JUDGMENT OF THE COURT (Eighth Chamber)

22 June 2023 ([\*](#Footnote*))

(Appeal – Plant protection products – Active substance – Regulation (EC) No 1107/2009 – Article 4(5) – Article 14(1) – Article 20(1) – Implementing Regulation (EU) No 844/2012 – Article 12(3) – Article 14(1) – Non-renewal of the approval of the active substance thiram for the purpose of placing it on the market – Rights of the defence – Precautionary principle – Equal treatment)

In Case C‐259/22 P,

APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 15 April 2022,

**Arysta LifeScience Great Britain Ltd,** established in Edinburgh (United Kingdom), represented by C. Mereu, avocat,

appellant,

the other parties to the proceedings being:

**Taminco BVBA,** established in Ghent (Belgium), represented by C. Mereu, avocat,

applicant at first instance,

**European Commission,** represented by G. Koleva and M. ter Haar, acting as Agents,

defendant at first instance,

THE COURT (Eighth Chamber),

composed of M. Safjan, President of the Chamber, N. Piçarra and M. Gavalec (Rapporteur), Judges,

Advocate General: P. Pikamäe,

Registrar: A. Calot Escobar,

having regard to the written procedure,

having decided, after hearing the Advocate General, to proceed to judgment without an Opinion,

gives the following

**Judgment**

1        By its appeal, Arysta LifeScience Great Britain Ltd seeks to have set aside the judgment of the General Court of the European Union of 9 February 2022, *Taminco and Arysta LifeScience Great Britain* v *Commission* (T‐740/18, EU:T:2022:61) (‘the judgment under appeal’), by which the General Court dismissed its action for annulment of Commission Implementing Regulation (EU) 2018/1500 of 9 October 2018 concerning the non-renewal of approval of the active substance thiram, and prohibiting the use and sale of seeds treated with plant protection products containing thiram, 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 Commission Implementing Regulation (EU) No 540/2011 (OJ 2018 L 254, p. 1) (‘the regulation at issue’).

**Legal context**

***European Union law***

*Regulation (EC) No 1107/2009*

2        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) states in recitals 8, 10 and 14 thereof:

‘(8)      The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment and at the same time to safeguard the competitiveness of Community agriculture. Particular attention should be paid to the protection of vulnerable groups of the population, including pregnant women, infants and children. The precautionary principle should be applied and this Regulation should ensure that industry demonstrates that substances or products produced or placed on the market do not have any harmful effect on human or animal health or any unacceptable effects on the environment.

...

(10)      Substances should only be included in plant protection products where it has been demonstrated that they present a clear benefit for plant production and they are not expected to have any harmful effect on human or animal health or any unacceptable effects on the environment. ...

...

(14)      To speed up the approval of active substances, strict deadlines should be established for the different procedural steps.’

3        Article 4 of that regulation, entitled ‘Approval criteria for active substances’, provides in paragraph 5 thereof:

‘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.’

4        The first subparagraph of Article 7(1) of that regulation, entitled ‘Application’, provides:

‘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), 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.’

5        Article 13 of that regulation, entitled ‘Approval Regulation’, provides in paragraphs 2 and 4 thereof:

‘2.      On the basis of the review report, other factors legitimate to the matter under consideration and the precautionary principle where the conditions laid down in Article 7(1) 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)] are relevant, a Regulation shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), providing that:

(a)      an active substance is approved, subject to conditions and restrictions, as referred to in Article 6, where appropriate;

(b)      an active substance is not approved; or

(c)      the conditions of the approval are amended.

...

4.      Approved active substances shall be included in the Regulation referred to in Article 78(3) containing the list of active substances already approved. The [European] Commission shall maintain a list of approved active substances electronically available to the public.’

6        Article 14 of Regulation No 1107/2009, entitled ‘Renewal of approval’, states, in paragraph 1 thereof:

‘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.’

7        Article 15 of that regulation, entitled ‘Application for renewal’, provides in the first subparagraph of paragraph 2 thereof:

‘When applying for renewal, the applicant shall identify new data he intends to submit and demonstrate that they are necessary, because of data requirements or criteria which were not applicable at the time of the last approval of the active substance or because his request is for an amended approval. The applicant shall at the same time submit a timetable of any new and ongoing studies.’

8        Article 17 of that regulation, entitled ‘Extension of approval period for the duration of the procedure’, states in the first paragraph thereof:

‘Where for reasons beyond the control of the applicant it appears that the approval is likely to expire before a decision has been taken on renewal, a decision shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), postponing the expiry of the approval period for that applicant for a period sufficient to examine the application.’

9        Under Article 20 of that regulation, entitled ‘Renewal Regulation’:

‘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.

2.      Where the reasons for not renewing the approval do not concern the protection of health or the environment, the Regulation referred to in paragraph 1 shall provide for a grace period not exceeding six months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. The grace period for the sale and distribution shall take into account the normal period of use of the plant protection product but the total grace period shall not exceed 18 months.

In the case of a withdrawal of the approval or if the approval is not renewed because of the immediate concerns for human health or animal health or the environment, the plant protection products concerned shall be withdrawn from the market immediately.

3.      Article 13(4) shall apply.’

10      Article 29 of Regulation No 1107/2009, entitled ‘Requirements for the authorisation for placing on the market’, provides in paragraph (1)(a):

‘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’.

11      Annex II to that regulation, entitled ‘Procedure and criteria for the approval of active substances, safeners and synergists pursuant to Chapter II’, includes point 3.6 on ‘Impact on human health’, points 3.6.2 to 3.6.4 of which require the Commission to carry out a risk assessment, such as tests concerning genotoxicity, carcinogenicity or reproductive toxicity.

*Implementing Regulation (EU) No 844/2012*

12      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), contained an Article 12, entitled ‘Comments on the draft renewal assessment report’, paragraph 3 of which provides:

‘The [European Food Safety] Authority shall allow a period of 60 days from the date the report is made available to the public for the submission of written comments. Such comments shall be communicated to the [European Food Safety] Authority, which shall collate and forward those comments, including its own comments, to the Commission.’

13      Article 14 of that implementing regulation, entitled ‘Renewal report and renewal Regulation’, provides in paragraph 1 thereof:

‘The Commission shall present to the Committee referred to in Article 79(1) of Regulation [No 1107/2009] a renewal report and a draft Regulation within six months from the date of receipt of the conclusion of the [European Food Safety] Authority or in cases where there is no such conclusion of the Authority, the expiry of the period referred to in Article 12(3) of this Regulation.

The renewal report and the draft Regulation shall take into account the draft renewal assessment report of the rapporteur Member State, the comments referred to in Article 12(3) of this Regulation and the conclusion of the [European Food Safety] Authority, 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.’

**Background to the dispute**

14      The background to the dispute is set out in paragraphs 11 to 37 of the judgment under appeal and may be summarised as follows.

