Contents
Judgment of the General Court (Fourth Chamber, Extended Composition)19 November 2025note(Plant protection products — Active substance dimoxystrobin — Application for renewal of an active substance — Extension of approval period — Length of the extension — Request for internal review — Article 10(1) of Regulation (EC) No 1367/2006 — Decision to reject the request — Article 17 of Regulation (EC) No 1107/2009)In Case T‑412/22,Pesticide Action Network Europe (PAN Europe), established in Brussels (Belgium), represented by A. Bailleux, lawyer,vEuropean Commission, represented by A. Becker, G. Gattinara and M. ter Haar, acting as Agents,supported byEuropean Parliament, represented by M. Menegatti and W. Kuzmienko, acting as Agents,byCouncil of the European Union, represented by A. Nowak-Salles, A. Maceroni and P. Pecheux, acting as Agents,and byCropLife Europe, established in Brussels, represented by D. Waelbroeck and I. Antypas, lawyers,THE GENERAL COURT (Fourth Chamber, Extended Composition),composed, at the time of the deliberations, of R. da Silva Passos, President, N. Półtorak, I. Reine, T. Pynnä (Rapporteur) and H. Cassagnabère, Judges,Registrar: P. Cullen, Administrator,having regard to the written part of the procedure, in particular:– the plea of inadmissibility raised by the Commission by document lodged at the General Court Registry on 23 September 2022,– the applicant’s observations on the plea of inadmissibility lodged at the Court Registry on 18 November 2022,further to the hearing on 13 February 2025,gives the following
Judgment
1By its action under Article 263 TFEU, the applicant, Pesticide Action Network Europe (PAN Europe), seeks annulment of Commission Decision Ares(2022) 3275139 of 27 April 2022 to reject its request for internal review as regards Commission Implementing Regulation (EU) 2021/2068 of 25 November 2021 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances benfluralin, dimoxystrobin, fluazinam, flutolanil, mecoprop-P, mepiquat, metiram, oxamyl and pyraclostrobin (OJ 2021 L 421, p. 25) (‘the contested decision’), in so far as that regulation extends the approval period of dimoxystrobin.
Background to the dispute and events subsequent to the bringing of the action
2The applicant is a not-for-profit association established in Brussels (Belgium) whose purpose is, inter alia, the promotion of activities designed to reduce and eliminate pesticides.
3Dimoxystrobin is part of the chemical group of strobilurins, which includes several similarly acting pesticides that are used as agricultural fungicides.
4Dimoxystrobin was approved for the first time by Commission Directive 2006/75/EC of 11 September 2006 amending Council Directive 91/414/EEC to include dimoxystrobin as active substance (OJ 2006 L 248, p. 3). In accordance with the annex to that directive, the approval entered into force on 1 October 2006 and was to expire on 30 September 2016.
5In 2009, Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ 2009 L 309, p. 1) entered into force. Dimoxystrobin was deemed to have been approved in accordance with Article 78(3) of that regulation.
6On 24 July 2013, an application for renewal of the approval of dimoxystrobin was submitted.
7On 12 November 2013, the approval period of dimoxystrobin was extended, until 31 January 2018, by Commission Implementing Regulation (EU) No 1136/2013 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances clothianidin, dimoxystrobin, oxamyl and pethoxamid (OJ 2013 L 302, p. 34), pursuant to Article 17 of Regulation No 1107/2009. Recital 2 of that regulation states that ‘it is necessary to allow applicants sufficient time to complete the renewal procedure’, that ‘consequently, the approvals of those active substances are likely to expire before a decision has been taken on their renewal’, and that ‘it is therefore necessary to extend their approval periods.’
8In 2015, dimoxystrobin was placed on the list of substances, the substitution of which is envisaged by Commission Implementing Regulation (EU) 2015/408 of 11 March 2015 on implementing Article 80(7) of Regulation No 1107/2009 concerning the placing of plant protection products on the market and establishing a list of candidates for substitution (OJ 2015 L 67, p. 18). Recitals 5 and 6 of that regulation explain that the Acute Reference Dose (ARfD) of that substance, which is persistent and toxic, is significantly lower than that of the majority of the approved active substances within its group. Recital 9 of that regulation adds that dimoxystrobin must be considered to have endocrine disrupting properties that may cause adverse effects in humans.
9In August 2017, the rapporteur Member State (Hungary) and the co-rapporteur Member State (Ireland) issued a renewal assessment report. That report identifies issues where the risk assessment could not be finalised and critical areas of concern.
10On 19 January 2018, the approval of dimoxystrobin was extended for a second time, until 31 January 2019, by Commission Implementing Regulation (EU) 2018/84 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances chlorpyrifos, chlorpyrifos-methyl, clothianidin, copper compounds, dimoxystrobin, mancozeb, mecoprop-p, metiram, oxamyl, pethoxamid, propiconazole, propineb, propyzamide, pyraclostrobin and zoxamide (OJ 2018 L 16, p. 8). Recital 7 of that regulation states that ‘due to the fact that the assessment of the substances has been delayed for reasons beyond the control of the applicants, the approvals of those active substances are likely to expire before a decision has been taken on their renewal’ and that ‘it is therefore necessary to extend their approval periods.’
