Provisional text

delivered on 5 June 2025 (1)

Case C‑316/24 P

Pesticide Action Network Europe (PAN Europe)

European Commission

( Appeal – Agriculture – Plant protection products – Regulation (EC) No 1107/2009 – Renewal of the approval of the active substance cypermethrin – Implementing Regulation (EU) 2021/2049 – Request for internal review – Article 10(1) of Regulation (EC) No 1367/2006 – Dismissal of the request – Precautionary principle – EFSA assessments – Careful and impartial examination of all relevant aspects – Gaps in the data – Toxicity of isomers – Endocrine effects – Long-term toxicity of plant protection products – Identification of critical areas of concern – Composition of the active substance – Realistic conditions of use – Duty to state reasons incumbent on the Commission )

Table of contents

II. Legal framework

B. Implementing Regulation (EU) No 844/2012

III. Facts and background to the dispute

1. The renewal procedure and the major provisions applicable to it

B. Third ground of appeal – data gaps

1. Admissibility of the submission relating to point 1.9 of Part A of the Annex to Regulation No 283/2013

3. Article 6(f) of the Plant Protection Regulation

4. Completeness of the application and assessment of the approval criteria

1. First part of the second ground of appeal – consequences of missing data and allocation of the burden of proof

(a) Statement of reasons

(b) Burden of proof

3. Second part of the second ground of appeal – discretion of the Commission

4. Third part of the second ground of appeal – evidence of a manifest error

1. Criteria for assessing the representative use of a plant protection product

3. Interim conclusion

1. Composition of the active substance

(a) Autumnal use

(b) Ecological recovery option

(c) Interim conclusion

3. Non-target arthropods

VI. Costs

VII. Conclusion

“I’m addicted to you

Don’t you know that you’re toxic?” (2)

Plant protection products, also known as pesticides, are of key importance to (conventional (3)) agriculture and consequently to our nutrition in particular. In order to function, they are necessarily harmful to the organisms they are intended to combat. However, they can also harm other organisms, meaning the environment and even humans.

The Plant Protection Regulation (4) is intended to ensure that plant protection products are effective but have no harmful effects on human health in particular and no unacceptable effects on the environment. To that end, it makes plant protection products and the active substances used in them subject to approval. Approval is granted only after it has been demonstrated in an elaborate procedure that those harmful effects do not occur.

The present proceedings concern the renewal of the approval of the active substance cypermethrin (‘the renewal at issue’). (5) The Commission effected the renewal at issue in 2021, although the European Food Safety Authority (EFSA) had expressed doubts as to compatibility with the authorisation criteria in its assessment of the application for renewal.

Pesticide Action Network Europe (PAN Europe) therefore first sent the Commission a request for internal review of the renewal at issue in accordance with the Aarhus Regulation (6) and then contested the review decision before General Court. After the General Court had dismissed the action by its judgment, now under appeal, of 21 February 2024, PAN Europe v Commission (T‑536/22, ‘the judgment under appeal’, EU:T:2024:98), PAN Europe lodged the present appeal.

The subject matter of the dispute is, in particular, the duty of the Commission to examine carefully and impartially all the aspects relevant to the renewal at issue (7) and the role of EFSA in that context. In the present Opinion, I shall demonstrate that the General Court was incorrect in assuming that the information necessary for the renewal at issue had been available in its entirety and that the General Court failed to object to the inadequate statement of reasons for deviating from certain of EFSA’s assessments.

II. Legal framework

The legal framework of the present dispute is derived from the provisions governing plant protection products and from the Aarhus Regulation.

The essential requirements for approval of active substances are laid down in Article 4 of the Plant Protection Regulation:

‘1. An active substance shall be approved in accordance with Annex II if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance meet the requirements provided for in paragraphs 2 and 3.

…

3. A plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, shall meet the following requirements:

…

(b) it shall have no immediate or delayed harmful effect on human health, including that of vulnerable groups, or animal health, directly or through drinking water (taking into account substances resulting from water treatment), food, feed or air, or consequences in the workplace or through other indirect effects, taking into account known cumulative and synergistic effects where the scientific methods accepted by the Authority to assess such effects are available; or on groundwater;

…

(e) it shall have no unacceptable effects on the environment, …

…

…’

Article 6 of the Plant Protection Regulation governs the adoption of conditions and restrictions in connection with the approval of active substances:

‘Approval may be subject to conditions and restrictions including:

…

(f) submission of further confirmatory information to Member States, the Commission and [EFSA], where new requirements are established during the evaluation process or as a result of new scientific and technical knowledge;

…’

Renewal of approval of active substances is governed by Article 14 of the Plant Protection Regulation:

‘1. On application the approval of an active substance shall be renewed where it is established that the approval criteria provided for in Article 4 are satisfied.

Article 4 shall be deemed to be satisfied where this has been established with respect to one or more representative uses of at least one plant protection product containing that active substance.

Such renewal of the approval may include conditions and restrictions, as referred to in Article 6.

…’

Point 2.2 of Annex II to the Plant Protection Regulation concerns the completeness of the information submitted by the applicant:

‘In principle an active substance … shall only be approved where a complete dossier is submitted.

In exceptional cases an active substance … may be approved even though certain information is still to be submitted where:

(a) the data requirements have been amended or refined after the submission of the dossier; or

(b) the information is considered to be confirmatory in nature, as required to increase confidence in the decision.’

Point 3.6.5 of Annex II to the Plant Protection Regulation concerns endocrine disrupting properties of active substances affecting humans:

‘An active substance … shall only be approved if, on the basis of the assessment of Community or internationally agreed test guidelines or other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not considered to have endocrine disrupting properties that may cause adverse effect in humans, …’

Under the third paragraph of point 3.6.5 of Annex II to the Plant Protection Regulation, substances that were or would have had to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, (8) as carcinogenic category 2 and toxic for reproduction category 2, are considered to have endocrine disrupting properties. Under the fourth paragraph, substances such as those that were or would have had to be classified as toxic for reproduction category 2 and which have toxic effects on the endocrine organs may also be considered to have such endocrine disrupting properties.

By its Regulation (EU) 2018/605, (9) the Commission supplemented the Plant Protection Regulation with scientific criteria for the determination of endocrine disrupting properties in point 3.6.5 of Annex II to the Plant Protection Regulation. Under Article 2 of Regulation 2018/605, the new criteria applied as of 10 November 2018. (10) They are set out in the fifth paragraph of point 3.6.5. of Annex II to the Plant Protection Regulation:

‘From 10 November 2018, an active substance … shall be considered as having endocrine disrupting properties that may cause adverse effect in humans if, based on points (1) to (4) of the sixth paragraph, it is a substance that meets all of the following criteria, unless there is evidence demonstrating that the adverse effects identified are not relevant to humans:

(1) it shows an adverse effect in an intact organism or its progeny, which is a change in the morphology, physiology, growth, development, reproduction or life span of an organism, system or (sub)population that results in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress or an increase in susceptibility to other influences;

(2) it has an endocrine mode of action, i.e. it alters the function(s) of the endocrine system;

(3) the adverse effect is a consequence of the endocrine mode of action.’