15      Thiram was first approved as an active substance on 1 August 2004 for a period of 10 years. The validity of its approval was extended three times, first until 30 April 2017, next until 30 April 2018 and, finally, until 30 April 2019.

16      In the course of 2014, the Thiram Task Force, composed of Taminco BVBA and Arysta LifeScience Great Britain (together, ‘the applicants for renewal’), companies which market thiram and plant protection products containing thiram for fungicidal purposes throughout the European Union, submitted an application for renewal of the approval of that active substance. That application concerned the use of thiram by foliar spraying and its use as a seed treatment.

17      Designated as the ‘rapporteur Member State’ for that application, the French Republic proposed, in January 2016, that the European Food Safety Authority (‘the Authority’ or ‘EFSA’) renew the approval of thiram solely for use as a seed treatment.

18      From 24 to 26 October 2016, an expert meeting was held at EFSA, where all the experts agreed that it was appropriate to submit a proposal for the classification of thiram as a category 2 carcinogen H351 due to hepatocellular adenoma and C-cell adenoma, since 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), recommended that benign tumours should also be taken into account. In addition, a decision was made at that meeting to reduce the reference value for the long-term risk assessment for mammals from 9 mg/kg body weight per day to 1.6 mg/kg body weight per day.

19      On 27 January 2017, EFSA communicated to the Commission its conclusion, in which it referred to several concerns, including a critical concern relating to the identification of a high dietary risk to birds and mammals.

20      On 31 January 2017, the Commission invited the applicants for renewal to submit their comments on those findings, which they did on 22 February 2017.

21      On 14 June 2017, the Commission sent the applicants for renewal its draft renewal report for the approval of thiram (‘the draft renewal report’) in which it proposed not to renew the approval of that active substance for use either as a seed treatment or by foliar spraying. Furthermore, in accordance with the third subparagraph of Article 14(1) of Implementing Regulation No 844/2012, the Commission invited the applicants for renewal to submit their comments on the draft report, which they did on 26 June 2017.

22      On 20 July 2017, the Commission sent to the Standing Committee on the Food Chain and Animal Health (‘the Standing Committee’) its draft renewal report and its draft implementing regulation in which it proposed not to renew the approval of thiram as regards both its use as a seed treatment and its use by foliar spraying.

23      The proposal for non-renewal of the approval of thiram was discussed in 10 meetings of the Standing Committee in 2017 and 2018. In particular, on 13 and 14 June 2018, during the meeting of the Standing Committee, and then, on 12 July 2018, at the Appeal Committee meeting, the draft renewal report was voted on and a ‘no opinion’ emerged from the votes, owing in particular to the existence of new data on the acceptable risk to birds and mammals concerning the use of thiram as a seed treatment, the possibility of dealing with that risk at national level and the view that the renewal of the approval of that active substance could be limited to its use as a seed treatment.

24      In the meantime, on 7 December 2017, a meeting took place between the Commission and the applicants for renewal, during which the latter presented the first results of the higher tier-field studies concerning the risk assessment of thiram for birds and mammals, which they had started in March and April 2017. The applicants for renewal provided the Commission with information on those studies and their results in a fact sheet dated 23 January 2018.

25      By letter of 19 March 2018, they proposed to the Commission, inter alia, to send it new data in order to address the concerns arising from the change in the reference value for the long-term risk assessment for mammals, referred to in paragraph 18 of the present judgment. By letter of 5 June 2018, the Commission rejected the proposal of the applicants for renewal.

26      Furthermore, after they withdrew, on 18 May 2018, their application for renewal of the approval of thiram for use by foliar spraying, the Commission stated, on 6 June 2018, that it had taken note of that withdrawal and consequently amended the draft implementing regulation and the draft renewal report.

27      By letter of 2 July 2018, the applicants for renewal asked the Commission to reconsider, on the basis of scientific evidence alone, its proposal for the renewal of the approval of thiram on the basis of the sole use of that active substance as a seed treatment. The Commission rejected that request by letter of 17 July 2018.

28      On 9 October 2018, the Commission adopted the regulation at issue, recitals 8 and 11 of which are worded as follows:

‘(8)      On 27 January 2017 the Authority communicated to the Commission its conclusion on whether thiram can be expected to meet the approval criteria provided for in Article 4 of [Regulation No 1107/2009]. The Authority identified a high acute risk to consumers and to workers from application of thiram by foliar spraying. Furthermore, it identified a high risk to birds and mammals from all representative uses assessed, including as a seed treatment, even taking into account the application of higher tier refinements in the risk assessment. Residue definitions for risk assessment purposes could not be derived from the incomplete information available on metabolite M1, consequently the assessment of consumer risk through dietary intake could not be completed and maximum residue levels could not be established. Furthermore, the formation of N,N-dimethylnitrous amide (NDMA), a substance of concern given its intrinsic hazard, in drinking water when surface water and groundwater containing thiram and its metabolite DMCS [dimethylamino(oxo)methanesulfonic acid] is subject to water treatment processes could not be excluded by the Authority based on the available information and in addition a high risk to aquatic organisms from exposure to DMCS was concluded by the Authority based on the limited information available. Also, based on the information available the Authority could not conclude on the endocrine disrupting potential of thiram.

...

(11)      Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation [No 1107/2009] are satisfied. It is therefore appropriate not to renew the approval of the active substance thiram in accordance with Article 20(1)(b) of that Regulation.’

**The procedure before the General Court and the judgment under appeal**

29      By application lodged at the Registry of the General Court on 18 December 2018, the applicants for renewal brought an action for annulment of the regulation at issue.

30      In support of their action, they relied on six pleas in law. In the context of the first three pleas in law, they alleged that the regulation at issue was vitiated by a formal defect and manifest errors of assessment resulting in infringement of Article 4(5) of Regulation No 1107/2009, in that the Commission had failed to take into account the fact that they had withdrawn their application for renewal of the approval of thiram for use of that active substance by foliar spraying and that they had maintained their application only for seed treatment use. As for the fourth to sixth pleas in law, they alleged misuse of powers in that EFSA had classified thiram as a carcinogen, breach of the rights of the defence and infringement of the precautionary principle, the principle of proportionality and the principle of equal treatment, respectively.

31      By the judgment under appeal, the General Court rejected each of those six pleas on the merits.

**Forms of order sought**

32      By its appeal, Arysta LifeScience Great Britain claims that the Court of Justice should:

–        set aside the judgment under appeal;

–        annul the regulation at issue; and

–        order the Commission to pay all the costs.

33      The Commission contends that the Court should:

–        dismiss the appeal; and

–        order the appellant to pay the costs.

