Court of Justice of the European Communities (including Court of First Instance Decisions)

JUDGMENT OF THE GENERAL COURT (Fourth Chamber)

28 May 2020 (*) (1)

(Plant-protection products — Active substance oxasulfuron — Non-renewal of approval for placing on the market — Obligation to state reasons — Article 41(2)(c) of the Charter of Fundamental Rights — Manifest error of assessment — Article 6(f) of Regulation (EC) No 1107/2009 and point 2.2 of Annex II to Regulation No 1107/2009 — Precautionary principle)

In Case T‑574/18,

Agrochem-Maks d.o.o., established in Zagreb (Croatia), represented by S. Pappas, lawyer,

applicant,

v

European Commission, represented by A. Lewis, I. Naglis and G. Koleva, acting as Agents,

defendant,

supported by

Kingdom of Sweden, represented by A. Falk, C. Meyer-Seitz, H. Shev, J. Lundberg and H. Eklinder, acting as Agents,

intervener,

APPLICATION based on Article 263 TFEU, seeking annulment of Commission Implementing Regulation (EU) 2018/1019 of 18 July 2018 concerning the non-renewal of approval of the active substance oxasulfuron, 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 183, p. 14),

THE GENERAL COURT (Fourth Chamber),

composed of S. Gervasoni, President, L. Madise (rapporteur) and R. Frendo, Judges,

Registrar: E. Coulon,

gives the following

Judgment

 Legal framework

1        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) entered into force on 14 June 2011. It was adopted on the basis of Article 37(2) EC (now, after amendment, Article 43(1) TFEU) concerning the common agricultural policy, Article 95 EC (now Article 114 TFEU) concerning the approximation of laws which have as their object the internal market, in relation, notably, to the environment, and Article 152(4)(b) EC (now, after amendment, Article 168(4)(b) TFEU) concerning public health.

2        Under Article 28(1) of Regulation No 1107/2009, a plant protection product is not to be placed on the market or used unless it has been authorised in the Member State concerned in accordance with that regulation.

3        In accordance with Article 29(1)(a) of Regulation No 1107/2009, authorisation of a plant protection product by a Member State presupposes, inter alia, that its active substances have been approved at EU level. An applicant is bound to identify, when submitting his or her application for authorisation of a plant protection product, any substance forming part of the composition of that product which corresponds to the criteria set out in Article 2(2) of Regulation No 1107/2009.

4        Article 1 of Regulation No 1107/2009 states, in paragraph 2, that that regulation applies to the active substances which the plant protection products contain, in paragraph 3, that its purpose is to ensure a high level of protection of both human and animal health and the environment, and in paragraph 4, that its provisions 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.

 Criteria for the approval of an active substance set by Regulation No 1107/2009

5        Article 4 of Regulation No 1107/2009, entitled ‘Approval criteria for active substances’, sets out, inter alia, the following criteria:

‘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, taking into account known cumulative and synergistic effects where the scientific methods accepted by the [European Food Safety Authority (EFSA)] to assess such effects are available, or on groundwater;

(b)      they shall not have any unacceptable effect on the environment.

For residues which are of toxicological, ecotoxicological, environmental or drinking water relevance, there shall be methods in general use for measuring them. Analytical standards shall be commonly available.

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 …

4.      …

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.

…’

6        Article 14 of Regulation No 1107/2009, entitled ‘Renewal of approval’, is worded as follows:

‘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.

…’

7        Article 6, entitled ‘Conditions and restrictions’, is worded as follows:

‘Approval may be subject to conditions and restrictions including:

…

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

8        Point 2.2 of Annex II to Regulation No 1107/1009 is worded as follows:

‘Submission of further information

In principle an active substance, safener or synergist shall only be approved where a complete dossier is submitted.

In exceptional cases an active substance, safener or synergist 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.’

9        Article 15, entitled ‘Application for renewal’, of the regulation is worded as follows:

‘1.      The application provided for in Article 14 shall be submitted by a producer of the active substance to a Member State, with a copy to the other Member States, the Commission and [EFSA], no later than three years before the expiry of the approval.

2.      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 …’

10      Article 20, entitled ‘Renewal Regulation’, is worded as follows:

‘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 …’

 Renewal process of an active substance set by Implementing Regulation (EU) No 844/2012

11      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 No 1107/2009 (OJ 2012 L 252, p. 26), lays down the provisions necessary for the implementation of the renewal procedure. It distinguishes, on the one hand, the conditions for the admissibility of the application (Chapter 1) and, on the other, the assessment of the application.

 Conditions for admissibility

12      With regard to the conditions for the admissibility of the application, Article 1 of Implementing Regulation No 844/2012, entitled ‘Submission of the application’, is worded as follows:

‘1.      An application for the renewal of an approval of an active substance shall be submitted by a producer of the active substance to the rapporteur Member State …

2.      The applicant shall send a copy of the application to the Commission, the other Member States and [EFSA], including the information on those parts of the application in respect of which confidentiality has been requested as referred to in paragraph 1.’

13      Article 2 of Implementing Regulation No 844/2012, entitled ‘Format and contents of the application’, is worded as follows:

‘1.      The application shall be submitted in the format set out in the Annex.

2.      The application shall list the new information the applicant intends to submit. It shall demonstrate that such information is necessary in accordance with the first subparagraph of Article 15(2) of Regulation … No 1107/2009’.

14      Article 3 of Implementing Regulation No 844/2012, entitled ‘Checking of the application’, is worded as follows:

‘1.      Where the application has been submitted by the date provided for in the first subparagraph of Article 1(1) and contains all the elements provided for in Article 2, the rapporteur Member State shall, within one month of the date of receipt of the application, inform the applicant, the co-rapporteur Member State, the Commission and [EFSA] of the date of receipt of the application and the fact that it has been submitted by the date provided for in the first subparagraph of Article 1(1) and contains all the elements provided for in Article 2.

…

2.      Where the application has been submitted by the date provided for in the first subparagraph of Article 1(1) but one or more elements provided for in Article 2 are missing, the rapporteur Member State shall, within one month of the date of receipt of the application, inform the applicant which elements are missing and set a period of 14 days for the submission of those elements to the rapporteur Member State and to the co-rapporteur Member State.

Where the application contains all the elements provided for in Article 2 at the expiry of that period, the rapporteur Member State shall, without delay, proceed in accordance with paragraph 1.

3.      Where the application has not been submitted by the date provided for in the first subparagraph of Article 1(1), or where the application still does not contain all the elements provided for in Article 2 at the expiry of the period set for the submission of the missing elements in accordance with paragraph 2, the rapporteur Member State shall, without delay, inform the applicant, the co-rapporteur Member State, the Commission, the other Member States and [EFSA] that the application is inadmissible and of the reasons why it is inadmissible …’

15      Article 6 of Implementing Regulation No 844/2012, entitled ‘Submission of supplementary dossiers’, is worded as follows:

‘1.      Where the rapporteur Member State has informed the applicant in accordance with Article 3(1) that its application has been submitted by the date provided for in the first subparagraph of Article 1(1) and that it contains all the elements provided for in Article 2 [the list of the new information which the applicant intends to submit], the applicant shall submit the supplementary dossiers to the rapporteur Member State, the co-rapporteur Member State, the Commission and [EFSA].

