JUDGMENT OF THE GENERAL COURT (Fifth Chamber)
6 October 2021 (*)
(Plant protection products – Active substance chlorothalonil – Non-renewal of inclusion in the annex to Implementing Regulation (EU) No 540/2011 – Assessment procedure – Rights of the defence – Proposed classification of an active substance – Legal certainty – Proportionality – Precautionary principle)
In Case T‑518/19,
Sipcam Oxon SpA, established in Milan (Italy), represented by C. Mereu and P. Sellar, lawyers,
applicant,
v
European Commission, represented by F. Castilla Contreras, A. Dawes and I. Naglis, acting as Agents,
defendant,
APPLICATION under Article 263 TFEU seeking annulment of Commission Implementing Regulation (EU) 2019/677 of 29 April 2019 concerning the non-renewal of the approval of the active substance chlorothalonil, 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 Commission Implementing Regulation (EU) No 540/2011 (OJ 2019 L 114, p. 15).
THE GENERAL COURT (Fifth Chamber),
composed of D. Spielmann, President, O. Spineanu-Matei and R. Mastroianni (Rapporteur), Judges,
Registrar: S. Jund, Administrator,
having regard to the written part of the procedure and further to the hearing on 28 April 2021,
gives the following
Judgment
Background to the dispute
1 Chlorothalonil is an active substance used, inter alia, as a fungicide for cereals, potatoes and vegetables.
2 The applicant, Sipcam Oxon SpA, is a company which markets, inter alia, chlorothalonil and plant protection products containing chlorothalonil in the European Union. Together with two other companies, the applicant is part of the ‘Chlorothalonil Task Force’, which cooperates in order to submit relevant data to the competent EU authorities for the renewal of the approval of chlorothalonil.
3 Chlorothalonil was included in 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) by Commission Directive 2005/53/EC of 16 September 2005 amending Directive 91/414 to include chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl as active substances (OJ 2005 L 241, p. 51).
4 The active substances listed in Annex I to Directive 91/414 are deemed to be approved under 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) and are listed in Part A of 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). The approval of chlorothalonil, as resulting from its inclusion in that annex, expired on 31 October 2019.
5 On 26 February 2013, the applicant submitted an application for the renewal of the approval of chlorothalonil in accordance with Article 1 of 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) within the period provided for in that article. The applicant was one of the three companies that submitted an application for the renewal of chlorothalonil.
6 In April 2015, the applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation No 844/2012. The rapporteur Member State (‘the RMS’), the Kingdom of the Netherlands, confirmed that the dossier was complete.
7 On 2 September 2016, the RMS, in consultation with the co-rapporteur Member State, the Kingdom of Belgium, submitted a draft of the renewal assessment report (‘the RAR’), which it sent to the European Food Safety Authority (‘EFSA’) and to the Commission.
8 On 24 October 2016, in accordance with Article 12 of Implementing Regulation No 844/2012, EFSA distributed the initial evaluation to all Member States and to the applicant for comment.
9 On 21 December 2016, the applicant submitted its comments.
10 The consultation period ended on 24 December 2016.
11 On 4 January 2017, EFSA forwarded all the comments to the Commission. The collated comments were forwarded to the RMS for compilation and evaluation in the format of a reporting table, as well as to the applicant, which was invited to respond to them by 20 January 2017.
12 On 24 February 2017, EFSA and the RMS agreed on the need for expert consultation and for additional information to be submitted by the applicant in accordance with Article 13(3) of Implementing Regulation (EU) No 844/2012.
13 On 28 February 2017, the applicant received that request for additional information.
14 In accordance with Article 13(3) of Implementing Regulation No 844/2012, the one-month procedure to ‘stop the clock’ began on 28 February 2017 and ended on 28 March 2017.
15 On 24 March 2017, the members of the Chlorothalonil Task Force replied to the request for additional information.
16 In August 2017, the revised RAR drawn up by the RMS was submitted for the EFSA expert meeting.
17 Between 11 and 14 September 2017, 13 and 15 September 2017, 19 and 21 September 2017, and 18 and 22 September 2017, expert meetings in the areas of mammalian toxicology, e-fate, residues and ecotoxicology took place. The opinion from the expert meeting concluded that the classification of chlorothalonil as carcinogen category 1B could not be excluded. Further, the experts considered that the acute risk to amphibians and chronic risk to fish was unacceptable. In addition, the view was taken that all groundwater metabolites were considered relevant due to the carcinogenic potential of the substance and a ‘read across’ approach was no longer considered appropriate. A genotoxicity concern for metabolites R417888 and SDS 3701 could not be excluded, and a data gap in the risk assessment for the consumer was identified.
18 On 6 December 2017, EFSA sent the Commission its conclusion on the peer review of the risk assessment of the active substance chlorothalonil (‘the EFSA Conclusion’).
19 On 29 January 2018, the Commission requested the applicant to submit its comments on the EFSA Conclusion by 19 February 2018.
20 On 19 February 2018, the applicant provided comments to the Commission on the EFSA Conclusion.
21 On 17 April 2018, the applicant requested that the Commission revise its position in the light of the applicant’s comments.
22 On 18 June 2018, the Commission issued the draft renewal report in respect of the substance at issue and sent it to the applicant. It invited the applicant to provide comments thereon within 14 days.
23 On 1 July 2018, the applicant provided comments on the draft renewal report in respect of the substance at issue.
24 The non-renewal proposal in respect of the substance at issue was discussed during the ‘SCoPAFF’ (Standing Committee on Plants, Animals, Food and Feed) meetings of 19-20 July 2018. Further discussions were held in the subsequent SCoPAFF meeting of 23-24 October 2018. On 22 March 2019, the SCoPAFF voted in favour of a decision not to renew the substance at issue.
