Opinion of the Advocate General — ECLI:EU:C:2025:422
Date: 2025-06-05
Language of the case: French
Procedure: Appeal - unfounded;Appeal - inadmissible;Action for annulment - successful;Appeal - successful
Origin: Belgium

summary, the second ground of appeal and the second part of the fourth ground of appeal are largely unfounded or not relevant to the decision. Only the statement of reasons in the judgment under appeal for the lack of probative value of data gaps is inadequate, but the Court of Justice may remedy that deficiency by substituting or supplementing the statement of reasons. E. Fifth ground of appeal – long-term toxicity 147. The fifth ground of appeal concerns the assessment of the long-term toxicity of the representative use of a cypermethrin-based plant protection product. 148. In its request for review, PAN Europe complained that no studies exist on the long-term toxicity of the representative use of the cypermethrin-based plant protection product investigated. It argued that such studies were necessary, however, because mutagenicity, carcinogenicity and toxicity for reproduction are exclusion criteria for authorisation. 149. In the contested review decision, the Commission countered that the composition of the plant protection product the representative use of which was considered during the renewal procedure was provided in detail, with safety data sheets for each component. It argued that that information had been set out in the confidential fourth volume of the draft renewal report and assessed. It submitted that neither the rapporteur Member State nor EFSA had raised concerns about long-term toxicity and no comments on the subject had been received during the public participation period. Besides, the Commission argued, the criteria set out in point 3.6 of Annex II to the Plant Protection Regulation which relate to mutagenicity, carcinogenicity and toxicity for reproduction were applicable not to the authorisation of plant protection products but to the authorisation of active substances. 150. Accordingly, the criteria for assessing the representative use of a plant protection product first need to be specified before their application by the General Court is examined. 1. Criteria for assessing the representative use of a plant protection product 151. As PAN Europe rightly criticises, the General Court bases its rejection of PAN Europe’s objections to the Commission’s view on contradictory findings regarding the key criteria. 152. According to paragraph 418 of the judgment under appeal, which PAN Europe criticises, a distinction should be drawn between approval of an active substance and approval of a plant protection product. It posits that Article 4(1) to (3) of the Plant Protection Regulation and the criteria set out in points 2 and 3 of Annex II are applicable to active substances and should not, in the view of the General Court, be extended by Article 4(5) to include plant protection products. 153. However, the following statements by the General Court contradict those findings. In paragraph 421 of the judgment under appeal, the General Court concedes that the Commission would not be permitted to approve an active substance if the only plant protection product using it which had been tested appeared to have long-term toxicity. According to paragraph 424, therefore, there is a link between the approval procedures for active substances and plant protection products. And according to paragraphs 425 and 426, the representative use of a plant protection product is then to be assessed in accordance with Article 4(1) to (3) of the Plant Protection Regulation after all. 154. Only those later statements are correct. 155. It is true that the Plant Protection Regulation differentiates in principle between the authorisation of active substances by the Commission under Chapter II and the authorisation of plant protection products by the Member States under Chapter III. Under Article 4(5), however, the provisions of Article 4(1) to (3) are deemed to be satisfied (only) where this has been established with respect to one or more representative uses of at least one plant protection product containing that active substance. The second subparagraph of Article 14(1) explicitly repeats that in respect of renewal of approval. 156. Accordingly, it is a precondition of authorising an active substance that the Commission examine one or more representative uses of at least one plant protection product containing that active substance. The standard of review is Article 4(1) to (3) of the Plant Protection Regulation. Paragraphs 2 and 3 of Article 4 even expressly lay down requirements for plant protection products. 157. By contrast, Article 4(1) of the Plant Protection Regulation governs the requirements for active substances, although in so doing it refers both to paragraphs 2 and 3 of the same article and to the approval criteria set out in points 2 and 3 of Annex II. 158. Points 2.1 and 3.2 of Annex II to the Plant Protection Regulation – like Article 4(2) and (3) – expressly refer to plant protection products. 159. However, contrary to the view of PAN Europe, the Commission’s view that point 3.6 of Annex II to the Plant Protection Regulation is not applicable to plant protection products, which the General Court confirms in paragraph 420 (also criticised) of the judgment under appeal, is correct. In particular the approval criteria set out in points 3.6.2 to 3.6.4, which PAN Europe cited in its request for review, but also most of the other provisions set out in points 2 and 3, indeed refer not to plant protection products but to their components, namely to active substances in particular. For instance, points 3.6.2 to 3.6.4 expressly provide that an active substance is only authorised if it is not to be classified as genotoxic, carcinogenic or toxic for reproduction. Those criteria therefore do not apply directly to the examination of representative uses of a plant protection product, (72) but do apply separately to the examination of the relevant active substance or other components. 160. As the Court of Justice has already established, however, that does not negate the need for tests of long-term toxicity relating to the combination of the various components within a plant protection product. (73) Under Article 4(3)(b) of the Plant Protection Regulation, a plant protection product may be authorised only where it has been demonstrated to have no immediate or delayed harmful effect on human health. A plant protection product does not satisfy that condition where it exhibits any long-term carcinogenicity and toxicity. (74) 161. The applicant must therefore submit sufficient material, primarily the tests, analyses and studies of the product, to exclude, in the light of current scientific and technical knowledge, the risk that that product exhibits such carcinogenicity or toxicity. (75) 162. PAN Europe is therefore right to complain that the findings in paragraph 418 of the judgment under appeal are incorrect and that they contradict the arguments set out below. That amounts to insufficient reasoning, (76) which the Court of Justice should remedy by substituting a statement of reasons to the effect of the above statements. 