CELEX: 62020CJ0374
Language: en
Date: 2021-12-09
Title: Judgment of the Court (Tenth Chamber) of 9 December 2021.#Agrochem-Maks d.o.o. v European Commission.#Appeal – Plant protection products – Active substance – Regulation (EC) No 1107/2009 – Article 6(f) – Annex II, point 2.2 – Definition of ‘further confirmatory information’ – Implementing Regulation (EU) No 844/2012 – Article 13(3) – Non-renewal of approval of the active substance ‘oxasulfuron’ for its placing on the market – Scope of the rapporteur Member State’s decision to declare the application for renewal to be admissible – Right of that Member State and of the European Food Safety Authority (EFSA) to require the applicant to provide further information – Right of the rapporteur Member State to amend its draft renewal assessment report – Precautionary principle.#Case C-374/20 P.

JUDGMENT OF THE COURT (Tenth Chamber)
9 December 2021 (*)
(Appeal – Plant protection products – Active substance – Regulation (EC) No 1107/2009 – Article 6(f) – Annex II, point 2.2 – Definition of ‘further confirmatory information’ – Implementing Regulation (EU) No 844/2012 – Article 13(3) – Non-renewal of approval of the active substance ‘oxasulfuron’ for its placing on the market – Scope of the rapporteur Member State’s decision to declare the application for renewal to be admissible – Right of that Member State and of the European Food Safety Authority (EFSA) to require the applicant to provide further information – Right of the rapporteur Member State to amend its draft renewal assessment report – Precautionary principle)
In Case C‑374/20 P,
APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 7 August 2020,

Agrochem-Maks d.o.o., established in Zagreb (Croatia), represented by S. Pappas and A. Pappas, avocats,
appellant,
the other parties to the proceedings being:

European Commission, represented initially by X. Lewis, I. Naglis and G. Koleva, and subsequently by G. Koleva, acting as Agents,
defendant at first instance,

Kingdom of Sweden, represented by J. Lundberg, O. Simonsson, C. Meyer-Seitz, A.M. Runeskjöld, H. Shev, H. Eklinder, R. Shahsavan Eriksson and M. Salborn Hodgson, acting as Agents,
intervener at first instance,
THE COURT (Tenth Chamber),
composed of C. Lycourgos (Rapporteur), President of the Fourth Chamber, acting as President of the Tenth Chamber, I. Jarukaitis and M. Ilešič, Judges,
Advocate General: E. Tanchev,
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, Agrochem-Maks d.o.o. asks the Court to set aside the judgment of the General Court of the European Union of 28 May 2020, Agrochem-Maks v Commission (T‑574/18, EU:T:2020:226; ‘the judgment under appeal’), in which the General Court dismissed its action for annulment of the 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 regulation at issue’).
 Legal context

 Regulation (EC) No 1107/2009

2        Under recital 8 of 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):
‘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. … 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.’

3        Article 1  of that regulation, under the heading ‘Subject matter and purpose’, provides, in paragraph 2 thereof, that that regulation lays down inter alia rules for the approval of active substances which the plant protection products contain, in paragraph 3 thereof, that its purpose is, in particular, to ensure a high level of protection of both human and animal health and the environment, and in paragraph 4 thereof, 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.

4        Article 4 of the regulation, under the heading ‘Approval criteria for active substances’, provides:
‘1.      An active substance shall be approved in accordance with Annex II if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance meet the requirements provided for in paragraphs 2 and 3.
The assessment of the active substance shall first establish whether the approval criteria set out in points 3.6.2 to 3.6.4 and 3.7 of Annex II are satisfied. If these criteria are satisfied the assessment shall continue to establish whether the other approval criteria set out in points 2 and 3 of Annex II are satisfied.
2.      The residues of the plant protection products, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, shall meet the following requirements:
(a)      they shall not have any harmful effects on human health, including that of vulnerable groups, or animal health, 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 …
…
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.
…’

5        Article 6 of the regulation, under the heading ‘Conditions and restrictions’, provides:
‘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;
…’

6        The first subparagraph of Article 7(1), under the heading ‘Application’, in Subsection 2, under the heading ‘Approval procedure’, which is part of Chapter 2, Section 1, of Regulation No 1107/2009, provides:
‘An application for the approval of an active substance … 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) …, demonstrating that the active substance fulfils the approval criteria provided for in Article 4.’

7        The first subparagraph of Article 12(3) of that regulation, under the heading ‘Conclusion by [EFSA]’, is worded as follows:
‘Where [EFSA]  needs additional information, it shall set a period of a maximum of 90 days for the applicant to supply it to the Member States, the Commission and [EFSA].’

8        Article 14(1) of the regulation, under the heading ‘Renewal of approval’, provides:
‘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.’

9        Under the heading ‘Submission of further information’, point 2.2 of Annex II to the regulation is worded as follows:
‘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.’
 Implementing Regulation (EU) No 844/2012

10      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), provided inter alia, first, in Chapter 1, provisions on the conditions for the admissibility of an application for renewal (Articles 1 to 10) and, second, in Chapter 2, provisions on the assessment of such an application (Articles 11 to 14).

11      Article 1 of Implementing Regulation No 844/2012, under the heading ‘Submission of the application’, read 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 … no later than three years before the expiry of the approval.
…
2.      The applicant shall send a copy of the application to the Commission, the other Member States and to [EFSA], including the information on those parts of the application in respect of which confidentiality has been requested as referred to in paragraph 1.
…’

12      Article 2(2) of that regulation, under the heading ‘Format and contents of the application’, provided:
‘The application shall list the new information the applicant intends to submit. …
…’

13      Article 6(1) of the regulation, under the heading ‘Submission of supplementary dossiers’, provided:
‘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 applicant shall submit the supplementary dossiers to the rapporteur Member State, the co-rapporteur Member State, the Commission and [EFSA].’

