agreement of EFSA, they provided the additional information requested on the endocrine disrupting properties of mancozeb.

12      At the beginning of December 2018, the applicants requested a meeting with the initial RMS in order to discuss, inter alia, the evaluation of the additional data provided following EFSA’s request of 4 July 2018 (see paragraph 11 above) and, more specifically, the question whether those data had been accepted and whether they were such as to demonstrate a safe use of mancozeb. That request was not granted. By email of 18 December 2018, the initial RMS responded to the questions put by the applicants.

13      In January 2019, the initial RMS submitted an updated draft RAR to EFSA.

14      In January and February 2019, EFSA held expert meetings within the framework of the peer review process to discuss various aspects of the risk assessment of mancozeb in the areas of mammalian toxicology, residues and ecotoxicology. In that regard, before those meetings, first, the applicants provided additional information to EFSA and the initial RMS which, in their view, substantiated a safe use of that substance and invited them to examine that information during the expert meetings.

15      Second, they wrote to the European Commission asking it, inter alia, to evaluate the risks of mancozeb in the light of their proposal to make changes to good agricultural practices (GAP) on cereals. By email of 12 February 2019, the Commission stated as follows:

‘With regards to changes to the GAP, normally such changes are not permitted since this can impact the risk assessment and delay and complicate the peer-review. However, in some cases the rapporteur Member State may be willing to accommodate changes and you should therefore contact the RMS on this matter.’

16      By their email of 14 February 2019, the applicants contacted the initial RMS concerning, inter alia, the amended GAP. In reply, by email of 18 February 2019, the initial RMS informed them that it was not in a position to examine their application concerning GAP, given that that request was out of time. It did, however, direct them to the authorities of the Hellenic Republic, who were due to take over the role of rapporteur Member State (‘the RMS’) from the initial RMS.

17      On 27 February 2019, the Commission adopted Implementing Regulation (EU) 2019/336 amending Regulation (EU) No 1141/2010 and Implementing Regulation No 686/2012 as regards the rapporteur Member State for the evaluation of 1-methylcyclopropene, famoxadone, mancozeb, methiocarb, methoxyfenozide, pirimicarb, pirimiphos-methyl and thiacloprid (OJ 2019 L 60, p. 8). In Annex I to that implementing regulation, the Hellenic Republic was designated as the new RMS for the evaluation of mancozeb. Pursuant to Article 3 of that implementing regulation, that designation was applicable as from 30 April 2019 or, in the event that a decision was taken to extend the two-year period referred to in Article 50(3) TEU, as from the day following that on which the legislation relating to plant protection products ceased to apply to and in the United Kingdom.

18      In March 2019, the initial RMS submitted to EFSA a further updated draft RAR (‘the draft RAR of March 2019’). The applicants received that draft on 22 March 2019. That draft proposed that the mancozeb be found not to satisfy the conditions of approval laid down in Article 4 of Regulation No 1107/2009 for the following three reasons: (i) mancozeb was considered to be an endocrine disruptor in humans; (ii) there was a risk resulting from non-dietary exposure; and (iii) there was a risk to birds and mammals, non-target arthropods and soil organisms.

19      On 12 April 2019, the applicants sent a letter to EFSA reiterating the fact that the additional data on endocrine disruption they had submitted in October 2018 had not been taken into account. In that letter, the applicants also expressed their concerns about the legal and scientific bases upon which the endocrine disruption assessment of mancozeb had been conducted, principally because in their view undue influence had been accorded to ETU rather than the substance itself.

20      On 12 June 2019, EFSA published its conclusions on the peer review of the pesticide risk assessment of mancozeb (‘the EFSA conclusions’), in which it stated that that substance could not be expected to meet the approval criteria laid down in Article 4 of Regulation No 1107/2009 (see paragraph 44 below).

21      On 20 June 2019, EFSA forwarded its conclusions to the Commission, which then invited the applicants to comment thereon, which they did on 16 July 2019.

22      By email of 18 September 2019, the initial RMS confirmed to the applicants that it would no longer attend meetings of the Standing Committee on Plants, Animals, Food and Feed (‘the standing committee’) concerning mancozeb.

23      On 9 October 2019, on their own initiative, the applicants met with Commission representatives. During that meeting, they made a presentation on mancozeb, focusing in particular on its potential safe use, procedural concerns concerning the withdrawal of the initial RMS from the European Union and the classification of mancozeb under Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1).

24      By email of 26 November 2019, the Hellenic Republic informed the Commission that, in view of its upcoming role as RMS, it would need until 30 July 2020 to ‘assess in detail the dossier’ on mancozeb, and ‘review in depth specific points raised by EFSA’.

25      In response, by email of 17 December 2019, the Commission informed the Hellenic Republic that it intended to prepare a renewal report and draft regulation based on the draft RAR of March 2019 and the EFSA conclusions. The Commission explained that the initial RMS had duly conducted its assessment, taking into account all available information and comments from the applicants. It also indicated that it intended to present a renewal report and draft regulation to the Member States at the 23 and 24 March 2020 meeting of the standing committee, and that the Hellenic Republic should complete its assessment and review in advance of that meeting.

26      On 16 January 2020, the Commission sent the applicants its draft renewal report, in which it proposed not to renew the approval of mancozeb. It also invited the applicants, in accordance with the third subparagraph of Article 14(1) of Implementing Regulation No 844/2012, to submit comments on the draft report, which they did on 31 January 2020.

27      On 24 January 2020, the representatives of the European Union and the United Kingdom signed the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (OJ 2020 L 29, p. 7) (‘the United Kingdom Withdrawal Agreement’). On 29 January 2020, the European Parliament approved the conclusion of the United Kingdom Withdrawal Agreement. On 30 January 2020, the Council of the European Union adopted Decision (EU) 2020/135 on the conclusion of the [United Kingdom Withdrawal Agreement] (OJ 2020 L 29, p. 1). Under Article 1 of that decision, the United Kingdom Withdrawal Agreement was approved on behalf of the Union and the European Atomic Energy Community. Article 126 of that agreement provided for a transitional period which began on the date of entry into force of that agreement and ended on 31 December 2020.

28      At midnight on 31 January 2020, the United Kingdom withdrew from the European Union and the European Atomic Energy Community and, on 1 February 2020, the United Kingdom Withdrawal Agreement entered into force, in accordance with Article 185 thereof.

29      On 1 February 2020, the Hellenic Republic officially became the RMS for the evaluation of mancozeb (‘the new RMS’).

30      Prior to the standing committee meeting of 23 and 24 March 2020, on an unspecified date, the new RMS circulated a document concerning mancozeb. According to that document, the applicants had ‘informed [the new RMS] that several pieces of information regarding (eco)toxicology and (non)dietary risk assessment were not considered in the Renewal Assessment Report (RAR, 2019) drafted by the [initial RMS, the United Kingdom], due to Brexit, and as such they were not considered in the EFSA Peer Review process’. The document also stated that the new RMS had ‘reviewed briefly the additional information claimed by the [applicants not to have been] considered and noted that a scientifically sound evaluation [would] only be possible if sufficient time [was granted to the new RMS] for assessment of all the points made by the [applicants] and all the available studies’.

31      Prior to that meeting, the Commission sent its draft renewal report and a draft implementing regulation to the standing committee, in accordance with the provisions of Article 14 of Implementing Regulation No 844/2012.

32      The proposal for non-renewal of mancozeb was placed on the agenda for the standing committee meeting of 23 and 24 March 2020. On that occasion, the applicants requested a meeting with the Commission, who proposed to meet with them on 18 March 2020. That meeting was cancelled due to the pandemic, as was the standing committee meeting of 23 and 24 March 2020. The Member States were invited by the Commission to communicate their views on the non-renewal of mancozeb no later than 14 April 2020.

33      On 5 May 2020, the applicants wrote to the Commission, requesting that the issue of non-renewal of mancozeb not be discussed at the standing committee meeting scheduled for 16 and 17 July 2020, given that the new RMS was still in the process of evaluating the data on the amended GAP, endocrine disruption and all aspects relating to birds and mammals, non-target soil organisms, and aquatic toxicology for metabolites and residues.