163. However, if the Court of Justice supplements and interprets the judgment under appeal to that effect, PAN Europe’s objections to the criteria recognised by the General Court will be rendered unfounded and must be rejected. 2. Assessment of long-term toxicity 164. That being said, PAN Europe’s argument that the General Court’s review of the application of those criteria is vitiated by errors of law must be accepted. 165. In essence, PAN Europe and the Commission disagree as to whether the Commission was entitled to rule out the long-term toxicity of the plant protection product without an explicit assessment by EFSA. In paragraph 427 of the judgment under appeal, the General Court rejects that complaint on the ground that PAN Europe submitted no evidence of such toxicity. It moreover agrees with the Commission in paragraph 428 that the absence of concerns raised by the rapporteur Member State, EFSA or the public is sufficient evidence to rule out long-term toxicity. 166. Under Article 4(3)(b) and Article 29 of the Plant Protection Regulation, however, the applicant must, when applying for authorisation for a plant protection product, adduce proof that the plant protection product has no immediate or delayed harmful effect on human health. (77) That must also apply where a plant protection product is examined with a view to renewing the approval of an active substance. The rapporteur Member State and EFSA must assess that proof, (78) and the Commission, under Article 13(1) and (2), must take that assessment into account in its decision on the active substance. (79) The precautionary principle requires that there be no presumption that plant protection products have no harmful effects. (80) It follows that the evidence in question is one of the relevant aspects of the case which the Commission must impartially and carefully examine before reaching a decision. (81) 167. Particular importance attaches to the EFSA conclusion. Under the second subparagraph of Article 12(2) of the Plant Protection Regulation and Article 13(1) of Implementing Regulation No 844/2012, which was in force at the time, that conclusion must answer the question whether, in the light of current scientific and technical knowledge using guidance documents available at the time of submission of the supplementary dossier, the active substance can be expected to meet the approval criteria provided for in Article 4 of the Plant Protection Regulation. The assessment required for that purpose must – as explained above – cover the long-term toxicity of the plant protection product the representative uses of which are being examined in connection with the authorisation of the active substance. 168. If, however, EFSA is silent on a key criterion – on long-term toxicity, in the present case – sufficient examination of an aspect relevant to the decision is lacking. 169. Neither the claim that the rapporteur Member State assessed the long-term toxicity in the confidential fourth volume of the draft renewal report (paragraph 431 of the judgment under appeal) nor approval of the plant protection product under examination in various Member States (paragraph 429) can make up for the absence of an assessment by EFSA. 170. Under the second subparagraph of Article 13(1) of Implementing Regulation No 844/2012, which was in force at the time, the Commission may decide that an EFSA conclusion is not necessary. In the present case, however, the Commission issued no waiver to that effect. It certainly did not state reasons as to why doing without an EFSA assessment of the long-term toxicity of the plant protection product under examination would be justified. 171. Consequently, the fifth ground of appeal is well founded if only because EFSA did not comment on the long-term toxicity of the plant protection product under examination. 172. However, even if the Court of Justice were to accept assessments by Member States as sufficient substitute for an EFSA assessment, PAN Europe’s submission raises significant doubts as to whether those assessments in fact took place on an adequate scale in the present case. 173. It is true, in principle, that the rapporteur Member State and the Member States which approve plant protection products must assess the long-term toxicity of the plant protection product under examination. (82) 174. However, it is doubtful whether any Member State has even examined the plant protection product under examination in the renewal procedure with regard to its long-term toxicity. 175. The relevant implementing provisions do expressly provide that applicants must provide data on the long-term toxicity of active substances. (83) As PAN Europe sets out, however, equivalent requirements are not in place in respect of plant protection products examined for the purposes of approval of active substances. Accordingly, applicants only have to provide – at least according to those provisions – data on certain other forms of toxicity. (84) 176. That surely bears some relation to the fact that it was the Court of Justice which, in the judgment in Blaise and Others, first clarified the necessity of assessing the long-term toxicity of plant protection products. As PAN Europe recalls, however, that judgment was not issued until 1 October 2019, after the application had been assessed by the rapporteur Member States and EFSA had published its conclusion. It is therefore reasonable to fear that the importance of assessing the long-term toxicity of plant protection products was underestimated before then. 177. Moreover, it is not apparent that individual Member States’ approval of the plant protection product under examination and, in particular, assessments on their part of its long-term toxicity had been taken into account in the renewal procedure. 178. Although the Commission considers the submission on the doubts regarding the assessment of long-term toxicity by Member States to be an inadmissible expansion of the subject matter of the proceedings, PAN Europe was right to present it for the first time at the appeal stage, as it does so in response to the arguments of the General Court. (85) 179. Finally, the Commission seeks to demonstrate that sufficient assessment of the long-term toxicity of the plant protection product under examination was nevertheless undertaken. Its argument is that the applicant provided the detailed composition of the plant protection product and safety data sheets for each component. The Commission submits that the long-term toxicity was assessed on that basis using the appropriate calculation for the classification of mixtures under Regulation No 1272/2008. 180. That approach is based, as regards the safety data sheets, on point 1.4.3 of the introduction to Part A of the Annex to Regulation No 284/2013 and, as regards the calculation, on point 1 of the introduction to Section 7 of Part A. The General Court was therefore right to reject at the outset PAN Europe’s objections on that subject in paragraph 433 of the judgment under appeal. 