14      Article 7(1) of that regulation, under the heading ‘Contents of supplementary dossiers’, listed what was required to be included in the supplementary summary dossier.

15      Article 8(1) of Implementing Regulation No 844/2012, under the heading ‘Admissibility of the application’, provided:
‘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.
…’

16      Article 11 of that regulation, under the heading ‘Assessment by the rapporteur Member State and the co-rapporteur Member State’, provided:
‘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.
…
5.      Where the rapporteur Member State requires additional information, it shall set a period for the applicant to supply that information. That period shall not lead to an extension of the period of 12 months provided for in paragraph 1. The applicant may, pursuant to Article 63 of Regulation [No 1107/2009], request such information to be kept confidential.
…’

17      Article 12 of the regulation, under the heading ‘Comments on the draft renewal assessment report’, was 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 …’

18      According to Article 13 of the regulation, under the heading ‘Conclusion by [EFSA]’:
‘1.      Within five months from the expiry of the period referred to in Article 12(3), [EFSA] shall adopt a conclusion in the light of current scientific and technical knowledge using guidance documents applicable at the date of the submission of the supplementary dossiers on whether the active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation [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 such information to the Member States, the Commission and [EFSA]. 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].
…’

19      Article 14 of Implementing Regulation No 844/2012, under the heading ‘Renewal report and renewal Regulation’, was worded as follows:
‘1.      The Commission shall present to the [Standing Committee on the Food Chain and Animal Health, as established by Article 58 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ 2002 L 31, p. 1), as amended by Regulation (EU) No 652/2014 of 15 May 2014 (OJ 2014 L 189, p. 1)], 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 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 [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

20      The appellant, Agrochem-Maks, 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.

21      The appellant also holds, inter alia, an authorisation in Croatia for ‘Laguna 75 WG’, a post-emergence broadleaf herbicide (used after the plant has emerged from the soil) the active substance of which is oxasulfuron (‘the active substance  in question’) and is intended for use on soya beans. The active substance in question is not currently used in the European Union, and plant protection products containing that substance have been authorised only in Italy and Croatia. In that respect, the appellant makes clear that it is the sole importer of the active substance in the European Union.

22      The active substance  in question, which comes from the pesticide family, 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).

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

24      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 in question to EFSA and to the Commission (‘the initial assessment report’). That report concluded that the renewal dossiers were sufficiently complete to allow for an in-depth assessment of the active substance 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 appellant and to the Member States for observations, and a public consultation was initiated.

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

26      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 the active substance in question could not be approved.

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

28      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 appellant. EFSA therefore 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 question in all probability satisfied the approval criteria, and that two issues contained ‘critical areas of concern’.

29      The Commission invited the appellant to submit its comments on EFSA’s conclusions. Furthermore, in accordance with the third subparagraph of Article 14(1) of Implementing Regulation No 844/2012, the Commission invited the appellant to submit observations on the draft renewal assessment report. The appellant submitted its observations.

30      In the light of the foregoing, the Standing Committee on Plants, Animals, Food and Feed, acting on behalf of the Commission, finalised the renewal assessment report for the active substance in question on 14 June 2018. That report states in Section 3 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’.

31      On 18 July 2018, the Commission adopted the regulation at issue. 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 [the active substance in question] 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’. According to recital 13 of that regulation, ‘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’.

32      The regulation at issue provides, in Article 1 thereof, that the approval of the active substance in question is not to be renewed and, in Article 2 thereof, that, in Part A of the annex to Implementing Regulation No 540/2011, row 42 on the active substance in question, is to be deleted.
 The procedure before the General Court and the judgment under appeal

33      By application lodged at the Registry of the General Court on 28 December 2018, the appellant brought an action for annulment of the regulation at issue.

34      The appellant raised four pleas in law, alleging (i) 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 and manifest errors of assessment, (ii) 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, (iii) misinterpretation and misapplication of the precautionary principle with regard to those issues and (iv) infringement of Article 4 of Regulation No 1107/2009 with regard to the alleged identification of a high risk for aquatic organisms.

35      Having rejected all of the pleas for annulment, the General Court dismissed that action in its entirety in the judgment under appeal.
 Forms of order sought by the parties to the appeal

36      The appellant claims that the Court should:
–        set aside the judgment under appeal;
–        refer the case back to the General Court; and
–        order the Commission to bear its own costs and pay the costs incurred by the appellant in the present proceedings.

37      The Commission contends that the Court should:
–        dismiss the appeal; and
–        order the appellant to pay the costs.

38      The Swedish Government submits that the Court should dismiss the appeal.
 The appeal

39      The appellant relies on five grounds of appeal in support of its appeal. First, the appellant claims that the General Court misinterpreted and misapplied the procedural requirements relating to requests for additional information in the context of the renewal of an approval of an active substance. Second, the appellant submits that the General Court erred in law by holding that 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. Third, according to the appellant, the General Court erred in law by failing to take into account all relevant information for the purpose of determining whether the appellant could rely on an infringement of the principle of legitimate expectations. Fourth, the appellant maintains that the General Court mischaracterised the facts and infringed Article 6(f) of Regulation No 1107/2009, point 2.2 of Annex II to that regulation and the principle of proportionality. Fifth, in the appellant’s submission, the General Court erred in law by incorrectly interpreting and applying the precautionary principle.
 The fourth ground of appeal

 Arguments of the parties

40      By its fourth ground of appeal, which it is appropriate to consider in the first place, the appellant claims that, in paragraphs 101, 102 and 104 of the judgment under appeal, the General Court mischaracterised the facts and infringed Article 6(f), point 2.2 of Annex II to Regulation No 1107/2009 and the principle of proportionality.