The sixth paragraph, also newly added, of point 3.6.5 of Annex II to the Plant Protection Regulation governs the data to be used and the methodology to be applied:

‘The identification of an active substance … as having endocrine disrupting properties that may cause adverse effect in humans in accordance with the fifth paragraph shall be based on all of the following points:

(1) all available relevant scientific data (in vivo studies or adequately validated alternative test systems predictive of adverse effects in humans or animals; as well as in vivo, in vitro, or, if applicable, in silico studies informing about endocrine modes of action):

(a) scientific data generated in accordance with internationally agreed study protocols, in particular those listed in the Commission Communications in the framework of setting out the data requirements for active substances and plant protection products, in accordance with this Regulation;

(b) other scientific data selected applying a systematic review methodology, in particular following guidance on literature data which is listed in the Commission Communications in the framework of setting out the data requirements for active substances and plant protection products, in accordance with this Regulation;

(2) an assessment of the available relevant scientific data based on a weight of evidence approach in order to establish whether the criteria set out in the fifth paragraph are fulfilled; in applying the weight of evidence determination, the assessment of the scientific evidence shall, in particular, consider all of the following factors:

(a) both positive and negative results;

(b) the relevance of the study designs, for the assessment of adverse effects and of the endocrine mode of action;

(c) the quality and consistency of the data, considering the pattern and coherence of the results within and between studies of a similar design and across different species;

(d) the route of exposure, toxicokinetic and metabolism studies;

(e) the concept of the limit dose, and international guidelines on maximum recommended doses and for assessing confounding effects of excessive toxicity;

(3) using a weight of evidence approach, the link between the adverse effect(s) and the endocrine mode of action shall be established based on biological plausibility, which shall be determined in the light of current scientific knowledge and under consideration of internationally agreed guidelines;

(4) adverse effects that are non-specific secondary consequences of other toxic effects shall not be considered for the identification of the substance as endocrine disruptor.’

B. Implementing Regulation (EU) No 844/2012

The first sentence of Article 13(1) of Implementing Regulation (EU) No 844/2012, (11) now repealed, as amended by Implementing Regulation (EU) 2018/1659, (12) governed the role of EFSA in the assessment of applications for authorisation:

‘… [EFSA] shall adopt a conclusion in the light of current scientific and technical knowledge using guidance documents applicable at the date of the submission of the supplementary dossiers on whether the active substance can be expected to meet the approval criteria provided for in Article 4 of [the Plant Protection Regulation].’

Article 14(1a) of Implementing Regulation No 844/2012 concerned the question of whether additional information was necessary where EFSA has adopted its conclusion before the supplemented criteria for the determination of endocrine disrupting properties.

‘1a. For the purposes of assessment of the approval criteria set out in point 3.6.5 and point 3.8.2 of Annex II to [the Plant Protection Regulation] as amended by [Regulation 2018/605], in relation to applications for which the conclusion by the Authority is adopted before 10 November 2018, and where the Committee referred to in Article 79(1) of [the Plant Protection Regulation] has not yet voted on a draft Regulation concerning the renewal or non-renewal of that active substance by that date, the Commission may consider that additional information is necessary to assess whether these approval criteria are met. In such cases, the Commission shall request that the Authority reassesses within a reasonable time period the available information and shall inform the applicant of that request.

When requested by the Commission in accordance with the first subparagraph, [EFSA] may … request the applicant to submit such information …’

Regulation (EU) No 283/2013 (13) governs what data are to be provided for decisions on active substances. Under Article 5(2), it applies as of entry into force, that is to say, as of 23 April 2013, for procedures concerning the renewal of approval of active substances whose approval expires on 1 January 2016 or later. The initial approval of cypermethrin expired on 28 February 2016, so the procedure for its renewal was subject to Regulation No 283/2013.

Point 1.9 of Part A of the Annex to Regulation No 283/2013 sets out requirements regarding the specification of purity of the active substance. Its fourth paragraph refers to isomers:

‘If the active substance is a mixture of isomers, the ratio or the ratio range of the content of isomers shall be provided. The relative biological activity of each isomer, both in terms of efficacy and toxicity, shall be reported.’

Article 2(1)(g) of the Aarhus Regulation defines the term ‘administrative act’ as follows:

‘any non-legislative act adopted by a Union institution or body, which has legal and external effects and contains provisions that may contravene environmental law …’

Article 10 of the Aarhus Regulation provides for a procedure for the internal review of administrative acts:

‘1. Any non-governmental organisation or other members of the public that meet the criteria set out in Article 11 shall be entitled to make a request for internal review to the Union institution or body that adopted the administrative act or, in the case of an alleged administrative omission, should have adopted such an act, on the grounds that such an act or omission contravenes environmental law within the meaning of point (f) of Article 2(1).

… The request shall state the grounds for the review.

…’

Article 12(1) of the Aarhus Regulation refers to the possibility of proceedings before the Courts of the European Union:

‘The non-governmental organisation which made the request for internal review pursuant to Article 10 may institute proceedings before the Court of Justice in accordance with the relevant provisions of TFEU.’

III. Facts and background to the dispute

Cypermethrin is a pyrethroid insecticide. That family of insecticides is widely used within the European Union in order to combat crop pests. Cypermethrin is highly toxic to insects.

The Commission had approved cypermethrin in 2005 pursuant to the Plant Protection Directive (14) in force at that time. That approval expired in 2016. A working party comprising two undertakings, Arysta LifeScience Benelux sprl and SBM Développement, (the applicant) applied for the renewal of that approval. The precise date of the application cannot be ascertained from the case file. During the procedure for assessing the renewal application, the Commission enacted several short extensions to the approval period in order to prevent the approval expiring for reasons beyond the applicant’s control before a decision was taken on renewal (Article 17 of the Plant Protection Regulation).

As the applicant submitted the application in Belgium and Germany, Belgium became the rapporteur Member State and Germany became a co-rapporteur Member State within the meaning of Article 7 of the Plant Protection Regulation. In accordance with Article 11, they submitted a draft report assessing the renewal. EFSA then reviewed that draft with the involvement of the applicant, the Member States and the public in accordance with Article 12.

On 31 July 2018, EFSA delivered a scientific opinion entitled ‘Peer review of the pesticide risk assessment of the active substance cypermethrin’ (15) (‘the EFSA conclusion’). In that conclusion, among other things, EFSA specifies four ‘critical areas of concern’ which could preclude authorisation.

Following discussions in the relevant comitology committee, the Standing Committee on Plants, Animals, Food and Feed, the Commission sought a further opinion from EFSA on risk mitigation measures for cypermethrin (16) (‘the 2019 EFSA statement’).

In the end, the Commission renewed the authorisation of cypermethrin on 24 November 2021.

On 20 January 2022, PAN Europe submitted a request for internal review of the renewal at issue to the Commission in French on the basis of Article 10(1) of Regulation No 1367/2006. Specifically, the request sought the adoption of a regulation repealing and replacing the renewal at issue and rejecting the application for the renewal of approval of the active substance cypermethrin. By letter from Commissioner Stella Kyriakides, which the Commission registered under Ares(2022)4621502 – 23/06/2022, and a decision appended to that letter (‘the contested review decision’), the Commission rejected the request. The Commission sent PAN Europe the letter and the contested review decision in English on 23 June 2022 and in French on 18 July 2022.