181. The Court of Justice has established, however, that the assessment of long-term toxicity requires specific tests which suffice to rule out the risk of such toxicity. (86) Mere ‘cursory tests’ do not suffice for the Court of Justice. (87) PAN Europe’s doubts as to whether an assessment based solely on safety data sheets and calculations is sufficient are therefore justified. 182. If only in light of those doubts as to sufficient examination of the long-term toxicity of the plant protection product by the rapporteur Member State, the General Court should have reviewed the assessment contained in the confidential fourth volume of the draft report – at least, if such an assessment could make up for the absence of an EFSA assessment. PAN Europe’s complaint that such a review was not undertaken is therefore well founded. 183. Had the General Court found an assessment of long-term toxicity which was sufficient in principle, if would have had to verify in a further step whether withholding that assessment from PAN Europe was justified. After all, the fundamental right to an effective legal remedy would be infringed if a judicial decision were founded on facts and documents which one of the parties has not had an opportunity to examine and on which it has therefore been unable to state its views. (88) 184. Only in exceptional cases can it be justified to restrict that fundamental right on the basis of overriding interests in the confidential treatment of certain information. That presupposes, however, effective judicial review both of the existence and validity of the reasons for confidentiality. (89) 185. The General Court likewise failed to carry out that review. Moreover, the justification for confidentiality is questionable. As the General Court itself mentions, the confidentiality of commercial information cannot justify refusing access to information relating to emissions into the environment under the second subparagraph of Article 4(2) of the Environmental Information Directive (90) and the first sentence of Article 6(1) of the Aarhus Regulation. That information includes the release into the environment of products or substances like plant protection products and substances contained in those products, where such release actually occurs or is foreseeable under normal and realistic conditions of use. (91) The present case concerns information required to assess the long-term toxicity of a plant protection product which is intended for use in the open – that is to say, for release into the environment. (92) 3. Interim conclusion 186. Accordingly, the fifth ground of appeal is well founded if only because the EFSA conclusion contains no assessment of the long-term toxicity of the plant protection product under examination. 187. However, the fifth ground of appeal would also be well founded if the Court of Justice were to accept as sufficient an assessment of that matter by the rapporteur Member State or by Member States which have approved the cypermethrin-based plant protection products. The General Court did not review whether those Member States had in fact sufficiently examined the long-term toxicity of the plant protection product under examination. Consequently, it also did not adequately review whether the Commission had fulfilled its obligation to examine carefully and impartially the relevant aspects. F. First ground of appeal – critical areas of concern 188. By its first ground of appeal, PAN Europe complains that the General Court did not take adequate account of the critical areas of concern identified by EFSA. The issues raised by PAN Europe concern the composition of the active substance which was used in the studies submitted by the applicant (section 1), a high risk to aquatic organisms (section 2) and a high off-field risk to non-target arthropods (section 3). 1. Composition of the active substance 189. It is a precondition of authorisation of an active substance that any harmful effect on human or animal health (Article 4(3)(b)) and any unacceptable effects on the environment (Article 4(3)(e)) must be ruled out. To provide evidence of that, the applicant submitted toxicological and ecotoxicological studies. 190. However, based on the batch data and the impurity profiles, EFSA disagreed with the proposed reference specification of the active substance and proposed updating it according to the renewal data. (93) It was therefore unclear whether the active substance used for the submitted studies satisfied that updated specification in respect of possible impurities and composition. As a result, EFSA was unable to finalise the assessment of mammalian toxicity (94) or ecotoxicity. (95) In EFSA’s view, that constitutes a critical area of concern in which the information available does not permit the conclusion that the conditions of authorisation are met. (96) 191. Although EFSA was unable in particular to rule out the genotoxic potential of impurities, (97) it found that, in light of the guideline-complaint studies, the active substance cypermethrin could be considered unlikely to be itself genotoxic. It conversely noted that one non-guideline study gave rise to a need for further investigation into certain questions in connection with that point. (98) 192. Following consultation with the rapporteur Member State, Belgium, the Commission took the position that those doubts on EFSA’s part did not stand in the way of authorising cypermethrin. The General Court concurred with the Commission and rejected PAN Europe’s objections. 193. In the appeal, PAN Europe first argues against the findings on the allocation of the burden of proof in paragraphs 134, 146, 147 and 158 of the judgment under appeal. That submission is based on misunderstandings, however. Unlike what it did in connection with the fifth ground of appeal, (99) the General Court makes no finding on those points, instead referring to the assessment of certain objections to the statement of reasons in the contested review decision. The submission regarding the burden of proof is therefore not relevant to the decision. 194. On the other hand, PAN Europe’s objections to the Commission’s findings on the consequences of the new specification for cypermethrin are well founded. 195. Specifically, the focus is on comparability between the different specifications of the active substance, its greater purity, the significance of the assessment of neurotoxicity, reproductive toxicity and developmental toxicity to the assessment of genotoxicity and on the possibility of answering those questions during the subsequent approval procedure for plant protection products or a subsequent renewal procedure. 196. In paragraphs 147, 148 and 154 of the judgment under appeal, the General Court relies, like the Commission, on the argument that the rapporteur Member State found the active substance used for the submitted studies to be comparable to the updated specification. 197. As PAN Europe objects, that finding contradicts the EFSA conclusion. That contradiction is all the more important as EFSA was aware of the rapporteur Member State’s finding of comparability when it nevertheless identified the different specifications as a critical area of concern in its conclusion. 