34      At a meeting of the standing committee, held remotely, on 18 and 19 May 2020, mancozeb was discussed and the Commission informed the Member States that the new RMS had committed to finalising its assessment and review of the data which, in its view, had been ignored by the initial RMS, for the beginning of July 2020. The Commission also invited Member States to submit any written observations they might have by 18 June 2020.

35      By letter of 10 June 2020, the Commission informed the applicants that the preliminary findings of the new RMS ‘do not contain sufficient elements to consider a revision of the proposal’, that ‘it remain[ed] to be seen whether the further evaluation announced by [the new RMS would] have that potential’, and that ‘information submitted by [the applicants] without having been requested, or provided after the expiry of the period set for its submission cannot be taken into account’. It also stated that it was prepared to ‘reconsider the situation once this additional assessment [had been] made’.

36      By letter of 10 July 2020, before the standing committee meeting of 16 and 17 July 2020, the applicants asked the Commission, inter alia, to await the outcome of the procedure before the European Chemicals Agency (ECHA) pursuant to Regulation No 1272/2008 (see paragraphs 45 to 50 below) before publishing a proposal for non-renewal based on a proposal for classification of mancozeb as a toxic substance for reproduction category 1B, which, according to the applicants, was liable to change, in the light of a proposal by the Republic of Malta for classification of the substance at issue as toxic for reproduction category 2.

37      At the standing committee meeting of 16 and 17 July 2020, the Member States once again considered the issue of non-renewal of mancozeb and agreed that a vote would be held on the draft regulation, under which approval for mancozeb would not be renewed under the written procedure, which was initiated following the meeting. However, the vote was postponed after the written procedure was halted by three Member States requesting further discussions.

38      On 2 September 2020, the new RMS submitted a further updated draft RAR (‘the draft RAR of September 2020’) to the Commission. It maintained the proposal of the initial RMS in its draft RAR of March 2019, namely, to conclude that mancozeb did not satisfy the conditions for approval laid down in Article 4 of Regulation No 1107/2009 (see paragraph 18 above). It also stated that mancozeb was considered to be an endocrine disruptor for humans and non-target organisms and that there was a risk to birds, mammals and non-target arthropods. However, the new RMS found that, by altering the GAP on cereals and using water-soluble bags, it was possible to find a use that was safe for human health (that is to say, for operators, workers and persons living nearby). The draft RAR of September 2020 was also made available to EFSA, the other Member States and the applicants.

39      By letter of 21 September 2020, the applicants asked the Commission to allow them to submit comments on the draft RAR of September 2020 and to mandate EFSA to organise expert meetings and to adjust its conclusions accordingly. They considered that the new RMS’s conclusions as to the existence of a safe use for human health meant that they could apply for application of the derogation provided for in Article 4(7) of Regulation No 1107/2009.

40      On the same day, the Commission sent the applicants an updated draft renewal report, in which it proposed not to renew the approval of mancozeb. The applicants submitted comments on the draft renewal report on 2 October 2020.

41      In September and October 2020, the applicants and the Commission were in contact on a number of occasions concerning the applicants’ request to mandate EFSA to organise a peer review of the draft RAR of September 2020.

42      At a standing committee meeting of 23 October 2020, the Member States finalised the renewal report and issued, by qualified majority, an opinion in favour of the draft implementing regulation not renewing approval for mancozeb.

43      On 14 December 2020 the Commission adopted the contested implementing regulation.

44      Recitals 12 to 15 of the contested implementing regulation set out the reasons for the non-renewal as follows:

‘(12)      [EFSA] identified certain specific concerns. In particular, it concluded that mancozeb has been classified as toxic for reproduction category 1B and that the new criteria to identify endocrine disrupting properties are met for humans and most likely for non-target organisms. In addition, it concluded that the non-dietary exposure estimates exceed the reference values for the representative uses in tomatoes, potatoes, cereals and grapevines. Therefore for the representative uses considered, non-dietary exposure to mancozeb also cannot be considered as negligible for the purposes of points 3.6.4 and 3.6.5 of Annex II to Regulation … No 1107/2009. Given the concerns identified the derogation provided for in Article 4(7) to Regulation … No 1107/2009 cannot apply.

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

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

(15)      Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product 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 mancozeb.’

C.      Harmonised classification and labelling of mancozeb under Regulation No 1272/2008

45      In August 2017, pursuant to Regulation No 1272/2008, the initial RMS sent ECHA a harmonised classification and labelling dossier (‘the CLH dossier’) providing data in support of a change to the classification of mancozeb as ‘toxic for reproduction category 2’. The initial RMS proposed ‘no classification’ of mancozeb with regards to reprotoxicity. In December 2017, it submitted an updated CLH dossier to ECHA, which formed the basis of a public consultation which ran from February to April 2018.

46      In May 2018, in accordance with Article 37(4) of Regulation No 1272/2008, the ECHA Risk Assessment Committee (‘the RAC’) circulated its draft opinion, which indicated that discussions on the classification of mancozeb were to be divided into two parts: first, issues relating to toxicity to be discussed at its forty-seventh meeting in November 2018 and, second, mutagenicity and carcinogenicity to be discussed at its forty-eighth meeting in March 2019.

47      At the RAC’s forty-seventh meeting in November 2018, it was concluded that mancozeb should be classified as a toxic substance for reproduction category 1B (‘the RAC opinion’). On 7 March 2019, at its forty-eighth meeting, the RAC adopted a proposal to classify mancozeb as Carcinogenic Category 2.

48      Following those two meetings, there were a number of exchanges of correspondence between the applicants, on the one hand, and the RAC secretariat, ECHA and the Commission, on the other. More specifically, ECHA stated, inter alia, in a letter of 29 March 2019, that the issue of classification of mancozeb as a toxic substance for reproduction category 1B would be reopened only on the basis of ‘new arguments’ and ‘new scientific evidence’.

49      After receiving confirmation from the initial RMS, on 16 May 2019, that it was not able to commit to taking forward another harmonised classification and labelling dossier for mancozeb, the applicants approached, inter alia, the Republic of Malta, asking it, in its capacity as a competent national authority, to prepare a new CLH dossier for the substance pursuant to Article 37(6) of Regulation No 1272/2008. The Republic of Malta agreed to that request on 3 February 2020.

50      On 4 May 2020, ECHA updated its registry of intentions for mancozeb, to indicate that the harmonised classification to be proposed by the Republic of Malta was that of a toxic substance for reproduction category 2. According to a registry update of 13 July 2020, the Republic of Malta was intending to submit a new CLH dossier by 30 June 2021.

II.    Forms of order sought

51      The applicants claim that the Court should:

–        annul the contested implementing regulation;

–        order the Commission to pay the costs.

52      The Commission contends that the Court should:

–        dismiss the action;

–        order the applicants to pay the costs.

III. Law

53      In support of their action, the applicants put forward five pleas in law, the first alleging procedural infringements; the second, infringement of their rights of defence; the third, infringement of the principle of sound administration; the fourth, manifest error of assessment; and the fifth, infringement of the principle of protection of legitimate expectations.

A.      Preliminary observations

1.      The procedure for approval and renewal of plant protection products at EU level 

(a)    Regulation No 1107/2009

54      Regulation No 1107/2009, which repealed Directive 91/414, establishes the EU scheme for authorisation for the placing of plant protection products on the market. Article 1(3) thereof provides that that regulation 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.

55      Article 4 of Regulation No 1107/2009, which refers to Annex II to that regulation, lays down criteria for the approval of active substances of plant protection products.

56      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 (Article 14(1) and Article 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, adopted in accordance with the regulatory procedure referred to in Article 79(3) of Regulation No 1107/2009, provides that the approval of an active substance is renewed, subject to conditions and restrictions where appropriate, or the approval of an active substance is not renewed (Article 20(1)).

(b)    Implementing Regulation No 844/2012

57      Implementing Regulation No 844/2012 lays down, inter alia, the rules concerning the various stages of the renewal procedure.

