Provisional text
JUDGMENT OF THE COURT (Fourth Chamber)
18 December 2025 (*)
Table of contents
Legal framework
Directive 91/414/EEC
Regulation No 1107/2009
Implementing Regulation (EU) No 540/2011
Implementing Regulation (EU) No 844/2012
Regulation (EU) No 283/2013
The Aarhus Regulation
Implementing Regulation 2021/2049
Background to the dispute
The proceedings before the General Court and the judgment under appeal
Forms of order sought
The appeal
The first ground of appeal: failure to take the critical areas of concern identified by EFSA into account
The first part of the first ground of appeal: an error of law, breach of the obligation to state reasons and distortion of the evidence vitiating the General Court’s assessment of the critical area of concern relating to the lack of information on the representativity of the batches used
– Arguments of the parties
– Findings of the Court
The second part of the first ground of appeal: contradiction in the reasoning and an error of law vitiating the General Court’s assessment of the critical area of concern relating to the high risk for aquatic organisms
– Arguments of the parties
– Findings of the Court
The third part of the first ground of appeal: breach of the obligation to state reasons, a contradiction in the reasoning, an error of law and distortion of the evidence vitiating the General Court’s assessment of the critical area of concern relating to the high risk for non-target arthropods
– Arguments of the parties
– Findings of the Court
The second ground of appeal and the second part of the fourth ground of appeal: errors of law and breach of the precautionary principle as regards the data gap concerning the endocrine effects of the active substance and the requirement for the applicant for renewal of approval to provide further data on the absence of such effects
Arguments of the parties
Findings of the Court
The first part of the fourth ground of appeal: the second request for confirmatory information on the toxicity of the isomers constitutes an abuse
Arguments of the parties
Findings of the Court
The third ground of appeal: failure to take the other data gaps identified by EFSA into account
Arguments of the parties
Findings of the Court
The fifth ground of appeal: failure to examine the long-term toxicity of the representative use submitted by the applicant for renewal of approval
Arguments of the parties
Findings of the Court
The action before the General Court
The first complaint in the second part of the single plea in the action: lack of information on the representativity of the batches of pesticides used
The third complaint in the second part of the single plea in the action: the risk mitigation measures in respect of non-target arthropods in off-field areas were unrealistic
The fourth complaint in the second part of the single plea in the action: the second request for confirmatory information on the toxicity of the isomers constituted an abuse
The seventh complaint in the second part of the single plea in the action: there was no examination of the long-term toxicity of the representative use of the PPP containing cypermethrin submitted by the applicants for renewal of the approval of that active substance
Costs
( Appeal – Agriculture – Plant protection products – Article 4 – Regulation (EC) No 1107/2009 – Implementing Regulation (EU) 2021/2049 – Renewal of the approval of the active substance ‘cypermethrin’ – Request for internal review – Regulation (EC) No 1367/2006 – Article 10(1) – Decision refusing the request – Risk assessment and risk management – Identification of critical areas of concern – Realistic conditions of use – Precautionary principle )
In Case C‑316/24 P,
APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, lodged on 29 April 2024,
Pesticide Action Network Europe (PAN Europe), established in Brussels (Belgium), represented by A. Bailleux, avocat,
appellant,
the other party to the proceedings being:
European Commission, represented by A.C. Becker, A. Dawes and M. ter Haar, acting as Agents,
defendant at first instance,
THE COURT (Fourth Chamber),
composed of I. Jarukaitis, President of Chamber, K. Lenaerts, President of the Court, acting as judge of the Fourth Chamber, M. Condinanzi (Rapporteur), N. Jääskinen and R. Frendo, Judges,
Advocate General: J. Kokott,
Registrar: A. Calot Escobar,
having regard to the written procedure,
after hearing the Opinion of the Advocate General at the sitting on 5 June 2025,
gives the following
Judgment
1 By its appeal, Pesticide Action Network Europe (PAN Europe) seeks to have set aside the judgment of the General Court of the European Union of 21 February 2024, PAN Europe v Commission (T‑536/22, ‘the judgment under appeal’, EU:T:2024:98), whereby the General Court dismissed its action for annulment of the decision of the European Commission of 23 June 2022 (‘the decision at issue’) refusing the request for internal review of Commission Implementing Regulation (EU) 2021/2049 of 24 November 2021 renewing the approval of the active substance cypermethrin as a candidate for substitution in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ 2021 L 420, p. 6).
Legal framework
Directive 91/414/EEC
2 Annex I to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1) contained the list of active substances authorised for incorporation in plant protection products. That directive was repealed, from 14 June 2011, by Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ 2009 L 309, p. 1), which provides that references to those directives are to be construed as references to Regulation No 1107/2009.
Regulation No 1107/2009
3 Recital 12 of Regulation No 1107/2009 is worded as follows:
‘In the interest of predictability, efficiency and consistency, a detailed procedure should be laid down for assessing whether an active substance can be approved. The information to be submitted by interested parties for the purposes of approval of a substance should be specified. In view of the amount of work connected with the approval procedure, it is appropriate that the evaluation of such information be performed by a Member State acting as a rapporteur for the Community. To ensure consistency in evaluation, an independent scientific review should be performed by the European Food Safety Authority [EFSA] … It should be clarified that [EFSA] performs a risk assessment whilst the Commission should perform the risk management role and take the final decision on an active substance. Provisions should be included to ensure the transparency of the evaluation process.’
4 Article 1 of that regulation, entitled ‘Subject matter and purpose’, provides, in paragraph 2, that that regulation lays down, in particular, rules for the approval of active substances which plant protection products contain. Paragraph 3 of that article states, in particular, that the purpose of the regulation is to ensure a high level of protection of both human and animal health and the environment. According to paragraph 4, the provisions of the regulation are underpinned by the precautionary principle in order to ensure that active substances or products placed on the market do not adversely affect human or animal health or the environment.
5 Chapter II of that regulation contains Section 1, entitled ‘Active substances’, consisting of three subsections, the first of which concerns ‘requirements and conditions for approval’.
6 Article 4 of that regulation, entitled ‘Approval criteria for active substances’, which is in Section 1, provides:
‘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.
The assessment of the active substance shall first establish whether the approval criteria set out in points 3.6.2 to 3.6.4 and 3.7 of Annex II are satisfied. If these criteria are satisfied the assessment shall continue to establish whether the other approval criteria set out in points 2 and 3 of Annex II are satisfied.
2. The residues of the plant protection products, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, shall meet the following requirements:
(a) they shall not have any harmful effects on human health, including that of vulnerable groups, or animal health … or on groundwater;
(b) they shall not have any unacceptable effect on the environment.
…
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:
(a) it shall be sufficiently effective;
(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 [EFSA] to assess such effects are available; or on groundwater;
(c) it shall not have any unacceptable effects on plants or plant products;
(d) it shall not cause unnecessary suffering and pain to vertebrates to be controlled;
(e) it shall have no unacceptable effects on the environment …
…
5. For approval of an active substance, paragraphs 1, 2 and 3 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.
…’
7 Article 6 of Regulation No 1107/2009, entitled ‘Conditions and restrictions’, provides:
‘Approval may be subject to conditions and restrictions including:
(a) the minimum degree of purity of the active substance;
(b) the nature and maximum content of certain impurities;
(c) restrictions arising from the evaluation of the information referred to in Article 8 taking account of the agricultural, plant health and environmental, including climatic, conditions in question;
(d) type of preparation;
(e) manner and conditions of application;
(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;
(g) designation of categories of users, such as professional and non-professional;
(h) designation of areas where the use of plant protection products, including soil treatment products, containing the active substance may not be authorised or where the use may be authorised under specific conditions;
(i) the need to impose risk mitigation measures and monitoring after use;
(j) any other particular conditions that result from the evaluation of information made available in the context of this Regulation.’
8 Subsection 2 of Chapter II, Section 1 of that regulation, entitled ‘Approval procedure’, contains Articles 7 to 13 of that regulation.
9 Article 7 of that regulation, entitled ‘Application’, provides, in paragraph 1:
‘An application for the approval of an active substance or for an amendment to the conditions of an approval shall be submitted by the producer of the active substance to a Member State, (the rapporteur Member State) [“the RMS”], together with a summary and a complete dossier as provided for in Article 8(1) and (2) or a scientifically reasoned justification for not providing certain parts of those dossiers, demonstrating that the active substance fulfils the approval criteria provided for in Article 4.
…’
10 Article 11 of Regulation No 1107/2009, entitled ‘Draft assessment report’, provides, in paragraphs 1 and 2:
‘1. Within 12 months of the date of the notification provided for in the first subparagraph of Article 9(3), the [RMS] shall prepare and submit to the Commission, with a copy to [EFSA], a report, referred to as the “draft assessment report”, assessing whether the active substance can be expected to meet the approval criteria provided for in Article 4.
2. …
The [RMS] shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge.
…’.
11 Article 12 of that regulation, entitled ‘Conclusion by [EFSA], provides, in paragraphs 1 and 2:
‘1. [EFSA] shall circulate the draft assessment report received from the [RMS] to the applicant and the other Member States at the latest 30 days after its receipt. …
[EFSA] shall make the draft assessment report available to the public, after giving the applicant two weeks to request, pursuant to Article 63, that certain parts of the draft assessment report be kept confidential.
[EFSA] shall allow a period of 60 days for the submission of written comments.
2. [EFSA], where appropriate shall organise a consultation of experts, including experts from the [RMS].
Within 120 days of the end of the period provided for the submission of written comments, [EFSA] shall adopt a conclusion in the light of current scientific and technical knowledge using guidance documents available at the time of application on whether the active substance can be expected to meet the approval criteria provided for in Article 4 and shall communicate it to the applicant, the Member States and the Commission and shall make it available to the public. In the event of a consultation as provided for in this paragraph, the 120-day period shall be extended by 30 days.
…’
12 Article 13 of that regulation, entitled ‘Approval Regulation’, states, in paragraph 1:
‘Within six months of receiving the conclusion from [EFSA], the Commission shall present a report, referred to as “the review report”, and a draft Regulation to the Committee referred to in Article 79(1), taking into account the draft assessment report by the [RMS] and the conclusion of [EFSA].
…’
13 Article 14 of that regulation, entitled ‘Renewal of approval’, provides:
‘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.
2. The renewal of the approval shall be for a period not exceeding 15 years. …’
14 Article 20 of Regulation No 1107/2009, entitled ‘Renewal Regulation’, provides, in paragraph 1:
‘A Regulation shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), providing that:
(a) the approval of an active substance is renewed, subject to conditions and restrictions where appropriate; or
(b) the approval of an active substance is not renewed.’
15 Article 24 of that regulation, entitled ‘Candidates for substitution’, provides, in paragraph 1:
‘An active substance complying with the criteria provided for in Article 4 shall be approved, for a period not exceeding seven years, as a candidate for substitution if it meets one or more of the additional criteria laid down in point 4 of Annex II. By way of derogation from Article 14(2), the approval may be renewed once or more for periods not exceeding seven years.’
16 Chapter III of that regulation, entitled ‘Plant protection products’, contains Section 1, entitled ‘Authorisation’, divided into six subsections. The articles that make up Subsection 1 of that regulation, entitled ‘Requirements and contents’, include Article 29, entitled ‘Requirements for the authorisation for placing on the market’, which provides:
‘1. Without prejudice to Article 50 a plant protection product shall only be authorised where following the uniform principles referred to in paragraph 6 it complies with the following requirements:
(a) its active substances, safeners and synergists have been approved;
…
(e) in the light of current scientific and technical knowledge, it complies with the requirements provided for in Article 4(3);
…
6. Uniform principles for evaluation and authorisation of plant protection products shall contain the requirements set out in Annex VI to Directive 91/414/EEC and shall be laid down in Regulations adopted in accordance with the advisory procedure referred to in Article 79(2) without any substantial modifications. Subsequent amendments to these Regulations shall be adopted in accordance with Article 78(1)(c).
…’
17 Point 2.2 of Annex II to Regulation No 1107/2009, entitled ‘Submission of further information’, is worded as follows:
‘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.’
18 Point 2.3 of Annex II, entitled ‘Restrictions on approval’, states:
‘Where necessary, the approval may be subject to conditions and restrictions as referred to in Article 6.
Where the [RMS] considers that the dossier provided lacks certain information, to the effect that the active substance could only be approved subject to restrictions, it shall contact the applicant at an early stage to obtain more information which may possibly enable these restrictions to be removed.’
19 Point 3 of Annex II, entitled ‘Criteria for the approval of an active substance’, sets out, in point 3.1, the information which the applicant’s dossier, submitted in accordance with Article 7(1) of Regulation No 1107/2009, must contain.
20 Point 3.6.2 of Annex II states:
‘An active substance, safener or synergist shall only be approved if, on the basis of assessment of higher tier genotoxicity testing carried out in accordance with the data requirements for the active substances, safeners or synergists and other available data and information, including a review of the scientific literature, reviewed by [EFSA], it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008 [of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1)], as mutagen category 1A or 1B.’
21 Point 3.6.4 of Annex II to Regulation No 1107/2009 provides:
‘An active substance, safener or synergist shall only be approved if, on the basis of assessment of reproductive toxicity testing carried out in accordance with the data requirements for the active substances, safeners or synergists and other available data and information, including a review of the scientific literature, reviewed by [EFSA], it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction category 1A or 1B, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible …’
22 Point 3.6.5 of Annex annexe II states:
‘An active substance, safener or synergist 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 [EFSA], it is not considered to have endocrine disrupting properties that may cause adverse effect in humans, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, …
By 14 December 2013, the Commission shall present to the Standing Committee on the Food Chain and Animal Health[, established by Article 58 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ 2002 L 31, p. 1)] a draft of the measures concerning specific scientific criteria for the determination of endocrine disrupting properties to be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).
…’
23 Commission Regulation (EU) 2018/605 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, and corrigendum OJ 2018 L 111, p. 10), applicable from 10 November 2018, added a fifth paragraph to point 3.6.5, which provides:
‘From 10 November 2018, an active substance, safener or synergist 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.’
24 Article 2 of Regulation 2018/605 provides that points 3.6.5 and 3.8.2 of Annex II to Regulation No 1107/2009, as amended by Regulation 2018/605, are to apply as of 10 November 2018, except for procedures where the [Standing] Committee [on Plants, Animals Food and Feed, established by Article 58 of Regulation No 178/2002, as amended by Regulation (EU) No 652/2014 of the European Parliament and of the Council of 15 May 2014 (OJ 2014 L 189, p. 1); ‘the Standing Committee’] has voted on a draft regulation by 10 November 2018.
25 Point 3.8 of Regulation No 1107/2009, as amended by Regulation 2018/605, entitled ‘Ecotoxicology’, lists, in point 3.8.2, the criteria against which an active substance, safener or synergist is to be considered to have endocrine disrupting properties.
26 Point 4 of Annex II to Regulation No 1107/2009, entitled ‘Candidate for substitution’, sets out the conditions on which ‘an active substance shall be approved as a candidate for substitution pursuant to Article 24’. They include the condition mentioned in the fourth indent of point 4, namely that that active substance must contain ‘a significant proportion of non-active isomers’.
Implementing Regulation (EU) No 540/2011
27 Article 1 of Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ 2011 L 153, p. 1), as amended by Commission Implementing Regulation (EU) 2015/2105 of 20 November 2015 (OJ 2015 L 305, p. 31), provides that ‘the candidates for substitution approved under Regulation (EC) No 1107/2009 are as set out in Part E of the Annex to this Regulation’.
Implementing Regulation (EU) No 844/2012
28 Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ 2012 L 252, p. 26) was the subject of various amendments before being repealed by Commission Implementing Regulation (EU) 2020/1740 of 20 November 2020 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and repealing Commission Implementing Regulation (EU) No 844/2012 (OJ 2020 L 392, p. 20). Implementing Regulation 2020/1740 nonetheless provided, in Article 17 thereof, that Implementing Regulation No 844/2012 is to continue to apply to the procedures for the renewal of the approval of the active substances whose approval period ends before 27 March 2024, such as the procedure concerned in the present case.
29 Under the first subparagraph of Article 1(1) of Implementing Regulation No 844/2012, an application for the renewal of an approval of an active substance is to be submitted by a producer of the active substance to the RMS and to the co-rapporteur Member State, both designated in accordance with the annex to Commission Implementing Regulation (EU) No 686/2012 of 26 July 2012 allocating to Member States, for the purposes of the renewal procedure, the evaluation of the active substances whose approval expires by 31 December 2018 at the latest (OJ 2012 L 200, p. 5).
30 According to Article 13 of Implementing Regulation No 844/2012, entitled ‘Conclusion by [EFSA]’:
‘1. Within five months from the expiry of the period referred to in Article 12(3), [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 Regulation (EC) No 1107/2009. [EFSA] shall, where appropriate, organise a consultation of experts, including experts from the [RMS] and co-rapporteur Member State. [EFSA] shall communicate its conclusion to the applicant, the Member States and the Commission.
By way of derogation from the first subparagraph, the Commission may inform [EFSA] without delay after the period referred to in Article 12(3) has expired that a conclusion is not necessary.
…
3. Where [EFSA] considers that additional information from the applicant is necessary, it shall, in consultation with the [RMS], set a period not exceeding one month for the applicant to supply such information to the Member States, the Commission and [EFSA]. The [RMS] shall, within 60 days from the date of receipt of the additional information evaluate the information received and send its evaluation to [EFSA].
…’
31 Article 13 of Implementing Regulation No 844/2012, as amended by Commission Implementing Regulation (EU) 2018/1659 of 7 November 2018 (OJ 2018 L 278, p. 3), contains a new paragraph 3a, which provides:
‘For the purposes of assessment of the approval criteria set out in point 3.6.5 … of Annex II to Regulation (EC) No 1107/2009 as amended by Commission Regulation (EU) 2018/605, in relation to applications submitted in accordance with Article 1 before 10 November 2018, for which the draft renewal assessment report [“the RAR”] has been submitted but the conclusion by [EFSA] is not yet adopted by that date, where the information available in the dossier is not sufficient for [EFSA] to conclude the assessment on whether these approval criteria are met, [EFSA] shall, in consultation with the Member States, request from the applicant the additional information to be submitted to [the RMS], the other Member States, the Commission, and [EFSA] in the form of an updated supplementary dossier including the additional information. [EFSA] shall, in consultation with [the RMS] and the applicant, set a period for the submission of that information. Such period shall be at least of 3 months, shall not exceed 30 months, and shall be justified in relation to the type of information which has to be submitted.
…
Where additional information is submitted in accordance with the first … subparagraph within the period set for its submission, the [RMS] shall, within 90 days from the date of receipt of the additional information evaluate the information received and send its evaluation to [EFSA] in the form of a revised draft [RAR]. [EFSA] shall conduct a consultation on the revised draft [RAR] with all the Member States and the applicant in accordance with Article 12. [EFSA] shall adopt the conclusion referred to in paragraph 1, within 120 days from the date of receipt of the revised draft [RAR] …’
32 Article 14 of Implementing Regulation No 844/2012, entitled ‘Renewal report and renewal Regulation’, states, in paragraph 1, which was not amended by Implementing Regulation 2018/1659:
‘1. The Commission shall present to the [Standing] Committee referred to in Article 79(1) of Regulation (EC) No 1107/2009 a renewal report and a draft Regulation within six months from the date of receipt of the conclusion of [EFSA] …
The renewal report and the draft Regulation shall take into account the draft [RAR] of the [RMS], the comments referred to in Article 12(3) of this Regulation and the conclusion of [EFSA], where such a conclusion has been submitted.