25 In February 2019, the applicant sent additional statements to the Commission.
26 On 29 April 2019, the Commission adopted Commission Implementing Regulation (EU) 2019/677 concerning the non-renewal of the approval of the active substance chlorothalonil, in accordance with Regulation No 1107/2009, and amending Implementing Regulation No 540/2011 (OJ 2019 L 114, p. 5) (‘the contested regulation’). Recitals 9 to 11 of the contested regulation state as follows:
‘(9) A critical concern was identified by [EFSA] in relation to the contamination of groundwater by metabolites of chlorothalonil. In particular, metabolites R417888, R419492, R471811, SYN507900, M3, M11, M2, M7and M10 are predicted to occur above the parametric value of 0,1 μg/L in all pertinent scenarios for all proposed uses of chlorothalonil. Therefore, it cannot currently be established that the presence of metabolites of chlorothalonil in groundwater will not result in unacceptable effects on groundwater and in harmful effects on human health as required by Article 4(3)(b) of Regulation … No 1107/2009. Furthermore, [EFSA] could not exclude a genotoxicity concern for residues to which consumers will be exposed and identified a high risk to amphibians and fish for all the uses evaluated.
(10) Furthermore, several areas of the risk assessment could not be finalised due to insufficient data in the dossier. In particular, the assessment of consumer risk from dietary exposure could not be completed because of lack of data to confirm the definition of the residue in plants and the livestock exposure assessment, including the toxicological assessment of a metabolite.
(11) Additionally, chlorothalonil is classified as carcinogen category 2 in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council … while in the [EFSA Conclusion] it is indicated that chlorothalonil should be classified as carcinogen category 1B. For the representative uses considered, residue levels as referred to in point (b) of Article 18(1) of Regulation (EC) No 396/2005 could not be confirmed for plant and animal products due to lack of data on the magnitude and toxicity of metabolites that are included in the residue definition for risk assessment. Consequently, the requirement set out in Point 3.6.3 of Annex II to Regulation … No 1107/2009 is not fulfilled.’
Procedure and forms of order sought
27 By application lodged at the Court Registry on 22 July 2019, the applicant brought the present action.
28 By a separate document lodged at the Court Registry on 30 July 2019, the applicant lodged an application for interim relief, seeking suspension of the operation of the contested regulation and the adoption of appropriate interim measures.
29 On 10 October 2019, the Commission lodged its defence.
30 The reply was lodged at the Court Registry on 9 December 2019. The rejoinder arrived at the Court Registry on 7 February 2020.
31 By order of 26 September 2019, Sipcam Oxon v Commission (T‑518/19 R, not published, EU:T:2019:696), the President of the General Court dismissed the application for interim measures and reserved the costs.
32 On a proposal from the Judge-Rapporteur, the Court decided to open the oral part of the procedure.
33 The parties presented oral argument and replied to the questions put by the Court at the hearing on 28 April 2021.
34 The applicant claims that the Court should:
– annul the contested regulation;
– order the Commission to pay the costs.
35 The Commission contends that the Court should:
– dismiss the action;
– order the applicant to pay the costs.
Law
36 In support of its action, the applicant relies on six pleas in law, in which it alleges that the Commission (i) made manifest errors of assessment, (ii) infringed the rights of the defence, (iii) infringed the prohibition on acting ultra vires, (iv) infringed the principles of legal certainty and of the protection of legitimate expectations, (v) infringed the principle of proportionality and (vi) infringed the precautionary principle.
The first plea in law, alleging that the Commission made manifest errors of assessment
37 The applicant claims that the contested regulation is vitiated by manifest errors of assessment, in so far as the Commission erred when it identified concerns about the substance at issue and data gaps in its assessment. That plea can be divided into four parts concerning, respectively, (i) the assessment of the relevance of metabolites contaminating groundwater, (ii) concerns about the genotoxicity of residues, (iii) risks for amphibians and fish, and (iv) data gaps.
Assessment of the relevance of metabolites contaminating groundwater
38 The applicant alleges that the Commission made a manifest error of assessment as to the relevance of the metabolites of chlorothalonil which are capable of contaminating groundwater following the use of plant protection products containing chlorothalonil.
39 First, the applicant claims that the rejection of the read-across approach was based on the comments from what proved to be only a minority of experts from the 28 Member States. There was no simple majority of all Member States; rather, there was at best a majority only of those who submitted comments.
40 Second, according to the applicant, the relevant guidance document had expressly permitted the read-across approach, and both the RMS and EFSA considered that that method, which had been used by the applicant, was valid.
41 Third, the applicant claims that the Commission was duty bound, as guardian of the Treaties, to examine whether the rejection of the read-across approach was sound and correct both scientifically and legally. The applicant argues that the Commission was, moreover, required to do so because it had adopted guidance stating that this was a valid approach, as supported by the RMS, EFSA and other Member States. To the extent that the definition of the read-across approach was unclear, the benefit of that doubt should have been given to the approach chosen by the applicant.
42 Lastly, the applicant submits that, by using the read-across approach, it demonstrated that metabolites related to the substance at issue were not relevant in groundwater.
43 The Commission disputes the applicant’s arguments.
44 As a preliminary point, it should be noted that, according to recital 9 of the contested regulation, ‘a critical concern was identified by [EFSA] in relation to the contamination of groundwater by metabolites of chlorothalonil[;] in particular, metabolites R417888, R419492, R471811, SYN507900, M3, M11, M2, M7 and M10 are predicted to occur above the parametric value of 0,1 μg/L in all pertinent scenarios for all proposed uses of chlorothalonil[;] therefore, it cannot currently be established that the presence of metabolites of chlorothalonil in groundwater will not result in unacceptable effects on groundwater and in harmful effects on human health as required by Article 4(3)(b) of Regulation … No 1107/2009.’
45 Furthermore, it should be noted that the guidance document applicable in the present case (Sanco/221/2000 – rev. 10 – final, 25 February 2003) states that ‘for parent active substances classified as category 1 or category 2 carcinogens (Carc. Cat. 1; R 45) or (Carc. Cat. 2; R 45) all metabolites are considered to be “relevant”[;] for parent active substances classified as category 3 carcinogens (Carc. Cat. 3; R 40), convincing evidence must be provided that the metabolite will not lead to any risk of carcinogenicity[;] this may be done by appropriate carcinogenicity testing, by the provision of mechanistic evidence (e.g. absence of the likely mechanistic effect leading to carcinogenicity with the parent molecule, such as target organ pathology, peroxisome proliferation, cytochrome P450 induction or metabolism of thyroid hormones) or by a convincing toxicological assessment taking into consideration all available data.’