16      Article 7, entitled ‘Contents of supplementary dossiers’, is worded as follows:

‘1.      The supplementary summary dossier shall include the following:

…

(c)      information with respect to one or more representative uses on a widely grown crop in each zone of at least one plant protection product containing the active substance, demonstrating that the approval criteria provided for in Article 4 of Regulation … No 1107/2009 are fulfilled; where the information submitted does not cover all zones or does not concern a widely grown crop, a justification shall be submitted;

(d)      data and risk assessments which were not part of the approval dossier or subsequent renewal dossiers and which are necessary: (i) to reflect changes in legal requirements which have occurred since the approval or last renewal of the approval of the active substance concerned; (ii) to reflect changes in scientific and technical knowledge since the approval or last renewal of the approval of the active substance concerned;

…

(e)      for each point of the data requirements for the active substance …;

(f)      for each point of the data requirements for the plant protection product …’

17      Article 8, entitled ‘Admissibility of the application’, is worded as follows:

‘1.      Where the supplementary dossiers have been submitted by the date provided for in Article 6(3) and contain all the elements provided for in Article 7, the rapporteur Member State shall, within a period of one month, inform the applicant, the co-rapporteur Member State, the Commission and [EFSA] of the date of receipt of the supplementary dossiers and of the admissibility of the application …

2.      Where the supplementary dossiers have been submitted by the date provided for in Article 6(3), but one or more elements provided for in Article 7 are missing, the rapporteur Member State shall, within a period of one month from the date of receipt of the supplementary dossiers, inform the applicant which elements are missing and set a period of 14 days for the submission of those elements to the rapporteur Member State and co-rapporteur Member State. Where at the expiry of that period the supplementary dossiers contain all the elements provided for in Article 7, the rapporteur Member State shall, without delay, proceed in accordance with paragraph 1.’

 Assessment of the application

18      With regard to the substantive assessment of the application, Implementing Regulation No 844/2012 makes provision for a four-step procedure, the conduct of which is laid down in Articles 11 to 14.

19      Article 11 of Implementing Regulation No 844/2012, entitled ‘Assessment by the rapporteur Member State and the co-rapporteur Member State’, is worded as follows:

‘1.      Where the application is admissible in accordance with Article 8(1), the rapporteur Member State shall, after consulting the co-rapporteur Member State, at the latest 12 months after the date referred to in Article 6(3), prepare and submit to the Commission, with a copy to [EFSA], a report assessing whether the active substance can be expected to meet the approval criteria, as provided for in Article 4 of Regulation … No 1107/2009 (“the draft renewal assessment report”).

2.      The draft renewal assessment report shall also include the following:

(a)      a recommendation with regard to the renewal of the approval;

(b)      a recommendation on whether the substance should be considered a low-risk substance;

…

3.      The rapporteur Member State shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge. It shall take into account the supplementary dossiers, and, where appropriate, the dossiers submitted for the approval and subsequent renewals of approval.’

20      Article 12, entitled ‘Comments on the draft renewal assessment report’, is worded as follows:

‘1.      [EFSA] shall circulate the draft renewal assessment report received from the rapporteur Member State to the applicant and to the other Member States at the latest 30 days after its receipt.

2.      [EFSA] shall make the draft renewal assessment report available to the public …

3.      [EFSA] 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 [EFSA], which shall collate and forward those comments, including its own comments, to the Commission.

4.      [EFSA] shall make the updated supplementary summary dossiers available to the public …’

21      Article 13, entitled ‘Conclusion by [EFSA]’, is worded as follows:

‘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 … No 1107/2009. [EFSA] shall, where appropriate, organise a consultation of experts, including experts from the rapporteur Member State and co-rapporteur Member State. [EFSA] shall communicate its conclusion to the applicant, the Member States and the Commission.

…

3.      Where [EFSA] considers that additional information from the applicant is necessary, it shall, in consultation with the rapporteur Member State, set a period not exceeding one month for the applicant to supply [it with] such information [and to supply that information to] the Member States [and] the Commission … The rapporteur Member State shall, within 60 days from the date of receipt of the additional information evaluate the information received and send its evaluation to [EFSA].’

22      Article 14, entitled ‘Renewal report and renewal Regulation’, is worded as follows:

‘1.      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 [EFSA] or in cases where there is no such conclusion of [EFSA], the expiry of the period referred to in Article 12(3) of … [Implementing] Regulation [No 844/2012].

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 [Implementing] Regulation [No 844/2012] 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.

2. On the basis of the renewal report and taking into account comments submitted by the applicant within the period referred to in the third subparagraph of paragraph 1, the Commission shall adopt a Regulation in accordance with Article 20(1) of Regulation … No 1107/2009.’

 Background to the dispute

 Assessment procedure

23      The applicant, Agrochem-Maks d.o.o., is a private, family owned company, incorporated under Croatian law. It currently conducts its activities solely on the Croatian market for plant protection products. It holds marketing authorisations in Croatia for certain plant protection products and markets others, also in Croatia, on behalf of authorisation holders. It sells those products to wholesalers and retailers who in turn sell them to farmers.

24      The applicant also holds, inter alia, an authorisation in Croatia for Laguna 75 WG (‘Laguna’), a post emergence broadleaf herbicide (used after the plant has emerged from the soil) the active substance of which is oxasulfuron and which is intended for use in soya beans. Oxasulfuron is not currently used in the European Union and plant protection products containing that substance have been authorised only in Italy and Croatia. The applicant states that it subcontracts the manufacturing to a chemical manufacturer in China. In that respect, it makes clear that it is the only importer of oxasulfuron in the European Union. Through the distribution of Laguna, the applicant, in 2017 and 2018, controlled the majority of the Croatian market for soya bean herbicides, with an estimated market share of 54.7% for 2017.

25      The active substance oxasulfuron, which comes from the pesticide family, was included in 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) by Commission Directive 2003/23/EC of 25 March 2003 amending Council Directive 91/414 to include imazamox, oxasulfuron, ethoxysulfuron, foramsulfuron, oxadiargyl and cyazofamid as active substances (OJ 2003 L 81, p. 39) for a period of 10 years expiring on 30 June 2013.

26      Since Directive 91/414 was replaced by Regulation No 1107/2009, the active substances (including oxasulfuron) listed in Annex I to that directive are deemed to have been approved under Regulation No 1107/2009, in accordance with Article 78(3) of that regulation. Oxasulfuron was listed in row 42 of the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation No 1107/2009 as regards the list of approved active substances (OJ 2011 L 153, p. 1).

27      In accordance with Article 14 of Regulation No 1107/2009 and Article 1 of Implementing Regulation No 844/2012, the applicant submitted an application for renewal of the approval of the active substance oxasulfuron to the relevant authorities of the Italian Republic, acting as the designated rapporteur Member State (‘the rapporteur Member State’) within the prescribed time limit.

28      The approval of oxasulfuron, like that of other substances, was extended until 31 July 2019 by Commission Implementing Regulation (EU) 2018/917 of 27 June 2018 amending Implementing Regulation No 540/2011 as regards the extension of the approval periods of the active substances alpha-cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, carvone, chlorpropham, cyazofamid, desmedipham, dimethoate, dimethomorph, diquat, ethephon, ethoprophos, etoxazole, famoxadone, fenamidone, fenamiphos, flumioxazine, fluoxastrobin, folpet, foramsulfuron, formetanate, Gliocladium catenulatum strain: J1446, isoxaflutole, metalaxyl-m, methiocarb, methoxyfenozide, metribuzin, milbemectin, oxasulfuron, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole, pymetrozine and s-metolachlor (OJ 2018 L 163, p. 13) so that the renewal assessment could be finalised without the approval expiring within that time limit.

29      On 29 January 2016, the rapporteur Member State and the Republic of Austria (acting as co-rapporteur Member State), in accordance with Article 11(1) of Implementing Regulation No 844/2012, sent their assessment report for the renewal of the approval of the active substance oxasulfuron to the European Food Safety Authority (EFSA) and to the European Commission. That report concluded that the renewal dossiers were sufficiently complete to allow for an in-depth assessment of oxasulfuron and that the information provided suggested that the renewal of that substance should be allowed. That report was communicated, in accordance with Article 12 of Implementing Regulation No 844/2012, to the applicant and to the Member States for observations, and a public consultation was initiated.

