1

By its action under Article 263 TFEU, the applicant, Pollinis France, seeks annulment of Commission Decision Ares(2022) 8437051 of 6 December 2022 to reject its request for internal review as regards 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 distilation 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 (OJ 2022 L 133, p. 1), in so far as that regulation extends the approval period of boscalid (‘the contested decision’).

2

The applicant is a not-for-profit association established in Paris (France) whose purpose, inter alia, is to promote environmental protection in the context of environmental law.

3

Boscalid is an active substance used in plant protection products of the succinate dehydrogenase inhibitors family.

4

Boscalid was first approved in the European Union by Commission Directive 2008/44/EC of 4 April 2008 amending Council Directive 91/414/EEC to include benthiavaliarb, boscalid, carvone, fluoxastrobin, Paecilomyces lilacinus and prothioconazole as active substances (OJ 2008 L 94, p. 13). In accordance with the annex to that directive, the approval entered into force on 1 August 2008 and was to expire on 31 July 2018.

5

In June 2015, an application for renewal of the approval of boscalid was submitted.

6

On 27 June 2018, the approval period for boscalid was extended, until 31 July 2019, by Commission Implementing Regulation (EU) 2018/917 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances alpha-cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, carvone, chlorpropham, cyazofamid, desmedipham, dimethoate, dimethomorph, diquat, ethephon, ethoprophos, etoxazole, famoxadone, fenamidone, fenamiphos, flumioxazine, fluoxastrobin, folpet, foramsulfuron, formetanate, Gliocladium catenulatum strain: J1446, isoxaflutole, metalaxyl-m, methiocarb, methoxyfenozide, metribuzin, milbemectin, oxasulfuron, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole, pymetrozine and s-metolachlor (OJ 2018 L 163, p. 13), pursuant to Article 17 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ 2009 L 309, p. 1). Recital 8 of that implementing regulation explains 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.’

7

In November 2018, the rapporteur Member State (Slovakia) and the co-rapporteur Member State (France) published a draft renewal assessment report for boscalid.

8

From 25 January to 27 March 2019, a public consultation on boscalid was organised by the European Food Safety Authority (EFSA).

9

On 7 May 2019, the approval for boscalid was extended for a second time, until 31 July 2020, by Commission Implementing Regulation (EU) 2019/707 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances alpha-cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, cyazofamid, desmedipham, dimethoate, dimethomorph, diuron, ethephon, etoxazole, famoxadone, fenamiphos, flumioxazine, fluoxastrobin, folpet, foramsulfuron, formetanate, metalaxyl-m, methiocarb, metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos‐methyl, propamocarb, prothioconazole, s-metolachlor and tebuconazole (OJ 2019 L 120, p. 16). Recital 7 of that regulation reproduces the same explanation as that set out in recital 8 of Implementing Regulation 2018/917.

10

In August 2019, EFSA requested additional information from the applicant for renewal concerning 122 points.

11

On 16 September 2019, the applicant for renewal replied to EFSA.

12

On 24 June 2020 boscalid’s approval was extended for a third time, until 31 July 2021, by Commission Implementing Regulation (EU) 2020/869 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, cyazofamid, dimethomorph, ethephon, etoxazole, famoxadone, fenamiphos, flumioxazine, fluoxastrobin, folpet, formetanate, metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole and S-metolachlor (OJ 2020 L 201, p. 7). Recital 4 of that regulation explains that ‘due to the fact that the assessment of all those 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.’ Recital 5 further states that ‘an extension of the approval period is required for [boscalid] to allow the time necessary to carry out an assessment relating to endocrine disrupting properties in accordance with the procedure set out in Articles 13 and 14 of Implementing Regulation (EU) No 844/2012’.

