JUDGMENT OF THE GENERAL COURT (First Chamber)
13 October 2021 (*)
(Plant protection products – Active substance ‘copper compounds’ – Renewal of approval for placing on the market – Candidates for substitution – Action for annulment – Admissibility – Associations – Proportionality – Precautionary principle – Manifest error of assessment – Expert’s report)
In Case T‑153/19,
European Union Copper Task Force, established in Springfield (United Kingdom), represented by I. Moreno-Tapia Rivas and C. Vila Gisbert, lawyers,
applicant,
v
European Commission, represented by F. Castilla Contreras and I. Naglis, acting as Agents,
defendant,
supported by
European Parliament, represented by L. Stefani, C. Ionescu Dima and A. Tamás, acting as Agents,
and by
Council of the European Union, represented by D. Kornilaki and E. Karlsson, acting as Agents,
interveners,
APPLICATION under Article 263 TFEU for annulment of Commission Implementing Regulation (EU) 2018/1981 of 13 December 2018 renewing the approval of the active substances copper compounds, as candidates 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 2018 L 317, p. 16),
THE GENERAL COURT (First Chamber),
composed of H. Kanninen, President, M. Jaeger (Rapporteur) and O. Porchia, Judges,
Registrar: P. Cullen, Administrator,
having regard to the written part of the procedure and further to the hearing on 27 October 2020,
gives the following
Judgment
I.      Background to the dispute
A.      Approval of copper compounds as an active substance for plant protection products
1        The applicant, European Union Copper Task Force, is an association of producers of copper compounds, some of which hold authorisations for placing plant protection products containing those compounds on the market.
2        The applicant was established for the purpose of submitting an application for inclusion of copper compounds 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). In that regard, it was the sole notifier of the active substance ‘copper compounds’.
3        By Commission Directive 2009/37/EC of 23 April 2009 amending Council Directive 91/414/EEC to include chlormequat, copper compounds, propaquizafop, quizalofop-P, teflubenzuron and zeta-cypermethrin as active substances (OJ 2009 L 104, p. 23), copper compounds were approved as active substances for plant protection products and were included in Annex I to Directive 91/414.
4        The active substances listed in Annex I to Directive 91/414 were deemed 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).
5        On 25 May 2011, the European Commission adopted Implementing Regulation (EU) No 540/2011 implementing Regulation No 1107/2009 as regards the list of approved active substances (OJ 2011 L 153, p. 1), which stated that approval of copper compounds as active substances for plant protection products was due to expire on 30 November 2016.
B.      Inclusion of copper compounds on the list of candidates for substitution and litigation relating to that inclusion
6        Regulation No 1107/2009 states that some active substances with certain properties should be identified at EU level as candidates for substitution (‘CFS’). In that regard, Member States are required regularly to examine plant protection products containing such active substances with the aim of replacing them with plant protection products containing active substances which require less risk mitigation or with non-chemical control or prevention methods.
7        Thus, under Article 80(7) of Regulation No 1107/2009, the Commission had to establish a list of substances included in Annex I to Directive 91/414 which fulfilled the criteria set out in point 4 of Annex II to that regulation for CFS. Under Regulation No 1107/2009, the main consequences of classifying substances as CFS are, first, the limitation of the duration of approval of those substances and of renewal of those approvals (7 years instead of 15 years), second, the absence of any obligation for a Member State to give authorisation, under the mutual recognition procedure, for the placing on the market of a pharmaceutical product containing CFS, to an undertaking which already has such an authorisation issued by another Member State and, third, the need for Member States to assess whether those substances may be replaced by other safer and more appropriate alternatives before authorising the placing on the market of a plant protection product containing it.
8        In 2013, the applicant became aware of the Commission’s intention to include copper compounds in the list of CFS on the ground that they met one of the conditions laid down in point 4 of Annex II to Regulation No 1107/2009, namely satisfying two of the criteria for being considered to be a persistent, bioaccumulative and toxic substance (‘the PBT criteria’), in this case persistence and toxicity.
9        On 19 November 2013, the applicant sent a letter to the Directorate-General (DG) for Health and Consumers of the Commission expressing its views regarding the inapplicability of the PBT criteria to inorganic substances. The Commission did not respond to that letter.
10      On 22 January 2015, the applicant sent a second letter to the Commission asking it to remove copper compounds from its list of CFS. On 11 February 2015, the Commission replied to that letter, but did not grant the applicant’s request.
11      On 27 January 2015, the list of CFS, including copper compounds, was approved by the Standing Committee on Plants, Animals, Food and Feed (‘SCoPAFF’). On 11 March 2015, that list was adopted by Commission Implementing Regulation (EU) No 2015/408 of 11 March 2015 on implementing Article 80(7) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and establishing a list of candidates for substitution (OJ 2015 L 67, p. 18).
12      On 5 June 2015, the applicant lodged before the General Court an action for annulment of Implementing Regulation 2015/408, also raising a plea of illegality in respect of Regulation No 1107/2009. That action was dismissed as inadmissible, on the ground that the applicant lacked locus standi, by order of 27 April 2016, European Union Copper Task Force v Commission (T‑310/15, not published, EU:T:2016:265). That order was confirmed on appeal by the judgment of 13 March 2018, European Union Copper Task Force v Commission (C‑384/16 P, EU:C:2018:176).
C.      Renewal of approval of copper compounds as an active substance for plant protection products
13      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), the applicant lodged an application, in November 2013, for renewal of the approval of copper compounds as active substances with the rapporteur Member State, namely the French Republic, and the co-rapporteur Member State, namely the Federal Republic of Germany. The rapporteur Member State, in consultation with the co-rapporteur Member State, drew up an assessment report for that renewal. It submitted that report to the European Food Safety Authority (EFSA) and to the Commission on 16 December 2016.
14      On 20 December 2017, EFSA sent to the European Commission its conclusion on whether copper compounds could be expected to meet the approval criteria set out in Article 4 of Regulation No 1107/2009. During the peer review, it appeared that the data provided by the applicant were insufficient to conclude safe use with regard to non-target organisms. That review highlighted a high risk to birds and mammals as well as to aquatic organisms, including sediment dwellers, with regard to all representative uses.
15      The applicant submitted additional monitoring data and requested the adoption of a different approach designed to model the long-term behaviour of metals, but that model was rejected during the peer review of the exposure assessment. EFSA concluded that there was a high risk to aquatic organisms in respect of all uses, despite the application of risk mitigation measures. As regards soil macro-organisms, several chronic exposure laboratory studies were conducted on earthworms and other relevant species, which lead to the conclusion that there was a high risk for soil organisms when the application rate was higher than four kilograms per hectare. That finding led to the setting of a restriction on use in the form of an upper application limit of 28 kilograms of copper per hectare over a period of seven years.
16      During the renewal procedure, the Commission assessed the application of the PBT criteria to copper compounds. That assessment led the Commission to consider that copper compounds could constitute CFS under point 4 of Annex II to Regulation No 1107/2009, on the ground that one of the conditions laid down in that point, namely the fulfilment of two of the PBT criteria, had been satisfied.
17      On 25 May 2018, the Commission submitted to SCoPAFF the draft assessment report on the PBT criteria, in which it proposed renewing the approval of copper compounds as CFS for a period of seven years, together with the restriction on use of 28 kilograms of copper per hectare over a period of seven years. The applicant was given the opportunity to submit comments on that draft report.
