62023TJ0094_RES
Case T‑94/23
Pollinis FrancevEuropean Commission
Judgment of the General Court (Fourth Chamber, Extended Composition) of 19 November 2025
(Plant protection products – Active substance boscalid – Application for renewal of an active substance – Extension of approval period – Delay in the renewal procedure – Reasons beyond the control of the applicant – 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)
Agriculture – Approximation of laws – Placing of plant protection products on the market – Regulation No 1107/2009 – Extension of the approval period until completion of the renewal procedure – Conditions – Length of the extension established in relation to the specific circumstances of the case which arise in the course of the renewal procedure – Period sufficient to complete the renewal procedure – Preclusion of an automatic or systematic extension
(European Parliament and Council Regulation No 1107/2009, recital 24 and Arts 13(2), 17, 18 and 20)
(see paragraphs 63-89)
Agriculture – Approximation of laws – Placing of plant protection products on the market – Regulation No 1107/2009 – Extension of the approval period until completion of the renewal procedure – Delay in the renewal procedure that is beyond the control of the applicant – Role of the applicant – Assessment by the Commission – Scope
(European Parliament and Council Regulation No 1107/2009, Arts 7 and 17; Commission Regulation No 844/2012, Arts 1, 3, 6, 7, 11(5), 12(3), 13(3) and 14(1))
(see paragraphs 99-116)
Résumé
Hearing three actions for annulment, brought respectively by Pesticide Action Network Europe (PAN Europe), Pollinis France and Aurelia Stiftung, the General Court, ruling in extended composition, annuls three Commission decisions to reject requests for internal review as regards the extension of the approval of three plant protection products, namely boscalid, glyphosate and dimoxystrobin. (
1
)
By those judgments the Court for the first time provides an interpretation of Article 17 of Regulation No 1107/2009, (
2
) which concerns the extension of the approval period of an active substance where a decision on a renewal of the approval cannot be taken before the approval period expires. That assessment is made with regard to two different aspects: the length of the extension and the reasons for the delay in the renewal procedure, which must be beyond the control of the applicant for renewal.
The applicants are non-profit associations which aim inter alia, as far as PAN Europe is concerned, to promote activities intended to reduce or eliminate pesticides and, as regards Pollinis France and Aurelia Stiftung, at protection of the environment.
Dimoxystrobin, an active substance used as an agricultural fungicide, was approved for the first time in the European Union by Directive 2006/75 (
3
) and its approval period was extended in 2013. In 2015, it was placed on the list of substances designated for substitution. (
4
) That said, its approval was further extended on several occasions on the ground that its assessment had been delayed for reasons beyond the control of the applicants for renewal and the approval was likely to expire before a decision had been taken on renewal. The penultimate extension (
5
) was the subject of a request for internal review, which was rejected by the Commission by a decision of 27 April 2022, the annulment of which is sought in Case T‑412/22.
Boscalid is an active substance approved for the first time in the European Union in 2008 (
6
) and is used in plant protection products belonging to the family of succinate dehydrogenase inhibitors. The approval period of that substance has also been the subject of successive extensions on the ground that the assessment of that substance had been delayed for reasons beyond the control of the applicants and that the approval of that active substance was likely to expire before a decision had been taken on its renewal. The implementing regulation adopting such an extension in 2022 was the subject of a request for internal review, which was rejected by the Commission by decision of 6 December 2022, the annulment of which is sought in Case T‑94/23.
Glyphosate, an active substance widely used in herbicides, was approved for the first time in the European Union in 2001. (
7
) Its approval was extended on several occasions, in particular on the ground that the assessment of the substance had been delayed for reasons beyond the control of the applicant. The implementing regulation on extension which was adopted in 2022 (
8
) was also the subject of a request for internal review, which was rejected by the Commission on 3 July 2023.
The applicants contested those three rejection decisions that had been adopted by the Commission, pleading, inter alia, misinterpretation and misapplication of Article 17 (
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) of Regulation No 1107/2009.
Findings of the Court
As regards, in the first place, the length of the extension of the approval in Cases T‑412/22 and T‑94/23, the Court observes that the Commission must take account of the precautionary principle when exercising its powers under Regulation No 1107/2009. Accordingly, where an active substance is concerned, the Commission may take measures which restrict the use of that substance, prioritising consumer safety, without waiting for the outcome of the procedure for the renewal of the approval of that substance.
The Court thus proceeds to interpret Article 17 of Regulation No 1107/2009 in the light of that principle as well as its wording, the context in which it occurs and the objectives pursued by the rules of which it is part.
It is apparent from that provision 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 is to be adopted postponing the expiry of the approval period for a period sufficient to examine the application. It follows that the length of the extension period must be adapted to the specific circumstances of the case, which have arisen in the course of the procedure, and may not be applied automatically, still less systematically.