46 It should be noted, as the Commission has pointed out, that the terminology used in the guidance document refers to the classifications provided for by Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ, English Special Edition 1967 (I), p. 234), and not to the legislation currently in force on the classification of substances, that is to say 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 and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1). The classification of chlorothalonil as carcinogen category 2 within the meaning of Regulation No 1272/2008 corresponds to substances classified as carcinogen category 3 (Carc. Cat. 3; R 40) within the meaning of Directive 67/548.
47 Consequently, it must be held that, on the basis of the harmonised classification applicable to the substance at issue for the purposes of the relevant guidance document (Sanco/221/2000 – rev. 10 – final, 25 February 2003), the applicant was required to adduce evidence establishing that metabolites of chlorothalonil were not carcinogenic.
48 However, the peer review concluded that the applicant had not succeeded in proving that those metabolites were not carcinogenic.
49 As regards the read-across approach, it should be noted, as was confirmed by the parties at the hearing, that, although the relevant guidance document permitted recourse to that approach, the use of that approach was not compulsory, contrary to what the applicant claims. In the present case, the experts expressed doubts on the use of the read-across approach proposed by the applicant; most of the participating experts did not consider that approach appropriate in order to confirm that the metabolites of chlorothalonil were not carcinogenic. Furthermore, as regards the applicant’s argument that the rejection of the read-across approach was based on the comments of a minority of experts from the 28 Member States, it should be noted that it does not indicate which provision of the applicable legislation requires all the Member States to be represented in the peer review process. Nor does the applicant explain how the fact that the Commission accepted the opinion expressed by the majority of the experts who submitted comments constitutes a manifest error of assessment.
50 Accordingly, that part of the first plea in law must be rejected.
Concerns about the genotoxicity of residues
51 The applicant alleges that the Commission made a manifest error of assessment as regards genotoxicity concerns. It considers that, on the basis of the scientific data in the renewal dossier, the Commission should not have raised a concern in the contested regulation.
52 Specifically, according to the applicant, in the light of the overwhelming scientific evidence that the metabolites of the substance at issue do not have genotoxic potential, the Commission did not take into account, first, all of the available data submitted by the applicant on genotoxicity linked to the metabolites of the substance at issue, which included both in-vivo and in-vitro studies, and, second, other available data, including all bacterial reverse mutation assays and the other three mammalian gene mutation assays, used at similar and higher concentrations. Taken together, those data clearly demonstrate that the metabolites of the substance at issue do not have genotoxic potential.
53 As regards metabolites R417888, R613636 and R182281, the applicant states that, during the procedure to ‘stop the clock’, it provided adequate data to exclude any concern as to genotoxicity.
54 The applicant claims that new concerns were raised during the EFSA expert meeting, concerns which neither it nor the RMS could anticipate, and to which the applicant was not allowed to respond by submitting further data.
55 The Commission disputes the applicant’s arguments.
56 In that regard, it should be noted, first of all, that, contrary to what is claimed, in essence, by the applicant, a disagreement between the opinion of the RMS and the EFSA Conclusion does not constitute a manifest error of assessment. It is clear from the regulatory framework that the RMS’s position in the assessment process is not decisive. The RMS gathers the data and suggests a decision, but it is the Commission which ultimately decides (see, to that effect, judgments of 9 September 2008, Bayer CropScience and Others v Commission, T‑75/06, EU:T:2008:317, paragraph 164, and of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 269). The peer review process ensures that the RMS’s assessment is thoroughly examined by experts from other Member States and by EFSA, and that those other opinions are taken into account.
57 As regards the information submitted by the applicant concerning the genotoxicity of the relevant metabolites, it must be noted, as the Commission has argued, that it is apparent from the EFSA Conclusion regarding metabolite R417888, that the applicant provided insufficient data on gene mutation and aneugenicity, two of the three parameters that must be examined for the purpose of determining genotoxic potential in accordance with the EU data requirements applicable to active substances. In addition, in the same conclusion, it is stated that the experts took the view, during the peer review, that the studies provided by the applicant did not address aneugenicity as regards the metabolite R613636 and that, for the metabolite R182281, the in-vivo follow-up was necessary given that the in-vitro gene mutation tests had yielded positive and equivocal results.
58 The applicant claims, in its reply, that the concerns relating to genotoxicity had been raised for the first time during the EFSA expert meeting, that it could not anticipate them and that it was not allowed to respond by submitting further data.
59 In that regard, it must be borne in mind that, contrary to what is claimed by the applicant, the RMS’s initial opinion concerning the adequacy of the data does not show any manifest error of assessment. The purpose of the peer-review phase is precisely to examine the RMS’s initial opinion and to reach a general conclusion as to whether a substance meets the approval criteria. The objection alleging that the applicant was not allowed to submit further data will be examined in the context of the second plea in law.
60 In any event, as regards the genotoxic potential of the metabolite R417888, doubts concerning that metabolite had already been raised at the time of the ‘stop-the-clock’ procedure and were confirmed by a request for additional information concerning that metabolite which was sent during that period of that procedure.
61 In the light of the foregoing, this part of the first plea in law must be rejected.
Risks to amphibians and fish
62 The applicant claims that, by concluding that there was a risk to amphibians and fish, the Commission failed to take into account the available and valid scientific data that had been presented during the renewal process of the substance at issue.
63 First, according to the applicant, the experts should have concluded, like the RMS did, that the study submitted by it which had been carried out using the pulsed-dose approach excluded any risk to amphibians and fish.
64 Second, contrary to what is advocated in the relevant guidance document, EFSA was wrong to reject the approach favouring a combined risk assessment. In particular, it made a manifest error of assessment in that it required data relating to amphibians to be submitted even though that submission was not required by law, and in that it refused to take into consideration information based on a combined assessment of amphibians and fish.
