Provisional text
JUDGMENT OF THE GENERAL COURT (Fourth Chamber)
21 February 2024 (*)
(Plant protection products – Active substance cypermethrin – Implementing Regulation (EU) 2021/2049 – Request for internal review – Article 10(1) of Regulation (EC) No 1367/2006 – Rejection of the request – Identification of critical areas of concern by EFSA – Risk assessment and risk management – Precautionary principle – Discretion enjoyed by the Commission)
In Case T‑536/22,
Pesticide Action Network Europe (PAN Europe), established in Brussels (Belgium), represented by A. Bailleux, lawyer,
applicant,
v
European Commission, represented by A. Becker, G. Gattinara and M. ter Haar, acting as Agents,
defendant,
THE GENERAL COURT (Fourth Chamber),
composed of R. da Silva Passos, President, I. Reine and T. Pynnä (Rapporteur), Judges,
Registrar: H. Eriksson, Administrator,
having regard to the written part of the procedure,
further to the hearing on 12 October 2023,
gives the following
Judgment (1)
1 By its action based on Article 263 TFEU, the applicant, Pesticide Action Network Europe (PAN Europe), seeks the annulment of the European Commission’s decision of 23 June 2022 (‘the contested decision’) by which the latter rejected the request for internal review made by PAN Europe in accordance with Article 10 of Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ 2006 L 264, p. 13), in respect of Commission Implementing Regulation (EU) 2021/2049 of 24 November 2021 renewing the approval of the active substance cypermethrin as a candidate for substitution 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 2021 L 420, p. 6).
I. Background to the dispute
2 Cypermethrin is a pyrethroid insecticide. That family of insecticides is widely used within the European Union in order to combat crop pests. Cypermethrin is highly toxic to insects.
3 By Directive 2005/53/EC of 16 September 2005 amending Council Directive 91/414/EEC to include chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl as active substances (OJ 2005 L 241, p. 51), the Commission listed cypermethrin as an active substance 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). 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 included 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).
4 That approval was due to expire on 28 February 2016. However, owing to significant delays in the reassessment and decision-making processes, the approval was extended, by means of Commission implementing regulations, for one year in 2017, 2018, 2019, 2020 and 2021 by the Standing Committee on Plants, Animals, Food and Feed (‘the Standing Committee’).
5 As part of the procedure for the renewal of approval of cypermethrin, the rapporteur Member State (‘the RMS’), in consultation with the co-rapporteur Member State, prepared a draft renewal assessment report, which it submitted to the European Food Safety Authority (EFSA) and the Commission on 8 May 2017.
6 EFSA communicated the draft renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. EFSA then forwarded the comments received to the Commission.
7 On 31 July 2018, EFSA delivered a scientific opinion entitled ‘Peer review of the pesticide risk assessment of the active substance cypermethrin’ (‘EFSA’s conclusions’). In that document, EFSA identifies four ‘critical areas of concern’.
8 As is apparent from EFSA’s conclusions, it identifies one or more critical areas of concern in the following situations:
– if there is enough information available to perform an assessment for the representative uses in line with the uniform principles in accordance with Article 29(6) of Regulation No 1107/2009 and as set out in Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation No 1107/2009 as regards uniform principles for evaluation and authorisation of plant protection products (OJ 2011 L 155, p. 127), and if this assessment does not permit the conclusion that, for at least one of the representative uses, it may be expected that a plant protection product (‘PPP’) containing the active substance will not have any harmful effect on human or animal health, the environment or on groundwater, or any unacceptable influence on the environment;
– if the assessment at the higher tier level could not be finalised due to a lack of information, and if the assessment performed at the lower tier level does not permit the conclusion that for at least one of the representative uses it may be expected that a PPP containing the active substance will not have any harmful effect on human or animal health, the environment or on groundwater, or any unacceptable influence on the environment;
– if, in the light of current scientific and technical knowledge using guidance documents available at the time of application, the active substance is not expected to meet the approval criteria provided for in Article 4 of Regulation No 1107/2009.
9 In the case of cypermethrin, EFSA identified the following critical areas of concern:
– a high risk to aquatic organisms;
– a high risk to honeybees;
– a high off-field risk to non-target arthropods;
– a lack of knowledge concerning the composition of the batches of pesticides used in the ecotoxicity studies submitted by the applicants for approval, which did not permit EFSA to ensure that those batches of pesticides actually reflect representative uses of a plant protection product containing the active substance, for the purposes of Article 4(5) of Regulation No 1107/2009.
10 At the January 2019 meeting of the Standing Committee, the Commission presented a proposal for renewal of approval, restricting cypermethrin use to the autumn and winter seasons in order to protect honeybees and aquatic environments, with risk mitigation measures reducing pesticide drift into the environment by 95%, in order to prevent adverse environmental effects.
11 In the light of the refusal by a majority of the Member States to support a proposal for renewal of approval subject to such restrictions, the Commission asked EFSA to publish a statement on risk mitigation measures for cypermethrin.
12 In September 2019, EFSA published a Statement on risk mitigation measures on cypermethrin (‘the 2019 statement’). In it, EFSA states that only a risk mitigation measure which reduces pesticide drift by more than 95% would justify the conclusion of a low level of risk to aquatic organisms. It arrived at the same finding with respect to non-target arthropods. EFSA also points out that the studies provided do not cover cypermethrin use in autumn. EFSA also considers that, in order to protect honeybees, an absence of flowering weeds in the crop, a ban on spraying flowering crops and drift mitigation of 54% is sufficient, and that it is possible to conclude that there is a low level of risk.
13 Following numerous meetings of the Standing Committee, the Commission adopted Implementing Regulation 2021/2049 on 24 November 2021. That renewal of approval is, however, accompanied by a series of specific provisions set out in Annex I to that regulation.
14 On 20 January 2022, on the basis of Article 10(1) of Regulation No 1367/2006, the applicant sent the Commission a request for internal review of Implementing Regulation 2021/2049 with a view to obtaining its repeal or replacement by a regulation rejecting the application for the renewal of approval of the active substance cypermethrin. In that request, the applicant sets out the reasons why it considers that that regulation is contrary to the precautionary principle and to the European Union’s obligation to ensure a high level of protection of human health and the environment, as set out in Articles 9 and 11, Article 168(1) and Article 191(1) TFEU and Articles 35 and 37 of the Charter of Fundamental Rights, and as given concrete expression, so far as concerns plant protection products, by Regulation No 1107/2009, in particular in Article 4 thereof.
15 On 18 February 2022, the Commission requested technical and scientific assistance from EFSA concerning all the relevant scientific matters presented in the request for internal review. In response to that request, on 15 March 2022 EFSA published a technical report (‘the technical report’) limited to consideration of a single complaint put forward by the applicant, that relating to the failure to take certain studies from the independent literature into account in the examination of the endocrine disrupting properties of cypermethrin.