41      First, the appellant submits that, in the light of the period of 90 days  set, the additional information which EFSA requested at the stage of the assessment of the application, on the basis of Article 12(3) of Regulation No 1107/2009, cannot but be information that reasonably can be provided within that deadline. Moreover, at the stage of the assessment of the application, the missing information should in principle be of a scientific nature or information to increase confidence in the decision, that is to say confirmatory data. In that regard, the wording ‘additional information’, used in that regulation, should be interpreted as referring to the confirmatory information defined in Regulation No 1107/2009, since, at the stage of the assessment of the application, it would not make sense to ask for additional information the lack of which would lead to non-renewal and would be impossible to provide within 90 days. The appellant claims that such an interpretation is also supported by the fact that all gaps identified by EFSA related to the need established during the assessment to produce new scientific and technical data.

42      Furthermore, in its view, it is clear from the draft renewal assessment report on which the Commission relied and from the judgment under appeal that the missing – confirmatory – information was aimed at increasing confidence in a substance that was not expected to present an unacceptable risk to human health and to the environment.

43      The appellant adds that, if EFSA asks, at an earlier stage of the procedure, for additional confirmatory information in order to increase confidence in the renewal decision, the Commission must consider such information and is not entitled to re-characterise the information in question retroactively to support its final decision. In the present case, since the rapporteur Member State checked that the file was complete at the stage of its admissibility, the appellant claims that EFSA requested additional information either in the light of requirements related to scientific-technical knowledge or because that information was necessary to increase confidence in the renewal decision, such that that additional information could have been nothing other than ‘confirmatory data’.

44      Second, the appellant claims that the General Court did not explain, in paragraph 102 of the judgment under appeal, why the scenario, referred to in point 2.2(b) of Annex II to Regulation No 1107/2009, presupposes that the Commission reached the conclusion that the risk is acceptable and that the approval criteria have been met.

45      The appellant is of the opinion that confirmatory data can, by definition, increase the confidence in the decision to renew an approval of an active substance in a situation similar to the present case, where a risk has neither been identified nor excluded and no major concerns have been identified since the first approval of that active substance. Furthermore, pursuant to Regulation No 1107/2009, the Commission still had the possibility of withdrawing an approval if it had been subsequently established, following the submission of confirmatory data, that the active substance no longer met the approval criteria. The appellant maintains that such an interpretation would be more in line with the principle of proportionality.

46      The Commission and the Swedish Government take the view that the fourth ground of appeal should be dismissed.
 Findings of the Court

47      By its fourth ground of appeal, the appellant claims that, in paragraphs 101, 102 and 104 of the judgment under appeal, the General Court erred in law in its characterisation of the facts before it and infringed Article 6(f) and point 2.2 of Annex II to Regulation No 1107/2009 as well as the principle of proportionality.

48      This ground of appeal is, in essence, based on the premiss according to which, where additional information requested by EFSA at the stage of the assessment of an application for renewal of an active substance is scientific in nature or is intended to increase confidence in the Commission’s renewal decision, that information should be characterised as ‘confirmatory’, within the meaning of those provisions of Regulation No 1107/2009.

49      Such an interpretation of the dispositions of that regulation cannot be upheld.

50      It is clear from Article 6(f) of, and point 2.2 of Annex II to, Regulation No 1107/2009 that the characterisation of information as ‘confirmatory information’, within the meaning of those provisions, assumes that the Commission has granted approval of an active substance subject to that information being provided.

51      Thus, in the absence of a Commission decision on approval of an active substance, information requested at the stage of the assessment of the renewal of such a substance cannot be characterised as ‘confirmatory information’, within the meaning of those provisions.

52      It must be found that those provisions do not establish an obligation, but merely the power of the Commission to grant such approval. In that regard, Article 6(f) of Regulation No 1107/2009 provides that approval may be subject to conditions, including submission of confirmatory information, and point 2.2(b) of Annex II to that regulation states that, in exceptional cases, an active substance may be approved even though certain information is still to be submitted, where the information is considered to be confirmatory in nature.

53      It follows from settled case-law that, in the case of complex factual assessments, the EU authorities enjoy, in some areas of EU law, a broad discretion, so that review by the EU judicature of those assessments must be confined to ascertaining whether there has been a manifest error of assessment or a misuse of powers, or whether those authorities have manifestly exceeded the limits of their discretion (see, to that effect, judgment of 28 January 2016, Heli-Flight v EASA, C‑61/15 P, not published, EU:C:2016:59, paragraph 101 and the case-law cited).

54      That applies in the case of a Commission decision granting first approval or renewal of approval of an active substance within the meaning of Regulation No 1107/2009.

55      By its fourth ground of appeal, the appellant has not submitted that the General Court erred in law by not finding that the Commission manifestly erred in its assessment or misused its powers or manifestly exceeded the limits of its discretion by not granting the renewal of the approval of the active substance in question subject to confirmatory information being provided. In addition, the appellant has not adduced any evidence demonstrating any manifest error, misuse of powers, or manifest exceeding of the limits of the discretion on the part of the Commission.

56      Accordingly, since it is common ground that the Commission has not adopted any decision granting renewal of the approval of the active substance in question subject to confirmatory information being provided within the meaning of Article 6(f) of, and of point 2.2 of Annex II to, Regulation No 1107/2009, the Commission cannot have infringed those provisions in the present case.

57      It follows that the General Court did not err in law by finding, in paragraphs 101 and 102 of the judgment under appeal, that it was not established that the information requested by EFSA did not constitute information within the meaning of those provisions and that the scenario referred to in point 2.2(b) of Annex II to Regulation No 1107/2009 presupposed that the Commission reached the conclusion that the risk is acceptable and that the approval criteria have been met, which was not the situation in the present case.

58      Furthermore, it should be noted, first, that the finding made in paragraph 102 of the judgment under appeal allows the appellant to understand that the General Court is relying on the wording of point 2.2 of Annex II to Regulation No 1107/2009 in order to substantiate its finding in that paragraph of the judgment under appeal. It therefore cannot be legitimately claimed that paragraph 102 of the judgment under appeal is vitiated by a failure to state reasons.