PAN Europe then brought an action before the General Court against the contested review decision. The General Court dismissed the action. By the present appeal, PAN Europe claims that the Court of Justice should

–declare the present appeal admissible and well founded;

–set aside the judgment under appeal;

–pursuant to the first paragraph of Article 61 of the Statute of the Court of Justice and Article 170(1) of the Rules of Procedure of the Court of Justice, give judgment in the matter and, granting the form of order submitted by the applicant at first instance, declare the contested review decision void;

–order the Commission to pay the costs of both sets of proceedings.

The Commission contends that the Court of Justice should

–dismiss the appeal and

–order PAN Europe to pay the costs.

The parties submitted written observations. In accordance with Article 76(2) of the Rules of Procedure, the Court of Justice dispensed with a hearing on the ground that it considered itself to have sufficient information to give a ruling.

For a better understanding of each ground of appeal, it is useful to begin with some preliminary observations (section A). Thereafter, I will first examine the third ground of appeal, which concerns the data gaps identified by EFSA in general terms (section B), then the first part of the fourth ground of appeal regarding the lack of information about the toxicity of the isomers of cypermethrin (section C), the second ground of appeal and the second part of the fourth ground of appeal concerning the allegedly insufficient information about the effects of cypermethrin on the endocrine system (section D), the fifth ground of appeal regarding the long-term toxicity of the cypermethrin-based plant protection product investigated (section E) and finally the first ground of appeal, which centres around three of the four critical areas of concern identified by EFSA (section F).

Given that the authorisation of active substances in accordance with the Plant Protection Regulation and the procedural context of the actions brought by environmental associations against such authorisations are legally and technically complex, it is useful to sketch out the renewal procedure at issue and the legal standards most relevant to it (section 1) and to demonstrate the standing of PAN Europe (section 2).

1. The renewal procedure and the major provisions applicable to it

The Plant Protection Regulation provides that the active substances of plant protection products require approval from the Commission. Plant protection products per se, on the other hand, are approved by the Member States.

Under Article 4 of the Plant Protection Regulation, the Commission approves active substances if it may be expected that plant protection products containing that active substance do not, in particular, have any harmful effects on human health, animal health or groundwater or any unacceptable effect on the environment. Under Article 4(5), those requirements shall be deemed to be satisfied 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 Court of Justice has inferred from that provision, read in conjunction with Article 7(1), Article 29(2) and the precautionary principle, that the applicant must provide proof that the active substance does not have the harmful effects referred to. (17) If the Commission grants such an application, that is to say, determines that the applicant has provided the necessary proof, the burden of proving the correctness of that determination in any dispute about the authorisation granted lies with the Commission.

Since the Commission can only approve active substances for a period not exceeding 10 years under Article 5 of the Plant Protection Regulation, their continued use requires the renewal of that approval, which may be granted for a period not exceeding 15 years. That renewal likewise requires the approval criteria set out in Article 4 to be satisfied.

When deciding on the renewal of approval of an active substance, the Commission must undertake a complex scientific and technical assessment, so it has a broad discretion, the exercise of which the EU judicature may review substantively only to verify whether manifest errors of appraisal have been committed. (18) In such a context, the EU judicature cannot substitute its assessment of scientific and technical facts for that of the institutions on which alone the legislature has placed that task. (19)

However, in particular where a party claims that the authority competent in the matter has committed a manifest error, the EU judicature must verify whether that authority has examined, carefully and impartially, all the relevant facts of the individual case on which that assessment was based. (20)

For the authorisation of active substances under the Plant Protection Regulation, that examination starts with the information which the applicant submits to the procedure on the basis of its burden of proof. The applicant must, under Articles 7 and 8, submit a complete dossier alongside its application for authorisation demonstrating that the active substance satisfies the authorisation criteria. The Commission has further fleshed out the requirements for such a dossier. (21)

Pursuant to Articles 11 and 12 of the Plant Protection Regulation, first the rapporteur Member State and then EFSA, with the participation of the other Member States and the public, evaluate that information as to whether the active substance can be expected to meet the approval criteria provided for in Article 4. However, that evaluation is not limited to the information submitted; under the second subparagraph of Article 11(2) and the second subparagraph of Article 12(2), it must also take account of current scientific and technical knowledge. (22)

As the General Court rightly points out in paragraphs 88 and 89 of the judgment under appeal, which are not disputed by PAN Europe, the Commission is not bound by EFSA’s findings when deciding on the renewal. Nevertheless, under Article 13(1) of the Plant Protection Regulation, it does have to take them into account when deciding on the active substance. (23)

Moreover, where the EU institutions – like the Commission in the present case – have a broad discretion, respect for the rights guaranteed by the EU legal order in administrative procedures is of even more fundamental importance. Those guarantees include, in addition to the duty of examination referred to above, the right to have an adequately reasoned decision. (24) The purpose of the obligation to state reasons is not only to provide the person concerned with sufficient information to assess the chances of success of a challenge before the Courts of the European Union but also to enable those Courts to review the legality of the act. (25) Only in that way can the Court verify whether the factual and legal elements upon which the Commission’s exercise of its power of appraisal depends were present, (26) in particular whether the Commission carefully and impartially examined all the relevant aspects of the individual case.

Consequently, where the Commission deviates from a scientific determination made by EFSA, it must in particular state the reasons why its finding differs from EFSA’s.

According to the EFSA conclusion, the applicant provided information on ‘Cypermethrin 500 EC’, which is an emulsifiable concentrate containing 500g/L of active substance. The representative uses evaluated were field spray applications as an insecticide in winter and spring cereals and spray applications in potato in the southern European Union and spray applications in winter and spring oilseed rape in the central and northern EU. (27)

First, the two rapporteur Member States evaluated that information, and then EFSA reviewed that evaluation with the participation of all Member States and the public. The findings of that review are set out in the EFSA conclusion of 2018. In it, EFSA identifies a total of 24 data gaps in the application for renewal, which are the focus of the third ground of appeal (see section B), three issues for assessment that could not be finalised and four critical areas of concern (see section F). The information available on the latter does not, in the view of EFSA, permit the conclusion that the representative plant protection product may be expected not to have any harmful effect on human or animal health or on groundwater, or any unacceptable influence on the environment, within the meaning of Article 4 of the Plant Protection Regulation.

The Commission nevertheless continued discussion of the renewal of approval in the Standing Committee on Plants, Animals, Food and Feed and sought the 2019 EFSA statement on the possibility of mitigating certain adverse effects of using cypermethrin-based plant protection products. Finally, the Commission granted the renewal at issue, which lays down certain conditions and restrictions regarding the use of cypermethrin-based plant protection products (see section F). In particular, the Commission requires the applicant to submit ‘further confirmatory information’ on four sets of issues within certain time limits (see sections C and D.2).