16 In an email of 18 July 2022, the Commission sent the applicant a French-language copy of the contested decision, to which was attached an annex setting out the reasons for the rejection of the request for internal review.
II. Forms of order sought
17 The applicant claims that the Court should:
– annul the contested decision;
– order the Commission to pay the costs.
18 The Commission contends that the Court should:
– dismiss the action;
– order the applicant to pay the costs.
III. Law
19 In support of its action, the applicant relies on a single plea in law, alleging breach of the precautionary principle and of the European Union’s obligation to ensure a high level of protection of human health and the environment, as set out in Articles 9 and 11, Article 168(1) and Article 191(1) TFEU and Articles 35 and 37 of the Charter of Fundamental Rights of the European Union, and as given concrete expression, so far as concerns plant protection products, by Regulation No 1107/2009, in particular Article 4 thereof.
20 The applicant’s single plea is divided into two parts. The first part of the plea is directed against the preliminary remarks contained in heading I of the annex to the contested decision. The second part of the plea is directed against the specific reasons put forward in Title II of that annex for rejecting the seven complaints raised by the applicant in its request for internal review.
21 As a preliminary point, it is necessary to examine the question of the starting point of the period for bringing an action under the sixth paragraph of Article 263 TFEU, as well as the arguments of the parties relating to the admissibility of certain arguments put forward by the applicant, in so far as those arguments are contested by the Commission. It is also appropriate to recall the scope of judicial review by the General Court.
A. Preliminary observations
1. The starting point of the period for bringing an action under the sixth paragraph of Article 263 TFEU
22 Although the admissibility of the action is not challenged by the Commission in the present case on the ground that it was out of time, the applicant maintained at the hearing that it was important for the Court to clarify the starting point of the period for bringing an action under the sixth paragraph of Article 263 TFEU, and stated that the starting point of that period was 18 July 2022, when the French-language copy of the contested decision was sent, and not 23 June 2022, when that decision was notified in English.
23 In that regard, it should first be recalled that, under Article 2 of Council Regulation No 1 of 15 April 1958 determining the languages to be used by the European Economic Community (OJ, English Special Edition, Series I, 1952-1958, p. 59), documents sent to institutions may be drafted in any one of the official languages selected by the sender and the reply is to be drafted in the same language.
24 Moreover, it should be noted that it is not apparent from any provision of Regulation No 1367/2006 that the legislature intended to derogate from the general provisions on the use of languages in Regulation No 1 and, in particular, from Article 2 of that regulation, as regards requests for internal review made under Article 10 of Regulation No 1367/2006.
25 In the present case, on 20 January 2022, the applicant made a request for internal review in French, concerning Implementing Regulation 2021/2049. It must therefore be held that it is the communication in French of the contested decision, which reached the applicant on 18 July 2022, which constitutes the starting point of the period for bringing an action referred to in the sixth paragraph of Article 263 TFEU.
26 Since the present action was lodged at the Court Registry on 31 August 2022, it must therefore be declared admissible.
2. The nature of an action based on Article 12 of Regulation No 1367/2006 and the scope of the rule of correspondence between the request for review and the action for annulment
27 While not contending that the action is inadmissible in its entirety, the Commission argues, in several passages of the defence and rejoinder, that certain arguments presented by the applicant had not been raised in its request for internal review. Such arguments should therefore be declared inadmissible, in accordance with the rule of correspondence between the request for review and the action for annulment. According to that rule, such annulment proceedings cannot be founded on new grounds or on evidence not appearing in the request for review (judgment of 12 September 2019, TestBioTech and Others v Commission, C‑82/17 P, EU:C:2019:719, paragraphs 38 and 39).
28 The Commission does not dispute that the applicant may, in support of its initial argument, respond to the arguments put forward in the contested decision, but the Commission argues that the applicant, in so doing, cannot support a new line of argument. This would alter the ‘scope’ of the procedure initiated by the request for review, which is precisely what it is necessary to prevent, according to recital 15 of Regulation (EU) 2021/1767 of the European Parliament and of the Council of 6 October 2021 amending Regulation (EC) No 1367/2006 (OJ 2021 L 356, p. 1) and paragraph 39 of the judgment of 12 September 2019, TestBioTech and Others v Commission (C‑82/17 P, EU:C:2019:719). In that regard, in the Commission’s submission, although the purpose of the internal review procedure is, admittedly, that of ensuring access to justice against acts liable to infringe environmental law, the use of that procedure should not undermine its ‘effectiveness’, which is related to maintaining the same ‘object’ throughout that procedure.
29 Moreover, the Commission recalls that the Court of Justice, in its judgment of 12 September 2019, TestBioTech and Others v Commission (C‑82/17 P, EU:C:2019:719), stated that the burden of proof of a party requesting an internal review concerns ‘facts or legal arguments’, without any limitation. This therefore leaves no room for ‘contextual elements’ to which the ‘rationale of correspondence does not apply’.
30 According to the Commission, the rationale of an action for annulment, as provided for in Article 12 of Regulation No 1367/2006, concerns only the quality and the merits of the response given to the request for review, which contains an assessment of the legality of a specific measure. If a party requesting an internal review is not satisfied with the response it has received, since its challenge under Article 12 specifically seeks to have that assessment of legality annulled, it cannot add new arguments without altering the object of the procedure initiated by the request for internal review.
31 It is clear from recital 21 of the preamble to Regulation 2021/1767 that the party making the request is required to submit, from the start of the procedure, matters of law or of fact which are sufficiently substantiated and give rise to ‘serious doubts’ as to the assessment made by the EU institution or body. The applicant cannot, therefore, rely on case-law relating to other legal proceedings, such as appeals or actions for failure to fulfil obligations, since that interpretation by analogy cannot derogate from the criteria for interpretation directly and specifically established by the Court of Justice in its case-law concerning Regulation No 1367/2006.
32 Accordingly, the action brought by the applicant, following the response to its request for internal review, cannot deprive the review procedure of its effectiveness and can have the objective only of ascertaining in practice whether the actual arguments or doubts put forward by the applicant in the request for review were addressed with due diligence and with plausible arguments.
33 The applicant challenges, in general terms, the Commission’s interpretation of the rule of correspondence. It states that the Commission appears to be seeking to place it in an impossible situation, since the Commission sometimes criticises the applicant for repeating the arguments put forward in the request for internal review without taking into account the arguments set out in the contested decision and sometimes objects that certain arguments are inadmissible, since they are new, because they were put forward by the applicant in response to arguments put forward by the Commission for the first time in the contested decision. Such an interpretation is manifestly contrary to the right to effective judicial protection and to the spirit of Regulation No 1367/2006.