The applicant shall be given the possibility to submit comments on the renewal report within a period of 14 days.’
33 Implementing Regulation 2018/1659 inserted into Article 14 of Implementing Regulation No 844/2012 paragraph 1a, the first subparagraph of which is worded as follows:
‘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 Regulation (EC) No 1107/2009 as amended by Commission Regulation (EU) 2018/605, in relation to applications for which the conclusion by [EFSA] is adopted before 10 November 2018, and where the Committee referred to in Article 79(1) of Regulation (EC) No 1107/2009 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 [EFSA] reassesses within a reasonable time period the available information and shall inform the applicant of that request.’
Regulation (EU) No 283/2013
34 Pursuant to Article 1 of Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ 2013 L 93, p. 1), the data requirements for the active substance provided for in Article 8(1)(b) of Regulation No 1107/2009 are to be set out in the annex to Regulation No 283/2013.
35 Point 1.9 of Part A of the annex to Regulation No 283/2013, entitled ‘Specification of purity of the active substance in g/kg’, provides, in the fourth paragraph, that ‘if the active substance is a mixture of isomers, the ratio or the ratio range of the content of isomers shall be provided’ and that ‘the relative biological activity of each isomer, both in terms of efficacy and toxicity, shall be reported’.
The Aarhus Regulation
36 Article 2(1)(g) of Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Union institutions and bodies (OJ 2006 L 264, p. 13), as amended by Regulation (EU) 2021/1767 of the European Parliament and of the Council of 6 October 2021 (OJ 2021 L 356, p. 1) (‘the Aarhus Regulation’), defines ‘administrative act’ as ‘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 …’.
37 Article 10 of the Aarhus Regulation, entitled ‘Request for internal review of administrative acts’, provides, in paragraph 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 … on the grounds that such an act or omission contravenes environmental law …’
38 Article 12 of that regulation, entitled ‘Proceedings before the Court of Justice’, provides, in paragraph 1:
‘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 the Treaty.’
Implementing Regulation 2021/2049
39 Recitals 4, 9, 11, 13, 15 and 16 of Implementing Regulation 2021/2049 are worded as follows:
‘(4) An application for the renewal of the approval of cypermethrin was submitted in accordance with Article 1 of Commission Implementing Regulation [No 844/2012] within the time period provided for in that Article.
…
(9) As regards the criteria to identify endocrine disrupting properties …, on the basis of the available scientific information summarised in the conclusion of [EFSA], the Commission considers that cypermethrin is not to be considered as having endocrine disrupting properties.
…
(11) The representative uses are spray applications outdoors, for which the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied provided that appropriate mitigation measures are taken to ensure the required protection level for aquatic organisms and non-targeted arthropods including bees. Therefore, it has been established with respect to one or more representative uses of at least one plant protection product containing cypermethrin that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied where appropriate conditions and restrictions according to Article 6 of Regulation (EC) No 1107/2009 are set.
…
(13) The Commission, however, considers that cypermethrin is a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. Given that cypermethrin is a mixture of eight isomers, and it contains a significant proportion of non-active isomers, it fulfils the condition set out in the fourth indent of point 4 of Annex II to Regulation (EC) No 1107/2009.
…
(15) In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to provide for certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information.
(16) In order to increase the confidence in the conclusion that cypermethrin does not have endocrine disrupting properties, the applicants should provide an updated assessment, in accordance with point 2.2(b) of Annex II to Regulation (EC) No 1107/2009, of the criteria laid down in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 …’
40 In the words of Article 1 of Implementing Regulation 2021/2049, ‘the approval of the active substance cypermethrin is renewed as set out in Annex I’. According to Article 2 of that implementing regulation, the annex to Implementing Regulation No 540/2011, as amended by Implementing regulation 2015/2105, is amended in accordance with Annex II to Implementing Regulation 2021/2049.
41 Annex I to that regulation provides that, when authorising plant protection products containing cypermethrin for spray applications outdoors, in order to ensure the protection of non-target organisms, in particular aquatic organisms and non-target arthropods, including bees, risk mitigation measures achieving reduction of drift are to be required that lead to exposure equal to or less than 5.8 mg/ha in off-crop areas.
Background to the dispute
42 The background to the dispute, which is set out in paragraphs 2 to 16 of the judgment under appeal, may be summarised as follows.
43 Cypermethrin is an insecticide of the pyrethroid family. That family of insecticides is widely used within the European Union in order to combat crop pests. Cypermethrin is highly toxic to insects.
44 In 2005, the Commission entered cypermethrin as an active substance in Annex I to Directive 91/414. Active substances in Annex I are deemed to be approved under Regulation No 1107/2009 and are included in Annex A, Part A to Implementing Regulation N 540/2011.
45 That approval was initially valid until 28 February 2016. Owing to significant delays in the review and decision-taking process, however, it was extended by one year, every year between 2017 and 2021.
46 In the context of the procedure for the renewal of the approval of cypermethrin, the RMS, in conjunction with the co-rapporteur Member State, drew up a draft RAR, which it communicated to EFSA and the Commission on 8 May 2017.
47 EFSA communicated the draft RAR to the applicants for renewal of approval and to the other Member States for comment and put it out to public consultation. It then forwarded the comments received to the Commission.
48 EFSA issued, on 31 July 2018, a scientific opinion entitled ‘Peer Review of the pesticide risk assessment of the active substance cypermethrin’ (‘the 2018 EFSA conclusion’), in which it identified four critical areas of concern.
49 As is apparent from that conclusion, EFSA identified one or more critical areas of concern in the following cases:
– if there is enough information available to perform an assessment for the representative uses in line with the uniform principles in accordance with Article 29(6) of Regulation No 1107/2009 and as set out in Commission Regulation (EU) No 546/2011 of 10 June 2011 Implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (OJ 2011 L 155, p. 127), and if that assessment does not permit the conclusion that, for at least one of the representative uses, it may be expected that a plant protection product (‘PPP’) containing the active substance will not have any harmful effect on human or animal health, the environment or groundwater, or any unacceptable influence on the environment;
– if the assessment at the higher tier level could not be finalised owing to lack of information, and if the assessment performed at the lower tier level does not permit the conclusion that, for at least one of the representative uses, it may be expected that a PPP containing the active substance will not have any harmful effect on human or animal health, the environment or groundwater, or any unacceptable influence on the environment; and
– if, in the light of current scientific and technical knowledge using guidance documents available at the time of application, the active substance is not expected to meet the approval criteria provided for in Article 4 of Regulation No 1107/2009.
50 As concerns cypermethrin, EFSA identified the following critical areas of concern:
– a high risk to aquatic organisms;
– a high risk to honeybees;
– a high off-field risk to non-target arthropods; and
– a lack of information concerning the composition of the batches of pesticides used in the ecotoxicity studies submitted by the applicants for approval, which did not allow EFSA to ensure that those batches of pesticides actually reflect representative uses of a PPP containing the active substance, for the purposes of Article 4(5) of Regulation No 1107/2009.
51 At the January 2019 meeting of the Standing Committee, the Commission presented a proposal for the renewal of approval limiting the use of cypermethrin to the autumn and winter seasons in order to protect bees and the aquatic environment, with risk mitigation measures reducing pesticide drift in the environment by 95%, to prevent harmful effects on the environment. Faced with the refusal of a majority of Member States to support a proposal for the renewal of approval with such limitations, the Commission requested EFSA to publish a statement on risk mitigation measures on cypermethrin.
52 On 16 September 2019, EFSA adopted a statement on risk mitigation measures on cypermethrin (‘the 2019 statement’). EFSA stated that only a risk mitigation measure reducing pesticide drift in the environment by more than 95% would allow a low risk to aquatic organisms to be concluded. It reached the same finding for non-target arthropods. EFSA also noted that available studies do not cover the use of cypermethrin in autumn. EFSA further considered that, in order to protect bees, the absence of flowering weeds in the crop, a ban on the spraying of flowering crops and a 54% reduction of drift would be sufficient and that a low risk level could be concluded.
53 Following numerous meetings of the Standing Committee, the Commission on 24 November 2021 adopted Implementing Regulation 2021/2049, whereby it renewed the approval of the active substance cypermethrin. That renewal, however, was accompanied by a set of specific provisions set out in Annex I to that regulation.
54 On 20 January 2022, in accordance with Article 10(1) of the Aarhus Regulation, the appellant made a request to the Commission for an internal review of Implementing Regulation 2021/2049 with a view to securing its repeal or its replacement by a regulation rejecting the application for renewal of the approval of cypermethrin. In that request, the appellant set out the reasons why it considers that that implementing regulation is contrary to the precautionary principle and the obligation for the European Union to ensure a high level of protection of human health and the environment, as given concrete form, so far as PPPs are concerned, by Regulation No 1107/2009, in particular in Article 4 thereof.
55 On 18 February 2022, the Commission requested EFSA to provide technical and scientific assistance with respect to all the relevant scientific elements put forward in the request for an internal review. In answer to that request, EFSA published on 15 March 2022 a technical report limited to examining a single objection raised by the appellant, that relating to the failure to take certain studies from the independent literature into account when examining the endocrine disruption property of cypermethrin.
56 By email of 18 July 2022, the Commission communicated to the applicant a copy in French of the decision at issue, to which an annex setting out the grounds for rejecting the request for an internal review was attached.
The proceedings before the General Court and the judgment under appeal
57 By application lodged at the Registry of the General Court on 31 August 2022, the appellant brought an action for annulment of the decision at issue.
58 In support of its action, the appellant relied on a single plea in law, divided into two parts, alleging breach of the precautionary principle and of the obligation for the European Union to ensure a high level of protection for human health and of the environment, as provided for in Articles 9 and 11, Article 168(1) and Article 191(1) TFEU and in Articles 35 and 37 of the Charter of Fundamental Rights of the European Union, as given concrete form, so far as PPPs are concerned, by Regulation No 1107/2009, in particular in Article 4 thereof.
59 By the judgment under appeal, the General Court rejected both parts of that single plea and dismissed the action in its entirety.
Forms of order sought
60 The appellant claims that the Court should:
– set aside the judgment under appeal;
– give judgment in the matter and, granting the form of order submitted by the appellant at first instance, annul the decision at issue; and
– order the Commission to pay the costs of both sets of proceedings.
61 The Commission contends that the Court should:
– dismiss the appeal; and
– order the appellant to pay the costs.
The appeal
62 In support of its appeal, the appellant raises five grounds of appeal. The first ground of appeal alleges failure to take the critical areas of concern identified by EFSA into account. The second ground of appeal alleges failure to have regard to scientific criteria for the determination of the endocrine disrupting properties. The third ground of appeal alleges failure to take the other data gaps identified by EFSA into account. The fourth ground of appeal alleges that confirmatory requests, in particular the second and third requests for confirmatory information, constituted an abuse. Last, the fifth ground of appeal alleges failure to examine the long-term toxicity of the representative formulation submitted by the applicant for renewal of approval.
63 It is appropriate to examine first of all the first ground of appeal, then the second ground of appeal together with the second part of the fourth ground of appeal, since both relate to the General Court’s assessment concerning the analysis relating to the absence of endocrine disrupting properties of cypermethrin. Next, it is appropriate to examine the first part of the fourth ground of appeal, the third ground of appeal and, last, the fifth ground of appeal.
The first ground of appeal: failure to take the critical areas of concern identified by EFSA into account
64 The first ground of appeal consists of three parts. The first part alleges an error of law, breach of the obligation to state reasons and distortion of the evidence, vitiating the General Court’s assessment of the critical area of concern relating to the lack of information on the representativity of the batches used. The second part alleges a contradiction in the reasoning and an error of law vitiating the General Court’s assessment of the critical area of concern relating to the high risk for aquatic organisms. Last, the third part alleges breach of the obligation to state reasons, a contradiction in the reasoning, an error of law and distortion of the evidence, vitiating the General Court’s assessment of the critical area of concern relating to the high risk for non-target arthropods.
The first part of the first ground of appeal: an error of law, breach of the obligation to state reasons and distortion of the evidence vitiating the General Court’s assessment of the critical area of concern relating to the lack of information on the representativity of the batches used
– Arguments of the parties
65 As a preliminary point, the appellant observes, generally, that, as is apparent from the General Court’s assessments in paragraphs 91 to 93 and 104 of the judgment under appeal, it follows from the precautionary principle that underpins Regulation No 1107/2009 that the Commission, in its capacity as risk manager, cannot renew the approval of an active substance for which, as in the present case, EFSA has identified critical areas of concern, unless risk mitigation measures make it possible, actually and not theoretically, and in a scientifically validated manner, to reduce the risk to an acceptable level, allowing the harmful effects on human health or the unacceptable effects on the environment to be precluded.
66 It follows, in the appellant’s submission, that where a critical area of concern has been identified by EFSA, the Commission is required to ensure that realistic and scientifically founded risk mitigation measures allow those risks to be reduced to an acceptable level.
67 In particular, the appellant maintains that, in its 2018 conclusion, EFSA had identified four critical areas of concern, including that relating to the lack of information about the representativity of the batches used in the ecotoxicological studies, which the Commission nonetheless deemed not to constitute an obstacle to the renewal of the approval of cypermethrin. The appellant claims that, although the General Court set out, in paragraphs 92, 93 and 104 of the judgment under appeal, the conditions under which an active substance may be renewed in spite of the fact that the risk assessment concerning that substance had made it possible to identify several critical areas of concern, it did not ascertain, in paragraphs 129 to 188 of that judgment, whether the grounds on which the Commission had precluded the existence of harmful effects for human health or unacceptable effects for the environment allowed the identified risk to be reduced to an acceptable level.
68 In that regard, first, the appellant claims that the General Court wrongly reversed the burden of proof when it stated, in paragraph 146 of the judgment under appeal, that it was for the party requesting an internal review of an administrative act to indicate the factors that made it possible to doubt the assessment made by the institution which had adopted that act. In the appellant’s contention, it was in fact for the Commission, and not for the person requesting an internal review, to show that it had responded, in Implementing Regulation 2021/2049 or, at the latest, in the decision at issue, to the critical area of concern identified by EFSA, by adopting risk mitigation measures that were both effective and scientifically validated. The General Court was therefore wrong when, in paragraphs 134, 147 and 158 of that judgment, reversing the burden of proof, it rejected as ‘contextual’, ‘vague’, ‘speculative’ and ‘unsubstantiated’ the arguments which the appellant had raised at first instance.
69 Second, the appellant maintains that, in paragraphs 147, 148 and 154 of the judgment under appeal, the General Court does not explain how the assertion that it was unlikely that the RMS had carried out checks of equivalence between, on the one hand, the technical material (namely the active substance and its impurities) used for the tests in support of the first approval and, on the other hand, the current technical specification was ‘vague’ and ‘speculative’, since the precise composition of the original technical material is not known. A similar breach of the obligation to state reasons and a distortion of the evidence are apparent from paragraphs 148 and 163 to 165 of the judgment under appeal, relating to the impurities, their relevance and their genotoxic potential. In addition, in paragraph 157 of the judgment under appeal, the General Court does not respond to the appellant’s argument that the existence of neurotoxicity and toxicity tests for reproduction and development is of no relevance in the assessment of the genotoxic potential of the current technical specification. Furthermore, in paragraphs 160 and 167 to 172 of the judgment under appeal, the General Court wrongly rejected the argument whereby the appellant maintained that the assertion of the RMS, repeated by the Commission, that the problem might be resolved at Member State level when marketing authorisations were issued or in the next procedure for the renewal of approval, was contrary to Article 4(5) of Regulation No 1107/2009.
70 The appellant further submits, in its reply, that the assertions of the RMS, even on the assumption that they are well founded, cannot constitute risk mitigation measures and cannot result in the rejection of the risk assessment carried out by EFSA, which has the final word in that respect, in accordance with Article 12 of Regulation No 1107/2009 and with the principle of excellence and independence of the scientific assessment which underpins the precautionary principle, especially since the RMS is in principle chosen by the applicant for renewal of approval.
71 Third, the appellant maintains that the assertion, made by the General Court in paragraphs 163 to 165 of the judgment under appeal, that EFSA found, after issuing its conclusion, that no impurity other than hexane would be considered relevant from a toxicologic viewpoint, is based on a distortion of the evidence, since there is no indication whatsoever in the file that EFSA adopted such a position.
72 The Commission disputes those arguments.
73 It contends, first of all, generally, that the fact that EFSA has identified one or more critical areas of concern does not necessarily mean that the active substance does not satisfy the approval criteria referred to in Article 4 of Regulation No 1107/2009.
74 Next, it states that, as explained in paragraphs 12, 96, 105, 112, 113, 193 and 227 of the judgment under appeal, which are not disputed by the appellant, the Commission relied on the 2019 EFSA statement in order to ensure that the critical areas of concern did not constitute an obstacle to the renewal of the approval of cypermethrin. It was therefore on a scientifically validated basis that the Commission satisfied itself that the risk mitigation measures were realistic and well founded.
75 Last, as regards more specifically the critical area of concern relating to the representativity of the batches used, as is apparent from paragraphs 136 to 144 of the judgment under appeal, which are not disputed by the appellant, and from paragraphs 168 to 172 of that judgment, the Commission relied on both the independent and objective assessment by the RMS and also on other factors in order to satisfy itself that the renewal of the approval of cypermethrin could be granted.
76 First, the appellant’s argument against paragraph 146 of the judgment under appeal is based on a misreading of that paragraph. The General Court did not reverse the burden of proof, but merely stated that it was for the party requesting an internal review of an administrative act based on environmental law to indicate the facts or the significant legal arguments that might give rise to ‘plausible doubts’ about the assessment carried out by the EU institution in the contested administrative act.
77 Second, as regards the reasoning set out in paragraphs 134, 147 and 158 of the judgment under appeal, the appellant merely reiterates before the Court the assertions which it made at first instance.
78 Third, the Commission observes, first, as regards the appellant’s arguments directed against paragraphs 164 and 165 of the judgment under appeal, that the General Court’s findings are based not on the 2018 EFSA conclusion, but on information obtained following contacts with EFSA and the RMS during the risk management procedure, that is to say, after that conclusion was published.
79 Furthermore, as regards the findings of the General Court set out in paragraphs 160 and 169 to 172 of the judgment under appeal, the Commission observes that the General Court did not reject the appellant’s argument on the sole ground that EFSA had considered that cypermethrin was not expected to be genotoxic. It also relied on the ground, set out in paragraph 170 of that judgment and not disputed by the appellant, that an assessment of the genotoxicity of the manufactured active substance had been carried out, in the sense that the material formed by that active substance and the impurities had been tested and that, moreover, an examination of each impurity had been undertaken in order to determine the toxicologic relevance, in view of the need to set specific limits in the material.