58      Articles 1 to 8 of Implementing Regulation No 844/2012 contain the rules concerning the admissibility of an application submitted by a producer of the active substance to a Member State. In accordance with Article 3 of that implementing regulation, such an application is first to be checked by the RMS to ensure that it has been submitted within the time limit laid down in the first subparagraph of Article 1(1) of that implementing regulation and that it contains all the elements required by Article 2 of that same implementing regulation. More specifically, 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 56 above). Next, in accordance with Article 6 of Implementing Regulation No 844/2012, after receiving the affirmative answer from the RMS on that verification, the applicant is to submit the supplementary dossiers to the RMS, the co-rapporteur Member State, the Commission and EFSA. Lastly, under Article 8 of that implementing regulation, where the supplementary dossiers have been submitted within the time limit and contain all the elements required, the RMS is to inform 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.

59      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 is to adopt, taking into account the state of scientific and technical knowledge and using the guidance documents applicable 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 Regulation No 1107/2009. Where appropriate, EFSA is to organise 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 same implementing regulation). Lastly, 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. 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).

2.      The scope of the Court’s review

60      According to the case-law, if the Commission is to be able to pursue effectively the objectives assigned to it by Regulation No 1107/2009, account being taken of the complex technical assessments which it must undertake, it must be recognised as having 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 it must take pursuant to that regulation.

61      The exercise of that power is not exempt from judicial review, however. 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).

62      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).

63      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 of Justice 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).

64      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).

3.      The burden of proof

65      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 will comply with the conditions set out in paragraphs 2 and 3 of that article. Those paragraphs, in turn, require that those 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 that wording 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).

66      The principles set out in paragraph 65 above are applicable in the context of the procedure for the renewal of approval of an active substance (judgment of 9 February 2022, AMVAC Netherlands v Commission, T‑317/19, not published, EU:T:2022:62, paragraph 51).

67      It is in the light of those considerations that the pleas referred to in paragraph 53 above must be examined. It is appropriate to begin by examining together the first and second pleas, alleging, respectively, infringement of essential procedural requirements and infringement of the applicants’ rights of defence.

B.      First and second pleas in law: infringement of essential procedural requirements and infringement of the applicants’ rights of defence

68      In the context of the first plea, the applicants claim, in essence, that the contested implementing regulation is based on an incomplete assessment of the risks of mancozeb and that it therefore lacks scientific reliability, for two main reasons.

69      In the first place, the applicants allege that, because of the initial date for its withdrawal from the European Union on 29 March 2019, the initial RMS did not take into account certain data which were crucial to the assessment of mancozeb relating to endocrine disruption and also risk to birds and mammals, non-target arthropods and soil organisms, and toxicological reference values.

70      In the second place, the Commission failed to follow the procedure provided for in Articles 11 to 14 of Implementing Regulation No 844/2012 following the assessment of the risks of mancozeb submitted by the new RMS in the draft RAR of September 2020. First, the applicants complain more specifically that the Commission adopted its renewal report in January 2020, that is to say, before the new RMS completed its risk assessment. Second, that assessment was not made subject to public consultation. Third, the Commission failed to ensure that EFSA would produce its conclusions on that assessment. Fourth, in the absence of such conclusions from EFSA, the requirement to make them subject to public consultation was not observed.

71      In support of their second plea, the applicants state that they were not afforded the opportunity to examine the new RMS’s draft RAR of September 2020, in accordance with Article 12(1) of Implementing Regulation No 844/2012, or to submit their comments thereon within 60 days, in accordance with Article 12(3) of that same regulation, even though that draft had updated and finalised the initial RMS’s evaluation in the procedure for the renewal of mancozeb. That failure to respect their rights to comment on the finalised draft RAR of September 2020 had the effect of preventing them from expressing their views on the updated Commission renewal report between 21 September and 2 October 2020. In that regard, they had only 14 days to make substantive observations on the finalised draft RAR and the updated renewal report.

1.      The complaint alleging failure by the initial RMS to take certain data into consideration due to the initial date of its withdrawal from the European Union

72      In the first place, as regards the data on endocrine disruption which were not taken into consideration by the initial RMS, the applicants rely on the data referred to by the new RMS in its document on mancozeb, sent to the standing committee before its meeting of 23 and 24 March 2020. Those data were submitted by the applicants in response to EFSA’s request of 4 July 2018. More specifically, the applicants refer to five passages of the new RMS’s mancozeb document.

73      According to the first passage, the new RMS acknowledged that the initial RMS had not carried out an assessment of endocrine disruption linked to mancozeb in its draft RAR of March 2019, whereas EFSA had asked for such an assessment in its request of 4 July 2018 and it had been provided by the applicant within the time limit. On reading the second to fifth passages, the initial RMS did not take into consideration several additional arguments submitted by the applicants concerning: (i) storage stability of mancozeb and ETU in potatoes; (ii) the intended use of the substance in cereals; (iii) the ETU animal dietary burden; and (iv) the processing factors for mancozeb and ETU for wheat and potato processed commodities.

74      As regards, first, the alleged absence of an assessment of endocrine disruption by the initial RMS in its draft RAR of March 2019, it is true that that draft RAR was adopted just before the initial date of the withdrawal of the initial RMS from the European Union, namely 29 March 2019. Nevertheless, in the present case, that fact alone does not in itself establish that the initial RMS’s evaluation was done in haste. On the contrary, it is apparent from the file that, following the information submitted by the applicants on 19 October 2018 at EFSA’s request, on 4 July 2018 (see paragraph 11 above), the initial RMS submitted an updated version of the draft RAR to EFSA in January 2019 (see paragraph 13 above), in accordance with Article 13(3) of Implementing Regulation No 844/2012.

75      Furthermore, contrary to what the applicants claim, it is apparent from the dossier that the initial RMS had taken into account the updated evaluation of endocrine disruption linked to mancozeb provided by the applicants in response to EFSA’s request of 4 July 2018.

76      As the Commission rightly points out, the draft RAR of March 2019 was updated following receipt of the applicants’ replies, in order to clarify that, ‘following the peer review process, an updated ED assessment has been provided by [the applicants] in two expert reports[; these] are included in this document in Appendix 2 and 3[;these] new expert reports provide no significant new information and do not change the conclusions reached by the [initial] RMS in this document before the peer review process’.

77      Thus, the applicants’ argument that there was no examination of the data on endocrine disruption in the initial RMS’s draft RAR of March 2019, allegedly motivated by the obligation to comply with the initial date of its withdrawal from the European Union, cannot succeed.

78      Moreover, as regards the alleged failure by the initial RMS to take into consideration the applicants’ additional arguments, referred to in paragraph 73 above, it should be noted that, in its written pleadings and at the hearing, the Commission claimed, without being challenged by the applicants, that those arguments had been submitted after the expiry of the time limit for responding to EFSA’s request of 4 July 2018. In that regard, at the hearing, the Commission referred to the email of 11 February 2019, sent by the applicants to the initial RMS.

79      It is apparent from that email that the applicants stated that they wished to provide certain ‘additional information’ which could be examined at the meetings of experts on mancozeb, which demonstrates that those arguments are indeed new. In addition, that email, as additional information, includes the applicants’ experts’ comments dated 11 February 2019 and two presentations provided to experts from an institute of the Hellenic Republic on 24 January 2019.

80      Thus, since the last information requested by EFSA should have been submitted by the applicants at the latest one month after EFSA’s request of 4 July 2018 (see paragraph 11 above), that is to say, on 4 August 2018, it must be held that the new information, sent on 11 February 2019 and relating to the period after 4 August 2018, was provided after the expiry of the time limit set for its communication in accordance with the first subparagraph of Article 13(3) of Implementing Regulation No 844/2012. Therefore, pursuant to paragraph 5 of that article, that information must not be taken into account.

81      In any event, it must be noted that, in response to a question put by the Court by way of measures of organisation of procedure, inviting the applicants to indicate whether they had submitted those additional arguments in response to EFSA’s request of 4 July 2018, they merely claimed that they had done so without, however, providing any supporting evidence. Thus, it is not apparent either from the document sent by the new RMS to the standing committee before its meeting of 23 and 24 March 2020 or from the parties’ pleadings before the Court that the arguments in question were submitted by the applicants in response to EFSA’s request of 4 July 2018. In those circumstances, the arguments in question must not be taken into account, in accordance with Article 13(5) of Implementing Regulation No 844/2012.