11On 20 November 2018, the approval of dimoxystrobin was extended for a third time, until 31 January 2020, by Commission Implementing Regulation (EU) 2018/1796 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances amidosulfuron, bifenox, chlorpyrifos, chlorpyrifos-methyl, clofentezine, dicamba, difenoconazole, diflubenzuron, diflufenican, dimoxystrobin, fenoxaprop-p, fenpropidin, lenacil, mancozeb, mecoprop-p, metiram, nicosulfuron, oxamyl, picloram, pyraclostrobin, pyriproxyfen and tritosulfuron (OJ 2018 L 294, p. 15). Recital 6 of that regulation repeats the reasons given in recital 7 of Implementing Regulation 2018/84.
12On 29 November 2019, the approval of dimoxystrobin was extended for a fourth time, until 31 January 2021, by Commission Implementing Regulation (EU) 2019/2094 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances benfluralin, dimoxystrobin, fluazinam, flutolanil, mancozeb, mecoprop-P, mepiquat, metiram, oxamyl and pyraclostrobin (OJ 2019 L 317, p. 102). Recital 5 of that regulation repeats the reasons stated in recital 7 of Implementing Regulation 2018/84.
13On 22 January 2021, the approval of dimoxystrobin was extended for a fifth time, until 31 January 2022, by Commission Implementing Regulation (EU) 2021/52 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances benfluralin, dimoxystrobin, fluazinam, flutolanil, mecoprop-P, mepiquat, metiram, oxamyl and pyraclostrobin (OJ 2021 L 23, p. 13). Recital 4 of that regulation repeats the reasons stated in recital 7 of Implementing Regulation 2018/84.
14On 25 November 2021, the approval of dimoxystrobin was extended for a sixth time, until 31 January 2023, by Implementing Regulation 2021/2068. Recital 4 of that regulation repeats the reasons given in recital 7 of Implementing Regulation 2018/84.
15On 14 January 2022, the applicant submitted a request for internal review of Implementing Regulation 2021/2068 on the basis of Article 10 of Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ 2006 L 264, p. 13).
16By letter of 27 April 2022, the European Commission rejected the applicant’s request for internal review.
17After the present action was brought, the Commission extended the approval of dimoxystrobin for a seventh time, until 31 January 2024, by Implementing Regulation (EU) 2023/115 of 16 January 2023 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval of the active substance dimoxystrobin (OJ 2023 L 15, p. 13).
18On 10 July 2023, by Implementing Regulation (EU) 2023/1436 concerning the non-renewal of the approval of the active substance dimoxystrobin, in accordance with Regulation No 1107/2009 and amending Commission Implementing Regulation (EU) No 540/2011 and Commission Implementing Regulation (EU) 2015/408 (OJ 2023 L 176, p. 10), the Commission decided not to renew the approval of dimoxystrobin.
Forms of order sought
19The applicant claims that the Court should:– annul the contested decision in so far as it concerns the extension of the approval period of dimoxystrobin;– order the Commission to pay the costs.
20The Commission, supported by the European Parliament, the Council of the European Union and CropLife Europe, contends that the Court should:– dismiss the action;– order the applicant to pay the costs.
Law
21The applicant relies on two pleas in law in support of its action, first, alleging, misinterpretation of Article 17 of Regulation No 1107/2009 in the contested decision and, second, in the alternative, raising a plea of illegality in respect of that article.
Continuing legal interest in bringing proceedings
22The Council observes that following the non-renewal of the approval of dimoxystrobin by Implementing Regulation 2023/1436, the extension of the approval of that active substance came to an end. It follows that the action has become without object and the applicant no longer has a legal interest in pursuing it. The Court should therefore apply Article 131(1) of its Rules of Procedure.
23The Court observes that an applicant’s interest in bringing proceedings must be vested and current. That interest must, in the light of the purpose of the action, exist at the stage of lodging the action, failing which the action will be inadmissible, and continue until the final decision, failing which there will be no need to adjudicate (see judgment of 17 September 2015, Mory and Others v Commission, C‑33/14 P, EU:C:2015:609, paragraphs 56 and 57 and the case-law cited).
24In the present case, as the Council submits, it follows from Implementing Regulation 2023/1436 that a decision on the non-renewal of the approval of dimoxystrobin has been adopted.
25However, first, the contested decision has not been withdrawn by the Commission, so that the dispute has retained its purpose (see, to that effect, judgment of 4 September 2018, ClientEarth v Commission, C‑57/16 P, EU:C:2018:660, paragraph 45 and the case-law cited).
