EuGH · C-773/23

JUDGMENT OF THE COURT (First Chamber) 10 September 2026 ( *1 ) (Appeal – Plant protection products – Active substances – Regulation (EC) No 1107/2009 – Article 4 – Approval criteria for active substances – Implementing Regulation (EU) 2020/17 – Non-renewal of approval of the active substance ‘chlorpyrifos-methyl’ – Admissibility – Second paragraph of Article 56 of the Statute of the Court of Justice of the European Union – Standing to bring proceedings – Condition that the applicant must be directly affected by the judgment against which it is appealing – Appeal brought by an intervener at first instance) In Case C‑773/23 P, APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 14 December 2023, European Crop Care Association (ECCA), established in Brussels (Belgium), represented by S. Pappas and A. Pappas, avocats, appellant, the other parties to the proceedings being: Ascenza Agro SA, established in Setúbal (Portugal), Industrias Afrasa, SA, established in Paterna (Spain), represented, by V. McElwee, Solicitor, M. Ombredane, avocate, P. Sellar and K. Van Maldegem, advocaten, applicants at first instance, European Commission, represented by F. Castilla Contreras and A. Dawes, acting as Agents, defendant at first instance, Kingdom of Denmark, French Republic, represented by P. Chansou and B. Travard, acting as Agents, Health and Environment Alliance (HEAL), established in Brussels, represented by A. Bailleux, avocat, interveners at first instance, THE COURT (First Chamber), composed of F. Biltgen, President of the Chamber, I. Ziemele, A. Kumin (Rapporteur), S. Gervasoni and M. Bošnjak, Judges, Advocate General: T. Ćapeta, Registrar: A. Calot Escobar, having regard to the written procedure, after hearing the Opinion of the Advocate General at the sitting on 13 November 2025, gives the following Judgment 1 By its appeal lodged on 14 December 2023, the European Crop Care Association (ECCA) seeks to have set aside the judgment of the General Court of the European Union of 4 October 2023, Ascenza Agro and Industrias Afrasa v Commission (T‑77/20, the judgment under appeal, EU:T:2023:602), by which the General Court dismissed the action for annulment brought by Ascenza Agro SA and Industrias Afrasa, SA against Commission Implementing Regulation (EU) 2020/17 of 10 January 2020 concerning the non-renewal of the approval of the active substance chlorpyrifos-methyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ 2020 L 7, p. 11; ‘the regulation at issue’). Legal context TFEU 2 Pursuant to the fourth paragraph of Article 263 TFEU: ‘Any natural or legal person may, under the conditions laid down in the first and second paragraphs, institute proceedings against an act addressed to that person or which is of direct and individual concern to them, and against a regulatory act which is of direct concern to them and does not entail implementing measures.’ The Statute of the Court of Justice of the European Union 3 Article 56 of the Statute of the Court of Justice of the European Union provides, in the first and second paragraphs thereof: ‘An appeal may be brought before the Court of Justice, within two months of the notification of the decision appealed against, against final decisions of the General Court and decisions of that Court disposing of the substantive issues in part only or disposing of a procedural issue concerning a plea of lack of competence or inadmissibility. Such an appeal may be brought by any party which has been unsuccessful, in whole or in part, in its submissions. However, interveners other than the Member States and the institutions of the [European] Union may bring such an appeal only where the decision of the General Court directly affects them.’ Background to the dispute 4 The background to the dispute was set out by the General Court in paragraphs 2 to 56 of the judgment under appeal and, for the purposes of the present case, may be summarised as follows. 5 Chlorpyrifos-methyl (‘CHP-methyl’) is an active substance used in plant protection products to control pests and to treat stored cereal grain and empty warehouses. CHP-methyl belongs to a group of chemicals called organophosphates, to which the active substance called chlorpyrifos also belongs. 6 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) established the legal regime for authorising the placing of plant protection products on the market in the European Union. 7 That directive provides for the inclusion of active substances in Annex I thereto, for an initial period not exceeding 10 years, if it may be expected that, first, their residues, consequent on application consistent with good plant protection practice, do not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment and, second, their use, consequent on application consistent with good plant protection practice, does not have any harmful effects on human or animal health or any unacceptable influence on the environment. 8 CHP-methyl and chlorpyrifos were included in Annex I to that directive by Commission Directive 2005/72/EC of 21 October 2005 amending Council Directive 91/414/EEC to include chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb, and metiram as active substances (OJ 2005 L 279, p. 63). The European Commission’s approval of CHP-methyl was extended on three occasions before expiring on 31 January 2020. 