PAN Europe is a not-for-profit association governed by Belgian law whose mission is to reduce the use of pesticides. (28)

However, an environmental association like PAN Europe is not directly affected by the renewal of approval of an active substance for plant protection products, as the active substances enter the environment only in the form of plant protection products which require additional approval. An environmental association therefore cannot bring an action directly before the Courts of the European Union against such a renewal. (29)

The Aarhus Regulation does give environmental associations the option of making a request for internal review to an institution which has adopted an administrative act under environmental law. The environmental association can challenge the decision which follows that request before the Courts of the European Union. However, the approval of an active substance has not to date been regarded as an administrative act to which that procedure would have been applicable but as an act of general application. (30)

That being said, Article 1(1) of Regulation 2021/1767 expanded the definition of the term ‘administrative act’ in the Aarhus Regulation to mean any non-legislative act adopted by an EU institution or body. Pursuant to the third subparagraph of Article 297(1) TFEU and as also expressed in the first sentence of Article 2 of Regulation 2021/1767, that provision entered into force on the twentieth day following that of the publication of the regulation – that is to say, on 28 October 2021.

The renewal at issue is such a non-legislative act. Consequently, PAN Europe was entitled to request, on 20 January 2022, internal review of it under Article 10 of the Aarhus Regulation with the aim of having it annulled or replaced by a regulation rejecting the application for the renewal of approval of the active substance cypermethrin.

Given the allocation of the burden of proof under the Plant Protection Regulation, (31) PAN Europe was not required to prove that an active substance had harmful effects on human or animal health or groundwater or had any unacceptable effect on the environment in order to be successful.

However, as the General Court rightly points out in paragraph 42 of the judgment under appeal, PAN Europe was required to provide, alongside the request for review, concrete and precise grounds which might be able to call into question the assessments on which the act to be reviewed was based. It was thus required to put forward the key facts or legal arguments of sufficient substance to give rise to serious doubts as to the assessment made in that act by the EU institution or body. (32)

55.PAN Europe’s arguments did not convince the Commission. It therefore rejected the request for review by the contested review decision. PAN Europe was subsequently able to challenge that decision under Article 12 of the Aarhus Regulation.

56.In that context, the subject matter of the dispute corresponds to the subject matter of the request for review. In principle, (33) proceedings brought against the rejection of a request for review cannot be founded on new grounds or on evidence not appearing in the request. Otherwise, the requirement in Article 10(1) of the Aarhus Regulation relating to the statement of grounds for such a request would be made redundant and the object of the procedure initiated by the request would be altered. (34)

B. Regulation (EU) No 283/2013 – data gaps

57.By its third ground of appeal, PAN Europe contests the assessment, in paragraphs 309 to 316 of the judgment under appeal, of its arguments relating to a total of 24 data gaps identified by EFSA in the application for renewal of the approval of cypermethrin.

58.PAN Europe raises three specific objections in relation to the – at first glance impressive – total number of data gaps. The first and third objections are directly concerned with the significance of the data gaps to the renewal. PAN Europe argues that those data gaps alone should have precluded the granting of the renewal at issue. In contrast, the second objection, which will be examined below, addresses the completeness of the application for renewal.

59.First, PAN Europe argues that the General Court was wrong to hold in paragraph 309 that data gaps did not necessarily show that the conditions for approval were not met. That is incompatible with the precautionary principle, it submits, arguing that, on the contrary, the number and nature of the gaps demonstrates so much uncertainty that the Commission – contrary to the view of the General Court – must be found to have committed a manifest error of appraisal in renewing the approval.

60.The third objection, which is directed against paragraph 312 of the judgment under appeal, goes in the same direction. According to that paragraph, PAN Europe would have had to indicate why the data gaps should have led to the conclusion that the criteria for renewal of approval were not met. PAN Europe argues in connection with the data gaps, however, that, in light of the precautionary principle, the onus was on the Commission to prove that those data gaps did not preclude the renewal of approval.

61.However, those findings of the General Court are not vitiated by any error of law.

62.It is true that, in the light of the precautionary principle, the Court of Justice has interpreted some provisions as meaning that certain activities cannot be authorised as long as scientific uncertainty remains as to whether harmful effects of those activities on the object of protection in question can be ruled out. (35) Article 4(3) of the Plant Protection Regulation also points in this direction. According to that provision, a plant protection product must have no harmful effect on human health, animal health or groundwater and no unacceptable effects on the environment. Under Articles 7(1) and 29(2), the applicant must demonstrate that that is the case. (36) And ultimately, the legitimate exercise of the Commission’s discretion requires it to have carefully and impartially examined all the relevant aspects of the individual case beforehand. (37)

63.However, data gaps do not necessarily mean that harmlessness has not been proved. They signify only that certain scientific information is not available. But the precautionary principle does not demand that all conceivable scientific information be established by means of additional studies. Rather, risks must be assessed on the basis of most reliable scientific evidence available and the most recent results of international research. (38) The Commission’s investigative duty also does not go further than that.

64.It is conceivable that certain data gaps might make it impossible to rule out the effects prohibited under Article 4(3) of the Plant Protection Regulation, namely harmful effects on human health, animal health or groundwater or unacceptable (other) effects on the environment.

65.However, in the context of proceedings based on a request for internal review, the applicant in those proceedings must explain why certain data gaps make it impossible to rule out the aforementioned effects. (39)

66.Although PAN Europe does substantiate its submission in respect of certain data gaps, in particular by its fourth ground of appeal (see sections C and D.2), the present ground of appeal refers to the data gaps as a whole.

67.It is also not apparent from the EFSA conclusion that the data gaps in the present case make it impossible to prove that cypermethrin is harmless. In fact, EFSA subjects most of the data gaps to no assessment at all in its conclusion. (40) While it does find that it was unable to finalise three issues for assessment, PAN Europe does not address that aspect of the conclusion, with the result that it is not part of the subject matter of the proceedings.

68.The General Court was therefore right to find that it was not apparent either from the data gaps per se or from PAN Europe’s arguments on the data gaps that the conditions for the renewal at issue were not met.

69.By its second objection, PAN Europe complains that the General Court was wrong to differentiate in paragraph 310 of the judgment under appeal between the completeness of the application for renewal of approval within the meaning of Regulation (EU) No 283/2013 (41) and the identification of data gaps in EFSA’s assessment. It argues that where an application falls short of the content requirements laid down by the Commission, the Commission cannot establish the findings necessary to grant approval.

70.However, that argument misconstrues the content of the contested finding of the General Court. The finding concerns neither the question of whether there are any data gaps within the meaning of Regulation No 283/2013, nor the consequences of such gaps. On the contrary, the General Court raises the possibility of EFSA identifying data gaps from a scientific perspective which do not constitute an infringement of the requirements set out in that regulation.

71.If PAN Europe sought by that submission to complain of an infringement of Regulation No 283/2013, that would constitute exceeding the subject matter of the dispute arising from its request for review. (42) Although PAN Europe cited that regulation in the context of other objections, it did not do so in relation to the total number of data gaps.

72.The third ground of appeal is therefore unfounded in its entirety.

