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General Court Rules the Systematic Extension of Active Substance Approvals Unlawful: What Next?

Published online by Cambridge University Press:  27 July 2026

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Julia Thibord*
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Abstract

In three rulings delivered simultaneously on 19 November 2025, the General Court upheld actions for annulment brought by three NGOs against the Commission’s rejection of their requests for internal review under the Aarhus Regulation. At the heart of these judgments is the interpretation of Article 17 of Regulation 1107/2009, which allows the Commission to extend the approval of an active substance pending its reassessment. The General Court brings some useful clarifications and limitations to a practice that has become systematic in the face of chronic delays in evaluation procedures. The practical implications of this ruling will however depend on how it is implemented by the Commission, and the level of control the Court will exercise thereupon. In the meantime, dozens of active substances whose approval should have expired many years ago remain on the market, at the expense of health and the environment. While the revised Aarhus procedure has helped to clarify the law, it may not be fully adequate for remedying systematic breaches of EU law.

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European Journal of Risk Regulation , First View , pp. 1 - 10
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© The Author(s), 2026. Published by Cambridge University Press

Case T-412/22 Pesticide Action Network (PAN) Europe v Commission [2025] ECLI:EU:T:2025:1034

Case T-94/23 Pollinis France v Commission [2025] ECLI:EU:T:2025:1036

Case T-565/23 Aurelia Stiftung v Commission [2025] ECLI:EU:T:2025:1040

I. Introduction

Pesticides – or plant protection products – are chemicals designed and used to control or eliminate organisms (microbes, animals, plants, fungi) that are considered harmful to plant production. They are formulated from one or more active substances. Pesticides are, by definition, hazardous.

In the EU, the evaluation and authorisation of plant protection products is regulated by Regulation (EC) No 1107/2009 of 21 October 2009 concerning the placing of plant protection products on the marketFootnote 1 (the “PPP Regulation”). The previous legislation, Directive 91/414/EEC,Footnote 2 was criticised for its cumbersome evaluation procedures and for its failure to achieve a high level of protection of health and the environment. The PPP Regulation, which is presented as one of the most rigorous pesticide legislations in the world, was adopted, in particular, with a view of speeding up the evaluation process and of ensuring the safety of plant protection products put on the market.Footnote 3

The PPP regulation provides for a two-stage procedure: active substances are first evaluated and approved at EU level,Footnote 4 then plant protection products containing these substances are evaluated and authorised at national level.Footnote 5 Active substances may only be approved if certain criteria are fulfilled, including that the substance presents a clear benefit for plant production, is not expected to have any harmful effect on human or animal health, and is not expected to have any unacceptable effects on the environment.Footnote 6

Active substances are first approved for a period not exceeding 10 years.Footnote 7 An approval may be renewed for a period not exceeding 15 years,Footnote 8 but only upon a new evaluation of the substance, based on the latest scientific data, so as to ensure that it still meets the criteria for its approval. The renewal procedure is subject to strict time limits that are detailed in an implementing regulation.Footnote 9 Article 17 of the PPP Regulation allows, on a transitional basis, for the approval to be extended 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”.

In practice, this provision has been used systematically by the Commission to make up for chronic delays in the renewal procedure. As a result, dozens of active substances remain on the market, sometimes for many years, pending their reassessment and despite the risks involved for health and the environment. In 2018, upon a complaint by the NGO Pesticide Action Network (PAN) Europe, the European Ombudsman found significant delays in the reassessment of active substances. Yet, as the delays appeared to be due to the complexity of the reassessment and the lack of resources of evaluating authorities, the Ombudsman concluded that the Commission had no choice under Article 17 but to extend the active substance approvals.Footnote 10

After the reform of the Aarhus Regulation,Footnote 11 several environmental NGOs challenged these extensions through the newly expanded internal request mechanism. Under this mechanism, environmental non-governmental organisations that meet certain criteriaFootnote 12 may file a request for internal review to the Commission (or to any other EU institution) to reconsider an act it has adopted, on the ground that it contravenes environmental law. If its request is rejected, the NGO may institute proceedings before the General Court against the rejection decision (but not against the contested act itself).Footnote 13

II. Facts

The judgments stem from three separate requests for internal review filed against regulations extending the approval of three substances – dimoxystrobin, boscalid and glyphosate. After the Commission rejected them as unfounded, applications for annulment were filed before the General Court, in accordance with Article 12 of the Aarhus Regulation.