34 It is apparent from recital 15 of Regulation 2021/1767 that the rule of correspondence prohibits applicants only from putting forward ‘grounds or … evidence not appearing in the request for review’, with a view to safeguarding the ‘purpose’ of the request for internal review and preventing applicants from ‘alter[ing]’ ‘the object of the procedure initiated by the request’. In the light of their ordinary meaning and the objective pursued by the rule of correspondence, the concepts of ‘grounds’ and ‘evidence’ cannot reasonably be interpreted as encompassing any elements intended to clarify or contextualise an argument already contained in the request for review.
35 In that regard, according to the applicant, a parallel should be drawn between that rule of correspondence and the rule which applies in appeal proceedings and in proceedings for a declaration of failure to fulfil obligations.
36 Nor can the concepts of ‘grounds’ and ‘evidence’ reasonably be understood as preventing an applicant from responding to an argument raised by the Commission itself to justify its decision refusing to conduct a review.
37 In the light of those considerations, the applicant asks the Court to find that none of the elements the admissibility of which the Commission challenges can be analysed as a new ‘ground’ or as new ‘evidence’. Those elements were all raised by the applicant with a view to responding to arguments put forward by the Commission, in the contested decision, to justify its refusal to conduct a review. Moreover, they were elements of context, clarification or discussion which the Commission was already aware of and which cannot be regarded as decisive or capable, in themselves, of forming the basis for a finding of unlawfulness. In that respect, they in no way alter the object of the procedure or undermine the effectiveness of the review procedure.
38 It should be recalled that, under Article 10(1) of Regulation No 1367/2006, any non-governmental organisation which meets the criteria set out in Article 11 of that regulation is entitled to submit a reasoned request and trigger an internal review of an administrative act by the EU institution or body that has adopted it under environmental law. Where the administrative act at issue relates, as in the present instance, to a decision to renew the approval of an active substance, such as cypermethrin, a request for review relates, pursuant to that provision, to the reassessment of that approval.
39 A request for internal review of an administrative act is thus intended to establish that, as alleged, the act in question is unlawful or that it is not well founded. The party making the request may then, in accordance with Article 12 of Regulation No 1367/2006, read in conjunction with Article 10 thereof, bring the matter before the EU judicature by instituting proceedings – on grounds of lack of competence, infringement of an essential procedural requirement, infringement of the Treaties or of any rule of law relating to their application, or misuse of powers – against the decision rejecting the request for internal review as unfounded.
40 It follows that, according to a combined reading of Articles 10 and 12 of Regulation No 1367/2006, an action for annulment is admissible only if it is directed against the response to that request and if the pleas in law relied on in support of annulment relate specifically to that response (see, to that effect, judgment of 15 December 2016, TestBioTech and Others v Commission, T‑177/13, not published, EU:T:2016:736, paragraph 56).
41 Such proceedings cannot be founded on new grounds or on evidence not appearing in the request for review, as otherwise the requirement, in Article 10(1) of Regulation No 1367/2006, relating to the statement of grounds for such a request would be made redundant and the object of the procedure initiated by the request would be altered (judgment of 12 September 2019, TestBioTech and Others v Commission, C‑82/17 P, EU:C:2019:719, paragraph 39).
42 Thus, it is inherent in the system of review that the party requesting the review provides concrete and precise grounds which might be able to call into question the assessments on which the authorisation decision is based. Accordingly, in order to state in the manner required the grounds for conducting the review, a party requesting the internal review of an administrative act under environmental law is required to put forward the facts or legal arguments of sufficient substance to give rise to serious doubts as to the assessment made in that act by the EU institution or body (see, to that effect, judgment of 12 September 2019, TestBioTech and Others v Commission, C‑82/17 P, EU:C:2019:719, paragraphs 68 and 69).
43 Moreover, the pleas and arguments raised before the General Court in an action for annulment of a decision rejecting a request for internal review can be regarded as being admissible only in so far as those pleas and arguments have already been presented by the applicant in the request for internal review, and in such a way that the Commission has been able to respond (see, to that effect, judgments of 15 December 2016, TestBioTech and Others v Commission, T‑177/13, not published, EU:T:2016:736, paragraph 68, and of 4 April 2019, ClientEarth v Commission, T‑108/17, EU:T:2019:215, paragraph 55).
44 However, as the Commission acknowledges, an applicant bringing an action before the General Court under Article 12 of Regulation No 1367/2006 cannot be required to confine itself to reproducing verbatim the arguments it had relied on in its request for internal review.
45 On the one hand, in the same way as an appellant is entitled to lodge an appeal relying, before the Court of Justice, on pleas arising from the judgment under appeal itself which seek to criticise, in law, its merits (judgments of 29 November 2007, Stadtwerke Schwäbisch Hall and Others v Commission, C‑176/06 P, not published, EU:C:2007:730, paragraph 17; of 10 April 2014, Commission v Siemens Österreich and Others and Siemens Transmission & Distribution and Others v Commission, C‑231/11 P to C‑233/11 P, EU:C:2014:256, paragraph 102; and of 25 January 2022, Commission v European Food and Others, C‑638/19 P, EU:C:2022:50, paragraph 77), an applicant under Article 12 of Regulation No 1367/2006 must be able to raise arguments which seek to criticise, in law, the merits of the decision adopted in response to its request for internal review. Such arguments may not, however, alter the object of the procedure initiated by that request, as otherwise it would be made redundant. In particular, they cannot include new arguments or evidence which could have been put forward at the time of the request for review.
46 On the other hand, an argument which was not raised at the stage of the request for review does not constitute a new argument that is inadmissible at the stage of the action before the General Court if it is simply an amplification of an argument already developed in the context of that request (see, to that effect and by analogy, judgments of 3 March 2016, Spain v Commission, C‑26/15 P, not published, EU:C:2016:132, paragraph 84; of 13 July 2017, Saint-Gobain Glass Deutschland v Commission, C‑60/15 P, EU:C:2017:540, paragraph 51; and of 9 December 2020, Groupe Canal + v Commission, C‑132/19 P, EU:C:2020:1007, paragraph 28). To be regarded as an amplification of a plea or a head of claim previously advanced, a new argument must, in relation to the pleas or heads of claim initially set out, present a sufficiently close connection with the pleas or heads of claim initially put forward in the application in order to be considered as forming part of the normal evolution of debate in proceedings before the Court (see, to that effect and by analogy, judgment of 13 July 2022, Delifruit v Commission, T‑629/20, EU:T:2022:448, paragraph 20 and the case-law cited).
47 In view of the particular nature of the review procedure established by Regulation No 1367/2006, such a possibility must nevertheless be reconciled with the need to preserve the effectiveness of that procedure, with the result that it cannot allow an applicant to alter the object of that procedure by putting forward new grounds or evidence not presenting a sufficiently close connection with the complaints raised at the stage of the request for review. Accordingly, in the present case, as the Commission argues, the applicant cannot rely on new ‘contextual’ arguments to which the rationale of that rule of correspondence does not apply, otherwise than by acknowledging that such arguments are, in any event, ineffective.
