62024CJ0316_RES
Case C‑316/24 P
Pesticide Action Network Europe (PAN Europe)
v
European Commission
Judgment of the Court (Fourth Chamber) of 18 December 2025
(Appeal – Agriculture – Plant protection products – Article 4 – Regulation (EC) No 1107/2009 – Implementing Regulation (EU) 2021/2049 – Renewal of the approval of the active substance ‘cypermethrin’ – Request for internal review – Regulation (EC) No 1367/2006 – Article 10(1) – Decision refusing the request – Risk assessment and risk management – Identification of critical areas of concern – Realistic conditions of use – Precautionary principle)
Environment – Aarhus Convention – Application to EU institutions – Ability of non-governmental organisations to request internal review of administrative acts in environmental matters – Administrative measure aimed at renewing the approval of an active substance – Subject matter of the review – Reassessment of the approval
(European Parliament and Council Regulation No 1367/2006, Art. 10(1))
(see paragraph 80)
Environment – Aarhus Convention – Application to EU institutions – Ability of non-governmental organisations to request internal review of administrative acts in environmental matters – Statement of the grounds for re-examination – Need to indicate factors likely to raise doubts as to whether the measure in question is well founded
(European Parliament and Council Regulation No 1367/2006, Art. 10(1))
(see paragraph 82)
Agriculture – Approximation of laws – Placing of plant protection products on the market – Regulation No 1107/2009 – Approval of an active substance – Risk assessment – Criteria – Taking into account the draft renewal assessment report of the rapporteur Member State and of the conclusion by the European Food Safety Authority (EFSA) – Obligation for the Commission to follow those documents on all points – None – Possibility of departing from a risk assessment identifying a critical area of concern – Conditions
(European Parliament and Council Regulation No 1107/2009, Arts 4(2) and (3), 11(1) and (2), 12(2), 13(1), 14(1) and Annex II, points 2 and 3)
(see paragraphs 87-94, 102)
Appeal – Grounds – Inadequate statement of reasons – Scope of the obligation to state reasons – Obligation for the General Court to disclose clearly and unequivocally its reasoning – Breach – Setting aside of the judgment under appeal
(Art. 256(1), second para., TFEU; Statute of the Court of Justice, Arts 36 and 53, first para.; Rules of Procedure of the General Court, Art. 117(m))
(see paragraphs 98, 107, 114, 120, 123, 200, 317, 318)
Agriculture – Approximation of laws – Placing of plant protection products on the market – Regulation No 1107/2009 – Approval of an active substance – Assessment of risks – Criteria – Examination of one or more representative uses of at least one plant protection product containing that active substance – Scope – Identification by the European Food Safety Authority (EFSA) of critical areas of concern – Approval subject to conditions or restrictions – Obligation for the Commission to demonstrate the effectiveness of the risk mitigation measures
(European Parliament and Council Regulation No 1107/2009, Arts 4(2) and (3), 6, 14(1), 20(1)(a) and 24)
(see paragraphs 170-172, 178, 179, 319)
Agriculture – Approximation of laws – Placing of plant protection products on the market – Regulation No 1107/2009 – Approval of an active substance – Assessment of risks – Criteria – Obligation for the competent authority to take into account the adverse effects of endocrine disruptors of an active substance present in the product – Taking into account relevant and reliable scientific or technical knowledge available at the time of the examination – Observance of the precautionary principle
(European Parliament and Council Regulation No 1107/2009, Art. 4(1), second para., and (3), 7(1) and Annex II, point 3.6.5)
(see paragraphs 204-207)
Agriculture – Approximation of laws – Placing of plant protection products on the market – Regulation No 1107/2009 – Approval of an active substance – Application for approval – Active substance composed of a mixture of isomers – Obligation to indicate the ratio or range of ratios of the isomer content and the relative biological activity of each isomer – Classification of that information as further confirmatory information – Not permissible
(European Parliament and Council Regulation No 1107/2009, Art. 6(f); Commission Regulation No 283/2013, Annex, Part A, point 1.9, fourth para.)