13

On 6 May 2021, approval for boscalid was extended for a fourth time, until 31 July 2022, by Commission Implementing Regulation (EU) 2021/745 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances aluminium ammonium sulphate, aluminium silicate, beflubutamid, benthiavalicarb, bifenazate, boscalid, calcium carbonate, captan, carbon dioxide, cymoxanil, dimethomorph, ethephon, extract from tea tree, famoxadone, fat distilation residues, fatty acids C7 to C20, flumioxazine, fluoxastrobin, flurochloridone, folpet, formetanate, gibberellic acid, gibberellins, heptamaloxyloglucan, hydrolysed proteins, iron sulphate, metazachlor, metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, plant oils/rape seed oil, potassium hydrogen carbonate, propamocarb, prothioconazole, quartz sand, fish oil, repellents by smell of animal or plant origin/sheep fat, S-metolachlor, Straight Chain Lepidopteran Pheromones, tebuconazole and urea (OJ 2021 L 160, p. 89). Recital 5 of that regulation reproduces the explanation in recital 4 of Implementing Regulation 2020/869.

14

On 5 May 2022, the approval of boscalid was extended for a fifth time, by Implementing Regulation 2022/708, until 31 July 2023. Recital 5 of that regulation explains that ‘due to the fact that the assessment of those active 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 to provide the time necessary to complete the assessment.’

15

The applicant submitted a request for internal review of Implementing Regulation 2022/708 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), which was registered on 4 July 2022.

16

By the contested decision, the European Commission rejected the applicant’s request for internal review.

17

After the present action was brought, the Commission extended the approval of boscalid for a sixth time, until 15 April 2026, by 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 (OJ 2023 L 119, p. 160). Recital 15 of that regulation explains that ‘for [boscalid], [EFSA] will need additional time, in accordance with Article 13 of Implementing Regulation (EU) No 844/2012, to adopt a conclusion and where appropriate to organise a consultation of experts’ and that ‘furthermore, additional time is needed for the ensuing risk management decision in accordance with Article 14 of Implementing Regulation (EU) No 844/2012.’ Recital 20 further states that ‘given that it is likely that no decision on the renewal of the approval of these active substances can be taken before the expiry of their respective approval periods and that the reasons for the delays in the renewal procedures are beyond the control of the respective applicants, the approval periods of the active substances should be extended in order to enable the completion of the assessments required and finalise the regulatory decision-making procedures on the respective applications for renewal of approval.’

18

On 16 June 2023, the applicant submitted a request for internal review of Implementing Regulation 2023/918 on the basis of Article 10 of Regulation No 1367/2006.

19

By decision of 1 December 2023, the Commission rejected the applicant’s request for internal review.

20

On 9 February 2024, the applicant brought an action against the decision referred to in paragraph 19 above, which was registered as Case T‑75/24.

21

The applicant claims that the Court should:

22

The Commission, supported by the European Parliament, the Council of the European Union, BASF SE and CropLife Europe, contends that the Court should:

23

The applicant relies on four pleas in law in support of its action, alleging, in essence, first, misinterpretation of Article 17 of Regulation No 1107/2009; second, in the alternative, raising a plea of illegality in respect of that article; third, error by the Commission in considering that the conditions laid down in Article 17 of Regulation No 1107/2009 were satisfied; and, fourth, an error of law by the Commission in finding in the contested decision that the statement of reasons for Implementing Regulation 2022/708 was sufficient and also insufficient reasoning in the contested decision.

24

BASF asks the Court to examine whether the applicant retains an interest in continuing the proceedings following the adoption of Implementing Regulation 2023/918, which extended the approval period for boscalid until 15 April 2026.

25

The 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).

26

In the present case, as BASF submits, a new implementing regulation has been adopted by the Commission in order to extend the approval period for boscalid after the end of the extension period set by Implementing Regulation 2022/708.

27

However, 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).

28

Second, 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).

29

That 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 concerning an extension of the approval period of boscalid or another substance. Indeed, it is apparent from the file in the present case that the Commission adopted Implementing Regulation 2023/918, by which it extends the approval period for boscalid and several other substances, on the basis of the criteria laid down in Article 17 of Regulation No 1107/2009 and that it subsequently rejected the applicant’s request for internal review concerning that extension.

30

It follows that, notwithstanding the adoption of Implementing Regulation 2023/918, the applicant retains a legal interest in bringing proceedings in the present case.