59      Second, as regards the claim in respect of paragraph 104 of the judgment under appeal that the General Court infringed the principle of proportionality, suffice it to note that, since the General Court did not err in law in paragraphs 101 and 102 of the judgment under appeal, it also cannot have erred in law in paragraph 104.

60      It follows from the foregoing considerations that the fourth ground of appeal must be dismissed.
 The first ground of appeal

 Arguments of the parties

61      By its first ground of appeal, the appellant submits that the General Court, in respect of paragraphs 106 and 107 of the judgment under appeal, misinterpreted and misapplied the requirements of the procedure regarding requests for additional information in the context of the renewal of an approval of an active substance.

62      The appellant claims that, although the gaps to which EFSA pointed in the data which the appellant had submitted in its application for renewal of the approval of the active substance in question were not related to major concerns, EFSA abided ‘by the letter of the law’ and concluded that the approval of the active substance in question should not be renewed. The appellant submits that, at that stage of the procedure, it could no longer fill in the missing data as it was not given the necessary time in which to produce them, which would have been the case if the missing data had been characterised as ‘confirmatory information’ or if the initial deadline had been renewed by analogy.

63      The appellant maintains that, as stated in the judgment under appeal, at the very early stages of the procedure comes the admissibility examination that is checked by the rapporteur Member State in consultation with the co-rapporteur Member State. Thus, assuming that exceptionally the rapporteur and co-rapporteur Member States (or even the Commission, the other Member States and EFSA) to whom a copy of the application is sent, according to Article 1(2) of Implementing Regulation No 844/2012, failed to require a critical document that was identified at a later stage, in this case the applicant for the renewal of approval of an active substance should be allowed to complete the file and not be faced with a rejection for this reason, resulting in the loss of a serious investment and most importantly of the relevant market due to the prohibition on placing the product containing the non-renewed active substance on the market.

64      Otherwise, no applicant for the renewal of approval of an active substance would be eager to embark upon a random procedure at the late stage of which all its efforts and plans could be reversed although this could have been prevented. Such a development would constitute for those applicants a business stalemate with considerable economic repercussions on the market and agriculture. Hence, Article 6(f) of Regulation No 1107/2009 and point 2.2 of Annex II thereto should be read and applied in the light of those considerations.

65      In addition, the appellant submits that the fact that, as stated by the General Court in paragraph 106 of the judgment under appeal, EFSA can request additional information, which does not fall within the scope of Article 6(f) of Regulation No 1107/2009 and that cannot be produced within a one-month period, creates a situation in which it is impossible for an applicant to comply. Accordingly, the General Court misinterpreted the provisions that govern the renewal procedure, in particular those that concern the admissibility of the application laid down in Articles 7 to 8 of Implementing Regulation No 844/2012, and those that provide EFSA and the rapporteur Member State with the possibility to request additional information laid down in Articles 11 and 13 of Implementing Regulation No 844/2012. The appellant also claims that its rights of defence were thereby infringed.

66      Lastly, the appellant takes the view that the General Court failed to examine its argument that when EFSA detects new issues that were not found by the rapporteur Member State, the applicant should be given a sufficient time limit in which to generate and present the new data  required.

67      The Commission contends that the first ground of appeal is ineffective and, in any event, unfounded. The Swedish Government also contends that this ground of appeal is unfounded.
 Findings of the Court

68      In the first ground of appeal, which refers to paragraphs 106 and 107 of the judgment under appeal, it is claimed that the General Court misinterpreted and misapplied the requirements of the procedure regarding requests for additional information in the context of the procedure for the renewal of an approval of an active substance.

69      The appellant maintains, in essence, that, where the rapporteur Member State considers that the application for renewal of the approval of an active substance is admissible in accordance with the provisions of Implementing Regulation No 844/2012, and in particular with Articles 7 and 8 of that regulation, on account of the fact that it considers that the file it submitted was complete, EFSA may, subsequently, request ‘additional information’, within the meaning of Article 13(3) of the regulation, only where such information is additional confirmatory information, as referred to in Article 6(f) of Regulation No 1107/2009 and in point 2.2(a) and (b) of Annex II thereto, or where the applicant is in a position to provide the information requested within the one-month period provided for in Article 13(3).

70      In the first place, it should be noted that, contrary to what the appellant claims, the General Court, in paragraph 106 of the judgment under appeal, correctly distinguished between the requirements under the provisions relating to the conditions of admissibility of an application for renewal, laid down, in particular, in Articles 7 and 8 of Implementing Regulation No 844/2012, and those requirements relating to the substantive assessment of the application.

71      The General Court was correct to state, in particular, in that paragraph of the judgment under appeal, that the fact that the dossier formally contains all the items in order for the rapporteur Member State to be able to declare that application to be admissible 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 that Member State and EFSA.

72      It must be borne in mind that under Article 14(1) of Regulation No 1107/2009 the approval of an active substance is, on application, to be renewed where it is established that the approval criteria provided for in Article 4 of that regulation have been satisfied. Article 14(1) of Regulation No 1107/2009 provides that an active substance is to be approved if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of Annex II to that regulation, plant protection products containing that active substance meet the requirements provided for in Article 4(2) and (3) thereof.

73      In that connection, as regards, first, the conditions for the admissibility of an application for renewal, which are governed by Implementing Regulation No 844/2012, Articles 6 to 8 thereof provide, in essence, that the applicant must provide, within the period set, the rapporteur Member State responsible for assessing the application with all the information requested, which includes the supplementary summary dossier. It is clear from Article 8(2) of Implementing Regulation No 844/2012 that, if the rapporteur Member State considers that that dossier is incomplete, it is to inform the applicant of which elements are missing and set a period of 14 days for the applicant to provide it with those elements.