30      On 13 July 2016, EFSA sent the applicant a request for additional information, pursuant to Article 13(3) of Implementing Regulation No 844/2012.

31      In the period between October and November 2016, the rapporteur Member State submitted a revised renewal assessment report (‘the revised assessment report’) in which it concluded that, due to the significant number of data gaps, the renewal of oxasulfuron could not be approved.

32      In January 2017, EFSA submitted the peer review report on oxasulfuron, in accordance with Article 12(3) of Implementing Regulation No 844/2012.

33      On 30 January 2017, EFSA adopted its conclusions in accordance with Article 13(1) of Implementing Regulation No 844/2012, in which it referred to the revised assessment report. In its conclusions, EFSA drew up a list of gaps in the data supplied by the applicant. Thus, EFSA considered that seven issues ‘could not be finalised’ (which meant that the information available was considered to be insufficient to conclude that the active substance in all probability satisfied the approval criteria) and that two issues contained ‘critical areas of concern’.

34      The issues which could not be finalised were referred to in Section 9.1 of EFSA’s conclusions as follows:

‘1.      The overall consumer exposure assessment cannot be finalised in view of the outstanding data regarding the metabolism and magnitude of the relevant compounds in rotational crops and the consumer exposure assessment through drinking water …

2.      The ground water exposure assessment cannot be finalised considering the lack of data for metabolites MT6, M3 and CGA 171895 (M5) … The groundwater relevance assessment regarding biological screening for herbicidal activity of oxetan-3-ol (CGA 297691) could not be finalised …

3.      The risk assessment to aquatic organisms cannot be finalised considering the lack of exposure estimates for metabolites MT6 and CGA 171895 (M5) …

4.      The risk assessment to earthworms cannot be finalised considering the lack of exposure estimates for metabolites MT6 …

5.      The [assessment of the] risk to soil macro-organisms other than earthworms could not be finalised due to the lack of data for oxasulfuron and the pertinent soil metabolites …

6.      The [assessment of the] risk to soil microorganisms could not be finalised for the pertinent soil metabolites due to the lack of data …

7.      The [assessment of the] risk to non-target terrestrial plants could not be finalised due to the lack of toxicity data on the vegetative vigour …’

35      In addition, EFSA in its conclusion (Section 9.2) referred to the following two issues as ‘critical areas of concern’:

‘8.      The risk to aquatic organisms was assessed as high for 1 out of the 2 relevant FOCUS surface water scenarios for the representative use of oxasulfuron …

9.      High risk to earthworms was identified for the metabolite saccharin (CGA 27913) …’

36      The Commission invited the applicant to submit its comments on the conclusion by EFSA. Furthermore, in accordance with the third paragraph of Article 14(1) of Implementing Regulation No 844/2012, the Commission invited the applicant to submit observations on the draft renewal assessment report. The applicant submitted its observations.

37      In the light of the foregoing, the Commission, in its Standing Committee on Plants, Animals, Food and Feed, finalised the renewal report for the substance at issue on 14 June 2018. The renewal report states in Section 3, entitled ‘Overall conclusion in the context of Regulation (No 1107/2009’, that ‘the overall conclusion of this evaluation, based on the information available and the proposed conditions of use, is that: the information available indicates that the approval criteria as set out in Article 4(1) to (3) of Regulation No 1107/2009 are not satisfied as concerns were identified’. In that regard, the renewal report states that a risk to aquatic organisms was assessed as high for one out of the two relevant FOCUS surface water scenarios concerning the representative use of oxasulfuron and for earthworms concerning the metabolite saccharin. The renewal report reiterates, moreover, that the information available is insufficient to satisfy the requirements set out in Article 4(1) to (3) of Regulation No 1107/2009, in particular with regard to the seven issues which could not be finalised.

 Contested regulation

38      On 18 July 2018, the Commission adopted Implementing Regulation (EU) 2018/1019 concerning the non-renewal of approval of the active substance oxasulfuron in accordance with Regulation No 1107/2009 and amending Implementing Regulation No 540/2011 (OJ 2018 L 183, p. 14, ‘the contested regulation’).

39      Recital 9 of the contested regulation states that ‘[EFSA] identified a large number of data gaps resulting in the inability to finalise the risk assessment in several areas’ and that ‘in particular, the available information on oxasulfuron and its metabolites did not allow finalising the assessment of the overall consumer exposure, the groundwater exposure, the risk to aquatic organisms, earthworms, soil macro and microorganisms and non-target terrestrial plants’. Recital 13 of the contested regulation states that ‘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 [were] satisfied’.

40      The contested regulation concludes, in Article 1, that the approval of the active substance oxasulfuron is not to be renewed and, in Article 2, that, in Part A of the Annex to Implementing Regulation No 540/2011, row 42 on oxasulfuron, is to be deleted. Under Article 3 of the contested regulation, Member States are required to withdraw authorisations for products containing oxasulfuron by 8 November 2018 at the latest. Article 4 of the contested regulation makes provision for a ‘grace period’ which will expire by 8 November 2019 at the latest.

 Procedure and forms of order sought

41      By application lodged at the Court Registry on 28 September 2018, the applicant brought the present action.

42      By separate document lodged at the Court Registry on the same date, the applicant applied for the present action to be decided under an expedited procedure in accordance with Articles 151 and 152 of the Rules of Procedure of the General Court. On 16 October 2018, the Commission submitted its observations regarding that request. By decision of 24 October 2018, the Court (Second Chamber) refused the application for an expedited procedure. Under Article 154(2) of the Rules of Procedure, the Commission was granted an additional period of one month in order to lodge its defence.

43      By separate document lodged at the Court Registry on the same day, the applicant made an application for interim measures under Articles 278 TFEU and 279 TFEU, seeking suspension of the operation of the contested regulation. By order of 21 January 2019, Agrochem-Maks v Commission (T‑574/18 R, EU:T:2019:25), the President of the Court rejected that application for interim measures and reserved the costs.

44      On 11 December 2018, the Commission lodged its defence.

45      By document lodged at the Court Registry on 20 December 2018, the Kingdom of Sweden sought leave to intervene in the present case in support of the form of order sought by the Commission. The applicant submitted its observations on that application within the prescribed period.

46      The applicant and the Commission respectively lodged a reply and a rejoinder on 30 January and 15 March 2019.

47      By decision of 4 February 2019, the President of the Second Chamber of the Court granted leave to intervene. The Kingdom of Sweden lodged the statement in intervention on 15 March 2019. On 17 April 2019, the Commission submitted its observations on that statement.

48      On 15 July 2019, pursuant to Article 27(3) of the Rules of Procedure, the President of the Court allocated the case to another Judge-rapporteur sitting in the Ninth Chamber.

49      After a change in the composition of the Chambers of the Court, the Judge‐rapporteur was assigned to the Fourth Chamber, to which the present case was consequently assigned.

50      As the parties did not request a hearing within the prescribed time-limit in accordance with Article 106(1) of the Rules of Procedure, the General Court (Fourth Chamber) considered that it had sufficient material available to it from the case file and decided, in accordance with Article 106(3) of the Rules of Procedure, to give judgment in the case without holding an oral hearing.

51      The applicant claims that the Court should:

–        annul the contested regulation;

–        order the Commission to bear its own costs and to pay the costs incurred by the applicant in relation to the present proceedings.