31

By the first and third pleas, which should be examined together since they are complementary, the applicant claims that the Commission misinterpreted Article 17 of Regulation No 1107/2009, in particular by considering that the conditions for application of that article were satisfied.

32

BASF submits that the applicant’s first plea, alleging misinterpretation of Article 17 of Regulation No 1107/2009, is inadmissible. The applicant 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 boscalid by Implementing Regulation 2022/708, which was the subject matter of the request for internal review. However, where an applicant brings an action for annulment of the reply to a request for internal review under Article 12(1) of Regulation No 1367/2006, it may challenge only the lawfulness of that reply.

33

The Court observes 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 …’.

34

A 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).

35

In the present case, first of all, the application clearly states that the subject matter of the action for annulment is the contested decision.

36

Next, the title of the first plea and its various limbs make it clear that, as the applicant claims, it is the contested decision that is based on a misreading of Article 17 of Regulation No 1107/2009.

37

Lastly, it is apparent from reading the first plea as a whole that the applicant, by its arguments, is referring to the Commission’s interpretation of Article 17 of Regulation No 1107/2009 made 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.

38

Consequently, BASF’s argument that the first plea is inadmissible because it does not relate to the contested decision must be rejected.

39

By the third limb of the first plea, in the first place, the applicant submits that the Commission erred in law in finding that it could renew the extension of the approval period of an active substance such as boscalid without any limitation in time. Extensions are transitional measures which, by their nature, must remain limited in time and be of an exceptional nature. In any event, an extension of five years as in the present case cannot be regarded as lawful. In the second place, the applicant submits that the risks to human health and the environment should be taken into account when adopting a renewal decision.

40

By the second limb of the third plea, the applicant claims that the length of the overall period of the extension of approval for boscalid does not comply with the requirements of Article 17 of Regulation No 1107/2009. The Commission erred in law in considering that the third paragraph of that article applies only to situations covered by the second paragraph thereof. In addition, the period of the extension of the approval of boscalid is not appropriate and the total length of the extension is excessive.

41

As 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).

42

There 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).

43

The 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).

44

The 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.

45

Recital 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).

46

It 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).

47

In order to respond to the applicant’s arguments, it is therefore necessary to interpret Article 17 of Regulation No 1107/2009 in the light of the precautionary principle, having regard to the duration and frequency of the extension of the approval of boscalid.

48

In that regard, 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).

49

In 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’.

50

Accordingly, 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.

51

The 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.

52

Furthermore, 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).

53

In 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.

54

That rule forms part of the section of Regulation No 1107/2009 which concerns the approval of active substances. Those approvals, as well as their renewal, are the subject of several provisions governing the conduct of the applicable procedure.

55

First, 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 boscalid 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).

56

It 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.

57

Second, 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 to complete that procedure and adopt a decision on the renewal of the approval applied for, while ensuring the effectiveness of the cyclical approach referred to in paragraph 56 above.

58

To 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.

59

Accordingly, 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.

60

In 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 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.

61

Similarly, 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).

62

Only 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.

63

It 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).

64

Compliance 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).

65

Accordingly, 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.

66

On 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.

67

In 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.

68

Furthermore, 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.

69

In that regard, the Commission’s argument that the third paragraph of Article 17 of Regulation No 1107/2009 applies only to the cases referred to in the second paragraph thereof must be rejected.

70

First, there is no basis for that interpretation in the wording of Article 17 of Regulation No 1107/2009. The first two paragraphs of that article use the same expression of ‘period sufficient’ for an extension and there is no reason to differentiate between the two. Moreover, the second paragraph of that article is transitional in nature since it applies to substances whose inclusion in Annex I to Directive 91/414 expired before 14 June 2014. That is not the case with the third paragraph, which also refers to other provisions of Regulation No 1107/2009, namely those of Article 18, which are not transitional in nature. The scope of the third paragraph of Article 17 of Regulation No 1107/2009 is therefore not limited to the second paragraph of that article.

71

Second, in 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, 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.