– Findings of the Court
80 It must be recalled, first, that under Article 10(1) of the Aarhus Regulation, any non-governmental organisation that meets the criteria set out in Article 11 of that regulation may make a request, in writing and by stating reasons, for an internal review to the Union institution or body that adopted it under environmental law. Article 2(1)(g) of that regulation defines, in that respect, ‘administrative act’ as 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. Where the administrative act relates, as in the present case, to the renewal of the approval of an active substance as a candidate for substitution, in application of Article 20(1) and Article 24(1) of Regulation No 1107/2009, the request for internal review relates to the reassessment of that renewal (see, to that effect, judgment of 3 September 2020, Mellifera v Commission, C‑784/18 P, EU:C:2020:630, paragraph 63 and the case-law cited).
81 The purpose of the request for an internal review of an administrative act is therefore to obtain a declaration that the contested administrative act is unlawful or unsubstantiated (see, to that effect, judgment of 3 September 2020, Mellifera v Commission, C‑784/18 P, EU:C:2020:630, paragraph 64 and the case-law cited).
82 It is inherent in that internal review procedure that the party requesting a review provides concrete and precise grounds which might be able to call into question the assessments on which that administrative act is based. In that regard, as the General Court rightly observed in paragraphs 42 and 146 of the judgment under appeal, in order to state in the manner required the grounds for conducting the review, the party requesting the review is required to put forward the facts or legal arguments of sufficient substance to give rise to ‘serious doubts’ as to the assessment made in the contested act by the EU institution or body (see, to that effect, judgments of 12 September 2019, TestBioTech and Others v Commission, C‑82/17 P, EU:C:2019:719, paragraphs 68 and 69, and of 6 October 2021, ClientEarth v Commission, C‑458/19 P, EU:C:2021:802, paragraph 60).
83 Where, as in the present case, the request for internal review is refused by the competent EU institution or body, the person making the request may, in accordance with Article 12 of the Aarhus Regulation, read in conjunction with Article 10 thereof, institute proceedings before the Courts of the European Union on grounds of lack of competence, breach of an essential procedural requirement, infringement of the Treaties or of any rule of law relating to their application, or misuse of powers, against the decision refusing the request as unfounded (see, to that effect, judgment of 12 September 2019, TestBioTech and Others v Commission, C‑82/17 P, EU:C:2019:719, paragraph 38).
84 In the context of that action, it is for the party making the request to put forward the pleas in law and arguments capable of demonstrating that the decision whereby that EU institution or body refused that request for internal review was vitiated by an error of law or an error of assessment (see, to that effect, judgment of 6 October 2021, ClientEarth v Commission, C‑458/19 P, EU:C:2021:802, paragraphs 49 to 51).
85 In the light of the case-law to which reference has just been made in paragraphs 83 and 84 of the present judgment, it should be stated that the appellant misreads paragraphs 134, 147 and 158 of the judgment under appeal, in which the General Court, without ruling on the burden of proof, merely assessed the arguments submitted to it, describing some of them as ‘vague’, ‘contextual’ or ‘speculative’, and then rejecting them as ineffective or unsubstantiated, where one or more critical areas of concern were identified. As for paragraph 146 of the judgment under appeal, the General Court merely referred to the case-law of the Court cited in paragraph 82 of the present judgment.
86 Second, the Court must examine the arguments which the appellant directs against paragraphs 147, 148, 154, 157, 160, 163 to 165 and 172 of the judgment under appeal, whereby the General Court upheld the Commission’s finding that the lack of information about the representativity of the batches used in the ecotoxicological studies, identified in the 2018 EFSA conclusion as a critical area of concern, did not prevent the genotoxic and ecotoxic potential of the specification proposed by the applicants for renewal of the approval of cypermethrin from being excluded.
87 In the first place, it should be borne in mind that, under Article 14(1) of Regulation No 1107/2009, the approval of an active substance is to be renewed, on application, where the approval criteria provided for in Article 4 of that regulation are satisfied.
88 According to Article 4(1) of that regulation, an active substance is to be approved in accordance with Annex II to that regulation 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 Annex II, PPPs containing that active substance meet the requirements provided for in paragraphs 2 and 3 of Article 4, namely where those products or their residues do not have, in particular, any harmful effects on human health or animal health and do not have any unacceptable effect on the environment.
89 It follows from Article 14 of Regulation No 1107/2009, read in conjunction with paragraphs 2 and 3 of Article 4 thereof, entitled ‘Procedure and criteria for the approval of active substances, safeners and synergists pursuant to Chapter II’, that, where the Commission is required to determine an application for renewal of the approval of an active substance, it must carry out a risk assessment, including, pursuant to points 3.6.2 to 3.6.4 of Annex II, tests of genotoxicity, carcinogenicity or reproductive toxicity and also tests of ecotoxicology referred to in point 3.8 of Annex II (see, to that effect, judgment of 22 June 2023, Arysta LifeScience Great Britain v Commission, C‑259/22 P, EU:C:2023:513, paragraph 130).
90 In that regard, as follows from the provisions of that regulation, the EU legislature chose to entrust the scientific assessment of the risks of an active substance to both the RMS and EFSA.
91 First of all, in accordance with Article 11(1) and (2) of that regulation, a Member State which receives an application for approval or for renewal of the approval of an active substance must, in the context of the RAR, undertake an independent, objective and transparent assessment of that application in the light of current scientific and technical knowledge, in order to assess whether the active substance can be expected to satisfy the approval criteria set out in Article 4 of that regulation (see, to that effect, judgment of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraphs 66 and 67).
92 Next, in accordance with Article 12(2) of Regulation No 1107/2009, read in conjunction with recital 12 thereof, EFSA is to adopt its conclusion on that active substance in the light of current scientific and technical knowledge, thus stating whether that active substance can be expected to satisfy the approval criteria set out in Article 4 of that regulation.
93 Last, pursuant to Article 13(1) of Regulation No 1107/2009, the Commission is to present a review report and a draft regulation ‘taking into account’ both the draft RAR prepared by the RMS and the conclusion adopted by EFSA.
94 Thus, contrary to the appellant’s assertions set out in paragraph 70 of the present judgment, the provisions of Regulation No 1107/2009 do not give EFSA ‘the last word’ on risk assessment. On the contrary, they require the Commission to take EFSA’s conclusion into account on the same basis as the draft RAR issued by the RMS. The General Court was therefore correct to consider, in paragraph 90 of the judgment under appeal, that the obligation for the Commission to take those documents into account cannot be interpreted as an obligation for it to follow on all points the conclusion adopted by EFSA or the report of the RMS.
95 In the second place, it must be held that the provisions of Regulation No 1107/2009 do not specify the way in which the Commission must determine the matter when the assessments carried out, respectively, by the RMS and by EFSA diverge.
96 In such a situation, it is for the Commission, which has a broad discretion, to carry out complex scientific and technical assessments, while review by the Courts of the European Union must be limited to ascertaining whether the procedural rules have been complied with, whether the facts have been accurately stated and whether there has been a manifest error of assessment or misuse of powers or whether there has been a failure to fulfil the obligation to state reasons (see, to that effect, judgments of 18 July 2007, Industrias Químicas del Vallés v Commission, C‑326/05 P, EU:C:2007:443, paragraph 76, and of 9 December 2021, Agrochem-Maks v Commission, C‑374/20 P, EU:C:2021:990, paragraphs 53 and 54).
97 In the latter respect, where the institutions have such a power of appraisal, respect for the guarantees which the EU legal order attaches to the conduct of administrative procedures is of particular importance. Those guarantees include, in particular, the duty of the competent institution to examine carefully and impartially all the relevant aspects of the individual case and the duty to provide an adequate statement of reasons for its decision. Only in those circumstances can the Courts of the European Union review whether the factual and legal elements on which the exercise of the power of appraisal depends were duly taken into account (see, to that effect, judgments of 21 November 1991, Technische Universität München, C‑269/90, EU:C:1991:438, paragraph 14; of 6 November 2008, Netherlands v Commission, C‑405/07 P, EU:C:2008:613, paragraph 56; and of 22 June 2023, Arysta LifeScience Great Britain v Commission, C‑259/22 P, EU:C:2023:513, paragraph 46).
98 In carrying out that review, the General Court must state the reasons on which its decision is based and clearly and unequivocally disclose the reasoning followed, so that the persons concerned can be apprised of the justification for the decision taken and so that the Court of Justice can exercise its power of review (see, to that effect, judgments of 29 April 2021, Achemos Grupė and Achema v Commission, C‑847/19 P, EU:C:2021:343, paragraph 60, and of 4 October 2024, UPL Europe and Indofil Industries (Netherlands) v Commission, C‑262/23 P, EU:C:2024:862, paragraph 132).
99 The obligation on the General Court to state reasons for its decisions, under Article 36 and the first paragraph of Article 53 of the Statute of the Court of Justice of the European Union, does not require it to provide an account that follows exhaustively and one by one all the arguments put forward by the parties to the dispute. The reasoning may therefore, according to settled case-law, be implicit, on condition that it enables the persons concerned to know the grounds of the General Court’s decision and provides the Court of Justice with sufficient material for it to exercise its power of review (judgment of 4 October 2024, UPL Europe and Indofil Industries (Netherlands) v Commission, C‑262/23 P, EU:C:2024:862, paragraph 133 and the case-law cited).
100 In the present case, first of all, the General Court observed, in paragraph 9 of the judgment under appeal, that it followed from the 2018 EFSA conclusion that, among the four critical areas of concern identified by EFSA, one of those areas related to the lack of knowledge concerning the composition of the batches of pesticides used in the ecotoxicity studies submitted by the applicants for approval, which did not permit EFSA to ensure that those batches of pesticides actually reflected representative uses of a PPP containing the active substance, for the purposes of Article 4(5) of Regulation No 1107/2009.
101 As has already been observed in paragraph 49 of the present judgment, and as is apparent from paragraph 8 of the judgment under appeal, EFSA identifies a critical area of concern where, depending on the circumstances, the assessment of the substance at issue does not permit the conclusion that, for at least one of the representative uses, it may be expected that a PPP containing the active substance will not have any harmful effect on human or animal health, the environment or groundwater or any unacceptable effects on the environment or where, in the light of current scientific and technical knowledge using guidance documents available at the time of application, the active substance is not expected to meet the approval criteria provided for in Article 4 of Regulation No 1107/2009.
102 It is for that reason, as the General Court stated, in essence, in paragraphs 92 and 93 of the judgment under appeal, that where the risk assessment leads to the identification of critical areas of concern, the Commission cannot, as a rule, depart from the results of such an assessment, without being in breach of the precautionary principle, unless it is adequately demonstrated that, notwithstanding the identification of such critical areas of concern, risk mitigation measures support the conclusion that the criteria of Article 4(1) to (3) of Regulation No 1107/2009 are fulfilled.
103 In that regard, it follows from paragraphs 143, 147, 148 and 154 of the judgment under appeal that, in order to reject the appellant’s argument based on the critical area of concern identified by EFSA and referred to in paragraph 100 of the present judgment, the General Court relied, as the Commission had done in the decision at issue, on the fact that the RMS had confirmed, in an email of 2019, that, in spite of the data gap, a number of checks of equivalence carried out in the context of the draft RAR had made it possible to establish equivalence between the technical material used at the time of the first approval and that used at the time of the renewal procedure, and that the data gap could be overcome either at zonal or national level or on the occasion of the next renewal.
104 In so deciding, the General Court did not state the reasons why it was necessary to give priority to the position of the RMS over that of EFSA, even though EFSA had identified a critical area of concern taking into account the position of the RMS on the representativity of the batches in the draft RAR, nor did it identify risk mitigation measures that would have allowed the Commission, in accordance with the rules set out by the General Court in paragraphs 92 and 93 of the judgment under appeal, referred to in paragraph 102 of the present judgment, to depart from a risk assessment that identified a critical area of concern.
105 In addition, the ground set out in paragraph 139 of the judgment under appeal, that various provisions of Regulation No 1107/2009 ‘reflect the choice of the [EU] legislature to give weight, on sundry occasions, to an independent and objective assessment by the experts of the Member States’, does not compensate for the insufficiency of the reasoning in paragraphs 147, 148 and 154 of the judgment under appeal.
106 Apart from the fact that the General Court does not clearly identify the provisions of Regulation No 1107/2009 that serve as the basis of its assessment, the reasoning set out in paragraphs 148 and 154 of the judgment under appeal relies on extracts from the decision at issue based not on an assessment by the experts of the Member States but on the draft RAR and on an email from the RMS alone. The 2018 EFSA conclusion is also based on assessments by the experts of the Member States and, as stated in paragraph 92 of the present judgment, constitutes an independent scientific risk assessment. It is therefore comparable to the draft RAR of the RMS, especially since it identifies one or more critical areas of concern, as in the present case.
107 Accordingly, as the appellant has correctly asserted, it must be held that paragraphs 147, 148 and 154 of the judgment under appeal are vitiated by insufficient reasoning.
108 Next, as regards the complaints whereby the appellant alleges breach of the obligation to state reasons and distortion of the evidence, which are directed against paragraphs 148 and 163 to 165 of the judgment under appeal, concerning the nature of the impurities present in the active substance and their genotoxic properties, it should be borne in mind that, in paragraph 148 of that judgment, the General Court endorsed the Commission’s position, set out in the decision at issue, that the increase in the level of minimum purity of the active substance according to the new specification chosen (920 g/kg instead of 900 g/kg in the initial reference specification) means, in itself, lower impurity levels by comparison with the situation prevailing at the time of the first approval of the active substance. In paragraphs 164 and 165 of that judgment, moreover, the General Court considered, in essence, referring to paragraphs 142 and 143 of that judgment, that the Commission had been correct to find, on the basis of the contacts with EFSA and the RMS, that is to say, after the 2018 EFSA conclusion had been issued, and with a view to obtaining further assurance, that no impurity other than hexane would be considered toxicologically relevant.
109 As regards the General Court’s statement, in paragraphs 164 and 165 of the judgment under appeal, that the Commission received further assurance, following contacts with the RMS after the 2018 EFSA conclusion had been issued, that, other than hexane, no impurity would be considered toxicologically relevant, it should be pointed out, first, that although paragraph 143 of that judgment refers to the 2019 email from the RMS, which postdates the EFSA conclusion, by that email the RMS, as the General Court explained in paragraph 142 of that judgment, is merely clarifying its own assessment set out in the draft RAR, which predated the EFSA conclusion. In any event, it is not apparent from the wording of that email, cited in paragraph 143 of the judgment under appeal, that the RMS ruled on the toxicological relevance of impurities other than hexane, as that email refers only to a ‘global assessment’ of impurities.
110 Furthermore, as regards ‘[the Commission’s] contacts with EFSA’, referred to in paragraph 164 of the judgment under appeal, neither paragraph 142 nor paragraph 143 of the judgment under appeal refers to such ‘contacts with EFSA’ after the EFSA conclusion had been issued, on the question of impurities, other than hexane, contained in the active substance. Nor did the General Court provide any explanation of the form in which such contacts between the Commission and EFSA took place, subsequent to that conclusion and supposedly referred to in the decision at issue.
111 While it is true, as the General Court observed in paragraph 165 of the judgment under appeal, that the Commission stated in the decision at issue that EFSA had ‘confirmed’ that, with the exception of hexane, no impurity would be considered toxicologically relevant, it is sufficient to state that the General Court did not explain, even succinctly, on which EFSA study or document the Commission had relied.
112 It follows from the decision at issue, as the Advocate General observed, in essence, in points 190 and 204 of her Opinion, that the identification of the critical area of concern in the 2018 EFSA conclusion, in conjunction with the representativity of the batches used, is not based on the fact that, as regards the new technical specification, impurities other than hexane were not relevant. On the contrary, the identification of that critical area of concern is expressly based on the fact that the analyses of quantitative structure-activity relationship had been provided for the other impurities, although they were not sufficient to preclude at least a genotoxic potential (data gap) and that, consequently, the assessment of the toxicological relevance of those impurities could not be finalised, especially for the examination of toxicity with respect to mammals and the environment.
113 It was therefore for the General Court to ascertain that the Commission had fulfilled its obligation to examine, carefully and impartially, the aspects of the particular case and that the dossier enabled it to substantiate its assertion that EFSA had ‘confirmed’ that, with the exception of hexane, no impurity would be considered relevant from a toxicological viewpoint, relying at least on a study or on a specific document drawn up by EFSA that was amenable to judicial review.
114 Consequently, as the appellant correctly maintained, the assessment carried out by the General Court, set out in paragraphs 164 and 165 of the judgment under appeal, is vitiated by both insufficient reasoning and distortion of the evidence relating to the further assurance obtained by the Commission concerning the absence of toxicological relevance of the impurities other than hexane.
115 The same applies to the General Court’s finding, in paragraph 172 of the judgment under appeal, which repeats, in identical terms, the errors made in paragraphs 164 and 165 of that judgment.
116 It should be added that the finding set out in the 2018 EFSA conclusion, referred to in paragraph 112 of the present judgment, has its origin in the fact, referred to in the decision at issue, that the batches of pesticides used by the applicants for renewal of the approval of the active substance contained ‘new impurities’ by comparison with the reference material used in support of the first approval.
117 As the appellant has claimed, the General Court could not merely adopt the Commission’s finding, contained in the decision at issue and cited in paragraph 148 of the judgment under appeal, that ‘is has been shown that the new material was of greater purity, which indicates in itself lower impurity levels by comparison with the previous situation’.
118 First, it is apparent from the 2018 EFSA conclusion that EFSA found a data gap concerning those new impurities other than hexane, which made it impossible to assess their toxicity and, consequently, their degree of harmfulness.
119 Second, apart from a reference to the email from the RMS, with respect to which it was stated, in paragraph 109 of the present judgment, that it did not make it possible to determine whether that RMS had ruled on the toxicological relevance of the impurities other than hexane, the General Court did not ascertain or indicate the scientific risk assessments forming the basis of the Commission’s assertion reproduced in paragraph 148 of the judgment under appeal.
120 It follows that paragraph 148 of the judgment under appeal, which merely reproduces the wording of the decision at issue, is vitiated by insufficient reasoning.
121 Last, by the argument which it directs against paragraph 157 of the judgment under appeal, the appellant takes issue with the General Court for having failed to fulfil its obligation to state reasons when it relied on the reasoning, set out in the decision at issue, that ‘the genotoxicity of cypermethrin had to be viewed as unlikely’, although that reasoning did not address the line of argument which the appellant had set out in its action for annulment before the General Court. The appellant then maintained that the decision at issue did not explain how the tests for neurotoxicity, development toxicity and reproduction toxicity, relating to the updated specification of the active substance, could take into account EFSA’s concerns relating to the fact that, owing to the data gap, it was impossible to exclude at least the genotoxic potential of the impurities.
122 In that regard, as the Advocate General observes, in essence, in point 205 of her Opinion, the critical area of concern identified in the 2018 EFSA conclusion related to the data gap concerning not the genotoxic properties of the active substance as such but, at least, the genotoxic potential of the impurities.
123 Consequently, having relied, in paragraph 157 of the judgment under appeal, on the fact that, in that conclusion, the genotoxicity of cypermethrin had been considered to be unlikely, the General Court did not respond to the requisite legal standard to the appellant’s argument relating to the genotoxic potential of the impurities.
124 The General Court did not state the reasons why the studies of reproduction and development toxicity and of neurotoxicity were capable of addressing the concern, identified by EFSA, that the data gap concerning the impurities did not allow at least their potential genotoxicity to be excluded.