52      The Commission contends that the Court should:

–        dismiss the action;

–        order the applicant to pay the costs.

53      The Kingdom of Sweden contends that the Court should dismiss the action.

 Law

54      In the present case, the applicant raises four pleas in law, alleging, first, in essence, infringement of the obligation to state reasons laid down in Article 41(2)(c) of the Charter of Fundamental Rights of the European Union (‘the Charter’) and manifest errors of assessment, second, infringement of Article 6(f) of Regulation No 1107/2009, of point 2.2 of Annex II to Regulation No 1107/2009 and of the principle of proportionality with regard to the issues raised by EFSA, which allegedly could not be finalised, third, misinterpretation and misapplication of the precautionary principle with regard to those issues, and fourth, infringement of Article 4 of Regulation No 1107/2009 with regard to the alleged identification of a high risk for aquatic organisms.

 First plea in law: breach of the obligation to state reasons laid down in Article 41(2)(c) of the Charter and manifest errors of assessment

55      The first plea is divided into three parts. In the first two parts, the applicant claims that the Commission’s assessments regarding the finding of a high risk, respectively, for aquatic organisms and for earthworms, first, do not contain an adequate statement of reasons and, secondly, are inaccurate. In the third part, the applicant claims that the Commission infringed its obligation to state reasons with regard to the issues which it is alleged could not be finalised, in that those issues do not identify any risk justifying the non-renewal of oxasulfuron.

56      Even if the first plea, according to its title, alleges a ‘violation of the administration’s obligation to give reasons for its decisions’, it is apparent from its content that it contains arguments which tend to challenge both the inadequacy of the reasoning and its merits. The plea alleging infringement of the second paragraph of Article 296 TFEU is a separate plea from the one alleging the manifest error of assessment. While the former, which alleges a failure to state reasons or the inadequacy of the reasons stated, concerns an infringement of essential procedural requirements, within the meaning of Article 263 TFEU, and is a ground involving a question of public policy, which must be raised by the EU Courts of their own motion, the latter, which concerns the substantive legality of a decision, is concerned with the infringement of a rule of law relating to the application of the Treaty, again within the meaning of Article 263 TFEU, and may be examined by the EU Courts only if it is raised by the applicant. The obligation to state reasons is thus a separate question from that of the merits of the reasons of the contested decision (see, to that effect, judgment of 2 April 1998, Commission v Sytraval and Brink’s France, C‑367/95 P, EU:C:1998:154, paragraph 67). Therefore, the Court takes the view, in essence, that the first plea seeks to challenge both the reasons for the contested regulation and its substantive legality.

57      With regard to the obligation to state reasons, it should be noted that, under Article 41(2)(c) of the Charter, which Article 6(1) TEU recognises as having the same legal value as the Treaties, the right to good administration includes, inter alia, ‘the obligation of the administration to give reasons for its decisions’.

58      Under Article 296 TFEU, legal acts must state the reasons on which they are based. The purpose of the obligation to state the reasons on which an act adversely affecting an individual is based, which is a corollary of the principle of respect for the rights of the defence, is (i) to provide the person concerned with sufficient information to make it possible to ascertain whether the act is well founded or whether it is vitiated by a defect which may permit its legality to be contested before the Courts of the European Union and (ii) to enable the latter to review the legality of that act (judgment of 15 April 2011, Czech Republic v Commission, T‑465/08, EU:C:2011:186, paragraph 162).

59      According to settled case-law, the statement of reasons required under the second paragraph of Article 296 TFEU must be appropriate to the measure in question and must disclose in a clear and unequivocal fashion the reasoning followed by the institution which adopted that measure, in such a way as to enable the persons concerned to ascertain the reasons for the measure and to enable the competent court to carry out its review. The requirement to state reasons must be assessed according to the circumstances of the case. It is not necessary for the reasoning to go into all the relevant facts and points of law, since the question whether the statement of reasons for a measure meets the requirements of the second paragraph of Article 296 TFEU must be assessed with regard not only to its wording but also to its context and to all the legal rules governing the matter in question (see judgment of 30 April 2014, Hagenmeyer and Hahn v Commission, T‑17/12, EU:T:2014:234, paragraph 173 and the case-law cited). In the case of measures of general application, such as the contested regulation, the statement of reasons may be confined to indicating the general situation which led to its adoption, on the one hand, and the general objectives which it is intended to achieve, on the other. In that regard, the EU Courts have repeatedly confirmed that, if the contested measure clearly discloses the essential objective pursued by the institution, it would be excessive to require a specific statement of reasons for the various technical choices made (see judgment of 11 September 2018, Apimab Laboratoires and Others v Commission, T‑14/16, not published, EU:T:2018:524, paragraph 77 and the case-law cited).

60      However, it should also be noted that, where the institutions enjoy a wide power of appraisal, respect for the safeguards guaranteed by the EU legal order in administrative procedures is of even greater fundamental importance. Those guarantees include, in particular, the right of the party concerned to have an adequately reasoned decision (see, to that effect, judgment of 20 May 2015, Yuanping Changyuan Chemicals v Council, T‑310/12, not published, EU:T:2015:295, paragraph 175).

61      As regards the review of the substantive legality of the contested regulation, it should be recalled that, if the Commission is to be able to pursue effectively the objective assigned to it by Regulation No 1107/2009, taking account of the complex technical assessments which it must undertake, it must be recognised as enjoying a broad discretion. That applies, in particular, to risk management decisions which it must take pursuant to that regulation (judgment of 17 May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph 92).

62      The exercise of that discretion is not excluded from review by the Court. In that respect, it is clear from the settled case-law that, in the context of such a review, the EU Courts must verify that the relevant procedural rules have been complied with, that the facts admitted by the Commission have been accurately stated and that there has been no manifest error of appraisal or misuse of powers (see judgment of 17 May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph 93 and the case-law cited).

63      As regards the assessment by the EU Courts as to whether there is a manifest error of assessment, it must be stated that, in order to establish that the Commission committed a manifest error of assessment in its examination of complex facts such as to justify the annulment of the contested act, the evidence adduced by the applicant must be sufficient to make the factual assessments used in the act implausible. Subject to the review of plausibility, it is not the Court’s role to substitute its assessment of complex facts for that made by the institution which adopted the act (judgment of 17 May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph 94).

64      However, according to the settled case-law of the Court of Justice and of the General Court, respect for the rights guaranteed by the EU legal order in administrative procedures is of 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 (see judgment of 11 September 2002, Pfizer Animal Health v Council, T‑13/99, EU:T:2002:209, paragraph 171 and the case-law cited).

65      It follows that a scientific risk assessment carried out as thoroughly as possible on the basis of scientific advice founded on the principles of excellence, transparency and independence is an important procedural guarantee whose purpose is to ensure the scientific objectivity of the measures adopted and preclude any arbitrary measures (judgment of 11 September 2002, Pfizer Animal Health v Council, T‑13/99, EU:T:2002:209, paragraph 172).

66      Finally, it is evident from the wording and the organisation of the relevant provisions of Regulation No 1107/2009 that the burden of proving that the conditions for approval or renewal under Article 4 of Regulation No 1107/2009 are met lies, in principle, with the notifier, as was expressly provided for in Directive 91/414 (judgment of 17 May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph 86).

67      Thus, it is the person seeking approval who must prove that the conditions of such approval are met in order to obtain it, and not the Commission which must prove that the conditions of approval are not met in order to be able to refuse it (judgment of 17 May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph 88).