198. It is true that the Commission is not bound by EFSA’s assessment in its authorisation of active substances, and is obliged only to take it into account in accordance with Article 13(1) of the Plant Protection Regulation. It may also be the case that the legislature intended to give weight to independent and objective assessment by experts from the Member States, as the General Court emphasises in paragraph 139 of the judgment under appeal. 199. Where the Commission diverges from EFSA’s view, however, it must present plausible reasons for that choice. If it does not, it infringes its obligation to state reasons. (100) 200. However, neither the General Court nor the Commission explains why the opinion of the rapporteur Member State should be preferred to that of EFSA in the present case. EFSA’s view, incidentally, is also founded on assessments by experts from the Member States. In terms of substance too, it is unclear how the rapporteur Member State could conclude that there was equivalence given that the exact dissimilarities between the different specifications are completely unknown. 201. In paragraph 148 of the judgment under appeal, the General Court likewise concurs with the Commission’s argument that the greater purity of the active substance under the new specification (920 g/kg instead of 900 g/kg) will reduce the risks associated with impurities. According to paragraphs 164 and 165, the Commission was able, on the basis of contact with EFSA and the rapporteur Member State following the EFSA conclusion, to conclude that impurities other than hexane were not of toxicological concern. 202. In that respect too, however, a statement of reasons is lacking, which the General Court does not criticise in the judgment under appeal. 203. The fact that the quantity of impurities is lower does not by itself mean that their harmful effects are also lower. According to the contested review decision, the active substance contains other impurities than it used to, as a result of changes in the manufacturing process, (101) which naturally may cause other, possibly greater, risks. 204. The identification of a critical area of concern in the EFSA conclusion is even explicitly based on the finding that it was impossible to exclude the genotoxic potential of those other impurities and therefore impossible to finalise the assessment of its toxicological relevance. (102) 205. Paragraph 157 of the judgment under appeal addresses PAN Europe’s objection that studies on neurotoxicity, reproductive toxicity and developmental toxicity based on the updated specification of the active substance could not adequately deal with the concerns about genotoxicity. The General Court rejects that objection with the argument that EFSA considers cypermethrin unlikely to be genotoxic and that the Commission found the active substance to have no more harmful effects under its new specification than under the previous specification. However, the genotoxic properties of cypermethrin must be differentiated from the genotoxic properties of the impurities – and EFSA was unable to finalise the assessment of the impurities and, in particular, to exclude such properties. (103) Consequently, the Commission’s assertion in that regard likewise lacks an adequate statement of reasons. 206. Finally, the argument made by the rapporteur Member State and espoused by the Commission that EFSA’s concerns could be cleared up in future, in the approval process for cypermethrin-based plant protection products or in a future renewal procedure, is unconvincing. It cannot be inferred from the Plant Protection Regulation, and from Article 4 in particular, that doubts as to the harmlessness of an active substance might be ignored on the basis of such considerations. While the General Court does mention the criticism of that argument in paragraph 159 of the judgment under appeal, it nevertheless rejects that criticism in paragraph 160 without addressing it on its merits. The possibility of later remedy therefore cannot remedy the failures to state reasons in the contested review decision. 207. It follows that the first part of the first ground of appeal is well founded. 2. Aquatic organisms 208. The EFSA conclusion found a high risk to aquatic organisms and identified that as a critical area of concern. (104) According to the 2019 EFSA statement, that risk can be reduced to an acceptable level by means of certain particularly intensive risk mitigation measures. (105) In the renewal at issue, the Commission requires risk mitigation measures to be taken in the event of spray application in the open in order to reduce drift to such an extent that springtime applications result in a concentration of the active substance in water bodies not exceeding 0.0038 μg/l. Under the contested review decision, that limit is supposed to reduce the risk to aquatic organisms to an acceptable level. 209. PAN Europe’s grounds of appeal concern first the circumstance that autumnal use was not expressly excluded (section a). Second, it challenges the setting of the limit on the basis of an ecological recovery option (ERO), which implies that recovery can be expected following a temporary deterioration. The Commission should instead have used a distinctly stricter ecological threshold option (ETO), which preclude deterioration (section b). (a) Autumnal use 210. PAN Europe argues that the Commission should have banned the autumnal use of cypermethrin, as EFSA concluded that such use had not been shown to be compatible with the Plant Protection Regulation. It asserts that the General Court’s rejection of that submission is vitiated by an error of law. 211. The submission is not convincing, however. 212. Under Article 6 of the Plant Protection Regulation, the Commission can impose conditions and restrictions when approving an active substance, but it is not obliged to. An obligation can be inferred from Article 4 only in so far as the active substance or representative use under examination of a plant protection product containing that active substance would not otherwise meet the requirements. As also held in paragraph 198 of the judgment under appeal, however, the Commission based the renewal at issue on springtime use of the plant protection product under examination. The Commission therefore had to define only the conditions and restrictions which were necessary to ensure that that use met the requirements. 213. By contrast, the Commission is not obliged, or even able, when authorising an active substance, to regulate for every conceivable use of all plant protection products containing that active substance. As is also apparent from paragraph 198 of the judgment under appeal, that is incumbent on the Member States when they approve plant protection products under Article 29(1)(e) of the Plant Protection Regulation. For those approval procedures, the Commission’s decision not to impose further restrictions does not mean that uses which are not expressly prohibited in the renewal at issue are permitted. The Member States can also approve only uses which are compatible with Article 4(3). Those uses must in particular have no unacceptable effects on the environment (Article 4(3)(e)). 