72

It follows that the third paragraph of Article 17 of Regulation No 1107/2009 is applicable in order to determine the ‘period sufficient’ for an extension.

73

Third, as observed in paragraphs 41 to 46 above, the precautionary principle underpins all the provisions of Regulation No 1107/2009.

74

In that context, the words ‘period sufficient’ employed in the first paragraph of Article 17 of Regulation No 1107/2009 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.

75

In the third place, account must be taken of the objectives pursued by Regulation No 1107/2009.

76

According 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.

77

In 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 this 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).

78

It 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.

79

The 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.

80

Fourth, 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 requirement of expeditious proceedings referred to in paragraph 64 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.

81

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.

82

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.

83

In the present case, the Commission finds in the contested decision, first, that the third paragraph of Article 17 of Regulation No 1107/2009 applies only to situations which fall within the scope of the second paragraph of that article and therefore does not apply to the extension of the approval period for boscalid. Second, the Commission justifies the extension at issue by the fact that it was awaiting the EFSA report. It argues that an extension of a more limited period, which could be extended again if necessary, is preferable to a one-off, longer extension period. Third, the argument based on the fact that the approval period for boscalid had already been extended several times is irrelevant. According to the Commission, there is no limitation as regards the frequency of the application of Article 17 of that regulation. The Commission also states that the conditions laid down in that article were met in the present case and that the renewal mechanism was established by the legislature in the interests of legal certainty.

84

Furthermore, the Commission denies in the contested decision that it had granted indefinite extensions. It concedes that there are problems in adhering to deadlines at Member State level, but argues that those systemic problems cannot render an extension decision unlawful.

85

Moreover, as regards the precautionary principle, the Commission explains in the contested decision that the application of Article 17 of Regulation No 1107/2009 requires neither a substantive analysis nor choice since a substantive decision is adopted at the end of the renewal procedure. Its discretion is limited to selecting the length of the approval extension period and it is only that choice to which the precautionary principle is applied. In the Commission’s view, the application of that principle entails that the extension should be as short as possible in order to obtain the necessary scientific conclusions, in accordance with Regulation No 1107/2009, and that it is not necessary to wait until the end of the extension period to adopt a decision on renewal or non-renewal.

86

Accordingly, first, the Commission, in the contested decision, explicitly rejected the applicability of the factors set out in the third paragraph of Article 17 of Regulation No 1107/2009 (see paragraphs 69 and 83 above). Second, it considers that the criteria laid down in that article were met, without, however, assessing the various aspects of the individual case in order to satisfy itself that it is applying an extension of sufficient length to examine the application for renewal of the approval of boscalid.

87

In that regard, it is apparent that Implementing Regulation 2022/708 applies the same extension period, namely one year, to 50 different substances. While it is true, as the Commission submits in its written pleadings, that it is not required to adopt 50 separate implementing regulations, each with regard to a different substance, it is difficult to reconcile the setting of an identical extension period for 50 substances, unaccompanied by any explanation as to the choice of that period, with the requirement for a case-by-case analysis. The Commission’s arguments, that it was not obliged to carry out a substantive analysis and could not allow the approval of those substances to expire owing to requests for additional information, have no bearing on its obligation to carry out an in concreto analysis of what constitutes a ‘sufficient’ period when extending the approval period of each substance, including boscalid.

88

Third, the Commission’s approach described in the contested decision, according to which it opted for extensions for a limited period, which could be extended again if necessary, rather than for a one-off, longer period, is in breach of Article 17 of Regulation No 1107/2009, which requires, as explained in paragraph 79 above, that the extension period be calculated in concreto and in relation to the stages of the procedure which are still to be completed, and that that period neither fall short of nor go beyond that which is necessary to complete the renewal procedure.

89

Fourth, the Commission errs in law when it asserts in the contested decision that the successive extensions of the approval of boscalid should not be taken into account and that there is no limitation as regards the frequency of the application of Article 17 of Regulation No 1107/2009. Such an approach is contrary to the principle set out in paragraph 80 above.