34      Taminco contends that the Court should uphold the appellant’s appeal in its entirety.

**The appeal**

35      In support of its appeal, the appellant raises five grounds of appeal. The first alleges that the General Court erred in law in holding that its rights of defence should be respected only to the extent of the rights specifically guaranteed by Article 12(3) and Article 14(1) of Implementing Regulation No 844/2012. By its second ground of appeal, the appellant complains that the General Court erred in law in holding, first, that it could not withdraw one of the representative uses of thiram from its notification dossier and, second, that the document entitled ‘EFSA, Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide substances actives’, adopted by EFSA on 27 March 2019 (‘EFSA’s administrative guidance’), which provides that [applicants for approval of pesticide active substances] may withdraw representative uses of the active substance concerned from their notification dossier at any time, was not applicable. The third ground of appeal alleges, first, an error in law in that the General Court referred to the use of thiram by foliar spraying to justify conclusions on the use of that substance as a seed treatment and, second, a distortion of the evidence in that the General Court held that the Commission had correctly amended the regulation at issue to reflect the withdrawal of the application for renewal of the approval of thiram for use by foliar spraying. By its fourth ground of appeal, the appellant claims that the General Court erred in law, distorted the evidence and/or based its conclusions on inconsistent reasoning and/or without a sufficient statement of reasons in holding that, first, metabolite M1 was relevant for the assessment of use of thiram as a seed treatment and, second, there was a risk for seed treatment uses due to the presence of metabolite DMCS. Finally, by the fifth ground of appeal, the appellant criticises the judgment under appeal on the ground that the General Court misinterpreted the precautionary principle and/or erred in law and/or distorted the evidence, thus reaching a legally flawed conclusion in holding that the Commission had conducted a proper impact assessment under the precautionary principle.

***The first ground of appeal***

*Arguments of the parties*

36      By its first ground of appeal, the appellant challenges paragraphs 67 to 74 of the judgment under appeal in that the General Court held in those paragraphs that its rights of defence should be respected only to the extent of the rights specifically guaranteed by Article 12(3) and Article 14(1) of Implementing Regulation No 844/2012.

37      The General Court wrongly assumes that, where an act is of general application, the person adversely affected by that act can exercise his or her rights of defence only within the limits of the provisions which expressly provide for respect for those rights, as provided for by the rules governing the procedure in question. In so doing, the Court failed to have regard to the fact that respect for the rights of the defence must be guaranteed in all proceedings resulting in an act adversely affecting that person, irrespective of whether or not that act is of general application.

38      Enjoyment of the rights of the defence stems from three conditions being satisfied, namely the administrative nature of the procedure which led to the adoption of the act in question, the fact that that act is capable of adversely affecting the person concerned and, lastly, the fact that that person initiated the procedure in question.

39      Since those three conditions are satisfied in the present case, the applicant’s rights of defence must be fully respected, as is apparent from the judgment of 17 May 2018, *Bayer CropScience and Others* v *Commission* (T‐429/13 and T‐451/13, EU:T:2018:280, paragraph 451). By contrast, the judgment of 27 September 2018, *Mellifera* v *Commission* (T‐12/17, EU:T:2018:616, paragraph 71), to which the General Court referred in paragraph 69 of the judgment under appeal, is not relevant since the proceedings at issue in the case giving rise to that judgment had not been initiated by the person concerned.

40      Furthermore, respect for the rights of defence of the person concerned is of even more fundamental importance since the Commission enjoys a wide discretion in the context of the procedure for the renewal of the approval of an active substance and must be guaranteed even in the absence of any provision expressly providing for respect for those rights, as provided for by the legislation concerning the procedure in question.

41      The appellant also maintains that had its rights of defence been fully respected, the outcome of that procedure could have been different. The use of thiram by foliar spraying would have been excluded from the risk assessment and the submissions on the use of that active substance as a seed treatment would have been assessed separately on their own merits. Similarly, the EFSA proposal for the classification of thiram as a carcinogen would have been disregarded. Lastly, new data and information on the use of thiram as a seed treatment, submitted by the appellant, would have been examined by both EFSA and the rapporteur Member State.

42      Consequently, the appellant submits that the judgment under appeal should be set aside and the regulation at issue annulled.

43      The Commission submits that the first ground of appeal is unfounded.

*Findings of the Court*

44      The first ground of appeal, which concerns paragraphs 67 to 74 of the judgment under appeal, is based on the premiss that the General Court erred in law in finding that respect for the appellant’s rights of defence is guaranteed only to the extent of the rights specifically guaranteed by Article 12(3) and Article 14(1) of Implementing Regulation No 844/2012.

45      As a preliminary point, it should be noted, as is apparent from recital 8 of Regulation No 1107/2009, that the objective of that regulation is, inter alia, to ensure a high level of protection of both human and animal health and the environment, while safeguarding the competitiveness of EU agriculture, in a context of scientific uncertainty, which justifies the application of the precautionary principle. Therefore, as the General Court held in paragraph 52 of the judgment at issue, which is not contested by the appellant, in order to enable the Commission to pursue effectively the objective thus assigned to it, and in view of the complex technical assessments which it must carry out, it must be granted a wide discretion (see, by analogy, judgment of 18 July 2007, *Industrias Químicas del Vallés* v *Commission*, C‐326/05 P, EU:C:2007:443, paragraph 75), in particular in the context of the procedure for the renewal of the approval of an active substance.

46      As is apparent from the settled case-law of the Court, where the EU institutions have such a wide discretion, observance of the guarantees conferred by the European Union legal order in administrative procedures is of even more fundamental 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 right of the person concerned to make his or her views known. Only in this way can the EU judicature verify whether the factual and legal elements upon which the exercise of the discretion depends were present (judgments of 21 November 1991, *Technische Universität München*, C‐269/90, EU:C:1991:438, paragraph 14, and of 19 July 2012, *Council* v *Zhejiang Xinan Chemical Industrial Group*, C‐337/09 P, EU:C:2012:471, paragraph 107).

47      In that regard, as the General Court correctly observed in paragraph 67 of the judgment under appeal, it is also settled case-law that respect for the rights of the defence constitutes, in any proceedings initiated against a person and likely to result in a measure adversely affecting that person, a fundamental principle of EU law which must be ensured even in the absence of any provision in the rules governing that procedure expressly providing for observance of those rights. Respect for the rights of the defence requires that the addressees of decisions which significantly affect their interests should be placed in a position in which they may effectively make known their views on the evidence on which the contested decision is based (see, to that effect, judgments of 10 July 1986, *Belgium* v *Commission*, 234/84, EU:C:1986:302, paragraph 27; of 24 October 1996, *Commission* v *Lisrestal and Others*, C‐32/95 P, EU:C:1996:402, paragraph 21; and of 15 June 2006, *Dokter and Others*, C‐28/05, EU:C:2006:408, paragraph 74).

48      That line of case-law, which covers simultaneously the concepts of ‘measure adversely affecting’ and ‘decision’, is particularly intended to apply to administrative procedures that may lead to the imposition on the person concerned of penalties for infringement of the rules of EU law, such as those concerning competition law or State aid (see, to that effect, judgments of 13 February 1979, *Hoffmann-La Roche* v *Commission*, 85/76, EU:C:1979:36, paragraphs 9 and 11, and of 10 July 1986, *Belgium* v *Commission*, 234/84, EU:C:1986:302, paragraph 27). In such circumstances, the person penalised is clearly the addressee of the decision which significantly affects his or her interests and which brings to an end proceedings initiated against him or her.