214. Under Article 29(2) of the Plant Protection Regulation, it is for the applicant for authorisation to demonstrate that such effects are ruled out. It can potentially submit studies not available to EFSA which show that autumnal use is also acceptable. Alternatively, stricter risk mitigation measures, such as larger buffer zones or stricter limits, may be sufficient to allow such use. 215. PAN Europe’s submission on non-prohibition of autumnal use is therefore unfounded. (b) Ecological recovery option 216. PAN Europe’s objections to the use of the ecological recovery option are in principle directed, first, against the General Court’s acceptance of it in paragraphs 204 and 210 of the judgment under appeal and, second, against the fact that the limit set is significantly higher than the relevant environmental quality standard set by the European Union in implementation of the Water Framework Directive. (106) 217. As far as the fundamental objections to the use of the recovery option is concerned, Article 4(3)(e) of the Plant Protection Regulation does not require that all damage to the environment be ruled out. Unlike for damage to health, for example (point (b)), only unacceptable effects on the environment are prohibited. Although PAN Europe’s objections suggest adverse effects on the environment, they do not demonstrate that a limit based on the ecological recovery option will result in unacceptable effects. It must also be taken into consideration that classifying effects as acceptable or unacceptable gives the Commission a broad discretion, which is political rather than primarily scientific in nature, (107) for determining what disadvantage to the environment is acceptable in light of the advantages of the active substance. 218. That being said, the infringement of environmental quality standards under the Water Framework Directive which PAN Europe alleges may be a strong indicator of unacceptable effects on the environment. After all, the EU legislature set those standards, and the 0.0038 μg/l limit set for cypermethrin in the renewal at issue is markedly less strict than the maximum permitted concentration for inland surface waters (0.0006 μg/l) and for other surface waters (0.00006 μg/l). (108) 219. That argument need not be pursued further, however. 220. PAN Europe’s first reference to the limit values governed by water law occurs in the action brought before the General Court, and even there it only takes up one sentence. That therefore constitutes an expansion of the subject matter of the proceedings in relation to its request for review. 221. In the appeal, PAN Europe claims that it made that argument merely in response to the Commission's reasoning in the contested review decision. It asserts that the Commission relied for justification of the recovery limit value on guidance issued by EFSA. (109) PAN Europe submits that its submission on water law was intended only to show that the limit value is incompatible with that guidance. 222. It is true that it must be possible to respond in the action before the General Court to new arguments with which the Commission has rejected a request for review. (110) What is not clear, however, is how the alleged infringement of limits established in water law is supposed to show that the limit set in the renewal at issue is not in line with the guidance. While the guidance does explain differences between the limits established in water law and those set in connection with the authorisation of plant protection products, (111) those explanations seem rather to suggest that EFSA assumes the limit set in water law are not always binding when it comes to authorisation of plant protection products. (112) 223. The submission on possible infringement of the limits set in water law was therefore, as understood in the case-law on the subject matter of the proceedings in actions based on internal review procedures, too late, (113) because PAN Europe had not already relied on it in the request for review but presented it for the first time in the action. The General Court was therefore right to reject it as inadmissible in paragraph 216 of the judgment under appeal. (c) Interim conclusion 224. The objections to the General Court’s findings regarding possible effects on aquatic organisms are therefore in part unfounded and otherwise inadmissible. 3. Non-target arthropods 225. The EFSA conclusion identified a high risk to non-target arthropods – that is to say, mainly insects – and saw that as a critical area of concern. (114) According to the 2019 EFSA statement, that risk can be reduced by certain particularly intensive risk mitigation measures which must, in particular, reduce spray drift by more than 95%. It also points out, however, that successful application of those measures is challenging in practice, in particular because of variable wind conditions and irregular soil surfaces. (115) In the renewal at issue, the Commission required risk mitigation measures to be taken in the event of spray application in the open in order to reduce drift to such an extent that exposure to the active substance is ≤ 5.8 mg/ha in off-crop areas. Under the contested review decision, that limit is supposed to reduce the risk to non-target arthropods to an acceptable level. 226. Both in the request for review and in the action before the General Court, PAN Europe referred to the 2019 EFSA statement to call into question whether that limit can be respected in compliance with Article 4(3) of the Plant Protection Regulation under realistic conditions of use. 227. By contrast, the General Court in paragraph 235 of the judgment under appeal confirmed the Commission’s contention that safe use had been confirmed (by the majority of experts from the Member States) in the Standing Committee on Plants, Animals, Food and Feed. 228. Contrary to PAN Europe’s contention, that finding does not constitute a distortion of evidence. As the Commission submits, it is undisputed that a qualified majority of the Member States in the Committee supported the renewal at issue and the Commission’s findings in that regard. It can therefore be assumed that those Member States considered safe use possible under realistic conditions. 229. However, as PAN Europe rightly sets out, that finding does not have the capacity to invalidate the doubts it raised on the basis of EFSA’s statements. As already mentioned, the Commission must state adequate reasons for any deviation from EFSA’s position. (116) Despite that, the Commission has given no statement of reasons in respect of realistic conditions of use. The aforementioned assumption of safe use under realistic conditions is therefore merely an assertion. 230. Particularly in light of the support of the Member States, I therefore fear that, in practice, many farmers will not uphold the limit specified and any instructions for use intended to ensure it is adhered to. It is hardly conceivable that effective verification measures might be implemented everywhere. The result could be damage to non-target arthropods which the Commission considers unacceptable. 