26Second, it is apparent from the case-law that an applicant may retain an interest in claiming the annulment of an act of an EU institution to prevent its alleged unlawfulness recurring in the future. That interest in bringing proceedings follows from the first paragraph of Article 266 TFEU, under which the institution whose act has been declared void is to be required to take the necessary measures to comply with the judgment of the Court. However, that interest in bringing proceedings can exist only if the alleged unlawfulness is liable to recur in the future independently of the circumstances of the case which gave rise to the action brought by the applicant (judgments of 7 June 2007, Wunenburger v Commission, C‑362/05 P, EU:C:2007:322, paragraphs 50 to 52, and of 27 September 2018, Mellifera v Commission, T‑12/17, EU:T:2018:616, paragraph 28).
27That is the situation in the present case since the unlawfulness alleged by the applicant is based, inter alia, on an interpretation of Article 17 of Regulation No 1107/2009 which the Commission is likely to repeat where there is a request for internal review of an extension of the approval period of an active substance other than dimoxystrobin.
28It follows that, notwithstanding the adoption of Implementing Regulation 2023/1436, the applicant retains a legal interest in bringing proceedings in the present case.
The first plea in law: misinterpretation of Article 17 of Regulation No 1107/2009
Admissibility of the first plea
29The Commission, by separate document, has lodged a plea of inadmissibility on the basis of Article 130(1) of the Rules of Procedure, by which it claims that both of the applicant’s pleas are inadmissible.
30In the first place, the Commission argues that the applicant, by its first plea, does not challenge the assessment in the reply to its request for internal review, but directs its arguments against the extension of the approval period for dimoxystrobin by Implementing Regulation 2021/2068, which was the subject matter of the request for internal review. However, it follows from a combined reading of Articles 10 and 12 of Regulation No 1367/2006 and from the case-law that where an applicant brings an action for annulment of the reply to a request for internal review under Article 12(1) of that regulation, the action may challenge only the lawfulness of that reply.
31In the second place, and in the alternative, the Commission claims that, if it were assumed that the first plea is admissible, the arguments challenging the lawfulness of its interpretation of Article 17 of Regulation No 1107/2009 must be rejected as inadmissible owing to a lack of concordance between the application and the request for internal review since the above arguments were not made in that request.
32The Court observes, in the first place, that Article 10(1) of Regulation No 1367/2006 provides that ‘any non-governmental organisation or other members of the public that meet the criteria set out in Article 11 shall be entitled to make a request for internal review to the Union institution or body that adopted the administrative act or, in the case of an alleged administrative omission, should have adopted such an act, on the grounds that such an act or omission contravenes environmental law …’. Article 12(1) of that regulation provides that ‘the non-governmental organisation which made the request for internal review pursuant to Article 10 may institute proceedings before the Court of Justice …’.
33A request for internal review of an administrative act is thus intended to establish that, as alleged, the act in question is unlawful or that it is not well founded. The party making the request may then bring the matter before the EU judicature by instituting proceedings – on grounds of lack of competence, infringement of an essential procedural requirement, infringement of the Treaties or of any rule of law relating to their application, or misuse of powers – against the decision rejecting the request for internal review as unfounded (judgment of 12 September 2019, TestBioTech and Others v Commission, C‑82/17 P, EU:C:2019:719, paragraph 38). It follows that, in that action, the applicant is not entitled to put forward arguments directly challenging the lawfulness or merits of the measure concerned by the request for internal review (see judgment of 27 September 2018, Mellifera v Commission, T‑12/17, EU:T:2018:616, paragraph 35 and the case-law cited). Indeed, the system of judicial review provided for by the Treaties does not provide for the possibility, for the General Court, to annul a decision which is not the subject of a direct action for annulment based on Article 263 TFEU (judgment of 4 April 2019, ClientEarth v Commission, T‑108/17, EU:T:2019:215, paragraph 28).
34In the present case, it is first of all clear from the application that the subject matter of the action for annulment is the contested decision in so far as it concerns dimoxystrobin.
35Next, the title of the first plea and the two limbs of which it is composed make it clear that the applicant claims that it is the contested decision that is based on a misreading of Article 17 of Regulation No 1107/2009.
36Lastly, it is clear from reading the first plea as a whole, and in particular the introductory paragraph of the part of the application concerning that plea, that the applicant, by its arguments, is referring to the Commission’s interpretation of Article 17 of Regulation No 1107/2009 in the contested decision. The fact that, owing to the very purpose of the internal review procedure and the logic of Articles 10 and 12 of Regulation No 1367/2006, there may be some overlap between the arguments put forward in the request for internal review and those relied on in support of an action for annulment of the decision rejecting that request as unfounded is not such as to alter that conclusion.
37Consequently, the Commission’s argument that the first plea is inadmissible because it does not relate to the contested decision must be rejected.