48 It is in the light of those considerations that the Court will examine below the admissibility of the arguments raised by the applicant, in relation to each of the specific complaints challenging the merits of the contested decision.
3. The scope of judicial review by the General Court
49 According to Article 1(3) of Regulation No 1107/2009, the purpose of the regulation is to ensure a high level of protection of both human and animal health and the environment and to improve the functioning of the internal market through the harmonisation of the rules on the placing on the market of plant protection products, while improving agricultural production.
50 In requiring that a high level of protection of the environment be maintained, Regulation No 1107/2009 is applying Article 11 and Article 114(3) TFEU. Article 11 TFEU provides that environmental protection requirements must be integrated into the definition and implementation of the European Union’s policies and activities, in particular with a view to promoting sustainable development. Giving concrete expression to that obligation, Article 114(3) TFEU provides that, in its proposals concerning, inter alia, environmental protection, made on the basis of the approximation of laws which have as their object the establishment and functioning of the internal market, the Commission will take as a base a high level of protection, taking account in particular of any new development based on scientific facts, and that, within their respective powers, the European Parliament and the Council of the European Union will also seek to achieve this objective. The protection of 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 (see judgment of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 106 and the case-law cited).
51 Moreover, recital 8 of Regulation No 1107/2009 states that the precautionary principle should be applied and that the regulation seeks to ensure that industry demonstrate that substances or products produced or placed on the market do not have any harmful effect on human or animal health or any unacceptable effects on the environment.
52 In that context, 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 enjoying a broad discretion (see, to that effect, judgment of 18 July 2007, Industrias Químicas del Vallés v Commission, C‑326/05 P, EU:C:2007:443, paragraph 75). That applies, in particular, to risk management decisions which it must take pursuant to that regulation (judgment of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 143).
53 However, the exercise of that discretion is not excluded from review by the Court. The Court has consistently held that in the context of such a review the EU judicature must verify whether the relevant procedural rules have been complied with, whether the facts admitted by the Commission have been accurately stated and whether there has been a manifest error of appraisal or a misuse of powers (see judgment of 18 July 2007, Industrias Químicas del Vallés v Commission, C‑326/05 P, EU:C:2007:443, paragraph 76 and the case-law cited).
54 As regards the assessment by the Courts of the European Union as to whether there has been a manifest error of assessment, it must be stated that, in order to establish that the Commission made a manifest error in assessing complex facts such as to justify the annulment of the contested measure, the evidence adduced by the applicant must be sufficient to make the factual assessments used in that measure implausible. Without prejudice to that examination of plausibility, it is not for the General Court to substitute its assessment of complex facts for that of the institution which adopted the measure (see judgment of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 145 and the case-law cited).
55 The limits to the review by the Courts referred to above do not, however, affect their duty to establish whether the evidence relied on is factually accurate, reliable and consistent and whether that evidence contains all the information which must be taken into account in order to assess a complex situation and whether it is capable of substantiating the conclusions drawn from it (see, to that effect, judgments of 15 February 2005, Commission v Tetra Laval, C‑12/03 P, EU:C:2005:87, paragraph 39; of 9 July 2015, Germany v Commission, C‑360/14 P, not published, EU:C:2015:457, paragraph 37; and of 4 May 2023, ECB v Crédit Lyonnais, C‑389/21 P, EU:C:2023:368, paragraph 56).
56 Moreover, it must be noted that, where an institution has a wide discretion, the review of observance of certain procedural guarantees is of fundamental importance. Thus, the Court of Justice has had occasion to specify that those guarantees include, inter alia, the obligation for the competent institution to examine carefully and impartially all the relevant elements of the individual case and to give an adequate statement of the reasons for its decision (see, to that effect, judgment of 22 November 2007, Spain v Lenzing, C‑525/04 P, EU:C:2007:698, paragraph 58 and the case-law cited).
B. The preliminary remarks set out under heading I of the annex to the contested decision (first part of the single plea)
57 The first part of the plea comprises three separate complaints, relating, first, to the role of the Commission in its capacity as risk manager under Regulation No 1107/2009, second, to the role of the precautionary principle and, third, to the role assigned to the Member States under Regulation No 1107/2009 with respect to the authorisation of PPPs.
58 In that regard, it should be noted that, in the annex to the contested decision, the Commission wished to make ‘a number of general preliminary remarks on the matters underlying its regulatory decisions under Regulation [No 1107/2009 and which are] relevant to the conduct of the internal review’.
59 As the Commission acknowledges in its defence, several arguments raised by the applicant in relation to those preliminary remarks concerning, respectively, the Commission’s role as risk manager, the precautionary principle and the role of the Member States are capable of having a bearing on the assessment of the substance of the action.
60 In those circumstances, the applicant’s arguments directed against those preliminary remarks, even though they are of a cross-cutting nature, cannot be regarded as inadmissible or inoperative. They should therefore be examined as to the substance.
1. The Commission’s role as risk manager and the role of the precautionary principle
61 In the first place, the applicant criticises the Commission for having considered that, in its capacity as risk manager, within the meaning of Article 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ 2002 L 31, p. 1), ‘it [was] not obliged to accept, in its regulatory decisions, the conclusions reached in the scientific risk assessment’ since it could take other legitimate factors into account and could attach risk mitigation measures to its approval decisions.
62 First of all, according to the applicant, it is wrong to apply en bloc to Regulation No 1107/2009 the general scheme and principles of Regulation No 178/2002. Unlike the latter, Regulation No 1107/2009 is based on the precautionary principle, so that it systematically places the protection of those interests above the satisfaction of economic interests. Moreover, Annex II to Regulation No 1107/2009 establishes a certain number of exclusion criteria, non-compliance with which precludes approval of the active substance concerned, without any discretion on the part of the Commission. This applies in particular to endocrine disrupting properties, the risk of which has been raised by the applicant, as well as to several environmental criteria. More generally, from an ecotoxicological perspective, point 3.8 of Annex II to Regulation No 1107/2009 allows the Commission to approve an active substance only if ‘the risk assessment demonstrates risks to be acceptable’, resulting, in particular, only in a ‘negligible exposure of honeybees’.
63 According to the applicant, it follows from those provisions that the Commission is not permitted, on the basis of the risk management, to approve active substances which an independent scientific assessment demonstrates do not comply with the criteria set out in Annex II to Regulation No 1107/2009. This also applies to the ‘acceptable’ nature of the risk, which can sometimes be determined at the risk assessment stage and not at the risk management stage. According to the Communication from the Commission on the precautionary principle of 2 February 2000 (COM(2000) 1 final), that risk management operation is carried out only where there is a ‘scientific evaluation of the risk which because of the insufficiency of the data, their inconclusive or imprecise nature, makes it impossible to determine with sufficient certainty the risk in question’. In other words, where the risk is established with sufficient certainty, the Commission cannot disregard the conclusions of the scientific assessment by relying on its powers as risk manager. This is the case, in particular, where EFSA states that there is a ‘high risk’ associated with the substance.