125 In fact, such an indication was all the more necessary because the assessment of toxicity and that of genotoxicity, and the results deriving from them, should not be confused and are not substitutable. Annex II to Regulation No 1107/2009 distinguishes, unambiguously, for the purposes of the assessment of the criteria that must be satisfied by an active substance for the purposes of its approval or of the renewal of its approval in accordance with Article 4 of that regulation, between, on the one hand, the assessment of genotoxicity testing, within the meaning of point 3.6.2 of Annex II, which must be able to preclude that substance from being or having to be classified, in accordance with the provisions of Regulation No 1272/2008, as mutagen category 1A or 1B and, on the other, the assessment of reproductive toxicity testing, within the meaning of point 3.6.4 of Annex II, which must be able to preclude that active substance from being or having to be classified, in accordance with Regulation No 1272/2008, as toxic for reproduction 1A or 1B.
126 It follows that, as the appellant has correctly maintained, paragraph 157 of the judgment under appeal is vitiated by insufficient reasoning.
127 The same applies with respect to paragraph 160 of the judgment under appeal, whereby the General Court considered, reiterating the 2018 EFSA conclusion on that point, that ‘cypermethrin may be considered to be unlikely to be genotoxic on the basis of available studies’, although the appellant had argued, as stated in paragraph 159 of that judgment, that, in accordance with Article 4(5) of Regulation No 1107/2009, an active substance can be approved only if a representative use, and therefore a use with the impurities which it contains, is deemed to be consistent with the requirements of Article 4 of that regulation and that the data gap could not therefore be overcome at zonal or national level or on the occasion of a forthcoming renewal.
128 Furthermore, in the light of the foregoing considerations, from which it is apparent that the General Court’s finding relating to the data gap concerning the impurities of the material and their genotoxic potential is vitiated by insufficient reasoning and distortion of the evidence, the General Court’s finding in paragraph 170 of the judgment under appeal that the ‘material constituted by the active substance and the impurities is tested’ is therefore unfounded.
129 Also unfounded are the grounds set out in paragraphs 175 to 187 of the judgment under appeal, which relate mainly to the global risk assessment carried out by the Commission with respect to the principle of proportionality.
130 As is apparent from paragraph 176 of the judgment under appeal, the Commission disregarded the concerns identified in the 2018 EFSA conclusion relating to the ‘assurances provided by the RMS’ and the identification of hexane as the ‘only toxicologically relevant impurity’, in order to justify the adoption of risk mitigation measures.
131 The General Court, having provided insufficient reasons for rejecting the appellant’s argument seeking to call into question the Commission’s analysis relating to the critical area of concern identified by EFSA concerning the data gap relating to the composition of the batches of pesticides, rendered its assessment of the proportionate nature of the risk mitigation measures adopted by the Commission devoid of substance. The latter assessment also contradicts paragraph 92 of the judgment under appeal, in which the General Court rightly held that, where the risk assessment leads to the identification of critical areas of concern, the Commission cannot, as a rule, depart from the results of such an assessment, as otherwise it would breach the precautionary principle.
132 It follows that the first part of the first ground of appeal must be upheld.
The second part of the first ground of appeal: contradiction in the reasoning and an error of law vitiating the General Court’s assessment of the critical area of concern relating to the high risk for aquatic organisms
– Arguments of the parties
133 The appellant submits, first of all, that in the 2019 statement EFSA had considered that the risk for aquatic organisms identified in the 2018 EFSA conclusion could be reduced to an acceptable level only where two conditions were satisfied. First, the capacity for recovery of those organisms following contamination by pesticides had to be taken into account (methodology based on the ecological reinstatement option method; ‘the ERO methodology’). In that regard, the appellant submits that EFSA observed that the ERO methodology was not appropriate for applications of pesticide in autumn, in the absence of data on that subject, so that any spraying during that season had to be excluded. Second, EFSA pointed out that it was necessary to ensure that pesticide drift, that is to say, its dispersion beyond the area treated during or after spraying, was reduced by 98.7%, or even by 99.5%. In that respect, the appellant observes that EFSA recalled that such a measure meant a reduction of drift that was not merely theoretical but also higher than the ceiling of 95% set by the guidance documents followed in that respect.
134 Next, the appellant claims that, in paragraphs 196 and 200 of the judgment under appeal, the General Court rejected the argument which the appellant had set out in its action against the decision at issue concerning the fact that Implementing Regulation 2021/2049 does not prohibit the Member States from authorising cypermethrin in autumn and does not fix a maximum level of concentration in water, following reasoning that contradicts the grounds set out in paragraphs 92, 93 and 104 of that judgment. In the appellant’s submission, the General Court considered that the Commission may depart from EFSA’s clear and unequivocal conclusion that no realistic and scientifically validated risk mitigation measure had been identified by EFSA or fixed in Implementing Regulation 2021/2049. That reasoning also fails to have regard to Article 4 of Regulation No 1107/2009, under which approval of an active substance is subject to proof of the absence of an unacceptable effect on the environment, and constitutes an error of law in the application of the precautionary principle. Furthermore, as regards the General Court’s finding in paragraph 200 of the judgment under appeal that the Member States could face an action at national level if they granted marketing authorisations for PPPs containing an active substance in breach of the requirements laid down in Implementing Regulation 2021/2049, the appellant claims that the indications contained in the Commission’s renewal report are too vague and general to substantiate an action at national level against such authorisations.
135 Last, the appellant maintains that, in rejecting, in paragraphs 210 to 217 of the judgment under appeal, its argument against the Commission’s use of the ERO methodology on the basis of the EFSA guidance, entitled ‘Guidance on tiered risk assessment for plant protection products for aquatic organisms in edge-of-field surface waters’, a document which, in the appellant’s view, has many limits, the General Court made a number of errors of law.
136 First, the appellant takes issue with the General Court for having declared, in paragraph 216 of the judgment under appeal, that its argument that the ERO methodology was required to comply with the EU legislation on water was inadmissible, on the ground that it was not raised at the stage of the request for internal review. The appellant observes that that element was set out in the application before the General Court to challenge the Commission’s assertion, put forward for the first time in the decision at issue, that the fixing of a concentration limit on the basis of the ERO methodology was consistent with the EFSA guidance. Therefore, in the appellant’s view, that argument had a sufficiently close link with the pleas in law and complaints initially put forward to be regarded as resulting from the normal development of the discussion in contentious proceedings.
137 Second, the appellant claims that the ground set out in paragraph 217 of the judgment under appeal – that the appellant sought to call into question, in a vague and general manner, scientific assessments which the General Court cannot review in an action against the decision at issue – contradicts the case-law of the Court of Justice, in particular paragraph 47 of the judgment of 9 March 2023, PlasticsEurope v ECHA (C‑119/21 P, EU:C:2023:180), according to which review of the legality of a Commission act based on an assessment by a scientific authority must lead to review, even if limited to review of a manifest error of assessment, of that assessment itself.
138 The Commission contends that the second part of the first ground of appeal is unfounded.
– Findings of the Court
139 In the first place, in so far as, by the second part of the first ground of appeal, the appellant disputes the findings of the General Court in paragraphs 196 and 200 of the judgment under appeal, it must be held, first, that the appellant’s argument rests on an incorrect interpretation of the facts, in that it maintains that EFSA considered it necessary to preclude all use of cypermethrin in autumn. In fact, it follows expressly from paragraph 196 of the judgment under appeal that EFSA did not ‘impose’ such a restriction, but merely observed that there was a data gap in respect of those uses, in particular with regard to aquatic organisms. By its argument, the appellant therefore seeks to call into question the finding of the facts and assessment of the evidence by the General Court.
140 In that regard, it should be borne in mind that, in accordance with Article 256(1) TFEU and the first paragraph of Article 58 of the Statute of the Court of Justice of the European Union, an appeal lies on points of law only. The General Court has exclusive jurisdiction to find and appraise the relevant facts and to assess the evidence. The appraisal of those facts and the assessment of that evidence is not, therefore, save where they have been distorted, a point of law which is subject, as such, to review by the Court of Justice on appeal (judgment of 4 October 2024, UPL Europe and Indofil Industries (Netherlands) v Commission, C‑262/23 P, EU:C:2024:862, paragraph 148 and the case-law cited).
141 Since the appellant does not argue that the General Court, in adjudicating as it did in paragraph 196 of the judgment under appeal, distorted the facts or the evidence, its complaint directed against that paragraph must be declared inadmissible.
142 Second, although the appellant disputes the appraisal in the second sentence of paragraph 200 of the judgment under appeal, concerning the possibility of bringing an action before the national courts in the event of a breach by the Member States of the obligation to comply with the conditions of use laid down in Implementing Regulation 2021/2049, it should be noted that it does not call into question the general assertion, in the first sentence of paragraph 200, that the Member States cannot approve the use of cypermethrin outside the conditions of use laid down in that implementing regulation.
143 As the second sentence of paragraph 200 is introduced by the expression ‘on the assumption that’, the appellant’s complaint is directed at a ground of the judgment under appeal included for the sake of completeness, which, in accordance with settled case-law, cannot result in the judgment under appeal being set aside and can only be rejected as ineffective (see, to that effect, judgment of 10 November 2022, Laboratoire Pareva v Commission, C‑702/21 P, EU:C:2022:870, paragraphs 52 and 58 and the case-law cited).
144 Consequently, the complaints which the appellant directs against paragraphs 196 and 200 of the judgment under appeal must be rejected as inadmissible in part and ineffective in part.
145 In the second place, as regards the appellant’s complaints relating to paragraphs 216 and 217 of the judgment under appeal, it must be held that they are unfounded.
146 First, the General Court, in accordance with the judgment of 12 September 2019, TestBioTech and Others v Commission (C‑82/17 P, EU:C:2019:719, paragraph 39), rightly stated, in paragraph 216 of the judgment under appeal, that the appellant’s argument alleging a breach by the Commission of the values fixed in the water regulations, in particular in Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ 2000 L 327, p. 1), was inadmissible on the ground that that argument had been put forward for the first time at the stage of the action before the General Court.
147 Next, it must be observed that the appellant does not argue that the General Court erred in law or that it distorted the facts or the evidence when it held that the appellant could not raise arguments based on the water regulations since the decision at issue made no reference to those regulations.
148 Last, as regards the appellant’s assertion that the reference, in its request for internal review, to the EFSA guidance had a sufficiently close link with the Commission’s breach of the limit values contained in the water regulations, it should be observed that, in paragraph 217 of the judgment under appeal, the General Court acknowledged that that guidance referred to those regulations. However, the appellant has not shown how the reference to that guidance – concerning which the General Court noted that EFSA had considered, in its conclusion, that the conditions of the use of the ERO methodology, as defined in that guidance, had been satisfied – ought to have led the General Court to consider that such a link existed and, consequently, to accept that the argument relating to that breach was admissible.
149 Second, the appellant’s argument directed, in essence, against the last two sentences of paragraph 217 of the judgment under appeal, in which the General Court – wrongly, in the appellant’s submission – held that it could not review the scientific assessments made by EFSA on the ground that the action for annulment was directed against the decision at issue, is the consequence of a misreading of those sentences. As the Commission has correctly observed, the General Court merely considered that the argument was a ‘vague and general challenge’ to EFSA’s scientific assessments, in that they did not satisfy the criteria of excellence and independence, and that such a complaint could not be examined in an action for annulment of the decision at issue. In so doing, the General Court did not fail to have regard to the scope of the judicial review which it was required to carry out of the scientific assessments forming the basis of the Commission decisions relating to the approval or renewal of the approval of an active substance.
150 It follows that the second part of the first ground of appeal must be rejected.
The third part of the first ground of appeal: breach of the obligation to state reasons, a contradiction in the reasoning, an error of law and distortion of the evidence vitiating the General Court’s assessment of the critical area of concern relating to the high risk for non-target arthropods
– Arguments of the parties
151 By the third part of the first ground of appeal, the appellant disputes the findings of the General Court set out in paragraphs 235 and 236 of the judgment under appeal.
152 First, it observes that, as regards the high risk which the use of cypermethrin represents for non-target arthropods, EFSA stated in the 2019 statement that the risk mitigation measure which it envisaged could be achieved only in a situation that was ‘theoretical’ and ‘hard to achieve in practice’, requiring a drift reduction greater than 95%, and even more than 99% for cereals and potatoes. The appellant maintains that, both in the decision at issue and in its written submissions to the General Court, the Commission, relying on the discussions within the Standing Committee, stated that a ‘safe’ use had been identified that would allow a desired risk reduction level greater than 95% to be achieved.
153 However, in approving that approach in paragraph 235 of the judgment under appeal, the General Court did not ascertain, contrary to the assessment criterion which it applied in paragraph 104 of that judgment, whether it was realistic and scientifically well founded to consider that such a drift reduction in the region of 99% could be achieved. As well as being contradictory, the reasoning stated is based on a distortion of the evidence, as the Commission was not in a position to establish that, during the discussions within that Standing Committee, at least one Member State had shown that the risk mitigation measures to which EFSA referred as theoretical were realistic on its territory.
154 Second, the appellant claims that, in holding, in paragraph 236 of the judgment under appeal, that it was ultimately for the Member States, when authorising the PPPs in the context of their national procedures, to examine the feasibility in practice of the drift reducing measure in the conditions which they fix at national level, the General Court adopted a contradictory position and infringed Article 4 of Regulation 1107/2009.
155 That assessment contradicts paragraph 104 of the judgment under appeal, in which the General Court considered that the Commission ‘cannot identify a “safe” use without ensuring that the risk mitigation measures adopted for that purpose actually, and not theoretically, [made] it possible to reduce the identified risk to an acceptable level’. The General Court thus disregarded that control criterion which it had itself defined as regards the verification of the realistic nature of such remedies.
156 Furthermore, the appellant maintains that the General Court’s assessment fails to have regard to Article 4(3) and (5) of Regulation No 1107/2009, from which it follows that an active substance can be approved only if it has been established that at least one representative use of a PPP containing that substance has no harmful effects for health and no unacceptable effects on the environment in realistic conditions of use. As that proof is required for renewal of the approval of the active substance at issue, the Commission cannot simply leave to the Member States the task of subsequently verifying, at the marketing authorisation stage, that the risk mitigation measures are realistic and scientifically well founded.
157 The Commission contends that the third part of the first ground of appeal is unfounded.
158 First, it submits that paragraph 235 of the judgment under appeal should be read in the light of paragraph 144 thereof, which the appellant does not challenge, in which the General Court observed that the appellant had not identified any provision that prohibited the Commission from requesting contributions from the RMS and the other Member States following the publication of the EFSA conclusion, in particular in the context of the discussions within the Standing Committee.
159 Furthermore, in the Commission’s view, the General Court clearly did not exceed the limits of a reasonable assessment of the evidence relating to the position expressed by the Member States’ experts within that committee. First, the Commission claims that, on a reading of Article 4 in conjunction with Article 13 of Regulation No 1107/2009, when the Standing Committee issues an opinion in favour of the renewal of the approval of an active substance, the identification of at least one ‘safe’ use constitutes a necessary element of that opinion. Second, the Commission observes that it follows expressly from the minutes of the October 2021 meeting of that standing committee, which are freely available, that one Member State, namely the Federal Republic of Germany, expressed its disagreement with the argument that the drift reduction measures were realistic and scientifically well founded. The Commission infers that the General Court was able to consider that the experts of the other Member States had, by contrary inference, considered that those measures were realistic and scientifically well founded. Last, although the Commission recognises, in its rejoinder, that such reasoning does not explicitly follow from paragraph 235 of the judgment under appeal, it maintains that it follows implicitly, but necessarily, from paragraphs 223, 227, 232 and 235 of that judgment.
160 Second, the Commission contends that the claims relating to paragraph 236 of the judgment under appeal are based on a misreading of that paragraph and of the case-law of the Court of Justice, in particular of paragraph 83 of the judgment of 25 April 2024, PAN Europe (Assessment of endocrine disrupting properties) (C‑309/22 and C‑310/22, EU:C:2024:356).
– Findings of the Court
161 As a preliminary point, it must be recalled that, as is apparent from paragraphs 9 and 227 of the judgment under appeal, according to the 2018 EFSA conclusion the use of cypermethrin gives rise to a high risk to non-target arthropods outside the treated area, even taking into account the measures reducing drift by up to 95%, as indicated in the guidelines of the Working Group on Landscape and Mitigation Factors in Ecological Risk Assessment. EFSA therefore considered that that high risk constituted a critical area of concern.
162 However, as stated in paragraphs 12 and 227 of the judgment under appeal, EFSA stated in the 2019 statement that only a risk mitigation measure bringing about a pesticide drift reduction of more than 95% permitted the view that the risk level for non-target arthropods was low, namely when the off-field exposure is reduced to edge-of-field levels not exceeding 5.8 mg/ha.
163 As is clear, in essence, from Annex I to Implementing Regulation 2021/2049, the wording of which is set out in paragraph 41 of the present judgment, when PPPs containing cypermethrin are authorised for spray applications outdoors, risk mitigation methods must be put in place in order to reduce drift in such a way that exposure to the active substance is equal to or less than 5.8 mg/ha in off-crop areas.
164 Before the General Court, the appellant claimed, in particular, that the Commission had not demonstrated that those risk mitigation measures were realistic, relying solely on assertions by certain Member States.
165 The General Court rejected that claim in paragraphs 235 and 236 of the judgment under appeal. First, it considered, in paragraph 235 of that judgment, that ‘the Commission had not placed blind trust in the declarations of a handful of Member States’, but had stated ‘that a safe use had been identified within the Standing Committee as regards the renewal of the approval of cypermethrin’. Second, it considered, in paragraph 236 of that judgment, that ‘it [was] ultimately for the Member States to examine, when authorising PPPs in the context of their national procedures, whether such measures [were] possible in practice, in the conditions which they fix at Member State level’. The General Court added, in paragraph 236, that ‘if those measures [were] necessary, but if it [proved] that they [could] not be applied in practice, or that they [did] not allow the result required for a product, a use or a specific crop to be achieved, then the product containing cypermethrin [could] quite simply not be authorised at national level’.
166 As pointed out in paragraph 88 of the present judgment, in the words of Article 4(1) of Regulation No 1107/2009, an active substance is to be approved in accordance with Annex II to that regulation 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 Annex II, PPPs containing that active substance meet the requirements provided for in paragraphs 2 and 3 of Article 4.
167 It is apparent from Article 4(2) and (3) of Regulation No 1107/2009 that, for the purposes of that approval, it must be excluded that a PPP containing that substance or the residues of such a product, in conditions of application consistent with good plant protection practice and having regard to realistic conditions of use, have harmful effects, whether immediate or delayed, on human health or animal health or an unacceptable effect on the environment.
168 In the words of Article 4(5) of that regulation, moreover, for approval of an active substance, the provisions of paragraphs 1 to 3 of that article are to be deemed to be satisfied if it has been established that that is the case for one or more representative uses or at least one PPP containing that active substance.
169 Likewise, Article 14(1) of that regulation provides that approval of an active substance is to be renewed where it is established that it satisfies the approval criteria provided for in Article 4. Article 4 is to be deemed to be satisfied if it is established that that is the case with respect to one or more representative uses of at least one PPP containing that active substance.