Dimoxystrobin is part of the chemical group of strobilurins, which are used as agricultural fungicides. Boscalid is a fungicide of the SDHI (succinate dehydrogenase inhibitors) family, which acts by inhibiting an enzyme involved in cellular respiration.

Both substances were first approved in the EU under the previous Directive 91/414/EEC, respectively on 1 October 2006 and 1 August 2008, for a period of 10 years. With the entry into force of the PPP Regulation, both substances were deemed to have been approved under the new legislation.Footnote 14 An application for renewal of approval was submitted for each substance but, due to significant delays in their reassessment, both benefited from repeated extensions based on Article 17 of the PPP Regulation.

On 25 November 2021, the approval of dimoxystrobin was extended for the sixth time.Footnote 15 A request for internal review was filed by PAN Europe against this regulation, leading to the proceedings in case T-412/22. Similarly, on 5 May 2022, the approval of boscalid was extended for the fifth time (along with forty-nine other substances).Footnote 16 This regulation was challenged by French NGO Pollinis, which led to the proceedings in case T-94/23.

Glyphosate is an active substance that is widely used in herbicides. It was initially approved in the EU under Directive 91/414. This initial approval was – after several extensions – renewed under the PPP Regulation, first in December 2017, for 5 years, and then again in November 2023, for an additional 10 years. In between, the approval for glyphosate was extended for one year.Footnote 17 This extension was challenged by Aurelia Stiftung, which led to the proceedings in case T-565/23.

III. Judgments

By three separate judgements issued on 19 November 2025, the General Court upheld the NGOs’ actions and annulled the Commission’s decisions to reject their requests for internal review. In the three judgments the central issue is the interpretation of Article 17 of the PPP Regulation.

The Commission advocated a literal and narrow interpretation of Article 17, considering itself bound to extend an approval for as long as the renewal procedure is delayed, regardless of its duration. The Commission explained that it opted for one-year extensions, which could be extended again as necessary, rather than for a one-off longer period.

PAN Europe and Pollinis argued for a contextual and teleological interpretation of Article 17 and considered that the Commission’s repeated and systematic use of extensions contravened the PPP Regulation and the precautionary principle.

In Pollinis and Aurelia Stiftung, the NGOs put forward elements that suggested that the applicant for renewal provided incomplete or inadequate data that had contributed to the delay. The Commission dismissed these allegations, considering that the applicant for renewal had acted within the time limits provided by law and that the delay was clearly attributable to other factors – the late submission of the revised draft report by the rapporteur Member State in the case of boscalid and the complexity of the assessment in the case of glyphosate.

At the outset, the General Court recalls that Article 17 of the PPP Regulation must be interpreted in light of the other provisions of that regulation as well as its objectives.

The Court notes that “the legislature took steps to lay down limited approval and renewal periods in order to avoid maintain active substances on the market which could prove to present unacceptable risks (…). Achieving that objective, in the light of the precautionary principle, requires that the re-assessment of substances take place periodically”.Footnote 18

The General Court further recalls that, while the objective of the PPP Regulation is manifold, “the Commission must attach particular importance to that of ensuring a high level of protection of human and animal health and the environment,”Footnote 19 including when it grants an extension under Article 17 of that regulation.

With that in mind, the Court annuls the Commission’s decisions based on two distinct grounds regarding, first, the use and duration of Article 17 extensions (PAN Europe and Pollinis cases) and, second, the condition that the delay in the renewal procedure be “beyond the control of the applicant” (Pollinis and Aurelia Stiftung cases).