 The first two parts of the first plea alleging that the finding of a high risk for aquatic organisms and earthworms is vitiated by an inadequate or inaccurate statement of reasons

68      In the first place, the applicant disputes the reasoning in the contested regulation concerning the finding of a high risk for aquatic organisms and earthworms. The applicant argues that the contested regulation does not justify, first as regards aquatic organisms, why the finding of a safe use for one scenario, one use and one product was not taken into consideration, but was dismissed in favour of the other scenario and, secondly with regard to earthworms, why EFSA relied on data originating from another active substance dossier and disregarded the favourable opinion of the rapporteur Member State which disputed EFSA’s findings. The applicant argues in that regard that EFSA did not take into account more recent and uncontested saccharin data which were available to it or higher-tier data relating to earthworms which it submitted with its dossier for the renewal of Laguna.

69      In the second place, the applicant asserts that EFSA’s finding of a high risk for aquatic organisms and earthworms is incorrect. The applicant submits that EFSA should only have concluded that it could not exclude the existence of a high risk for aquatic plants and not that a high risk had been identified. Similarly, EFSA was wrong to conclude that a high risk for earthworms had been established in connection with the metabolite saccharin.

70      The Commission, supported by the Kingdom of Sweden, disputes those arguments.

71      Since the applicant claims that the reasons for the finding of a high risk for aquatic organisms and earthworms are insufficient and erroneous, it is necessary, first of all, to ascertain whether the contested regulation incorporates in its reasons for rejecting the applicant’s application for renewal the finding of a high risk for aquatic organisms and earthworms.

72      As is apparent from paragraph 59 above, the reasons must be assessed having regard not only to the wording of the contested act, but also the context in which it was adopted. Account must also be taken of the overall situation which led to the contested act being adopted.

73      In that regard, it should be stated that, as regards aquatic organisms and earthworms, EFSA’s conclusions referred to in recital 9 of the contested regulation set out two reasons to justify the non-renewal of the approval of oxasulfuron, that is to say, first, in Section 9.1 of the report, the ‘lack of exposure estimates [concerning earthworms] for metabolites MT6’ and the ‘lack of exposure estimates [concerning aquatic organisms] for metabolites MT6 and CGA 171895 (M5) and, secondly, in Section 9.2 of the report, a risk considered high for aquatic organisms in one of the two scenarios used and a high risk for earthworms in connection with their exposure to the metabolite saccharin (CGA 27913).

74      Both those reasons based on data gaps and the finding of a high risk are included, in order to justify the non-renewal of the approval of oxasulfuron, in the Commission’s renewal report referred to in recitals 10 to 12 of the contested regulation.

75      It therefore follows from the context and the overall situation which led to the contested act being adopted that the proposal for non-renewal of the authorisation of oxasulfuron was based on two sets of factors concerning aquatic organisms and earthworms, that is to say, first, the existence of data gaps and, secondly, a high risk linked to exposure to oxasulfuron. It must be stated in that respect that EFSA’s conclusions and the renewal report which set out those sets of factors are expressly referred to in recitals 8 to 12 of the contested regulation.

76      However, in order to refuse renewal, the contested regulation, in recital 9, relies on the fact that ‘[EFSA] identified a large number of data gaps resulting in the inability to finalise the risk assessment in several areas’. In particular, the contested regulation states that ‘the available information on oxasulfuron and its metabolites did not allow finalising the assessment of the … risk to aquatic organisms [and] earthworms’. At the same time, the contested regulation makes no mention of any high risk for aquatic organisms or earthworms.

77      It follows therefore from the clear wording of the contested regulation that the refusal to renew the approval of oxasulfuron is based solely on the ‘data gaps’, including those concerning earthworms and aquatic organisms referred to in EFSA’s conclusions, and not on the ‘high risks’ associated with them. The fact that there is no mention of such high risks, identified by EFSA after the assessment, for earthworms and aquatic organisms is not explained by the Commission’s willingness to take into account essential elements of the reasoning and leads the Court to conclude that, on the contrary, when the contested regulation was adopted, the Commission made the deliberate choice not to base that regulation on the high risk concerning aquatic organisms (in one of the two scenarios studied) and earthworms mentioned in paragraphs 35 and 37 above.

78      It is for that reason that the first two parts of the first plea must be rejected as ineffective.

 The third part of the first plea alleging breach of the obligation to state reasons and manifest errors of assessment concerning the seven issues which could not be finalised

–       The arguments alleging infringement of the obligation to state reasons

79      The applicant claims that, with regard to the seven non-finalised issues, the contested regulation does not justify why the position adopted by the rapporteur Member State and the co-rapporteur Member State was rejected in its entirety, while EFSA’s position was accepted without reservation. In the applicant’s submission, that grave disagreement requires an explicit, exhaustive and in-depth justification.

80      The Commission, supported by the Kingdom of Sweden, disputes those arguments.

81      In that regard, it should be observed that, even if they diverge on certain aspects, the conclusions of the revised assessment report of the rapporteur Member State concerning the seven non-finalised issues are not in ‘grave disagreement’ with the conclusions of EFSA and the Commission; quite the contrary. Thus:

–        as regards the first issue which could not be finalised concerning the overall consumer exposure assessment, it must be pointed out first that, as the applicant states, the rapporteur Member State indicated in the revised assessment report that ‘rotational crop metabolism should be further addressed’ and secondly that ‘analytical methods for enforcement purposes are required for [the consumer exposure assessment through drinking water]’;

–        as regards the second issue which could not be finalised concerning ground water exposure, the rapporteur Member State, contrary to what the applicant maintains, considered that the relevance of the metabolites M3, CGA 27913 and CGA 297691 had not been taken into consideration in certain respects and that the metabolite MT6 had been detected in soil, but had not been identified and characterised, and that therefore its impact on groundwater had not been assessed; the rapporteur Member State thus considered that particular attention had to be paid to the risk for groundwater;

–        as regards the third issue which could not be finalised concerning ‘the risk to aquatic organisms’, the rapporteur Member State considered that the assessment of the risk to aquatic organisms had not been finalised for the active substance or the metabolites M3 and MT6; it stipulated that particular attention had to be paid to the risk to aquatic organisms;

–        as regards the fifth issue which could not be finalised concerning ‘the risk to soil macro-organisms other than earthworms’, the applicant acknowledges that the rapporteur Member State went from a positive conclusion to a negative conclusion with regard to the assessment of that risk complying with the conditions laid down in Article 29(6) of Regulation No 1107/2009, that is to say, with the uniform principles for evaluation and authorisation of plant protection products;

–        as regards the sixth issue which could not be finalised concerning ‘the risk to soil microorganisms’, it is apparent from EFSA’s report, as the Commission maintains and as the applicant, moreover, acknowledges, that the finding of that risk stems from a ‘clerical error’; it follows that there is no substantive divergence between EFSA’s conclusions and those of the rapporteur Member State, both of whom considered that the gaps in the data concerning soil microorganisms had been filled;

–        finally, as regards the seventh issue which could not be finalised concerning ‘the risk to … terrestrial plants’, the rapporteur Member State stated that ‘no valid studies on vegetative vigour [had been] submitted’.

82      It is true that, as regards the fourth issue which could not be finalised concerning ‘the risk to earthworms’, EFSA stated that ‘the risk assessment to earthworms [could not] be finalised considering the lack of exposure estimates for metabolites MT6’, whereas it is apparent from the revised assessment report that the rapporteur Member State did in fact take those exposure estimates into account. The rapporteur Member State thus considered that ‘oxasulfuron [was] essentially non-toxic to earthworms (Eisenia foetida) with no adverse effects being observed at the maximum treatment levels tested in both acute and chronic’.

83      However, that divergence between the rapporteur Member State and EFSA, even if it actually required additional reasoning from the Commission, cannot in itself lead the Court to uphold the first plea and annul the contested regulation on the ground of an infringement of the obligation to state reasons, since, in any event, both the rapporteur Member State and EFSA concluded that oxasulfuron should not be renewed given the numerous data gaps.