170 It follows that an active substance can be approved, or indeed its approval renewed, only if it is established that at least one representative use of a PPP containing that substance has no harmful on human or animal health and has no unacceptable effect on the environment, in realistic conditions of use.
171 The same applies where, in accordance with Article 6 of Regulation No 1107/2009, read in conjunction with Article 20(1)(a) thereof, the renewal of the approval of the active substance is subject to conditions or restrictions, or where, in application of Article 24 of that regulation, the substitution of that active substance is envisaged, as in the present case.
172 That, in particular, is the reason why, as the General Court correctly held in paragraph 104 of the judgment under appeal, the Commission, in its capacity as risk manager, cannot conclude that the criteria set out in Article 4(2) and (3) of Regulation No 1107/2009 are satisfied, where such a conclusion is based on the imposition of risk mitigation measures that do not preclude the harmful effects on human or animal health or the unacceptable effects on the environment, in particular where those measures seem unrealistic. The General Court was also correct to add, in paragraph 104, that the Commission cannot conclude that there is a ‘safe’ use without ensuring that the risk mitigation measures adopted for that purpose actually and not merely theoretically make it possible to reduce the identified risk to an acceptable level.
173 As the appellant rightly maintains, although the General Court recalled, in essence, in paragraph 104 of the judgment under appeal, that the approval of an active substance was subject to verification, by the Commission, that at least one representative use of a PPP containing that substance may be considered ‘safe’, it is not apparent from paragraphs 235 and 236 of that judgment that the General Court ascertained that, for the purposes of the renewal of the approval of cypermethrin, the Commission had actually ensured that such a use had been demonstrated, in realistic conditions of use, in such a way as to achieve the level of risk mitigation required for non-target arthropods.
174 On the contrary, it is clear from paragraph 235 of the judgment under appeal that the Commission had merely indicated that a ‘safe’ use had been identified within the Standing Committee. In that regard, contrary to the Commission’s assertion, it cannot be inferred from the fact that one Member State has claimed that the risk mitigation measures are unrealistic that, conversely, the existence of a ‘safe’ use of a PPP in realistic conditions has been established in one or more other Member States, having regard to the opinion in favour of renewal of approval issued by that committee.
175 It follows, moreover, from paragraph 236 of the judgment under appeal that the General Court followed the Commission’s position that the verification of the realistic and practicable nature of the risk mitigation measures which it adopted is ultimately a matter for the Member States when they authorise PPPs containing cypermethrin.
176 Admittedly, when it adopted Regulation No 1107/2009, the EU legislature intended to distinguish the procedure for the approval of active substances, governed by Chapter II of that regulation, from the procedure for the authorisation of PPPs, provided for in Chapter III thereof.
177 Furthermore, under Article 29(1)(e) of Regulation No 1107/2009, the Member States can authorise a PPP containing a specific active substance only if it complies with the requirements provided for in Article 4(3) of that regulation.
178 However, the power recognised to the Member States at the PPP authorisation stage cannot dispense the Commission, when approving or renewing the approval of an active substance, from ensuring that at least one representative use of such a product satisfies, under realistic conditions of use, the requirements of Article 4(1) to (3) of Regulation No 1107/2009.
179 Therefore, as the General Court held, in essence, in paragraph 104 of the judgment under appeal, the Commission cannot fail to verify, when, in the context of risk management, it is claimed that a ‘safe’ use of a PPP containing the active substance at issue has been identified as permitting the envisaged level of risk mitigation to be achieved, that that use satisfies, in a realistic manner, the criteria provided for in Article 4(1) to (3) of Regulation No 1107/2009.
180 In that regard, as the appellant has submitted, and as the Advocate General has also observed in point 225 of her Opinion, the 2019 EFSA statement emphasises that the effective application of a drift reduction measure greater than 95% is ‘challenging in practice’, in particular because of wind conditions and the irregular soil surfaces of agricultural plots.
181 As the General Court was wrong to reject the appellant’s argument calling into question the Commission’s assertion that a ‘safe’ use had been identified within the Standing Committee, it vitiated its judgment by an error of law. The third part of the first ground of appeal must therefore be upheld.
182 In the light of the foregoing reasoning, the first and third parts of the first ground of appeal must be upheld and the second part of that ground of appeal must be rejected.
The second ground of appeal and the second part of the fourth ground of appeal: errors of law and breach of the precautionary principle as regards the data gap concerning the endocrine effects of the active substance and the requirement for the applicant for renewal of approval to provide further data on the absence of such effects
Arguments of the parties
183 By the second ground of appeal, the appellant observes, as a preliminary point, that under point 3.6.5 of Annex II to Regulation No 1107/2009 an active substance which presents endocrine disrupting properties cannot be approved. That criterion, called an ‘exclusion’ criterion, means that no risk management measure can make the risk posed by such a substance acceptable. The appellant submits that, in the 2018 conclusion, EFSA recognised that cypermethrin presented endocrine mediation, while stating that, because of a data gap, it could not rule on the endocrine disrupting potential. The appellant also maintains that, before the General Court, it claimed that, in such a situation, the Commission could not renew the approval of the active substance at issue, especially since numerous independent scientific studies that were not taken into account in the risk assessment referred to endocrine disrupting properties.
184 In rejecting those arguments in paragraphs 272, 273, 275 and 276 of the judgment under appeal, the General Court made several errors of law and infringed Article 4 of Regulation No 1107/2009 and acted in breach of the precautionary principle.
185 First, the appellant disputes the General Court’s assessment, in paragraph 272 of the judgment under appeal, that a data gap does not necessarily mean that the criteria set out in Article 4 of that regulation are not satisfied. It claims that, in application of the precautionary principle, a doubt cannot in any event operate to the advantage of the active substance. In the absence of proof that the active substance satisfies the requirements laid down in Article 4 of that regulation, its approval must be refused, a fortiori when the uncertainty relates, as in the present case, to an exclusion criterion referred to in point 3 of Annex II to that regulation. The General Court’s assessment therefore fails to have regard to paragraph 95 of the judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800).
186 Second, the appellant maintains that the General Court’s assertion, in paragraph 273 of the judgment under appeal, that the Commission considered that the criterion indicated in the fifth paragraph of point 3.6.5 of Annex II to Regulation No 1107/2009 was satisfied because it was ‘unlikely that cypermethrin is an endocrine disruptor’, disregards the separation of powers between the scientific risk assessment, entrusted to EFSA, and risk management, which is a matter for the Commission. As EFSA had never stated that it was ‘unlikely’ that cypermethrin presented such properties, the Commission could not draw such a conclusion without providing a detailed statement of reasons or without the support of a separate scientific expert report. The General Court was therefore also wrong to consider, in paragraph 276 of the judgment under appeal, that the Commission, in its capacity as risk manager, had a broad discretion.
187 Third, the appellant challenges the assessment made in paragraph 275 of the judgment under appeal, whereby the General Court held that the appellant had not established that the Commission had made a manifest error of assessment in considering that the criteria set out in the fifth paragraph of point 3.6.5 of Annex II to Regulation No 1107/2009, as amended by Regulation 2018/605, were ‘manifestly’ not satisfied. The appellant maintains, first, that that assessment is not preceded by any examination of the evidence which it had adduced. Second, although the General Court examined that evidence in subsequent paragraphs of the judgment under appeal, it artificially divided that evidence between different parts of its reasoning. In the appellant’s submission, the General Court was required, on the contrary, to examine the decision at issue in the light of all the material in the file. By examining each argument in isolation, the General Court in reality refrained from exercising, even in a restrained manner, its power to review the scientific risk assessment carried out by the Commission and by EFSA, contrary to the statement of principle in paragraph 56 of the judgment under appeal.
188 The appellant maintains that the General Court was therefore required to ascertain whether EFSA and the Commission had examined all the relevant factors, carefully and impartially, without giving preponderant weight to the studies provided by the applicant for renewal of the approval of the active substance and taking proper account of the works resulting from the independent scientific literature, in particular the 30 or so studies cited in paragraph 75 of the application for annulment, in accordance with paragraphs 93 and 94 of the judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800). The appellant claims, moreover, that, in the light of those studies, the General Court was also required to ascertain whether it was ‘plausible’ for the Commission to conclude that it was established that cypermethrin does not present any harmful effect for human or animal health.
189 In the context of the second part of its fourth ground of appeal, the appellant observes that it argued that it was for the Commission, as soon as the new criteria relating to endocrine disruption introduced by Regulation 2018/605 amending point 3.6.5 of Annex II to Regulation No 1107/2009 entered into force, to ask the applicant for renewal of approval for additional information. Such an approach would have made it possible to avoid renewing the approval having regard to the data gap noted and to ensure compliance with the judgment 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800).
190 The appellant maintains that, in rejecting that argument, the General Court failed to have regard to the precautionary principle and the requirement to act diligently to which the Court referred in paragraph 92 of the judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800).
191 First, the General Court acted in breach of that principle when it held, in paragraphs 357 to 359 of the judgment under appeal, that, unlike in the case that gave rise to the judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800), the Commission had concluded in that case that cypermethrin had no harmful effects, not on the ground that the information was insufficient but, on the contrary, on the ground that it was unlikely that that substance would be an endocrine disruptor. In the appellant’s contention, however, the 2018 EFSA conclusion found that the available data were insufficient, and the Commission failed to produce scientific evidence that would allow that conclusion to be nuanced. The precautionary principle therefore required either that the approval not be renewed or that further information be obtained before it could be concluded that the new criteria relating to endocrine disruption were satisfied.
192 Second, the appellant maintains that, in rejecting its line of argument in paragraphs 361 and 363 of the judgment under appeal, the General Court distorted it. Contrary to the General Court’s findings, the appellant never maintained that the new requirements relating to endocrine disruption did not constitute new requirements within the meaning of Article 6(f) of Regulation No 1107/2009 or that the judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800), covered all situations in which a request for confirmatory information may be made. It claimed only that, since those new requirements relating to an exclusion criterion had been known since 2018, the competent authorities ought to have requested further information without delay, on the basis of the provisions of Regulation No 1107/2009 cited in paragraph 92 of the judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800), rather than wait for three years to send a request for confirmatory information to the applicant for renewal of approval after it had renewed the approval of cypermethrin.
193 The Commission disputes those arguments and submits that the second ground of appeal and the second part of the fourth ground of appeal must be rejected as unfounded.
Findings of the Court
194 It should be pointed out, by way of a preliminary point, that on the date of the application for renewal of the approval of cypermethrin, point 3.6.5 of Annex II to Regulation No 1107/2009 provided only provisional criteria for the assessment of the endocrine disrupting effects of an active substance. However, new criteria were introduced by Regulation 2018/605, applicable from 10 November 2018, which the Commission was to apply to any procedure for renewal of the approval of an active substance, provided that, on 10 November 2018, the Standing Committee had not yet voted on a draft renewal regulation.
195 In the present case, it is common ground that the Commission was required to apply those new criteria, as no draft renewal regulation had been communicated to that Standing Committee on that date. The General Court established, in paragraphs 258 to 262 of the judgment under appeal – and it is not disputed by the appellant – that the Commission had in fact taken those new criteria into account when it adopted Implementing Regulation 2021/2049.
196 Before the General Court, the appellant claimed, however, that as the criteria set out in point 3.6.5 of Annex II to Regulation No 1107/2009 constitute ‘exclusion criteria’, an active substance can be approved only if it is not considered to present endocrine disrupting properties. Therefore, because of a data gap, as EFSA observed in its 2018 conclusion, the Commission could not renew the approval of cypermethrin without having first requested further information from the applicant for renewal, on the date on which the new criteria for the assessment of endocrine disruption were applied. The appellant observes, moreover, that the fact that the Commission, in Implementing Regulation 2021/2049, had made the maintenance of the approval of that active substance conditional on the production, within a period of two years from the adoption of that implementing regulation, of ‘confirmatory information’ by the applicant for renewal of approval, shows that the latter had not provided the data necessary for a full assessment of the risks of endocrine disruption. Accordingly, in the light of the precautionary principle and the judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800), the appellant maintained that the Commission ought to have either requested that information before renewing the approval or refused to renew it.
197 As the General Court rejected that argument, the appellant challenges the assessment set out in the second sentence of paragraph 272 of the judgment under appeal, according to which the Commission was correct to consider that a data gap did not necessarily mean that the conditions laid down in Article 4 of Regulation No 1107/2009 were not satisfied. In the appellant’s submission, when a data gap, and therefore scientific uncertainty, concerns the exclusion criteria set out in point 3.6.5 of Annex II to that regulation, the doubt cannot result in the renewal of the active substance being approved.
198 First, it is true, as the appellant claims, in essence, that the reasoning set out in the second sentence of paragraph 272 of the judgment under appeal is ambiguous. In stating that a data gap did not ‘necessarily’ mean that the conditions of Article 4 of Regulation No 1107/2009 were not satisfied, the General Court gave the impression that there may be situations in which such a data gap leads to the opposite conclusion, but without stating which those situations might be. In that regard, as the Advocate General observed, in essence, in points 105 to 107 of her Opinion, the General Court’s reference to paragraphs 69 to 97 of the judgment under appeal in the first sentence of paragraph 272 does not permit the inference that it made findings as to the way in which the Commission must assess a data gap, including in the circumstances of the present case.
199 In any event, it must be recalled that, under Article 4 of Regulation No 1107/2009, an active substance may be approved only if, inter alia, according to paragraph 3(b) of Article 4, a PPP containing that substance has no harmful effect on human health. In accordance with Article 7(1) of that regulation, it is for the applicant for approval or renewal of the approval of such an active substance to adduce evidence that that condition is satisfied (see, to that effect, judgment of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraphs 78 and 114). It follows that the General Court ought to have specified the legal impact of a data gap in the assessment of the conditions of approval laid down in Article 4 of that regulation.
200 In those circumstances, the second sentence of paragraph 272 of the judgment under appeal is vitiated by insufficient reasoning, since the General Court did not explain, clearly and unequivocally, the reasoning which it followed, in such a way that the persons concerned can understand the reasons for its decision and the Court of Justice can exercise its power of review (see, to that effect, judgment of 4 October 2024, UPL Europe and Indofil Industries (Netherlands) v Commission, C‑262/23 P, EU:C:2024:862, paragraph 132 and the case-law cited).
201 However, it should be borne in mind that, if the grounds of a decision of the General Court reveal an infringement of EU law but the operative part of the judgment can be seen to be well founded on other legal grounds, that infringement is not capable of leading to the annulment of that decision and a substitution of grounds must be made (judgment of 11 November 2021, Autostrada Wielkopolska v Commission and Poland, C‑933/19 P, EU:C:2021:905, paragraph 58 and the case-law cited).
202 That is the case here.
203 First of all, as the Commission has correctly submitted, the appellant does not dispute paragraphs 101, 249, 274 and 292 of the judgment under appeal. In particular, it does not claim that the General Court distorted the evidence or made an error of law when it considered, in essence, that the Commission was correct to conclude, in its capacity as risk manager, on the basis of the 2018 EFSA conclusion and the draft RAR prepared by the RMS, which are expressly cited in the sixth subparagraph of paragraph 249 and in paragraph 274 of the judgment under appeal, that although cypermethrin may present an endocrine mediation activity, one of the cumulative criteria laid down in the fifth paragraph of point 3.6.5 of Annex II to Regulation No 1107/2009, as amended by Regulation 2018/605, namely the criterion relating to the harmful effect on human health, was not satisfied and that it was therefore unlikely that cypermethrin was an endocrine disruptor.
204 Next, the General Court rightly held, in paragraph 100, in the first sentence of paragraph 276 and in paragraph 359 of the judgment under appeal, that the criteria set out in point 3.6.5 of Annex II to Regulation No 1107/2009 constitute exclusion criteria, in the sense that an active substance is to be approved when it is not considered to have endocrine disrupting effects that may be harmful to humans.
205 As the Advocate General observed, in essence, in points 111 to 117 and 140 of her Opinion, the approval of such an active substance does not depend on proof of the absence of endocrine disrupting effects but, in accordance with the criteria set out in the fifth and sixth paragraphs of point 3.6.5 of Annex II to that regulation, as amended by Regulation 2018/605, depends, conversely, on the possibility of establishing whether that substance presents endocrine disrupting properties capable of entailing adverse effects in humans, in the light of the available scientific data. In those circumstances, and taking into account the factors referred to in paragraph 203 of the present judgment, the fact that the available scientific data, which may have been the subject of a scientific assessment, present gaps, so that it is not possible to establish that the active substance produces such effects, does not prevent the renewal of its approval from being granted, as the General Court held, in essence, in paragraph 276 of the judgment under appeal.
206 Last, it should be pointed out that, in the second sentence of paragraph 309 of the judgment under appeal, the General Court supplemented the reasoning set out in the first sentence of that paragraph, identical to the reasoning in the second sentence of paragraph 272 of that judgment, which must be read in the light of the second sentence of paragraph 309 of that judgment. In that regard, it should be noted that the appellant does not dispute the assessment in the second sentence of paragraph 309, according to which the Commission had rightly considered in the decision at issue that the subject, the extent and the importance of the data gaps had to be assessed by the risk manager in the light of the overall findings of the risk assessors, who ultimately take a view on whether such data gaps were capable of calling into question the findings on a possible ‘safe’ representative use, in accordance with Article 4 of Regulation No 1107/2009.
207 In any event, the precautionary principle cannot, in all situations, in the event of a data gap, be interpreted as depriving the risk manager of any discretion in the application of the criteria laid down in Article 4 of Regulation No 1107/2009, since it is incumbent on the risk manager to assess the measures suitable for reducing the risk to an acceptable level, in compliance with the precautionary principle.
208 Second, and in the light of the foregoing considerations, the complaints formulated by the appellant with respect to paragraphs 273, 357 and 358 of the judgment under appeal must be rejected as ineffective, since the grounds to which they relate are based on those, not criticised by the appellant, set out in paragraphs 101 and 274 of that judgment. As for the argument directed against paragraph 359 of that judgment, it must be rejected as unfounded.
209 Third, the Court must also reject the assertions which the appellant directs against paragraphs 361 and 363 of the judgment under appeal, claiming that the General Court ought to have found that the Commission was required, before adopting Implementing Regulation 2021/2049, to invite the applicant for renewal of the approval of cypermethrin to provide further information on the endocrine effects of that substance, rather than approve the choice to seek, after the adoption of that regulation and up to 15 December 2023, additional confirmatory information on those effects, in order not to reach a decision without having sufficient scientific data available and in order to comply with the precautionary principle.
210 As the General Court correctly observed in paragraphs 256, 257 and 364 of the judgment under appeal, without that observation being disputed by the appellant, it follows from Article 14(1a) of Implementing Regulation No 844/2012, as amended by Implementing Regulation 2018/1659, that the Commission is not required to request additional information to assess whether the new criteria set out in point 3.6.5 of Annex II to Regulation No 1107/2009 are met, but is merely empowered to do so.
211 It follows that the second ground of appeal and the second part of the fourth ground of appeal must be rejected as ineffective in part and unfounded in part.
The first part of the fourth ground of appeal: the second request for confirmatory information on the toxicity of the isomers constitutes an abuse
Arguments of the parties
212 By the first part of the fourth ground of appeal, the appellant challenges the findings of the General Court relating to the second request for confirmatory information concerning the relative toxicity of the different isomers of cypermethrin which the Commission addressed to the applicant for renewal of the approval of that active substance.