18      Following SCoPAFF’s adoption of a favourable opinion on 27 November 2018, the Commission adopted, on 13 December 2018, Implementing Regulation (EU) 2018/1981 renewing the approval of the active substances copper compounds, as candidates for substitution, in accordance with Regulation No 1107/2009, and amending the Annex to Commission Implementing Regulation No 540/2011 (OJ 2018 L 317, p. 16; ‘the contested regulation’), with the abovementioned restriction on their use.
II.    Procedure and forms of order sought
19      By application lodged at the Court Registry on 11 March 2019, the applicant brought the present action.
20      On 30 May 2019, the Commission lodged the defence.
21      By decision of 21 June 2019, the President of the Sixth Chamber of the General Court granted the European Parliament leave to intervene in support of the form of order sought by the Commission.
22      On 24 July 2019, the applicant lodged the reply.
23      By decision of 31 July 2019, the President of the Sixth Chamber of the General Court granted the Council of the European Union leave to intervene in support of the forms of order sought by the Commission.
24      On 2 August 2019, the Parliament lodged its statement in intervention, on which the applicant submitted its observations on 16 September 2019.
25      The Commission lodged the rejoinder on 26 September 2019. On the same day, the Council lodged its statement in intervention, on which the applicant submitted its observations on 16 October 2019.
26      Following a change in the composition of the Chambers of the General Court, in the interest of the proper administration of justice, by decision of 21 October 2019, the President of the General Court, pursuant to Article 27(3) of the Rules of Procedure of the General Court, reallocated the case to a new Judge-Rapporteur, assigned to the First Chamber.
27      By letter of 4 November 2019, the applicant made a reasoned request, pursuant to Article 106(2) of the Rules of Procedure, to be heard during the oral stage of the procedure.
28      On a proposal of the Judge-Rapporteur, the Court allowed the applicant’s request and opened the oral stage of the procedure.
29      The parties presented oral argument and answered oral questions put by the Court at the hearing on 27 October 2020, at the end of which the oral part of the procedure was closed.
30      By order of 10 December 2020, the Court decided to reopen the oral part of the procedure. On 29 January 2021, the Commission, the Parliament and the Council lodged their observations on the applicant’s supplementary observations added to the file on 14 December 2020.
31      The applicant claims, in essence, that the Court should:
–        order the appointment of an expert in accordance with Article 96 of the Rules of Procedure;
–        annul the contested regulation in so far as it renews the approval of copper compounds as a CFS and extend the effects of the present action to Implementing Regulation 2015/408, in so far as it implemented Article 80(7) of Regulation No 1107/2009 and included copper compounds in the list of CFS;
–        in the alternative, declare that the contested regulation infringes the principle of proportionality;
–        order the Commission to pay the costs.
32      The Commission, supported by the Parliament and the Council, contends that the Court should:
–        reject the request for the appointment of an expert;
–        dismiss the action;
–        order the applicant to pay the costs.
III. Law
A.      Admissibility
33      Without formally raising a plea of inadmissibility by separate document in the present proceedings, the Commission disputes the admissibility of the action on the grounds, first, that the applicant has not demonstrated that it has legal personality and, second, that it is not directly and individually concerned by the contested regulation.
34      Both the Parliament and the Council support the Commission’s position in that regard.
1.      Whether the applicant has legal personality
35      It is settled case-law that the admissibility of an action for annulment brought by an entity under Article 263 TFEU depends primarily on the legal personality of the applicant. It is apparent from the relevant case-law that, in the EU judicial system, an applicant is a legal person if, at the latest by the expiry of the period prescribed for bringing proceedings, it has acquired legal personality in accordance with the law governing its constitution or if it has been treated as an independent legal entity by the EU institutions (see, to that effect, judgment of 11 July 1996, Sinochem Heilongjiang v Council, T‑161/94, EU:T:1996:101, paragraph 31 and the case-law cited).
36      For the purpose of determining whether an applicant has been treated as an independent legal entity by an institution, it is necessary to take into account three criteria: first, the entity in question must be representative in character; second, it must be independent, which is necessary in order to act as a responsible body in legal matters, as ensured by its constitutional structure under its rules, and, third, a European Union institution must have recognised the entity in question as a negotiating body (see order of 21 January 2014, EPAW v Commission, T‑168/13, EU:T:2014:47, paragraph 24 and the case-law cited).
37      In that regard, the Commission, which does not dispute that the first criterion is fulfilled in the present case, claims that fulfilment of the second criterion is doubtful and that the third criterion is not fulfilled, since the fact that the Commission corresponded with the applicant as an association designated by the producers for the purposes of notification does not constitute a form of negotiation and cannot therefore lead to the applicant being recognised as a negotiating body.
38      First, it should be borne in mind that in the case-law it has been recognised that entities have the status of negotiating body in situations not only involving ‘negotiations’ but, more broadly, exchanges with the defendant institution (see, to that effect, judgments of 28 October 1982, Groupement des Agences de voyages v Commission, 135/81, EU:C:1982:371, paragraphs 8 to 11; of 11 July 1996, Sinochem Heilongjiang v Council, T‑161/94, EU:T:1996:101, paragraph 34; and of 25 September 1997, Shanghai Bicycle v Council, T‑170/94, EU:T:1997:134, paragraph 29). In the present case, the special and unique role assumed by the applicant in the process leading to the adoption of the contested regulation is apparent, in particular, from recitals 4, 5 and 9 of that regulation. Thus, the Court considers that, in the context of the present case, the exchanges made in the context of obtaining approvals of substances as CFS and renewing those approvals appear sufficient to fulfil the third criterion.
39      Second, it should be noted that the applicant, an association of producers, brought the present action ‘on behalf and on the account of’ its members and provided, pursuant to Article 78(4) of the Rules of Procedure, the document which establishes it, namely an agreement of 26 July 2000 (date of its authentication, the signatures having been appended in 1999). The fulfilment of the second criterion is apparent both from Article 2.1 of that agreement of 26 July 2000, which gives the applicant the independence necessary to act as a responsible body in legal matters, and from a document annexed to the application as part of the formal documents required, from which it is apparent that, at its meeting on 7 February 2019, the applicant decided to mandate its lawyers to bring the present action. That assessment is, moreover, consistent with the applicant’s previous litigation activity before the Courts of the European Union in Cases T‑310/15, European Union Copper Task Force v Commission, and C‑384/16 P, European Union Copper Task Force v Commission, and was not disputed by the Commission on those occasions.
40      Furthermore, it may also be noted that the applicant provided, as an annex to the reply, a value added tax (VAT) certificate. It is apparent from the case-law relating to the existence of a taxable transaction (judgment of 27 March 2014, Le Rayon d’Or, C‑151/13, EU:C:2014:185, paragraph 29), on the one hand, and the case-law relating to the taxable person’s function in the VAT system (judgment of 8 May 2019, A-PACK CZ, C‑127/18, EU:C:2019:377, paragraph 22), on the other, that only a structure with legal capacity can identify tax on an invoice and collect it via the price or enforce it (see, to that effect, Opinion of Advocate General Kokott in Valstybinė mokesčių inspekcija prie Lietuvos Respublikos finansų ministerijos and Others (Joint activity agreement), C‑312/19, EU:C:2020:310, points 35 to 37).