82      Consequently, in the light of what has been held in paragraphs 75 to 81 above, the complaint alleging failure to take into consideration data on endocrine disruption must be rejected as unfounded.

83      In the second place, as regards the failure to take into consideration data on the risk to birds and mammals, non-target arthropods, soil organisms and toxicological reference values, the applicants refer to the ‘scientific data’ which they submitted before the expert meetings of 28 January and 11 February 2019.

84      In that regard, it is clear, once again, that those are data submitted after the expiry of the time limit for the submission of the additional information requested by EFSA in accordance with the first subparagraph of Article 13(3) of Implementing Regulation No 844/2012. It must be borne in mind that, on 4 July 2018, EFSA had requested the applicants to provide further information within one month, that is to say, by 4 August 2018, and that, under Article 13(5) of Implementing Regulation No 844/2012, information submitted without having been requested or submitted after expiry of the time limit set for its communication in accordance with the first subparagraph of paragraph 3 is not to be taken into account.

85      In those circumstances, the Commission cannot be criticised for the initial RMS’s failure to take account of that data during the procedure for renewal of the approval of mancozeb.

86      In the third place, in their reply, the applicants allege that, during the evaluation of mancozeb, the interim criteria for endocrine disruption set out in point 3.6.5 of Annex II to Regulation No 1107/2009 should have been applied and that, on the basis of those interim criteria, that active substance should not have been considered to have endocrine disrupting properties. In that regard, at the hearing, they alleged infringement of Article 13(3)(a) of Implementing Regulation No 844/2012, a provision in force at the material time, which provides for the application of new endocrine disruption criteria for applications made before 30 November 2018 and for which EFSA had not yet tabled conclusions. The applicants also took the view at the hearing that that provision should not have been applied to them if the authorities involved in the procedure for the renewal of mancozeb had complied with the time limits applicable in that procedure. According to the applicants, in compliance with those time limits, EFSA’s conclusions should have been adopted before 30 June 2017, the date on which the provisional endocrine disruption criteria applied.

87      It should be borne in mind that Article 84(1) of the Rules of Procedure of the General Court provides that no new plea in law may be introduced in the course of proceedings unless it is based on matters of law or fact which have come to light in the course of the procedure.

88      According to the case-law, that provision is also applicable to submissions or arguments. Furthermore, the general nature of the heading of a plea relied on at the stage of the application initiating proceedings cannot cover the development, at a later stage of the proceedings, of specific arguments which are not sufficiently closely connected with the arguments raised in that application (see judgment of 14 July 2021, AQ v eu-LISA, T‑164/19, not published, EU:T:2021:456, paragraph 59 and the case-law cited).

89      However, a submission or complaint which constitutes an amplification of a plea or submission previously made, either expressly or by implication, in the original application and is closely linked to it must be declared admissible (see judgment of 24 September 2019, Yanukovych v Council, T‑301/18, not published, EU:T:2019:676, paragraph 74 and the case-law cited). In order to be regarded as amplifying a plea or submission previously put forward, a new argument must present, with the pleas or heads of claim initially set out in the application, a sufficiently close connection to be regarded as forming part of the normal evolution of debate in proceedings before the Court (see judgment of 20 November 2017, Petrov and Others v Parliament, T‑452/15, EU:T:2017:822, paragraph 46 and the case-law cited).

90      In the present case, it must be held that there is nothing in the application to indicate that the failure by the authorities involved in the procedure for the renewal of mancozeb to comply with the time limits, as described in paragraph 86 above, was mentioned therein. The plea alleging infringement of, inter alia, Article 13 of Implementing Regulation No 844/2012 cannot be read as implicitly setting out such an argument.

91      At the hearing, although the applicants relied on a paragraph of the application and an annex cited therein, it must nevertheless be noted that that paragraph does not refer to the provisional endocrine disruption criteria or compliance with time limits so that those criteria are applied in the present case. Furthermore, it is apparent from the annex cited that the applicants merely asked the Commission to invite EFSA to update its conclusions in the light of the new findings of the new RMS. That request bears no relation to the procedure which took place before the new RMS was involved, however, including in particular compliance with its time limits.

92      Consequently, the argument alleging non-compliance with the time limits by the authorities involved in the procedure for the renewal of mancozeb, as described in paragraph 86 above, must be regarded as new and therefore inadmissible.

93      In addition, the applicants also state at the reply stage that the assessment carried out by the two RMS corresponds to an evaluation of ETU’s endocrine disruption properties, and not of mancozeb. That argument is ineffective as it is formally put forward in support of the first plea, but will be addressed in the context of the examination of the fourth plea, alleging manifest errors of assessment (see paragraphs 153 to 157 below). That argument relates to the substantive issue, and not to compliance with the procedure and procedural rights at issue in the context of the first two pleas.

94      In the light of the foregoing, the complaint alleging that certain data was not taken into consideration by the initial RMS due to the initial date for its withdrawal from the European Union must be rejected.

2.      The complaint alleging failure to comply with the renewal procedure laid down in Implementing Regulation No 844/2012

(a)    The alleged lack of public consultation on the new RMS’s assessment and EFSA’s conclusions on that assessment

95      The applicants submit, in essence, that the implication of the Commission’s decision to continue the procedure for renewal of mancozeb, without making the new RMS’s assessment subject to public consultation and without ensuring that EFSA produced its conclusions on that assessment, is that the contested implementing regulation is based on an incomplete assessment and is, therefore, scientifically unreliable, meaning that the Commission exceeded its regulatory powers as risk manager and usurped EFSA’s mandate as risk assessor.

96      As a preliminary point, it should be noted that Implementing Regulation No 844/2012, which lays down, inter alia, the rules concerning the various stages of the procedure for the renewal of an active substance, including that involving its evaluation by the RMS (see paragraph 59 above), does not contain any provision concerning the conduct of those stages in the event of the appointment of a new RMS during that procedure.

97      Thus, given that Implementing Regulation No 844/2012 is silent as to the conduct of the procedure for the renewal of an active substance in the event of the designation of a new RMS in the course of that procedure, the designation of a new RMS cannot be regarded as requiring the evaluation procedure provided for in Articles 12 and 13 of that implementing regulation to be recommenced.

98      In addition, it is apparent from Articles 11 to 14 of Implementing Regulation No 844/2012 (see paragraph 59 above) that the RMS’s assessment as part of the renewal procedure for a substance is one of the mandatory stages of that procedure. It is compulsory for that assessment to be submitted to EFSA and the applicant and be the subject of public consultation, followed by the adoption of EFSA’s conclusions, unless the Commission decides to inform EFSA that such conclusions are not necessary (see the second subparagraph of Article 13(1) of Implementing Regulation No 844/2012).

99      In the present case, the appointment on 1 February 2020 of the new RMS for the evaluation of mancozeb and its assessment of that substance took place after completion of the process of assessment of mancozeb’s risks by the initial RMS in its draft RAR of September 2017, as updated by the draft RAR of March 2019, and by EFSA in its conclusions of 12 June 2019 (see paragraphs 17, 18 and 20 above). Accordingly, in the present case, the applicants had already had the opportunity to submit comments, on 16 July 2019, thus making use of their rights under Article 12(3) of Implementing Regulation No 844/2012, on the updated draft RAR of March 2019 and EFSA’s conclusions of 12 June 2019 (see paragraphs 10 and 21 above).

100    Nevertheless, the applicants submit, in essence, that if they had had the opportunity to submit their comments on the new RMS’s assessment, namely the updated draft RAR of September 2020, and if the Commission had asked EFSA to update its conclusions of 12 June 2019, the Commission might have submitted a different proposal to the standing committee. In that regard, they observe that in the section of its September 2020 report concerning human health, the new RMS had identified a safe use for single applications of the substance in the area of non-dietary exposure (in other words for operators, workers and persons living nearby). Furthermore, in the residues sections, a safe use was identified in the report, particularly for cereals, grapevines and potatoes.

101    In that regard, it should be borne in mind that it is apparent from the draft RAR of March 2019 that the initial RMS proposed that mancozeb be found not to satisfy the conditions for approval laid down in Article 4 of Regulation No 1107/2009, given that mancozeb was considered to be an endocrine disruptor for humans and that there was a risk resulting from non-dietary exposure, as well as a risk to birds and mammals, non-target arthropods and soil organisms (see paragraph 18 above).