73.The fourth ground of appeal further develops the idea of data gaps, fleshing it out in respect of two particular issues. PAN Europe criticises the Commission’s request, attached to the renewal of approval, that the applicant submit ‘further confirmatory information’ within certain time limits. The aim of that submission is not to have that condition lifted. Rather, PAN Europe seeks to demonstrate that the applicant should already have provided the information in question in the dossier for renewal of approval. It argues that the absence of that information should have led the Commission to refuse to renew the approval.

74.The second part of the fourth ground of appeal, like the second ground of appeal, concerns endocrine effects. I will therefore examine those objections together with the second ground of appeal (see section D).

75.The first part of the fourth ground of appeal is about the toxicity of isomers. Under point 2 in the sixth column of Annex I to the renewal at issue, the applicant was required to communicate confirmatory information on the relative toxicity of individual cypermethrin isomers, in particular the enantiomers (1S cis αR).

76.That requirement relates to the eleventh data gap which EFSA had identified. According to EFSA, there was insufficient data on relative toxicity. (43) Unlike for other data gaps, EFSA finds that the information is required, because in ruminant matrices the residues are enriched with the two enantiomers that constitute alpha-cypermethrin. In brackets, EFSA points out that the reference values for these are lower than for cypermethrin. (44) In addition, EFSA emphasises the importance of reducing uncertainty in that area. (45)

77.PAN Europe therefore considers that the information in question should have been provided before the renewal of approval. In that view, it relies in particular on point 1.9 of Part A of the Annex to Regulation No 283/2013. Under that provision, in respect of mixtures of isomers, the relative biological activity of each isomer in terms of toxicity must be reported.

78.The General Court rejected that view in paragraphs 342 to 348 of the judgment under appeal. However, PAN Europe impugns those arguments of the General Court.

1. Admissibility of the submission relating to point 1.9 of Part A of the Annex to Regulation No 283/2013

79.The General Court rejects the submission relating to point 1.9 of Part A of the Annex to Regulation No 283/2013 as inadmissible in paragraph 345 of the judgment under appeal on the ground that PAN Europe did not rely on that provision in its request for internal review under Article 10 of the Aarhus Regulation.

80.As PAN Europe describes, the General Court distorted the clear sense of its submission (46) in paragraph 44 of that request, (47) PAN Europe contests that it expressly criticised the infringement of that provision in connection with the additional data requested in that paragraph. Moreover, the Commission acknowledges in its rejoinder that PAN Europe’s submission in paragraph 89 of the application before the General Court was already a repetition of its submission on that provision in the request for review.

81.The finding in paragraph 345 of the judgment under appeal that that submission is inadmissible is therefore manifestly at odds with the document in the case file and is consequently vitiated by an error of law. The submission relating to point 1.9 of Part A of the Annex to Regulation No 283/2013 was indeed admissible and should have been taken into consideration by the General Court.

82.Point 1.9 of Part A of the Annex to Regulation No 283/2013 specifies the requirements for carefully and impartially examining the aspects relevant to the approval of an active substance. (48) Under that provision, the applicant must provide information on the relative toxicity of cypermethrin isomers.

83.The obligation to comply with the fourth paragraph of point 1.9 of Part A of the Annex to Regulation No 283/2013 also does not cease to apply simply because, at the time of the application, EFSA had not yet provided guidance on determining that data. EFSA did not publish that guidance until 2019. (49) However, the fourth paragraph of point 1.9 is not attached to the delaying condition that the data required under it need not be provided until after EFSA has published the relevant guidance. On the contrary, it is apparent from point 1.7 of the introduction to the Annex that, in the absence of suitable internationally or nationally validated test guidelines, test guidelines accepted by the European competent authority are to be used. Under the same provision, any deviations are to be described and justified.

84.Furthermore, contrary to the view of the Commission, (50) the EFSA conclusion cannot be understood to mean that EFSA’s criticism was merely that the information provided did not correspond to the aforementioned guidance. EFSA adopted its conclusion in 2018 – that is to say, before it published the guidance in 2019.

85.As the Commission renewed the approval of the active substance in the absence of the data required under point 1.9 of Part A of the Annex to Regulation No 283/2013, it follows that it infringed its obligation to examine carefully and impartially the relevant aspects.

3. Article 6(f) of the Plant Protection Regulation

86.The failure to take into consideration the fourth paragraph of point 1.9 of Part A of the Annex to Regulation No 283/2013 also renders paragraph 342 of the judgment under appeal unfounded. In that paragraph, the General Court holds that subsequent communication of the requested information is permissible under Article 6(f) of the Plant Protection Regulation because new requirements were established during the procedure as a result of new scientific and technical knowledge. In so doing, it refers to the aforementioned guidance.

87.The Commission could therefore have attached to the renewal at issue the condition that the applicant must submit information on the toxicity of the isomers of cypermethrin on the basis of the new guidance, rather than delaying the procedure until that information was available.

88.Nevertheless, neither the new guidance nor Article 6(f) of the Plant Protection Regulation change the fact that the applicant should already have provided sufficient information on the toxicity of the isomers of cypermethrin with the application in accordance with the fourth paragraph of point 1.9 of Part A of the Annex to Regulation No 283/2013. Article 6(f) only allows for ‘further confirmatory information’ to be required. That cannot cover information which is already required to be provided with the application.

89.Consequently, Article 6(f) of the Plant Protection Regulation cannot justify waiving the information required under the fourth paragraph of point 1.9 of Part A of the Annex to Regulation No 283/2013.

4. Completeness of the application and assessment of the approval criteria

90.Lastly, PAN Europe also demonstrates that the General Court’s reasoning in paragraphs 343, 344 and 346 of the judgment under appeal cannot justify the renewal at issue despite the lack of information on the toxicity of isomers.

91.In paragraph 343, the General Court invokes the argument that the Court of Justice has acknowledged that the rapporteur Member State’s formal assessment as to the completeness of the dossier and EFSA’s qualitative assessment may reach divergent conclusions. (51) It is not clear, however, why that finding allows the renewal of approval although EFSA found that necessary information about the toxicity of isomers, which the applicant should have provided under point 1.9 of Part A of the Annex to Regulation No 283/2013, was lacking. After all, the Member State’s failure to criticise that data gap cannot mean that the Commission can ignore the gap once EFSA has discovered it.

92.Besides, the judgment in Agrochem-Maks v Commission of the Court of Justice cited by the General Court concerned a different situation. The commonality it shares with the present case is that the rapporteur Member State accepted an application as complete whereas EFSA later found data gaps. However, those data gaps led to the renewal being refused, and the Court of Justice upheld the refusal.

93.Since EFSA can establish data gaps relevant to the decision, the claim in paragraph 344 of the judgment under appeal that PAN Europe conflates the two assessments is also ineffective.

94.That remains unaffected by the finding in paragraph 346 of the judgment under appeal, referring to the Commission’s assertions in the contested review decision set out in paragraph 341, that the isomers had indeed been taken into consideration but EFSA found a data gap on the ground that more specific information was required. That finding can be favourably understood as a superfluous repetition of the assertions regarding the differences between the rapporteur Member State’s and EFSA’s assessment of the dossier.