(see paragraphs 231, 237)
Agriculture – Approximation of laws – Placing of plant protection products on the market – Regulation No 1107/2009 – Approval of an active substance – Assessment of risks – Criteria – Examination of one or more representative uses of at least one plant protection product containing that active substance – Presence on the market of a plant protection product containing that substance – No effect
(European Parliament and Council Regulation No 1107/2009, Arts 4(1) to (3) and (5), 14(1) and 29(1))
(see paragraphs 279-285, 295-298)
Agriculture – Approximation of laws – Placing of plant protection products on the market – Regulation No 1107/2009 – Approval of an active substance – Assessment of risks – Criteria – Examination of one or more representative uses of at least one plant protection product containing that active substance – Taking into account the effects resulting from the interaction between that active substance and the other components of the product
(European Parliament and Council Regulation No 1107/2009, Arts 4(1) to (3) and (5), 13, 14(1) and 29(1))
(see paragraph 301)
Agriculture – Approximation of laws – Placing of plant protection products on the market – Regulation No 1107/2009 – Marketing authorisation for plant protection products – Conditions – Absence of immediate or delayed harmful effect on human health – Exemption from testing of the long-term toxicity of the products – None
(European Parliament and Council Regulation No 1107/2009, Arts 4(3)(b) and 29(1)(e) and (2))
(see paragraph 302)
Résumé
By its judgment, the Court of Justice sets aside in part the judgment of the General Court in PAN Europe v Commission, whereby the General Court dismissed the action for annulment of the decision (
1
) of the European Commission of 23 June 2022 refusing the request for an internal review of Implementing Regulation 2021/2049 (
2
) renewing the approval of the active substance ‘cypermethrin’. Finding that the state of the proceedings so permits, the Court of Justice itself gives final judgment and annuls the Commission’s decision in part.
Cypermethrin is an insecticide used within the European Union and was authorised for incorporation in plant protection products in 2005.
In the context of the renewal of the approval of cypermethrin, the European Food Safety Authority (EFSA) identified, in its 2018 conclusion, four critical areas of concern relating to that active substance. Next, in September 2019, at the Commission’s request, it adopted a statement on risk mitigation measures for cypermethrin.
Following that risk assessment, the Commission on 24 November 2021 adopted Implementing Regulation 2021/2049, which renews the approval of cypermethrin, accompanied by a set of specific provisions.
In January 2022, the appellant, the environmental organisation Pesticide Action Network Europe (PAN Europe), made a request to the Commission for an internal review (
3
) of Implementing Regulation 2021/2049. It claimed that there had been a breach of the precautionary principle and of the obligation for the European Union to ensure a high level of protection of human health and the environment. The Commission refused that request.
PAN Europe’s action against the decision at issue was dismissed by the General Court and it lodged an appeal against the judgment of the General Court.
Findings of the Court
In the first place, the Court of Justice considers that the General Court acted in breach of the obligation to state reasons, distorted the evidence and made an error of law vitiating its assessment of the critical area of concern relating to the lack of information on the representativity of the batches used and that relating to the high risk for non-target arthropods.
As a preliminary point, the Court observes that, where the Commission is required to determine an application for renewal of the approval of an active substance, it must carry out a risk assessment, taking account of both the draft renewal assessment report (‘the RAR’) prepared by the rapporteur Member State (‘the RMS’) and the conclusion adopted by EFSA. Where the assessments carried out by the RMS and by EFSA diverge, the Commission, which has a broad discretion, must carry out complex scientific and technical assessments. Therefore, review by the Courts of the European Union must be limited to ascertaining whether the procedural rules have been complied with, whether the facts have been accurately stated and whether there has been a manifest error of assessment or misuse of powers or whether there has been a failure to fulfil the obligation to state reasons.
In carrying out that review, the General Court must state the reasons on which its decision is based and clearly and unequivocally disclose the reasoning followed, so that the persons concerned can be apprised of the justification for the decision taken and the Court of Justice can exercise its power of review.
In the present case, the Court of Justice finds, first, that the General Court provided insufficient reasons for rejecting the appellant’s argument seeking to challenge the Commission’s analysis relating to the critical area of concern identified by EFSA concerning the data gap relating to the composition of the batches of pesticides used in the ecotoxicological studies submitted by the applicants for approval.
The Court of Justice observes, on one hand that in relying on the fact that the RMS had confirmed that a number of checks of equivalence carried out in the context of the draft RAR had made it possible to establish equivalence between the technical material used at the time of the first approval and that used at the time of the renewal procedure, and that the data gap could be overcome either at zonal or national level, or on the occasion of the next renewal, the General Court did not state the reasons why it was necessary to give priority to the position of the RMS over that of EFSA, or identify risk mitigation measures that would have allowed the Commission to depart from a risk assessment that identified a critical area of concern.