Furthermore, the application for renewal must be submitted no later than three years before the expiry of the approval period, with the renewal procedure being based on a precise timetable and the requirement of expeditious proceedings. Those requirements are all the more important since the extension of the approval of an active substance on the basis of the first paragraph of Article 17 of Regulation No 1107/2009 has the same consequences as an initial approval or a renewal of approval.
Consequently, the Court finds that Article 17 of Regulation No 1107/2009 provides for a mechanism which should be applied on an exceptional basis. The Commission must make an assessment of the individual case whenever it extends the approval of an active substance. To that effect, it must take into account the relevant factors in order to define the necessary ‘period sufficient’ to carry out the ongoing assessment of the substance until completion.
While that article gives the Commission discretion to determine what constitutes a ‘sufficient period’, that power, however, is not absolute. 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.
In addition, 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 requirement of expeditious proceedings. It cannot be accepted that an 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.
Interpreted 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. On 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.
As regards, in the second place, the reasons for a delay in the renewal procedures concerned, the Court, in Cases T‑94/23 and T‑565/23, interprets the expression ‘reasons beyond the control of the applicant’ in the first paragraph of Article 17 of Regulation No 1107/2009, observing that where there is divergence between the various language versions of an EU legislative text, the provision in question must be interpreted by reference to the general scheme and the purpose of the rules of which it forms part.
As regards the context of that rule, the Court examines the role of the applicant in the renewal procedure under Article 17 of that regulation.
In that regard, both the approval and the renewal procedure are launched on the initiative of the producer of the active substance, which is a central actor. It is responsible for the contents of the application, the submission of supplementary dossiers and for providing additional information to the rapporteur Member State or the European Food Safety Authority (EFSA), to which it may also submit comments on the renewal report. The applicant for renewal is thus an actor that participates in all the stages of the procedure, which enables it to influence the conduct thereof.
By contrast, as regards an extension of the approval period, the applicant for renewal is not required to submit an application and there is no provision for a procedure of consultation with it. The procedure is initiated automatically and the Commission must ascertain whether or not the delay in the conduct of the renewal procedure is due to reasons ‘beyond the control of the applicant’. Given those factors, the applicant’s conduct must be assessed in the light of the various stages of the renewal procedure that precede a possible extension of the approval period and in which the applicant had a role as a participant.
Among the objectives covered by the first paragraph of Article 17 of Regulation No 1107/2009, the Commission must attach particular importance to the objective of ensuring a high level of protection of human and animal health and the environment and must also satisfy itself not only that the applicant acted within the time limits, but also that the delay in the conduct of the renewal procedure is unconnected with its actions. In that context, an approach which would require an element of intent on the part of the applicant for renewal concerning delays in the conduct of the procedure is too restrictive and risks upsetting the balance struck by the legislature in a manner that would favour the interests of the applicant for renewal. In order to respect that balance, it is necessary to carry out an objective and in concreto analysis of the reasons for the delay in order to establish that that delay is beyond the control of the applicant, which must have diligently complied with all the rules applicable to the application and the renewal procedure.
However, by failing to carry out an in concreto analysis of the role of the applicant for renewal, by applying a restrictive approach to the role of the applicant for renewal in possible delays in the renewal procedure, and by disregarding any possible role played by the latter where another actor contributed, even in part, to the delay, the Commission erred in law in interpreting Article 17 of Regulation No 1107/2009.
(
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)	Commission Decision Ares(2022) 3275139 of 27 April 2022, Commission Decision Ares(2022) 8437051 of 6 December 2022, and Commission Decision Ares(2023) 4611321 of 3 July 2023.
(
2
)	Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ 2009 L 309, p.1).
(
3
)	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).
(
4
)	By Commission Implementing Regulation (EU) 2015/408 of 11 March 2015 on implementing Article 80(7) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and establishing a list of candidates for substitution (OJ 2015 L 67, p.18).
(
5
)	By 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).
(
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)	By Commission Directive 2008/44/EC of 4 April 2008 amending Council Directive 91/414/EEC to include benthiavalicarb, boscalid, carvone, fluoxastrobin, Paecilomyces lilacinus and prothioconazole as active substances (OJ 2008 L 94, p. 13).
(
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)	By Commission Directive 2001/99/EC of 20 November 2001 amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include glyphosate and thifensulfuron-methyl as active substances (OJ 2001 L 304, p. 14).
(
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)	Commission Implementing Regulation (EU) 2022/2364 of 2 December 2022 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval period of the active substance glyphosate (OJ 2022 L 312, p. 99).
(
9
)	The first paragraph of Article 17 of Regulation No 1107/2009 states: ‘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 of that regulation sets out the factors to be taken into consideration when establishing the length of 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.’