41      In the light of the foregoing, the applicant must be recognised as having capacity to bring the present legal proceedings before the Court.
2.      Locus standi
42      According to settled case-law, the fourth paragraph of Article 263 TFEU provides for two situations in which natural or legal persons are accorded standing to institute proceedings against an act which is not addressed to them. First, such proceedings may be instituted if the act is of direct and individual concern to that person. Second, such persons may bring proceedings against a regulatory act not entailing implementing measures if that act is of direct concern to them (see judgment of 16 May 2019, Pebagua v Commission, C‑204/18 P, not published, EU:C:2019:425, paragraph 26 and the case-law cited; judgment of 11 July 2019, Air France v Commission, T‑894/16, EU:T:2019:508, paragraph 24).
43      In the light of the documents in the case file, the second alternative must be examined first.
44      As a preliminary point, it should be recalled that, according to the case-law, the applicant, as an association representing producers of copper compounds, is entitled to bring an action for annulment only if it can prove an interest of its own or, if that is not the case, if the undertakings which it represents or some of those undertakings themselves have locus standi (judgment of 13 March 2018, European Union Copper Task Force v Commission, C‑384/16 P, EU:C:2018:176, paragraph 87).
45      In the present case, in accordance with the final limb of the fourth paragraph of Article 263 TFEU, if (i) the contested act is a regulatory act which is of direct concern to the applicant’s members, and (ii) that act does not entail implementing measures, those members’ standing to bring proceedings will be demonstrated.
46      In the first place, as regards the nature of the contested regulation, first, it should be noted that its purpose is the renewal of an active substance defined according to objective characteristics and that, by giving concrete expression to the effects associated with the categorisation of that substance as a CFS, in accordance with Implementing Regulation 2015/408, to which it gives rise, it affects categories of persons envisaged in general and in the abstract, namely any operator whose activity is linked to that substance. Consequently, the contested regulation is an act of general application (see, to that effect, order of 27 April 2016, European Union Copper Task Force v Commission, T‑310/15, not published, EU:T:2016:265, paragraphs 26 and 27), which is not, moreover, disputed by the parties.
47      Second, the contested regulation does not constitute a legislative act since it was not adopted in accordance with either the ordinary legislative procedure or the special legislative procedure within the meaning of Article 289(1) to (3) TFEU. The concept of ‘regulatory act’ must be construed as referring to any act of general application, save for legislative acts (order of 27 April 2016, European Union Copper Task Force v Commission, T‑310/15, not published, EU:T:2016:265, paragraph 33). In that regard, it should be noted that, as is clear from the provisions of Article 20(1) and Article 79(3) of Regulation No 1107/2009, read together, which refer to Articles 5 and 7 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (OJ 1999 L 184, p. 23), the contested regulation was adopted by the Commission in the exercise of implementing powers. As a result, it constitutes a regulatory act within the meaning of the fourth paragraph of Article 263 TFEU, a point which, moreover, is not disputed by the parties.
48      In the second place, as regards the absence of implementing measures, first of all, it must be borne in mind that, in paragraph 59 of its judgment of 13 March 2018, European Union Copper Task Force v Commission (C‑384/16 P, EU:C:2018:176), the Court of Justice confirmed the General Court’s analysis that, in so far as the effects of the contested regulation – in respect of the performance, by the Member States, of a comparative assessment of the health or environmental risks of plant protection products containing copper compounds compared with a substitute product or a non-chemical method of pest control or prevention – would not arise with respect to the members of the applicant except through measures taken by the competent authorities of the Member States, such acts constituted, therefore, implementing measures within the meaning of the final limb of the fourth paragraph of Article 263 TFEU.
49      Next, the Court of Justice confirmed the General Court’s conclusion that, in so far as the effects of the contested regulation in respect of the procedure for the mutual recognition of marketing authorisations for plant protection products containing a CFS concern only the margin of discretion available to Member States in ruling on an application to that effect, those effects will not arise – if they do arise – as regards the members of the applicant except through measures by national authorities ruling on the applications for mutual recognition lodged by those members and, consequently, such measures constituted implementing measures within the meaning of the final limb of the fourth paragraph of Article 263 TFEU (judgment of 13 March 2018, European Union Copper Task Force v Commission, C‑384/16 P, EU:C:2018:176, paragraph 62).
50      In the present case, as the Commission points out, those two conclusions remain relevant in the context of the examination of the existence of implementing measures in relation to the contested regulation.
51      Lastly, regarding the existence or otherwise of implementing measures as regards the effects of Implementing Regulation 2015/408 on the period of validity of the approval renewal of copper compounds as CFS, the General Court, confirmed by the Court of Justice, concluded that such measures existed, since those effects will affect the applicant’s members only through a regulation adopted by the Commission in the course of renewing that approval (order of 27 April 2016, European Union Copper Task Force v Commission, T‑310/15, not published, EU:T:2016:265, paragraph 44).
52      As the Commission acknowledges, the act contested in the present action constitutes the act identified by the Court in the order of 27 April 2016, European Union Copper Task Force v Commission (T‑310/15, not published, EU:T:2016:265), as being the act through which the effects of the rules on the duration of the validity of the renewal of approval of copper compounds as CFS are produced.
53      As a result, it follows from the foregoing that no implementing measure is necessary to give rise to those effects. Thus, it must be concluded that the contested regulation does not entail implementing measures within the meaning of the final limb of the fourth paragraph of Article 263 TFEU, with regard to at least one of its effects.
54      In the third place, in the light of the assessment relating to the absence of implementing measures as regards the rules relating to the period of validity of the renewal of approval of copper compounds as CFS, it is necessary to examine whether the effects of the contested regulation in that regard directly affect the applicant’s members.
55      It is important to note that those members are producers of copper compounds and that some hold marketing authorisations for plant protection products containing copper compounds (see paragraph 1 above). The fact that they have to submit applications for renewal of the approval of that substance after 7 years instead of 15 directly affects the legal position of those producers in so far as, whereas previously they benefited from a legal regime which gave them certainty, including legal certainty as regards the approval of that substance and, consequently, as regards the marketing authorisations for their plant protection products containing that substance, as the duration of those authorisations is linked to the approval of that substance in accordance with Article 32 of Regulation No 1107/2009, they are now subject to a stricter legal regime, the period of legal stability being reduced by more than half compared to the previous legal regime. That automatic amendment is sufficient grounds for considering that the applicant’s members are directly affected by the contested regulation within the meaning of the final limb of the fourth paragraph of Article 263 TFEU.
56      Furthermore, in its judgment of 19 December 2019, Probelte v Commission (T‑67/18, EU:T:2019:873, paragraphs 53 to 55), the Court carried out an analysis of the criterion of direct concern, referred to in the second situation envisaged by the fourth paragraph of Article 263 TFEU, with regard to the applicant in that case, specifically the effects of Implementing Regulation 2015/408 on the period of validity of the renewal of approval of a substance on the list of CFS. In that context, the Court held that the condition relating to the direct concern of the applicant in that case was satisfied. The present case concerns a regulation which produces the effects of Implementing Regulation 2015/408 in that regard.
57      As a result, the contested regulation is of direct concern to the applicant’s members within the meaning of the final limb of the fourth paragraph of Article 263 TFEU, with regard to at least one of its effects.