74      Second, where, in accordance with Article 8(1) of Implementing Regulation No 844/2012, the rapporteur Member State considers the application for renewal to be admissible in that the complementary dossiers were submitted within the period set and that they contain all the elements set out in Article 7 of that regulation, that application is to be assessed in a procedure which is set out in Articles 11 to 14 of the regulation.

75      It thus follows from Articles 11 and 12 of Implementing Regulation No 844/2012 that the rapporteur Member State draws up and submits to the Commission and EFSA a draft renewal assessment report, which is sent to the applicant, the other Member States and the public for observations. Any observations are to be addressed to EFSA which, in accordance with Article 13(1) of that regulation, is to adopt its conclusions, in which it states whether it may be expected that the active substance satisfies the approval criteria set out in Article 4 of Regulation No 1107/2009. In that regard, as is provided in Article 13(3) of Implementing Regulation No 844/2012, if EFSA considers that the applicant must provide additional information, it is to set a period not exceeding one month for the applicant to supply that information.

76      It therefore follows from all of those provisions that, contrary to what the appellant claims, once the rapporteur Member State has declared the application for renewal of an active substance admissible, within the meaning of Articles 7 and 8 of Implementing Regulation No 844/2012, EFSA is entitled to call into question the completeness of the information provided by the applicant at the merits stage of its application for renewal. Any other interpretation would undermine the provisions of Regulation No 1107/2009 and of Implementing Regulation No 844/2012.

77      Thus, even if the rapporteur Member State declares the application for renewal admissible, it is expressly provided, in Article 11(5) and Article 13(3) of Implementing Regulation No 844/2012, respectively, that that Member State and EFSA may, at the assessment stage of that application, require that the applicant supply additional information.

78      In that connection, it should be observed that the information relating to the admissibility of the application, communicated to the applicant by the rapporteur Member State, in accordance with Article 8(1) of Implementing Regulation No 844/2012, serves principally, first, to confirm to the applicant that its application and complementary dossiers contain all of the elements required under Articles 2 and 7 of that implementing regulation and, second, to trigger the 12-month period, laid down in Article 11(1) thereof, which requires the rapporteur Member State to prepare and submit the draft renewal assessment report to the Commission, with a copy to EFSA.

79      In so far as concerns Article 6(f) of, and point 2.2 of Annex II to, Regulation No 1107/2009, on which the appellant relies, it should be noted that it is clear from the examination of the fourth ground of appeal that those provisions are not applicable in the present case. The appellant cannot, therefore, put forward any meaningful argument whatsoever alleging infringement of those provisions on the part of the General Court.

80      In the second place, the appellant cannot validly claim that it should have been granted additional time.

81      It must be held that Article 11(5) and Article 13(3) of Implementing Regulation No 844/2012 fix specific periods for the applicant to supply that information, the exceedance of which has practical consequences for the next part of the procedure. Thus, Article 13(3) lays down a maximum period of one month and, under Article 13(5), the information that the applicant supplies after the expiry of that period is not taken into account, unless it is submitted in accordance with Article 56 of Regulation No 1107/2009, which provision is not applicable in the present case.

82      The imposition of those periods and the requirement that they be observed are, moreover, as the Commission states, consistent with the requirement that the duration of the procedure as a whole not exceed three years, as is clear from Article 1(1) of Implementing Regulation No 844/2012.

83      Accordingly, in the light of the foregoing considerations, the first ground of appeal must be dismissed.
 The second ground of appeal

 Arguments of the parties

84      By its second ground of appeal, the appellant submits that, in paragraphs 81, 83, 84 and 93 of the judgment under appeal, the General Court erred in law by declaring that the complaint alleging that, as regards the seven non-finalised issues, the existence of disagreements between EFSA’s assessment and that of the rapporteur Member State requires an in-depth statement of reasons on that question had to be rejected as unfounded as regards the fourth point and ineffective as regards the other points.

85      It submits, principally, that, in paragraphs 81 and 84 of the judgment under appeal, the General Court wrongly rejected, in its examination of the third part of the first plea in support of its action for annulment, the appellant’s argument claiming infringement of the obligation to state reasons, by basing that rejection on the revised assessment report, whereas that report was not referred to in the regulation at issue. The General Court thereby, first, failed to take account of relevant elements when rejecting the appellant’s plea in law and, second, distorted the content of the regulation at issue as the General Court substituted its own reasoning for that set out in that regulation.

86      The appellant submits that it is clear from the wording of that regulation that the refusal to renew the approval of the active substance in question is based solely on the initial assessment report, drawn up by the rapporteur Member State. It should therefore be concluded from the absence of any reference to the revised assessment report in the regulation at issue that, when adopting the latter, the Commission deliberately chose not to take account of the revised assessment report. The appellant submits further that it follows from the content of the Commission’s renewal report that the intensive consultation of technical experts from Member States, organised by EFSA, examined the initial assessment report only and not the revised assessment report.

87      The appellant submits, furthermore, that, implicitly, the General Court also erred in law in paragraph 83 of the judgment under appeal, since that paragraph was also based on the revised assessment report.

88      In any event, it states that, even if the regulation at issue had indeed taken account of the revised assessment report, the latter should not have been taken into consideration. In the appellant’s submission, it is in fact apparent from the structure of the complex administrative procedure laid down in Implementing Regulation No 844/2012 that the rapporteur Member State’s draft renewal assessment report, referred to in Article 11 of that regulation, is, in principle, final and irrevocable. Thus, once that draft renewal assessment report has been submitted, the rapporteur Member State, in order to safeguard and respect its own independent assessment, can no longer re-examine it in the light of any subsequent observations from EFSA, the other Member States or the public.

89      Furthermore, and in the alternative, the appellant submits, first, that it is clear from the judgment under appeal that, while observations were made on the draft initial assessment report, the revised assessment report was, however, never sent to the parties which would have been entitled to submit observations thereon. Second, it submits that, should it be found that the revised assessment report was in fact taken into consideration in the regulation at issue, the General Court erred in law by failing to take account of the relevant elements when it examined the conclusions to be drawn from that report as, in paragraphs 83 and 93 of the judgment under appeal, the General Court based its findings exclusively on the operative part of that report.