1. On the use and duration of extensions

The General Court clarifies that “Article 17 of Regulation No 1107/2009 provides for a mechanism which should be applied on an exceptional basis (…). 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.”Footnote 20

Accordingly, “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”.Footnote 21

The length of an extension must be assessed by the Commission on a case-by-case basis and be sufficient to examine the application for renewal of each active substance.Footnote 22 It “must not be longer than necessary”.Footnote 23 Furthermore, account must be taken 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”.Footnote 24 In particular, “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”.Footnote 25

Applying these principles to the contested decisions, the General Court considers that the Commission erred in law by considering that it could extend the approvals of dimoxystrobin and boscalid without concretely assessing the time deemed necessary to complete the renewal procedure and without taking into account relevant factors such as the overall length of the successive extensions.

2. On the condition that the delay be beyond the control of the applicant for renewal

Under Article 17, an approval may only be extended when the delay in the renewal procedure is “beyond the control” of the applicant for renewal.

In Pollinis and Aurelia Stiftung, the Court clarifies that Article 17 requires “an objective and in concreto analysis of the reasons for the delay in order to establish that the delay is beyond the control of the applicant.”Footnote 26 In that regard, “the fact that the delay may, at least in part, be due to the late submission of a report or conclusion by one or more of the authorities involved in the renewal procedure is not sufficient to rule out that some role has been played by the applicant, since it may itself have been at the origin of such a delay, even if it adhered to the time limits imposed on it by Regulation No 1107/2009.”Footnote 27 That may be the case, in particular, where the quality of the data provided in the course of the procedure proves to be inadequate.Footnote 28

The General Court also clarifies that, as part of this analysis, no element of intent on the part of the applicant needs to be established.Footnote 29

Applying these principles to the contested decisions, the Court finds that it is apparent from the Commission’s reasoning in both decisions that it did not scrutinize concretely, even in brief, the role of the applicant for renewal in the delay, but rather considered that such analysis was neither necessary nor required. It concludes that the Commission erred in law “by failing to carry out 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 exonerating the latter where another actor contributed, even in part, to the delay.” Footnote 30

IV. Comments

Based on a teleological and contextual interpretation of Article 17, the General Court brings some useful and welcome limitations on the use of extensions. The practical implications of these rulings will depend, however, on how they are subsequently implemented by the Commission – and the level of control the court will exercise thereupon.

1. The importance of periodical re-evaluation for health and environmental protection

The rulings highlight the importance of periodical re-evaluation which is at the heart of the PPP Regulation. Pesticides are, by definition, harmful. Their full effects on health or the environment, in particular long-term or sub-lethal effects,Footnote 31 may not be revealed immediately and may only become apparent over time and/or based on new scientific knowledge. For instance, neonicotinoids were deemed to be safe until new scientific evidence led the European Union to progressively restrict their uses because of the threat they pose to bees in particular.Footnote 32 The link between cancer and glyphosate, the world’s most used herbicide, was only revealed in 2015 by the International Agency for Research on Cancer.Footnote 33 This is why the PPP Regulation requires that active substances be periodically re-evaluated, in line with the objective of a high level of health and environmental protection and with the precautionary principle.Footnote 34 This is also why, as recently emphasised by the Court of justice, evaluating authorities have the duty to take into account – at any given time – “the most reliable scientific and technical data”Footnote 35 when deciding on the fate of a plant protection product or an active substance.

These findings should be kept in mind in the face of the recent Commission’s proposal to amend the PPP Regulation so as to grant unlimited approvals to a number of active substancesFootnote 36 and which has been met with strong opposition by civil society.Footnote 37 According to well-established caselaw, the EU legislature itself is bound by the precautionary principle when it adopts rules governing pesticides, in order to ensure a high level of protection of human health and the environment, in accordance with Articles 35 and 37 of the Charter of Fundamental Rights and with Articles 9 and 168 of the Treaty on the Functioning of the EU.Footnote 38 An erosion of the principle of periodical re-evaluation – in blatant circumvention of the res judicata – would undermine core environmental principles that are enshrined in Treaty law.

2. The applicant’s influence in the assessment procedure

Under the PPP Regulation, it is for the substance manufacturer to prove that its substance will not adversely impact human health or the environment.Footnote 39 To this end, the applicant for approval must provide all relevant data and studies for assessing the substance’s effects, based on the most recent scientific and technical knowledge. The same goes for renewal. It is on the basis of the data provided by the applicant that the designated Rapporteur Member State and EFSA will verify whether or not the substance still meets the approval criteria.Footnote 40 The evaluating authorities are therefore dependent on the quality of the data provided by the applicant for renewal. If the data is incomplete, obsolete or otherwise inadequate, it makes the assessment more difficult and/or it may trigger requests for additional information, thus provoking further delays.

In this respect, the Commission’s systematic use of Article 17 does not encourage applicants to speed up the renewal procedure; as long as they formally comply with the time limits, they know that their substances will be automatically extended for as long as the procedure lasts. By recognizing the applicant’s potential influence on the delays in the renewal procedure, the General Court’s ruling should oblige the Commission to scrutinise the applicant’s role in these delays including, in particular, the quality of the data provided, prior to granting an extension.

3. Interpreting Article 17 in the light of the precautionary principle

The EU judiciary has played a crucial role in clarifying the meaning of the precautionary principle. This general principle of EU law entails that, where there is uncertainty as to the existence or extent of risks to human health, protective measure may be taken without having to wait until the reality and seriousness of those risks become fully apparent.Footnote 41 It requires the Commission, when exercising its powers, to take appropriate measures to prevent specific risks to health and the environment by giving precedence to the requirements related to the protection of those interests over economic interests.Footnote 42 While the precautionary principle underpins all provisions of the PPP Regulation,Footnote 43 its concrete application may prove thorny, as the present cases illustrate.

As observed by the Court, a regulation that extends the approval of an active substance has, de facto, the same consequences as a regulation approving or renewing the approval of a substance.Footnote 44 It permits that substance to remain on the market and be used all over Europe. Both PAN Europe and Pollinis argued that the systematic and repeated use of Article 17 was incompatible with the precautionary principle. Pollinis specifically submitted to the Commission numerous recent scientific studies and reports by public research institutes highlighting the risks of boscalid for both human health and the environment.Footnote 45 The NGO submitted that those risks should be taken into account when deciding on an extension.

While confirming that Article 17 must be interpreted in the light of the precautionary principle,Footnote 46 the Court upholds the Commission’s view that Article 17 does not include any substantive assessment of the active substance.Footnote 47 This position, based on a strict reading of Article 17, may appear difficult to reconcile with the precautionary principle, especially when an extension exceeds a certain duration. It is in the latter respect, essentially, that the Court captures the precautionary principle, by inferring a requirement of expeditious proceedings and by setting limits to the duration and frequency of extensions.

4. Limits to the duration of an extension

Three criteria emerge from the Court’s ruling, that the Commission will have to take into account when deciding on the length of an extension. First, that determination must be made in concreto, taking into account the individual circumstances of the case, including the nature of the substance.Footnote 48 Second, the length of the extension must not be longer than what is necessary to complete the renewal procedure. Third, account must be taken of the overall length of the extension (and, subsequently, of the renewal procedure), which must remain within reasonable limits in the light of the requirement of expeditious proceedings. The length of an extension must not, in particular, “greatly exceed” the period of the initial approval.

Since January 2023 – probably in the face of the various proceedings against Article 17 extensions – the Commission has revised its approach for determining the duration of an extension. The Commission now choses “to extend approval periods based on an estimation of the minimum time needed for the completion of all the remaining procedural steps, rather than adopting repetitive yearly extensions”.Footnote 49 In May 2023, the Commission thus extended, for the sixth time, the approval of boscalid, this time until 15 April 2026.Footnote 50 The Commission claims that it “carefully deliberated on the extension’s duration”,Footnote 51 which it ultimately set at 2 years and 8.5 months, taking into consideration “the pending steps required to complete the risk assessment and the subsequent decision-making”.Footnote 52 This sixth extension – which brings the overall length of the extension to 7 years and 8.5 months – is the subject of a separate action before the General Court that it still pending.Footnote 53 In the meantime, in February 2026, a seventh regulation was adopted, extending the approval of boscalid for two additional years, that is until 31 March 2028 (thus an overall extension of almost 10 years), on the ground that “additional time is needed for [EFSA] to complete the evaluations and to finalise its conclusions”.Footnote 54

The Court will have to decide whether these new extensions are compatible with its own ruling.