58      In the light of the foregoing, it must be held that the applicant’s members have standing to bring proceedings under the fourth paragraph of Article 263 TFEU.
59      Therefore, without it being necessary to examine the admissibility of that action with regard to other situations, it must be concluded that the applicant’s action is admissible, in accordance with the case-law referred to in paragraph 44 above.
B.      Substance
60      The applicant seeks the partial annulment of the contested regulation in so far as it renews the approval of copper compounds as a CFS. In support of its action, the applicant puts forward three pleas in law.
61      By its first plea, without expressly referring to Article 277 TFEU, the applicant raises a plea of illegality against Article 24 of Regulation No 1107/2009 and point 4 of Annex II to that regulation (‘the contested provisions of Regulation No 1107/2009’), taking the view that, since the PBT criteria are not, from a scientific perspective, appropriate for inorganic substances, the fact that the legislature did not exclude the application of those criteria to copper compounds constitutes a manifest error of assessment.
62      By its second plea and ad cautelam, the applicant raises, again without expressly referring to Article 277 TFEU, a plea of illegality against Implementing Regulation 2015/408, which had previously established that copper compounds fulfilled the PBT criteria.
63      By its third plea, the applicant claims, in the alternative, that the contested regulation infringes the principle of proportionality in that it applies the PBT criteria even though the Commission was aware that the guidance documents relating to the assessment of copper compounds as CFS were inappropriate.
1.      Preliminary observations on the scope of judicial review
64      In the first place, it should be noted that the present action comes within a complex technical and scientific context that is evolving. As such, it is settled case-law that the EU authorities have a broad discretion, in particular as to the assessment of highly complex scientific and technical facts in order to determine the nature and scope of the measures which they adopt. Therefore, review by the EU judicature must be confined to verifying whether the exercise of such powers has been vitiated by a manifest error of assessment or misuse of powers, or whether those authorities have manifestly exceeded the bounds of their discretion. In such a context, the European Union judicature cannot substitute its assessment of scientific and technical facts for that of the institutions on which alone the FEU Treaty has placed that task (see, to that effect, judgment of 21 July 2011, Etimine, C‑15/10, EU:C:2011:504, paragraph 60 and the case-law cited). Thus, when reviewing the legislature’s discretion, the criterion to be applied is not whether a measure adopted in such an area was the only or the best possible measure, since its legality 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, judgment of 8 June 2010, Vodafone and Others, C‑58/08, EU:C:2010:321, paragraph 52 and the case-law cited).
65      In order to establish that an institution committed a manifest error in assessing complex facts such as to justify the annulment of that act, the evidence adduced by the applicant must be sufficient to make the factual assessments used in the act implausible. Subject to that review of plausibility, it is not the Court’s role to substitute its assessment of complex facts for that made by the institution which adopted the decision. The abovementioned limits to the review by the Courts of the European Union do not, however, affect their duty to establish whether the evidence relied on is factually accurate, reliable and consistent, 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 judgment of 11 February 2015, Spain v Commission, T‑204/11, EU:T:2015:91, paragraphs 32 to 33 and the case-law cited).
66      In other words, even though such judicial review is of limited scope, it requires that the EU authorities which have adopted the act in question must be able to show before the EU judicature that in adopting the act they actually exercised their discretion, which presupposes that they took into consideration all the relevant factors and circumstances of the situation the act was intended to regulate (see judgment of 11 May 2017, Deza v ECHA, T‑115/15, EU:T:2017:329, paragraph 164 and the case-law cited).
67      In that regard, in paragraph 35 of the judgment of 22 November 2017, Commission v Bilbaína de Alquitranes and Others (C‑691/15 P, EU:C:2017:882), the Court of Justice noted that the exercise of that discretion was not excluded from review by the Court and, in particular, that, where a party claimed that the institution competent in the matter had committed a manifest error of assessment, the EU judicature had to verify whether that institution had examined, carefully and impartially, all the relevant facts of the individual case on which that assessment was based. That duty to act diligently is inherent in the principle of sound administration and applies generally to the actions of the EU administration.
68      In the second place, it should be noted that, in so far as the present action seeks the annulment of a regulation adopted in accordance with Regulation No 1107/2009, account must be taken of the fact that, pursuant to Article 1(3) and (4) thereof, Regulation No 1107/2009 seeks to ensure a high level of protection of human and animal health and the environment.
69      In the third and last place, it should be recalled that the lawfulness of an EU measure must be assessed on the basis of the facts and the law as they stood at the time when the measure was adopted and cannot depend on retrospective considerations of its efficacy. Where the EU legislature is obliged to assess the future effects of rules to be adopted and those effects cannot be accurately foreseen, its assessment is open to criticism only if it appears manifestly incorrect in the light of the information available to it at the time when the rules in question were adopted (see, to that effect, judgment of 28 July 2011, Agrana Zucker, C‑309/10, EU:C:2011:531, paragraph 45 and the case-law cited).
2.      The first plea: the contested provisions of Regulation No 1107/2009 are unlawful
70      The applicant divides its first plea into three parts, alleging, first, that scientific evidence indicates that the PBT criteria, in particular persistence, are inappropriate for inorganic substances, second, that the application of the PBT criteria to inorganic substances under Regulation No 1107/2009 is inconsistent with other regulatory acts implemented in the same field before and after that regulation and, third, that the precautionary principle was misinterpreted and that it was not necessary, in the light of the objectives pursued by Regulation No 1107/2009, to apply the PBT criteria to inorganic substances in so far as CFS are concerned.
(a)    The first part of the first plea: scientific evidence indicates that the PBT criteria, in particular persistence, are inappropriate for inorganic substances
71      The applicant submits that, by applying the contested provisions of Regulation No 1107/2009 to copper compounds without sound scientific basis, the EU authorities clearly exceeded the bounds of their discretion.
72      In the first part of its first plea, the applicant sets out why the PBT criteria cannot be applied to inorganic substances, a fact that, it claims, (i) is borne out in the light of current scientific knowledge and (ii) has been recognised by EFSA, SCoPAFF and the DG for Health and Consumers.
(1)    Recognition that applying the PBT criteria to inorganic substances is inappropriate in the light of current scientific knowledge
73      Given the intrinsic properties of copper compounds, the applicant claims that it is wrong for them to be regulated on the basis of the PBT criteria, which were developed in order to address the hazards posed by synthetic organic chemicals.
74      It is clear from the file that the applicant disputes more specifically the relevance of the persistence criterion, as it confirmed at the hearing. According to the applicant, persistence is measured by determining the lack of degradability of a substance, usually from a form that is bioavailable and active in nature to a form that is less available or less toxic. However, metals and metal inorganic compounds are by definition present in nature and do not degrade in the environment. As a result, it is impossible for them not to be persistent. Therefore, while it is relevant to synthetic organic substances, the persistence criterion is, by contrast, meaningless as regards inorganic substances.
75      As a preliminary point, it should be borne in mind that the degree of the review of the appropriateness of the PBT criteria is governed by the principles set out in paragraphs 64 to 68 above.
76      In that context, it is necessary to examine whether the evidence provided by the applicant shows that the non-applicability of the persistence criterion to inorganic substances could clearly be regarded as being the scientific standard at the time of the adoption of Regulation No 1107/2009.
77      In that regard, in its statement in intervention, the Council observes that the European Union’s ability to legislate cannot be conditional on the existence within the scientific community of a perfect consensus on all the elements of a legislative text. Although that view may be shared, it cannot, by contrast, be acceptable, in the present case, for the European Union to legislate in a way that goes against a scientific consensus that applying the PBT criteria to inorganic compounds is inappropriate, if such a consensus exists. In addition, it must be noted, as the applicant does, that it is not a question of requiring ‘a perfect consensus on all the elements of a legislative text’, but rather of not departing from such a consensus, where there is one. If the EU legislature wishes deliberately to depart from that consensus, it must address the subject explicitly during the legislative process leading to the adoption of a regulation and must state the reasons why it is departing from that consensus in that way. However, that is not the case here.
78      It is therefore necessary to examine whether such a consensus is apparent from the evidence submitted by the applicant.
79      In that respect, while it is true, first, that in the application the applicant merely referred to an annex containing several documents, listed in a footnote, without specifying the relevant passages, in what way the content of those documents supported its arguments or the precise link between those documents and the numerous arguments on which it relied, and, second, that it is settled case-law that the Court may take an annex into consideration only in so far as it supports or supplements the pleas or arguments expressly put forward by the applicant in the body of the application and where it is possible for the Court to determine precisely the matters contained in that annex that support or supplement those pleas or arguments (see, to that effect, judgment of 13 December 2018, Slovak Telekom v Commission, T‑851/14, EU:T:2018:929, paragraph 87 (not published)), the Commission, the Parliament and the Council nonetheless submitted their observations, at the hearing, on the relevance of those documents. On that occasion, the applicant stated that it was unable to comment specifically on the technical aspects of the case on account of the absence of its chairman owing to the COVID-19 health crisis and lodged additional observations on 4 November 2020, the admissibility of which is contested by the Commission and the interveners.
80      Nevertheless, the Court considers that it is necessary, in the present case, to examine the present part of this plea by taking account of that annex and the additional observations, without there being any need to rule on their admissibility (see paragraphs 91 and 102 below).
81      In the first place, it is necessary to examine the five documents identified by the applicant in its additional observations, which it claims demonstrate that there is a scientific consensus.
82      First, the applicant submits a summary of a book by the Society of Environmental Toxicology and Chemistry, published in 2007 and entitled Assessing the Hazard of Metals and Inorganic Metal Substances in Aquatic and Terrestrial Systems, which resulted from discussions that took place during a workshop held from 3 to 8 May 2003 and draws conclusions from that workshop on the possibility of developing a model that makes it possible to assess the hazards represented by metals better, highlighting the unsuitability of the persistence criterion in respect of inorganic substances.
83      Although, in the absence of the full version of that book, it cannot be concluded with certainty that it actually supports the applicant’s position, the probative value of the document produced can, in any event, be assessed in the light of the examination of another document provided by the applicant, namely an article published in 2007 in the scientific journal Environmental Toxicology and Chemistry, entitled ‘Can the unit world model concept be applied to hazard assessment of both organic chemicals and metal ions?’. Although it is clear from that document that the persistence criterion may pose certain difficulties when applied to the hazard assessment of inorganic substances, it cannot, in contrast, be inferred from this that there is a scientific consensus to the effect that it is meaningless to apply the PBT criteria to inorganic compounds. First of all, the subject matter of the article is whether it is possible to apply another approach, to both organic and inorganic substances. Next, the approach advocated in that article appears to reveal that an alternative model is potentially conceivable, but that it is not free from difficulties in its application. Lastly, it is not apparent that the persistence criterion is completely rejected in that model, but that it is simply integrated with other criteria.
84      In the light of that article, it therefore appears that the remarks made in the Society of Environmental Toxicology and Chemistry’s book as summarised in the document annexed to the application, which are implicitly referred to in the article in the Environmental Toxicology and Chemistry journal, reflect merely the expression by a certain number of scientists of the need to find a more appropriate method for assessing the hazards of metals.
85      Second, the applicant relies on a document entitled Metals Environmental Risk Assessment Guidance published in January 2007 by the International Council on Mining & Metals (ICMM). The applicant has extracted a passage indicating, generally, that because the majority of the compounds assessed are organic substances rather than inorganic metals, the various methodologies and guidance documents provided for performing those assessments are lacking in detail on how to account for metal-specific attributes. However, that document concerns, in essence, the criterion of bioaccumulation and not the unsuitability of the persistence criterion. Since the bioaccumulation criterion was not taken into account in classifying copper compounds as CFS, that document cannot support the demonstration of the existence of the consensus the proof of which is sought. Furthermore, as the Commission, the Parliament and the Council point out, that document does not have indisputable probative value, since it was drawn up by two sectoral associations and a private undertaking, the independence of which has not been established in the present case.
86      Third, the applicant has submitted a guidance document from the European Centre for Ecotoxicology and Toxicology of Chemicals (Ecotoc), published in July 2014. That document concerns the information to be taken into consideration in the evaluation of the PBT criteria and the criteria relating to very persistent and very bioaccumulative substances applicable to chemicals falling within the scope of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1). Contrary to what the applicant appears to claim, the fact that that document does not change the field of application of the PBT criteria is insufficient to demonstrate the existence of a consensus as to the non-applicability of the criterion of persistence to inorganic substances, since that issue is not specifically addressed in that document.
87      Moreover, the same observations as those relating to the relevance of the Ecotoc document in the present case may be made in relation to the European Chemicals Agency (ECHA) Guidance on Information Requirements and Chemical Safety Assessment of June 2017, which the applicant also submits in support of its position.
88      In the second place, it may be noted that the applicant has failed to demonstrate convincingly that it is apparent from the approach followed in other countries that there was consensus within the scientific community and among the competent legislative bodies.
89      In that regard, first, it should be noted that the slide to which the applicant refers in order to illustrate its comments, in the reply, provides no explanation with regard to the legislative texts adopted around the world that it merely lists. Second, and similarly, in its observations on the Parliament’s statement in intervention, the applicant merely asserts that the only piece of legislation within the European Union, and even worldwide, that applies the PBT criteria (with particular attention to the persistence criterion) to inorganic compounds, such as copper compounds, is Regulation No 1107/2009. Third, the alternative model discussed in the documents referred to in paragraphs 82 and 83 above dates from 2007. Moreover, nothing indicates that it has been implemented since then, even though it was developed by a multi-disciplinary and international group of 47 scientists, managers and political decision-makers from Europe, Canada and the United States.
90      In the light of the foregoing, although it may be accepted that there is a debate as to the relevance of applying the persistence criterion in the context of the assessment of the hazards of inorganic substances, it cannot however be concluded that the applicant has adduced evidence that that criterion was inapplicable or that there was consensus within the scientific community in that regard. The most relevant documents in that regard do not demonstrate that failing to include inorganic substances in the context of assessments applying the PBT criteria was the scientific standard that the legislature should have taken into account when adopting Regulation No 1107/2009, but relate, above all, to research for a method more suited to the specific characteristics of those substances which enable their hazards – the existence of which is in no way excluded – to be better identified (see, in that regard, paragraphs 82 to 84 above and paragraphs 110 and 111 below).
91      As a result, by failing to adduce evidence demonstrating the existence of that consensus, the applicant has not proved to the requisite legal standard that there was a manifest error of assessment on the part of the legislature as a result of its failure to exclude inorganic substances from the scope of the assessment applying the PBT criteria in Regulation No 1107/2009 at the time when that regulation was adopted.