90      The Commission submits that the second ground of appeal is unfounded.

91      The Swedish Government submits, principally, that the second ground of appeal is inadmissible. It contests the appellant raising, in the present appeal, the claim that the Commission voluntarily chose not to take account, in the regulation at issue, of the revised assessment report, given that that claim was not relied upon in the course of the proceedings before the General Court and that the latter was therefore unable to examine it. The Swedish Government takes the view, in the alternative, that this second ground of appeal should be dismissed as unfounded.

92      As regards the objection of inadmissibility raised by the Swedish Government, the appellant contends that it stated that the regulation at issue does not take account of the revised assessment report for the sole purpose of challenging the lawfulness of the judgment under appeal, with the result that that argument is not directed against the regulation at issue per se. In other words, the second ground of appeal is based on arguments drawn from paragraph 81 of the judgment under appeal, which adversely affects the appellant. Furthermore, this ground of appeal is a criticism of a point of law, since it relates to the question of which elements were relevant to the examination which the General Court should have carried out.
 Findings of the Court

93      The second ground of appeal is based, in essence, on the argument that, in paragraphs 81, 83, 84 and 93 of the judgment under appeal, the General Court wrongly based its rejection of the third part of the first plea in law in support of the action for annulment, which alleged failure to state reasons for the regulation at issue, on the revised assessment report, when it should have referred to the initial assessment report. The appellant makes the inference that the Commission based its refusal to renew the approval of the active substance in question solely on the initial assessment report, and deliberately chose not to take account of the revised assessment report, from the fact that the regulation at issue makes no reference to the revised assessment report. The General Court thus distorted the content of the regulation at issue as it substituted its own reasons for those put forward by the Commission as the basis for that regulation. In any event, the appellant claims that, even if the revised assessment report had been referred to in the regulation at issue and the judgment under appeal, it could not have been taken into consideration.

94      As a preliminary point, the objection of inadmissibility raised by the Swedish Government must be rejected. It must be held that, although the argument that the regulation at issue does not take account of the revised assessment report was not raised at first instance, such an argument seeks to challenge the lawfulness of the assessment of the content of that regulation, carried out in the judgment under appeal by the General Court, since the latter based its examination on that report (see, to that effect, judgment of 26 February 2020, EEAS v Alba Aguilera and Others, C‑427/18 P, EU:C:2020:109, paragraph 54 and the case-law cited).

95      As regards the examination of the merits of the second ground of appeal, it must be noted that, admittedly, in its reply to the appellant’s argument that, in the regulation at issue, the Commission failed to justify why the position adopted by the rapporteur Member State had been rejected whereas EFSA’s position had been accepted, the General Court, in paragraphs 81 to 84 of the judgment under appeal, makes reference to the revised assessment report, although it is common ground that the regulation at issue does not expressly refer to that report.

96      However, first, it is also common ground that EFSA’s conclusions – to which the Commission expressly refers in the regulation at issue and on which the latter is based – take account of both the initial assessment report and the revised assessment report. Thus, in the part of the judgment under appeal on the background to the dispute, the General Court states, in paragraph 33 of that judgment, that the appellant does not, in its action, dispute that ‘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’.

97      It follows that the Commission did indeed take account of the latter report for the purposes of adopting the regulation at issue, and that the General Court, in order to compare the positions taken by the rapporteur Member State and EFSA and therefore respond to the appellant’s argument referred to in paragraph 94 of the present judgment, did not err in law by referring to the revised assessment report, which expresses the rapporteur Member State’s final position as to the assessment of the application for renewal of the active substance in question. It cannot, therefore, be claimed that the General Court distorted the content of the regulation at issue on the ground that the latter contained no statement of reasons based on the revised assessment report, with the result that the General Court substituted its own reasons for those put forward by the Commission in support of that regulation.

98      Second, although, by its draft assessment report, referred to in Article 11 of Implementing Regulation No 844/2012, the rapporteur Member State assesses whether the active substance concerns can be expected to meet the approval criteria in accordance with Article 4 of Regulation No 1107/2009, none of the provisions of Implementing Regulation No 844/2012 precludes that Member State from thereafter amending the position expressed in that report.

99      Conversely, first, the fact that Article 11 together with Articles 12 to 14 of Implementing Regulation No 844/2012 use the words ‘the draft renewal assessment report’ from the rapporteur Member State clearly indicates that, as a draft, that report is liable to be revised.

100    Second, it follows from Article 13(3) of that implementing regulation that where, as in the present case, EFSA, in the conclusions that it must adopt after receiving the draft renewal assessment report from the rapporteur Member State as well as the observations of the parties concerned, considers that additional information from the applicant is necessary, ‘the rapporteur Member State shall … evaluate the information received and send its evaluation to [EFSA]’.

101    It follows that if, in particular, in the light of the additional information sent by the applicant under Article 13(3) of Implementing Regulation No 844/2012, the rapporteur Member State finds that data gaps, identified by EFSA in its request for information, have not been filled, it may avail itself of the possibility of amending its initial assessment. Consequently, it does not follow from that provision that the rapporteur Member State is bound by its initial assessment, set out in its draft assessment report, if that assessment has changed on scientific grounds over the course of the process to which that regulation refers. On the contrary, it is clear from that provision that the procedure put in place seeks to afford that Member State the possibility, or even the obligation, to amend its draft renewal assessment report.