38In the second place, as regards the lack of concordance between the request for review and the application, the Court observes that, according to settled case-law, an action for annulment of a decision rejecting a request for internal review cannot be founded on new grounds or evidence not appearing in the request for review, as otherwise the requirement, in Article 10(1) of Regulation No 1367/2006, relating to the statement of grounds for such a request, would be made redundant and the object of the procedure initiated by the request would be altered (judgments of 12 September 2019, TestBioTech and Others v Commission, C‑82/17 P, EU:C:2019:719, paragraph 39, and of 17 April 2024, Föreningen Svenskt Landskapsskydd v Commission, T‑346/22, not published, EU:T:2024:246, paragraph 70).
39In addition, the pleas and arguments raised before the General Court in an action for annulment of a decision rejecting a request for internal review can be regarded as being admissible only in so far as they have already been presented by the applicant in the request for internal review, and in such a way that the Commission has been able to respond thereto (see, to that effect, judgment of 15 December 2016, TestBioTech and Others v Commission, T‑177/13, not published, EU:T:2016:736, paragraphs 68 and 69). However, an applicant bringing an action before the General Court under Article 12 of Regulation No 1367/2006 cannot be required to confine itself to reproducing verbatim the arguments it had relied on in its request for internal review.
40In the present case, it is clear from its request for internal review that the applicant in particular challenged the Commission’s application of Article 17 of Regulation No 1107/2009 when it adopted Implementing Regulation 2021/2068. In particular, it raised arguments based on the precautionary principle, on the extensions being automatic and on the assessment periods laid down in Regulation No 1107/2009, and referred to Articles 4, 5, 7, 9, 14 and 15 of that regulation. Accordingly, it must be held that such arguments overlap with the first plea of the present action for annulment.
41Consequently, the Commission’s argument concerning a lack of concordance between the request for internal review and the application must be rejected.
42It follows that the first plea is admissible.
Substance
43The applicant observes in the first plea that Regulation No 1107/2009 is based on the objective of securing a high level of protection of human health and is founded on the precautionary principle and the principle of protection of the environment.
44In particular, the applicant submits in the second limb of the first plea that Regulation No 1107/2009 was adopted mainly with a view to the speeding up of the assessment of active substances. Strict deadlines have been set for every step of the renewal process, which allows the preparatory process to be ended in two and a half years and gives the Commission and the Member States more than six months to decide whether or not to renew an approval.
45In that context, Article 17 of Regulation No 1107/2009 can only be understood as providing for a limited extension of a few months, or a year at most, and cannot be interpreted as allowing for successive extensions which, taken together, amount to an extension of more than six years, that is to say, more than twice the time provided for the renewal process, without any justification or explanation from the Commission. The fact that a failure to comply with the time limits is not accompanied by any sanction makes the system vulnerable to strategic abuses.
46As a preliminary point, the Court observes that Article 191(2) TFEU provides that the policy on the environment is to be based on, inter alia, the precautionary principle, a principle that is also applicable in the context of other EU policies, in particular the policy on the protection of public health and where the EU institutions adopt, under the common agricultural policy or the policy on the internal market, measures for the protection of human health (see judgment of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraph 41 and the case-law cited).
47There is therefore an obligation on the EU legislature, when it adopts rules governing the placing on the market of plant protection products, such as those laid down in Regulation No 1107/2009, to comply with the precautionary principle, in order to ensure, in particular, in accordance with Article 35 of the Charter of Fundamental Rights of the European Union and Article 9 and Article 168(1) TFEU, a high level of protection of human health (see judgment of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraph 42 and the case-law cited).
48The precautionary principle entails that, where there is uncertainty as to the existence or extent of risks to human health, protective measures may be taken without having to wait until the reality and seriousness of those risks become fully apparent (see judgment of 1 October 2019, Blaise and Others, C‑616/17, EU:C:2019:800, paragraph 43 and the case-law cited).
49The precautionary principle, a general principle of EU law, requires the authorities in question, in the particular context of the exercise of the powers conferred on them by the relevant rules, to take appropriate measures to prevent specific potential risks to public health, safety and the environment, by giving precedence to the requirements related to the protection of those interests over economic interests. (see judgments of 21 October 2003, Solvay Pharmaceuticals v Council, T‑392/02, EU:T:2003:277, paragraph 121 and the case-law cited, and of 12 April 2013, Du Pont de Nemours (France) and Others v Commission, T‑31/07, not published, EU:T:2013:167, paragraph 134 and the case-law cited). The precautionary principle underpins all the provisions of Regulation No 1107/2009.
50Recital 8 of Regulation No 1107/2009 states that the precautionary principle should be applied and that the 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. In that regard, it should be noted that the prior authorisation and approval procedures put in place by that regulation for plant protection products and their active substances were based on the precautionary principle (see judgment of 17 March 2021, FMC v Commission, T‑719/17, EU:T:2021:143, paragraphs 60 and 61 and the case-law cited).