84      Thus, the complaint relating to the seven non-finalised issues that the existence of disagreements between EFSA’s assessment and that of the rapporteur Member State requires in-depth reasoning on that question must be rejected as unfounded in relation to the fourth issue and as ineffective in relation to the other issues.

–       The arguments alleging manifest errors of assessment

85      In the first place, the applicant submits that one of the seven issues in EFSA’s conclusions which could not be finalised and on which the contested regulation is based contains a ‘clerical error’. In the applicant’s submission, the issue concerning the risk posed by oxasulfuron to soil microorganisms as regards the pertinent soil metabolites should not be included. In the second place, the applicant argues that, as regards the six other issues which could not be finalised, each one is linked to one of the alleged data gaps listed in EFSA’s conclusions. The applicant claims that the rapporteur Member State had found in its assessment that the information available was sufficient to allow a conclusion in favour of renewing the approval of oxasulfuron. EFSA’s conclusion therefore contradicts those of the rapporteur Member State. In the third place, the applicant claims that it could rely on a legitimate expectation that it would be asked for those data as confirmatory data after renewal of the approval (as was proposed by the rapporteur Member State).

86      The Commission, supported by the Kingdom of Sweden, disputes those arguments.

87      In the first place, the applicant is correct in its claim that there was an error regarding the fact that the contested regulation contained data gaps which prevented the assessment of the risk posed by oxasulfuron to soil microorganisms for the pertinent soil metabolites. EFSA had indicated in that respect in its peer review report that ‘the data gap ha[d] been removed’. Furthermore, it must be pointed out that the Commission expressly acknowledges the existence of that error.

88      As is apparent from paragraphs 61 and 62 above, although the Commission has a broad discretion in that area, that discretion is not excluded from judicial review. The EU Courts must in particular verify the material accuracy of the facts relied on by the Commission and that there are no manifest errors of assessment.

89      As is apparent from Section 5 of EFSA’s conclusions, although EFSA found that a ‘low risk to soil microorganisms [had been] identified for the active substances and the pertinent metabolites’, it did not withdraw the section concerned from Section 9 which was intended to draw conclusions from that assessment which still states that it is an ‘issue which could not be finalised’ even though the data gap has been filled in.

90      Even if, from EFSA’s point of view, that error may be qualified as a clerical error, that cannot be the case as regards the Commission which, in its risk assessment, necessarily relied on that manifestly inaccurate conclusion. However, it must be pointed out that that inaccuracy, in itself, has no impact on the legality of the contested regulation, in that it does not disprove the presence of other data gaps referred to in Section| 9.1 of EFSA’s conclusions which prevented it from finalising the assessment of the risks in the other areas, in accordance with Article 4(1) to (3) of Regulation No 1107/2009.

91      In the second place, the applicant argues that EFSA’s conclusions are the reverse of those of the rapporteur Member State and that, accordingly, the Commission committed a manifest error of assessment by following them. However, it is not apparent from Article 13 of Implementing Regulation No 844/2012 that EFSA is bound by the conclusions of the Member State, nor indeed is it apparent from Article 14 of that regulation that the Commission is bound by EFSA’s conclusions. In addition, the revised assessment report is compatible with EFSA’s conclusions regarding the recommendation not to renew the approval of oxasulfuron.

92      Contrary to what the applicant states, the rapporteur Member State did not conclude that it should be renewed in the revised assessment report. On the contrary, in Section 3.2 of that report, entitled ‘Proposed Decision’, the rapporteur Member State recommends that ‘due [to] the great amount of data gap[s]: Oxasulfuron cannot be approved under Regulation No 1107/2009’.

93      In that respect, it must be observed that, as is apparent from paragraph 81 above, for almost all of the non-finalised issues mentioned by the applicant, the revised assessment report and EFSA’s conclusions are not conflicting, contrary to what the applicant claims. It is true that, as regards one issue concerning the risks to earthworms (see paragraph 82 above), EFSA’s conclusions do not repeat those of the rapporteur Member State. However, it is apparent from the second paragraph of Article 14(1) of Implementing Regulation No 844/2012 that the Commission is not bound by the conclusions of the rapporteur Member State, even though it must ‘take [them] into account’ when preparing the renewal report which serves as a basis for the contested regulation, as indeed it must take EFSA’s conclusions into account. Taking those conclusions into account may not, however, be interpreted as an obligation for the Commission to follow the conclusions of the rapporteur Member State on all points, even if those conclusions are the starting point for the assessment and therefore have a significant bearing on that assessment.

94      In the third place, in so far as the applicant relies on a legitimate expectation that the data which EFSA considered to be gaps would be requested as confirmatory data after renewal of the approval (as was proposed by the rapporteur Member State), it must be observed that the right to rely on the protection of legitimate expectations extends to any persons in a situation in which it is clear that the EU administration, in giving them precise assurances, has caused them to entertain expectations which are justified (judgments of 15 July 2004, Di Lenardo and Dilexport, C‑37/02 and C‑38/02, EU:C:2004:443, paragraph 70, and of 17 December 1998, Embassy Limousines & Services v Parliament, T‑203/96, EU:T:1998:302, paragraph 74). However, in the present case, no precise assurances such as to cause the applicant to entertain expectations which were justified have been provided, in that both EFSA and the rapporteur Member State proposed that the approval of oxasulfuron should not be renewed in view of the large number of data gaps.

95      In those circumstances, the Court rejects the third part of the first plea and therefore dismisses the first plea in its entirety.

 Second plea in law: infringement of Article 6(f) of Regulation No 1107/2009, of point 2.2 of Annex II to that regulation and of the principle of proportionality with regard to the alleged data gaps

96      In the second plea, first of all, the applicant claims that the Commission infringed the provisions of Article 6(f) of Regulation No 1107/2009 and of point 2.2 of Annex II to that regulation. The Commission was wrong to refuse the renewal of the approval of oxasulfuron, at least provided that the applicant furnishes the data which EFSA and the Commission consider to be missing. The applicant argues that those provisions stipulate that an active substance may be renewed, even if the renewal dossier is deemed incomplete, provided that the additional, confirmatory or further information required under those provisions is submitted within a fixed deadline after the renewal. In the present case, the applicant maintains that, even though the Commission itself identified seven issues which could not be finalised due to alleged data gaps, the fact that the rapporteur Member State considered that oxasulfuron could be approved even though some information still had to be provided shows that Article 6(f) of Regulation No 1107/2009 or point 2.2 of Annex II to that regulation could have been applied to the data gaps or to the issues which could not be finalised. In that regard, the applicant states that the additional information requested by EFSA on 13 July 2017 (see paragraph 30 above) in order to address the non-finalised issues corresponds to the information referred to in Article 6(f) of Regulation No 1107/2009 and in point 2.2(a) and (b) of Annex II to that regulation and shows that the Commission should have used the procedure relating to confirmatory or further information.

97      Next, in the applicant’s submission, since the conditions for the application of the procedure relating to confirmatory or further information have been satisfied, the Commission, by not making use of that procedure, infringed the principle of proportionality. Thus, the fact that neither Article 6(f) of Regulation No 1107/2009 nor point 2.2 of Annex II to that regulation was applied in the present case infringed not only those provisions but also the principle of proportionality.

98      Finally, the applicant adds that, with regard to the approval or the renewal of the approval of an active substance, the completeness of the dossier is checked definitively by the rapporteur Member State at the admissibility stage of the application. Following that stage, the admissibility of the application can no longer be questioned. EFSA can ask for further information which must be provided within 90 days (approval) or one month (renewal), but it cannot call into question the actual admissibility of the application for renewal of the substance.