95.If, on the other hand, the General Court’s intention in paragraph 346 of the judgment under appeal was to state that sufficient assessment of the risks emanating from the toxicity of isomers had taken place, that would be a distortion of the Commission’s assertions set out in the judgment under appeal. As set out in paragraph 341, the Commission specified only that information had been provided and considered sufficient by the rapporteur Member State for the conduct of a risk assessment. (52) That does not cast doubt on the contrary EFSA finding. Moreover, the description in paragraph 341 corresponds to the substance of the contested review decision. (53)

96.The first part of the fourth ground of appeal is therefore well founded, since the General Court did not criticise the Commission’s failure to acquire the information on the toxicity of cypermethrin isomers required under the fourth paragraph of point 1.9 of Part A of the Annex to Regulation No 283/2013. For that reason alone, the judgment under appeal must be set aside.

98.The second ground of appeal and the second part of the fourth ground of appeal are focused on the assessment of endocrine effects in humans. Such effects are concerned with the function of hormones. (54)

99.Under point 3.6.5 of Annex II to the Plant Protection Regulation, the Commission must not approve an active substance which is found to have endocrine disrupting properties in humans (an ‘endocrine disruptor’). As the General Court finds in paragraph 100 of the judgment under appeal, that therefore constitutes an ‘exclusion criterion’.

100.According to EFSA, cypermethrin can be found to have endocrine-mediated activity but, because of a data gap, the potential for endocrine disruption could not be concluded upon. (55) At the same time, EFSA saw that neither as a critical area of concern nor as an issue for assessment that could not be finalised. (56)

101.In the ninth recital of the renewal at issue, the Commission considered, on the basis of the available scientific information summarised in the EFSA conclusion, that cypermethrin was not to be considered as having endocrine disrupting properties. ‘In order to increase confidence’ (57) the Commission in point 4 in the sixth column of Annex I to the renewal at issue requested that the applicant provide an updated evaluation of the information already provided and further information as appropriate by 15 December 2023. And in the contested review decision, the Commission stated that it considered cypermethrin unlikely to have endocrine disrupting properties.

102.PAN Europe argues that it is impossible to rule out endocrine disrupting properties given the data gaps identified by EFSA (second ground of appeal). It insists that the gap should have been eliminated by requesting additional information before the renewal at issue (second part of the fourth ground of appeal).

103.An examination is therefore required, first, of the burden of proof regarding the absence of endocrine disrupting properties (section 1), then of the request for additional information (section 2), then of the Commission’s margin of discretion (section 3) and finally of the question whether PAN Europe provided evidence of a manifest error of appraisal (section 4).

104.First part of the second ground of appeal – consequences of missing data and allocation of the burden of proof

105.PAN Europe first criticises the finding in paragraph 272 of the judgment under appeal that a data gap does not mean that the criteria set out in Article 4 of the Plant Protection Regulation are not met. It argues that the finding is not further substantiated and is therefore incompatible with the precautionary principle and the burden of proof which the Commission consequently bears.

106.Statement of reasons

107.In criticising a lack of substantiation, PAN Europe alleges a failure to state reasons in the judgment under appeal. The statement of the reasons on which a judgment is based must clearly and unequivocally disclose the General Court’s thinking, 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. (58)

108.Although the General Court refers to paragraphs 69 to 97 of the judgment under appeal as stating reasons, those paragraphs in fact contain neither the assertion regarding the lack of probative value of a data gap nor a specific statement of reasons for that assertion.

109.The Commission nevertheless considers that the statement of reasons can be derived from paragraph 73 of the judgment under appeal. In that paragraph, the General Court finds that whether to have recourse to the precautionary principle depends as a general rule on the level of protection chosen by the competent authority in the exercise of its broad discretion, where scientific evaluation does not make it possible to determine the existence of a risk with sufficient certainty.

110.That, too, is not a finding on the probative value of a data gap. As explained above, however, (59) a data gap does not by itself justify adequate doubt as to whether the conditions for authorisation are satisfied. The Court of Justice can therefore remedy that failure to state reasons by substituting (60) or supplementing the statement of reasons.

111.Burden of proof

112.The more important objections are those regarding the burden of proof. PAN Europe submits that approval is not possible where there is uncertainty about an exclusion criterion. It relies for that assertion on Article 4(3)(b) of the Plant Protection Regulation. Under that provision, a plant protection product may only be authorised if it has no harmful effect on human health. As PAN Europe correctly states, the Court of Justice has inferred from that provision, read in conjunction with Article 7(1), Article 29(2) and the precautionary principle, that the applicant must provide proof that the active substance does not have the harmful effects referred to. (61)

113.However, at least according to the EFSA conclusion, no evidence was provided that cypermethrin had no endocrine disrupting properties in humans. Indeed, because of the data gap, EFSA was unable to assess the potential for endocrine disruption. (62)

114.That being said, the assessment of endocrine effects is not governed solely by the provisions of the Plant Protection Regulation, in particular Article 4(3)(b), which the Court of Justice has interpreted in respect of the burden of proof. Under the first subparagraph of Article 4(1), the approval criteria set out in points 2 and 3 of Annex II are also to be taken into account.

115.Endocrine disrupting properties are the subject of point 3.6.5 of Annex II to the Plant Protection Regulation. That provision reverses the burden of proof: as the General Court highlights in paragraph 276 of the judgment under appeal, the effect of that provision is that an active substance will already be authorised if it is not considered to have endocrine disrupting properties in humans.

116.That reversal of the burden of proof might be doubted if one looks at the German or Italian version of the first paragraph of point 3.6.5 of Annex II to the Plant Protection Regulation. According to those versions, the Commission can authorise an active substance only if it is established that it has no endocrine disrupting properties in humans. If that is the case, establishing the absence of such properties, which has not yet been done, and providing the corresponding evidence, would have been a precondition of the renewal at issue.

117.By contrast, the Spanish, English, French and Dutch versions of that provision make it a precondition of authorisation that endocrine disrupting properties have not been established. Under those language versions, therefore, EFSA’s finding that a data gap rendered it unable to assess the potential for endocrine disrupting properties precluded the possibility of refusing the renewal at issue on the basis of such properties.

118.Reading the first paragraph of point 3.6.5 in conjunction with the other paragraphs of point 3.6.5 of Annex II to the Plant Protection Regulation and with the approval criteria relating to genotoxicity (point 3.6.2), carcinogenicity (point 3.6.3) and reproductive toxicity (point 3.6.4) shows that the second group of language versions merit preference.

119.That is because, in accordance with the third and fourth paragraphs of point 3.6.5 of Annex II to the Plant Protection Regulation and the other approval criteria referred to above, endocrine disrupting, genotoxic, carcinogenic or reproductive toxic properties only stand in the way of authorisation of the active substance if the property in question is or should be ascribed to that substance in accordance with Regulation No 1272/2008.