(2)    Recognition that the application of the PBT criteria to inorganic substances is inappropriate having regard to the positions adopted by EFSA, SCoPAFF and the DG for Health and Consumers
92      The applicant asserts that EFSA, SCoPAFF and the DG for Health and Consumers have recognised that the guidelines on the risk assessment of metals are inappropriate with regard to copper compounds.
93      It observes, first of all, that, in its conclusion of 20 December 2017 on the peer review of the pesticide risk assessment of copper compounds, EFSA states that the available data were not sufficient to take into account fully the specific nature of copper in the context of the environmental risk assessment and that the available guidance in the area of pesticide active substance environmental risk assessment does not specifically cover metal compounds.
94      It notes, next, that, in its final renewal report for the active substances copper compounds, SCoPAFF specifically mentions the need for EFSA to develop a new methodology that takes into account the available methodology applied in other areas by the ECHA.
95      Lastly, it states that, in its letter of 13 February 2019, the DG for Health and Consumersinstructed EFSA to develop new guidance, stating that the guidance documents available regarding environmental risk assessment of pesticides are not always directly applicable to those metal compounds because, inter alia, metal compounds are already present in the environment at varying levels, either appearing naturally or in different sources. It also claims that the DG for Health and Consumers is calling for a consistent approach across all EU legislation.
96      In the first place, although, as the applicant points out, those documents reveal a certain awareness, at the level of certain EU authorities, of the need to improve the methodology for the risk assessment of copper, that awareness does not amount to recognition by those authorities of the inappropriateness of the PBT criteria for assessing the hazards posed by inorganic substances, let alone to demonstrating the existence of evidence which enables identification of a manifest error of assessment committed by the legislature at the time Regulation No 1107/2009 was adopted.
97      In the second place, it should be noted that, although the EFSA document refers to the fact that the available guidance in the area of pesticide active substance environmental risk assessment does not specifically cover metal compounds, it nevertheless states that the available data on copper compounds were assessed and considered for their merits in the light of the methodologies and knowledge available at the time taking into considerations the specific characteristics of copper.
98      In the third place, the documents submitted by the applicant concerning risk assessment methodologies which, as the applicant itself explains in the reply and in its observations on the Parliament’s statement in intervention, depend on the intended uses, may therefore vary according to the regulated field, as the applicant concedes in the reply. Therefore, the fact that EFSA and ECHA follow different methods is irrelevant in the context of the applicant’s argument that the methods for assessing the hazards of inorganic substances must be consistent because the intrinsic properties of those substances are identical.
99      In the fourth place and in any event, the legislature’s decision not to exclude inorganic substances from the scope of application of the assessment applying the PBT criteria dates from the adoption of Regulation No 1107/2009 on 21 October 2009. No position capable of reflecting with certainty a state of scientific knowledge at the relevant time that supports the applicant’s claim, in the context of which the Court’s review must be carried out in the context of the first plea, is apparent from any of the documents.
100    Consequently, while it may be accepted that it is apparent from the EFSA, SCoPAFF and DG for Health and Consumers documents on which the applicant relies that the relevance of the application of the PBT criteria in respect of inorganic substances is under discussion, it must nevertheless be noted that the applicant has not provided sufficient evidence to support the conclusion that the non-applicability of the PBT criteria to inorganic substances was the scientific standard when Regulation No 1107/2009 was adopted.
101    In addition, as the Parliament notes in its observations on the applicant’s additional observations, beyond the mere existence of a debate on the inappropriateness of applying the PBT criteria to inorganic substances, the series of assessments and procedures to which copper compounds were subjected in order to obtain their approval and the renewal of that approval shows in itself that there was no scientific consensus on the issue.
102    Therefore, by failing to adduce evidence demonstrating the existence of a consensus, at the time Regulation No 1107/2009 was adopted, as to the non-applicability of the PBT criteria to inorganic substances, and so that that alleged non-applicability constituted the scientific standard, the legislature did not commit any manifest error of assessment for having applied the PBT criteria to copper compounds.
103    In the light of the foregoing, the first part of the first plea must be rejected as unfounded.
(b)    The second part of the first plea: application of the PBT criteria to inorganic substances under Regulation No 1107/2009 is inconsistent with other regulatory acts implemented in the same field before and after Regulation No 1107/2009
104    The applicant submits that it is apparent from the Commission document entitled ‘Questions and Answers on Candidates for Substitution’, dating from January 2015, that the PBT criteria contained in point 4 of Annex II to Regulation No 1107/2009 are used to assess the intrinsic properties of substances. It points out that, by definition, the intrinsic properties of a substance do not vary depending on its use. Thus, any legislation, where it relates to the intrinsic properties of a substance, should reflect that constancy. However, the applicant is of the view, in essence, that its analysis of the EU legislation does not result in such a finding, in so far as inconsistencies are apparent with regard to Regulation No 1907/2006, Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ 2012 L 167, p. 1), to Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers (OJ 2003 L 304, p. 1) and to Commission Regulation (EU) 2017/1432 of 7 August 2017 amending Regulation No 1107/2009 as regards the criteria for the approval of low-risk active substances (OJ 2017 L 205, p. 59).
105    The applicant asserts that the intrinsic properties of a substance should be subject to the same hazard assessment criteria across legislative frameworks and thus irrespective of what the subsequent use of the active substance will be, since, in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation No 1907/2006 (OJ 2008 L 353, p. 1), it is necessary to harmonise as far as possible all hazard assessments based on intrinsic properties.
106    In the first place, in so far as the applicant alleges an infringement of EU law by reason of the application of the PBT criteria to inorganic substances under Regulation No 1107/2009 being inconsistent with other legislative acts implemented in the same field before and after that regulation, it is sufficient to note that there is no obligation on the legislature to harmonise the approaches followed in different regulatory frameworks. Recognition of the need to adopt a coherent approach, on which the parties agree, does not create a legal obligation and still less an ipso facto ground of illegality of an act.
107    Similarly, the arguments regarding Regulation No 1272/2008 put forward by the applicant in the reply, which seek to demonstrate that the need for harmonisation was established therein, must be rejected, in so far as the specific purpose of that regulation is, in accordance with Article 1(1)(a) of that regulation, to harmonise the criteria for classification of substances and mixtures, and the rules on labelling and packaging for dangerous substances and mixtures. First, Regulation No 1107/2009 does not pursue any objective of transversally harmonising the assessment criteria for chemical substances in order to make them applicable in the context of all the regulatory frameworks involving such substances and, second, the hierarchy of norms does not require Regulation No 1107/2009 to be subject to Regulation No 1272/2008. In that regard, it must be borne in mind that those regulations reflect the political and economic decisions taken by the legislature specific to each of those legislative instruments.
108    In the second place, if the applicant’s argument must be understood as claiming that, by applying the PBT criteria to inorganic substances, contrary to the obligation imposed on it by the scientific and technical knowledge at the time as apparent from other regulatory frameworks, the legislature infringed the principle of proportionality to the point of committing a manifest error of assessment, that argument must be rejected.
109    It is true that Article 4(1) of Regulation No 1107/2009 does indeed require the approval procedure for an active substance to be carried out in the light of current scientific and technical knowledge.