65 The applicant adds that the Commission underestimates the role of the RMS, which was its main interlocutor throughout the procedure. That approach is confirmed by guidance document Sanco/10387/2010 (Rev. 8 – 28 October 2010) and by the EFSA ‘Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances’.
66 Lastly, the applicant claims that EFSA found, in essence, that the risk for amphibians and fish was low.
67 The Commission disputes the applicant’s arguments.
68 In the present case, it must be held, first of all, that, as has already been pointed out in connection with the second part of the present plea, any disagreement between the RMS and the majority of the experts does not constitute evidence of a manifest error of assessment, since the opinion of the RMS is only a first stage in the assessment.
69 Furthermore, as regards the passage from the relevant guidance document concerning aquatic organisms relied on by the applicant, it should be noted that, contrary to what the applicant claims, that document confirms that the relevance of a combined risk assessment covering both amphibians and fish is a matter to be assessed by experts. In that regard, it should be noted that the experts concluded that, on the basis of the available data, a combined assessment was impossible, in particular because the data on amphibians showed that their sensitivity was greater than that of fish. Consequently, the applicant’s objection that EFSA was wrong to reject the approach using a combined risk assessment must be rejected.
70 Lastly, the applicant’s claim that EFSA found, in essence, that the risk for amphibians and fish was low is incorrect. On the contrary, in the EFSA Conclusion it concluded that the risk was high: ‘High risk to amphibians (acute and chronic) and to fish (chronic) for chlorothalonil was identified for all the representative uses’.
71 In the light of the foregoing, that part of the first plea in law must be rejected.
Data gaps
72 The applicant alleges a manifest error of assessment as regards the existence of data gaps. First, it claims that the RMS declared that the dossier submitted in July 2015 was ‘complete’, that sufficient data had been submitted in the renewal dossier for the substance at issue in order to show that there was no unacceptable chronic risk to human health from the consumption of foodstuffs such as tomatoes, barley, wheat and potatoes treated according to the uses envisaged for the substance at issue, and that any gaps became apparent only at a late stage in the procedure, in September 2017. Furthermore, the applicant was not asked for any additional data after the EFSA expert meeting.
73 Second, as regards the analytical methods used in the toxicological studies, the applicant submits, in the first place, that the available toxicological information was all in fact provided in the updated renewal dossier but that it was not taken into account and, in the second place, that that alleged data gap, taken in isolation or in combination with other alleged data gaps, is insufficient to justify the non-renewal of the substance at issue. The data gaps do not, in themselves, prevent approval of a substance.
74 The Commission disputes the applicant’s arguments.
75 In that regard, it should, first of all, be borne in mind that, according to recital 10 of the contested regulation, ‘the risk assessment could not be finalised due to insufficient data in the dossier[;] in particular, the assessment of consumer risk from dietary exposure could not be completed because of lack of data to confirm the definition of the residue in plants and the livestock exposure assessment, including the toxicological assessment of a metabolite’.
76 It should also be recalled, as was noted in the context of the second part of the present plea, that the studies provided by the applicant were insufficient to exclude the genotoxic potential of metabolites, which is relevant for the purposes of assessing the risk for consumers.
77 First, as regards the applicant’s argument that no data gap was noted by the RMS, it should be recalled, as has been pointed out previously in paragraph 56 above, that the opinion of the RMS is only the first stage of the assessment procedure. The fact, which is not disputed by the Commission, that the dossier which the applicant submitted in July 2015 was regarded as complete by the RMS is not decisive. As the Commission points out, the check of the completeness carried out by the RMS is merely a review designed to verify that all the required research reports are available. It is only during the subsequent evaluation by the RMS and during the peer review of that assessment that a qualitative check of the data submitted is carried out.
78 As regards, moreover, the applicant’s argument that the question of data gaps did not arise until September 2017, it suffices to note that, in February 2017, EFSA had already requested additional information from the applicant in respect of 120 points on which more data were necessary, in accordance with Article 13(3) of Regulation No 844/2012. At the time when the assessment was finalised, at the end of 2017, considerable data gaps remained. The EFSA Conclusion refers to 38 data gaps.
79 Second, as regards the applicant’s argument that the analytical methods used in the available toxicological studies were all provided in the updated renewal dossier but were not taken into account, it should be noted that the final renewal report for the active substance chlorothalonil states that the analytical methods used in the toxicological studies had not been identified.
80 In that regard, it is indeed true, as the applicant submits, that in March 2017 it sent a general presentation of all the analytical methods used in the toxicological studies (see Annex C.13). However, it should be noted that that document states, in the first place, that it is an overview of those methods and, in the second place, that ‘any omissions in the reported analytical methodology compared to current analytical reporting requirements are only due to changing requirements and do not express a lack of scientific diligence of the study directors’. In those circumstances, the Commission did not make a manifest error of assessment in finding, like EFSA did, that that information was insufficient to fill the data gaps concerning the analytical methodologies used in the toxicological studies.
81 Lastly, as regards the applicant’s argument that that alleged data gap, taken in isolation or in association with other alleged data gaps, is insufficient to justify the non-renewal of the substance at issue, it suffices to note that the data gaps are not the only reason which led to the non-renewal of that substance. In addition to the data gaps referred to in recital 10 of the contested regulation, there are also concerns as to, first, the contamination of groundwater by the metabolites of chlorothalonil, second, the genotoxicity of residues to which consumers will be exposed and, third, the high risk for amphibians and fish for all uses assessed, all of which were referred to in recital 9 of that regulation.
82 In those circumstances, that part of the first plea in law and, consequently, the first plea in law in its entirety must be rejected.
The second plea in law, alleging breach of the rights of the defence and of the right to be heard
83 By its second plea in law, the applicant claims that the Commission infringed its rights of the defence during the renewal procedure.
84 In particular, the applicant claims that it was unable effectively to make known its views on complex issues raised at a late stage of the renewal procedure, that is to say more than four years after the submission of the renewal dossier.