102    It should be added that this interpretation of the provisions of Implementing Regulation No 844/2012 and, in particular, of Article 13(3) contributes to achieving one of the main objectives pursued by Regulation No 1107/2009 which, as it follows from Article 1(3) of that regulation, read in the light of recital 8 thereof, consists in ensuring a high level of protection of both human and animal health and the environment, which objective Implementing Regulation No 844/2012 implements in so far as concerns the renewal procedure for active substances. This interpretation serves to ensure that EFSA’s conclusions, which take account of the rapporteur Member State’s assessment further to the additional information provided by the applicant under Article 13(3) of Implementing Regulation No 844/2012, and which the Commission must take into account in its renewal report as well as its draft regulation, as provided in the second subparagraph of Article 14(1) of that regulation, are based on all information deemed relevant in the light of current scientific and technical knowledge.

103    Lastly, as regards the arguments submitted in the alternative by the appellant, it should, first, be observed that the fact that, unlike the draft initial assessment report, the revised assessment report was not submitted to the various intervening parties for their observations does not mean that the latter report cannot be taken into account. The revised assessment report was in fact adopted by the rapporteur Member State in question further to the answers given by the applicant under Article 13(3) of Implementing Regulation No 844/2012. Furthermore, and in any event, the applicant still has the possibility of submitting observations on the renewal report adopted by the Commission which, as stated in the preceding paragraph, must take account, inter alia, of EFSA’s conclusions, since these include any assessments made by the rapporteur Member State and submitted by it after its initial assessment report.

104    Second, it should be noted that the appellant’s argument that the General Court failed to take account ‘of all relevant elements when examining the conclusions to be drawn from the revised assessment report’ lacks clarity and that, in any event, the appellant merely makes assertions that are in no way substantiated.

105    It follows from the foregoing that the second ground of appeal must be dismissed.
 The third ground of appeal

 Arguments of the parties

106    By its third ground of appeal, the appellant submits that the General Court erred in law by failing to take account of all relevant elements before rejecting the appellant’s argument that it had legitimate expectations that the data which EFSA considered to be gaps would be requested as confirmatory data after the renewal of the approval, as was proposed by the rapporteur Member State.

107    It is submitted that it is apparent from paragraph 94 of the judgment under appeal that the General Court concluded that the appellant could not entertain legitimate expectations on the basis of the revised assessment report. As has allegedly been demonstrated in the context of the second ground of appeal, the Commission failed to take account of that report in the regulation at issue. The General Court should therefore have determined whether the appellant could entertain legitimate expectations on the basis of the initial assessment report.

108    The Commission and the Swedish Government take the view that the third ground of appeal is unfounded.
 Findings of the Court

109    As the third ground of appeal starts from the premiss that the Commission failed to take account, in the regulation at issue, of the revised assessment report, whereas that premiss has already been rejected in the examination of the second ground of appeal, this third ground must be dismissed.
 The fifth ground of appeal

 Arguments of the parties

110    By its fifth ground of appeal, the appellant submits that, in paragraph 123 of the judgment under appeal, the General Court erred in law by incorrectly interpreting and applying the precautionary principle.

111    Principally, it submits that, while the objective of the precautionary principle is to prevent potential risks for public health, safety and the environment, the approval or the renewal of the approval of an active substance does not, however, lead to any form of risk and, accordingly, cannot trigger the application of that principle.

112    According to the appellant, for the purposes of the placing of plant protection products on the market in the European Union, Regulation No 1107/2009 introduced a system in which the approval procedures for active substances, at EU level, are separate from authorisation procedures, at Member State level, for plant protection products including the active substance in question and other elements, which is then used by operators.

113    Thus, the approval of an active substance is not comparable to an authorisation to place a plant protection product on the market, but is only a prerequisite for the competent authorities of the Member States to accept an application for authorisation of a plant protection product which contains the approved active substance and to decide, on the basis of the information submitted, whether or not to grant an authorisation. In that connection, there is, in principle, no link between the assessment and approval of an active substance at EU level in that regard, and the actual subsequent use that will be made of that substance.

114    Therefore, as the General Court has already held, while it is true that an active substance is inevitably released into the environment at some stage of its life cycle, that is the case only via a plant protection product subject to the authorisation procedure.

115    Moreover, the appellant submits that it is not certain that all applicants who secure approval of an active substance will subsequently seek authorisation of a plant protection product containing that substance. Furthermore, even in the event that the active substance in question is approved, notifiers have the possibility of submitting an application in relation to any plant protection product containing that substance, which means that the use, the conditions of use and the composition of the plant protection product for which authorisation is sought may be very different from the products evaluated at EU level during the approval procedure for the active substance contained in those products.

116    Accordingly, at the stage of approval of the active substance, the risks for human health, safety and the environment are hypothetical and, contrary to the General Court’s findings in the judgment under appeal, it would be justified that the precautionary principle be applied more flexibly for active substances than for plant protection products.

117    The appellant submits that it also follows that the substantive criteria applicable to the approval or renewal of the approval of an active substance differ to those applicable in the case of an authorisation of a plant protection product. In the latter case, the decision-making authority has to be twice as careful and strict since the authorisation means placing of the plant protection product on the market while the approval of the substance does not entail any direct risk on health and on the environment. This is confirmed by the fact that Article 4 of Regulation No 1107/2009 allows approval if it ‘may be expected’ that the plant protection products containing the active substance meet the requirements, and Annex II, point 2.1, in its explanation of the ‘single safe use concept’, requires only that, on the basis of the dossier submitted, authorisation in at least one Member State is expected to be possible.

118    The appellant adds that, in matters of environmental protection, in which EU legislation provides for a certain degree of subsidiarity, the Commission should not ‘rule over the heads’ of the Member States by denying them the exercise of the powers that are conferred on them, particularly when it is a given fact that the Member States have all the facts, tools and information available to ensure compliance with EU legislation, namely in close consultation with the Commission.