110    However, in accordance with the conclusions reached by the Court in its examination of the first part of the first plea, it is not apparent from the documents submitted by the applicant either that there is a scientific consensus on the issue, or that inorganic substances pose no danger, but only that the approach of using the PBT criteria is not optimal. According to Article 1(3) and Article 1(4) of Regulation No 1107/2009, the purpose of that regulation is to ensure a high level of protection of human and animal health and of the environment, and its provisions are underpinned by the precautionary principle (see, in that regard, paragraph 68 above).
111    As a result, in the absence of an entirely appropriate method for taking into account the potential hazards represented by inorganic substances, the application of the PBT criteria seems, ultimately, to be an appropriate measure for attaining the legitimate objectives pursued by the legislation at issue. It allows the substance concerned to be subject to the CFS regime, which expresses the legislature’s intention progressively to replace that substance with an appropriate solution. In that regard, the documents before the Court show that the copper compounds covered by that measure do appear to be capable of being replaced, contrary to what is claimed by the applicant. It should, in fact, be pointed out that, in the defence, the Commission specifically stated that it was not correct that copper compounds could not be replaced by another fungicide or another bactericide, indicating, by way of illustration and without being contradicted on that point by the applicant in the reply, that, first, there are at least three natural compounds approved at EU level as bactericide and included to that effect in the annex to Implementing Regulation No 540/2011, namely Bacillus subtilis (entry 138), plant oils/clove oil (entry 241) and vinegar (entry 5), second, there are also many other substances that are fungicides, such as fenhexamid, flutianil, and phosphonates and, third, copper compounds could be also replaced by an integrated pest management approach combining alternative compounds and resistant plant varieties.
112    In the light of the foregoing, it must be held that the applicant has not adduced, to the requisite legal standard, the proof necessary to establish a manifest error of assessment on the part of the legislature as a result of applying the PBT criteria to inorganic substances in the context of Regulation No 1107/2009.
113    The second part of the first plea must therefore be rejected.
(c)    The third part of the first plea: misinterpretation of the precautionary principle and the lack of necessity, as regards the objectives pursued by Regulation No 1107/2009, to apply the PBT criteria to inorganic substances, as regards CFS
114    As a preliminary matter, it must be recalled that it is settled case-law, first, that the principle of proportionality requires that acts of the EU institutions be appropriate for attaining the legitimate objectives pursued by the legislation at issue and do not exceed the limits of what is necessary in order to achieve those objectives, it being understood that, when 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 (see judgment of 30 April 2019, Italy v Council (Fishing quota for Mediterranean swordfish), C‑611/17, EU:C:2019:332, paragraph 55 and the case-law cited).
115    Second, as regards judicial review of the implementation of that principle, bearing in mind the wide discretion enjoyed by the EU institutions when they are called upon to regulate situations falling within a complex technical and scientific context that is evolving, as in the present case (see, in that regard, paragraph 64 above), the lawfulness of a measure adopted in that sphere can be affected only if the measure is manifestly inappropriate in terms of the objective which the competent institution is seeking to pursue. What must be ascertained, therefore, is not whether the measure adopted by the legislature was the only one or the best one possible but whether it was manifestly inappropriate (see, to that effect, judgment of 30 April 2019, Italy v Council (Fishing quota for Mediterranean swordfish), C‑611/17, EU:C:2019:332, paragraph 56 and the case-law cited).
116    In the third part of its first plea in law, the applicant submits that the contested provisions of Regulation No 1107/2009 infringe the principle of proportionality in so far as the inclusion of copper compounds in the assessment applying the PBT criteria for the purposes of the CFS regime exceeds what is necessary to achieve the objectives of that regulation.
117    In support of its position, first, the applicant notes that the CFS identification mechanism pursues the objective of progressively replacing active substances which have certain properties that the Commission considers to be of concern. Yet, according to the applicant, since copper is present in nature, it cannot be replaced by another substance. However, the substitution at issue relates to copper compounds which, as explained in paragraph 111 above, appear to be capable of being replaced. Furthermore, as the Parliament points out in its statement in intervention, the contested measure is intended to encourage the search for alternatives and thus comes within the scope of the objectives pursued by Regulation No 1107/2009.
118    Second, as regards the fact that, when there is a choice between several appropriate measures, recourse must be had to the least onerous, the applicant submits that there is, in the present case, a possibility of adopting a less restrictive measure. In its observations on the Council’s statement in intervention, the applicant states that an exemption statement for inorganic compounds not to be subjected to a PBT assessment in the working document entitled ‘Evidence needed to identify POP, PBT and vPvB properties for pesticides’ would be sufficient.
119    However, in the context of the examination of the first two parts of the present plea, it was concluded that (i) it was not apparent from the evidence adduced by the applicant that the inorganic substances should be exempted from a hazard assessment, (ii) the applicant had not demonstrated that there was a scientific consensus as regards the inappropriate nature of applying the PBT criteria to inorganic substances and (iii) the measure adopted was appropriate for attaining the legitimate objectives pursued by the legislation at issue.
120    As a result, although those substances continued to be subject to a risk assessment as regards intended uses, it must be concluded that, given that the alternative proposed by the applicant would lead to a total exemption from assessment of the hazards of inorganic substances, without that being justified, the measure that the applicant proposes would not take into account the objectives pursued by Regulation No 1107/2009.
121    Third, in response to the argument put forward by the interveners that the legislature could have opted for a more restrictive approach, the applicant observes that, on the one hand, the alternative envisaged by the Council is not realistic, because it would have led to the prohibition of most plant protection products currently available to farmers and, on the other hand, that does not mean that the choice actually made is proportionate and thus that choice should be assessed on its own merits.
122    In that regard, it should be noted that the system in place allows an alternative to the possible non-renewal of approval of copper compounds. In addition, reassessment according to the most recent scientific data and methods is carried out by reviewing the status of CFS when assessing the renewal of approvals, in accordance with Article 11(2)(c) of Implementing Regulation No 844/2012, read in conjunction with Article 11(3) of that regulation. Lastly, as the applicant itself indicates in the application, scientific developments may lead to a review of Regulation No 1107/2009 so that they may be taken into account.
123    Fourth, with regard to the fact that the disadvantages caused must not be disproportionate to the aims pursued, it should be noted that the applicant considers it illogical to make producers of copper compounds in the European Union subject to the consequences of the CFS regime when it is impossible to substitute copper. In that regard, first of all, it has already been stated in paragraphs 111 and 117 above that the substitution sought by applying the CFS regime to copper compounds is conceivable and that, consequently, the disadvantages caused by the requirement to carry out a comparative assessment are not disproportionate to the aims pursued. Next, the absence of automatic authorisation on the basis of mutual recognition does not preclude Member States from continuing to apply such a mechanism, in accordance with Article 41(2)(b) of Regulation No 1107/2009 (also see paragraph 49 above). Lastly, although shortening the period of renewal may lead to an increase in certain costs as a result of the increase in the frequency of renewals of approval, it nonetheless allows any scientific developments to be raised sooner.
124    Fifth, as regards the applicant’s argument that the precautionary principle cannot justify the legislature’s decision to subject inorganic substances to an assessment applying the PBT criteria, suffice it to note that it is not apparent from the evidence adduced by the applicant that inorganic substances must be exempted from a hazard assessment, but only that, in that context, the application of the PBT criteria is the subject of debate (see, in that regard, paragraphs 82 to 84 and paragraphs 110 and 111 above). As a result, the hazards at issue relate not to hypothetical situations but to potential situations, in accordance with the requirements laid down by the case-law (see, to that effect, judgment 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).