49      Such an analysis is borne out by Article 41 of the Charter of Fundamental Rights of the European Union, paragraph 2(a) of which provides for the right of every person to be heard before any individual measure which would affect him or her is taken.

50      The right of every person to be heard is not intended to apply where a person considers himself or herself to be affected by an act of general application.

51      Accordingly, the General Court was right to state, in paragraph 68 of the judgment under appeal, first, that neither the process of the preparation of acts of general application nor those acts themselves require, under the general principles of EU law, such as the right to be heard, consulted or informed, the participation of those affected and, second, that the position is different if an express provision of the legal framework governing the adoption of that act confers such a procedural right on an affected person. Even though Article 41(2)(a) of the Charter of Fundamental Rights of the European Union does not require it to do so, it remains open to the EU legislature to provide for a right, for persons deemed to be affected by an act of general application, to be heard, consulted or informed and to regulate the exercise of that right.

52      In the present case, the procedure for the renewal of the approval of thiram concerns an active substance, with the result that it was not initiated against the applicant.

53      Moreover, the measures taken by the Commission in the context of a procedure for the renewal of the approval of an active substance are acts of general application. As the General Court held in paragraphs 58 and 60 of its judgment of 27 September 2018, *Mellifera* v *Commission* (T‐12/17, EU:T:2018:616), which was upheld on appeal by the judgment of 3 September 2020, *Mellifera* v *Commission* (C‐784/18 P, not published, EU:C:2020:630, paragraphs 68 and 69), an implementing regulation adopted on the basis of the first paragraph of Article 17 of Regulation No 1107/2009 extends the duration of the approval of the active substance in question for a certain period. That measure therefore has the same effects as an implementing regulation approving such a substance for the first time under Article 13(2) of Regulation No 1107/2009 or a regulation renewing approval of that substance under Article 20 of that regulation.

54      Furthermore, it is apparent in particular from Article 29(1)(a) of that regulation that a plant protection product may be authorised only if the active substance which it contains has been approved. Consequently, approval of an active substance on the basis of Regulation No 1107/2009 entails legal effects not only for the person who has applied for such approval, and also for any operator whose activities require such approval, such as producers of plant protection products containing that substance, and for any competent public authority, in particular the public authorities of the Member States in charge of authorising those products.

55      It follows that the regulation at issue applies to objectively determined situations and it produces legal effects with respect to a category of persons envisaged in general and in the abstract (see, by analogy, judgment of 3 September 2020, *Mellifera* v *Commission*, C‐784/18 P, not published, EU:C:2020:630, paragraphs 73 and 74). The appellant cannot therefore be regarded as being the addressee of the regulation at issue, as the General Court correctly pointed out in paragraph 70 of the judgment under appeal.

56      It follows that the only procedural rights on which the appellant could rely were those granted to it by Regulation No 1107/2009 and Implementing Regulation No 844/2012. As the General Court correctly held, in paragraphs 72 to 74 of the judgment under appeal, the appellant derived from Article 12(3) and the third subparagraph of Article 14(1) of Implementing Regulation No 844/2012 a right to be heard in the context of the examination of the application for renewal of the approval of thiram, which, it is common ground, has been observed. The appellant was given the opportunity to submit comments on the draft renewal assessment report, in accordance with Article 12(3) of that regulation, and comments on the draft renewal report, in accordance with the third subparagraph of Article 14(1) of that regulation.

57      The first ground of appeal must therefore be rejected as unfounded.

***The third ground of appeal***

*Arguments of the parties*

58      The appellant criticises, in the first place, paragraphs 102 to 105 of the judgment under appeal. It complains that the General Court concluded that the Commission was not required to base the regulation at issue solely on grounds relating to the use of thiram as a seed treatment. After the withdrawal of the application for renewal of the approval of that active substance for the purposes of its use as a foliar spray, the Commission should have considered that the data relating to that use were irrelevant to the assessment of the use of that substance as a seed treatment. However, the General Court refused to annul that regulation, even though recital 8 of that regulation referred without distinction to those two uses.

59      In the second place, the General Court also erred in law by assuming that the Commission had to carry out a new assessment of the use of thiram as a seed treatment following the withdrawal of that application for use of that active substance as a foliar spray. That latter use had already been assessed and there was no need to conduct a new assessment of that use. In so doing, the General Court failed to have regard to the appellant’s right to withdraw voluntarily one of the representative uses of thiram which it had initially included in its notification dossier.

60      In the third place, the appellant complains that the General Court distorted the facts and evidence in paragraph 99 of the judgment under appeal and, therefore, erred in law in finding that the Commission had taken account of the withdrawal of the application for renewal of the approval of thiram for the purpose of the use of that active substance as a foliar spray and, consequently, had intended to amend 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), although the regulation at issue relies on data relating to the use of thiram as a foliar spray to justify the non-renewal of the approval of that active substance for use as a seed treatment. That regulation is thus based on issues that are immaterial to seed treatment, such as the ‘high acute risk to consumers and to workers from application of thiram by foliar spraying’, referred to in recital 8 of the regulation at issue.

61      The Commission contends, primarily, that the third ground of appeal is inadmissible and, in the alternative, that it is unfounded.

*Findings of the Court*

62      By its third ground of appeal, the appellant criticises the reasoning of the General Court in paragraphs 99 and 102 to 105 of the judgment under appeal.

63      In the first place, as regards the argument that the General Court distorted the facts and evidence, in paragraph 99 of the judgment under appeal, in considering that the Commission had taken into account the withdrawal of the application for renewal of the approval of thiram for the purpose of the use of that active substance as a foliar spray and, consequently, had intended to amend Implementing Regulation No 540/2011, it must be recalled that distortion must, according to settled case-law, be obvious from the documents in the Court’s file without any need for a new assessment of the facts and the evidence (see, to that effect, judgments of 28 May 1998, *New Holland Ford* v *Commission*, C‐8/95 P, EU:C:1998:257, paragraph 72; of 2 September 2010, *Calvin Klein Trademark Trust* v *OHIM*, C‐254/09 P, EU:C:2010:488, paragraph 50; and of 2 March 2021, *Commission* v *Italy and Others*, C‐425/19 P, EU:C:2021:154, paragraph 52).

64      In paragraph 99 of the judgment under appeal, the General Court merely reproduced the wording of recitals 12 and 13 of the regulation at issue; accordingly, the alleged distortion cannot be established. Therefore that argument must be rejected as unfounded.

65      In the second place, the same is true of the argument that the General Court distorted the evidence by finding, in paragraph 99 of the judgment under appeal, that the Commission had correctly amended the regulation at issue to reflect the withdrawal of that application for the use of thiram as a foliar spray. Since the distortion is not obvious from the file, that argument must be rejected as unfounded.