231. It follows that paragraph 235 of the judgment under appeal is vitiated by an error in law. 232. Paragraph 236 of the judgment under appeal does not correct that error but is likewise vitiated by an error of law. It is true that the Member States may likewise approve plant protection products under Article 29(1)(e) and Article 4(3) of the Plant Protection Regulation only where there is evidence that they are safe to use under realistic conditions. Nevertheless, as similarly set out above in connection with the assessment of long-term toxicity, (117) the Commission cannot therefore dispense with that evidence when authorising the active substance. 233. What is more, the limit value set by the Commission is an invitation to the Member States to provide, when approving plant protection products, for similar risk mitigation measures which cannot be implemented under realistic conditions of use, with the result that they are not upheld in practice. 234. It follows that the third part of the first ground of appeal is also well founded. G. Result of the examination of the grounds of appeal 235. The appeal must therefore be upheld, because the General Court was wrong to accept the Commission’s failure before the renewal at issue to examine – the toxicity of cypermethrin isomers (first part of the fourth ground of appeal) and – the long-term toxicity of the plant protection protect under examination (fifth ground of appeal) with sufficient care and to state reasons explaining – why toxicity studies using the new cypermethrin specification were not necessary (first part of the first ground of appeal) and – how unacceptable damage to non-target arthropods can be prevented under realistic conditions of use (third part of the first ground of appeal). 236. The judgment under appeal should therefore be set aside. V. The action brought before the General Court 237. Under the first paragraph of Article 61 of its Statute, the Court of Justice is to set aside the decision of the General Court if the appeal is well founded. It may itself give final judgment in the matter, where the state of the proceedings so permits, or refer the case back to the General Court for judgment. 238. As summarised above, the success of the appeal is based on the fact that the General Court in the judgment under appeal confirmed the Commission’s findings in the contested review decision although the Commission either failed to identify all relevant aspects or failed to state adequate reasons for deviating from EFSA’s position. In consequence, the state of proceedings permits final judgment on those points and the contested review decision must also be set aside. 239. Only on the fifth ground of appeal might further examination by the General Court be useful, were the Court of Justice to take the view – unlike me – that a missing assessment by EFSA can be replaced with an assessment by the rapporteur Member State. (118) However, I would not consider it useful to refer the case back to the General Court solely on the ground that PAN Europe did not have access to the assessment alleged to exist. Furthermore, the other deficiencies of the judgment under appeal affect the contested review decision in any event. In that instance too, therefore, I would suggest setting aside the contested review decision. 240. That does not necessarily mean that the Commission would have to set aside or amend the renewal at issue. It would in fact need to reexamine PAN Europe’s well-founded objections, possibly in cooperation with EFSA and taking into account the new information which has become available in the meantime. All further steps depend on the outcome of that reexamination. VI. Costs 241. In accordance with Article 184(2) of the Rules of Procedure of the Court of Justice, where the appeal is well founded and the Court itself gives final judgment in the case, the Court is to make a decision as to the costs. 242. Under Article 138(1) of those rules, which applies to appeal proceedings 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. 243. Consequently, the Commission must pay the costs incurred by PAN Europe and bear its own costs. VII. Conclusion 244. I therefore propose that the Court of Justice should: (1) set aside the judgment of the General Court of 21 February 2024, PAN Europe v Commission (T‑536/22, EU:T:2024:98); (2) annul the contested review decision, which the European Commission communicated to Pesticide Action Network Europe by letter from Commissioner Stella Kyriakides in English on 23 June 2022 and in French on 18 July 2022 and registered under Ares(2022)4621502 – 23/06/2022; (3) order the European Commission to pay the costs incurred by Pesticide Action Network Europe in the proceedings before the General Court and the Court of Justice and to bear its own costs. 1 Original language: German. 2 Karlsson, C., Winnberg, P., Dennis, C., and Jonback, H., Toxic, 2003 (originally interpreted by Britney Spears). 3 Regarding the use of plant protection products in organic agriculture, see Article 1 of Commission Implementing Regulation (EU) 2021/1165 of 15 July 2021 authorising certain products and substances for use in organic production and establishing their lists (OJ 2021 L 253, p. 13). 4 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/EEC (OJ 2009 L 309, p. 1). 5 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). 6 Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ 2006 L 264, p. 13), 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). 7 See judgments of 21 November 1991, Technische Universität München (C‑269/90, EU:C:1991:438, paragraph 14); of 18 July 2007, Industrias Químicas del Vallés v Commission (C‑326/05 P, EU:C:2007:443, paragraph 77); of 22 December 2010, Gowan Comércio Internacional e Serviços (C‑77/09, EU:C:2010:803, paragraph 57); and of 22 November 2017, Commission v Bilbaína de Alquitranes and Others (C‑691/15 P, EU:C:2017:882, paragraph 35). 8 Regulation 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). 9 Commission Regulation of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ 2018 L 101, p. 33). 10 Although the second part of that provision makes an exception for procedures where the committee had voted on a draft regulation by the date specified, the deliberations of the committee in the present case did not begin until 2019. 11 Commission Implementing Regulation of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in [the Plant Protection Regulation] (OJ 2012 L 252, p. 26). 12 Commission Implementing Regulation of 7 November 2018 amending Implementing Regulation (EU) No 844/2012 in view of the scientific criteria for the determination of endocrine disrupting properties introduced by Regulation (EU) 2018/605 (OJ 2018 L 278, p. 3). 13 Commission Regulation of 1 March 2013 setting out the data requirements for active substances, in accordance with [the Plant Protection Regulation] (OJ 2013 L 93, p. 1), as amended by Commission Regulation (EU) No 1136/2014 of 24 October 2014 amending Regulation (EU) No 283/2013 as regards the transitional measures applying to procedures concerning plant protection products (OJ 2014 L 307, p. 26). 14 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). 