On the other hand, the Court of Justice considers that the General Court’s finding relating to the data gap concerning the impurities of the material and their genotoxic potential is vitiated by insufficient reasoning and distortion of the evidence.
In that regard, the Court of Justice emphasises first of all that it was for the General Court to ascertain whether the Commission had fulfilled its obligation to examine carefully and impartially the aspects of the particular case and whether the dossier enabled it to substantiate its assertion that EFSA had ‘confirmed’ that, other than hexane, no impurity would be considered toxicologically relevant, relying at least on a study or on a specific document drawn up by EFSA that was amenable to judicial review.
In those circumstances, the General Court could not merely adopt the Commission’s finding, contained in the decision at issue, that the increase in the level of minimum purity of the active substance according to the new specification chosen means lower impurity levels by comparison with the situation prevailing at the time of the first approval of the active substance.
Last, having relied on the fact that in the EFSA conclusion the genotoxicity of cypermethrin had been considered to be unlikely, the General Court did not respond to the appellant’s argument to the requisite legal standard relating to the genotoxic potential of the impurities.
The Court of Justice concludes from all of those considerations that the General Court’s assessment of the proportionate nature of the risk mitigation measures adopted by the Commission is unfounded.
Second, as regards the critical area of concern relating to the high risk for non-target arthropods, the Court observes that an active substance can be approved or have its approval renewed, only if it is established that at least one representative use of a plant protection product (‘PPP’) containing that substance has no harmful effect on human or animal health and has no unacceptable effect on the environment, in realistic conditions of use. The same applies where the renewal of the approval of the active substance is subject to conditions or restrictions, or where the substitution of that active substance is envisaged, as in the present case.
However, it is not apparent from the judgment under appeal that the General Court ascertained that, for the purposes of the renewal of the approval of cypermethrin, the Commission had actually ensured that such a safe use had been demonstrated, in realistic conditions of use, in such a way as to achieve the level of risk mitigation required for non-target arthropods.
Furthermore, the General Court followed the Commission’s position that the verification of the realistic and practicable nature of the risk mitigation measures which it adopted is ultimately a matter for the Member States when they authorise PPPs containing cypermethrin. It is for the Commission to verify, when, in the context of risk management, it is claimed that a ‘safe’ use of a PPP containing the active substance at issue has been identified as permitting the envisaged level of risk mitigation to be achieved, that that use satisfies, in a realistic manner, the criteria provided for in Article 4(1) to (3) of Regulation No 1107/2009.
The Court of Justice therefore considers that the General Court vitiated its judgment by an error of law in rejecting the appellant’s argument calling into question the Commission’s assertion that a ‘safe’ use had been identified within the Standing Committee.
In the second place, the Court of Justice holds that the General Court made an error of law in holding that the second request for confirmatory information on the toxicity of the isomers did not constitute an abuse.
In declaring that the appellant’s argument that that second request failed to satisfy the requirement laid down in the fourth paragraph of point 1.9 of Part A of the annex to Regulation No 283/2013 (
4
) was inadmissible, on the ground that that argument was put forward only at the stage of the reply, when the appellant had expressly relied on it in its request for an internal review and in its application for annulment, the General Court distorted the appellant’s arguments.
The Court of Justice observes that that distortion is not in itself sufficient to justify the judgment under appeal being set aside, since the General Court examined the substance of that argument and rejected it on the ground that the isomers had indeed been taken into account, but that EFSA had considered it necessary to have more specific information and had found that there was a data gap.
Nonetheless, the General Court’s reasoning makes it difficult to understand how it actually responded to the appellant’s argument.
In so far as cypermethrin is a mixture of eight isomers, the dossiers submitted by the applicants for renewal of its approval had to include the information specified in the fourth paragraph of point 1.9 of Part A of the annex to Regulation No 283/2013, namely the ratio or range of ratios of the isomers and the relative biological activity of each isomer.
In the present case, it was not established that those data were to be found in the dossiers submitted by the applicants for renewal of the approval of cypermethrin. The General Court was therefore wrong to consider that that information was mere ‘additional confirmatory information’, within the meaning of Article 6(f) of Regulation No 1107/2009.
In the third place, the Court of Justice holds that the General Court was wrong to consider that the appellant had not given rise to ‘plausible doubts’ as to the legality of the decision at issue on account of the absence of an assessment of the long-term toxicity of the representative use submitted by the applicant for renewal of the approval of cypermethrin.