119    In the alternative, the appellant submits that, contrary to its own case-law, the General Court failed to take account, in the judgment under appeal, of all of the relevant information and, in particular, the fact that the application of the plant protection product Laguna, which contains the active substance in question, has never raised a health or environmental concern, or that the non-renewal is based on gaps in the data which, had they been requested on time, could have been filled. In that connection, in the context of the precautionary principle, the appellant takes the view, contrary to what the General Court held in paragraph 121 of the judgment under appeal, that the fact that the appellant bears the burden of proof does not relieve the Commission of  its obligation to take all relevant elements into account in order to exercise its discretion.

120    The Commission and the Swedish Government take the view that the fifth ground of appeal must be dismissed.
 Findings of the Court

121    The appellant submits, in essence, that the approval or renewal of an active substance does not lead to any form of risk for health or the environment, since that substance is released into the environment only via a plant protection product, once the latter has been authorised. Accordingly, the precautionary principle cannot apply to such an approval or renewal of an active substance or, in any event, it would be justified that the precautionary principle be applied more flexibly for active substances than for plant protection products.

122    In paragraph 123 of the judgment under appeal, the General Court observed that ‘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 connection, Article 13(2) of that regulation states that the regulation approving an active substance must take the precautionary principle into account. Accordingly, the appellant wrongly relies on 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.

123    It should be observed that the General Court’s assessment is not vitiated by any error of law.

124    First, it is clear from the wording of Article 1(4) of Regulation No 1107/2009 that the precautionary principle applies to active substances. That article provides that the provisions of the regulation are underpinned by the precautionary principle in order to ensure that active substances or products placed on the market do not adversely affect human or animal health or the environment. Furthermore, recital 8 of the regulation states that the precautionary principle should be applied and that 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.

125    Moreover, as the General Court observes in paragraph 123 of the judgment under appeal, it follows from Article 13(2) of Regulation No 1107/2009 that the Commission adopts the regulation approving an active substance on the basis of the review report, other factors legitimate to the matter under consideration and the precautionary principle.

126    The appellant therefore cannot validly claim that that principle is not applicable during the procedure for the assessment of an active substance in the light of Regulation No 1107/2009 and of Implementing Regulation No 844/2012. It should be added that it cannot be inferred from those regulations that there is any possibility of lessening or tempering the application of that principle depending on whether it is aimed at the assessment of active substances or that of plant protection products.

127    Second, it must be borne in mind that the Court has already accepted that the precautionary principle applies to such a procedure for the assessment of an active substance in its judgment of 1 October 2019, Blaise and Others (C‑616/17, EU:C:2019:800). In that judgment, the Court examined the validity of Regulation No 1107/2009 in the light of that principle by carrying out a detailed examination of the rules governing the authorisation of plant protection products and the approval of the active substances which those products contain, with a view to placing them on the market. Thus the Court held, inter alia, in paragraph 47 of that judgment, that the EU legislature ought to establish a normative framework that ensures that the competent authorities have available to them, when they decide on that authorisation and that approval, sufficient information in order adequately to assess, in accordance with the requirements of the precautionary principle, the risks to health resulting from the use of those active substances and those plant protection products.

128    In particular, the Court held that the applicant’s obligation to adduce evidence that the active substance or plant protection product that is the subject of an application for approval or authorisation fulfils the relevant criteria laid down by Regulation No 1107/2009 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 (judgment of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraph 80).

129    As regards the appellant’s arguments, raised in the alternative, it should be noted that it follows, in essence, from paragraph 120 of the judgment under appeal that the General Court found that, in the context of applying the precautionary principle, the Commission had acquainted itself with all of the relevant information before giving a decision on the application for renewal of the active substance in question. In that connection, the General Court carried out, within the limits of its powers, an assessment of factual elements in order to examine the validity of the regulation at issue and, in particular, whether the Commission had correctly applied the precautionary principle. Such an assessment thus does not, save where the facts and evidence have been distorted, constitute a point of law which is subject, as such, to review by the Court of Justice on appeal (see, to that effect, judgment of 15 July 2021, Deutsche Lufthansa v Commission, C‑453/19 P, EU:C:2021:608, paragraph 46 and the case-law cited). In the present case, the appellant does not rely on any distortion whatsoever of those factual elements. Accordingly, the fifth ground of appeal must be dismissed as inadmissible in that, by that ground of appeal, the appellant submits that the General Court failed to take account of all of the relevant information.

130    Furthermore, as to the argument that, contrary to what the General Court held in paragraph 121 of the judgment under appeal, the fact that the burden of proof is borne by the appellant does not relieve the Commission of its obligation to take account of all of the relevant elements in the exercise of its discretion, it is sufficient to find that the General Court did  not err in law in holding that, since the appellant had not discharged its burden of proving that the conditions for approval set out in Article 4 of Regulation No 1107/2009 had been satisfied, the approval of the active substance could not be renewed.

131    It follows that the General Court did not err in law in the assessment set out in paragraph 121 of the judgment under appeal and that the arguments raised in the alternative by the appellant must be rejected.

132    It therefore follows from the foregoing considerations that the fifth ground of appeal must be dismissed.

133    Since all the grounds of appeal raised by the appellant have been dismissed, the appeal must be dismissed in its entirety.
 Costs

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

135    Article 138(1) of those rules, applicable to appeal proceedings pursuant to Article 184(1) thereof, provides that the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.

136    Since the appellant has been unsuccessful and the Commission has applied for costs, the appellant must, in addition to bearing its own costs, pay those incurred by the Commission.

137    Furthermore, it is appropriate to decide that the Kingdom of Sweden shall bear its own costs relating to the present appeal, pursuant to Article 184(4) of the Rules of Procedure.
On those grounds, the Court (Tenth Chamber) hereby:
1.      Dismisses the appeal;

2.      Orders Agrochems-Maks d.o.o. to bear its own costs and pay those incurred by the European Commission;

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

Lycourgos

Jarukaitis

Ilešič

Delivered in open court in Luxembourg on 9 December 2021.

A. Calot Escobar
 
K. Lenaerts

Registrar 
 
President

*      Language of the case: English.