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(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,
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
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’).
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.’
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.
Article 4 of the regulation, under the heading ‘Approval criteria for active substances’, provides:
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.
(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.
(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.
…
‘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;
…’
‘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.’
‘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].’
‘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.’
‘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.’
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).
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.
…
…’
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. …
…’
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].’
14.14
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.
15.15
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.
…’
16.16
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”).
(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;
…
…
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.
…’
17.17
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.
18.18
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.
…
…’
19.19
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.
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.
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.
22.22
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).
23.23
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.
24.24
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.
25.25
On 13 July 2016, EFSA sent the appellant a request for additional information, pursuant to Article 13(3) of Implementing Regulation No 844/2012.
26.26
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.
27.27
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.
28.28
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’.
29.29
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.
30.30
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’.
31.31
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’.
32.32
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.
33.33
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.
34.34
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.
35.35
Having rejected all of the pleas for annulment, the General Court dismissed that action in its entirety in the judgment under appeal.
36.36
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.
The Commission contends that the Court should:
–dismiss the appeal; and
–order the appellant to pay the costs.
38.38
The Swedish Government submits that the Court should dismiss the appeal.
39.39
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.
40.40
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.
41.41
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.
42.42
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.
43.43
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’.
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.
45.45
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.
46.46
The Commission and the Swedish Government take the view that the fourth ground of appeal should be dismissed.
47.47
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.
48.48
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.
49.49
Such an interpretation of the dispositions of that regulation cannot be upheld.
50.50
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.
51.51
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.
52.52
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.
53.53
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).
54.54
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.
55.55
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.
56.56
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.
57.57
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.
58.58
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.
59.59
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.
60.60
It follows from the foregoing considerations that the fourth ground of appeal must be dismissed.
61.61
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.
62.62
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.
63.63
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.
64.64
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.
65.65
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.
66.66
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.
67.67
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.
68.68
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 renewal of an approval of an active substance.
69.69
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).
70.70
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.
71.71
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.
72.72
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.
73.73
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.
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.
75.75
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.
76.76
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.
77.77
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.
78.78
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.
79.79
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.
80.80
In the second place, the appellant cannot validly claim that it should have been granted additional time.
81.81
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.
82.82
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.
83.83
Accordingly, in the light of the foregoing considerations, the first ground of appeal must be dismissed.
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.
85.85
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.
86.86
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.
87.87
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.