15 EFSA, Arena, M., Auteri, D., et al., conclusion on the ‘Peer review of the pesticide risk assessment of the active substance cypermethrin’, EFSA Journal, Vol. 16, Issue 8, 2018, https://doi.org/10.2903/j.efsa.2018.5402. 16 EFSA, ‘Statement on risk mitigation measures on cypermethrin’, EFSA Journal, Vol. 17, Issue 10, 2019, https://doi.org/10.2903/j.efsa.2019.5822. 17 Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraphs 78, 79, 95 and 114). 18 Judgment of 9 December 2021, Agrochem-Maks v Commission (C‑374/20 P, EU:C:2021:990, paragraphs 53 and 54), and, already regarding the Plant Protection Regulation, judgments of 18 July 2007, Industrias Químicas del Vallés v Commission (C‑326/05 P, EU:C:2007:443, paragraphs 75 and 76), and of 22 December 2010, Gowan Comércio Internacional e Serviços (C‑77/09, EU:C:2010:803, paragraphs 55 and 56). 19 Judgments of 15 October 2009, Enviro Tech (Europe) (C‑425/08, EU:C:2009:635, paragraph 47); of 21 July 2011, Etimine (C‑15/10, EU:C:2011:504, paragraph 60); and of 9 March 2023, PlasticsEurope v ECHA (C‑119/21 P, EU:C:2023:180, paragraph 46). 20 Judgments of 21 November 1991, Technische Universität München (C‑269/90, EU:C:1991:438, paragraph 14); of 18 July 2007, Industrias Químicas del Vallés v Commission (C‑326/05 P, EU:C:2007:443, paragraph 77); of 22 December 2010, Gowan Comércio Internacional e Serviços (C‑77/09, EU:C:2010:803, paragraph 57); and of 22 November 2017, Commission v Bilbaína de Alquitranes and Others (C‑691/15 P, EU:C:2017:882, paragraph 35). 21 Initially, Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing [the Plant Protection Regulation] as regards the data requirements for active substances (OJ 2011 L 155, p. 1); later, Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with [the Plant Protection Regulation] (OJ 2013 L 93, p. 1). 22 Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 69). 23 Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 70). 24 Judgments of 21 November 1991, Technische Universität München (C‑269/90, EU:C:1991:438, paragraph 14), and of 6 November 2008, Netherlands v Commission (C‑405/07 P, EU:C:2008:613, paragraph 56). 25 Judgments of 26 November 1981, Michel v Parliament (195/80, EU:C:1981:284, paragraph 22); of 29 April 2004, IPK-München and Commission (C‑199/01 P and C‑200/01 P, EU:C:2004:249, paragraph 66); and of 26 July 2017, Council v LTTE (C‑599/14 P, EU:C:2017:583, paragraph 29). 26 Judgment of 21 November 1991, Technische Universität München (C‑269/90, EU:C:1991:438, paragraph 14). 27 Cited in footnote 15, point 7 (p. 7). 28 Judgment of the General Court of 13 November 2024, PAN Europe v Commission (T‑104/23, EU:T:2024:823, paragraph 2). 29 Judgment of 28 October 2020, Associazione GranoSalus v Commission (C‑313/19 P, EU:C:2020:869, paragraph 63). 30 Judgment of 3 September 2020, Mellifera v Commission (C‑784/18 P, EU:C:2020:630, paragraph 79 et seq.). 31 See point 36 above. 32 Judgment of 12 September 2019, TestBioTech and Others v Commission (C‑82/17 P, EU:C:2019:719, paragraphs 68 and 69). See also recital 21 of Regulation 2021/1767 (though its German version reflects unfortunate translation choices). 33 However, see point 222 below. 34 Judgment of 12 September 2019, TestBioTech and Others v Commission (C‑82/17 P, EU:C:2019:719, paragraph 39). 35 On Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ 1992 L 206, p. 7), see judgments of 7 September 2004, Waddenvereniging and Vogelbeschermingsvereniging (C‑127/02, EU:C:2004:482, paragraph 59), and of 10 October 2019, Luonnonsuojeluyhdistys Tapiola (C‑674/17, EU:C:2019:851, paragraph 66); on waste law, see judgment of 24 October 2019, Prato Nevoso Termo Energy (C‑212/18, EU:C:2019:898, paragraph 58); and on Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (OJ 2010 L 334, p. 17), see judgment of 9 March 2023, Sdruzhenie ‘Za Zemyata – dostap do pravosadie’ and Others (C‑375/21, EU:C:2023:173, paragraph 53). See also Sobotta, C., ‘Recent applications of the precautionary principle in the jurisprudence of the CJEU – a new yardstick in EU environmental decision making?’, ERA Forum, 2020, p. 723. 36 Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraphs 78, 79 and 114). 37 See point 39 above. 38 Judgments of 9 September 2003, Monsanto Agricoltura Italia and Others (C‑236/01, EU:C:2003:431, paragraph 113); of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 46); and of 9 November 2023, Global Silicones Council and Others v Commission (C‑558/21 P, EU:C:2023:839, paragraph 66). 39 See point 54 above. 40 Unlike a conclusion regarding the renewal of approval of glyphosate (Álvarez, F., Arena, M., et al., ‘Peer review of the pesticide risk assessment of the active substance glyphosate’, EFSA Journal, Vol. 21, Issue 7, 2023, pp. 1 to 52. http://doi.org.10.2903/j.efsa.2023.8164). In it, EFSA refers to ‘Remaining data gaps not leading to critical areas of concern or issues not finalised but considered necessary to comply with the data requirements, and which are relevant for some or all of the representative uses assessed at EU level (unless stated otherwise). Although not critical, these data gaps may lead to uncertainties in the assessment and are considered relevant.’ (p. 37). 41 Commission Regulation of 1 March 2013 setting out the data requirements for active substances, in accordance with [the Plant Protection Regulation] (OJ 2013 L 93, p. 1), as amended by Commission Regulation (EU) No 1136/2014 of 24 October 2014 amending Regulation (EU) No 283/2013 as regards the transitional measures applying to procedures concerning plant protection products (OJ 2014 L 307, p. 26). 42 See point 54 above. 43 Section 2 of the conclusion (cited in footnote 15), p. 10, fifth paragraph. 44 Section 3.1 of the conclusion (cited in footnote 15), p. 11, last paragraph. 45 Section 3.1 of the conclusion (cited in footnote 15), p. 12, second-last paragraph of the section. 46 On the distortion of submission, see judgment of 6 May 2021, Bayer CropScience and Bayer v Commission (C‑499/18 P, EU:C:2021:367, paragraphs 60 and 61). 47 See p. 67 of the annexes to the application before the General Court. 48 See point 39 above. 49 See section 1 of EFSA, Bura, L., Friel, A., Magrans, J.O., et al., ‘Guidance of EFSA on risk assessments for active substances of plant protection products that have stereoisomers as components or impurities and for transformation products of active substances that may have stereoisomers’, EFSA Journal, Vol. 17, Issue 8, 2019, https://doi.org/10.2903/j.efsa.2019.5804. 50 Paragraph 51 of the response. 51 Judgment of 9 December 2021, Agrochem-Maks v Commission (C‑374/20 P, EU:C:2021:990, paragraph 71). 52 ‘Des informations ont été fournies et jugées suffisantes par l’EMR pour effectuer l’évaluation des risques’. 53 See p. 96 of the annexes to the application. 54 In that regard, see Opinion of Advocate General Medina in Joined Cases C‑309/22 and C‑310/22, PAN Europe (Assessment of endocrine disrupting properties) (EU:C:2023:717, point 6). 55 Section 2 of the conclusion (cited in footnote 15), p. 9, seventh paragraph. 56 Section 9 of the conclusion (cited in footnote 15), p. 19 et seq. 57 16th recital of the renewal at issue. 