85 In addition, the applicant argues that the Commission did not react to its comments on the EFSA Conclusion or on the draft renewal report on the substance at issue. In that regard, it is not clear to the applicant whether or not the Commission properly took its comments into account.
86 Lastly, the applicant claims that it should have had the right to express its opinion at an oral hearing in order to discuss the new issues raised. Only one face-to-face meeting took place with one other member of the Chlorothalonil Task Force, in order to discuss its own products. That meeting was not directly related to the renewal process of the substance at issue.
87 The Commission disputes the applicant’s arguments.
88 In that regard, it should be noted, first, that, according to settled case-law, where an EU institution enjoys a broad discretion, the guarantees conferred by the EU legal order in administrative proceedings are of even more fundamental importance. Those guarantees include, in particular, the duty of the competent institution to examine carefully and impartially all the relevant aspects of the individual case (see judgment of 11 September 2002, Pfizer Animal Health v Council, T‑13/99, EU:T:2002:209, paragraph 171 and the case-law cited).
89 It follows 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).
90 It should also be noted that, according to settled case-law, respect for the rights of the defence is, in all proceedings initiated against a person which are liable to culminate in a measure adversely affecting that person, a fundamental principle of EU law which must be guaranteed even in the absence of any rules governing the proceedings in question. That principle requires that the addressees of decisions which significantly affect their interests should be placed in a position in which they may effectively make known their views (see, to that effect, judgments of 15 June 2006, Dokter and Others, C‑28/05, EU:C:2006:408, paragraph 74, and of 9 September 2008, Bayer CropScience and Others v Commission, T‑75/06, EU:T:2008:317, paragraph 130). The right to be heard in an administrative procedure taken against a specific person is a consequence of the rights of the defence which must be observed, even in the absence of any rules governing the procedure in question (see, to that effect, judgment of 11 September 2002, Alpharma v Council, T‑70/99, EU:T:2002:210, paragraph 388 and the case-law cited).
91 In the light of the factors mentioned above, in the first place, it should be noted that, in the present case, the renewal procedure for the substance at issue lasted from February 2013 to April 2019, that is to say more than six years.
92 It should also be noted that, during that period, the applicant was able to submit its comments in good time. As noted in paragraphs 5 to 26 above, the Commission received the applicant’s comments on the RMS’s RAR and on the EFSA Conclusion and its renewal report on the substance at issue.
93 It follows that the applicant was invited to submit its comments and that it made them in writing several times. In those circumstances, it must be held that the applicant has effectively exercised its rights of the defence.
94 In the second place, the applicant’s claim that new questions were raised for the first time at the end of 2017 cannot succeed.
95 First, it should be noted that the RMS did not initially recommend the renewal of the approval for chlorothalonil. On the contrary, it stated that ‘it [was] still inconclusive whether chlorothalonil [could] be approved under Regulation (EC) No 1107/2009[;] additional information (which [could] be submitted during the peer review) [was] needed to finalise the risk assessment’.
96 Second, the RAR had already identified those issues as creating a high chronic risk to fish in all representative uses, and it had not been possible to complete the risk assessment for amphibians.
97 Third, in February 2017, EFSA sent a request for additional information covering 120 points on which further data were necessary. Several parts of that request relate to the reasons for non-renewal.
98 As regards the applicant’s argument that the Commission did not take into consideration any other scientific evidence submitted by the applicant for renewal, it should be noted that, under Article 16(4) of Commission Regulation (EU) No 1141/2010 of 7 December 2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Directive 91/414 and establishing the list of those substances (OJ 2010 L 322, p. 10), new data submitted without having been requested or submitted after the end of the approval process and after the peer review could not be taken into consideration by the Commission.
99 Although it is true that no provision in Regulation No 1107/2009 expressly prohibits the Commission from examining additional data submitted after the end of the peer review, it should be noted that, according to recital 14 of that regulation, ‘to speed up the approval of active substances, strict deadlines should be established for the different procedural steps’. Regulation No 1107/2009 indeed provides for fairly strict time limits for each stage of the approval process. In that respect, it should be noted that Regulation No 1141/2010 adopts the same approach to structure the renewal process.
100 It must also be considered that an indefinite extension of the assessment period for an active substance would be contrary to the objective pursued by Regulation No 1107/2009 of ensuring a high level of protection of human and animal health and the environment.
101 The legal framework applicable to the renewal process does not therefore support the applicant’s assertion that it has a right to submit comments and additional information where issues remain at the end of the assessment process.
102 In those circumstances, the Commission cannot be criticised for refusing to examine additional data submitted after the end of the peer review.
103 In the third place, as regards the applicant’s argument that the Commission has not given it an opportunity to discuss the EFSA Conclusion or the draft renewal report orally during a hearing, it should be pointed out, as the Commission did, that the applicant does not have a general or absolute right to submit oral observations in addition to its option of sending written observations as provided for in Regulation No 1107/2009 and Implementing Regulation No 844/2012 (see, by analogy, orders of 21 March 2019, Troszczynski v Parliament, C‑462/18 P, not published, EU:C:2019:239, paragraphs 51 to 55; of 21 March 2019, Gollnisch v Parliament, C‑330/18 P, not published, EU:C:2019:240, paragraphs 59 to 61; and of 21 May 2019, Le Pen v Parliament, C‑525/18 P, not published, EU:C:2019:435, paragraphs 65 to 69).
104 Furthermore, it should be noted that, in December 2018, the Commission had a meeting with Syngenta, another member of the Chlorothalonil Task Force, which acted throughout the renewal process as spokesperson for the task force, assembling and submitting comments on behalf of all the members of that task force, including the applicant. At that meeting, the process for renewing chlorothalonil was discussed, as was confirmed by an email from Syngenta of 11 February 2019.
105 Lastly, the applicant’s claims that the Commission did not share its comments with the Member States and that those comments were not taken into consideration seriously cannot succeed either. In that regard, in the first place, it should be noted that that assertion is not substantiated. In the second place, those comments led the Commission, inter alia, to send a request for information to EFSA concerning a point raised regarding the contamination of groundwater (see Annex D.1).