99      The Commission, supported by the Kingdom of Sweden, disputes those arguments.

100    In the first place, it should be pointed out that it is not apparent from the dossier that the provisions of Article 6(f) of Regulation No 1107/2009 or point 2.2(a) and (b) of Annex II to that regulation (paragraphs 7 and 8 above) apply in such a way that the renewal of the approval of oxasulfuron could have been granted provided that the data which the Commission considered to be missing was communicated subsequently.

101    It is not established that the data considered by EFSA to be missing, and which was requested by EFSA on 13 July 2017, are data for which, in accordance with Article 6(f) of Regulation No 1107/2009, ‘new requirements [had been] established during the evaluation process or as a result of new scientific and technical knowledge’. Nor is it established that, in accordance with point 2.2(a) and (b) of Annex II to Regulation No 1107/2009, the data requirements have been ‘amended or refined after the submission of the dossier’ or constitute ‘further information, confirmatory in nature, required to increase confidence in the decision’.

102    With regard to the latter scenario, referred to in point 2.2(b) of Annex II to Regulation No 1107/2009, it presupposes, as the Commission rightly submits, that the Commission reached the conclusion that the risk is acceptable and that the approval criteria have been met, which is not the situation in the present case.

103    In those circumstances, no infringement of Article 6(f) of Regulation No 1107/2009 or of point 2.2(a) and (b) of Annex II to that regulation has been established.

104    In the second place, the applicant maintains, as is apparent from paragraph 97 above, that, by not granting the renewal of the approval for oxasulfuron unless the data gaps are rectified after the renewal, even where the conditions specified in Article 6(f) of Regulation No 1107/2009 or in point 2.2 of Annex II to that regulation have been fulfilled, the Commission infringed not only those provisions but also the principle of proportionality. However, it must be observed that, since the complaints alleging infringement of Article 6(f) of Regulation No 1107/2009 or of point 2.2 of Annex II to that regulation are unfounded, the complaint alleging infringement of the principle of proportionality, which is based on those other complaints, cannot succeed either.

105    That conclusion is not called into question by the fact that, among the eight approval renewals in 2016, five were issued with confirmatory data requirements and eight contained a range of issues to which the Member States were alerted to pay particular attention when assessing authorisations after the renewal. In that regard, it should be observed that the principle of equal treatment requires that comparable situations must not be treated differently and that different situations must not be treated in the same way, unless such treatment is objectively justified (see judgment of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 310 and the case-law cited). However, given that it is the applicant which is invoking an infringement of that principle, it falls to the applicant to set out and establish what comparable situation has been treated differently. As it is, the applicant, by merely listing the active substances which were treated differently in 2016, has not demonstrated this in any way, even though, as the applicant itself confirms, ‘no two dossiers are comparable, and each substance must be assessed by its own merits’.

106    In the third place, the applicant’s argument that, since the rapporteur Member State declared the renewal application admissible in accordance with Article 8 of Implementing Regulation No 844/2012, EFSA can no longer call into question the completeness of the information communicated by the applicant, is unfounded. The fact that the dossier formally contains all the items referred to in Article 7 of that regulation does not in itself constitute a decision on the quality of those items from a scientific point of view, which may necessitate an in-depth study and may result in diverging assessments by the rapporteur Member State and EFSA with regard to whether or not they are sufficient to allow a renewal application. It must be observed in that regard that Article 7 of Implementing Regulation No 844/2012 requires only that the items referred to in its provisions for the purposes of setting up a ‘supplementary’ dossier be communicated. In accordance with Article 8 of that regulation, this is a condition for the admissibility of the application and therefore a formal requirement which, if satisfied, triggers the substantive assessment of the dossier, referred to in Chapter 2 of that regulation. It must be pointed out that the fact that the application is formally declared to be admissible for the purposes of Article 8 of Implementing Regulation No 844/2012 does not preclude the Member State from requiring additional information in accordance with Article 11(5) of that regulation, or EFSA from requiring additional information in accordance with Article 13(3) of that regulation. Moreover, that was the situation in the present case since, by communication of 13 July 2016, the applicant received a letter from EFSA requiring further information concerning oxasulfuron.

107    In that regard, the argument, in essence, that the application does not comply with Article 13(3) of Implementing Regulation No 844/2012 in that, under that article, EFSA cannot recommend new studies to be conducted in order to reply to a request for information must be rejected as irrelevant, since EFSA was not required under that article to ask the applicant for further information in order the fill in the gaps in the data which it sent.

108    In those circumstances, the second plea must be rejected.

 Third plea in law: misapplication of the precautionary principle with regard to the alleged gaps in the issues which could not be finalised

109    In the third plea, the applicant disputes the contested regulation’s application of the precautionary principle.

110    The applicant states, first, that the Commission did not carry out any analysis of the costs and benefits of a renewal or a non-renewal of the approval of oxasulfuron before taking its decision, as is required by point 6.3.4 of Commission Communication COM(2000) 1 final of 2 February 2000 on the precautionary principle (‘the Communication on the precautionary principle’), the principle of proportionality and the judgment of 17 May 2018, BASF Agro and Others v Commission (T‑584/13, EU:T:2018:279, paragraphs 169 to 172).

111    The applicant states, secondly, that the Commission did not satisfy the requirement for an exhaustive scientific risk assessment by experts on the basis of the available information, in order to have available to it sufficiently reliable and cogent information that would allow it to understand the ramifications of the scientific question raised and to decide upon a policy in full knowledge of the facts. In particular, the Commission has not taken into consideration the opinion of the rapporteur Member State and the co-rapporteur Member State, which found the relevant dossier submitted to them to be sufficiently complete, thus suggesting that there was enough information for a comprehensive risk assessment despite the alleged data gaps identified by EFSA.

112    The Commission, supported by the Kingdom of Sweden, disputes those arguments.

113    As a preliminary point, it is important to note that while Article 191(2) TFEU provides that the policy on the environment is to be based on, inter alia, the precautionary principle, that principle is also applicable in the context of other EU policies, in particular the policy on the protection of public health and where the EU institutions adopt, under the common agricultural policy or the policy on the internal market, measures for the protection of human health (see judgment of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraph 41 and the case-law cited).

114    There is therefore an obligation on the EU legislature, when it adopts rules governing the placing on the market of plant protection products, such as those laid down in Regulation No 1107/2009, to comply with the precautionary principle in order to ensure, in particular in accordance with Article 35 of the Charter and Article 9 and Article 168(1) TFEU, a high level of protection of human health (see judgment of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraph 42 and the case-law cited).

115    That principle implies that, where there is uncertainty as to the existence or extent of risks to human health, protective measures may be taken without having to wait until the reality and seriousness of those risks become fully apparent (see judgment of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraph 43 and the case-law cited).

116    According to settled case-law, in the implementation of measures to be taken for the protection of public health, the EU institutions enjoy a wide discretion as regards the definition of the objectives to be pursued and choice of the appropriate means of action (see judgment of 11 February 2015, Spain v Commission, T‑204/11, EU:T:2015:91, paragraph 30 and the case-law cited).

117    In the first place, in so far as the applicant claims that the Commission did not carry out any analysis of the costs and benefits of a renewal or a non-renewal of the approval of oxasulfuron before taking its decision, as is required by point 6.3.4 of the Communication on the precautionary principle, it should be pointed out that point 6.3.4 of the Communication on the precautionary principle, entitled ‘Examination of the benefits and costs of action and lack of action’, is worded as follows:

‘A comparison must be made between the most likely positive or negative consequences of the envisaged action and those of inaction in terms of the overall cost to the [Union], both in the long and short term. The measures envisaged must produce an overall advantage as regards reducing risks to an acceptable level.