102    Similarly, in its conclusions of 12 June 2019, EFSA expressed certain specific concerns (see paragraph 44 above). In particular, it concluded that mancozeb was classified as a toxic substance for reproduction category 1B and that the new criteria for identifying endocrine disrupting properties were met for humans and most likely for non-target organisms. It also concluded that the non-dietary exposure estimates exceeded the reference values for the representative uses in tomatoes, potatoes, cereals and grapevines. Consequently, in its view, for the representative uses considered, nor could non-dietary exposure to mancozeb be considered negligible in terms of endocrine disrupting properties causing adverse effect in humans (point 3.6.5 of Annex II to Regulation No 1107/2009). EFSA also considered that, in view of the concerns raised, nor could the derogation provided for in Article 4(7) of Regulation No 1107/2009 apply.

103    It is true that, in its updated draft RAR of September 2020, following its own assessment of the mancozeb risks, the new RMS found that, by altering the GAP on cereals and using water-soluble bags, it was possible to identify a use that was safe for human health (that is to say, for operators, workers and persons living nearby) (see paragraph 38 above). The applicants stated, in their replies to the measures of organisation of procedure, that that conclusion related only to non-dietary exposure to mancozeb.

104    However, as the Commission points out, without being challenged on this point by the applicants, the new RMS’s assessment led to the same conclusion as that of the initial RMS in its draft RAR of March 2019, namely that mancozeb did not satisfy the conditions for approval laid down in Article 4 of Regulation No 1107/2009. In its assessment, the new RMS stated, inter alia, that mancozeb was considered to be an endocrine disruptor for humans and non-target organisms and that there was a risk to birds and mammals as well as non-target arthropods (see paragraph 38 above).

105    As noted in paragraph 98 above, in the context of the procedure for the renewal of a substance, it is for the RMS and EFSA to carry out a scientific assessment. In the present case, it is apparent that the new RMS’s conclusions are not substantively different from EFSA’s conclusions as regards two concerns identified, first, that mancozeb was considered an endocrine disruptor for humans and non-target organisms and, second, that there was a risk to birds and mammals as well as non-target arthropods.

106    It follows that those concerns had already been assessed by the initial RMS and EFSA and that the new RMS had adopted the same position in that regard.

107    Furthermore, at the hearing, the Commission argued, without being challenged on the point by the applicants, that each risk identified was sufficient on its own for the non-renewal of mancozeb. It is true that the possibility of concluding that there was a safe use for human health concerning non-dietary exposure to mancozeb, identified by the new RMS in its evaluation (see paragraph 103 above), could mean, as indicated by the applicants during the procedure for the renewal of the substance at issue (see paragraph 39 above), that they could apply for the derogation provided for in Article 4(7) of Regulation No 1107/2009. However, that derogation is not applied at the scientific assessment stage, but at the risk management stage.

108    Moreover, as is apparent from recital 12 of Regulation No 1107/2009, in the procedure for approval of plant protection products at EU level, it is the Commission which assumes the risk management role and takes the final decision concerning an active substance.

109    Thus, in the circumstances described in paragraphs 99 to 108 above, and having regard to the broad discretion conferred on the Commission by Regulation No 1107/2009 to adopt appropriate protection measures at the stage of managing risks identified during the scientific evaluation, the Commission could choose to continue with the procedure for the renewal of mancozeb without submitting the new RMS’s assessment to public consultation and without ensuring that EFSA would produce its conclusions on that assessment.

110    In the light of the foregoing considerations, the applicants’ argument that the Commission exceeded its regulatory powers as risk manager and usurped EFSA’s mandate as risk assessor must be rejected. Nor can their argument concerning the Commission’s usual practice of mandating EFSA to update its conclusions succeed. In the present case, the Commission performed its function as provided for by Regulation No 1107/2009. Moreover, the applicants do not specify how the four examples on which they rely are comparable to the situation in the present case and how they establish that the implication of the Commission’s decision in the present case to continue the procedure is that the contested implementing regulation is based on an incomplete and therefore scientifically unreliable assessment of the risks.

111    In the light of the foregoing, the complaint alleging failure to comply with the renewal procedure as a result of the Commission’s decision to continue the procedure for renewal of mancozeb without submitting the assessment of the new RMS to public consultation and without ensuring that EFSA produces its conclusions on that assessment must be rejected.

(b)    The alleged lack of public consultation on any updated version of EFSA’s conclusions

112    The applicants state that a public consultation on any updated version of EFSA’s conclusions is required by Article 12(3) of Implementing Regulation No 844/2012.

113    As the Commission correctly states, that provision does not require EFSA’s conclusions or their updated version to be the subject of public consultation, as that kind of consultation is required only for the draft RAR. This complaint must therefore be rejected.

(c)    The adoption by the Commission of its draft renewal report of January 2020 before the end of the assessment by the new RMS

114    The applicants complain that the Commission adopted its renewal report in January 2020 before the new RMS completed its assessment. It is true that, before the completion of that assessment and the expiry of the time limit set by the Commission in that regard, at the beginning of March 2020, in January 2020 the Commission adopted a draft renewal report pursuant to Article 14 of Implementing Regulation No 844/2012. It forwarded that draft to the applicants on 16 January 2020, giving them a time limit in that regard of 31 January 2020, and submitted the draft implementing regulation to the standing committee containing the proposal not to renew mancozeb for inclusion on the agenda of the meeting of 23 and 24 March 2020 (see paragraphs 26, 31 and 32 above).

115    Nevertheless, it is clear from the file that, later in the procedure for the renewal of mancozeb, namely in October 2020, the Commission sent the applicants and the standing committee the updated version of its draft renewal report following the submission by the new RMS of the updated version of the draft RAR of September 2020 (see paragraphs 38 to 42 above).

116    In those circumstances, it cannot be maintained that the Commission adopted its renewal report before the new RMS completed its own risk assessment. Consequently, this complaint must be rejected in so far as it has no factual basis.

117    In conclusion, in the light of the foregoing, the complaint alleging failure to comply with the renewal procedure provided for in Implementing Regulation No 844/2012 must be rejected as unfounded, as must, therefore, the first plea as well.

3.      The alleged infringement of the applicants’ rights of defence

118    The Court notes that the applicants’ arguments examined in paragraphs 95 to 111 above are essentially the same as those which they put forward in their second plea, alleging infringement of their rights of defence in that they were not given an opportunity to comment on the draft RAR of September 2020, in accordance with Article 12(1) of Implementing Regulation No 844/2012. It should be noted that the applicants do not put forward, in the context of the second plea, any specific evidence as to the aspects on which they wished to express their views in that regard. They again object to how the procedure following the draft RAR of September 2020 was conducted and, more specifically, the complete lack of public consultation about that draft RAR under Article 12 of Regulation No 1107/2009. In the light of the conclusion drawn in paragraph 111 above, the second plea must therefore also be rejected.

C.      Third plea in law: infringement of the principle of sound administration

119    The applicants submit that the Commission failed to carry out an impartial assessment of the risks associated with mancozeb. They argue that it curtailed the evaluation procedure for that substance by proposing that it not be renewed without waiting for the final risk assessment by the new RMS and EFSA’s final conclusions. In the applicants’ submission, that approach taken by the Commission reflects its unwillingness to renew mancozeb, which led it to take a biased decision as quickly as possible, thereby vitiating all subsequent decisions by bias.

120    The applicants submit that the Commission’s bias is also demonstrated by the fact that, in July 2020, it commenced a procedure for the permanent committee to vote in writing on the proposal for non-renewal of mancozeb, pursuant to Article 3(5) of Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ 2011 L 55, p. 13). The applicants maintain that such a procedure pursued a political objective of prohibiting mancozeb.

121    The applicants add that the Commission did not make any substantive change to its updated renewal report, which shows that it had already taken its decision on non-renewal of mancozeb. In that regard, they draw attention to two aspects. First, that report simply refers to the fact that the new RMS had submitted its assessment on 2 September 2020, but does not contain any substantive assessment or any request addressed to EFSA to carry out such an assessment, even though the new RMS had identified a safe use for mancozeb. Second, that same report is dated 23 October 2020 and states that it was ‘finalised by the [standing committee] on 23 October 2020’, which was the date of the standing committee meeting at which the substance was banned, whereas the report was sent to the applicants on 21 September 2020.