64 Moreover, the applicant states that, even if the Commission were able to approve, in the light of other interests, in particular of an economic nature, a substance which EFSA’s assessment demonstrates does not satisfy the criteria in Annex II to Regulation No 1107/2009, no such rationale underpins Implementing Regulation 2021/2049.
65 In the second place, the applicant criticises the Commission’s finding that an approval regime accompanied by ‘strict risk mitigation measures’, such as Implementing Regulation 2021/2049, may be both an application of the precautionary principle and a means of complying with the principle of proportionality. On the one hand, it considers that reliance on such principles cannot have the effect of rendering ineffective the clear and precise conditions for approval set out in Article 4 of Regulation No 1107/2009 and in Annex II thereto. If the scientific assessment leads to a finding that a substance does not satisfy those conditions, the Commission cannot take the place of the legislature by nevertheless approving that substance for policy or economic reasons. On the other hand, the adoption of risk mitigation measures must comply with the principle of effectiveness. However, that principle would be undermined by conditions which are so strict as to be impracticable and therefore liable not to be applied, complied with or monitored. Some of the conditions underlying Implementing Regulation 2021/2049, such as buffer zones of more than 100 metres, are manifestly unrealistic. Moreover, no specific measure is imposed on Member States, which makes compliance with those conditions even more illusory.
66 The Commission disputes those arguments.
67 As a preliminary point, it must be observed that, contrary to what the Commission argues, the applicant’s position that the Commission is automatically deprived of ‘any discretion’ in the event of uncertainty as to whether one of the criteria set out in point 3 of Annex II to Regulation No 1107/2009 is satisfied presents a sufficiently close connection with the argument, raised by the applicant in paragraph 16 of its request for internal review, that, ‘in accordance with the precautionary principle, the high level of protection of human health and the environment and Article 4(1) of Regulation [No] 1107/2009, the identification even of only a single [critical area of concern] should lead to [non-renewal of the approval] of the substance, in so far as the protection of human health or the environment cannot be safeguarded’.
68 Similarly, as regards the argument based on point 3.8 of Annex II to Regulation No 1107/2009, it must be regarded as presenting a sufficiently close connection with the arguments raised by the applicant in its request for internal review, and consequently must be held to be admissible, in accordance with the case-law referred to in paragraph 46 above.
69 On the substance, as regards the Commission’s role as risk manager and the role of the precautionary principle, it should first of all be recalled that the authorisation and approval procedures put in place by Regulation No 1107/2009 for plant protection products and their active substances emanate from the precautionary principle (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 108 and the case-law cited).
70 The precautionary principle is a general principle of EU law requiring the authorities in question, in the particular context of the exercise of the powers conferred on them by the relevant rules, to take appropriate measures to prevent specific potential risks to public health, safety and the environment, by giving precedence to the requirements related to the protection of those interests over economic interests. Since the EU institutions are responsible, in all their spheres of activity, for the protection of public health, safety and the environment, the precautionary principle can be regarded as an autonomous principle stemming from the Treaty provisions, in particular Article 11, Article 168(1), Article 169(1) and (2) and Article 191(1) and (2) TFEU (see, to that effect, judgments of 26 November 2002, Artegodan and Others v Commission, T‑74/00, T‑76/00, T‑83/00 to T‑85/00, T‑132/00, T‑137/00 and T‑141/00, EU:T:2002:283, paragraph 184; of 21 October 2003, Solvay Pharmaceuticals v Council, T‑392/02, EU:T:2003:277, paragraph 121, and of 11 July 2019, BP v FRA, T‑838/16, not published, EU:T:2019:494, paragraph 396).
71 The precautionary principle means that, where there is uncertainty as to the existence or extent of risks, including risks to the environment, protective measures may be taken without having to wait until the reality and seriousness of those risks become fully apparent. Where it proves to be impossible to determine with certainty the existence or extent of the alleged risk, because the results of studies conducted are inconclusive, but the likelihood of real harm to the environment persists should the risk materialise, the precautionary principle justifies the adoption of restrictive measures (see judgment of 6 May 2021, Bayer CropScience and Bayer v Commission, C‑499/18 P, EU:C:2021:367, paragraph 80 and the case-law cited).
72 That being the case, it must be held that the precautionary principle justifies the adoption of restrictive measures on condition that they are not only non-discriminatory and objective, but also proportionate. Accordingly, the precautionary principle, as laid down in Article 191(2) TFEU, is directed at action at EU level and cannot be interpreted as meaning that an EU institution is required, solely on the basis of that principle, to adopt a specific measure, such as the refusal of an authorisation. While it is true that that principle may warrant the adoption of a restrictive measure by an institution, it does not require it to do so in all circumstances (see, to that effect and by analogy, judgment of 4 April 2019, ClientEarth v Commission, T‑108/17, EU:T:2019:215, paragraphs 282 and 284).
73 Where scientific evaluation does not make it possible to determine the existence of a risk with sufficient certainty, whether to have recourse to the precautionary principle depends as a general rule on the level of protection chosen by the competent authority in the exercise of its broad discretion. That choice must, however, comply with the principle that the protection of public health, safety and the environment is to take precedence over economic interests, as well as with the principles of proportionality and non-discrimination (see, to that effect, judgments of 26 November 2002, Artegodan and Others v Commission, T‑74/00, T‑76/00, T‑83/00 to T‑85/00, T‑132/00, T‑137/00 and T‑141/00, EU:T:2002:283, paragraph 186, and of 21 October 2003, Solvay Pharmaceuticals v Council, T‑392/02, EU:T:2003:277, paragraph 125).
74 Within the process leading to the adoption by an institution of appropriate measures to prevent specific potential risks to public health, safety and the environment by reason of the precautionary principle, three successive stages can be identified: first, identification of the potentially adverse effects arising from a phenomenon; second, assessment of the risks to public health, safety and the environment which are related to that phenomenon; and, third, when the potential risks identified exceed the threshold of what is acceptable for society, risk management by the adoption of appropriate protective measures (judgment of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 111).
75 First, the applicant argues, in essence, that, where a risk is established with sufficient certainty by EFSA, the Commission cannot disregard the conclusions of the scientific assessment by relying on its powers as risk manager.