51It follows that the Commission, when exercising its powers under Regulation No 1107/2009, must take account of the precautionary principle. As regards, more specifically, active substances, it is apparent from the case-law that the Commission may take measures which restrict the use of a substance, thereby prioritising consumer safety, without waiting for the outcome of the procedure for the renewal of the approval of that substance (see, to that effect, judgment of 19 September 2019, Arysta LifeScience Netherlands v Commission, T‑476/17, EU:T:2019:618, paragraph 97).
52As regards the interpretation of Article 17 of Regulation No 1107/2009, it should be observed that, in accordance with settled case-law, in interpreting a provision of EU law, it is necessary to consider not only its wording, but also the context in which it occurs and the objectives pursued by the rules of which it is part. The origins of a provision of EU law may also provide information relevant to its interpretation (see judgments of 2 September 2021, CRCAM, C‑337/20, EU:C:2021:671, paragraph 31 and the case-law cited, and of 25 January 2017, Rusal Armenal v Council, T‑512/09 RENV, EU:T:2017:26, paragraph 56 and the case-law cited).
53In the first place, it is apparent from the wording of the first paragraph of Article 17 of Regulation No 1107/2009 that ‘where for reasons beyond the control of the applicant it appears that the approval is likely to expire before a decision has been taken on renewal, a decision shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), postponing the expiry of the approval period for that applicant for a period sufficient to examine the application.’ The third paragraph of Article 17 thereof sets out the factors to be taken into consideration when setting the extension period, namely ‘(a) the time needed to provide the information requested; (b) the time needed to complete the procedure; (c) where appropriate, the need to ensure the establishment of a coherent work programme, as provided for in Article 18’.
54Accordingly, that provision shows that where, for reasons beyond the control of the applicant, it appears that the approval is likely to expire before a decision on renewal has been taken, ‘a decision … postponing the expiry of the approval period’ is to be adopted, ‘for a period sufficient to examine the application’. Although it cannot be ruled out by the wording of that provision that a new extension decision may be adopted at the end of that period, that extension, which is applied only in order to complete the renewal procedure, may be solely provisional in nature, as the Council explains in its statement in intervention.
55The length of the extension period must therefore be adapted to the specific circumstances of the case and may not, therefore, be applied automatically, still less systematically.
56Furthermore, according to the case-law, Article 17 of Regulation No 1107/2009 has the effect of allowing the procedure for the renewal of approval of the active substance to be extended on account of reasons arising in the course of the procedure itself that were previously unknown (judgment of 19 September 2019, Arysta LifeScience Netherlands v Commission, T‑476/17, EU:T:2019:618, paragraph 104).
57In the second place, account must be taken of the context of the rule set out in the first paragraph of Article 17 of Regulation No 1107/2009.
58That rule forms part of the section of Regulation No 1107/2009 which concerns the approval of active substances.
59First, approval may be granted only for a period not exceeding 10 years (Article 5 of Regulation No 1107/2009), a limit which reproduces that laid down in Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1), which was in force when dimoxystrobin was approved. As explained in recital 15 of Regulation No 1107/2009, it is in the interest of safety that the approval period for active substances is limited in time and that it should be proportionate to the possible risks inherent in the use of the substances. A renewal is valid for a period not exceeding 15 years (Article 14(2) of Regulation No 1107/2009).
60It follows that the legislature took steps to lay down limited approval and renewal periods in order to avoid maintaining active substances on the market which could prove to present unacceptable risks in terms of Article 4 of Regulation No 1107/2009. Achieving that objective, in the light of the precautionary principle, requires that the re-assessment of substances take place periodically, as the Commission rightly observes in its explanation of the cyclical approach of Regulation No 1107/2009.
61Second, the application for renewal must be submitted no later than three years before the expiry of the approval period (Article 15 of Regulation No 1107/2009). That deadline is therefore intended to be sufficient, in principle, to complete that procedure and adopt a decision on renewal of the approval, while ensuring the effectiveness of the cyclical approach referred to in paragraph 60 above.
62To that end, Article 19 of Regulation No 1107/2009 empowered the Commission to adopt, by means of an implementing regulation, the provisions necessary for implementation of the renewal procedure.
63Accordingly, that gave rise to the adoption of 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), which, inter alia, lays down periods for the different steps of the renewal procedure to ensure that it functions properly (recital 3). The purpose of that regulation is to give effect to the rules already set out in Regulation No 1107/2009 while ensuring uniform conditions of application in the European Union.
64In particular, Articles 1 to 8 of Implementing Regulation No 844/2012 prescribe the rules concerning the admissibility of an application submitted by a producer of the active substance to a Member State and attach certain time limits to that first stage of the procedure. In accordance with Article 3 of that regulation, the application is first checked by the rapporteur Member State, which ensures that it has been submitted by the date provided for in the first subparagraph of Article 1(1) of the regulation and contains all the elements provided for in Article 2 thereof. More specifically, in accordance with Article 2(2) of that regulation, the renewal application must list the new information that the applicant intends to submit and which is necessary in accordance with the first subparagraph of Article 15(2) of Regulation No 1107/2009. Next, in accordance with Article 6 of the implementing regulation, after the applicant has received an affirmative reply from the rapporteur Member State concerning that verification, it is to submit the supplementary dossiers to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (EFSA). Lastly, under Article 8 of that regulation, where the supplementary dossiers have been submitted within the time limit and contain all the elements required, the rapporteur Member State is to inform the applicant, the co-rapporteur Member State, the Commission and EFSA of the date of receipt of the supplementary dossiers and the admissibility of the application.