122    At the hearing, the applicants stated that the Commission’s bias is also apparent from the fact that it had not taken account of all the relevant factors before its proposal that mancozeb not be renewed in February 2020. More specifically, they stated that the Commission had proposed that non-renewal before obtaining the assessment of the new RMS.

123    The Commission disputes the applicants’ arguments.

124    It is apparent from the settled case-law of the Court of Justice that it is for the institutions, bodies, offices and agencies of the European Union to comply with both components of the requirement of impartiality, which are, first, subjective impartiality, under which no member of the institution concerned may show bias or personal prejudice, and, second, objective impartiality, in accordance with which that institution must offer guarantees sufficient to exclude any legitimate doubt as to bias (see, to that effect, judgment of 27 March 2019, August Wolff and Remedia v Commission, C‑680/16 P, EU:C:2019:257, paragraph 27 and the case-law cited).

125    It is apparent from the dossier that the contested implementing regulation was adopted after the new RMS’s assessment had been completed and after the Commission had adopted the updated version of its draft renewal report in order to take account of the new RMS’s assessment. Thus, although the Commission proposed the non-renewal of mancozeb in January 2020, that is, before the new RMS had finalised its assessment (see paragraph 26 above), the final decision was not taken before that assessment.

126    It follows that the applicants’ argument alleging that the Commission was biased in failing to take account of the new RMS’s assessment after its proposal not to renew mancozeb in January 2020 is unfounded. For the same reasons, it is necessary to reject, first, their argument relating to the commencement of the written voting procedure on the Commission’s proposal not to renew mancozeb in July 2020 and, second, their claim that such a written procedure sought to achieve a political objective of prohibiting that substance.

127    As regards the applicants’ argument that the Commission did not make any substantive change to its updated renewal report, which shows that it had already taken its decision not to renew mancozeb, suffice it to observe that that assertion is not supported by any evidence. In that regard, it was found that the new RMS’s assessment led to the same conclusion as that of the initial RMS in its draft RAR of March 2019, namely that mancozeb did not satisfy the conditions for approval laid down in Article 4 of Regulation No 1107/2009 and that the Commission could opt to continue with the procedure for the renewal of mancozeb without submitting the new RMS’s assessment to public consultation and without ensuring that EFSA would produce its conclusions on that assessment (see paragraphs 101 to 109 above). In those circumstances, it cannot be considered that the decision not to renew the substance in question was simply taken from by the position expressed by the Commission in February 2020. In the light of those considerations, the applicants’ argument relating to the failure to take EFSA’s final conclusions into account must also be rejected.

128    As regards the applicants’ argument that the updated version of the Commission’s draft renewal report of 21 September 2020 was dated 23 October 2020 and stated that it had been ‘finalised by the [standing committee] on 23 October 2020’, the Commission explained that it was its practice to add dates to the reports according to the scheduled date of the meetings of the standing committee at which reports were to be finalised. In the light of that explanation, which is not disputed by the applicants, it must be concluded that the procedure followed by the Commission offered sufficient guarantees to dispel all legitimate doubt as to any bias on its part.

129    In the light of the foregoing, the third plea must be rejected.

D.      Fourth plea in law: manifest error of assessment

130    The applicants submit that the Commission made manifest errors of assessment in the mancozeb renewal procedure, for three reasons.

131    First of all, they state that, in the contested implementing regulation, the Commission relied on a classification proposal that was based on the properties of the metabolite ETU and not on the properties of the substance itself. The Commission thus incorporated irrelevant factors into its decision-making process relating to mancozeb. In that regard, the applicants submit that it is clear from Article 3(32) of Regulation No 1107/2009 that metabolites are not to be a decisive factor in the renewal procedure for an active substance. The Commission’s approach is also inconsistent with the principle according to which each substance must be assessed separately on the basis of its own intrinsic properties.

132    Next, the applicants criticise the Commission for failing to take account of significant new factors supporting the classification of mancozeb as toxic for reproduction category 2 in the context of the CLH dossier. More specifically, they refer to scientific flaws in the classification of mancozeb as a toxic substance for reproduction category 1B and to the Republic of Malta’s notification of its intention to submit a new classification dossier for that substance to ECHA in March 2020, confirming the category 2 classification of the substance. The applicants also refer to subsequent updates to the ECHA registry of intentions on 4 May and 13 July 2020 They further submit that the Commission ignored the recent studies relied on by them in their comments on EFSA’s conclusions, even though those studies refuted the conclusions of a 1980 study on the basis of which the RAC had proposed that mancozeb should be classified as a toxic substance for reproduction category 1B.

133    Lastly, the RAC opinion proposing that mancozeb should be classified as a toxic substance for reproduction category 1B is not legally binding, as only delegated acts deciding on the procedure for classifying a substance and published in the Official Journal of the European Union are legally binding.

134    The Commission disputes the applicants’ arguments.

135    It is appropriate to begin by examining the complaints alleging, first, that the classification of mancozeb as a toxic substance for reproduction category 1B is not legally binding and, second, that the Commission failed to take account of significant new factors concerning the classification of mancozeb as a toxic substance.

1.      The complaint that the classification of mancozeb as a toxic substance for reproduction category 1B is not legally binding

136    As a preliminary point, it should be noted that EFSA’s conclusions, set out in recital 12 of the contested implementing regulation, to the effect that mancozeb had ‘been classified as toxic for reproduction category 1B’ (see paragraph 44 above), was based on the RAC’s opinion (see paragraph 47 above) adopted in November 2018 on the proposal of the initial RMS of August 2017 (see paragraph 45 above), submitted to ECHA pursuant to Regulation No 1272/2008.

137    Regulation No 1272/2008 lays down, inter alia, rules concerning the various stages of the procedure for the harmonisation of the classification and labelling of substances. In accordance with Article 37(4) thereof, where a proposal for classification is submitted to the ECHA, the RAC set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1, corrigendum OJ 2007 L 136, p. 3) is to adopt an opinion on that classification proposal, which opinion ECHA is to forward to the Commission, along with any comments received from the parties concerned. Article 37(5) of that regulation provides that, where the Commission finds that the harmonisation of the classification of the substance concerned is appropriate, it is to submit a draft decision concerning the inclusion of that substance together with the relevant classification elements in the list of harmonised classifications of hazardous substances.

138    As the applicants state, in essence, the RAC’s opinion is merely a recommendation in the context of the harmonised classification and labelling procedure for an active substance, since only delegated acts adopted in the context of the procedure for classifying a substance and published in the Official Journal are legally binding. Moreover, as is also apparent from the information available in the dossier, at the time of adoption of the contested implementing regulation on 14 December 2020, no delegated act on the substance classification procedure had yet been adopted following the RAC’s opinion. It follows that, on that date, mancozeb was formally classified as a toxic substance for reproduction category 2 for developmental toxicity, which the Commission does not dispute.

139    The question thus arises whether EFSA, and then the Commission, could take into consideration the RAC’s opinion on the classification of mancozeb as a toxic substance for reproduction category 1B, given that, formally, at the time of the adoption of EFSA’s conclusions and the contested implementing regulation, that substance was classified as toxic for reproduction category 2 for developmental toxicity.

140    According to the case-law, as is apparent from Article 4(1) and (7) and point 3.6.4 of Annex II to Regulation No 1107/2009, the elements emerging from the harmonised classification and labelling procedure for an active substance, governed by Regulation No 1272/2008, may have a substantive impact on the approval of that substance under Regulation No 1107/2009 (see, to that effect, judgment of 19 December 2019, Probelte v Commission, T‑67/18, EU:T:2019:873, paragraph 91). The question whether an active substance is or should be classified in a particular hazard class may be relevant not only for the purpose of identifying and communicating the hazards of substances, in accordance with Regulation No 1272/2008, but also for the purposes of determining whether or not it meets the approval criteria provided for in Article 4 of Regulation No 1107/2009.