76 In that regard, it should first of all be recalled that, in the contested decision, the Commission stated the following:
‘When adopting implementing regulations concerning the approval or renewal of approval of an active substance under [Regulation No 1107/2009], the Commission acts as risk manager within the meaning of Article 3 of Regulation (EC) No 178/2002. It acts following a two-stage risk assessment process conducted by a[n RMS] and EFSA, in close consultation with the Member States’ risk managers represented on the Standing Committee on Plants, Animals, Food and Feed – Section Phytopharmaceuticals – Legislation.
The Commission therefore wishes to point out, first, that, in its capacity as risk manager, it is not obliged to accept, in its regulatory decisions, the conclusions reached in the scientific risk assessment, but that it uses them as a basis for taking informed risk management decisions (see recital 34 of Regulation (EC) No 178/2002), having regard to various elements. Those elements include the draft renewal assessment report prepared by the [RMS] and EFSA’s conclusions on the results of the peer review of that draft renewal assessment carried out under its direction. The second subparagraph of Article 14(1) of [Implementing] Regulation (EU) No 844/2012 provides that the Commission is to “take into account” those results when taking risk management decisions. Moreover, the Commission may ask EFSA for any clarification which it deems necessary in order to take its risk management decision, in accordance with Regulation (EC) No 178/2002, in particular where it considers that there is a need to increase scientific certainty. Those statements also form part of the risk assessment on which the Commission bases its decision.
The Commission’s role as risk manager presupposes that its decisions may involve a choice in the selection of appropriate prevention and control options in order to mitigate the risks identified in the risk assessment. Indeed, Article 6 of [Regulation No 1107/2009] provides that the approval and renewal of approval decisions by the Commission may be subject to conditions and restrictions including the “need to impose risk mitigation measures” [Article 6(i)], in order to ensure compliance with the approval criteria set out in Article 4 of [Regulation No 1107/2009] and Annex II thereto.
The Commission would point out in that context that the approval criterion in the environmental field is the absence of “unacceptable” effects on the environment [see Article 4(3)(e) of Regulation No 1107/2009], which differs from the criterion relating to human health, namely “no immediate or delayed harmful effect on human health … or animal health” [see Article 4(3)(b) of Regulation No 1107/2009].’
77 First of all, it should be borne in mind that, according to the case-law, assessment of the risks to public health, safety and the environment consists, for the institution required to cope with potentially adverse effects arising from a phenomenon, in scientifically assessing those risks and in determining whether they exceed the level of risk deemed acceptable for society. Thus, in order for the institutions to be able to carry out a risk assessment, it is important for them, first, to have a scientific assessment of the risks and, second, to determine what level of risk is deemed unacceptable for society (see judgment of 17 March 2021, FMC v Commission, T‑719/17, EU:T:2021:143, paragraph 65 and the case-law cited).
78 A scientific risk assessment is a scientific process consisting, in so far as possible, in the identification and characterisation of a hazard, the assessment of exposure to that hazard and the characterisation of the risk (see judgment of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 138 and the case-law cited).
79 As a scientific process, the scientific risk assessment must be entrusted by the institution to scientific experts (see judgment of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 115 and the case-law cited).
80 The scientific risk assessment is not required to provide the institutions with conclusive scientific evidence of the reality of the risk and the seriousness of the potential adverse effects were that risk to become a reality. A situation in which the precautionary principle is applied by definition coincides with a situation in which there is scientific uncertainty. Furthermore, the adoption of a preventive measure, or, conversely, its withdrawal or relaxation, cannot be made subject to proof of the lack of any risk, in so far as such proof is generally impossible to give in scientific terms since zero risk does not exist in practice. However, a preventive measure cannot properly be based on a purely hypothetical approach to the risk, founded on mere conjecture which has not been scientifically verified (see judgment of 17 March 2021, FMC v Commission, T‑719/17, EU:T:2021:143, paragraph 69 and the case-law cited).
81 The scientific risk assessment should be based on the best scientific data available and should be undertaken in an independent, objective and transparent manner (see judgment of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 141 and the case-law cited).
82 Furthermore, a preventive measure may be taken only if the risk, although the reality and extent thereof have not been fully demonstrated by conclusive scientific evidence, appears nevertheless to be adequately backed up by the scientific data available at the time when the measure was taken (judgments of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 143; of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 120; and of 17 March 2021, FMC v Commission, T‑719/17, EU:T:2021:143, paragraph 73).
83 Next, the responsibility for determining the level of risk which is deemed unacceptable for society lies, provided that the applicable rules are observed, with the institutions responsible for the political choice of determining an appropriate level of protection for society. It is for those institutions to determine the critical probability threshold for adverse effects on public health, safety and the environment and for the degree of those potential effects which, in their judgement, is no longer acceptable for society and above which it is necessary, in the interests of protecting public health, safety and the environment, to take preventive measures in spite of the existing scientific uncertainty (see judgment of 17 March 2021, FMC v Commission, T‑719/17, EU:T:2021:143, paragraph 75 and the case-law cited).
84 In determining the level of risk deemed unacceptable for society, the institutions are bound by their obligation to ensure a high level of protection of public health, safety and the environment. That high level of protection does not necessarily have to be the highest that is technically possible, in order to be compatible with Article 114(3) TFEU. Moreover, those institutions may not take a purely hypothetical approach to risk and may not base their decisions on a ‘zero risk’ (judgments of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 146, and of 17 March 2021, FMC v Commission, T‑719/17, EU:T:2021:143, paragraph 76).
85 The level of risk deemed unacceptable for society will depend on the assessment made by the competent public authority of the particular circumstances of each individual case. In that regard, the authority may take account, inter alia, of the severity of the impact on public health, safety and the environment were the risk to occur, including the extent of possible adverse effects, the persistency or reversibility of those effects and the possibility of delayed effects as well as of the more or less concrete perception of the risk based on available scientific knowledge (judgments of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 147; of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 124; and of 17 March 2021, FMC v Commission, T‑719/17, EU:T:2021:143, paragraph 77).
86 Finally, risk management corresponds to the body of actions taken by an institution faced with a risk in order to reduce it to a level deemed acceptable for society having regard to its obligation, in accordance with the precautionary principle, to ensure a high level of protection of public health, safety and the environment (judgments of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 148; of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 125; and of 17 March 2021, FMC v Commission, T‑719/17, EU:T:2021:143, paragraph 78).
87 Those actions include the adoption of provisional measures, which must be proportionate, non-discriminatory, transparent, and consistent with similar measures already taken (see judgment of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, EU:T:2018:280, paragraph 126 and the case-law cited).
88 In the light of the foregoing, the applicant cannot validly maintain that, once EFSA identifies certain critical areas of concern, the Commission no longer has any discretion in that regard.