213 According to the appellant, the fourth paragraph of point 1.9 of Part A of the annex to Regulation No 283/2013 clearly provides that, ‘if the active substance is a mixture of isomers, the ratio or the ratio range of the content of isomers shall be provided’ and that ‘the relative biological activity of each isomer, both in terms of efficacy and toxicity, shall be reported’. It follows that, in the absence of information on the relative toxicity of the different isomers of cypermethrin, the dossier of the request for renewal of approval was incomplete. Furthermore, EFSA referred to that data gap in its conclusion, stating that ‘the relative toxicity of individual isomers was not provided, but is required (data gap)’. Under point 2.2 of Annex II to Regulation No 1107/2009, an active substance may be approved only on the basis of a complete dossier, save in exceptional cases, where the missing information is characterised as confirmatory data and required only to increase confidence in the decision.
214 The appellant maintains that the General Court made a number of errors of law in rejecting the complaints which it had put forward.
215 First, the finding in paragraphs 342 and 347 of the judgment under appeal, that the confirmatory information could be requested on the basis of Article 6(f) of Regulation No 1107/2009, is vitiated by three errors of law. First of all, that provision does not cover requests for additional information relating to data that should be supplied in the dossier for approval under Regulation No 283/2013. In other words, it does not apply to situations in which the dossier is incomplete, which come under point 2.2 of Annex II to Regulation No 1107/2009. Next, on the assumption that Article 6(f) of that regulation does apply, the General Court does not explain how an EFSA guidance document, published in 2019 and presented as a mere aid for applicants for approval, constitutes a new requirement, within the meaning of Article 6(f). Last, the General Court was wrong to limit its review to the absence of an error of assessment by the Commission, when what was involved was a question of the interpretation of Article 6(f).
216 Second, the appellant claims that the General Court distorted the material in the dossier when it held, in paragraph 343 of the judgment under appeal, that there was no contradiction between EFSA’s finding that additional information ought to have been submitted and the Commission’s view, in the decision at issue, that the dossier was complete. The appellant claims that the absence in a dossier of data required by the applicable legislation necessarily precludes that dossier from being regarded as complete and that it is incorrect to assert, as the General Court did in paragraph 346 of the judgment under appeal, that EFSA merely requested more specific information.
217 Third, the General Court also distorted the appellant’s arguments, in holding, in paragraph 345 of the judgment under appeal, that the argument alleging infringement of the fourth paragraph of point 1.9 of Part A of the annex to Regulation No 283/2013 was inadmissible, on the ground that it was out of time, when that argument had been put forward in the appellant’s request for internal review and repeated in paragraph 89 of its action for annulment.
218 The Commission disputes those arguments.
219 It contends, primarily, that the appellant’s arguments are inadmissible, as they are based on the premiss that the appellant maintained at first instance that the applicant for renewal of approval had not reported the biological activity of each isomer, as provided for in the fourth paragraph of point 1.9 of Part A of the annex to Regulation No 283/2013. The appellant does not deny that that argument was raised only at the stage of the reply. In its rejoinder, the Commission acknowledges, however, that paragraph 89 of the application for annulment already claimed that the applicant for renewal of approval had not reported the biological activity of each isomer in accordance with the fourth paragraph of point 1.9 of Part A of the annex to Regulation No 283/2013. It contends, however, that contrary to the finding of the General Court, referring to paragraph 337 of the judgment under appeal, the appellant has not demonstrated a sufficiently close link between that argument and the complaints put forward in its request for internal review. The Commission therefore asks the Court of Justice to make substitution for the grounds of paragraph 345 of the judgment under appeal, as the appellant’s argument is inadmissible on a different legal ground, since it is out of time and is not based on matters which have come to light in the course of the procedure, within the meaning of Article 84(1) of the Rules of Procedure of the General Court.
220 In any event, the Commission submits that the appellant’s argument is unfounded.
221 As regards, in the first place, the interpretation of Article 6(f) of Regulation No 1107/2009, the Commission accepts that that provision does not cover supplementary requests relating to information that should be in the approval dossier. However, in the Commission’s submission, as the General Court observed in paragraph 343 of the judgment under appeal, that circumstance does not contradict the position expressed in the decision at issue, namely that the dossier had been submitted in complete form. First, Article 6(f) of Regulation No 1107/2009 allows the Commission to request additional confirmatory information where new requirements have been introduced during the evaluation process. Second, it follows from paragraphs 341 and 346 of the judgment under appeal that, at the time of submission of the dossier, no guidance specified the way in which the isomers were to be evaluated and taken into account, and the data gap became apparent only after EFSA adopted the 2019 guidance. It follows that, at the time of submission of the approval dossier, the applicant for renewal of approval had indeed supplied in complete form the requisite information concerning the isomers.
222 Furthermore, the Commission maintains, relying on paragraph 69 of the judgment of 6 May 2021, Bayer CropScience and Bayer v Commission (C‑499/18 P, EU:C:2021:367), that the new EFSA guidance necessarily constituted new technical knowledge, within the meaning of Article 6(f) of Regulation No 1107/2009, irrespective of its origin or of the document containing it.
223 In addition, as is apparent from paragraph 342 of the judgment under appeal, the General Court, contrary to the appellant’s contention, did not merely find that there was no manifest error of assessment on the part of the Commission. It also ascertained that the Commission had not disregarded the applicable procedural rules.
224 In the second place, the Commission observes that the criticisms made with regard to paragraph 343 of the judgment under appeal reiterate, essentially, those already directed against paragraphs 341 and 346 of that judgment, and must be rejected, for the same reasons. It adds that the appellant adduces no evidence capable of substantiating its other assertions.
Findings of the Court
225 As regards, first of all, the complaint which the appellant directs against paragraph 345 of the judgment under appeal, in which the General Court declared inadmissible the appellant’s argument alleging infringement of point 1.9 of Part A of the annex to Regulation No 283/2013 on the ground that it had been raised only at the stage of the reply, it should be borne in mind that an appellant alleging distortion of its own arguments must, under Article 256 TFEU, the first paragraph of Article 58 of the Statute of the Court of Justice of the European Union and Article 168(1)(d) of its Rules of Procedure, indicate precisely the arguments alleged to have been distorted and demonstrate the errors in the analysis which, in its view, resulted in the General Court making that distortion (see, to that effect, judgment of 13 July 2023, Commission v CK Telecoms UK Investments, C‑376/20 P, EU:C:2023:561, paragraph 212 and the case-law cited).
226 That is the case here.
227 As the appellant has maintained, and as the Advocate General observed in point 80 of her Opinion, it is clear from paragraph 44 of the request for internal review and from paragraph 89 of the application for annulment that the appellant had expressly claimed that the second request for confirmatory information, concerning the relative toxicity of the different isomers of cypermethrin, failed to satisfy the requirement laid down in the fourth paragraph of point 1.9 of Part A of the annex to Regulation No 283/2013.
228 It follows that, in declaring, in paragraph 345 of the judgment under appeal, that the appellant’s argument alleging infringement of the fourth paragraph of point 1.9 of Part A of the annex to Regulation No 283/2013 was inadmissible, on the ground that it was put forward only at the stage of the reply, the General Court distorted the appellant’s arguments.
229 That distortion, however, is not in itself sufficient to justify the judgment under appeal being set aside, since the General Court in any event examined the substance of that argument and rejected it on the ground that, as is apparent from paragraph 346 of the judgment under appeal, the isomers had indeed being taken into account, but EFSA had considered it necessary to have more specific information and had found that there was a data gap.
230 Although the General Court examined the substance of that argument, the reasoning which it set out in paragraph 346 of the judgment under appeal makes it difficult to comprehend how it actually addressed that argument.
231 It must be recalled that, under the fourth paragraph of point 1.9 of Part A of the annex to Regulation No 283/2013, which sets out the requirements relating to the data on the active substances that should be included in the dossiers for approval or renewal of approval, ‘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’.
232 As is apparent, in particular, from recital 13 of Implementing Regulation 2021/2049, cypermethrin is a mixture of eight isomers. The dossiers submitted by the applicants for renewal of its approval therefore had to include the information specified in the fourth paragraph of point 1.9 of Part A of the annex to Regulation No 283/2013.
233 Consequently, the mere fact that, as the General Court stated in paragraph 346 of the judgment under appeal, the isomers were ‘taken into consideration’ – whatever the precise scope of that expression may be – as the Advocate General emphasised in points 94 and 95 of her Opinion, cannot mean either that the applicants for renewal of the approval of cypermethrin indicated the ratio or the range of ratios of the content of isomers or that they reported in their renewal dossiers the relative biological activity of each isomer, in terms of both the efficacy and the toxicity of that active substance.
234 That assessment is especially justified because, first, as the General Court itself observed in paragraph 343 of the judgment under appeal, the 2018 EFSA conclusion stated that no specific toxicological study had been supplied for the individual isomers, so that it was not possible to reach a conclusion as to their relative toxicity.
235 Second, as the Commission observed, in essence, in the decision at issue, the second request ‘for confirmatory information’ – which the applicants for renewal of the approval of the active substance were required to submit to the Commission, the Member States and EFSA by15 December 2023 at the latest– which is found in Annex I to Implementing Regulation 2021/2049, covered the ‘relative toxicity of the individual cypermethrin isomers, in particular the enantiomer (1S-cis-α-R)’. That request could only attest that the data on the relative toxicity of those individual isomers were not yet in the dossiers submitted by the applicants for renewal of the approval of that active substance, as EFSA had stated in its 2018 conclusion.
236 While it is true that, at the time of the application for renewal of approval, EFSA had not yet published any guidance on the identification of the data, it should be observed that, as the Advocate General notes in point 83 of her Opinion, the obligation resulting from the fourth paragraph of point 1.9 of Part A of the annex to Regulation No 283/2013 is not attached to any delaying condition, in particular with regard to the prior adoption of such guidance.
237 Since it was not established that the data on the relative toxicity of the cypermethrin isomers, although required under the fourth paragraph of point 1.9 of Part A of the annex to Regulation No 283/2013, were found in the dossiers submitted by the applicants for renewal of the approval of cypermethrin, the General Court was wrong to hold, in paragraphs 342 and 347 of the judgment under appeal, that the Commission was correct to regard that information as mere ‘additional confirmatory information’, within the meaning of Article 6(f) of Regulation No 1107/2009. As the Advocate General observed in point 88 of her Opinion, data that must be included in the dossiers submitted with a view to renewal of the approval of an active substance cannot be covered by that provision.
238 It follows that the first part of the fourth ground of appeal must be upheld.
The third ground of appeal: failure to take the other data gaps identified by EFSA into account
Arguments of the parties
239 By the third ground of appeal, the appellant disputes the findings made by the General Court in paragraphs 309, 310, 312 and 313 of the judgment under appeal.
240 The appellant maintains, first of all, that in holding, paragraph 309 of the judgment under appeal, that a data gap data did not necessarily indicate that the criteria provided for in Article 4 of Regulation No 1107/2009 were not satisfied, the General Court made an error of law. Since EFSA had identified 24 data gaps, which the appellant had expressly referred to in its application for annulment, such a finding is inconsistent with precautionary principle that underpins that regulation and with the allocation of the burden of proof which it provides for. In view of the number and the nature of the data gaps, the renewal of the approval of cypermethrin without additional information being obtained constitutes a manifest error of assessment.
241 The appellant claims, next, that the General Court misinterprets the meaning of its argument when it asserts, in paragraph 310 of the judgment under appeal, that the appellant confused the factual completeness of a dossier submitted to the RMS and the data gap which EFSA may find in its risk assessment. In the appellant’s submission, the absence in the dossier relating to the application for renewal of approval of data which the applicant for renewal is required to provide means that a complete assessment of the active substance concerned cannot be carried out and, accordingly, precludes the renewal of its approval by the Commission.
242 Last, the appellant submits that, in holding, in paragraph 312 of the judgment under appeal, that the appellant had not indicated how the numerous data gaps ought necessarily to have prompted the Commission to find that the criteria laid down in Article 4 of Regulation No 1107/2009 were not fulfilled and to refuse to renew the approval of cypermethrin, the General Court reversed the burden of proof, contrary to the scheme of that regulation. In the appellant’s submission, the General Court assumed that those criteria were fulfilled, thus placing on the appellant the burden of proving the opposite. Such an approach, however, is tantamount to requiring the appellant to prove facts which, by definition, are impossible to establish, since a data gap refers to a situation of scientific ignorance that prevents any assessment of compliance with those criteria. The appellant maintains that it showed, on the contrary, during the procedure, that those data gaps, relating to regulatory and mandatory elements, rendered a priori impossible any positive conclusion as to compliance with those criteria, thus casting serious doubt on the legality of Implementing Regulation 2021/2049. It is also for that reason that the appellant maintains that the case-law referred to in paragraph 313 of the judgment under appeal, according to which a preventive measure cannot be based on a purely hypothetical approach to the risk is ineffective, because where information which the EU legislature considers necessary is not provided, the question is not whether the risk is ‘hypothetical’ but whether it is even possible to identify the risk and therefore to manage it.
243 The Commission submits that the third plea should be rejected as ineffective in part and unfounded in part.
Findings of the Court
244 As regards the complaint which the appellant directs against the finding of the General Court in paragraph 309 of the judgment under appeal, it should be observed that the first sentence of paragraph 309, which is identical to the second sentence in paragraph 272 of that judgment, reveals the same ambiguity as that pointed out in paragraph 198 of the present judgment. It follows that, for the same reasons, that finding is vitiated by insufficient reasoning.
245 However, as already stated in paragraph 206 of the present judgment, the General Court supplemented the reasoning set out in the first sentence of paragraph 309 of that judgment, by observing, in the second sentence of that paragraph, that the Commission had been correct to consider, in the decision at issue, that the subject, the extent and the importance of the data gaps had to be assessed by the risk manager in the light of the overall findings of the risk assessors, who ultimately take a view on whether evaluators, who have the final word on whether such data gaps were capable of calling into question the findings on a possible safe representative use in accordance with Article 4 of Regulation No 1107/2009.
246 The appellant does not dispute the reasoning set out in the second sentence of paragraph 309 of the judgment under appeal.
247 Nor, likewise, does it formulate any specific complaint against paragraph 314 of the judgment under appeal, in which the General Court considered that the fact that there were ‘numerous data gaps’ did not in itself permit the conclusion that the criteria provided for in Article 4 of Regulation No 1107/2009 were not satisfied, as the Commission, in its capacity as risk manager, could assess, on a case-by-case basis, in compliance with the precautionary principle, whether those criteria can be satisfied for a particular active substance, notwithstanding any data gaps.
248 As was observed in paragraph 207 of the present judgment, the precautionary principle cannot in all situations, in the event of a data gap, be interpreted as depriving the risk manager of all discretion in the application of the criteria laid down in Article 4 of Regulation No 1107/2009, since the risk manager is required to assess the measures appropriate for reducing the risk to an acceptable level, in compliance with the principle of proportionality.
249 That applies a fortiori since, in its risk assessment, EFSA did not consider that the data gaps in question constituted critical areas of concern or, as the Advocate General observed in point 67 of her Opinion, that they prevented the active substance in question from being found to be harmless.
250 In those circumstances, it was for the appellant, in accordance with the case-law cited in paragraph 82 of the present judgment, and as the General Court correctly held in paragraph 312 of the judgment under appeal, to establish how the ‘numerous data gaps’ referred to ought necessarily to have caused the Commission to find that the criteria laid down in Article 4 of Regulation No 1107/2009 were not fulfilled and to refuse to renew cypermethrin.
251 It follows that the third ground of appeal must be rejected.
The fifth ground of appeal: failure to examine the long-term toxicity of the representative use submitted by the applicant for renewal of approval
Arguments of the parties
252 By its fifth plea, the appellant maintains that the General Court made a number of errors of law in interpreting Article 4(3) and (5) of Regulation No 1107/2009, by rejecting the appellant’s argument that cypermethrin could be approved only on condition that the long-term toxicity of a representative use of a PPP containing that active substance had been assessed.
253 First, the appellant takes issue with the General Court for having misinterpreted, in paragraph 418 of the judgment under appeal, Article 4(5) of that regulation, by holding that it was not the purpose of that provision to extend to PPPs, in one or more of their representative uses, the requirements laid down in paragraphs 1 to 3 of Article 4. It maintains that, on the contrary, Article 4(5) of that regulation requires that at least one representative use of a PPP containing the active substance in question comply with the criteria laid down in Article 4(1) to (3) of Regulation No 1107/2009 in order for that substance to be deemed to meet those requirements. The appellant adds that those criteria apply to the PPPs themselves and not just to the active substance. Consequently, in so far as they give expression to and implement the criteria laid down in Article 4(1) to (3) of that regulation, the criteria laid down in point 3 of Annex II to that regulation also apply to the representative use. The Commission was therefore required, before renewing the approval of an active substance, to ensure that the representative use does not present any immediate or delayed harmful effect on human or animal health.
254 Second, the appellant submits that it was by contradictory and incomplete reasoning that the General Court held, in paragraphs 421 and 424 of the judgment under appeal, that the finding in paragraph 418 of that judgment could not be understood as authorising the Commission to renew the approval of an active substance of which the only PPP tested presents long-term toxicity, as the EU legislature had provided that the cumulative effects of the components of a PPP must be taken into account both on renewal of the approval of the active substances and on the authorisation of the PPPs. The appellant claims that the General Court did not explain how the Commission could ensure that the representative use did not present long-term toxicity if that use is not subject to the criteria laid down in Article 4(1) to (3) of Regulation No 1107/2009 or to those set out in point 3 of Annex II to that regulation.
255 Third, the appellant claims that the General Court made an error of law and failed to respect the allocation of the burden of proof when it held, in paragraph 427 of the judgment under appeal, that the appellant had adduced no evidence capable of giving rise to ‘plausible doubts’ as to the legality of the assessment carried out by the Commission in the decision at issue, according to which cypermethrin, in one of its representative uses, did not present any form of carcinogenicity or long-term toxicity.
256 The appellant maintains that the General Court was wrong to refer to the absence of long-term toxicity or carcinogenicity of only the active substance, when the issue was that of the formulation used in the context of the application for renewal of approval, namely the PPP ‘cypermethrin 500 EC’, which contains components other than the only active substance and the absence of long-term toxicity of which had to be ascertained.
257 Furthermore, the appellant maintains that the General Court reversed the burden of proof, thus failing to have regard to the scheme of Regulation No 1107/2009 and the precautionary principle that underpins it. In the appellant’s submission, it was not required to demonstrate the absence of long-term toxicity of the representative use, but, on the contrary, the applicant for renewal of approval was required to adduce that proof. The absence of such an assessment is sufficient, in the appellant’s submission, to give rise to serious doubts as to the legality of the decision to renew the approval of the active substance contained in that representative use. The Commission was therefore required to show that such an assessment had indeed been carried out, which it failed to do in the decision at issue. Consequently, the appellant maintains that, in presuming that the representative use did not present any long-term toxicity, the General Court required the appellant to adduce proof to the contrary, although no long-term toxicity test was carried out on the product ‘cypermethrin 500 EC’, which is tantamount to requiring the appellant to adduce proof which is impossible to provide.