141    However, it is also apparent from the case-law that the procedures laid down in Regulations No 1272/2008 and No 1107/2009 are separate, each of them being organised according to its own rules (see, to that effect, judgment of 19 December 2019, Probelte v Commission, T‑67/18, EU:T:2019:873, paragraph 91). First, in accordance with Regulation No 1272/2008, operators are required to classify and label substances or mixtures in a certain way, and ECHA is the competent authority for classifying or reclassifying substances as hazardous. Second, under Regulation No 1107/2009, active substances are checked for the purpose of approving their placing on the market, and assessing compliance with objective categories or classes of hazard belonging to EFSA.

142    However, the fact that the RAC’s opinion adopted in the context of the harmonised classification and labelling procedure for mancozeb is not legally binding does not diminish the scientific value of that opinion and, therefore, does not prevent it from being taken into consideration for the purposes of the approval of an active substance under Regulation No 1107/2009. In that regard, as the Commission observes, the existence of a formal classification of an active substance is not decisive for the purposes of its approval under Regulation No 1107/2009. Under point 3.6.4 of Annex II to Regulation No 1107/2009, an active substance is to be approved only if it is ‘not’ or ‘not to be’ classified as toxic for reproduction category 1A or 1B in accordance with the provisions of Regulation No 1272/2008.

143    In the light of the foregoing, it must be held that the Commission did not commit a manifest error of assessment when it took into consideration, for the purposes of the procedure for the renewal of mancozeb, the RAC’s opinion on the classification of that substance as toxic for reproduction category 1B, despite the fact that it is not legally binding for the purposes of the procedure for harmonising classification and labelling provided for in Regulation No 1272/2008.

2.      The complaint alleging that the Commission failed to take account of significant new factors concerning the classification of mancozeb as a toxic substance

144    By this complaint, the applicants again object to how EFSA and subsequently the Commission took account of the RAC’s opinion. First, they submit that that opinion is based on an old study, the Gallo study dating from 1980, which does not comply with the applicable guidelines, in particular as regards the number of animals, posology and duration of exposure. In calling into question the reliability of that study, they rely on a recent study from 2015 on developmental toxicity. Second, according to the applicants, that RAC opinion does not present the latest scientific advances for the purposes of classifying mancozeb as a toxic substance. In their submission, the Commission should have taken into account the Republic of Malta’s notification concerning its intention to submit a new classification dossier for that substance to ECHA in March 2020, confirming the classification of mancozeb as a toxic substance for reproduction category 2.

145    Article 114(3) TFEU, on which inter alia Regulation No 1107/2009 is based, provides that, in its proposals concerning health, safety, environmental protection and consumer protection which have as their object the establishment and functioning of the internal market, the Commission is to take as a base a high level of protection, taking account in particular of any new development based on scientific facts. Furthermore, it has been held that that protection, in particular of public health and the environment, takes precedence over economic considerations, with the result that it may justify adverse economic consequences, even those which are substantial, for certain traders. It follows from those principles, which constitute the basis of the general protection goal of that regulation, that, unless otherwise specified, the decisions which the Commission is required to take in the context of that regulation must always take account of the latest scientific and technical knowledge (see judgment of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 289 and the case-law cited).

146    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 58 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 that provision that the need for new information is aimed inter alia at meeting data requirements or criteria which did not apply at the time of the last approval of the active substance. Furthermore, it is for applicants to identify that new scientific information.

147    Second, as regards the supplementary dossiers submitted for renewal, recital 8 of Implementing Regulation No 844/2012 indicates that such dossiers should include necessary new data and new risk assessments. In that regard, it is apparent from Article 7 of that implementing regulation, relating to the content of supplementary dossiers, that those dossiers must include data and risk assessments which were not included in the approval dossier or subsequent renewal dossiers and which are necessary to reflect, inter alia, changes in legal requirements which have occurred since the approval or last renewal of the approval of the active substance concerned and changes in scientific and technical knowledge since the approval. It is also for applicants to identify the new information in question.

148    In the present case, the RAC’s opinion was adopted in the context of the procedure for harmonising the classification and labelling of substances in accordance with Regulation No 1272/2008. As is apparent from paragraph 137 above, the RAC carries out its scientific evaluation on any proposal submitted in the context of that procedure.

149    Thus, it was under Regulation No 1272/2008, and not under Regulation No 1107/2009, that the RAC adopted its opinion on the classification of mancozeb as a toxic substance for reproduction category 1B, a classification which was adopted by EFSA and subsequently by the Commission in the context of the procedure for the renewal of that substance under Regulation No 1107/2009. It follows that any complaint alleging that that classification by the RAC is not well founded must be examined solely in the light of the rules laid down in Regulation No 1272/2008, with the result that the applicants may not rely on an alleged material infringement occurring in that procedure in order to call into question the lawfulness of the contested implementing regulation. Accordingly, the complaint alleging that the RAC’s opinion is based on an old study must be rejected.

150    As to whether the Commission could consider the RAC’s opinion to be the latest scientific development for the purposes of classifying mancozeb as a toxic substance, it should be noted that that opinion was adopted on a proposal from the initial RMS and before EFSA’s conclusions were adopted in the procedure for the renewal of that substance (see paragraphs 45 to 47 above), namely when the scientific assessment of mancozeb was under way in that procedure. It follows that the RAC’s opinion could be regarded as a document showing the most recent scientific knowledge concerning the classification of mancozeb as a toxic substance, especially since, during the procedure for the renewal of that substance, the applicants provided the data requested by EFSA after the expiry of the time limit for their communication.

151    Furthermore, as regards the Republic of Malta’s notification concerning its intention to submit a new classification dossier for mancozeb to ECHA in March 2020, it should be noted, as the Commission did, that the submission of a dossier by a competent authority of a Member State is only the first stage of the procedure for the harmonisation of the classification and labelling of substances in accordance with Regulation No 1272/2008, without prejudice to the final outcome. According to the information available in the dossier, on the date of adoption of the contested implementing regulation, that proposal had not yet been assessed from a scientific point of view in the context of that procedure.

152    Accordingly, it must be held that the Commission did not make a manifest error of assessment when it relied on the RAC’s opinion, and not on the notification from the Republic of Malta in question, to propose the classification of mancozeb as a toxic substance.

3.      The complaint alleging that the RAC’s opinion accorded undue influence to the metabolite ETU rather than to the substance itself

153    The applicants claim that the Commission adopted a proposal for classification of mancozeb as a toxic substance for reproduction category 1B on the basis of the properties of the metabolite ETU and not on the properties of the substance itself. In so doing, the applicants confirm that that proposal is apparent from the RAC’s opinion.

154    As held in paragraph 149 above, the applicants may not rely on an alleged material infringement occurring in the context of the procedure for the harmonisation of the classification and labelling of substances in accordance with Regulation No 1272/2008 in order to call into question the lawfulness of the contested implementing regulation.

155    Moreover, although the applicants state that it follows from Article 3(32) of Regulation No 1107/2009 that metabolites are not a determining factor in the procedure for the renewal of an active substance, it is nevertheless apparent from that article that, in certain cases, metabolites may be so.

156    In that regard, Article 3(32) of Regulation No 1107/2009 provides as follows:

‘…

A metabolite is deemed relevant if there is a reason to assume that it has intrinsic properties comparable to the parent substance in terms of its biological target activity, or that it poses a higher or comparable risk to organisms than the parent substance or that it has certain toxicological properties that are considered unacceptable. Such a metabolite is relevant for the overall approval decision or for the definition of risk mitigation measures[.]’

157    Second, as regards the applicants’ argument that each substance must be assessed separately on the basis of its intrinsic properties, it is common ground that mancozeb is a metabolised substance. In that regard, the applicants do not dispute the Commission’s contention that, if a substance is metabolised and the resulting metabolites produce critical effects, that is relevant for the classification of an active substance, since it is exposure to the substance that leads to the critical toxic effect (directly or through metabolic activity in humans).

158    Accordingly, the applicants’ arguments in support of the present complaint do not demonstrate that the RAC’s opinion accorded undue influence to the metabolite ETU rather than to the substance itself. The present complaint must therefore also be rejected as unfounded.

159    In the light of the foregoing, the Commission did not commit a manifest error of assessment and, consequently, the fourth plea must be rejected.