89 Although, pursuant to the second subparagraph of Article 14(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 (EC) No 1107/2009 (OJ 2012 L 252, p. 26), the Commission must, in its capacity as risk manager, ‘take into account’ EFSA’s conclusions and the draft renewal assessment report issued by the RMS, when adopting a regulation relating to the renewal of the approval of an active substance it is not bound by the findings made by EFSA or the RMS (see, to that effect, judgment of 4 October 2023, Ascenza Agro and Industrias Afrasa v Commission, T‑77/20, EU:T:2023:602, paragraphs 246 and 247).
90 Such taking into account cannot be interpreted as an obligation on the part of the Commission to follow EFSA’s conclusions or the conclusions of the RMS in all respects, even if those conclusions are the starting point of the assessment and therefore have a significant weight in that assessment (see, to that effect, judgment of 9 February 2022, Taminco and Arysta LifeScience Great Britain v Commission, T‑740/18, EU:T:2022:61, paragraph 141).
91 However, the Commission’s broad discretion in its capacity as risk manager remains governed by the need to comply with the provisions of Regulation No 1107/2009, in particular Article 4 of that regulation, read together with Annex II thereto, and by the precautionary principle which underpins all the provisions of that regulation.
92 In particular, where the risk assessment leads to the identification of several critical areas of concern, as referred to in paragraph 8 above, and to a recommendation not to renew the approval of the active substance concerned, the Commission cannot, as a rule, depart from the results of such an assessment, as otherwise it would breach the precautionary principle.
93 In that regard, the Commission can renew the approval of an active substance only if it is adequately demonstrated that, notwithstanding the identification of critical areas of concern, risk mitigation measures support the conclusion that the criteria of Article 4(1) to (3) of Regulation No 1107/2009 are fulfilled. This cannot be regarded as having been adequately demonstrated in the absence of scientific verification of the appropriateness of such measures in the light of the those criteria.
94 Accordingly, as the Commission argues, and subject to compliance with the principles set out in paragraphs 89 to 93 above, its specific role is to determine the risks which are acceptable to society, with a higher tolerance threshold for environmental protection than as regards human or animal health, and taking into account management measures to mitigate the risks identified.
95 Contrary to what the applicant argues, this does not mean that, in renewing the approval of the active substance cypermethrin, while imposing certain risk management measures, the Commission ‘overrode’ or disregarded EFSA’s scientific assessments.
96 In that regard, it should be recalled that, in the present case, the risk assessment by EFSA in its conclusions was subsequently clarified by its 2019 statement, in which it confirmed the possibility of adopting risk management measures. Consequently, the mere fact that EFSA identified four critical areas of concern in its conclusions does not support the conclusion that the Commission, in its capacity as risk manager, no longer had any discretion, provided that it ensured that the criteria set out in Article 4 of Regulation No 1107/2009 were fulfilled. In other words, the Commission is not precluded from ascertaining, in compliance with the precautionary principle, whether the risk could have become acceptable by imposing certain measures.
97 Moreover, the applicant is incorrect to refer to such risk management measures only where there is a ‘lack of data’. Article 4(2) and (3) of Regulation No 1107/2009 refers to ‘realistic conditions of use’ and therefore also permits the adoption of the measures in question for well-established risks, even where a risk is established on the basis of a complete set of data.
98 The applicant’s first complaint must therefore be dismissed.
99 Second, the applicant submits, in essence, that Annex II to Regulation No 1107/2009 establishes a number of exclusion criteria, non-compliance with which prohibits approval of the active substance concerned, without any discretion on the part of the Commission. This is the case, in particular, with regard to endocrine disrupting effects provided for in points 3.6.5 and 3.8.5 of Annex II to that regulation.
100 In that regard, it is apparent from the case-law that the criteria set out in points 3.6.2, 3.6.3 and 3.6.5 of Annex II to Regulation No 1107/2009, which relate to genotoxicity, carcinogenicity and endocrine disrupting effects, respectively, are worded and must be interpreted in the same way as the criterion set out in point 3.6.4 of that annex, namely that an active substance ‘shall only be approved if’ that substance ‘is not or has not to be’ classified as mutagenic, carcinogenic or as having endocrine disrupting effects. In that respect, they are ‘exclusion criteria’, as opposed to the requirements in Article 4(2) and (3) of Regulation No 1107/2009, in respect of which Article 4(1) of the same regulation provides that, where it may be expected that they will be met, the substance in question is to be approved (see, to that effect, judgment of 4 October 2023, Ascenza Agro and Industrias Afrasa v Commission, T‑77/20, EU:T:2023:602, paragraphs 118 to 121).
101 However, it is sufficient to note that, in the present case, it is not apparent from the contested decision that the criterion set out in point 3.6.5 of Annex II to Regulation No 1107/2009 does not constitute an exclusion criterion as referred to in the case-law cited in paragraph 100 above. Moreover, cypermethrin has at no time been classified by EFSA or the RMS as an active substance having endocrine disrupting effects within the meaning of point 3.6.5 of Annex II to Regulation No 1107/2009. Furthermore, compliance with the criterion relating to endocrine disrupting effects was not one of the ‘critical areas of concern’ identified by EFSA in its conclusions.
102 The applicant’s second complaint must therefore be dismissed as ineffective.
103 Third, as regards the applicant’s arguments concerning the need to comply with the principle of effectiveness, as stated in paragraph 91 above, the Commission’s broad discretion in its capacity as risk manager remains governed by Article 4 of Regulation No 1107/2009, read in conjunction with Annex II to that regulation. In that regard, it follows from Article 4(2) and (3) of that regulation that approval of an active substance may be granted only if it is demonstrated that the conditions for approval are satisfied under realistic conditions of use. In accordance with Article 4(5) of that regulation, it must be demonstrated that at least one representative use of at least one plant protection product containing that substance satisfies those criteria, under realistic conditions of use.
104 Therefore, the Commission, in its capacity as risk manager, cannot consider that the criteria of Article 4(2) and (3) of Regulation No 1107/2009 are satisfied where such a conclusion is based on the imposition of risk mitigation measures which do not make it possible to exclude harmful effects on human health or unacceptable effects on the environment, in particular because such measures are unrealistic. In other words, it cannot identify a ‘safe’ use without ensuring that the risk mitigation measures adopted for that purpose actually, and not theoretically, make it possible to reduce the identified risk to an acceptable level.
105 That said, the Commission did not argue in the contested decision that it was entitled to lay down risk mitigation measures which are unrealistic. On the contrary, it relied on the 2019 statement in which EFSA itself found that the risk mitigation measures set out in Annex I to Implementing Regulation 2021/2049, compliance with which must be verified by the Member States as part of the authorisation procedures for plant protection products containing the active substance in question, supported the conclusion that there was a low risk to aquatic organisms, non-target arthropods and honeybees. The Commission also considered that it was for Member States, in the context of those authorisation procedures, to ascertain whether such measures were possible in practice. The applicant’s argument must therefore be dismissed.