125    Furthermore, it must be borne in mind, as the Commission does, that the classification of copper compounds as CFS pursues the objective of progressively finding alternatives. As the Council points out, although the substances in question were not, at the time of the assessment, known to give rise to risks such as to prevent their approval, they nevertheless have properties which could pose a greater risk to human health and the environment than a less dangerous alternative.
126    Sixth, as regards the arguments raised by the applicant regarding the sufficient degree of protection afforded by the regime applicable prior to the adoption of Regulation No 1107/2009, it is sufficient to recall that, in accordance with Article 1(3) thereof, that regulation seeks to ensure a high level of protection of both human and animal health and the environment. As a result, as the Parliament points out in its statement in intervention, the legislature is entirely justified in increasing the degree of protection. The fact that copper compounds are put to other uses in the same environmental compartment or that they are used as fertiliser or manure does not lead to the conclusion that the measure is disproportionate. As was pointed out in paragraph 106 above, there is no legal obligation to harmonise all the regulatory frameworks applicable to copper. Consequently, the proportionality of the measure must be assessed in the context of the situations governed by Regulation No 1107/2009.
127    In the light of the foregoing, it must be concluded that the applicant has not succeeded in demonstrating either that the application of the PBT criteria to inorganic substances exceeded the limits of what was necessary to achieve the objectives pursued by Regulation No 1107/2009, or that that regulation misinterpreted the precautionary principle.
128    It follows that the third part of the first plea in law must be rejected as unfounded and, accordingly, that the first plea in law must be rejected in its entirety.
3.      The second plea in law: plea of illegality of Implementing Regulation 2015/408 in relation to the classification of copper compounds as CFS
129    The applicant raises, ad cautelam, a plea of illegality against Implementing Regulation 2015/408, in so far as, although not cited in the contested regulation, it implemented Article 80(7) of Regulation No 1107/2009 by drawing up a list of CFS that included copper compounds.
130    Given that the plea of illegality raised in the context of the first plea in law against Regulation No 1107/2009 aims at removing copper compounds from the scope of application of the PBT criteria, the applicant takes the view that any applications of those criteria to copper compounds must be covered by the effects of a potential annulment of Regulation No 1107/2009. Thus, it submits that, if the Court upholds its first plea in law, the effects of that conclusion must inevitably lead to the removal of the effects of the inclusion of copper compounds on the list of CFS approved by Implementing Regulation 2015/408.
131    Since it has been concluded that the first plea in law should be rejected and since the arguments raised in the context of the present plea are identical, the second plea in law must be rejected.
4.      The third plea in law: the contested act infringes the principle of proportionality by renewing the approval of copper compounds as CFS
132    In the alternative, the applicant alleges that the Commission infringed the principle of proportionality by renewing the approval of copper compounds as a CFS instead of subjecting them to the general regime, even though the Commission was aware, at the time of the adoption of the contested regulation, that the guidelines were inappropriate for assessing copper compounds.
133    The applicant submits, in essence, that the Commission exceeded the limits of what was appropriate and necessary, in so far as it should have made copper compounds subject to the general regime on account of (i) the inappropriate nature of the persistence criterion in relation to those compounds, (ii) the fact that the sectoral legislation already takes account of the intrinsic properties of inorganic compounds and that the general approach followed is that those compounds must not be subject to the PBT criteria, and (iii) the fact that subjecting copper compounds to the CFS regime is not necessary in order to achieve the objective pursued by the contested regulation. Moreover, the applicant states that the applicable legislation already foresees a complex notification procedure involving a thorough examination of the safety of a substance and copper has already gone through that process.
134    The third plea in law is based on the premiss that the Commission knew, at the time the contested regulation was adopted, that the application of the PBT criteria to copper compounds was inappropriate. Although it was not demonstrated in the context of the analysis of the plea of illegality raised in the first plea in law that it was inappropriate to apply those criteria, it is nevertheless necessary to examine whether the applicant has proved that factors which arose between the adoption of Regulation No 1107/2009 and the adoption of the contested regulation could alter that assessment.
135    In that regard, first, it may be noted that, although since 2012 Annex XIII to Regulation No 1907/2006 no longer mentions the exclusion of inorganic substances from the scope of the PBT criteria, the guidance published by ECHA in June 2017 expressly states that, in that regulatory framework, the PBT criteria are not applicable to inorganic substances. However, the impact of such a document in the context of determining whether the Commission infringed the principle of proportionality when adopting the contested regulation must be subject to the same reservations as those expressed in paragraph 110 above.
136    Second, it should be noted that the slide show submitted by the applicant as an annex to the reply contains a slide on which it is stated that the ‘PBT criteria are not appropriate for substances with non-hydrophobs properties (ionic substances, perfluorated compounds, UVCB substances, microplastics, etc.)’. Without it being necessary to rule on the meaning of that quotation, which is interpreted differently by the Commission, it is sufficient to note that that reference is found on a slide entitled ‘Emerging issues’ dated 24 May 2019. Consequently, it cannot be concluded that, when the contested regulation was adopted, specific scientific data existed regarding the need not to apply the PBT criteria to inorganic substances. Again, in the absence of any scientific consensus in that regard, the Commission cannot be found to have committed a manifest error and it cannot be criticised for having taken those criteria into account in making copper compounds subject to the CFS regime. Accordingly, it must be held that there is nothing in the file which makes it possible to identify new scientific data or methods which might have led to a different conclusion as regards the status of copper compounds as a CFS.
137    Accordingly, the third plea in law must be rejected as being unfounded.
138    It follows from all the above considerations that the action must be dismissed in its entirety.
C.      The request to appoint an expert
139    Pursuant to Article 96 of the Rules of Procedure, the applicant asks the Court to name an expert, with the required scientific credentials and impartiality, who could draw up a report or submit an oral statement on the applicability of the PBT criteria to the assessment of copper compounds.
140    However, in the light of the various conclusions drawn from the analysis of the evidence in the file, the request for the appointment of an expert must be rejected.
141    Even if an expert were to conclude that the PBT criteria are inapplicable to inorganic substances, that would not mean that the legislature was under an obligation to take such a conclusion into account in 2009 or that the Commission was under an obligation to take such a conclusion into account in 2018.
142    The identification of such an obligation depends not only on the allegedly inappropriate nature of the PBT criteria with regard to inorganic substances, but also on factors which lead to the conclusion that there was a manifest error of assessment in not taking that inappropriate nature into account. In the present case, the applicant has failed to provide any such evidence.
IV.    Costs
143    Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.
144    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.
145    In accordance with Article 138(1) of the Rules of Procedure, the Parliament and the Council must bear their own costs.
On those grounds,
THE GENERAL COURT (First Chamber)
hereby:
1.      Dismisses the action;
2.      Orders European Union Copper Task Force to bear its own costs and to pay those incurred by the European Commission;
3.      Orders the European Parliament and the Council of the European Union to bear their own costs.
Kanninen
Jaeger
Porchia
Delivered in open court in Luxembourg on 13 October 2021.
E. Coulon
M. van der Woude
Registrar
President
*      Language of the case: English