106 In the light of the circumstances above, it must be concluded that the contested regulation does not infringe the applicant’s rights of the defence or its right to be heard. Accordingly, the second plea in law must be dismissed.
The third plea in law, alleging infringement of theprohibition on acting ultra vires
107 The applicant claims that the contested regulation was adopted ultra vires in so far as the Commission followed EFSA’s classification proposal. In support of the contested regulation, the Commission relied on a recommendation made by EFSA that chlorothalonil should be classified as carcinogen category 1B, despite EFSA having neither the mandate nor the competence to propose the classification of a substance.
108 The applicant states that there is no doubt that EFSA proposed a new classification and therefore acted ultra vires. According to the applicant, the relevant factor is not whether the substance’s category was changed, but is the fact that EFSA and, consequently, the Commission acted ultra vires by proposing a new classification. According to the applicant, it is only the European Chemicals Agency (‘ECHA’) which has the power to propose a new classification following a hazard assessment procedure.
109 In addition, the applicant claims that the statement that ‘EFSA clearly notes that such a suggestion for a classification does not constitute a formal proposal for a harmonised classification pursuant to Regulation No 1272/2008’ is incorrect in that EFSA cannot intervene in the classification procedure.
110 Lastly, the applicant submits that the Commission’s argument that this plea is ineffective is unsubstantiated since it does not develop it or provide any legal basis to substantiate it.
111 The Commission disputes the applicant’s arguments.
112 At the outset, it must be held, as the Commission submits, that the present plea is ineffective in that, even if the Commission could not rely on a proposal by EFSA that chlorothalonil should be classified as carcinogen category 1B, the other grounds for non-renewal of chlorothalonil referred to in recitals 9 and 10 of the contested regulation are sufficient in themselves to justify the operative part of the contested measure and are not vitiated by illegality, as was found in the context of the first plea (see, to that effect, judgment of 14 July 2021, Nike European Operations Netherlands and Converse Netherlands v Commission, T‑648/19, not published, EU:T:2021:428, paragraphs 140 and 141). It should be noted, in that regard, that, after setting out the principal grounds for non-renewal of chlorothalonil, the contested regulation also makes reference, in recital 11, to the classification of chlorothalonil as carcinogen category 2, which is potentially outdated.
113 In any event, as regards the substance of the argument raised by the applicant, it should be noted that recital 11 of the contested regulation states that, even though chlorothalonil is classified as carcinogen category 2 under Regulation No 1272/2008, EFSA takes the view that chlorothalonil should be classified as carcinogen category 1B. On that basis, the contested regulation concludes that the requirement set out in point 3.6.3 of Annex II to Regulation No 1107/2009 is not fulfilled.
114 Point 3.6.3 of Annex II to Regulation 1107/2009 provides that ‘an active substance, safener or synergist shall only be approved, if, on the basis of assessment of carcinogenicity testing carried out in accordance with the data requirements for the active substances, safener or synergist and other available data and information, including a review of the scientific literature, reviewed by [EFSA], it is not or has not to be classified, in accordance with the provisions of Regulation … No 1272/2008, as carcinogen category 1A or 1B, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with Article 18(1)(b) of Regulation (EC) No 396/2005’.
115 It is indeed true that, as is claimed by the applicant, EFSA is not competent to propose or decide on the hazard classification for plant protection product substances. Under the provisions of Regulation No 1272/2008, EFSA has no role to play either in the context of self-classification, which is open to any manufacturer, importer and downstream user of the substance concerned, or in the context of the harmonised classification, which may be proposed by the abovementioned actors or by the competent authority of a Member State and is subject to an opinion from ECHA. Moreover, it is misleading to refer to a ‘classification proposal’ since EFSA has no competence formally to propose that classification (judgment of 17 March 2021, FMC v Commission, T‑719/17, EU:T:2021:143, paragraphs 119 and 120).
116 However, it should be noted that, in the present case, point 3.6.3 of Annex II to Regulation No 1107/2009 acknowledges that ‘a review of the scientific literature, reviewed by [EFSA]’ has a role in determining whether the substance at issue ‘is not or has not to be classified, in accordance with the provisions of Regulation … No 1272/2008, as carcinogen category 1A or 1B’.
117 Therefore, in the present case, what is at issue is not a genuine classification proposal, by EFSA, in respect of the substance at issue, but rather the taking into account, in the exercise of the powers conferred on the Commission by Regulation No 1107/2009, of the review of the scientific literature examined by EFSA, according to which that substance should be classified as carcinogen category 1A or 1B.
118 In those circumstances, it must be held that the applicant’s claim that the contested regulation was adopted ultra vires is, in any event, unfounded.
119 In those circumstances, the third plea in law must be dismissed.
The fourthplea in law, alleging infringement of the principles of legal certainty and of the protection of legitimate expectations
120 The applicant alleges that the principle of legal certainty has been infringed. According to the applicant, first, the assessment of the relevance of the metabolites of chlorothalonil contradicts the relevant guidance document and, second, the high risk identified for amphibians and fish also contradicts the relevant guidance document.
121 The applicant claims that the infringement of the principle of legal certainty is therefore linked to the fact that it was legitimately expecting its data to be assessed on the basis of the standards and criteria set out by the applicable guidance in force when the dossier was submitted.
122 The Commission disputes the applicant’s arguments.
123 In that regard, suffice it to note that, as was pointed out in the analysis of the first plea, in paragraphs 45 to 49 and in paragraph 69 above, neither the assessment of the relevance of metabolites of chlorothalonil nor the identification of a high risk for amphibians and fish contradicts the relevant guidance documents. The applicant’s claims are therefore unfounded.
124 As regards the alleged infringement of the principle of the protection of legitimate expectations, it is settled case-law that any individual who has been caused to have justified expectations by specific assurances provided to him or her by an EU institution may rely on that principle (see, to that effect, judgment of 11 March 1987, Van den Bergh en Jurgens and Van Dijk Food Products (Lopik) v EEC, 265/85, EU:C:1987:121, paragraph 44; see also judgment of 8 September 2010, Deltafina v Commission, T‑29/05, EU:T:2010:355, paragraph 427 and the case-law cited).