58 Judgments of 2 April 2009, France Télécom v Commission (C‑202/07 P, EU:C:2009:214, paragraph 29); of 13 December 2018, European Union v Kendrion (C‑150/17 P, EU:C:2018:1014, paragraph 80); and of 8 June 2023, Severstal and NLMK v Commission (C‑747/21 P and C‑748/21 P, EU:C:2023:459, paragraph 40). 59 See points 61 to 65 above. 60 Judgments of 9 June 2011, Diputación Foral de Vizcaya and Others v Commission (C‑465/09 P to C‑470/09 P, EU:C:2011:372, paragraph 171), and of 17 January 2023, Spain v Commission (C‑632/20 P, EU:C:2023:28, paragraph 48). 61 Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraphs 78, 79, 95 and 114). 62 Section 2 of the conclusion (cited in footnote 15), p. 9, seventh paragraph. 63 Judgment of 25 April 2024, PAN Europe (Assessment of endocrine disrupting properties) (C‑309/22 and C‑310/22, EU:C:2024:356, paragraph 86). 64 See point 39 above. 65 Judgments of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 80); of 9 December 2021, Agrochem-Maks v Commission (C‑374/20 P, EU:C:2021:990, paragraph 128); and of 22 June 2023, Arysta LifeScience Great Britain v Commission (C‑259/22 P, EU:C:2023:513, paragraph 73). 66 Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraphs 112, 114 and 116). 67 Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 112). 68 Judgment of 25 April 2024, PAN Europe (Assessment of endocrine disrupting properties) (C‑309/22 and C‑310/22, EU:C:2024:356, paragraph 87). 69 Those requirements are further fleshed out by the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) with the technical support of the Joint Research Centre (JRC), Andersson, N., Arena, M., et al., ‘Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009’, EFSA Journal, Vol. 16, Issue 6, 2018, https://doi.org/10.2903/j.efsa.2018.5311. ECHA-18-G-01-EN. 70 See point 39 above. 71 See references in footnote 35. 72 See, to that effect, judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 112). 73 Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 113). 74 Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 115). 75 Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 116). See also points 124 to 128 above. 76 See judgment of 3 April 2014, France v Commission (C‑559/12 P, EU:C:2014:217, paragraph 103). 77 Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 114). 78 Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraphs 69 and 116). 79 Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 70). 80 Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 80). 81 See point 39 above. 82 Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraphs 113 to 116). 83 Point 5.5 of the Annex to Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing [the Plant Protection Regulation] as regards the data requirements for active substances (OJ 2011 L 155, p. 1) and point 5.5. of the Annex to Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with [the Plant Protection Regulation] (OJ 2013 L 93, p. 1). The Commission and the General Court refer to the latter of those provisions, but it was not possible to verify that on the basis of the information available about the renewal procedure. 84 Section 7 of Part A of the Annex to Commission Regulation (EU) No 545/2011 of 10 June 2011 implementing [the Plant Protection Regulation] as regards the data requirements for plant protection products (OJ 2011 L 155, p. 67) and Section 7 of Part A of the Annex to Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with [the Plant Protection Regulation] (OJ 2013 L 93, p. 85). Here too, the Commission and the General Court refer to the latter of those provisions, but it was not possible to verify that on the basis of the information available about the renewal procedure. 85 See judgments of 6 September 2018, Czech Republic v Commission (C‑4/17 P, EU:C:2018:678, paragraph 24), and of 19 March 2020, ClientEarth v Commission (C‑612/18 P, EU:C:2020:223, paragraph 15). 86 Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraphs 113 and 114). 87 Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 116). 88 Judgments of 22 March 1961, Snupat v High Authority (42/59 and 49/59, EU:C:1961:5, p. 169 of the German version), and of 4 June 2013, ZZ (C‑300/11, EU:C:2013:363, paragraph 56). 89 Judgment of 4 June 2013, ZZ (C‑300/11, EU:C:2013:363, paragraph 58). 90 Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC (OJ 2003 L 41, p. 26). 91 Judgments of 23 November 2016, Commission v Stichting Greenpeace Nederland and PAN Europe (C‑673/13 P, EU:C:2016:889, paragraph 74), and Bayer CropScience and Stichting De Bijenstichting (C‑442/14, EU:C:2016:890, paragraph 77). 92 See judgments of 23 November 2016, Commission v Stichting Greenpeace Nederland and PAN Europe (C‑673/13 P, EU:C:2016:889, paragraph 75), and Bayer CropScience and Stichting De Bijenstichting (C‑442/14, EU:C:2016:890, paragraph 78), and of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 108). 93 Section 1 of the conclusion (cited in footnote 15), p. 8, second paragraph. 94 Section 2 of the conclusion (cited in footnote 15), p. 8, third paragraph. 95 Section 5 of the conclusion (cited in footnote 15), p. 14, third paragraph. 96 Section 9.2 of the conclusion (cited in footnote 15), p. 20. 97 Section 2 of the conclusion (cited in footnote 15), p. 8, third paragraph. 98 Section 2 of the conclusion (cited in footnote 15), p. 9, fourth paragraph. 99 See point 164 et seq. above. 100 See points 43 and 44 above. 101 See p. 84 of the annexes to the application. 102 Sections 2 and 5 of the conclusion (cited in footnote 15), p. 8, third paragraph, and p. 14, third paragraph). 103 Section 2 of the conclusion (cited in footnote 15), p. 8, third paragraph. 104 Section 5 of the conclusion (cited in footnote 15), p. 14, fifth and sixth paragraphs. 105 Cited in footnote 16, section 2.1, p. 6 et seq., and Annex A, pp. 13 and 14. 106 Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ 2000 L 327, p. 1). 107 See Opinion of Advocate General Ćapeta in Joined Cases C‑71/23 P and C‑82/23 P, France v Commission and Commission v CWS Powder Coatings and Others (EU:C:2025:65, points 72 and 73). 108 See point 41 of Annex I to Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy, amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council (OJ 2008 L 348, p. 84), as amended by Directive 2013/39/EU of the European Parliament and of the Council of 12 August 2013 (OJ 2013 L 226, p. 1). 109 EFSA PPR Panel (EFSA Panel on Plant Protection Products and their Residues), ‘Guidance on tiered risk assessment for plant protection products for aquatic organisms in edge-of-field surface waters’, EFSA Journal, Vol. 11, Issue 7, https://doi.org/10.2903/j.efsa.2013.3290. 110 On the response to new arguments in the judgment under appeal, see the references in footnote 85. 111 Guidance, cited in footnote 109, section 11.5, pp. 157 to 159. 112 See Guidance, cited in footnote 109, p. 165. 113 See point 56 above. 114 Section 5 of the conclusion (cited in footnote 15), p. 14, seventh paragraph, and p. 15, fourth paragraph. 115 Cited in footnote 16, sections 2.2 and 2.3, p. 8 et seq., and Annex A, p. 14 et seq.. 116 See point 43 above. 117 See point 169 et seq. above. 118 See points 172 to 185 above.