9 In June 2013, two companies producing CHP-methyl – Ascenza Agro, then known as Sapec Agro SA, and Dow AgroSciences Ltd – each submitted an application for renewal of the approval of CHP-methyl. 10 On 9 February 2017, the Kingdom of Spain, as the rapporteur Member State (‘the RMS’), sent Ascenza Agro a draft assessment report relating to the renewal of the approval of CHP-methyl, which did not recognise the existence of harmful effects of CHP-methyl on human health and in which it was proposed to renew the approval of CHP-methyl. 11 After that draft assessment report had been sent to the European Food Safety Authority (EFSA), to the Commission, to the Member States, to Sapec Agro and to Dow AgroSciences, a public consultation began on 18 October 2017. 12 On 31 July 2019, EFSA sent the Commission and the Member States a ‘statement’ on the available outcomes of the assessment of the risks for human health posed by CHP-methyl (‘the statement of 31 July 2019’), which it published on its website on 28 August 2019. It is apparent from that statement that the experts appointed to assess the risks of CHP-methyl had agreed that no reference values could be set for either genotoxicity or developmental neurotoxicity of that active substance, which made it impossible to perform a risk assessment of CHP-methyl for consumers, operators, workers, bystanders and residents. It is also apparent from the statement of 31 July 2019 that the experts had taken a conservative approach in considering that CHP-methyl would also meet the criteria for classification as toxic for reproduction, category 1B, in accordance with the provisions of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1). The approach adopted by the experts was largely based on structural similarities between CHP-methyl and chlorpyrifos. 13 Those experts had noted that there was no public literature available on the genotoxic potential of CHP-methyl, whereas several publications were available for chlorpyrifos, for which concerns had been raised. They therefore agreed that the uncertainties relating to the potential effects of CHP-methyl had to be considered in the assessment of risks posed by that active substance and that it therefore could not be ruled out that there was a potential risk of deoxyribonucleic acid damage. 14 On 8 November 2019, following a second consultation of experts, EFSA adopted an update of the statement of 31 July 2019, in which it concluded that the criteria relating to human health laid down in Article 4 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414 (OJ 2009 L 309, p. 1) were not met for the renewal of the approval of CHP-methyl. 15 On that basis, on 10 January 2020, the Commission adopted the regulation at issue by which it decided not to renew the approval of CHP-methyl. It based its refusal to renew that approval on three grounds, namely, first, the fact that ‘a genotoxic potential of [CHP]-methyl cannot be ruled out’, second, that ‘concerns were identified concerning [its] developmental neurotoxicity’ and, third, that ‘it may be appropriate to classify [CHP]-methyl as toxic for reproduction, category 1B’. The procedure before the General Court and the judgment under appeal 16 By application lodged at the Registry of the General Court on 10 February 2020, Ascenza Agro and Industrias Afrasa (‘the applicants at first instance’) brought an action seeking the annulment of the regulation at issue. They were supported by ECCA, which was granted leave to intervene in the proceedings before the General Court by order of the President of the Seventh Chamber of the General Court of 26 November 2020. By the same order, the Health and Environment Alliance (HEAL) was granted leave to intervene in support of the Commission. By order of the same date, the President of the Seventh Chamber of the General Court also granted the Danish and French Governments leave to intervene in support of the Commission. 17 In support of their action, the applicants at first instance relied on eight pleas in law, alleging, first, infringement of essential procedural requirements, second, infringement of the transparency obligation, third, infringement of the right to be heard, fourth, infringement of the precautionary principle, fifth, breach of the obligation to take into account all relevant factors and circumstances of the situation which the regulation at issue was intended to regulate, sixth, infringement of the principle of sound administration, seventh, a manifest error of assessment with regard to the risk assessment adopted by EFSA and subsequently by the Commission and, eighth, a manifest error of assessment and infringement of the principle of proportionality. 18 ECCA put forward three further pleas, namely the ninth and tenth pleas, alleging breach of the obligation to state reasons, and the eleventh plea, alleging infringement of Article 14 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 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ 2012 L 252, p. 26). 