125 In that regard, it is sufficient to note that the applicant, in its written pleadings, does not mention any assurance given to it by the Commission assuring it that it would obtain the renewal of the active substance in question.
126 In those circumstances, the fourth plea in law must be dismissed.
The fifth plea in law, alleging infringement of the principle of proportionality
127 The applicant claims that the contested regulation is disproportionate, since the Commission could have achieved the same objective by adopting less restrictive measures.
128 According to the applicant, applying the principle of proportionality to the renewal process of an active substance supposes that all options with regard to the renewal of the substance at issue are duly and carefully examined as well as any other reasonable solution to preserve the renewal of the substance at issue on the basis of a proper risk assessment before taking any decision on the substance at issue.
129 The applicant submits, in particular, that the Commission could have renewed the approval of chlorothalonil and allowed it to benefit from the confirmatory data procedure (‘the CDP’) under Article 6(f) of Regulation No 1107/2009. It states that, in the past, the Commission renewed certain active substances subject to the submission of confirmatory information.
130 The Commission could also have assessed the possibility of imposing risk mitigation measures on the renewal of the substance at issue in order to respond to the risk to amphibians and fish.
131 Lastly, the applicant claims that no risk mitigation measure in addition to those already proposed would have been necessary if new concerns had not been raised at a late stage of the renewal procedure. In any event, it maintains that the Commission, in its capacity as risk manager and in line with the principle of proportionality, can itself propose risk mitigation measures.
132 The Commission disputes the applicant’s arguments.
133 It should be recalled that, according to settled case-law, the principle of proportionality, which is one of the general principles of EU law, requires that measures adopted by institutions should not exceed the limits of what is appropriate and necessary in order to attain the legitimate objectives pursued by the legislation in question, and where there is a choice between several appropriate measures, recourse must be had to the least onerous, and the disadvantages caused must not be disproportionate to the aims pursued (judgments of 11 September 2002, Pfizer Animal Health v Council, T‑13/99, EU:T:2002:209, paragraph 411, and of 7 March 2013, Acino v Commission, T‑539/10, not published, EU:T:2013:110, paragraph 85; see also, to that effect, judgment of 18 November 1987, Maizena and Others, 137/85, EU:C:1987:493, paragraph 15).
134 Nevertheless, it should be noted that, in agricultural matters, judicial review of compliance with the principle of proportionality is special in so far as the Court of Justice and the General Court recognise that the EU legislature has a discretionary power which corresponds to the political responsibilities conferred on it by Articles 40 to 43 TFEU in that field. In the present case, the contested regulation is based on Regulation No 1107/2009 the legal basis of which is, inter alia, Articles 43 and 114 TFEU. Consequently, the legality of a measure adopted in that sphere can be affected only if the measure is manifestly inappropriate having regard to the objective which the competent institution is seeking to pursue (see, to that effect, judgments of 5 May 1998, National Farmers’ Union and Others, C‑157/96, EU:C:1998:191, paragraph 61, and of 3 September 2009, Cheminova and Others v Commission, T‑326/07, EU:T:2009:299, paragraph 195).
135 The applicant claims that the Commission could have chosen alternative approaches with less serious consequences, such as making use of the CDP, rather than adopting a decision not to renew the approval of chlorothalonil.
136 In that respect, it should be noted that Article 6(f) of Regulation No 1107/2009 does indeed provide that approval may be subject to conditions and restrictions such as the submission of further confirmatory information to Member States, the Commission and EFSA, where new requirements are established during the evaluation process or as a result of new scientific and technical knowledge. Point 2.2 of Annex II to Regulation No 1107/2009 provides for the possibility, in exceptional cases, that approval of the active substance may be granted even though certain information is still to be submitted where ‘the data requirements have been amended or refined after the submission of the dossier’ or where ‘the information is considered to be confirmatory in nature, as required to increase confidence in the decision’.
137 Under those provisions, it is not possible to have recourse to the CDP where the data should have been included in the renewal dossier at the time it was submitted and where adequate guidance is available to perform the assessment required. Those provisions may not be used to fill data gaps detected during the approval process. Furthermore, those provisions do not allow for the approval of active substances in respect of which the absence of harmful effects on human or animal health or the absence of unacceptable effects on the environment or on groundwater have not been demonstrated.
138 As regards the risk to groundwater, it has previously been noted in the context of the examination of the first plea that the Commission, in accordance with the precautionary principle and in its capacity as risk manager, had, without making a manifest error of assessment, considered the relevance, within the meaning of Regulation No 1107/2009, of the metabolites of chlorothalonil and had held that they were capable of contaminating groundwater following the use of plant protection products containing chlorothalonil.
139 Accordingly, the Commission was right not to have recourse to the CDP.
140 As regards the claim concerning the risk mitigation measures, it is sufficient to note, as the Commission does, that the applicant does not indicate any risk mitigation measure likely to reduce the risk to fish and amphibians or to resolve the problem of the contamination of groundwater by the relevant metabolites. Moreover, in view of the wide discretion which the Commission must be recognised as enjoying in order to enable it effectively to pursue the objective assigned to it by Regulation No 1107/2009, it cannot be obliged itself to propose risk mitigation measures.
141 In those circumstances, having regard to the broad discretion which the Commission must be recognised as enjoying in its application of Regulation No 1107/2009 and taking account of the complex technical assessments which it has to undertake, it must be held that the contested regulation does not appear manifestly disproportionate either as regards the risk to groundwater or as regards the risk to fish and amphibians.
142 The fifth plea in law must therefore be rejected.
The sixth plea in law, alleging infringement of the precautionary principle
143 By its sixth plea, the applicant claims that, by failing to carry out an adequate impact assessment, that is to say, a thorough assessment of the most likely positive or negative consequences of non-renewal of the substance at issue, before adopting the contested regulation, the Commission infringed the precautionary principle. It argues that the need to conduct an impact assessment has nothing to do with the burden of proof, but requires the institutions, before taking any decision, to consider the specific circumstances of the case and, then, balance all the options they have in order to apply the least burdensome measure. Lastly, the applicant expresses doubts as to the depth of the impact assessment allegedly carried out by the Commission.