258 Fourth, the appellant maintains that the General Court made a number of errors of law by endorsing, in paragraphs 428 to 433 of the judgment under appeal, the Commission’s argument that there was no need to carry out an evaluation of the long-term toxicity of the product ‘cypermethrin 500 EC’, since the safety datasheets had been provided for each of its components, evaluated in a confidential section of the draft RAR, and since no concern had been raised by either the RMS, or EFSA or the public concerning the long-term toxicity of that product.
259 In the first place, the appellant maintains that the finding in paragraph 428 of the judgment under appeal, that the Commission was able to consider that the long-term toxicity of the product ‘cypermethrin 500 EC’ was not ‘problematic’ in the absence of any concerns expressed by the RMS or EFSA, is based on both a reversal of the burden of proof and at the same time the incorrect assumption that the requirement relating to the absence of long-term toxicity concerns only the active substance. The appellant maintains that such a requirement also applies to the representative use. It recalls, in that regard, that EFSA observed, in its 2018 conclusion, with respect to the first critical area of concern, that the genotoxicity of the technical specification of cypermethrin – namely the active substance and the impurities resulting from the manufacturing process that were present in the basic products of that active substance – could not be excluded, which relates directly to the long-term toxicity of the representative use.
260 In the second place, the appellant claims that the finding, in paragraph 429 of the judgment under appeal, that the Commission was not required to carry out its own supplementary assessment, on the ground that the product ‘cypermethrin 500 EC’ was already authorised on the market and that, moreover, neither the Member States nor EFSA had indicated any potential problem, is based on several errors and has inconsistent consequences. The appellant claims, in particular, that the existence of earlier national authorisations cannot relieve the Commission from itself ascertaining that the product complies with the requirements of Regulation No 1107/2009.
261 First of all, the absence of any indication of a problem on the part of the authorities or the assessing bodies does not exempt the Commission from its obligation to ascertain for itself whether such a problem exists, especially when its absence is the result of a failure to carry out studies that would enable a potential risk to be identified. Next, the argument that the Member States have necessarily verified the absence of long-term toxicity of the product in question is inadmissible, on the ground that it was late in being raised by the Commission, at the stage of the rejoinder. In any event, such an argument appears to be irrelevant, as the need to carry out such a verification was clearly established only after the judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800), and that requirement is generally not applied at Member State level. Last, the appellant adds that, if such tests of the product ‘Cypermethrin 500 EC’ had been carried out and communicated to the Member States, they would also have been communicated to the RMS and to EFSA in the context of the renewal of the approval of the active substance, which was not the case.
262 In addition, the appellant maintains that the General Court’s reasoning has inconsistent consequences. It amounts to allowing the Commission to presume that a representative use meets all the criteria laid down in Article 4(1) to (3) of Regulation No 1107/2009 provided that no Member State has expressed any reservation when a PPP of identical composition is authorised. Such a presumption would mean that, on approval of the renewal of the active substance, that substance would be deemed to satisfy the same criteria in application of Article 4(5). Consequently, the Member States would then be required to authorise the placing on the market of any PPP identical to that representative use, as it has already been deemed by the Commission to comply with the requirements of Article 4. Such circular reasoning would render meaningless the periodic and in-depth re-evaluation of the active substances provided for by that regulation.
263 In the third place, the appellant disputes the findings in paragraphs 431 and 432 of the judgment under appeal, in which the General Court dismissed as ‘mere speculation’ the appellant’s assertion that the long-term toxicity of the representative use was not evaluated. The General Court considered that the fact that there was no reference to such an evaluation in the 2018 EFSA conclusion or in the draft RAR of the RMS did not permit the inference that such an evaluation had not taken place, adding that the confidential part of that draft RAR contains the information on which that evaluation is based.
264 The appellant maintains that that reasoning is tantamount to requiring it to prove a negative, which constitutes a probatio diabolica, especially since some parts of the dossier are confidential. In its submission, the Commission was required to show that such an evaluation had actually been carried out and the General Court to request the Commission to produce it, so that its content could be verified. The General Court, conversely, could not rely on the confidential nature of that part of the draft RAR to support an irrebuttable presumption that the evaluation in question had in fact been carried out.
265 Last, in the fourth place, the appellant casts doubt on the General Court’s finding in paragraph 433 of the judgment under appeal, in which it approved the Commission’s view that the safety datasheets, prepared for each component of the representative use pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1) (‘the REACH Regulation’), and Regulation No 1272/2008, were sufficient to determine the long-term toxicity of that use. The appellant claims that the reasoning employed is both insufficient and incorrect in law.
266 First, the General Court did not provide sufficient reasons for its finding that the methods of classification of the mixtures, provided for in the REACH Regulation and in Regulation No 1272/2008, also apply to PPPs. In the appellant’s submission, and in accordance with the judgment of 4 October 2023, Ascenza Agro and Industrias Afrasa v Commission (T‑77/20, EU:T:2023:602, paragraphs 463 to 467), Regulation No 1107/2009 constitutes a lex specialis establishing a stricter legal framework than those regulations, so that the methods used in application of those regulations cannot necessarily be transposed to PPPs. Second, the General Court did not respond to the arguments which the appellant raised in paragraph 115 of the application for annulment, relating to the limited and insufficient nature of the data requirements laid down in the REACH Regulation and in Regulation No 1272/2008 and to the failure to take into account the cumulative or synergetic effects – known as the ‘“cocktail” effects’ – resulting from the interaction of the different components of a PPP. In that regard, the appellant claims that the General Court disregarded the requirements identified in paragraphs 68 and 69 of the judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800).
267 The Commission contends that the fifth plea is unfounded.
268 First, it claims that, as the General Court held in paragraphs 418 and 419 of the judgment under appeal, Article 4(1) and (3) of Regulation No 1107/2009 does not apply to the PPPs containing approved active substances, but only to the active substances themselves.
269 Second, as regards the appellant’s criticisms concerning paragraphs 421 and 424 of the judgment under appeal, the Commission maintains that the General Court provided sufficient reasons for its finding. The Commission emphasises that the grounds set out in paragraphs 422, 423, 425 and 426 of that judgment, paragraphs which, moreover, the appellant does not dispute in its appeal, provide an adequate response to the arguments raised at first instance.
270 Third, as regards the assertions relating to paragraph 427 of the judgment under appeal, the Commission claims first of all that the appellant misreads that paragraph. Contrary to the appellant’s assertion, the General Court referred to the absence of long-term toxicity or the carcinogenicity of cypermethrin not as an active substance, but solely ‘in one of its uses’. Next, the Commission submits that the argument alleging a reversal of the burden of proof is based on a misreading of the applicable case-law and also of paragraph 427 of the judgment under appeal. In fact, the General Court merely placed on the appellant the burden of proof borne by any party requesting an internal review. Last, as regards the appellant’s argument that the Commission did not adduce proof of an evaluation of the long-term toxicity of the product ‘Cypermethrin 500 EC’, the Commission refers to the observations whereby it responded to the appellant’s complaints against paragraphs 428 to 433 of the judgment under appeal, which are set out in paragraphs 271 to 274 of the present judgment.
271 Fourth, the Commission claims that the appellant misreads paragraph 428 of the judgment under appeal. The General Court did not hold that the absence of long-term toxicity could be inferred, in the abstract, from the mere fact that no concern had been expressed by the competent authorities because there had been no study of the matter. The General Court merely found that, in the present case, the absence of concerns expressed at the time of the risk assessment relating to the toxicity of cypermethrin indicated that the product, in one or more representative uses, did not present problematic aspects, that is, that it was not toxic in the long-. In addition, the appellant wholly fails to substantiate its assertion concerning paragraph 430 of the judgment under appeal.
272 Fifth, the Commission claims, first of all, that the criticism directed against paragraph 429 of the judgment under appeal repeats, in part, that made against paragraph 428 thereof and for that reason calls for the same response. It further submits that the argument which it put forward, and which the General Court rightly upheld in paragraph 429, was admissible, since it responded to the reply lodged at first instance, and on which the appellant had the opportunity to express its views at the hearing. Next, the appellant’s assertions that the requirements identified in the judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800), remain largely disapplied and inapplicable at Member State level are inadmissible, as they were not raised before the General Court and, in any event, are unsubstantiated. Last, as regards the inconsistent consequences to which the General Court’s reasoning is alleged to lead, the Commission submits that the General Court sought only to determine whether the Commission, and not the Member States, was required to carry out its own supplementary evaluation in the absence of any indication by the Member States or by EFSA of a potential problem. The Commission adds that the appellant’s argument that a Member State would be required to authorise the placing on the market of a PPP the active substance of which was approved is contradicted by the judgment of 25 April 2024, PAN Europe (Assessment of endocrine disrupting properties) (C‑309/22 and C‑310/22, EU:C:2024:356, paragraph 83).
273 Sixth, as regards the appellant’s assertion in regard to paragraphs 431 and 432 of the judgment under appeal, according to which the General Court imposed an impossible evidential burden on it, the Commission refers to the observations which it has already submitted in respect of the criticisms directed against paragraph 427 of that judgment and observes, in that regard, that paragraph 432 refers to paragraph 42 of that judgment and to the case-law of the Court of Justice.
274 Last, and seventh, as regards the complaints referring to the findings set out in paragraph 433 of the judgment under appeal, the Commission maintains, in the first place, that the General Court was not required to state reasons for the finding that the methods used in the context of the REACH Regulation and Regulation No 1272/2008 also apply to PPPs, since the appellant had not raised such an argument at first instance. In the second place, the Commission maintains that the applicant misreads paragraphs 463 to 467 of the judgment of 4 October 2023, Ascenza Agro and Industrias Afrasa v Commission (T‑77/20, EU:T:2023:602). That judgment did not recognise that Regulation No 1107/2009 is in the nature of a lex specialis by reference to the REACH Regulation and Regulation No 1272/2008. The General Court merely observed that the Commission was not required to apply, in the context of Regulation No 1107/2009, the approach taken in the REACH Regulation. However, there is nothing to prevent EFSA, when assessing the risks, from applying a method resulting from the latter regulation or from Regulation No 1272/2008, provided that it corresponds to current scientific and technical knowledge, within the meaning of Article 12(2) of Regulation No 1107/2009 and the first subparagraph of Article 13(1) of Implementing Regulation No 844/2012. In the third place, the Commission claims that, contrary to the appellant’s contention, Regulation No 1107/2009 does not establish a stricter regime than the REACH Regulation and Regulation No 1272/2008, which are also explicitly based on the precautionary principle, as confirmed by the judgments of 9 November 2023, Chemours Netherlands v ECHA (C‑293/22 P, EU:C:2023:847, paragraph 60), and of 21 July 2011, Etimine (C‑15/10, EU:C:2011:504, paragraph 129). In the fourth and last place, the Commission maintains that the General Court did respond to the arguments raised by the appellant in paragraph 115 of its application for annulment, and states that it endorses the analysis developed by the General Court in paragraph 433 of the judgment under appeal.
275 In its reply, the appellant confirms, first, that it set out in detail, in paragraph 115 of its application for annulment, the reasons why the methods relating to the classification of mixtures set out in the REACH Regulation and Regulation No 1272/2008 were not transposable in the context of Regulation No 1107/2009. Second, it explains that Regulation No 1107/2009 is based on a principle that prohibits the placing of a PPP on the market in the absence of prior proof that it is harmless, while the REACH Regulation operates on the opposite principle, based on the free movement of chemical products, in the absence of proof that they are harmful and an ex post prohibition decision. The appellant further submits that the grounds of prohibition set out in the REACH Regulation are limited and do not cover all harmful effects to human or animal effects or unacceptable effects on the environment within the meaning of Article 4 of Regulation No 1107/2009.
276 In its rejoinder, the Commission contends that none of the four arguments put forward by the appellant in paragraph 115 of its application for annulment related to the applicability to PPPs of the mixture classification methods set out in the REACH Regulation and Regulation No 1272/2008. It adds that the appellant’s argument does not call into question the possibility that EFSA may apply an assessment method resulting from those regulations when evaluating an active substance.
Findings of the Court
277 By the fifth ground of appeal, which relates to the evaluation of the long-term toxicity of the representative use of a PPP containing the active substance cypermethrin, the appellant claims that the General Court made several errors of law in interpreting Article 4(3) and (5) of Regulation No 1107/2009. It maintains, first, that the General Court was wrong to hold that the criteria laid down in point 3 of Annex II to that regulation apply only to the active substance, when they also relate to the representative use of a PPP containing that substance, thus vitiating paragraphs 418 to 426 of the judgment under appeal by a contradiction in the reasoning and a misinterpretation of Article 4(5) of that regulation. Second, the appellant takes issue with the General Court for having endorsed, without having verified it, the Commission’s position, set out in the decision at issue, that the fact that no concerns were raised by the RMS, EFSA or the public is sufficient to preclude the long-term toxicity of a PPP containing that active substance and thereby reversed the burden of proof.
278 In the first place, as regards the errors of law alleged by the appellant concerning paragraphs 418 to 426 of the judgment under appeal, it must be observed, as a preliminary point, that the General Court held, in paragraphs 418 to 420 of the judgment under appeal, that the criteria laid down in points 2 and 3 of Annex II to Regulation No 1107/2009, to which Article 4(1) of that regulation makes reference, apply not to the authorisation of a PPP but to the approval of an active substance. The General Court considered, moreover, that Article 4(5) of that regulation does not have the effect of extending to PPPs the requirements laid down in paragraphs 1 to 3 of Article 4, since the EU legislature expressly distinguished the approval of the active substances at EU level and the authorisation, under the responsibility of the Member States, of the products containing those substances for uses as pesticides.
279 Admittedly, as the General Court rightly observed, notably in paragraphs 419 and 423 of the judgment under appeal, in adopting Regulation No 1107/2009, the EU legislature intended to distinguish the procedure for the approval of active substances, governed by Chapter II of that regulation, from the procedure for the authorisation of PPPs, governed by Chapter III.
280 It must also be observed that Article 4 of Regulation No 1107/2009, in accordance with its title, lays down the approval criteria for active substances.
281 However, paragraph 1 of Article 4 refers, for the approval of a given active substance, to the requirements which PPPs containing that active substance must meet, as defined in paragraphs 2 and 3 of Article 4.
282 Furthermore, in the words of Article 4(5) of Regulation No 1107/2009, ‘for approval of an active substance, paragraphs 1, 2 and 3 shall be deemed to be satisfied where this has been established with respect to one or more representative uses of at least one [PPP] containing that active substance’.
283 Thus, the presumption established by paragraph 5 of Article 4 assumes that it is demonstrated that at least one representative use of a PPP containing the active substance concerned meets the requirements laid down in Article 4(1) to (3) of that regulation.
284 It follows that, in accordance with the distinction which Regulation No 1107/2009 makes between the procedure for the approval of an active substance and the procedure for authorisation of a PPP containing such an active substance, the proof required in Article 4(5) of that regulation must be produced either in the context of a request for authorisation to place a PPP on the market, when the requested Member State must verify that the requirements laid down in Article 29(1) of that regulation, which refer to the requirements of Article 4(2) and (3) of that regulation, are met, or in the context of a procedure for approval or for renewal of the approval of an active substance carried out by before the Commission. Article 14(1) of Regulation No 1107/2009, moreover, expressly confirms that, when the approval of an active substance is renewed, Article 4 of that regulation is to be deemed to be satisfied where it has been established with respect to one or more representative uses of at least one PPP containing that active substance.
285 Accordingly, as the Advocate General observed, in essence, in point 156 of her Opinion, the approval or renewal of the approval of an active substance implies that the Commission examines one or more representative uses of at least one PPP containing that active substance, in the light of the evaluation criteria laid down in Article 4(1) to (3) of Regulation No 1107/2009.
286 It follows that the General Court erred in law in holding, in paragraph 418 of the judgment under appeal, that it was not the purpose of Article 4(5) of that regulation to extend to PPPs, in one or more representative uses, the requirements laid down in Article 4(1) to (3) of that regulation.
287 However, as already pointed out in paragraph 201 of the present judgment, if the grounds of a judgment of the General Court reveal an infringement of EU law but the operative part can be seen to be well founded on other legal grounds, that infringement is not capable of leading to the judgment being set aside and a substitution of the grounds must be made.
288 In the present case, the General Court was correct to hold, in essence, in paragraph 421 of the judgment under appeal, that the Commission cannot approve or renew the approval of an active substance where the only PPP tested containing that active substance presents long-term toxicity.
289 It follows, first, from Article 4(5) and Article 14(1) of Regulation No 1107/2009 that, in the context of the approval or of the renewal of the approval of a specific active substance, the Commission must ensure that it has been shown that at least one representative use of a PPP containing that active substance does in fact meet the requirements of Article 4(1) to (3) of Regulation No 1107/2009.
290 Second, it must be recalled that, in accordance with Article 4(3)(b) and Article 29(1)(e) and (2) of that regulation, a PPP can be authorised only if it is established by the applicant for approval of the product, in particular by tests, analyses and studies relating to the product, that, in the light of current scientific and technical knowledge, the product has no immediate or delayed harmful effect on human health. That requirement cannot be considered to be satisfied where a PPP presents a form of carcinogenicity or long-term toxicity (see, to that effect, judgment of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraphs 114 to 116).
291 In the second place, the appellant takes issue with the General Court for having wrongly held, in paragraphs 427 to 433 of the judgment under appeal, that the Commission was entitled to take the view, in the decision at issue, that the PPP containing cypermethrin, in one of its representative uses, presented no form of carcinogenicity or long-term toxicity.
292 In that regard, it follows from the grounds of the judgment under appeal that the General Court first of all considered, in paragraph 428 of the judgment under appeal, that, if ‘neither the 2018 EFSA conclusion nor the draft [RAR] prepared by the RMS contain[ed] an explicit reference to long-term toxicity, there [was] nothing to indicate that the product, in one or more of its representative uses, presented problematic aspects’. It then considered, in paragraph 429 of that judgment, that, since that product had already been authorised on the market, following national authorisation procedures during which the Member States had ‘necessarily’ ascertained the absence of long-term toxicity, the absence of any indication of a potential problem relieved the Commission ‘from carrying out its own supplementary evaluation’. Last, in paragraphs 431 and 432 of the judgment under appeal, the General Court rejected the appellant’s argument relating to the absence of an evaluation of the long-term toxicity of cypermethrin, relying on the Commission’s observations that the evaluation documents of the RMS included Volume 4, of a confidential nature, containing the information on the basis of which the ‘formulation’ was evaluated, and held that that argument did not permit ‘plausible doubts’ to arise as to the legality of the decision at issue.
293 First, it must be observed that the General Court’s findings in paragraphs 428 and 429 of the judgment under appeal are based on the presumption that long-term toxicity was evaluated.
294 First of all, as is apparent from the case-law of the Court, in order to ensure compliance with the precautionary principle, there is no presumption that a PPP has no harmful effects (judgment of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraph 80).
295 Next, the General Court could not consider, without vitiating its judgment by an error of law, that the Commission was able to infer from the fact that the RMS and EFSA had not examined the long-term toxicity of a PPP, in one or more of its representative uses, that that product did not present any problematic aspect.