65Similarly, Articles 11 to 14 of Implementing Regulation No 844/2012 set out the procedure for assessing applications for renewal of the approval of an active substance and lay down precise deadlines within which the various parties involved in the procedure must draw up and communicate their report or conclusions. First of all, the rapporteur Member State, after consulting the co-rapporteur Member State, is to 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 (Article 11 of Implementing Regulation No 844/2012). After receiving the draft assessment report from the rapporteur Member State, EFSA is to circulate it to the applicant and to the other Member States (Article 12 of Implementing Regulation No 844/2012). Following the expiry of the period for the submission of written comments, EFSA is to 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. Where appropriate, EFSA is to organise a consultation of experts, including experts from the rapporteur Member State and the co-rapporteur Member State. It is to communicate its conclusion to the applicant, the Member States and the Commission and make it available to the public (Article 13 of Implementing Regulation No 844/2012). Lastly, following receipt of the EFSA conclusion and taking into account the draft assessment report prepared by the rapporteur Member State, the comments of the applicant and the other Member States and the conclusion adopted by EFSA, the Commission is to present a report, referred to as the ‘renewal report’, and a draft regulation to the standing committee. The applicant is to be given the possibility to submit comments on the renewal report (Article 14(1) of Implementing Regulation No 844/2012). On the basis of the renewal report and taking into account the comments submitted by the applicant, the Commission is to adopt a regulation in accordance with Article 20(1) of Regulation No 1107/2009 (Article 14(2) of Implementing Regulation No 844/2012).
66Only the final stage of the procedure laid down in Article 14(2) of Implementing Regulation No 844/2012, which concerns the adoption of the regulation on the renewal of approval in accordance with Article 20(1) of Regulation No 1107/2009, is not subject to a time limit.
67It follows that the renewal procedure is based on the implementation of a precise timetable (see, to that effect, judgment of 19 September 2019, Arysta LifeScience Netherlands v Commission, T‑476/17, EU:T:2019:618, paragraph 103). The imposition of those periods and the requirement that they be observed are moreover 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 (judgment of 9 December 2021, Agrochem-Maks v Commission, C‑374/20 P, not published, EU:C:2021:990, paragraph 82).
68Compliance with those periods and with the requirement of an expeditious procedure is all the more important since an implementing regulation adopted on the basis of the first paragraph of Article 17 of Regulation No 1107/2009, which extends the approval of the active substance at issue for a certain period, has the same consequences as an implementing regulation approving such a substance for the first time under Article 13(2) of that regulation or a regulation renewing approval under Article 20 thereof (see, to that effect, judgment of 27 September 2018, Mellifera v Commission, T‑12/17, EU:T:2018:616, paragraphs 57 and 58).
69Accordingly, it must be held that Article 17 of Regulation No 1107/2009 provides for a mechanism which should be applied on an exceptional basis, when the conditions it lays down are met. A systematic application of that mechanism in procedures for renewal of the approval of an active substance is therefore not compatible with the requirements of Regulation No 1107/2009 and, more generally, with the spirit of that regulation.
70On the contrary, the Commission must, whenever it extends an approval period, make an assessment of the individual case and take into account the relevant factors in order to define the necessary ‘period sufficient’ to carry out the ongoing assessment until completion.
71In addition, Article 17 of Regulation No 1107/2009 gives the Commission discretion to determine what constitutes a ‘sufficient period’. That discretion is not absolute but is circumscribed by the third paragraph of that article, which sets out the factors to be taken into consideration when setting the extension period.
72Accordingly, the first paragraph of Article 17 of Regulation No 1107/2009 cannot be read and applied in isolation but must be done so in conjunction with the provisions of the third paragraph, which supplements it. That relationship between the first and third paragraphs of that article is apparent, in particular, from the original text of the Commission proposal for a regulation of the European Parliament and of the Council COM (2006) 388 final of 12 July 2006 concerning the placing of plant protection products on the market, in which the first and second paragraphs of what is now Article 17 of Regulation No 1107/2009 were part of the same paragraph, which was immediately followed by the paragraph concerning the length of the extension. That shows the legislature’s intention that the factors to be taken into consideration in determining the length of the extension should be applied in the situations now covered by the first two paragraphs of Article 17 of that regulation. Furthermore, as the Council rightly observes, the length of the extension period is fixed by taking into account the factors of the matter at hand on a case-by-case basis.