Examination of the pros and cons cannot be reduced to an economic cost-benefit analysis. It is wider in scope and includes non-economic considerations.

However, examination of the pros and cons should include an economic cost-benefit analysis where this is appropriate and possible.

Besides, other analysis methods, such as those concerning the efficacy of possible options and their acceptability to the public may also have to be taken into account. A society may be willing to pay a higher cost to protect an interest, such as the environment or health, to which it attaches priority.

The Commission affirms, in accordance with the case-law of the Court that requirements linked to the protection of public health should undoubtedly be given greater weight [than] economic considerations.

The measures adopted presuppose examination of the benefits and costs of action and lack of action. This examination should include an economic cost/benefit analysis when this is appropriate and feasible. However, other analysis methods, such as those concerning efficacy and the socio-economic impact of the various options, may also be relevant. Besides the decision-maker may, in certain circumstances, [be] guided by non-economic considerations such as the protection of health.’

118    First of all, in that regard, it should be noted that point 6.3.4 of the Communication on the precautionary principle provides for an examination to be carried out of the benefits and costs of action and lack of action. However, the format and scope of that examination are not specified. In particular, it is not at all apparent that the authority concerned is obliged to initiate a specific assessment procedure culminating, for example, in a formal, written assessment report. In addition, it is apparent from the text that the authority applying the precautionary principle enjoys considerable discretion regarding methods of analysis. Although the communication indicates that the examination ‘should’ include an economic analysis, the authority concerned must in any event also include non-economic considerations. Furthermore, it is expressly stated that it may be the case that, in certain circumstances, economic considerations must be considered less important than other interests which are given priority; interests such as the environment or health are expressly mentioned by way of example (judgment of 17 May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph 162).

119    Next, the requirements of the Communication on the precautionary principle are satisfied where the authority concerned — in the present case, the Commission — has in fact acquainted itself with the effects, positive and negative, economic and otherwise, to which the proposed action, as well as the failure to act, may lead, and has taken that into account in its decision. By contrast, it is not necessary for those effects to be estimated precisely, if that is not possible or would require disproportionate effort (judgment of 17 May 2018, BASF Agro and Others v Commission, T‑584/13, EU:T:2018:279, paragraph 163).

120    It must be pointed out that, in the present case, the Commission in fact acquainted itself with the effects, positive and negative, economic and otherwise, to which the renewal or non-renewal of the approval of oxasulfuron may lead, and that it took that into account in its decision. Thus, it is apparent from the information provided on 24 and 25 May 2018 by the Commission to the Standing Committee on Plants, Animals, Food and Feed that the Commission did indeed take into account the costs and benefits of the non-renewal of the approval of oxasulfuron before taking its decisions not to renew. Indeed, the Commission stated that ‘alternative herbicidal active substances [were] still approved at EU level’ and that ‘given the risks and the high number of data gaps identified, … the nature of the (potential) risks overrule[d] the economic considerations’. The Commission was therefore aware of the challenges, both economic and environmental, linked to the use of the substances covered (see, to that effect, judgment of 17 May 2018, Bayer CropScience and Others v Commission, T‑429/13 and T‑451/13, under appeal, EU:T:2018:280, paragraph 461).

121    In the second place, in so far as the applicant claims that the Commission did not satisfy the requirement for an exhaustive scientific risk assessment by experts on the basis of the available information and did not take into consideration the opinion of the rapporteur Member State and the co-rapporteur Member State which considered that the dossier was complete, as is apparent from paragraph 66 above, the burden of proving that the conditions for approval or renewal under Article 4 of Regulation No 1107/2009 are met lies, in principle, with the notifier. Therefore, when the applicant worded its renewal application, it bore the burden of proving the efficacy and safety of the substance in question. Since it did not discharge that burden, the approval of the active substance could not be renewed. Moreover, with regard to the applicant’s argument that the Commission did not take into consideration the opinion of the rapporteur Member State and the co-rapporteur Member State, it must be observed that, as is also indicated in paragraph 106 above, the fact that the dossier contains all the items mentioned in Article 7 of Implementing Regulation No 844/2012 does not in itself constitute a decision on the quality of those items from a scientific point of view, which may necessitate an in-depth study and may result in diverging assessments by the rapporteur Member State and EFSA with regard to whether or not they are sufficient to allow a renewal application.

122    In the light of the foregoing, the applicant is wrong to claim that the Commission misapplied the precautionary principle.

123    That conclusion is not called into question by the applicant’s argument that the precautionary principle is strictly applicable not at EU level (when the active substance is approved) but at the stage of the authorisation of the plant protection product at national level. As is apparent from Article 1(4) of Regulation No 1107/2009, the precautionary principle applies in relation to both active substances and plant protection products. In that regard, Article 13(2) of Regulation No 1107/2009 stipulates that the regulation approving an active substance must take the precautionary principle into account. In those circumstances, the applicant is wrong to invoke the judgment of 21 November 2018, Stichting Greenpeace Nederland and PAN Europe v Commission (T‑545/11 RENV, EU:T:2018:817). As regards the intensity of the application of the precautionary principle, that judgment does not distinguish between active substances and plant protection products. Moreover, it must be pointed out that that judgment concerns the specific issue of access to information relating to emissions into the environment for the purposes of the first sentence of Article 6(1) of Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ 2006 L 264, p. 13). In that respect, the fact that that judgment states in paragraph 90 that the use, the conditions of use and the composition of a plant protection product authorised by a Member State on its territory may be very different from those of products evaluated at EU level during the approval of the active substance does not lead to the conclusion that the precautionary principle is to be applied more flexibly for active substances than for plant protection products.

124    In view of the foregoing, the third plea must be rejected.

 Fourth plea in law: infringement of Article 4 of Regulation No 1107/2009 with regard to the identification of a high risk for aquatic organisms

125    In support of the fourth plea, the applicant claims that EFSA infringed Article 4 of Regulation No 1107/2009 by establishing a high risk for aquatic organisms in one of the two scenarios used, when the other scenario did not establish such a risk, and that the high risk related only to aquatic plants. In the applicant’s submission, since EFSA established safe use in one of the two scenarios, the criteria set out in Article 4 of Regulation No 1107/2009 were in fact met.

126    In that regard, as was already mentioned in paragraph 76 above, it must be pointed out that the contested regulation only refers in recital 9 to the fact that the assessment of the risks to aquatic organisms could not be finalised due to the data gaps and does not mention that a high risk for aquatic organisms was identified.

127    Therefore, the fourth plea, for reasons similar to those relied on in relation to the first two parts of the first plea, must be dismissed as ineffective.

128    As a result of all of the foregoing, the action must be dismissed in its entirety.

 Costs

129    Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.

130    Since the applicant has been unsuccessful, it must be ordered to bear its own costs and to pay those incurred by the Commission in the present action and in the proceedings for interim measures in accordance with the form of order sought by the Commission.

131    Under Article 138(1) of the Rules of Procedure, Member States which have intervened in the proceedings are to bear their own costs. The Kingdom of Sweden must therefore bear its own costs.

On those grounds,

THE GENERAL COURT (Fourth Chamber)

hereby:

1.      Dismisses the action;

2.      Orders Agrochem-Maks d.o.o. to bear its own costs and to pay those incurred by the European Commission in the present action and in the proceedings for interim measures;

3.      Orders the Kingdom of Sweden to bear its own costs.

Delivered in open court in Luxembourg on 28 May 2020.

*      Language of the case: English.

1      The present judgment is to be published by extracts.

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