66      In the third place, it follows from paragraph 101 of the judgment under appeal that the General Court implicitly considered that the withdrawal of the application for renewal of the approval of thiram for use as a foliar spray had occurred at too advanced a stage of the procedure for it to be taken into account by the Commission. The Court observed, in essence, that that withdrawal took place more than a year after the completion of the risk assessment process, which materialised in the adoption of the EFSA conclusion.

67      In view of the wide discretion enjoyed by the Commission in the context of the adoption of the risk management decisions which it must take pursuant to Regulation No 1107/2009, as recalled in paragraph 45 of the present judgment, the General Court was entitled to find, without erring in law, that the Commission could, in the light of the particularly advanced stage which the procedure for the renewal of the approval of thiram had reached, take into consideration data relating to the use of that active substance as a foliar spray in order to decide on the application for renewal of the approval of that substance for use as a seed treatment.

68      That finding is all the more compelling since it follows from recital 14 of Regulation No 1107/2009 that strict deadlines should be established for each stage of the procedure in order for the approval of active substances to progress as fast as possible.

69      An indefinite extension of the assessment period for an active substance would be contrary to the objective set out in recital 8 of that regulation, which is to ensure a high level of protection of both human and animal health and the environment. In this case, the temporal scope of Implementing Regulation No 540/2011, which approved thiram, was extended on several occasions, in order to allow the Commission to decide on the application for renewal of the approval of that active substance.

70      In that regard, it should be noted, as the General Court observed in paragraph 103 of the judgment under appeal without being strongly contradicted by the appellant, that the risks identified and linked to the application of thiram by foliar spraying concerned products already on the market, with the result that the risks assessed were real risks and not hypothetical risks. It was therefore crucial for the Commission to decide on the application for renewal of the approval of thiram within a reasonable period of time.

71      Lastly, the General Court also pointed out, in essence, in paragraph 105 of the judgment under appeal, that the Commission was entitled to consider, in its capacity as risk manager, that the arguments put forward by the applicants for renewal were not capable of dispelling concerns relating to thiram and, in particular, concerns relating to its use as a foliar spray.

72      In so doing, by emphasising that it was for the applicants for renewal to dispel the Commission’s concerns, the General Court merely recalled that the burden of proving the safety of the various uses of thiram lies with them. As is apparent from paragraph 57 of the judgment under appeal, which is not disputed by the appellant, it follows from Article 14(1) and Article 15(2) of Regulation No 1107/2009, read in conjunction with recitals 8 and 10 thereof, that the burden of proving the safety of the uses of an active substance, renewal of the approval of which is sought, rests on the applicant for renewal of the approval of that substance, and not on the Commission or the General Court.

73      Those provisions thus constitute the corollary of Article 7(1) of that regulation, under which the producer of an active substance who submits an application for the approval of an active substance or for an amendment to the conditions of an approval of an active substance must demonstrate that that substance fulfils the approval criteria provided for in Article 4 of that regulation. The obligation for the applicant to prove that the renewal of the approval of an active substance satisfies the conditions imposed by that latter provision contributes to achieving compliance with the precautionary principle by ensuring that there is no presumption that active substances and plant protection products have no harmful effects (see, by analogy, judgment of 1 October 2019, *Blaise and Others*, C‐616/17, EU:C:2019:800, paragraph 80).

74      In any event, it should be noted that the General Court was right not to consider that recital 8 of the regulation at issue, which reflects the conclusion reached by EFSA, referred without distinction to the use of thiram by foliar spraying and its use as a seed treatment.

75      Only the second sentence of that recital relates to a high acute risk to consumers and to workers linked, exclusively, to the application of thiram by foliar spraying. By contrast, the third sentence of that recital emphasises that EFSA ‘identified a high risk to birds and mammals from all representative uses assessed, including as a seed treatment, even taking into account the application of higher tier refinements in the risk assessment’. As for the last five sentences of that recital, they all point to the insufficiency of the information available to carry out the risk assessment caused by the two uses of thiram in respect of which renewal of the approval of that active substance had originally been sought.

76      It follows that the third ground of appeal must be rejected as in part inadmissible and in part unfounded.

***The second ground of appeal***

77      The second ground of appeal is divided into two parts, alleging, first, an error of law on the part of the General Court in that it excluded the possibility for the appellant to withdraw from its application one of the representative uses of thiram which it had previously mentioned and, second, an error of law committed by the General Court in that it declared that EFSA’s administrative guidance was inapplicable.

*The first part*

–       *Arguments of the parties*

78      The appellant complains that the General Court erred in law in concluding, in paragraph 98 of the judgment under appeal, that ‘Regulation No 1107/2009 does not provide for the situation in which the applicant for renewal of an approval of an active substance withdraws its application for one of the representative uses which it has previously designated’. Apart from the fact that that statement by the General Court is reversible since no provision prohibits such a withdrawal, the freedom of applicants for renewal to choose the representative uses of an active substance at the beginning of the process for renewal of the approval of such a substance implies the freedom to withdraw them during that process. In that regard, Article 4(5) of that regulation provides that applicants must only demonstrate that their substance is safe ‘with respect to one or more representative uses of at least one plant protection product containing that active substance’. Therefore, the withdrawal of a representative use of an active substance should be allowed as long as another representative use of that substance is the subject of an assessment.

79      Finally, contrary to what the General Court stated in paragraph 103 of the judgment under appeal, the withdrawal of an application for renewal of the approval of an active substance of a representative use of that substance has no bearing on the duration of the renewal procedure or the safety of consumers. In the present case, the Commission should simply have deleted from the regulation at issue any reference to the use of thiram as a foliar spray and renewed the approval of that active substance for use as a seed treatment, since that use had already been assessed by the rapporteur Member State and EFSA had submitted it to peer review, as provided for in EFSA’s administrative guidance.

80      The Commission contends that the first part of the second ground of appeal is unfounded.

–       *Findings of the Court*

81      As the appellant noted, the General Court stated, in the first sentence of paragraph 98 of the judgment under appeal, that Regulation No 1107/2009 does not provide for the situation in which the applicant for renewal of an approval of an active substance withdraws its application for one of the representative uses of that substance which it has previously designated.

82      That finding cannot, in itself, be criticised, since the General Court merely pointed out that, objectively, that regulation contained no provision expressly giving the applicant for renewal of an approval of an active substance the option of withdrawing part of its application.

83      Nevertheless, that finding implies, implicitly but necessarily, that the General Court interpreted the fact that that regulation is silent on the matter as prohibiting the applicant for renewal of the approval of an active substance from partially withdrawing its application. By failing to substantiate that inference in any way, the General Court did not examine the appellant’s argument that, in essence, since in an administrative procedure the administrative authorities are responsible for processing only applications submitted to them at the discretion of applicants, those applicants should retain control over that procedure, with the result that Regulation No 1107/2009 should be interpreted as allowing applicants to withdraw part of their application.

84      It follows that the prohibition to partially withdraw an application for the approval of an active substance directed at an applicant for renewal can be inferred solely from the first sentence of paragraph 98 of the judgment under appeal. Accordingly, that paragraph is vitiated by a failure to state reasons.

85      That being said, since it follows in particular from paragraph 75 of the present judgment that the appellant has not demonstrated the safety of any use of thiram, it must be held that that failure to state reasons is ineffective.

86      It follows that the first part of the second ground of appeal must be rejected.

*The second part*

–       *Arguments of the parties*

87      The appellant claims that the General Court was wrong to conclude, in paragraph 98 of the judgment under appeal, that EFSA’s administrative guidance was inapplicable.

88      In the first place, it criticises the General Court for having considered that it was necessary to separate, within the procedure for the renewal of the approval of an active substance, the stage which starts with the submission of an application and ends with the adoption and publication of the EFSA conclusion and that relating to the adoption of the Commission’s decision.

89      First of all, EFSA, as risk assessor, examines the data and provides a scientific opinion to support the Commission’s decision-making process. Next, the Commission, as risk controller, reaches a decision on the basis of the EFSA conclusion. The renewal procedure is thus a single process in which the assessments of EFSA and the Commission are linked, which the General Court moreover acknowledged in paragraphs 120 and 121 of the judgment under appeal.

90      In addition, the decision of an applicant for renewal of the approval of an active substance to withdraw from its application a representative use of that substance can be taken only at a stage where it is possible to determine whether a given representative use has a chance of being renewed, that is to say, after the publication of the EFSA conclusion. That applicant should therefore be able to withdraw from its application a representative use of the active substance concerned when it becomes evident that it will not be renewed. That is the case where that use may have a negative effect on the assessment of the remaining use of such a substance. It is therefore wrong to limit the possibility of requesting the withdrawal of a use to the period prior to the publication of the EFSA conclusion. Moreover, the Commission has accepted, on several occasions, the withdrawal of applications for renewal of the approval of active substances at any time.

91      In the second place, the fact that EFSA’s administrative guidance was published after the adoption of the regulation at issue is irrelevant, since it merely confirms a solution already established by Regulation No 1107/2009 and Regulation No 844/2012 and by the Commission’s practice.

92      In the third place, the General Court’s argument concerning the lack of a reference, in EFSA’s administrative guidance, to the partial withdrawal of the application for renewal of the approval of thiram is irrelevant. Furthermore, according to Article 4 of Regulation No 1107/2009, it is solely for the applicant for renewal of the approval of an active substance to prove that there is at least one representative use of that substance that presents no risk. Consequently, the withdrawal of such an application for a representative use of the active substance in question is legally valid since a representative use of that substance remains available for the purpose of its assessment.

93      The Commission contends that the second part of the second ground of appeal must be rejected as unfounded.

–       *Findings of the Court*

94      The complaint relating to paragraph 98 of the judgment under appeal, according to which the General Court wrongly stated in that paragraph that EFSA’s administrative guidance was inapplicable, must be rejected. The General Court was right to find that that administrative guidance could not be applied, *ratione temporis*, by the Commission in the present case, since it was not adopted by EFSA until 27 March 2019, whereas the regulation at issue was adopted on 9 October 2018.

95      Furthermore, the appellant has in no way demonstrated its claim that EFSA’s administrative guidance merely confirms a solution already established by Regulation No 1107/2009 and Regulation No 844/2012 and by the Commission’s practice.

96      In any event, as the General Court correctly pointed out in paragraph 98 of the judgment under appeal, while it is true that EFSA’s administrative guidance states, in paragraph 2.9 thereof, entitled ‘Withdrawal of an application’, that ‘Should an applicant wish to withdraw its application at any time, he/she should inform in writing the [rapporteur Member State (RMS)], notifying via email also EFSA and the European Commission’, that same paragraph states, however, that ‘the withdrawal of an application after the adoption of an EFSA conclusion has no effect on the adopted output, which will be in any case published on the EFSA Journal’. Therefore, although the late withdrawal of an application is deemed not to have any effect on the EFSA conclusion, it is likely that the Commission may, in the light of the advanced stage of the procedure for the renewal of the approval of an active substance, continue that procedure until its conclusion, notwithstanding the occurrence of such a withdrawal.

97      It follows that the second part must be rejected.

98      Consequently, the second ground of appeal must be rejected as in part unfounded and in part ineffective.

***The fourth ground of appeal***

99      The fourth ground of appeal is divided into two parts, alleging, first, the irrelevance of metabolite M1 in the assessment of the use of thiram as a seed treatment and, second, a failure to state reasons in the judgment under appeal as regards the existence of a risk linked to the presence of metabolite DMCS.

*The first part*

–       *Arguments of the parties*

100    The appellant notes that, in paragraph 127 of the judgment under appeal, the General Court acknowledged that metabolite M1 was not relevant in the context of the assessment of the representative seed treatment use of thiram on maize. That question which relates to metabolite M1 concerned only the use of thiram as a foliar spray and the renewal assessment report prepared by the French Republic, in its capacity as rapporteur State, expressly found, in that regard, that no residue of metabolite M1 had been observed in the uses of thiram as a seed treatment. That question is therefore unrelated to the use of thiram as a seed treatment and should have been ignored by the Commission after the voluntary withdrawal of the application for renewal of the approval of thiram from the use of that active substance as a foliar spray. The General Court ought to have found, in paragraph 134 of the judgment under appeal, that the Commission had made a manifest error of assessment in relying on the incomplete nature of the information available in relation to metabolite M1, as regards the use of thiram as a seed treatment.

101    The Commission contends, primarily, that the first part of the fourth ground of appeal is inadmissible and, in the alternative, that it is unfounded.

–       *Findings of the Court*

102    The appellant’s argument that the Commission should not have taken account of metabolite M1 in its assessment of the application for renewal of the approval of thiram for use as a seed treatment cannot be accepted.

103    The fact that the General Court noted, in paragraph 127 of the judgment under appeal, that metabolite M1 was not relevant in the context of the assessment of the specific use of thiram on maize cannot undermine the fact that the appellant had not established that metabolite M1 was irrelevant in the context of the assessment of all the uses of thiram as a seed treatment or that, in its conclusion, EFSA, as is apparent from the fourth sentence of recital 8 of the regulation at issue, noted that the incomplete information available on metabolite M1 did not allow definitions of residues to be established for the purpose of the risk assessment.

104    In so doing, as the Commission maintained in its response, the appellant misinterprets paragraph 127 of the judgment under appeal. The Court finds in that paragraph that metabolite M1 ‘is not relevant for the specific representative use on maize’, and not that metabolite M1 is not relevant for any other use of thiram as a seed treatment.