73Third, as observed in paragraphs 46 to 51 above, the precautionary principle underpins all the provisions of Regulation No 1107/2009.
74In that context, the words ‘period sufficient’ must be understood as requiring that a period be set which neither falls short of nor goes beyond that which is necessary to complete the renewal procedure for each individual case.
75In the third place, account must be taken of the objectives pursued by Regulation No 1107/2009.
76According to Article 1(3) thereof, the purpose of Regulation No 1107/2009 is to ensure a high level of protection of both human and animal health and the environment and to improve the functioning of the internal market through the harmonisation of the rules on the placing on the market of plant protection products, while improving agricultural production. The Commission is therefore right when it submits that the objective of Regulation No 1107/2009 is manifold. However, as is apparent from recital 24 of Regulation No 1107/2009, when granting authorisations of plant protection products, the objective of protecting human and animal health and the environment, in particular, should take precedence over the objective of improving plant production.
77In requiring that a high level of protection of the environment be maintained, Regulation No 1107/2009 is applying Article 11 TFEU, which provides that environmental protection requirements must be integrated into the definition and implementation of the European Union’s policies and activities, in particular with a view to promoting sustainable development, and Article 114(3) TFEU, which gives concrete expression to that obligation. The latter provision indeed states that, in its proposals concerning, inter alia, environmental protection, made on the basis of the approximation of laws which have as their object the establishment and functioning of the internal market, the Commission will take as a base a high level of protection, taking account in particular of any new development based on scientific facts, and that, within their respective powers, the Parliament and the Council will also seek to achieve that objective. That protection takes precedence over economic considerations, with the result that it may justify adverse economic consequences, even those which are substantial, for certain traders (see judgment of 17 March 2021, FMC v Commission, T‑719/17, EU:T:2021:143, paragraph 59 and the case-law cited).
78It follows that, among the various objectives of Regulation No 1107/2009, the Commission must attach particular importance to that of ensuring a high level of protection of human and animal health and the environment when it is managing a procedure for the renewal of the approval of an active substance, that being all the more the case when that procedure exceeds the time frame laid down for carrying it out and when it grants an extension of the approval period under Article 17 of that regulation.
79The following principles may be derived from all the foregoing considerations. First, an extension of an approval period is of a temporary and exceptional nature and is permitted owing to circumstances that arose in the course of the procedure itself and were not previously known. The extension must be adopted in the light of the specific circumstances of the case and may not, therefore, be applied automatically, still less systematically. Second, the length of the extension must be sufficient to examine the application for renewal. When setting that length, the Commission must take into account the factors set out in the third paragraph of Article 17 of Regulation No 1107/2009 and carry out an assessment on a case-by-case basis. Third, that period must neither fall short of nor go beyond that which is necessary to complete the renewal procedure.
80Fourth, in more general terms, the Commission, when it intends to apply Article 17 of Regulation No 1107/2009, must take account of the overall length of the renewal procedure in order to ensure that it remains within reasonable limits in the light of the principle of expeditious proceedings referred to in paragraph 68 above. In particular, in view of the limited duration of an approval and the cyclical approach chosen by the legislature, which is based on a re-assessment of the risks of active substances at regular intervals, it cannot be accepted that the extension of the approval, which is temporary and exceptional in nature, allows an active substance to remain on the market for a period which greatly exceeds that of the initial approval, otherwise the renewal system established by that regulation will be deprived of any practical effect.
81Interpreted in that way, Article 17 of Regulation No 1107/2009 is the expression of a balancing of the various interests at stake that is compatible with the objectives of that regulation and with the precautionary principle. On the one hand, account is taken of interests that support the view that a substance which has been approved in accordance with EU rules should not be prohibited unexpectedly owing to delays in the timetable for the renewal procedure which are beyond the control of the applicant.
82On the other hand, the extension granted is only temporary, it may be brought to an end by a non-renewal decision or be made subject to restrictions on the use of the substances and, above all, it must not be longer than necessary, having regard to the circumstances of each individual case.
83In the present case, according to the contested decision, the Commission considers that Article 17 of Regulation No 1107/2009 obliges it to deviate from the general time limits laid down for the approval of substances where the conditions laid down in that article are fulfilled. The Commission states that the extensions of the approval of dimoxystrobin granted by successive implementing regulations were limited to one year since it opted for extensions of a limited period that could be extended if necessary, rather than a one-off longer extension period. Reference is also made to the fact that, as stated in a standard recital in Implementing Regulation 2021/2068, the extension period would be rescinded if a non-renewal regulation was adopted during the extension period.
84Accordingly, the Commission found in the contested decision that the criteria laid down in Article 17 of Regulation No 1107/2009 were met without, however, assessing the various aspects of the individual case in order to satisfy itself that it was applying an extension of sufficient length to examine the application for renewal of the approval of dimoxystrobin.