19 In the first place, in so far as the regulation at issue had not been addressed to the applicants at first instance, the General Court examined the admissibility of the action in the light of the fourth paragraph of Article 263 TFEU and, in paragraph 78 of the judgment under appeal, declared the action admissible. 20 In the second place, the General Court examined the pleas put forward by the applicants at first instance and by ECCA. 21 After examining them in paragraphs 101 to 174, 175 to 181, 182 to 226, 227 to 258, 259 to 288, 289 to 316, 317 to 339, 340 to 393, 394 to 597, 598 to 631 and 632 to 655 of the judgment under appeal, the General Court did not uphold any of those pleas and, consequently, dismissed the action in its entirety. Forms of order sought by the parties 22 ECCA claims that the Court of Justice should: – set aside the judgment under appeal; – annul the regulation at issue; and – order the Commission to pay the costs of the present proceedings and of the proceedings before the General Court. 23 The applicants at first instance claim that the Court of Justice should allow the appeal. 24 The Commission and HEAL contend that the Court should: – dismiss the appeal; and – order ECCA to pay the costs. 25 The French Republic contends that the Court should dismiss the appeal. The appeal 26 In support of its appeal, ECCA, supported by Ascenza Agro, puts forward four grounds of appeal. 27 The first ground of appeal alleges infringement of Regulation No 1107/2009 and the lack of a legal basis for the application of the read-across approach and the weight of evidence approach. The second ground of appeal alleges infringement of Article 296 TFEU and the third ground of appeal alleges infringement of essential procedural requirements. 28 Raised in the alternative, the fourth ground of appeal alleges infringement of the read-across approach and contradictory reasoning. 29 The Commission and HEAL submit that the appeal is inadmissible and, in the alternative, that it must be dismissed as unfounded. 30 The French Republic considers that none of the grounds of appeal raised by ECCA is well founded and that, as a result, the appeal must be dismissed. Admissibility of the appeal Arguments of the parties 31 The Commission and HEAL contest the admissibility of the appeal on the ground that ECCA, as an intervener, is not directly affected by the judgment under appeal and does not have standing to bring an appeal. In order to be directly affected, in accordance with the second sentence of the second paragraph of Article 56 of the Statute of the Court of Justice of the European Union, it is not sufficient merely to have been granted leave to intervene at first instance. Relying on the case-law of the Court of Justice, they state that an intervener is directly affected where the judgment under appeal brings about a detrimental change in its own legal position or adversely affects its own economic or moral interests. In the present case, in their view, ECCA is affected only indirectly by the judgment under appeal. 32 Furthermore, according to the Commission and HEAL, it is not possible to apply, by analogy, the case-law on the standing of associations under the fourth paragraph of Article 263 TFEU to standing to bring an appeal under the second paragraph of Article 56 of the Statute of the Court of Justice of the European Union, since, in particular, ECCA has not demonstrated that it is directly affected by the judgment under appeal. Any other approach would render meaningless the requirement of being directly affected set out in the latter provision. Indeed, since any intervener before the General Court other than the Member States and the EU institutions would necessarily have demonstrated an interest in the result of the case in order to be granted leave to intervene, that approach would mean that such a party would always satisfy that requirement of being directly affected. 33 ECCA, for its part, claims, in the first place, that it meets the requirement of being directly affected by the judgment under appeal for the purposes of the second paragraph of Article 56 of the Statute of the Court of Justice of the European Union. Indeed, in its view, that judgment significantly and immediately affects its interests, with the result that it has standing to bring the present appeal. 34 In that regard, ECCA claims that the judgment under appeal impacts the attainment of its statutory objectives, as an association, and the interests of its members. It states, first of all, that according to its statutes, its objectives include to represent the views of the post-patent (generic) plant protection industry in Europe in general, and those of the small and medium-sized enterprises (SMEs) thereof in particular, in consultations on new legislation envisaged at EU and Member State level, as well as to keep its members updated as regards developing legislation concerning the registration and renewal of registration of active substances in Europe. In addition, it helps with the legal, financial, scientific and technical problems of its members and also initiates legal proceedings in the context of approval of active substances and plant protection products. Its tasks under its statutes include, moreover, defending the interests of its members before the EU Courts, with the result that it should not have to produce a mandate or specific authorisation from one of its members in order to have standing to bring proceedings. 