144 The Commission disputes the applicant’s arguments.
145 It must be noted, at the outset, that, while Article 191(2) TFEU provides that the policy on the environment is to be based on, inter alia, the precautionary principle, that principle is also applicable in the context of other EU policies, in particular the policy on the protection of public health and where the EU institutions adopt, under the common agricultural policy or the policy on the internal market, measures for the protection of human health (see judgment of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraph 41 and the case-law cited).
146 There is therefore an obligation on the EU legislature, when it adopts rules governing the placing on the market of plant protection products, such as those laid down in Regulation No 1107/2009, to comply with the precautionary principle, in order to ensure, in particular, in accordance with Article 35 of the Charter of Fundamental Rights of the European Union and Article 9 and Article 168(1) TFEU, a high level of protection of human health (see judgment of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraph 42 and the case-law cited).
147 That principle entails that, where there is uncertainty as to the existence or extent of risks to human health, protective measures may be taken without having to wait until the reality and seriousness of those risks become fully apparent (see judgment of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraph 43 and the case-law cited).
148 According to settled case-law, the institutions of the European Union possess, in the implementation of measures to be taken for the protection of public health, a wide discretion regarding the definition of the objectives to be pursued and the choice of the appropriate means of action (see judgment of 11 February 2015, Spain v Commission, T‑204/11, EU:T:2015:91, paragraph 30 and the case-law cited).
149 In so far as the applicant claims that the Commission did not carry out any analysis of the costs and benefits of the impact of a renewal or non-renewal of the approval of chlorothalonil before adopting its decision, as is required by point 6.3.4 of Commission Communication COM(2000) 1 final of 2 February 2000 on the precautionary principle, it should be noted that that point 6.3.4, headed ‘Examination of the benefits and costs of action and lack of action’, is worded as follows:
‘A comparison must be made between the most likely positive or negative consequences of the envisaged action and those of inaction in terms of the overall cost to the [Union], both in the long and short term. The measures envisaged must produce an overall advantage as regards reducing risks to an acceptable level.
Examination of the pros and cons cannot be reduced to an economic cost-benefit analysis. It is wider in scope and includes non-economic considerations.
However, examination of the pros and cons should include an economic cost-benefit analysis where this is appropriate and possible.
Besides, other analysis methods, such as those concerning the efficacy of possible options and their acceptability to the public may also have to be taken into account. A society may be willing to pay a higher cost to protect an interest, such as the environment or health, to which it attaches priority.
The Commission affirms, in accordance with the case-law of the Court that requirements linked to the protection of public health should undoubtedly be given greater weight [than] economic considerations.
The measures adopted presuppose examination of the benefits and costs of action and lack of action. This examination should include an economic cost/benefit analysis when this is appropriate and feasible. However, other analysis methods, such as those concerning efficacy and the socio-economic impact of the various options, may also be relevant. Besides the decision-maker may, in certain circumstances, by guided by non-economic considerations such as the protection of health.’
150 First of all, in that regard, it should be noted that point 6.3.4 of the Communication on the precautionary principle provides for an examination to be carried out of the benefits and costs of action and lack of action. However, the format and scope of that examination are not specified. In particular, it is not at all apparent that the authority concerned is obliged to initiate a specific assessment procedure culminating, for example, in a formal, written assessment report. In addition, it is apparent from the text that the authority applying the precautionary principle enjoys considerable discretion regarding methods of analysis. Although the communication indicates that the examination ‘should’ include an economic analysis, the authority concerned must in any event also include non-economic considerations. Furthermore, it is expressly stated that it may be the case that, in certain circumstances, economic considerations must be considered less important than other interests which are given priority; interests such as the environment or health are expressly mentioned by way of example (judgment of 17 May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph 162).
151 Moreover, the requirements of the Communication on recourse to the precautionary principle are satisfied where the authority concerned – in the present case, the Commission – has in fact acquainted itself with the effects, positive and negative, economic and otherwise, to which the proposed action, as well as the failure to act, may lead, and has taken that into account in its decision. By contrast, it is not necessary for those effects to be estimated precisely, if that is not possible or requires disproportionate effort (judgment of 17 May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph 163).
152 It must be pointed out that, in the present case, the Commission did in fact acquaint itself with the effects, positive and negative, economic and otherwise, to which the renewal or non-renewal of the approval of chlorothalonil may lead, and that it took them into account in its decision.
153 Thus, it is apparent from a note on the Commission’s file of 5 December 2018 that the Commission took account of the costs and benefits of the non-renewal of the approval of chlorothalonil before adopting the non-renewal decision. The Commission stated that, ‘given the risks and data gaps identified, … the nature of these [risks overrules] economic considerations’. It was therefore aware of the challenges, both economic and environmental, linked to the use of the substances covered (see, to that effect, judgment of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 461).
154 It is indeed true, as the applicant submits, that the file contains no information on the depth of that analysis. However, it must be borne in mind that the format and scope of that examination are not specified in point 6.3.4 of the Communication on the precautionary principle and that it does not follow from that point that the authority concerned is required to provide detailed information on its analysis. Consequently, that objection must be rejected.
155 In the light of the foregoing, the sixth plea in law must be rejected and the action must be dismissed in its entirety.
Costs
156 Under Article 134(1) of the Rules of Procedure of the General Court, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. As the applicant has been unsuccessful, it must be ordered to bear its own costs and to pay those incurred by the Commission, in accordance with the form of order sought by the Commission, including the costs of the proceedings for interim measures.
On those grounds,
THE GENERAL COURT (Fifth Chamber)
hereby:
1. Dismisses the action;
2. Orders Sipcam Oxon SpA to pay the costs, including those relating to the proceedings for interim measures.
Spielmann | Spineanu-Matei | Mastroianni |
Delivered in open court in Luxembourg on 6 October 2021.