First of all, the Court of Justice observes that the General Court erred in law in holding that it was not the purpose of Article 4(5) of Regulation No 1107/2009 to extend to PPPs, in one or more representative uses, the requirements laid down in paragraphs 1 to 3 of Article 4 of that regulation. It considers, however, that such an infringement is not capable of leading to that judgment being set aside. In the present case, the General Court was correct to hold that the Commission cannot approve or renew the approval of an active substance where the only PPP tested containing that active substance presents long-term toxicity.
The Court notes, next, that the General Court’s findings are based on the presumption that long-term toxicity was evaluated. However, in order to ensure compliance with the precautionary principle, there is no presumption that a PPP has no harmful effects.
In those circumstances, the Court of Justice holds that the General Court could not consider, without vitiating its judgment by an error of law, that the Commission was able to infer from the fact that the RMS and EFSA had not examined the long-term toxicity of a PPP, in one or more of its representative uses, that that product did not present any problematic aspect. On the contrary, the General Court was required to ensure that, in the context of the procedure for renewal of the approval of cypermethrin, the Commission had ascertained that it was indeed ‘established’ that at least one of the representative uses of the PPP containing that active substance did not present long-term toxicity. The Court makes clear, in that regard, that the fact that the PPPs are already present on the market has no impact on the Commission’s obligation under Article 4(5) of Regulation No 1107/2009.
Furthermore, there is no indication in the case file that the General Court, while seeking to preserve the confidentiality of Volume 4 of the evaluation dossier prepared by the RMS, requested access thereto in order to ascertain, with the necessary rigour, the reality of the Commission’s assertions that the long-term toxicity of at least one representative use was the subject of an evaluation.
Last, the ground on which the General Court relied, alleging that the safety data sheets were drawn up, in application of the REACH Regulation (
5
) and Regulation No 1272/2008, (
6
) for each component of the representative use of a PPP containing the active substance in question, does not address the appellant’s argument that the evaluation of each of the components in isolation did not permit an assessment of the overall toxicity resulting from their interaction. In order to ensure that the criteria laid down in Article 4(3) of Regulation No 1107/2009 have been met, the effects resulting from the interaction between the active substance concerned and the other components of the product must be taken into consideration. Furthermore, the evaluation of long-term toxicity requires that specific tests are carried out that allow the risk of such toxicity to be excluded.
In the light of the foregoing, the Court of Justice sets aside the judgment of the General Court in that it rejected the appellant’s arguments alleging, respectively, that:
–
no information about the representativity of the batches of pesticides was provided;
–
the risk mitigation measures in respect of non-target arthropods in off-field areas were unrealistic;
–
the second request for confirmatory information about the toxicity of the isomers constituted an abuse; and
–
the long-term toxicity of the representative use of the plant protection product containing cypermethrin submitted by the applicants for renewal of the approval of that active substance was not examined.
Finding that the state of the proceedings so permits, the Court itself gives final judgment in the matter and annuls the decision of the Commission of 23 June 2022 in that it:
–
finds that the batches of pesticides used for the assessment of cypermethrin were shown to be representative;
–
justifies the renewal of the approval of cypermethrin on the basis of a risk mitigation measure in respect of non-target arthropods in off-field areas which was not shown to be realistic;
–
considers that the second request for further confirmatory information which the Commission sent to the applicants for renewal of the approval of cypermethrin did not constitute an abuse;
–
finds that there was no long-term toxicity in the representative use of the plant protection product containing cypermethrin submitted by the applicants for renewal of the approval of that active substance.
(
1
)	Judgment of 21 February 2024, PAN Europe v Commission (T‑536/22, EU:T:2024:98; ‘the judgment under appeal’).
(
2
)	Commission Implementing Regulation (EU) 2021/2049 of 24 November 2021 renewing the approval of the active substance cypermethrin as a candidate for substitution in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ 2021 L 420, p. 6).
(
3
)	On the basis of Article 10(1) of Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Union institutions and bodies (OJ 2006 L 264, p. 13), as amended by Regulation (EU) 2021/1767 of the European Parliament and of the Council of 6 October 2021 (OJ 2021 L 356, p. 1).
(
4
)	Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, 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 (OJ 2013 L 93, p. 1).
(
5
)	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).
(
6
)	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).