35 Next, as regards its members, ECCA refers to the list published on its website, according to which it has 19 members; those include Ascenza Agro, as well as Albaugh Europe SARL, Barclay Chemicals R&D Ltd and Lainco SA, which also applied for the renewal of the approval of various active substances. 36 Lastly, the judgment under appeal has significant and immediate consequences for the procedures for the approval and renewal of active substances in accordance with Regulation No 1107/2009. First, it sets a precedent regarding the use of the read-across approach and the weight-of-evidence approach in the context of such procedures. Second, that judgment establishes the principle that EFSA and the Commission may arbitrarily amend the procedure for the evaluation of those substances, as provided for by that regulation, inter alia by changing the number of criteria to be analysed in the approval process for active substances and by replacing EFSA’s Conclusion with a statement. 37 In the second place, ECCA submits that, as an association, it represents the interests of Ascenza Agro, which is a member of the association and which itself has standing to bring an appeal. In that regard, ECCA maintains that the admissibility requirements for associations to bring an action for annulment on behalf of their members under the fourth paragraph of Article 263 TFEU should be applied by analogy to appeals brought by associations under the second paragraph of Article 56 of the Statute of the Court of Justice of the European Union. In its view, it follows from that case-law that an association has standing to bring proceedings provided that its members, or some of them, themselves have standing to bring proceedings (see, by analogy, judgments of 6 July 1995, AITEC and Others v Commission, T‑447/93 to T‑449/93, EU:T:1995:130, paragraph 60; of 12 December 1996, AIUFFASS and AKT v Commission, T‑380/94, EU:T:1996:195, paragraph 50; of 11 June 2009, Confservizi v Commission, T‑292/02, EU:T:2009:188, paragraph 52; and of 18 March 2010, Forum 187 v Commission, T‑189/08, EU:T:2010:99, paragraph 58). Findings of the Court 38 In the first place, it should be borne in mind that the second sentence of the second paragraph of Article 56 of the Statute of the Court of Justice of the European Union provides that interveners other than the Member States and the institutions of the Union may bring an appeal only where the decision of the General Court directly affects them. 39 As is apparent from the Court’s case-law, that provision must be interpreted as meaning that it is not sufficient to demonstrate an interest in the result of the dispute and to have been granted leave to intervene in the case at first instance in order to be entitled to bring an appeal (see, to that effect, judgment of 24 September 2002, Falck and Acciaierie di Bolzano v Commission, C‑74/00 P and C‑75/00 P, EU:C:2002:524, paragraph 55). 40 The criterion of being directly affected, for the purposes of the second sentence of the second paragraph of Article 56 of the Statute of the Court of Justice of the European Union, limits the circle of persons entitled to request that a judgment of the General Court be set aside to those affected by that judgment beyond the interest they have in the result of the case, which is sufficient for leave to intervene. The purpose of circumscribing the category of persons capable of bringing an appeal before the Court of Justice in a given case is to safeguard the proper administration of justice, not least by ensuring a degree of foreseeability in the appeals which can be brought against decisions of the General Court and by avoiding the circumvention of time limits and conditions of admissibility which apply to other legal remedies provided for by EU law (see, to that effect, order of 5 June 2025, Tertianum Services v EUIPO, C‑800/24 P, EU:C:2025:425, paragraph 23 and the case-law cited). 41 Accordingly, the mere fact that an intervener at first instance supported the form of order sought by one of the parties to the action for annulment brought before the General Court is not sufficient to establish that that intervener is directly affected by the judgment by which that action was decided. It is for that party to establish, in detail, that that judgment is liable to affect it directly. 42 In that regard, it should be noted that it is apparent from the case-law that an intervener is directly affected, for the purposes of the second sentence of the second paragraph of Article 56 of the Statute of the Court of Justice of the European Union, where the decision of the General Court which it seeks to have set aside brings about a detrimental change in its legal position or adversely affects its interests, on account of necessary measures which that party is required to take in order to comply with that decision (see, to that effect, judgments of 24 September 2002, Falck and Acciaierie di Bolzano v Commission, C‑74/00 P and C‑75/00 P, EU:C:2002:524, paragraph 58, and of 2 October 2003, International Power and Others v NALOO, C‑172/01 P, C‑175/01 P, C‑176/01 P and C‑180/01 P, EU:C:2003:534, paragraphs 52 and 53). 