85Moreover, the Commission’s explanation that it opted for extensions of a limited period that could be extended again if necessary, rather than a one-off longer extension period, does not comply with the principles established in paragraphs 79 and 80 above. It in fact follows from those principles that the extension period must be calculated in concreto and in relation to the stages of the procedure which are still to be completed, and that it cannot fall short of or go beyond that which is necessary to complete the renewal procedure.
86In addition, Implementing Regulation 2021/2068 extends the approval period for dimoxystrobin, for the sixth time in succession. As a result of that extension, the approval period of that active substance, which was initially set at 10 years in accordance with Article 5 of Regulation No 1107/2009, was prolonged to more than 16 years and 3 months. That extension period is more than twice as long as the three years laid down in Implementing Regulation No 844/2012 for completing a renewal procedure. Nevertheless, the Commission considered in that regard that Article 17 of Regulation No 1107/2009 allowed it to extend the approval period of dimoxystrobin without any limit in time, notwithstanding the total length of the renewal procedure.
87It should also be observed that Implementing Regulation 2021/2068 was adopted in the context of an application for renewal of an active substance which the Commission itself classified as a ‘persistent and toxic’ substance and which is a candidate for substitution in view of its endocrine disrupting properties that may cause adverse effects in humans (see paragraph 8 above).
88As regards candidates for substitution, Article 24 of Regulation No 1107/2009 provides that each period of renewal may not exceed seven years.
89Accordingly, following the sixth extension of the approval period for dimoxystrobin, the total extension period corresponds, bar a few months, to the maximum length of the renewal of approval which it was possible to permit at the end of the renewal procedure at issue, assuming that the other criteria had been met.
90By asserting in the contested decision that it could extend the approval of dimoxystrobin for a sixth time without taking those circumstances into account, the Commission disregarded the temporary and exceptional nature of the mechanism for extending the approval of an active substance and the requirements of expeditious proceedings laid down by the system established for the renewal of such an approval.
91It follows that the contested decision is vitiated by an error in law.
92The Commission’s arguments are not such as to call that conclusion into question.
93First, the Commission is correct in arguing that Regulation No 1107/2009 has manifold objectives. However, that factor corroborates rather than calls into question the interpretation of Article 17 of that regulation set out in paragraph 52 et seq. above (see, in particular, paragraph 76 above).
94Second, the Commission submits that the finding of critical areas of concern or data gaps concerning dimoxystrobin has no relevance when applying Article 17 of Regulation No 1107/2009 and that the extension of the approval period provided for in Article 17 of that regulation is not based on substantive criteria.
95It is indeed apparent from reading Article 17 of Regulation No 1107/2009 that it does not include any considerations relating to substantive assessments of active substances. However, first, the interpretation of Article 17 of that regulation carried out in paragraphs 54 to 82 above is not based on such considerations. Second, the obligation to carry out an in concreto analysis of the circumstances that make it possible to extend the approval period of an active substance such as dimoxystrobin, including of the nature of that substance (see paragraph 85 above), likewise does not presuppose a substantive assessment.
96Consequently, the arguments made by the Commission do not affect the Court’s conclusion.
97Lastly, CropLife Europe may likewise not succeed with its argument that the interpretation of Article 17 of Regulation No 1107/2009 put forward by the applicant would be contrary to legal certainty since it would render the extension mechanism arbitrary. First, the Commission’s obligation to verify compliance with the criteria laid down in Article 17 of that regulation, while taking into account the circumstances of the case and the requirements of expeditious proceedings inherent in that regulation, flows from the very wording of that regulation.
98Second, as stated in paragraphs 81 and 82 above, legal certainty has been taken into account in the balancing of the various interests at issue, which is consistent with the objectives of Regulation No 1107/2009.
99It follows from all of the foregoing that the second limb of the applicant’s first plea is well founded.
100Consequently, the contested decision must be annulled in so far as it concerns dimoxystrobin, without it being necessary to examine the first limb of the first plea or the second plea.
Costs
101Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the Commission has been unsuccessful, it must be ordered to bear its own costs and to pay those incurred by the applicant, in accordance with the form of order sought by the latter.
102Pursuant to Article 138(1) and (3) of the Rules of Procedure, the Parliament, the Council and CropLife Europe are to bear their own costs.
Operative part
On those grounds,THE GENERAL COURT (Fourth Chamber, Extended Composition)hereby:
1.Annuls Commission Decision Ares(2022) 3275139 of 27 April 2022 to reject the request for internal review made by Pesticide Action Network Europe (PAN Europe) as regards Commission Implementing Regulation (EU) 2021/2068 of 25 November 2021 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances benfluralin, dimoxystrobin, fluazinam, flutolanil, mecoprop-P, mepiquat, metiram, oxamyl and pyraclostrobin in so far as that decision concerns dimoxystrobin;
2.Orders the European Commission to bear its own costs and to pay those incurred by PAN Europe;
3.Orders the European Parliament, the Council of the European Union and CropLife Europe to bear their own costs.
Delivered in open court in Luxembourg on 19 November 2025.
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