296 On the contrary, the General Court was required to ensure that, in the context of the procedure for renewal of the approval of cypermethrin, the Commission, in accordance with its obligations under Article 4(5) and Article 14(1) of Regulation No 1107/2009, had ascertained that it was indeed ‘established’ that at least one of the representative uses of the PPP containing that active substance did not present long-term toxicity.
297 Admittedly, the Commission may, under the second subparagraph of Article 13(1) of Implementing Regulation No 844/2012, consider that a conclusion by EFSA is not necessary. However, even on the assumption that it may dispense with an evaluation by EFSA of the long-term toxicity of a PPP containing a particular active substance, it is common ground in the present case that the Commission did not inform EFSA that a conclusion was not necessary.
298 Last, the fact, referred to in paragraph 429 of the judgment under appeal, that the PPPs were already present on the market has no impact on the Commission’s obligation under Article 4(5) of Regulation No 1107/2009. As the appellant correctly claims, the argument based on the fact that a PPP has been placed on the market amounts to allowing the Commission to presume that a representative use meets the criteria laid down in Article 4(1) to (3) of Regulation No 1107/2009 provided that no Member State has expressed any concerns in a procedure for the authorisation of a PPP the composition of which is identical to that of the representative use. Such a presumption would have the effect, in the context of the renewal of the approval of an active substance, that that substance would be considered also to meet those criteria in application of Article 4(5) of that regulation. However, in view, in particular, of the duration of procedures for the renewal of the approval of active substances, those authorisations may have been issued several years, or indeed several decades, previously, on the basis of scientific or technical knowledge that may have become obsolete.
299 Second, as regards the finding in paragraph 431 of the judgment under appeal, as the appellant correctly maintains, there is no indication in the case file that the General Court, while seeking to preserve the confidentiality of Volume 4 of the evaluation dossier prepared by the RMS, requested access thereto in order to ascertain, with the necessary vigour, the reality of the Commission’s assertions that the long-term toxicity of at least one representative use was the subject of an evaluation. By simply repeating those assertions and taking issue with the appellant for not having given rise to ‘plausible doubts’ as to the legality of the decision at issue, when it could not, by definition, have access to that confidential part of the evaluation dossier of the RMS, the General Court also vitiated its finding by an error of law.
300 Third, it is indeed true, as the Advocate General observed in point 180 of her Opinion, that the General Court was right to hold, in paragraph 433 of the judgment under appeal, that the classification methods applied pursuant to the REACH Regulation and Regulation No 1272/2008 may be taken into account in the context of Regulation No 1107/2009. However, the ground on which the General Court relied, alleging that the safety data sheets were drawn up, in application of the first two regulations, for each component of the representative use of a PPP containing the active substance in question, does not address the appellant’s argument, put forward both at first instance and on appeal, that the isolated evaluation of each of the components does not permit an assessment of the overall toxicity resulting from their interaction.
301 In fact, since a PPP must satisfy all the requirements laid down in Article 29(1) of Regulation No 1107/2009, as the General Court correctly held, moreover, in paragraph 422 of the judgment under appeal, that obligation means that the known cumulative and synergetic effects of the components of the PPPs are taken into account, in order to ensure that the criteria laid down in Article 4(3) of that regulation have been met. It follows that, as the appellant asserts, the effects resulting from the interaction between the active substance concerned and the other components of the product must be taken into consideration (see, to that effect, judgment of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraph 68).
302 In addition, it follows from the Court’s case-law that the evaluation of long-term toxicity requires that specific tests that allow the risk of such toxicity to be excluded be carried out, as ‘cursory tests’ cannot be considered sufficient in that respect (see, to that effect, judgment of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraphs 113, 114 and 116).
303 In those circumstances, having regard to the doubts expressed by the appellant as to the relevance of an evaluation based solely on safety data sheets and on the classification methods referred to above, taking into account the insufficient reliability of those tools for assessing the overall toxicity resulting from the interaction of the components of the representative use of a PPP containing the active substance concerned, the General Court could not consider, without vitiating its assessment by an error of law, that the appellant had not given rise to serious doubts as to the legality of the decision at issue.
304 It follows that the fifth ground of appeal must be upheld.
305 Having regard to all of the foregoing grounds, the Court must uphold:
– the first and third parts of the first ground of appeal, in that the General Court acted in breach of the obligation to state reasons, distorted the evidence and made an error of law vitiating its assessment of the critical area of concern relating to the lack of information on the representativity of the batches used and that relating to the high risk for non-target arthropods;
– the first part of the fourth ground of appeal, in that the General Court made an error of law in considering that the second request for confirmatory information about the toxicity of the isomers did not constitute an abuse; and
– the fifth ground of appeal, in that the General Court was wrong to consider that the appellant had not given rise to ‘plausible doubts’ as to the legality of the decision at issue owing to the failure to evaluate the long-term toxicity of the representative use submitted by the applicant for renewal of the approval of cypermethrin.
306 The judgment under appeal must therefore be set aside in part and the appeal must be dismissed as to the remainder.
The action before the General Court
307 Under the second sentence of the first paragraph of Article 61 of the Statute of the Court of Justice of the European Union, the Court of Justice may, where it quashes the decision of the General Court, itself give final judgment in the matter, where the state of the proceedings so permits.
308 That is the case here, as the single plea in the action for annulment was the subject of an exchange of arguments before the General Court and its examination does not require any further measure of organisation of procedure or inquiry to be taken in the case (see, to that effect, judgment of 8 September 2020, Commission and Council v Carreras Sequeros and Others, C‑119/19 P and C‑126/19 P, EU:C:2020:676, paragraph 130).
The first complaint in the second part of the single plea in the action: lack of information on the representativity of the batches of pesticides used
309 In the context of the first complaint put forward in support of the second part of the single plea in the action, the appellant claims that in the decision at issue the Commission plays down the importance of the critical area of concern, identified in the 2018 EFSA conclusion, relating to the lack of information about the composition of the batches of pesticides used in the ecotoxicological studies, which did not permit EFSA to verify that those batches actually corresponded to the representative uses of a PPP containing cypermethrin.
310 In that regard, it must be recalled that, in the decision at issue, the Commission considered that, on the basis of an additional assurance given by the RMS in an email of 2019 and subsequent exchanges with EFSA, it was apparent that, other than hexane, no impurity was to be considered toxicologically relevant. The Commission inferred that ‘the overall data available in the renewal dossier [were] sufficient to conclude that the new technical materials [had] no more adverse effects than those tested for the first approval’ and that the critical area of concern in the EFSA conclusion would be sufficiently addressed by increasing the minimum purity level of cypermethrin to 920 g/kg and setting a maximum content of 5 g/kg for hexane.
311 However, as stated in paragraph 116 of the present judgment, it follows, first, from the decision at issue that the batches used by the applicants for renewal of the approval of cypermethrin differed from those used at the time of the initial approval, in that they disclosed the existence of new impurities other than hexane. As is apparent from the 2018 EFSA conclusion, and contrary to what is stated in the decision at issue, EFSA did not ‘confirm’ that those impurities were irrelevant. On the contrary, it stated that ‘QSARs [quantitative structure-activity relationship analyses] [had] been provided for the other impurities but [were] not sufficient to exclude at least a genotoxic potential (data gap)’, with the consequence that ‘the assessment of the toxicological relevance of these impurities [could not] be finalised’, in particular for the toxicity for mammals and the environment.
312 Second, as regards the Commission’s argument that the information confirming that no impurity other than hexane was toxicologically relevant was obtained following an exchange with EFSA subsequent to the publication of the EFSA conclusion, it is sufficient to state that the decision at issue does not refer to the existence of any exchange of that nature or, a fortiori, the form taken by those exchanges. In particular, it should be noted that the 2019 EFSA statement is silent on the matter.
313 Third, as regards the Commission’s argument that the exchanges with the RMS provided additional assurance on that matter, the decision at issue states that the RMS, in its email of 2019, acknowledged a data gap concerning the impurities contained in the batches of pesticides used by the applicants for renewal of the approval of cypermethrin, as stated in the 2018 EFSA conclusion. Neither that email nor the decision at issue mentions that a scientific evaluation of those impurities, other than hexane, was carried out by the RMS, which merely states that, ‘taking into account the overall assessment of the impurities’, it ‘considers that the data gap can be addressed either at zonal/national level, or [on] the occasion of the next renewal’, thus expressly recognising that there was a data gap.
314 On the one hand, as regards the data gap identified by EFSA and acknowledged by the RMS in its email of 2019, the reference in that email to the ‘overall assessment of the impurities’ does not establish whether the RMS actually ruled on the toxicological relevance of the new impurities other than hexane or whether the assessment referred to in that email covered those new impurities.
315 On the other, as stated, in essence, in paragraph 178 of the present judgment, the Commission cannot, in the context of the renewal of the approval of a particular active substance, absolve itself of the obligation to verify that at least one representative use of a PPP containing that active substance satisfies the criteria laid down in Article 4(1) to (3) of Regulation No 1107/2009 by transferring that responsibility to the Member States in the context of the procedure for the authorisation of the PPPs containing that active substance or by postponing that verification to the occasion of a possible future procedure for the renewal of the approval of that active substance.
316 Fourth, as the appellant rightly argues, the decision at issue contains no explanation of the way in which the increase in the minimum purity level of cypermethrin to 920 g/kg and the setting of a maximum content of 5 g/kg for hexane are capable of addressing the concern expressed by EFSA about a data gap concerning the impurities other than hexane, corresponding to 75 g/kg, the genotoxic potential of which could not be excluded.
317 In the light of the foregoing grounds, and in accordance with the case-law referred to in paragraph 97 of the present judgment, it should be stated that, in rejecting the appellant’s argument based on the lack of information about the representativity of the batches of pesticides used, the Commission failed to fulfil its obligation to examine carefully, impartially and transparently all the relevant elements of the present case and its obligation to provide sufficient reasons for the decision at issue.
318 The decision at issue must therefore be annulled in that the Commission could not consider that the representativity of the batches of pesticides used for the evaluation of cypermethrin had been demonstrated.
The third complaint in the second part of the single plea in the action: the risk mitigation measures in respect of non-target arthropods in off-field areas were unrealistic
319 As regards the third complaint, relating to the unrealistic nature of the risk mitigation measures chosen by the Commission for non-target arthropods in off-field areas, it should be borne in mind that, as stated in paragraph 178 of the present judgment, the Commission is required to demonstrate that, where a ‘safe’ use of a PPP containing an active substance is identified as permitting the proposed level of risk mitigation to be achieved, that use actually, and not merely theoretically, satisfies the criteria laid down in Article 4(1) to (3) of Regulation No 1107/2009.
320 While it is apparent from the decision at issue that the Commission asserted that such a ‘safe’ use had been identified within the Standing Committee, it does not follow either from that decision or from the material in the case file that the Commission adduced proof that there existed a ‘safe’ use that made it possible to ensure, actually and realistically, a drift reduction greater than 95% that satisfied the criteria laid down in Article 4(1) to (3) of Regulation No 1107/2009.
321 Furthermore, the fact that the Commission applied as a risk mitigation measure for non-target arthropods the reduction of their exposure in off-field areas to levels not exceeding 5.8 mg/ha at the edge of the field, which corresponds to a ‘low risk’ in the sense of the 2019 EFSA statement, does not suffice to demonstrate that a ‘safe use’ of the PPPs containing cypermethrin, understood as an actual and realistic use, has been established.
322 In that regard, as the appellant correctly submitted, it follows from that 2019 statement that such a reduction of exposure by non-target arthropods could be achieved ‘in theory’ by methods to reduce spray drift and the establishment of buffer zones, the width of which varies according to the types of crops, on which spraying at the edge of the non-cultivated zones would be prohibited. The 2019 statement states, in particular, that for winter and spring crops of cereal and rape seed, a buffer zone of 150 metres would permit a drift reduction of 99.3%, corresponding to the minimum reduction necessary to achieve a globally acceptable risk level. On the other hand, for potato crops, the 2019 statement makes clear that a buffer zone of 250 metres, which would correspond to a drift reduction of 99.6%, was not considered sufficient to achieve such a risk level and also that, on the basis of currently available data for cypermethrin, no globally acceptable risk level could be obtained, even with a drift reduction of 99.6%.
323 In addition, as already observed in paragraph 180 of the present judgment, the 2019 EFSA statement emphasises that the effective implementation of a drift reduction measure greater than 95% is ‘challenging in practice’ notably because of wind action and the irregular soil surface in agricultural plots.
324 Therefore, having regard to those factors and to the doubts expressed in the 2019 EFSA statement about the real possibility of achieving a globally acceptable risk level by means of measures requiring, ultimately, a drift reduction greater than 99%, the mere fact that the Commission adopted for non-target arthropods a risk mitigation measure examined in that 2019 statement cannot suffice to establish that it fulfilled its obligation to ensure that that measure was realistic or, a fortiori, that it demonstrated the existence of a ‘safe’ use relating to at least one representative use of a PPP containing cypermethrin.
325 As the decision at issue is not based on any source of a scientific nature other than the 2019 EFSA statement to justify the risk mitigation measure applied for non-target arthropods in off-field areas, the appellant’s argument must be upheld and that decision must be annulled, in that it justifies the renewal of the approval of cypermethrin on the basis of a risk mitigation measure for non-target arthropods in off-field areas which was not shown to be realistic.
The fourth complaint in the second part of the single plea in the action: the second request for confirmatory information on the toxicity of the isomers constituted an abuse
326 As regards the fourth complaint, relating to the abusive nature of the second request for confirmatory information about the toxicity of the isomers, as was stated in paragraph 232 of the present judgment, cypermethrin is a mixture of eight isomers. The dossiers submitted by the applicants for renewal of the approval of that active substance were therefore required to include the information provided for in the fourth paragraph of point 1.9 of Part A of the annex to Regulation No 283/2013.
327 As held in paragraphs 232 to 237 of the present judgment, that requirement meant that those applicants were required to indicate in their dossiers, with a view to the renewal of the approval of cypermethrin, the relative biological activity of each of the isomers, from the viewpoint of both the effectiveness and the toxicity of that active substance. The Commission could not therefore, without infringing Article 6(f) of Regulation No 1107/2009, consider, as it did in the decision at issue, that, in the absence of such information, as observed in the 2018 EFSA conclusion, it remained possible, after the renewal of the approval of that active substance, to send the applicants for renewal of approval a request for ‘further confirmatory information’, within the meaning of Article 6(f) of that regulation.
328 It follows that the decision at issue must be annulled in that it considers that the second request for further confirmatory information which the Commission sent to the applicants for renewal of the approval of cypermethrin does not constitute an abuse.
The seventh complaint in the second part of the single plea in the action: there was no examination of the long-term toxicity of the representative use of the PPP containing cypermethrin submitted by the applicants for renewal of the approval of that active substance
329 As regards the seventh complaint, as was held in paragraph 296 of the present judgment, the Commission must verify, in accordance with its obligations under Article 4(5) and Article 14(1) of Regulation No 1107/2009, that it was established that at least one of the representative uses of a PPP containing a specific active substance does not present long-term toxicity. In that regard, as pointed out in paragraphs 300 and 301 of the present judgment, not only the isolated effects of each of the components of a PPP containing an active substance, but also the known cumulative and synergetic effects of such components must be taken into account in order to satisfy the requirements laid down in Article 4(3) of Regulation No 1107/2009.
330 In the present case, as the appellant rightly submitted, the decision at issue merely indicates that the detailed composition of the PPP that is the subject of the application for renewal of the approval of cypermethrin was supplied and evaluated and that datasheets were also supplied for each component.
331 As is apparent from paragraphs 293 to 303 of the present judgment, those elements are insufficient to show that the Commission verified, carefully and impartially, that before renewal of the approval of that active substance was granted, an evaluation of the known cumulative and synergetic effects of the components of that PPP had been carried out, permitting the conclusion that it had been established that the criteria in Article 4(1) to (3) of Regulation No 1107/2009 were satisfied, for the purposes of Article 4(5) thereof.
332 The mere fact, referred to in the decision at issue, that neither the RMS nor EFSA ‘expressed reservations as to the long-term toxicity of the product’ cannot suffice to establish that an appropriate evaluation, as described in the preceding paragraph of the present judgment, was carried out. Neither the draft RAR nor the 2018 EFSA conclusion contains an express reference to an examination of the long-term toxicity of cypermethrin or of a representative use of a PPP containing that active substance.
333 It follows that the seventh complaint, alleging failure to assess the long-term toxicity of the representative use of the PPP containing cypermethrin submitted by the applicant for renewal of the approval of that active substance, must be upheld.
334 The decision at issue must therefore be annulled in that it finds that the representative of the PPP containing cypermethrin submitted by the applicants for renewal of the approval of that active substance presented no long-term toxicity.
Costs
335 Under Article 184(2) of the Rules of Procedure, 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.
336 Article 138(1) of the Rules of Procedure, which is applicable to the proceedings on appeal pursuant to Article 184(1) of those rules, provides that the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Article 138(3) of the Rules of Procedure, which is also applicable to the proceedings on appeal pursuant to Article 184(1) thereof, provides, moreover, that where each party succeeds on some and fails on other heads, the parties are to bear their own costs. However, if it appears justified in the circumstances of the case, the Court may order that one party, in addition to bearing its own costs, pay a proportion of the costs of the other party.
337 In the present case, as the Commission has been unsuccessful in a significant part of the form of order sought by it, it must be ordered, in addition to bearing its own costs, to pay three quarters of the costs incurred by PAN Europe, relating, in accordance with the form of order sought by the latter, both the proceedings at first instance and to the proceedings on appeal.
On those grounds, the Court (Fourth Chamber) hereby:
1. Sets aside the judgment of the General Court of the European Union of 21 February 2024, PAN Europe v Commission (T‑536/22, EU:T:2024:98), in that it rejects both parts of the single plea of Pesticide Action Network Europe (PAN Europe), alleging, respectively, that
– no information about the representativity of the batches of pesticides usedwas provided;
– the risk mitigation measures in respect of non-target arthropods in off-field areas were unrealistic;
– the second request for confirmatory information about the toxicity of the isomers constituted an abuse; and
– the long-term toxicity of the representative use of the plant protection product containing cypermethrin submitted by the applicants for renewal of the approval of that active substance was not examined;
2. Dismisses the appeal as to the remainder;
3. Annuls the decision of the European Commission of 23 June 2022 (registered under the reference Ares (2022)4621502) in that it
– finds that the representivity of the batches of pesticides used for the assessment of cypermethrin was demonstrated;
– justifies the renewal of the approval of cypermethrin on the basis of a risk mitigation measure in respect of non-target arthropods in off-field areas which was not shown to be realistic;
– considers that the second request for further confirmatory information which the Commission sent to the applicants for renewal of the approval of cypermethrin did not constitute an abuse;
– finds that there was no long-term toxicity in the representative use of the plant protection product containing cypermethrin submitted by the applicants for renewal of the approval of that active substance;
4. Orders the European Commission to bear its own costs and to pay three quarters of the costs incurred by Pesticide Action Network Europe (PAN Europe) relating to the proceedings at first instance and the proceedings on appeal;
5. Orders Pesticide Action Network Europe (PAN Europe) to bear one quarter of its own costs relating to the proceedings at first instance and the proceedings on appeal.
[Signatures]