120.Since 2018, the fifth paragraph of point 3.6.5 of Annex II to the Plant Protection Regulation moreover provides that an active substance has endocrine disrupting properties if it has an endocrine mode of action and consequently it shows an adverse effect in an intact organism or its progeny.

121.In all those scenarios, therefore, authorisation is not subject to proof of the absence of the hazardous properties in question. On the contrary, for authorisation to be refused, the relevant properties need to be expressly established on the basis of appropriate evidence.

122.Although those criteria are set out ‘only’ in an annex to the Plant Protection Regulation, they are not a priori subordinate to Article 4(3)(b).

123.It is true that the Commission adopted the additional fifth and sixth paragraphs of point 3.6.5 of Annex II to the Plant Protection Regulation in 2018 in the exercise of a delegated regulatory power, while the Parliament and the Council adopted Article 4(3)(b) in a legislative procedure. However, the other criteria in point 3 of Annex II are also the result of that legislative procedure, as they were already part of the original version of the regulation.

124.It therefore also appears improbable that the Commission exceeded its delegated regulatory power when adopting the addition to point 3.6.5 of Annex II to the Plant Protection Regulation. On the contrary, the Commission is guided as regards the burden of proof by the approval criteria already in place. Furthermore, the provision is in line with the recommendations of the World Health Organization, which have been approved by EFSA. (63) Besides, PAN Europe does not complain that those powers were exceeded in the adoption of the addition.

125.However, the question arises whether the approval criterion laid down in point 3.6.5 of Annex II to the Plant Protection Regulation may indeed, in the light of higher-ranking law, be reduced to the idea that endocrine disrupting properties do not preclude authorisation as long as the findings it specifies cannot be inferred from the available information.

126.That outcome would hardly be compatible with the Commission’s obligation to examine carefully and impartially all the relevant aspects of the individual case. (64) Moreover, specifically on the subject of authorising active substances, the Court of Justice has repeatedly held that the applicant’s burden of proof regarding the approval conditions contributes to achieving compliance with the precautionary principle (of primary law) by ensuring that there is no presumption that active substances and plant protection products have no harmful effects. (65)

127.Accordingly, the Court of Justice concluded in the judgment in Blaise and Others, in particular on the basis of Article 4(3)(b) of the Plant Protection Regulation, that the material submitted by the applicant must be sufficient to exclude, in the light of current scientific and technical knowledge, the risk that a plant protection product exhibits carcinogenicity or toxicity within the meaning of points 3.6.3 and 3.6.4 of Annex II to the Plant Protection Regulation. It held that mere ‘cursory tests’ would not suffice to perform that verification properly. (66)

128.However, evidence that the risk of carcinogenic or toxic properties can be ruled out is qualitatively different from absence of sufficient information to classify the active substance as carcinogenic or toxic for reproduction under Regulation No 1272/2008, which appears prima facie to suffice for the approval criteria set out in points 3.6.3 and 3.6.4 of Annex II to the Plant Protection Regulation.

129.That being said, the context of those findings in the judgment in Blaise and Others shows that the Court of Justice did not wish to contradict the wording or the schematic relationship of the approval criteria in points 3.6.3 and 3.6.4 of Annex II to the Plant Protection Regulation. That is clear from the Court’s reminder that the assessment to be undertaken in line with those criteria must be made on the basis of certain tests. (67) Under the provisions specified, that refers to assessment of testing carried out in accordance with the data requirements for the active substances and other available data and information, including a review of the scientific literature, reviewed by the Authority.

130.Similarly, the first paragraph of point 3.6.5 of Annex II to the Plant Protection Regulation provides that the testing must be in line with ‘Community or internationally agreed test guidelines’. The sixth paragraph added to point 3.6.5 reiterates the requirement in more detail that all available relevant scientific data be taken into account and assessed on the basis of a weight of evidence approach. (68) Those data must be generated in accordance with internationally agreed study protocols, in particular those listed in the Commission Communications in the framework of setting out the data requirements for active substances and plant protection products. (69)

131.Authorisation cannot therefore be granted simply because data on endocrine disrupting properties are lacking. On the contrary, at least the data specified in the first and sixth paragraphs of point 3.6.5 of Annex II to the Plant Protection Regulation must be submitted and taken into account. That is the only way for the Commission to fulfil its obligation to examine carefully and impartially all the relevant aspects of the individual case. (70)

132.It is true that that interpretation of the approval criteria in points 3.6.3, 3.6.4 and 3.6.5 of Annex II to the Plant Protection Regulation gives less stringent expression to the precautionary principle than for other provisions, where scientific uncertainty about harmful effects, in the view of the Court of Justice, already precludes authorising certain activities. (71) In that interpretation, it would not suffice for the applicant to provide the required data and for the Commission (with the support of EFSA and the Member States) to assess it and conclude that the harmful effects in question cannot be established. On the contrary, those data would also have to demonstrate that the effects are ruled out. Nevertheless, the present, less extensive interpretation must be favoured, in particular in view of the wording of the criteria specified.

133.The above interpretation would be contradicted if the General Court’s finding in paragraph 276 of the judgment under appeal was in fact intended to mean that absence of evidence of endocrine disrupting properties, irrespective of the quality of the testing data submitted, sufficed alone to satisfy the approval criterion set out in point 3.6.5 of Annex II to the Plant Protection Regulation.

134.It can be assumed, however, that the General Court sought to express only that the criterion was satisfied if proof was impossible to provide despite sufficient testing data. That assumption is supported in particular by the reference, in paragraph 275 of the judgment under appeal, to the draft renewal report prepared by the rapporteur Member State, since, according to the Commission, that Member State carried out a very extensive assessment of endocrine disrupting effects.

135.It follows that the first part of the second ground of appeal is unfounded.

136.Second part of the fourth ground of appeal – request for further data

137.Regarding the assessment of endocrine disrupting properties of cypermethrin, the appeal can be successful in accordance with the considerations set out above only if PAN Europe demonstrates that the General Court was wrong to consider that the data necessary under the first and sixth paragraphs of point 3.6.5 of Annex II to the Plant Protection Regulation had been provided and that the Commission had assessed them.

138.PAN Europe does not expressly raise that complaint. However, by the second part of its fourth ground of appeal, it does complain that the Commission requests further information on the endocrine effects of cypermethrin in the renewal at issue.

139.Specifically, the Commission, in point 4 in the sixth column of Annex I of the renewal at issue, required the applicant to communicate an updated evaluation of the information already provided and further information as appropriate by 15 December 2023, in order to confirm the absence of endocrine effects.

140.The fact that the Commission is requesting those further confirmatory data could appear prima facie to be an indication that the information originally submitted was insufficient.

141.In fact, however, points of such an indicative nature are immaterial, as they cannot replace verifying whether the information provided in the renewal procedure satisfies the applicable provisions. PAN Europe made no submission regarding that verification.

142.The second part of the fourth ground of appeal is therefore not relevant to the decision to be given.