105    In those circumstances, the appellant has not demonstrated that the General Court erred in law by refusing, in paragraph 134 of the judgment under appeal, to find that the Commission had made a manifest error of assessment when it relied, in the regulation at issue, as regards the use of thiram as a seed treatment, on the incomplete nature of the information available on metabolite M1.

106    It follows that the first part must be rejected as unfounded.

*The second part*

–       *Arguments of the parties*

107    The appellant challenges paragraph 130 of the judgment under appeal, in that the General Court accepted that, with regard to environmental concentrations in surface waters, the rates of application after use of thiram as a seed treatment are much lower than those related to the use of that active substance as a foliar spray, on which EFSA and the Commission had based their risk assessment calculations. The General Court failed to state reasons for its assertion that, despite the lower levels of application for use of thiram as a seed treatment, there is still a risk to aquatic organisms resulting from their exposure to metabolite DMCS. Since those levels are much lower in the context of the use of that active substance as a seed treatment and are below the threshold of toxicological concern, which is not disputed, the risk resulting from lower environmental concentrations should logically also be lower.

108    The Commission contends that the second part of the fourth ground of appeal is unfounded.

–       *Findings of the Court*

109    In so far as the appellant challenges paragraph 130 of the judgment under appeal, it suffices to note that the General Court did indeed find that the environmental concentrations in surface waters are less significant as regards the use of thiram as a seed treatment than when that active substance is used as a foliar spray. It should be observed, however, that the General Court emphasised above all, in that paragraph of the judgment under appeal, the data gap found by EFSA with regard to the existence of a high risk to aquatic organisms resulting from their exposure to metabolite DMCS.

110    In so ruling, the General Court did not err in law, since it cannot be ruled out that, while being lower than in the context of the uses of thiram by foliar spraying, the environmental concentrations in surface waters relating to the uses of that active substance as a seed treatment remain at a high level. Therefore, the latter uses could pose a risk to aquatic organisms due to their exposure to metabolite DMCS.

111    Furthermore, the applicant’s line of argument presupposes that the burden of proving the existence of a risk to aquatic organisms caused by their exposure to metabolite DMCS rests with the General Court. As has been recalled in paragraphs 72 and 73 of the present judgment, it is for the applicant for renewal of the approval of an active substance to prove the safety of the uses of that substance.

112    In those circumstances, the second part must be rejected as unfounded, as must the fourth ground of appeal in its entirety.

***The fifth ground of appeal***

*Arguments of the parties*

113    By its fifth ground of appeal, the appellant criticises paragraphs 178 to 202 of the judgment under appeal. After finding, in paragraphs 186 to 194 of that judgment, that the precautionary principle required the Commission to carry out an impact assessment in accordance with the Communication from the Commission on the precautionary principle of 2 February 2000 (COM(2000) 1 final) (‘the Communication on the precautionary principle’), the General Court wrongly concluded, in paragraphs 195 to 202 of that judgment, that the Commission had carried out an appropriate impact assessment.

114    In the first place, by stating, in paragraph 198 of the judgment under appeal, that the Commission ‘did in fact take cognisance of the effects, positive and negative, economic and otherwise, likely to be induced by the non-renewal of the approval of thiram and that it took them into account in adopting the [regulation at issue]’, the General Court distorted the facts and the evidence.

115    The Commission did not carry out any impact assessment, nor did it compare the most likely positive or negative consequences of the non-renewal of the approval of thiram. In validating its assessment, the General Court departed from the approach it had taken in the judgment of 17 May 2018, *Bayer CropScience and Others* v *Commission* (T‐429/13 and T‐451/13, EU:T:2018:280).

116    In the second place, the reference, in paragraphs 102 to 107 of the judgment under appeal, to paragraph 163 of the judgment of 17 May 2018, *BASF Agro and Others* v *Commission* (T‐584/13, EU:T:2018:279) is irrelevant and inappropriate. In that judgment, the General Court held that it is not necessary for the economic analysis of the costs and benefits to be made on the basis of a precise calculation of the respective costs of the action proposed or of inaction. The appellant does not claim that a precise calculation was necessary but merely seeks to establish a middle ground between the complete absence of a calculation and a precise calculation. The Communication on the precautionary principle refers to the ‘most likely positive or negative consequences of the envisaged action and those of inaction in terms of the overall cost to the Community’, which entails the conduct of an appropriate study in order to, at the very least, give an overview of those consequences.

117    The General Court also distorted the facts and evidence by stating, in paragraph 200 of the judgment under appeal, that the appellant had not put forward any specific argument as to a possible error on the part of the Commission concerning the examination of the benefits and costs, within the meaning of point 6.3.4 of the Communication on the precautionary principle. The appellant addressed the question of the absence of an impact assessment in the application at first instance, in its reply and in its answers to the questions put by the General Court. However, it was not able to put forward any specific argument as to a possible error concerning the impact assessment, since no such study was carried out. The General Court therefore requires it to adduce ‘diabolical proof’.

118    The Commission contends that the fifth ground of appeal is, primarily, unfounded and, in the alternative, in part inadmissible and in part unfounded.

119    However, as a preliminary point, it asks the Court of Justice to find that the General Court erred in law, in paragraphs 186 to 194 of the judgment under appeal, by imposing on it a separate obligation to carry out an impact assessment of its decision not to renew the approval of thiram for use as a seed treatment.

120    First, in finding that an impact assessment was necessary, the General Court failed to have regard to the judgment of 6 May 2021, *Bayer CropScience and Bayer* v *Commission* (C‐499/18 P, EU:C:2021:367, paragraphs 172 and 176), in which the Court of Justice held that such an additional analysis was not mandatory under Regulation No 1107/2009. The Court pointed out that that regulation required only that a risk assessment be carried out and not an analysis which specifically took into account the benefits and costs of action or inaction. Nor did the Court rely on the Communication on the precautionary principle.

121    Second, nor does point 6.3.4 of that communication impose a separate obligation to carry out an impact assessment or any other form of cost/benefit analysis in the context of a procedure for the renewal of the approval of an active substance under Regulation No 1107/2009.

122    Section 2 of that communication states that the guidelines contained therein ‘serve ... in no way to modify or affect the provisions of the Treaty or secondary Community legislation’. Moreover, a communication is inappropriate for defining the limits of the Commission’s discretion where those limits are set in a regulation adopted after that communication.

123    Finally, point 6.3.4 of the Communication on the precautionary principle states that the examination of the benefits and costs should include an economic cost/benefit analysis ‘where this is appropriate and possible’. Thus, the very wording of that communication clearly indicates that it may be impossible or inappropriate to carry out an economic impact assessment. That is the case for the assessment of the renewal of the approval of an active substance carried out in accordance with the criteria exhaustively defined by Regulation No 1107/2009.