E.      Fifth plea in law: infringement of the principle of protection of legitimate expectations

160    The applicants claim that the Commission infringed the principle of protection of legitimate expectations on three occasions.

161    First, they had a well-founded legitimate expectation that the modified GAP which they had proposed to the initial RMS would be duly assessed, based on the Commission’s recommendation, in its email of 12 February 2019, to ‘contact the [initial] RMS on this matter’, and the fact that the initial RMS itself had advised them to contact the authorities of the new RMS in order to have the new GAP assessment completed. In that regard, the applicants quote an EFSA document of March 2019, containing administrative guidance on dossiers and assessment reports for peer review of active substances, which states that ‘the GAP is a fundamental element of the dossier and assessment report since it sets out the details of the representative uses which are being applied for’.

162    Second, the applicants expected that, after an extension of time had been granted to the new RMS for it to make its own assessment, the renewal procedure for mancozeb would be suspended until that assessment had been completed. The applicants observe that the Commission published a renewal report proposing the non-renewal of the substance one month after it had granted an extension of time for the new RMS to complete its assessment, and two months before the time limit it had agreed with the authorities of the new RMS.

163    Third, the applicants consider that the Commission gave them legitimate assurances when it stated, in its letter of 10 June 2020, that it would be ready to ‘reconsider the situation, once the additional evaluation [to be carried out by the new RMS had been] delivered’. According to the applicants, the Commission failed to take account of that written assurance in that its updated renewal report on mancozeb simply referred to the report delivered by the new RMS and did not contain any substantive changes to reflect the assessment carried out by the new RMS.

164    The Commission disputes the applicants’ arguments.

165    It should be borne in mind that the right to rely on the principle of the protection of legitimate expectations extends to any individual who is in a situation in which it is apparent that the EU administration, by giving him or her precise assurances, has led him or her to entertain justified expectations (judgments of 15 July 2004, Di Lenardo and Dilexport, C‑37/02 and C‑38/02, EU:C:2004:443, paragraph 70, and of 17 December 1998, Embassy Limousines & Services v Parliament, T‑203/96, EU:T:1998:302, paragraph 74). The right to rely on that principle assumes that three conditions are satisfied. First, precise, unconditional and consistent assurances originating from authorised and reliable sources must have been given to the person concerned by the administration. Second, those assurances must be such as to give rise to a legitimate expectation on the part of the person to whom they are addressed. Third, the assurances given must comply with the applicable rules (see judgment of 15 July 2015, Socitrel and Companhia Previdente v Commission, T‑413/10 and T‑414/10, EU:T:2015:500, paragraph 174 and the case-law cited).

166    In the present case, first of all, it is true that, in its email of 12 February 2019, the Commission proposed that the applicants contact the initial RMS concerning the amendments to GAP on cereals (see paragraph 15 above). It is also true that, on that occasion, the initial RMS advised them, in its email of 18 February 2019, to contact the authorities of the new RMS in order to deal as soon as possible with their request to evaluate those changes in the case of mancozeb (see paragraph 16 above). However, those two statements, one on the part of the Commission and the other on the part of the initial RMS, do not amount to a precise and unconditional assurance that amendments to GAP on cereals would be taken into consideration in the evaluation of mancozeb’s risks either by the initial RMS or by the new RMS. In addition, the Commission warned the applicants that ‘normally such changes [were] not permitted since this [could] impact the risk assessment and delay and complicate the peer-review’.

167    Next, the fact that the Commission granted the new RMS an additional period in which to carry out its own assessment cannot be regarded as equivalent to precise assurances given to the applicants that the procedure for the renewal of mancozeb would be suspended pending the outcome of that evaluation. On the contrary, it is apparent from the dossier that the Commission informed the new RMS of its intention to continue the decision-making process on mancozeb and to submit the renewal report in that regard in accordance with Article 14 of Implementing Regulation No 844/2012 on the basis of EFSA’s conclusions and the initial RMS’s RAR, for the meeting of the standing committee of March 2020 (see paragraph 25 above). The applicants have not adduced any other evidence to show that assurances were given by the Commission regarding the suspension of the procedure in question.

168    Lastly, the Commission’s willingness, declared in its letter of 10 June 2020, to reconsider the situation when the new RMS had completed its assessment (see paragraph 35 above) cannot be interpreted as a precise assurance that it would change its position with regard to mancozeb as compared with that expressed in the draft renewal report of January 2020 and that it would abide by the conclusions of the new RMS in its assessment. Furthermore, in the same letter, after noting that the preliminary findings of the new RMS did not contain sufficient information to consider a revision of the proposal not to renew mancozeb, the Commission added that ‘it remain[ed] to be seen whether the further evaluation announced by [the new RMS] [would] have that potential’. That last observation by the Commission clearly shows the absence of precise assurances on its part regarding the change in its position with regard to mancozeb as compared with that expressed in the draft renewal report of January 2020.

169    Thus, it is not apparent from the file that the Commission gave the applicants precise assurances such as to give rise to justified hopes on their part. The fifth plea must therefore be rejected as unfounded.

170    In view of all the above, the action must be dismissed in its entirety.

 Costs

171    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.

172    Since the applicants have been unsuccessful, they must be ordered to bear their own costs and to pay those incurred by the Commission in the present action, in accordance with the form of order sought by the Commission.

173    Furthermore, by order of 19 March 2021, Indofil Industries (Netherlands) v Commission (T‑742/20 R, not published, EU:T:2021:199), upheld on appeal by order of 16 July 2021, Indofil Industries (Netherlands) v Commission (C‑276/21 P(R) and C‑276/21 P(R)-R, not published, EU:C:2021:634), the President of the General Court dismissed the application for suspension of operation of the contested implementing regulation, lodged by Indofil Industries (Netherlands), and reserved the costs. Indofil Industries (Netherlands) must therefore be ordered to bear its own costs and to pay those incurred by the Commission in the proceedings for interim measures before the Court, in accordance with the form of order sought by the Commission.

On those grounds,

THE GENERAL COURT (Seventh Chamber)

hereby:

1.      Dismisses the action;

2.      Orders UPL Europe Ltd and Indofil Industries (Netherlands) BV to bear their own costs and to pay those incurred by the European Commission in the present action;

3.      Orders Indofil Industries (Netherlands) to bear its own costs and to pay those incurred by the Commission in the proceedings for interim measures.

da Silva Passos Valančius Reine

Delivered in open court in Luxembourg on 15 February 2023.

E. Coulon M. van der Woude

Registrar President

Table of contents

I. Background to the dispute

A. Approval of mancozeb at EU level

B. Renewal of the approval of mancozeb at EU level

C. Harmonised classification and labelling of mancozeb under Regulation No 1272/2008

II. Forms of order sought

III. Law

A. Preliminary observations

1. The procedure for approval and renewal of plant protection products at EU level

(a) Regulation No 1107/2009

(b) Implementing Regulation No 844/2012

2. The scope of the Court’s review

3. The burden of proof

B. First and second pleas in law: infringement of essential procedural requirements and infringement of the applicants’ rights of defence

1. The complaint alleging failure by the initial RMS to take certain data into consideration due to the initial date of its withdrawal from the European Union

2. The complaint alleging failure to comply with the renewal procedure laid down in Implementing Regulation No 844/2012

(a) The alleged lack of public consultation on the new RMS’s assessment and EFSA’s conclusions on that assessment

(b) The alleged lack of public consultation on any updated version of EFSA’s conclusions

(c) The adoption by the Commission of its draft renewal report of January 2020 before the end of the assessment by the new RMS

3. The alleged infringement of the applicants’ rights of defence

C. Third plea in law: infringement of the principle of sound administration

D. Fourth plea in law: manifest error of assessment

1. The complaint that the classification of mancozeb as a toxic substance for reproduction category 1B is not legally binding

2. The complaint alleging that the Commission failed to take account of significant new factors concerning the classification of mancozeb as a toxic substance

3. The complaint alleging that the RAC’s opinion accorded undue influence to the metabolite ETU rather than to the substance itself

E. Fifth plea in law: infringement of the principle of protection of legitimate expectations

Costs

*      Language of the case: English.

1      This judgment is published by extracts.