106 As regards the reference to economic or policy considerations to which the Commission gave priority by adopting Implementing Regulation 2021/2049, this is a new argument in relation to the complaints raised in the request for review and is therefore inadmissible in the context of the present action. In any event, such an argument is too vague and hypothetical to be able to call into question the legality of the contested decision.
107 Lastly, the Commission did not commit an error of law in stating, in essence, in the contested decision, that it could use the precautionary principle in the application and implementation of Regulation No 1107/2009, while respecting the principle of proportionality, as the Court of Justice has confirmed (see, to that effect, judgment of 6 May 2021, Bayer CropScience and Bayer v Commission, C‑499/18 P, EU:C:2021:367, paragraph 166).
108 Accordingly, without prejudice to the question whether the Commission could validly consider that cypermethrin fulfilled the conditions for approval set out in point 3.6.5 of Annex II to Regulation No 1107/2009, which will be examined below, the applicant’s line of argument must be dismissed.
2. The role assigned to Member States under Regulation No 1107/2009
109 The applicant submits that the Commission cannot validly consider that it is for the Member States, when issuing marketing authorisations for products containing cypermethrin, to ‘lay down appropriate conditions, such as risk mitigation measures’ and to carry out the comparative assessment provided for in Article 50 of Regulation No 1107/2009, where cypermethrin has been classified as a candidate for substitution.
110 The applicant maintains that the Commission cannot offload its responsibilities onto Member States. On the one hand, most Member States do not have the administrative capacity to design such risk mitigation measures, let alone ensure that they are complied with in practice. By passing on responsibility to the Member States in this way, the Commission therefore breaches the principle of sincere cooperation enshrined in Article 4(3) TEU. On the other hand, Regulation No 1107/2009 provides for a principle of mutual recognition which enables the holder of an authorisation in one Member State to rely on it in other States. That mechanism deprives Member States of genuine control over the products used on their territory and is likely to give rise to a ‘race to the bottom’. In the light of that context, the Commission’s position undermines the two objectives of Regulation No 1107/2009, namely harmonisation of the rules on plant protection products in the internal market and the attainment a high level of protection for health and the environment.
111 The Commission disputes those arguments.
112 In the annex to the contested decision, as ‘preliminary remarks’ under section (c), entitled ‘The role assigned to the Member States under [Regulation No 1107/2009] for the authorisation of PPPs’, the Commission stated the following:
‘The Commission wishes to recall that the legislature decided to separate action at EU level, relating to the approval of active substances, from the Member States’ responsibility for authorising products containing those substances for pesticide uses (see recitals 10 and 23 of [Regulation No 1107/2009]). Accordingly, Member States must ensure safety by laying down appropriate conditions, such as risk mitigation measures, including, but not limited to, those required as part of approval at [EU] level. Moreover, where a substance is classified as a candidate for substitution, Member States may grant authorisations only if the conditions set out in Article 50 of [Regulation No 1107/2009] are met, that is to say after a comparative assessment has been carried out.
In the case of cypermethrin, the Commission acted with care, examining in detail the views expressed by the risk assessors concerning the renewal of approval for cypermethrin. It renewed contacts with EFSA and the [RMS]. It further strengthened its decision by asking EFSA for an additional statement on the effectiveness of potential risk mitigation measures and by requiring Member States to impose such measures by means of their authorisations (see “specific conditions” set out in Annexes I and II of the Commission regulation), concerning inter alia the following elements:
– Restriction of use to professional users
– Specific and measurable conditions for the protection of aquatic organisms and non-target arthropods, including honeybees
– Specific instructions requiring Member States, when they examine an application for authorisation, to pay particular attention to several matters, including the protection of aquatic organisms and non-target arthropods, inter alia honeybees, the assessment of risks to consumers and the technical specification of the active substance as manufactured
– Provision of follow-up measures, where appropriate.’
113 As the Commission rightly argues, the applicant does not challenge the merits of the above arguments set out in the annex to the contested decision, but confines itself to stating, in essence, first, that the Commission is shirking its obligations by ‘passing the buck’ to the Member States and, second, that the principle of mutual recognition of authorisations, set out in Article 40 et seq. of Regulation No 1107/2009, is contrary to the objectives of that regulation.
114 As regards the first argument, it must be observed that the Commission did not make an error of law in recalling that, under Regulation No 1107/2009, it is responsible for approving the active substance, while Member States are responsible for authorising the product. Moreover, the applicant confines itself to referring to problems of administrative overload which the national authorities face, but does not contest the argument that it is indeed for Member States, under Article 50 of Regulation No 1107/2009, to carry out a comparative assessment before granting authorisation in respect of a plant protection product containing a candidate for substitution.
115 In the reply, the applicant asserts that Article 50 of Regulation No 1107/2009 in no way prevented the Commission from itself laying down risk mitigation measures in Implementing Regulation 2021/2049. Such an argument is ineffective, however, in so far as it does not call into question the finding made by the Commission in the contested decision that, on the basis of the system established by Regulation No 1107/2009, it is for the Member States to lay down appropriate conditions when authorising products, which may go beyond restrictions on the active substance imposed at EU level. Nor do the references made by the applicant to Article 6 and Article 36(3) of Regulation No 1107/2009, even if they are admissible, allow that conclusion to be called into question.
116 As regards the second argument, concerning mutual recognition, the points raised by the applicant are also ineffective, in so far as, in the case of a candidate for substitution, Article 41(2)(b) of Regulation No 1107/2009 exempts precisely such a substance from the application of compulsory mutual recognition.
117 The applicant nonetheless argues that, under that provision, Member States are permitted to apply the mutual recognition procedure, which, in practice, leads to a race to the bottom. However, even if such a phenomenon were to be established, in the absence of a plea of illegality of Article 41 of Regulation No 1107/2009 raised by the applicant, such an argument is also incapable of establishing that the Commission committed an error of law or a manifest error of assessment in recalling, in the contested decision, the role of Member States under Regulation No 1107/2009.
118 Consequently, all the applicant’s arguments relating to the preliminary remarks set out by the Commission in the annex to the contested decision must be dismissed.
C. The complaints raised by the applicant in support of its request for internal review (second part of the single plea)
[omissis]
7. The seventh complaint, alleging failure to examine the chronic toxicity of the representative formulation submitted by the party making the request
[omissis]
435 Consequently, the seventh complaint must be dismissed and the action must be dismissed in its entirety.
Costs
436 Pursuant to 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. Since the applicant has been unsuccessful, it must be ordered to pay the costs in accordance with the form of order sought by the Commission.
On those grounds,
THE GENERAL COURT (Fourth Chamber)
hereby:
1. Dismisses the action;
2. Orders Pesticide Action Network Europe (PAN Europe) to pay the costs.
da Silva Passos | Reine | Pynnä |
Delivered in open court in Luxembourg on 21 February 2024.
[Signatures]