Lastly, PAN Europe criticises paragraphs 275 and 301 of the judgment under appeal. According to paragraph 275, PAN Europe did not provide evidence of a manifest error of appraisal in respect of endocrine disrupting properties. Moreover, according to PAN Europe, in paragraph 301, the General Court refuses to review the Commission at even a marginal level, not to mention the risk assessment undertaken by EFSA. Therefore, PAN Europe argues, it does not verify whether EFSA and the Commission carefully and impartially examined all the relevant aspects of the individual case. PAN Europe claims that the General Court instead ascribes overwhelming weight in all instances to the studies submitted by the applicant while systematically underestimating the independent studies cited by PAN Europe. PAN Europe further complains that the General Court does not verify whether the Commission’s conclusion that cypermethrin has no harmful effect on human and animal health was plausible in light of those studies. In connection with the present ground of appeal, I understand that last argument to mean that PAN Europe refers only to the assumption that there are no endocrine disrupting effects.

That submission can be countered by pointing out that the General Court, far from ignoring the standards of review specified by PAN Europe, either explicitly mentions or at least refers to them in paragraph 301.

Moreover, PAN Europe does not identify any points in the judgment under appeal at which the General Court is supposed to have infringed the aforementioned standards of review. In fact, the objections under consideration relate to the General Court’s evaluation of the studies submitted – that is to say, to the assessment of facts which the Court of Justice has no power to review on appeal. Consequently, such a submission would also be inadmissible.

It follows that the third part of the second ground of appeal is unfounded.

Interim conclusion

In 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.

Fifth ground of appeal – long-term toxicity

The fifth ground of appeal concerns the assessment of the long-term toxicity of the representative use of a cypermethrin-based plant protection product.

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.

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.

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.

Criteria for assessing the representative use of a plant protection product

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.

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.

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.

Only those later statements are correct.

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.

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.

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.

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.

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.

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)

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)

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.

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.

Assessment of long-term toxicity

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.

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.

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)

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.

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.

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.

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.

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.

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.

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)

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.

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)

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.

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.

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)

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.

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.

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.

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.

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)

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)

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)

Interim conclusion

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.

—

1Original language: German.

2Karlsson, C., Winnberg, P., Dennis, C., and Jonback, H., Toxic, 2003 (originally interpreted by Britney Spears).

3Regarding 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).

4Regulation (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).

5Commission 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).

6Regulation (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).

7See 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).

8Regulation 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).

9Commission 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).

10Although 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.

11Commission 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).

12Commission 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).

13Commission 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).

14Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1).

15EFSA, 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.

16EFSA, ‘Statement on risk mitigation measures on cypermethrin’, EFSA Journal, Vol. 17, Issue 10, 2019, https://doi.org/10.2903/j.efsa.2019.5822.

17Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraphs 78, 79, 95 and 114).

18Judgment 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).

19Judgments 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).

20Judgments 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).

21Initially, 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).

22Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 69).

23Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 70).

24Judgments 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).

25Judgments 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).

26Judgment of 21 November 1991, Technische Universität München (C‑269/90, EU:C:1991:438, paragraph 14).

27Cited in footnote 15, point 7 (p. 7).

28Judgment of the General Court of 13 November 2024, PAN Europe v Commission (T‑104/23, EU:T:2024:823, paragraph 2).

29Judgment of 28 October 2020, Associazione GranoSalus v Commission (C‑313/19 P, EU:C:2020:869, paragraph 63).

30Judgment of 3 September 2020, Mellifera v Commission (C‑784/18 P, EU:C:2020:630, paragraph 79 et seq.).

31See point 36 above.

32Judgment 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).

However, see point 222 below.

Judgment of 12 September 2019, TestBioTech and Others v Commission (C‑82/17 P, EU:C:2019:719, paragraph 39).

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.

Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraphs 78, 79 and 114).

See point 39 above.

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).

See point 54 above.

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).

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).

See point 54 above.

Section 2 of the conclusion (cited in footnote 15), p. 10, fifth paragraph.

Section 3.1 of the conclusion (cited in footnote 15), p. 11, last paragraph.

Section 3.1 of the conclusion (cited in footnote 15), p. 12, second-last paragraph of the section.

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).

See p. 67 of the annexes to the application before the General Court.

See point 39 above.

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.

Paragraph 51 of the response.

Judgment of 9 December 2021, Agrochem-Maks v Commission (C‑374/20 P, EU:C:2021:990, paragraph 71).

‘Des informations ont été fournies et jugées suffisantes par l’EMR pour effectuer l’évaluation des risques’.

See p. 96 of the annexes to the application.

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).

Section 2 of the conclusion (cited in footnote 15), p. 9, seventh paragraph.

Section 9 of the conclusion (cited in footnote 15), p. 19 et seq.

16th recital of the renewal at issue.

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).

See points 61 to 65 above.

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).

Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraphs 78, 79, 95 and 114).

Section 2 of the conclusion (cited in footnote 15), p. 9, seventh paragraph.

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).

See point 39 above.

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).

Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraphs 112, 114 and 116).

Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 112).

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).

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.

See point 39 above.

See references in footnote 35.

See, to that effect, judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 112).

Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 113).

Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 115).

Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 116). See also points 124 to 128 above.

See judgment of 3 April 2014, France v Commission (C‑559/12 P, EU:C:2014:217, paragraph 103).

Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 114).

Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraphs 69 and 116).

Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 70).

Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 80).

See point 39 above.

Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraphs 113 to 116).

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.

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.

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).

Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraphs 113 and 114).

Judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800, paragraph 116).

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).

89Judgment of 4 June 2013, ZZ (C‑300/11, EU:C:2013:363, paragraph 58).

90Directive 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).

91Judgments 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).

92See 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).

93Section 1 of the conclusion (cited in footnote 15), p. 8, second paragraph.

94Section 2 of the conclusion (cited in footnote 15), p. 8, third paragraph.

95Section 5 of the conclusion (cited in footnote 15), p. 14, third paragraph.

96Section 9.2 of the conclusion (cited in footnote 15), p. 20.

97Section 2 of the conclusion (cited in footnote 15), p. 8, third paragraph.

98Section 2 of the conclusion (cited in footnote 15), p. 9, fourth paragraph.

99See point 164 et seq. above.

100See points 43 and 44 above.

101See p. 84 of the annexes to the application.

102Sections 2 and 5 of the conclusion (cited in footnote 15), p. 8, third paragraph, and p. 14, third paragraph).

103Section 2 of the conclusion (cited in footnote 15), p. 8, third paragraph.

104Section 5 of the conclusion (cited in footnote 15), p. 14, fifth and sixth paragraphs.

105Cited in footnote 16, section 2.1, p. 6 et seq., and Annex A, pp. 13 and 14.

106Directive 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).

107See 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).

108See 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).

109EFSA 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.

110On the response to new arguments in the judgment under appeal, see the references in footnote 85.

111Guidance, cited in footnote 109, section 11.5, pp. 157 to 159.

112See Guidance, cited in footnote 109, p. 165.

113See point 56 above.

114Section 5 of the conclusion (cited in footnote 15), p. 14, seventh paragraph, and p. 15, fourth paragraph.

115Cited in footnote 16, sections 2.2 and 2.3, p. 8 et seq., and Annex A, p. 14 et seq..

116See point 43 above.

117See point 169 et seq. above.

118See points 172 to 185 above.