With regard to the second criterion, one way to apply it is to consider that the length of the extension should be based on how long the renewal procedure is expected to take, in the light of the remaining steps. An extension may thus be prolonged for as long as the renewal procedure is not complete. Such interpretation seems, however, hardly compatible with the precautionary principle and with the requirement of expeditious proceedings. A more consistent interpretation requires that the length of the extension be strictly tailored to the time actually and reasonably needed for completing the renewal procedure – and that it may not be extended again except in new, unforeseen circumstances.

In a similar fashion, the third criterion raises the question as to when the length of the renewal procedure exceeds “reasonable limits” and at which point the overall duration of an extension “greatly exceeds” that of the initial approval. The fact that the PPP Regulation foresees a period of 3 years for completing the renewal procedure should, in this respect, be taken into account. At the very least, an extension of 7 years and 8.5 months (or a renewal procedure of 10 years and 8.5 months) – thus bringing the overall duration of the initial approval to 17 years and 8.5 months – appears excessive and at odds with both the precautionary principle and the requirement of expeditious proceedings.

One might regret that the Court did not rule more clearly on this point, especially in case T-94/23, so as to not leave any doubt that any further extension of boscalid should be considered unlawful.

5. Systematic use of an exceptional measure, at the expense of health and environmental protection

Finally, by emphasising that the extension of an approval is a temporary and exceptional measure which may not be applied systematically, the rulings in PAN Europe and Pollinis should – at least in theory – put an end to the Commission’s systematic use of Article 17. And yet, to this day, the practice of systematically extending the approval of active substances continues, unabated. As a result, more than a hundred active substances, many of which were approved under the – less protective – Directive 91/414/EEC, remain used in plant protection products all over Europe.Footnote 55 Furthermore, out of the forty-seven substancesFootnote 56 that were eventually not renewed under the PPP Regulation because they no longer met the criteria for approval, all benefited from such, often lengthy, extensions.Footnote 57 As an example, flufenacet benefited from repeated extensions stretching over more than 11 years, until the Commission decided not to renew it because of its endocrine-disrupting properties and other risks in terms of groundwater contamination and reproductive toxicity.Footnote 58

In fact, Article 17 extensions are the rule rather than the exception, despite the General Court’s ruling that a systematic application of that mechanism is not compatible with the requirements and the spirit of the PPP Regulation. At the expense of human health and biodiversity.

This calls for two more comments:

First, the systematic use of Article 17 is the consequence of the chronic delays that persist under the PPP Regulation. It is clear that the PPP Regulation has failed to speed up the evaluation process. Far from being reduced, delays have been accommodated and institutionalised. While the lack of resources of evaluating authorities remains clearly an issue, the central role in the assessment process given by the PPP Regulation to the applicant – whose interest is obviously in commercialising its pesticides – raises questions.

Second, while no appeal was filed against the judgements, the question arises as to how the Court’s ruling can be enforced. The revised Aarhus procedure has helped to clarify the law, yet it may not be the most suitable venue for sanctioning systematic breaches of EU law – especially when these breaches are the consequence of systemic weaknesses. Requests for internal review may only be brought against separate, individual regulations – and within a strict 8-week deadline.Footnote 59 The court may rule on one extension at a time – or rather, on one Commission’s decision rejecting a request for internal review of an extension at a time. In addition, by the time a judgement is rendered, the challenged extension may have been replaced by a new one. It should be noted, in this respect, that the Commission widely uses the 22 weeks provided by Article 10 of the Aarhus Regulation before replying to requests for internal reviewFootnote 60 – thus delaying further the possibility of bringing an action before the General Court. In view of these limitations, other types of proceedings could be contemplated that might be more appropriate to address the systematic use of Article 17 extensions, such as an action for damages before the Court of JusticeFootnote 61 or proceedings before national courts.Footnote 62

Competing interests

The author has no conflicting interests to declare.

Footnotes

1 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Directives 79/117/EEC and 91/414/EEC [2009] OJ L 309 (the “PPP Regulation”).

2 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market [1991] OJ L 230.

3 See, e.g., INRAE Ifremer, “The impacts of plant protection products on biodiversity and ecosystem services” (collective scientific expert report, 2022, doi: 10.17180/0gp2-cd65), p. 1004; Emanuela Bozzini, Pesticide Policy and Politics in the European Union (palgrave macmillan 2017); European Commission, “Commission proposes a revised approach towards the evaluation of pesticides safety” (press release, IP/01/1132, 27 July 2001); European Parliament, Report on the Commission report entitled: “Evaluation of the active substances of plant protection products (submitted in accordance with Article 8(2) of Council Directive 91/414/EEC on the placing of plant protection products on the market)” (COM(2001) 444 - C5-0011/2002 - 2002/2015(COS)); European Parliament, Resolution of 16 January 2019 on the Union’s authorisation procedure for pesticides (2018/2153(INI)).

4 PPP Regulation, Art. 4–13.

5 Footnote Ibid., Art. 28–9 and 33–7.

6 Footnote Ibid., Art. 4(3).

7 Footnote Ibid., Art. 5.

8 Footnote Ibid., Art. 14.

9 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 (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market [2012] OJ L 252, which has been repealed and replaced, since 27 March 2021, by Commission Implementing Regulation (EU) 2020/1740 of 20 November 2020 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and repealing Commission Implementing Regulation (EU) No 844/2012 [2020] OJ L 392.

10 European Ombudsman [2019] Decision in case 687/2018/TE on the European Commission’s prolongation of the approval of certain active substances used in pesticides.

11 Regulation (EC) 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 [2006] OJ L 264, as amended by Regulation (EU) 2021/1767 of the European Parliament and of the Council of 6 October 2021 [2021] OJ L 356 (the “Aarhus Regulation”).

12 Aarhus Regulation, Art. 11.

13 Footnote Ibid., Art. 12.

14 PPP Regulation, Art. 78(3).

15 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 [2021] OJ L 421.

16 Commission Implementing Regulation (EU) 2022/708 of 5 May 2022 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 2,5-dichlorobenzoic acid methylester, acetic acid, aclonifen, aluminium ammonium sulphate, aluminium phosphide, aluminium silicate, beflubutamid, benthiavalicarb, boscalid, calcium carbide, captan, cymoxanil, dimethomorph, dodemorph, ethephon, ethylene, extract from tea tree, fat distillation residues, fatty acids C7 to C20, fluoxastrobin, flurochloridone, folpet, formetanate, gibberellic acid, gibberellins, hydrolysed proteins, iron sulphate, magnesium phosphide, metam, metamitron, metazachlor, metribuzin, milbemectin, phenmedipham, pirimiphos-methyl, plant oils/clove oil, plant oils/rape seed oil, plant oils/spear mint oil, propamocarb, proquinazid, prothioconazole, pyrethrins, quartz sand, fish oil, repellents by smell of animal or plant origin/sheep fat, S-metolachlor, Straight Chain Lepidopteran Pheromones, sulcotrione, tebuconazole and urea [2022] OJ L 133.

17 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 [2022] OJ L 312.

18 Case T-412/22 Pesticide Action Network (PAN) Europe v Commission [2025] ECLI:EU:T:2025:1034, para. 60; Case T-94/23 Pollinis France v Commission [2025] ECLI:EU:T:2025:1036, para.56; Case T-565/23 Aurelia Stiftung v Commission [2025] ECLI:EU:T:2025:1040, para. 45.

19 Case T-412/22, para. 78; Case T-94/23, para.78; Case T-565/23, para. 55.

20 Case T-412/22, para. 69; Case T-94/23, para. 65.

21 Case T-412/22, para. 79; Case T-94/23, para. 79.

22 Case T-412/22, para. 79; Case T-94/23, para. 79.

23 Case T-412/22, para. 82; Case T-94/23, para. 82.

24 Case T-412/22, para. 80; Case T-94/23, para. 80.

25 Case T-412/22, para. 80; Case T-94/23, para. 80.

26 Case T-94/23, para. 112; Case T-565/23, para. 58.

27 Case T-94/23, para. 112; Case T-565/23, para. 58.

28 Case T-565/23, para. 58.

29 Case T-94/23, para. 111; Case T-565/23, para. 57.

30 Case T-94/23, para. 116; Case T-565/23, para. 66.

31 Sublethal effects refer to the impact of a toxic substance that does not result in immediate death but affects an organism’s or a species’ functions, health or long-term resilience over time, including, for instance, life span, population growth, fertility, etc.

32 See EFSA, “Neonicotinoids: risks to bees confirmed” (press release, 28 February 2018), <https://www.efsa.europa.eu/en/press/news/180228> (last accessed 15 June 2026).

33 See International Agency for Research on Cancer, “IARC Monograph on Glyphosate” (featured news, 20 March 2015) <https://www.iarc.who.int/featured-news/media-centre-iarc-news-glyphosate/> (last accessed 15 June 2026).

34 Case T-412/22, para. 60; Case T-94/23, para. 56.

35 Case C-308/22 PAN Europe (Closer) [2024] ECLI:EU:C:2024:350, para. 90. See also T-429/13 and T-451/13, Bayer CropScience AG [2019] EU:T:2018:280, in particular para. 142, where the General Court held that the precautionary principle requires the withdrawal or amendment of an approval of an active substance where new data invalidate the earlier conclusion that that substance satisfies the approval criteria.

36 European Commission, Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EC) No 999/2001, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 852/2004, (EC) No 853/2004, (EC) No 396/2005, (EC) No 1099/2009, (EC) No 1107/2009, (EU) No 528/2012, (EU) 2017/625 as regards the simplification and strengthening of food and feed safety requirements, COM(2025) 1030 final, 2025/0410 (COD), 16 December 2025.

37 See press releases by Pesticide Action Network Europe: “EU Commission retreats from worst plan, but still opens the door to unlimited pesticide approvals and weaker protection” (16 December 2025) <https://www.pan-europe.info/press-releases/2025/12/eu-commission-retreats-worst-plan-still-opens-door-unlimited-pesticide> (last accessed 15 June 2026); “Pesticide Action Network raises alarm over 49 pesticides facing unlimited approval in EU ‘omnibus’ proposal” (5 Feb. 2026) <https://www.pan-europe.info/press-releases/2026/02/pesticide-action-network-raises-alarm-over-49-pesticides-facing-unlimited> (last accessed 15 June 2026).

38 Case T-412/22, para. 47; Case T-94/23, para. 42, citing Case C-616/17 Blaise and Others [2019] ECLI:EU:C:2019:800, para. 42.

39 PPP Regulation, Art. 4, 7, 8 and 29.

40 PPP Regulation, Art. 15 and Commission Implementing Regulation (EU) 2020/1740 of 20 November 2020 setting out the provisions necessary for the implementation of the renewal procedure for active substances, Art. 6.

41 Case T-412/22, para. 48; Case T-94/23, para. 43, citing Case C-616/17 Blaise and Others [2019] ECLI:EU:C:2019:800, para. 43.

42 Case T-412/22, para. 49; Case T-94/23, para. 44, and the caselaw cited.

43 PPP Regulation, Art. 1(4).

44 Case T-412/22, para. 68; Case T-94/23, para. 64.

45 Pollinis’ request for internal review ref. Ares(2022)4873898, pp. 14–16, and Annex to the request for internal review, “Environmental contamination and adverse effects of boscalid”.

46 Case T-94/23, para. 47.

47 Case T-412/22, para. 95.

48 Case T-412/22, para. 95. In PAN Europe, the Court specifies that the Commission should have taken into account the fact that dimoxystrobin was classified, by the Commission itself, as a persistent and toxic substance and a candidate for substitution – subject, as such, to shorter approval and renewal periods.

49 Annex to the Commission’s Reply to Internal review request ref. IR/2023/509914 by Pollinis concerning Commission Implementing Regulation (EU) 2023/918 of 4 May 2023, para. 20.

50 Commission Implementing Regulation (EU) 2023/918 of 4 May 2023 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances aclonifen, ametoctradin, beflubutamid, benthiavalicarb, boscalid, captan, clethodim, cycloxydim, cyflumetofen, dazomet, diclofop, dimethomorph, ethephon, fenazaquin, fluopicolide, fluoxastrobin, flurochloridone, folpet, formetanate, Helicoverpa armigera nucleopolyhedrovirus, hymexazol, indolylbutyric acid, mandipropamid, metalaxyl, metaldehyde, metam, metazachlor, metribuzin, milbemectin, paclobutrazol, penoxsulam, phenmedipham, pirimiphos-methyl, propamocarb, proquinazid, prothioconazole, S-metolachlor, Spodoptera littoralis nucleopolyhedrovirus, Trichoderma asperellum strain T34 and Trichoderma atroviride strain I-1237 [2023] OJ L 119.

51 Annex to the Commission’s Reply to Internal review request ref. IR/2023/509914 by Pollinis concerning Commission Implementing Regulation (EU) 2023/918 of 4 May 2023, para. 107.

52 Footnote Ibid.

53 Case T-75/24 Pollinis France v Commission.

54 Commission Implementing Regulation (EU) 2026/372 of 20 February 2026 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-decanol, 1-naphthylacetamide, 1-naphthylacetic acid, 6-benzyladenine, aluminium sulfate, boscalid, dodine, esfenvalerate, eugenol, fenpyroximate, fluazifop-P, fluazinam, fluometuron, fluopyram, flutolanil, geraniol, malathion, penoxsulam, pinoxaden, prohexadione, proquinazid, prosulfuron, pyrethrins, pyridaben, pyrimethanil, sintofen, spiroxamine, sulphur and thymol [2026] OJ L, 2026/372, Recitals (42).

55 Several of these substances were first approved in the early 2000s and have benefited from repeated extensions of up to 13 years, such as, for example, deltamethrin, which was first approved in November 2003 and has been extended, so far, until August 2026, or fosthiazate, which was approved in January 2004 and has been extended until January 2027 (along with many other substances), by Implementing Regulation (EU) 2023/1757 of 11 September 2023 [2023] OJ L 224/28.

56 As of 1 April 2026. These are: ethoprophos, dimethoate, methiocarb, fenamiphos, linuron, chlorothalonil, isoproturon, chlorpyrifos, chlorpyrifos-methyl, picoxystrobin, Triflusulfuron-methyl, iprodione, benfluralin, propineb, thiram, desmedipham, quinoxyfen, phosmet, chlorpropham, amitrole, mancozeb, propiconazole, Thiophanate-methyl, clofentézine, fenamidone, triasulfuron, flurtamone, thiacloprid, oxasulfuron, benthiavalicarb, bromoxynil, benalaxyl, famoxadone, indoxacarb, Tritosulfuron, Flupyrsulfuron-methyl, Beta-cyfluthrin, Dimetomorph, oxamyl, dimoxystrobin, diquat, pymetrozine, metribuzin, metiram, S-metolachlor, mepanipyrim, flufenacet.

57 Including dimoxystrobin, for which the Commission issued a decision of non-renewal in July 2023: Commission Implementing Regulation (EU) 2023/1436 of 10 July 2023 [2023] OJ L 176.

58 Commission Implementing Regulation 2025/910 of 20 May 2025 [2025] OJ L, 2025/910.

59 PPP Regulation, Art. 10(1).

60 Pursuant to Art. 10 (2) and (3) of the PPP Regulation, the Commission must reply “as soon as possible” and, in principle, within 16 weeks, although that period can be extended to up to 22 weeks based on a reasoned decision. The Commission took 22 weeks to reply to the requests for internal review filed by Pollinis and Aurelia Stiftung against, respectively, the 5th and 6th extensions of boscalid and the extension of glyphosate, but also to most if not all requests filed by NGOs against Article 17 extensions, some of which are currently pending before the General Court (see e.g. Cases T-50/24, T-201/24, T-467/24).

61 Pursuant to Article 340 of the Treaty on the Functioning of the European Union.

62 For instance, by challenging the national authorities’ failure to withdraw the marketing authorisations of plant protection products containing the active substances in question.

Ibid
Ibid
Ibid
Ibid
Ibid
Ibid