124    Third, that regulation already establishes an autonomous and comprehensive system of risk assessment and management, based on the precautionary principle, as the Court of Justice pointed out in the judgments of 6 May 2021, *Bayer CropScience and Bayer* v *Commission* (C‐499/18 P, EU:C:2021:367, paragraph 79), and of 1 October 2019, *Blaise and Others* (C‐616/17, EU:C:2019:800, paragraph 44).

125    Fourth, the Court has stated, as regards the examination of the proportionality of legislative acts, that there is no formal and autonomous obligation to carry out an impact assessment. Consequently, the absence of such an assessment is not capable of demonstrating that an act manifestly exceeded the limits of what was necessary to achieve the objective pursued, as is apparent from the judgments of 8 July 2010, *Afton Chemical* (C‐343/09, EU:C:2010:419, paragraph 57); of 4 May 2016, *Pillbox 38* (C‐477/14, EU:C:2016:324, paragraphs 64 and 65); and of 3 December 2019, *Czech Republic* v *Parliament and Council* (C‐482/17, EU:C:2019:1035, paragraph 85). In addition, Regulation No 1107/2009 takes full account of the principle of proportionality by adapting the specific procedure for the approval and renewal of approval of active substances, in particular by authorising the approval of such substances subject to limitations and restrictions. However, once a risk is established, it is for the risk managers alone to determine whether or not such a risk is acceptable.

126    The Commission submits, primarily, that the considerations set out in paragraphs 120 to 125 of the present judgment, which should be substituted for the grounds set out in paragraphs 186 to 194 of the judgment under appeal, are such as to lead to the rejection of the fifth ground of appeal in its entirety. In the alternative, it contends that the arguments put forward by the appellant are unfounded.

*Findings of the Court*

127    It is necessary, as a preliminary point, to examine the Commission’s complaints concerning paragraphs 186 to 194 of the judgment under appeal, in so far as those paragraphs impose on it a separate obligation to carry out a cost/benefit analysis of the regulation by means of which it decides on an application for renewal of the approval of an active substance.

128    In that regard, it should be noted that Article 20(1) of Regulation No 1107/2009, read in conjunction with Article 14(1) thereof, provides that, when the Commission receives such a request, it may adopt a regulation authorising the renewal requested, but it may also refuse or authorise such renewal subject to conditions and restrictions.

129    Thus, by providing for the non-renewal or renewal of the approval of an active substance subject to conditions and restrictions, those provisions expressly incorporate the principle of proportionality, which is one of the general principles of EU law. That principle requires that acts of the EU institutions should not exceed the limits of what is appropriate and necessary for the achievement of the legitimate objectives pursued by the legislation in question, it being understood that, where there is a choice between several appropriate measures, the least restrictive should be used and that the inconvenience caused must not be disproportionate to the aims pursued (see, by analogy, judgment of 6 May 2021, *Bayer CropScience and Bayer* v *Commission*, C‐499/18 P, EU:C:2021:367, paragraph 166).

130    In addition, Article 20(1) of Regulation No 1107/2009 does not impose any particular form or detailed rules to ensure compliance with the principle of proportionality (see, by analogy, judgment of 6 May 2021, *Bayer CropScience and Bayer* v *Commission*, C‐499/18 P, EU:C:2021:367, paragraph 169). Article 14 of that regulation, read in conjunction with Article 4 and points 3.6.2 to 3.6.4 of Annex II, entitled ‘Procedure and criteria for the approval of active substances, safeners and sygergists pursuant to Chapter II’, of that regulation, requires the Commission to carry out a risk assessment, such as tests of genotoxicity, carcinogenicity or reproductive toxicity, only when it is called on to decide on an application for renewal of the approval of an active substance (see, by analogy, judgment of 6 May 2021, *Bayer CropScience and Bayer* v *Commission*, C‐499/18 P, EU:C:2021:367, paragraph 172).

131    Those provisions do not therefore require the Commission to draw up a document specifically intended to present its examination of the benefits and costs resulting from its action or inaction. Nor can such an obligation arise from the Communication on the precautionary principle, since, as stated in Section 2 thereof, ‘The guidelines outlined in this Communication ... [must] in no way ... modify or affect the provisions of the Treaty or secondary Community legislation’.

132    It therefore follows from paragraphs 128 to 131 of the present judgment that, when it receives an application for renewal of the approval of an active substance under Article 14 of Regulation No 1107/2009, the Commission is not bound by the guidelines contained in the Communication on the precautionary principle. While it is admittedly for the Commission to demonstrate that it has complied with the principle of proportionality when ruling on such an application for renewal, the Commission is in no way required to base its assessment on a calculation of the respective costs associated with the renewal or non-renewal of the approval of the active substance concerned.

133    It must therefore be held that the General Court erred in law by imposing on the Commission the obligation to examine separately the benefits and costs of the non-renewal of thiram for use as a seed treatment, in accordance with point 6.3.4 of the Communication on the precautionary principle.

134    That being said, the judgment under appeal cannot be set aside, since the General Court rightly found, in that judgment, that, in the present case, the Commission had not failed to observed the precautionary principle, on which the provisions of Regulation No 1107/2009 are based.

135    The General Court has justified to the requisite legal standard that the Commission had fulfilled its obligation to examine the benefits and costs of non-renewal of the approval of an active substance and, therefore, that it had complied with the principle of proportionality, by referring, in paragraph 197 of the judgment under appeal, to the information that the Commission had provided to the Standing Committee at the meetings of 24 and 25 May 2018, to which reference is made in paragraph 23 of this judgment. Moreover, the appellant has not shown that the extract from the summary of that meeting, which is cited in the same paragraph of the judgment under appeal, was distorted by the General Court.

136    In addition, the appellant’s arguments relating to paragraphs 196 and 200 of the judgment under appeal, according to which the General Court did not require the Commission to comply with point 6.3.4 of the Communication on the precautionary principle, must be declared ineffective, since it follows from paragraphs 128 to 132 of the present judgment that the Commission is not bound by the guidelines contained in that communication when it acts under Regulation No 1107/2009.

137    The fifth ground of appeal must therefore be rejected as in part unfounded and in part ineffective.

138    Since none of the five grounds of appeal put forward by the appellant in support of its appeal has been upheld, the appeal must be dismissed in its entirety.

**Costs**

139    In accordance with the Article 184(2) of the Rules of Procedure of the Court of Justice, where the appeal is unfounded, the Court is to make a decision as to costs.

140    Under Article 138(1) of those Rules, which applies to appeal proceedings by virtue of Article 184(1) thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the Commission applied for costs and the appellant’s appeal was unsuccessful, the appellant must be ordered to pay the costs.

On those grounds, the Court (Eighth Chamber) hereby:

1.      **Dismisses the appeal;**

2.      **Orders Arysta LifeScience Great Britain Ltd to pay the costs.**

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| Safjan | Piçarra | Gavalec |

Delivered in open court in Luxembourg on 22 June 2023.

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| A. Calot Escobar | | M. Safjan |

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| Registrar | | President of the Chamber |

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[\*](#Footref*)      Language of the case: English.