43 It follows that an intervener at first instance can be regarded as directly affected by the judgment which it seeks to have set aside only where that judgment produces, in itself, binding effects on that intervener’s own legal situation, since any binding effects produced by that judgment with regard to the legal situation of the main party supported at first instance by the intervener are irrelevant in that regard. 44 In the present case, it is therefore necessary to ascertain whether ECCA has established that it is directly affected by the judgment under appeal, in the light of the criteria referred to in paragraph 42 of the present judgment. 45 In that regard, it must be noted that, whilst it is true that ECCA claims that the judgment under appeal significantly and immediately affects its interests, the fact remains that the arguments put forward in support of that assertion, which are set out in paragraphs 34 to 36 of the present judgment, are not such as to substantiate such a claim. Indeed, the explanations provided by ECCA merely list the various operations and services that it carries out for its members in the performance of its duties pursuant to its statutes, without identifying the measures it would be obliged to adopt in order to comply with the judgment under appeal and which would bring about a detrimental change in its legal position or adversely affect its own interests. 46 In the light of the foregoing, it must therefore be held that ECCA has not established to the requisite legal standard that it is directly affected by the judgment under appeal, for the purposes of the second sentence of the second paragraph of Article 56 of the Statute of the Court of Justice of the European Union. 47 In the second place, as regards the application by analogy of the principles established in the context of actions for annulment under the fourth paragraph of Article 263 TFEU brought by a representative association against an act which is not addressed to it, it should be noted that it is apparent from settled case-law that such an action is subject to the condition that that legal person be accorded standing to bring proceedings. That situation arises in two situations. First, such proceedings may be instituted if the act is of direct and individual concern to that person. Second, such a person may bring proceedings against a regulatory act not entailing implementing measures if that act is of direct concern to them (judgment of 21 September 2023, China Chamber of Commerce for Import and Export of Machinery and Electronic Products and Others v Commission, C‑478/21 P, EU:C:2023:685, paragraph 48 and the case-law cited). 48 In the present case, and without it being necessary to rule on whether or not it is appropriate to apply by analogy in the context of an appeal the criteria established in the context of actions for annulment under the fourth paragraph of Article 263 TFEU brought by a representative association against an act which is not addressed to it, it is sufficient to note that, in any event, those criteria are not satisfied. 49 Indeed, first, ECCA has not established that it is itself directly affected by the judgment under appeal, with the result that it does not come within either of the two situations described in paragraph 47 of the present judgment. Second, contrary to the requirements arising from the relevant case-law, ECCA has failed to establish that, by bringing the present appeal, it acted on behalf of Ascenza Agro. On the contrary, the ECCA has merely produced a document showing that Ascenza Agro is one of its members. 50 In the light of the foregoing, ECCA’s appeal must be dismissed as inadmissible. Costs 51 Under Article 184(2) of the Rules of Procedure of the Court of Justice, where the appeal is unfounded, the Court is to make a decision as to costs. 52 Under Article 138(1) of those rules, which applies to the procedure on appeal by virtue of Article 184(1) thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. 53 In the present case, since the Commission and HEAL have applied for costs to be awarded against ECCA and the latter has been unsuccessful, ECCA must be ordered to bear its own costs and to pay those incurred by the Commission and by HEAL. 54 Article 140(1) of the Rules of Procedure, which is applicable to appeal proceedings by virtue of Article 184(1) thereof, provides that the Member States and institutions which have intervened in the proceedings are to bear their own costs. 55 In the present case, the French Republic must be ordered to bear its own costs. On those grounds, the Court (First Chamber) hereby: 1. Dismisses the appeal; 2. Orders European Crop Care Association (ECCA) to bear its own costs and to pay those incurred by the European Commission and by the Health and Environment Alliance (HEAL); 3. Declares that the French Republic is to bear its own costs. Biltgen Ziemele Kumin Gervasoni Bošnjak Delivered in open court in Luxembourg on 10 September 2026. A. Calot Escobar Registrar F. Biltgen President of the Chamber ( *1 ) Language of the case: English.