90

The Commission’s arguments, maintaining that extension periods cannot be added up and that the concept of an accumulated duration, during which the approval of a substance is extended on the basis of Article 17 of Regulation No 1107/2009, does not appear in that regulation, are not such as to call that conclusion into question.

91

It is true that Implementing Regulation 2022/708 provides for a one-year extension of the approval period of boscalid and that it is only that regulation which is the subject matter of the request for internal review. It is also common ground that it was only that regulation whose lawfulness the Commission could review.

92

However, in view of the temporary nature of the extension of the approval period of active substances and of the fact that it is a measure which is applied during a renewal procedure of which it may possibly be a stage, it is not possible to view that extension in isolation from the whole of the procedure of which it is part.

93

In the present case, Implementing Regulation 2022/708 provides for a fifth extension of the approval period of boscalid, thus taking the period for examining the application for renewal of the approval of that substance to eight years and extending the approval by five years.

94

If that context were to be ignored, a review of the lawfulness of the successive extensions would on each occasion produce a result similar to that of an initial extension. However, such an outcome would be contrary to the principles set out in paragraphs 79 and 80 above.

95

Analysing each extension period in isolation would also contribute to worsening what the Commission describes in the contested decision as ‘systemic’ problems relating to adhering to the deadlines set in the renewal procedure.

96

The arguments made by the Commission must therefore be rejected.

97

Accordingly, the third limb of the first plea and the second limb of the third plea must be upheld, it not being necessary to examine the other limbs of the first plea.

98

By the first limb of the third plea, the applicant submits that the Commission erred in law when it considered that the delay in the renewal procedure was due to reasons beyond the control of the applicant for renewal.

99

At the outset, it should be observed that there are differences in the various language versions of the first paragraph of Article 17 of Regulation No 1107/2009. Although some versions, including that in French, employ the expression ‘reasons independent of the intent of the applicant’ (in French: ‘raisons indépendantes de la volonté du demandeur’), the concept of ‘intent’ (in French: ‘volonté’) is not found in other language versions. A number of other language versions, including English, use the concept of ‘control’. Others, such as German, use the concept of ‘liability’ or even that of influence. Other versions merely refer to reasons ‘independent of the applicant for renewal’.

100

According to the Court’s settled case-law, the wording used in one language version of a provision of EU law cannot serve as the sole basis for the interpretation of that provision or be made to override the other language versions. Provisions of EU law must be interpreted and applied uniformly in the light of the versions existing in all languages of the European Union. 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 (see judgment of 12 September 2019, A and Others, C‑347/17, EU:C:2019:720, paragraph 38 and the case-law cited).

101

Accordingly, the first paragraph of Article 17 of Regulation No 1107/2009 and, more specifically, the expression ‘reasons beyond the control of the applicant’ must be interpreted in the light of both the purpose of that provision and the context of which it is part.

102

As regards the context of that rule, first, reference should be made to the considerations set out in paragraph 54 et seq. above. Second, it is necessary to examine the role of the applicant for renewal in the framework of Article 17 of Regulation No 1107/2009.

103

Both the approval procedure and the renewal procedure are launched on the initiative of the producer of the active substance, which is then, potentially, an applicant for renewal, as is apparent from Article 7 of Regulation No 1107/2009 and Article 1 of Implementing Regulation No 844/2012 respectively. The producer of the active substance, which is then, potentially, an applicant for renewal, is a central actor throughout the approval and renewal procedures and is a main interlocutor for the bodies involved in those procedures.

104

As regards, more specifically, the renewal procedure, the applicant for renewal is responsible for the contents of the application (Article 3 of Implementing Regulation No 844/2012), for the submission of supplementary dossiers (Articles 6 and 7 of Implementing Regulation No 844/2012) and for providing additional information to the rapporteur Member State or EFSA (Article 11(5) and Article 13(3) of Implementing Regulation No 844/2012), and it may submit comments to EFSA on the rapporteur Member State’s draft assessment report or the renewal report (Article 12(3) and Article 14(1) of Implementing Regulation No 844/2012. All those interactions with the applicant for renewal are subject to specific deadlines.

105

It follows that the applicant for renewal is an actor that participates in all the stages of the procedure by providing data or submitting comments, which enables it to influence the conduct of the procedure. That is why the legislature decided to make the extension of the approval period subject to the condition that any delay be ‘beyond the control of the applicant’ for renewal.

106

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’.

107

Accordingly, 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.

108

In that regard, 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.

109

As regards the objectives covered by the first paragraph of Article 17 of Regulation No 1107/2009, reference should be made to paragraphs 75 to 78 above and specifically to the fact that the Commission must attach particular importance to the objective 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 an active substance.

110

When assessing the role of the applicant for renewal in delays occurring in a renewal procedure, the Commission must satisfy itself not only that that applicant acted within the time limits, but also that the delay in the conduct of the renewal procedure is unconnected with its actions, that is to say, that it did not act in such a way as to cause or contribute to delays.

111

It follows that 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. Such a restrictive approach that is favourable to the applicant for renewal would also conflict with the case-law, which requires that the high level of protection for human health and the environment take precedence over economic considerations (see, to that effect, judgment of 17 March 2021, FMC v Commission, T‑719/17, EU:T:2021:143, paragraph 59 and the case-law cited), and with the context of which the rule set out in the first paragraph of Article 17 of Regulation No 1107/2009 is part, and which is composed of a regulatory framework which defines in detail the way in which the applicant for renewal participates in the procedure.

112

In order to respect the balance established by the legislature, the first paragraph of Article 17 of Regulation No 1107/2009 should be interpreted as requiring 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. 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.

113

In the present case, the Commission considers in the contested decision that the delay is beyond the control of the applicant for renewal where that delay may be attributed to other actors in the renewal procedure, for example the rapporteur Member State, EFSA or itself, or to force majeure. The Commission explains that it must merely establish that the delay is not due to the applicant for renewal, without having to consider why the delay occurred, who could be considered ‘at fault’ or to supervise the other actors involved in the renewal procedure. First, the Commission explains that the delay at issue in the present case was due to the late submission of the revised draft report by the rapporteur Member State, which clearly fulfilled the requirement of Article 17 of Regulation No 1107/2009 that the delay must not be attributable to the applicant for renewal. Second, the Commission states that the applicant’s claims, that the data gaps identified in the draft renewal report and the fact that EFSA had requested additional information might have contributed to the delay, must be rejected as speculative. Third, and in any case, those claims are based on a confounding of the completeness of the supplementary dossiers and the conclusions which may be drawn from the evaluation of the dossiers submitted. The applicant for renewal must submit supplementary dossiers that comply with the data requirements of the applicable regulatory framework in order to support its application for renewal. Consequently, according to the Commission, an applicant for renewal cannot be responsible, for the purposes of Article 17 of Regulation No 1107/2009, for data gaps or for requests for additional information that result from them by virtue of Implementing Regulation No 844/2012.

114

In that regard, it is apparent from the contested decision that the Commission did not consider it necessary to scrutinise concretely, even in brief, the role of the applicant for renewal in relation to the fact that there were delays in the renewal procedure.

115

In its written pleadings, the Commission also argues that a delay caused, at least in part, by an actor other than the applicant for renewal, in this case the rapporteur Member State, cannot be understood as falling within the responsibility or control of the applicant. The Commission considers that it is not required to take account of the weight of the contribution of the applicant for renewal to a delay.

116

However, by failing to carry out an in concreto analysis of the role of the applicant for renewal and 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 and failed to respect the balance established by the legislature (see paragraphs 111 and 112 above).

117

It follows that the first limb of the third plea must also be upheld.

118

Accordingly, the contested decision must be annulled in so far as it concerns boscalid, without it being necessary to examine the second and fourth pleas.

119

Under Article 134(1) of the Rules of Procedure of the General Court, 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.

120

Pursuant to Article 138(1) and (3) of the Rules of Procedure, the Parliament, the Council, BASF and CropLife Europe are to bear their own costs.

On those grounds,

THE GENERAL COURT (Fourth Chamber, Extended Composition)

hereby: